RESTRICTED  WORLD TRADE  
ORGANIZATION  IP/C/M/64 
17 February 2011  
 
(11-0833) 
Council for Trade-Related Aspects of 
Intellectual Property Rights  
 
 
 
MINUTES OF MEETING 
 
Held in the Centre William Rappard on 26-27 October 2010  
 
Chairperson:  Mr. Martin Glass (Hong Kong, China) 
 
  The present document contains the record of the discussion which took place during the 
Council for TRIPS meeting held on 26-27 October 2010. 
 
Subjects discussed
 Page nos.  
A. NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT .........................................................3  
B. REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION ..............................................................4  
C. REVIEW OF THE PROVISIONS OF ARTICLE 27.3( B)......................................................................5  
D. RELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE CONVENTION ON 
BIOLOGICAL DIVERSITY .............................................................................................................5  
E. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE ...................................................5  
F. REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF 
PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS  AGREEMENT AND PUBLIC 
HEALTH ............................................................................................................................... ......20  
1. Experience of Members who have used or considered using the system .................................21  
2. Implementation of the System into domestic  legislative and regulatory framework................34  
3. Process of ac ceptance .......................................................................................................... .....42  
4. Capacity building on the Paragraph 6 Sy stem and related TRIPS flexibilities.........................45  
5. Any alternatives to the use of the Paragr aph 6 System to achieve the objective of 
access to medicines, procurement policies, and other related aspects affecting access 
to medicines ................................................................................................................... ...........54  
6. Next steps and recommendations..............................................................................................68  
G. NON-VIOLATION AND SITUATION COMPLAINTS ......................................................................71  
H. REVIEW OF THE IMPLEMENTATION OF THE AGREEMENT UNDER ARTICLE 71.1 ......................72  
I. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON 
GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2 ...............................................................73  
J. EIGHTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON THE 
IMPLEMENTATION OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT ............................................73  
K. TECHNICAL COOPERATION AND CAPACITY BUILDING .............................................................76  
L. LETTER FROM THE CHAIR OF THE GENERAL COUNCIL CONCERNING WAYS TO 
IMPROVE THE TIMELINESS AND COMPLETENESS OF NOTIFICATIONS AND OTHER 
INFORMATION FLOWS ...............................................................................................................87  
M. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO ..............................88  IP/C/M/64 
Page 2  
 
  N. O
BSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS ...............88  
O. ANNUAL REPORT ......................................................................................................................91  
P. OTHER BUSINESS ......................................................................................................................92  
  IP/C/M/64 
 Page 3 
 
 
  A. NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  
1. The Chairman  said that, since the Council's meeting in  June 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: 
• Albania had notified its Law on Industrial Prope rty, and regulations on trademarks, utility 
models, geographical indications  and industrial designs, as well a decision on tariffs for the 
services of the Directorate General of Patents and Trademarks; 
 
• Peru had notified various laws and decrees relating, inter alia , to copyright, plant varieties, 
border measures, implementation of the Trade Promotion Agreement between Peru and the 
United States and the operation of the National Institute for the Defence of Competition and 
Protection of Intellectual Property (INDECOPI), as well as decisions by the Andean 
Community clarifying and amending its common industrial property regime; 
• Sri Lanka had notified its Intellectual Property Act; 
• Hong Kong, China had notified amendmen ts to its Copyright Ordinance; 
• Colombia had notified a decree on border enfo rcement as well as a decision by the Andean 
Community amending its common industrial property regime; 
• Cape Verde had notified a decree relating to the establishment of an Intellectual Property 
Institute of Cape Verde; 
• Oman had notified two decrees promulgating th e Law of Copyrights and Neighboring Rights 
and the Law on Industrial Property Rights, respectively; 
• Bulgaria had notified laws on copyright and rela ted rights;  on patents and utility models;  on 
trademarks and geographical indications;  and on industrial designs; 
• Madagascar had notified an ordinance on the protection of industrial property and related 
regulations;  and a law on lite rary and artistic property; 
• Czech Republic had notified various laws concer ning industrial property;  pharmaceuticals;  
topographies of semiconductor products;  geographi cal indications;  consumer protection;  
industrial designs;  biotechnological inventions;  intention and rationalization proposals;  and 
utility models; 
• Lithuania had notified a law on trademarks; 
• Slovak Republic had notified laws relating to designs;  trademarks;  utility models;  copyright 
and related rights;  provisions of the crim inal code concerning IPR infringements;  
topographies of semiconductor products;  ge ographical indications;  and patents and 
supplementary protection certificates; 
• Korea had notified its copyright, trademark, d esign protection, patent, and layout-design acts, 
and acts on agricultural products quality cont rol and prevention of unfair competition; 
• United States had notified its consolidated pa tent rules;  and its trademark law;  and IP/C/M/64 
Page 4  
 
  • Croatia had notified laws on ge ographical indications;  on the protection of topographies of 
semiconductor products;  industrial designs;  tr ademarks and patents;  as well as related 
regulations;  the amended Pa tent Act inter alia implements the WTO Decision on the 
"Implementation of Paragraph 6 of the Doha Declaration on th e TRIPS Agreement and Public 
Health", providing the legal basis for Croatia to act as an exporting Member. 
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 reminded in particular those Members who had made any changes to their laws and/or 
regulations to implement the Deci sion on TRIPS and Public Health a nd who had not yet notified such 
changes to the Council to do so. 
3. With respect to notifications of contact points under Article 69 for the exchange of 
information and cooperation on trade in infringing go ods, he said that, since the Council's meeting in 
June, Belize and Gabon had notified their contact poi nts.  In addition, updates to contact points 
notified earlier had been received from Belize, Oman, El Salvador, Kuwait, the Kyrgyz Republic, and 
the European Union.  These notifications were  being circulated in addenda to document 
IP/N/3/Rev.11. 
B. R
EVIEWS OF NATIONAL IMPLEMENTING LEGISLATION  
4. 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 four reviews that still remained 
on the Council's agenda.  These reviews concerned Cuba ;  Fiji;  Saint Kitts and Nevis;  and Suriname. 
5. Since the Council's meeting in June 2010, Suri name had provided responses to all of the 
outstanding follow-up questions posed to it in its review.  These responses had been circulated in 
document IP/Q/SUR/1/Add.1.  He suggested that the review of Suriname be deleted from the agenda, 
it being understood that any delegation should feel free to revert to any matter stemming from this 
review at any time. 
6. The representative of Switzerland  thanked Suriname for its r esponses to Switzerland's follow-
up questions.  Having examined them, his delegation in tended to seek clarification with regard to one 
of them directly from Suriname. 
7. The Council agreed  to proceed as proposed by the Chair. 
8. The Chairman  urged the other delegations concerned to  provide the outstanding material as 
soon as possible, so as to allow the Council to complete these reviews. 
9. The Council took note  of the statements made and agreed  to revert to the matter at its next 
meeting.  IP/C/M/64 
 Page 5 
 
 
  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  
10. The Chairman  suggested that the Council continue it s past practice of addressing these three 
agenda items together on the basis of the contributions by Members.  
11. The representative of the Plurinational State of Bolivia  said that, at the TRIPS Council's 
meeting of 27 June 2010, a number of Memb ers had asked questions about the Bolivian 
communication (document IP/C/W/545), which proposed  to examine Article 27.3(b) with a view to 
prohibiting the patentability of all life forms.  Responding to some Members' concerns about the 
scope of the Council's mandate to review Article 27.3( b), he said that the mandate arose out of Article 
27.3(b) itself, which provided that its provisions shall be reviewed four years after the date of entry into force of the WTO Agreement.  To date, the re view had not been conducted.  He noted that the 
mandate did not prejudge the outcome, and that it w as appropriate for the Council to review trends in 
patenting in the light of Article 27.3(b), new de velopments, their economic, social and cultural 
implications and impact, and to take the necessary action to resolve problems.  The possibility of an 
amendment could not be ruled out, if the Council deem ed it appropriate as a result of this process.   
12. He said that, in accordance with paragraph 19 of the Doha Ministerial Declaration, in carrying 
out such a review, the Council should examine, inter alia , the relationship between the TRIPS 
Agreement and CBD, the protection of traditional knowledge and folklore, a nd other relevant new 
developments raised by Members.  These elements we re the subject of preliminary analysis contained 
in document IP/C/W/545 and in other earlier documents  and statements.  At the Council's meeting of 
June 2010, some Members had affirmed that it w as not life forms that were being patented but 
biotechnological inventions which met the requi rements for patentability.  However, in many 
countries, discoveries of elements that already existed in nature were being pate nted.  In particular, in 
considering an element isolated from its natural environment as "novel" and therefore patentable, 
various legal systems authorized the patenting of life forms or components thereof which, in reality, 
had been discovered in nature or the human body, for example genes th at were simply isolated and for 
which a function had been discovered, and not invent ed.  He said that an element found in nature, 
even when it had been isolated or separated from its habitat, could not be cons idered an invention and 
was therefore not patentable.  From a conceptu al standpoint, the relevant criteria for defining 
exclusion were social values, public ethics and morality, development criteria and public policies, 
rather than technical criteria.  He  therefore stressed that, in undertaking this review of Article 27.3(b), 
these criteria, together with the world vision  of indigenous peoples and other peoples and 
communities, should be the most important considera tion.  Nevertheless, this did not at all mean 
sidestepping the technical debate on the quality of pa tents granted in the field of biotechnology, which 
raised serious questions about the fulfilment of patentability criteria.   
13. Responding to the concern about the negative im pact that the Bolivian proposal might have 
on innovation, i.e. there could be no innovation without patents and the major challenges facing 
humankind, including those in the areas of agricult ure and health, could not be resolved without 
innovation, he said that the global crises facing hu mankind and the planet were a source of great 
concern to Bolivia.  A system that consider ed life as a mere commodity and promoted the 
privatization of nature was part of the problem , not the solution to the major challenges facing 
humankind.  The concern being expressed these days by various communities, including the scientific 
community in developing and developed countries, wa s that the patenting of life limited scientific 
research and reduced innovation, because the multi ple and extensive demands made it possible to 
control entire areas of technological research and bl ock continued innovation.  The biodiversity which IP/C/M/64 
Page 6  
 
  was being appropriated by transnational corporati ons as "inventions" had been  developed by nature 
for centuries and preserved and developed by indi genous peoples, peasant farmers and communities 
in many Member states without the incentive of in tellectual property.  This model had worked and 
there were other models which could also work wit hout the monopolistic effects of the patent system.  
If patenting of life was permitted, the major decisi ons of fundamental importance to the future of 
humankind would be taken by a small group of ac tors who had control over life forms, such as 
transnational corporations and certain instituti ons, so that only those innovations and technologies 
would be promoted that strengthened their monopol ies and boosted their profits.  Members could not 
hope to save humanity and the planet with solutions th at had profit as their sole objective.  What was 
required was to protect life from commercializat ion and privatization and to create spaces for 
collective deliberation, exchange a nd cooperation for the common good.   
14. He then referred to a possible case of biopiracy, another possible case of commercialization 
and privatization of life involving a sorghum gene co llected in Bolivia, as a concrete illustration of his 
delegation's concern.  He said that Kansas State University in the United States had submitted an 
international patent application for a gene tolera nt of certain herbicides taken from a variety of 
sorghum collected in Bolivia in 2006, the valuable characteristic of which had been discovered by a 
Bolivian public research centre in 2000, and not by the university in question.  The international 
patent application had been published under the Pa tent Cooperation Treaty on 24 July 2008 and the 
US application had been made public on 6 May 2010.  In the international application, the university 
concerned indicated that it would seek to obtain pa tents worldwide.  A press release of 6 February 
2008 from the university stated that the transnational corporation DuPont had already acquired an 
exclusive licence and was planning to sell varieties of sorghum containing the valuable gene.  This 
would mean that the characteristic discovered in th e variety of sorghum collected in Bolivia was about 
to be made the subject of private appropriation by a university and a transnational corporation, in clear 
contravention of the Bolivian Constitution an d laws which expressly prohibited the private 
appropriation of any living material and parts thereo f.  This apparent new case of biopiracy was of 
great illustrative value for the work of the Council.  He said that given the negligible effect that 
national laws had at the international level in reso lving the problem of biopiracy, the solution lay in 
the international prohibition of the patenting of life forms.  Also clearly  exposed were the poor 
standards of patentability applied in  developed countries which claime d that they were only patenting 
life forms that were "biotechnological inventions".   In many cases, these were in fact patents on 
existing elements discovered in nature.   
15. He said that transnational corporations offere d patented seeds which were tolerant to the 
massive application of the herbicides they were selli ng, or other solutions the sole objective of which 
was to make profits for a few and not to serve  the common good.  The United Nations Special 
Rapporteur on the Right to Food, in his 2009 report  to the General Assembly, warned that "the 
expansion of intellectual property rights can constitute an obstacle to the adoption of policies that 
encourage the maintenance of agrobiodiversity and reliance on farmers' varieties" because 
"intellectual property rights reward and encourag e standardization and homogeneity, when what 
should be rewarded is agrobiodive rsity" and "in addition ... can cons titute a direct impediment to 
innovation by farmers".  The Government of Bo livia was currently analysing the information 
available in the sorghum case with a view to taki ng the necessary measures.  He reiterated Bolivia's 
commitment to the rights of indigenous peoples, as set out in the United Nations Declaration of 
September 2007, its defence of life against priv ate appropriation and its defence of its genetic 
resources and traditional knowledge.  He said that Bo livia's ancestral cultures were closely associated 
with harmony, reciprocity and complementarity with nature and respect for life.  Some elements of 
Article 27.3(b) were offensive and contrary to this cu lture of life, particularly those that promoted the 
commercialization and privatization of life.  Theref ore, the best contribution that the Council could 
make to serve this purpose was to prohibit all kind s of patenting of life forms, which would be an 
outstanding outcome for this Doha Development Round.   In conclusion, he reinforced the importance 
of continuing to deepen the discussion on the non-pa tentability of life forms so that further progress  IP/C/M/64 
 Page 7 
 
 
  could be made towards the necessary amendments to Article 27.3(b) of the TRIPS Agreement which 
had created a series of problems for Members, particularly developing country Members.   
16. The representative of China  said that the problems identified in document IP/C/W/545 were 
worth noting and discussing, especially the prolifer ation of patents on life forms as a monopolistic 
tool by oligopolies in the world food sector.  There was a close connection between disclosure 
requirements and these problems.  An amendment of  the TRIPS Agreement to include the mandatory 
disclosure requirements would surely help to address Bolivia's concerns.  He said that there was an 
extremely broad convergence of views among Member s on the need to prevent misappropriation of 
genetic resources and associated traditional knowledge and to avoid erroneous patents.  Development 
and strengthening of national regime s and legal framework as put forward by several Members might 
help to address biopiracy, but most developing count ries, especially LDCs, were facing the problem 
of insufficient institutional capacitie s and lack of enforcement resources and professionals.  It would 
take a much longer time for developing countries to  achieve the same policy outcome as developed 
countries in terms of national re gimes and databases.  The mandatory disclosure requirement was a 
shortcut to efficiently address the urgent con cerns of developing Members over biopiracy.  He 
encouraged the Director-General to continue hi s consultation on the issues of TRIPS/CBD and GI 
extension and to report on the outcome of the cons ultations reflecting the convergence and obstacles.  
He also encouraged Members to enter into text-based negotiations as supported by 108 WTO 
Members.  He welcomed the new mandate and progress in WIPO's Intergovernmental Committee on 
Intellectual Property and Genetic resources, Trad itional Knowledge and Fo lklore (IGC) and the 
CBD's recent efforts in Nagoya, Japan to push forward the discussion on the TRIPS/CBD issue.  
Nevertheless, he said that the discussions in othe r forums could not replace an amendment to the 
TRIPS Agreement which was associated with the WT O dispute settlement mechanism – the "teeth" of 
the WTO.  
17. The representative of Israel  said that, as a party to the CBD, Israel was closely following the 
negotiations on the international regime on access a nd benefit sharing in Japan as mandated by the 
Conference of the Parties of the CBD (COP).  He  asked whether the access and benefit-sharing model 
proposed under the CBD was the most appropriate r esponse to the misuse of genetic resources - also 
referred to as biopiracy - in order to ensure th at physical access to genetic resources was indeed 
facilitated, and that the benefits obtained from their use were shared equitably.  The current text under 
negotiations seemed too demanding on industries a nd might run the risk of impeding research and 
development which made use of genetic resources for the benefit of all.  It might also run the very 
tangible risk of putting unnecessary regulatory burd ens and costs on national patent offices, which 
might not be in a position to oversee proofs of prior informed consent and mutually agreed terms for 
each and every patent application.  He emphasise d the importance of the ongoing negotiations in the 
CBD and WIPO, and said that although Members wide ly shared the CBD objectives, namely finding 
solutions to misappropriation of genetic res ources and traditional knowledge, the proposal of 
incorporating mandatory disclosure requirements in the TRIPS Agreement in order to harmonize it 
with the principles of the CBD, was too narrow and re strictive.  The CBD principles could be satisfied 
without amending the TRIPS Agreement and by other solutions, for example by establishing 
improved, transparent and searchable databases on traditional knowledge at WIPO.  He said that 
much work remained to be done before Members reached a common understanding on an 
international access and benefit-shar ing regime, and this work should remain in the right forum.  The 
WTO and its binding dispute settlement system was not the right place to expl ore various avenues to 
reach the common goal of promoting benefit sharing.   
18. He said that the artificial linkage between thr ee TRIPS issues, which attempted to broaden the 
process in the TRIPS Special Session and in other WTO negotiating groups with additional areas of 
work not foreseen in the Doha mandate, was problem atic and seemed unrealistic and unjustified.  The 
three issues have their own merits and therefore shoul d not be treated as a pack age.  Further technical 
work was needed on two implementation-related i ssues, and his delegation remained available and IP/C/M/64 
Page 8  
 
  ready to work together with other Members to find solutions.  Members' efforts in the Special Session 
should remain focused on the GI register for wines and spirits.   
19. The representative of India
 recalled that Bolivia had proposed to prohibit the patenting of all 
life forms, including plants and animals and parts th ereof, gene sequences, micro-organisms as well as 
all processes including biological, microbiological and non-biological processes for the production of 
life forms and parts thereof.  He said that the I ndian Patent Act 1970, as amended in 2005, excluded 
plants, animals, seed varieties, species, and esse ntially biological processes for production or 
propagation of plants and animals from being pate nted.  However, the Act allowed patenting of 
micro-organisms under its section 3(h) (j).  The Bo livian proposal of exclusion from patentability of 
micro-organisms and other non-biological and micr obiological processes might hamper development 
in the field of biotechnology and microbiology in India.   
20. He recalled that Bolivia had proposed to ensu re the protection of innovation of indigenous 
and local farming communities and the continuatio n of traditional farming practices, including the 
right to exchange and save seeds, and sell their harvest.  He said that Section 39(1) (iv) of India's Protection of Plant Varieties and Farmers' Rights Act provided "a farmer sh all be deemed to be 
entitled to save, use, sow, re-sow, exchange, shar e or sell his farm's produce including seed of a 
variety protected under this Act in the same manner as  he was entitled before the coming into force of 
this Act, provided that the farmer shall not be en titled to sell branded seed of a variety protected under 
this Act."  He said that as the TRIPS Agreement did not prescribe UPOV to be a benchmark for fulfilling the obligation regarding the protection of pl ant varieties, Article 27.3(b) provided adequate 
flexibility as regards the protection of plant varie ties by each WTO Member.  This flexibility should 
not be circumscribed in any way.   
21. He further recalled that Bolivia had proposed  to prevent anti-competitive practices which 
threatened food sovereignty of people in developing  countries.  He said that Article 40 of the TRIPS 
Agreement already provided for th e control of anti-competitive practices through provisions in 
domestic legislation for controlling or preventing the abuse of intellectual property rights, and 
conditions such as coercive pack age licensing.  In India, the Essential Commodities Act dealt with 
aspects of food security.  He also recalled that Bolivia had proposed to protect the rights of indigenous communities and to prevent private monopolistic in tellectual property claims over their traditional 
knowledge.  He said that India, along with 107 other Members, was demanding the protection of 
genetic resources and associated traditional knowledg e through a mandatory disclosure requirement as 
contained in document TN/C/W/52.  
22. He said that the inadequacy in the TR IPS Agreement to combat biopiracy and 
misappropriation of genetic resources and traditi onal knowledge needed no further elaboration 
following exhaustive technical discussions over the last  ten years.  The solution proposed by India in 
documents IP/C/W/474 and TN/C/W/52 was a ma ndatory disclosure requirement in patent 
applications.  The disclosure requirement, in addition to combating biopiracy, would further 
strengthen the credibility of the patent system by  facilitating assessment of novelty and inventiveness 
criteria, and contribute to ensuring that the patent sy stem did not issue bad patents.  Erroneous patents, 
even if they existed temporarily were harmful fo r third parties.  The procedure for revocation of 
patents was more expensive and burdensome than merely requiring patent applicants to meet the 
disclosure requirement.  The mandatory disclosure re quirement would thus lead to a greater legal 
certainty, transparency and procedural completene ss.  He said that document TN/C/W/52 provided a 
sound basis on substantive and procedural treatment  of the issues of TRIPS/CBD, GI extension and 
GI register.  It contained key parameters that the 108 proponents would like to be reflected in a 
Ministerial modalities decision on the three TRIPS i ssues.  The document was a balanced proposal 
since it was an outcome of constructive engage ment, flexibilities and accommodation of interests of 
over two-thirds of the WTO Membership, including  developed and developing countries, and most 
LDCs.  He appreciated the consultations on the i ssues of TRIPS/CBD and GI extension held by the  IP/C/M/64 
 Page 9 
 
 
  Director-General Pascal Lamy since March 2009  in accordance with the mandate contained in 
paragraph 39 of the Hong Kong Ministerial Declara tion, and said that the consultations so far had 
provided an opportunity for detailed technical disc ussions without getting tr apped in theological 
issues concerning the mandate.  He called upon the Dir ector-General to resume his consultations at an 
early date.   
23. He said that India had pioneered a Traditional Knowledge Digital Library (TKDL), which 
overcame language and format ba rriers with the help of information technology and a unique 
classification called the Traditional Knowledge Res ource Classification.  At present the TKDL 
contained 34 million pages in a patent application fo rmat in five international languages.  India had 
signed the TKDL Access Agreement with the US Pate nt and Trademark Office, the European Patent 
Office (EPO), the German Patent Office, the UK Intellectual Property Office, and the Canadian 
Intellectual Property Office.  Twenty patent appli cations had already been cancelled or withdrawn by 
the EPO based on the evidence from th e TKDL.  India stood ready to share its experience with other 
countries which were concerned a bout misappropriation of their tr aditional knowledge.  During the 
WIPO General Assemblies in September 2009, India had requested the inclusi on of the TKDL in the 
minimum PCT documentation requirement in WIPO .  The formal follow-up process was underway.  
While India was taking initiatives such as the TKDL to improve prior art search, it was only part of 
the solution.  The TKDL represented a subset of th e universe of available traditional knowledge.  The 
realm of traditional knowledge in areas other than he rbal cures and genetic resources was not covered 
by the TKDL.  The flip side of databases in gene ral was that they might attract undesirable attention 
and might become a tool for misappropriation of ge netic resources and trad itional knowledge and then 
aggravate the problem if they were not handled carefully.   
24. In conclusion, he said that the 10th CBD COP was in progress in Nagoya, Japan, and that the 
Inter-Regional Negotiating Group constituted by the CBD Ad Hoc  Open-ended Working Group on 
Access and Benefit-Sharing had met on 13-15 October 2010.  These important meetings were directly 
connected with agenda items in the TRIPS Council, in particular the TRIPS/CBD issue.  He proposed 
that, at the next TRIPS Council's meeting, the CBD Secretariat be invited to make a presentation on 
the developments in the 10th CBD COP relevant to  the issues being discussed in the TRIPS Council.  
25. The representative of Cuba  said that the amendment to th e TRIPS Agreement, which would 
make it possible to multilateralize the requirement that patent applicants identify the source and 
country of origin of the biological materials us ed in inventions, and the requirements concerning 
evidence of prior informed consent and benefit shar ing, and that of mandatory publication.  These 
requirements formed an important basis for minimizing the misappropriation of genetic resources.  
The argument that the disclosure requirement would impose an excessive burden on patent applicants was offset by the scope of these rights which in practice was sometimes used abusively to maximize 
profit-making interests disregarding and marginalizi ng the rights of indigenous and local communities 
over their traditional knowledge and the rights of States over their genetic resources.  These rights 
were just as important as those of patent holders in  the face of acts of piracy and counterfeiting.  The 
TRIPS Agreement failed to address some important aspects such as the human rights involved in this issue.  She said that the lack of political will show in addressing biopiracy created obstacles and 
distortions in recognizing the real or potential value of the genetic res ources, knowledge, innovations 
and practices that formed the basis of important  public policy measures.  While seemingly technical 
justification was being given to prevent the discl osure requirement, the underlying reasons for it was 
the use of delaying tactics, and unequal attentio n given to the interests of the various parties 
concerned.  If the interests of patent holders were the only ones i nvolved here, it was not possible to 
speak of cooperation for development.  Nor was it  possible to consider in good faith other claims 
made by developed countries.  Results were n eeded, not sophistry.  She said that the Bolivian 
statement, which related to the classical doctrine of  the patent system and the quality of patents, was 
important.  The use of patents for strategic purposes had seriously distorted the original objectives of 
patent rights, thus making it difficult to distinguish  between discoveries and inventions.  In any case, IP/C/M/64 
Page 10  
 
  the TRIPS Agreement made it possible to introduce limits and exceptions as flexibilities to address 
this distortion. 
26. The representative of Bolivarian Republic of Venezuela
 supported the statement made by 
Bolivia.  He said that what was being requested fo rmed part of the Doha Mandate, and was in no way 
different from what was claimed by WTO Members th rough their Ministers in the Doha Declaration.  
The wording of Article 27.3(b), which provided for the possibility for Members to exclude plants and 
animals but not micro-organisms or non-biological  or microbiological processes from patentability, 
ran counter to the constitutional and legal order of Venezuela, contradicting principles associated with 
food security, cultural values, the protection of in tellectual property related to the knowledge and 
innovations of the indigenous peoples and the express prohibition of patentabilit y on genetic resources 
or ancestral knowledge.  It was therefore appropriate , nine years after the Doha Declaration and with 
nearly five years' delay in the review of Article 27.3(b) ordered by Ministers, to modify and clarify 
the precise wording of this article.  Over and above  the constitutional and lega l content of this matter 
in relation to the patentability of life forms, its force derived from moral and ethical conviction of the 
impossibility of implementation, which was a basic te net of legal order.  He therefore requested the 
Chairman to use his good offices to initiate the necessary consultations on this subject. 
27. The representative of Ecuador  said that 11 years of discussion had led to a convergence of 
views on the need to prevent misappropriation of  biological/genetic resources and associated 
traditional knowledge.  The way to achieve this w ould be an amendment to Article 27.3(b) of the 
TRIPS Agreement to introduce the principles of prior informed consent and fair and equitable benefit 
sharing, and the disclosure requirement.  The propo sals, co-sponsored by Ecuador and contained in 
documents IP/C/W/474 and TN/C/W/52, would ma ke it easier to achieve a balance between 
Members' rights and obligations under the TRIPS Ag reement and fulfil the development dimension in 
the intellectual property field.   
28. Turning to Bolivia's proposal in document IP/C /W/545, he supported in principle Bolivia's 
position that life forms should not be patented and th at Article 27.3(b) needed to be amended to lay 
down a binding obligation on all Members to excl ude from patentability plants and animals and 
essentially biological processes for the production of pl ants or animals.  He also shared Bolivia's 
concern over misappropriation of bi ological wealth by foreign firm s and universities and accordingly 
reiterated the need to protect each country's sove reignty over its biological resources in accordance 
with the provisions of the CBD.  He emphasized that the only way to protect Members' sovereignty over their biological/genetic resources was to prev ent misappropriation or biopiracy, which could not 
be achieved without an effective solution within the framework of the TRIPS Agreement.  Therefore 
he requested the Director-General to carry on his consultations.  
29. The representative of Angola, speaking on behalf of the LDC Group
, said that the outcome of 
review of Article 27.3(b) shoul d not constrain LDCs from using the TRIPS Agreement to advance 
national development interests nor result in situa tions that would run counter to morality.  As 
highlighted in paragraph 19 of the Doha Minister ial Declaration, the discu ssions under this agenda 
item were closely linked to the discussions on the TRIPS/CBD issue as well as the protection of traditional knowledge and folklore.  The LDC Group appreciated efforts undertaken by the Director-General to conduct parallel informal consultations on the issues of TRIPS/CBD and GI extension.  He 
said that the review of Article 27.3(b) should clarif y the patentability of plants and animals as well as 
of microorganisms and all other living organisms and th eir parts.  Life forms and natural processes for 
the production of plants, animals and other livin g 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, which allowed Memb ers to develop their own systems based on their 
own needs.  The flexibility would contribute to improving food security by ensuring that indigenous 
peoples' inventions were protected and access to s eed was guaranteed.  He said that biodiversity was 
an important resource for the livelihood of populations  living in rural areas in most LDCs, yet benefits  IP/C/M/64 
 Page 11 
 
 
  arising from the appropriation of such resources and the use of traditional knowledge by multinational 
corporations had barely been shared with the co mmunities concerned.  This issue should be addressed 
through introducing a mandatory disclosure requireme nt into the TRIPS Agreement.  It was equally 
important to ensure that patent applicants demonstr ated that they had obtain ed prior informed consent 
from competent authorities in the country of origin  of genetic resources and that arrangements to 
facilitate the sharing of benefits arising from th e appropriation of such resources and/or traditional 
knowledge were in place. 
30. The representative of Colombia  said that, according to the Doha Declaration, the review of 
Article 27.3(b) should include an examination of the relationship between the TRIPS Agreement and 
the CBD.  Genetic resources and associated traditiona l knowledge were considered by Colombia to be 
of fundamental importance, since they constituted a source of wealth which, if adequately promoted 
and recognized, would serve as the cornerstone of nati onal development.  To that end, it was essential 
that the nexus between the TRIPS Agreement and th e CBD be clearly defined.  Recognition of the 
concept of genetic resources and their derivatives was of crucial importance to Colombia, because 
they were the expression of the State's right to re gulate the use of its natural resources, as well as its 
right to claim the benefits deriving therefrom.  In this connection, access to and use of genetic 
resources had been identified as important sources of income for authorized users.  One example of 
this was the application of clean technologies by th e pharmaceutical and cosmetic industries.  Further 
evidence of these benefits could be seen in new in ventions in the field of traditional and modern 
medicines.  Consequently, it was important to estab lish a legal framework which offers security in the 
granting of benefits derived from trade in innovatio ns in respect of access to and use of biological 
resources.   
31. He said that the CBD, in the same vein as th e United Nations Charter and the principles of 
international law, recognized the sovereignty of St ates over their natural resources and their authority 
to regulate access to genetic resources.  In additi on, the CBD explicitly recognized the link between 
intellectual property rights and gene tic resources.  Paragraph 2 of Article 16 of the CBD established 
the link between genetic resources and intellectual pr operty, which was evidenced by paragraph 5.  
The Doha Declaration established the need to ex amine that relationship through the evaluation and 
negotiation of matters relevant to the protection of access to biodiversity, as well as the sharing of its benefits.  In addition, the TRIPS Agreement had the potential to make such protection subject to 
common international standards included within th e framework of its Article 7.  Within that 
framework, Colombia, together with numerous other developing country members of this 
Organization, had submitted the disclosure proposal  which would require applicants for patents 
relating to genetic resources and/or traditional kno wledge to disclose the source and the country of 
origin of those resources and knowledge and demons trate evidence of prior informed consent and 
benefit sharing in the place of origin.  The propo sal went in the right direction since it sought to 
achieve common objectives of the Membership, such as avoiding erroneously granted patents; 
ensuring that inventors who used genetic resources and associated traditional knowledge comply with 
prior informed consent and access and equitable be nefit sharing conditions; and enabling patent 
offices to have enough information to decide whethe r a patent was correctly granted.  The proposal 
was the best alternative among those that had been  discussed within the WTO.  The other solutions 
did not satisfy Members' interests for reasons re lated to cost, time, efficiency, asymmetric or 
inadequate information, unequal negotiating capacity and non-compliance by third parties.  Nor did 
they provide legal certainty, because national legal sy stems varied and the private nature of contracts 
did not create international obligations.  He said th at it was important to establish a legal framework 
that defined the rights and obligations of Members with regard to trade generated on the basis of 
genetic resources.  It was necessary to establish a link between the CBD and TRIPS and to elaborate standards that incorporated the interests of Me mber countries, highlighting the maintenance of 
biodiversity and fair and equitable benefit sharing.  This implied the granting of rights, including 
patents, on an equitable basis, thereby creating a favourable framework not only for the countries of 
origin but for researchers and users, who would be  governed by clear and pre-established rules.  In IP/C/M/64 
Page 12  
 
  conclusion, he said that Members should be open-mi nded and constructive in their consideration of 
the disclosure proposal, so that they could finally find the best solution to the problem of biopiracy.   
32. The representative of Indonesia
 said that, considering the importance and potential economic 
value of micro-organisms, his delegation supporte d the discussion of patentability of life forms in 
order to have a wider perspective and constructive reflection on this issue.  He said that Members 
should take bold steps to address the TRIPS/CBD issue so that the TRIPS Council not only 
contributed to fruitful results but also to substantiv e progress within the WTO.  Given the fact that the 
protection of genetic resources and traditional know ledge was crucial for developing countries, he 
stressed the urgency of enhancing the discipline of disclosure requirements.  He said that this issue 
had been addressed in several multilateral forums  and that negotiations in the WTO should be 
supportive to and did not run counter to negotiations  in other forums, such as the WIPO IGC and the 
CBD.  These negotiations would complement each ot her in creating a fair, balanced and effective 
regime for the protection of genetic resour ces and traditional knowledge.  He urged all WTO 
Members who were also CBD parties to show flexibility and support ongoing negotiations on the 
Protocol on Access to Genetic Resources and the Fair  and Equitable Sharing of Benefits Arising from 
Their Utilization at the tenth CBD COP in Nagoya, Japan .  He said that it was in everyone's interest 
that genetic resources and traditional knowledge should be utilized in an appropriate manner to ensure 
their sustainability and the fair and equitable benef it sharing for the guardians of these resources.  He 
asked Members to consider the importance of this issu e, in particular for the welfare of people.  The 
goal to create a beneficial regime could only  be achieved through a mutual cooperation and 
partnership among all stakeholders .  He invited Members to strengthen their commitments and to 
stimulate further dialogue to accomplish the desired result. 
33. The representative of Peru  said that his delegation's position on these three issues had been 
reflected in the statements made by Indonesia, Colombia and India.  While the CBD recognized 
national sovereignty over genetic resources, the TR IPS Agreement contained provisions that allowed 
the granting of patents on biological resources and did not prevent biopiracy, so that a person might 
claim patent rights in one country over genetic r esources that were under the sovereignty of another 
country.  Similarly, the TRIPS Agreement contai ned no provisions that ensured prior informed 
consent or equitable sharing of benefits derived from the use of the biological resources in an 
invention, unlike the CBD, whose protocol on  access and benefit sharing was currently under 
negotiation in Nagoya, Japan.  For this reason, Pe ru was in favour of ame nding the TRIPS Agreement 
so as to bring it into line with the CBD by including a requirement for disclosure of the origin and 
source of genetic resources, whether or not related to traditional knowledge, and for evidence of prior 
informed consent and of access and benefit sharin g in the patent system.  Since 2003, Peru had 
submitted about 11 working papers on this topic, t ogether with other Members.  Peru had submitted 
four papers by itself, including concrete case studi es of biopiracy and legal and practical arguments on 
the need to include disclosure of origin requirements in the patent system.  A requirement for 
multilateral and mandatory disclosure would be the most efficient way to address the international 
problem of misappropriation of genetic resour ces and traditional knowledge, as it would allow all 
countries to identify the supplying country by requiring patent applicants to disclose the country of origin as well as evidence of compliance with pr ior informed consent and benefit sharing.  
Furthermore, disclosure of origin would provide  a platform to facilitate compliance with the 
provisions of the CBD by helping to prevent biopiracy through the patent system.  This would ensure 
adequate compatibility and linkage  between the TRIPS Agreement a nd the CBD.  Peru was convinced 
that the intellectual property system was an impor tant tool for the economic, social and cultural 
development of Members.  This conviction, in addition to the need to improve the intellectual 
property system in order to prevent its misuse to  the detriment of developing countries, prompted 
about 110 Members to co-sponsor document TN/C /W/52.  Peru was not, through that proposal, 
seeking to prevent access to or use of its genetic re sources, but to protect them against biopiracy by 
ensuring that they were used sustainably and to the benefit of all Peruvians, particularly indigenous 
communities.  With the inclusion of a requirement to disclose the country of origin, it would be  IP/C/M/64 
 Page 13 
 
 
  possible to recognize the rights of peoples over their genetic resources, thereby adding to their 
development potential.  Only by taking acti on against biopiracy would Members succeed in 
establishing a proper balance in the patent system an d in the intellectual property system in general 
for the benefit of all, particularly the local a nd indigenous communities of developing countries, while 
society would be benefited by the lega l use of such knowledge and resources. 
34. The representative of Uruguay  agreed with the introduction into the TRIPS Agreement of a 
mandatory requirement to disclose the origin of  biological resources an d associated traditional 
knowledge in patent appli cations.  Nevertheless, he said that such a measure was not sufficient to 
resolve the biopiracy issue and hence negotiations  in other competent forums (e.g. WIPO, CBD) on 
further related aspects were equally  important.  In this connexion,  Uruguay supported India's initiative 
of inviting the CBD Secretariat to inform the Counc il about its negotiations.  He did not agree with 
the establishment of a linkage between the TRIPS/CB D issue and other TRIPS -related issues because 
each had its own specificity and content.  It was necessary to adhere to the Doha mandate in this regard. 
35. The representative of South Africa
 said that the TRIPS/CBD issue had been on the TRIPS 
Council's agenda for an inordinately long time with out tangible results.  A large group of developing 
country Members had proposed an amendment of the TRIPS Agreement to introduce a mandatory 
disclosure requirement in patent applications and ha d sought clear guidance on this matter as part of 
the modalities decision.  The basis of the am endment proposal, as contained in document 
WT/GC/W/590, required patent applications to discl ose the origin of biological resources and/or 
associated traditional knowledge in patent applica tions, including prior informed consent and access 
and benefit sharing.  South Africa was a signato ry to the CBD.  The CBD was conducting its 10th 
COP in Nagoya, Japan while the Access and Bene fit Sharing (ABS) Group was working towards a 
protocol.  Key elements of the access and benefit- sharing regime included the concepts of utilization 
of genetic resources and its derivatives; traditional knowledge;  the scope and relationship with other 
instruments, non-commercial research and emergency s ituations.  Many of these elements related to 
the work conducted in WIPO and the TRIPS Council.  It was therefore important to involve the CBD 
Secretariat in the work of the TRIPS Council.  He called on Members to reconsider the status of the 
CBD Secretariat as an observer to the Council's meetings .  He supported the proposal by India that the 
CBD Secretariat be invited to brief the Council on the outcome of its 10th COP. 
36. He said that protection of traditional knowledge  played a key role in the preservation and 
sustainability of biodiversity, especially for mega biodiverse countries such as South Africa.  Many 
activities based on traditional knowle dge had become an important source of income, food and 
healthcare for many indigenous and local communi ties.  The growing vulnerability of traditional 
knowledge had increased the demand for its protection, and created a sense of urgency for most governments, especially in developing countries, to develop legal frameworks that would effectively 
preserve and protect traditional knowledge.  Most countries had identified intellectual property laws 
as the ideal system that could offer the protection.  A multilateral disclosure system would be the most 
efficient way to realize such protection.  He th erefore urged Members to crystallise the TRIPS/CBD 
issue by moving swiftly to  text-based negotiations.  
37. The representative of Brazil
 said that his delegation attached importance to reaching a 
balanced and comprehensive agreement on three TRIPS-related issues, i.e. TRIPS/CBD, GI register, and GI extension.  He said that an agreement on th e TRIPS issues would be an important element of 
the possible Single Undertaking emerging from the D oha Round, and that the mandatory requirement 
for the disclosure of the origin of genetic resour ces and/or associated traditional knowledge in patent 
applications would be a necessary component of the agre ement.  He agreed with the proposal to invite 
the CBD Secretariat to brief the Council on develo pments in the CBD negotiations.  Referring to 
Bolivia's intervention, he said that the Brazilian legislation excluded from patentability any life forms, 
with the exception of genetically modified organism s that complied with the three criteria of novelty, IP/C/M/64 
Page 14  
 
  inventive step and industrial application, and that  plant varieties were protected in Brazil through sui 
generis  systems.   
38. The representative of Egypt
 supported the statements made by the African Group and other 
like-minded Members.  He said that the protection of biological resources, traditional knowledge and 
folklore were issues of high priority for devel opment.  These issues undoubtedly had implications on 
the preservation and development of natural and cultural heritage.  Discussions, and ultimately 
negotiations, should aim to enable WTO Members to meet their obligations under both the TRIPS 
Agreement and the CBD.  In this regard, the TR IPS Agreement should be amended in order to 
provide that Members shall require an applicant for a patent relating to biological materials or 
associated traditional knowledge to disclose the s ource and country of origin of the biological 
resource and associated traditional knowledge used in th e invention.  Furthermore, the applicant must 
also provide evidence of prior informed consent a nd evidence of fair and equitable benefit sharing 
under relevant national regimes.  He urged Members to engage on th is issue of prime importance to 
developing countries as part of deve lopmental gains of the Doha De velopment Agenda.  He supported 
the proposal made by India to invite the CBD Secretariat to brief the TRIPS Council on the Nagoya 
developments.  Referring to Bolivia's proposal of th e review of Article 27.3(b), he said that three 
issues raised in the proposal, namely  patenting of life forms;  protection of plant varieties;  and 
traditional knowledge and rights of  indigenous communities, represen ted central issues with key 
implications for developing countries.  He s upported conducting the review  of Article 27.3(b), 
including an in-depth assessment of the ethical implications and the c oncrete impact of Article 27.3(b) 
on life forms. 
39. The representative of Nigeria  said that a great deal of debate on the TRIPS/CBD issue had led 
to the broad convergence on the need to prevent misappropriation of genetic resources.  As a 
co-sponsor of document TN/C/W/52,  his delegation wished to see that the objectives set out in the 
document could be achieved, in particular the pr evention of misappropriation of genetic resources.  
He urged the Director-General to intensify his consultations with a view to moving discussions 
forward.  He supported the proposal by India to invi te the CBD Secretariat to make a presentation on 
the outcome of the 10th CBD COP at the next TRIPS Council's meeting.  
40. The representative of Canada  said that the review of Article 27.3(b) was meant to focus on 
Members' implementation rather than to revise th e content of this article.  Flexibility should be 
maintained in Article 27.3(b) to allow Members to implement it domestically as appropriate.  His 
delegation had not been shown that there was a c ontradiction between the TRIPS Agreement and the 
CBD and therefore there was no need to amend the TRIPS Agreement.  However, there was a 
contradiction between the proposals containe d in documents IP/C/W/474 and TN/C/W/52 
respectively.  He wondered whether the cosponsors of document TN/C/W/52, who had yet to sponsor 
or co-sponsor document IP/C/W/474, intended to do so.  He continued to believe that the most 
meaningful way to advance discussion on the TRI PS/CBD issue in the WTO was to engage in a 
fact-based technical discussion of the various propo sals made in the TRIPS Council, with particular 
focus on those who had either best practices to shar e or had experienced cases of misappropriation.  
Unfortunately, process-oriented considerations had b een Members' focus of late in the Council.  He 
said that Canada was committed to work to avoid the granting of erroneous patents, to secure 
compliance with national agreements on benefit-shari ng regimes and to ensure that patent offices have 
available the information needed to make proper d ecisions on patent grant.  He encouraged Members 
to consider other mechanisms to protect biodi versity and prevent misappropriation of genetic 
resources, such as developing broader, more globa lly accessible and functional prior art databases, 
using mutually agreed terms in material transfer  agreements, licensing, codes of conduct and other 
contracts, such as the access agreemen t in the India's TKDL system.   
41. Referring to the artificial linkage between three TR IPS issues, he said that the mandate of the 
Special Session remained lim ited to the GI register  issue.  His delegation continued to support the  IP/C/M/64 
 Page 15 
 
 
  Director-General consultation process, while tec hnical discussion should continue to occur in the 
Council with all Members' participati on in substantive discussions.     
42. The representative of Switzerland  said that inventions in all fields of technology, including 
biotechnology, deserved to be adequately protected by  patent systems.  Life forms as such, however, 
could not be patented, and patent s should only be granted for new inventive technologies which were 
capable of industrial application.  Such inven tive activity required a considerable effort and 
investment by the inventor, which needed to be re couped through time-limited patent rights.  He said 
that, as a co-sponsor of document TN/C/W52, his de legation, together with two-thirds of Members 
had proposed key modalities language for three TRI PS issues, including the proposal for introducing a 
requirement to disclose the source of genetic  resources and traditional knowledge in patent 
applications.  Such a requirement could contribu te to enhancing transparency, legal certainty, 
legitimacy, understanding, a nd wide acceptance of the benefits of the patent system by all.  As 
mandated by Ministers in Hong-Kong in 2005, the Director-General had held a number of consultations on the issues of TRIPS/CBD and GI extension in 2009 and 2010.  These consultations 
had enhanced Members' understanding of these two issues and allowed them to present and explain 
their proposals in detail.  He encouraged the Direct or-General to resume his consultations to advance 
the work under the Doha Agenda.  Referring to the linkage between three TRIPS issues, he said that 
there were procedural and substantive links among th ese three issues, and that it was necessary to treat 
them in tandem.  Meaningful progress on the three issues needed to be made in parallel as well as with other negotiations toward the succ essful conclusion of the Doha Round.  
43. The representative of Japan
 said that the review of the Article 27.3(b) should be limited to the 
review of the optional exclusions and the exceptions  to exclusions stipulated in Article 27.3(b). 
Discussion in the Council should be limited to th e scope of its mandate.  Patent protection was 
important and essential for innovation in the field of  biotechnology, which ha d brought benefits for 
human beings in terms of public health.  If there were no patent protection for innovations in this 
field, no medicine would be invented.  He said that the TRIPS/CBD issue should be discussed with a 
distinction drawn between the issues of erroneously  granted patents and that of CBD compliance.  
Article 29 of the TRIPS Agreement stemmed from the foundation of patent systems, under which 
exclusive patent rights were granted to inventor s who in return disclosed the invention.  The 
disclosure requirement in the context of the CBD compliance was outside the patent system.  The 
information on the source or origin of genetic re sources was irrelevant to the operation of patent 
systems.  The mandatory disclosure requirement woul d have an impact on the patent system.  Given 
the technical nature of this issue, he said that  the best way forward was to continue fact-based 
technical discussions in the TRIPS Council.  He further said that the establishment of comprehensive 
databases for patent examiners could be a useful solu tion to the issue of erroneously granted patents.  
In conclusion, he said that his delegation's position on the parallelism of three TRIPS issues remained 
unchanged. 
44. The representative of Australia  said that, as a megabiodiverse country with a unique 
indigenous culture, her delegation had a strong interest in equitable access to genetic resources and 
associated traditional knowledge.  As a party to the CBD, Australia shared relevant objectives in 
relation to genetic resources and traditional know ledge, including facilitating access to genetic 
resources with prior informed consent and on mutua lly agreed terms, to take measures aimed at 
equitable sharing of benefits aris ing from the utilisation of genetic resources, and to respect, preserve 
and maintain traditional knowledge.  Australia's sy stem provided access and benefit sharing based on 
the system of permits and contracts.   Australia's  national experience indicated that effective benefit 
sharing regime could be implemen ted without making changes to th e patent system.  Therefore, 
Australia considered that the TRIPS Agreemen t and the CBD were consistent and could be 
implemented in a mutually supportive manner.  Accordingly, her delegation did not support the 
proposal of the TRIPS amendment.  Australia was pr epared to engage constr uctively in discussions on 
genetic resources in all relevant international fo rums, including the WTO, WIPO, the CBD and the IP/C/M/64 
Page 16  
 
  WHO.  She said that the disclosure requirement merited further consideration as long as this was 
taken in conjunction with consid eration of other options, such as databases.  She said that the 
Director-General's informal consultations on th e TRIPS/CBD issue had been productive but there 
were a range of central policy issues yet to be reso lved or even discussed, b ecause of the lacking of 
detail on the nature and scope of the proposed discl osure requirement.  Progress in those discussions 
was also hampered by the artificial linkage between the TRIPS/CBD issue and the two GI issues.   
45. The representative of Argentina
 did not support the artificial pa rallelism between three TRIPS 
issues as proposed in document TN/C/W/52.  She sa id that misappropriation of genetic resources and 
traditional knowledge was a serious problem but  her delegation did not support the disclosure 
proposal as contained in document TN/C/W/52.  Members should continue discussions on the 
TRIPS/CBD without losing sight of the substantive on-going work in WIPO and the CBD.   
46. The representative of the European Union  said that there was common ground on the 
importance of the TRIPS Agreement and the CBD be ing implemented in a mutually supportive way, 
and the need to find solution on misappropriation of genetic resources and/or associated traditional knowledge.  A mandatory requirement for disclosur e of the source or country providing genetic 
resources and/or associated traditional knowledge in pa tent applications was an area where patent 
laws could make a valuable contribution to a br oad framework of access and benefit sharing.  The 
European Union, together with the large majo rity of the WTO Membership, had co-sponsored a 
proposal of specific modalities language for three TRIPS-related issues under the Doha Development 
Agenda, as contained in document TN/C/W/52.  He  reaffirmed his delegation's commitment to the 
common platform on the TRIPS issues and supported the parallel treatment of these three issues with 
a view to a decision on the modalities.   
47. He supported amending the TRIPS Agreement to introduce the disclosure requirement, 
provided it was properly calibrated.  In this case , it would positively contribute to the mutual 
supportiveness between patent systems and access and bene fit-sharing regimes.  First, it would help 
countries providing access to genetic resources to m onitor and keep track of compliance with access 
and benefit-sharing rules as well as  with the contractual arrangement s between providers and users of 
genetic resources, thanks to the information recei ved through foreign patent offices.  Secondly, it 
would increase confidence among bio-collectors (p rivate companies or research centres) and 
biodiversity-rich countries and indigenous commun ities, which would generate less complex or 
burdensome but more effective access and benefit-sh aring regimes, thus creating a win-win situation 
for both providers and accessors.  Thirdly, it would he lp to prevent inappropriate patenting of genetic 
resources and/or associated traditional knowledge by allowing patent examiners to make more 
focused search and therefore to establish prior art mo re accurately.  Fourthly, it would act as a strong 
incentive for patent applicants to comply with do mestic rules on access and benefit sharing - where 
they existed - and/or with contr actual arrangements.  Fifthly, it would increase transparency about the 
use of genetic resources and/or associated traditiona l knowledge.  He said that a broad consensus for a 
decision on DDA modalities could only be  found if the three TRIPS-related issues were part of it.  He 
encouraged the Director-General to pursue and intensify his consultations on the issues of GI 
extension and TRIPS/CBD as an important contribu tion to the DDA.  His delegation remained open 
to discuss and prepared to engage construc tively in these issues with other Members. 
48. The representative of Norway
 shared some of the objectives identified in the Bolivian 
proposal, including the protection of innovation of indigenous and local farming communities and the 
continuation of traditional farming practices.  Howe ver, she did not support the proposal of general 
prohibition of patenting of all life forms.  She said that there was no conflict between the TRIPS 
Agreement and the CBD and that these two instrument s were mutually supportive.  Nevertheless, the 
relationship between the TRIPS Agreement and the CBD would be enhanced by introducing a 
mandatory requirement in the TRIPS Agreement to  disclose the origin of genetic resources and 
traditional knowledge in patent applications.  Sh e said that her delegation's proposal of June 2006  IP/C/M/64 
 Page 17 
 
 
  would support the CBD objectives and be useful in ensu ring that patents were not granted contrary to 
the fundamental principles of patent law.  
49. The representative of Korea  said that the patent system provided an incentive to develop new 
technologies, and that the world had benefited from the advancement of biotechnology.  Since 
patenting of certain biological materials might di sturb public order, aggravate food insecurity or 
compromise farmers' rights, Members could use their own discretion to decide the patentability of life 
forms according to Article 27.3(b).  Meanwhile, Ar ticle 27.2 provided for broad exceptions of public 
order and morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment.  Article 27 contai ned a balance between the incentive mechanism of 
patent systems and public policy concerns.  Given the balance and wide discretion provided for in 
Article 27, making certain subject matter non-patentab le would not contribute to Members' capability 
to cope with these public policy concerns.   
50. He said that his delegation did not see the n ecessity of amending the TRIPS Agreement as the 
TRIPS Agreement and the CBD had different purposes , i.e. the TRIPS Agreement was an agreement 
regulating trade-related aspects of intellectual prope rty rights, while the CBD was about the protection 
of biological diversity.  Protection of biological dive rsity was one of the public policy concerns that 
was addressed in Article 27.  Any measures that were necessary for the protection of biological 
diversity, but not directly related to the trade-related aspects of inte llectual property rights should be 
left to the CBD.  In addition, he said that the mandatory disclosure requirement might not be a good 
approach to address the concern over access and benef it sharing compared to national regimes.  It 
might place too much of a burden on patent applicants and researchers and might act as disincentives 
to research and development.  He said that th e Korean Traditional Knowledge Portal (KTKP) had 
accumulated a database of about 250,000 articles on traditional knowledge in the field of traditional 
medicine.  The database was open to the public  and might be used for third-party opposition 
proceeding.  Korean patent examiners used  the KTKP to conduct prior art search.  
51. The representative of New Zealand
 said that Members had several shared objectives on the 
TRIPS/CBD issue, but not on other TRIPS issues.  The linkage between the TRIPS/CBD issue and 
the other TRIPS issues would not assist Members in  finding solutions, but undermine prospects for 
progress.  There had been little constructive discussi on of the TRIPS/CBD issue in the Council since 
the political linkage had been proposed in document TN/C/W/52.  He said that while some Members 
preferred to discuss this issue in a restricted small group chaired by the Director-General, his 
delegation preferred to use the ope n-ended and transparent forum provided by the TRIPS Council.   
52. The representative of the United States  said that the TRIPS Council had continued to engage 
in a useful and constructive exchange of views on these three items based on a sharing of national 
experiences.  This manner of working could and should continue to be the basis for the TRIPS 
Council's work.  Indeed, it was helpful when Me mbers expressed elaborated views in writing and 
Bolivia's paper was a contribution to the Council's wo rk in this regard.  He acknowledged that some 
Members had advocated commencing negotiations on the basis of a proposed text to amend the 
TRIPS Agreement.  His delegation did not suppor t amending the TRIPS Agreement to address the 
issues raised by these Members as doing so would not  be the most effective way to addressing these 
issues.  Instead, Members should focus on the shar ed objectives, and start from a common basis.  All 
Members supported access and benefit sharing and prio r informed consent for genetic resources, and 
shared an interest in improving the quality of patents.  A requirement to disclose information 
concerning genetic material in pate nt applications was not an appropr iate or effective approach to 
these issues.   
53. The key to addressing concerns about poten tial misappropriation was domestic laws and 
contact points.  He said that driving the discu ssion of the TRIPS/CBD issue was a concern about 
suspected misappropriation of genetic resources a nd associated traditional knowledge.  One aspect of IP/C/M/64 
Page 18  
 
  potential misappropriation had been expressed as pate nts being granted in error and Members had 
considered how to ensure that the basic patentability requirements were met.  The TRIPS Agreement 
provided that "patent shall be av ailable for any inventions...provid ed there are new, involve in 
inventive step and are capable in industrial appli cation."  Therefore, no applicant should be able to 
obtain a patent unless they had contributed some thing new and nonobvious to what had been done 
before.  Many patent offices, including in the Unite d States, were also using databases to ensure well-
informed decision on novelty and inventive step.  Hi s delegation continued to struggle to understand 
how new disclosure requirements, including the possi bility of denial of patents or revocation of 
patents in some circumstances, would help accomplis h the legitimate and im portant objectives that 
Members shared.   
54. He said that the most effective way to ensure the effective sharing of benefits was to bring 
about the generation of benefits in the first place, and benefits would be generated when useful and 
good products were developed and co mmercialized.  The existence of an incentive through the patent 
system was a critical element in encouraging su ch development and commercialization.  When 
meaningful national prior informed consent and access and benefit sharing systems were in place, 
Members then could have confidence to achieve th e common objectives.  He said that the sufficiency 
of the disclosure might be questioned, and, in response, the patent applicant might abandon the 
application after publication or allow the patent to lapse after the granting of the patent.  Without a 
patent, the patent owner's ability to commercialize an invention might be reduced, resulting in fewer 
benefits to share with others.  Furthermore, once the patented inve ntion entered the public domain due 
to lapse or invalidation, there might be no legal obl igation on anyone to share benefits of the use of 
the genetic resource.  He said that his delegation was also gravely concerned about a chilling effect on 
the innovation process.  By making the filing of a patent application more complicated and the granting of patents more difficult, the incentive to innovate could be lost.  In particular, universities 
and small businesses might be unable to obtain th e capital necessary to deve lop inventions and seek 
patents for them.  Without financial support, universities around the world would be unwilling and 
unable to conduct basic research leading to invent ions.  Without financial support, small businesses 
would be unable to build upon the university's b asic research and develop the genetic-based research 
into a commercial embodiment that  was suitable for patenting.  He said that that a broad patent 
disclosure requirement could be very burdensome fo r patent applicants to comply with and for 
national patent offices to administer.  He also  expressed his delegation's concerns related to 
uncertainty surrounding the practical application of  the disclosure requirement.  His delegation had 
reviewed some national laws that required disclosure of source or origin, but it did not gain a clear 
understanding of when the disclosure requirement needed to be met, and how the amendment to 
patent applications impacted the disclosure requirement.   
55. He said that within this consensus-based orga nization, the number of supporters on one side 
was not sufficient to set aside profound and subs tantive disagreements among Members.  As the 
proponents of the disclosure requirement were advocating for a significant change to existing 
international patent standards, it would be helpful for the proponent s to explain how the requirements 
would work and whether the disclosure requirement  had helped to avoid suspected misappropriation 
and to reduce the incidence of erroneously granted patents. 
56. The representative of Chinese Taipei
 said that her delegation ha d raised some important 
technical issues at previous meetings, such as th e definition of associated traditional knowledge and 
the trigger for the disclosure requirement.  She hoped that the Director-General's consultations could 
provide some clarity on these questions and she ther efore urged the Director General to intensify his 
open-ended consultations.  She said that her delegation did not support the artificial parallelism and 
that the attempt to make a linkage between three TRIPS issues and to include them as part of the 
Single Undertaking was not helpful and that each issue should be discussed on its own merits.   IP/C/M/64 
 Page 19 
 
 
  57. Referring to the Bolivian submission, she said that the flexibilities provided for in 
Article 27.3(b) allowed Members to implement this ar ticle appropriately at domestic level, taking into 
account their own needs and interests.   Nevertheless , the review of Article 27.3(b) should not lead to 
lowering of the level of patent prot ection for biotechnological inventions. 
58. The representative of Canada  questioned whether the cos ponsors of document TN/C/W/52 
intended to cosponsor document IP/C/W/474, as there was a contradiction between the proposals 
contained in these two documents respectively.  Some Members advocated that the disclosure 
requirement needed to addresses both the source and or igin of genetic resources, while others limited 
their responses to source.  He sought clarifica tion on whether the proposal contained in document 
IP/C/W/474 should be amended accordingly, whic h might lower the threshold as proposed in 
document TN/C/W52, or the reverse.   
59. The Chairman  said that he would pass on Members' comments on the Director-General's 
consultations on the implementation-related issues.   He opened the floor for Members' comments on 
India's proposal to invite the CBD Secretariat to make a briefing on the outcome of the Nagoya meeting at the next TRIPS Council's meeting.   
60. The representative the United States
 said that India's proposal of inviting the CBD Secretariat 
should be taken up under agenda item on observership of the CBD Secretariat.  Given that all 
international organizations were products of Members themselves and those Members were in a good 
position to share relevant information, he objected India's proposal.   
61. The Chairman  said that the Council would be discussing the issue of observership of the CBD 
Secretariat under another agenda item.  However,  as the proposal had been raised under these 
particular items, it would be more  appropriate to deal with it un der agenda items C, D, and E. 
62. The representative of India  clarified that what his delegation proposed was not ad hoc 
observership for the CBD Secretariat, which would be  discussed later in the course of the meeting.  
What he proposed was that the CBD Secretariat be  invited to the Council's meeting in March 2011 to 
share with the Members about the proceedings in th e Nagoya meeting.  He said that the CBD was an 
international organization with more than 180 Memb ers and engaged in significant work in this area, 
and that the CBD Secretariat had been invited to  the WIPO IGC in December 2009 because the CBD 
work had a strong bearing on the discussion in the WIPO IGC.  He urged the United States to 
reconsider its position.   
63. The representative of the United States  said that WTO formal meetings were open to WTO 
observers but not to non-observers, and that non-obser vers might be included at workshops but not at 
formal meetings. 
64. The representative of India  said that the purpose of inviting the CBD Secretariat to make a 
presentation was to enrich Members' discussion on th e TRIPS/CBD issue.  There was a precedent in 
the WTO to invite non-observer to WTO meetings. 
65. The representatives of Ecuador , China , Cuba , Peru , the European Union , South Africa  and 
Switzerland  supported India's proposal to invite the CBD Secretariat to report on the outcome of the 
10th COP held in Nagoya at the next Council meeti ng, noting that such an invitation was separate 
from the consideration of the request for observer status from the CBD Secretariat. 
66. The Chairman  said that there was no consensus on the proposal of inviting the CBD 
Secretariat to give a briefing on the Nagoya Pr otocol at the next TRIPS Council meeting.   IP/C/M/64 
Page 20  
 
  67. The Council took note
 of the statements made under these three agenda items and agreed  to 
revert to them at its next meeting.   
F. REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 
OF THE DOHA DECLARATION ON THE TRIPS  AGREEMENT AND PUBLIC HEALTH  
68. The Chairman  recalled that, at its meeting of 8- 9 June 2010, the Council for TRIPS had 
agreed to set aside the second day of the present me eting for the annual revi ew under paragraph 8 of 
the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement 
and Public Health ("the Decision").  In preparati on of the review, he had he ld consultations with a 
number of Members on how to structure the Council' s discussion in order to make the review as 
useful as possible.  In the light of those consultati ons, he had faxed a list of topics for discussion in the 
annual review to delegati ons on 11 October.    
69. He further recalled that paragraph 8 of the Decision provided that the Council for TRIPS 
should annually review the functioning of the System set out in the Decision ("the System") with a view to ensuring its effective operation and re port on its operation to the General Council.  
Furthermore, the paragraph provided that this review should be deemed to fulfil the review 
requirements of Article IX:4 of the WTO Agreement.   
70. He said that the Secretariat had circulated a draft cover note for the Council's report modeled 
on previous years' reports (JOB/IP/1).  This  document contained factual information on the 
implementation and use of the System established under the Decision, on discussions held earlier in the year regarding its operation, and on the acceptance of the Protocol Amending the TRIPS Agreement.  In accordance with the way that the Council had prepared its reports in previous years, 
the part of the minutes of the meeting reflecting th e discussions held under this agenda item would be 
attached to the cover note as an annex. 
71. With respect to the status of acceptances of  the Protocol Amending the TRIPS Agreement 
that was done at Geneva on 6 December 2005, the Ch airman said that, since the Council's meeting in 
June 2010, Uganda and Mongolia had notified their acceptance of the Protocol on 12 July and 
17 September (documents WT/Let/ 678 and WT/Let/684, respectively).  So far 31 notifications of 
acceptance of the Protocol, including from the Eu ropean Communities, had been received.  The 
Secretariat had also circulated an update to the note on the status of acceptances of the Protocol 
(IP/C/W/490/Rev.7) which it would continue to upda te periodically.  The Protocol would enter into 
force for the Members that had accepted it upon acceptance of the Protocol by two thirds of the Members.  The Protocol was open for acceptance by Members until 31 December 2011 or such later 
date as might be decided by the Ministerial Conference. 
72. He said that he had prepared the list of topics for discussion in the annual review in the light 
of consultations he had held with a number of Memb ers.  He had made every effort to ensure that 
there were appropriate headings under which all the topics delegations had mentioned could 
adequately be discussed.  It was his hope that this way of structuring the discussion would ensure that 
the Council would have a productive and useful disc ussion of the System that would help it better 
understand its operation and any concer ns related to it.  Bearing in mind that Members had expressed 
interest in making the review as useful and produc tive as possible, he had encouraged them in the 
cover note to the fax to make introductory presentati ons under topics 1, 2 and 5.  He expressed his 
appreciation to those delegations that had volunt eered to make introductory remarks under various 
headings, and also thanked the secretariats of UNCTAD, the WHO and WIPO, as well as of the 
WTO, for their willingness to contribute to the discussion.   IP/C/M/64 
 Page 21 
 
 
  1. Experience of Members who have used or considered using the system 
73. The Chairman  said that, in the Council's earlier discussions and his own consultations, 
Members had expressed an interest in hearing about the experience in the case of export of medicines 
from Canada to Rwanda, and also about the e xperience of any other Members who might have 
considered using the System as potential importers or exporters and reasons why the System had not 
been used.  In particular, Members had indicated th at they wished to better understand any obstacles 
or concerns about notifying their needs to the WTO, as well as any other obstacles or concerns faced by Members. 
74. The representative of Canada
 recalled that the 2003 WTO Decision on TRIPS and Public 
Health was an intensely negotiated decision th at had garnered unanimous support from all WTO 
Members.  His delegation was very pleased with th is historic and multilateral solution.  It had 
implemented its Access to Medicines Regime (CAM R) in 2005 to facilitate the export of affordable 
generic drugs to developing countries.  It had also been the first, and to date only, WTO Member to 
ship generic medicines under the waiver.  An HIV antiretroviral drug – Apo-TriAvir – had been sent 
to Rwanda in two shipments by the Canadian  pharmaceutical company Apotex Inc. in 
September 2008 and 2009.  This example clearly show ed that Canada's regime and the System were 
efficient, effective and timely.   
75. He said that, in the Apotex-Rwanda example, the role of the Government of Canada and 
CAMR had been very limited in  the overall process.  This process could be divided into three 
components:  first, the issuance of an export auth orization under CAMR;  second, Apotex's role;  and 
third, Rwanda's own domestic requirements. 
76. Apotex had undertaken to develop Apo-TriAvir,  a new triple combination HIV/AIDS drug, 
before any recipient country had been identifie d, and had sought Health Canada's safety and 
efficiency review of the drug, as per CAMR's re quirement.  In December 2005, Health Canada had 
received a submission from Apotex to manufacture A po-TriAvir.  No recipient importing country had 
been identified at that point in time.  In June 2006 , Health Canada completed its review of Apotex's 
Apo-TriAvir submission, less than six months af ter it had been received, although CAMR would 
allow for a time-period of 12 months.   
77. After an eligible importing Member had identif ied its needs to the WTO, the CAMR process 
was completed in just over two months, starting w ith a request for voluntary licences and ending with 
the granting of the export authorization by means of  a compulsory licence.  On 13 July 2007, Apotex 
had sent letters to three pharmaceutical companies,  namely GlaxoSmithKlin e, Boehringer Ingelheim 
and Shire BioChem Inc., seeking voluntary licences to use their relevant patents to produce and export 
15,600,000 tablets of Apo-TriAvir to Rwanda.   
78. On 19 July 2007, Rwanda had notified the WTO of its intention to import 15,600,000 tablets 
of Apo-TriAvir under the waiver (IP/N/9/RWA/1).   On 4 September 2007, Apotex had filed an 
application with the Commissioner of Patents fo r authorization under CAMR to produce and export 
Apo-TriAvir to Rwanda.  On 19 September 2007, 15 days after receiving the application from 
Apotex, Canada's Commissioner of Patents had gr anted Apotex an authorization to produce and 
export Apo-TriAvir under CAMR.  Once such authoriza tion had been given, the role of the Canadian 
Government and CAMR in the process had been subs tantively complete.  On 4 October 2007, Canada 
had notified the WTO of the first authorization issued under the Waiver (IP/N/10/CAN/1).   
79. In October 2007, Rwanda had ope ned a public tender for the supply of Apo-TriAvir.  In 
May 2008, Apotex announced that it had won the Rwanda public tender to supply Apo-TriAvir.  
Apo-TriAvir had been manufactured by Apotex in May-September 2008, and in September 2008 IP/C/M/64 
Page 22  
 
  Apotex had sent its first shipment of 6,785,000 ta blets to Rwanda, followed by the second shipment of 
7,628,000 tablets in September 2009, completing the country's order.   
80. The representative of Canada said that in the Apotex-Rwanda case, CAMR represented a 
small part of the more than two years which had lapsed between the WTO notification by Rwanda and 
the final shipment by Apotex.  The shipments of Apo-TriAvir to Rwanda had occurred within the 
timelines specified in the export authorization that  had been granted by the Canadian Commissioner 
of Patents.  To evaluate CAMR and the System, it was necessary to return to the basic premises.  The 
purpose of the System and domestic implementation mechanisms, such as CAMR, was to ensure that 
TRIPS and patent rules did not prevent exports for humanitarian purposes of more affordable generic 
medicines to those countries that did not have manufacturing capacities. 
81. Taking into account his delegation's experience,  he concluded that CAMR or any similar 
exporting regime that a WTO Member implemented under the Waiver could only assist in supplying low-cost drugs if a demand was notified to the WTO by an eligible importing Member for generic drug(s) that required use of the System.  This w as a demand-driven process by countries in need, and 
only applied to instances where countries were seeking generic versions of patented drugs.  He noted 
that, since the adoption of the Decision in 2003, many options had become available to importing 
countries.  The international environment for procur ement of drugs had changed significantly with the 
introduction of a variety of global mechanisms and alliances which offered greater choice to countries 
to obtain medicines.  The role and effectiveness as  well as the potential for broader use of the Waiver 
needed to be understood in this broad global context.   
82. He said that the System had never been intende d to solve the issue of access to medicines on 
its own, but was seen as part of a broader inte rnational strategy to combat diseases impacting the 
developing world.  The System and CAMR functione d well.  They played a supporting role and were 
not a panacea to the challenges faced on global access to  medicines and were not designed to generate 
global supply. 
83. The representative of India
 presented some examples of cases in which there had been an 
attempt to use the Paragraph 6 System.  In Sept ember 2007, three applications under Section 92A of 
the Patents Act 1970 had been received for the gran t of a compulsory licence for the manufacture and 
export of patented drugs to a leas t developed country in Asia.  After the process envisaged under the 
Act had been initiated, the applicant had subse quently withdrawn the applications.  This had 
apparently been caused by the non-availability  of the corresponding compulsory licences or 
notifications from the importing country.  His delega tion had delved deeper in to the reasons for the 
withdrawal and had discovered that  one of the reasons was the additional burden of compliance with 
the conditions in paragraphs 2(a), (b) and (c) of  the WTO Decision, which included the notification 
requirements and anti-diversion measures.  He w ondered why such notification requirements were 
needed when they were not n eeded for a routine compulsory licence.  Moreover, the detailed 
requirements for suppliers to dis tinguish products produced under the System, such as pill colouring, 
labeling and website tracking did not only seem costly and time-consuming but were also a 
disincentive for generic producers. 
84. The System required notification to the WTO of both the quantity of the pharmaceutical 
products to be manufactured and the period of supp ly.  He said that ideally, when the quantity was 
specified, it should not be necessary to restrict th e period of supply, which would depend on a number 
of factors related to manufacture of medicines, quantity of shipment and trade.  If an additional 
quantity was required, the process had to be in itiated again, which was time-consuming.   
85. He also reported that in 2004, the Doctors W ithout Borders (Médecins Sans Frontières, MSF) 
had attempted to place an order with the Canadi an company Apotex for a fixed-dose combination 
drug, but had found it too cumbersome and, after trying in vain for two years, had procured the  IP/C/M/64 
 Page 23 
 
 
  generic version of the same fixed-dose combina tion drug, which had been WHO pre-qualified and 
reasonably priced, from two Indian generic companies. 
86. The representative of Brazil  said that her country had not tried to use the System either as an 
importer or an exporter.  In 2007, following a case of abuse of price, a compulsory licence had been issued for an anti-retroviral medicine called Efavir enz that was part of the cocktail of drugs freely 
distributed by the Ministry of Health to HIV/AIDS  patients.  For a number of reasons, including lack 
of sufficient disclosure in the patents description, it had taken two years for the Oswaldo Cruz Foundation, an international refere nce institution in medical research in her country, to be able to 
produce the medicine.  During this time, Brazil had imported the medicine from a supplier in India. 
87. The representative of the United States
 asked whether Canada had carried out any activities to 
promote the waiver process and/or CAMR to poten tial importing countries and asked it to share any 
experiences in this regard. 
88. The representative of India  asked the delegation of Canada how much time it would take for 
CAMR processes to be completed the next time a request was submitted by a least developed country, counting from the receipt of the request, taking in to account the voluntary licence process, and ending 
with the grant of an export authorization.  Furthe rmore, his delegation's unde rstanding was that the list 
of products for which a compulsory licence could be  issued was set out in Schedule 1 of Canada's 
amended Patent Act which did not cover the full scope  of products envisaged by the Decision.  He 
asked whether this meant that the Decision could not be entirely implemented under Canadian law.  
He also inquired as to the status of Bill C- 393 to amend CAMR, and the issues which were under 
consideration and whether the amendment would completely address the limitations of CAMR.  As 
the Decision was sufficiently detailed, he asked w hy it was considered necessary to impose additional 
qualifications, such as the limited list of medici nes, the approval required from Health Canada, a 
two-year limit on compulsory licensing and the list of eligible countries.   
89. According to his information, Ghana had expressed an interest in 2005 in using CAMR in 
collaboration with two Canadian NGOs to import generics both for itself and as a regional importer 
for the ECOWAS countries.  It had even issued a regular compulsory licence in 2005.  He asked 
whether Canada could share any experience as to why the effort had not fructified. 
90. The representative of Malaysia
 asked the delegation of Canada to clarify whether the fourth 
event on the timeline outlined by it, i.e.  the review  of the Apotex submission, referred to the review 
of the safety and efficacy of the drug and, if so, wh ether Apotex had generated its own clinical data 
when submitting the application or whether it had re lied on the data submitted by the patent owner.   
91. The representative of Angola , speaking on behalf of the LDC Group, said that the adoption of 
the Decision of 6 December 2005 to amend the TRI PS Agreement in order to respond to difficulties 
experienced by countries with no or insufficient ma nufacturing capacity was an important milestone.  
However, five years had elapsed since this Decision had been adopted, and few Members had 
deposited instruments of acceptance of the Protocol Amending the TRIPS Agreement.  It was 
important to establish why countries were not comi ng forward so that collective measures could be 
taken.  The LDC Group welcomed the informal consultations undertaken by the Chairman in 
September and October 2010 to f acilitate dialogue between Members on the opportunity to hold a 
workshop on the implementation of the System.  This could help to get a sense of where impediments 
lay with regard to the acceptance process and how  the removal of such impediments could be 
facilitated including through expedite d acceptance of the amendment by individual Members.  Issues 
related to the acceptance of the TRIPS amendment c ould also be incorporated into the national and 
regional technical assistance and capacity-building ac tivities undertaken by the WTO Secretariat.  He 
noted that the list of topics circulated by the Ch airman had been prepared through the consultation 
process to facilitate the annual review under Paragraph 8 of the Decision.  The sharing of experiences IP/C/M/64 
Page 24  
 
  and views on the System would enable Members to have clarity on how the System could be 
meaningfully used and where obstacles lay.  Informat ion on alternatives to the System would also be a 
valuable resource for the LDC Group.   
92. The representative of New Zealand
 said that his delegation's interest in this issue was largely 
systemic as it did not have significant manufactur ing capacity of either brand name or generic 
pharmaceuticals.  He strongly supported the princi ples that underpinned the Declaration on the TRIPS 
Agreement and Public Health.  He noted that Ca nada had emphasized that the system was demand-
driven and that one year had passed between the au thorization by Health Canada and the request by 
Rwanda.  He asked the delegation of Canada why th ere had been such a delay.  He wondered whether 
Health Canada had done anything to advertise th e system to potential applicants, whether any other 
requests had been received, and whether there were countries that  were excluded from eligibility 
under CAMR.  With respect to the reported thr ee applications made under India's legislation 
implementing the System that were subsequently w ithdrawn, he requested the delegation of India or 
the least developed country involved to share more details of their experience. 
93. The representative of the Bolivarian Republic of Venezuela  asked why Canada had 
established CAMR.  He noted that the delegation of  Canada had said that the System had not been 
created to resolve the problem of access to medicine s in developing countries.  He said that, in his 
view, access to medicines had become worse with the promulgation of the TRIPS Agreement.  He 
asked the delegation of Canada what the intention of the General Council had then been in adopting 
the System. 
94. The representative of Egypt  supported the review of the Decisi on, as well as the proposal by a 
number of delegations to hold a dedicated workshop in order to facilitate the discussion of the issues 
arising under the System, including the lack of its use and the limited acceptance of the Protocol.  The participation of relevant stakehol ders could help to achieve this goal.  When the African Group had 
brought the critical issue of access to medicines to the Council for TRIPS in 2001, this had been an 
attempt to target an important public health problem.  Over the years since then, Members had 
engaged in laborious work  on consulting and discussing draft lan guage as a way out of this critical 
public health crisis.  When the Decision had been r eached in 2003,  his delegation had hoped that this 
problem had been resolved.  It had notified its acceptance of the Protocol Amending the TRIPS Agreement in 2008, in the belief that it was expedien t to do so to provide room for a solution to the 
urgent public health needs and that Egypt would be  able to provide urgently needed medicines to 
countries in need.  His delegation had anticipated  itself as both potential beneficiary and supplier 
under the System.  However, the System had not been as helpful as hoped in addressing this critical 
public health problem.  The fact that it had onl y been used once raised questions as to its 
effectiveness, let alone expeditiousness.  Likewise,  the frail drive to accept the amendment Protocol 
was incomprehensible in its own right.  The admini strative and regulatory complexity of the system, 
the lack of appreciation of business methods in s upplying markets and associat ed overhead costs, as 
well as constraining requirements, would merit further discussion. 
95. Canada's experience as one of the two Memb ers having used the System was important in 
shedding light on the issues.  The representative of Egypt put a number of questions to the delegation 
of Canada.  Firstly, in the light of its own experi ence, did Canada consider the System to be an 
expeditious solution?  Secondly, as part of CAMR's reform process, was the possibility of issuing one 
compulsory licence for several countries in order to  avoid duplication and time lags considered?  
Thirdly, could the delega tion of Canada share any information on the experience of Apotex in seeking 
a voluntary licence prior to applying for a compulsory licence?  Fourthly, to what extent had the anti-
diversion measures been onerous on Apotex?  He note d that paragraph 7 of the Decision stated that 
"Members recognize the desirability of promoting the transfer of technology and capacity building in 
the pharmaceutical sector in order to overcome the problem identified in paragraph 6 of the 
Declaration.  To this end, eligible importing Me mbers and exporting Members are encouraged to use  IP/C/M/64 
 Page 25 
 
 
  the system set out in this Decision in a way which would promote this objective..."  He asked to what 
extent CAMR was promoting the objective of transf er of technology as enshrined in paragraph 7 of 
the Decision.   
96. The representative of Brazil  noted that, according to the delegation of Canada, Apotex had 
decided to produce the antiretroviral Apo-TriAvir be fore there had been a request from any country.  
Even when Rwanda had identified itself as a poten tial importer, Apotex still had to go through the 
process of government procurement with other comp anies.  She asked what the economic incentives 
had been for Apotex to engage in this process and why it had not attempted to repeat this experience 
with other countries.   
97. The representative of Argentina  supported the holding of an  open-ended workshop or any 
other initiative with the objective of evaluating the functioning of the System.   
98. The representative of Switzerland  considered that the attempt by the MSF to procure generic 
medicines from Apotex was an important case, and said that it would be useful to know why the attempt had failed.  The information available see med to indicate that price had been the issue 
between MSF and the potential generic manufacturer .  In his view, the price offered by generic 
manufacturers could not be influenced by the Syst em itself.  The challenge was to find the most 
competitive and thus most affordable price under such  a scheme.  He asked the delegation of India to 
provide more detailed informati on regarding the precise nature of the problem between MSF and 
Apotex and wondered if the delega tion of Canada also had additiona l information on this particular 
case. 
99. The representative of Indonesia
 noted that the delegation of Canada had presented the use of 
the System as effective.  However,  the use of th e System had only been able to help 21,000 patients 
in Rwanda.  He inquired whether the number of pa tients in need of HIV/AIDS treatment had been 
increasing at that time and what would have happened if Rwanda had wished to import a greater amount of Apo-TriAvir, i.e.  whet her it would have had to start the process again from scratch.  The 
utilization of the System was not as easy and expe ditious as his delegation had thought.  He asked 
what the situation would be if, due to a miscalculation, further disasters or other reasons, there were a 
call for more medicines after the licence had been issued.  Starting from scratch would require more time and would not fulfil the intention of the Sy stem, which was designed to be an expeditious 
solution to public health concerns.   
100. He quoted a September 2008 statement by Mr. Jack Kay, Apotex President and CEO, who 
had said that, "if other critical medicines are to go to Africa in a reasonable timeframe, the Federal 
Government must change the CAMR legislation.  CAMR is unworkable as it now stands."  This was a 
signal that CAMR might need to be improved in order to e xpeditiously serve public health needs.  His 
delegation commended the reform process in Canada.  However, a complete review or an overhaul of 
the System should be considered too, if necessary. 
101. The representative of Malaysia
 asked the delegation of Canada how the royalties had been set 
for the compulsory licence under CAMR, and how that amount had been calculated.  He asked 
whether the methodology used in determining the am ount was different from that  used in the case of 
standard compulsory licences. 
102. The representative of the European Union  welcomed the full day of discussions, based on 
experiences and facts rather than on alleged obstacl es, and which would enable Members to evaluate 
the operation of the System.  He requested the dele gation of India to provide more information about 
the three applications to which it had referred.  He agreed with the delegation of New Zealand that the 
conclusions drawn by India with resp ect to the withdrawal of these a pplications were not obvious.  He 
asked the delegation of Canada whether it ha d reviewed CAMR since the Apotex case.   IP/C/M/64 
Page 26  
 
  103. The representative of Zimbabwe
 noted that the delegation of Canada had said that it had only 
taken 15 days for the compulsory licence to be granted by the Commissioner of Patents under CAMR and that the system was very efficient.  However,   the domestic process in Canada was not the only 
issue to be considered, given that the System involved various players including small countries, big countries, big and  small industries.  For a system  to be efficient and suitable and user-friendly for 
even the smallest players, Members n eeded to look at the bigger picture. 
104. The representative of India
 said that, in September 2007, three applications for compulsory 
licences had been received by the Indian compan y Natco for export to Nepal.  Detailed discussions 
between officials at the Indian patent office, Na tco and Nepalese authorities had taken place.  He 
agreed with the delegation of Switzerland that pr icing was not covered by the System.  He said, 
however, that, pricing had not been the issue in the MSF case which had tilted the balance in favour of 
the Indian generic companies. 
105. The representative of Canada  invited potential importing countries to share specific examples 
of obstacles or concerns with respect to the use of  the System.  With respect  to the question by the 
delegation of India concerning the MSF's request fo r Apo-TriAvir in 2004, he noted that CAMR was 
a demand-driven process.  CAMR would be trigge red when the importing country as well as the drug 
and quantities needed had been identified.  In th e case involving the MSF, these specific elements had 
not been provided, so Apotex was not in a position to request even a voluntary licence from the patent 
holders, nor to request an export authorization fro m the Commissioner of Patents.  The question by 
the delegation of India about hypo thetical future instances of use of CAMR could not be answered 
without specifics.  However, the Rwanda case ha d shown that CAMR operated efficiently and 
effectively.   
106. With respect to the process to amend CAMR, Bill C-393 was a private member's bill, 
submitted by an individual, in this case a member of Parliament, which was not sponsored by the Government.  As part of the ongoing discussions , the Bill was currently before a parliamentary 
committee.  The standing committee on Industry, Science and Technology was scheduled to report 
back to the House of Commons by 3 November 2010 for a third reading.  The Bill suggested a 
number of changes with respect to CAMR, in cluding the introduction of a single licence, not 
restricted in time or quantity.  It was also propo sed that the anti-diversion measures be removed.  His 
Government viewed those particular changes as inconsistent with the way that Members were 
supposed to interpret the waiver of 2003. 
107. With respect to the question from the delegation of India about Ghana's request in 2005, he 
noted that his Government had not been involved in the discussions.  It was possible that some 
developing countries, Ghana in particular, had cont acted a Canadian generic manufacturer to discuss 
the possibility of importing medicines from Canada.  It would be worth addressing the question to the 
delegation of Ghana, which could have some additio nal details to offer, including whether the need 
expressed by Ghana had been filled.  According to hi s information, an Indian generic firm had been 
able to satisfy the request.  He invited the de legations of Ghana or India to confirm this. 
108. Regarding Schedule 1 of CAMR, th is was intended to be a flexib le list of pre-approved drugs 
for export that remained current with the needs of developing countries and LDCs.  Schedule 1 had 
been modified twice since CAMR had been implem ented, to add a fixed dose combination HIV/AIDS 
therapy and a drug for the treatment of influenza in the case of a pandemic, i.e. Tamiflu.  The 
Canadian Patent Act had also provided for the cr eation of an advisory committee prior to May 2008, 
composed of experts from various health disciplines, to facilitate future amendm ents to Schedule 1.   
109. With respect to the additional elements cont ained in CAMR, the representative of Canada 
noted that these were related to the interpretation of  the waiver.  In his delegation's view, the waiver 
required a number of conditions to be met:  namely , that the importing country was required to notify  IP/C/M/64 
 Page 27 
 
 
  the WTO of its intent to use the Decision, the licensee was required to request a voluntary licence 
from the patentee prior to seeking an export author ization under the Decision;  the quantity produced 
under a compulsory licence could not exceed the amount notified;  adequate remuneration was 
required to be paid to the patentee, products shi pped, under the agreement should not be diverted to 
other markets, products were required to be sp ecifically marked and labelled, the licensees were 
required to post on a website the quantities and feat ures of the product being shipped and the intention 
was to support humanitarian policy objectives, not commercial ones.   
110. In response to the question from the delegation of Ma laysia, he said that clinical test data had 
been provided or generated by Apotex itsel f by way of proof of bio-equivalence. 
111. He noted that the delegation of New Zealand had highlighted the fact that CAMR was a 
demand-driven process.  The time in between the safety and efficacy review of Health Canada and the 
start of voluntary licence negotiations could be explai ned by the fact that there had been no specific 
demand made by a country, thus preventing the process  from moving to the next level.  In response to 
the second question by the delegation of New Zeala nd, he said that no additional requests had been 
received by the Government of Canada either prior to or subsequent to Rwanda's request.  He could 
not provide any definitive information with resp ect to discussions that may have occurred between 
Apotex or other Canadian generic manufacturers and countries and/or NGOs.  With respect to the 
eligibility of countries as potential importing Memb ers, he answered that CAMR went beyond the 
Decision in that it did not have any restrictions with respect to non-WTO Members.  Restrictions 
would only apply to countries which had voluntarily opted out of the system.   
112. With respect to the question from the delegati on of the United States as to what had been 
done to publicize CAMR, he said that, since CAMR  had received royal assent in 2004, government 
officials had made numerous efforts to raise the profile of CAMR both nationally and internationally 
to promote uptake of the regime by generic manufacturers.  These efforts were aimed at both eligible importing countries and their party purchasers such as NGOs.  In July 2006, these efforts had been 
reinforced with the launch of a government  website (www.camr-rcam.gc.ca) which served as a 
manual for interested parties.   
113. In turn, he asked what potential importing count ries had done to publicize the System within 
their own countries, specifically through discussions be tween trade and/or patent officials and health 
officials, whether at a national level or sub-national level. 
114. With respect to the question from the delegati on of Venezuela as to why CAMR had been 
established, he answered that his delegation had felt that it was in a position to make a contribution to 
access to essential medicines in times of public h ealth emergencies, it had a manufacturing capacity, 
and it had the political will to undertake the necessary domestic legislative chang es to ensure that this 
happened. 
115. In response to the questions asked by the de legation of Egypt, he said that his delegation 
considered the System to be expeditious.  In resp ect of the experience of Apotex, he noted that his 
Government had not been a party to those discuss ions.  The CAMR process had only been activated 
when Rwanda had come forward as a potential impor ting country in July 2007.  The three brand-name 
companies concerned had either entered into voluntar y licence discussions, or had confirmed that they 
would not contest the issuance of an export authoriz ation within two to three weeks of having been 
approached by Apotex.  Apotex had subseque ntly applied for an export authorization on 
4 September 2007, which was granted two weeks later.   While he could not fully answer the question 
with respect to anti-diversion measures, he did not think that a globally competitive pharmaceutical 
company like Apotex had encountered difficulties sa tisfying the very limited anti-diversion measures 
that were set out in CAMR. IP/C/M/64 
Page 28  
 
  116. The representative of Canada took up the qu estions asked by the delegation of Brazil 
regarding the government procurement process in Rw anda, in particular whether the export of the 
pharmaceutical product concerned had been of any ec onomic interest to Apotex and whether other 
brand-name companies had competed with Apotex.  He noted that, besides the participation of some 
Indian generic companies, he had no detailed info rmation regarding any other companies that had 
participated in the Rwanda tendering process.  This question could only be fully answered by 
Rwanda.  Apotex had won the supply contract in Ma y 2008, about eight months after the process had 
been launched.  Price had been a key factor.  When creating Apo-TriAvir, Apotex  had indicated that it 
would manufacture and sell a useful made-in-Canada  AIDS treatment without profit at its production 
cost of USD 0.39 per tablet.  Apotex had said pub licly that this price would be competitive with 
Indian products.  However, from 2006 to 2008, Apotex had not been able to sell at that price due to 
competition from Indian companies who had been selli ng their own version of TriAvir.  Rwanda had 
at least four alternatives from Indian generic supp liers which had been in a position to offer a lower 
price than the one which had been offered throug h CAMR, which would have made the use of CAMR 
unnecessary.  In 2008, as part of this Rwanda te ndering process, Apotex had, however, reduced its 
price by half to USD 0.195 per tablet.  Since Apotex  had publicly noted that the price of USD 0.39 per 
tablet would have enabled it to break even, it coul d be assumed that the sale at the lower price of 
USD 0.195 implied a loss in this transaction.  By accepting Apotex's new offer, Rwanda had become 
the first user of the System. 
117. In response to the question asked by the delega tion of Indonesia, the representative of Canada 
confirmed that Rwanda would have to start the a pplication process anew if it wished to increase its 
order.  The Rwandan authorities would simply have to follow the same procedures as previously.  
This process would only take a matter of months, or  less compared to the initial case.  It would also 
depend on the Rwandan government procurement process.  With respect to the quote from the CEO of Apotex, he said that CAMR did function and was therefore workable.   
118. With respect to the question asked by Malaysia about royalties, he said that the royalty rates 
ranged between 0.02 and 3.5 per cent.   Under CAMR, the remuneration to be paid by the licensee to 
the patentee was calculated by multiplying the mone tary value of the supply contract by an amount 
that fluctuated on the basis of the importing count ry's standing on the UN Human Development Index.  
According to this formula, the lowest country on th e index would pay a royalty of approximately 0.02 
per cent, and the highest country of 3.5 per cent.  Where patentees disagreed with the royalty fixed on the basis of this formula, it was possible to appl y to the federal court for an order setting a higher 
amount.  This had not been the case as regards Rwanda , where the patent holders had entirely waived 
the royalty fee. 
119. With respect to the question from the delegation of the European Union as to whether Canada 
had reviewed its regime, the representative of Canada explained that a statutory review was 
incorporated into CAMR.  As one of the first c ountries to implement the Decision, Canada had found 
itself addressing many key legal and policy issues regarding the Decision for the first time.  The 
review had sought to ensure that CAMR was meeti ng its humanitarian objectives to make it easier for 
poorer countries to obtain cheaper generic versions  of patented medicines without derogating from 
international trade obligations or  undermining the intellectual prope rty rights necessary for continuing 
innovation in Canada.  It had provi ded an opportunity to compare Canada's legislation with that of 
other jurisdictions which had implemented the Deci sion in the meantime.  Information on the review 
along with numerous other documents, including a discussion paper and submissions from interested 
parties, were available on the dedi cated website (www.camr-rcam.gc.ca). 
120. The representative of Canada agreed with the de legation of Zimbabwe about the need to look 
at the bigger picture.  IP/C/M/64 
 Page 29 
 
 
  121. He asked the delegation of India whether it ha d any information about a possible partnership 
between Apotex and the Indian company Ranbaxy La boratories to export to Liberia the same fixed-
dose combination that had been sent to Rwanda a year  earlier.  He was interested to learn whether a 
voluntary licence had been secured in this case and wh ether any shipment had taken place.  He further 
asked whether there were other partnerships betw een Indian generic pharmaceutical firms and other 
foreign firms under which essential medicines were expor ted to developing countries, based on either 
voluntary or compulsory licences. 
122. The representative of India  thought that Canada had raised a very important point about 
partnerships between Indian generic pharmaceutical  firms and other foreign firms to provide essential 
medicines to developing countries.  Information regarding the partnershi p between Apotex and 
Ranbaxy Laboratories would be provided at the next  TRIPS Council meeting.  He noted that the 
question raised by the delegation of Canada had al so underscored the importance of participation of 
relevant pharmaceutical companies in TRIPS Council  discussions.  This strengthened his delegation's 
call for a dedicated workshop on the System whic h would also include relevant pharmaceutical 
companies and civil society organizations.   
123. The representative of the Bolivarian Republic of Venezuela  reiterated his question to the 
delegation of Canada on what, in its view, the inte ntion of the General Council had been in adopting 
the System.   
124. In response, the representative of Canada  said that, in his view, WTO Members had been 
looking to provide another option for developing countries, in particular  LDCs, to access essential 
medicines by allowing those with manufacturing capacity to export such medicin es in an efficient and 
effective manner.  This objective had been  achieved through the TRIPS Council's work. 
125. The representative of Cuba  asked what clinical trials and other methods had been used by 
Apotex, what test data had been referred to and what kind of quality control had been applied.   
126. As regards Venezuela's intervention about th e General Council's motivation for adopting the 
Decision in 2003 and the TRIPS amendment in 2005, the representative of Switzerland recalled that 
the mandate under paragraph 6 of the Doha Declara tion instructed the Council for TRIPS to find an 
expeditious solution to the problem of the diffi culties that WTO Members with insufficient or no 
manufacturing capacities in the pharmaceutical sector could face.  The mandate had not, and could not possibly have been, to solve the problem of afford able access to medicines for the poor in developing 
countries through such a solution, although some Memb ers seemed to expect the System to achieve 
exactly that goal and measured its success by this st andard.  By this standard, the System was deemed 
to be a failure.  In Doha, Ministers had mandate d the TRIPS Council to find a solution which would 
allow WTO Members without manufacturing capacity in the pharmaceutical sector to make effective 
use of compulsory licensing as provided for in Artic le 31 TRIPS.  This had been achieved through the 
System, as had been evidenced by its use for exports from Canada to Rwanda.   
127. The representative of Brazil
 noted that it was very important to know that there had been no 
royalties paid and that Apotex had most probably lost money when it had to reduce its price to 
USD 0.195 to compete with Indian generic companies.  This would raise the question of whether the System was economically viable and if there would be  other examples of its use.  With the end of the 
transition period for the implementation of the TR IPS Agreement in 2005 in developing countries 
except LDCs, affordable generic medicines from s uppliers such as India would become more and 
more scarce.  This was particularly important for medicines to treat HI V/AIDS, namely second and 
third line treatments.  In 2008, the report by the Swedish National Board of Trade on "The WTO 
Decision on Compulsory Licensing" had stated that "HIV is a highly changeable virus and patients 
need to switch and update their medicines regularly .  Some types of AIDS medicines were launched 
before the TRIPS rules on patent protection for me dicines were introduced in developing countries, IP/C/M/64 
Page 30  
 
  and they could therefore be freely copied and sold  in these countries.  This has resulted in vigorous 
price competition for many of the older medicines u sed as the standard 'first line' treatment, even 
though most of them are still patented in high income  countries.  With many suppliers to choose from, 
there has been no need to use the Decision for these medicines." The report had also explained that 
"the situation in regards to competition and pri ce is different for the second or third line AIDS 
medicines, i.e.  medicines that patients will need wh en they have developed resistance to the first line 
medicines.  The same holds for new, more effectiv e substitutes for first line medicines.  All of these 
are patented in many countries and the prices are much higher than for older medicines.  This is 
becoming a grave concern for the countries and inte rnational agencies that offer treatment.  Patients 
need to switch to the second line medicines within a couple of years after starting treatment and these 
medicines may cost up to 12 times as much."  
128. Therefore, the discussions at this meeting would have a fundamental impact on access to 
affordable medicines in the near future.  Effo rts in the TRIPS Council and in other fora should 
concentrate on analyzing whether the economic and political incentives provided by the System were 
adequate to secure investment in the production of generic medicines at affordable prices to markets 
with no manufacturing capacity.  TRIPS-plus provisions  that adversely affected the right to access to 
medicines, such as data exclusivity of clinical tr ials, should also be analyzed.  Given that economies 
of scale were an essential element in incentives for i nvestment in this area, it was also important to 
design ways to improve the utility of the system to serve small markets. 
129. The representative of the Bolivarian Republic of Venezuela
 said that his delegation saw the 
background to the System in a different way to Sw itzerland.  Before looking into the intention of 
establishing the System, the importance of the Doha Declaration in 2001 for developing countries had 
to be recalled.  The System launched pursuant to  paragraph 6 of the Declaration was the only escape 
valve to protect public health in developing count ries.  From 2001 onwards, prices of medicines had 
increased.  Before the TRIPS Agreement, there had been no issue with respect to the patenting of 
medicines.  Despite the fact that Canada considered  this mechanism to be successful, he believed that 
it had been a serious failure.  He therefore supporte d the organization of a workshop so that delegates 
could discuss in an informed manner, taking in to account the experience of the pharmaceutical 
industries and NGOs. 
130. Noting that the delegation of Canada had stat ed that implementing anti-diversion measures 
had not been onerous on Apotex given that it was a well-established global company with presence in 
a number of jurisdictions, the representative of Eg ypt said that while this might be the case for a 
Canadian company, it would not necessarily apply to generic companies from other countries.  While 
generic companies in his country would be able to  produce certain products, they might not have the 
same global reach or presence in various markets, so the anti-diversion measures could be perceived 
as onerous by them.  In his view, there was no leve l playing field with regard to such measures.  
Given that a number of questions had been raised in this discussion that would necessitate replies 
from the stakeholders, he reiterated his support for the convening of a workshop that would take on 
board comments and replies from all these stakeholders. 
131. With respect to the purpose of the System, he considered it to be part of a constellation of 
measures that had been adopted in the Doha Declarati on, in particular addressed in its first and second 
paragraphs.  He stressed the need for the WTO Agr eement and the TRIPS Agreement to be part of the 
wider national and international action to address the i ssue of the gravity of public health concerns.  
He saw the Doha Declaration as part of a constellation of measures to ensure that the TRIPS 
Agreement played its part and was not an obstructio n to addressing the issue of access to medicines.  
Its Paragraph 6 dealt with an extremely important element of that, addressing the difficulties of Members that had limited or no pharmaceutical manufacturing capacity.    IP/C/M/64 
 Page 31 
 
 
  132. While the generic pharmaceutical industry was present in his country, there had been three 
instances in the past decad e when it would not have been able  to supply needed medicines in 
sufficient quantities.  These case s included anthrax, the H5N1 avian flu pandemic and finally the 
H1N1 virus.  He thought that this situation was sh ared by the vast majority of Members.  An agile, 
dynamic and expeditious solution was therefore needed .  The fact that the System had only been used 
once over the past decade and that it had taken many years to provide a measure of workability 
indicated that it was by no means an expeditious solu tion.  This did not forebode well for the future. 
133. The representative of India  referred to the statement by the delegation of Venezuela regarding 
the purpose of the System.  Two valid points had been made with respect to the role of the System in 
access to medicines and regarding the fact that TRI PS was perceived by several developing countries 
as a problem in the context of public health.  This  was also reflected in the report of the UN Special 
Rapporteur on the right of everyone to the enjoymen t of the highest attainable standard of health 
which had been accepted by the United Nations  Human Rights Council in 2009.  The report had 
further mentioned that TRIPS-plus was aggravati ng the problem of access to medicines and public 
health.  In his delegation's view, the Swiss reading of  the System was very narrow.  Paragraph 4 of the 
Doha Declaration clearly said that "we affirm that  the Agreement can and should be interpreted and 
implemented in a manner supportive of WTO Member s' right to protect public health and, in 
particular, to promote access to medicines for all."  The Doha Declaration was significant, since it was a political assertion signifying that public health concerns overrode intellectual property rights. 
134. The representative of Canada
 expanded upon the discussion on anti-diversion measures.  
According to the System, products manufactured under a compulsory licence should be physically 
distinguishable from the patented product and, in addition, the licensee was required to post 
information on a website describing the distinguishin g features, as well as information regarding the 
quantities being shipped to each des tination.  CAMR required physical markings as part of the anti-
diversion measures.  Products exported under the licen ce had to bear the mark "XCL" for solid oral 
dosage forms, and had otherwise to be of a col our significantly different from the version sold 
domestically or had to include certain informa tion on all labelling to distinguish them from the 
domestic version.  Instead of putting its company name on the pill, Apotex had apposed the mark "XCL", and had chosen to make the colour of the pill white, instead of blue.   
135. Products were also issued an export tracking number by Health Cana da, which was required 
to be printed on the product label.  Since products had to have a product labe l, Apotex had put this 
additional information there.  Before exporting a pharmaceutical product under CAMR, the licensee 
was also required to establish a website disclosi ng the name of the licensed product, distinguishing 
characteristics, the identity of the importing country and the amount to be manufactured and sold for 
export, as well as the information identifying every known party that would be handling the product while it was in transit from Canada to the impor ting country.  Large companies were capable of 
providing or creating a website, as it was not a very onerous demand.  To further promote 
transparency, the licensee was also required to provi de to the patentee, the importing country and the 
purchaser, within 15 days of the product being exported, a note specifying the quantity to be exported and the identity of every known party that would be handling the product while in transit.   
136. In his delegation's view, paragraph 2 of the D oha Declaration was very important.  In this 
paragraph, Ministers had stressed "the need for the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights to be part of the wi der national and internati onal action to address these 
problems."  Since 2003, there had been a concerte d effort amongst WTO Members to take national 
and international action to address these problems of which the System was just one tool in a growing 
arsenal of tools.  This was a very positive developm ent and reflected a change in the environment that 
needed to be taken into account as this important issue was discussed.   IP/C/M/64 
Page 32  
 
  137. As regards questions relating to safety and efficacy, Canada had taken an early policy 
decision that drugs exported under CAMR should meet  the same standards for safety, efficacy and 
quality as any drug sold on the domestic market.  Health  Canada would, in any event, be in charge of 
undertaking a review, once the patents had expired,  to enable off-patent drugs to come to the 
Canadian market.  It was therefore in its best interest to  ensure that there was no double standard.  In 
the case of Apo-TriAvir, Apotex had submitted a re quest for approval of a generic drug, based on the 
three reference products that it had been using.  Safety and efficacy had been established on the basis 
of bioequivalence, as for any other generic product.  The quality of the drug had been established on the basis of a chemistry manufacturing review, which was also applied to drugs for the domestic market, as well as good manufacturing practices which were a worldwide recognized quality standard.  
The clinical trials to establish bioequivalence of the generic drug and the reference product had been 
undertaken in Canada under Health Cana da's authorization for clinical tria ls.  Such clinical trials came 
under the Food and Drugs Act and had to be approved  by Health Canada, as in any other country.  
That process had provided the information that ha d been requested for the establishment of safety, 
efficacy and quality. 
138. The representative of New Zealand
 noted that there had been a lot of discussion about the 
Canada-Rwanda case which showed that the System  could work.  There had been little discussion, 
however, about instances where the System had been considered but not used.  It was necessary to 
examine those situations at least as closely as the Canada-Rwanda case had been examined.  He 
requested more information from the delegation of India as to the three cases it had mentioned where 
applications under the System had been initiated but ha d later been discontinued.  He wished to better 
understand the facts on the basis of which the delegati on of India had drawn its conclusions.  He also 
requested more information from the delegation of  Egypt as to why it would be easier for generic 
producers in Canada to comply with the requireme nts of the System than for generic producers in 
Egypt.   
139. Furthermore, he echoed the request made by th e delegation of Canada to hear from potential 
importers.  As it was the TRIPS Counc il that was responsible for the review of the System, he felt that 
it was ultimately the responsibility of the Memb ers to communicate and understand the facts.  
Consequently, he requested to hear more from Me mbers who had considered using the System, but 
had subsequently not done so.   
140. The representative of Malaysia  asked the delegation of Canada whether there was any bar 
under Canadian law which prevented a manufacturer from applying for marketing approval of a drug 
before the expiry of the patent for the drug.  If th ere was such a bar, he asked whether there was an 
exception applying in cases where the System would be used. 
141. The representative of Indonesia  commented on a number of constraints on the System's 
implementation.  Firstly, there was resistance fro m patent holders.  Secondly, for medicines that 
needed specific technologies, developing and l east developed Members would face problems or 
would even find it impossible to manufacture those me dicines.  There was therefore a need to look 
also at Article 7 of the TRIPS Agreement with respect to the objectives of the Agreement which 
included transfer of technology.  This was one  of the solutions to address problems currently 
encountered with the System, because it was nec essary to reduce the number of countries who were 
on the demand side and sought to become manufacturi ng countries in the future.  Thirdly, he shared 
the concerns raised by the delegation of Brazi l with respect to TRIPS-plus provisions which 
represented one of the constraints in implementing the System.  Fourthly, donations from international 
funding organizations and NGOs, such as the World Bank, UNICEF, the MSF and  the Global Fund, 
generally required that manufacturers needed to  be pre-qualified under the WHO pre-qualification 
system.  Pre-qualification involved the national regulatory authority, as well as the respect of pharmaceutical industry requirements which were not easy to fulfilfulfill.  For developing Members, 
and least developed Members particularly, pre-qualifi cation requirements were even more difficult to  IP/C/M/64 
 Page 33 
 
 
  implement.  Therefore, improving their capacity as exporting countries or manufacturing countries 
was similarly much more difficult.  He thought th at holding a dedicated workshop on this issue was 
necessary and very timely. 
142. The representative of India  noted that his delegation could not provide a complete timeline of 
events regarding the instances where applications to  use the System had been submitted and had later 
been aborted, as only one step had been taken.  First-hand information on this case could best be 
provided by the delegation of Nepal.  He end eavoured to gather more information from NATCO 
Pharma, the company which had applied for the com pulsory licences, to share with Members at the 
next TRIPS Council meeting.   
143. The representative of Canada  asked the delegation of Indonesia for specific examples in terms 
of resistance encountered from patent holders, and asked whether this was in relation to a potential 
use of the System.  He also asked which medici nes Indonesia had found difficult to obtain, what 
efforts it had made to try to obtain them, whethe r the System was entertained as an option to obtain 
those essential medicines and, if not, why this had not been done.   
144. With respect to Malaysia's question regarding th e ability for a generic drug to be marketed in 
Canada, the representative of Health Canada said that  the Patent Act had an early working clause that 
allowed the development of a generic drug in ad vance of the patent expiry for the purpose of 
preparing a submission seeking market authorization.  Health Canada would complete the review, but 
the market authorization would not be granted until su ch time as all issues related to the protection of 
patents were addressed.  For this reason, Apo-TriA vir could not come to the Canadian market until 
the patents concerned expired, which explained why Apotex had sought a compulsory licence to 
export Apo-TriAvir.  As regards the comments on the national drug regulatory authorities, their 
involvement was useful because they played a role  in access to medicines.  Based on the review by 
Health Canada, Apo-TriAvir had been included on the WHO's list of pre-qualified drugs by using the 
alternative procedure available to the European Union, the US Food and Drug Administration and to 
Canada. 
145. The representative of the European Union  noted that the System addressed only a specific 
aspect of the broader issue of access to medicines in the developing world.  But this was a mechanism 
that contributed to improving access to medicines.  Th e approach to this System should be voluntary 
as Members had to make it work.  Other aspects had to be taken into account with regard to access to 
medicines, such as financing of medicine purch ases, the setting-up and financing of health-care 
systems, the financing of research targeting negl ected diseases and the development of appropriate 
pricing and reimbursement policies.  These issues went well beyond intellect ual property and patent 
protection.  They exceeded the Council's mandate and were well  addressed by other organizations, 
such as the WHO, in other fora. 
146. In response to questions from the delegations of Malaysia and Indonesia regarding marketing 
authorization, the representative of the United Stat es referred to a policy initiative, which had been 
launched by the US Food and Drug Administration (FDA) in May 2004 to help ensure that those 
being served by the President's Emergency Plan for AIDS Relief (PEPFAR) would receive safe, effective and quality manufactured antiretroviral drug s.  This initiative included an expedited review 
process.  Through guidance and an active outreach programme to the pharmaceutical industry, FDA 
actively encouraged any sponsors worldwide to s ubmit US marketing applications for single entity, 
fixed-dose combination, and co-packaged versions of previously approved antiretroviral therapies, 
even if there was still patent or exclusive marke ting protection for the product in the United States.  
Drug products used in PEPFAR received a "tentati ve approval" where the manufacturing of these 
products met all the FDA's manufacturing quality, clinical safety, and efficacy requirements as 
required for domestic marketing purposes.  After approval or tentative approval from the FDA under 
the expedited process, a generic antiretroviral would quickly pass onto the WHO's pre-qualification IP/C/M/64 
Page 34  
 
  list, because of a confidentiality agreement that allo wed FDA to share its review data with the WHO 
secretariat in Geneva.  This was relevant to the implementation of the System, because this relied not 
only on what Canada had described as its implem enting legislation, but also on other related 
measures. 
2. Implementation of the System into dom estic legislative and regulatory framework 
147. The Chairman
 said that under this topic the intention was to focus on the experience of those 
Members who had implemented the System as pot ential exporting and/or importing Members.  In 
order to have a full understanding of the situation, Me mbers had indicated that it would also be useful 
to get some feedback from those Members that had not yet implemented the System, particularly with respect to any problems they had encountered in its implementation. 
148. The representative of Canada
 said that CAMR was the Canadian legislation that implemented 
the humanitarian objectives of the Decision, bala ncing often competing policy objectives.  The 
following conditions applied under the Decision:  th e importing country had to notify the WTO of its 
intent to use the Decision;  the licensee had to request voluntary licence(s) from the patentee(s) prior 
to seeking a compulsory licence under the Decision;  the quantity produced under compulsory licence 
could not exceed the amount notified by the importing country;  adequate remune ration had to be paid 
to the patentee(s);  products shipped under the Agreem ent should not be diverted to other markets;  
products had to be specially marked and labelled;   licensees had to post on a website the quantities 
and features of the product being shipped;  and, lastly, the intention was to support humanitarian 
policy objectives, not commercial ones. 
149. During the development of legislation in 2003 and 2004, and again during the statutorily 
mandated review of  the legislation in 2006, key stakeholders, including from the R&D industry, the 
generic industry and civil society, had been consulted.  All stakeholders had supported the establishment of CAMR and continued to support it , but diverged on certain aspects of the regime.  
For example, brand name companies wanted st rong anti-diversion measures, generic companies 
sought streamlined processes with incentives to par ticipate, and NGOs wanted a liberal regime with 
no restrictions on eligible importing countries or products.  CAMR's overridi ng key challenge was to 
ensure a delicate balance between facilitating access  to medicines while ensuring that incentives for 
the innovation of new medicines and technologies remained.  CAMR pursued several objectives, 
including to:  (i) facilitate access to lower-cos t pharmaceutical products in countries facing public 
health problems;  (ii) respect Canada's obligatio ns under TRIPS and other international treaties;  
(iii) respect the domestic patent system;  and (iv)  encourage generic companies to participate in 
CAMR.   
150. CAMR's key features concerned eligible importi ng Members, eligible medicines for export, 
requirements regarding safety and quality of pr oducts, steps required to be taken by a local 
manufacturer seeking to export under CAMR, distingui shing features of products, royalties, dispute 
settlement and statutory review.  Eligible importi ng countries were listed under Schedules 2, 3 and 4.  
All LDCs and WTO Members were eligible to import except those that had opted out, such as his own 
country, the United States and France.  Non-WTO Memb er developing countries were also eligible to 
import pharmaceutical products under CAMR upon request.   
151. Eligible products for export were listed in Sc hedule 1.  Every product on the WHO's list of 
Essential Medicines that was patented in Canada w as eligible for export.  He noted that Schedule 1 
had been amended twice since 2005 to include new products such as the HIV/AIDS triple-
combination therapy Apo-TriAvir and Tamiflu.   CAMR ensured that a product exported under 
CAMR met the same safety, efficacy and quality standards as those products destined for the 
domestic market.    IP/C/M/64 
 Page 35 
 
 
  152. A local manufacturer who sought to export under CAMR was required to submit the 
following information to the Commissioner of Patent s:  (i) the name of the patented product for 
export, the eligible importing country, the existing pa tents and the quantity to be manufactured;  (ii) a 
certified copy of the importing country's notification to the WTO or to Canada (if the importing country was not a WTO Member);  and (iii) a declara tion that the applicant had attempted to negotiate 
a voluntary licence with the patentee(s) at least 30 days prior to submitting an application for an 
export authorization. 
153. Exported products had to carry prescribed marki ngs and labelling.  The name of the product, 
quantity, markings, and importing country had to be  disclosed on the manufacturer's website.  The 
royalties paid to the patentee(s) ranged between 0. 02 per cent and 3.5 per cent and were linked to the 
importing country's level of development as lis ted on the UN Human Development Index and the 
value of the contract.  If the licensee failed to meet the terms and conditions of the export 
authorization, or if diversion occurred, terminati on of the licence by the Federal Court was possible. 
154. Recognizing the importance and the groundbreaking nature of CAMR, its enabling legislation 
included a clause requiring the Minister of Industry to  review the relevant sections of the Patent Act 
two years after CAMR's coming into force.  In  November 2006, the Government of Canada had 
launched a 60-day consultation seeking public views and opinions on CAMR.  Through this process, 
the Government had received numerous submissions from the pharmaceutical industry, NGOs, academia, and Parliamentarians.   
155. In December 2007, the Minister of Industry had tabled a report in Parliament containing the 
results of the consultation period and review.  The report and submissions were available online at the 
CAMR website (www.camr-rcam.gc.ca).  The report on Canada's statutory review of CAMR had 
been a comprehensive analysis that considered each element of the regime in the context of relevant 
international trade rules.  It had also take n into consideration circumstances surrounding the 
Commissioner of Patents granting of an export author ization to Apotex under CAMR.  In addition, the 
report had examined the broader context of disease bu rden in the developing world, international and 
country-based initiatives to address that burden, a nd some economic consider ations affecting the 
supply of antiretroviral drugs used to treat  HIV and AIDS.  The 2007 report had found that 
insufficient evidence had accumulate d since the coming into force of CAMR to warrant legislative 
changes at that juncture. 
156. However, the report had also highlighted ot her systemic factors outside the operational 
aspects of CAMR that appeared to be discouraging its  use.  These factors included a lack of eligible 
importing Member notifications to the WTO or to  Canada and a lack of awareness of CAMR among 
eligible importers.  In response to the second fact or, Canada had varied a nd intensified its outreach 
activities to continue to raise awareness of CAMR among eligible importers, pharmaceutical 
regulatory authorities and generic manufacturers.  Mere  months before the report had been released, 
Apotex had applied for and received an author ization to manufacture and export under CAMR in 
order to fulfil the need identified by Rwanda in its  WTO notification.  The report had been released 
well before Apotex had shipped Apo-TriAvir to Rwanda in September 2008.   The report had taken 
note of this and had provided the following assessment:  "...  for the moment at least, the granting of 
the first and only export licence under the waiver to Apotex, and the circumstances surrounding it, 
suggest that CAMR works reasonably well and quick ly, provided an importing country has made a 
requisite notification to the WTO".  With no further notifications to the WTO since the report's release 
in 2007, this observation remained valid. 
157.
 The representative of China  provided an overview of the domestic implementation of the 
System and the main changes relating to public health  in the amended Patent Act.  The patent law of 
the People's Republic of China had first entered in to force on 1 April 1985 and had been amended in 
1992, 2000 and 2008.  On 27 December 2008, th e Standing Committee of the National People's IP/C/M/64 
Page 36  
 
  Congress had adopted a decision to revise the patent la w.  The new patent law had come into effect on 
1 October 2009.  Subsequently, the State Counc il had promulgated its decision on revising the 
implementing regulations of the patent law in January 2010.  They had come into force on 
1 February 2010, concluding th e third revision process.   
158. The 2003 Decision and the Protocol Amending the TRIPS Agreement provided a means to 
assist Members who had insufficient or no manufactur ing capacities in the pharm aceutical sector to 
address public health problems.  WTO Members could grant a compulsory licence to manufacture and export patented pharmaceuticals to such Members.  China had accepted the Protocol in October 2007.  
To implement it, Article 50 had been added to the Chinese Patent Law, enabling the State Intellectual 
Property Office (SIPO) to grant compulsory licences to manufacture patented pharmaceuticals for the 
purpose of exporting to eligible Members.  Article  50 provided that, for the purposes of public health, 
the patent administration department and the State Council could grant a compulsory licence to manufacture a patent-protected pharmaceutical product for export to countries or regions specified in the relevant international treaties to which China wa s a party.  In Article 53, the requirement that 
compulsory licensing should be used predominan tly for the supply of the domestic market was 
waived with respect to the export of a patented medicine for the benefit of public health.  The 
amendment of Article 57 clarified that royalties had to  be paid to the patentee according to relevant 
provisions in the Decision and the Protocol when a compulsory licence was granted for public health 
purposes.  The implementing regulations provided further details, such as the definition of a 
pharmaceutical product in Rule 73, paragraph 2.  Ru le 74, paragraph 4, provided that the grant of 
compulsory licences pursuant to Article 50 of the Pate nt Act had to be in accordance with the relevant 
international treaties to which China was a party.  The amendments to the Chinese patent system had 
fully implemented the System into the domestic law.   As of 1 October 2010, no compulsory licence 
had been granted by the Chinese authorities.  SIPO was planning to revise the procedures relating to 
compulsory licensing to provide specific requirements in line with the Protocol. 
159. The representative of the European Union
 said that his delegation had implemented the 
System as a potential exporting Member.  On 17 May 2006, it had adopted new legislation to that 
effect.  Regulation (EC) No. 816/2006 of the Euro pean Parliament and of the Council represented an 
instrument that allowed the compulsory licensing pr ocedure under the System to fit within the context 
of EU member States' national patent laws and th e respective compulsory licensing procedures.  This 
gave transparency and clarity for those companie s operating within the EU internal market and 
wishing to apply for compulsory licences for export to countries in need.  It created a legal basis at the 
EU level to enable European generic producers to  manufacture medicines under compulsory licences  
for export to countries in need.  It did not impose further restrictions on the Decision. 
160. The scope was one of the main elements of this regulation.  Firstly, the beneficiary countries 
included both least developed countries and low-in come developing countries, including those who 
were not members of the WTO.  Secondly, there were no specific exclusions as to the scope of 
diseases.  The Regulation referred to public health  problems and did not target specific diseases.  
Thirdly, the Regulation applied to any product of  the pharmaceutical sector, including medicinal 
products, active ingredients and dia gnostic kits ex vivo.  The Regulation also foresaw a role for 
non-governmental and internationa l organizations who could become involved in any purchasing 
procedures and could also make requests on behalf of an importing country with that country's 
approval.   
161. An applicant for a compulsory licence unde r the System was required to submit its 
application to the competent authority of the EU member State where the medicine was going to be manufactured, or from where it was going to be exporte d.  The applicant was able to avail himself of 
the EU scientific opinion procedure or equivale nt national procedures to ensure the safety and 
efficacy of the medicine.  The EU had felt th is was a necessary complement to the licensing 
mechanism in order to assist importing countries.  Th e application had to contain information as to the  IP/C/M/64 
 Page 37 
 
 
  name and contact details of the applicant, the non-proprietary name of the product concerned, the 
amount of medicine to be produced and the name  of the importing country or countries.  The 
competent authority would grant the compulsory licen ce and determine the remuneration to be paid to 
the patent holder.  In the case of an urgency, the remuneration was a maximum of 4 per cent of the 
total price to be paid by the importing country.  In  other cases, the remuneration had to be adequate. 
162. The licence had to be non-exclusive, non-assignabl e and limited in scope and duration.  The 
products had to be clearly identified.  The licensee had to inform the authorities of the quantities and 
distinguishing features of the products and also keep records in order to allow verification of whether 
the terms of the licence, in particular those relati ng to the final destination of the product, had been 
met.  The scope and duration of the licence were determined by the needs stated by the importing 
country or countries.  Appeals against competent authorities' decisions and disputes relating to the 
compliance with the licence conditions were hear d by the appropriate body under the law of the 
member State concerned.  Once e xport had occurred, all parties had an interest in seeing that 
medicines were not diverted from those in need.  The Regulation prohibited re-importation into the 
European Union and provided for cu stoms authorities to take action against goods being re-imported.  
The patent holder could use existing national proc edures to enforce its rights against re-imported 
goods if they did enter the European Union.  Te rmination of the licence granted under the Regulation 
would be notified to the TRIPS Council.  No com pulsory licence had thus far been granted under the 
Regulation, but any application from developing co untries would be welcome.  Moreover, he noted 
that his delegation had committed itself not to use the System as an importer.   
163. The representative of Hong Kong, China  said that her delegation had notified its acceptance 
of the Protocol on 27 November 2007.  The Pa tent Amendment Ordinance 2007 had been passed on 
30 November 2007 and had taken effect on 22 February 2008.  It had introduced two new parts to the 
Patents Ordinance, one dealing with the importa tion of pharmaceutical products under the Protocol 
and the other dealing with the exportation of such pr oducts.  Prior to the Protocol coming into effect, 
the Amendment Ordinance allowed her delegation to rely on the temporary waiver to enable it to 
import patented pharmaceutical products from a WTO Me mber to address a public health crisis or to 
export such products to a WTO Member.   
164. Her delegation had declared that it would not use the System as an importer unless in a 
situation of national emergency or  other circumstances of extreme urgency, which the chief executive 
in Council may declare.  During such a declared pe riod of extreme urgency, the Director of Health 
would be empowered, if he consider ed there were insufficient or no manufacturing capacity, to grant a 
non-exclusive compulsory licence to any person to import the pharmaceutical product or to do any 
other act which would otherwise amount to an in fringement of the patents concerned, without the 
consent of the patentee.  The Director of Health w ould be required  to notify the patentee of the grant 
of the import compulsory licence as soon as was prac ticable and to publish the grant of the licence 
and its terms and conditions in the specified official journal.   
165. The Amendment Ordinance stipulated that the import compulsory licence would be subject to 
the following conditions:  (a) the entire quantit y of the pharmaceutical product imported under the 
licence should only be used domestically and not be exported to other places;  (b) the pharmaceutical 
product should be clearly identified through specifi c labelling or marking as being imported pursuant 
to such licensing system;  (c) the licence was not assignable except as part of the business of the 
assignor that enjoyed the use of the patent under th e compulsory licence;  and (d) such other terms 
and conditions as the Director of Health deemed fit, having regard  to the public health needs in 
Hong Kong, China in a declared period of extreme urge ncy.  The Director of Health had the power to 
terminate an import compulsory licence where there w as contravention of any term or condition of the 
licence.  Payment of royalties to the patent owne r was only required where he could show that 
remuneration had not been paid in the exporting juri sdiction and that all legal remedies to recover 
royalties had been exhausted.  The amount of rem uneration should be agreed between the Director of IP/C/M/64 
Page 38  
 
  Health and the patentee.  Where an agreement could not be reached, the amount of remuneration 
could be determined by the court.  The Amendm ent Ordinance provided for the disposal of any 
remaining stocks upon the termination of the period of extreme urgency.  The licensee was required to 
take reasonable steps to recall such stocks and eith er surrender them to the government or to the Hong 
Kong Special Administrative Region or dispose of them in such a way as may be agreed with the 
patentee. 
166. The Amendment Ordinance also empowered the Di rector of Health to grant a compulsory 
licence for the making and export of a pharmaceutical product to be supplied to a WTO Member recognized as a least developed country or a WTO Member that had given notice to the TRIPS Council that it intended to import pharmaceutical products under the System.  Where the importing 
WTO Member did not declare a national emergency or  other circumstances of extreme urgency, the 
applicant for an export compulsory licence was re quired to make reasonable efforts to obtain an 
authorization from the patentee on reasonable comme rcial terms and conditions  before applying for 
the licence.  The grant of the export compulsory  licence was subject to the terms and conditions 
stipulated in the Amendment Ordinance, including  as regards (a) the quantity of the pharmaceutical 
products that could be produced and sold for export; (b) the need to clearly identify the 
pharmaceutical products through specific labelling or  marking as being produced pursuant to such 
licensing system;  (c) the posting on a dedicated webs ite of information relating to the amount of the 
pharmaceutical product that would be exported to th e importing Member and the labelling or marking 
used to identify the product;  and (d) such othe r terms and conditions as the Director of Health 
deemed fit.  The Director of Health had the pow er to terminate an export compulsory licence where 
there was non-compliance with any term or condition of the licence or where any information, 
documents or evidence specified in or accompanyi ng the application for the compulsory licence was 
false, incorrect or incomplete.  The remunerati on payable by the licensee of an export compulsory 
licence was to be determined by the Director of Health on a case-by-case basis. 
167. The representative of India
 said that his delegation had implemented the System in its patent 
legislation in the form of Section 92A of the Indian Patent Amendment Act 2005.  Under 
Section 92A, a compulsory licence would be available for manufacture and export of patented pharmaceutical products to any country having in sufficient or no manufacturing capacity in the 
pharmaceutical sector for the concerned product to  address public health issues, provided the 
compulsory licence had been granted by such a country, or the country had by notification or otherwise allowed importation of th e patented pharmaceutical products from India.  Use of Section  
92A was not restricted to WTO Members and was simp le to use.  The guiding principle for India had 
been to make the use of the System as easy as po ssible.  India had accepted the Protocol Amending 
the TRIPS Agreement on 26 March 2007. 
168. The representative of Korea
 said that his delegation had accep ted the Protocol Amending the 
TRIPS Agreement on 24 January 2007.  At the time of the adoption of the Protocol, his delegation 
had declared that it would not use the System as an importer.  In 2005, Article 107(1)(v) of the Patent 
Act and other relevant provisions had been en acted, and the Regulation on Expropriation and 
Licensing of Patents had been amended to provi de statutory grounds and to set procedures for 
granting a compulsory licence for export.  In July 2010, the Regulation had be en further amended to 
make the procedures easier and more transparent.   
169. To obtain a compulsory licence under domestic pate nt law, an applicant had to make a request 
for the grant of a compulsory licence.  This app lication had to include the method for calculating 
remuneration, the reason for the request and supporti ng evidence, and evidence of failed negotiations 
with the right holder.  In the case of a compulsory licence for export, the applicant additionally had to 
attach:  (i) proof that the compulsory licence re quest was for the purpose of treating a disease that 
threatened public health in the importing country;  (ii) confirmation of the intent of the importing 
country;  (iii) an evaluation of the economic va lue of the pharmaceutical product in the importing  IP/C/M/64 
 Page 39 
 
 
  country;  and (iv) proof that the importing country had notified the WTO of the name and quantity of 
the pharmaceutical product and its lack of manufacturing capacity.  In the case of non-WTO Member LDCs, the applicant additionally had to provide proof that the importing country had notified the 
Government of Korea of the name and quantity of  the pharmaceutical product and the country's lack 
of manufacturing capacity.  In addition, the appli cant had to submit the dis tinguishing features that 
differentiated the product manufactured for export under the compulsory licence from products 
manufactured by the patentee or other interested part ies, as well as the internet address where such 
details would be made available. 
170. Copies of the request for a compulsory licence had to be delivered by the Commissioner of 
Patents to the patent right holder and other interest ed parties in order to provide an opportunity to 
submit comments.  The Commissioner also had to pu blish the request for the compulsory licence in 
the patent gazette and proceed to a preliminary regi stration of the terms of adjudication.  If necessary 
to decide on the grant of the compulsory licen ce, the Commissioner could seek assistance from the 
Intellectual Property Dispute Mediation Counc il which was composed of representatives from 
different ministries and other expert bodies.  The Commissioner had to determine in writing the scope 
and duration of the compulsory licence, the amount of remuneration, the method of payment, as well 
as other terms of implementation.  The adjudication ha d to be made within six months of the request.  
In case of compulsory licensing for export, the licence had to be granted if all the legal requirements were satisfied.  This feature differentiated su ch licences from procedures applying to standard 
compulsory licences.  Following the grant of the licence,  a copy of the decision had to be delivered to 
the patentee and other interested parties, an abstr act of the decision had to be published in the patent 
gazette, and the non-exclusive licence be registered.  Remuneration had to be pa id or a bond be posted 
as a security by the licensee.   
171. Amendments had been made to the Regulation on Expropriation and Licensing of Patents in 
July 2010 to make procedures for export com pulsory licences easier, more transparent and 
predictable.  To achieve this objective, among othe rs, any competent Minister seeking the grant of a 
compulsory licence could also request that a search be  carried out regarding the patents related to the 
invention for which a compulsory licence was requested.  An additional provision also provided detailed criteria for calculating the amount of re muneration to be paid to the patentee.   
172. The representative of Switzerland
 said that Switzerland was a WTO Member which had 
manufacturing capacity in the pharmaceutical se ctor.  The Swiss pharmaceutical industry had 
particular expertise and strength in the area of re search and development of innovative medicines and 
also was active in the generic medicines sector.  His delegation had fully opted out of the System as 
an importing country in 2003.  It had implemented th e System in its national legislation as a potential 
exporting country and had been the second WTO Memb er to notify its acceptance of the Protocol 
Amending the TRIPS Agreement (WT/Let/547) on 13 September 2006.  The Bill implementing the 
System had met the approval of the various stakehol ders, including all relevant Government agencies, 
political parties, NGOs, industry associations and consumer organizations.  The relevant report 
summarizing the consultations that had taken place could be accessed on the Swiss Government homepage (http://www.admin.ch/ch/d/gg/pc/doc uments/1167/Ergebnisse_d.pdf).  The Swiss 
Parliament had accepted the amended Patent Act, which included the implementation of the System, 
on 22 June 2007.  The Act had entered into for ce on 1 July 2008 and had been notified to the WTO 
(IP/N/1/CHE/P/9).   
173. The revised Patent Act contained a new Article  40(d), which provided for the possibility of 
applying for a compulsory licence for export purposes.  The pre-existing and, in the revision, renumbered Article 40(e) contained general provisions on uses without  authorization of the patent 
right holder.  It had been revised to incorporat e additional and specific terms and conditions for a 
Paragraph 6-type compulsory licence.  The Patent  Ordinance, which served as an executive regulation 
complementing the Patent Act, provided in its Artic le 111 further terms and c onditions to be respected IP/C/M/64 
Page 40  
 
  in the grant of such an export co mpulsory licence.  In addition to the legal provisions in the Patent Act 
and in the Ordinance, further helpful information and policy guidance on the contents of the amended 
law as well as the legislator's intention and interp retation of the relevant legal provisions could be 
found in a so-called legislative dispatch, which was a sort of explanatory report by the Government 
which had been sent together with the proposed Bill to the Parliament.  The substance of the Swiss 
legislation implementing the System was thus clo sely following the provisions and requirements as 
contained in the Protocol.  Those were mirrored in  a clear and straightforward manner in the amended 
Swiss Patent Act. 
174. Under the Swiss implementing legislation, com pulsory licences could be issued for specific 
medicines, active ingredients, diagnostic kits or vaccines patented or manufactured under a patented 
process.  Any country that met the terms and c onditions established by the System could be an 
importing country under Swiss law.  Exclusions a pplied to WTO Members in accordance with their 
full or partial opt-out status.  A country did not need to be a WTO Member in order to be a beneficiary country.  Responsible for the grant of the compulsory licence were the courts responsible 
for patent matters to which an a pplication had to be submitted.  As  part of the application, the 
applicant had to submit the notifications require d under the System.  The court had to treat the 
application expeditiously.  It was re quired to submit the details of the licence, if granted, to the Swiss 
Intellectual Property Office which would notify them  to the WTO.  As in the case of standard 
compulsory licences, adequate remuneration was to be determined on a case-by-case basis by the 
Court.  However, the Government's explanatory re port had specified that the economic value of the 
patent's legal use under a compulsory licence in the beneficiary country had to be taken into account, 
as well as the country's level of development, based on its position on the UN Human Development 
Index.  The owner of a Paragraph 6 compulsory licence had to obtain authorization from the Swiss 
Agency for Therapeutic Products to manufacture und er the Federal Drug Law.  The standards of good 
manufacturing contained in that Law also had to be  complied with.  Sanctions and criminal penalties 
would apply if the terms and conditions of th e licence were not complied with, including anti-
diversion measures.  In case of a failure of comp liance with the terms and conditions, the Court could 
also revoke the licence.  His delegation had not en countered any particular problems in implementing 
the System, which provided sufficient guidance.   
175. His delegation did not consider the System or  its domestic implementation, whether as an 
importing or exporting country, to be a panacea for affordable access to medicines in developing countries.  Rather, it was one contribution that the TRIPS Council had been able to make to combat 
challenges posed to public health.  His delegation had no practical experience using the System, as to 
date it had not received any request for a compulsory licence thereunder.   
176. The representative of Croatia
 said that Croatia had implemen ted provisions pertaining to the 
grant of compulsory licences, supplementary certif icates and prohibition of re-importation into its 
Patent Act in 2007, which was reflected in the Act on Amending the Patent Act of December 2009.  
Croatian authorities had begun the process of accepti ng the Protocol Amending the TRIPS Agreement 
in May 2010.  Acceptance of the Protocol had b een passed in Parliament and the process would be 
completed and the outcome be published in the offici al journal in due course.  The instrument of 
acceptance would soon be notified to the WTO.   
177. The representative of Ecuador  noted that, under the Ecuadorean Constitution, the State had to 
guarantee the health of the Ecuadorian people and to facilitate the availability and accessibility of high 
quality, safe and effective medicines.  The Constituti on further provided that public health interests 
prevailed over economic and commercia l interests (Articles 3 and 32).  It also provided that health 
was a human right.  It was therefore not just a political commitment to promote and secure health, but a constitutional right to which every Ecuadorian citiz en was entitled.  This implied an obligation for 
the State to secure the enjoyment of the highest pos sible standard of health care and the establishment 
of a health protection system which guaranteed equal health opportunities for all citizens.    IP/C/M/64 
 Page 41 
 
 
  178. He said that Ecuador had adopted a common i ndustrial property regime with other Members 
of the Andean Community, through Decision No.  486 of September 2000.  This legislation, which was part of Ecuador's domestic law and had direct  legal effect, had enabled all Andean Community 
member countries to entertain compulsory licensing re quests and, where appropriate, to grant them as 
provided for by Articles 61 to 66 of Decision No.  4 86.  Moreover, Ecuador's Industrial Property Law 
of May 1998 had established compulsory licensing regulations at the domestic level as per its 
Articles 154 to 156.  These regulations were to be  interpreted in conjun ction with the Andean 
Community regulations.  Other components of the legal framework for compulsory licensing were Article 31 TRIPS and the Doha Declaration on the TR IPS Agreement and Public Health.  All of these 
elements provided the legal basis for authorizing co mpulsory licensing for reasons of public interest, 
emergency or national security in Ecuador. 
179. The Government's domestic policy guaranteed universal access to medicines for Ecuadorian 
people, through the provision of safe and reliable generic medicines under compulsory licence.  This health policy was the result of the implementati on of the national development plans 2007-2009 and 
2010-2013.  To grant a compulsory licence for reas ons of public interest, emergency, or national 
security, the law required the President to first make a declaration of a state of emergency or other 
extreme urgency.  Once that had been done, Ecua dor's Intellectual Property Authority (IEPI) was 
authorized to initiate the necessary procedures to cons ider the request and, if relevant, the granting of 
compulsory licences.  For example, on 14 April 2010, IEPI had granted a compulsory licence for Ritonavir, a first-generation drug for the treatment  of HIV/AIDS.  He noted that this compulsory 
licensing process had taken six months, as opposed to  three years in the case of export under the 
System from Canada to Rwanda. 
180. He said that the fundamental problem in the use of Article 31 of the TRIPS Agreement was 
that compulsory licensing under this provision did not cover all public health needs since it did not provide for situations where a country had no cap acity, or limited capacity, to produce pharmaceutical 
products.  To address the territorial restrictions in Article 31(f), the System had been adopted.  
However, whereas it had been intended to provide a viable and expeditious solution to address public 
health problems of countries with limited or no production capacity in the pharmaceutical sector, it had only resulted in limited access to generic versions  of last generation essential medicines, such as 
those needed to treat HIV/AIDS.  As regards the compulsory licence granted for the generic medicine 
Ritonavir, it was patent-protected in Ecuador, but  not in the manufacturing country, which had made 
it possible to export it to Ecuador under the standard rules of Article 31 of the Agreement. 
181. Instead of meeting the objective of expeditiously  satisfying the urgent public health needs of 
developing countries, the implementation of the Sy stem would, on the contrary, establish burdensome 
and excessive processes, conditions and limitations  for those countries that had no or limited 
production capacities, as in the case of Ecuador, th ereby further complicating the already demanding 
conditions imposed by Article 31 and hampering access to imported generic versions of essential 
medicines.  Those considerations explained why his delegation was reluctant to ratify the Protocol and 
to make the System a permanent part of the Agreement. 
182. The representative of Japan
 said that his delegation had notified its acceptance of the Protocol 
Amending the TRIPS Agreement in August 2007.  He  elaborated on the related domestic rules for 
administering the System as a potential exporting Member.  The "Guideline for Administering Award System" was binding on administrative authorities and provided for a comprehensive compulsory 
licensing scheme in accordance with international oblig ations which applied to his delegation.  Under 
this guideline, compulsory licences for the purpose of  the System could be granted in accordance with 
the provisions of the TRIPS Agreement, the Decision and the Protocol Amending the TRIPS Agreement.  Compulsory licences for the purpose of  the System could be requested under Article 93 
of the Japanese Patent Act, which allowed for an  "award granting non-exclusive licence for public 
interest".  IP/C/M/64 
Page 42  
 
  183. To accept the Protocol, the approval of th e House of Representatives, the House of 
Councillors and the National Diet of Japan had been  needed.  In the proceedings of the Diet, the 
question had been posed as to what acceptance of the Protocol would mean, taking account of the fact that pharmaceutical companies already exported pharma ceutical products to LDCs  at affordable prices 
and that, although being the main  potential beneficiary, no LDC had accepted the Protocol at that 
point.  The System was nevertheless considered im portant to increase the options available to LDCs 
in the case of a national emergency.  Acceptance of  the Protocol was important to facilitate the 
entering into force of the TRIPS Amendment.   
184. He said that, in this context, his delegation would appreciate receiving further information on 
the state of play from LDCs who had not yet accepted the Protocol as potential importing Members. 
185. The representative of Chile
 noted that the incentives provided to Members to implement the 
System could be usefully looked at.  Such incen tives seemed to be largely for countries that had 
capacity to produce generic medicines.  A large nu mber of developing countries had a well-developed 
pharmaceutical sector with manufacturing capacity.  However, it was unlikely that these developing 
countries would be called upon to manufacture drugs  under the System, as importing countries would 
prefer to rely on exporting countries where safet y and efficacy of the pharmaceutical products was 
assured.  He wondered about incentives to accept th e Protocol for a Member who would not use the 
System as an importing country, and was unlikely to use it as an exporting country.  It was therefore important to look at the incentives provided to count ries to accept the Protocol and to implement the 
System, in order to enable a broader discussion of why only a limited number of Members had 
accepted the Protocol.   
186. The representative of Canada
 said that one benefit of the System was that royalties to the 
patent holder would have to be paid in the e xporting country.  He noted that some WTO Members 
who wished to import under the System might, ne vertheless, still be required under their domestic 
legislation to pay a royalty when a compulsory licence was issued, unless they had made the appropriate changes to their domes tic legislation to take full advantage of the System.  He asked 
whether any potential importing countries had ha d any experiences in that regard.   
187. The representative of Nigeria
 asked whether there had been any efforts made by governments 
or generic companies to transfer technology to l east developed countries.  He also asked whether 
potential exporting Members, other than Canada  and the European Union who had specifically 
addressed this point, had safeguards in place to ensu re the safety and efficacy of drugs produced under 
the System.   
3. Process of acceptance 
188. A representative of the Secretariat  briefed the Council on the procedural requirements of 
acceptance and current status of acceptances of the am endment to the TRIPS Agreement.  He recalled 
that the TRIPS Amendment was a formal amendm ent to an international treaty, the TRIPS 
Agreement.  The amendment process had started with the adoption, on 6 December 2005, of the 
General Council decision on the Amendment of the TR IPS Agreement.  This decision reflected the 
political consensus reached by all WTO Members to amend the Agreemen t.  In terms of international 
treaty law, it was the Protocol attached to th e General Council decision that amended the TRIPS 
Agreement.  However, for the amendment to have  legal effect in the WTO, Members needed to 
formally express their consent to be bound by th e Protocol.  The General Council decision and the 
Protocol explicitly invited Members to accept the Protocol.  The WTO Agreement, to which the 
TRIPS Agreement was attached as Annex 1C, included special rules on amendments in its Article X.  
Under Article X:7 of the WTO Agreement, formal  acceptance of the TRIPS Amendment occurred by 
Members depositing an instrument of acceptance with the Director-General, who served as the depositary of the multi- and plurilateral trade agreements.  IP/C/M/64 
 Page 43 
 
 
  189. He said that there were several requirements for depositing a valid instrument of acceptance.  
First, the instrument of acceptance had to be a written document.  He noted that there was no 
established form for this document, and that each  Member would have its own practice in accepting 
international treaties and treaty amendments.  Howeve r,  under international law, the instrument of 
acceptance had to have certain elements in orde r to give clear and unambiguous expression to the 
relevant Member's intention and consent to be bo und by the relevant instrument, in this case, the 
Protocol.  In particular, the instrument of acceptance had to:  (i) reproduce or at least clearly identify the Protocol by its title and by the place and date  of its adoption, for ex ample, "the Protocol 
Amending the TRIPS Agreement, done at Geneva on 6 December 2005";  (ii) indicate that the Member concerned formally accepted the Protocol;  (i ii) indicate the date and the place of issuance of 
the instrument of acceptance;  and (iv) be issued by one of the "the Big Three", namely the head of 
state, the head of government, or the foreign mi nister of the Member concerned, depending on the 
Member's constitution and practice.  Alternatively, the instrument of acceptance could be issued by 
another person, provided that one of the Big Three had formally issued what was known in treaty law 
as "full powers", which was a document specifically authorizing this person to accept the Protocol on 
behalf of the Member concerned.  In any event, the instrument of acceptance had to be signed and had 
to indicate the name and title of the person signing the instrument. 
190. He noted that the instrument needed to be  deposited within the period of acceptance.  
Following two extensions of the original accep tance period, the current deadline for depositing 
acceptances was 31 December 2011.  In other words, a Member had until this date to provide its 
signed instrument of acceptance to the Director-General. 
191. On the question of the current status of accepta nces, the representative of the Secretariat said 
that, as the General Council Decision and the Protocol pr ovided, the Protocol was due to take effect in 
accordance with Article X:3 of the WTO Agreement.  Pursuant to Article X:3, the amendment to the 
TRIPS Agreement resulting from the Protocol "shall ta ke effect for the Members that have accepted 
[it] upon acceptance by two thirds of the Memb ers and thereafter for each other Member upon 
acceptance by it".  He noted that two thirds of the Me mbership would need to deposit an instrument of 
acceptance for the Protocol Amending the TRIPS Agreemen t to enter into force;  this had not, as yet, 
occurred. 
192. He said that there was a need to clearly dis tinguish between acceptance of the Protocol and 
implementation of the Paragraph 6 System in Member s' domestic legal framework.  He noted that it 
had been brought to the attention of the Secret ariat that certain Members had postponed the 
acceptance of the Protocol because they had linke d it to the adoption of domestic implementing 
legislation.  Acceptance of the Protocol was an  international treaty law act expressing a Member's 
consent to be bound by the Protocol on the internatio nal plane.  It represented a Member's consent that 
WTO Members were entitled, i.e.  permitted but not re quired, to use the system incorporated in the 
TRIPS Agreement through the Amendment.  This pro cess of acceptance needed to follow the relevant 
Member's constitutional requirements and the international treaty law requirements.   
193. He noted that the act of ac ceptance was not dependent upon do mestic implementation of the 
Protocol.  The international act of accepting the Protocol needed to be clearly distinguished from the domestic  implementation of the Pa ragraph 6 System.  WTO Members could choose to take advantage 
of the flexibility provided in the Protocol and, if they did so, there could be a need to put it in place through a domestic legislative and regulatory pr ocess as governed by each Member's domestic 
procedures.  Legally speaking, those two processes were therefore entirely separate.  Members could 
choose to deal with them either jointly or separat ely.  For example, a Member could choose to deposit 
an instrument of acceptance for the Protocol with out adopting domestic legislation implementing the 
Paragraph 6 System, because the Member was onl y committing itself to accept that additional 
flexibilities became an integral part of the TRI PS Agreement.  Similarly, a Member could put IP/C/M/64 
Page 44  
 
  implementing legislation into place without having accepted the Protocol.  There were examples for 
both approaches. 
194. The representative of the Secretariat noted that the purpose of his presentation was to 
facilitate Members' understanding of the procedural implications of accepting the Protocol Amending 
the TRIPS Agreement.  To further assist Members in  drawing up their instruments, the information he 
had provided together with a model instrument of acceptance would be made available in writing.  If 
particular Members had queries on how to accept the TRIPS Amendment, they could contact the 
Legal Affairs Division of the WTO Secretariat to seek further information. 
195. The Chairman
 emphasized the importance of the final point made by the representative of the 
Secretariat, namely that it was not necessary for a Member to have taken any decision whether and, if 
so, how to implement the TRIPS Amendment at th e time when it would deposit its instrument of 
acceptance.  In essence, the accepta nce only expressed the willingness of the Member to be bound to 
accept that other Members were entitled to use the m echanism.  It was his understanding that some 
Members had postponed acceptance of the amendment because they had linked it to domestic implementing legislation.  While there could be dom estic reasons to do so, it was not necessary for the 
purposes of acceptance. 
196. The representative of Argentina
 informed the Council that the draft law for the approval of 
the Protocol Amending the TRIPS Agreement had passed  the first steps in the relevant procedures of 
the Senate.  In the chamber of deputies, the Commi ssions of Foreign Affairs, Religious Affairs and 
Industry had expressed a favourable opinion.  On 28 September 2010, the draft law had been included 
on the agenda for the plenary meeting. 
197.  The representative of the United States  said that his delegation would find the circulation of 
draft templates for acceptance of the Protocol an d related legal materials to be a very helpful 
contribution to the Council's work .  His delegation had been the first Member to notify its acceptance 
of the Amendment, and looked forward for other Members to follow as expeditiously as possible so 
that the two thirds requirement would be met in order for the amendment to enter into force.   
198. The representative of India  said that the presentation by the Secretariat had made it clear that 
the acceptance of the protocol and the implementing legislation were two different, not sequential, 
procedures.  He asked whether this distinction w as reflected in the technical assistance activities of 
the Secretariat and whether the Secretariat was planning to circulate a list of Members who had adopted implementing legislation? 
199. Another representative of the Secretariat
 responded that, with respect to the first question by 
the delegation of India, a distinction was made in  technical assistance activities of the Secretariat 
between the use of the system and its implemen tation, including through domestic law, and the 
separate procedure of preparing and submitting a fo rmal acceptance of the Protocol Amending the 
TRIPS Agreement.  Technical assistance was a major priority for the Secretariat.  It was constantly 
evolving depending on demand.   
200. With respect to the second question, he noted th at the Secretariat had an informal list of 
Members that had adopted implementing legislation, based on the notifications to the Council.  The 
Secretariat had not analyzed the laws and regula tions notified by Members in detail.  Informal 
materials had been compiled which provide a ge neral overview of choices made by Members to 
implement the System.   
201. The representative of Brazil  noted that her delegation was interested in receiving this informal 
compilation of countries that had implemented domestic  legislation and asked if the Secretariat could 
provide it informally.  IP/C/M/64 
 Page 45 
 
 
  202. The representative of India  said that his delegation was also interested in receiving a copy of 
the informal compilation of countries who had implementing legislation in place. 
203. The representative of the Secretariat  noted that there was a formal list of countries with 
implementing legislation, which was contained in  the draft report to the General Council on the 
annual review of the Paragraph 6 System.  While the list of formally notified legislation was therefore 
on the record of the Council, the informal material to which he had referred was merely a summary of 
the details of such legislation. 
4. Capacity building on the Paragraph 6 System and related TRIPS flexibilities 
204. The Chairman  noted that the Council had held the a nnual review of technical cooperation and 
capacity building on the previous day.  He recalled that, on the previous day, the Council had held its 
annual review of technical cooperati on and capacity building.  He drew  attention to the written reports 
that the Secretariats of the WTO, UNCTAD, WHO and WIPO had provided to the Council 
(IP/C/W/553, and IP/C/W/549 and addenda 3, 4 and 5, respectively) which also contained useful 
information relevant for the discussion of this topic.   
205. The representative of the Secretariat  provided an overview of the technical cooperation 
undertaken by the WTO Secretariat in relation to  public health and access to medicines, with a 
particular focus on the System, supplementi ng the more comprehensive report on technical 
cooperation that had been provided the previous day under agenda item K (IP/C/W/553).  Public 
health and the TRIPS provisions most directly relevant to innovation and access to medicines had 
formed an integral part of technical assistance activ ities undertaken by the Secret ariat in relation to the 
TRIPS Agreement.  In general, technical coope ration activities relating to TRIPS were directed 
towards assisting Members to understand the rights and obligations, including  the available options, 
which flowed from the TRIPS Agreement and re levant decisions of WTO bodies and dispute 
settlement jurisprudence.  This covered TRIPS fl exibilities and policy options under TRIPS, including 
the System, and the interplay between TRIPS sta ndards and policy choices.  Technical cooperation 
activities had also developed an increasing practic al focus, so that presentations and descriptive 
materials were supplemented by practical ex ercises and simulations, and dialogue between 
participants.   
206. Since the adoption of the TRIPS waiver in 2003 and the TRIPS amendment in 2005, virtually 
all technical cooperation activities concerning TRIPS had addressed the System, whether they took 
the form of regional workshops, Geneva-based events , national seminars, or more tailored activities.  
He estimated that the number of relevant activities certainly exceeded one hundr ed.  Over such a wide 
range of activities, the extent to which the System  was covered, and the specific aspects which were 
explored, varied considerably, dependent on several factors, including the level of the participants, 
ranging from introductory overviews to detailed reviews of the operation of the system, and on the 
particular thrust of the programme, i.e.  whether it was, for example, a dedicated workshop on TRIPS 
and public health, or a general overview of current  TRIPS issues.  The coverage of such activities 
would typically include:  (i) the negotiating histor y and policy background of the Doha Declaration 
and the System, based on WTO documents;  (ii) th e specific scenarios in which the System was 
intended to operate;  (iii) the operational details of  the System, including the content and procedures 
for filing the required notifications;  (iv) practi cal group exercises on the use of the System;  and 
(v) the legal acceptance of the TRIPS amendment and the nature of the steps required to give effect to 
it. 
207. Strong emphasis had been laid on cooperation with  other international organizations in the 
conduct of such technical assistance.  Following th e Doha Declaration and the development of the 
System this meant, for instance, that the World He alth Organization had become a regular participant 
in virtually all regional and Ge neva-based activities, the only constraints being the inevitable IP/C/M/64 
Page 46  
 
  logistical ones, bringing a vital public health pers pective to each of these programmes.  The larger or 
more focused programmes had been enhanced furthe r by the participation of the full spectrum of 
those concerned with access to me dicines: civil society, public sector procurement initiatives, industry 
representatives, public-private partne rships, and policy analysts.  Events, such as the Colloquium and 
Advanced Course had included presentations from pa rticipating scholars and policy analysts from a 
wide range of countries, many of whom had chosen  to address access to medicines and related issues. 
208. He highlighted the series of six workshops on the TRIPS Agreement and Public Health that 
had been convened in Ge neva.  These programmes had opened w ith expert overviews from the WHO, 
WIPO and WTO Secretariats on the interplay between  intellectual property a nd public health, and had 
included extensive material on the public health -related elements and flexibilities in the TRIPS 
Agreement.  They had dealt with the wider contex t of public health and intellectual property and the 
full range of relevant TRIPS standards, policy optio ns and flexibilities.  They  had naturally covered 
extensively the implementation and application of the System, including through case studies.  These 
workshops had drawn on experts with a wide ra nge of experiences and backgrounds to provide 
sessions on a range of key issues in the interplay between public health and intellectual property, 
including regulatory approval and quality control of medicines, the role of competition rules, 
procurement policy and strategies for essential medici nes, and the use of patent landscaping to guide 
policymakers.  The workshops had emphasized di alogue and diverse perspectives.  Recent sessions 
had concluded with a wide-ranging panel discussi on on the relationship between TRIPS, innovation 
and public health.  This discussion had provided an opportunity for representatives of the research and 
generic industries, access to medicines progra mmes, not-for-profit product development, and 
innovation and production capacity programmes for deve loping countries to share their views and for 
participants to engage actively with them.  Substa ntive contributions had been made by the WHO and 
WIPO, and presentations by speakers with different backgrounds (including a range of Geneva-based 
missions, NGOs and academia), so as to afford a co mprehensive overview of the key players' views 
and the most important aspects related to public health.  These workshops had also aimed to bring 
together participants (not only speakers) with di fferent backgrounds (from the areas of health policy, 
intellectual property and trade) so that they coul d learn from each other and to promote understanding 
that interdepartmental cooperation was beneficial on the domestic front just as it was internationally. 
209. The increased focus on technical cooperation relating to public health and intellectual 
property had been assisted through active dialogue, coordination and partnership with the WHO and 
WIPO.  This very productive cooperation had fac ilitated further involvement of WHO and WIPO 
experts in WTO technical cooperation activities, whic h had enabled more effective and more tailored 
technical cooperation from a richer and more well  informed factual background.  This cooperation 
had also led to joint technical cooperation ac tivities, including a technical symposium jointly 
organized by the three secretariats on "Access to Me dicines: Pricing and Procurement Practices" in 
Geneva on 16 July 2010.  The purpose of the sympos ium had been to gather experiences in the pricing 
and procurement of medicines as important determinants of access and to examine how and where to 
obtain information on access to medicines, their pri ces and their availability.  It had provided an 
opportunity for participants with different backgr ounds, coming from governments, international and 
philanthropic initiatives on the procurement of medici nes, civil society organizations and industry, to 
share experiences, take stock of the presen t situation and examine future needs. 
210. Three future directions might be considered w ith respect to the technical cooperation work of 
the WTO Secretariat.  First, the increasing trend towards partnership with other organizations, both 
within the established trilateral part nership, and beyond it, would be highly desirable, at the level of 
planning, coordination and programme delivery, so as to ensure the necessary breadth of expertise 
was available and to leverage the investment of resources more effectively.  Second, a practical 
understanding of the relevant elemen ts of the TRIPS Agreement and the System in particular might be 
embedded in a practical way into operational procurement programmes,  with greater interconnection 
between the technical cooperation activities and t hose who undertook procurement of medicines, for  IP/C/M/64 
 Page 47 
 
 
  instance to facilitate the communication of demand for medicines through the System.  Third, the 
enhanced and more integrated information base that  was gradually emerging concerning, for example, 
patent coverage, prices and access to medicines by  vulnerable populations, would enable technical 
cooperation to be more focused, tailored and practic ally oriented towards specific drug procurement 
objectives. 
211. The representative of UNCTAD  noted that his organization's initial mandate on issues related 
to access to medicines had come from the Commission on Investment in 2005.  The 2005 Commission had requested UNCTAD to initiate work  on local production of pharmaceuticals in 
developing countries, with particular reference to the role that IP and technology transfer might play.  
That mandate had been taken up later at the Ac cra Accord, by which UNCTAD had been given a 
broader mandate to work on the development dimens ions of intellectual property.  The Accra Accord 
mandate, which governed UNCTAD's activities directly , had also mentioned the WIPO Development 
Agenda and had called upon UNCTAD to  cooperate with WIPO on issu es related to the development 
dimension of intellectual property.  Finally, UNCTA D had been named as a stakeholder in the WHO 
Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, in 
particular for issues related to technology tran sfer, intellectual property and local production of 
pharmaceuticals.  UNCTAD defined intellectual propert y broadly, looking at where to draw the line 
between the grant of exclusive rights and what should  be in the public domain, and not just covering 
the exclusive rights themselves.  Intellectual propert y formed part of larger development concerns 
including health, education, i ndustrial development, technology transfer, innovation, agricultural 
development and various other areas of development.  There was a need to ensu re that the intellectual 
property system functioned to support important development objectives.  Intellectual property was 
therefore not an objective in its own right, but rather  a means to an end.  In the context of flexibilities 
for public health, the strategic use of flexibilities ba lanced with obligations under international treaties 
could help to ensure better alignment of intell ectual property policies with development objectives. 
212. UNCTAD's intellectual property advisory ser vices were based on requests from developing 
countries and LDCs.  They resulted in advisory re ports, which contained analysis, recommendations 
to the country based on research field missions and wide stakeholder consultations in the country.  These advisory reports could be either published,  such as the report on Uganda's Development 
Dimensions in IP, published in June 2010 (accessibl e at http://www.unctad.org/ddip), or they could be 
private.  The output would be given only to the requesting government Ministry.  In addition to advisory services, UNCTAD had run a series of regional workshops on TRIPS and local production 
of pharmaceuticals in developing countries.  UNC TAD had held four regional workshops, two for 
Eastern Africa, one for Southern and Western Afri ca, and one for South-East Asia.  These workshops 
had had a total of 203 participants, 33 in 2009, 52  in 2008, 74 in 2007 and 44 in 2006.  The audience 
for these workshops had been government officials, local pharmaceutical producers, health NGOs and 
academia.  In total, the beneficiaries had include d 19 countries and three regional organizations.  The 
textbook that had been used to conduct these works hops had been developed in-house and would soon 
be published in a document called the "Refer ence Guide on Intellectual Property and Local 
Production of Pharmaceuticals".  Follow up courses to these regional workshops had been organized 
by a German NGO called INVENT, with the support of a German grant. 
213. UNCTAD's technical assistance activities were backed up through an active programme of 
research and analysis.  Examples of the products of  this programme had included joint publications 
with the International Centre for Trade and Su stainable Development (ICTSD) on issue papers, a 
paper series on Technology Transfer for Successf ul Integration into the Global Economy and 
UNCTAD-ICTSD policy briefs on WIPO Development Agenda issues.  UNCTAD had considered the 
possibility of a policy brief on the IP and medici nes issue in the future.  Presently, UNCTAD was 
engaged with the WHO and the European Union in  a series of case studies on local pharmaceutical 
production and related tec hnology transfer.  All research was either commissioned or written in house 
by staff and then peer-reviewed.  UNCTAD had e ngaged in a limited amount of consensus building IP/C/M/64 
Page 48  
 
  activities, with respect to TRIPS and public health issues.  With respect to the WHO Global Strategy 
and Plan of Action, UNCTAD had co-hosted with UNIDO, WHO and ICTSD an ECOSOC Ministerial Breakfast Roundtable on global public health, high quality, low cost pharmaceutical 
production in developing countries.  UNCTAD had also had a few expert seminars on an ad hoc basis 
in 2006 and 2007, dealing specifically with the question of local production of pharmaceuticals. 
214. The representative of the WHO
 outlined the foundation of his organization's perspective on 
access to medicines.  The Constitutio n of WHO stated that the enjoym ent of the highest attainable 
standard of health was one of the fundamental rights of every human being.  In recent years, the scope 
and content of the right to health had been further clarified in international law.  Access to essential 
medicines today was established as a part of the right to health that obliged governments to work for 
its progressive realization and intellectual property rights were one of the many determinants for 
access to medicines.  WHO had a longstanding mandate to work at the interf ace of public health and 
intellectual property.  This had been reinforced by the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property that  had stated that "WHO shall play a strategic 
and central role in the relationship between public  health and innovation and intellectual property…" 
215. The Global Strategy had recognized the impor tance of patents as an  incentive for the 
development of new health-care products, but had co ncluded that "this incentive alone does not meet 
the need for the development of new products to  fight diseases where the potential paying market is 
small or uncertain." The Global Strategy had also affi rmed that "there is a crucial need to strengthen 
innovation capacity as well as capacity to manage  and apply intellectual property in developing 
countries, including, in particular, the use to the full of the provisions in the TRIPS Agreement and 
instruments related to that agreement, which provi de flexibilities to take measures to protect public 
health." In fulfilling this mandate, the WHO had worked continuously in collaboration with other 
relevant international organiza tions and with WHO Country and Regional Offices, to support its 
member states in their endeavours to apply and manage intellectual property in a manner that 
maximized health-related innovation, protected public  health, and promoted access to medicines for 
all.   
216. In accordance with the Global Strategy, the W HO had strengthened its efforts to coordinate 
work in the field of public health and intell ectual property with other relevant international 
organizations.  The Director-General of the WHO ha d exchanged letters with the Directors-General of 
the WIPO and the WTO to enhance collaboration a nd coordination of respective activities in this 
field.  Based on this exchange of letters the Secr etariats met every month to coordinate activities and 
to discuss possible areas of cooperation and joint wo rk around public health and intellectual property. 
217. The WHO's priorities in technical cooperation had been to provide member states with 
information, training and technical assistance on how  to apply and manage intellectual property in a 
manner that maximized health-related innovation an d promoted access to medical products.  Special 
emphasis had been given to the implementation and use of flexibilities and public policy options in 
accordance with the TRIPS Agreement and the Doha  Declaration to promote implementation of the 
TRIPS Agreement that supported access to medical pr oducts and needs-driven innovation.  Further 
details of the activities carried out since 2008 were contained in the WHO's report on its technical and 
financial cooperation activities. 
218. The representative of the UNAIDS
 noted that the work of the UNAIDS and its co-sponsoring 
agencies was guided by the health-related Mille nnium Development Goals (MDGs) with special 
attention to MDG 6 which was "to halt and reverse th e spread of HIV, Malaria and other epidemics by 
2015".  With AIDS being the leading cause of death worldwide among women of reproductive age, and with the possibility of virtually eliminating mo ther-to-child transmission of HIV, an integrated 
approach to the AIDS response was centra l to improving maternal and child health.  IP/C/M/64 
 Page 49 
 
 
  219. This TRIPS Council discussion was timely for a number of reasons, not least because of the 
increasing number of people living with HIV in need of antiretroviral treatment, and concerns about 
increasing costs.  Antiretroviral treatment for HIV infection was significantly reducing mortality for people living with HIV.  At the end of 2009, 5.2 million people were on HIV treatment, a twelve-fold 
increase from 2003 when the WHO and UNAIDS had first launched the historic 3-by-5 Initiative.  
According to estimates, the number of additional pe ople for whom antiretroviral treatment would be 
needed could soon reach 15 million.  The global ec onomic crisis had begun to adversely affect 
prospective commitments to AIDS from both donors and low- and middle-income countries.  For the 
first time in a decade, disbursements from donors for HIV/AIDS actually fell in 2009 from a high of USD 7.7 billion one year earlier.  The 2009 report of the inquiry of the United Kingdom's All-Party 
Parliamentary Group on AIDS into long-term ac cess to HIV medicines had reported that "we are 
sitting on a 'treatment time bomb.'" The cost of the least expensive first generation regimen had 
dropped to less than USD 70 per patient, per y ear.  But as increasing numbers of people moved 
towards more efficacious and tolerable treatment regimens, some experts projected drug prices to double compared to first generation regimens.  As patients developed drug resistance and required 
more expensive and more highly patent-protected  second- and third-line antiretroviral medicines, 
some projections saw treatment costs escalating as much as twenty-fold.   
220. In addition to the important work being undertaken by the WHO, under the UNAIDS division 
of labour, UNDP had been given a mandate to serv e as the lead cosponsoring agency within the 
UNAIDS in providing support to governments to in corporate public health -related TRIPS flexibilities 
into domestic legislation.  In cooperation with  the WHO and on behalf of the UNAIDS, the UNDP 
had provided policy and technical support to c ountries reforming domestic intellectual property 
legislation in this area.  As part of its cap acity building activities on the System, the UNDP had 
recently provided assistance to civil society or ganizations advocating for a revised Access to 
Medicines Regime in Canada.  Canada  had been the first country to ame nd its law to give effect to the 
Decision.  Bill C-393 had been proposed to streamlin e the practicability of CAMR.  Together with the 
Canadian HIV/AIDS Legal Network, UNDP had co-org anized consultations to explore opportunities 
to strengthen the CAMR in February 2010.  The focus of the discussions had been on ensuring 
compliance of Bill C-393 with the TRIPS Agreement and on giving more flexible and rapid effect to 
the Decision.  In addition, a the UNDP staff member  had been invited by and had appeared before the 
Canadian Parliament to provide technical information. 
221. In 2003, the UNAIDS had welcomed the multilateral consensus among WTO Members 
regarding access to affordable medicines for count ries without sufficient manufacturing capacity in 
the pharmaceutical sector.  We had appreciated that the consensus covered other public health problems in addition to AIDS, since people living with HIV were prone to  a host of opportunistic 
infections, such as tuberculosis, cancers, funga l infections and others, and these diseases were 
important health problems in themselves.  The U NAIDS had urged that the arrangements under the 
Decision be implemented in the most flexible manner possible, so that countries could utilize the 
System easily and efficiently in their efforts to  ensure greater access to HIV medicines for their 
peoples.  In reality, very few importing countries ha d introduced provisions that would facilitate the 
System's use.  In 2007, the UNDP had provided assi stance for the introduction of such provisions to 
the legislator in Zanzibar, United Republic of Ta nzania.  The Industrial Property Act 4 of 2008 had 
come into operation in the second half of 2008  and contained a number of important TRIPS 
flexibilities, including the exclusion of pharmaceutical  patents until 2016 or such other time as might 
be agreed by WTO Members.  Similar technical assistance had been provided by the UNDP to other sub-Saharan African countries in the process of amending legislation.   
222. The UNDP had provided technical and policy support on the utilization of non-voluntary 
licences under Article 31 TRIPS.  In partnership with  the Intellectual Property Institute of Ecuador, 
UNDP had held stakeholder consultations on compulso ry licensing in Quito in March 2010.  Similar 
assistance had also been provided to the Governme nt of Thailand through a WHO mission in 2008 in IP/C/M/64 
Page 50  
 
  which resource persons from the UNDP, UNCTAD and WTO had participated to provide technical 
information with regard to the TRIPS Agreemen t.  The UNDP had provided capacity development 
activities to assist States to implement their inte llectual property commitments made either through 
the process of acceding to the WTO or during negotiations on free trade agreements.  Examples of such technical co-operation had included a regiona l conference on access to essential medicines, HIV 
and intellectual property, held in  Kiev in September 2009, organized by the UNDP and the Open 
Society Institute.  The UNDP had supported capac ity development trainings for patent examiners 
focusing on the examination of pharmaceutical patents.   Those had been carried out in Africa, the 
Arab States and Latin America.  He noted that  the UNDP, WHO and UNAIDS would soon be issuing 
a joint briefing paper on the use of TRIPS fl exibilities to improve access to HIV treatment.   
223. The UNAIDS and UNDP had also provided techni cal and policy support to recipients of 
Global Fund Grants in using public  health-related TRIPS flexibilities to increase the availability of 
affordable antiretroviral medicines.  The proc urement policy of the Global Fund called for its 
beneficiaries to obtain quality medicines at the lo west possible price and encouraged grantees to 
utilize the TRIPS flexibilities to this end.  As donor s faced a period of extended financial uncertainty 
and understandably heightened their focus on accountability and value for money, the UNAIDS 
expected continuing and even heightened inter est in TRIPS flexibilities, including the System. 
224. The representative of WIPO
 said that his organization's activities comprised studies and 
documents on flexibilities and options, legislative a nd policy assistance related to patents, as well as 
national and regional seminars, me etings and workshops, which also addressed flexibilities, including 
the System.  Among the studies that WIPO had prepared as part of the first group was a document 
presented to the Committee on Development and In tellectual Property (CDIP) on patent-related 
flexibilities in the multilateral legal framework and their domestic implementation.  Another example 
was a document presented to the Standing Committee on Patents, containing an experts' study on 
exclusions from patentable subject matter and exceptions and limitations to patent rights.  Some of the 
topics covered were closely related to the TRIPS Co uncil's discussions.  He also noted the existence 
of other studies related to health.  For example,  there had been a WIPO study on patents and their 
relationship with viruses, influenza and other health  issues, that had been prepared by WIPO upon the 
request of the WHO in 2007.  There had also been a joint study by WHO and WIPO on innovation and public health.   
225. With respect to legislative assistance and pub lic policies, WIPO's work had looked at 
114 Member countries' national legislation.  In those countries, WIPO had identified 19 cases where 
the Decision had been implemented domestically.  Out of those 19 countries, one group, including 
Canada and the EU, had implemen ted the Decision with a purely exporting vision.  Another group, 
including Singapore, had implemented it with an importing country's approach.  From October 2009 
to October 2010, the WIPO Secretariat had review ed the respective draft laws of ten Member 
countries on their request, looking at the way in wh ich the rules included flexibilities, in particular 
with reference to the System.  During the same pe riod, upon request by certain member states, WIPO 
had also drafted six laws focusing exclusively on patents, including the domestic implementation or 
proposed implementation of the System.  Six expert  missions and two visits to Geneva had been 
carried out in order to discuss details relating to flexibilities, in particular the System, with the 
authorities concerned.  Among the issues that had b een studied, and the different options that had 
been explored, was the Decision and how to make fu ll use of the System even before acceptance of 
the Protocol Amending the TRIPS Agreement had take n place.  Furthermore, the waiver regarding the 
payment of remuneration in the importing country had also been considered.  Finally, WIPO had also 
provided legislative advise with respect to the id entification of enforcemen t mechanisms to ensure 
that products were not diverted from their intended markets under the System.   
226. As regards the organisation of  and participation in nationa l and regional workshops and 
meetings.  WIPO's Legislative and Policy Advise S ection, Patent and Innovation Division, had taken  IP/C/M/64 
 Page 51 
 
 
  part in 4 regional meetings and 6 regional semi nars from October 2009 to October 2010, most of 
which had been organised in cooperation with the WTO.   The topic of flexibilities, in particular the 
System, had been discussed at length.  The Secretar iat of WIPO was currently carrying out a series of 
other activities, including several colloquia on selected patent issues, such as the research exemption 
(October 2006) and flexibilities in the patent system (February 2007), as well as the Symposium on 
intellectual property (December 2008) and the conf erence on intellectual property and public policy 
issues (July 2009). 
227. Another representative of WIPO noted that  new pharmaceutical products resulted from 
innovation.  Innovation systems were increasingly global and this had profound implications for 
technology transfer, market competition, economic development and public policy.  Many policy 
debates saw science, technology and innovation as cruc ial to identify threats and find solutions.  This 
posed two main challenges: first, ensuring that  policy responses worked, and second, ensuring that 
critical innovations did not bypass the developing world.  WIPO had created the Global Challenges 
Programme to contribute to these policy debates.  The approach built upon the contribution of 
intellectual property to economic growth and societ al benefit.  The goal was to ensure that the 
mechanisms operate effectively and that the n eeds of the poor in developing countries were not 
overlooked.  Intellectual property was not seen as an end in itself but as an instrument of public 
policy, i.e.  an instrument to stimulate innovation and to support the diffusion of innovation.  This 
required transparent and effective structures, nati onal and multilateral policies, intellectual property 
management capacity, and support for licensing stru ctures that enhanced the use of intellectual 
property.  WIPO's activities focused on four areas:  (i) reinforcing interactions with WIPO's member 
states;  (ii) promoting informed policy discussions;  (iii) strengthening WIPO's networks;  and (iv) 
developing effective concepts and mechanis ms and facilitating their implementation.   
228. Cooperation and dialogue with partners from othe r international organizations, such as the 
WHO, WTO, and UNCTAD, and also with region al and national organizations, NGOs and civil 
society, the private sector and academia were importa nt aspects of WIPO's work in the area of public 
health.  WIPO had engaged actively with WHO in th e context of the adoption of the Global Strategy 
and Plan of Action on Public Health, Innovation and Intellectual Property.  It was working actively 
with WHO and WTO to identify and provide its contribution to the implementation of the Global Strategy.  To this effect the three organizations met on a regular basis to discuss and exchange on their 
relevant programme activities.  A technical Symposium on "Access to Medicines:  Pricing and 
Procurement Practices" had been jo intly organized on 16 July 2010. 
229. WIPO supported WHO's Intergovernmental Mee ting on Pandemic Influenza Preparedness:  
Sharing of Influenza Viruses and Access to Vaccines and other Benefits (IGM) with its intellectual 
property expertise.  Upon request by WHO, it ha d contributed a working paper on "Patent issues 
related to influenza viruses and thei r genes", published on WIPO's website 
(http://www.wipo.int/patentscope/en/lifesciences/ip_h ealth.html) and on the WHO Avian influenza 
website (http://www.who.int/csr/disease/avian_inf luenza/wipo_ipdoc/en/index.html).  WIPO was 
equally engaged in providing intellectual property ex pertise to the initiative of  the Special Programme 
for Research and Training in Tropical Diseases to set up an African Network for Drugs and Diagnostics Innovation, the African Union Pharmaceutical Manufacturing Plan for Africa, and the UNITAID Medicines Patent Pool Initiative. 
230. He noted that it was a particular challenge to show how intellectual property systems and 
policies could enable access to medicines.  A centra l aspect was information about (i) applicable laws, 
(ii) the existence or absence of rights and (iii)  technology.  A special focus was on information 
generated in developing countries.  Such informatio n remained difficult to obtain.  WIPO worked to 
improve capacity in national offices to administer the patent system.  Increasingly, information was 
available via the Patentscope portal (http://www.wi po.int/patentscope/en/lifesciences/ip_health.html), 
WIPO's gateway to patent information.  The challe nge was to appropriately use that information.  IP/C/M/64 
Page 52  
 
  This required capacity in making the informati on available, as well as finding and analyzing the 
information.  It required capacity to proactively use the information to ge t access to technology and 
innovation.  Intellectual property was not the goal but the tool.  An intellectual property right could also be an indication for an opportunity.  WIPO remained committed to con tinue working with all 
stakeholders in the context of in tellectual property and public health. 
231. The representative of India
 asked the representative of WIPO how technical assistance had 
changed following the adoption of the development ag enda, particularly the focus on the exercise of 
TRIPS flexibilities.  With respect to the presentation by  the WHO, he noted that it had been stated that 
special emphasis had been given to the implemen tation and use of TRIPS flexibilities and public 
policy options.  However, the WHO's annual report (I P/C/W/549/Add.4) did not reflect this emphasis.  
He asked the representative of the WHO how th e WHO assessed the System and whether it had 
conducted a study as to why the System had only been used once in the past sev en years.  Noting that 
the System provided for measures to harness economi es of scale, he asked whether the WHO factored 
this into its programmes, particularly for LDCs.  Finally, he wondered how free trade agreements 
promoted by developed Members which circumsc ribed TRIPS flexibilities impinged on efforts made 
by the WHO.   
232. The representative of the European Union  acknowledged that devel oping and least developed 
countries might have faced structural challenges in  implementing the System.  In many instances, 
technical assistance and capacity building had been crucial to enab le those countries to recognize and 
act on the implications of the TRIPS Agreement on public health policies and establish workable 
laws, procedures and practices to give effect to th e Doha Declaration and the Decision.  This had 
required sound technical advice on how to best inte grate the Doha Declaration and the Decision into 
intellectual property policies and practices.  His de legation had integrated sound legislative advice and 
clarification on how to give effect to the System in order to facilitate access to medicines into its 
intellectual property technical cooperation programmes with developing countries. 
233. In response to the question from the delegation of India, the representative of WIPO noted 
that, within the CDIP, the Secretariat had been requested to prepare a document on patent-related 
flexibilities and legislative implementation at the nati onal and regional level.  This had been submitted 
to the previous session of the Committee.  WIPO  was currently working on forthcoming documents 
that would include all the flexibilities regarding patents and related technological fields.  WIPO 
provided information to Member countries with respec t to the implementation of  legal frameworks of 
which flexibilities within the multilateral framework we re part.  Efforts had been made to identify 
those flexibilities that would fit into the developm ent goals of each of the countries that requested 
WIPO's advice.   
234. The representative of the WHO  noted that his organization's work emphasized the use of 
TRIPS flexibilities.  The way in which member  states implemented Article 27 of the TRIPS 
Agreement, how they defined what was new, what was an inventive step and what was capable of 
industrial application, had a great impact on what c ould be patented under natio nal patent laws.  This 
provision, therefore, offered public policy options, which might  be called flexibilities under the 
TRIPS Agreement.  The WHO had not studied or commissioned a study as to why the Paragraph 6 System had only been used once.  Member states had not requested such a study, perhaps because the 
System was part of the WTO framework.   
235. He said that the needs of LDCs received par ticular attention in the WHO's work.  It had 
participated actively in the workshops on the LDCs needs assessment organized by the WTO 
Secretariat, including the recent workshop in Bangl adesh and the forthcoming workshop in Senegal 
which was directed to the needs assessment of Fr ench-speaking African LDCs.  However, the WHO 
had not received any request with regard to the implementation of the System from LDCs or other 
developing countries, nor had it received any request with respect to the regional dimension of the  IP/C/M/64 
 Page 53 
 
 
  System.  With regard to the bilateral free trade ag reements and their impact on the WHO's work, he 
referred to the Global Strategy, which urged governme nts to take into account, where appropriate, of 
the impact on public health when considering adopt ing or implementing more extensive intellectual 
property protection than was required by the TRIP S Agreement, without prejudice to the sovereign 
rights of member states.  The WHO gave advice and technical assistance to its member states to the 
effect that, when they entered into agreements th at went beyond the level of protection provided by 
the TRIPS Agreement, they should carry out a public  health impact assessment in order to take an 
informed decision on the agreement they  were envisaging to enter into.   
236. The representative of Brazil  noted that the TRIPS Agreement contained many more 
exceptions than those contained in its Article  27, citing a recent WIPO study on exclusions, 
exceptions and limitations to patentable subject ma tter.  Supporting India, she called for a broadening 
of the discussion.   
237. The representative of Ecuador  noted that technical cooperation programmes of international 
organizations seemed to increasingly take into acc ount flexibilities.  However, such programmes 
continued to be focused on institutions such as intell ectual property offices.  It would be beneficial to 
know whether similar technical assistance activities were  planned to broaden participation to involve 
other stakeholders and how the development dimens ion was covered with respect to the effective 
implementation and use of TRIPS flexibilities, in particular as regards compulsory licences and the System.  He asked the representative of WIPO  for more details on their projects under the 
development agenda, including relevant items rela ted to TRIPS flexibilities.  He also wondered how 
international organizations, such as the WTO and WI PO, could make better use of their resources for 
technical cooperation in collaboration with other organizations, including UNCTAD, WHO and 
UNAIDS, to implement the flexibilities.   
238. As regards the inclusion of stakeholders outside the intellectual property offices, the 
representative of WIPO said that national policy make rs were primarily in charge of legislating and 
incorporating TRIPS flexibilities into domestic law.   Beyond this initial implementation stage, there 
might well be other actors who could be involved in the intellectual property system.  With respect to 
WIPO's work in the area of flexibilities, he noted th at it provided assistance not just in implementing 
laws, but also in identifying the most appropriate public policies for a country. 
239. The representative of India
 requested the representative of the WHO to prepare a detailed 
study on TRIPS flexibilities pertaining to public h ealth in its technical cooperation activities.   
240. Supporting the statement made by the delegation of Ecuador regarding WIPO's intervention, 
the representative of the Bolivarian Republic of Venezuela  quoted from a lecture on TRIPS 
flexibilities which had stated that "almost all the na tional patent regimes in developing countries were 
based on the European and American  systems.  Patent rights in developing countries were often based 
on colonial laws or on drafts elaborated with technical assistance from WIPO and patent offices from developed countries.  Most of the technical assistance provided to developing countries focused more 
on conformity with the provisions of the laws re lating to rights of patent holders than on the 
implementation of flexibilities within a multilateral framework that protected public health.  The 
inability to access information about optimal practice were another problem that explained the lack of technical knowledge to implement TRIPS flexibil ities in national laws.  As a result, developing 
countries were unaware of the measures and successful  strategies put in place by other developing 
countries to overcome problems with access to medi cines.  Consequently, countries from the same 
region which encountered similar or identical difficu lties, applied different strategies with varying 
degrees of success.  More importantly, while the ma jority of developed countries offered technical 
assistance and best practices on how to protect patent rights, no manual or technical assistance had addressed best practices with respect to compulso ry licensing and competition law, looking at, for IP/C/M/64 
Page 54  
 
  example, the extensive use made of it by the United States to stop the abuse of patent rights and to 
address other public interests. 
5. Any alternatives to the use of the Paragraph 6 System to achieve the objective of access 
to medicines, procurement policies, and other related aspects affecting access to 
medicines 
241. The representative of the Secretariat
 informed Members about its recent technical cooperation 
activities that shed light on the broader context a ffecting procurement strategies to promote effective 
access to medicines.  In July 2010, the WHO, WIPO  and WTO had jointly organized a technical-level 
symposium on access to medicines, pricing and procurement practices.  This symposium had aimed to promote understanding as to the experience of intern ational and regional agencies in the pricing and 
procurement of medicines as an important determin ant of access.  It had provided an opportunity to 
discuss where to obtain information on access to medi cines, their prices and availability, covering 
core questions on drug procurement,  pricing and relevant intellectua l property issues.  Arising from 
technical level dialogue between the organizati ons, the activity had been planned to lay the 
groundwork for continuing dialogue among the collabor ating organizations and their partners and the 
ongoing trilateral cooperation, which included the im plementation of the WHO Global Strategy and 
Plan of Action.  The event had heard the perspectives of the three Directors-General and from technical-level officials from the three Orga nizations, as well as representatives from global 
procurement agencies and NGO procurement initiati ves, other active NGOs and several industry 
perspectives.   
242. The WTO's technical-level contribution had been  to set out an overview of the practical 
information available on trade-related measures that had a bearing on all aspects of the access 
equation.  These included information on intell ectual property policy settings, procurement and 
competition policies, tariffs and regulatory matte rs ensuring the quality, safety and efficacy of 
medicines.  The aim had been to  provide as complete a factual picture as possible.  Hence the 
emphasis had been on strengthening the informati on base for practical cooperation on drug access and 
procurement questions.  Director-General Pascal Lamy  had commented 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 al so a practical craft, rather than a theoretical excursion meaning that 
we can and should learn from the actual experience of others in their efforts to create and disseminate 
needed treatments.  The pooled pers pective needs to cover the intern ational trade dimension but also 
consider domestic policies and prac tices, and above all the evolving st ate of the actual global disease 
burden, a priority setting for front-line treatments and patents for the production and dissemination of 
medicines". He had expressed the hope that the pr ogramme of the technical symposium would help 
illuminate this far bigger picture so that each organization could complete its specific areas of work with the benefit of greater understanding about how all the elements interacted and what priority 
targets should be aimed at, a task that could on ly be undertaken by public health colleagues. 
243. The symposium had not been intended as a po licy forum and accordingly no conclusions or 
outcomes had been intended to emerge.  However, the improved flow of data and the ideas for more 
effective use of diverse sources that had been explored during the symposium should allow for 
technical cooperation to be better designed and fo r a firmer empirical base for understanding access to 
medicines issues to be built.  It was clear th at, to progress the goal of access to medicines, 
strengthened cooperation and impr oved information resources from diverse resources would make a 
significant difference.  The technical symposium had reviewed a number of available resources of 
information, covering prices, availability and qualit y of medicines, concerning patents and the scope 
of patent coverage, and a range of trade and intellectual property policy issues and measures available 
in various WTO notifications and databases.  IP/C/M/64 
 Page 55 
 
 
  244. Based on the Secretariat's practical experience with technical assistance in the field, the 
current trend had appeared to be to try to ma rry the understanding about legal options and legal 
mechanisms with the broader pe rspective of procurement strate gies and an improved information 
base.  For example, since patents were national and territorial in scope, effective procurement 
practices entailed understanding what relevant patents were in for ce and in what jurisdictions.  
Similarly, information about pricing trends was helpful both in understanding the existing state of 
play regarding access and in undertaking practical  procurement activities.  Information about the 
broader regulatory framework, including on tariffs, ta xes, health regulation, competition policy, and 
intellectual property matters, helped to illumi nate the operational context of procurement 
programmes, in turn enabling them to be more e ffective and to derive better health impact from 
available resources.   
245. The representative of the WHO  presented his organization's experience from a public health 
perspective.  Among its most important missions was the improvement of access to quality essential 
health services and products, including essential me dicines, vaccines, diagnostics, medical devices 
and equipment, especially for disadvantaged peop le.  Reliable and sustainable access to health 
products was determined by different macro hea lth system factors.  These included strong, 
accountable and transparent health governance with well-developed health policies for national health 
systems, health financing, social protection mech anisms, trained and available health workforce, 
health care delivery infrastructure, and reliable health management and information systems. 
246. He said that, more specifically, access to medicines was determined by four factors:  
(i)rational selection of medicines;  (ii) affordable pri ces;  (iii) sustainable financing;  and (iv) reliable 
supply systems.  The rational selection of medicines required a country to decide, according to 
well-defined criteria, which medicines were most impor tant to meet existing public health challenges.  
Through its model list of essential medicines, WHO provided guidance to member states in the 
development of their national essential medicine lists .  An essential medicine had to be a safe and 
effective product and should represent the best rati onal choice, regardless of its price, to address a 
specific health problem.  As regards affordab le prices, while in high-income countries a high 
percentage of expenditures on medicines was publicly financed or reimbursed by  health insurance, a 
high percentage of expenditure came directly fro m the pockets of patients in low- and many 
middle-income countries.  The public sector was not alwa ys a viable alternative.  In a number of low- 
and middle-income countries, the average availability  of medicines in public health facilities turned 
around 35 per cent.  When patients therefore had to tu rn to private pharmacies, the price of medicines 
became one of the most important determinants of access to medicines.  With respect to sustainable 
financing, per capita expenditure on medicines in re al terms remained regrettably very low in poor 
countries, despite governments spending a large pr oportion of recurrent health budgets on buying 
medicines.  As regards reliable medicine s upply systems, these included forecasting needs, 
procurement, storage, transporta tion and inventory keeping of medicines.  All these areas remained 
weak in many developing countries.  Without investing in and improving supply systems, access to 
medicines would remain a formidable challenge. 
247. The representative of the WHO noted that hi s organization was involved with its member 
states in improving access to medicines in each of those four areas, both by developing norms and standards, and by providing direct technical assistan ce.  It used availability and prices of medicines as 
indicators to measure access to medicines.  Looking at access to high-priced patent-protected essential 
medicines, especially in countries with no or limited manufacturing capacity, he noted that more than 
90 per cent of medicines on the WHO model list of essential medicines were not patent-protected.  
Nevertheless, a majority of patients in low-income countries continued to suffer and to die due to lack 
of access to treatment interventions, including lack of supply of generic medicines.  Nearly 30,000 
children died every day from diseases that could easily be treated if they had access to a range of basic 
patent-free essential medicines.  Also 1.8 million child ren under the age of five years died every year 
of pneumonia alone that could be treated with chea p inexpensive antibiotics.  Only 20 per cent of IP/C/M/64 
Page 56  
 
  children received these antibiotics.   This was a long and tragic list of circumstances where 
inexpensive generic medicines were available, but did not get to the people when they needed them 
the most.  These issues needed urgent attention. 
248. High prices of patent-protected essential medicines also constituted a barrier to access to 
medicines, especially in the case  of second-line HIV/AIDS medicines and tuberculosis in Africa and 
other poor countries and for non-communicable diseases like cancer.  Generic competition in the 
market was one of the most efficient mechanisms to  bring prices down, as seen in the case of first-line 
antiretroviral medicines for the treatment of HIV/AI DS.  Because of generic competition, the cost of 
one year of treatment for one patient with first- line antiretroviral medicines had dropped from more 
than USD 10,000 to around USD 100 between 2002 and 2010.  This drastic decrease in the cost of 
medicines had resulted in increased access to those medicines.  As of December 2009, an estimated 
5.2 million people in low- and middle-income countries living with HIV had been receiving 
antiretroviral therapy, a twelve-fold increase sin ce 2003.  The importance of affordable prices of 
antiretroviral therapy would increase in the near fu ture.  Because of changes in the newly published 
WHO HIV treatment guidelines, the number of peop le for whom treatment would be needed could 
increase to 15 million. 
249. The System addressed a very specific situ ation when a country without sufficient 
manufacturing capacity wanted to procure a patent ed medical product, and there were no generic 
producers in other countries that could supply the product.  Other ways of obtaining the needed medicines could be explored before invoking the Syst em, for example, through a search of therapeutic 
equivalents which were not patent-protected or thr ough negotiation with the patent holder.  However, 
where no other possibility existed, the System could be legitimately put into action to procure the 
needed medicines.  The WHO Global Strategy and Plan of Action on Public Health, Innovation and 
Intellectual Property had been very explicit about the right of the member states to make optimal use 
of TRIPS flexibilities.  Element 5.2 of the Stra tegy had urged governments to "consider, where 
appropriate, taking necessary measures in countries w ith manufacturing capacity to facilitate through 
export, access to pharmaceutical products in countri es with insufficient or no manufacturing capacity 
in the pharmaceutical sector in a manner consistent with the TRIPS Agreement, the Doha Declaration 
and the WTO Decision of 30 August 2003". 
250. He noted that, although the System had rarely b een used to date, it might be considered more 
frequently in the future, given the changing requirem ents for new medicines to treat diseases, and the 
implementation of the TRIPS Agreement in member st ates.  A recent study had revealed that Indian 
generic manufacturers had accounted for more than 80 per cent of donor-funded annual purchase 
volumes of antiretroviral medicines between 2003 a nd 2008.  The implementation of full patent 
protection for pharmaceutical products in India and the approaching expiry of transition periods in LDCs might make it more difficult in the future to procure generic versions of  new medicines.  Under 
such circumstances, the System might assume a greate r significance.  He confirmed that to date the 
WHO had not formally received any request from any member state for technical assistance in the use 
of the System.  He concluded that access to medicines was determined by many factors and the situation was far from perfect even for those medici nes which were not patent-protected.  All possible 
legitimate measures had to be consid ered when access to patent-prot ected medicines of public health 
importance was at stake, especially when countries did not have sufficient local manufacturing capacity.  In such situations, the System was de finitely one of the possible options and it might 
become more important in the future.   
251. The representative of India
 appreciated the positive references that had been made to the 
Indian generic industry.  The latter had undoubtedly  brought a paradigm shift in changing the global 
discourse about access to life-saving medicines at affo rdable prices.  A recent study, published in the 
Journal of the International AIDS Society of Se ptember 2010, had noted that, over the last seven 
years, 80 per cent of donor-funded AIDS medicines had been supplied by Indian generic  IP/C/M/64 
 Page 57 
 
 
  manufacturers to developing countries.  The same stud y had also mentioned that the cost of the Indian 
generic version of the most commonly used fi rst-line adult regimen for HIV/AIDS treatment 
(Lamivudine/Nevirapine/Stavudine) had dropped from USD 404 per person per year in 2003 to 
USD 74 per person per year in 2008.  However, the cr edit could not be entirely attributed to the Indian 
generic industry, given that the largest generic manufacturer was in the European Union and the 
second largest in Israel.  But these manufacturers might  not be price-competitive in all generics.  He 
cautioned that the Indian generic industry was not  a panacea for addressing the reasons which had 
necessitated the establishment of the System.  Many  life-saving medicines were off-patent in India 
and therefore were readily available as generics.  He  noted that most first-line antiretroviral medicines 
predated the TRIPS Agreement and were therefore not patented in India.  This situation might change 
in the future, as more product patents were filed an d block-buster drugs were invented.  This might 
lead to a decline of the present generic advantag e, making the developing world, including the LDCs, 
dependent on high-priced patented drugs.  Switc hing to second-line antiretroviral medicines was at 
least three times more expensive, costing abou t USD 465 per person per year.  Possible third-line 
drugs like Etravirine, for which there was no generic alternative, cost USD 3,204 per person per year.  
Those medicines represented the real challenge for the System and other TRIPS flexibilities that could 
be invoked for public health reasons. 
252. With respect to voluntary contributions and tie red pricing by some developed Members, he 
noted that, while these attempts were appreciated, th ey were not lasting solutions.  The Report of the 
UN Special Rapporteur had indicated that one third of the world's population did not have access to 
affordable medicines.  The number of patients be ing treated for HIV/AIDS in developing countries 
had jumped to 5.2 million in 2010 from 400,000 in 2003.   Given the breadth of the problem, he noted 
that, while voluntary efforts and tiered pricing made an important contribution, they could not be the 
entire solution and did not obviate from the need to use the System.  He wondered whether the futile attempts of MSF and Ghana to use the System  through CAMR had had a chilling effect.   
253. The representative of India said that Articles 30 and 31(k) of the TRIPS Agreement 
represented possible alternatives to the use of th e System to achieve the objective of access to 
medicines.  During the preparatory work in the TRIPS Council which had led to the adoption of the System, the European Union had presented a con cept paper (IP/C/W/339).  One of the two possible 
solutions proposed had been the interpretation of "t he limited exceptions clause of Article 30 of the 
TRIPS Agreement in a way which would allow pr oduction for export, to certain countries and under 
certain conditions, of products needed to combat  serious public health problems".  The EU had 
acknowledged that "the advantage of this approach would be that it could fit within the flexibility 
offered by the existing TRIPS Agreement, without ther e being a need to amend any of its provisions".  
He noted that this option was always available to  Members.  In the September 2002 meeting of the 
TRIPS Council, the WHO representative had said that "t he solution...  that was most consistent with 
the principle was the provision of a limited exce ption under Article 30.  Such an exception would 
meet the mandate of the Declaration and provide e xpeditious authorization to third parties to make, 
sell, and export patented drugs and other technologies to meet public health needs" (IP/C/M/37). 
254. He noted that Article 31(k) performed the same  purpose as the Decision in that it waived the 
restriction imposed by Article 31(f) on compulsory  licensing for export when a Member issued a 
compulsory licence "to remedy a practice determined  after judicial or administrative process to be 
anti-competitive".  This provision had been used thr ee times in the last five years by a developed 
country Member of the EU.  Interestingly, the Member concerned had opted out as an importing 
country under the System.  Both Articles 30 and 31 (k) were existing provisions in TRIPS and were 
covered by Paragraph 4 of the Doha Declaration wh ich stated that "we reaffirm the right of WTO 
Members to use, to the full, the provisions of th e TRIPS Agreement, which provide flexibility for this 
purpose".  IP/C/M/64 
Page 58  
 
  255. The representative of Japan
 believed that the objective of the System, which was to facilitate 
access to medicines by Members with insufficient or no manufacturing capacity in the pharmaceutical 
sector had to be kept in mind.  The System should no t be considered in an isolated manner but as part 
of a broader effort to contribute to access to medi cines.  At the trilateral Symposium on "Access to 
Medicines:  Pricing and Procurement Practices",  organized by the WHO, WIPO and WTO, it had 
been noted that elements other than intellectua l property rights were important to access medicines, 
such as procurement and tariffs.  It had also been noted that only five per cent of medicines included 
in the WHO list of essential medicines were protected by patent. 
256. He informed Members of Japan's efforts to  contribute to access to medicines.  In 
September 2010, Mr. Kan, the Prime Minister of Japan, had announced the "Kan commitment" to 
contribute USD 800 million  in the coming years to the Global Fund to Fight AIDS, tuberculosis and 
malaria which Japan had co-founded.  In orde r to accelerate progress towards the Millennium 
Development Goals by halting the spread of HIV/AI DS, tuberculosis and malaria, Japan would scale 
up effective interventions through the Global Fund .  To do so, it would promote an integrated 
approach, combining the Global Fund efforts with  strengthening health systems and maternal, 
newborn and child survival programmes, utilizing Japan's bilateral assistance.  Although the number 
of people receiving life-saving antiretroviral therapy against HIV/AIDS had increased from 0.4 million in 2003 to 5.2 million in 2009, he recognized that there was an urgent need for expanded 
efforts to address the issue.  His delegation had contributed USD 1.04 billion to the Global Fund.  Furthermore, as part of the Global Plan "Stop TB  2006-2015", Japan had provided anti-tuberculosis 
drugs and testing tools to tuberculosis-affected  countries, designated by the WHO as high burden 
countries.  Japan had also contributed to combati ng other infectious diseases, such as influenza and 
polio.  It had also provided an emergency gran t aid of approximately JPY 1.1 billion through the 
WHO in September 2009 to carry out immunizations in developing countries with the H1N1 influenza vaccine.  In addition, in order to prep are for a pandemic influenza, Japan was stockpiling 
and providing antiviral medicines in cooperation with ASEAN and the ASEM.  It supported the 
provision of polio vaccines through UNICEF to some  countries that had been designated as countries 
of prevalence.  The importance of local producti on in developing countries was also recognized.  
Japan had cooperated with the Government Pharma ceutical Organization of Thailand to locally 
produce influenza vaccine.  He reiterated the importa nce of access to medicines, and the importance 
of keeping the bigger picture in mind when discussing this issue. 
257. The representative of the United States
 said that the TRIPS Agreement provided an important 
balance between providing incentives to research a nd develop new medicines and promoting access to 
existing patented medicines.  The Doha Declaratio n had stated that the TRIPS Agreement "does not 
and should not prevent members from taking measures to  protect public health".  His delegation was a 
global leader on improving public health.  US funding for global health had increased significantly over time, particularly in the last decade.  Funding had more than doub led between 2004 and 2008, 
reaching USD 9.6 billion in 2008.  In 2009, the Un ited States had been the largest donor in the world 
for the global response to HIV/AIDS, accounting for more than half of disbursements by governments.  As part of the US Government 's global health programme, his delegation was 
committed to promoting equitable access to safe and effective medicines of assured quality around the 
world.  It was also fully committed to helping coun tries that were experiencing public health crises to 
find real and comprehensive solutions.   
258. He said that his delegation had strongly supported the General Council Decision of 
August 2003 to implement the Doha Declaration so that drugs could be exported under a compulsory 
licence under the terms set out in the Decision and the accompanying Chairman's Statement.  It had also lent strong support to the Protocol Amending the TRIPS Agreement in 2005 to make the System 
a permanent part of the Agreement and to appropr iately preserve reference to the Chairman's 
Statement.  He recalled that the System had been the result of robust discussions and had attracted the 
consensus of the Members;  other prior proposals ha d been left behind.  His delegation had been the  IP/C/M/64 
 Page 59 
 
 
  first Member to notify its acceptance of the amendmen t.  The System was intended to be only one tool 
to assist in promoting access to medicines and provided an important failsafe in Members work to improve access to medicines.  In the past, some dele gations had shared their view that the System had 
been used sub-optimally and that an analysis of its functioning was needed.  As his delegation had affirmed at previous meetings, the Council's a nnual review was the forum at which Members had 
intended reviews of the operation of the System to be conducted.  It was also the place where 
Members, who were the users of this intergove rnmental system, should share their experiences 
regarding any concerns. 
259. He noted that in the past some delegations had attached importance to the fact that the System 
had been used only once.  Counting the frequency of use was, however, not the right metric to 
measure the effectiveness of the System.  Instead, the results had to be evaluated.  Members needed to 
look at the extent to which medicines were reach ing affected populations.  With respect to that 
question, the number of times that Members had relied on the System as a safety valve mechanism did not provide the right focus.  Instead, the System should be viewed in its proper, larger prism.  This principle had been reflected in paragraph 2 of the Doha  Declaration.  He noted that the majority of the 
drugs on the WHO's Model List of Essential Medicines were off-patent.  Additionally, it was also 
important to recall that the System's development had been one element of a larger international 
exchange of ideas that WTO Member government s, the donor community, companies, and other 
stakeholders had had, and continue d to have, in order to improve access to medicines.  That work had 
led to real and measurable progress over the past d ecade in improving access to medicines.  Further, it 
had led to partnerships between  governments, between governments and stakeholders, and between 
stakeholders themselves. 
260. In his delegation's discussions with stakeholde rs across the spectrum, he had consistently 
heard that access to medicines was being improved th rough numerous means.  Those means included 
developed country policies and programmes that placed greater emphasis on building sustainable 
capacity in the public sectors of developed country  partners and at their national and community 
levels to provide basic services over the long term.  They also included efforts to expand research and 
development of innovative drugs and production cap acity for both innovator and generic drugs in 
developing countries.  Further, those means incl uded donations of health products by Members, the 
private sector, and international bodies, as well as tiered pricing, bulk purchase mechanisms, 
innovative licensing models and other measures by innovative and generic companies and multilateral 
bodies.  The United States, through the National Institut es of Health (NIH), had been the first patent 
holder to share its patents with the newly establishe d Medicines Patent Pool Foundation.  The initial 
contribution by the NIH and its co-patent owner, the University of Illinois, had embodied these 
commitments and had taken an important step toward making affordable and appropriate HIV 
medicines available to patients around the world.  It had built on the US President's previous 
commitment to support humanitarian licensing polic ies to ensure that medications developed with 
taxpayer dollars were available off-patent in developing countries. 
261. With respect to measures undertaken by innova tive and generic companies to meet the needs 
of LDCs and others, he noted that in many cases, innovator companies simply did not apply for patent 
protection in many developing countries.  There ha d been widespread tiered pricing of pharmaceutical 
products tied to individual and sub-re gional developing country markets.  Tiered pricing was linking 
the price of a pharmaceutical product in a market to what the consumer or purchasing government 
could afford to pay.  While tiered pricing w as not a new strategy, its frequency of use had 
dramatically increased in the past decade.  For example, Bristol Myers Squibb, partnering with many 
Health Ministries, had announced a number of years ago that it would make all of its HIV medicines available at no-profit prices in sub-Saharan A frica.  In 2005, the company had announced that 
paediatric formulations would be priced below co st, in order to further reduce barriers to provide 
access to this treatment.  He understood that other companies, such as GlaxoSmithKline, had offered 
certain antiretroviral drugs at not-for-profit prices in 64 different countries.  A number of other IP/C/M/64 
Page 60  
 
  companies were reportedly working together to provid e a "single tablet a day" product at significantly 
reduced prices.  These examples made it clear that  private actors were improving access to medicines 
in a manner that simply had not been present five to seven years ago. 
262. Many patent owners also reported that they ha d partnerships with generic manufacturers to 
make their products more generally available.  They relied upon these generic manufacturers, often in 
developing countries, to scale up their manufacturing.  The partnership between Gilead, an innovative 
pharmaceutical company, and Indian and South A frican generic manufacturers represented one 
example in this regard.  It had increased the num ber of people receiving various treatments from 100 
at the time of the Doha Declaration in 2003, to 7 00,000 in 2010.  Gilead had entered into licensing 
agreements with those pharmaceutic al companies to transfer its patented technology for the 
formulation of the medicine.  These treatments addressed HIV infection and chronic Hepatitis B in 
adults.  With respect to its Indian partners, Gil ead had entered into licensing agreements to produce 
and distribute a generic version of the drug to 95 low-income countries much earlier than otherwise possible, due to India's production capacity and ca pable generics industry.  The licensing revenue 
from these agreements was also reinvested to fund medical education, safety reporting, and product 
registration/marketing approval in destination market s.  He noted that a number of companies around 
the world had granted licences to generic pharmaceutical  companies to make generic versions of their 
drugs.  He understood that licensing contracts were being explored by pharmaceutical companies in Bangladesh, Ethiopia, Kenya, Tanzania and Zimbabwe, as well as other countries.   
263. Another example of a partnership between innova tors and generics was the global Meningitis 
Vaccine Project (MVP).  The MVP had been establis hed in 2001, using tech nology licensed by the 
NIH.  In 2001 and 2002, the MVP had approached  various vaccine manufactures, seeking a 
manufacturer who could agree to manufacture the vaccine for 50 cents a dose, the price that NIH had been told by countries in Sub-Saharan Africa was n ecessary for the vaccine to be affordable in their 
marketplaces.  The Serum Institute of India had accep ted the challenge, and, after about eight years of 
work, had begun to ship the vaccine to Mali,  Burkina Faso, and neighbouring Niger in 
September 2010.  This eight year lag did reveal a larg er point, i.e.  that the procurement of medicines 
was a long process.  Any measure of length of obtaining a licence under the System should take this into account.  The results of this collaboration sp oke for themselves.  With respect to the MVP 
project, over a recent 17-day period, over 1 million pe ople had been vaccinated.  The target was to 
distribute 40 million doses.  The Gilead and MVP ap proaches were just two examples of partnership 
trends that were increasing and delivering real results.  These approaches had not existed ten or 
15 years ago.  There were many such cutting-edge partnerships that were promoting access to 
medicines.  Other similar partnership trends that had been reported included an increase in the number 
of research collaborations targeting areas of need  and increased voluntary sharing of intellectual 
property, such as "compound libraries" for research purposes.  One company had launched a knowledge pool, now run independently by a third pa rty, that had placed approximately 80 patent 
families in a pool to help others devel op new medicines for neglected diseases.   
264. In addition to collaboration with innovator co mpanies, the generic drug industries had also 
had a significant role to play in improving access.  For example, generic companies were engaging in more research activities for adapting existing products to the needs of developing countries as well as 
assisting in capacity advancement in poor countries.  Many of those partnerships also provided jobs, 
access to doctors and nurses, and training for medica l staff, schools and hospitals.  He said that the 
ability to patent an invention was critical to ensu re that there was an incentive for developing the 
medicine and that its benefits c ould be shared widely.  The devel opment of new, life-saving drugs was 
a risky and expensive process, and it was necessary to provide incentives for the private sector to 
undertake this effort.  Intellectual property rights were essential to provide this incentive so that new 
drugs could be brought to the market.  Moreover, patent systems could provide important incentives 
to reward innovators who had identified ways to  adapt medicines to many different challenging 
circumstances, such as a lack of refrigeration or a need for more patient-friendly ways of  IP/C/M/64 
 Page 61 
 
 
  administering a drug that might be particularly rele vant in developing country markets.  Many actors 
were working to promote access to medicines.  The intellectual property system played a critical role 
in assisting this effort.   
265. Time had shown that intellectual property rights were not often the determining factor in the 
larger issue of access to medicines, as had someti mes been asserted.  Many complex factors hampered 
access to medicines in developing countries, in cluding sub-optimal procur ement systems and poor 
distribution networks for medicines, caused by l ack of basic infrastructure, hospitals, clinics and 
healthcare professionals, among others.  The goal of  equitable access to medicines was not achievable 
or sustainable without fostering improvements to the health systems themselves to ensure that patients 
could actually receive the drugs.  Additionally, systemic problems, taxes and tariffs on imported 
medicines, and a lack of cold-chain storage, we re often overlooked problems in many multilateral 
discussions. 
266. With respect to problems that inhibited access to medicines, he noted that in some cases taxes 
or tariffs were levied on products being supplied at  cost, or on donated products, the cost of which 
was passed directly to patients.  Moreover, hea lth care was often delivered far from the community 
being served.  Weak drug procurement and deliv ery systems were another barrier to access to 
medicines.  Lack of transportation and infrastructur e also made it difficult to distribute pharmaceutical 
products and for a patient to see a doctor.  B acklogs, regulatory redundancy, as well as other non-
tariff barriers also hindered the distribution of both generic and innovative drugs where they were 
most needed.  Finally, if the healthcare system wa s flooded with counterfeit pr oducts, true access was 
not achieved.  Because of weak regulatory regime s and global criminal networks, counterfeit and 
substandard medicines harmed or killed sick people across the globe, with the developing world being 
disproportionately affected.  The WHO had estimated that "in over 50 per cent of cases, medicines purchased over the Internet from illegal websites that conceal their physical address have been found 
to be counterfeit".  These were all problems that co uld be solved.  Many of the issues would require 
action by both developed and devel oping countries.  It was clear that, without accounting for the full 
range of problems that existed, Members coul d not make the improvements that would foster 
improved access. 
267. With respect to some of the solutions with wh ich the United States was involved, he said that 
on 22 September 2010, President Obama had announ ced a new US global development policy, the 
first ever for a US Administration.  Through the policy, President Obama had made it clear that sustainable development was a long-term propos ition, and progress depended on the choices of 
political leaders and the quality of institutions in developing countries.  Where leaders governed 
responsibly, set in place good policies, and made i nvestments conducive to development, sustainable 
outcomes could be achieved.  Where those conditi ons were absent, it was difficult to engineer 
sustained progress, no matter how good the intentions  or the extent of engagement.  The policy had 
placed greater emphasis on building sustainable capacity  in the public sectors of US partners and at 
their national and community levels to provide basi c services over the long term.  The United States 
would continue to provide medicine, emergency food aid, humanitarian relief and other assistance 
where it was urgently needed.  But the United States would also strive to help increase the capacity of 
its partners to meet those needs by investing in systemic solutions for issues such as service delivery 
and public administration.  President Obama's six-year, USD 63 billion Global Health Initiative (GHI), had focused on sustainable service delivery wh ere the needs were greatest and the conditions 
were right to build effective health service deliver y systems.  As to shortages of skilled health care 
professionals, the US Government, as well as ma ny private companies, had undertaken significant 
efforts to improve healthcare systems in developing countries.  In the President's Emergency Plan for 
AIDS Relief (PEPFAR) and the President's Malaria Initiative (PMI), the United States was training a 
significant number of health workers in support of su stainable health systems.  The United States was 
also a leader in the implementation of task-shi fting initiatives in Africa.  The PEPFAR had promoted 
access to medicines and other products through ma ny means, including by improving supply chain IP/C/M/64 
Page 62  
 
  management.  This approach was saving lives; through PEPFAR, 2.5 million people were being 
supported for life-saving antiretroviral treatment. 
268. The PMI was working to improve access to ma laria medicines through their procurement and 
distribution in the 15 PMI focus countries (Angol a, Tanzania, Uganda, Malawi, Mozambique, 
Rwanda, Senegal, Benin, Ethiopia, Ghana, Ke nya, Liberia, Madagascar, Mali and Zambia), 
distributing over 80 million treatments.  With resp ect to government tariffs, as part of the WTO 
NAMA negotiations, Switzerland, Singapore, the Un ited States and Chinese Taipei had proposed an 
Enhanced Healthcare Initiative for Members to jointly reduce or eliminate tariffs on medicines and 
key medical equipment and supplies.  He hoped that  other Members would join in this effort, as it 
would result in lower medicine prices.  Simila rly, the use of transparent, competitive and non-
discriminatory procurement procedures and practi ces would provide governments with more choices 
from a broader array of suppliers that could mean  lower prices and more effective use of limited 
financial resources.  Access to me dicines was a complex issue that required a multifaceted, and often 
multi-sectoral approach, that address ed all aspects in a meaningful way.  The System must be located 
in this larger prism.  The United States' experi ences on approaches that were producing results were 
an illustration that Members should not focus only on reliance on the System as a proper or 
meaningful gauge of its operation. 
269. The representative of Canada
 said that the trilateral Symposium jointly organized by the 
WTO, WHO and WIPO had been very useful.  He disagreed with India's characterization of the Ghana case as having had a "chilling effect".  Acco rding to his information, when Indian generic 
firms had first brought TriAvir to the market, the tr iple ARV combination which had eventually been 
exported to Rwanda had been priced between 30 a nd 40 cents.  There had also been shipments from 
Indian generic firms to African countries.  When  Apotex had become a viable option and CAMR 
could be exercised by interested parties, the price of TriAvir from Indian firms had dropped substantially to 19 to 20 cents per pill.  Instead of a chilling effect, CAMR and the System as a whole 
could have had a beneficial effect on price. 
270. Since the System had come into  existence, a number of international procurement systems 
had been developed, such as the Clinton Foundation,  which had been key to delivering medicines to 
people in need.  He asked potential importing count ries whether they had taken advantage of such 
international procurement systems and if they coul d relate their experiences in this regard.  Many 
pharmaceutical companies also had charitable programmes by which they donated medicines.  This alternative was actively promoted by Canada thr ough tax incentives made available to brand name 
and generic pharmaceutical companies which donated medicines.  However, tariffs had a chilling 
effect on such initiatives.  It would therefore be interesting to hear from potential importing Members 
whether they still imposed tariffs or duties on donate d medicines which were imported.  There also 
continued to be growing manufact uring capacities of the pharmaceu tical industry in developing 
countries which were able to produce drugs at lower costs.  This had been a factor in the Rwanda 
case.  His delegation was interested to learn whether Members had increased their domestic 
manufacturing capacities since 2003. 
271. Voluntary licences were another available a lternative for obtaining essential medicines.  
Although the information was difficult to obtain, as these were transactions between private parties, 
there was some evidence that vol untary licences were being successfu lly deployed.  In the Rwanda 
case, if a voluntary licence had been secured by Apot ex, it would not have been necessary for Apotex 
to request an export authorization from the Commissi oner of Patents.  Nevertheless, this would still 
have constituted a success for CAMR.  With respect to Canada's 2007 Statutory Report on CAMR, he 
noted that it had stated that Canada should continue to pursue non-legislative measures to improve access to medicines in the developing world.  The Canadian International Development Agency 
(CIDA) was working with the global community to  address health needs in developing countries.  
ClDA worked with qualified, experienced organizations  and partners to improve health in the most  IP/C/M/64 
 Page 63 
 
 
  effective and cost-efficient way.  For example,  Canada was a founding donor of the global drug 
facility in 2001 and had been the largest single donor country for first-line tuberculosis drugs since the 
facility had been created.  The global drug fac ility, a programme of the "Stop TB" Partnership, 
worked to improve access, supply and distribution of  low-cost quality-assured anti-tuberculosis drugs 
in developing countries and was the only bulk procurer  of such drugs.  CIDA also provided significant 
support for initiatives such as the GAVI Alliance, th e WHO's universal access plan, and the Global 
Fund to fight AIDS, tuberculosis and malaria.  He was pleased to note that Canada's commitment to 
the Global Fund had recently been enhanced.  In September 2010, Canada ha d announced that an 
additional commitment of USD 540 million would be provi ded over the next three years.  This was in 
addition to the USD 978.4 million that Canada ha d already committed and disbursed to the Global 
Fund since 2002. 
272. Under its G8 Presidency in 2010, Canada ha d championed the Muskoka initiative, a major 
global effort to improve maternal, newborn and child  health in developing countries.  Eighty per cent 
of Canada's contribution of USD 1.1 billion would go to sub-Saharan Africa which had the greatest 
burden of maternal and child mortality.  However,  some countries simply could not afford essential 
medicines, no matter how low the costs were.  Moreover, the health delivery systems in some 
developing countries were inadequate to deliver and administer medicines, among others, because of 
an insufficient number of well-trained medical staff and lack of modern infrastructure.  This was 
another reminder that the main problems of access to medicines were the result of poverty, not patent 
laws. 
273. With respect to counterfeit and sub-standard me dicines, the representative of Canada referred 
to a statement by Minister H.E. Prof. Dr. Hatem El-Gabaly of Egypt.  At a conference in 2009, the 
Minister had provided some important remarks regarding the scourge that counterfeit and sub-
standard medicines had had with respect to their effe ct on the health of citizens.  He had also made 
some remarks about the economic aspects.  He  quoted the Minister who had said: "counterfeit 
medicines also inflict serious damage and injury  to national economies and manufacturers.  These 
negative economic consequences are not limited to depriving legitimate businesses and their workers 
of income.  Discouraging innovation and creativity  can provide an easy source of revenue for 
organized crime, but they also entail loss of nati onal tax revenues.  As su ch, both governments and the 
private sector stand to lose from proliferation of trade in counterfeit medicines.  As part of our collective endeavours to address this global challenge , we must be cognizant of the underlying factors 
that feed such illicit trade.  These factors can be  technical, economic or legal.  However, the 
inescapable fact is that counterfeiting of medicines is a lucrative business due to the continued high 
demand for medicines and low production costs.  Expe rts indicate that when prices of medicine are 
high and price differentials betwee n identical products exist, there is a greater incentive for the 
consumer to seek medicines outside the normal supply  system.  In this context, poverty and lack of 
awareness appear as important issues to be addressed in our fight against counterfeit medicines.  No 
country is immune from the threat posed by co unterfeit medicine, and Egypt is no exception.  
Therefore it is our firm conviction that counterfeiting medicines, including the entire range of activities, from manufacturing to providing them to patients, is a serious criminal offence that puts human lives at risk and undermines the credibility of health systems.  Let me shed some light on our 
response strategy.  At the international level, Egyp t supports global efforts aiming at eradication of the 
threat of counterfeit medicines.  In the face of th is trans-boundary threat, we continually coordinate 
with our international partners to design more effective collaboration mechanisms that involve 
international organizations, enforcement agencies,  national drug regulatory authorities, customs and 
associations for consumer protection.  We also pr omote sharing of information and exchanging best 
practices amongst all stakeholders.  More importantly, tightening border controls to diminish the risk 
of trans-shipment of counterfeit medicines should be a priority for regional and international 
cooperation." The representative of Canada asked wh ether the delegation of Egypt could expand upon 
these timely initiatives of the Egyptian Government. IP/C/M/64 
Page 64  
 
  274. He also quoted the Indian Minister of Health  and Family Welfare, Ghulam Nabi Azad, who 
had stated: "I propose to introduce a whistleblower po licy to involve the public to provide information 
on any kind of unlawful activity in the manufacture of drugs.  There is no dearth of good intentioned people who may wish to work for his country's in terests as a whistleblower in eradicating this 
menace.  People's participation is imperative in this  regard." The media report had also indicated that 
a country-wide survey in India was under way to assess the exact size of India's spurious counterfeit 
drug industry.  The study had apparently alr eady identified 61 popular drug brands from nine 
therapeutic drug categories that were being tested .  Canada asked the dele gation of India whether 
there were any specific results from this study that could be shared with Members.  Apparently, the 
Indian Health Ministry had estimated that 5 per cen t of the drugs sold in India were counterfeit while 
0.3 per cent were spurious.  A counterfeit medicine was one that had no active ingredient or was an 
expired drug that had been relabelled or sold.  It was different from a fake drug which might resemble 
the original in any way, according to the report.  The Minister had also stated that the Drugs and 
Cosmetics Act had recently been amended to prov ide stricter penalties for offences under the Act, 
particularly to those engaged in  making spurious, adulterated, mi sbranded and sub-standard drugs.  
The maximum penalty was life imprisonment and a fine of three times the value of confiscated goods.  
Some of the offences were now cognizable and non-b ailable.  His delegation was interested in any 
updates about this particular Act and any other Indian initiatives. 
275. The representative of Brazil
 shared her delegation's experien ce with the System.  Paragraph 7 
of the Decision of August 2003 had established that "Members recognize the desirability of promoting 
the transfer of technology and capacity building in the pharmaceutical sector in order to overcome the 
problem identified in paragraph 6 of the Declara tion".  Her delegation regarded this as an essential 
element of the Decision.  While not directly related to the System's implementation, she referred to a recent initiative funded by Brazil in an attempt to solve the problem of countries with limited 
manufacturing capacity.  The Brazilian Governme nt was helping Mozambique set up a small 
manufacturing unit for the production of first-line an tiretroviral medicines based on the portfolio of 
drugs produced by the Oswaldo Cruz Foundation.  The output of this unit was initially intended for 
the local market.  In the future, the producing pl atform of Mozambique might also supply other 
neighbouring markets. 
276. The representative of Cuba
 said that her delegation was not in a position to accept the 
Protocol Amending the TRIPS Agreement until the ope ration of the System had proven to be fully 
effective.  Moreover, regulatory aspects, incl uding a quality examination regarding safety and 
efficacy, did not form part of the System.  Other as pects had to be clarified which had a bearing on the 
lengthy period needed to manufacture and expor t pharmaceutical products under the System.  The 
preparation and approval by the relevant government  authorities of the legal instrument that was 
required to apply the System at national level en tailed a complex process.  There was therefore no 
justification for undertaking such a process until it ha d been demonstrated that the System complied 
with the objectives of paragraph 6 of the Doha Declaration.  Some Members considered this system to 
be an historic milestone which it undoubtedly was.  The mandatory patent protection of 
pharmaceutical products had made it necessary to find a solution to ensure that profit-making interests 
of patent holders were not maximized  to the detriment of the right to life and health.  Nevertheless, 
the System was still far from proving its practical effectiveness.  Certain clarifications made in this discussion should have already been addressed by the Decision establishing the System.  She said that 
the System had also been distorted bilaterally by  developed countries through free trade agreements.   
277. The representative of the European Union
 said that the System was a measure among many 
others that could contribute to improving access to medicines in the developing world.  He 
highlighted some of the reasons that could explain why the System had not been used frequently.  First, a number of medicines were simply no long under patent protection.  For those medicines, there 
was therefore no need for a compulsory licence, and therefore no need to invoke the System.  
Secondly, least developed country Members were not obliged to implement their obligations under  IP/C/M/64 
 Page 65 
 
 
  the TRIPS Agreement regarding patents and undiscl osed information in the pharmaceutical sector 
until 1 January 2016.  Until then, those countries who had not implemented the TRIPS Agreement 
could import medicines without making use of compulso ry licensing.  Finally, developing countries in 
need could use all available channels to ensure access to affordable medicines.  Those included the 
use of the existing TRIPS flexibilities, direct nego tiations with the pharmaceutical companies, public-
private partnerships and donations.  With regard to the efforts made by the European Union to 
facilitate access to medicines, he recalled that his delegation was taking an active part in promoting 
access to medicines in developing countries.  It was the biggest provider of resources to support health 
policies in developing countries.  Projects and programmes funded by the European Union in developing countries covered a wide range of ac tivities, research, production, procurement and 
delivery, including quality control.  It was as sociated with a number of WHO programmes for 
research and development and capacity building.  It was also one of the oldest and biggest 
contributors to the Global Fund to fight AIDS, Tuberculosis and Malari a and had donated EUR 872 
million since 2002.  Under its cooperation programme  in the form of the Seventh Research and 
Development Framework Progra mme covering the period 2007-2013, the European Union had 
allocated a total of EUR 6.1 billion to help resear ch and development worldwide.  Moreover, it had 
also set up a tiered pricing mechanism for the suppl y of cheaper medicines to developing countries.  
His delegation remained fully committed to fac ilitating access of medicines in the developing world 
and to making the System work. 
278. The representative of Colombia
 noted that his delegation was interested in examining whether 
the international rules that Members had agreed  upon genuinely facilitated access to medicines.  
Access to medicines involved correctly assessing the needs of the population and undertaking 
research, development, production and supply of medi cines to meet those n eeds, so as to ensure 
timely access to the medicines in su fficient quantities and at affordable prices for all.  The regulatory 
environment should be both favourable to the industry and in the interests of public health.  A balance 
needed to be found between the in centives for the industry and the cr eation of a competitive market.  
The System had sought to achieve this goal in res ponse to the specific situation of Members who had 
insufficient or no manufacturing capacities in the ph armaceutical sector and faced difficulties in 
making effective use of compulsory licensing. 
279. He questioned, however, whether the System wa s the only instrument and whether its design 
and implementation were optimal for achieving the goa l of supporting public health.  With respect to 
the first question, the System was clearly not th e only intellectual property instrument aimed at 
attaining these goals.  Compulsory licensing, more  stringent patentability criteria, exceptions to 
patentability, parallel imports and control of abuse of  intellectual property rights by right owners were 
other valid tools for protecting public health.  Likewise, there were mechanisms beyond the 
intellectual property sphere that were directed to wards the same objective.  Accurate and widely 
available price information and mechanisms to prom ote competition were powerful tools to that end.  
With respect to the second question, his delegation viewed the System as both limited and complex.  
Moreover, its requirements had led to delays and costs which made it a somewhat unattractive option 
presently.  Those aspects should be further discussed in the interests of achieving an effective 
implementation of the System.  He noted that only 30 Members had notified their acceptance of the Protocol Amending the TRIPS Agreement.  Colomb ia had notified its acceptance in August 2009.  If 
the rate of adoption continued at its current pace of  six Members per year since 2008, it would take at 
least three more years for this flex ibility to become a permanent part of the Agreement.  He urged all 
Members whose domestic acceptance procedures were  still under way to complete the process. 
280. Referring to the statement by his Health Mini ster which had been quoted by Canada, the 
representative of Egypt
 outlined his delegation's perspective on th e issue of counterfeit medicines.  He 
referred to a statement made by Minister Hatem El gabaly at the 63rd Session of the World Health 
Assembly.  On this occasion, he had said that "t he quality, safety, and efficacy of medicines is 
a primary concern of national drug regulatory regim es.  Likewise, the World Health Organization has IP/C/M/64 
Page 66  
 
  an important role to undertake in supporting these  effo rts of its member States.  We believe that the 
activities of the WHO in this regard should be given mo re focus and clarity.  There needs to be a clear 
distinction between on one hand, ensuring the qualit y, safety and efficacy of medicine, which is a 
public health issue directly within the remit of  the WHO, and on the other hand, the issue of 
counterfeiting, which is a term pertaining to the field of intellectual property, and specifically, a 
problem of trademark violation, as referred to in  the World Trade Organization TRIPS Agreement.  
As such, this latter issue should be dealt with unde r relevant national IP legislation, and pertinent 
national IP enforcement procedures, and multilaterally,  it should be dealt with at the more competent 
Geneva-based organizations, chiefly the WTO and WI PO.  At the WHO, attention should be paid and 
solutions must be urgently found from a pub lic health perspective and not through the 
lens of intellectual property rights.  By bringing mo re clarity to the issue at hand, we can note that 
sub-standard medicines lacking in quality, safety and efficacy represent a far larger risk to public 
health than counterfeit medicines.  These two classe s should not be confounded and particularly so at 
the WHO which has a clear mandate relating to public health."  
281. The representative of the Bolivarian Republic of Venezuela
 noted that the delegation of 
Canada had described poverty as the main problem fo r access to medicines.  He questioned this 
statement, noting that poor patients in developing  countries sometimes resort ed to counterfeit drugs 
out of despair.  The problem therefore was high prices applied by multinational companies which they placed above the public health interests of the poorest nations.   
282. In reaction to the quotation of the Indian Hea lth Minister by the delegation of Canada, the 
representative of India
 noted that his Government attached hi gh importance to the issue of spurious, 
sub-standard and falsified medicines, which posed  a big challenge for public health and access to 
medicines.  This was backed by the Minister's st atement which had referred to deterrent punishments 
under the Drugs and Cosmetics Act.  With respect to  counterfeit medicines, he endorsed the statement 
made by the delegation of Egypt.  At the World Health Assembly, as well as at other international 
fora, his delegation had deplored the deliberat e confusion which was being created between 
intellectual property rights and public health-related issues.   
283. The representative of Ecuador  queried what budgets private actors had for the distribution of 
essential medicines, compared with the budgets of member  states.  He also asked  to what extent such 
donations and grants made by pharmaceutical comp anies which were usually profit-driven businesses 
could be compared.  He was also interested to know more about questions of government procurement.  In Ecuador, a compulsory licence had been issued and in less than a month contracts 
had been exchanged.  Moreover, he asked how many voluntary licences had been granted and what 
the time-frame was for the negotiations leading to  the grant of such licences.  As regards the 
discussion of benefits, he noted that these were a bout access to essential medicines and human lives at 
stake, not about trade and profitability.  He suppor ted the statement by the delegation of Venezuela 
regarding poverty and access.  He said that issues re lated to public interest as discussed in the TRIPS 
Council were the responsibility of all Members a nd therefore different from donations from private 
business, companies or initiatives.  With respect to counterfeit and sub-standard medicines, he 
cautioned Members not to target or undermine generic medicines. 
284. The representative of Norway
 said that his delegation fully supported the intention behind the 
System which had been duly implemented domestica lly.  He noted that his delegation was a major 
donor to a number of public and private partnershi ps that had improved access to medicines such as 
the Global Fund to fight AIDS, Tuberculosis and Malaria, the GAVI Alliance and the drug purchase 
facility UNITAID. 
285. The representative of Switzerland  supported a number of points made by the US delegation.  
In particular, his delegation had co-sponsored the enhanced health care initiative which targeted the 
elimination of tariffs on medicines and medical devi ces in the WTO.  An obvious alternative to the  IP/C/M/64 
 Page 67 
 
 
  System was a favourable outcome of procurement ne gotiations with the patent holder itself.  This 
would result in direct delivery from the patent holde r or alternatively, in the grant of a voluntary 
licence to a potential manufacturer, who would, in cooperation with the patent right holder, provide 
the medicines required to the recipient country at a mo re affordable price.  This alternative was often 
a more expeditious process and a better guarantee for the safety and efficacy of the medicines.  The 
Government's position to negotiate the terms of such a licence agreement was strengthened by the 
System's very existence as an altern ative to such a mutually agreed so lution with the right holder.  The 
System enabled countries without manufacturing cap acity in the pharmaceutical sector to effectively 
consider issuing a compulsory licence as a polic y tool and as a fallback option to contractual 
agreements. 
286. However, to advocate compulsory licences, wh ether under Article 31 or the new Article 31bis 
of the TRIPS Agreement as a simple solution to pr ovide easy and sustainable access to medicines was 
not only simplistic but also a misleading message to  countries in need of medicines to address a 
pressing public health problem.  Compulsory licences posed a number of practical problems that were time consuming to solve.  The search for an appropr iate generic manufacturer who was ready, capable 
and available to produce a generic medicine was a ch allenge in itself and could be time-consuming.  
Some generic producers were also not in a position to  provide more affordable or competitive prices.  
The issue of high-quality medicines and regulatory review of the quality and efficacy of medicines produced under a compulsory licence constituted anothe r set of considerable challenges.  It would 
therefore be simplistic to present compulsory licences as a panacea for access to medicines for 
developing countries.  Where it was possible to find a mutually agreeable and affordable solution for 
the supply of the needed medicines by the original manufacturer holding the patent right, this was the 
most efficient and expeditious solution for a country  facing an urgent public health problem.  Thus, 
the production lines would already be there and the r espect of tested and reliable standards regarding 
health and efficacy would be assured.  Howeve r, sometimes a compulsory licence, which was 
available to Members under the TRIPS Agreement,  was a useful policy tool.  The System had 
facilitated the use of compulsory licensing by WT O Members without manufacturing capacities in the 
pharmaceutical sector on a level playi ng field with all other Members. 
287. With respect to India's intervention, he noted that in 2002, Article 30 TRIPS had been 
considered as a potential solution.  However, this  approach had been quickly discarded, and had not 
reached consensus.  In any event, his delegation did not consider Article 30 to be a viable alternative 
to the System which covered new ground.   
288. The representative of Australia
 recalled that the System had been developed to improve the 
ability of countries without manufacturing capacity to  access affordable medicin es.  It had not been 
intended to be a panacea solution to the problem of  access to medicines.  Her delegation would be 
interested to hear from those Members who ha d spoken of occasions when the availability of 
alternative sources of medicine, including generics, had vitiated their need to utilize the System.  The 
availability of effective alternatives to the System  provided no evidence of its  failure, but constituted a 
useful example of alternative pathways through wh ich access to medicines could be realized.  The 
operation of the System could therefore not be c onsidered in a vacuum, as it represented but one 
weapon in the armoury of mechanisms and policies intended to improve access to medicines.  Any 
assessment of its effectiveness had to take into account the specificities of what the System was 
intended for and was able to achieve, as well as the wa y in which it impacted upon, and was impacted 
upon by, a diverse range of bigger picture issues af fecting access to medicines.  These were much 
broader than the intellectual property issues discussed  in the Council.  They included the rate and 
relevance of innovation, the reliability of procurem ent and supply chains at both the national and 
international level and the safety, affordability and appropriate use of medicines.  These and other 
issues were affected by and had implications for the System's operation.  They were also being 
considered in other multilateral fora, such as under the WHO's Global Strategy and Action Plan on 
Innovation, Public Health and Inte llectual Property.  These discussi ons could usefully inform the IP/C/M/64 
Page 68  
 
  Council's debate, including with respect to how WTO Members could more effectively use the 
system.  Her delegation looked forward to continuing  the consideration of the System's operation in 
the context of the broader discussion of access to me dicines, bearing in mind the issues which could 
be addressed by the System. 
6. Next steps and recommendations 
289. The Chairman
 said that the purpose of this topic was to provide the Council an opportunity to 
discuss whether there was a need for follow-up to th e present annual review and, if so, what it should 
be. 
290. The representative of India  noted that the meeting had provided a good opportunity to discuss 
in greater detail the implementation of the System and several other associated issues, but discussions 
had not been exhaustive.  With the track record  of a single use in seven years, he remained 
unconvinced that the System was workable.  It could certainly not respond to public health 
emergencies.  He regretted that  key stakeholders, including phar maceutical companies and civil 
society organizations which had first-hand experience  of using or attempting to use the System, had 
not participated in the discussion.  At the Counc il's previous meeting, some developed country 
Members had made a discussion among Members a prer equisite to enlarging participation.  He 
considered that this condition had now been me t.  He therefore recommended that a dedicated 
workshop be held with an enlarged participati on, including pharmaceutical companies and civil 
society organizations.  Further details regarding ma tters such as participation, timing and scope should 
be discussed in informal consultati ons to be held by the Chair. 
291. Moreover, he recommended that international or ganizations, which had made presentations at 
the meeting, be invited to respond to the remaini ng questions at the Council's next meeting.  In 
particular, he requested the WHO to prepare a de tailed report on the coverage of flexibilities in its 
technical assistance activities.  He also requested  the delegation of Canada to report on further 
developments regarding efforts to amend CAMR.  In addition, Members might make submissions for 
future focused discussions.  He also invited deve loped country Members to report at the Council's 
next meeting on how they had implemented paragra ph 7 of the Decision, which was part of their 
obligations under Article 66.2.  He added that it w ould be useful if the Chair could prepare his own 
summary of the discussion. 
292. The representative of Mauritius, sp eaking on behalf of the ACP Group , supported India's 
recommendation to hold a dedicated workshop with th e participation of pharmaceutical companies, 
NGOs and other relevant actors.  Lessons drawn fro m experiences discussed at this meeting should be 
used to prepare the grounds to improve the System.  The implementation of practical solutions and the 
avoidance of ideological stances was important.  Wh ile alternatives to the System should be pursued, 
it should remain a main pillar to enable access to essential medicines, especially in times of 
pandemics and health crises.  He encouraged the WTO, WHO and WIPO to increase coordination, focusing more on flexibilities.  Their activities shoul d incorporate the regional perspective regarding  
the use such flexibilities with a vi ew to enabling access to medicines, and should also provide more 
targeted advice as opposed to general seminars. 
293. The representatives of Brazil
, the Bolivarian Republic of Venezuela , Ecuador , Argentina , 
Peru, Chile , Egypt  and China  supported India's recommendation that a dedicated workshop be held 
with an enlarged participation, including pharma ceutical companies and civil society organizations.  
The representative of Peru  also supported India's suggestion that the Chair prepare his own summary 
of the discussion. 
294. The representative of Canada  said that his delegation would be prepared to provide an update 
with respect to Bill C-393 in future Council meeti ngs.  His delegation had some ideas with respect to  IP/C/M/64 
 Page 69 
 
 
  matters such as information dissemination and how it  could better publicize its work, particularly as 
an exporting Member.  Some of this work dove tailed with other aspects of the Council's work, 
particularly under Articles 66.2 and 67 TRIPS.  He  invited Members who had not done so to respond 
to the questions raised by his delegation under th e first and second topics.  The Council had not yet 
met its full potential with respect to the engagement of Members, in terms of providing their specific 
national experiences.  He proposed that the Chair under take consultations in the near term to further 
explore some of these questions and how best to pr oceed.  He did not rule out the possibility of a 
workshop, but thought that more time was need ed to assess what had been done and to enable 
Members to provide responses.  His delegation was open to meet bilaterally, and would be happy to 
accept written responses and would welcome further input.   
295. The representative of the United States  associated his delegation with the points made by 
Canada.  The WTO was a Member-driven organization and the System was a Member-based solution.  
Members' experiences were therefore the most importa nt.  Before other stakeholders were brought in, 
it was incumbent upon the TRIPS Council to continue to  work through some of the issues.  He noted 
that, while the Council had heard from exporting Member s, it still needed to hear the experiences of 
potential importing Members, as the System had been d esigned for their benefit.  Therefore, there was 
no need for the Council to organize a workshop at this point.   
296. The representative of Australia  noted the absence of the voice of potential importing countries 
in the discussions, and the identification by such coun tries of obstacles or alternatives to the use of the 
System.  This would be an essential contribution that  would greatly facilitate the Council's work in its 
review of the System.  Her delegation supported Cana da's proposal that consultations on next steps be 
held by the Chair.  These could include holding a workshop, provided that it were sufficiently broad 
to allow meaningful and frank discussions of all the issues related to access to medicines.  The issues 
to be considered went beyond the narrow question of intellectual property rights and included aspects 
in the field of government procurement, supply chains and gender issues.   
297. The representative of Japan  requested further information from potential importers and in that 
regard supported the delegations of Ca nada, Australia and the United States with respect to next steps.   
298. The representative of India  reiterated his request for a dedicated workshop which could 
probably feed into the Member-driven discussions at the Council's next meeting.  Even in a Member-
driven organization like the WTO, there was scope for presentations and workshops involving 
external stakeholders.  For example, the US delega tion had in the past requested to have a workshop 
held by Caterpillar in the NAMA negotiations.  An  open-ended workshop befo re the Council's next 
meeting would further enrich discussions at that meeting.   
299. The representative of the European Union  said that more feedback from potential importing 
countries as to why they had not used the System thus far would be useful.  While not perfect, the System offered a mechanism that could be helpful to developing countries in getting medicines they 
needed.  He supported India's suggestion that the Chair conduct further consultations to discuss next 
steps.   
300. The representative of Switzerland
 regretted the absence of interventions from potential 
importing countries on potential concerns  or obstacles they may have met when wanting to make use 
of the System.  He supported the suggestion that delegations respond to outs tanding questions at the 
Council's next meeting.  His delegation was also in terested in being associated with any informal 
consultations the Chair might conduct.   
301. The representative of Mexico  said that it would be useful to receive in writing information 
about the experience of national pharmaceutical  sectors, including multinational pharmaceutical 
companies.  He also wished to be associated with any informal consultations the Chair might conduct.   IP/C/M/64 
Page 70  
 
  302. The Chairman
 said that he had found the discussion of the topics under the annual review 
very useful.  As to next steps, there were two dis tinct views.  Some delegations were in favour of a 
workshop with an enlarged participation, while others believed that the Member-to-Member process 
had not yet been exhausted.  As recommended by a number of delegations, he suggested that he 
consult on follow-up to the review, including both the question of a workshop and other proposals 
made.   
303. The Council took note  of the statements made and so agreed . 
304. Turning to the Council's report to the General Council on the Annual Review of the Decision 
on the Implementation of Paragraph 6 of the Doha  Declaration on the TRIPS Agreement and Public 
Health, the Chairman  recalled that the WTO Secretariat had prepared a draft cover note to this report 
(JOB/IP/1).  It contained factual information on the implementation and use of the System established 
under the Decision, on discussions earlier in the y ear regarding its operation, and on the acceptance of 
the Protocol Amending the TRIPS Agreement.  He proposed that, in accordance with the way that the 
Council had prepared its report in previous years, th e part of the Minutes of the meeting reflecting the 
discussions held under this agenda item be a ttached to the cover note as an annex.   
305. As he had noted under item A, Croatia had just notified its amended Patent Act which 
implemented the System.  In addition, Albania ha d notified its new Law on Industrial Property, which 
also implemented the System.  Therefore, Croatia and Albania would be added to the list of Members 
who had notified their domestic implementation, c ontained in paragraph 4 of the draft cover note.  
Furthermore, Uganda had notified its  acceptance of the Protocol and would, therefore, be added to the 
list of Members in paragraph 12 of the draft cover note. 
306. The delegation of Canada  requested that some minor changes be made to the draft report, 
which had been submitted to the Secretariat.  Specifically, he suggested that the sentence in 
paragraph 8 of that report readi ng "The delegation of Canada shar ed its experience in using the 
System, including a detailed timeline of events" be re moved, and the subsequent sentence modified to 
read "Some delegations expressed concern that th e System had only been used once since 2003 and 
that it had taken some three years to deliver the me dicines from Canada to Rwanda in this context".  
He suggested that the following sentence remain  the same, and suggested inserting a subsequent 
sentence which would read:  "The delegation of Canada shared its experience in using the system, 
including a detailed timeline of events which, it its view, demonstrated the fact that Canada's access to 
medicines regime CAMR had been successfully uti lized and only a very small portion of this three-
year time period had been taken up by procedures associated with that regime.  It said that much of 
the time that elapsed between the regulatory review of the medicine in question and the shipping to 
Rwanda could be attributed to other variables". 
307. The representative of China  asked whether its amended Patent Act could be added to the draft 
cover note in the section listing Members who had notified their implementing legislation to the 
Council, if notified to the Council by the end of November.   
308. The Chairman  proposed that the Council agree to the cover note to the report as contained in 
JOB/IP/1, together with the updated information concerning Croatia, Albania and Uganda and the 
changes suggested by Canada, and also that the Council minutes containing the record of the discussion be attached thereto.  In addition, he proposed that the cover note be updated to include a 
reference to China's amended Patent Act,  provided that it was notified in time. 
309. The Council took note
 of the statements made and so agreed .  IP/C/M/64 
 Page 71 
 
 
  G. NON-VIOLATION AND SITUATION COMPLAINTS  
310. 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 subpara graphs 1(b) and 1(c) of Article XXIII of GATT 
1994 and make recommendations to their next Session.  It was agreed that, in the meantime, Members 
will not initiate such complaints under the TRIPS Ag reement.  At its meeting on 21 October 2010, the 
General Council had announced that the eighth Mini sterial Conference will be held in Geneva on 
15-17 December 2011.  At its mee ting in March 2010, the TRIPS Council had agreed to keep the item 
on non-violation and situation complaints on the agenda as a regular item so as to allow Members 
who would have new thinking to share it, and also en able the Council to revert to the question of the 
further organization of its work in the light of any future suggestions. 
311. The representative of China  said that he found it difficult to explain why non-violation 
complaints were relevant to TRIPS, since its natu re and structure was different from GATT.  So far, 
not even a hypothetical case had been presented on how  they could work under TRIPS.  Unlike the 
CBD and public health, keeping non-violation on the Council's agenda was not based on factual 
concerns.  Renewing the moratorium every two y ears could only result in legal uncertainties.  
Therefore, he suggested that the next Minister ial Conference either ban the application of non-
violation and situation complain ts under TRIPS or decide on an unlimited moratorium until Members 
decide otherwise.  
312. The representative of the United States  said that, in the past, Members had agreed to extend 
the moratorium on non-violation and situation compla ints.  This had been a significant concession on 
the part of the United States, as the moratorium had been set to expire at the Sixth Ministerial 
Conference.  He said that he nonetheless maintain ed that non-violation complaints were fully 
appropriate in the context of the TRIPS Agreemen t.  The possibility of non-violation disputes had 
been a part of the GATT dispute settlement system  since its beginning.  The TRIPS Agreement had 
been carefully negotiated to accommodate different 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 could frustrate legitimate expectations.  As his de legation had noted in the past, the failure to allow 
this possibility in connection with the TRIPS Agre ement could invite Members to seek creative ways 
to avoid their TRIPS obligations.  It continued to be of the view that it was entirely appropriate for non-violation and situation complaints to be a pplicable to the TRIPS Agreement and that the 
moratorium should expire at the next Ministerial Conference. 
313. The representative of Argentina
 said that non-violation and situation complaints were 
inapplicable to the TRIPS Agreement.  She recalled that Argentina had circulated, together with other 
cosponsors, a communication on this topic (IP/C/W/385).  
314. The representative of Switzerland  said that, during the Uruguay Round negotiations, there had 
been consensus that the DSU should apply simi larly to various WTO agreements, including the 
TRIPS Agreement.  Switzerland continued to ta ke the view that non-violation and situation 
complaints were applicable to the TRIPS Agreemen t in a similar way as to GATT and GATS.  In light 
of Article 64.2 and 3 of the TRIPS Agreement, it seemed clear that, after the expiry of the moratorium 
at the Ministerial Conference at the end of 2011,  such complaints should be applicable to the 
Agreement.  He reiterated his willingness to partic ipate in any meaningful discussion in the Council 
regarding the scope and modalities for such complain ts under the Agreement, if  other delegations felt 
that such further examination was necessary.   
315. The representative of Ecuador  recalled that his delegation had co-sponsored document 
IP/C/W/385.  He believed that non-violation and situ ation complaints were not applicable to IPRs IP/C/M/64 
Page 72  
 
  and, thus, not to the TRIPS Agreement that establis hed minimum IPR standards.  Over the years, the 
majority of Members had taken the view that non-violation should be made inapplicable to 
intellectual property  
316. The representative of Peru
 endorsed the views of China, Ecuador and Argentina with regard 
to the non-violation and situation complaints and recalled that Peru was one of the co-sponsors of 
IP/C/W/385.  The TRIPS Agreement explicitly establis hed that Members were not required to provide 
further protection.  The application of non-viola tion and situation complaints could disturb the 
delicate balance of obligations under it and limit the u se of its flexibilities to ensure, inter alia, public 
health and transfer of technology.  Thus, th e Council should recommend that non-violation and 
situation complaints be made inapp licable to the TRIPS Agreement.   
317. The representative of the Bolivarian Republic of Venezuela  believed that non-violation and 
situation complaints were not appropriate unde r the TRIPS Agreement and supported China's 
suggestion concerning the next Ministerial Conference.  
318. The representative of Cuba  said that document IP/C/W/385, co-sponsored by Cuba, provided 
a comprehensive overview of the reasons why non-violation and situation complaints were 
inapplicable to the field of trade in intangible assets.  No document had ever been submitted to the 
Council setting forth reasons that justified applying  such complaints to the field of intellectual 
property.  Moreover, contrary to what some Members believed, there would be no end to the 
moratorium at the next Ministerial Conference. 
319. The representative of India  supported the interventions made by China, Argentina, Ecuador, 
Peru, Venezuela and Cuba.  He said that ther e was an emerging consensus towards banning non-
violation and situation complaints in the detaile d discussions which had taken place in the Council, 
particularly leading to the report by the Chair in 2003 .  In order to avoid legal uncertainties, he urged 
delegations to work towards banning such complaints. 
320. The representative of Nigeria, speaking on behalf of the African Group , recalled that he had 
presented the position of the African Group at the Council's meeting in June 2010.  He supported 
China's proposal that the next Ministerial Conference should, at least, ban the usage of non-violation 
complaints.  At the Council's meeting in June, Pakist an had requested the proponents of non-violation 
complaints to explain how such complaints would a pply to the TRIPS Agreement.  He believed such 
information would further the discussion, leading to  some consensus before the next Ministerial 
Conference. 
321. The Chairman  said that  it was incumbent on the Council to try to reach consensus.  There 
were only three more meetings before the Coun cil was due to provide recommendations to the 
Ministerial Conference in December 2011. He urged Members to look for creative ways to resolve the 
issue. 
322. The Council took note  of the 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 
323. No statements were made  under this agenda item. 
324. The Council agreed  to revert to the matter at its next meeting.  IP/C/M/64 
 Page 73 
 
 
  I. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHICAL 
INDICATIONS UNDER ARTICLE 24.2 
325. 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.  At the Council's meeting in June, Peru and Korea had presented their communications 
providing information on this matter, which at that time had only been available in their original 
languages.  Since then, these communications had been  circulated in all three official languages in 
documents IP/C/W/547 and addendum 1, respective ly.  No new communications relating to this 
agenda item had been received for the present meeting. 
326. The representative of the European Union  said that the European Union was party to a 
number of bilateral and regional free trade agreemen ts with provisions that addressed, among other 
things, the protection of geographical indications.  Those agreements could be  found on the website of 
the Directorate-General for Agricultu re of the European Commission at 
http://ec.europa.eu/agriculture/mar kets/wine/third/index_en.htm. 
327. The representative of China  said that China  had concluded FTAs with Chile and Peru, both of 
which contained a chapter on geographical indications .  The FTA with Peru had already been notified 
by the delegation of Peru in document IP/C/W/547.   The FTA with Chile could be found on the portal 
for China's FTAs at http://fta.mofcom.gov.cn, whic h contained English langua ge versions of FTAs. 
328. The Chairman  urged those delegations that had not yet provided responses to the Checklist of 
Questions contained in document IP/C/13 and Add.1 to do so.  Also those Members that had already 
provided responses could provide updates to the exte nt there had been any significant changes on the 
way they provided protection for geographical indications.  
329. The Council took note  of the statements made and agreed  to revert to the matter at its next 
meeting. 
J. EIGHTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON THE IMPLEMENTATION 
OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT  
330. The Chairman  recalled that, at its meeting in February 2003, the Council had adopted a 
decision on the "Implementation of Article 66.2 of  the TRIPS Agreement".  Paragraph 1 of the 
Decision provided that developed country Member s should submit reports a nnually on actions taken 
or planned in pursuance of their commitments under Artic le 66.2.  To this end, they were to provide 
new detailed reports every third year and, in the intervening years, provide updates to their most 
recent reports.  These reports were to be submitted prior to the last Council meeting scheduled for the 
year in question.  He said that the third set of  detailed annual reports unde r the Decision had been 
presented to the Council's meeting in October 2009.  At its meeting in June 2010, the Council had 
requested developed country Members to submit a first set of updates to these reports for the present 
meeting.  The Secretariat had issued on 28 July  an airgram (WTO/AIR/3595) to remind developed 
country Members of this request. 
331. The Council had received updates to the th ird set of detailed annual reports from the 
following developed country Members:  Norway;  Aust ralia;  Switzerland;  Japan;  New Zealand;  the 
United States;  and Canada.  Th is documentation was being circulated in document IP/C/W/551 and 
addenda. IP/C/M/64 
Page 74  
 
  332. As regards the purpose and conduct of the revi ew of this information, he recalled that 
paragraph 2 of the Decision on the Implementation of Article 66.2 of the TRIPS Agreement explained 
that the annual review meetings should provide Me mbers with an opportunity to pose questions in 
relation to the information submitted and request add itional information;  discuss the effectiveness of 
the incentives provided in promoting and encouraging technology transfer to least developed country 
Members in order to enable them to create a sound and viable technological base;  and consider any 
points relating to the operation of the reporting procedure established by the Decision.  
333. Since some of the information had only been received very recently and most of it was 
available only in its original language, he said that he intended to provide an opportunity at the next 
meeting for Members to make further comments on  the information submitted for the present meeting 
that they might not yet have been able to study, and on any further information that might be provided 
before the next meeting. 
334. He informed the Council that, for the third year in a row, the Secretariat had organized, at the 
request by LDC Members, a workshop on transfer of technology under Article 66.2 back-to-back with 
the Council's end-of-year meeting.  This time, th e workshop had been held in the afternoon of the 
previous day.  It had again broug ht together LDC and de veloped country experts to discuss this matter 
at a very practical level, building on the earlier workshops in 2008 and 2009.  There had been a constructive exchange of views that had been usef ul to both LDC and develo ped country delegations. 
335. The representative of the Secretariat
 said that the previous day had seen the third in the series 
of workshops on the implementation of Article 66.2.  This workshop had been undertaken in 
coordination with the LDC Group to complement the more formal review of implementation of this 
provision that took place in the TRIPS Council.  It had drawn together the two groups of Members 
most directly concerned – the LDC Members them selves, and the developed country Members who 
submit annual reports on their implementation of this  provision.  The event had been structured to 
enable notifying Members to outline their activiti es under Article 66.2, to give LDC Members the 
opportunity to pose questions and comment on specific aspects of those reports, and then to facilitate 
a wider dialogue about the implementation of the pr ovision and the reporting and review mechanism.  
The workshop had opened with an overview of the LDC Group's interests and concerns provided by 
the delegation of Angola, and it had heard reports  from Australia, Canada, the European Union, 
Japan, New Zealand, Norway, Switzerland, and the United States. 
336. Discussions had centered on two general themes:  the content and format of Article 66.2 
reporting and the substantive aspects of implementa tion of Article 66.2.  Noting that the Members 
concerned might wish to put on record their own positions and observations, he said that he would 
confine his report to a simple synopsis.  On the notification process, reporting on Article 66.2 implementation had included a great deal of detaile d factual information and descriptive text.  There 
had been now 89 documents in this series, some running to over 100 pages, or altogether over 11MB 
of text, posing a practical challenge for learning from this wealth of information.  While LDC 
Members had been able to undertake some systematic  analysis of these reports, this effort would be 
facilitated for future notifications by some convergence on the structure and format of the 
notifications;  several Members had individually de veloped ideas on structuring their reports and the 
LDC Group had suggested an illustrative format wh ich had been introduced by the delegations of 
Angola and Zambia. 
337. On the substantive aspects, discussions had covere d the scope and definition of transfer of 
technology in general terms, in relation to the Article 66.2 provision itself, and in other specific 
contexts;  the specificity of reported programmes pr ovided for LDCs in particular;  the nature of 
incentives for technology transfer;  choice of appr opriate technology in line with priority needs 
identified by the LDCs themselves;  sustainability  in ensuring continued access to technology on 
which training was given; and the distinction be tween incentives for technology transfer to be  IP/C/M/64 
 Page 75 
 
 
  reported upon under Article 66.2 a nd the technical assistance activities to be reported upon under 
Article 67.   
338. He observed that further work would be direct ed by the Members concerned, principally the 
LDC Members, but that the Secretariat was at hand as a resource to the extent that it could play a useful role in supporting and facilitating future wo rk.  One possibility would be to work towards a 
more systematic analysis of submissions, for cons ideration at a future workshop, and including the 
implementation of the ideas circulated for convergence on structure and format of notifications to facilitate consideration of future notifications.  Ho wever, any such work – if considered useful – 
would entail finding the necessary resources, a nd continuing guidance from the delegations most 
concerned and interested in information on the impl ementation of Article 66.2.  Given the informal 
feedback already received from the most recent wo rkshop, the Secretariat was provisionally planning 
to proceed with a follow-up work shop the following year, as a minimum step, but again would be 
guided by the interests and priorities of the dele gations concerned and of  course the LDC Group in 
particular. 
339. The representative of Angola, speaking on behalf of the LDC Group
, said that the previous 
day's dialogue had facilitated exchange of informat ion on developed country partners' initiatives.  
Since such dialogues had been initiated, there ha d been notable progress made in the format and 
contents of reports submitted unde r Article 66.2 review.  However, there was still room for further 
improvement to ensure that this process was not ju st about fulfilling notifica tion obligations, but about 
having tangible results, as far as transfer of tec hnology and building a viable and sound technological 
base in LDCs were concerned.  Although this item had been on the Council's agenda for some time, 
there had been limited progress reported to date. 
340. She thanked those developed countries that ha d provided reports for this eighth review.  
Article 66.2 contained an obligation for develope d country Members that was specific to LDCs, 
i.e. providing incentives to enterprises and institution s in developed country Members' territories.  The 
purpose was to promote and encourage the transfer of technology.  Last but not least, the ultimate 
objective was to enable LDCs to create a sound and vi able technological base.  This should therefore 
be the basis for measuring the effectiveness and imp act of incentives provided to LDCs.  In order to 
ensure quality reporting, it was necessary for the Council to begin deliberating on critical elements 
with a view to develop a common understa nding of the contents of the reports. 
341. She identified the following two critical areas:  the definition of technology transfer and an 
illustration of "types of incentives".  As regards "t echnology transfer", it was clear from the submitted 
reports that there was a lack of common understa nding of what constituted technology transfer, hence 
the inclusion in some reports of technical coopera tion activities.  Therefore, it would be useful to 
provide a non-exhaustive list of what could possibl y be regarded as "technology transfer" for purposes 
of Article 66.2.  Regarding the "types of incentiv es", it would be equally important to have a non-
exhaustive list of types of incentives to guide the reports.  It would also be useful to have specific 
examples of incentives that had led to transfer of  technology and subsequent contribution to the 
building of a sound and viable technological base in  LDCs, so that one could draw best practices. 
342. As had already been stated in the past, including  in the dialogue held the previous day, there 
was a need to ensure that the reports:  (i) were LDC specific and assessed whether incentives had 
resulted in actual transfer of technology;  (ii) did not contain technical cooperation activities that were 
to be reported under Article 67;  (iii) provided an  indication of funding or budget allocated for each 
incentive programme;  and (iv) followed a harmonized format.  To this end, she proposed that the 
Council considered the development of the followi ng:  (i) clear parameters on what constituted 
"technology transfer";  (ii) clear parameters on "t ypes of incentives" by developed countries to their 
enterprises and institutions;  and (iii) a uniform re porting mechanism.  The LDCs had circulated a IP/C/M/64 
Page 76  
 
  possible template that could be considered for this purpose.  It would also be useful to work towards 
having a toolkit for assessing the impact of technology transfer. 
343. The Chairman
 thanked the Secretariat for orga nizing once more a workshop and the 
delegations concerned for their constructive contribu tions at it.  He urged those developed country 
Members that had not yet provided reports to do so as soon as possible, and reiterated his intention to 
provide another opportunity, at the Council's next meeting, for Members to make further comments 
on the information submitted for the present meeting that they had not yet been able to study. 
344. The Council took note  of the statements made. 
K. TECHNICAL COOPERATION AND CAPACITY BUILDING  
345. The Chairman  recalled that the Council had agreed, at its meeting in June 2010, to hold its 
annual review of technical cooperation at the present meeting.  In preparation for this annual review, 
developed country Members had once more been requ ested to update information on their technical 
and financial cooperation activities re levant to the implementation of  the TRIPS Agreement.  Other 
Members who had also made available technical c ooperation were encouraged to share information 
on these activities if they so wished.  The S ecretariat had issued on 28 July an airgram 
(WTO/AIR/3594) reminding Members of this request.  In addition, intergovernmental organizations 
observers to the Council as well as the WTO Secretar iat had been invited to provide information. 
346. The Council had received information from th e following developed country Members:  
Norway, Australia, Switzerland, Japan, New Zealand,  the United States and Canada (being circulated 
in document IP/C/W/550 and addenda ).  Updated information had b een received from the following 
intergovernmental organizations:  the OECD, WCO, FAO, UNCTAD, WHO and WIPO (being 
circulated in document IP/C/W/549, addenda and su pplements).  In addition, the IMF had informed 
the Secretariat, by means of a communication da ted 9 August 2010, that none of its technical 
assistance or financial cooperation activities pertaine d directly to the TRIPS Agreement.  Updated 
information on the WTO Secretariat's technical cooperation activities in the TRIPS area could be found in document IP/C/W/553. 
347. As regards notifications of contact points for technical cooperation on TRIPS, since the 
Council's meeting in June, an update to a contact  point notified earlier had been received from the 
European Union (being circulated in an  addendum to document IP/N/7/Rev.3). 
348. He also recalled that paragraph 2 of the TRIPS Council's 2005 decision on the "Extension of 
the Transition Period under Article 66.1 for Least-D eveloped Country Members" provided that "with 
a view to facilitating targeted technical and financ ial cooperation programmes, all the least-developed 
country Members will provide to the Council for TRI PS, preferably by the 1 January 2008, as much 
information as possible on their individual priority needs for technical and financial cooperation in order to assist them taking steps necessary  to implement the TRIPS Agreement".   
349. Rwanda had just provided Annex 2 to th e document it had submitted to the Council's 
June 2010 meeting (IP/C/W/548/Add.1).  It out lined a proposed Rwanda Development and IP 
Capacity Building Project, which intended to transl ate the identified needs into a concrete technical 
assistance project.  For the present meeting, the Council had also received such information from 
Tanzania (IP/C/W/552).  Such information had earlier been received from four other Members, 
namely Sierra Leone, Uganda , Bangladesh and Rwanda.   
350. He also recalled that, at the Council's meeti ng in June 2009, the LDC Group had requested the 
WTO Secretariat to arrange a series of events to  discuss and coordinate work on their needs for 
technical and financial cooperation.  Following up earlier similar activities it had organized in  IP/C/M/64 
 Page 77 
 
 
  response to this request, the Secretariat had held  the previous day an informal meeting on LDC 
priority needs, bringing together delegates and other officials from LDCs and donor countries, and from the Secretariats of the WTO, ARIPO, OAPI, UNCTAD, WHO and WIPO.  This technical-level meeting had been part of this on-going practical dialogue aimed at enhanc ing coordination and the 
alignment of available resources with the need s identified by LDCs, and it had provided an 
opportunity to discuss the work already undertaken and the current state of play, and to plan 
coordination of future work. 
351. The representative of the United States
, introducing his delegation's Article 67 report, said 
that the United States engaged in IPR technical assi stance and capacity buildin g on a significant and 
regular basis.  The present report detailed much of  the IPR technical assist ance and capacity building 
efforts in WTO Members around the world.  In the reporting period, the United States held at least 
135 programmes providing training to thousands  of WTO Members' citizens from over 120 
participating countries.  He said that he looke d forward to providing updates on these activities where 
necessary each year and that he would be pleased to discuss further with other Members on a bilateral basis if they had specific questions.   
352. The representative of the Secretariat
, introducing the Secretariat's report, said the technical 
cooperation it had provided had re mained focused entirely on the n eeds and priorities identified by 
Members and accession candidates.  As Members' interests and identified needs continued to evolve and grow more diverse, the technical cooperation made  available also had to evolve and diversify.  
The Secretariat had seen increasing interest in understanding the range of policy choices pursued by 
different countries within the framework of the TRIPS Agreement, and an increasing interest in 
understanding the policy context of TRIPS implemen tation, for instance, the economic dimension, 
and some specific sectors of interest, notably h ealth, but also the environment, agriculture, and 
education, as well as the practical aspects of making use of the IP system in specific operational 
contexts to promote policy outcomes.  
353. For the Secretariat, technical assistance was a major and constantly growing component of its 
programme activities, due to the brisk and in creasing demand experienced, placing considerable 
pressure on resources.  Apart from the specific activiti es principally organized by the IP Division in 
cooperation with its partners within the Secretaria t, in particular the Institute for Training and 
Technical Cooperation (ITTC), TRIPS and IP issu es were covered by many additional activities, 
ranging from trade policy courses and "Geneva We eks" for non-residents, to support for accession 
processes.  
354. Technical cooperation activities relating to the TRIPS Agreement continued to be directed 
towards assisting Members to understand the rights and obligations, including  the available options, 
which flow from the Agreement and relevant de cisions of WTO bodies.  This covered TRIPS 
flexibilities and policy options under the Agreement,  including the Paragraph 6 Mechanism on TRIPS 
and public health, and the interp lay between TRIPS standards and policy choices.  Assistance on 
practical use of notifications and reviews of nationa l legislation had also been provided.  Programme 
activities had paid increasing attention to building sust ainable capacity, including through the training 
of trainers and strengthening regionally based e xpertise.  Many ad hoc activities undertaken had 
included servicing the specific requests from Member s and acceding countries on such matters as 
notification and review procedures, the meaning of  particular provisions of the Agreement, the 
options available under these provisions, and background on the matters under discussion or 
negotiation in the Council.   
355. Major activities in the previous 12 months had included the seventh joint WIPO-WTO 
Colloquium for Teachers of Intellectual Property from Developing Countries.  In line with the emphasis in the WTO Biennial Technical Assistan ce and Training Plan 2010-2011, this activity had 
promoted cooperation with the academic community in developing countries so as to build local IP/C/M/64 
Page 78  
 
  research and teaching capacity.  The Colloquium had updated university teachers and researchers 
from 20 developing countries on activities and legal in struments of WIPO and the WTO, strengthened 
the independent research and teaching capacity of  developing countries on IP law and policy, and 
provided a forum for exchange of informati on and ideas between the teachers and the two 
Secretariats, as well as a wide range of stakeholde rs, experts and WTO delegates.  Participating 
university teachers had also made presentations on current policy issues and their own research. 
356. An important new component of Geneva-based activities, the first and second joint WIPO-
WTO Advanced Courses on Intellectual Property ha d been held respectively in October 2009 and 
April-May 2010.  This initiative had drawn on the experience of the successful Colloquium for teachers of intellectual property, and applied a si milar programme structure and pedagogic strategy, 
but had been tailored and focused on government o fficials and public sector policymakers instead of 
university teachers and researchers.  As advan ced courses, supplementing the continuing programme 
of general capacity building on the TRIPS Agreem ent, these activities had responded to the strong 
capacity already present in many countries, the mo re diversified and tailo red demands expressed for 
technical assistance, and the interest in refining sk ills and exploring new issues.  The courses had been 
able to work from a truly advanced baseline and t hus explore cutting edge issues through interactive 
debate and practical case studies, so as to stre ngthen the capacity of government officials and 
policymakers to critically review policy options a nd their implications, and to learn from the wide 
range of practical experiences. 
357. Further activities had included two regional worksh ops with a focus on certain topical issues 
under discussion, examination or negotiation in the TRIPS context, in particular TRIPS and public 
health, biotechnology/traditional knowledge/biodiversity, and geogra phical indications, in Tunis, 
Tunisia in October 2010 for the Francophone Africa, and in Nairobi, Kenya, in January 2010 for the Anglophone Africa.  These activities had been enha nced by participation from WIPO and the WHO 
and by invited experts from Members participati ng in WTO work on these topical issues.  Warm 
thanks had been recorded to the two host govern ments, Tunisia and Kenya, for their invaluable 
support.  Other regional efforts had included a Workshop on Intellectual Property for Customs 
Officers of the Central American Secretariat fo r Economic Integration (SIECA) members, Panama 
and the Dominican Republic, organized jointly with  SIECA and held in Costa Rica in November 
2009, and a Workshop on TRIPS Standards and Public Policy Options for WTO Members and 
Observers in Asia and the Pacific, organized join tly with the Government of Singapore and held in 
Singapore in January 2010.  A follow-up workshop  was to take place in Singapore the following 
week, again looking at current policy issues and the TRIPS context.  The support of the Government 
of Singapore was invaluable for these programmes th at responded to evolving  demands and interests 
in Asia and the Pacific region. 
358. The Secretariat had also organized six nationa l seminars or workshops at the request of 
Members or observers concerned, namely the Philippin es, Iran, Senegal, Grenada, Uganda and China.  
These activities had been increasingly tailored to the specific needs and priorities identified by 
Member governments.  For instance, in line with  the requirements of the host government, the 
workshop in Beijing had concentrated on the econom ic dimension of the TRIPS Agreement, and 
approaches to economic analysis of two topical issues  in the area of the TRIPS Agreement, namely its 
relationship with the CBD and geographical indi cations.  The national workshop in Uganda had 
addressed elements of the individual priority needs identified in its needs ass essment submitted to the 
TRIPS Council.   
359. Cooperation with other organizations and agenci es had been central to technical cooperation 
in relation to the TRIPS Agreement, includi ng a longstanding programme of cooperation and 
coordination with WIPO, as well as the WHO, UN CTAD and other cooperating partners in the UN 
community.  The reporting period had seen an increased focus on activities on public health and 
intellectual property in dialogue with the WHO a nd WIPO, upon which further details were reported  IP/C/M/64 
 Page 79 
 
 
  under agenda item F, in view of the request for a specific briefing on technical assistance relating to 
public health under that item.   
360. Turning to the LDC needs assessment and n eeds communication process, the Secretariat 
recalled that the Council's 2005 decision on Article 66.1 provided for three elements relating to the 
identification, communication and fulfilment of LDC needs for technical and financial cooperation 
relating to TRIPS implementation:  LDCs were to provide information on their individual priority 
needs;  developed countries were to provide tec hnical and financial help to address the identified 
needs;  and the WTO was to enhance cooperation w ith WIPO and with other relevant international 
organizations.  The report to the Council provid ed an update on Secretariat activities aimed at 
progressing each of these elements. 
361. At the request of the LDC Group, the Secr etariat was convening a series of regional 
workshops to enable mutual learning from the need s assessment process, to harvest the lessons of 
practical experience with needs assessment and coordi nation of resources to meet the needs identified, 
to promote horizontal cooperation and the stre ngthening of methodologies and coordination with 
other policymaking and needs assessment processe s, and to work with other international 
organizations, including WIPO, WHO and UNCTAD, to  ensure that the TRIPS needs assessment and 
needs fulfilment activities were integrated with  or properly complementary to the many existing 
programme activities that were already working on the same subject matter. 
362. Accordingly, following the request made by Angola and Tanzania on behalf of the LDC 
Group in June 2009, the Secretaria t had convened two regional work shops on needs assessment, one 
in Uganda for English-speaking Africa and one in Dhaka for Asia and the Pacific region. A similar 
workshop for French-speaking Africa was scheduled for 9-11 November 2010 in Dakar, Senegal.  
Warm thanks were offered to the host government s, Uganda, Bangladesh and Senegal, for their 
support, guidance and substantive input to these wo rkshops.  In line with the request by the LDC 
Group, plans were under way for a major workshop for the latter half of 2011, to build on the lessons 
from individual needs assessment and fulfilment activities, and from the regional workshops.  The 
Secretariat would be in dialogue with delegati ons as to how to take that process forward. 
363. At the request of the LDC Group, a workshop had been convened in Geneva in 2009 on LDC 
priority needs that brought together delegates and other officials from LDCs and donor countries, and 
from the WTO and WIPO secretariats. The WTO Secretariat had also explored options for closer systematic coordination at the WIPO Conference on Building Partnerships for Mobilizing Resources 
for IP and Development, held in November 2009.  In general, closer interagency coordination 
remained a high priority in carrying this process fo rward, in line with the third element of the 
2005 TRIPS Council decision.   
364. A key practical matter that had emerged at th ese workshops was the need to enhance the 
systematic linkages between the TRIPS-relate d process and the Aid-for-Trade and Enhanced 
Integrated Framework (EIF) programmes.  The Secr etariat had circulated a note on "Least Developed 
Country Members' Priority Needs Assessments:  the Aid-for-Trade Initiative and the Enhanced 
Integrated Framework" (IP/C/W/544).   
365. The Secretariat was continuing to consult closely with delegates as to how to take this work 
forward.  Subject to the continuing guidance of  Members, and the LDC Group in particular, the 
following general directions had been suggested:   
• Given the wide range of existing policymaki ng and IP needs assessment processes already 
under way, it would be most effective to work  with those processes as far as possible, rather 
than launching discrete and stand-alone needs assessment exercises that duplicate or overlap 
with existing processes, some of which had al ready undertaken needs assessments directly IP/C/M/64 
Page 80  
 
  relevant to TRIPS implementation in LDCs.  Th is would involve careful dialogue with other 
IGOs, notably WIPO and UNCTAD, with donor s and bilateral programmes, and above all 
with the authorities in LDC Members. 
• An improved flow of information would ensu re that specific activities planned under the 
needs assessment process would truly compleme nt existing programmes and directly address 
unfulfilled needs, rather than overlapping with  current programme efforts to meet the same 
needs;  possibilities to achieve this would incl ude informal dialogue with LDC authorities to 
obtain updates on progress toward fulfilling iden tified needs so that additional resources 
could be focused most effectively on specific needs that remained unmet and were not targeted by existing programme activities.  An improved flow of inform ation about relevant 
IGO and bilateral technical cooperation progra mmes would also help identify resources that 
could be applied to progress the communication a nd fulfilment of individual priority needs.   
• In turn, this flow of information would facilita te practical setting of priorities and programme 
coordination, both through continuing bila teral coordination and a continuation of 
coordination activities in Geneva, such as the wo rkshops that had been convened and planned 
for the future.   
• Finally, there was now a great deal of practi cal experience with needs assessment activities.  
Five Members had already filed reports to the Council identifying their priority needs, and 
this reporting represented a wealth of inform ation about the process and methodology of 
needs assessment, as well as of course communi cating the individual needs of the countries 
concerned.  A clear highlight of each of the wo rkshops on this subject had been the practical 
experiences reported by officials of the LDC Members concerned.  For instance, a senior 
colleague of Uganda had made an invaluable  contribution to the Asia Pacific workshop by 
sharing hard won practical experience and the lessons learned from Uganda's own process.   
366. Accordingly, based on the experience so fa r achieved, specific avenues for follow up had 
been identified: 
• Targeted follow up of existing needs assess ments already tabled in the Council, and 
exploration of how to integrate the TRIPS n eeds assessment process with the Aid-for-Trade 
and EIF programmes, both to support further n eeds assessments and to ensure resources to 
meet identified needs. 
• Continued workshops, including b ilateral meetings, to promot e coordination of technical 
cooperation programmes and ma king most effective use of  existing needs assessment 
activities and technical assistance resources. 
• Further development of the draft guidebook that  was under preparation both as a vehicle for 
communicating the practical experience and case studies, and as a means of identifying sources of technical cooperation programmes that might be relevant to TRIPS implementation. 
• Facilitating reporting on progress achieved in re lation to identified needs, and on LDC 
Members' specific concerns relating to needs that remained unmet or for which specific 
resources or expertise might be needed. 
367. The report had been characterized as only a gene ral outline of the possible ways forward.  The 
Secretariat would continue to consult with and ta ke the guidance of Members, particularly the LDC 
Group and individual LDC Members, in order to suppor t the fulfilment of the three elements of the 
TRIPS Council decision on this important matter.    IP/C/M/64 
 Page 81 
 
 
  368. The representative of Tanzania  recalled that, on 29 November 2005, the TRIPS Council had 
extended the original TRIPS Article 66.1 tran sition period for implementation of the TRIPS 
Agreement by LDCs from 1 January 2006 to 1 July 2013.  That decision had called for LDCs to 
provide the TRIPS Council, preferably before 1 January 2008, as much information as possible on 
their individual priority needs for technical and financial assistance for implementing the TRIPS 
Agreement.  Under TRIPS Article  67, developed country Members had an obligation to provide 
technical and financial assistance to developing co untries for implementing the TRIPS Agreement.  
Tanzania had taken the initiative to respond to th e TRIPS Council decision of 29 November 2005 by 
making use of a diagnostic toolkit and consultanc y support from a pilot project undertaken by the 
International Centre for Trade and Sustainable Development and Saana Consulting in 2007, with 
financial support from the UK Department for Interna tional Development.  With active participation 
from a wide range of stakeholders, the pilot proj ect had completed a comprehensive needs assessment 
and stakeholder consultation exercise in Tanzania  in October 2007, under the leadership of the 
Ministry of Industry, Trade and Marketing (MITM)  in collaboration with the Business Registrations 
and Licensing Agency (BRELA).  
369. The report on the needs assessment and consultation exercise had identified the problems, 
challenges and key issues related to the implemen tation of the TRIPS Agreement, as well as the long-
term requirements for technical assistance and ca pacity building on the implementation of the 
objectives, principles, rights and obligations of  the Agreement for Tanzania according to the 
guidelines provided by the toolkit, covering  the na tional development context, intellectual property 
framework, IPR administrative regime, enforc ement and regulation regime, and promoting 
innovation, creativity and technology transfer.   
370. The section on the national development cont ext looked at broad range of economic, 
industrial, human, social and institutional factors which were of importance not only for development 
but also for the design of technical assistance and capacity building for economic development.  Like 
any other LDC, Tanzania lacked the technical a nd financial capacity requi red to develop the IP 
system based on the needs identified in the re port.  Secondly, the key issues and challenges 
concerning the intellectual property policy framework were related to the fo rmulation of policy and 
legislation on intellectual property and the capacity to  participate in the international standard setting 
meetings and negotiations, which re quired specialized technical and analytical skills.  The other key 
challenges discussed were related to the lack of cap acity to coordinate the policy development process 
and to ensure full participation of main stake holders both within and outside the Government. 
371. IPR administrative regime, enforcement and regulation regime also required specialized 
technical and analytical skills.  The same applied to setting up and effectively operating institutions 
charged with the administration of the IPR policies and laws.  Regarding the promotion of innovation, 
creativity and technology transfer, the key challe nge was little or no availability of resources for 
innovation and creativity, which generated very lo w level of industrial property that could be 
protected by the formal system of patents and trademarks. 
372. She said that, based on this assessment, Tanzan ia was submitting formally its needs for 
technical and financial assistance to the TRIPS Council with encouragement from the TRIPS Council Members.  She thanked the LDC Members who had already submitted their needs assessment, namely 
Uganda, Sierra Leone, Rwa nda and Bangladesh, for their encouragement.   
373. Tanzania would follow up the needs assessment work by translating it into a national capacity 
building programme through BRELA under MITM.  Work would be undertaken in close 
collaboration with stakeholders a nd development partners to formul ate suitable priority technical 
assistance projects and activity clusters within an  overall national capacity building programme on 
trade, IP and TRIPS for Tanzania.  The overall objec tive was to further integrate Tanzania into the 
global economy and world trading system by increasing the contribution of IP towards the IP/C/M/64 
Page 82  
 
  achievement of sustainable economic growth an d poverty reduction; and to upgrade the national 
system for IP generation, protection, administrati on and enforcement in Tanzania in line with the 
TRIPS Agreement and applicable regional and international IP agreements.   
374. The main expected results of the programme could be summarized as follows:  (i) improved 
legal context harmonized with objectives, principles, rights, obligations and flexibilities set out in the 
TRIPS Agreement, as well as other commitments to  international and regional IP standards;  
(ii) modern, service-oriented, and accessible and automated administration services for IPRs available for enterprises, creators and inventors in Tanzania ;  (iii) strengthened institutional framework and 
improved national IP coordination mechanism;  (iv)  increased awareness and use of IP as a tool for 
economic development and integration in Tanzania;  (v) structured expansion of IP education, training 
and research institutions and programmes within a common national network;  (vi) enabling 
Tanzania's regular and effective participation in the meetings of the WTO Council for TRIPS and at 
WIPO;  (vii) strengthen the coordination capacity in the Ministry of Industry, Trade and Marketing;  
and (viii) development of the multi-disciplinary IP policy research and analysis capacity in different 
institutions dealing with IP issues in Tanzania. 
375. For the next step, she requested the developm ent partners, including potentially multilateral 
organizations and WTO Members, to provide IPR technical assistance and capacity building including expertise for specific programme activities.  The project implementing team  would use financial 
support from development partners to procure c onsultancy services from international and national 
experts and academics in the fields of IP law, economics, administration, education and training, 
enforcement and management.  In this regard, Tanzania welcomed multilateral organizations and 
WTO Members to provide support towards the implementation of the programme. 
376. The representative of Uganda
 said that this item on the agenda  was important for many LDCs, 
particularly those who had carried out the needs a ssessment.  Uganda and Sierra Leone had been the 
first LDCs to carry out the assessment.  So far,  Uganda had received suppor t from some development 
partners and intergovernmental organizations, which had funded some activities identified in the 
project document.  Uganda had also identified IP as a priority in the National Development plan.  The 
Diagnostic Trade Integration Study (DTIS) was also  due for review and the revised version would 
include IP as a priority not only in the area of le gislation and enforcement but also in the area of IP 
and development, especially with regards to IP fo r innovation, business promotion, market penetration 
and promotion of different export products and also sensitization a nd public awareness.  She called 
upon developed country Members to comply with their promise by providing support to those LDCs 
that had carried out the needs assessment by supp orting their programmes so that, by 2013, they 
would have made positive progress in this regard.  Uganda proposed that de veloped country Members 
and international agencies explore the possibility of supporting regional IP programmes based on countries needs assessment reports.  She also calle d upon developing countries that had made progress 
in the area of IP to share their experiences with  LDCs, to enable them derive benefits from 
implementation of the TRIPS Agreement. 
377. The representative of Switzerland
 thanked Tanzania for presenting its priority needs 
assessment to the Council and Rwanda for providing further information on its earlier priority needs 
assessment, as well as the Secretariat for its con tinuing efforts to assist LDCs in establishing their 
priority needs assessments and bringing togeth er LDC and developed c ountry Members and other 
relevant stakeholders to discu ss the needs assess ments and explore possib ilities for the funding and 
provision of technical cooperation.  He was convin ced of the importance of the TRIPS Agreement in 
providing a safe and reliable regulatory framework for the protection of IPRs in world trade and in incentivizing economic growth.  He was also convin ced of the importance for all Members, including 
LDCs, of the implementation of the TRIPS Agreement at the national level.  While this was first and 
foremost the responsibility of each individual Memb er, he acknowledged the importance of technical 
and financial cooperation in order to assist LDC Members in taking  the necessary steps.  IP/C/M/64 
 Page 83 
 
 
  378. WTO Members had confirmed their commitment to this task when they had extended the 
LDC transition of period until July 2013.  Switzerla nd had contributed to the WTO regional workshop 
for the Asia-Pacific region in July 2010 in Dhaka,  Bangladesh.  It had been a fruitful exercise 
contributing to a better understanding, both for the LDCs and developed coun try Members and other 
stakeholders, of the challenges and the opportunities th at lay in this process.  Time had been reserved 
for bilateral contacts between LDC delegations  present and participating developed country 
delegations.  The priority needs assessment su bmitted by Bangladesh had enabled Switzerland and 
Bangladesh to hold well-informed, focused and u seful discussions on the needs for technical 
assistance in the area of IPR and TRIPS implementa tion, which had allowed Switzerland to identify 
areas where it could offer assistance.   
379. Both countries were currently in the identifi cation phase for a focused  bilateral technical 
assistance project under Bangladesh's priority needs assessment.  He hoped that a planning mission to 
Dhaka could take place at the be ginning of 20 11.  Bangladesh's priority needs assessment was an 
example of a very comprehensive inventory of need s for assistance in the area of intellectual property 
and TRIPS implementation, and Switzerland could onl y provide for a fraction of the assistance that 
was requested.  He hoped that other potential don or countries would further support Bangladesh and 
the other LDC Members that had submitted th eir own priority needs assessments.   
380. Switzerland had, as a potential donor country, limite d resources, both human and financial, to 
provide such technical assistance.  For the sake of efficiency and efficacy, in selecting potential LDC 
partners for technical cooperation, Switzerland need ed to give priority to LDCs in which it had 
already substantial experience and resources fo r development cooperation.   Further technical 
assistance requests could be answered and assistance  given in IP areas where Switzerland was in a 
position to provide the required high level expertise.   
381. Considering that other potential donor count ries might face similar constraints, good 
coordination was a key importance for the work under Article 67 of the TRIPS Agreement.  
Coordination between potential recipient and donor countries, and between donor countries 
themselves, was needed to inform countries i nvolved the types of assistance and partners.  
Furthermore, coordination with other important stakeholders like WIPO, UNCTAD and others was 
needed to avoid duplication and to ensure cohere nce and sustainability of assistance.  Another key 
issue was coordination with existing multilateral f unding mechanisms, in particular the Enhanced 
Integrated Framework.  He encouraged LDCs, fo llowing the example of Uganda that had expressed 
its intention to do so, to introduce systematically th eir TRIPS priority needs assessment also in their 
diagnostic trade integration studies for the EIF.   
382. He was looking forward to continuing bilate ral contacts with Bangladesh to explore how 
Switzerland could assist in its efforts to implemen t TRIPS obligations at the national level, and 
expressed his appreciation of the WTO Secretariat's efforts to facilitate contacts of the various stakeholders under Article 67.   
383. The representative of the European Union
 said that his delegation was committed to providing 
technical and financial co-opera tion to developing and least developed countries under Article 67 of 
the TRIPS Agreement.  His delegation was ready to look at in a positive spirit LDC submissions on their priority needs for technical and financial co -operation in order to assist them taking the steps 
necessary to implement the Agreement.  It was cr ucial to ensure maximum co-ordination among the 
providers of technical assistance to avoid waste of  resources and duplication of efforts.  Uganda and 
Sierra Leone had submitted their individual needs, a nd his delegation had been in contact with these 
countries on how to assist and support them.  It had agreed to support a number of activities identified 
by Uganda, which had already benefited from severa l projects.  The European Union had also been 
working with Sierra Leone and h oped to be able to provide shortly the same kind of assistance and 
support to it.  With regard to the request from Ba ngladesh, his delegation had initiated a three-year IP/C/M/64 
Page 84  
 
  project of technical co-operation, the purpose of wh ich was to strengthen national capacity to develop, 
modernize, administer and use the IP system to  meet national developmental objectives taking into 
account the relevant international standards incl uding the TRIPS Agreement.  Furthermore, he 
welcomed the requests more recently submitted by Rw anda and Tanzania, and was ready to consider 
them in the context of existing programmes.  More over, his delegation had participated in the WTO 
workshops held in Entebbe on 1-3 June and in Dhak a on 27-29 July 2010, and intended to participate 
in the upcoming workshop in Dakar on 9-11 November 2010.  The European Union stood ready to consider any submission of priority needs by ot her LDC Members, in co-ordination with existing 
multilateral mechanisms, and encouraged other deve loped country Members to contribute to this 
important process. 
384. The representative of Canada
 thanked Tanzania and Uganda  for their reports and the 
Secretariat for organizing a constructive meeting th e previous day.  His delegation was committed to 
provide assistance, including in relation to trade -related commitments under TRIPS.  A multilateral 
approach was the most effective way to provid e such assistance.  The Enhanced Integrated 
Framework was an important mechanism for th is purpose.  Canada had already dispersed 
Can$7.68 million towards the EIF and was on trac k in needs commitment of Can$19.2 million over 
five years.  He encouraged countries to explor e these avenues for technical and financial assistance 
and to ensure that diagnostic trade integration studi es reflect LDCs priorities.  In this regard, he 
welcomed Uganda's intervention which no ted its efforts to update its DTIS.   
385. The representative of Bangladesh  thanked all developing c ountry Members who had shown 
interest in Bangladesh' needs as sessment, especially Switzerland and European Union for their 
readiness to provide assistance.  Bangladesh  greatly valued support by all partners in its national 
process of development, especially on meaningfully promoting IP in Bangladesh.  He also thanked the WTO Secretariat for its efforts and for holding th e recent workshop in Dhaka.  He hoped that other 
development partners would follow suit and come  forward to help Bangladesh to carry out its 
obligations under TRIPS.   
386. The representative of Egypt
 believed that technical cooperation and capacity building 
activities were a core function and mandate in the TR IPS system, as well as in the broader context of 
the international IP system.  Such activities had to go beyond generating IP awareness and capacity 
building in national IP offices aiming at facilitating mo re efficient award and protection of IP rights.  
They should focus on promoting domestic innovation,  fostering a development-oriented IP culture 
and provide balanced advice on a ppropriate national IP strategies based on available flexibilities, 
exceptions and limitations.  They should ensure the transparency, neutrality and effectiveness of 
technical assistance and capacity building prog rammes.  These programmes should support the 
development of national scientific  and technological infrastructure in developing countries, in 
accordance with their national priorities and different  levels of development.   Technical cooperation 
and capacity building activities must be provided in  a balanced manner, conducted in a transparent 
and neutral fashion, and delivered through channels that involve no conflict of interests.  In this 
regard, Egypt believed that the principles containe d in Cluster A of the WIPO Development Agenda 
provided universally agreed principles on technical assistance and capacity building in the IP field 
that should be adhered to in other institutional settings, both mu ltilaterally such as in the WTO 
context, and in bilateral and regional contexts.   
387. He welcomed the updates presented by the dele gations of Norway, Australia, Switzerland, 
Japan, New Zealand, the United States and Canada , as well as the information by intergovernmental 
organizations.  Expressing his appreciation of the WIPO Secretariat's report, he said that it was his understanding that WIPO was currently undertakin g a project evaluating its technical cooperation 
activities, to be presented to its Committee on Deve lopment and IP in its next session.  He believed 
that such an exercise of evaluating cooperation activities in a systematic manner brought good value  IP/C/M/64 
 Page 85 
 
 
  to members.  He said that this was an idea that could be considered by the TRIPS Council in view of 
the increasing number of reports on such activ ities submitted to the Council over the years. 
388. The representative of Ecuador  said that Article 7 of the TRIPS Agreement provided that 
intellectual property should be conducive to social  and economic welfare, and to a balance of rights 
and obligations.  He believed that the proposal presen ted by several delegations in previous and the 
present meetings regarding the recommendations of  Cluster A of WIPO Development Agenda were 
relevant for the work on this ag enda item because they contained information that provided a clear 
work plan based on development for the area of IPRs in the WTO.  Technical cooperation and 
capacity building should not just be limited to ensuring the compliance with obligations but also 
extended, with the same level of intensity a nd commitment, to the flexibilities in the TRIPS 
Agreement.  It would be interes ting if developed country Members c ould provide to the Council's next 
meeting addressing this topic details on the capacity  building and technical assistance programmes on, 
and use made of, the TRIPS flexibilities.  
389. The representative of Japan  expressed his appreciation of Tanzania's work to submit its 
priority needs which formed a go od basis to discuss assistance.  He also thanked the Secretariat for 
organizing two regional workshops on LDC needs assessment, to which Japan had contributed by 
dispatching technical experts.  At these workshops , Japan had explained the technical cooperation it 
provided to LDCs through the JICA, WIPO and WCO,  including the funds in trust for LDC countries 
in WIPO.  Japan had had bilate ral meetings with 10 countries during the workshops, including 
Uganda, Bangladesh and Tanzania, which had alread y submitted their priority needs.  Japan had 
explained its basic scheme for technical coope ration, including the coordination between the 
government of the potential beneficiary country and the embassy in that country.  He believed that 
Japan and LDCs shared the view that it was importa nt to integrate IPR capacity building needs with 
the overall development strategy.  Japan would c ontinue to make efforts to deepen mutual 
understanding between developed c ountries and LDCs for the purpose of TRIPS compliance by LDC 
Members.  
390. The representative of China  said that technical assistance activities should be demand-driven, 
transparent, neutral and accountable and, theref ore, he supported Brazil's communication IP/C/W/513 
and its addendum, especially with regard to the relevance of Cluster A proposals of the WIPO 
Development Agenda.  As the third global review of Aid for Trade in 2011 was approaching and the 
WTO Secretariat was encouraging Members to provid e Aid for Trade case stories, he encouraged the 
IP Division to contact colleagues in the Development Division, responsible for Aid for Trade 
initiatives, and integrate the LDCs priority needs assessments under TRIPS Article 66 and the 
discussions on TRIPS Article 67 in the work on Aid for Trade.  He also encouraged developed country Members to provide some Aid for Trade case stories in the area of technology transfer for the 
better functioning of the third global review on Aid for Trade.   
391. The representative of Tanzania
 thanked the delegations who had shown their willingness and 
interest to assist Tanzania.  In addition, she noted that there was an error in her delegation's 
submission in document IP/C/W/552, namely the date on the first line of paragraph 2 on the first page 
should read "29 November 2005" instead of "29 December 2005". 
392. The Chairman  suggested that, subject to a decision on the renewal of their ad hoc invitation to 
the Council's next meeting, also ARIPO and OAPI be invited to provide information on their technical 
cooperation activities to the Council's next meeting. 
393. The representative of OAPI  thanked the Council for granting OAPI ad hoc observer status, 
which he hoped would develop into permanent partic ipation in future meetings.  OAPI was interested 
in taking part in the Council's work on technical  cooperation and capacity building.  It was an 
inter-governmental organization made up of 16 memb er States:  Benin, Bu rkina Faso, Cameroon, IP/C/M/64 
Page 86  
 
  Central African Republic, Chad, Congo, Côte d'Iv oire, Gabon, Guinea, Guinea-Bissau, Equatorial 
Guinea, Mali, Mauritania, Niger, Senegal, and T ogo.  OAPI member States had developed a system 
which, unlike other inter-governmental intellectua l property organizations, rested on the following 
principles:  common and uniform legislation (the Bangui Agreement), which served both as the treaty 
establishing OAPI and the legislation of its member States;  a common office (OAPI granted 
industrial property titles on behalf of the member States);  and centralized procedures (acquisition and 
maintenance of rights as well as entry in the special registers for patents, trademarks, industrial designs etc., were centralized within the Organiza tion).  There were a numbe r of legal consequences 
attached to this original and i ndeed unique structure.  The treat y establishing OAPI was administered 
by the Organization which, on the basis of comm on and centralized procedures, granted industrial 
property titles on behalf of the States.  There were no national systems for granting titles.  
Management of the administrative procedures for acq uiring and maintaining rights, including relevant 
inter partes procedures and administrative disputes (review of rejections by the Director-General of applications for titles), were under the responsibility, respectively, of the Directorate-General and the 
High Commission of Appeal, two independent organs  of OAPI.  The idea of a common court of 
justice had been included in OAPI's plan of action and strategic orientation which would be submitted 
to the member States for consideration in 2011.  For these reasons, OAPI, as the industrial property 
office of its member States, played a direct role  in implementing the TRIPS Agreement.  Its presence 
as observer at the meetings of the Council fo r TRIPS was clearly a welcome development. 
394. Capacity building was at the heart of the implem entation of the TRIPS Agreement.  To a large 
extent, it determined the capacity of developing countries to fulfil their obligations under the 
multilateral trading system in general.  Capacity  building began with training.  OAPI was honoured 
that the WTO was increasingly concerned with the needs of developing countries.  When establishing 
needs in this area, due account was to be taken of th e type of training provided, the adaptation of that 
training, the targets, the administrative frame work, and the capacity to tackle the process of 
implementation of the Agreement.  To ensure that the training truly contributed to capacity building, 
the WTO and development partners needed to adapt to the specific needs of each country.  In addition 
to training, technical cooperation consisted above  all of building up the trade capacity of the 
developing and least deve loped countries.  OAPI had read with great interest the information on the 
subject circulated by certain industrialized count ries since the beginning of the Council's session. 
395. The communications contained in document IP/C/W/551/Add1 testified to the efforts made 
by numerous developed countries in the technical cooperation area, which were most welcome.  He 
said that, however, development assistance tended to be directed towards specific regions or 
countries, sometimes purely on the basis of linguistic  proximity.  The English-speaking countries, for 
example, tended to focus their cooperation on deve loping countries that shared their language.  The 
same applied to the French-speaking countries, the Portuguese-speaking countries etc.  The large 
countries of Asia tended to focus on the South-East  Asia.  In statistical terms, this meant that 
development assistance was not distributed equally, as shown, for example, in Australia's report on 
the incentives for transfer of technology in document IP/C/W/551/Add.1. 
396. He said that there was a need to establish correlation between technical cooperation and a 
developing country's potential, or its capacity to  absorb technologies.  The cooperation provided 
might not match countries' needs.  For example, ge ographical indications were a sector that could be 
of interest for developing countries, but it did not  enjoy much attention or support.  Clearly, the 
discussions in the Council which generally co ncerned additional protection of geographical 
indications for wines and spirits, and the establishm ent of a multilateral notification and registration 
system, could only interest developing countries if  they had their own system of protection of 
geographical signs, and above all if  they were convinced of the va lue of such a system to their 
economy.  IP/C/M/64 
 Page 87 
 
 
  397. The representative of Nigeria, speaking on behalf of the African Group , said that, having 
heard the representative of OAPI regarding the centralized registration and other issues that had bearing on IP, he believed that OAPI and ARIPO should be granted permanent observer status. 
398. The representative of Mauritius, speaking on behalf of ACP Group
, supported the proposal 
made by the African Group.  Since OAPI shar ed many common objectives with the WTO, its 
participation in the Council would be beneficial for both Organizations.   
399. The representative of India  said that he supported the proposal made by the African Group 
coordinator. 
400. The Chairman  urged those Members that had not yet provided updated information on their 
technical cooperation activities to do so as soon as possi ble.  Since some of the information had been 
received only very recently and most was, so far, av ailable only in its original language, he said that 
he intended to provide Members an opportunity at the next meeting to make further comments on the 
information submitted for the present meeting that they  might not yet have been able to study.  He 
also urged those LDC Members that had not yet provided information on their individual priority needs for technical and financial cooperation to do so.   
401. The Council took note
 of the statements made.   
L. LETTER FROM THE CHAIR OF THE GENERAL COUNCIL CONCERNING WAYS TO IMPROVE THE 
TIMELINESS AND COMPLETENESS OF NOTIFICATIONS AND OTHER INFORMATION FLOWS  
402. The Chairman  recalled that, at its past four 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 encouraged the Secretariat to pursue this task 
403. The representative of the Secretariat
 said that, in May 2009, in response to the letter from the 
Chair of the General Council, and in order to facilit ate its consideration of the issue of improving the 
timeliness and completeness of notifications and other information flows, the TRIPS Council had 
requested the Secretariat to pr epare a factual background note su mmarizing the relevant procedures 
and providing references to the relevant deci sions, as well as information on the use of these 
procedures by Members, and also to prepare sugg estions for the Council's consideration on how to 
improve the transparency and user-friendliness of the notification system.  In October 2009, the 
Council had considered the ensuing document, IP /C/W/543, which contained several suggestions 
which had since been progressively put into effect , as reported to successive meetings of the Council. 
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.  The improved system for providing notifi cations, and incorporation of this element into 
regular technical cooperation activities, seemed to have helped Members in updating their 
notifications, and had simplified and streamlined the flow of documentation.  Since the Council's last 
meeting, the WIPO-WTO Common Portal had become fully operational, and had been the source of a 
number of the new notifications circulated before th e Council at its current session.  So far, in recent 
weeks, 64 additional legislative texts had been notified by nine Members.  IP/C/M/64 
Page 88  
 
  404. The WIPO Secretariat had been an excellent pa rtner in this process, and deep gratitude was 
recorded for their extensive cooperation and collegi al approach to improving the Secretariat services 
provided to Members.  The two Secretariats we re working together to promote awareness and 
practical functionality of the system, guided by several practical suggesti ons from delegations who 
had used the system.  The WTO Secretariat remained  on hand to work with any delegate who wished 
to have a practical demonstration or otherwise requi red assistance in making use of this mechanism.  
He recalled that the portal was not an alternative to  the notification procedures already laid down by 
the TRIPS Council:  As reported to earlier meeti ngs of the Council, these procedures were well 
established and no need to alter them had been identi fied in the work on this agenda item.  From the 
formal or procedural point of view, the portal a rrangement was simply another practical avenue for 
submitting legislative texts – in effect, another opening in the post-box rather than a separate 
post-box.  Legislative texts continued to be submit ted, also, in the conventional way – by direct 
communication to the Secretariat, in person, by e- mail or by post, and were processed alongside other 
notifications regardless of the specific avenue cho sen by the Member concerned.  In recent months, 
the Secretariat had received notifications from seve n Members in this manner, and it remained of 
course an open option for other delegations wishing to  use it.  Notifications submitted that way would 
continue to be processed as normal, and also would be passed to WIPO in lin e with the longstanding 
arrangements.   
405. Whatever avenue Members chose for their no tifications under the TRIPS Agreement, the 
Secretariat continued strongly to encourage Members to submit their texts in digital form, as close as 
possible to a clean text with a minimum of unusua l formatting (such as headers and footers and line 
breaks), and in a standard word processing documen t format.  This step alone would make an 
enormous difference in the timeliness and accessibility of  the notified materials.  The original request 
by the Council in 2009 had included suggestions that  the notifications should be made more easily 
accessible on the WTO webpage.  This had partly been achieved through the TRIPS Transparency 
Toolkit that was reported upon in earlier meetings.  In  addition, in the light also of the Paperless 
Secretariat initiative, the Secretariat was working upo n approaches to make the notification materials 
more accessible for the u sers wishing to consult them, for inst ance, in technical cooperation activities 
for which accessible notified materials were an increasingly useful practical resource.  
406. The Chairman
 suggested that the Council revert to the matter at its next meeting so as to 
provide Members a further opportunity to share any comments they might have on it, and also to allow the Secretariat to inform the Council on any fu rther enhancements to its services improving the 
transparency and user-friendliness of the notification system.   
407. The Council took note
 of the statements made and so agreed . 
M. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO 
408. 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.   However, information on acceptances of the 
TRIPS amendment was provided 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  
409. The Chairman  said that the Secretariat had circulat ed an updated list of the pending requests 
for observer status in the TRIPS Council by othe r intergovernmental organizations in document 
IP/C/W/52/Rev.12.  At its meeting in June 20 09, the Council had granted ARIPO and OAPI ad hoc 
observer status on a meeting-by-meeting basis, and they had accordingly been deleted from the list.  
There were now 15 pending requests.  The updated lis t also took into account two name changes since  IP/C/M/64 
 Page 89 
 
 
  the list had been last circulated in 2005, namely the International Plant Ge netic Resources Institute 
had changed its name into Bioversity  International, and the Internati onal Office of Vine and Wine was 
now called the International Organisation of Vine and Wine.  At its last meeting, the Council had 
requested him to continue his consultations on the request for observer status from the CBD Secretariat.  A proposal on the table was that it be granted ad hoc observer status on a 
meeting-by-meeting basis.  He had been in touch with  some of the delegations most interested in this 
matter but, unfortunately, he was not in a position to report any developments in their thinking 
concerning this request. 
410. The representative of India
 said that, on this issue of ad hoc  observership for the CBD 
Secretariat, there had been discussions in the l ast several TRIPS Council meetings.  The Council had 
not heard from the United States any subs tantive reasons to oppose the ad hoc  observership of the 
CBD Secretariat.  One could think of at least four  reasons why the CBD Secretariat should participate 
in the Council, namely that there were three permanent agenda items relevant to the CBD; 
108 Members had co-sponsored proposal TN/C/W/52 of  which TRIPS/CBD relationship was a part;  
the Director-General's consultative process under paragraph 39 of the Hong Kong Ministerial 
Declaration included consultations  on TRIPS/CBD;  and there was the coherence mandate of the 
WTO, a strong reason for the CBD Secretariat to be  observer.  Against this backdrop, he proposed 
that the CBD Secretariat be allowed to participate in this Council as an ad hoc  observer on a meeting-
by-meeting basis. 
411. The representative of Brazil  said  that the earlier discussion under another agenda item on 
India's proposal to invite the CBD Secretariat to brief the Council on developments related to 
negotiations underway on access and benefit sharing on genetic resources did not make him optimistic 
regarding the consideration of the observer status.  His delegation considered  it important, however, to 
put on record that it continued to support the admissi on of the CBD Secretariat as an observer to the 
TRIPS Council. 
412. The representative of Nigeria, speaking on behalf of the African Group , said that the African 
Group continued to support the suggestion that the CBD Secretariat be granted ad hoc observer status.  
Since he had not heard any dissenting voice, he re iterated his suggestion made under an earlier item 
that ARIPO and OAPI be included as permanent observers to the Council.   
413. The representative of Ecuador  said that it was obvious that, since the Council had three items 
on its agenda relating to the protection of trad itional knowledge and considering the synergies 
between the TRIPS Agreement and the CBD, it should gr ant the CBD Secretariat observer status in its 
regular meetings and, if not, at least ad hoc observer status on a meeting-by-meeting basis.  He joined 
those requesting that the Member reluctant to  join the consensus should provide a reasoned 
explanation of why it objected to the CBD Secretariat being granted observer status.  
414. The representative of Colombia  reiterated his support for the st atements made previously for 
the CBD Secretariat to be invited to participate in the Council as an observer, either on a permanent 
basis or on an ad hoc  meeting-by-meeting basis.   
415. The representative of Peru,  endorsing what had been said by the delegations of India, Brazil, 
Ecuador and Colombia, said that the request of the CBD for observer status wa s particularly relevant 
because, under items C, D and E, there was an ob vious relation between the TRIPS Agreement and 
the CBD.   He found no reason for the CBD Secretariat not  to be allowed to participate as an observer, 
at least on an ad hoc  basis.  Its participation would be valu able as the negotiations at the CBD on an 
ABS regime on TK and genetic resources were partic ularly important to intellectual property.  For 
these reasons, he supported the request of the CBD S ecretariat to attend meetings as an observer, at 
least on an ad hoc  basis, and called on the flexibility and unde rstanding of Members in this matter.   IP/C/M/64 
Page 90  
 
  416. The representative of China
 said that the relevance of the CBD Secretariat to the Council was 
clear and had been continuously mentioned by Member s.  An observer status of the CBD Secretariat, 
be it permanent or ad hoc, was very important and therefore he strongly supported the request. 
417. The representative of Egypt  said that there were 15 pending requests from international 
intergovernmental organizations for observer status.  All requests were equally  relevant and important 
to the work of the Council.  Recently, the Council had taken the decision to admit two international 
intergovernmental organizations, namely OAPI and ARIPO, on an ad hoc basis, to be renewed 
meeting-by-meeting.  He welcomed these two organiza tions.  Furthermore, he noted that for the rest 
of the 15 pending requests, he strove to reach a c onstructive solution, especially with regard to the 
request submitted by the CBD Secretariat, partic ularly relevant due to the centrality of the 
TRIPS-CBD issue to the work of the Council.  As such, he proposed a similar admission on an ad hoc 
meeting-by-meeting basis and he called on all othe r delegations to also engage in a similar 
constructive spirit. 
418. The representative of Indonesia  supported the proposal to invite the CBD Secretariat as an 
observer on an ad-hoc basis. Given the importance of the issue as well as the peak of negotiations 
underway on the Protocol on Access to Genetic Re sources and the Fair and Equitable Sharing of 
Benefits Arising from Their Utilization, it was ti mely for the Council to agree on this proposal. 
419. The representative of the United States  said that his delegation had made its position known 
on this issue and had no developments to report .  The United States could not join the Members 
seeking to include the CBD as an observer. 
420. The representative of Mauritius, speaking on behalf of ACP Group , said that he supported 
India's request to have the CBD Secretariat as an ad hoc observer.  India had given four good reasons 
to grant this status to the CBD Secretariat.  He appealed to any Member having any objection to have 
a consensual approach and also to give a full ju stification for such objection.  It was not for 
ideological reason that he wanted the CBD Secretaria t to be present, but rather for practical reasons 
and also with regard to the relevance that th e CBD had within the framework of issues being 
discussed at the WTO.   
421. The representative of India  said that, after hearing the position of the United States, he had a 
few other suggestions to make.  One of the point s which had come from the delegation of the United 
States in the Council's earlier discussions had been about precedence. One could, however, think of 
several examples.  For example, at the NAMA nego tiations, several of the standard setting bodies had 
participated and made presentations during their meetings.  The earlier point made by the United 
States was about formal council sessions or formal co mmittee meetings.  He therefore asked if it was 
possible for the United States to agree for a presentati on in an informal session of the TRIPS Council.  
In this regard, he recalled that a couple of meetings back, there ha d been two TRIPS Council meetings 
the same day, one informal session followed by a form al one.  He suggested thinking about that kind 
of structure.  Finally, he asked to think about some kind of workshop parallel to the TRIPS Council.  
For instance, there had been some workshops the previous day preceding the TRIPS Council.  He 
suggested thinking about a small workshop in wh ich the CBD Secretariat could brief the Council 
about the Nagoya process.   
422. The representative of the United States  said that his delegation had consistently objected the 
CBD being included as an observer in the TRIPS Council.  He could not agree to change this position today.  The best course of action was to conti nue the Chair's consultations among the Members and 
discuss this issue further.    IP/C/M/64 
 Page 91 
 
 
  423. The Chairman  said that it seemed that consensus c ould not be reached on the CBD request, 
which left the proposal by Nigeria for the current ad hoc  meeting-by-meeting observership of OAPI 
and ARIPO to be converted into a permanent observership.   
424. The representative of Egypt  said that the decision of June 2010 had been that the Council 
would confer the status to OAPI and ARIPO on a meeting-by-meeting basis.  He requested the 
delegation of Nigeria to clarify whether it was cu rrently presenting a suggestion to renew the status 
for the next meeting or whether it was requesting full observer status. 
425. The representative of Nigeria, speaking on behalf of the African Group , said that the two 
regional organizations were respons ible for the implementation of the TRIPS Agreement within the 
African sub-region.  In view of that and the good work that these two organizations were doing, he 
believed that the ad hoc status should be converted  into a permanent one, so that there could be 
certainty for ARIPO and OAPI.  This would also ma ke it possible for them to prepare and come to 
Council meetings without any problems.  
426. The representative of Egypt  welcomed both OAPI and ARIPO to the present as well as the 
next session as ad hoc  observers.  Since this was the first time his delegation had heard the suggestion 
to grant them permanent observer status, he did not ha ve instructions in that regard.  Therefore, he 
needed to go back to his regional group as well as  to his capital for further instructions.   
427. The Chairman  suggested that he continue his consulta tions on the issue of observer status for 
international intergovernmental or ganizations and that the Council revert to the matter at its next 
meeting. 
428. The Council took note  of the statements made and agreed  to proceed as suggested by the 
Chair. 
O. ANNUAL REPORT  
429. The Chairman  said that the draft Annual Report of the Council to the General Council had 
been circulated in document JOB/IP/2.  It still needed  to be updated so as to re flect the discussions at 
the present meeting.  
430. The representative of China  said that, in order to better refl ect the discussion at the Council's 
June meeting, paragraph 21 of th e draft should be amended to read :  "At the request of China and 
India, at its meeting in June the Council had on its agenda an ad hoc  item on Enforcement Trends 
(originally put forward as TRIPS-plus Enforcement Trends)." 
431. The representative of the United States  said that it was clear from the minutes of the June 
meeting that there had been a discussion on this issue and that in connection with that discussion the 
title had been changed.  He believe d that Members should let the histor ical record speak for itself in 
the minutes that clearly listed all Members' interventions. 
432. The representative of India  said that the minutes reflected th e fact that the item had initially 
been requested under a certain title, which after a di scussion had been changed.  He saw no harm in 
reflecting this in the Annual Report. 
433. The representative of China  said that he was proposing this minor modification only to avoid 
a misunderstanding of paragraph 21,  which would otherwise suggest that China and India had put 
forward an agenda item on "Enforcement Trends".  This, however, had not been the original intention 
of China and India and this was clearly on the record of the June meeting.  The preference of India and China, shared by many other Members, had been for the original title.  IP/C/M/64 
Page 92  
 
  434. The Chairman
 said that, as the item in question had been put on the proposed agenda at the 
request of China and India, there wa s no need to refer to it as an " ad hoc  item", but it could just be 
referred to as an "item".  He proposed to reflect  the text suggested by China in a footnote to 
paragraph 21 which would read:  "This was origina lly put forward on the proposed agenda as 'TRIPS 
Plus Enforcement Trends'".  He further proposed that  the Secretariat be requested to update the draft 
with this  amendment to reflect the discussions at the present meeting, and that the revised draft be 
faxed to Members who would have one week to co mment on the updated parts of the draft report once 
it had been circulated by the Secretariat. 
435. The Council so agreed .1 
P. OTHER BUSINESS  
(i) Dates of the Council's meetings in 2011 
436. The Chairman  suggested that the Council agree on the following dates for its meetings in 
2011:  Tuesday and Wednesday, 1 and 2 March;  Tuesday and Wednesday, 7 and 8 June;  and 
Tuesday and Wednesday, 25 and 26 October. 
437. The Council so agreed . 
(ii) Observer Status 
438. The Chairman  recalled that the Council had agreed to grant ad hoc  observer status on a 
meeting-to-meeting basis to the African Regional Intellectual Property Organization (ARIPO) and the 
African Intellectual Property Organization (OAPI).  He suggested that the Council again invite 
ARIPO and OAPI to attend the Council's next formal meeting on an ad hoc  basis.   
439. The Council so agreed . 
(iii) IP enforcement trends  
440. The Chairman  recalled that the delegations of India and Indonesia had indicated that they 
wished to raise under "Other Business" the issue of IP enforcement trends. 
441. The representative of India  recalled that, at the Council's meeting in June 2010, China and 
India had requested the inclusion of an agenda ite m on "TRIPS-plus Enforcement Trends" to highlight 
the systemic implication of the multiple TRIPS- plus initiatives launched by  a group of developed 
country Members.  The ensuing discussions had demons trated that the concerns regarding TRIPS-plus 
enforcement were not those of China and India alone, but were echoed by a vast majority of 
developing countries, including LDCs.  He had re quested for a discussion on "Enforcement Trends" 
under agenda item "Other Business" at this meetin g due to continuing concerns on the issue of 
TRIPS-plus enforcement.  He would elaborate a number of systemic and specific concerns over the 
Anti-Counterfeiting Trade Agreement (ACTA) in par ticular and TRIPS-plus enforcement trends in 
general.  His delegation was not sure whether ACTA was in compliance with TRIPS, but would 
reserve its final position on this question until the text of ACTA was finalized. 
442. After years of negotiations in secrecy, the negotia ting text of ACTA had been released due to 
the pressure of civil society, civil liberty groups  and groups of parliamentarians.  The text of 
2 October 2010 now available in the public domain c ontained several elements that had far reaching 
                                                      
1 The Annual Report (2010) of the Council for TRIPS was subsequently circulated as 
document IP/C/56.  IP/C/M/64 
 Page 93 
 
 
  implications for Members not part of ACTA.  Wh ile patents had been removed from the section on 
"border measures", ACTA remained a plurilateral intellectual property enforcement agreement that 
was substantially broader than only trademarks and copyrights.  His delegation's concern over the 
proponents' ambivalence whether to include patent s in the section on "civil enforcement", as well as 
in the overall scope of the agreement, was further a ggravated by the fact that "in-transit" goods was 
otherwise included in the overall scope of the Agre ement.  There was no general assurance that border 
measures shall not apply to goods "in-transit", in "c ustoms transit" and in "transhipment".  Damages 
and injunctions, as well as provisions for seizures, forfeiture and destruction, continued to be 
applicable to certain patent infringements.  Tr ademarks and copyright were covered under border 
measures.  There remained provisions with signifi cant implications for trade in legitimate generics, 
including those dealing with labelling which could affect the practice of parallel importation, as well 
as the importation of legitimate gene rics more generally.  Although  border measures regarding patent-
infringing goods, including those in transit, appeared  to be excluded from the scope of the Agreement, 
there remained in ACTA provisions that could othe rwise provide the basis for seizures of legitimate 
generic drug consignments.  His de legation noted with interest that European ACTA negotiators 
appeared to be suggesting that non-EU countries grante d rights with respect to goods in transit that its 
own Court of Justice had expressly de nied to EU customs authorities. 
443. He said that the civil enforcement section c ontinued to include patents.  It encouraged 
significant damage awards, e.g., damages based on "suggested retail price" of goods;  valuation and 
lost profit presumptions in favor of right holders which represented an inflated damages basis.  That 
section also extended injunctions to third parties not directly accused of infringement and contained 
no time limitations for determinations or for noti ce to accused infringers.  The United States appeared 
to have proposed the exclusion of patents from the civil enforcement section.  India presumed this was 
because the US negotiators had rec ognized that the provisions of that section were inconsistent with 
the US patent law, and would adversely prejudge the outcome of patent reform legislation in its 
Congress.  
444. With respect to systemic concerns he said that, first and foremost, ACTA completely 
bypassed existing multilateral process es, in particular those provided by the WTO and WIPO.  ACTA 
scaled up the minimum enforcement level enshrined in the TRIPS Agreement.  The floor and ceiling 
in the TRIPS Agreement conformed to a certain bala nce encapsulated in the objectives and principles 
of the TRIPS Agreement. The MFN provisions of the TRIPS Agreement meant that any TRIPS-plus 
protection secured by one trading partner in a re gional or a plurilateral trade agreement was ipso facto  
applicable to imports from all WTO Members.  Therefore, ACTA would have a direct impact on 
exports, even of Members which were not involve d in ACTA negotiations.  The trade restrictive 
effects of such scaling up was contrary to one of the main principles of th e WTO rules based system, 
which was to liberalize trade.  While GATT a nd GATS provided for bilateral and multilateral 
derogations under Articles XXIV and V respectivel y, there was only a limited derogation from MFN 
in the TRIPS Agreement that did not apply to ne w agreements.  Members might therefore not be 
allowed to agree on higher enforcement levels si nce such levels would impinge on the rights and 
obligations of Members not party to the plurilateral negotiations. 
445. He said that while Article 1.1 of ACTA r ecognized that parties would not derogate from 
obligations under existing agreements, including the TRIPS Agreement, there was no explicit 
obligation regarding GATT provisions.  India had rai sed the issue of a violation of GATT Articles V 
and X in the request for consultations regarding th e drug seizure issue.  TRIPS-plus enforcement 
initiatives in general and ACTA in particular coul d lead to serious trade distortions by creating 
barriers to legitimate trade in contravention of Artic le 41 of the TRIPS Agreement.  Given that ACTA 
members accounted for about 70% of world tr ade, ACTA provisions could undermine trade 
liberalization at a time when there were already sever al threats to the multilateral trading system in the 
form of trade protectionist measures in the wa ke of the economic crisis and simmering currency 
issues.  He said that ACTA negotiators had deci ded among themselves to overturn the decision of the IP/C/M/64 
Page 94  
 
  WTO dispute settlement panel in the recent China-IPRs  case by reinterpreting the phrase "commercial 
scale" with respect to wilful trademark counterfe iting and copyright piracy so as to refer to any 
activity carried out for a direct or indirect economic  or commercial advantage.  This was startling in 
light of the WTO panel's contrary decision that the te rm "scale" referred to a le vel or magnitude of an 
activity, and it highlighted the risk posed to WTO law by turning enforcement matters over to small 
groups of plurilateral nego tiators operating outside the WTO legal framework.   
446. He said that ACTA would substantially increase customs authorities' ex officio  activity in 
enforcing intellectual property rights, meaning that  the public would be paying more for enforcement 
of intellectual property rights of originator pharm aceutical industries.  Th e draft ACTA limited the 
protection otherwise available to accused infringe rs under the TRIPS Agreement by potentially 
lowering knowledge thresholds, limiting due process re quirements, e.g., requirements to act within 
particular time frames, limiting evidentiary requireme nts, and by not specifying the type of authority 
empowered to make critical decisions.  This shift to summary administrative action might curtail the 
rights of accused infringers to defend themselves against claims of patent infringement, or of ordinary 
trademark or copyright infringement which represen ted a substantial departure from the enforcement 
concept under the TRIPS Agreement.  His delegatio n was also concerned about the setting up of a 
plurilateral intellectual property enforcement body ou tside the purview of either WIPO or the WTO, 
which might undermine the role of the multilateral organizations.   
447. He said that ACTA contained substantial sections  on enforcement in the digital environment.  
While the TRIPS Agreement belonged to the pre-di gital era, this subject matter was being addressed 
in the WIPO Copyright Treaty and the WIPO Perfo rmances and Phonograms Treaty.  His delegation 
had a direct stake in this issue due to its large and growing software and en tertainment industry and it 
was his view that the best way to act was th rough existing multilateral processes.  Although ACTA 
related only to procedure and did not touch on substantive intellect ual property law, it was no secret 
that TRIPS-plus substantive commitments were  being actively pursued through RTAs and other 
means.  Substantive provisions such as limiting the grounds for compulsory licences, data exclusivity, 
and patent linkage figured in several US FTAs with  developing countries.  Therefore, ACTA was part 
of the multipronged efforts to make substantive and pr ocedural changes in intellectual property law.   
448. His delegation was concerned that enforcemen t was seen as divorced from other obligations 
in the TRIPS Agreement.  Articles 7 and 8 of th e TRIPS Agreement bore out a balance of rights and 
obligations by referring to transfer of technol ogy, socio-economic deve lopment, promotion of 
innovation and access to knowledge.  Enforcement provisi ons of ACTA could potentially disturb this 
balance.  While the preamble of ACTA made re ference to the Doha D eclaration on the TRIPS 
Agreement and Public Health, the provisions in ACTA pointed to the opposite direction.  The UN 
Special Rapporteur on the right to health at an  event organized by the UN Human Rights Commission 
on 11 October 2010 had given concrete  examples of TRIPS-plus me asures highlighting the adverse 
impact of such measures on access to medicines for one-third of humanity.  
449. While India was committed to dealing with in tellectual property enforcement issues in line 
with its TRIPS obligations, it did not view the introduction of intrusive intellectual property 
enforcement rules in international trade as a reasona ble or realistic response.  Agreements such as 
ACTA had the potential to upset the balance of right s and obligations of the TRIPS Agreement. They 
could also undermine multilateral decisions such  as the Doha Declaration on the TRIPS Agreement 
and Public Health in the WTO and the Development Agenda in WIPO.  Any enforcement response, if 
required, had to emerge from a multilateral and transparent process, as w as available in the WTO 
TRIPS Council, and should conform to the objectiv es and principles of the TRIPS Agreement and the 
balance of rights and obligations enshrined in the TRIPS Agreement.  As goods and services of 
developing countries were becoming competitive with those of developed coun try producers, TRIPS 
plus measures, like ACTA, sought to introduce a ne w set of non-tariff barriers to trade that could  IP/C/M/64 
 Page 95 
 
 
  hinder developing country exporters, and it was his de legation's view that the WTO could not remain 
oblivious to such developments.   
450. In conclusion, he reiterated India's unwa vering commitment to the TRIPS Agreement, 
including dealing with counterfeiting and piracy.  To  find an effective and enduring solution to the 
problem, Members needed to step back from a pur ely mercantilist approach and needed to avoid 
exaggerating the issue of counterfeiting and piracy in vi ew of the lack of empirical data.  Even the US 
Government Accountability Office (GAO) had recently raised serious questions concerning the data 
that had been relied on by proponents of ACTA to support their efforts.  Members needed to work 
collectively to create respect for intellectual property and to reduce economic incentives for counterfeiting and piracy by judicious pricing of intellectual property products and working 
collectively towards realizing the ob jectives of the TRIPS Agreement.  
451. The representative of Brazil
 said that, according to press releas es circulated in the first week 
of October 2010, the negotiating process of ACTA ha d virtually been concluded.  A few points still 
remained open but these points would not prevent a final agreement from being reached, according to 
the statements released by authorities from the count ries participating in the ACTA negotiations.  He 
shared the concerns expressed by other Members on the possible negative impact of ACTA, and said 
that ACTA might affect the balance of rights and obligations embodied in the international 
intellectual property system between rights holders a nd users of protected goods and services.  Brazil 
favoured multilateralism and multilateral solutions in  legitimate multilateral fora, such as the WTO 
and WIPO, whose deliberations were not only open to  more than 150 member countries, but were also 
conducted in as transparent a way as possible, incl uding also representatives from civil society and 
NGOs.  ACTA proposed only one remedy against counterfeiting and piracy, and that remedy was 
repression.  Repression was necessary, but was not enough  to combat a problem that resulted from the 
interplay of factors that were found in different ec onomic and social realities.  As victims of piracy 
and counterfeiting, Brazil knew from direct experience  that repression alone was not a substitute for a 
much-needed integrated approach to dealing with  this complex problem.  He said that certain 
provisions in the ACTA draft text of 6 October might be interpreted as creating the seeds of a new 
international unit or organization.  Chapter 4 c ontained elements of inte rnational cooperation and 
capacity building that were not restricted to AC TA members, but extended to other international 
organizations, including the private sector and pros pective member countries.  Chapter 5 created a 
secretariat for ACTA.   Chapter 6 foresaw that any WTO Member country would be allowed to 
negotiate its "terms of accession" and become a part y to ACTA.  Taken togeth er, chapters 4, 5 and 6 
contained the necessary ingredients that might convert  ACTA into a truly international organization 
dealing with the enforcement of intellectual prope rty rights, whose impact on WIPO and the WTO, 
especially on capacity building and technical assi stance, was unpredictable at this stage. 
452. The representative of Argentina  said that she shared the concerns expressed by Brazil, India 
and China that ACTA could upset the balance en shrined in the TRIPS Agreement and erode its 
flexibilities. 
453. The representative of Indonesia  said that his delegation supp orted the agenda item on "IPR 
Enforcement Trends" in the TRIPS Council, discu ssion of which was timely and necessary given the 
latest developments in IPR enforcement trends in the global trade context.  He said that although it 
was argued that the ACTA initiative was solely plur ilateral in nature and therefore did not require 
interventions by non-parties, this initiative had the pot ential to undermine existing global rules, and in 
particular the TRIPS Agreement.  The ACTA initiativ e had failed to keep within the TRIPS standards 
and thus undermined the safeguards provided by the TRIPS Agreement.   
454. He said that the most problematic part of ACTA was the chapter on "Legal Framework for 
Enforcement of Intellectual Property Rights".  The issues regarding civil enforcement, border 
measures, criminal enforcement and internet provi sions all had intrinsic problems, and therefore IP/C/M/64 
Page 96  
 
  merited further clarification.  The need to illust rate the negative impact on Members who were not 
parties to the agreement was a case in point.  The c oncerns outlined above were not just held by WTO 
Members.  In July 2010, a number of internationa l civil society groups had formulated the Berkeley 
Declaration on Intellectual Property Enforcement a nd Access to Medicines, which expressed a deep 
concern on the ACTA initiative and called for its term ination on the basis of its weak substance on 
legal enforcement practices as well as its exclusive processes.  The Declaration also demanded 
rejection of developing and least -developed countries involvement in the ACTA initiative, citing 
concerns about the negative impact on access to generic medicines.  He urged WTO Members to 
refrain from supporting this TRIPS-pl us initiative as it could create a new type of non-tariff barrier, 
particularly for developing and least-develope d country Members.  Implementing the TRIPS 
Agreement, let alone the process of gaining benefits from it, was already a challenge for some 
Members.  He hoped that WTO Members would firs t aim to establish a more balanced intellectual 
property system which was benefici al to developing and least-dev eloped country Members.  Poor 
countries were still striving for equal and fair impl ementation of the intellectual property system and 
for ways to ensure that intellectual property would assist in their economic development, which was a 
sine-qua-non  for WTO Members in order to proceed further. 
455. The representative of South Africa
 said that Members' enforcement obligations of intellectual 
property rights were outlined in Article 41 of the TRIPS Agreement, which stated that Members shall 
ensure that enforcement procedures as specified in this part are av ailable under their law so as to 
permit effective action against any act of infringement  of intellectual property rights covered by this 
agreement, including expeditious remedies to pr event infringements and remedies which constitute a 
deterrent to further infringements.  These procedures shall be applied in such a manner as to avoid the 
creation of barriers to legitimate trade and to provide  for safeguards against their abuse.  South Africa 
had enacted its Counterfeit Goods Act in 1997, which was in line with the minimum standards 
required by TRIPS.   
456. He said that the standards required in ACTA lay far above these minimum standards.  While 
the TRIPS Agreement required criminal enforcem ent provisions only for wilful trademark and 
copyright infringement on a commercial scale, ACTA  expanded the definition of commercial scale to 
potentially incriminate the non-commercial use of allege dly infringing goods or services.  He said that 
ACTA contained a proposal to define "commercial s cale" to include activities that had no direct or 
indirect motivation of financial ga in.  ACTA also extended criminal enforcement measures to cases of 
wilful use of labels or packaging to which a mark had been applied that was identical to a registered 
trademark or which could not be distinguished from a trademark in its essential aspects.  This could 
also apply to legitimate business without any intent  of deceiving consumers.  For instance, labels of 
generic medicines were made similar to brande d medicines and used the same words for giving 
information about active ingredient s, warnings and indications.   
457. ACTA required parties to empower their judicial  authorities to issue injunctions against an 
infringer of any intellectual property rights.  Howe ver, it did not make an exception from injunctive 
relief for cases of innocent infringement by a person  who acquired or ordered the protected subject 
matter prior to knowing or having reasonable grounds  to know that they were involved in the 
infringement.  This was an important exception to injunctive relief for intellectual property 
infringement that was available under Article 44.1 of  the TRIPS Agreement.  Thus, by signing on to 
ACTA, a country would not be able to use this ex ception provided for in the TRIPS Agreement.  Not 
only did ACTA undermine the exceptions to inju nctions that were permitted under the TRIPS 
Agreement, it also expanded the scope of in junctive relief beyond the TRIPS Agreement to 
intermediaries.  Under ACTA, Parties must ensure  that right holders could apply for injunctions 
against infringing intermediaries whose services were u sed by a third party to infringe an intellectual 
property.  The word "intermediaries" was not defi ned and could be applied to a broad spectrum of 
intermediaries involved in providing an intellectua l property protected service, or in producing or  IP/C/M/64 
 Page 97 
 
 
  distributing intellectual property protected goods.  This could apply to generic drug producers and 
suppliers, internet service providers (ISPs ), libraries, universities and schools.   
458. He said that ACTA expanded the scope of damages that might be awarded in civil 
enforcement proceedings, such as injunctions, to in nocent infringers.  This un dermined the exceptions 
available for innocent acts of infringement under Arti cle 45.1 of the TRIPS Agreement.  ACTA also 
stated that in determining the amount of damage s for intellectual property infringement, judicial 
authorities shall consider "any legitimate measure of value submitted by the right holder, which might 
include lost profits, the value of the infringed good  or service, measured by the market price, the 
suggested retail price, or the profits of the infringer that are attributable to the infringement".  Another 
crucial departure from the TRIPS Agreement was th at, in the ACTA section on civil enforcement, 
there was no provision on indemnification of th e defendant against abuse of the enforcement 
proceedings as available under Article 48 of the TR IPS Agreement.  Hence, while ACTA expanded 
the scope of enforcement proceedings that might be  used by the right holder, it provided no safeguard 
indemnifying the defendant against abuse of such proceedings.  Rather, innocent infringers and third 
parties were brought within the ambit of enforcement actions. 
459. The representative of China  said that excessive or unreasonably high standards for intellectual 
property protection could unfairly increase monopolistic  profits of right holders, eating into the 
consumer surplus and further broadening the gap between the rich and the poor in the world.  Article 7 of the TRIPS Agreement stressed the importance of a balance between right holders and users, and Article 8 emphasized the prevention of intellectual propert y abuses and unreasonable 
obstacles to trade and technology transfer.  The TRIPS Agreement also provided for special and 
differential treatment and other flexibilities for de veloping countries.  As ACTA did not have any 
multilateral WTO mandate, any negative spill-over e ffects of ACTA on WTO Members which were, 
in their majority, not party to ACTA would not on ly be subject to review in various WTO councils 
and committees, but also subject to the WTO di spute settlement mechanism and possible counter 
measures in accordance with the DSU, the TR IPS Agreement, GATT, GATS, and other WTO 
Agreements.  It was therefore worth examining th e consistency and compatibility between ACTA and 
the WTO legal framework; whether it encroached on rights and flexibilities or added to obligations of 
WTO Members, especially in the light of G20 and A PEC leaders' continuous call on the prevention of 
new trade protectionist measures.  In this connec tion, WTO Members' concerns over the poor record 
on the transparency of the ACTA negotiations were pertinent.  
460. The representative of the United States
 said that his delegation and others had been interested 
in discussing the issue of intellectual property en forcement in the TRIPS Council for many years.  
Counterfeiting and piracy continue d to negatively impact states and companies, and increasingly 
affected the everyday life of citizens.  He sai d that, besides the often-copied luxury goods and 
blockbuster movies, counterfeiters and pirates we re now taking liberties with common household 
articles – everything from home appliances to toot hpaste.  From the perspective of public and 
consumer health and safety, the appearance of counterfeit medicines and items, such as counterfeit 
spare parts for cars, buses, and planes posed a threat that could not be ignored.   
461. He said that the 11th and final round of the negotiations of ACTA had been held in Tokyo 
from 23 September to 2 October 2010.  Thereafter, nego tiators had released the almost final draft text 
that included the highest standards for enforcement of intellectual pr operty rights ever achieved in an 
agreement with such broad and wid espread participation.  The current text was available on the USTR 
website, as well as the websites of the other negotia ting partners.  There were still a small number of 
outstanding issues that participants were working to  resolve expeditiously with a view to finalizing 
the text of the agreement as quickly as possible.   The draft agreement would undergo final legal 
review and be released to the public again before th e participants sign it.  Each signatory would then 
pursue its relevant procedures for approval and the agreement would enter into force after six 
signatories deposited their acceptance of ACTA.  The diverse participants in the negotiations were IP/C/M/64 
Page 98  
 
  Australia, Canada, the European Union represen ted by the European Commission and the EU 
Presidency (Belgium) and the EU Member States,  Japan, Korea, Mexico, Morocco, New Zealand, 
Singapore, Switzerland and the United States.  ACTA included provisions allowing other WTO 
Members to apply for accession after a specified period.  He welcomed all Members who were interested in enhancing IPR enforcement to consid er joining the agreement, and also welcomed the 
opportunity to discuss that possibility with any Member  that was interested in enhancing enforcement 
of IPRs. 
462. He said that the goal of ACTA was to establish a state-of-the-art international framework that 
provided a model for effectively combating th e global proliferation of commercial-scale 
counterfeiting and piracy in the 21
st century.  The state-of-the-art  framework called for police and 
border officials to have authority and tools to e ffectively address large scale infringements such as 
cargo containers loaded with counterfeit goods to  protect the public and preserve markets for 
distributors of legitimate goods.  These tools would include not only strong laws on the books, but also a network of similarly trained specialized enfo rcement authorities.  The agreement also included 
innovative provisions to deepen international cooperation and to promote strong enforcement 
practices.   
463. He highlighted a few of the key accomplishments  of ACTA.  First, ACTA would generally 
enable authorities responsible for enforcing cr iminal laws to act on their own initiative (" ex officio ") 
in context of piracy and counterfeiting cases, rather than waiting for a complaint.  This fixed a gap in existing standards that had sometimes left police and prosecutors powerless to take action against 
counterfeiters and pirates without a complaint fro m a right holder.  Second, ACTA would clarify 
existing international requirements for the ava ilability of criminal penalties when piracy or 
counterfeiting was carried out for commercial advant age.  Companies that benefited from using 
pirated products, such as pirated software products, would be exposed to criminal penalties.  This 
would help deter those companies from stealing copy righted or trademarked products and using those 
products to make themselves more competitive.  Third, ACTA would establish new obligations on 
criminal seizure and destruction of fake goods, seizu re of the equipment and materials used in their 
manufacture, and seizure of the criminal proceed s from piracy and counterfeiting offenses.  This 
ensured that police and prosecutors would have stat e-of-the-art tools to crack down on counterfeiters 
and pirates, and to take away both ill-gotten gains and the tools of illicit trade.  Fourth, ACTA would 
clarify existing international re quirements to protect against circumvention of digital security 
technologies (such as passwords or encryption).  This  protected the ability of legitimate online content 
providers to create innovative business models for securely distributing movies, games, software, 
music, and other content to customers.  Fifth, AC TA would require parties to address copyright piracy 
on digital networks, while preserving principles such  as freedom of expression, fair process, and 
privacy.  ACTA would be the first agreement of its kind to include an obligation to address the 
scourge of piracy over digital netw orks, and to do so in a way that respects fundamental values, such 
as freedom of expression, fair process, and privacy.  Sixth, ACTA would enhance the international 
framework for civil enforcement provisions dea ling with issues such as damages, provisional 
measures, recovery of costs and attorneys' fees, and destruction of infringing goods.  Private parties 
would have access to effective civil systems that cracked down on counterfeiters and pirates, and would be able to obtain court orders to stop ille gal activity, and to secure meaningful damages to 
remedy violations of their rights.  ACTA would al so be the first agreement of its kind to promote 
several key best practices that contributed to effec tive enforcement of intellect ual property rights.  He 
looked forward to continuing discussion on this  important issue in the TRIPS Council.   
464. The representative of Japan
 said that enforcement was an important part of effective 
protection of intellectual property rights.  Accordi ng to Article 1 of the TRIPS Agreement, Members 
were free to implement in their law more extensiv e protection than was required by the Agreement so 
long as such implementation was consistent with the obligations of the WTO agreements including 
the TRIPS Agreement.  Each Member should decide what kind of IP enforcement system was  IP/C/M/64 
 Page 99 
 
 
  appropriate for its own territory.   Members were also free to negotiate and conclude bilateral or 
plurilateral agreements as long as these were c onsistent with its WTO obligations.  ACTA was 
consistent with these obligations and would be impl emented in such a manner as to avoid the creation 
of barriers to legitimate trade.  It was therefore not appropriate to criticize ACTA as such, as it was a 
useful tool to combat counterfeiting and piracy in order to protect legitimate trade without creating 
barriers for it.  Members already implemented so-called "TRIPS plus" measures, such as border 
measures for infringing goods destined for exportatio n, which showed that it was not appropriate to 
criticize "TRIPS-plus" measures in general.   
465. The representative of Canada  said that the conclusion of the ACTA negotiation represented an 
important initiative undertaken by like-minded coun tries to achieve progress on enhancing intellectual 
property enforcement.  The purpose was to more ef fectively combat the growing and internationally 
recognized problems of large-scale trademark c ounterfeiting and copyright piracy.  Numerous 
statistics existed, including from the OECD, demons trating the growth of this illegal activity which 
undermined legitimate trade, threatened sustainabl e development of the global economy, and in some 
cases posed a risk to public health and safety.   
466. He said that ACTA was consistent with the TRI PS Agreement.  It clearly stated that it would 
not derogate from any obligation found in the TRIPS Agreement, and that the objectives and 
principles of the TRIPS Agreement applied mutatis mutandis to ACTA.  Nor did ACTA create or alter 
rights relating to the protection of intellectual property rights.   Rather it set new standards for the enforcement of existing intellectual property rights  which were complementary to those provided in 
the TRIPS Agreement.  ACTA was in line with wh at countries already did on enforcement, such as 
setting a minimum threshold for criminal enforcem ent of wilful counterfeiting and piracy.  ACTA 
would not hinder the cross-border transit of legitima te generic medicines, and it was intended to be 
implemented consistently with the Doha Declara tion on TRIPS and Public Health.  ACTA had been 
negotiated with a view to be inclusive and attract  accessions from other countries.  It was designed to 
be cooperative and mutually benefici al by facilitating information excha nge, such as statistical data or 
best practices, as well as capacity building and technical assistance, where appropriate.  In 
encouraging higher standards, there was no intention to  exclude any country from joining this effort to 
combat counterfeiting and piracy. 
467. The representative of Australia
 welcomed the opportunity to discuss enforcement of 
intellectual property within the TRIPS Council a nd looked forward to continuing constructive 
discussions on this topic within this group.  She al so welcomed the substantive conclusion of ACTA 
negotiations.  ACTA was an important initiative to counter the very large and growing international 
trade in counterfeit and pirated material.  The c onclusion of ACTA negotia tions sent a positive signal 
on the outlook for cooperation at the multilateral leve l on the trade and intellectual property agendas.  
She said that her delegation believed that ACTA  complemented existing intellectual property 
enforcement standards, including the TRIPS Agreement.   
468. The draft ACTA text showed that ACTA nego tiating parties had worked hard to achieve a 
balanced agreement.  ACTA captured important elements of the balance struck in the TRIPS 
Agreement, for example including the objectives and principles in Articles 7 and 8 and the standards 
in Articles 41 and 46 of the TRIPS Agreement.  AC TA was not meant to replace any institution, but 
to complement the work on intellectual property en forcement already being undertaken in numerous 
organizations, including the WTO.  The preamble of ACTA stated parties' desire for ACTA to operate 
in a manner mutually supportive of international en forcement work and cooperation conducted within 
relevant international organizati ons.  ACTA had been negotiated w ith a view to attracting a broad 
membership and Australia welcomed the interest of  other WTO Members in the initiative.  Australia 
would also welcome further opportunities for dial ogue on ACTA and its contribution to the global 
intellectual property enforcement agenda.   IP/C/M/64 
Page 100  
 
  469. The representative of European Union
 said that his delegation had a clear preference for 
dealing with enforcement within the WTO or WIPO.  The European Union had attempted to initiate a 
debate on intellectual property enforcement in the Council several years ago, as this issue affected 
both developed and developing country Members.  Ho wever, several Members had refused to engage 
and had objected to any discussion on IP enforcement in the TRIPS Council.  Faced with this refusal 
to engage, the European Union and others who had shared the same concerns had had to pursue such 
discussions outside this forum.   
470. He said that all WTO Members were confront ed with the development of trade in IPR 
infringing goods, which was reflected in an OECD study carried out in 2008.  Intellectual property 
infringement was a threat to legitimate trade and consumers everywhere , and undermined the 
sustainable development of the world economy.  ACTA was the beginning of a response to this 
problem.  ACTA would build upon the existing intern ational framework to more effectively combat 
counterfeiting activities with a special focus on co -operation among ACTA partners to address the 
cross-border dimension of trade in IPR infringin g products;  best practices among law enforcement 
agencies;  and establishment of a legal framework of  enforcement measures.  Such an agreement was 
fully in line with the TRIPS Agreement which stated in its Article 1 that "Members may, but shall not 
be obliged to, implement in their law more exte nsive protection than is required by the TRIPS 
Agreement".  Nothing in the TRIPS Agreement prevented Members to go beyond the TRIPS 
Agreement as long as they complied with their existing obligations.  In fact, in the last 15 years many 
WTO Members, including the European Union, had done so in their domestic law in full compliance 
with the TRIPS Agreement.  ACTA, as a catalogue of best practices, put together some of these 
provisions.  Moreover, ACTA did not create barriers  to legitimate trade.  On the contrary, in 
combating trade in infringing products, ACTA promoted legitimate trade.   
471. He said that the benefits of ACTA would not be limited to right holders based in ACTA 
countries, and all right holders would benefit from a comprehensive, efficient and balanced 
international framework to combat IPR infringement s.  ACTA also contained all guarantees regarding 
respect of fundamental rights such as privacy, freedom of expression and data protection.  As regards 
medicines, he reiterated the EU commitment to  promoting access to medicines in developing 
countries.  ACTA did not contain any provisions th at could directly or indirectly threaten the 
legitimate trade in generic medicines or, more broadly, global public h ealth.  The ACTA text 
contained unequivocal language saf eguarding access to health consistently with the Doha Declaration 
on the TRIPS Agreement and Public Health.  Furt hermore, ACTA would not hinder the cross-border 
transit of generic medicines.  In any event, pa tents would not be covere d by border enforcement 
provisions.  ACTA would not conflict with the WT O dispute settlement mechanism, nor would it 
create a parallel system.  The issue of commercial scale, which was not defined by the TRIPS Agreement, had to be defined in each country by la w and/or jurisprudence.  On this matter, ACTA 
simply reflected the common understanding among its  parties regarding the definition they had 
established since the TRIPS Agreement had been sign ed.  The ACTA definition was fully compatible 
with the TRIPS Agreement and with the panel's deci sion.  In conclusion, he said that ACTA would 
help combat more effectively infringing activiti es among ACTA partners and also hoped that other 
countries would see the advantages and join as well.   
472. The representative of Bolivarian Republic of Venezuela
 said that, given the importance of this 
issue, the Council should take a decision on whethe r this discussion should still fall under the agenda 
item "Other Business". 
473. The representative of Mexico  said that Mexico had suffered from counterfeiting and piracy in 
its new economic sectors such as clothing, tobacco, medical drugs, music, books etc.  A study carried 
out by the OECD had pointed out that piracy and transport of counterfeiting per year amounted to more than US$205 billion, which had seriously aff ected developing countries.  As a developing 
country, Mexico had done its best to combat th ese illegal practices.  As one of the most open  IP/C/M/64 
 Page 101 
 
 
  countries to foreign investment and to global trade,  Mexico had signed 11 free trade agreements with 
more than 40 countries, such as the free trade agre ements with Canada and the United States (North 
American Free Trade Agreement), the free trade agreement with the European Union, and the 
economic complementarity agreement with Japan.  Mexico was a party to ACTA because it was 
important to have effective border measures to combat counterfeiting and piracy.  The rules and 
regulations set up in ACTA would ensure better pr otection of intellectual property rights in ACTA 
members and would help to establish a homogeneous sy stem for transporters.  At the national level, 
counterfeiting and piracy would be co mbatted in an efficient manner.  
474. The representative of Egypt  supported the request made by India and Indonesia for the 
addition of this item to the agenda.  He said that  his delegation regarded the TRIPS Agreement as the 
international legally binding text  on intellectual property enforcement and was therefore concerned 
about the increasing number of instances relating to TRIPS-plus intellectual property enforcement that 
negatively affected the flexibilities enshrined in th e TRIPS Agreement.  As a result of these TRIPS-
plus enforcement trends, there was an erosion of po licy space in key public policy areas, including but 
not limited to public health, food security, and access to knowledge.  These trends had occurred in a 
manner that distorted and ran counter to the TRI PS Agreement, and were symptomatic of a broader 
push to instill enforcement provisions globally that were opposed to developing country interests.  
These recent trends that were manifest in multilateral, plurilateral and bilateral settings and arrangements were part of a systematic attempt to instill more stringent enforcement norms globally.   
475. He said that these trends risked to ultimately up setting the balance of rights and obligations in 
the TRIPS Agreement as they increasingly led to the creation of barriers to legitimate trade and to 
instances of abuse.  At the multilateral level, the a ttempt to introduce TRIPS-plus enforcement trends 
in intergovernmental organizations, such as the World Customs Organization and the World Health 
Organization, could run counter to the 2001 Doha  Declaration on the TRIPS Agreement and Public 
Health.  At the plurilateral level, initiatives such as the draft ACTA, focusing squarely on TRIPS-plus 
enforcement measures had raised a number of concerns.  Fundamentally, there was a lack of 
transparency and clarity in the process, even for so me of the parties involved in the negotiations and 
their legislatures.  More substantively, there were  serious discords between the provisions of the draft 
ACTA text and the TRIPS Agreement.  For exampl e, ACTA provisions exceeded TRIPS levels and 
extended border measures beyond exports of goods th at violated trademark or copyright and related 
rights.  At the bilateral level, initiatives, including  some economic partnership agreements (EPAs) and 
free trade agreements, ran counter to the idea that enforcement of IPRs should not create barriers to 
legitimate trade or instances of abuse, including da mage to fundamental public policy priorities such 
as access to medicines.  These were all worrisome de velopments that undermined the balance of the 
international intellectual property system w ith serious negative impact on development. 
476. The representative of Ecuador
 said that many countries had launched initiatives of 
enforcement of intellectual property which had le d to developing countries having TRIPS-plus 
obligations.  Some tried to deve lop intellectual property enforcement measures not only in the WTO, 
but also in other fora, such as SECURE at the World Customs Organization and ACTA.  Combating 
piracy and counterfeiting was a legitimate objective, but rules and actions should be developed in a 
transparent and democratic manner.  The provisi ons being proposed in ACTA favoured intellectual 
property right holders and limited the legitimate righ ts of consumers and the public.  While the draft 
ACTA stated that accession was voluntary, there was a danger that the TRIPS-plus provisions would 
be transferred to developing countries through b ilateral and regional free trade agreements.   
477. He said that WIPO had agreed to establis h a development agenda, recommendation 45 of 
which said that "WIPO should consider the enforcing of intellectual property rights from the perspective of the greatest general interest of soci ety and the objectives of encouraging development".  
These principles should guide the framework for enfo rcement of IPRs.  Developing countries should 
also be pro-active in dealing with the enforcement is sue and other issues of interest to them, especially IP/C/M/64 
Page 102  
 
  biopiracy.   Addressing biopiracy was an overdue demand of developing countries rich in biodiversity.  
It was unacceptable that while the issues of mi sappropriation of genetic resources and associated 
traditional knowledge were inadequately addressed at the international level, some countries sought to 
increase intellectual property enforcement.  While the definition of biopiracy had not yet been agreed 
at the international level, this concept was used in the discussion of protection of biological resources 
against their illegal exploitation.  The biopiracy i ssue was as legitimate as the issue of counterfeiting 
and piracy.  IPR enforcement was not an end in itsel f, but should be understood in the context of the 
right to development, which could not be compromi sed.  Discussions should therefore take place in a 
transparent and democratic manner, in proper fo ra and within the context of development. 
478. The Chairman
 said that, given the lateness of the hour , the delegations that had requested the 
floor could choose to submit their statements to the Secretariat in writing to be included in the record 
of the meeting. 
479. The following statements were submitt ed to the Secretariat in writing: 
Chinese Taipei 
480. My delegation believes that all Members appreci ate the importance of protecting intellectual 
property rights in the world trade system.  My dele gation has always paid close attention to worldwide 
developments on IPR protection, including the An ti-Counterfeiting Trade Agreement (ACTA).  It 
seems that many uncertainties and questions in previo us version of ACTA have already been clarified 
in the final version as well as many wordings which had caused great concerns have been softened or 
diluted.  My delegation wishes to stress that s ubjects such as the allocation of administrative 
resources, cost and benefit analysis, free trade market access, and the influence on consumers and 
traders, should all take into consideration the tim e when intellectual property rights protection comes 
into force.  My delegation shall continue to lo ok carefully at this issue to see how it develops. 
 Singapore 
481. Colleagues from other ACTA negotiating parties ha ve covered a lot of ground in terms of the 
substantive aspects of the agreement.  I will thus  focus my comments on the value that Singapore sees 
in participating in the ACTA process: 
• With global trade increasingly driven by  innovation, Singapore sees importance in 
encouraging greater cooperation in protec ting intellectual property rights (or IPRs) 
more effectively.   
• In this regard, Singapore had entered into the ACTA negotiations on the premise that 
a robust IPR regime strengthens our economy and is essential to encourage 
innovation, creativity and the growth of industry and commerce.   
• As a small country, with strong interests in international trade, Singapore places great 
importance on a multilateral rules-based system.  In this regard, a key priority for us 
was to ensure that the enfo rcement measures in ACTA are consistent with existing 
international IP agreements and do no t create new barriers to trade.   
• We see the ACTA as strengthening coopera tion to better protect the interests of 
consumers and industries alike.  We be lieve that ACTA w ill complement and 
strengthen the role of the multilateral ins titutions and their processes as it represents 
an extension of the intent of existing frameworks. 
482. The Council took note  of the statements made.   
__________