RESTRICTED  
  
IP/C/M/79/Add.1  
 
2 September 2015  
(15-4433)  Page: 1/71  
Council for Trade-Related Aspects of  
Intellectual Property Rights   
 
 MINUTES OF MEETING 
HELD IN THE CENTRE WILLIAM RAPPARD ON 9-10 JUNE 2015 
Chairperson: Ambassador Al-Otaibi (Kingdom of Saudi Arabia) 
Addendum 
The present document contains statements made during the Council for TRIPS meeting held on  
9-10 June 2015. 
______________ 
 
Subjects discussed 
INDEX OF THE STATEMENTS MADE AT THE MEETING OF THE COUNCIL FOR 
TRIPS  9-10 JUNE 2015 .................................................................................................... 2  
AGENDA ITEM 1: NOTIFICATIONS UNDE R PROVISIONS OF THE AGREEMENT .................. 4  
AGENDA ITEM 3: REVIEW OF THE PROVISIONS OF AR TICLE 27.3(B ................................ 6  
AGENDA ITEM 4: RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE 
CONVENTION ON BIOLOG ICAL DIVE RSITY ...................................................................... 6  
AGENDA ITEM 5: PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE ............... 6  
AGENDA ITEM 6: NON-VIOLATION AND SITUATION COMPLAINTS ................................. 15  
AGENDA ITEM 7: REVIEW OF THE IMPLEMENTATION OF THE TRIPS AGREEMENT 
UNDER ARTICLE 71.1 ..................................................................................................... 30  
AGENDA ITEM 8: REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE 
SECTION ON GEOGRAPHICAL IN DICATIONS UNDER ARTICLE 24.2 ................................ 30  
AGENDA ITEM 9: TECHNICAL COOPER ATION AND CAPACI TY-BUILDING ....................... 30  
Agenda Item 9.1 Protocol Am ending the TRIPS Agreement .................................................... 30 
AGENDA ITEM 10: IP AND INNOVA TION: THE ROLE OF INTELLECTUAL 
PROPERTY IN FINANCING INNOVATION ........................................................................ 33  
AGENDA ITEM 11: REQUEST FOR AN EXTENSION OF THE TRANSITIONAL PERIOD 
UNDER ARTICLE 66.1 FOR LEAST DEVELOPED COUNTRY MEMBERS WITH RESPECT TO PHARMACEUTICAL PRODUCTS AND FOR WAIVERS FROM THE 
OBLIGATION OF ARTICL ES 70.8 AN D 70.9 ..................................................................... 50
 
AGENDA ITEM 13: OBSERVER STATUS FOR INTERNATIONAL 
INTERGOVERNMENTAL ORGANIZATIONS ....................................................................... 69  
AGENDA ITEM 14: OTHER BUSINESS .............................................................................. 70  
Agenda Item 14.1   Invitati ons to ad ho c observers .............................................................. 70 
Agenda Item 14.4:  Contribution of Intellectual Property to Facilitate the Transfer of 
Environmentally So und Technology .................................................................................... 71 IP/C/M/79/Add.1 
 
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  INDEX OF THE STATEMENTS MADE AT THE MEETING OF THE COUNCIL FOR TRIPS  
9-10 JUNE 2015* 
 
Argentina  
Extension of LDC transition period, 61 
Non-violation, 18 
Australia  
Biotech, Biodiversity, TK, 15 
Extension of LDC transition period, 65 Non-violation, 49 
Technical cooperation, 31 
Bangladesh, on behalf of the  LDC Group  
Biotech, Biodiversity, TK, 6 Extension of LDC transition period, 50, 68 
Financing Innovation, 43 
Non-violation, 17 Observer status, 70 
Technical cooperation, 31 
Barbados, on behalf of the ACP Group  
Extension of LDC transition period, 57 
Non-violation, 29 
Brazil  
Biotech, Biodiversity, TK, 7 Extension of LDC transition period, 60, 67 
Financing innovation, 48 
Non-violation, 15 Observer status, 70 
Technical cooperation, 32 
Canada  
Biotech, Biodiversity, TK, 14 Extension of LDC transition period, 61 
Financing innovation, 48 
Non-violation, 27 Notifications, 4 
Chile  
Biotech, Biodiversity, TK, 12 Extension of LDC transition period, 64 
Financing innovaton, 44 
Non-violation, 21 Technical cooperation, 30 
China  
Biotech, Biodiversity, TK, 9 
Extension of LDC transition period, 61 Non-violation, 25 
Colombia  
Biodiversity, Biotech, TK, 9 Non-violation, 20 
Congo, Democratic Republic of  
Extension of LDC transition period, 63 
Cuba  
Biotech, Biodiversity, TK, 13 
Extension of LDC transition period, 60 
Non-violation, 20 
Ecuador  
Biodiversity, Biotech, TK, 8 
Non-violation, 18 Observer status, 70 
Other Business, 71 
Egypt  
Biotech, Biodiversity, TK, 8 Non-violation, 26 European Union  
Biotech, Biodiversity, TK, 15 
Extension of LDC transition period, 63 Financing innovation, 40, 49 
Technical cooperation, 31, 33 
Haiti  
Extension of LDC transition period, 63 
Holy See  
Extension of LDC transition period, 65 
Hong Kong, China  
Non-violation, 27 
India  
Biotech, Biodiversity, TK, 10 Extension of LDC transition period, 58 
Financing innovation, 42 
Non-violation, 19 Observer status, 69 
Technical cooperation, 30 
Indonesia  
Biotech, Biodiversity, TK, 10 Non-violation, 24 
Observer status, 70 
Japan  
Biotech, Biodiversity, TK, 14 
Extension of LDC transition period, 62 
Financing innovation, 46 Non-violation, 26 Notifications, 4 
Korea, Republic of  
Biotech, Biodiversity, TK, 14 Financing innovation, 46 
Non-violation, 25 
Lesotho, on behalf of the Africa Group
 
Extension of LDC transition period, 54 
Non-violation, 21 
Mali 
Biotech, Biodiversity, TK, 12 Extension of LDC transition period, 59 
Myanmar  
LDC Extension of transition period, 57 
Nepal  
LDC Extension of transition period, 55 
Non-violation, 24 Observer status, 70 
Nigeria  
Other Business, 70 
Norway  
Extension of LDC transition period, 59 
Non-violation, 25 
Pakistan  
Biotech, Biodversity, TK, 12 
Financing innovation, 48 
Non-violation, 25 Technical cooperation, 33 
Peru 
Biotech, Biodiversity, TK, 9 Non-violation, 23 
 IP/C/M/79/Add.1 
 
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  Russian Federation  
Non-violation, 26 Notifications, 4 
Rwanda  
Extension of LDC transition period, 64 
Technical cooperation, 33 
Seychelles  
Technical cooperation, 32 
Sierra Leone  
Extension of LDC transition period, 63 
Singapore  
Financing innovation, 39 
South Africa  
Biotech, Biodiversity, TK, 7 
Extension of LDC transition period, 55 
Non-violation, 20 
Switzerland  
Biotech, Biodiversity, TK, 12 
Extension of LDC transition period, 65 Financing innovation, 37 Non-violation, 22 
Chinese Taipei  
Extension of LDC transition period, 62 Financing innovation, 44 
Non-violation, 26 
Technical cooperation, 32 
 
 Tanzania  
Biotech, Biodiversity, TK, 12 Extension of LDC transition period, 58 Non-violation, 25 
Togo  
Extension of LDC transition period, 61 
Turkey  
Extension of LDC transition period, 63 
Uganda, on behalf of the LDC Group  
Extension of LDC transition period, 50, 68 
United States of America  
Biotech, Biodiversity, TK, 13 
Financing innovation, 33 Non-violation, 27 
Observer status, 70 
Other Business, 70 
Uruguay  
Extension of LDC transition period, 64 
Non-violation, 27 
Venezuela, Bolivarian Republic of  
Non-violation, 21, 29 
WHO Secretariat  
Extension of LDC transition period, 67 
WTO Secretariat  
Notifications, 5 
Yemen  
Extension of LDC transition period, 60 
 
  
 
  
 
  
 
   
 
  
 
  
 
   
 
  
 
  
 
___________________ 
* A record of statements as deli vered. Some statements have been lightly edited as appropriate 
to ensure the consistency of presentation. IP/C/M/79/Add.1 
 
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AGENDA ITEM 1: NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT 
1.1 Canada   
 
1.  Canada was pleased to notify a number of changes to its domestic IP regime to the WTO earlier 
this year. The majority of the changes are found in two bills that received royal assent in 2014. Bill C-8, also known as the Combating Counterfeit Products Act amends the Trademarks Act and 
the Copyright Act. The bill aims to reduce trade in counterfeit and pirated goods sold to Canadian 
consumers and businesses by providing new enforcement tools. The amendments made by the bill enact new border enforcement measures and create civil causes of action and criminal offences. Bill C-43, known as the Budget Implementation Act 2, amends the Industrial Design Act and 
Patent Act.  
2.  These amendments allow Canada to come into compliance with two intellectual property 
treaties, The Hague Agreement and the Patent Law Tr eaty. The Patent Law Treaty aims to simplify 
and harmonize administrative practices among national patent offices with respect to the patent 
application process and the Hague Agreement allows for protection of industrial designs in a number of countries through a single international application filed with the international bureau of 
WIPO. The coming into force date of the changes w ill be established in the new industrial design 
regulations and the patent rules which are currently being drafted.  
3.  Finally, Canada's Copyright Modernization Act, which implemented the changes needed to bring 
Canada in line with the WIPO Internet Treaties, was notified last year under document 
IP/N/1/CAN/6. The WCT and the WPPT entered into force with respect to Canada on 13 August 
2014. On 14 July 2014 the Minister of Industry Ca nada issued a statement limiting the right to 
equitable remuneration in relating to sound re cordings of certain Rome Convention or WPPT 
countries, which we also included in our notifications. 
1.2 Russian Federation   
4.  The Russian Federation would like to present its Federal Law No.364-FZ of 24 November 2014, 
which has been notified. This federal law has introduced significant changes to the current 
anti-piracy laws. The list of objects of copyright and related rights in respect of which a procedure for limiting internet access can be applicable was expanded. The judicial procedure restricting access to illegal content stipulated by Article 15.2 of the Federal Law of 27 July 2006 No. 149-FZ 
on information technologies and protection of information is now applicable not only to the movies 
but for all objects of copyright and related righ ts which can be distributed by information and 
telecommunication networks except for photographic works and works obtained by processes 
similar to photography.  
5.  The law specifies the possibility of out-of-cou rt settlement of copyright holders' claims. Thus 
the right holder has the right to send the website owner a notification about violation of its 
copyright and/or related rights on the internet wh ich shall meet the statutory requirements. Within 
one day from date of receipt of the right holder's notification, the website owner shall remove illegal content. In addition, the law provides possibility to block the access to the website without the right for restitution in case when this website repeatedly and illegally distributed information 
containing copyright and/or related rights objects o r  i n f o r m a t i o n  n e e d e d  to  o b t a i n  s u c h  k i n d  o f  
information using the internet. 
1.3 Japan   
 
6.  This delegation is pleased to inform the TRIPS Council that Japan recently amended some of its Acts pertaining to intellectual property, namely, the Patent Act, the Design Act and the Trademark 
Act, which have been notified to the Secretar iat and will be available on the WTO document 
website before long. 
7.  These amendments were made in order to make our domestic intellectual property system 
more user-friendly for applicants and more closely harmonized with intellectual property systems 
around the world, taking into account international developments in the relevant areas. We would 
like to touch upon major points of the amendments. IP/C/M/79/Add.1 
 
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  8.  First, the Patent Act was revised in order to establish relief measures for applicants in respect 
of time limits. Specifically, the amendment enables applicants for patents, utility models, industrial designs and trademarks, to extend deadlines for f iling, examination, and other procedures due to 
compelling circumstances such as natural disasters. This amendment also establishes a new post-
grant opposition system that accepts oppositions fr om any third party within 6 months after patent 
grants, in order to attain the stability of patent rights in an earlier stage. 
9.  The Design Act was revised in order to enable Japan to accede to the Geneva Act of the Hague 
Agreement Concerning the International Registration  of Industrial Designs. Finally, the Trademark 
Act was amended to provide protection for some non-traditional trademarks such as motion marks and sound marks. 
10.  To conclude, the Government of Japan will continuously fulfil its obligation to ensure 
accessibility to and the transparency of the Japanese intellectual property system. 
1.4  WTO Secretariat   
11.  The Council has directed the Secretariat, under this item, to keep it up to date on the various 
practical steps that are underway to improve the service provided to Members by creating a more 
user-friendly, accessible and efficient system for capturing, handling and disseminating the 
information contained in the notifications made under the TRIPS Agreement. This statement 
supplements successive past reports, in anticipation of a full report and associated technical 
presentation at the time of the next meeting of the Council, scheduled for October.  As ever, we stress that the steps being taken are practical and technical in character, so as to improve and facilitate the provision, handling and dissemination of this information; this work remains squarely 
within the requirements established by the Agreem ent itself and by the guidelines already agreed 
by the Council.  
12.  We have already briefed the Council on th e  w o r k  i n  p r o g r e s s  t o  c r e a t e  a n  i n f o r m a t i o n  
management system that will enable streamlined and more efficient handling of the large volumes 
of data that have been collected and will continue to flow into this system in the context of notification and review.  This information management system or 'IMS' will form the basis of a 
more workable and user friendly system for Members to submit notifications.   
13.  A specific feature of the recent pattern of no tifications, and one that is increasingly coming 
into focus, is the tendency for notifications to comprise amendments, revisions or consolidated texts of intellectual property laws and regulations that have already been notified in previous 
versions. In other words, almost all Members have already notified their basic IP legislation – in 
some cases, principally developed country Members, almost 20 years ago. However, it is not uncommon in many jurisdictions for there to be a regular process of reviewing and updating IP 
legislation, and this explains the trend we se e today of notifications largely consisting of 
amendments and updates to past notifications:  indeed, that comprises the bulk of notifications that have just been announced in this meeting. This means that, in order to be workable and user-
friendly, the notification system has to provide links and references referring back to the previous 
notifications. As these legacy data, comprising some 4500 document symbols, are in the process of digitisation and tran sformation into a more user-friendly format and structure, there is a 
significant challenge in ensuring that new notifications refer in a practically useful way to the 
previous notifications.  
14.  We are working to improve the clarity and uti lity of the Council documents that report on new 
notifications, and these cross-references to previous notifications concerning the same law or 
regulations are now systematically included in these documents. Another very useful feature is the 
brief description of the law or regulation that many Members are now making in the course of their notifications. As has been discussed before, such a brief description is actually even more useful 
when it concerns an amendment or revision of an existing law than for an original notification. In 
effect, the general contours and content of, for instance, a patent law when first notified would be well-known.  However, it can be difficult for one not well versed in the jurisdiction in question to grasp the significance of a detailed amendment to that law when it is subsequently notified. We 
therefore thank the Members concerned for improvin g the quality and utility of the notification 
system by furnishing these brief descriptions – an option that has for a long time been part of the practice of this Council, but one that perhaps is more  helpful than ever today. If I may add, this is IP/C/M/79/Add.1 
 
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  exactly the kind of useful information that the delegations of Canada, the Russian Federation and 
Japan have shared with the Council today. 
15.  The pattern of notifications varies signific antly between Members. At last count, 132 Members 
have notified laws, regulations or enforcement me asures.  The most recent notification filed by 
individual Members ranges in date from those filed in 1997 in some cases, to those filed earlier 
this month in other cases.  Some Members have notified a series of amendments and revisions of their IP laws, and others have only notified the law once in an original notification. More details will 
be available during an informal briefing and demonstration that we propose to offer Delegations in 
an informal setting at 10am tomorrow. At that ti me, too, we will seek to illustrate the steps being 
taken to facilitate notification and use of these materials., and will be at the disposal of delegates, as ever, to respond to any more detailed question s as well as gaining the guidance of Members on 
how best to fine tune and adapt the system so as to make it more useful and efficient for your 
purposes. We look forward to reaching out to Members and consulting with delegates in the course of the next six months as we move towards im plementation of the revised and updated system, 
with a view as ever to provide a better service for Members. 
AGENDA ITEM 3: REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B AGENDA ITEM 4: RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE 
CONVENTION ON BIOLOGICAL DIVERSITY 
AGENDA ITEM 5: PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  5.1  Bangladesh, on behalf of the LDC Group   
 
16.  I am taking the floor on behalf of the LD C Group to address these issues which embody the 
unjust and unfair existing structure of international trade under the existing intellectual property regime. Our Group is happy to see you as Chair of this very important committee, and we are 
hopeful that under your leadership we will have consensus on all the issues before us and our 
Members are at your disposal to assist you. We also commend the Secretariat for their hard work in arranging this session and for all the relevant documents.  
17.  The review of Article 27.3(b) has been a long -standing item on the agenda of this Council, 
unfortunately without any substantial progress. Due to the importance and magnitude, even our Ministers, as early as in the fourth WTO Ministerial Conference held in Doha in 2001 emphasized these particular issues. The members of the LDC Gr oup consider that the review of Article 27.3(b) 
is an important aspect of the work of this Counc il. Based on standards of morality and ethics, we 
cannot support patentability of life forms for tr ade and trade-related gains, and these unethical 
provisions should not be subject to any kind of pr otection, either by granting patent or otherwise. 
In the same vein, it is important to maintain the flexibility in the form of sui generis  regime 
developed especially for the protection of plant varieties based on individual countries' systems 
and requirements. This, we believe, will contribute towards improving the food security situation of 
indigenous people by ensuring that their inventions are protected and access to seed is 
guaranteed. In this respect, we note that the TR IPS Council has an in-built mandate to review the 
provisions of the Agreement, which had been reinforced by the Doha Ministerial Declaration paragraph 19 in line with TRIPS Article 71.  
18.  Regarding the relationship between the TRIP S Agreement and the Conv ention on Biological 
Diversity, the LDCs appreciate the work that has gone into these discussions, including the efforts 
undertaken by the Office of the Director-General to narrow the differences among Members. Our 
Group considers that by harmonizing the benefits of both agreements, all of our just interests will 
be served. Mutually supportive and harmonious implementation of the two agreements will ensure fulfilment of our objectives.  
19.  For LDCs, biodiversity is a core issue and important source of livelihood for the majority of 
populations living in most LDCs. Yet they have been denied their due right to the benefit sharing. We also believe that genetic resources, traditional knowledge and folklore are absolutely autonomous issues of the state. The benefits derived from the appropriation of the biological 
resources by external entities are almost never shared with the common entities concerns. This 
continues to be a matter of great concern for the LDCs. We maintain that inserting a mandatory IP/C/M/79/Add.1 
 
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  requirement in the TRIPS Agreement on disclosure of country of origin of the genetic resources 
and the associated traditional knowledge used in the invention is the only effective way forward to ensure proper benefit sharing. In addition patent applicants should also mention whether they have obtained prior informed consent from compet ent authorities in the country of origin of the 
genetic resources. This will ensure the mechanism to  facilitate the sharing of benefits arising out of 
appropriation of such resources and traditional knowledge.  
20.  We need to streamline the work on these issues and we further need to get assistance from 
the CBD Secretariat at the WTO in the TRIPS Counc il which would close the remaining gaps which, 
in our view, can be achievable with political will. 
5.2  Brazil   
 
21.  Brazil has a well-known position regarding the importance of promoting the mutual support 
between the TRIPS agreement and the Convention on Biological Diversity. For us, enhancing the transparency in the utilization of genetic resources and associated traditional knowledge, through 
the introduction in the TRIPS Agreement of a mandatory requirement for the disclosure of the 
origin of these resources in patent applications, is a priority. All of us gathered here in the TRIPS Council to protect intellectual property should also protect the intellectual property of traditional 
communities. 
22.  In this regard, I would like to restate here the terms of the proposal detailed in document 
TN/C/W/59, particularly regarding its foreseen mechanism to prevent the misappropriation of genetic resources and traditional knowledge and the grant of erroneous patents, reiterating the 
understanding that the patent offices would not be overloaded with extra work, since they would 
be just checking-points in the new system. 
5.3  South Africa   
 
23.  South Africa would like to associate itself with the statement made by Brazil, and further supports the inclusion of the W/59 proposal in the TRIPS Agreement. South Africa believes that 
there is a fundamental conflict between the sp irits and objectives of the CBD and the TRIPS 
Agreement. We believe that there are three areas of conflict that are identifiable based on the objectives of the two agreements. First, Article 3 of the CBD provides that states have sovereign 
rights over their biological resources and the TR IPS Agreement overlooks states sovereignty as it 
recognizes private intellectual property rights over biological resources.  
24.  Secondly, the CBD provides states with an opportunity to demand benefit-sharing from 
commercial use of biological resources and the TRIPS Agreement negates that legal authority. 
25.  Thirdly, the CBD is aimed at reducing cases of biopiracy by requiring prior informed consent 
whereas TRIPS does not. This means that patent applications can be submitted over biological resources or knowledge of certain local community in any country. This is because TRIPS 
recognizes rights on the basis of novelty which does not take into account traditional knowledge 
and cultural practices. South Africa also belie ves that there is a need to avoid erroneous 
application of patents or inventions that involve the use of genetic resources and related traditional knowledge. There is also a need to secure compliance with national access benefit sharing 
regimes.  
26.  Having stated the above it is therefore clear that the application of the TRIPS Agreement may 
threaten the preservation of biological resources and traditional knowledge. The noted conflicts are 
what the CBD under Article 16.5 advised against. It is stated that intellectual property rights must 
not conflict with the sustainable use of biodiversity. What could aid in reconciling the two agreements is a proper legal review of both agreements with the aim of making amendments 
where necessary to ensure mutually supportive application. South Africa believes that under the 
current review of Article 27.3(b), amendments can be made to incorporate the CBD objectives under the TRIPS Agreement in order to preserve biodiversity, prevent biopiracy and include protection of local community rights in accordance  with the spirit and purport of the CBD. Lastly, 
there has been substantial discussion over the issu e of formally inviting the CBD Secretariat for a 
briefing on the Nagoya Protocol. We therefore support inviting the CBD Secretariat for a formal IP/C/M/79/Add.1 
 
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  briefing in the interest of the large majority of  developing countries and urge the Members holding 
a different position on this issue to reconsider their position. 
5.4  Egypt   
 
27.  Regarding our position, we would like to highlight that the protection of biotech resources, 
traditional knowledge and folklore represents an important developmental issue for Egypt. In view of this importance, we continue to support engagement in further negotiations on the relationship 
between the TRIPS Agreement and the CBD. We consider this relationship is a crucial part of the 
implementation-related issues and concerns, as contained in the Doha Work Programme. Therefore we urge other Members to engage in this issue of prime importance to developing 
countries as part of the conclusion of the DDA.  
28.  In fact the technical discussions on this issue have been ongoing for almost a decade so far, 
the essence of our efforts is that the TRIPS Agreem ent 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 source and country of origin of the biological resources and 
the traditional knowledge used in the invention. Furthermore, the applicant shall also provide evidence of prior consent and evidence of fair and equitable benefit sharing under the relevant 
national regime. Finally, Egypt continues to enco urage the engagement of the Director-General in 
his mandated consultative process on the relati onship between the TRIPS Agreement and CBD. We 
look forward to the outcome of these consultati ons, and we request other Members to engage 
constructively in these negotiations, taking into consideration that this issue is one of high priority 
for developing countries and LDCs. 
5.5  Ecuador   
 
29.  Ecuador's position is well known and has not changed. We therefore request that the previous 
statements made by my delegation on these thr ee issues be placed on record. (See previously 
IP/C/M/78/Add.1 paras 13-18 and para 20). 
Ecuador's position on the issues under consideration, as outlined by my delegation on 
numerous occasions, is well-known and does no t therefore need to be restated. We do, 
however, wish on this occasion to express our concern over the impasse that characterizes these three issues. 
 
We have attended the consultations held by a number of TRIPS Chairs at the request of this 
Council, but note with regret the lack of w illingness to move forward. My delegation has 
suggested that the Secretariat prepare a compila tion of the discussions and proposals of the 
past nine years on these issues, with a view  to finding elements that help identify 
approaches that open the way for constructive dialogue. The positions of certain countries 
are, however, impossible for us to understand and we call for flexibility to be shown in these 
divergent positions.  Why not allow the Secretariat of the Convention on Biological Diversity (CBD) to report on 
the outcome of the Nagoya negotiations on the establishment of a Protocol on Access to 
Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization? 
 
My delegation considers that, on the basis of such information, countries could either adopt new positions or, where appropriate, endorse those already advanced, but new elements 
would at least be available. Ecuador believes that this information could be used to analyse 
the feasibility of establishing regulations governing the access to and use of genetic resources and derivatives thereof and defining aspects relating to prior informed consent, mutually agreed terms and benefit sharing. 
Furthermore, knowing the work of the CBD Secretariat would allow clear parameters to be 
established, thereby enabling the CBD and th e TRIPS Agreement to be mutually supportive 
and thus fulfil their individual objectives. 
 
Lastly, Ecuador endorses the documents submitted by Bolivia in 2010 and 2011 in respect of the review of Article 27.3(b), which set out the adverse effects of the patenting of life forms 
and parts thereof. IP/C/M/79/Add.1 
 
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Ecuador's proposal is that these three factual notes should be updated with new documents and at least my delegation has not received any update on those notes. That was my request.  
 
5.6  Colombia   
 
30.  Our statement will focus on Agenda Item 4 "Relationship between the TRIPS Agreement and 
the Convention on Biological Diversity". 
31.  Colombia wishes to reiterate its interest in the issue of misappropriation, notably the 
misappropriation of components of biological diversity through product or process patents, 
where access to biological or genetic resources or products derived therefrom and/or the 
corresponding traditional knowledge has not been legally obtained. Our interest is that such access is on the basis of prior informed consent and term s mutually agreed with the country of origin of 
the material, as agreed under the Convention on Biological Diversity (CBD). 
32.  We therefore believe it is necessary to revi se intellectual property systems and incorporate 
mechanisms that would help to address the monitoring and follow-up difficulties highlighted by 
mega-diverse countries dealing with biopiracy, by  identifying points of convergence between the 
rules on intellectual property protection and those relating to the conservation of biological diversity and the use of its components, including genetic resources. The regime covering access to genetic resources and benefit-sharing would theref ore be consistent with the objectives of both 
protection systems and these would thus be mutual ly supportive, pursuant to Article 16.5 of the 
CBD and Article 4 of the Nagoya Protocol. This, in turn, would make it possible to address the mandate provided for in paragraph 19 of the Doha Declaration in a constructive manner. 
5.7  Peru   
 33.  We would like to add a couple of additional comments – we are working on a Bali work 
programme in accordance with the General Counc il decision contained in WT/L/141. For Peru, a 
balanced programme must necessarily include intellectual property. In particular in connection with an amendment to the TRIPS Agreement wh ich would make it possible to include the 
requirement for disclosure. Also, in line with the Doha work programme there is a need to review 
two aspects that is TRIPS and the CBD and the protection of traditional knowledge and folklore. 
Peru considers that including this item on the agenda is not enough in order effectively to comply with the mandate given to the Council. Of course there should be a greater commitment on the 
part of Members towards these issues, all the more so since for my delegation, it is quite clear that 
faced with the impossibility of people agreeing on a mandate in WIPO, we have to continue with work in this forum as well. Today the WTO is th e only forum where these issues can be discussed. 
For this reason the Council must think about the best way of tackling these problems so that we 
can cover the concerns of Members, and in particular developing country Members. 
5.8  China   
 
34.  The relationship between TRIPS and CBD ha s been an important outstanding issue at the 
TRIPS Council. China believes that it requires effective joint efforts of Members to find a solution for this matter.  
35.  China considers it is necessary to amend the TRIPS Agreement with the purpose of 
introducing a mandatory disclosure requirement of the origin of genetic resources and/or traditional knowledge into patent applications, as  co-held by the majority of Members and can be 
found in documents TN/C/W/52 and TN/C/W/59. The proposed solution can contribute to prevent 
the misappropriation of genetic resources and the grant of erroneous patents due to lack of information, to improve the transparency of the utilization of genetic resources, and to enhance 
legal certainty.  
36.  Considering the legitimate objective pursued by the system, China does not think it would be 
burdensome for the patent applicant to provide th e information concerning prior informed consent 
and access and benefit sharing.  IP/C/M/79/Add.1 
 
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  37.  China also notices the contractual arrangements or database solution proposed by some 
Members. However, those solutions are still far from enough for the protection of genetic resources.  
5.9  Indonesia   
 
38.  Indonesia believes it is imperative that the Members of this Council place sufficient focus on this issue. The relationship between the TR IPS Agreement and the CBD requires cohesion, 
coherence and consistency. This would only be realized should both international instruments be 
implemented in a manner that is mutually supportive and does not run counter to their respective objectives. 
39.  It is therefore paramount that we peruse the objectives, definitions and principles of the 
TRIPS Agreement, the CBD, and the Nagoya Protocol . My delegation would like to place particular 
focus on the provisions of prior informed consent for access and fair and equitable benefit sharing enshrined within the CBD and the Nagoya Protocol. These principles are the foundation for the 
protection of genetic resources and associated traditional knowledge. Article 27.3(b) of the TRIPS 
Agreement does not oblige Members to take necessa ry measures for fair and equitable sharing of 
benefits as required by the CBD and the Nagoya Protocol. This leaves room for misappropriation 
and the grant of erroneous patents which would defeat the purpose of the CBD and the Nagoya 
Protocol.  
40.  Indonesia would also like to address the issue of Article 29 of the TRIPS Agreement with 
regard to its disclosure requirement. We are of the view that this provision is incomplete without 
the inclusion of a disclosure of origin of genetic resources and associated traditional knowledge. 
Including such a provision would enhance transparency in the utilization of genetic resources and associated traditional knowledge. In this regard, Indonesia would like to align itself with document 
W/59 and maintains its view on the urgency of the mandatory disclosure requirement to be 
included in the TRIPS Agreement to prevent both  misappropriation of genetic resources and the 
grant of erroneous patents. 
41.  It is also important to take into account the current deliberation of the Post 2015 
Development Agenda in the United Nations. These deliberations urge to ensure fair and equitable 
benefit sharing arising from the utilization of genetic resources as one of its targets in order to achieve one of the goals of the future agenda of global development that would replace the 
Millennium Development Goals. In line with this, Indonesia believes that it is timely for the Council 
to give simultaneous and adequate attention to address issue towards common efforts to ensure that genetic resources and associated traditional knowledge are utilized in an appropriate manner 
in accordance with the objectives of the CBD,  the Nagoya Protocol and future development 
agenda. 
42.  In addition, as a country with immense biodiversity, Indonesia reaffirms its support for the 
protection of traditional knowledge and folklore. It is worthy to note that misappropriation of 
traditional knowledge and folklore remain rampant as indigenous and local communities continue t o  f a c e  c l a i m s  f r o m  o t h e r  p a r t i e s  u t i l i z i n g  t h e  e x i s t i n g  I P  s y s t e m  t o  o b t a i n  r i g h t s  o v e r  t h e s e  traditional knowledge and folklore.  
43.  It is to this end that Indonesia has consistently been in favor of establishing a sui generis 
regime in the protection of genetic resources, traditional knowledge and folklore, specifically through the Intergovernmental Committee on GRTKF in WIPO. Efforts being made by countries in 
WIPO could be put at risk should the existing TR IPS Agreement not be amended. Therefore, in line 
with our views on Agenda item 4, Indonesia emphasizes the need to ensure that the Council takes into account discussions carried out in other fora, such as WIPO, as reflected in the preamble of 
the TRIPS Agreement. 
5.10  India   
 44.  India would like to associate with the statements made by Brazil, South Africa, Egypt, Peru, 
China, Indonesia and other like-minded countries . We have been extensively discussing these 
agenda items for many years. During the course of the discussions, many Members have not only highlighted the misappropriation of genetic resources and traditional knowledge but have also IP/C/M/79/Add.1 
 
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  proved beyond doubt that such misappropriation and granting of wrongful patents is possible 
because of the inadequacy of the TRIPS Agreement to address these issues. 
45.  India has been a major victim of biopiracy. Pu rsuant to the ratification of the Convention on 
Biological Diversity (CBD), India developed a comprehensive legislation on biodiversity, enacted 
Biological Diversity Act in 2002 and notified Biological Diversity Rules in 2004. In 2003 the 
National Biodiversity Authority (NBA) was set up. All matters relating to requests for access by 
foreign individuals, institutions or companies, and all matters relating to transfer of results of 
research to any foreigner are dealt with by the National Biodiversity Authority.  
46.  The Government of India has also develope d a Traditional Knowledge Digital Library (TKDL) 
database to prevent misappropriation of traditional knowledge at international patent offices so that cases of biopiracy can be prevented. India has signed TKDL Access Agreement with nine 
International Patent Offices. So far about 211 patent applications of pharmaceutical companies 
from the United States, Great Britain, Spain etc.  have either been set aside/withdrawn/amended, 
based on the Prior art evidences present in th e TKDL database. While India has pioneered the 
Traditional Knowledge Digital Library (TKDL) to overcome language and format barriers, the 
results could only be limited.  Improving prior ar t searches through the TKDL was only one part of 
the solution. Further, the TKDL represented a su bset of the universe of available traditional 
knowledge. The realm of traditional knowledge in areas other than herbal cures and genetic 
resources was not covered by the TKDL.   
47.  While India is undertaking a number of measures at the national level in order to prevent 
misappropriation of genetic resources and/or associated traditional knowledge, the problem has an 
obvious international dimension and needs an international solution in order to be addressed 
effectively. The TRIPS Agreement continues to ignore the numerous IPR-related obligations in the CBD which are of interest to the developing countries. The disclosure proposal (IP/C/W/474) which 
was submitted in 2006 was followed up by the submission TN/C/W/52 in June 2008 with the 
support of 108 countries. The latest submission on this issue TN/C/W/59 "Enhancing mutual supportiveness between TRIPS and CBD" has been proposed by a vast majority of the WTO 
membership. A mandatory disclosure requirement in patent applications to include disclosure of 
origin and evidence of prior informed consent and access and benefit sharing, would, in addition to 
combating biopiracy, further strengthen the credibility of the patent system by facilitating assessment of the novelty and inventiveness criteria. 
48.  The Nagoya Protocol of the Convention on Biodiversity (CBD) entered into force on 
12 October 2014. So far 60 countries have ratified the Protocol. According to the CBD website, the Access and Benefit-sharing Clearing-House (ABS -CH), which is a platform for exchanging 
information on access and benefit-sharing established by Article 14 of the Protocol, is a key tool 
for facilitating the implementation of the Nagoya Protocol, by enhancing legal certainty and transparency on procedures for access, and for monitoring the utilization of genetic resources 
along the value chain, including through the internationally recognized certificate of compliance. 
By hosting relevant information regarding access and benefit-sharing, the Clearing-House will offer opportunities for connecting users and providers of genetic resources and associated traditional knowledge. 
49.  In view of the entry into force of the Nagoya  Protocol, there is now an urgency to request the 
CBD Secretariat to brief the TRIPS Council regarding the implications of the entry into force of the Nagoya Protocol. We reiterate our demand for a formal briefing by the CBD Secretariat in the 
interest of the large majority of developing countries. We also support Ecuador's proposal for 
updating the three factual briefs by the Secretariat. 
50.  To mark the adoption of the text of the CBD, 22 May every year is celebrated as the 
International Day for Biological Diversity, to increase awareness about the importance of and 
threats to biodiversity. The theme for this year, 'Biodiversity for Sustainable Development' is very topical, as the international community accelerates its efforts to define the post-2015 agenda including adopting a set of goals for sustainable development. 
51.  I conclude by stating that the TRIPS-CBD issue is one of the outstanding implementation 
issues and positive outcomes on outstanding implementation issues are one of the most important deliverables of the Doha Round for the developing countries.   IP/C/M/79/Add.1 
 
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  5.11  Mali   
 52.  My delegation takes the opportunity to insist upon respect for traditional knowledge because of its importance in developing our societies an d also our economies and also in the name of 
preserving the biodiversity of the resources result ing from that at a precise time when the very 
devastating effects of climate change are increasingly weighing upon our economies and the development prospects of our countries. My delegati on would like to say how very much interested 
it is in a thorough overview of the provisions of  Article 27.3(b) in order, as advocated by others 
and in particular our colleague from Bangladesh who in his statement on behalf of the LDCs underscored this fully and for which we ourselves fully endorse. It is very important for us for there to be a consistent relationship between the TRIPS Agreement and the Convention on 
Biodiversity, so that we can limit all of the disastrous effects on our countries and in order to give 
a change for our traditional societies to develop and to preserve and even develop further our environment. 
5.12  Tanzania   
 53.  The relationship between the TRIPs Agreement and the Convention on Biological Diversity is 
critically important to be explored by Members. The genetic resources, traditional knowledge and 
folklore are essential resources for the livelihood for most of the populations in the LDCs. My delegation believes the benefits could be shared with the communities concerned by respective owners of inventions. This would be possible if a mandatory requirement is enshrined in the TRIPS 
Agreement to ensure transparency by disclosing the origin of genetic resources used in inventions. 
Therefore, as alluded to by the delegation of Bangladesh, the LDC Group coordinator, my 
delegation also supports further discussions in re spect of this matter, with a view to allowing 
benefit-sharing between inventors and the communities endowed with the respective resources, 
particularly in LDCs. 
5.13  Chile    
 
54.  Regarding this agenda item, it should be noted that Chile makes use of the TRIPS flexibilities on the patenting of plants and animals. 
55.  For Chile, this is a topic that addresses ethical principles and public health criteria. The 
creation of monopolies over life forms is an issue which involves interests that transcend 
innovation and trade, and which, we believe, sh ould be left to the judgement of individual 
Members. It is therefore important to preserve the flexibility contained in the TRIPS Agreement. 
5.14  Pakistan   
 First of all I wish to align my position with what has already been stated, and we totally echo what 
Brazil, China, Indonesia and other like-minded Me mbers have stated. Let us not forget that the 
relationship between TRIPS and CBD is well-known to all of us, it is mandated under paragraph 19 
of the Doha Ministerial Declaration. We attach significant importance to carrying the work forward and our position is well-known, we do not wa nt to repeat what has already been stated. 
  
5.15  Switzerland   
 
56.  Switzerland is a member of the so-called W/52-Coalition of 108 WTO Members which in 
document TN/C/W/52 have proposed modalities language for the 3 TRIPS issues under discussion in the Doha-Round. Next to the multilateral GI-register and the so-called GI-extension proposal, it 
also covers the disclosure of source requirement for patent applications for inventions based on 
genetic resources and traditional knowledge.  
57.  Switzerland is of the view that a non-burdensome disclosure requirement in the TRIPS 
Agreement for patent applications relating to the source of a genetic resource or traditional 
knowledge on which the invention is based will enhance transparent use of GR and TK in 
inventions and corresponding patent applications. Such transparency is crucial to help access and benefit sharing systems put in place by Members at their national level to work properly.  IP/C/M/79/Add.1 
 
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  58.  Such transparency is ultimately in the interest of those in favour of the patentability of 
biotechnological inventions. Switzerland is convinced of the eminent role that this field of technology plays today and will play in the future for the benefit of mankind. 
59.  My delegation associates itself with the in tervention made earlier by China as regards the 
work to be undertaken on these three issues by the end of this year. The three TRIPS issues need 
to be taken appropriately into account in the cu rrent Doha Work Programme process. Accordingly, 
my delegation joins others in calling upon the Director-General to resume the relevant 
consultations under his mandate from the Hong Kong Ministerial Conference.  
5.16  Cuba   
 60.  Cuba does consider that this debate should take place in the TRIPS Council so as to proceed 
to the review of the relationship between the TRIPS Agreement and the CBD and the extension of 
traditional knowledge and folklore. This is indeed of great importance, and as Members have already said, this is still pending application, despite the fact that there is an explicit mandate 
expressed in paragraph 19 of the Doha Ministerial Declaration. Cuba would like to repeat once 
again that we have to move this pending work forward, and one of the ways of doing so would be to apply the request which has been submitted fo r the update of the three elements, so that 
consultations take place with the Secretariat of the CBD so that we have the information that so 
many Members have requested.  
61.  We would also like to highlight an aspect wh ich was raised by India and that is the proposal 
that are contained in IP/C/W/474 and document TN/C/W/59, subscribed by a large number of 
countries as far back as 2006 and 2008 respectively. These documents serve as a very good basis 
so as to be able to move forward in our work. We do indeed regret to hear year after year, Council after Council, a great number of Members expressing their positions on the need of progress to be 
made in this work, but unfortunately no progress is being made. We do hope that under your 
leadership, Chairman, we will be able to move forward markedly and we do hope that we will have some positive signals on these issues which I say once again are issues which have pending 
application, and which do, however, have a specific mandate contained in the Ministerial 
Declaration of Doha. 
5.17  United States of America   
 
62.  In February 2014, we noted "the inherent tension between those Members intervening under 
item 3 on Article 27.3(b) of the TRIPS Agreement regarding prohibiting patents in certain areas, 
and those intervening under items 4 and 5 on th e relationship between the TRIPS Agreement and 
the CBD, who are seeking to use the patent system to do this very thing. 
63.  We also noted that the "statement that life forms such as plants and animals should belong to 
the whole of mankind…is inconsistent with the position that States have sovereignty over plants 
and animals and can exercise exclusive rights and insist upon prior informed consent and mutually 
agreed terms for others to use those plants and animals."   
64.  We asked "[w]hy is it that a country can have a perpetual right to insist upon benefit sharing 
under the CBD, but an inventor of a new plant cannot be given a 20-year term for the plant they 
invented?" We continue to look forwar d to a response to these questions.  
65.  Regarding genetic resources, traditional knowledge and folklore, we continue to believe that 
WIPO serves as the best forum to address these issues.  
66.  As to the relationship between the TRIPS Agreement and the CBD, some delegations have 
noted that they believe that there is a need to avoid erroneous patents that involve the use of genetic resources and related traditional knowledge. We agree that there is a need to avoid 
erroneous patents, but disagree that a disclosure of origin requirement would help improve the 
quality of patents as we have explained extensively in past meetings of the TRIPS Council.  
67.  Finally, we are not in a position to support decisions on this issue by this Council at this 
meeting, including with respect to an update of the three factual notes or a briefing by the CBD 
Secretariat. IP/C/M/79/Add.1 
 
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  5.18  Japan   
 68.  These three issues have been discussed for a long time at a series of meetings of the TRIPS Council. This delegation, therefore, believes that  our position is well-recognized among Members, 
so we would like to make our intervention  brief, highlighting some major points. 
69.  Our delegation shares the idea that appropriate and effective measures should be taken 
against misappropriation of genetic resources, traditional knowledge and folklore. At the same 
time, however, we believe that such measures sh ould not have adverse effects on the intellectual 
property system and should not hinder innovation in this area. 
70.  Considering the mandatory disclosure requiremen t from this point of view, our delegation is 
still not convinced that the disclosure requirement is appropriate or effective because of its 
potential undue burden on applicants and legal uncertainty surrounding the patent system itself. 
Furthermore, this delegation has a strong concern that these possible negative effects on the IP system could stifle innovation utilizing genetic resources and associated traditional knowledge. 
Unfortunately, our concern has been materializing before our eyes. We hear a lot from our 
industries, including pharmaceutical industry and cosmetic industry, that they have decided to abandon developing new materials based on biological materials overseas because of the high risk 
and uncertainty associated with such development. 
71.  Finally, our delegation believes that WIPO/IGC is still the most appropriate forum for technical 
discussions on these issues. Moreover, we think that the WIPO seminar on Intellectual Property and Genetic Resources, Traditional Knowledge and Traditional Cultural Expressions, which is 
scheduled late this month, is a good opportunity  to share information and experiences. Japan is 
committed to constructively contributing to discussions on these issues. 
5.19  Canada   
 
72.  Canada continues to firmly believe that the TRIPS Agreement and the Convention on Biological Diversity are mutually supportive, that  there is therefore no need to amend the TRIPS 
Agreement. Canada also believes that WIPO Intergovernmental Committee on Intellectual Property 
and Genetic Resources, Traditional Knowledge and Folklore also known as IGC remains the best forum to discuss technical discussions on aspects of intellectual property related to genetic resources, traditional knowledge and traditional cultural expressions. Canada remains committed 
to the IGC and looks forward to continuing its work with other WIPO member states in the future 
at WIPO, and as part of a balanced overall WIPO  work programme towards a mutually acceptable 
outcome.  
73.  Canada and many other Members, have on a number of occasions, sought further details on 
the experience of other members of the IGC with respect to patent disclosure issues, and sui generis protection of genetic resources, traditiona l knowledge and traditional cultural expressions. 
We remain keen to learn about other Members' practices in order to further advance discussions 
on these questions. We continue to believe that it is through this type of exchange and engagement that we can work towards a mutually agreeable and successful outcome. 
5.20  Korea, Republic of   
 
74.  On these agenda items, Korea has been making clear its position in the TRIPS Council meetings as other Members do. We do not recognize any development warranting a change to our 
position this time around, so we would like to replace our intervention with our statement made at 
the previous meetings. (See previous IP/C/M/78/Add.1 paras 90-92). 
As there have been no developments regarding our position on these agenda items, we 
would like to reiterate our position briefly. 
 K o r e a  i s  n o t  i n  f a v o u r  o f  a  r e v i s i o n  o f  A r t i c l e  2 7 . 3 ( b )  a s  w e  b e l i e v e  t h a t  t h e  c u r r e n t  provisions offer the necessary flexibilities to allow Members to protect biotechnological 
inventions with their specific protection systems. In this regard, we believe that our work 
should focus more on implementation issues such as information sharing on individual Members' practices regarding the patentability of life forms and their implementation. IP/C/M/79/Add.1 
 
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We do believe that the implementation of the TRIPS Agreement and the Convention on Biological Diversity (CBD) should be supportive of each other. However, we do not support 
the proposal to revise the TRIPS Agreement to ensure the implementation of the Convention 
on Biological Diversity, since the objectives and subject matters of the two agreements are 
different. 
 
5.21  European Union   
 75.  Regarding the review of Article 27.3(b) the EU stance has not changed, in that we do not see any reason to amend this Article as it currently stands. The TRIPS Agreement allows WTO 
Members sufficient flexibility to modulate patent protection of biotechnological inventions 
according to their needs, interests or ethical standards. Moreover Article 27.3(b) in conjunction with Article 27.2 on exclusions from patentability and Article 27.1 on patentability criteria provides 
considerable and sufficient leeway.  
76.  Regarding the protection of traditional knowle dge and folklore, again, as in the past, the EU 
supports the work being carried out in WIPO on the three separate texts related to genetic 
resources, traditional knowledge and traditional cultural expressions.  
77.  Finally, regarding the relationship between  the TRIPS Agreement and the Convention on 
Biological Diversity, the EU would like to point out that our legislation to implement the Nagoya Protocol is now fully adopted, this regulation implements the EU's international obligations and it is 
being further developed by guidelines and by very  concrete rules on how to proceed, and other 
than that our position has been expressed in the W/52 document and I have nothing to add to 
that. 
5.22  Australia   
 78.  Australia's positions on these issues are we ll known and so we will endeavour to keep our 
intervention to the point.  
79.  Australia regards WIPO as best placed to consider the complex intellectual property issues 
relating to genetic resources and traditional kn owledge. Australia wishes to see WIPO members 
conclude this important, substantive work on which considerable progress has already been made.  
80.  Through informal processes, small-group initiatives and Secretariat-initiated seminars, we 
also have the chance to forge stronger understandings and common approaches. We continue to encourage Members to reflect on their positions and return to negotiations committed to achieving 
a meaningful and balanced outcome. 
81.  Australia regards the current flexibilities under TRIPS Article 27.3(b) as sufficient to allow 
Members to take decisions on the patentability of life forms in accordance with national policies. 
We regard it to be appropriate to retain these flexibilities. We consider that prohibiting patents 
that relate to life forms would have a profound adverse impact on innovation, limit scientific advancement and result in significant commercial impact. 
82.  As we have said at previous TRIPS Council sessions, Australia considers the TRIPS Agreement 
and the Convention on Biological Diversity are consistent. Australia fully implements its obligations 
under both agreements, which we view as mutually supportive. 
AGENDA ITEM 6: NON-VIOLATION AND SITUATION COMPLAINTS 
6.1  Brazil   
 83.  Brazil has the honor of introducing the document IP/C/W/385/Rev 1 to the TRIPS Council. The 
document entitled "Non Violation and Situation Nullification or Impairment under the TRIPS 
Agreement" was submitted to this Council on 22 May, expressing the views of seventeen countries that consider non violation and situation complaints should be deemed inapplicable under the TRIPS Agreement. In order to present the revised version of a document, a brief historical IP/C/M/79/Add.1 
 
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  introduction is needed. I ask the indulgence of the Members to take us back to 2002, when a 
group of 14 countries submitted IP/C/W/385. 
84.  At that time, Members were struggling du ring TRIPS Council Sessions to consider the 
possibility of allowing non violation and situation complaints to apply to intellectual property 
disciplines. A number of WTO agreements, decisions and declarations refer to non-violation 
complaints. Nonetheless it was unclear how such an exceptional mechanism used in market access treaties would interact with the international IP System. 
85.  Even though GATT Article XXIII established the basic rules on non-violation and situation 
complaints and Article 26.1 of the Dispute Settl ement Understanding provided basic procedures, 
Article 64.3 of the TRIPS Agreement requested a consensus on the adoption of scope and 
modalities prior to their use. According to the text of the treaty: 
3. "(…) , the Council for TRIPS shall examine the scope and modalities for complaints 
of the type provided for under subparagraphs 1(b) and 1(c) of Article XXIII of the GATT 
1994 made pursuant to this Agreement, and submit its recommendations to the 
Ministerial Conference for approval.  Any de cision of the Ministerial Conference to 
approve such recommendations or to extend the period in paragraph 2 shall be made 
only by consensus, and approved recommendations shall be effective for all Members 
without further formal acceptance process." 
86.  In 2002, a group of 14 Member states, comp rised by Argentina, Bolivia, Brazil, Colombia, 
Cuba, Ecuador, Egypt, India, Kenya, Malaysia, Pakistan, Peru, Sri Lanka and Venezuela, submitted the document W/385, in order to express the vi ew that the application of non-violation and 
situation complaints to TRIPS would raise systemic concerns that could adversely affect not only 
the IP system, but also the World Trade Syst em and its dispute settlement mechanism. The 
elements that led to this shared interpretation are, inter alia, the understanding that non-violation and situation complaints would, 
(i) introduce incoherence among WTO agreements by allowing something which a WTO 
Member has agreed to accept in one part of the single undertaking (e.g. the GATT or the GATS) to be challenged on the basis that it could nullify or impair benefits in another 
area (e.g. TRIPS); 
 (ii) upset the delicate balance of rights and obligations in the TRIPS Agreement by elevating 
private rights over the interests of the user s of intellectual property – both within and 
between countries – and over other important public policy considerations in a manner 
inconsistent with Article 3.2 of the DSU; 
 
(iii) undermine regulatory authority and infringe sovereign rights by exposing to challenge 
any measure that affects intellectual property and that could not have been foreseen at the time of the Uruguay Round; 
 
(iv) limit use of the flexibilities inherent in the TRIPS Agreement to secure objectives relating 
to public health, nutrition, the transfer of technology and other issues of public interest in sectors of vital importance to socio-economic and technological development. 
 
87.  Taking into consideration the document W/385, communications from Canada, the European Communities, the United States, as well as discussions inside the TRIPS Council, no decision could 
be adopted on scope and modalities at the 4th Ministerial Conference. The MC4 oriented the TRIPS 
Council to "continue its examination of the scope and modalities for complaints of the types provided for under subparagraphs 1(b) and 1(c) of Article XXIII of the GATT 1994 and make 
recommendations to the Fifth Session of the Mi nisterial Conference.  (…), in the meantime, 
Members (would) not initiate such complaints under the TRIPS Agreement."  
88.  Moratorium to the use has been approved in  every Ministerial Conference, every two years, 
since the 4
th Ministerial.  
89.  In 2013, the Bali Ministerial Conference ex tended the moratorium and Members agreed they 
would intensify their work in the TRIPS Council on NVNI complaints. Approximately one year ago, IP/C/M/79/Add.1 
 
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  on 10 June 2014, the delegation of the United St ates circulated the document IP/C/W/599. The 
communication intended to advance the Council's intensified examination of non-violation complaints under the TRIPS Agreement, while tr ying to address concerns raised by other 
Members. The US document presented, also, a ne w interpretation on the implementation of the 
Article 64.3 TRIPS. According to this interpretati on, "questions regarding the implementation of 
Article 64 have to a great extent been answered, in part by the text of the relevant covered agreements and in part by the GATT and WTO dispute settlement system. Where additional 
questions remain, dispute settlement continues to be the mechanism agreed by WTO Members to 
further clarify provisions of the covered agreement, including Article 64". 
90.  Taking into account previous discussions as well as the contribution of the document W/599 to 
the debate, the group of co-sponsors of docume nt W/385 intensified discussions on non-violation 
and situation complaints in order to produce an updated version of the document that would also 
encompass eventual changes in the last 13 years of discussion. This work involved new co-sponsors and a huge effort of coordination among Geneva delegates and capitals. 
91.  The result of our discussions is reflected in document W/385/Rev 1, circulated to Members on 
27 May 2015, co-sponsored by Argentina, Plurinational State of Bolivia, Brazil, China, Colombia, Cuba, Ecuador, Egypt, India, Indonesia, Kenya, Malaysia, Pakistan, Peru, Russian Federation, 
Sri Lanka and Bolivarian Republic of Venezuela. Besides providing a document up to date, this 
group of countries conveyed a common understandi ng on the implementation of Article 64.3. 
92.  This group of countries understands that "non-violation and situation complaints only apply to 
the TRIPS Agreement in accordance with the procedure established under Article 64.3 and 
complying with this procedure should be a matter of priority for the Council for TRIPS". The 
document expresses the view that "non-violation and situation complaints would be applicable to TRIPS only when there is a consensus on the scope  and modalities as envisioned in Article 64.3 of 
the TRIPS Agreement." 
93.  Taking all aforementioned into account  the result of the discussion was that  
"introducing non-violation and situation complaints into the TRIPS Agreement is 
unnecessary and inconsistent with the interests of the WTO Members. Any benefits 
arising from the Agreement can be adequately protected by applying the text of the 
Agreement in accordance with accepted principles of international law. The absence of 
non-violation complaints in the TRIPS context does not in any manner threaten or dilute the enforceability of TRIPS related rights and obligations. On the contrary, the application of non-violation complaints in the TRIPS context could potentially present 
issues relating to rights of intellectual property right holders versus the legitimate 
exercise of regulatory policy choice by Governments." 
94.  Consequently, we propose that the TRIPS Co uncil recommend to the Ministerial Conference 
that complaints of the type provided for under subparagraphs 1(b) and 1(c) of Article XXIII of 
GATT 1994 shall not apply to the settlement of disputes under the TRIPS Agreement." 
95.  The document is open to new co-sponsors that share the same understanding regarding non-
violation and situation complaints. 
6.2  Bangladesh, on behalf of the LDC Group   
 
96.  LDCs are concerned that Non-violation and situation complaints have every possibility to pose 
unnecessary problems to LDCs which can be otherwise available if we do not implement this provision under TRIPS. In this respect, we support the proposal IP/C/W/385/Rev.1 submitted by 
different developing countries. Our fundamental understanding is that TRIPS is not a market 
access agreement. The TRIPS Agreement was designed in a manner which only provides the minimum level of territorial protection to IP by the Members. Its operation is also unique and quite 
different from any other WTO agreement. While some other agreements are explicit about 
facilitating market access and concessions, TRIPS provides for a minimum level of protection and flexibility with a view to achieve the socio-economic  objectives. Most of the IP issues are actually 
owned by individuals or business concerns, instead of being owned by the State. Therefore, to our 
best judgement, drawing any parallelism in terms of non-violation and situation complaints with IP/C/M/79/Add.1 
 
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  other WTO Agreements is not compatible with the context of TRIPS. Consequently, we do not see 
any scope of non-violation and situation complaints to be applicable in a sui generis system like TRIPS as the nature and scope of obligations under the TRIPS Agreement permit Members to determine the level of protection according to their respective domestic legal system and practices.  
So from the systemic point of view, non-violation and situation complaints will infuse huge legal 
uncertainty in the total system and the LDCs could be the worse victim of any abuse or misuse of the mechanism. Hence the LDCs support the perman ent deletion of this provision from the TRIPS 
Agreement and until that time we should continue the current moratorium. 
6.3  Ecuador   
 97.  As a co-sponsor of document IP/C/W/385/Rev.1, Ecuador endorses the presentation given by 
the delegation of Brazil. We are co-sponsoring this new document because we are convinced that 
the application of non-violation and situation complaints raises fundamental concerns and is therefore unnecessary. 
98.  Other countries have joined the list of co-sponsors and many more will surely support the 
proposed document for the simple reason that the complaints provided for in Article XXIII:1(b) and 1(c) of the GATT 1994 are not applicable to the settlement of disputes under 
the TRIPS Agreement. 
99.  Ecuador reiterates its belief that the TRIPS Agreement does not seek to protect market 
access, as there is no exchange of tariff concessions, but rather it is a sui generis  agreement that 
establishes minimum standards on the acquisition, exploitation, scope and exercise of intellectual 
property rights. Ecuador remains concerned that the application of non-violation complaints to the 
TRIPS Agreement threatens to undermine the regu latory authority of Members and may infringe 
sovereign rights by constraining their ability to introduce new measures on economic development, 
social welfare, health, the environment and culture in their countries. 
100.  Ecuador does not share the position expressed by the United States in document 
IP/C/W/599, which considers that, once the moratorium established under Article 64.2 has 
expired, application becomes automatic. Although Ecuador believes that Article 64.2 is an 
exception to Article XXIII of the GATT 1994, as the very nature of the TRIPS Agreement precludes 
non-violation and situation complaints from being set forth under its provisions, the application of paragraph 2 is not automatic. On the contrary, the scope and modalities for complaints are to be 
examined under Article 64.3, and any decision on the matter must be adopted by consensus by 
the Ministerial Conference. 
101.  It is clear that no consensus on this issue has been reached, as the discussions to define 
the aforementioned scope and modalities have not progressed, and no recommendations have 
been made to the Ministerial Conference. For this reason, we firmly believe that this item should 
be removed definitively from the agenda of this  Council at the upcoming Ministerial Conference 
in Nairobi. 
6.4  Argentina   
 102.  As a co-sponsor of document IP/C/W/385/Rev.1, Argentina still considers that the 
non-violation and situation complaints identified in Article XXIII:1(b) and (c) of the GATT 1994 are 
not applicable to the TRIPS Agreement. 
103.  Complaints of this type are inherent in  agreements where there is an exchange of 
concessions and where the parties reciprocally assume obligations that are directly linked to 
market access. In this context, the agreed concessions can be nullified or impaired by non-tariff measures. 
104.  The TRIPS Agreement is not a market a ccess agreement but rather establishes minimum 
standards of intellectual property protection. Theref ore, there can be no nullification of a benefit if 
there is no violation or infringement of an agreed rule. 
105.  The possibility of a non-violation or situation complaint would give rise to uncertainty as to 
the legality of governmental measures which a Member might legitimately adopt. It would also IP/C/M/79/Add.1 
 
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  open up the possibility of such measures, even when they were legal and legitimate, being called 
into question by other Members. Furthermore, su ch complaints would upset the balance of rights 
and obligations which exist under the TRIPS Agreement. 
106.  The Argentine delegation therefore support s the proposal contained in paragraph 57 of 
document IP/C/W/385/Rev.1 that this Council recommend to the Ministerial Conference that 
complaints of the type provided for under Arti cle XXIII:1(b) and (c) of the GATT 1994 should not 
apply to the settlement of disputes under the TRIPS Agreement. 
6.5  India   
 107.  India is a co-sponsor of document IP/C/W/385/Rev 1 which Brazil has introduced in the TRIPS Council meeting today along with sixteen other WTO Members. The revised document is the 
reiteration of the serious concerns that we have with respect to the introduction of non-violation 
complaints in the TRIPS context. We extend our su pport to the statement of Brazil and Bangladesh 
on behalf of the LDC Group which have been ma de in support of the non-applicability of non-
violation and situation complaints to TRIPS. Brazil has outlined the rationale and history of our 
position on non-applicability of non-violation complaints to the TRIPS and the basic thrust of the revised document. 
108.  Serious concerns on the ambiguity, incoherence and limit on flexibilities of Members due to 
the applicability of non-violation complaints in the TRIPS context continue. They have been discussed in great detail in previous meetings. Pa st GATT/WTO jurisprudence or explanations to 
the contrary by proponents do not allay our fears.  Over the last year, intensive discussions on the 
applicability of non-violation complaints have taken place in the Council. This has re-affirmed our 
belief on the detrimental consequences non-violation complaints would have in the TRIPS context. 
109.  India would like to highlight only some of the issues that we consider pivotal in 
understanding our concerns on the applicability of NVCs to TRIPS. It is clear that when negotiating 
the TRIPS Agreement, non-violation complaints were made inapplicable to TRIPS under Article 64.2. This is in stark contrast to the GATT and GATS where NVCs were made applicable without 
any discussion on scope and modalities. This, by itself, clearly indicates the serious concern the 
Membership had in applying NVC in the special context of the TRIPS agreement. 
110.  Further, Article 64.2 clearly mandated that there had to be an agreement on the scope and 
modalities of NVCs in the TRIPS context. This, again, is not present in the context of GATT and 
GATS. The entire thrust of Article 64 and the intention of the negotiators clearly show that 
Members viewed TRIPS in a very different way in the context of applicability of NVCs. If this was not the case, there would have been no issue in applying NVCs like in the case of GATT without 
any debate or consensus on scope and modalities. It would also not be the case of proponents of 
NVCs in TRIPS that the TRIPS Agreement does not envisage a consensus on scope and modalities. If NVCs were to automatically apply after a time frame, there would be no need for Article 64.3. 
The fact that scope and modalities need to be discussed and agreed upon recognizes the unique 
n a t u r e  o f  t h e  a p p l i c a b i l i t y  o f  N V C s  t o  T R I P S .  T h e  n e g o t i a t o r s  r e c o g n i z e d  t h i s  a n d  w e  m u s t  n o t  interpret it otherwise. 
111.  The fears that many delegations, especially  developing country Members, have expressed on 
the ambiguities that NVCs bring cannot be underestimated. Those fears have not been allayed by 
the discussion but have only strengthened. It strikes at the very ability of governments to function as well as the ability to deal with challenges to that ability. What are the circumstances in which 
they will be used to suppress Member's sovereign policy space. What are the limits? What are the 
various policy measures that will come under its scanner. I am afraid, there are no satisfactory answers to it and neither will there be any. 
112.  The TRIPS Agreement lays down a delicate balance between rights and obligations of 
Members. NVCs tilt that balance. The very nature of NVCs makes it impossible to lay down various practical scenarios on how they would impact a Members sovereign space. A new cause of action arises even when there is no textual violation of the TRIPS Agreement. Article 3.2 of the DSU 
states, inter alia, that the DSB recommendations cannot diminish the rights and obligations 
provided in the covered agreements. The applicab ility of NVCs to the TRIPS Agreement will widen IP/C/M/79/Add.1 
 
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  the rights and obligations of the Members under the TRIPS beyond the express terms of the TRIPS 
Agreement. This is how the delicate balance th at now exists will inevitably be affected.  
113.  The ambiguity and lack of clarity that NVCs will usher in in the TRIPS context will especially 
affect developing countries and LDCs severely. Lack of legal capacity to handle such cases will be a 
serious issue. It would inevitably lead to addition of litigation cost. The vast array of measures that 
will suddenly be open to potential challenge will be insurmountable. India believes that this is an unnecessary burden that was not intended by the TRIPS Agreement.  
114.  India requests Members to seriously reflect on the concerns expressed by an overwhelming 
number of delegations in this meeting and earlier and should join the consensus that complaints on the grounds of nullification or impairment of th e type identified in Article XXIII:1(b) and (c) of 
the GATT 1994 be determined inapplicable to the TRIPS Agreement, in the interest of the stability 
and certainty of the multilateral system. 
6.6  South Africa   
 
115.  South Africa supports the statements of Indi a, Brazil and other like-minded countries. South 
Africa as a Member of the WTO is fully committed to upholding its obligations and commitments as set out in the different WTO laws and regulations with specific reference to the TRIPS Agreement. 
The purpose and aim of Article XXIII is to ensure compliance with the GATT rules and principles by 
providing Members with an opportunity to make re presentations should the situation provided for 
in sub-paragraphs 1(a) and 1(b) arise - this is different to the TRIPS Agreement. The TRIPS Agreement is a sui generis  agreement; it is not aimed at promoting market access or harmonizing 
the standards of Members with regards to the prot ection and enforcement of intellectual property 
rights. It is there to provide the minimum standa rds for protection and enforcement of intellectual 
property rights. The insertion of Article XX III:1(a) and 1(b) of GATT 1994 under the TRIPS 
Agreement will undermine the sovereign rights of the respective Member states in as far as putting 
into place the laws that will protect intellectual property rights within their borders are concerned. The insertion will furthermore restrict the flexib ilities provided to the Members and defeat the 
balance that that has been maintained under the TRIPS Agreement. South Africa recognises the 
need for the protection and enforcement of intell ectual property rights, however we believe that 
the insertion of non-violation and situation complaints will not be practical under the TRIPS Agreement.  
6.7  Colombia   
 116.  Colombia is a co-sponsor of document IP/C/W/385, submitted by a group of Members 
in 2002, and now also co-sponsors the revised version thereof since it shares the view that 
Article 64.2 of the TRIPS Agreement should not be applicable to that Agreement. 
117.  Scarce case-law in this area and the resultin g gaps in respect of major issues are yet further 
evidence that permitting non-violation nullification and impairment complaints under the 
TRIPS Agreement would upset the balance between the policies that a Member can adopt and the trade liberalization undertaken by that Member. Permitting such complaints also risks going 
against the very objectives and aims of the TR IPS Agreement and infringing the principle of 
predictability that is enshrined in the preamble of this Agreement, as well as creating uncertainty 
as to the scope of the commitments undertaken thereunder by each Member. 
118.  Colombia thus reiterates its wish that the TRIPS Council recommend to the Tenth Ministerial 
Conference that complaints on the grounds of nullifi cation or impairment of the type identified in 
Article XXIII:1(b) and (c) of the GATT 1994 be dete rmined inapplicable to the TRIPS Agreement. 
6.8  Cuba   
 
119.  Cuba fully endorses the statement made by Brazil, supported by the Members that took the 
floor before us as well. Cuba was one of the initial proponents of this proposal in the first version in 2002. Consequently, we consider that the application of complaints in the TRIPS Agreement 
would seriously undermine the system of WTO standards, possible leading to distinct disequilibria 
amongst rights and obligations in connection with public policy. It would limit the policy of flexibility of agreements in TRIPS and would lead to practical problems which have been broadly IP/C/M/79/Add.1 
 
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  described in the proposal. We wish to highlight the fact that the document submitted today is a 
strengthened proposal in connection with the one submitted already in 2002. It has been strengthened in terms of its content and also in  terms of a number of Members endorsing it now, 
which shows the importance of this topic for a considerable number of WTO Members. As has been 
well mentioned by others already, when representing  this group of countries, their vision has to be 
taken into account in the context of decisions to be taken on the subject. 
6.9  Venezuela, Bolivarian Republic of   
 
120.  This type of complaint does not apply to intellectual property cases, as explained at length in document IP/C/W/385/Rev.1, of which Venezuela is a co-sponsor. We support the request that the Council for TRIPS recommend to the Ministerial Conf erence to be held in Kenya in December 2015 
that such cases be determined inapplicable to in tellectual property issues, thereby putting an end 
to this long pending issue. 
121.  Consensus is a fundamental principle of the WTO since, unlike other organizations; rulings 
are binding on all Members, with no possibility of  reservations. The only possible case of reverse 
consensus under the WTO is during the establishment of a DSB panel in the event of the responding Member once again objecting on the se cond occasion that the establishment of a panel 
is requested by the complainant. WTO rules clearly stipulate that a panel will be established in 
such cases. 
122.  Were reverse consensus to apply under Article 64.2 of the TRIPS Agreement, which is how 
the United States claims it should be interpreted, it would simply be contrary to the principles of 
this legal instrument and should be deemed invalid and declared as such. 
123.  It does not, however, seem logical that an issue relating to national security and affecting 
public health and food security issues, inter alia, could have been regulated by our ministers in an 
agreement, only for others to rule on domestic issues on the basis of a reverse consensus. 
6.10  Lesotho, on behalf of the Africa Group   
 
124.  I am making this brief intervention on behalf of the Africa Group. The TRIPS Agreement, 
unlike other WTO agreements, is a sui generis  agreement, which is not designed to protect market 
access or the balance of tariff concessions. The TRIPS Agreement permits Members to determine the level of intellectual property protection accordin g to their respective legal systems. As such its 
operation is unique as it provides for a minimum level of protection and flexibilities to developing 
countries and LDCs for their socio economic development objectives.  
125.  The Africa Group broadly shares and support s the concerns and views contained in document 
IP/C/W/385/Rev.1. Furthermore it is the view of the Africa Group that the application of 
non-violation and situation complaints raises systemic concerns.  
126.  The Africa Group supports the proposal that  non-violation and situation complaints should 
not apply under the TRIPS Agreement. 
6.11  Chile   
 127.  This is an extremely important issue for our country. As mentioned previously, we support 
further extension of the moratorium, in the absence of consensus on its application to the TRIPS 
Agreement, under which consensus is required. 
128.  We thank the proponents of document IP/C/W/385/Rev.1, which was circulated recently, 
and welcome the explanations provided during  this session. We are examining the issue, 
as we are interested in exploring a definitive solution, such as the one put forward in the aforementioned document. IP/C/M/79/Add.1 
 
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  6.12  Switzerland   
129.  We thank Brazil and the other delegations co-sponsoring document rev. 1 of IP/C/W/385. 
Whilst it reflects well-known positions expressed back in 2002, its structure has facilitated our 
reading of the document and preparing comments. 
130.  The list of points we are going to make may not be exhaustive. We reserve the right to 
further expand our comments, if need be or in li ght of delegations' comments at this meeting.  
Market access agreement or not 
 
131.  My delegation is not going to address at gr eat length the issue of whether TRIPS is a market 
access agreement by nature or not, an argument reiterated in IP/C/W/385/Rev.1, as this risks to be a rhetorical debate.  
132.  What my delegation wishes to observe in that context is that it was the TRIPS negotiators' 
concern in the Uruguay Round to adhere to the general GATT/WTO philosophy of market access. An example of this can be found in the very firs t recital of the preamble of the TRIPS Agreement 
where the goal of the TRIPS Agreement is referred to as "Desiring to reduce distortions and 
impediments to international trade…" etc. This confirms my delegations view that the TRIPS Agreement is about market access eventually.  If not at "first sight", then undoubtedly at close 
look.  
Flexibilities 
 133.  A concern raised by the co-sponsors in Rev. 1 again and to which my delegation considers it 
important to respond is whether the application of NVCs under TRIPS has implications on the 
flexibility provisions foreseen in the Agreement.  
134.  By protecting the balance of rights and obligations under the WTO agreements as concluded 
in the Uruguay Round, NVCs do not apply to actions or measures taken by Members under a 
flexibility provision as identified and confirmed in  the TRIPS Agreement. These provisions are, just 
a s  i s  A r t i c l e  6 4 ,  p a r t  o f  t h e  b a l a n c e  o f  r i g h t s  a n d  o b l i g a t i o n s  u n d e r  T R I P S  a s  a g r e e d  a m o n g  
Members in the Uruguay Round.  
Necessary or Not 
 135.  One proposition that is repeated in document IP/C/W/385/Rev.1 is that NVCs are said to be 
unnecessary. Unnecessary in GATT and GATS, and even more so in the TRIPS context.  
136.  Well, my delegation is not claiming that NVCs are a remedy under the WTO system that 
needs to or ever has been taken recourse to frequently. On the contrary, the instances where a 
panel or the Appellate Body have addressed or examined this WTO principle in a dispute case are 
very rare, indeed.  
137.  Some would say that this would justify the suppression of NVC. We disagree with such a 
conclusion. The risk of a single measure corresponding to NVCs would – and should speak in favor 
of applying NVCs under TRIPS, for the sake of legal certainty and trade security which should be guaranteed to all Members, no matter what is their size or economic importance at the international level. 
138.  Be that as it may, it doesn't matter whether my delegation believes that NVCs are frequently 
or rarely used, nor whether they are necessary or not. The fact is that Article 64 is part of the TRIPS Agreement and of the Uruguay Round deal th at all WTO Members subscribed to at the time. 
Article 64 provides in para. 2 that during a limited period of five year, called a 'moratorium', NVCs 
shall not apply. This in the clear understanding that after these five years, i.e. once the moratorium ends, these complaints are applicable to TRIPS just as they are to the other two WTO 
pillars of GATT and GATS.  IP/C/M/79/Add.1 
 
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  139.  As far as the principle of applicability of NVCs to TRIPS is concerned, we are thus looking at 
a consensus dating back to the Uruguay Round. The TRIPS Council cannot renegotiate this consensus today by questioning whether such complaints are necessary or not. 
Legally Imprecise Notion – Good Faith Principle Instead 
140.  Co-sponsors of IP/C/W/385/Rev.1 criticize the legally imprecise notion of NVCs. They 
recommend that instead, rights and obligations in the TRIPS Agreement should be performed through good faith application. While I personally would hope that this will be sufficient as a rule, I 
doubt whether the concept of good faith will not prove a criterion legally even more imprecise, 
certainly if you ask the two parties in a specific dispute case as to what they would consider that an action or measure in the situation at hand was taken in good faith or not.  
141.  The instrument of NVCs thus provides a clearer legal frame to the extent it is embodied in a 
set of rules and has to respect the examination of certain steps under the DSU to ensure a 
maximum of coherence. 
DSU Guidance Sufficient or Not 
142.  Now co-sponsors repeat in in IP/C/W/385/Rev.1 that in their view, the DSU, GATT/GATS 
disputes provide too little guidance for panels and the AB to apply NVCs in the TRIPS context. As is well-known, my delegation believes that the DS U does provide the bodies of the DSM with 
sufficient guidance to apply such complaints also in the TRIPS Context.  
143.  If the delegations co-sponsoring IP/C/W /385/Rev.1 of 385 actually disagree with this 
position, my delegation would have hoped that, ra ther than repeating their position from 13 years 
ago, they would have helpfully proposed additi onal modalities they think necessary for such 
complaints to apply in the TRIPS context. This would have been a valuable contribution under the 
work of the TRIPS Council under its mandate from the Ministerial Conference and the very purpose 
of the moratorium and its extensions. 
144.    As this is not and has not been the case for the last 20 years, my delegation sees no merit 
in further extending this moratorium at the end of this year. Rather it should be recommended to the Ministers that, moratorium expired and thus  NVCs applicable, the DSU shall provide the 
relevant guidance, should ever such a complaint be presented to the DSM under the auspices of 
the TRIPS Agreement. 
6.13  Peru   
 
145.  Non-violation and situation complaints have been deprived of an advantage because of a 
measure taken by a government. Quite clearly, the idea would be to try to maintain the balances achieved in the multilateral negotiations . Despite the time that has run since 2002, when we 
co-sponsored document IP/C/W/385, Members with different positions to ours, such as the 
delegation that spoke just before me, have no t given any example to support their position. 
Thirteen years after the submission of the document  that I have just mentioned, our delegation is 
proud to co-sponsor this revised proposal. As it has been recognized by others, these cases are 
rare and exceptional. As was said by the panel in the case Japan Films and I quote "non-violation and situation nullification or impairment must endure a very cautious focus which should also be exceptional". So the group of Members that co-sponsor this proposal have presented a 
recommendation that the Ministerial Conference decide that this type of complaint is not applicable 
within the ambit of the TRIPS Agreement. Finally I would like to refer to consultations that you referred to when opening this item, that is how to carry forward the discussions in this area, 
because as you recalled, quite clearly, following an instruction from Ministers in Bali, which is to be 
found in MIN/13/31 of 11 December 2013, my delegation requests that before our next meeting in October, you hold regular consultations on this matter, so that we can find a consensus amongst 
Members and that such a consensus will then be submitted to the next TRIPS Council. I think also 
that there are two clear positions on this subject an d there is still a lot of work to do, so we do 
hope that this is an issue that you will help us find a consensus on, Mr Chairman. IP/C/M/79/Add.1 
 
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  6.14  Nepal   
 146.  The delegation of Nepal would like to thank and associate itself with Brazil, Argentina, India, China and other developing country Members who jointly submitted a paper contained in 
IP/C/W/385/Rev.1 on Non-Violation and Situation Complaints (NVSC). We also would like to join 
our voice with other delegations including Bangladesh who expressed their views supporting this document.  
147.  In our understanding, the application of no n-violation and situation complaints, which is 
originally a GATT provision fits only in trade in goods and services but not in any sui generis  type 
system like TRIPS. As NVSC is basically related with  market access issue, it has less possibility and 
less relevance of application with regard to TRIPS which basically intends to provide minimum 
protection to IP-related instruments. Application of this in TRIPS regime is inappropriate and will 
reduce flexibility and policy space of many developing countries in general and LDCs in particular and prevent them from pursuing developmental goal s through legitimate exercise of policy choices 
in the field of IPRs. 
148.  In this context the paper jointly submitte d by Brazil and other developing country Members 
is a self-explanatory note which very clearly explains why NVSC is not applicable and is irrelevant 
in the field of IP. Against this backdrop, we cannot support any idea to bring non-violation and 
situation complaints within the ambit of TRIPS, as  has been argued by some Members. We express 
our deep concern on views expressed by some de legations that MC 10 should end the moratorium 
given so far in this regard, which in our understanding does not reflect the sentiment of the 
majority of developing co untries and LDC Members.  
149.  While supporting the paper put forth by developing country Members not to bring NVSC 
issue under TRIPS, we call upon Council to recommend to the 10th Ministerial Conference that 
complaints of the type provided for under subpara graph 1(b) and 1 (c) of Article 23 of GATT 1994, 
shall not apply to the settlement of disputes under the TRIPS Agreement. 
6.15  Indonesia   
 
150.  At the outset my delegation would like to align ourselves with the statement made by Brazil, 
Bangladesh on behalf of the LDCs, India and other like-minded countries on the inapplicability of the non-violation and situation complaints to the TRIPS Agreement. Our view on this matter has 
not changed, we believe the NVSC is an ancient concept aimed at protecting the balance of tariff 
concessions in past non-comprehensive agreements, such as GATT pre-Uruguay Round or early bilateral agreements. When Members tried to apply this concept into a system with extensive rules 
on non-tariff measures and a binding dispute settlement system, like what we have now in the 
WTO, it becomes more of a stumbling block to the system. The NVSC would strongly contradict the basic principles of transparency, predictability an d equitability which have so far been principles 
firmly upheld by the WTO. It would also create legal uncertainty which would undermine the 
predictability and security that the system seeks to provide to all WTO Members. This ancient concept is even inapplicable and unnecessary for TRIPS which is a sui generis  agreement to 
establish minimum standards of IP protection an d not designed to protect market access or the 
balance of tariff concessions. The uniqueness of TRIPS protecting private rights over public 
interest, if abused, may even undermine market access itself.  
151.  As a developing country Member who is tr ying to tap the full benefits of the system, 
Indonesia is learning and striving to observe and follow all its commitments in this rules-based 
organization over its highly-need interest to enlarge policy space for development. The NVSC would nullify these efforts by creating legal uncertainty and unpredictability even when all WTO 
rules and its commitments have been observed and followed. 
152.  Indonesia is also of the view that preserving the rule of consensus in the debate on scope 
and modalities for NVSC in TRIPS is a prerequisite to the implementation of this concept to the Agreement. In this light, Indonesia strongly supports that the proposal in document 
IP/C/W/385/Rev.1, i.e. that this Council recommend to the Ministerial Conference that complaints 
provided for under GATT 1994 Article 23.1(b) and (c), shall not apply to any settlement of disputes under the TRIPS Agreement.  IP/C/M/79/Add.1 
 
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  153.  Additionally, in an effort to move the discussion forward, our delegation would like to support 
the proposal of Peru, asking you, Mr Chairman, to hold a series of consultations to discuss this issue among the interested Members leading up to our next TRIPS Council meeting, and Indonesia would like to be included in such consultations. 
6.16  Pakistan   
 154.  At the outset, Pakistan wishes to echo what has already been stated by Brazil, India and 
other like-minded group Members. Being one of the co-sponsors of the document 
IP/C/W/385/Rev.1 on NVSC we reiterate our commitment and express our firm support on this issue. Pakistan has already been very expressive on this important and sensitive issue which is at the heart of the LDCs and the developing countries. At the same time we also welcome other 
Members who have expressed their interest to have a closer look at the document sponsored by 
us. TRIPS as we know has been crafted with a very delicate balance between the rights and the 
obligations, and non-violation and situation complaints might deserve that apple cart, so we have 
to be very careful in terms of whatever we stat e here as one of our distinguished Members stated. 
However, let us assure you that we, the co-sponsors, are having closer engagements and we also wish to be associated during your consultations in order to move ahead finding a way forward for 
the MC10. 
6.17  China   
 155.  China has also co-sponsored document IP/C/W/385/Rev.1 and agrees with many other 
Members that the application of non-violation and situation complaints to the TRIPS Agreement is 
unnecessary and raises many systemic concerns as well. Especially these types of complaints would bring significant uncertainty into the TRIPS Agreement, which is a delicate balance of 
interests among Members. Moreover, China notices many Members are concerned that such 
complaints might undermine the regulatory authority and infringe their sovereign rights.  
156.  Therefore, we propose that the Council for TRIPS recommend to the Ministerial Conference 
that these types of complaints shall not apply to the settlement of disputes under the TRIPS 
Agreement. 
6.18  Korea, Republic of   
 
157.  We echo the concerns expressed by other delegations over applying non-violation and 
situation complaints to the TRIPS Agreement, so we  would like to reiterate our position made at 
the previous meetings. 
6.19  Norway   
158.  We would like to join the overwhelming majo rity of Members that have intervened today. In 
our view, non-violation and situation complaints should not be applicable to the TRIPS Agreement. 
We therefore favour a ministerial decision to this effect in Nairobi. Should no consensus on such 
decision be reached, the Ministerial Conferen ce should extend the present moratorium.  
6.20  Tanzania   
159.  My delegation aligns itself with the statement made by the delegation of Bangladesh on 
behalf of the LDC Group, and Lesotho on behalf of the African Group. We support the proposal 
introduced by the delegation of Brazil aimed at bringing to an end the use of non-violation and 
situation complaints in dispute settlement. We believe the TRIPS Agreement is balanced, 
negotiated by Members, to provide agreeable st andards to serve the diverse interest of all 
Members. The non-violation and situation complaints raise some systemic concerns to some Members due to their subjective nature in defining  the potential benefits of a Member. This creates 
an alternative to Members in preventing the TRIPS Agreement in applying flexible policies 
embedded therein. We urge Members to consider the revised proposal IP/C/W/385/Rev.1 as submitted by the concerned group of Members. IP/C/M/79/Add.1 
 
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  6.21  Russian Federation   
160.  The Russian Federation thanks the delega tion of Brazil for introducing the document 
IP/C/W/385/Rev.1. We support the statements made by other proponents of the document. Also we would like to note that in comparison with the GATT or GATS where non-violation complaints 
provisions are supposed to protect legitimate commercial expectations that may go beyond 
obligations under these agreements, TRIPS is different. The TRIPS Agreement ensures the compliance of Members with a number of regulatory standards in intellectual property which is 
different from exchange of concessions under GATT.  
161.  Another important difference is that in TRIPS the exchange of rights and obligations defines 
the balance between the producers and users of  intellectual property, and not between WTO 
Members. This sense of balance must be carefully maintained. Nevertheless, as it is stipulated in 
the above-mentioned document the application of non-violation complaints may upset the balance 
of rights and obligations under the TRIPS Agreemen t by elevating private rights over the interests 
of users of intellectual property, both between countries and other public considerations. This is 
another single risk of practical application of non-violation provisions as defined in the document. 
The other one is the possibility of state authoritie s to take measures designed to achieve important 
national policy goals such as the protection of public health and promotion of access to medicines. 
It is very important to maintain the confidence  of Members on the possibility of the use of 
flexibilities of the TRIPS Agreement also in acco rdance with the Doha Declaration on TRIPS and 
Public Health.  
162.  Therefore, when considering the possibility  of application of non-violation and situation 
complaints to the TRIPS Agreement the Russian Federation as a co-sponsor of 
document IP/C/W/385/Rev.1 suggests that the TRIPS Council recommend to the Ministerial Conference that the complaints of the type pr ovided for under sub-paragraph 1(b) and (c) of 
Article XXIII of GATT 1994 shall not apply to the settlement of dispute under the TRIPS 
Agreement. 
6.22  Egypt   
163.  Egypt would like to associate itself with Brazil, India, Lesotho and others. As a co-sponsor of 
document IP/C/W/385/Rev.1 our position is well-known. We continue to believe that the provisions of the type identified in Article XXIII.1(b) and (c) of GATT 1994 are not applicable to the TRIPS 
Agreement. We would like to support the proposal made by Peru that you Chair continue informal 
consultations in order to find a permanent solution on this matter. 
6.23  Japan   
164.  We recall that we exchanged our views on this topic based on document IP/C/W/599, which 
was submitted by the United States last June. On  top of that, this May, several Members revised 
document IP/C/W/385/Rev.1, which helps us to understand their recent views on this topic. We appreciate our colleagues' contributions to activating discussion on this issue. 
165.  Japan's view on this issue has not changed. Both clarity and predictability should be ensured 
when applying non-violation and situation complaints to the TRIPS Agreement. From this point of view, making factual analyses on specific and concrete circumstances in which non-violation and situation complaints should be available would facilitate examination on the scope and modalities 
of non-violation and situation complaints in the area of TRIPS. 
166.  This delegation has been and is willing to engage in discussions at this Council in a 
constructive and dedicated manner. 
6.24  Chinese Taipei   
167.  Non-violation and situation complaints have been a longstanding issue at the TRIPS Council. 
We feel that this is an extremely complex issue with many sides to be considered. 
168.  The concept of non-violation and situation co mplaint is allowed if one government can show 
that is has been deprived of an expected benefit because of another government's action, or IP/C/M/79/Add.1 
 
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  because of any other situation that exists. The aim of the concept is to help preserve the balance 
of benefits struck during multilateral negotiations. However there are many concerns among Members over the applicability of non-violation and situation complaints to dispute settlement under the TRIPS Agreement. 
169.  We look forward to an in-depth discussion  on the issue among Members, particular with 
regard to possible scope and modalities for the complaints in the context of the TRIPS Agreement. 
170.  So my delegation would like to associate it self with those that welcome the debate with a 
constructive spirit and look forward to continuing the discussion in the TRIPS Council. 
6.25  Uruguay   
 171.  The delegation of Uruguay would like to thank the co-sponsors of document 
IP/C/W/385/Rev.1 for the proposal and the explanations therein. 
172.  To avoid repeating what has already been said or the arguments put forward by the many 
delegations that have already taken the floor, we wish to echo the statements made by Brazil, 
Argentina, Venezuela, Colombia and Ecuador, inter alia . 
173.  We should therefore be grateful if Uruguay' s support for the solution proposed in document 
IP/C/W/385/Rev.1 with regard to the non-applicability of such complaints could be placed on the 
record. 
6.26 Hong Kong, China   
 174.  We thank the group of like-minded developi ng country Members for the detailed paper. The 
non-violation and situation complaints issue is a long-standing problem waiting for a solution. In 
our view, a sustainable IP regime must strike a balance between the interests of rights holders and users as well as a balance between predictability and flexibility. 
175.  While experience from other WTO agreements provides great reference value, we must be 
careful when trying to apply it to the TRIPS context. Many delegations have pointed out the unique nature of the TRIPS Agreement before me, namely , it is a minimum-standards agreement and it 
does not address market access per se. It is vital to consider carefully the implications of our 
actions or inaction on the balance that the TRIPS Agreement currently provides before making any decisions. 
176.  It would also be important to continue the dialogue in a positive way. In this regard, Hong 
Kong, China stands ready to contribute constructively to the discussions to find a solution that is 
agreeable among the Membership.   
6.27  Canada   
 
177.  Canada is pleased to contribute to the impo rtant discussion regarding the applicability of the 
NVNI remedy to the TRIPS Agreement. Our position  on this issue is well-known and has remained 
unchanged over the years. Canada continues to believe that providing for NVNI under the TRIPS 
Agreement would be undesirable, considering the diffi culty of defining what constitutes a benefit, 
such as could be nullified by a measure otherwise compliant with the TRIPS Agreement. Canada also believes that the TRIPS Agreement is not a market access agreement based on concessions, 
such that NVNI would be difficult to establish. Canada stresses its commitment to the TRIPS 
Agreement and to our work in this Council. 
6.28  United States of America   
 
178.  We again look forward to the opportunity to  discuss the topic of non-violation and situation 
complaints under the TRIPS Agreement with delegations today. The United States associates itself 
with the interventions of the delegation of Sw itzerland on this matter. We also thank the 
proponents of IP/C/W/385  from 2002 for resubmitting this document, with some limited additional 
clarifications. IP/C/M/79/Add.1 
 
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  179.  The United States recalls its communication to the TRIPS Council on 10 June 2014, which 
was circulated to Members as IP/C/W/599, and notes that that communication responds to each of the issues identified in the W/385 document as well as to issues raised in the subsequent dozen or so years. We also recall that our interventions ov er the past two years on this issue, including 
most recently in the February and October meetings of this Council, have elaborated further on 
those issues and have introduced a series of new considerations as well. 
180.  Today, we wanted to address two issues – first to respond to one of the new aspects of the 
W/385 document regarding consensus, and second to return to our questions regarding the 
relationship of Articles XX  and XXIII of the GATT 1994. 
181.  Turning to the first issue regarding Article 64 of the TRIPS Agreement and the issue of 
consensus, Section 2.2 of W/385 states that NVNI complaints are not automatically applicable to 
the TRIPS Agreement, and instead that there must  be consensus on scope and modalities before 
such complaints would be applicable to the TRIPS Agreement.  
182.  We do not agree. The TRIPS Agreement is unambiguous on this point. Article 64.1 states 
clearly that non-violation complaints shall apply to consultations and dispute settlement under the 
TRIPS Agreement, subject to Articles 64.2 and 64.3. Article 64.2 established a five-year non-application period for such disputes, which was until 1 January 2000. 
183.  Finally, Article 64.3 provides that during the five-year non-application period, the TRIPS 
Council shall examine the scope and modalities for non-violation complaints and submit its recommendations to the Ministerial Conference. And "[a]ny decision of the Ministerial Conference 
to approve such recommendations or to extend the [non-application] period…shall be made only 
by consensus." 
184.  This provision is consistent with the consensus-based nature of the WTO as an institution.  
NVNI complaints shall apply after the five-year period, unless the Ministerial Council agrees to 
extend the non-implementation period by consen sus.  While that consensus was reached most 
recently in 2013 to extend the non-application period , consensus is again required to extend it at 
the 2015 Ministerial. 
185.  Likewise, if there are any recommendations on the scope and modalities, those 
recommendations must be made by consensus.  Here, consensus has not been reached. That does not mean however that the failure to reach consensus on such recommendations alters the TRIPS Agreement requirement to reach consensus on extending the non-application period. 
186.  Some delegations suggest that the failure to reach consensus on such recommendations 
renders the requirement to reach consensus to extend the non-applications null and void. This is inconsistent with the clear language of Article 64 and would lead to a perverse result. In other 
words, the consensus requirement for extension does not simply vanish because the consensus 
requirement for recommendations is not met. Thus, it is clear that the non-application period will terminate at the next Ministerial Conference, unless consensus is reached to extend. And where 
consensus to extend is not reached under Article 64.3, Article 64.1 is clear – non-violation 
complaints apply to the TRIPS Agreement. 
187.  I should also respond here to the suggestion made today that NVNI complaints should not 
apply to the TRIPS Agreement. This position appears to be in fundamental tension with Article 64 
of the TRIPS Agreement. As we have said, Articl e 64 is clear – NVNI claims shall apply to the 
TRIPS Agreement, except as provided under Articles 64.2 and 64.3.  But, the suggestion that NVNI complaints shall apply to the TRIPS Agreement, except that NVNI shall not apply to the TRIPS 
Agreement would be a perverse outcome.  
188.  Second, we continue to look forward to delegations' views regarding the relationship 
between Articles XX and XXIII of the GATT 1994, in light of the views of some Members regarding 
possible impacts of NVNI claims on TRIPS Agreement flexibilities. While the W/385 document 
suggests that NVNI claims could limit the use of the exceptions in the TRIPS Agreement, it is 
unclear why that would be the case. IP/C/M/79/Add.1 
 
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  189.  This suggestion raises many as yet unanswer ed questions in our view.  Why, for example, 
would NVNI claims limit the use of the exceptions in the TRIPS Agreement, when NVNI claims have 
not been suggested to limit the use of the exceptions under Article XX of the GATT 1994? 
190.  Take the EC – Asbestos  dispute, where the complaining party made an NVNI claim among 
other claims, and the defending party claimed an Article XX exception.  In that dispute, the NVNI 
claim in no way limited the use of the GATT Article XX(b) exception regarding the use of measures necessary to protect human, animal or plant life or health. In fact, the panel found that the 
measure was justified under the chapeau and sub-paragraph (b) of the Article XX exception.    
191.  In fact, NVNI claims have been available for 63 years. As have GATT Article XX exceptions.  
Yet, we are not aware of instances in which an NVNI claim has imperilled or otherwise limited the ability of a GATT contracting party or WTO Member  to adopt or enforce measures covered by GATT 
Article XX. In this context, the W/385 paper refers to measures addressing public health, nutrition, 
and other issues of public interest.  Yet, these are the very issues covered by GATT Article XX.  As delegations know, Article XX covers measures: 
 Necessary to protect public morals; 
 Necessary to protect human, animal or plant life or health; 
 Relating to the products of prison labor; 
 Imposed for the protection of national treasures of artistic, historic or archaeological value; 
and  
 Relating to the conservation of exhaustible natural resources… 
 
192.  Anticipating one possible response, some may suggest that GATT Article XX is explicit on 
these issues, whereas the TRIPS Agreement is no t. Yet, the TRIPS Agreement is explicit. The 
TRIPS Agreement has its objectives and principles. Beyond those provisions, the TRIPS Agreement 
provides for numerous obligations as well as exceptions. With regard to those exceptions, we 
remain interested to hear from other delegati ons as to why TRIPS Agreement exceptions are 
vulnerable with respect to NVNI complaints in contrast to the longstanding and harmonious use of 
GATT exceptions and GATT NVNI claims. 
193.  So, for these reasons, and those expressed in document W/599 and the interventions of the 
United States and Switzerland, we maintain our position that NVNI complaints are applicable to the TRIPS Agreement, that the moratorium should ceas e, and that it will cease without consensus to 
extend. 
6.29  Barbados, on behalf of the ACP Group   
 
194.  The ACP Group has noted the points made in document IP/C/W/385/Rev.1 to the effect that 
applying non-violation and situation complaints to the TRIPS Agreement is not required to protect market access commitments made in other WTO Agreements. The Group further notes the 
arguments that non-violation and situation complaints are also unnecessary to protect market 
access commitments embodied in the GATT or GATS agreements. Having noted these, and other concerns, the ACP Group wishes to record its support for the proposal that non-violation and situation complaints should not apply under the TRIPS Agreement. 
6.30  Venezuela, Bolivarian Republic of   
195.  It should be recalled that the WTO consensus rule is positive, never negative. Assuming that 
what the United States says is true, this rule would not be consistent with today's reality, and rules 
that fail to take reality into account lose their validity and should be amended. If there is such 
strict adherence to rules, why are the very same delegations that seek to implement these cases opposing the review of Article 27.3(b), which specifically provides for such a review after four 
years? The same delegation that is promoting this, say that it is not possible to do that.  IP/C/M/79/Add.1 
 
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  AGENDA ITEM 7: REVIEW OF THE IMPLEMENTATION OF THE TRIPS AGREEMENT UNDER 
ARTICLE 71.1 
196.  No statements were made under this agenda item AGENDA ITEM 8: REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION 
ON GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2 
197.  No statements were made under this Agenda item. AGENDA ITEM 9: TECHNICAL COOPERATION AND CAPACITY-BUILDING 
Agenda Item 9.1 Protocol Amending the TRIPS Agreement 
9.1  Chile   
198.  Chile once again welcomes the proposed initiative and supports the Director-General's call to 
Members that have yet to deposit their instrument of acceptance of the Protocol amending the 
TRIPS Agreement under the terms of the "Paragraph 6 System". It should be noted that, based on 
the communication from the Director-General, Chile has incorporated the issue into its dialogue with trading partners that have still not deposited this instrument, in order to share its experience 
of accepting the Protocol. 
9.2  India   
199.  India attaches high importance to the Doha  Declaration on the TRIPS Agreement and Public 
Health, the Paragraph 6 System as established under the 2003 waiver decision and the Protocol. 
The Paragraph 6 System is also the first ever proposed amendment to the WTO Agreement in the 
form of the 2005 Protocol Amending the TRIPS Agreement. India had notified its acceptance of the Protocol in March 2007. We would like to congratulate Brunei Darussalam for depositing its 
instrument of acceptance of the Protocol since the last TRIPS Council meeting. However, in spite of 
the fourth extension of the period for acceptance until 31 December 2015, only 54 Members, including the European Union have accepted the Protocol so far.  The fact that there is still a long 
way to go for it to enter into force, as acceptance by two thirds of the Membership is required, is 
not a positive signal.  
200.  While we reiterate our concern that the Paragraph 6 System was only used once so far and 
the System is too complex and administratively unwi eldy for further use, we have always been of 
the view that the Doha Declaration on TRIPS and Public Health constituted a major landmark in 
the short history of the WTO because it recogniz ed the primacy of public health needs and the 
preparedness of the Organization to take up the problems faced by the poor in developing 
countries. Along with several other Members, India had worked relentlessly on the Doha 
Declaration and the Decision. The Decision was expected to address the public health problems faced by Members with insufficient or no manufacturing capacities in the pharmaceutical sector.  
201.  According to the Trilateral study by WTO, WHO and WIPO on "Promoting Access to Medical 
Technologies and Innovation: Intersections between public health, intellectual property and trade" 
(2013), the Paragraph 6 System might assume a grea ter significance in the future in the following 
scenarios: 
 Implementation of full patent protection for pharmaceutical products in key export countries 
like India could make it more difficult in the future to procure generic versions of new medicines;  
 The System could be used more extensively in response to a pandemic or some other health 
security event, where effective treatments are more likely to be patented in established major supplier countries.  
202.  We would like to appreciate the Secretar iats of WTO and WIPO for providing technical 
assistance for the process for entry into force of  the amendment, and also for the implementation 
and use of the Paragraph 6 System. We would like to appreciate the initiative taken by the 
Director-General by addressing letters to all Members and encouraging those Members who are IP/C/M/79/Add.1 
 
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  yet to accept the Protocol Amending the TRIPS Agreement to complete the process as a priority. 
India is ready to share its experience and assist those Members who are yet to accept the Protocol Amending the TRIPS Agreement to complete the process.  
203.  We encourage Members who are yet to accept the Protocol Amending the TRIPS Agreement 
to accept the Protocol and notify their acceptance on a priority basis so that the Protocol will enter 
into force by the time of the Nairobi Ministerial. 
9.3  European Union   
204.  Like our Indian colleagues, we very much appreciate and welcome the initiative by Director-
General Azevêdo, and I would like to share with you the letter that our Commissioner Cecilia Malmström sent to him in reply: 
"Improving access to essential medicines is indeed of utmost importance for the European 
Union. We consider that the Protocol Amending the TRIPS Agreement provides an important 
contribution allowing WTO Members to export patented medicines to third countries with no manufacturing capacity in the pharmaceutical sector by making use of compulsory licence. 
Therefore the EU accepted the Protocol Am ending the TRIPS Agreement already on 30 
November 2007, within the original deadline of 1 December 2007. We agree with Director-General Azevêdo that the entry into force of the Protocol will be an important signal that will 
ensure a legally secure, predictable, effective and sustainable solution for those countries 
wishing to use the TRIPS flexibilities to get affordable medicines. Therefore, as suggested by Director-General Azevêdo, the European Commission will continue to encourage and assist the remaining WTO Members to accept the Protocol so that it can enter into force, if possible 
in time for the Ministerial Conference to be held in Nairobi". 
9.4  Bangladesh, on behalf of the LDC Group   
205.  I am taking the floor on behalf of the LDC Group. May we inform you that the LDC Group is 
taking particular actions so that our Members may ratify and deposit instruments of acceptance 
very soon. While we are discussing under this agenda item, I will take the opportunity to make some general comments.  
206.  We all know that technical cooperation and capacity building in the area of IP remains an 
important cornerstone for creating the needed balance to ensure that IP serves as an effective tool 
to development and innovation. The LDCs appreciate the efforts of the Secretariat and thank those Members that are providing such support to the rest of us, as IP is a sector which requires 
maximum amount of technical cooperation and capacity-building. 
207.  For IP to truly serve as a development tool, much is required from the existing friends to the 
LDCs, especially data at a lower level of IP development. We would like to remind all Members the 
requirement and responsibility of th e transfer of technology and knowledge. It will save all of us a 
huge amount of money and resources by avoiding the duplication of activities and wastage of time by repeating the same actions elsewhere. These effo rts will ensure specific focus on assisting our 
economies and consolidating innovation and cont ribute to the sustainable development of the 
world we live in. Here we must emphasize that technical cooperation should be demand-driven and based on true requirements.  
208.  LDCs will therefore continue to emphasize the importance of enhanced assistance beyond 
mere workshops and seminars if real impact and tangible benefits are to be achieved. We 
appreciate those Members that have submitted repo rts on what they are doing in the area of IP 
and encourage those that have not shared their experience with this Council to do the same at the 
earliest convenience. We again thank the Memb ers for their continued assistance towards the 
LDCs. 
9.5  Australia   
209.  Australia adds its voice in support of the TRIPS Protocol's entry into force before this 
December's Ministerial Conference. This outcome will benefit Members by providing a permanent IP/C/M/79/Add.1 
 
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  legal basis for countries to import medicines to help address public health needs if they have no or 
limited capacity to produce medicines. 
210.  Australia commends Members from every region and at every stage of development that 
have already accepted this important instrument. We welcome the Protocol's recent acceptance by 
Brunei Darussalam. Australia encourages Members yet to do so to take this important step. 
211.  Australia accepted the Protocol in 2007, and while the Protocol's acceptance does not 
necessarily require legislative action, in February 2015 the Australian Parliament passed legislation 
implementing the Protocol in our domestic system. This will allow Australia to assist countries 
which do not have the capacity to manufacture or purchase their own medicines. 
212.  This scheme extends to non-WTO Members, consistent with the humanitarian principles 
underpinning the TRIPS Protocol. These measures will come into effect on 25 August 2015, and we 
will notify the measures in due course. 
9.6  Brazil   
213.  The Paragraph 6 System exists today as a pending amendment allowing generic medicines 
to be made under "compulsory licences" exclusively for export to countries that cannot produce 
the medicines themselves. The system deals with a problem identified in Paragraph 6 of the 2001 Doha Declaration on the TRIPS Agreement and Public Health by removing a limit in the TRIPS 
Agreement's Article 31(f) and allowing nations to export under a compulsory licence to countries 
needing the medicines. 
214.  In the 20 years of TRIPS implementation an d 19 years of our national industrial property 
law, only one compulsory license has been issued in order to allow access to medicines.  
215.  At that time, Brazil had the benefit of the fact that the medicine was not protected by 
patents in another WTO Member, allowing the international supply without the need to resort to the Paragraph 6 System. With the growing protection  of IP throughout the globe, situations where 
a high-cost life-saving medicine is not protected by patents in manufacturing countries will grow 
scarce. In this context, the formal ratification  and entry into force of the Paragraph 6 System 
becomes more urgent in order to grant to all countries the assurances that the TRIPS Agreement 
would not prevent Members from taking measures to protect public health. 
216.  Brazil urges all Members to expedite the implementation process of the Protocol. We are 
ready to share our experience with the accept ance of the Protocol with other Members. 
9.7  Seychelles   
217.  Speaking on behalf of my delegation, I would like to give a brief update on our efforts to sign 
the amendment to the TRIPS Agreement. At national level there is engagement in finalizing the process with stakeholders. Once this step is completed, the Protocol Amending the TRIPS 
Agreement will be submitted to the Cabinet for their consideration and subsequent approval. 
Seychelles is expected to be in a position to sign by November this year. 
9.8  Chinese Taipei   
218.  On behalf of my delegation, I would like to thank the WTO Secretariat for its efforts to 
promote the Paragraph 6 System. Public health problems afflict many developing and LDCs. We would like to highlight the need for the TRIPS Agreement to be part of the wider national and international action to address these problems. It would be also emphasized that the TRIPS 
Agreement does not and should not prevent Members from taking measures to protect public 
health and, in particular, to promote access to medicines for all. 
219.  This delegation supports the Paragraph 6 System and encourages other Members to notify 
their acceptance of the amendment so that it  can enter into force by the 10th Ministerial 
Conference. IP/C/M/79/Add.1 
 
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  9.9  Pakistan   
220.  Pakistan shares the concerns raised in needing for an early ratification of this, and urges 
those Members who have not yet submitted the required Protocol to do so. Pakistan has already done so in 2007, and we look forward to this im portant issue, indeed the importance of public 
health and access to medicines cannot be over-emphasized. It is important, it is a matter of life. 
9.10  Rwanda   
221.  My delegation welcomes the Director-General's efforts to ensure that ratification is done for 
this important issue relating to access to essential medicines for countries without manufacturing 
capacity. Rwanda has ratified and also it happens to be the only country that benefited from the Paragraph 6 System. We are willing to share experien ce in this process, including both ratification 
and access. 
9.11  European Union   
222.  Following the intervention of my colleag ue from Bangladesh, the European Union much 
values this issue of technical cooperation and we take very seriously our obligations and 
commitments in this area. With Bangladesh, a few years ago, we had an extensive cooperation 
programme. I would propose to my colleague if they would like, on a future occasion, to discuss here at the TRIPS Council, their experiences an d their assessment of how this programme went, 
and we would certainly be willing to work with them on this, so that maybe we could give an 
example, hopefully a best practice. I am taking a gamble here, because I do not know really what 
the evaluation of Bangladesh would be, but we would very much like to work with them and hopefully to present at a future occasion an example of what can be done, and what can be 
improved. 
AGENDA ITEM 10: IP AND INNOVATION: THE ROLE OF INTELLECTUAL PROPERTY IN 
FINANCING INNOVATION 
10.1 United States of America   
 223.  The United States would like to thank the EU, Singapore, and Switzerland for co-sponsoring 
today's agenda item on Intellectual Property and Innovation: The Role of Intellectual Property in 
Financing Innovation. 
224.  Financing is a critical part of the innovation lifecycle that we have been discussing 
extensively under this agenda item at the TRIPS Counc il, and it is pervasive in every aspect of that 
life cycle. Innovation funding is a key part of our respective national innovation policies, and it is 
essential to the success of our innovative small-and-medium-sized enterprises (SMEs). It is a core consideration in research and development by universities and the startups they create as well as 
for social entrepreneurs seeking to maximize the social benefits of their IP. As we heard repeatedly 
at the WTO Innovation Fair, for innovators both large and small, the quest for capital is inextricably linked to the quest for innovation.   
225.  Whether we recall our discussions in this Council on green technology or sports, IP plays a 
central role in securing investment in climate change adaptation and mitigation technology as well as athletic competition at the local, national and international level. And as we have also explored in depth, innovation intermediaries – such as incubators and accelerators – often serve as 
essential companions for early-stage companies and inventors, including by simultaneously 
lowering the risk of innovation and increasing the incentives for investment, both by inventors and investors.   
226.  In its most elemental form, financing deci sions are driven by a risk/reward calculus. IP 
protection mitigates the risk of innovation and can radically change the reward profile of R&D 
investment. We have devoted considerable time in this Council to supporting our own view that IP 
incentivizes innovation by investors. Today, we will look at a different dimension of IP's catalytic 
effect, and present what we view as prolific and compelling data demonstrating that IP also incentivizes innovation through financing. More si mply put, IP couples creativity with capital. IP/C/M/79/Add.1 
 
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  227.  We will focus our intervention on the role of  financial intermediaries in the innovation life 
cycle. First, we will describe the significant and positive relationship between financing, innovation 
and IP.  Having reviewed the extensive literat ure on the correlation between financing and 
innovation we will describe the unique and defining features – as well as the diversity – of capital 
structures and stages in the innovation life cycle, including venture capital.   
228.  Second, we will then discuss the role of IP as an asset that drives access to and lowers the 
cost of financing. Finally, we will turn to the ro le governments can and have played in this context. 
The Significant and Positive Relationship between Financing and Innovation 
 229.  Turning to the first issue, there is considerable data supporting the view that financing is critical to innovation. In their recent paper on "Financing Innovation", Kerr and Nanda cite to 
growing literature in support of the view "that well-functioning financial markets play a central role 
in driving economic growth through their ability to spur technological innovation."
1   
230.  Their study focuses on the role capital market s and financial intermediaries play in impacting 
firm-level innovation. They conclude that "there is clear evidence that financing constraints have 
the possibility to be considerable in the context of firms engaged in R&D and innovation – with the ability to shape both the rate and the trajectory of innovation."
2 Numerous studies reach similar 
conclusions.  For example, in their paper on "Financial Dependence and Innovation: The Case for 
Public Versus Private Firms", Acharya and Xu find th at public listing on stock markets is beneficial 
to innovation firms in industries dependent on more external finance.3  
231.  Another study evaluates the innovation impacts on R&D firms during the Great Depression.  
This analysis by Nanda and Nicholas demonstrates negative effects of bank and stock market 
distress on innovation, in both quantitative and qualitative terms.4 During that period, the severe 
constraints on the ability to raise public equity and debt finance not only stunted the rate of 
innovation, but also negatively impacted the type of R&D undertaken, with a move from greater 
risk to more conservative projects in those count ries with higher economic distress. The authors 
conclude that the financial sector impacts both the immediate amount of innovation by individual 
firms as well as a "longer run effect on the trajectory of innovation that firms choose to 
undertake".  And with economic recovery in the 1930s, came innovation recovery as well.5 
The Nature of Innovation Financing 
 
232.  While financing impacts innovation positively, what is the nature of investment in innovative 
firms?  Generally speaking, such firms, especially young R&D-intensive start-ups, are particularly reliant on financing and have unique demands beyond other entrepreneurs. For Hall and Lerner, 
R&D investment is different than ordinary investment in at least three key ways:  
 that approximately half of R&D spending is on the wages and salaries of highly-educated 
scientists and engineers; 
 that there can be a high degree of uncertainty associated with the output of R&D firms; and 
                                               
1 Kerr, W. and Nanda, R., "Financing Innovation", Working Paper 20676, National Bureau of Economic 
Research, November 2014, page 1. See Comin, D. and Nanda, R. "Financial Development and Technology 
Diffusion", Working Paper, 2014; Hsu,  P.H., Tian, X. and Xu, Y. "Financial Development and Innovation: Cross-
Country Evidence", Journal of Financial Economics, 112(1), 2014, pages 116-135; Brown, J.R. Fazzari, S.M. and Peterson, B.C., "Financing Innovation and Grow th: Cash Flows, External Equity, and the 1990s R&D 
Boom", Journal of Finance, 2009, 64(1), pages 151-185; Levine, R., "Financial Development and Economic Growth: Views and Agenda", Journal of Economic Lite rature, 1997, pages 688-726; King, R.G., and Levine, R., 
"Finance, Entrepreneurship and Growth: Theory and Ev idence", Journal of Monetary Economics, 32, 1993, 
pages 513-542; King, R.G., and Levine, R., "Finance an d Growth: Schumpeter Might Be Right", Quarterly 
Journal of Economics¸108, 1993, pages 717-737.  
2 Kerr, W. and Nanda, R., "Financing Innovation", Working Paper 20676, National Bureau of Economic 
Research, November 2014, p.14.  
3 Archarya, V. and Xu, Z., "Financial Dependence an d Innovation: The Case fo r Public Versus Private 
Firms", National Bureau of Economic Research, 2013, page 45. 
4 Nanda, R. and Nicholas, T., "Did Bank Distress Stifle Innovation During the Great Depression", 
Working Paper, Harvard Business School, 12-106, 2013, pages 24-25. 
5 Nanda, R. and Nicholas, T., "Did Bank Distress Stifle Innovation During the Great Depression", 
Working Paper, Harvard Business School, 12-106, 2013, pages 24-25. IP/C/M/79/Add.1 
 
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   that there is often asymmetrical information between the innovator and investor.6 
233.  These factors were confirmed by several of the speakers at today's side event on "The Role 
of IP in Financing Innovation" sponsored by th e EU, Switzerland and the United States. Kerr and 
Nanda highlight additional innovation-specific fact ors with respect to the R&D financing paradigm.  
In addition to uncertainty and information asymmetries, these include: 
 the skewed nature of innovation returns, which makes evaluation difficult; and 
 the high percentage of intangible assets, including intellectual property, held by innovative 
firms.7 
234.  The nature of innovation financing, theref ore, can impact the capital structure of such 
investment. The relatively higher nature of risk involved in financing innovation coupled with the expertise required for valuation and management of innovative firms, often impacts the source 
and staging of capital. Debt and equity financing are both used to infuse much needed capital into 
the innovative process. However, while debt financing is available, innovators can be constrained in their ability or interest to use debt finance for R&D investment. This is because of the relatively 
lower risk tolerance and expertise of banks coupled with the higher cost of capital and challenges 
of debt serving faced by innovators, particularly young R&D intensive SMEs.
8 
235.  Regarding equity financing, venture capital, angel investors, public and private equity, and 
hedge funds all play a role in financing innovati on. We heard from two angel investors at today's 
side event, and will return to the significance of  venture capital to innovation shortly. Before we 
do, it is important to note that investors may change at different stages. For example, in their intensive analysis of clean tech venture capital in 31 countries from 1996-2010, Cumming, 
Henriques and Sadorsky, identify four stages of clean tech innovation and financing: 
 Stage 1 covers research and involves government funding as well as venture capital and 
private equity; 
 Stage 2 covers development, where venture capital and private equity predominate; 
 Stage 3 covers manufacturing and scale-up, where venture capital and private equity as well 
as public equity markets and mergers and acquisitions all provide financing; and 
 Stage 4 covers roll out, where public equity markets, mergers and acquisitions, and debt 
markets finance clean tech commercialization.
9 
236.  In addition, capital structures differ by co untry and region. Hall and Lerner, for example, 
identify distinctions by country in terms of the type  of debt and equity financing, including data on 
the percentage of venture investments by GDP in  36 countries and a country-by-country share of 
worldwide seed and startup venture capital funding.10   
237.  Likewise, Groh, Liechtenstein and Lieser, rate the top ten countries for venture capital and 
private equity activity.11 
Venture Capital and Innovation Financing 
 
238.  Turning specifically to venture capital, ther e is extensive analysis demonstrating the strong 
and positive impact of venture financing on innovation.12 For example, Hellmann and Puri 
                                               
6 Hall, B. and Lerner, J., "The Financing of Innovation", National Bureau of  Economic Research , Working 
Paper, 2009, pages 5-7. 
7 Kerr, W. and Nanda, R., "Financing Innovation", National Bureau of Economic Research , Working Paper 
20676, Working Paper 20676, 2014, pages 3-4. 
8 Hall, B. and Lerner, J., "The Financing of Innovation", National Bureau of  Economic Research , Working 
Paper, 2009, pages 14 and 34. 
9 Cumming, D., Henriques,  Irene, and Sadorsky, P., "'Cleantech' Venture Capital Around the World", 
Draft Paper, September 21, 2004. 
10 Hall, B. and Lerner, J., "The Financing of Innovation", National Bureau of  Economic Research , Working 
Paper, 2009, pages 13, 54 (Figure 4), and 55 (Figure 5). 
11 Groh, A., Lichtenstein, H., and Lieser, K., "The European Venture Capital and Private Equity Country 
Attractiveness Indices," Journal of Corporate Finance , 16(2), 2010, pages 205-224. 
12 See Kortum, S., and Lerner, J., "Assessing the Cont ribution of Venture Capital to Innovation", The 
RAND Journal of Economics , 31(4), 2000, pages 674-692, 675; Caselli, S ., Gatti, S., and Perrini, F, "Are IP/C/M/79/Add.1 
 
- 36 - 
 
  evaluated 170 Silicon Valley innovative firms, including firms that were VC-backed and those that 
were not. They concluded that where a firm is engaging in an "inventor strategy" that firm was more likely to receive venture capital, to obtain it more quickly, and to experience significant time reductions in bringing its innovations to market.
13 
239.  Generally, venture capital firms often serve as "specialized financial intermediaries" that 
intensively and expertly scrutinize innovative firms prior to providing capital and monitoring such investments thereafter.
14 Critically, venture capital also plays a vital role in assisting innovative 
companies, including clean tech startups, through the "Valley of Death", where there is a shortage 
of R&D and commercialization funding.15 
240.  Beyond financing, the research shows that venture capital provides additional added value.  
In their extensive review of 98 countries from 200-2011, Safari, Cumming and Cozzarin, identify a 
lengthy list of contributions made by venture intermediaries to innovative firms.   
241.  These important contributions include: board Membership and firm leadership; strategic 
business plan involvement; organizational and design assistance; internal process execution and 
improvement; internationalization advice; and the list goes on.16 
IPR is Critical Factor in Innovation Financing 
 
242.  There is also growing research with respect to the positive impact of venture capital and the 
protection and diffusion of the innovation with intellectual property rights. Kortum and Lerner, for instance, survey 20 US industries over 30 year s, and find that venture capital activities 
significantly increase patenting rates.
17 They also show that VC firms do not only promote patent 
protection, but other forms of IP as well, including trade secrets, as ways to protect important 
intangible assets.18 
243.  If, as the literature demonstrates, financing is critical to innovation, then IPR is critical to 
financing. IP is an important asset and value driver; and widely regarded as the sixth asset class 
after cash, real estate, stock, fixed income and private equity. Beyond sale and licensing, IP can 
also serve as collateral and can be securitized.19 IP, from patents to trade secrets, copyright to 
trademarks, provides a basis for investors to risk their resources.20 
244.  Regarding collateralization, according to one commentator, "higher [IP] asset values may 
also help in negotiations with a company's bank and facilitates access to credit, or help to negotiate cheaper interest rates on credit".
21 Where IP is pledged, the size of the collateral pool 
grows in value and the possibility of a success ful loan increases. In fact, Thomas Edison 
collateralized his patent on the incandescent electric light bulb to obtain financing for his startup – General Electric. 
                                                                                                                                               
Venture a Catalyst for Innovation or Do they Simply Exploit It?", European Financial Management Journal , 
5(1), 2009; Hirukawa, M., and Ueda , M., "Venture Capital and I nnovation: Which is First?", Pacific Economic 
Review , 16(4), 421-465; and Hall, B. and Lerner, J., "The Financing of Innovation", National Bureau of 
Economic Research , Working Paper, 2009, page 35. 
13 Hellman, T., and Puri, M., "The Interaction Between Product Market and Financing Strategy: The Role 
of Venture Capital", Review of Financing Studies , 13, 2000, pages 959-984. 
14 Hall, B. and Lerner, J., "The Financing of Innovation", National Bureau of  Economic Research , Working 
Paper, 2009, page 26. 
15 Cumming, D., Henriques,  Irene, and Sadorsky, P., "'Cleantech' Venture Capital Around the World", 
Draft Paper, September 21, 2004, page 23. 
16 Safari, A., Cumming, D., and Cozzarin, B., "Venture  Capital and Innovation around the World", pages 
7, available at:http://www.law.northwestern.edu/research-faculty/searlecenter/events/entrepreneur/documen ts/Safari_Venture_Capita l_and_Innovation.pdf 
17 See Kortum, S., and Lerner, J., "Assessing the Co ntribution of Venture Capital to Innovation", The 
RAND Journal of Economics , 31(4), 2000, pages 674-692, 675; and Safari, A., Cumming, D., and Cozzarin, B., 
"Venture Capital and Innovation around the World", pages 29, available at:http://www.law.northwestern.edu/research-faculty/searlecenter/events/entrepreneur/documen ts/Safari_Venture_Capita l_and_Innovation.pdf 
18 See Kortum, S., and Lerner, J., "Assessing the Co ntribution of Venture Capital to Innovation", The 
RAND Journal of Economics , 31(4), 2000, pages 674-692, 675; 
19 WIPO, "Intellectual Property Financing; An Introduction", WIPO Magazine , 2008. 
20 Cardullo, M., "Intellectual Property: The Basis for Venture Capital Investments", WIPO,  
21 WIPO, "Intellectual Property Financing; An Introduction", WIPO Magazine , 2008. IP/C/M/79/Add.1 
 
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  245.  Turning to securitization, IP is an amenable asset because it can have great value and has 
the potential to generate stable cash flows.22 For example, David Bowie as well as Ashford and 
Simpson respectively issued copyright-backed bonds.  Other forms of IP, including patents, are also 
securitized.23   
Governments, Innovation Financing and IP 
 246.  Finally, governments can play an important an d positive role in the financing of innovation.
24 
In some countries, for some sectors, public venture capital can be prevalent.  Beyond direct 
financing, studies show that governance indicators are positively correlated with innovation financing.   
247.  For example, Cummings, Henriques, and Sadorsky, conclude that factors such as 
government effectiveness, regulatory quality, accountability, and rule of law have a positive and 
significant impact on clean tech venture capital activity. Likewise, increased contract enforcement, property right policing and effective judicial system s are found to be important determinants of VC 
financing in the clean tech sector.
25 
248.  In short, financing increases where risk diminishes. While not the only driver of financing, IP 
can play a powerful role in attracting critical  investment. Likewise, increased respect for IP, 
through protection and enforcement, can in turn, increase access to financing, while lowering the 
cost of such investment, particularly for capital-intensive innovative startups.26 
249.  To conclude, IP, Innovation and Finance form a virtuous triangle. Each begets the other, and 
governments can play a critical role in facilitating the necessary incentives to allow them to 
increase economic prosperity and development. 
10.2  Switzerland   
 
250.  My delegation is pleased to co-sponsor this  agenda item together with the Delegations of 
Singapore, the US and the EU. In previous TRIPS Council meetings we have looked at a number of 
factors which matter in a countries innovation landscape  
251.  Today, we propose to look at the important ro le that intellectual property plays in attracting 
capital to stimulate innovation. And yes, what is true for so many areas, is also true for the field of innovation: money makes the world go round! (Whether one likes it or not) In this particular case, financing helps to lubricate the various stages of the innovation cycle:  
1 - Allowing an ingenious idea to be developed into an invention  
2 - Making an innovative product out of this invention  3 - Bringing the innovative product to the market and make it a financial success  
4 - Remunerating both the inventor and the investor for their efforts  
5 - Allowing the financial reward to be invested in new inventive activity, thereby concluding – 
and restarting – the innovation cycle.  
 
252.  At a panel event over lunchtime we heard so me fascinating insights by experts who showed 
u s  t h a t  I P  c a n  b e  h i g h l y  r e l e v a n t  f o r  a n  i n v e s t o r ' s  d e c i s i o n  t o  s u p p o r t  t h e  d e v e l o p m e n t  o f  innovative products and services. The necessary funding can be decisive particularly for an 
innovation to take the final hurdle of enteri ng the market successfully. The presentations 
demonstrated that IP can mean capital. Or in other words, as the WIPO summarises well on its website: IP turns intangible assets into property rights; it enables to claim ownership over the 
intangible assets and exploit them. As a result, IP assets of an enterprise regularly are worth more 
than its physical assets. The value of some of the international brands is estimated in value in the billions. To take a Swiss example, the brand Nescafé  was estimated to be worth US$11 billion in 
                                               
22 Clarke, A., and Guedj, I., "Is Intellectual Property Amendable to Securitization", Law360 , May 23, 
2014. 
23 WIPO, "Intellectual Property Financing; An Introduction", WIPO Magazine , 2008. 
24 See Jeng, L., and Wells, P., "The Determinants of Venture Funding: Evidence Across Countries", 
Journal of Corporate Finance , 6, 2000, 241-289;  
25 Cumming, D., Henriques,  Irene, and Sadorsky, P., "'Cleantech' Venture Capital Around the World", 
Draft Paper, September 21, 2004, page 21-22. 
26 Cardullo, M., "Intellectual Property: The Basis for Venture Capital Investments", WIPO. IP/C/M/79/Add.1 
 
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  2014. Let me emphasize, in this context, the myriad  of SMEs in Switzerland that make active use 
of IP for their economic development.  
253.  An example of such a small start-up company is the Zurich-based "Doodle", an Internet 
calendar tool for time management and arranging meeting dates. The tool was developed in 2003 
by a Swiss software engineer who was looking for an  easy solution to arrange a meeting date for a 
dinner with a number of friends. In 2007, Doodle was registered as a trademark and thereafter several investors engaged with substantial investments. Today, Doodle is one of the world's most 
successful online meeting date arrangement tools, available in 17 languages.  
254.  So, why does capital like intellectual property ? Intellectual property rights constitute a first 
available guarantee and value that the investor can calculate in. Intellectual property allows innovators to approach investors in a position of power, knowing that they have a substantive case 
that the investor is able to calculate with. They have a protected asset which can be included in a 
business plan. 
255.  It is not only for the bigger venture capitalists that IP matters for their investment decisions, 
but it represents an incentive to invest also for private individuals who consider investing their own 
money in a start-up, and have a particular interest in looking for securing the return on their investment. This may even apply to the recently become fashionable crowd-funding via internet-
based platforms.  
Case study: Innovative Medicine fo r the Tuberculosis Foundation - iM4TB 
 256.  We would like to take up the case of a project discussed at the panel over lunchtime. The 
project spearheaded by the Swiss Federal Institut e of Technology in Lausanne, EPFL.project is 
about fighting new forms of tuberculosis, The project is called - Innovative Medicine for Tuberculosis (or in short: iM4TB TB). 
257.  There are several forms of drug-resistant tuberculosis bacteria which have changed over 
time so that they can no longer be killed by th e two best known antibiotics, isoniazid and rifampin. 
Usually, these antibiotics would be used to cure tuberculosis. The main reason for the bacteria to 
change and adapt is inconsistent use of TB antibiotics. One of the forms of drug-resistant 
tuberculosis is the so-called Multi-Drug Resistant Tuberculosis (MDR TB). Studies have shown that in 2013 more than half of the global burden of MD R TB cases was carried by the three countries of 
China, India and the Russian Federation. 
258.  The EPFL's iM4TB Foundation, founded in March 2014, is working on the development of a 
new antibiotic, carrying the name of PBTZ169, which is designed to kill drug resistant TB bacteria 
in a - compared to conventional therapies - shortened therapy. The medicine works by destroying 
the bacterium's cell wall that shields it against the immune system and antibiotics.  
259.  A US patent filed in 2011 was granted in 2014; further patent applications are pending at the 
European and at the Eurasian Patent Organisations, as well as in China, and the foundation is 
considering filing further patent applications. 
260.  In its search for a powerful new drug that would substantially diminish the risk of failure of a 
TB treatment, the EPFL was able to enter in to a collaboration with Nearmedic, a Russian 
pharmaceutical, biotechnology and medical company. The cooperation was preceded by 
negotiations and an audit into the strength of the patent application filed. The terms and 
conditions transferred IP rights to Nearmedic for countries covered by the Eurasian Patent Organisation, and thereby allowed the EPFL to obta in, via the venture capital paid by Nearmedic, 
its return on investment. Apart from the financial aspect, the main terms between the parties 
stipulated a co-sharing of the drug's test results and exchange of experience in order to facilitate the further development and distribution of iM4TB in other countries. 
261.  It was thanks to iM4TB Foundation's patent portfolio and the data generated that the project 
could be developed to the advanced stage at which it has arrived today. The intellectual property, in conjunction with quality results of the resear ch and development, triggered the interest of 
companies to further invest in the project. Eventually, those were also the major factors for IP/C/M/79/Add.1 
 
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  Nearmedic's decision to embark upon cooperation and participate in the development of that new 
treatment of tuberculosis. 
262.  Testing of the compound is in the pre-clin ical phase and studies have shown PBTZ169 to be 
effective and quicker than the current TB drugs recommended by the World Health Organization. 
According to the pre-clinical studies, the chemical  structure of the new compound and high specific 
activity provides a significantly higher safety prof ile than existing drugs which are associated with 
toxicity problems. The low toxicity of the new substance is essential for patients, taking into 
account the long duration of TB treatment. 
263.  This case study and other examples of projects mentioned in the lunch panel today show 
how innovators are able to turn their ideas into real inventions with the support of funding received from investors. In many of these cases, securing IPRs will be a key consideration for such 
investors to whether or not to engage in a start-up.  
10.3  Singapore   
 
264.  Thank you for the opportunity to share Singapore's perspective on the positive impact that 
our intellectual property (IP) regime has had on  our national innovation efforts. For knowledge-
based economies like Singapore, IP is a key driv er of business performance and economic growth. 
With a credible IP regime in place, businesses have the peace of mind to develop innovative 
technologies and ideas, as they know that their IP rights will be protected.  
What Singapore has done in the realm of IP to help businesses and build a conducive environment 
for innovation  
 
265.  In Singapore, we have focused our effort s on building a conducive IP environment to 
facilitate innovation. Businesses are able to acquire a range of IP rights such as patents, 
trademarks and registered designs
27 to protect their products. We have tried to make the IP 
protection process as smooth and efficient as possible. For instance, businesses can make filings online through an integrated system called IP
2SG, which is a one-stop portal that facilitates patent, 
trademark and design related transactions and searches. Soon, businesses and innovators will also 
be able to tap on the quality search services and patent analytics offered by our multilingual patent search and examination team. Singapore was appointed as a WIPO Patent and Cooperation Treaty International Search Authority/International Preliminary Examining Authority last year, and 
we expect to be fully operational by September. Given the small size of our domestic market, we 
have also established international patent work -sharing arrangements to facilitate Singapore-
based companies' expansion to other markets.  
266.  One good example is the ASEAN Patent Examination Cooperation (ASPEC), which is a 
regional arrangement among 9 ASEAN Member states for sharing search and examination results between IP offices. Under ASPEC, companies are able to fast-track patent applications in the 
ASEAN region using an initial examination report from any Member country's patent office. A 
patent application that used to take more than five years in some countries to process can now be completed in under two years. The establishment of such regional IP infrastructure plays an 
important role in supporting and spurring innovation efforts throughout ASEAN, as new products 
and services flow through the region.  
Public-Private Partnership 
 
267.  We also have public-private partnerships in place to spur IP and innovation. For example, 
our Agency for Science, Technology and Rese arch (A*STAR), encourages small and medium 
enterprises to leverage on emerging technologies, participate in research and development, and 
create their own novel products and solutions. Our two public universities have programmes to link 
their research with the relevant industries as well.  
268.  The Singapore government has also established an agency known as the IP Intermediary, 
which works with companies to market their technologies to overseas partners. IP Intermediary 
                                               
27 These are just a few examples – the whole range of IP covered in Singapore include patents, 
trademarks, copyright, registered desi gns, geographical indications, plant varieties protection, trade secrets 
and layout-design of integrated circuits.  IP/C/M/79/Add.1 
 
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  also helps companies search for the best available innovation tools and partners to boost business 
growth.  
Case study – Razer 
 
269.  Razer, an entertainment devices and software company, is one of numerous businesses in 
Singapore that have used IP protection to propel their growth. Razer has grown from its early days as a gaming peripherals start-up to become an established company selling computer peripherals, 
laptops, wearables and software platforms in over 60 markets around the world. 
270.  Razer's products are protected by a range of IP rights, including patents, registered designs, 
trademarks, trade secrets and copyrights. To supp lement their in-house engineering and design 
work, they have put in place formal innovation proc esses and strategies for filing and enforcement.  
In this way, Razer has been able to use IP protection as a tool for marketing its products and 
defending its share in major consumer markets. 
Outcomes  
 
271.  We have tried to create a virtuous cycle, where R&D is followed through by patenting activity to protect innovations. These efforts have borne some fruit. Between 2003 and 2013, there was a 
7.3% year-on-year growth rate for the total number of patents first granted as a result of R&D in 
Singapore
28. 
272.  Singapore was ranked as the leading economy in Asia in the 2014 Global Innovation Index 
and the top Asia-Pacific economy in the World Economic Forum's Global Competitiveness Report 
for 2014-2015.  
Conclusion 
 
273.  These are some of the steps that Singapore has taken to boost IP and innovation. We are 
continually strengthening our IP regime, and refining the support programmes so that the best possible environment can be in place to spur innovation and growth.  
274.  We hope that our sharing today has been useful, and we look forward to further discussions 
at the TRIPS Council on how Members, particularly developing countries, can successfully develop innovative economies by boosting their IP regimes. 
10.4  European Union   
 
275.  It is our pleasure to participate once more in this series of debates on intellectual property 
and innovation and to co-sponsor it. Today I will present out of the wealth of studies and papers 
and work that has been done in financing by the European Union in this area, mainly two studies. 
You will see that these studies address a lot of the issues that were discussed during the lunchtime presentation except that they will not be illustrated by comics, so the presentation may be a little 
more boring but we hope it will still have interesting content, and it will only highlight a couple of 
points. I will provide the links to these studies.  We also did not manage to squeeze in any 
examples with David Bowie, but that is us Eurocr ats. But these are valuable studies that give a 
very extensive detailed and precise picture of the role of intellectual property in financing 
innovation in Europe. 
 
276.  Intellectual property rights play an increa singly important role in corporate strategy. The 
intangible assets created through the processes of  innovation represent a major share of the value 
of today's businesses. The IP rights associated with those assets are the legal underpinning for potential returns on investment in that innovation. 
                                               
28 Source:  A*STAR's 2013 National Survey of Research & Development in Singapore 
 IP/C/M/79/Add.1 
 
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  European Expert Group on Intellectual Property Valuation 
 277.  The European Expert Group on Inte llectual Property Valuation assessed the 
commercialisation of innovative ideas, with the value of the IP asset acting as collateral. They 
looked especially at small and medium-sized enterpri ses. They found the role of IP in the financing 
process is often an indirect one. IP plays a support ing part in the bigger picture for the provision of 
loans and equity investments. In the regular bankin g, venture capital or private equity sectors IP 
is generally evaluated but not formally valued. 
278.  Equity investors typically invest into companies as a unit, but not into IP assets as such. In 
return for their investment investors receive an equity stake of a company which owns IP and intends to exploit the IP. Therefore, investors using this model are indirectly financing based on IP. 
The equity finance community considers the importance of IP when financing companies, but the 
actual value of IP assets per se is rarely considered important.  
279.  However, low quality IP can be a deal breaker for investors. An IP audit is considered by 
some Venture Capitalists as an important tool to assist the investment process by signalling the 
quality of the IP in possession of the investee. IPR may especially be of interest to a Venture Capitalist at exit if the buyer is a company. Investors may consider formal IP valuation to be 
fruitless in the case of SMEs as validity can be challenged when companies are still nascent and 
small companies find it difficult fina ncially to defend their position.  
280.  The Expert Group notes that an issue that in fluences a company's decision to protect its IP, 
especially in the case of SMEs, is to what extent  such rights are enforceable, the time and costs 
involved in litigation, and the foreseeable economic  results. The quality of the enforcement system 
has an important impact in IP protection. SMEs, and large companies, need to be assured an accessible justice system for infringement, validity and other cases. 
281.  Large investment banks and private equity firms alike have raised and invested funds 
targeted at IP and other intangible assets. Rather than looking for entrepreneurs and start-up companies, these firms are looking to invest in IP and IA for development and commercialization 
purposes. These enterprises work with companies to  either buy the IP/IA or invest in the company 
for commercialization of the IP/IA. 
PATLICE Survey 
 
282.  The PATLICE Survey enquired about European  firms patent licensing activities and found 
financial use is very important for SMEs. It looked at out-licensing and other use. The most important motive for SMEs to out-license is revenue-generating, especially from newly developed, 
core technologies. SMEs are also looking to earn revenue from non-core or mature technologies 
and to use out-licensing as an enabler for 'joint R&D and innovation'. Large firms out-license more to ensure Freedom-to-Operate and stop infringement. 
283.  In the pharma sector both SMEs and larg e firms are particularly motivated by earning 
revenue from core/newly developed technology. Patents are a currency for doing business with 
other firms and licensing is hence more commonplace. The health care sector puts also more emphasis on the motive to enable joint R&D and innovation. 
284.  The importance of licensing has increased over the years. Most firms report an increasing 
number of licensing deals and increasing licensing revenues over time. Out-licensing agreements usually cover more than just the patents and are more technology licensing. Growth in the number 
of licensing deals can be observed across all industries. Hence, the growing significance of 
licensing is not due to sectorial effects.  
285.  The most important other use of patents for all firms is to negotiate R&D collaboration 
agreements. There is a significant difference in the use of patents to obtain funding and finance by 
small and medium-sized enterprises and start-ups co mpared with larger firms. All types of finance 
uses are much more important for SMEs than for large firms. SMEs particularly use patents more for raising capital through private investors and venture capital and private equity.  IP/C/M/79/Add.1 
 
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  10.5  India   
 286.  My delegation would like to thank the delegations of the United States, Switzerland, the European Union and Singapore for tabling an agenda item on "Intellectual Property and 
Innovation: The Role of Intellectual Property in Financing Innovation". 
287.  Let me just recall our intervention when  the agenda item on Intellectual Property and 
Innovation was first introduced in the TRIPS Council. Our statement is still relevant when we are 
discussing 'the Role of Intellectual Property in Financing Innovation' under the broad theme of 
Intellectual Property and Innovation. In that meet ing India pointed out that the word "innovation" 
appeared just once in the TRIPS Agreement, in Ar ticle 7, which states that Intellectual Property 
Rights (IPRs) "should contribute to the promotion of technological innovation and to the transfer 
and dissemination of technology," and not for the sake of innovation itself, but "to the mutual 
advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of righ ts and obligations." Thus the TRIPS Agreement 
makes it very clear that the purpose of the Intellectual Property system is not solely to protect the 
commercial interests of the Intellectual Property holder but it is one of the many tools available to society to achieve technological development, social and economic welfare and innovation.  
288.  According to Petra Moser, faculty at Stanford University, U.S.A.:
29 
"Overall, the weight of the existing historical evidence suggests that patent policies, which 
grant strong intellectual property rights to early generations of inventors, may discourage innovation. On the contrary, policies that encourage the diffusion of ideas and modify 
patent laws to facilitate entry and encourage competition may be an effective mechanism 
to encourage innovation."  
289.  Innovation should not be viewed within th e narrow prism of intellectual property monopolies 
but framed within a holistic, knowledge ecosystem that includes open innovation, open knowledge 
approaches and de-linkage of R&D costs from product prices. According to the Trilateral Study by 
WTO, WHO and WIPO on "Promoting Access to Medi cal Technologies and Innovation: Intersections 
between public health, intellectual property and trade (2013)"(Page 126),   
"Patent law is not a stand-alone innovation system. It is only one element of the 
innovation process, and one which can be deployed differently in diverse innovation 
scenarios. Patent law has little bearing on many other factors that lead to the successful 
development of technologies, e.g. the nature and extent of demand, commercial advantages gained by marketing and ancillary services and support, commercial and 
technical viability of production processes, and compliance with regulatory requirements, 
including through effective management of clinical trials data." 
 
290.  The trilateral study also highlights that i nnovation in medical technologies for neglected 
diseases suffers from market failure as conventional IP-based incentives do not correspond with the nature of demand for treatments of these dise ases. To overcome the market failure of the IP 
system for neglected diseases, the trilateral study mentions open innovation structures such as the 
Open Source Drug Discovery (OSDD) model of India's Council of Scientific and Industrial Research 
(CSIR), and collaborative research such as WIPO Re:Search - Sharing Innovation in the Fight against Neglected Tropical Diseases. The study also talks about the concept of delinking price of 
the final product from the costs of R&D by 'push' mechanisms such as grant funding and tax 
credits for investment in R&D and by 'pull' mechanisms that offer rewards for the final outcome of R&D of certain products like milestone or end prizes. The trilateral study also talks about the 
emergence of Product Development Partnerships (PDPs), which are constituted usually with the 
involvement of non-profit organizations, foundations and industry, to focus R & D towards diseases that disproportionally affect low- and middle-in c o m e  c o u n t r i e s  ( L M I C s ) .  E x a m p l e s  o f  P r o d u c t  
Development Partnerships are Medicines for Malaria Venture (MMV), the international AIDS 
Vaccine Initiative (IAVI), the Aeras Global TB Vaccine Foundation, etc., 
291.  The World Health Organisation (WHO) at the recently concluded 68
th World Health Assembly 
(WHA) has adopted the ' Global Action Plan on antimicrobial resistance '. The action plan, inter alia, 
                                               
29 "Patents and Innovation: Evid ence from Economic History", Journal of Economic Perspectives, Volume 
27, Number 1—Winter 2013—Pages 23–44 IP/C/M/79/Add.1 
 
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  states that most pharmaceutical companies have stopped research and development of new 
antibiotics and calls it as a "serious market failure" and a "particular cause of concern". The action plan also suggests that "the cost of investment in research and development may need to be de-linked from price and the volume of sales to facilitate equitable and affordable access to new 
medicines, diagnostic tools, vaccines and other results from research and development in all 
countries". The G-7 countries yesterday came out in full support of the WHO Global Action Plan on 
anti-microbial resistance. 
292.  The Report to the President on Combating Antibiotic Resistance in September 2014, which 
was prepared by the United States President's Council of Advisors on Science and Technology (PCAST), while stating that market failure is the reason for the inadequate state of antibiotic development, it also talks about new mechanisms to incentivize the development of antibiotics, 
like 'push mechanisms (federal funding, subsidies etc.)' and 'pull' mechanisms (user licenses, lump 
sum prizes, patent buy-outs etc.).  
293.  India declared the decade of 2011-2020 as the Decade of Innovation. The spirit of innovation 
has to permeate all sectors of economy from universities, business and government to people at 
all levels. The future prosperity of India in th e new knowledge economy would increasingly depend 
on its ability to generate new ideas, processes and solutions, and the process of innovation would 
convert knowledge into social good and economic wealth.  
294.  With regard to financing of innovation in India, there are many ways, but due to paucity of 
time, I would limit myself to few initiatives of the Government and private sector in India. CSIR-Tech Private Limited works with laboratories across India to commercialize their technologies and 
intellectual property; Grassroots Technological Innovations Acquisition Fund (GTIAF),  which is 
operated by the National Innovation Foundation of India,  is to obtain the rights of technologies 
from grass root innovators after compensating them for the same with the purpose to 
disseminate/diffuse them at low cost or no cost for the larger benefit of the society. Global 
Innovation and Technology Alliance (GITA), promot ed jointly by Confederation of Indian Industry 
(CII) and Department of Science & Technology, Government of India, inter alia, has a mandate of 
professional management of Government Fund for the industry through flexible modes of funding 
support like grant, loan and equity. Some private sector initiatives that invest mainly in technology-led innovations include India Innovation Fund, a venture capital fund promoted by National Association of Software and Services Companies (NASSCOM) and IKP Knowledge Park, 
and Tata Capital Innovation Fund.  
295.  I would like to conclude by requesting the WTO to organize a symposium on "New Business 
Models for Fostering Innovation and Access: Innovation Inducement Prizes and Open Source 
Development Models."  This could be organized by the WTO along with the WHO and the WIPO as 
part of their trilateral cooperation on intellectual property and public health. 
10.6  Bangladesh, on behalf of the LDC Group   
 
296.  I am taking the floor on behalf of the LDC Group. We thank the proponents US, Switzerland, EU and Singapore for presenting this item for discussion and sharing their ideas to increase resources for innovation. We agree broadly with the general premise of the proposal, but we would 
caution against any one-size fits all approach, as  the situation in developed and technologically 
advanced resource rich countries and the situation in LDCs are completely different. For example, availability of venture capital in LDCs and availability of venture capital in developed countries will 
be completely different unless the developed countries decide to provide to the LDCs. Since they 
have lots of priorities and very little resources and facilities, they do not have adequate allocation for any venture or adventure. We all know that in novation plays a vital role in the development of 
the socio economic scenario and the living standard of the people and we agree with the 
proponents on this premise and proposal.  
297.  However international standards and long-sta nding terms of intellectual property law do not 
always foster innovation everywhere in today's technologically advanced and interconnected world 
and they did not also play a similar role in the past. We consider that a strict intellectual property 
regime is not an essential prerequisite to promote innovation and technological diffusion when we examine and analyze the past history of deve lopment of the present developed countries. 
Intellectual property regimes and innovation propels the world to move further to a higher level of 
development, but unfortunately according to our experience, not all the countries of the world IP/C/M/79/Add.1 
 
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  benefited from intellectual property and innovation  in the same way. Less than expected growth, 
the process of globalization, and competition have ra ised the stakes for IP policy to overcome this 
adverse situation for LDCs. LDCs need to have a flexible policy and ambiance for promoting innovation as the promotion of innovation has become a key growth strategy for all nations 
irrespective of the level of deve l o p m e n t .  H o w e v e r ,  a v a i l a b i l i t y  o f  m o n e y  o r  r e s o u r c e s  d o e s  n o t  
necessarily guarantee innovation, as we have seen that great innovations in history actually derived from human genius rather than availability of vast resources. So we feel that there is no 
natural inevitable correlation between IP and financing innovation, rather encouraging and flexible 
rules, regulation and ambiance and availability of proper facilities will largely contribute towards 
innovation and development.  
298.  We again thank the proponents for drawing our attention to a very important issue and we 
hope that all of us will gain from this free discussion on how to increase allocation for innovation 
without depleting scant resources that we have at our disposal. 
10.7  Chile   
 
299.  Firstly, I would like to thank the proponents of this proposal and note that, as demonstrated 
by the presentations given during the lunch break, the use of intellectual property as an intangible 
asset tends to be of great benefit to major enterprises. The development of this idea at national 
level is consistent with Chile's national public agenda for innovation, which seeks to transform our production structure from one that is commodity-based into one that is more diverse and innovation-oriented. 
300.  In order to achieve this, not only do innovators need to be directly empowered, but an 
ecosystem that indirectly promotes and facilitates innovative processes implemented by enterprises also needs to be created. The elemen ts required for the successful development of the 
national innovation system include the use of intell ectual property as collateral for the granting of 
funding to enterprises. 
301.  Intellectual property rights are intangible assets that allow for the ownership and value of 
innovations to be determined. The correct valuation of these assets should enable innovators to 
use them as collateral for funding from financial institutions. 
302.  Nevertheless, in Chile the valuation of inte llectual property rights is not recognized, and 
there is a general lack of trust in the use of IP rights as collateral for such funding. Consequently, 
many entrepreneurs who become established as a result of their efforts and government funding 
for innovation face a financing problem when they want to expand their business. 
303.  This is why the necessary mechanisms should be developed to enable intellectual property 
rights to be assimilated as an additional asset, and not only in the case of large enterprises, but 
also for small- and medium-sized enterprises. This requires the provision of training for accountants, bank employees, entrepreneurs, venture capitalists and other actors in the market to 
enable them to duly consider and value this type of asset, which opens up opportunities and 
effectively contributes to the implementation of the country's innovation plans. 
10.8  Chinese Taipei   
304.  My delegation would first like to join others in thanking the United States, Singapore, 
European Union and Switzerland for adding this important, newly-emerging item to the Agenda, 
and for their introduction to the subject. 
305.  We are very pleased to have the opportunity  of sharing with fellow-Members the experiences 
we have had with our own policies in this area , and of learning from the experiences of other 
countries at the same time. 
306.  We fully identify with the observation made by several Members that corporations are only 
just beginning to tap into the potential of IP, and that recent multi-billion dollar deals on patent 
and trademark portfolios, as well as IP assets-backed financing, have kick-started what looks like being a sustainable trend. This innovative approach  to IP - which could turn into a new pillar of IP/C/M/79/Add.1 
 
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  cooperate finance - is a growing trend that will su rely consolidate and give Members a distinctive 
edge.  
Small- and Medium-sized Enterprise Credit Guarantee Fund  (SMEG)  . 
307.  As you may be aware, the main focus of our policy on local industrial development is to 
assist SMEs - which account for nearly 98% of all local companies - with using intellectual 
properties in their financing arrangements. Being an intangible asset, the actual value of an intellectual property is very difficult to measure, so banks tend to place a relatively higher level of 
risk on loans provided to SMEs using IPs as collateral. Our government, therefore, has set up a 
special organization, the SMEG, (Small- and Medium-sized Enterprise Credit Guarantee Fund), to help SMEs engaged in innovation and R&D to secure loan finance from banks and to facilitate risk diversification for the banks themselves. 
308.  When assessing loan applications from SMEs using IPs as collateral, the SMEG would place 
much more emphasis on evaluating the future business potential and profit outlook for the intellectual property/ies in the market, rather than focusing solely on an estimate of the current 
value of the IP being proposed as loan collateral. In addition to that, the SMEG would carry out 
comprehensive reviews of both the enterprise and its IPs, including assessment of the management teams, future prospects in the industry, its business models and the feasibility of its 
programmes. 
309.  Since the start of 2013 up to April of this year (2015) the SMEG has facilitated the 
completion of 235 cases, resulting in loans to the value of US$3.86 billion in total. 
Government assistance to financial institutions in their evaluation of an intangible asset. 
 
310.  Intellectual properties such as patents, trademarks, copyrights, and other IPRs are intangible assets, and a range of specialist professional skills and expertise are required in the areas of 
industrial know-how, legal compliance, market forecasting, etc. in order to properly assess their 
true and potential value. Our government quickly realized that enhancing the skills and expertise of financial institutions in evaluating IPs would be a vital factor in helping enterprises to secure 
loans from banks. Thus, the Ministry of Economic Affairs and the Financial Supervisory Commission 
(the FSC) have launched a series of relevant training programmes for financial institutions to upgrade their capabilities in the evaluation of intangible assets. 
311.  One of these is our International Certified Valuation Specialist (ICVS) Programme,  and there 
are other training programmes  as well, aimed at enhancing skills and expertise in this area. 
312.  The Ministry of Economic Affairs introduced the ICVS (International Certified Valuation 
Specialist) training programme on intangible asset valuation in 2006, and since then a total of 174 
valuation specialists have been trained, of which 58 have obtained the International Association of 
Consultants, Valuators and Analysts (IACVA) credentials. 
313.  The FSC also launched a plan for financial sectors to support the creative industries from 
January, 2014. The plan consists of a training programme, a fundraising programme, a 
consultation platform and corresponding measures. In this training programme, by the end of April 2015, the FSC had already hosted more than 58 seminars and courses for a total of 3,279people. 
314.  Concerning the fundraising aspect, the FSC has been actively encouraging the generation of 
funds through various channels from bank financin g and insurance funding, to the "Go Incubation 
Board for Start-up and Acceleration Firms". By th e end of April, 2015, the Incubation Board, for 
example, had successfully assisted 13 companies fr om the creative industries in raising funds of 
US$26.71 million and had cooperated with the SMEG in raising the loan-to-value ceiling from 80% 
to 90%. 
315.  As for corresponding measures, the FSC has a programme to encourage local banks to 
provide loans to enterprises in the creative industries with sound risk management practices. By end-April 2015, the outstanding balance of loans to en terprises of the creative industries from local 
banks was NT$285.7 billion. In addition, on 3 Ja nuary 2014, the FSC gave its approval to the IP/C/M/79/Add.1 
 
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  Financial Asset Services Corporation to launch intangible asset valuation services for the creative 
industries. The Financial Asset Services Corporation has already succeeded in establishing a database for 15 different industries, includ ing the film-making and TV programme-making 
industries, as well as the music, advertising and digital content industries. 
316.  Today, there are still some challenges to be  faced. For example, fraudulent and misleading 
valuation reporting, such as overestimating the software turnover and growth rates, leads to 
overpricing. When the investment being considered is in an intangible asset with no active market 
there will always be some difficulty in making a true and fair value assessment. Valuations based 
on the subjective judgement of so-called specialists and valuators are easily doubted as well. For these reasons, we believe we must continue to enhance the knowledge and expertise of our valuation specialists in all types of intangible assets, such as patents, trademarks, copyrights and 
other forms of IPR, as well as improve the quality of the appraisal operations and the credibility of 
appraisal reports. 
317.  I would also like to raise some questions here, if I may, for Members' further discussion and 
reflection. 
 How can patents secure a stable banking infrastructure? 
 How can we convert an asset or a stream of cash flows into marketable securities? 
 How can we achieve win-win situations for both the IP owners and the investors? 
318.  So, as I hope I have shown you, my delegation attaches great importance to this item, as 
we assume all WTO Members do. We very much look forward to hearing about other Members' 
policies and their experiences with various practices and programmes. 
10.9  Korea, Republic of   
 
319.  This delegation thanks the proponents of this important and interesting agenda item. Korea 
also recognizes the importance of innovation in productivity, job creation, new market creation and economic development as a whole. In this regard, Korea adopted a serious of policies to promote 
innovation under the new policy initiative of creative economy which is based on innovative 
science and technology. 
320.  In line with new national agenda, Korea has established a new value chain that extends from 
the inception of an idea to its eventual commercialization in order to protect fledgling invention 
and encourage its commercialization.  
321.  Korea established a financing system in which companies possessing outstanding patents 
technologies can access to bank loan even without other assets for collateral. In the past practices, 
banks usually requested other collaterals in addition to patents. 
322.  When such company applies for loan, the bank  asks one of the Korean Intellectual Property 
Office (KIPO)-designated organizations to estimate the value of outstanding patent and 
technologies. Then the bank provides loan based on  the value estimation. This system allows SMEs 
and start-ups to access to bank loan which is essential to commercialize patents and ideas. 
323.  To make IP-based financing operational, KIPO concluded a MOU with Korea Development 
Bank, Korea Credit Guarantee Fund in 2013 and Industrial Bank of Korea in 2014. These financial 
entities provided 303 companies with US $150.7 million loan during the year 2014.  
324.  KIPO also established the Korea Institute of  Intellectual Property Evaluation & Transaction 
(KIPET) in January 2014 with a view to sophistica te IP valuation system which is an essential 
factor for IP-based financing. And KIPO is making  efforts to make more companies eligible for the 
IP-based financing. 
10.10  Japan  
 
325.  This delegation would like to express its gratitude to the United States, Switzerland, the European Union and Singapore for proposing this interesting agenda item. Japan fully recognizes IP/C/M/79/Add.1 
 
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  the importance of the role of intellectual property in financing innovation. Japan appreciates this 
opportunity to share its experience on how we  have been promoting the use of intellectual 
property to finance innovation. We believe that  our experience is useful for other Members. 
326.  Firstly, since 2014, the Japan Patent Office, or JPO, has been providing an assessment report 
on small and medium-sized companies that utilize intellectual property. This report, which is free 
upon request by any financial institution, assesses how the companies' intellectual properties and technologies contribute to their business. It can help financial institutions make informed decisions 
on whether to issue loans and financing for companies. 
327.  So far 22 institutions used this service. One of them provided funding to a plastics 
manufacturing company to develop beads cushion products, taking advantage of the assessment report made by the JPO. As stated by the financial institution, the objective analysis in the report 
facilitated the evaluation of the company's competit ive edge over others in the same industry from 
different perspectives. It also outlined the growth  potential of the business. Successful cases like 
this will result in an increasing number of financial institutions using this service and vitalizing local 
economies through innovation. 
328.  Another initiative this delegation believes wo rth sharing with other Members is an initiative 
taken by the Ministry of Economy, Trade and In dustry, or METI. Since 2005, the METI has focused 
its attention on the importance of "Intellectual Asset-Based Management" and promoted 
assistance to raise public awareness on it, especially for small-medium enterprises. Under "Intellectual Asset-Based Management," enterprises recognize and value their intellectual properties for generating revenue. The disclosure of such management principle based on 
recognition and valuation of their intellectual properties gives them an advantage when it comes to 
receiving funding. This is because they are able to show financial institutions the appeal of their enhanced credibility and certainty, based on the value of their intellectual properties. The METI 
operates a portal site to provide financial institutions and small-medium enterprises with wide-
ranging information on intellectual asset-based management. The portal site includes different guidelines and manuals the Japanese Government has produced on this subject, as well as reports 
on relevant seminars. This one-stop service also raises awareness on intellectual asset-based 
management. 
329.  As an example, the METI holds an "Intellectual Asset - Based Management Week" every 
year. This initiative is recognized as a valuable opportunity to share best practices and to develop 
cooperative relations among stakeholders from industry, academy and government. 
330.  Finally, this delegation would like to touch upon one case demonstrating the important role 
of intellectual property in financing innovation. A Japanese metal fabrication company, SEKI Press, 
developed a new technology called "Warisaki" in 2011. The technology allowed complex and three 
dimensional-shaped metal products to be manufacture d with higher productivity at lower costs. In 
this field, technologies were generally protected as know-how rather than as patents. However, 
since the company was convinced that the new technology could be a key to their global business 
development, they obtained patents for the technology worldwide. 
331.  With regard to this case, this delegation wo uld like to bring one thing to your attention. The 
Company, SEKI Press, took part in a competition called "business award 2012", organized by a 
local financial institution in order for local companies to obtain financing to further develop their 
technologies and expand their businesses overseas, the objective of which was to encourage local companies to develop new industries and to vitalize the local economy by creating an innovative 
business plan. And the company won the highest award in this competition, because the local 
financial institution gave high recognition not only to SEKI Press' original technology itself but also to the fact that the technology was protected by patents globally. The local financial institution 
group said that it would support commercialization of this new technology. 
332.  In summary, Japan, which attaches great importance to the use of intellectual property in 
financing innovation, is undertaking a number of initiatives to further advance such financing targeted for innovation through the use of intellectual property. Japan continues to develop new 
initiatives in the hope that they can contribute to further promoting innovation and economic 
growth. We would welcome other Members' insightful comments on this issue. IP/C/M/79/Add.1 
 
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  10.11  Brazil   
 333.  We would like to thank the delegations of US, Switzerland, EU and Singapore for proposing 
this discussion item "IP and financing of innovation". Brazil welcomes the discussion. This theme is 
clearly described in the objectives of TRIPS. In article 7, objectives, the legal text states that the 
protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation. The rationale behind this objective is that intellectual property is capable 
of fostering investment through the legal certainty provided by the IP protection. 
334.  Beyond this, it is important to recall that th e mere existence of IP rights, by itself, is not 
sufficient to promote technological innovation. As it was mentioned in one of the presentations in a parallel event held today, "IP is only one part in a package" when we discuss financing innovation. 
In fact, deficient financing for innovation, based only in IP rights, can also generate 
anticompetitive practices or deprive research areas from necessary and sometimes essential resources. Research on basic science and on pharmaceuticals for the treatment of neglected 
diseases are examples of intangibles that cannot be satisfactorily financed through the monopolies 
provided by the IP system. 
335.  In a nutshell, Brazil understands that all elements related to an optimal innovation system 
should be taken into account when building a balanced national innovation system. In the same 
way as Bangladesh, Brazil does not favor interpretations that suggest that "one size fits all" approaches can be applied to national innovation systems.  
336.  As a last remark, we would only like to recall a point that we have made in previous TRIPS 
Council sessions when discussing IP and Innovation: An IP system that provides good quality 
patents is an important element to foster innovation, since it can provide the guarantee to entrepreneurs and their financers that innovative businesses would not be a target of frivolous 
litigation based on low quality patents. 
10.12  Pakistan   
337.  Pakistan wishes to join others in thanking the co-sponsors of the side event on the Role of IP 
in Financing Innovation, indeed an innovative tool for knowledge creation and management. It was 
useful, yet we wish to have a closer look at what we heard today. At the same time due diligence with respect to market failure owing to information asymmetry and moral hazard issues ought to be addressed, especially when it comes to IP along with the unknown externalities because we do 
not exactly know at this point in time. Although financing innovation and technological 
developments are crucial and we deem them to be critical, it raises several cross-cutting legal and public health issues as well. It raises a lot of important things and elements which are difficult to 
address at the moment. I wish in the room we had one personality by the name of Ben Bernanke 
that we remember still today.  
10.13  Canada   
338.  Canada is pleased to take the floor to offer food for thought on the role of IP and financing 
innovation and we wish to thank the co-sponsors for having proposed a discussion of these important issues. Canada believes that these issues are as much about awareness of and accessibility to IP rights by entrepreneurs and small business that may not necessarily realize that 
they are creators and innovators and that their creations and innovations hold value, as they are 
about the importance of those rights themselves. In a way the innovation ecosystem has at its core a sort of positive feedback loop, that is, innovation can lead to the acquisition of IP rights, the 
acquisition of IP rights can lead to new sources of funding through both the sale of products or 
services and the credit opportunities that both the new IP realized value and the related income create and funding allows investment in further innovation, promoting growth and so on. While 
this is admittedly a very simplified outline, Canada believes this process can apply to and benefit 
businesses of all sizes, including micro, small and medium-sized enterprises. It can help launch small business and enhance the competitiveness of existing ones.  
339.  But particularly for enterprises at the smaller end of that scale, this feedback loop can only 
really be positive in Canada's view if three key ingredients are present. Foremost is access to IP 
rights through the provision by governments of easily-accessible affordable, effective and small IP/C/M/79/Add.1 
 
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  business friendly IP services. IP rights nurture and support creative and innovative entrepreneurs 
by providing them with the certainty that they  will be able to protect and monetize their 
investments, enhance value, create jobs and opportunities, attract investment and grow.  
340.  Second is a general awareness of IP itself and of its benefits and value, including an 
appreciation of the monetary and non-monetary value of the intangible assets imbedded in 
creative and innovative products and services. Third is access to credit and finance, including at the smallest scale such as micro finance. Here awareness of the value of IP by lending institutions 
and investors of all sizes can be instrumental in getting even the smallest innovative business off 
the ground and is necessary for leveraging IP assets for financing and growth and ultimately attract inward foreign investment, further expanding the loop.  
341.  Of course, these are complex issues that  are the subject of intensive and widespread 
research. Canada is certainly not pretending to hold any answers, but we thought that we could 
offer a few thoughts for discussions and further reflection. 
10.14  European Union   
342.  Apologies for taking the floor a second time, I would like to say how much we have 
appreciated this discussion today, and we note that other Members of the TRIPS Council are also recognizing the importance of intellectual property for financing innovation. Because we have a 
close relation with one of these Members in the area of research and technological development 
and also because in the European Union we have a new competence in the area of investment, I would like to call attention to an important and interesting document called Investment Op p ortunitie s  in I nd ia- M ake  in I nd ia .  T he  "M ake  in I nd ia" s trate g y aims  to c re ate  a c ond uc ive  
environment for the protection of intellectual property rights of innovators and creators by bringing 
about changes at legislative and policy level. The plan highlights the importance of IP in many 
sectors. It notes one of the main reasons to in vest in Biotechnology is that India adopted the 
product patent regime in 2005.  
343.  On space it notes the Indian Space Research Organization has forged a strong relationship 
with a large number of industrial enterprises to im plement its space projects and that it licensed a 
number of technologies for commercialisation. The Make in India strategy notes that 
Semiconductor Wafer Fabrication (FAB) manufacturing facilities are being set up in India with a total investment of US$10.5 billion. This is only possible with solid IPR rules and enforcement, as the World Semiconductor Council, the body of the world’s leading semiconductor industry 
associations noted at its May 2015 meeting in China. Effective protection of intellectual property is 
crucial to protect semiconductor investments and promote further innovation. 
The plan highlights the Indian film industry is expected to reach US$3.5 billion by 2018, up from 
US$2 billion in 2013 with an increasing number of digital screens and 3D films. The music industry 
is expected to grow to US$284 million by 2018 whereby Mobile Internet and the arrival of 3G is likely to lead to a surge in paid digital downloads. All this would not have been possible without 
good copyright rules and enforcement. 
10.15  Australia   
344.  Australia thanks the cosponsors for bringing this item to the agenda. The Australian 
Government is taking an active interest in the role that intellectual property can play in securing 
finance for businesses seeking to develop, commercialise and market their innovations.  
345.  It is well recognised that access to finance can be made more challenging when the main 
asset of a business is an intangible asset, such as an intellectual property right.   
346.  Traditional models of lending and debt finance are not always suited to such businesses. This 
is because of the difficulties in valuing, securing and liquidating such assets and in understanding the risks involved in successfully commercialising innovating intellectual property. Australia, 
therefore, welcomes the contributions from WTO Me mbers today, which will enrich consideration of 
policy options in this area. IP/C/M/79/Add.1 
 
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  347.  We have been interested to hear about case studies and initiatives that have assisted 
innovative businesses secure finance on the basis of the value held in their intellectual property rights. 
AGENDA ITEM 11: REQUEST FOR AN EXTENSION OF THE TRANSITIONAL PERIOD UNDER 
ARTICLE 66.1 FOR LEAST DEVELOPED COUNTRY MEMBERS WITH RESPECT TO 
PHARMACEUTICAL PRODUCTS AND FOR WAIVERS FROM THE OBLIGATION OF ARTICLES 70.8 AND 70.9 
11.1  Bangladesh, on behalf of the LDC Group   
 348.  I have the honour to raise one issue of extreme importance to the LDC Group under this 
agenda item. You may recall that our Ministers in Doha recognized the gravity of the public health 
problems afflicting many developing and LDCs, especially those resulting from HIV AIDS, 
tuberculosis, malaria and other epidemics. They also felt and agreed that the TRIPS Agreement did not, and should not prevent Members from undertaking measures to protect public health, while 
redirecting their commitment to the TRIPS Agreem ent, they affirmed that the Agreement could 
and should be interpreted and implemented in a manner supportive of WTO Members right to protect public health and in particular to promote access to medicines for all. Accordingly, WTO 
Members adopted the decisions IP/C/25 and WT/L/478 to exempt LDCs from TRIPS obligations in 
respect of pharmaceutical products.  
349.  These decisions are due to expire on 1 January 2016, and considering the gravity of the 
situation of lack of access to medicines and prop er healthcare, LDCs require adequate time to 
reasonably overcome their public health problems. Under the circumstances, we had submitted a 
duly motivated request, in WTO document IP/C/W/605 dated 23 February 2015, for the extension of the transition period for pharmaceutical pr oducts and for a waiver from TRIPS Article 70.8 
and 70.9.  
350.  I seek your approval to invite the delegation of Uganda, our focal point for TRIPS, to present 
a comprehensive picture of the current situation and resulting requirements for the understanding 
of all Members. 
11.2  Uganda, on behalf of the LDC Group   
351.  I make this presentation on behalf of the LDCs Group. During the last Council meeting our 
coordinator Bangladesh submitted a duly motivated request on the extension of the transition 
period under Article 66.1 of the TRIPS Agreement for the LDC Members with respect to 
Pharmaceutical Products and for Waivers from Obligations of Article 70.8 and 70.9 of the TRIPS Agreement. That request is reflected in document IP/C/W/605. Today is the first opportunity for 
the Group to formally present this request.  
352.  It will be recalled that the current pharmaceut ical transition period, which is set to expire on 
1 January 2016 is comprised of two WTO decisions, TRIPS Council Decision, IP/C/25, dated 
1 July 2002, addressing pharmaceutical product patent and data protections; and General Council 
Decision, WT/L/478,  addressing market exclusivity ri ghts under Article 70.9. This 2002-2016 
transition period was specifically without prejudice to the right of LDCs to seek and obtain further extensions. This special pharmaceutical transition period was first agreed upon in Paragraph 7 of 
the Doha Declaration on the TRIPS Agreement and Public Health in recognition of the gravity of 
the public health problems afflicting LDCs and th eir acknowledged right to maximum flexibility to 
take steps to ensure access to medicines for all. 
353.  The classification of LDCs is contingent on a number of key human development indicators 
including levels of poverty, literacy, infant mortality and economic vulnerability. There are currently 48 countries which meet these criteria. 34 of these countries are Members of the WTO. 
Four countries have so far graduated out of this category, namely: Botswana in 1994; Cape Verde, 
in 2007; Maldives in 2011 and Samoa in 2014. To tr y and illustrate our point and put things into 
perspective, we would like to invite the Council on this short trip of numbers.  
354.  The LDC Report of 2014, prepared by UNCTAD, entitled Growth With Structural 
Transformation: A Post-2015 Development Agenda , observed that in 2013, the LDC current IP/C/M/79/Add.1 
 
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  account deficit reached US$40 billion. According to the market access study undertaken by the 
WTO in 2014 , the LDCs share in world merchandise trade in 2013 was at 1.24%, with a staggering 
deficit of US$60.6 billion. Our participation in world services exports was a paltry 0.68%. Investment going to LDCs is not any different. According to the 2013 UNCTAD Investment Report, 
inflows to the LDCs represented only 1.9% of gl obal inflows. According to the 2013 UNIDO Report, 
the share of manufacturing value added for LDCs actually declined from 2% in 1992 to 1% in 
2012.  
355.  That notwithstanding, in 2013 UNCTAD also reported that the population growth is projected 
to double to 1.7 billion by 2050. Many LDCs are now at a critical stage of development whereby population growth is high, and the socio-econ omic challenges are massive. 400 million of our 
people, i.e. 46% of our population , live below the poverty line (US$1.25 a day). They 
disproportionately suffer health  risks associated with poverty such as malnutrition, unsafe water 
and poor sanitation. About 50% of health expenditur e in LDCs is also out of pocket. LDCs are the 
world's most impoverished countries with the weakest technological capacity. 
356.  It was with this in mind that the fram ers of the TRIPS Agreement recognized in its 
preambular  paragraphs, the special needs of the LDC Members in respect of providing maximum 
flexibility in the domestic implementation of laws and regulations in order to enable them to create 
a sound and viable technological base. 
357.  This now brings us to the substance of why we are here. Our request is premised on 
Article 66.1 of the TRIPS Agreement. It states as follows: "In view of the special needs and 
requirements of least-developed country Members, their economic, financial and 
administrative constraints , and their need for flexibility to create a viable technological 
base, such Members shall not be required to apply the provisions of this Agreement, other than 
Articles 3, 4 and 5, for a period of 10 years from the date of application as defined under 
paragraph 1 of Article 65. The Council for TRIPS shall , upon duly motivated request by a least-
developed country Member, accord extensions of this period." [emphasis added] 
358.  As we have highlighted in our request, access to affordable pharmaceutical products is a 
prerequisite, to deal with the numerous public health challenges facing LDCs. LDCs are home to some of the world's most vulnerable people and bear considerable health burdens. They face growing burdens of neglected, infectious, and chronic non-infectious diseases. Because of market 
failure in the patent-based innovation system, diseases that mainly affect poor people in lower 
income countries – so-called neglected diseases, including Ebola – still do not have many treatment options.  
359.  In 2011, some 9.7 million of the 34 million people living with HIV worldwide, lived in LDCs. 
4.6 million were eligible for antiretroviral (ARV ) treatment in accordance with the 2010 World 
Health Organization HIV treatment guidelines, however only 2.5 million were receiving it. 
360.  In 2013, the situation was different. UNAIDS and UNDP observed in their statement of 
support issued on 21 May, that people living with  HIV who are not receiving anti-retroviral therapy 
has reduced from 90% in 2006 due to the effective use of the transition period to scale up access to treatment for HIV and its co-infections by importing or manufacturing lower-cost generic 
medicines. However the treatment gap remains ma ssive. At the end of 2013, 63% of the 10.7m 
people living with HIV in LDCs do not have access to anti-retroviral therapy. 
361.  According to UNAIDS, "there is concern that without extension of the transition period, 
access to antiretroviral therapy and other key medici nes in LDCs will face real  challenges." Further, 
that the situation regarding availability and pricin g of HIV-related medicines will be more complex 
than the situation in 2001 when the Doha Declar ation was adopted….and the progress that has 
been made to improve access to HIV-related medicines in these countries will be reversed." 
362.  LDCs also bear increasing health burden s of Non Communicable Diseases (NCDs) than in 
higher income countries. According to a WHO Status Report of 2010, on non-communicable diseases, in the African Region, a region with many  LDCs, the prevalence of NCDs is rising rapidly 
and is projected to cause almost three-quarters as many deaths as communicable, maternal, 
perinatal, and nutritional diseases by 2020, and to exceed them as the most common causes of death by 2030. In the specific case of cancer, data from low-income countries suggests that IP/C/M/79/Add.1 
 
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  cancer incidence is expected to rise by 82% from 2008 to 2030, whereas in high-income countries 
incidence is expected to rise at a much lower rate of 40%, in part due to widespread access to vaccines and medicines. 
363.  The UN Human Rights Council adopted Resolution A/HRC/23/L.10/Rev.1 of 11 June 2013 on 
access to medicines in the context of the right of everyone to the enjoyment of the highest 
attainable standard of physical and mental health; the 2011 UN Declaration on HIV and AIDS; the WHO Global Action Plan for the Prevention an d Control of NCDs 2013-2020; and the 2012 RIO+20 
United Nations Conference on Sustainable Develo pment have all urged States to promote access 
to medicines for all, including through the use, to  the full, of the provisions of the Agreement on 
Trade-Related Aspects of Intellectual Property Rights which provide flexibility for that purpose. The extension of the transition period, therefore, is critical to enable LDCs to be able to import 
affordable generic medicines as well as to  strengthen local production capacity.  
Bilateral consultations 
 
364.  Upon submission of this request, we engage d the partners in bilateral consultations, both 
developed and developing. The objective was to understand their concerns with the view to explaining our request. A number of issues were ra ised, but we would like to address four of them, 
which seemed common to almost all the meetings we had: (i) what is the relationship between the 
2013 general transition period and the 2002 pharmaceut ical decision; (ii) whether or not LDCs had 
utilized the pharmaceutical transition period affo rded by Paragraph 7 of the Doha Declaration and 
adopted by the TRIPS Council in 2002; (iii) the rationale behind the request for waivers from 
Articles 70.8 and 70.9; and (iv) the question of duration. 
The general transition period vis-a-vis the 2002 pharmaceutical decision 
 
365.  It will be recalled that in 2001, WTO Members agreed to Paragraph 7 of the Doha Declaration 
on TRIPS & Public Health, which accorded LDCs a specific pharmaceutical transition period for 15 years until 2016. In 2002, Paragraph 7 of the Doha Declaration was formally adopted as a 
TRIPS Council decision (IP/C/25). It is important to recall that this specific pharmaceutical 
transition period was granted to supplement the general transition period that continued until 2005. It was adopted in recognition of the gravity and magnitude of public health challenges afflicting LDCs. Clearly it was also recognized that unlike other intellectual property, 
pharmaceutical products, and access to such products, deserve special attention and measures, as 
it is a matter of life and death. It is for this reason, that the duration granted for the pharmaceutical transition period was much longer than the general transition period at the time.  
366.  It is important to stress that the negotiatio ns and the decision of the 2013 general transition 
period, did not give any special consideration to the matter of pharmaceutical products. This is evidenced by the 2013 decision text which states that it is "without prejudice" to the 2002 
pharmaceutical decision and the right of LDCs to seek further extensions. This phrase can only be 
interpreted, in good faith, as the WTO Member s' confirmation that the 2013 general extension 
does not affect or preclude the right of LDCs to request for further extensions of the 2002 pharmaceutical transition period. LDCs consented to the text of the 2013 decision on the basis of 
this understanding. Their position would have been different if any Member had expressed at that 
time the view that LDCs would have no right to such further extensions. 
367.  A specific decision on pharmaceutical products is critical to address the public health needs 
of LDCs. Unlike the 2013 extension, which is general, the 2002 pharmaceutical extension 
specifically mentions that "with respect to pharmaceutical products", LDCs do not have to "IMPLEMENT OR TO APPLY" patents or test data protection or "TO ENFORCE" such "rights". The 
specificity and clarity of Paragraph 7 of the Doha mechanism and the 2002 pharmaceutical decision has provided LDC governments, donors and suppliers, the certainty to confidently supply 
and procure affordable generic medicines. Thus it is without a doubt that a specific pharmaceutical decision is important to enable procurement of affordable generic medicines.  
368.  The 2002 pharmaceutical extension decision does not have any real or perceived 
conditionalities whatsoever. It provides certai nty among policy makers with regard to the 
application of the transition period by LDCs. Given the critical importance of pharmaceutical 
products and the known concerns of the effects of  intellectual property on access to medicines, 
LDCs need an unconditional decision as granted in  2002 that is explicit that there is no obligation IP/C/M/79/Add.1 
 
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  to implement, apply or enforce patents and test data obligations with respect to pharmaceutical 
products.  
369.  For the reasons we have described about the particular health challenges faced by LDC 
populations what the LDC Group is requesting of the TRIPS Council is merely a continuation of the 
Para 7 understanding in Doha. The 2013 decision does not preclude the need for a specific 
extension addressing the issue of pharmaceutical products. 
Whether the 2002 specific pharmaceutical transition period has been valuable to LDCs? 
 
370.  Yes. The 2002 TRIPS Council Decision has been used extensively by LDCs and has been invaluable in assisting LDCs to access affordable pharmaceutical products. According to available information, following the adoption of the 2001 Doha Declaration, more than 20 LDCs have relied 
on Paragraph 7 of the Doha Declaration and the 2002 pharmaceutical decision, for the importation 
of generic medicines. Several LDCs such as Sierra Leone, Djibouti and Zambia relied on the 2002 pharmaceutical decision and issued declarations with regard to non-enforcement of patents for 
certain medicines to facilitate importation, and to speed up the supply of the medicines. In 
addition, inspired by the 2002 pharmaceutical deci sion and with the aim to  improve their health 
situation, several LDCs including Uganda, Rwanda and Burundi have excluded pharmaceutical 
products from the scope of patenting.  
371.  Recently the IDA Foundation, a non-profit provider of generic drugs to LDCs sent a letter to 
our coordinator, the Ambassador of Bangladesh, wh ere they expressed their full support for the 
LDC Group request.  It observed that the pharma ceutical waiver "allows LDCs to authorize the 
importation of generic medication regardless of patent status" and the existence of "the 
pharmaceutical waiver and specifically the provisions of Paragraph 7", gave IDA "the necessary legal protection to be able to supply ARVs on a large scale without fear of patent infringement 
suits". It also stresses that the use of the pharmaceutical waiver is not limited to ARVs but is 
"relevant for both the production and procurement of products increasingly needed in LDCs, such 
as those for the treatment of non-communicable diseases". The IDA Foundation letter illustrates 
that in the absence of a TRIPS Council decision continuing the pharmaceutical extension, suppliers 
of medicines and procurement agencies would be ve ry, very reluctant to supply medicines that are 
patented or whose patent status is unknown  for fear of patent infringement suits. 
372.  Further, UNITAID, which is an organisation that funds projects to improve access to 
medicines for HIV, TB and malaria in 94 countries, including many LDCs, in its statement of 
support for the extension acknowledged the fact that "this exemption has facilitated access to affordable medicines in LDCs, and UNITAID urges WTO Members to unconditionally approve the 
request by the LDCs." 
373.  To that end therefore, it serves to show that Paragraph 7 of the Doha Declaration and the 
2002 pharmaceutical decision have been effective and successful in promoting access to medicines 
and saving lives in LDCs. Civil society organizations from around the world have in their letter 
dated 5 June to WTO Members referred to the Paragraph 7 mechanism as "one of the most successful provisions of the Doha Declaration on TRIPS and Public Health". 
The waiver from Exclusive Marketing Rights (EMR) obligations under Article 70.9 
 
374.  Exclusive Marketing Rights or EMRs in short confer patent-like rights and are another form of monopoly. If LDCs are bound to grant EMRs, the value of a pharmaceutical transition period would 
be very limited, since access to medicines and other pharmaceutical products could be effectively 
blocked for at least five years.  
375.  The transition period would be redundant if its basic objective of enabling access to 
affordable generic medicines is curtailed. Theref ore, following the 2002 pharmaceutical transition 
period, the WTO General Council in 2002 granted a waiver from obligations to grant Exclusive Marketing Rights. If this obligation had not been waived, LDCs would have been required to recognize monopolies of patent applicants for pharmaceutical products for 5 years, delaying the 
introduction of generic medicines and thus limiting  access to affordable medicines. There is need 
to renew this waiver along with the pharmaceutical transition period.  IP/C/M/79/Add.1 
 
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  The waiver from mailbox obligations under Article 70.8 
 376.  The mailbox obligation requires LDCs not recognizing pharmaceutical patents at the time of entry into force of the WTO Agreement to create a system for receiving such patent applications to 
be examined at the end of the transition period . The mailbox obligation should be waived for the 
following reasons:  
377.  The requirement to install patent filing systems implies considerable financial and 
administrative efforts that will place additional burdens on vulnerable LDCs. Further, requiring 
LDCs to install mailbox when they don't even have to grant any patents (under the General extension) does not make sense. The mailbox obliga tion may also have a chilling effect on generic 
producers, who may be deterred from investing in  generic production of pharmaceuticals, which 
could in future be patented. This will have an ad verse effect on the availability of affordable 
generic medicines for LDCs.  
The issue of duration for as long as we are LDCs 
 
378.  It would be remiss if we closed our presentation without tackling the issue of duration. As we highlighted before in our opening paragraphs, the health challenges facing LDCs are massive – 
with communicable and non-communicable diseases. The state of economy remains appalling; 
while poverty levels remain high. 
379.  It would be unconscionable for WTO Members to grant LDCs – the most vulnerable segment 
of countries – a time limited transition period, requiring them to repeatedly seek extensions. A 
time limited transition period creates an uncertain environment  for the producers of affordable 
medicines, procurement agencies, donors as well as LDC governments that rely on the specific pharmaceutical transition period to produce and import affordable medicines. This in turn 
jeopardizes the health situation of the people and communities within LDCs, with especially 
adverse consequences for the scaling up of HIV/AIDS treatment. LDCs cannot deal with increasing communicable and non-communicable disease burden without the assurance of continuous 
availability of generic medicines as long as they remain LDCs. This view has been echoed by the 
Communities Delegation of People living with HI V, in their statement of support issued on 
5 May 2015. In the same vein, in 2012, the Global Commission on HIV and Law recommended that "WTO Members must indefinitely extend the exemption for LDCs from the application of TRIPS 
provisions in the case of pharmaceutical products".  
380.  By granting a renewable transition period, Article 66.1 recognizes that for as long as a 
country remains an LDC, it will face various cons traints, and will need an exemption from TRIPS 
obligations. Previously a time-limited duration was given; yet during this period, the socio-
economic situation in LDCs has worsened and the health needs remain even greater. You have heard the numbers.  
381.  In closing, considering that our health needs persist, and in many ways are growing because 
of the continued threat of infectious, neglected, and non-communicable diseases and other new emerging diseases. As evidenced by our continuing LDC status, we still face unrelenting development and capacity challenges. To address thes e pressing public health needs, to secure the 
ability to progressively realize the right to health, and to ensure our continuing right of access to 
more affordable medicines of assured quality, we the LDCs call upon you and the Council to grant the extension of the transitional period under Ar ticle 66.1 of the TRIPS Agreement for LDCs with 
respect to Pharmaceutical Products, and for waiver s from the obligation of Articles 70.8 and 70.9 
for as long as the Member is an LDC. 
11.3  Lesotho, on behalf of the Africa Group   
382.  I am making this brief intervention on behalf  of the Africa Group. At the outset, the Africa 
Group fully supports the Extension of the LDC Transition Period for Pharmaceutical Products under Article 66.1 of the TRIPS Agreement, and Waivers from the obligations of Article 70.8 and Article 
70.9.  
383.  The challenging circumstances faced by LDCs in  addressing their public health issues cannot 
be overemphasised. LDCs still face developmental challenges that affect their social and economic IP/C/M/79/Add.1 
 
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  development due to high burdens of infectious and non-infectious diseases. Access to affordable 
medicines and vaccines is a necessary basic requirement for LDCs to address the scourge of diseases including HIV/AIDS, tuberculosis, and other pandemics. 
384.  The flexibility under Article 66.1 was given to LDCs in recognition of the special needs and 
requirements, their economic, financial and administrative constraints, as well as their need for 
more time to create a viable technological base. LDCs maximum flexibility to address their special needs and requirements, which include their special needs for access to affordable medicines and 
development of a local pharmaceutical industry remains important for their development to this 
day.  
385.  The Africa Group supports the unconditional  extension of the transitional period under 
Article 66.1 and the Waivers from the obligations of Article 70.8 and Article 70.9. In conclusion, 
the Africa Group aligns itself with the interventi ons made by Bangladesh and Uganda on behalf of 
the LDC Group that the extension should be in place for as long as a Member is an LDC.  
11.4  South Africa   
 
386.  I wish to start by recalling that as far back as 2001 in recognition of the unique circumstances of LDCs in particular, the need to im prove access to public health by bringing life-
saving drugs within reach of those in dire need, the WTO granted LDCs a specific exemption for 
pharmaceutical products in Paragraph 7 of the Do ha Declaration on TRIPS and Public Health which 
was later adopted as a TRIPS Council decision.  
387.  Almost 15 years later the conditions that gave rise to the initial request continue to exist in 
many LDCs. Severe public health challenges conti nue to confront LDCs. As we have seen recently 
in West Africa, such public health challenges persist even after a country graduates from LDC status. We therefore fully support the LDCs request to be granted an unconditional expansion 
linked to graduation or for as long as a country remains an LDC. Article 66.1 of TRIPS states: "the 
Council for TRIPS shall, upon duly motivated request by [an LDC] Member, accord extensions of this period".  
388.  Accordingly we as the TRIPS Council are obliged to approve without conditions the duly 
motivated request that the LDCs submitted. The requ est that the extension of the transition period 
for LDCs to implement TRIPS be so long as they remain an LDC is fully justified under Article 66.1. Thus we request that all WTO Members honour their legal obligation under Article 66.1 and 
unconditionally accord to the LDCs their request that demands, in particular, a TRIPS Council 
decision expanding the transitional period with respect to pharmaceutical products for as long as a M e m b e r  r e m a i n s  a n  L D C  a n d  l a s t l y  a  G e n e r a l  C o u n c i l  d e c i s i o n  g r a n t i n g  a  w a i v e r  t o  L D C s  f r o m  
Article 70.8 and Article 70.9 obligations for as long as a WTO Member remains an LDC. 
11.5  Nepal  
389.  The delegation of Nepal supports the statem ent made by Bangladesh on behalf of LDCs. I 
also appreciate and endorse the statement and presentation made by Uganda on this subject.  
390.  As highlighted by Bangladesh and Uganda, exte nsion of the transitional period for LDCs with 
respect to pharmaceutical products under Article 66.1 is a very important issue for LDCs. As we all know a still significant portion of the population in LDCs lives below the poverty line without having 
access to safe drinking water, nutritious food and primary health care facilities, making them 
highly vulnerable to many communicable and non-communicable diseases. 
391.  In addition, due to low income, these poor people cannot afford the high price for medicines, 
including life-saving drugs, which are under patent and are normally sold at high prices in the 
international market. Access to life saving generi c medicines and other pharmaceutical products at 
an affordable price is a great challenge for many LDCs, but an essential component of the right to 
health and ensuring health services to poor and vulnerable communities. 
392.  Available data and survey reports prepared by different international organizations reveal 
that LDCs bear increasing health burdens of both  infectious and non-infectious diseases and they 
have to increasingly confront several health risks. Indeed, LDCs are disproportionately exposed to IP/C/M/79/Add.1 
 
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  several health risks associated with poverty, malnutrition, unawareness and poor sanitation. A 
report published by WHO in 2010 discloses that ca ncer incidence is expected to rise 82% from 
2008 to 2030 in low income countries compared to 58% in upper-middle and 40% in high-income countries. In the similar way, of the 35 million people living with HIV worldwide in 2013, about 
10.7 million, or almost one-third of these people lived in LDCs. LDCs also lack adequate 
technological base and local pharmaceutical manufacturing capacity to cope with these alarming diseases. 
393.  Considering LDCs' vulnerable condition in the health sector, in 2001, in Doha, WTO Members 
recognized the special needs of LDCs and their need for maximum policy space to address their public health challenges. Thus WTO Members agre ed to Paragraph 7 of the Doha Declaration on 
TRIPS and Public Health which explicitly states that LDCs do not have to implement, apply or 
enforce patents and test data obligations until 1 January 2016 without prejudice to the right to 
seek further extensions. Following the adoption of the Doha Declaration on TRIPS and Public Health, this specific extension on pharmaceutical products was formally granted by the TRIPS 
Council in 2002.  
394.  This specific pharmaceutical extension has been used extensively and successfully by many 
LDCs including Nepal. Several LDCs have authorized the importation of generic antiretroviral 
(ARVs) medicines to treat HIV/AIDS and other diseases relying on this decision. This decision has 
given generic companies as well as suppliers of generic medicines such as the IDA Foundation the 
necessary confidence and legal protection to p r o m p t l y  s u p p l y  t h e  L D C s  w i t h  m u c h  n e e d e d  
affordable medicines. It is without a doubt that the specific pharmaceutical extension has been 
supportive in facilitating access to affordable medicines in LDCs. As this existing pharmaceutical 
extension is going to expire on 1 January 2016, it is of great concern to LDCs. Thus they submitted a duly motivated request to extend the specific pharmaceutical extension for a WTO LDC Member 
until they graduate from the LDC status.  
395.   The LDC Group is requesting a continuation of Paragraph 7 of the Doha Declaration, which 
as mentioned, has been used successfully. Even in 2002, all WTO Members recognized the need to 
complement the General transition period, with a specific pharmaceutical transition period, which 
was more explicit, and for a much longer period, in view of the seriousness of the public health situation in LDCs. The situation today is no different.  
396.  In addition, when the General transition period was negotiated in 2005 and 2013, it was 
agreed that the general transition period was "without prejudice" to the 2002 pharmaceutical 
transition period and the right to request a further extension of this transition period. So arguments that use the General transition peri od to refuse LDCs an extension of the 2002 
pharmaceutical transition period are unjustifiable and cannot be accepted.  
397.  With regard to the duration, we stress that a short time-limited transition requires LDCs to 
repeatedly request extensions. This is extremely burdensome on LDCs that are already resource 
constrained. Besides, a short transition period creates an uncertain and unpredictable environment 
for the producers of affordable medicines, donors as well as LDC Governments. So considering the special needs and circumstances of LDCs, we urge Members to sympathetically consider and grant our request to tie up the extension of the pharmaceutical transition period to the point of LDC 
graduation. This is very much in line with Article 66.1 of the TRIPS Agreement.    
398.  Similarly, we strongly support the idea th at LDCs must be exempted from complying with 
TRIPS Article 70.8 and 70.9, which create an obligation for LDCs to maintain a mail box and 
provide exclusive marketing rights (EMR). Thes e are not only burdensome for LDCs, but also 
oblige LDCs to confer patent-like rights in their territories. Hence, if LDCs are legally bound to grant EMRs, the value of pharmaceutical transition period would be very limited or say 
meaningless. As the flexibility given by the extension decision can be curtailed or constrained by 
these two articles, we strongly argue for waivers to be given to LDCs from complying with these two Articles for as long as a WTO Member remains a LDC.  
399.  I would end by saying that the LDC Group request before the WTO TRIPS Council is an 
extremely modest request, considering the massive challenges LDCs have to face on a daily basis. 
It is seeking to continue with Paragraph 7 of the Doha Declaration on TRIPS and Public Health, a measure that has been successfully used by LDC governments and donors to facilitate access to IP/C/M/79/Add.1 
 
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  affordable medicines in LDCs.  For the LDC population it is a matter of life and death. Clearly a 
positive decision by this Council will go a long way in saving many lives in LDCs.    
11.6 Myanmar   
400.  The delegation of Myanmar fully endorses the statements delivered by Uganda and 
Bangladesh the previous day on behalf of LDCs. 
401.   LDCs have a lot of challenges in confront ing disease and illness due to the socio-economic 
and financial constraints along with lack of adequate technological base and local pharmaceutical 
manufacturing capacity. In this regard, the extensio n of the pharmaceutical transition is extremely 
crucial for the LDCs for being able to access affordable pharmaceutical products and to strengthen local pharmaceutical manufacturing capacity. 
402.  In this regard, we would like to request and urge Members to support the LDC proposal 
which requests an extension of the transitional pe riod (that ends on 1 January 2016) for as long as 
the WTO Member remains an LDC.  
11.7  Barbados, on behalf of the ACP Group   
403.  I make this intervention on behalf of the African Caribbean and Pacific Group. The ACP Group 
supports the request for the extension of the LDC transition period for pharmaceutical products under Article 66.1 of the TRIPS Agreement and for waivers from the obligations of Articles 70.8 
and 70.9. Less developed economies face significan t social and economic challenges brought on 
principally by the very poor and vulnerable communities and this affects their ability to deliver the level and quality of healthcare and support necessary to raise the quality of public health delivery. It is therefore critical that improved access to affordable medicines and vaccines be 
accommodated in order that they can combat infectious and non-infectious diseases.  
404.  For this reason Article 66.1 of the TRIPS Agreement is important for LDCs as it offers more 
time and therefore greater opportunity to address this special and severe health related 
challenges. To the extent that LDCs are able to use the flexibility offered to take advantage of this 
extension, then the quality of public health can be improved as we learnt from the comprehensive presentation yesterday from Uganda on behalf of  the LDCs. The ACP Group therefore fully supports 
the unconditional extension of the transitional period under Article 66.1 of the TRIPS Agreement 
on the terms requested by LDCs and for waivers from obligations of Article 70.8 and 70.9. We urge all WTO Members to support the LDCs request. 
11.8  Cambodia   
405.  Cambodia associates itself with the statem ent made by Bangladesh on behalf of LDCs and 
the presentation made by Uganda, LDC focal poin t on TRIPS. As we all know, LDCs including 
Cambodia face serious challenges as they lack access to medicines and proper health care. Many 
millions of people living with various diseases can therefore not afford to buy medicines for 
treating their diseases and illnesses. 
406.  We have found that most LDCs have been using the 2002 decision to partly tackle those 
challenges. In order to continue fulfilling the needs of LDCs and to overcome the existing 
confrontation as well as to ensure our continuing right of access to affordable medicines, we would like to echo in urging you and all Members for a positive response to the February 2015 LDCs' 
request for an extension of the transitional peri od under Article 66.1 of the TRIPS Agreement for 
LDCs with Respect to Pharmaceutical Products, and for waivers from the obligation of Articles 70.8 
and 70.9 of TRIPS Agreement as long as the WTO Member remains a LDC. 
407.  Finally, an unconditional extension will enable  LDCs to reap economic benefit from the use of 
affordable medicines, which will therefore ensure  the sustainable development in LDCs and help 
many millions of people to release from diseases and poverty. IP/C/M/79/Add.1 
 
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  11.9  Tanzania   
408.  My statement aligns with the statement by th e delegation of Bangladesh as LDC Coordinator, 
and well-elaborated by the focal point, the delega tion of Uganda. We highly value the importance 
of ensuring accessible and affordable medicines to save human lives, especially in a country where 
there are immense challenges of prevalent chronic diseases such as HIV AIDs, hepatitis B and C, 
tropical diseases such as malaria and others. We appreciate the continued global commitment being always exhibited in the United Nations by according health matters with a higher priority. 
We have witnessed this in the Millennium Deve lopment Agenda. It was one of the goals being 
pursued again in the new sustainable development goals to be adopted by the UN in September, where health matters have been included. For this goal to be realised in developing countries, especially LDCs and particularly in my country, affordable medicines and vaccines must be made 
available. Therefore an extension of the waiver  for the WTO TRIPS Agreement on pharmaceuticals 
should be a commitment from all Members of the WTO as we ascribe all together to the global 
agenda. So most of the Members here understand th at LDCs are weak, they lack the right capacity 
to establish a sound and viable technology base in the pharmaceutical sector. In view of this we 
request an extension of the waiver, as well el aborated by Uganda, until an LDC graduates. 
11.10  India   
409.  My delegation would like to thank the delegation of Bangladesh for submitting, on behalf of 
LDC Members, a duly motivated request under article 66.1 of the TRIPS Agreement. We would also like to thank Uganda and other LDC Members for introducing their proposal contained in the document IP/C/W/605 and providing Members very convincing reasons for seeking an extension of 
the transitional period under article 66.1 of the TRIPS Agreement for LDCs with respect to 
pharmaceutical products and for waivers from th e obligations of Articles 70.8 and 70.9 of the 
TRIPS Agreement. 
410.  In 2001, recognizing the special circumstances of LDCs, WTO Members granted LDCs a 
specific exemption for pharmaceutical products in paragraph 7 of the Doha Declaration on TRIPS and Public Health, which was later adopted as a TRIPS Council Decision contained in document 
IP/C/25 dated 27
th June 2002. This decision exempted LDCs from having to implement the 
provisions of the TRIPS Agreement relating to the protection of pharmaceutical patents and clinical data until 1 January 2016 in order to enable their access to low-cost generic medicines given the high prevalence of both communicable and non-communicable diseases in LDCs like HIV/AIDS, 
malaria, cancer etc. The General Council also granted a waiver (WT/L/478 dated 12 July 2002) to 
LDCs from their obligation under Article 70.9 of the TRIPS Agreement to grant exclusive marketing 
rights (EMRs). 
411.  The 2002 TRIPS Council decision (WT/C/25) supplemented by the General Council waiver 
(WT/L/478) has facilitated access to affordable medicine s in LDCs. However, LD Cs continue to bear 
high burdens of infectious and non-infectious diseases and face numerous challenges in 
confronting disease and illness.  
412.  In June 2013, WTO Members agreed to extend the transition period for LDCs to implement 
the overall TRIPS Agreement until July 2021. We wo uld like to recall statement made by India at 
the TRIPS Council meeting held in June 2013. While joining the consensus to extend the transition 
period until July 2021, we said in the June 2013 meeting of the TRIPS Council that we have 
consistently supported the LDCs' request for an extension of the transition period under Article 66.1 of the TRIPS Agreement without any co nditionalities and we hoped that any future 
request by the LDCs for extending the transition pe riod for pharmaceuticals, which will expire in 
2016, would be looked at in a positive manner wi thout any conditionalities being imposed on them. 
The statement made by India in June 2013 is still relevant today. 
413.  We would like to reiterate that Article 66.1 of the TRIPS Agreement which states "the Council 
for TRIPS shall, upon duly motivated request by a least-developed country Member, accord extensions of this period." We are of the view th at the language used in Article 66.1 is mandatory 
in nature, in that it does not give the TRIPS Council any discretion to deny a request for extension 
of the transition period or to impo se any further conditions on LDCs.  IP/C/M/79/Add.1 
 
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  414.  Since July 2002, the two transition periods- one general and one specific to pharmaceutical 
p r o d u c t s  -  a r e  i n  f o r c e .  W e  a r e  o f  t h e  v i e w  t h a t  a  s p e c i f i c  d e c i s i o n  o n  p h a r m a c e u t i c a l  p r o d u c t  transition period is absolutely critical to provide suppliers, procurers and donors of affordable medicines in LDCs the clarity and certainty to manufacture, export and import generic medicines. 
In addition, the LDCs request for waivers from Articles 70.8 (mailbox obligation) and 70.9 
(exclusive marketing rights) are fully warranted as these obligations create further obstacles to access to affordable pharmace utical products to LDCs.  
415.  Importantly, according to the June 2013 decision, the general extension was "without 
prejudice to the Council Decision of 2002" on th e extension of the LDC transition period for 
"certain obligations with respect to pharmaceutical products" that expires in 2016 and to the right of LDCs to seek further extensions of the period provided for in para. 1 of Article 66 of the TRIPS 
Agreement. 
416.  I conclude by reiterating India's support for the proposal of the LDCs contained in document 
IP/C/W/605 and request all Members to support the above proposal without any conditionalities.   
11.11  Norway   
417.  Norway would like to thank the LDCs for their submission, and for explaining it in more detail 
yesterday. Norway recognizes the gravity of th e public health challenges faced by the LDCs. 
Indeed, the representative of Uganda yesterday pain ted a stark and troubling, yet realistic, picture 
of the situation on the ground in the LDCs. In our view, the TRIPS Agreement should not prevent 
Members, and particularly those in dire need like many of the LDCs, from taking measures to protect public health. In this regard, access to affordable medicines is particularly important.  
418.  Norway acknowledges the relationship between the protection of patent rights and pricing of 
patented drugs. Access to essential medicines depends heavily on prices. This is particularly true for Members who have neither the production capacity nor the means to provide prevention, 
treatment or care for their inhabitants. This ma y very well be an issue of life and death. 
419.  With this in mind, Norway fully supports the LDCs' request for an extension of the transition 
period under Article 66.1 as regards pharmaceuticals. We also support the request for waivers 
from the obligations of Articles 70.8 and 70.9 of the TRIPS Agreement with respect to 
pharmaceuticals.  
420.  Norway notes that the LDCs have been gran ted a general extension of the transition period 
up until 2021. We still see merits in a particular extension of the transition period for the 
provisions in question as regards pharmaceuticals. In our view, this would ensure the legal 
certainty that the LDCs and the relevant operators need in order to ensure access to medicines vital to life and health.  
421.  We also support the request that the extension and waivers shall last as long as a Member 
remains an LDC. As we know, a Member does not self-designate itself as an LDC. That status depends on particular socio-economic indicators. As long as a Member is an LDC, it will have 
institutional and financial constraints, as well as lack of adequate technological base and 
pharmaceutical manufacturing capacity. It will th erefore need flexibility and maximum policy space 
to enable it to confront its health challenges wi th effective and affordable  strategies. An extension 
for as long as a Member is an LDC will also ensure legal certainty and predictability, which may 
contribute to keeping costs for medicines down and ensuring investment in the pharmaceutical 
sector of the LDCs. 
422.  To conclude, Norway is of the firm opin ion that the request from the LDCs is "duly 
motivated" and we call upon the Council to grant th e extension in accordance with Article 66.1, as 
well as to recommend to the General Council  that the requested waivers be adopted. 
11.12  Mali   
423.  My delegation would like to join those who ha ve spoken before me to thank the focal point of 
the LDCs for TRIPS for the statement that they have  made on behalf of the LDC Group – the clarity 
and exactitude of illustrations I think make this a very somber but realistic statement. On the state IP/C/M/79/Add.1 
 
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  of affairs and diseases of our population we ca n also add the Bamako Initiative to our current 
hopes which is well known by most countries. By most LDCs especially from West Africa. This is an initiative which has helped to save thousands of people in LDCs in Africa.  
424.  The delegation of Mali would also like to associate itself with the other delegations to give 
strong support to the statement made on behalf of  the LDC Group, so as to obtain an additional 
extension for pharmaceutical products which will allow our countries to gain access to these products which are extremely pricey for our popu lations. My delegation supports the request put 
forward by the LDCs and we would also like to thank the LDC Group for requesting the inclusion of 
this item on the agenda.  
11.13  Cuba   
425.  Cuba would also wish to speak to fully support the statement made by Bangladesh and 
Uganda on the request put forward by LDCs fo r the approval without any conditions of an 
extension of the transitional period which, as we all know, comes to an end in January 2016. Cuba also agrees that it is extremely important to go  through with Articles 70.8 and 70.9 of the TRIPS 
Agreement. Both the extension and the waivers should remain in place as long as these countries 
are considered as LDCs. We are talking about the poorest countries in the world with the weakest 
technological capacities, indeed, the countries which are most exposed to health hazards due to 
poverty. That is why Cuba would like to stress the need there is to take into account this request 
in accordance with the flexibilities laid out in Article 66.1 of the TRIPS Agreement. 
11.14  Brazil   
426.  We thank the delegation of Bangladesh for sharing the LDCs request for extension of the 
transition period under Article 66.1 of the TRIPS Ag reement, as well as the delegation of Uganda 
for the very eloquent intervention that recalled us the dire public health situations faced by LDCs. 
427.  Brazil would like to restate its longstandi ng position about the need for a balance between 
the interests of users and producers of intellectual property, so that our societies can reap the 
benefits from the system. If this is true for all areas dealt with in the TRIPS Agreement, it is even more pertinent when it relates to matters of public health.  
428.  We understand document IP/C/W/605 as a duly motivated request in the terms of Article 
66.1 of the TRIPS Agreement. Thus, we are ready to  support the request made by LDCs to extend 
the transition period under Article 66.1 for LDC Members with respect to pharmaceutical products and for waivers from the obligations of Articles 70.8 and 70.9 of the TRIPS Agreement. 
11.15  Yemen   
429.  The Yemen delegation associates itself with LDC Group Coordinator presentation as well as 
LDC delegations and other Members who spoke before  in support of the LDCs extension request. 
Therefore, extension of the transition period und er Article 66.1 of the TRIPS Agreement for LDCs 
with respect to pharmaceutical products as well as for waivers from obligations of Article 70.8 and 70.9 of the same Agreement is quite timely and appropriate.  
430.  Yemen with 25 million people continues to face many health-related challenges that need to 
be addressed seriously. Indeed, the gravity of the health-related problems affecting LDCs and thus 
right to ensure access to medicines remain similar to the 2002 situation when the TRIPS Council decision was taken to address such concerns.  
431.  We hope that WTO Members shall favorably support the LDCs request, accordingly, as this 
matter is vital for the livelihood of millions of people living under extremely difficult situations. IP/C/M/79/Add.1 
 
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  11.16  Argentina   
432.  Argentina supports the request submitted by Bangladesh and Uganda on behalf of the LDCs, 
contained in document IP/C/W/605. 
433.  We believe that an extension of the transi tional period under Article 66.1 for LDC Members 
with respect to pharmaceutical products and for waivers from the obligations of Articles 70.8 and 
70.9 would give LDC Members the flexibility, policy space and time they need to address serious and urgent public health issues relating to communicable and non-communicable diseases and 
access to medicines. 
11.17  Togo   
434.  Togo would like to highlight that as an LDC we join our voice to all of those that have taken 
the floor in asking for an extension in as far as pharmaceutical products issue is concerned. 
Coming back to the reasons underlying this new request – those reasons were eloquently stated 
already by the LDC coordinator and by the focal po int, the distinguished representative of Uganda. 
Nevertheless, allow me to say that there are many sick people in LDCs suffering great distress and 
this is why LDCs believe it is important to grant an unconditional extension concerning 
pharmaceutical products. I would like to say that the Members of the WTO were on the right side of history in accepting this. They must bear in mind the concern to stay on the right side of 
history. Human life is what is most important on this earth and we should work together to protect 
it. 
11.18  Canada   
435.  Canada would like to thank the LDC Group for its detailed and very useful intervention 
yesterday and the openness it has demonstrated in  recent weeks in engaging with Canada and 
other parties on the issue of its proposal. We understand this proposal to seek first an extension of the transition period granted in 2002 in TRIPS Council decision IP/C/25 and ending on 
1 January 2016 for LDCs to not be obliged to implement or apply Sections 5 and 7 of Part 2 of the 
TRIPS Agreement, or to enforce rights provided for under these sections for as long as the WTO Member remains an LDC.  
436.  Second, the proposal seeks a renewal of the waiver of the obligation under TRIPS Article 
70.9 for as long as the WTO Member remains an  LDC and a new waiver of the obligation under 
TRIPS Article 70.8 for as long as the WTO Member remains an LDC. 
437.  Canada is supportive of a meaningful solution that would effectively allow LDCs to address 
their difficulties in implementing TRIPS obligations and better integrate the international trading 
system, and we are committed to working with all Members towards this goal. Canada is of the view that the general extension of the transition period to implement TRIPS that was granted to 
LDCs in 2013 does apply to pharmaceutical products. We have had informal discussions with many 
Members on this proposal and we look forward to continuing these conversations and to reaching a 
better understanding, for example, of the LDCs posi tion on the Article 70.8 mailbox provision, and 
to what extent LDCs already have mailbox sy stems in place. We look forward to working 
constructively with all Members towards a solution. 
11.19  China   
438.  China always values the concerns of LDC Members and would like to try its best to devote to 
the capacity building of the latter. Considering the economic, financial and administrative 
constraints of LDC Members, as well as the close relation between the access to certain pharmaceutical products and human life, China hereby echoes many other Members and 
completely agrees to the request that the transitional period under Article 66.1 with respect to 
pharmaceutical products and waivers from the obligations under Article 70.8 and 70.9 of the TRIPS Agreement should be extended. We also urge the developed country Members to provide more 
incentives to promote and encourage technology transfer to LDC Members as required by 
Article 66.2 of the TRIPS Agreement. IP/C/M/79/Add.1 
 
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  11.20  Japan   
439.  This delegation would like to thank the LDC Members for their proposal numbered 
IP/C/W/605. Japan is aware of the importance of th is issue to the LDC Members, and therefore, we 
are ready to play an active role in future discussions on this issue to make a constructive 
contribution. 
440.  Today, we would like to make some comments on this proposal. Firstly, this delegation 
recognizes that the 11 June 2013 decision by the TRIPS Council, IP/C/64, also applies to 
pharmaceutical products, for which the LDC Members are requesting an extension of the 
transitional period in the current proposal. It means that without any further decision on the extension of the general transitional period for pharmaceutical products, the LDC Members can benefit from the transitional period under Article 66.1 until 1 July 2021. In this connection, this 
delegation considers that the necessity and its rationale for the extension of the transitional period 
for pharmaceutical products should be further examined in future discussions. 
441.  Secondly, if the obligations under Articles 70.8 and 70.9 are waived, the expiry for such 
waivers should also be stated in the decision, a ccording to Article 9.4 of the Marrakesh Agreement 
Establishing the World Trade Organization. In this connection, it should be noted that all waivers 
granted so far in the WTO have expressly provided their own expiration dates. 
442.  Furthermore, this delegation is of the view  that the TRIPS Council decision, IP/C/64, does 
not affect the obligations under Articles 70.8 and 70.9, since these Articles clearly oblige Members to take measures "notwithstanding the provisions of Part VI". Therefore, while the obligation under Article 70.9 has been waived by the decision of the General Council of 8 July 2002, WT/L/478, 
Members have been already obliged to take measures, as required under Article 70.8. In this 
connection, this delegation considers that thes e aspects need to be elaborated in future 
discussions. 
443.  What Japan also puts emphasis on is that IP rights are important instruments to support 
economic development. The protection of IP rights makes it possible that more investments would be made in research and development activity, which lead to promoting innovation. IP rights, 
therefore, are conducive to promoting economic de velopment. In the discussions on this subject, 
due consideration should be given to this crucial role of IP rights. 
11.21  Chinese Taipei   
444.  I would like to thank Bangladesh as representative and coordinator of the LDCs for that 
valuable proposal circulated in IP/C/W/605. We recognize the seriousness of the public health 
problems facing many LDCs, particularly involving HIV/AIDs, tuberculosis, malaria and other tropical diseases. We stress the fact that it is necessary for the TRIPS Agreement to assist in 
solving these national and international prob lems. The TRIPS Agreement should not prevent 
Members from taking measures to protect public health. That is why the LDCs benefit from an extension of the transitional period in order to implement protection measures within the TRIPS 
Agreement, thus supporting efforts at improving the public health issues in LDCs.  
445.  The WTO has granted a specific exception for pharmaceutical products, this is set forth in the 
Doha Declaration on TRIPS and Public Health, ad opted subsequently as a decision of the TRIPS 
Council. This is a credit to those who took these decisions - it is difficult for LDCs to become 
involved in patent issues. They have been given a date of 1 January 2016. Also exceptions have 
been granted to LDC obligations under Article 70 of the TRIPS Agreement in order to guarantee exclusive marketing rights. This decision of the WTO is a crucial one in order rapidly to enable 
pharmaceutical products to become available in LD Cs at an affordable price to combat epidemics. 
The use of this mechanism is helped by proposals and provisions from Doha concerning TRIPS and Public Health.  
446.  My delegation believes that all Members of the WTO should help the LDCs to promote public 
health within the TRIPS Agreement. My delegation  also supports the idea that all WTO Members 
should provide assistance to the LDCs for them effectively to participate in the multilateral trading system. Nevertheless the LDCs proposal for an indeterminate extension for the whole transitional 
period may mean that there is little flexibility for possible adjustment in the future. That is why, IP/C/M/79/Add.1 
 
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  like Canada, we are quite in favour of bearing this in mind in a constructive spirit in order better to 
understand the needs of the LDCs. We would be pl eased to continue this discussion in the TRIPS 
Council.  
11.22  Sierra Leone   
447.  We deeply appreciate the support already provided to LDCs in response to their health 
challenges. Our delegation fully endorses the position contained in the respective presentations made by the delegates of Bangladesh, the coordinator of the LDC Group, as well as that of 
Uganda, of the Africa Group and of the ACP Gr oup including other like-minded delegates all 
relating to the request for extension of its transition period for pharmaceutical products and the relevant waivers in favour of the LDC Group. My delegation earnestly looks forward to a positive 
outcome of this request. 
11.23  Turkey   
448.  The special needs of LDCs as well as the economic and financial constraints that they have 
been facing particularly in affording pharmaceuticals are well known. According to the World 
Health Organization in 2011, out of 4.6 million people living in the LDCs who were eligible for anti-
retroviral treatment, only 2.5 million were receiving it. The obstacles LDCs have been facing in terms of accessing essential medicines require specific flexibilities and exceptions to be foreseen 
for them. In this regard we welcome the request ci rculated by Bangladesh on behalf of the LDCs 
and support the extension of the transitional pe riod for LDCs with respect to pharmaceutical 
products.  
449.  On the other hand, regarding the duration of the transition period, we prefer to follow the 
precedent and to mention a specific date, as was the case in the decision taken by this Council on 
27 June 2002.  
11.24  Haiti   
450.  We endorse the statement made by Banglade sh as coordinator of the LDC Group, and also 
the statement by the delegate of Uganda speaking  as focal point requesting an extension of the 
transitional period for pharmaceutical products. Given the situation and vulnerability of LDCs which 
have to confront epidemics and have vulnerable populations, we stress the need for the extension 
and the waiver to be granted in as far as these countries have LDC status. 
11.25  Congo, Democratic Republic of   
451.  The delegation of the Democratic Republic of Congo endorses the statements by Bangladesh 
and Uganda on behalf of the LDCs. 
452.  Rather than launching into a long speech, I will restrict myself to expressing our support for 
the request made by the LDCs to extend the transitional period that is due to end on 
1 January 2016, with respect to pharmaceutical products and for waivers from the obligations of 
Articles 70.8 and 70.9. 
453.  There is no need to reiterate the innumerable health issues faced by LDCs. Based on 
paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health, I therefore ask all 
Members to grant the request made by the LDCs until they are no longer in this category. 
454.  This is a question of life or death! Let us choose life, for this is written in the Word of God. 
I therefore encourage recalcitrant Members to give serious thought to this matter, as it is also 
written that it is a sin to know the right thing to do and then not do it. 
11.26  European Union   
455.  The European Union would like to thank in particular Uganda for the detailed presentation 
further detailing the request submitted by the LD C Members for an extension of the transition 
period to provide protection for pharmaceutical products under the TRIPS Agreement. IP/C/M/79/Add.1 
 
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  456.  The European Union has always supported extending the transition periods for LDCs in 
relation to pharmaceutical products and related requirements and continues to do so. 
457.  The EU was part of a unanimous decision on 11 June 2013 by the World Trade Organisation's 
Membership to extend the transition period for LD Cs to comply with TRIPS provisions in general 
until 1 July 2021, which covers also the pharmaceutical related provisions.  
458.  The EU is willing to look at how to resolve any legal uncertainty and ensure LDCs flexibility 
not to provide patent protection for pharmaceutical products. The Commission is examining the 
request submitted by Bangladesh on behalf of the LDCs as a matter of priority against the 
background of the general extension granted to LDCs in 2013. In that sense, the submissions 
made at this TRIPS Council yesterday and today we re highly valuable and informative and we look 
forward to the discussion among WTO Members between now and the next TRIPS Council.     
459.  The main urgency should however remain the efforts to solve the problem in a more holistic 
perspective and seek ways to address the current and very real obstacles faced by LDCs in providing their population with pharmaceuticals and health treatments. The WHO, WIPO and WTO 
have, for example, in a recent study on Promoting Access to Medical Technologies and Innovation  
noted the many access determinant other than IP, such as lack of access to quality health care, poor infrastructure, lack of distribution and supply systems, and lack of quality control, that affect 
access to medical technologies. 
460.  The European Union consistently tries to address these challenges and ensure that trade 
policy does not undermine these efforts. It has supported countries in reforming and in strengthening their health care systems, and is a major donor to organisations and funds 
dedicated to achieving improvements such as WHO, UNICEF, Global Fund, and GAVI. 
11.27  Chile   
461.  Chile welcomes the proposal by Bangladesh on behalf of the LDCs, and the presentation by 
Uganda. The request in document IP/C/W/605 includ es elements that have already been reviewed 
by this Council, in addition to new elements that were explained yesterday. 
462.  In our view, LDCs are faced with major public health issues and there is clearly a need for 
low-cost medicines. For Chile, exceptional situations obviously call for an exceptional response, 
particularly when human lives may be at stake. This is a question of basic justice, and the 
international community should therefore provide the support required to help LCDs overcome this and other issues. 
463.  We thus support the proposal and hope th at it will meet with the consensus of WTO 
Members. 
11.28  Uruguay   
464.  The delegation of Uruguay would like to thank Bangladesh for the proposal submitted on 
behalf of the LDC Group, and Uganda for the detailed substantiation provided to Members 
yesterday afternoon. 
465.  I do not want to dwell too long on this item, since I believe that other delegations have 
already given sufficient clear and convincing reason s that compel us to accede to this request. 
466.  Accordingly, we wish to express Uruguay's support for the requests set out in 
document IP/C/W/605. 
11.29  Rwanda   
467.  My delegation would like to fully endorse the statement made by Bangladesh and the 
comprehensive elaboration by Uganda. Like the previous speaker I will not get into health 
problems in LDCs, I think many delegations ha ve already elaborated that, I will limit my 
intervention to comparing the two extensions  – the one general extension of 2013 and the IP/C/M/79/Add.1 
 
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  extension of 2002, because I hear that some are saying that the general extension covers also 
pharmaceuticals.  
468.  It is not appropriate at all because the 2002 extension was a very clear straightforward legal 
decision, clear to everyone, while the general extension is vague and with conditions. It is vague 
because in some parts you see together the determination of LDCs to apply the TRIPS Agreement 
and flexibilities. But more importantly it has a condition of no rollback of laws – the famous no rollback of laws provision which ensures that during the transitional period no changes in law of 
LDCs would result in a lesser IP protection. This means that any LDC currently, with a law 
protecting pharmaceutical products, and there are many, would not be allowed to amend its law if manufacturing capacity is acquired. So with those incentives, and the no rollback laws, I am not sure whether we would be taking the right decision for this huge health problem. As Chile stated, 
for exceptional problems it is required to have exceptional solutions. So I hope that the Council will 
take the right decision. 
11.30  Switzerland   
469.  My delegation thanks Bangladesh for introducing the LDC Group's submission in IP/C/W/605 
and Uganda for its presentation, giving the Council an update and overview of the challenges LDCs 
face in regard of the health situation in their countries. My delegation considers this an important 
task of the Council, to reassess the situation and new developments in the matter at regular 
intervals. Switzerland fully acknowledges the special needs and requirements of LDC Members, particularly where health issues are concerned. TRIPS or patents cannot be said to be a barrier to affordability or availability of pharmaceuticals in LDCs. They have not applied to LDCs for the last 
20 years, during which the situation in LDCs, according to Uganda's information yesterday, has not 
improved, if not worsened. This is certainly unsettling news.  
470.  Switzerland is supportive of a further extension of the transitional period recognizing the 
special vulnerability, the formidable challenges and the many pressing priorities that LDCs face in 
sustaining their population, economy and publ ic health. Therefore the scarce resources and 
capacity should first and foremost be dedicated to addressing these challenges. As a corollary of 
our support to extending the general LDC transiti onal period in 2013, Switzerland supports that 
the further extension shall apply also to the TRIPS provision in relation to pharmaceutical products.  
471.  My delegation will examine further the modalities for this extension as proposed by 
Bangladesh yesterday, and additional information received at this Council meeting. Should we 
need further information or clarification we will seek advice of the LDC Group. My delegation looks forward to discussing this matter further with Members and to come to a decision swiftly. 
11.31  Australia   
472.  Australia thanks the LDC Group for its proposal and appreciates the deep importance of this 
issue. We recognise the challenge LDCs face in ta ckling disease and illness, including in our own 
region. We welcome discussions had today and yesterday and the ongoing efforts of the LDC 
Coordinator and Focal Point to engage Members on this issue. 
473.  While an outcome today may not be possible, we hope we, as a Council, can move efficiently 
toward an outcome that responds to the unique position of LDC Members while continuing to 
recognise the role intellectual property can play as a tool for supporting innovation, investment 
and development. 
11.32  Holy See   
474.  I join previous speakers to congratulate you on your election. The World Health Organization 
(WHO) estimates that about one-third of the population lacks regular access to essential medicines and vaccines. It believes that 10 million lives could be saved annually if such resources were more 
readily available. 
475.  The LDCs, as the poorest and weakest segm ent of the international community, are most 
vulnerable. The classification of LDCs is contingent on a number of key human development IP/C/M/79/Add.1 
 
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  indicators, including levels of poverty, literacy and infant mortality. At the beginning of the 
Millennium, the LDCs enjoyed the strongest and longest growth rates since the 1970s, benefiting from sustained global growth, surging commodity prices and buoyant capital flows. Between 2000 
and 2008, the average annual growth of this Grou p's real gross domestic product (GDP) exceeded 
7%, raising hopes that some LDCs may be able to graduate from this category within the present 
decade. However, with the global financial crisis in 2008 and the drastic change in external conditions, LDCs have experienced a slowdown of economic activity. As a result, their economic 
growth has been much weaker during the past five years.  It has been well below the target rate 
of 7% annual growth established in the Istanbul Programme of Action (IPoA) which is considered necessary for attaining the Millennium Development Goals (MDGs).  
476.  With the recovery of the global economy remaining slow and uneven, the LDCs faced a 
challenging international environment in 2013. Th is sluggish global economic growth, which 
translated into weaker international demand for commodities and a consequent decline in their prices, adversely affected the economic growth and export performance of several LDCs. The 
outlook for the LDCs in the short and medium term remains uncertain. While global output is 
expected to strengthen moderately in the me dium term, uncertainty about the pace and the 
strength of the recovery persists. A fragile an d uncertain global recovery could hinder LDCs' 
economic performance due to weak international demand and lower commodity prices. Adjusting 
to a changing external environment has always been a key challenge for these economies, but this is now exacerbated by a weak world economy an d prevailing uncertainties. The less favourable 
external environment, coupled with LDCs' weaker  growth performance, suggests that achieving 
the MDGs, or the SDGs that are planned to succeed them, will be difficult. 
477.  As underlined in the Istanbul Program of Action, LDCs are the most "off-track" in the 
achievement of the internationally agreed developmen t goals. Their productive capacity is limited, 
and they have severe infrastructure deficits
30.  In 2011, of the 34 million people living with HIV 
worldwide, some 9.7 million lived in LDCs. Of these, 4.6 million were in need of antiretroviral treatment (ART); however only 2.5 million had received it
31. Up to one-half of those deprived of 
treatment were expected to die within 24 months32. In the 49 countries designated as LDCs by the 
United Nations, non-communicable diseases as well are rising much faster than in higher income countries.  
478.  Some LDCs have used the transition period as a major selling point for attracting investment 
in their local pharmaceutical industry
33. However, some LDCs have provided patent protection for 
medicines despite the availability of the transition  period or have signed free trade and investment 
agreements that may contain IP provisions curtailing any benefits arising from the transition 
period. In this context, the report observed that the transition period in itself, though important, 
will not be sufficient to attract generic companies to invest in local pharmaceutical production34. 
However, the transition period is intended to provide LDCs with the necessary policy space to take 
measures that would facilitate the growth of industrial capacity in desired sectors without being 
impeded by the existence of patents, which coul d hinder the development of the local industry. 
479.  Since 2000, there has been a noticeable decline in the number of new HIV infections in LDCs 
since 2000, as in the developing world as a whole, reflecting improvements in early diagnosis, 
access to treatment, nutrition, and responsible behaviour change. However, despite such 
improvements, the goal of universal access to anti -retroviral treatment is far from achieved and 
requires continuing investment and both health  and community system strengthening. Moreover, 
the deficiencies of health systems in LDCs have been sharply highlighted during 2014 and 2015, in 
conjunction with the significant outbreak of the Ebola Virus Disease in Coastal West Africa. Such 
                                               
30 Istanbul Plan of Action (par.4) doc. A/CONF.219/3. http://ldc4istanbul.o rg/uploads/IPoA.pdf  
31 TRIPS transition period extensio ns for least-developed countries, UNDP and UNAIDS Issues 
Brief,/13 February 2013.  
32 Mr. Michel Sidibé, UNAIDS Executive Director, Report to 31st UNAIDS Programme Coordinating 
Board, December 2012, http://www.unaids.org/en/media/unaids/contenta ssets/documents/speech/2012/12/20121211_SP_EXD_31st_
PCB.pdf  
33 UNCTAD (2011), Investment in Pharmaceutical Prod uction in the Least Developed Countries: A Guide 
for Policymakers and Investment Pr omotion Agencies (UNCTAD Secretariat, Geneva, New York), pp. 40-42, 
available at http://unctad.org/en/Docs/diaepcb2011d5_en.pdf (last visited 3 June 2015) 
34 Ibid. IP/C/M/79/Add.1 
 
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  health emergencies could jeopardize, or even reve rse, the achievements of several LDCs in terms 
of human and economic development. 
480.  We have before us a critical opportunity to help LDCs to reach health and sustainable 
development goals and the failure to do so could put millions of lives at risk. Access to adequate 
healthcare, including affordable medicines, rema ins a key challenge in most LDCs. The current 
flexible intellectual property arrangements for LDCs are a crucial tool for improving health. In fact, the flexibility agreed in TRIPS Article 66.1 has been accepted in recognition of the economic, 
financial, and administrative constraints preventing LDCs from immediate observance of all the 
obligations set out in the TRIPS Agreement. The general transition period may be useful in supporting the development of a strong chemical industry that could gradually move toward production of active pharmaceutical ingredient  (API). Long-term sustainability of the local 
pharmaceutical industry would require the develo pment of the internal capacity to manufacture 
generic formulations thus reducing dependency and the high import costs for obtaining APIs. In particular, there is a need to develop a second line HIV treatment which, at present, is more than 
double the price of the first line regime.  Moreover, the costs for a third line HIV treatment could 
be as much as 15 times the price of first line trea tment. Clearly, in this context, the establishment 
of a pharmaceutical industry is particularly important.  
481.  As clearly stated by the TRIPS Agreement,  a well-designed intellectual property system 
"should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge, in a manner conducive to social and economic welfare, and to a balance of rights and 
obligations"
35. 
482.  In conclusion, the Holy See Delegation hopes that a sense of common responsibility, as 
shown in the decision adopted, will bring us all to recommend to the General Council a waiver for 
LDCs from obligations under Articles 70.8 and 70.9 of the TRIPS Agreement for as long as they 
remain LDCs. 
11.33  Brazil   
483.  I apologise for taking the floor on the same subject, but, as stated by Rwanda, I believe it 
would be beneficial to the discussion to draw a clear distinction between the two TRIPS extensions 
currently in force related to obligations from LDCs.  
484.  The general transition period, extended in 2013, was based on administrative, financial and 
economic limitations faced by LDC capacities. Ag ainst this background, WTO Members decided to 
grant extended flexibility so LDCs could build their national IP systems without international 
constraints until 2021. 
485.  Regarding the extension related to pharmaceutical products, a very specific situation on the 
ground was the reason of existence of this exte nsion. In 2002, in the Doha Declaration on TRIPS 
and Public Health, all WTO Members agreed that the reason of existence of this specific extension 
was "the gravity of the public health problems afflicting many developing and least-developed 
countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics". We understand that this background should guide our discussions. 
11.34  WHO Secretariat   
486.  Universal health coverage is  the central policy objective in global public health and part of 
the future UN Sustainable Development Goals. Universal health coverage means that all people obtain the full spectrum of essential, quality heal th services they need without suffering financial 
hardship. This requires a strong, efficient, well-r un health system that meets priority health needs 
through people-centred integrated care. Health systems must provide for a system for financing health services, a sufficient capacity of well-trained health workers and be able to ensure access to 
safe, effective and affordable essential medicines and technologies. 
                                               
35 Article 7 TRIPS Agreement. IP/C/M/79/Add.1 
 
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  487.  Access to essential medicines is also recognized as part of the human right to health as an 
integral component of primary health care. Unfortunately, we as a community have not yet achieved this aim in all countries. There are many reasons for this gap, which include inadequate health systems, lack of political commitment, lack  of good governance and insufficient investment 
in health in general. Where people have to buy medicines out of their pocket, it is essential that 
patients are provided with financial protection and essential medicines are affordable. This is particularly true for those countries that the UN classifies as LDCs.  
488.  Currently, LDCs that are Members of the WTO are not required to apply most of the 
substantial rules of the TRIPS Agreement until 1 Ju ly 2021. In particular, they have no obligation 
to provide any protection for clinical test data or to grant patents, including on pharmaceutical products or processes. In parallel, LDCs benefit from a specific transitional period with respect to 
the pharmaceutical field under the 2001 Declaration on TRIPS and Public Health which if not 
extended, ends on 1 January 2016.  
489.  Being exempted from granting patents allows LDCs to either locally produce or to import 
generic products even when those are still under patent in other countries. This can help countries 
i n  e x p a n d i n g  h e a l t h  c o v e r a g e  b y  a l l o w i n g  t h e  h e a l t h  s e c t o r  t o  r e l y  o n  m o r e  a f f o r d a b l e  g e n e r i c  suppliers. Being able to do competitive procurement, including from local or foreign manufacturers 
is in particular important in the area of HIV as well as for the new treatments for highly prevalent 
conditions like hepatitis.  
490.  The possibility not to grant patents on pharmaceuticals can also play a crucial role for LDCs 
to enhance local production of generic versions of essential medicines through strategic joint 
ventures. This can strengthen domestic manufacturing which can contribute to achieving public 
health objectives by ensuring security of supply as well as creating a knowledge economy.  
491.  Consequently, the LDC Group stated that the re quest aims at facilitating access to affordable 
medicines in LDCs and is motivated by the massive health challenges resulting from communicable 
and non-communicable diseases in LDCs, their socio-economic and financial constraints, as well as the lack of adequate technological base and local manufacturing capacities in the pharmaceutical 
sector. 
492.  WHO welcomes and supports the LDC request for extension as part of an overall effort to 
facilitate access to essential medicines in these countries and urges the Council for TRIPS to favourably consider this request.  
11.35  Bangladesh, on behalf of the LDC Group   
493.  We thank all Members for their responses and we are encouraged to see that Members took 
serious interest in this important issue. We thank wholeheartedly the Groups and Members and 
International Organizations that expressed instant support. We also thank other Members who are 
in the process of examining the proposal and hope that they will come back to us with positive 
responses soon. Actually there is hardly any need to explain or justify the causes and 
requirements for this position. We are hoping for sympathetic comprehension of Members and we 
are waiting for the same efforts and understanding that Members have demonstrated a number of times in the WTO, including the previous extensio n of transition periods. However Members will 
notice that in spite of severe constraints, many  LDCs progress significantly to implement these 
provisions.  
494.  Meanwhile we have taken note of the comments and queries of the Members regarding the 
proposal and we will come back to them accordin gly. The LDC Group is at the disposal of all 
Members to provide further information and clarification if required and we will be intimately 
engaged in the process. We also thank you for your indication to help the process and we rely on your wise guidance. We also thank the WTO Secretariat for their continuous support with various 
WTO documents and voluntary statistics. I again thank all the Members for their kind support.  
11.36  Uganda, on behalf of the LDC Group   
495.  I join my colleague from Bangladesh in expressing our profound appreciation for the 
extensive support that we have received from all the distinguished Members in this Council, IP/C/M/79/Add.1 
 
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  Members of Parliaments in various jurisdictions who have written letters of support to their 
respective Governments urging them to grant this request; and International Organizations, such as the WHO, UNDP and UNAIDS, UNITAID, the NGO delegation to UNITAID; and Communities 
Delegation on the Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria; hundreds and 
hundreds of Civil Society Organizations and networks from around the world as well as suppliers of 
generic medicines in LDCs. We also express our appreciation to the WTO Secretariat for all the support we have received, and continue to receive. 
496.  We also express our sincere appreciation to all the partners who have raised concerns and 
expressed keen interest in learning more about our request. We have attempted to address most 
of those concerns by highlighting the four areas in our presentation emerging out of our bilateral 
consultations. We look forward to further engagement that would make it easy for our partners in 
their own consultations with the view to ensuring a quick conclusion of this matter with the 
adoption of the decision to extend the tran sition period consistent with our request 
497.  We have tried to demonstrate the rationale for this request. We have shown you the 
numbers. We have also demonstrated that this is not the first time that this request has been 
granted on top of an existing general waiver. We have shown the distinction between the 2013 
text and the 2002 Decision. In 2002, there was a general extension that would elapse in three 
years, but yet the Members granted us this specif ic extension on pharmaceutical products. This 
was because of the recognition of the challenges that we continue to face as highlighted in paragraph 1 of the Doha Declaration on TRIPS and Public Health.  
498.  In closing, I would like to conclude with a quote from the statement made by UNAIDS and 
UNDP. They said: "WTO Members have before them a critical opportunity to help Least Developed 
Countries to reach health and sustainable develo pment goals-failure to support them could put 
millions of lives at risk."  
AGENDA ITEM 13: OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL 
ORGANIZATIONS 
13.1  India   
499.  India supports the granting of permanent observer status to three intergovernmental 
organizations- South Centre, the CBD Secretariat and the International Vaccine Institute.  
500.  South Centre is an intergovernmental organisation with 51 developing countries as members 
and South Centre already has observer status in  WIPO, WHO, CBD and many other UN bodies.  
501.  The Convention on Biological Diversity (CBD) fulfils all the required parameters for 
observership of the WTO. The WTO Secretariat has observer status at the CBD and regularly participates in the CBD meetings. So as a matter  of reciprocity, the CBD Secretariat shall be 
granted observer status.  
502.   We would also like to support the request from the International Vaccine Institute (IVI) for 
observer status in the Council for TRIPS. The International Vaccine Institute, which was created 
initially as an initiative of the United Nations Development Programme (UNDP), is the world's only 
international organization devoted exclusively to  developing and introducing new and improved 
vaccines to protect the world's poorest people, especially children in developing countries. The Institute conducts research in more than 20 countries of Asia, Africa and Latin America on vaccines 
against enteric and diarrheal infections, Japanese encephalitis, and dengue fever, and develops 
new and improved vaccines at its headquarters in Seoul, Republic of Korea. 
503.  India again urges the Council to positively and expeditiously consider the request of South 
Centre, the Secretariat of the Convention on Bi ological Diversity (CBD) and the International 
Vaccine Institute (IVI) for observer status and, until then, ad hoc observer status on a meeting-by-meeting basis should be granted to them. IP/C/M/79/Add.1 
 
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  13.2  Bangladesh, on behalf of the LDC Group   
504.  Taking cue from the comments of India, the LDC Group also feels that the legal position and 
capacity of observers in the WTO are very weak. Still, they could provide important information and inputs to support Members to understand and analyze complex issues. In this respect the LDC 
Group also supports the application of the South Centre, the CBD Secretariat and International 
Vaccine Institute whenever there is an opportunity. 
13.3  Ecuador   
505.  Ecuador is in favour of the South Centre receiving observer status, or at least ad hoc 
observer status, in this Council. 
13.4  Indonesia   
 
506.  With regard to the Observer Status for the CBD Secretariat and South Centre, Indonesia 
firmly holds its position to grant the observer status to these organizations. Their positive and valuable contribution to the work and discussion of this Council are still imperative for developing 
country Members to tap the full benefits of the Agreement as well as rectifying the existing 
provisions in accordance with the development interests of such Members. 
13.5  Nepal   
 
507.  Nepal supports the views expressed by Memb ers including Bangladesh on behalf of LDCs, 
India, Indonesia and Ecuador that observer status  should be given to some of the international 
intergovernmental organizations on their merit who have been closely working on IP-related issue, 
for a long time. In this regard we strongly su pport the CBD Secretariat, International Vaccine 
Institute and South Centre to be given observer status of this esteemed Council. Granting observer status to these three international organizations will not only help co-operation between 
the WTO and those international organizations, but also help Members become familiar with other 
activities and events being undertaken by these Or ganizations through regular exchange of views  
and experience-sharing. Hence we support granting  observer status to these organizations which 
are directly engaged in, and associated with the work of the TRIPS Council and dealing with IP 
matters. 
13.6  Brazil   
 
508.  Brazil would like to add its voice to the statements made by the delegations of India, 
Bangladesh, Ecuador, Indonesia and Nepal regarding granting of observer status to a number of organizations, especially to the CBD Secretariat and the South Centre. 
13.7  United States of America   
 509.  The United States is not in a position to support the request proposed in the previous 
interventions.  
AGENDA ITEM 14: OTHER BUSINESS Agenda Item 14.1   Invitations to ad hoc observers 14.1  United States of America   
 
510.  As we have in the past, we support the ad hoc observership status of the organizations you have identified. We are also in a position to su pport their permanent status as observers of this 
Council and would suggest a decision by the Council on that basis. 
14.2  Nigeria   
 
511.  Just to lend a voice from the Africa Group, we support the proposal by the United States. IP/C/M/79/Add.1 
 
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  Agenda Item 14.4:  Contribution of Intellect ual Property to Facilitate the Transfer of 
Environmentally Sound Technology 
14.3  Ecuador   
 
512.  Ecuador has requested to speak on this agenda item in order to keep the Membership duly 
informed of the developments under way concerning the proposal in document IP/C/W/585 of 27 February 2013. 
513.  In this regard, Ecuador is pleased to announce that on 12 May 2015, a workshop on the 
contribution of intellectual property to facilitati ng the transfer of environmentally sound technology 
was organized in Crozet, France, with the collaboration of the Friedrich Ebert Foundation. 
514.  The objective of the workshop was successfully  achieved, as from the very beginning of the 
event, opinions were freely exchanged on the Ecua dorian proposal by sector specialists who were 
participating as speakers, and by the country representatives invited, who demonstrated their support and sympathy for the proposal. 
515.  The sector specialists who attended the workshop were from the International Centre for 
Trade and Sustainable Development (ICTSD), the United Nations Conference on Trade and Development (UNCTAD), the South Centre, the Worl d Trade Organization and the Advisory Centre 
on WTO Law. 
516.  The main conclusions from the workshop were as follows: 
(i) The issue is very current and should continue to be addressed by the TRIPS Council, 
which is the only forum that discusses the role of intellectual property rights in the 
transfer of environmentally sound technology; 
(ii) the link between environmentally sound technolo gy and intellectual property is vital for 
sustainable development; 
(iii) the key is that the flexibilities exist as permissive provisions under the Agreement, 
and therefore should be used; 
(iv) the review of the proposal should determin e the objective and the types of technology 
required; 
(v) intellectual property should reflect global interests, which are constantly changing, and 
take into account developments in sustainable technology; 
(vi) technology is essential for confronting the adverse effects of climate change and is a key 
part of the solution to the issue; 
(vii) the TRIPS Agreement contains not only protective provisions but also rules on 
flexibilities, which could be useful for addressing the challenges posed by climate change; 
(viii)  Ecuador will keep the Members of this Council informed of the steps that will be taken in 
the future, both at national level and with other countries and international organizations; 
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