RESTRICTED  
  
IP/C/M/80/Add.1  
 
22 February 2016  
(16-1062)  Page: 1/76  
Council for Trade-Related Aspects of  
Intellectual Property Rights 
  
 
 MINUTES OF MEETING 
HELD IN THE CENTRE WILLIAM RAPPARD  ON 15-16 OCTOBER, 6 NOVEMBER AND 
23 NOVEMBER 2015 
Chairpersons: Ambassador Al-Otaibi (Kingdom of Saudi Arabia) and  
Ambassador Alfredo Suescum (Panama) 
Addendum 
The present document contains the statements ma de during the Council for TRIPS meetings held 
on 15-16 October, 6 November and 23 November 2015 respectively. 
 
 
_______________ 
 
Subjects discussed 
  
INDEX OF THE STATEMENTS MADE AT THE MEETINGS OF THE COUNCIL FOR 
TRIPS 15-16 OCTOBER, 6 NOVEMB ER AND 23 NOVEMBER 2015* .................................... 3
 
AGENDA ITEM 1: ELECTION OF INTERIM CHAIRPERSON .................................................. 5  
AGENDA ITEM 2: NOTIFICATIONS UNDE R PROVISIONS OF THE AGREEMENT .................. 5  
AGENDA ITEM 3: REVIEWS OF NATION AL IMPLEMENTING LEGISLATION ........................ 7  
AGENDA ITEM 4: REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B) ............................... 8  
AGENDA ITEM 5: RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE 
CONVENTION ON BIOLOG ICAL DIVE RSITY ...................................................................... 8  
AGENDA ITEM 6:  PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE .............. 8  
AGENDA ITEM 7:  REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE 
IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE 
TRIPS AGREEMENT AND PUBLIC HE ALTH ....................................................................... 17  
AGENDA ITEM 8:  NON-VIOLATION AND SITUATION COMPLAINTS ................................ 25  
Statements made at the meeting on 15 October 2015 ........................................................... 25 
Statements made at the reconvened meeting on 23 November 2015 ....................................... 36 
AGENDA ITEM 9:  REVIEW OF THE IMPLEMENTATION OF THE TRIPS AGREEMENT 
UNDER ARTICLE 71.1 ..................................................................................................... 39  
AGENDA ITEM 10: REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHICAL IN DICATIONS UNDER ARTICLE 24.2 ................................ 39
 
AGENDA ITEM 11:  THIRTEENTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE 
DECISION ON THE IMPLEMENTATION OF ARTICLE 66.2 OF THE TRIPS 
AGREEMENT ................................................................................................................... 3 9 IP/C/M/80/Add.1 
 
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  AGENDA ITEM 12: TECHNICAL COOP ERATION AND CAPACITY BUILDING ...................... 41  
AGENDA ITEM 13:  REQUEST FOR AN EXTENSION OF THE TRANSITIONAL 
PERIOD UNDER ARTICLE 66.1 FOR LEAS T DEVELOPED COUNTRY MEMBERS WITH 
RESPECT TO PHARMACEUTICAL PRODUCTS AND FOR WAIVERS FROM THE 
OBLIGATION OF ARTICL ES 70.8 AN D 70.9 ..................................................................... 47  
Statements made at reconvened meeting on 6 November 2015 .............................................. 47 
AGENDA ITEM 14:  INTELLECTUAL PROPERTY AND INNOVATION: 
ENTREPRENEURIALISM AND NEW TECHNOLOGIES ........................................................ 57  
AGENDA ITEM 15: INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN 
THE WTO ....................................................................................................................... . 73 
AGENDA ITEM 16: OBSERVER STATUS FOR INTERNATIONAL 
INTERGOVERNMENTAL ORGANIZATIONS ....................................................................... 74  
AGENDA ITEM 17: ANNUAL REPORT ............................................................................... 76  
AGENDA ITEM 18: OTHER BUSINESS .............................................................................. 76  
 
 IP/C/M/80/Add.1 
 
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  INDEX OF THE STATEMENTS MADE AT TH E MEETINGS OF THE COUNCIL FOR TRIPS 
15-16 OCTOBER, 6 NOVEMBER AND 23 NOVEMBER 2015* 
Argentina  
Non-violation, 29, 37 
Australia  
Entrepreuneurialism and new technologies, 
58 
Extension of LDC transition period, 55 
Notifications, 5 Review of Para. 6, 19 
Technical cooperation, 42 
Bangladesh, on behalf of the LDC  Group  
Biotech, Biodiversity, TK, 11 Extension of LDC transition period, 47 
Non-violation, 31, 38 
Review of Para. 6, 24 
Barbados, on behalf of the ACP Group  
Extension of LDC transition period, 52 
Bolivia, Plurinational State of  
Non-violation, 32 
Brazil  
Biotech, Biodiversity, TK, 13 Entreprenurialsim and new technologies, 
73 
Extension of LDC transition period, 55 
Non-violation, 26, 38 Observer status, 75 
Review of Para. 6, 20 
Canada  
Biotech, Biodiversity, TK, 14 Entrepreneurialism and new technologies, 
65 
Extension of LDC transition period, 54 Non-violation, 29 
Review of Para. 6, 18 
Chairman  
Observer status, 75 
Chile  
Biotech, Biodiversity, TK, 13 Extension of LDC transition period, 56 Non-violation, 32, 39 
Review of Para. 6, 21 
China  
Biotech, Biodiversity, TK, 12 
Extension of LDC transition period, 53 
Non-violation, 30, 37 
Colombia  
Biotech, Biodiversity, TK, 12 
Non-violation, 30, 38 
Cuba  
Biotech, Biodiversity, TK, 12 
Non-violation, 28 
Review of Para. 6, 19 
Ecuador  
Biotech, Biodiversity, TK, 11 
Non-violation, 30, 37 Observer status, 74 
Other business, 76 
Review of Para. 6, 21 Technical cooperation, 47 
 Egypt  
Biotech, Biodiversity, TK, 10 
Non-violation, 30, 37 
Observer status, 74 Review of Para. 6, 20 
European Union  
Article 66.2, 39 Entrepreuneurialism and new technologies, 
57 
Extension of LDC transition period, 53 Non-violation, 33, 38 Review of Para. 6, 21 
Technical cooperation, 41 
Fiji 
Review of legislation, 8 
Gulf Cooperation Council  
Technical cooperation, 43 
Haiti  
Extension of LDC transition period, 52 
Holy See  
Extension of LDC transition period, 55 
Hong Kong, China  
Entrepreuneurialism and new technologies, 
66 
Non-violation, 33, 39 
India  
Biotech, Biodiversity, TK, 9 Entrepreneurialism and new technologies, 
67 
Extension of LDC transition period, 52 Non-violation, 28, 37 Observer status, 74, 75 
Review of Para. 6, 18, 24 
Indonesia  
Biotech, Biodiversity, TK, 10 
Non-violation, 29 
Observer status, 74 Review of Para. 6, 20 
Japan  
Biotech, Biodiversity, TK, 14 
Entrepreneurialism and new technologies, 
68 
Extension of LDC transition period, 53 
Non-violation, 35, 37 Review of Para. 6, 22 
Korea, Republic of  
Biotech, Biodiversity, TK, 15 Entrepreneurialism and new technologies, 
71 
Non-violation, 34, 37 
Lesotho, on behalf of the African  Group  
Extension of LDC transition period, 50 
Malaysia  
Non-violation, 38 
Myanmar  
Extension of LDC transition period, 51 
   IP/C/M/80/Add.1 
 
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  Nepal  
Biotech, Biodiversity, TK, 15 Extension of LDC transition period, 51 Non-violation, 35 
Observer status, 75 
New Zealand  
Article 66.2, 40 
Biotech, Biodiversity, TK, 16 
Entrepreneurialism and new technologies, 
72 
Extension of LDC transition period, 56 
Non-violation, 34 
Review of Para. 6, 21 
Nigeria, on behalf of the African Group  
Biotech, Biodiversity, TK, 13 
Non-violation, 31, 39 Observer status, 75 
Norway  
Extension of LDC transition period, 54 Non-violation, 32 
Pakistan  
Extension of LDC transition period, 56 
Peru 
Biotech, Biodiversity, TK, 8 
Non-violation, 25, 36 
Philippines  
Non-violation, 31 
Russian Federation  
Non-violation, 31, 39 
Singapore  
Entrepreneurialism and new technologies, 
60 
South Africa  
Biotech, Biodiversity, TK, 13 
Extension of LDC transition period, 55 
Non-violation, 33, 39 Review of Para. 6, 24 
Sri Lanka  
Non-violation, 34, 38 
Switzerland  
Biotech, Biodiversity, TK, 14 
Entrepreneurialism and new technologies, 
69 
Extension of LDC transition period, 54 
Non-violation, 34, 37 
Review of Para. 6, 22 
 Chinese Taipei  
Entrepreneurialsim and new technologies, 
59 
Extension of LDC transition period, 53 
Non-violation, 33, 38 
Notifications, 5 
Review of Para. 6, 19 Tajikistan  
Review of Legislation, 7 
Tanzania  
Extension of LDC transition period, 50 Observer status, 74 
Thailand  
Non-violation, 31 Review of Para. 6, 21 
Turkey  
Extension of LDC transition period, 56 
Uganda  
Extension of LDC transition period, 48 
Review of Para. 6, 25 
UNCTAD Secretariat  
Technical cooperation, 44 
United States of America  
Biotech, Biodiversity, TK, 16 Entrepreuneurialism and new technologies, 
61 
Extension of LDC transition period, 48 Non-violation, 26, 36 
Observer status, 74 
Review of Legislation, 8 Review of Para. 6, 23 
Venezuela, Bolivarian Republic of  
Non-violation, 35 
Observer status, 75 
WHO Secretariat  
Technical cooperation, 45 
WIPO Secretariat  
Technical cooperation, 46 
WTO Secretariat
 
Notifications, 5 Review of Para. 6, 17 Technical cooperation, 42 
 
  
 
 
 
   
 
  
 
  
 
 ___________________ 
* A record of statements as deli vered. Some statements have been lightly edited as appropriate 
to ensure the consistency of presentation. IP/C/M/80/Add.1 
 
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  AGENDA ITEM 1: ELECTION OF INTERIM CHAIRPERSON 
1.  No statements were made under this agenda item. AGENDA ITEM 2: NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT 2.1  Chinese Taipei   
 
2.  My delegation is pleased to inform the TRIPS Council that some acts or regulations pertaining to intellectual property have recently been am ended. The changes are found in two regulations. 
3.  Firstly, Articles 4, 27 and 36 of the Enforc ement Rules of the Trademark Act were amended in 
order to streamline the trademark application proce ss. Accordingly, the applicant is exempted from 
submitting the original copy of proof for rights of priority and exhibition priority, as well as a copy 
of the written request and related documents of the original application for division of an 
application for registration. 
4.  Secondly, Article 11 of the Regulations Gove rning the Implementation of Filing Trademark 
Applications and Services by Electronic Means has been amended to comply with the deletion of 
Article 4.2 of the Enforcement Rules of the Tr ademark Act requiring that the applicant be 
exempted from submitting the original copy of proof  for rights of priority and exhibition priority. 
5.  My delegation will continue to fulfil its obligation to comply with Article 63.2 of the TRIPS 
Agreement and increase the transparency of our intellectual property system.  
2.2  Australia
   
 
6.  As is reflected in the Article 63.2 notifi cations referred to by the Chair, Australia has 
undertaken significant intellectual property reform s over the course of 2015. In August 2015, 
Australian legislation to implement the TRIPS Protocol entered into force. This reinforces our 
commitment to improving access to medicines. We in tend to touch upon this again under item 7 of 
the Council's agenda. Australia also passed legislation in June to reduce online copyright infringement. Australia's approach to tackling this challenge is intended to ensure creators are 
rewarded for their creativity and creative industri es continue to thrive. We would be pleased to 
respond to any queries from Members about these important reforms. 
2.3 WTO Secretariat   
 
7.  Since 2009, in response to the request from the Chair of the General Council, the Council has considered how to improve the timeliness and completeness of notifications and other information flows. The Secretariat has progressively updated the Council on the work being done in this 
direction. There is one very important caveat, mentioned each time, that all this work takes place 
entirely within the guidelines of notifications already set within the TRIPS Agreement itself and the guidelines and procedures agreed by this Council. Accordingly, the focus has been on practical 
ways of improving how we work with this information and ensuring that it is more user-friendly 
and more transparent. This concerns particularly , but not exclusively, the laws and regulations 
notified under Article 63.2 of the TRIPS Agreement. This has been a particular focus because it 
constitutes the overwhelming bulk of notified materials. At a previous meeting, the Council 
requested that this update now be provided as a regular part of this agenda item concerning notifications, rather than as a distinct agenda item.  
8.  We are making the unusual step of making a presentation under this item
1 because we have 
moved towards a modernized way of handling this information; ultimately we will be inviting 
delegates and Members to make use of a much more user-friendly online system as an optional means of submitting notifications. In the past, we have received notification material from 
Members in a wide range of formats, ranging from sheaves of paper, to a whole range of digital 
formats on discs, floppy and otherwise, on US B keys, and by email. The current efforts to 
modernize the system would not limit the existing options of Members to notify material in any 
                                               
1 Available at: https://prezi.com/obkzp8yhnsen/trips-council/  
 IP/C/M/80/Add.1 
 
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  way they choose. The idea is to provide an optional tool, which we hope will ease the work of 
delegates and Members in tracking and updating their notifications, and in submitting material in a way that will make it quicker and more e fficient for the Secretariat to process it.  
9.  A further caveat - this presentation is in  only one of the three working languages of the 
Organization, but I stress that the tools and the screens that we are describing and developing 
would of course be fully functional and operational in the three working languages of the Organization.  
10.  The focus has been especially on notifications of legal texts under Article 63.2. There are 
other extremely important areas of notification, but this one presents the greatest practical challenge in managing information. This transparency requirement is a fundamental obligation under the TRIPS Agreement and a fundamental role of the Secretariat to manage this material 
because of the essential principle of transparency. It is a unique record of legal and policy 
development and experiences in over 140 different jurisdictions at a time that has been most active ever in human history in terms of intellectual property law and policy development. It is a 
very large amount of material. There are 4,500 dist inct document references to work with. These 
refer to over 3,000 distinct legal texts. That is a reminder that there is no direct correlation 
between a document reference and one distinct lega l text; hence, much of the effort is in cross 
referencing this material, so that you can navigate it more easily. The coverage is slightly variable 
and Members have taken different approaches to updating their notifications. In some cases, the most recent notification was in 1996 or 1997; in other cases, it was received earlier this month. Thus, the time coverage, the timeliness and the completeness of the material is not uniform. This 
is one of the reasons to make it easier to track what has been notified and to provide a much more 
straightforward tool for updating notifications.  
11.  The pattern of notifications over the last 20 years shows variation over time: an initial surge, 
particularly from 1996 to1997, when developed countr y Members notified the bulk of their existing 
laws; a further surge in activity from 2000 to roughly 2004, representing the majority of 
developing country Members who notified their laws at that point; and then a third period of 
increased activity from 2008 and in particular, from 2011 to 2012, when several accessions took 
place and when Members responded to the call from  the General Council to look at the timeliness 
and completeness of notifications. So we have seen a rise in the activity since then. That said, we know that there are some quite significant gaps in coverage and once again that is why we are 
hoping to provide a more user-friendly tool for Members.  
12.  The key difference between when the current system was set up, a very robust and functional 
system in 1995, and today, is that the principal me ans of capturing, working and distributing data 
at that time was the paper document. A great deal of information is contained in these documents 
and in the intial stage of the work of this Council, if you wanted to know what was notified by a Member in a particular area, you would go to typically the third secretary's office in the Mission 
and leaf through a large pile of paper to find it. Frankly, at this stage it seems that nobody is using 
the documents in that way any more. We do have a general expectation today that material will be 
available online in a reasonably accessible way. But that simply is not the case. If we look at the way you would access data/notification material today, the gateway is the documentation service. 
Because this is a pivotal point, I wanted to illustrate the challenges that we currently face in using 
this material, because it is central to achieving in practice transparency of the notification function under the TRIPS Agreement. To locate informatio n, you would need to search documents through 
an online table. You would need to know the code s of the documents' symbols very well. Very few 
people do know the system well: it is not intuitive and even experienced users of this system need constant refreshment and need to understand what to  look for. When you do identify one of these 
documents, the title is normally not very informative, so in a typical example we only find that it is 
a law notified under Article 63.2. We don't know its content, we don't know even whether it is 
about patents or plant varieties, or both. Finally, by following the links in the table, you get to a longer list of documents and you would need to click through each of them one by one to find out 
what is inside. Earlier documents are not text searchable at all, so, if you get past the gateway, 
you need to open up, in on typical example, one si ngle document that is divided into nine parts, 
each of which needs to be opened up individually , and scrolled through page by page to find what 
it contained. For example, if in following the no tification at today's session of the Council of 
Australia's copyright amendment, you wanted to go back to the original Australian notification on 
copyright law, you would find that it is in 19 se parate parts divided from one document. There is 
no way of knowing in advance which part of this document contains the provision of interest to IP/C/M/80/Add.1 
 
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  you. You might guess that the provision you are looking for is roughly in the middle. You would 
then have to download that part of the document an d open it up. In this example, it turned out to 
be the wrong part of the document. I tried again, and finally got to the part of the document I was looking for; but I had to scroll through, page by page, because it is not text searchable, and again 
I had to guess as to which section of document co ntains the material I am looking for. Finally, I 
get to the provision I was interested in. Then, it is still an image. So if I need to use this text, for instance to cite or quote it, I will have to transcribe it manually and retype it if I am going to use 
the text in any way. So it is cumbersome. Because of quite significant reasons that were entirely 
applicable in the mid-nineties, it was an entirely suitable system for that time. But if you look at this example, which took nearly 25 minutes to get to this point, you can see why people don't use this day to day, given current expectations about the availability of data.  
13.  For this reason, we have moved towards a restructuring of the documents so that they are 
more informative and more useable. You will see this from the documents that have been circulated for this session of the Council. The earlier format simply provided a cover page for a 
legal text; you would have to leaf through that document again to find out anything significant 
about it. By contrast, the new format, which is now used for the documents in front of you for this session of the Council, sets out information about the notification in a much more systematic and 
informative way.  
14.  To capture this data, we have developed this prototype online submission gateway, which is 
still very much a prototype. It is not ready, frankly, to go online and to be used more widely. We are still working with it internally. But this would provide an easy gateway for Members to submit 
notifications and other reporting. I will quickly illustrate how it would work in this case. It is simply 
an online form. It is all quite obvious inform ation: the notifying Member, the name of the 
legislative text that is being notified, as well as the status of the text. This is an important 
development because well over 25% or nearly 30% of laws that are being notified are now 
amendments to consolidations of earlier notifications. So to be worthwhile and useful, we need to have a link to the previous notifications. Accordingly, we are providing an easy way of making that 
linkage, as well as obvious things such as identifying which area of law it covers. This would be a 
conventional online form; we are working to making it easy to use. However, we will be inviting delegates early next year to volunteer as beta testers, to sit down with us and work through this in a practical way, because the final design will be entirely crafted according to your needs. It is there 
to serve you as delegates, and as capital-based offi cials. It is therefore going to be very important 
to make sure that it has all of your feedback an d there will also be support and guidance materials 
to assist in the use of this. Our aim is to make this as user-friendly as possible.  
15.  In the interim, because we certainly don't want to impede the flow of new and updated 
notifications, we have prepared a simple PDF form. This is a form that once again is quite a conventional part of our paperwork today, a simple PDF form that can be filled in and submitted to 
us, which effectively in the interim does the task  that the final online submission process would 
enable. And so, in short, very simply, if any Member is looking at its notifications and wishing to update them to provide us with notifications, we  would strongly encourage you to come and speak 
to us or get in touch with us. We will work with you to greatly simplify your task and to help us 
also to prepare the materials so that it can be circulated to Members in a much more useable form 
than the rather awkward historic arrangement that I outlined earlier.  
16.  I have taken a little time and illustrated this because it is at a critical stage. We are working 
intensively on this within the Secretariat, very much as a prototype. It will most likely be early 
next year that we will be inviting delegates and Members to explore this, to give us feedback, and 
to give us direction before it is packaged up and put online as a resource for Members. Of course, 
we are available for more informal discussions and explanation of this project. 
AGENDA ITEM 3: REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION Review of the national implemen ting legislation of Tajikstan 
 
3.1  Tajikistan   
 17.  As mentioned by the Chairman, Tajikstan ha s received follow-up questions from the United 
States concerning copyright issues and we have  submitted our responses to the US questions. 
Tajikistan would like to express its thanks to the United States for their questions and if there are IP/C/M/80/Add.1 
 
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  any questions from other Members, please let us kn ow and Tajikistan will provide answers as soon 
as possible. 
3.2  United States of America   
 
18.  Thank you again to the Secretariat following Australia's intervention for preparing today's 
meeting, including the very interesting presentation with respect to notifications. On this note, we 
would like to thank Tajikistan for its continued engagement on this issue. We welcome your sets of 
responses and look forward to receiving additional responses. I think we will follow up bilaterally 
on one further clarification that we have and look forward to continued engagement on this important issue. 
Follow-up to reviews already undertaken 
 
3.3  Fiji   
 
19.  My capital is currently working on the ou tstanding questions. We are working with the 
Secretariat. By the next Council we should have completed our review. 
AGENDA ITEM 4: REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B) 
AGENDA ITEM 5: RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE 
CONVENTION ON BIOLOGICAL DIVERSITY 
AGENDA ITEM 6:  PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE 6.1  Peru    
 
20.  Peru joins other delegations in welcoming the fact that this morning, 15 October, those of us who are WIPO Members succeeded in setting aside our differences and agreed to renew the 
mandate of the Intergovernmental Committee on Intellectual Property and Genetic Resources, 
Traditional Knowledge and Folklore (IGC) for the period 2016-2017. 
21.  Biological diversity is one of the main pill ars of the Peruvian economy. Some 99% of Peru's 
fishing activities depend on hydrobiological resources, 65% of its agricultural production is based 
on native genetic resources, 95% of its livestock farming uses native natural pastures, and 99% of its forestry industry uses native woodland and species. Moreover, biological diversity is an important source of direct employment and livelihoo d for much of Peru's population. This reflects 
the concerns of a great part of ou r population with this issue.  
22.  As we have stated on previous occasions in this Council, a requirement for multilateral and 
mandatory disclosure would be the most effective way to address the international problem of 
misappropriation of genetic resources and traditional knowledge, as it would allow all countries to 
identify the country supplying the biological resour ce by requiring patent applicants to disclose the 
country of origin and provide evidence of compliance with prior informed consent and 
benefit sharing. 
23.  Peru is fully convinced of the importance of the intellectual property system as a tool for the 
economic, social and cultural development of our countries, and it is because of this that we attach such importance to this issue as one of the ou tstanding implementation-related issues mentioned 
in paragraph 12 of the Doha Declaration. 
24.  In our view, only a balanced result that deals with the problem of biopiracy will enable 
Members to establish a proper balance in the patent  system and in the intellectual property system 
in general for the benefit of all, particularly the local and indigenous communities of 
developing countries. Peru therefore believes that the WIPO negotiations should take into consideration the following points: 
 The inclusion of the concept of "derivatives" of genetic resources as protected subject-
matter. More than 60% of patents in the area of biotechnology, pharmaceuticals and cosmetics etc. are awarded to inventions based on products derived from the genetic IP/C/M/80/Add.1 
 
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  resource concerned, which means it would be of little use to protect only the genetic 
resource as such. 
 The requirement to disclose the origin of the genetic resource and/or its derivatives and 
associated traditional knowledge in a patent application should be clear and expressly 
recognized. 
 This disclosure requirement should also oblige the patent applicant to present the respective 
access contract for the genetic resource concerned, along with the formal agreement with 
the respective local communities, where appropriate. 
6.2  India   
 25.  Firstly, I would like to associate myself with the statement made by Peru. 
26.  There has been extensive discussion on th ese 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 proved beyond doubt that such 
misappropriation and granting of wrongful patent s is possible because of the inadequacy of the 
TRIPS Agreement to address these issues. 
27.  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 
the Biological Diversity Act in 2002 and notified the 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 the transfer of results of 
research to any foreigner are dealt with by the National Biodiversity Authority.  
28.  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 the TKDL Access Agreement with nine 
International Patent Offices. While India has pion eered the TKDL to overcome language and format 
barriers, the results could only be limited. Improv ing prior art searches through the TKDL was only 
one part of the solution. Further, the TKDL re presented a subset of the universe of available 
traditional knowledge. The realm of traditional knowledge in areas other than herbal cures and genetic resources was not covered by the TKDL.   
29.  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 developing countries. The disclosure proposal (IP/C/W/474) which 
was submitted in 2006 was followed up by the su bmission contained in TN/C/W/52 in June 2008 
with the support of 109 Members. The latest submi ssion on this issue, TN/C/W/59, "Draft Decision 
to Enhance Mutual Supportiveness between the TRIP S Agreement and the Convention on Biological 
Diversity" 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. 
30.  The Nagoya Protocol of the CBD entered into force on 12 October 2014. So far 68 countries, 
including India and the European Union have ratifi ed the Protocol. According to the CBD website, 
the Access and Benefit-sharing Clearing-House (A BS-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 the legal certainty and 
transparency of procedures for accessing 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. IP/C/M/80/Add.1 
 
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  31.  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 on 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. 
32.  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 developing countries.   
6.3  Egypt  
 33.  We would like first to associate ourselves with the statements made by Peru and India. 
34.  The protection of biological resources, traditional knowledge and folklore presents an 
important developmental issue for Egypt. In view of the importance of this issue, we continue to support the engagement in full on the negoti ations regarding the TRIPS Agreement and the 
Convention on Biological Diversity (CBD). This is a crucial part of the implementation-related 
issues and concerns as contained in the Doha Work Programme. We urge other Members to engage in this issue of prime importance for develo ping countries as a part of the conclusion of the 
DDA.  
35.  In fact, technical discussions on this issue have been ongoing for almost a decade so far. The 
essence of our efforts so far is that the TRIPS Agreement should be a mandate in order to provide that Members shall require an applicant for a patent relating to biological resources and/or 
associated traditional knowledge to disclose the source and country of origin of the biological 
resources and the associated traditional knowledge used in the invention. Furthermore, the applicant shall also provide evidence or prior co nsent and evidence of fair and equitable benefit 
sharing under the relevant national regime. We would like here to make reference to document 
IP/C/W/474.  
36.  Finally, Egypt continues to encourage the engagement of the Director-General in his 
mandated consultative process on the relationship between the TRIPS Agreement and the CBD. 
We look forward to the outcome of this kind of  consultation and we request other Members to 
engage constructively in this negotiation, taking into consideration that this issue is one of high priority for developing countries. We would also like to support the proposal to invite the CBD 
Secretariat to brief the TRIPS Council on the Nagoya Protocol. 
6.4  Indonesia   
 
37.  We would like to associate ourselves with the statements made by Peru, India and Egypt. 
38.  Indonesia's position on this matter is alread y known by the house. The implementation of the 
TRIPS Agreement and the Convention on Biological  Diversity (CBD) should be carried out in a 
manner that is mutually supportive and does not run counter to their respective objectives. In this 
light, my delegation would like to place particular focus on the provisions of prior informed consent for access and fair and equitable benefit sharing em bodied within the CBD and Nagoya Protocol. As 
the foundation for the protection of genetic resources and associated traditional knowledge, this 
principle shall become the most important capita l for the development of indigenous people and 
their livelihood. So far the TRIPS Agreement does not oblige Members to take necessary measures on fair and equitable benefit sharing as required by the CBD and Nagoya Protocol. This could lead 
to misappropriation and granting of erroneous patents, which would defeat the purpose of the CBD 
and the Nagoya Protocol. 
39.  With this motion, Indonesia would like to point out that the disclosure requirements will be 
incomplete without the disclosure of origin of genetic resources and associated traditional 
knowledge. The inclusion of the mandatory requirements for disclosure of origin would enhance transparency concerning the utilization of genetic resources and associated traditional knowledge and thus avoid biopiracy that has robbed the Indonesian people of the benefits which are essential 
for their development and livelihood. Therefore,  as a proponent of document TN/C/W/52, 
Indonesia remains consistent with its view on the urgency of the inclusion of the mandatory IP/C/M/80/Add.1 
 
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  disclosure requirement in the TRIPS Agreement. Indonesia would also like to reaffirm its support 
for the protection of traditional knowledge and folklore. It is worth noting that misappropriation of traditional knowledge and folklore remains rampant as Indonesian indigenous and local communities continue to face claims from other parties utilizing the existing IP system to obtain 
rights over this traditional knowledge and folklore. For this purpose, Indonesia consistently 
supports the establishment of a sui generis  regime for the protection of genetic resources, 
traditional knowledge and folklore.  
40.  The existing TRIPS Agreement, if not amende d, could jeopardize the effort being made by 
countries in WIPO through the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore. Therefore, in line with our views on agenda item 5, Indonesia underlines the need to ensure cohe siveness between the TRIPS Agreement and the 
discussion carried out in WIPO, as reflected in the preamble of the TRIPS Agreement.  
6.5 Bangladesh, on behalf of the LDC Group   
 
41.  I am taking the floor on behalf of the LDC Gr oup. In line with existing laws on patents and 
also on moral and ethical grounds, we do not supp ort the patenting of life forms such as plants 
and animals. We consider that natural resources such as plants and animals belong to the whole of 
mankind and should not be appropriated by any individual or corporate body. We believe that 
genetic resources and associated traditional knowledge  are integral parts of the sovereign rights of 
states or their indigenous peoples. Just like the protection of any other sovereign interest of state, genetic resources and traditional knowledge and folklore must also be safeguarded from any form 
of misappropriation, which denies the very benefits to its own rightful owners and holders. The 
most effective way to ensure against misappropriation is implementation of a disclosure mechanism with the introduction of prior informed consent on mutually acceptable terms. 
Harmonization with the Convention on Biological Diversity (CBD) has been a critical 
implementation issue for all of us. This is impo rtant for developing countries, and especially for 
LDCs to ensure health, food security and livelihood of local communities. Both the TRIPS 
Agreement and the CBD, with its Nagoya Protocol, uphold the promotion of innovation for the 
development of all countries and their socioeconomi c environment, irrespective of the levels of 
development. These two instruments are complementary to each other.  
42.  Accordingly, we think that it would be beneficial if the CBD Secretariat could brief all Members 
of this Council and explain the advantages of th e provisions of the CBD and the Nagoya Protocol. 
The CBD has, in particular, provided for the es tablishment of legitimate rights over genetic 
resources. Patent applications should disclose the source of the invention if they access and use a 
particular genetic resource of which they are not the rightful owner. The disclosure requirement is 
also consistent with the transparency principle that we are seeking to strengthen in the multilateral trading system and will help to redu ce the number of erroneous patents and biopiracy. 
The disclosure mechanism will also ensure access to  benefit sharing for the rightful owners of the 
resources. We hope that the mandate provided for in paragraph 19 of the Doha Declaration and that was reinforced in subsequent Ministerial Declarations will be implemented in an early and concerted manner for the sake of justice and fairness.  
6.6  Ecuador   
43.  Ecuador believes that the Council should en gage in discussion and analysis with a view to 
reviewing Article 27.3(b) to take into considerat ion the patentability of all forms of life. Harm 
should not be caused to cultures and to peoples and patentability should not affect life forms. 
Ecuador stands firm in its belief that there is a strong relationship between the TRIPS Agreement and the Convention on Biological Diversity (CBD). We need to have legal multilateral instruments 
that allow us to provide protection for genetic and traditional cultural expressions. We also need to 
establish clearly the source of origin in this regard and there should also be a clear and balanced distribution of benefits.  
44.  Ecuador supports India and other delegations in asking that the CBD Secretariat inform the 
Council of negotiations carried out within the framework of the Nagoya Protocol on genetic 
resources and benefits that may arise from their use. IP/C/M/80/Add.1 
 
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  45.  On several occasions Ecuador has raised the need for the Secretariat to update its factual 
notes, which has not been done since 2006. We consider that documents IP/C/W/368/Rev.1, IP/C/W/369/Rev.1, IP/C/W/362/Rev.1 and IP/W/C/ 273/Rev.1 will provide us with greater clarity 
on these issues.  
6.7  Cuba   
 46.  Cuba would like to lend its support to the statements by the delegations that have already 
taken the floor, in particular Ecuador, Peru, Bangladesh and India. Cuba is in favour of intensifying 
work on these issues, for which a mandate has been expressly provided in the Doha Declaration. Furthermore, these issues are of vital importance for developing and the LDCs. 
47.  As the delegation of India has expressed, th ere are proposals on the table that constitute a 
good basis for our work, in addition to other documents that have been submitted in order to 
follow up and deliver on the Ministerial mandate throughout these years of negotiations. We also recommend working more closely with other organizations such as UNCTAD, WIPO and the FAO, 
which would, moreover, be in keeping with the WIPO Development Agenda. 
48.  Finally, advancing the negotiations on these topics could make an unprecedented WTO 
contribution to the objectives of the post-2015 Development Agenda agreed within the framework 
of the United Nations. 
6.8  Colombia   
 49.  We would also like to lend our support to what has been said by other delegations which have 
taken the floor.  
50.  Colombia wishes to reiterate its position concerning the need to review the TRIPS Agreement 
and incorporate mechanisms that would help a ddress the issues of monitoring and follow-up 
highlighted by mega biodiverse 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. This 
will ensure that the regime covering access to genetic resources and benefit sharing is consistent 
with the objectives of both protection system s and that these are thus mutually supportive, 
pursuant to the Convention on Biological Diversity and Article 4 of the Nagoya Protocol. 
6.9  China   
 
51.  I would also like to echo the views expressed by the previous delegations. It is well recognized that the issue of the relationship be tween the TRIPS Agreement and the Convention on 
Biological Diversity (CBD) has been largely de bated at the TRIPS Council. Therefore, China 
suggests that Members should work jointly and effectively with a view to finding a solution to this matter. China considers that the TRIPS Agreement needs to be amended with a view to 
introducing a mandatory disclosure requirement of the origin of genetic resources and traditional 
knowledge in patent applications, as jointly held by the majority of Members and as reflected in documents TN/C/W/52 and TN/C/W/59.  
52.  The proposed solution can contribute to preventing the misappropriation of genetic resources 
and the granting of erroneous patents due to lack  of information to improve the transparency of 
the utilization of genetic resources and to enhance legal certainty. Considering the legitimate objectives pursued by the system, it is China's view that it would be burdensome for the patent 
applicant to provide the information concerning prior informed consent and access and benefit 
sharing. The contractual arrangements of the da tabase solution proposed by some Members are 
still far from providing sufficient protection of genetic resources. As we all know, the forthcoming 
Ministerial meeting provides us with a good opport unity to make some achievements on this issue. 
China proposes that, according to the Hong Kong Ministerial Declaration, the Director-General should continue to lead and further intensify the consultations on TRIPS and CBD issues, in order to achieve some positive outcomes at MC10. IP/C/M/80/Add.1 
 
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  53.  Once again, China would like to requ est that the three factual notes, namely, 
IP/C/W/368/Rev. 1, IP/C/W/369/R ev. 1 and IP/C/W/273/Rev.1 be updated with new documents. 
This would provide Members with helpful information, which will enable a constructive debate. 
6.10  South Africa   
 
54.  Paragraph 19 of the Doha Ministerial Declaration instructs the TRIPS Council "in pursuing its work programme including under the review of Arti cle 27.3(b), the review of the implementation of 
the TRIPS Agreement under Article 71.1, and the work foreseen pursuant to paragraph 12 of this 
Declaration, to examine, inter alia , the relationship between the TRIPS Agreement and the 
Convention on Biological Diversity, the protection of traditional knowledge …". 
55.  Bearing this in mind, the debate regarding the relationship between TRIPS and the Convention 
on Biological Diversity (CBD) has been on the TRIPS agenda for an inordinately long time without 
many tangible results. A large group of developing country Members proposed an amendment to the TRIPS Agreement to introduce a mandatory disclosure requirement in patent applications and 
have sought clear guidance on this matter as part of a modalities decision. The basis of this 
amendment is contained in TNC/W/59, which requires access and benefit sharing, prior informed consent and disclosure of the source of material when a patent is applied for.  
56.  The relationship between TRIPS and the CBD remains a core aspect of the Doha Mandate and 
specifically as an outstanding implementation issu e. It is therefore the plea of the South African 
delegation that the relationship between TRIPS and the CBD be crystallized by moving swiftly to text-based negotiations. We join other delegations in calling on the TRIPS Council to invite the 
CBD Secretariat to update this Council on the developments in respect of the Nagoya Protocol and 
other relevant developments. Finally we also call for the completion of the three factual briefs by the Secretariat. 
6.11  Nigeria, on behalf of the African Group  
 57.  The position of the African Group is well kn own. We support the statements made by previous 
speakers, in particular, India, Peru, Indonesia, Bangladesh, China and others that the TRIPS 
Agreement be amended in order to ensure that th ere is a disclosure of country of origin, genetic 
resources and evidence that the applicant has re ceived prior informed consent, as well as 
equitable benefit sharing of those genetic resources. 
6.12  Brazil   
 58.  I will be brief in my comments to avoid reit erating our well known position on the importance 
of promoting the neutral support between the TRIP S Agreement and the Convention on Biological 
Diversity (CBD). As for many delegations that intervened before, enhancing the transparency and 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 for Brazil. At the national level, earlier this year Brazil updated its legislation on the regulation of the access to genetic resources and associated traditional knowledge, in which the principles of access and benefit sharing, as well as informed 
participation of the indigenous communities, are duly respected. We hope to see the necessary 
measures to prevent biopiracy reflected in the TRIPS Agreement as well. We would also like to emphasize the importance of the request that the CBD Secretariat brief this Council on the 
developments in the Nagoya Protocol in force since last year. The information provided during this 
briefing would be of benefit for us all, so we hope that there is agreement on this point soon, so that the CBD Secretariat can contribute to our work in the Committee. 
6.13  Chile   
 59.  Our delegation would like to make reference to item 4 on the agenda. As we have pointed out time and time again, in our view the TRIPS Agr eement provides sufficient flexibility so that 
countries may in a sovereign way opt in favour of the type of protection they require. Surely this is 
a theme which we have to look at when it comes to the patentability of animals and on the basis of the analysis made by different countries and on the basis of their biological diversities.  IP/C/M/80/Add.1 
 
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  6.14  Switzerland   
 60.  Switzerland would like to thank the Chair and the Secretariat for the consultations held yesterday, and for the guidance provided on these three agenda items. 
61.  While considering discussions on this issue in a broader perspective, Switzerland takes note 
that the relationship between TRIPS and the Convention on Biological Diversity (CBD) remains, together with GI extension, one of the two outstanding implementation issues. 
62.  Even if those issues, in tandem with the GI register, were not mentioned in the list of 
promising issues identified by the Director-Gener al at the last General Council as being among the 
most realistic deliverables for MC10, Members need to  continue to engage constructively to obtain 
results on the three TRIPS issues in the process in Nairobi, and thereafter if no outcome can be 
achieved at MC10. 
63.  The modalities language for the multilateral GI-register, the GI-extension and the disclosure 
of the source requirement for patent applications based on genetic resources and traditional 
knowledge proposed in document TN/C/W/52 by 108 WTO Members provides a solid basis for the 
further work undertaken in this context. 
64.  As for the proposals which have been take n up in yesterday’s informal consultations and 
today again, Switzerland supports the proposal by several delegations that the CBD Secretariat 
inform the Council at a subsequent meeting abou t the entry into force of the Nagoya Protocol. 
65.  As also endorsed by the Swiss delegation in  earlier Council meetings, we are supportive of the 
proposal by Ecuador and others that the WTO Secretariat update its earlier factual notes, 
compilations and documents on the TRIPS/CBD and GI issues to include the discussions held in 
past years. 
6.15  Japan   
 
66.  These three issues have been discussed at le ngth during meetings of the TRIPS Council. My 
delegation, therefore, believes that its position is well recognized among Members, so we would 
like to make our intervention brief,  highlighting some major points.  
67.  The delegation of Japan would like to reiter ate its position that it is necessary to seek 
appropriate ways to deal with the misappropriation of genetic resources, bearing in mind that any 
measures that would be taken should in no way adversely affect the existing intellectual property 
system and any innovations utilizing genetic resources and associated traditional knowledge. 
68.  At the last Council meeting in June, my delegation shared its industries’ experiences to show 
that the inclusion of the disclosure requirement substantially impacts innovation. In other words, 
some industries have withdrawn their R&D activities on biological materials overseas because of 
legal uncertainty surrounding securing fruits of such R&D activities utilizing such biological materials, due to the introduction of mandatory disclosure requirements in some countries, which 
we have been trying to avoid all along. Therefor e, we believe that the disclosure requirement is 
not an appropriate means to deal with misappropriation, and as such, should not be introduced into the intellectual property system.  
69.  Finally, Japan respects the outcome from the WIPO General Assembly this morning, which is 
to renew the WIPO/IGC mandate and allow us to continue discussions on these important issues 
among experts. We believe that WIPO is the most  appropriate entity to coordinate these issues. 
The delegation of Japan will continue to work in this regard in a constructive and effective manner.  
6.16  Canada   
 70.  Canada would also like to join others in congratulating those who were up in the small hours 
of the morning to resolve some of the outstanding issues at WIPO and, in particular, we welcome 
the decision of the WIPO General Assembly to resume work in the Intergovernmental Committee 
on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC). We IP/C/M/80/Add.1 
 
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  have been and are very pleased to continue to be active and committed participants in this work, 
which is clearly very important to Members here today.  
71.  As we have noted previously, we believe that WIPO, and particularly the IGC is the best and 
most appropriate forum for discussion of these complex issues. We look forward to concrete 
discussions and the exchange of national experi ences at the IGC over the coming biennium, 
including discussions with Members that implement mandatory disclosure regimes with a view to identifying appropriate balanced and mutually beneficial approaches.  
72.  Canada believes that the existing patent sy stem is fundamentally equipped to prevent patents 
from being branded in error, including by ensuring that patent offices have at their disposal the appropriate information required to make proper  decisions on granting patents. We encourage 
Members to consider other non-patent-based mechanisms to promote conservation of biodiversity 
and prevent misappropriation of genetic resources, such as developing broader and more globally 
accessible and functional prior art bases, such as those mentioned by my colleague from India, encouraging the use of mutually agreed terms, an d contractual agreements and codes of conduct. 
73.  In the context of the WTO, we wish to reiterate our longstanding position that the TRIPS 
Agreement and the Convention on Biological Dive rsity (CBD) are mutually supportive and we do 
not agree that there is a negotiating mandate attached to this relationship outlined in the Doha 
Declaration. Rather, it is an implementation issue for discussion in this Council and we continue to 
support that approach and the flexibility it provides  at national level. In this regard, we remain 
committed to working constructively with all WTO Members. 
6.17  Korea, Republic of   
 
74.  On this agenda item, Korea has made clear its position in this Council, as other Members have done, and we do not recognise any new developments warranting a change to our position this 
time, so would like to replace our intervention  with our previous statement. (See previous 
IP/C/M/78/Add.1 paras 90-92 and IP/C/M/79/Add.1 para 74). 
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. 
 
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. 
 
6.18  Nepal   
 75.  At the outset, the delegation of Nepal aligns itself with the interventions made by Bangladesh, 
on behalf of the LDC Group, and some developing countries, including Peru, India, Egypt, 
Indonesia and some others, on this agenda item.  
76.  The delegation of Nepal emphasizes the revi ew of Article 27.3(b) as mandated by the Doha 
Declaration paragraph 19. While supporting the re view for addressing the issue of protecting 
inventions of indigenous local farming practices, genetic resources and traditional knowledge, we hold strongly negative views of the patenting of any kind of life forms. 
77.  We underscore the need for a mutual linkage between the relationship between the TRIPS 
Agreement and the Convention on Biological Diversity (CBD), including consistency and cohesiveness to be established between these two important international agreements. In this regard, we welcome the views expressed by Member s that the CBD Secretariat be invited to this 
Council to brief Members on the Nagoya Protocol. It is our firm belief that states have the right to 
preserve their genetic resources, traditional knowledge and folklore to suit their own methods and requirements.  IP/C/M/80/Add.1 
 
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  78.  As stipulated by the CBD, we are of the vi ew that countries deserve the full right to take 
sustainable economic advantage of genetic resources and traditional knowledge through legal provisioning in their national country. Small countri es like Nepal, each with their biodiversity, are 
becoming victims of misappropriation of their precious genetic resources, traditional knowledge 
and folklore on a massive scale and they are deprived of enjoying adequate advantage of each. 
That is why we emphasize due legal recognition and protection under TRIPS in the interest of vulnerable countries.  
79.  In the light of this, we call for the TRIPS Agreement to be modified in such a way that it 
requires patent applicants for biological material to provide information on source and the country of origin of biological resources and the traditional knowledge used in the inventions. For reasons related to the mandatory disclosure requirement, if included in the TRIPS Agreement, it will 
contribute to preventing misappropriation of genetic resources and associated traditional 
knowledge, along with improving transparency in the utilization of resources and entities. 
Furthermore, we are of the view that patent app licants must also provide proof of prior informed 
consent (PIC) and agree on proportionate benefit sh aring with authorities of the relevant country 
of origin. This obligation of information and mandatory provision of benefit sharing will assist in reducing the number of patents granted erroneously or through biopiracy and at the same time 
enable developing and least developed countries to benefit from the use of their indigenous 
resources. 
6.19  New Zealand   
 
80.  As some have also mentioned this morning, we welcome the news from WIPO concerning the 
renewal of the mandate of the WIPO Intergover nmental Committee on Intellectual Property and 
Genetic Resources, Traditional Knowledge and Folklore (IGC). I think it was worth the lack of sleep 
to achieve that outcome. 
81.  As we have previously stated, New Zealand agrees with the views expressed by many 
Members about the importance of preventing the misappropriation of genetic resources and 
associated traditional knowledge. At a broader level, we have a systemic interest in preventing the 
granting of erroneous patents and measures that contribute to high-quality patent examinations 
that are important to ensuring the health and integrity of patent systems. New Zealand considers that there is a significant degree of common und erstanding among Members of these high-level 
objectives. But with that said, there is still  much disagreement over the appropriate policy 
responses that would best achieve these objectives. New Zealand's domestic policy is still evolving in this area. We are, however, committed to engaging constructively in relevant international 
forums to address these important issues. As others have mentioned this morning, the WIPO IGC 
has been mandated to undertake a detailed consideration of the relationship between intellectual property and genetic resources, as well as traditional knowledge and traditional cultural 
expressions and to develop a text of an internat ional instrument(s) on the protection of these 
subject matters.  
82.  New Zealand considers that the WIPO IGC is the most appropriate forum to discuss in detail 
these issues relating to the protection of traditional knowledge and genetic resources, because it is 
able to look at these issues in a holistic and coordinated way. In this regard, we will welcome the 
renewal of IGC's mandate this morning and we look  forward to engaging constructively in this 
forum in order to contribute to the fulfilment of this mandate. 
6.20  United States of America   
 83.  The United States associates itself with the interventions made by the delegates from Japan 
and Canada.  
84.  We congratulate delegates on their hard work leading to an outcome at WIPO on the 
Intergovernmental Conference on Genetic Reso urces, Traditional Knowledge and Traditional 
Cultural Expressions. This outcome confirms our position that WIPO remains the appropriate forum 
to address this issue. 
85.  Regarding the briefing on the Convention on Biological Diversity (CBD), we recall the 
delegation of Japan’s very helpful and informative presentation on the Convention and continue to IP/C/M/80/Add.1 
 
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  believe that this presentation represents a good model for this Council in terms of updates on 
developments outside of this body. We query why the CBD Secretariat is in a better position than 
TRIPS Council Members themselves to provide such an update.  
86.  Finally, turning to the requests today for a CBD Secretariat briefing, with respect to the 
Director-General's engagement, and for the update of the three factual notes by the Secretariat, 
while we are not in a position to accept such requests, we are quite open to having conversations with delegations on these issues. We look forward to engaging constructively on these issues and 
invite those delegations to discuss those issues with us. 
AGENDA ITEM 7:  REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE 
IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH 
7.1  WTO Secretariat  
 87.  We have engaged in dialogue with a num ber of Members about this matter following the 
Director General's introduction of this issue in the General Council in February and following 
Ambassador Al-Otaibi's communication to Members as Chair of this Council in May.  
88.  Our feedback has been very much about practical matters concerning the instrument of 
acceptance of the Protocol Amending the TRIPS Agreement. The key message that comes up in 
many conversations is this: there is concern that before accepting the Protocol, the assumption has often been that it is necessary to introduce domestic implementing legislation, in other words to implement this new TRIPS flexibility before accepting the amendment. Without questioning or 
analysing individual Members' constitutional arrangements, the wide experience among the 
membership is that this is not the case. Indeed , as a rough estimate, almost fifty members have 
lodged their acceptances without having first passed any legislation implementing the System. 
Why is this? It is because this is a new flexibility, not a new obligation. It is an optional measure 
for WTO Members to use if they wish, so as to advance their public health interests.  
89.  The Protocol as such, and the amendment of the Agreement, create no obligation to 
implement this flexibility in domestic law, just as is the current situation under the interim waiver, 
which applies at the moment – that situation has not obliged Members to avail themselves of the waiver. It would remain entirely a matter of choice for individual Members to implement or not to implement, even when the waiver is conver ted into a permanent amendment of the TRIPS 
Agreement. From that point of view it is important to understand, that it is a flexibility – it is an 
additional flexibility, and not a mandatory standard.  
90.  In that sense the TRIPS amendment is different in character from the Agreement itself, which 
does require positive implementation in domestic law. Therefore if a Member does accept the 
Protocol, it does not assume any legal obligation to have in place or to put in place implementing legislation. Effectively, the step of accepting the Protocol means that a Member is confirming its 
agreement that other Members are entitled to use the System of special compulsory licences for 
trade in pharmaceuticals if they so wish. Of course, it is an important step to accept the Protocol, but essentially because it will mainly give other Members legal certainty and confidence to use the System. If they do choose to use the new flexibility to obtain affordable medicines, their access to 
medicines by these means will thus be on a legal parity with any other health-related flexibility in 
the TRIPS Agreement. Therefore, it is clear th at many Members - in fact the overwhelming 
majority of acceptances of the Protocol from a wide range of legal, economic, geographic 
backgrounds - have accepted the Protocol without fi rst putting implementing legislation in place. I 
have mentioned this at length, because this is a recurrent issue that does come up in a more informal dialogue with Members. We hope that this clarifies at least one practical obstacle to 
acceptance of the Protocol.  
91.  The other constraint that has been mentioned has been simply the process of getting an 
instrument of acceptance signed and lodged. From that point of view, we would draw Members' attention to what is available on the website – a resource providing background on how to accept 
the Protocol and including a Model Instrument of Acceptance, as well as a map depicting the range 
of acceptances and other details that you have seen earlier. And just to clarify – the Model Instrument of Acceptance is a very simple document. It refers to the Protocol Amending the TRIPS IP/C/M/80/Add.1 
 
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  Agreement, it refers to the process of acceptance in general terms, and it has in effect one very 
brief operational paragraph stating that the signatory (who does have to be a sufficiently senior figure in the administration) hereby formally declares that the Member concerned accepts the Protocol and expresses consent to be bound by it. Th at is the full operative paragraph, it is nothing 
more than that. Being bound by it is effectively saying: other Members may wish to avail 
themselves of this option, rather than binding any Member to make use of it itself, or to implement it.  
92.  We have had very constructive conversations with a wide spectrum of delegations on this 
matter. The Director General has flagged that this would be a highly desirable outcome in the context of the Nairobi Ministerial, for a whole host of reasons, of course, and we look forward to working with Members, with interested delegations, in a practical way to help them take this 
process forward. 
7.2  Canada   
 
93.  I am happy to take the floor on behalf of Canada on this major issue. Canada would like to 
urge all Members having not done it as yet to deposit their instruments of acceptance. We consider the Protocol on access to medicines which Canada has been the first country to implement. As a 
major tool permitting access to medicines for developing and LDCs.  
7.3  India  
 94.  India attaches high importance to the Doha  Declaration on the TRIPS Agreement and Public 
Health, the Paragraph 6 System as established under the 2003 Decision and the 2005 Protocol 
Amending the TRIPS Agreement.  
95.  India notified its acceptance of the Protocol in March 2007. We would like to congratulate 
Members who have deposited their Instrument of A cceptance of the Protocol since the last TRIPS 
meeting held in June 2015. However, in spite of the fourth extension of the period of acceptance until 31 December 2015, only 60 Members including the EU have accepted the Protocol so far. The 
fact that it is still a long way to go for it to enter into force and that acceptance by two thirds of 
the membership is required is not a positive signal.  
96.  While we reiterate the 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 the TRIPS Agreement and Public Health constituted a major 
landmark in the short history of the WTO, because it recognised the primacy of public health needs and the preparedness of the Organization to take up the problems faced by the poor and 
developing countries.  
97.  Along with several other Members, India has worked relentlessly on the Doha Declaration and 
the Decision. The Decision established the framework for special compulsory licences which is an 
additional flexibility aimed at enabling exports of  medicines to WTO Members with insufficient or 
no manufacturing capacity in the pharmaceutical sector.  
98.  The TRIPS Council has been reviewing the Paragraph 6 mechanism for the last several years. 
Our delegation feels that the review mechanism has become ritualistic in nature and it will not 
serve any purpose if we go on repeating the similar questions and get similar replies. The 
implementation of the Paragraph 6 mechanism in volves several stakeholders and our discussions 
would not be effective if we restrict the discussion to this level.  
99.  At the TRIPS Council meeting in October 2014, we have also proposed a multi-stakeholder 
symposium. I proposed it again during yesterday's informal meeting, and the membership accepted in principle and asked me to provide more information on this suggestion. I am providing 
more information now.  
100.  Discussion in the symposium with relevant stakeholders including international 
organisations, public health experts, industry  experts, civil society organisations and WTO 
Members would be extremely useful to explore th e issue in depth. The symposium could discuss 
the implementation of the Paragraph 6 System so far, the challenges and opportunities involved as IP/C/M/80/Add.1 
 
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  well as ways of improving the System to make it effective and meaningful. In this regard India 
proposes that a technical symposium be held in March 2016 under the trilateral cooperation of WHO, WIPO and WTO. The symposium could be aimed to increase our understanding of the System, the challenges in its implementation so far and suggestions on the way forward. It would 
be an experience sharing and exploratory basis with various views on the System being discussed 
and debated. We request that the Council for TR IPS agree to hold this technical symposium and 
direct the Secretariat to draw the broad contours  of the symposium based on the suggestions of 
various Members.  
101.  It is also requested that the Chair continues to hold informal consultations with interested 
Members in this regard in the coming months.  
102.  With regard to the proposal for the extension of the period for acceptance of the Protocol for 
a further period of two years up to 31 of Decemb er 2017, we support the proposal. I conclude by 
encouraging Members who are yet to accept the Protocol Amending the TRIPS Agreement to accept the Protocol and notify their acceptance on a priority basis.  
7.4  Australia   
 103.  May I begin by thanking the Secretariat for what was a very clear explanation of a simple 
process for acceptance. Certainly Australia's experience bears out the simplicity of the process, but 
also, as the Secretariat noted, the fact that there is no need for implementation necessarily attached to the acceptance. In our case there was an eight year gap between our acceptance in 2007 and our implementing, domestic implementation  arrangements, which we notified this year 
and which are referred to in my intervention under item 2.   
104.  Australia adds its voice in support of desiring to see the TRIPS Protocol enter into force. We 
believe that this outcome will reinforce the WTO's potential to deliver practical, development-
orientated outcomes. And like Canada and India before us, we commend Members from every 
region and at every stage of development that  have already accepted this Instrument. In 
particular, we welcome recent acceptances this year of the Protocol by Members in the Asia-
Pacific, including Brunei Darussalam, and as the Chair has mentioned, most recently: Lao PDR and 
Sri Lanka.  
105.  Australia is very encouraged by interventi ons that have been made at the TRIPS Council 
earlier this year that indicated that other Members are preparing to take this important step and 
we look forward to seeing the number of 21 that was mentioned reduce further.  
106.  Now mindful that a number of Members are ac tively pursuing acceptance and noting what 
the Chair has referred to as the proposal that has been informally discussed for an extension of 
the period of time for acceptance, Australia adds it s voice in support of an extension period and we 
are flexible about the time-period of this extension.  
7.5  Cuba  
 
107.  Cuba would wish to support in full the pr oposal presented by the delegation of India 
regarding the organization of the technical symposium next year under trilateral cooperation. We hope Members will be able to support this proposal. In this regard we encourage all to show a 
constructive spirit. All delegations should see this technical workshop as an excellent opportunity 
to discuss the implementation of the System. This  would furthermore help Members that have not 
as yet accepted the Protocol.  
7.6  Chinese Taipei   
 108.  We wish to thank the Secretariat for their excellent work regarding the implementation of 
Paragraph 6 of the Doha Declaration on the TRIP S Agreement and Public Health. My delegation 
attaches great importance to the Paragraph 6 System , particularly in the view of the 2003 Decision 
and the 2005 Protocol.  
109.  We have ratified the Protocol on 31 July 2012. We also wish to congratulate Sri Lanka and 
the other seven Members which have accepted the TRIPS amendment this year. We welcome the IP/C/M/80/Add.1 
 
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  efforts of the Secretariat in order to obtain more acceptances of the amendmen t. In this regard we 
wish to call the delegates' attention to the TRIPS webpage, where Members will be able to find the 
link taking them to a manual on notifications as contemplated by Paragraph 6 which we also consider very useful.  
110.  Many developing countries and many LDCs suffer from public health problems. We wish to 
highlight that this Agreement does not prevent Me mbers and should not prevent them from taking 
measures protect public health, particularly in terms of facilitating access to medicines for all. We 
encourage Members to notify their acceptance of the amendment in order to allow it to come into 
force.  
7.7  Egypt   
 
111.  We would like first to associate ourselves with India and Cuba. Many questions spring to 
mind, including the administrative and regulatory co mplexity of the System, lack of appreciation of 
business methods in supplying markets and associated overhead costs, as well as constraining 
requirements.  
112.  These questions need to be addressed. Egypt strongly supports the proposal to organize a 
workshop to address these questions and others of relevance, and include in this workshop 
participants from all stakeholders. Therefore we urge those Members that seem to be reluctant to 
join consensus on the convening of this workshop with the participation of all stakeholders to reconsider their position in view of the direct relevance for access to medicines and ultimately for human rights involved in this problem.  
7.8  Brazil   
 113.  We welcome the information about the acceptan ce of the Protocol by Moldova, Kenya, Saint 
Kitts and Nevis, Sri Lanka, Lao PDR and Iceland. We congratulate these countries and urge those 
that have not yet accepted it, to take the necessary measures to do so at an early stage. As mentioned, taking these steps is even more urgent when we consider that the overwhelming 
majority of Members that are still to accept the Protocol are comprised by developing countries, 
potentially beneficiaries of this instrument.  
114.  We thank the Director of the IP Division for his detailed explanation on the details for the 
acceptance of the Protocol. We hope the efforts of  the Secretariat led by the Director General bear 
the expected fruit soon, so that we reach the 21 needed instruments of acceptance soon. Thus, 
the beneficiaries of this mechanism can start enjoying the flexibilities of the System.  
115.  On the proposal for a multi-stakeholder technical symposium on Paragraph 6 of the Doha 
Declaration on the TRIPS Agreement and Public Heal th, we would like to thank the delegation of 
India for this timely initiative. We believe it is a timely initiative for one simple reason, namely: that the Paragraph 6 has not been used in practice except on one occasion. We believe that this 
would suffice to make it necessary or at least timely, to bring other stakeholders to discuss the 
reasons for this, well, lack of knowledge about the benefits of the System. Yesterday during our informal meeting, we heard some delegations requesting something on paper. I don’t know if all of us have a document that was prepared by India, but I believe, regardless of the details that can be 
discussed further during the time till we prepare the conference, that the contours of this multi-
stakeholder event would benefit those countries that need more information in order to consider the possibility of using the System. So we fully su pport the initiative and we hope we can agree to 
hold it on a date that is fore seen here in this document.  
7.9  Indonesia   
 
116.  First of all we would like to thank the Secretariat for the presentation on the notification of 
the Paragraph 6 System.  Access to medicines still remains a problem for most developing countries and LDCs. A WHO report said that with growing recent numbers of trade in medicines, developing countries and LDCs only contribute to  70% of all imports and 6% of all exports. The 
situation will affect the health profile of the population which will subsequently hamper the 
productivity of their people which is significant for their development. Therefore, the unanimously 
adopted 2005 General Council Decision to amend the TRIPS Agreement to give legal certainty to 
the implementation of the Paragraph 6 System was a great breakthrough to help developing IP/C/M/80/Add.1 
 
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  countries and LDCs obtain greater access to affordable medicines when needed. We would like to 
congratulate Brunei, Lao PDR, Sri Lanka, Moldov a, Kenya, Iceland and other Members that have 
accepted the Protocol this year. Yet, we still n eed more Members to submit their instruments of 
acceptance before this noble objective can be implemented. In this light, while calling on Members 
to expedite their ratification process, Indonesia wo uld like to lend its support for the extension of 
the period of acceptance by the Members of the Protocol Amending the TRIPS Agreement. On this 
opportunity, we would also like to support the proposal of India that a technical symposium be 
held on the Paragraph 6 System of the Doha Declaration on the TRIPS Agreement and Public 
Health. 
7.10  Thailand   
 
117.  Regarding Paragraph 6 of the Doha Declarat ion on the TRIPS Agreement and Public Health, 
Thailand is currently accelerating the internal process for accepting the Protocol Amending the TRIPS Agreement and aims to accept the Protocol, possibly by the tenth Ministerial Conference. 
7.11  Chile   
 118.  Our delegation has been attentive to the efforts of the Director General and those 
undertaken by delegations regarding the Paragraph 6 System. As we see it, it is very important to 
extend the period for acceptance as proposed in Job/IP/13. We would also like to voice our concern that this very important amendment has not yet received a sufficient number of ratifications so as to enter into force. Given the potential of this measure to save thousands of 
lives on a daily basis, we would like to extend our appeal to all the remaining countries to ratify 
this draft amendment and thank all those who have taken this initiative. Finally, we would like to thank India for their proposal. We see the propos ed symposium as an important element, and it 
could make it possible for those countries that have not been able to ratify so far to avail 
themselves of the necessary information so that they can ratify very swiftly.  
7.12  European Union   
 
119.  The European Union agrees with DG Azevêdo th at 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, 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 by the time of the next Ministerial Conference, if not, as soon as possible thereafter. Commissioner Malmström herself has included 
this in her briefing and each time she is meeting with countries concerned she is stressing the 
importance of this, as was requested by DG Azevêdo. On the idea of a symposium, and noting that there are different positions held here, we wonder whether it would not be possible to have a more 
Member-driven approach and to have the kind of events in the margins of this Council that have 
been taking place for a number of years regarding issues that we consider very valuable like the debate on IP and innovation. If the intention is to provide information and assistance to the countries who need it in this process, we believe it is perfectly possible to do it as a Member-driven 
approach and have these informative sessions organized in the margins of a TRIPS Council 
meeting. 
7.13  New Zealand   
 
120.  Since the last annual review, New Zealand has notified its legislation implementing the system established under this Decision. We would like to congratulate Members who have 
accepted the Amendment this year. As others have mentioned, we would like to encourage 
Members who have not completed domestic procedures to take the relevant steps to deposit instruments to accept the Amendment before MC10 given the humanitarian objectives of the 
Amendment and the development dimension as we ll. We hope that the TRIPS Amendment can 
enter into force at the tenth Ministerial Conference; that would be a highly-desirable outcome.  
7.14  Ecuador   
 
121.  We would like to thank those delegations who have accepted the Protocol and also add our 
voice to the request made by India to have this technical symposium or workshop. This ought to IP/C/M/80/Add.1 
 
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  make it possible for countries to be more knowledgeable regarding a number of items and ratify 
the Protocol so that it could come into force.  
7.15  Switzerland   
 
122.  We would first like to congratulate Brunei Darussalam, Iceland, Kenya, Lao PDR, Moldova, 
Sri Lanka, and St. Kitts and Nevis for notifying the WTO of their acceptance of the Protocol Amending the TRIPS Agreement.  
123.  Switzerland seizes the opportunity to encourage Members who have not yet notified their 
acceptance to undertake the necessary steps and proceed so that the required acceptance by two thirds of WTO Members may be met and that the Protocol can enter into force. The Paragraph 6 system is a significant mechanism. Its goal is to put those WTO Members on a level playing field 
with the other WTO Members that do not have manufacturing capacity in the pharmaceutical 
sector. It enables those Members to make use of the flexibility offered by Article 31 TRIPS, thereby filling the shortfall of this article. 
124.  As the Director General stressed in his letter to the WTO Members last February, acceptance 
of the Protocol is a concrete contribution that WTO Members can make to global efforts to strengthen the legal framework for access to medicines. We would also like to remind that the 
procedure of acceptance of the Protocol is straightforward, as was just explained by the 
Secretariat. The WTO Secretariat's website provides helpful information on the procedure in general and the few formalities that apply.  
125.  My delegation thus calls on all those WTO Members who have not yet done so, to proceed 
with their acceptance of the Protocol without further delay.  
126.  As for the proposal for a multi-stakeholder symposium, taken up by a number of 
delegations, in order to discuss the workability of the Paragraph 6 mechanism and associating 
therefore a broad range of WTO external stakeholders, we consider this premature. We have not 
heard from potential beneficiary Members whether at all they face specific obstacles, and if so, which ones, when wishing to make use of the Pa ragraph 6 mechanism. Before having heard about 
such concerns and problems from beneficiary WTO Members, we see neither the need nor the 
merits of considering including external stakeholders to the Council’s discussion. Experience sharing should in the first place be deepened in this Council. 
7.16  Japan   
 
127.  Firstly, this delegation would like to reiterate that Japan attaches great importance to the issue of access to medicines, which needs to be discussed in a broader context, taking into account 
not only the Paragraph 6 System but also various other relevant measures and factors, such as 
procurement and tariffs to name a few. Japan supports the Paragraph 6 System as established under the 2003 waiver Decision and the 2005 Protoc ol Amending the TRIPS Agreement. At the 
same time, however, we would like  to recall that the very objective of the System is merely, but 
importantly, to enable those WTO Members that have either insufficient or no pharmaceutical manufacturing capacity to make use of compulsory licenses as a policy tool under the TRIPS Agreement, just like other WTO Members with pharmaceutical manufacturing capacity, for the 
purpose of promoting access to medicines. Compulsory licenses are, whether granted under the 
Paragraph 6 System or not, just one of the potential policy tools that can be utilized for this purpose and therefore, the Paragraph 6 System shou ld not be considered as the only solution, but 
rather as just an option we could consider. 
128.  Secondly, the delegation of Japan would like to congratulate Republic of Moldova, Kenya, 
Saint Kitts and Nevis, Sri Lanka, Lao People’s Democratic Republic and Iceland for depositing their 
instruments of acceptance of the Protocol most recently. To our disappointment, however, the list 
of Members has not yet reached the necessary number for the Protocol to enter into force and we are looking into the fifth extension of the deadline for the acceptance of the Protocol. We would like to call upon all Members that have not yet done so to deposit their instruments of acceptance 
of the Protocol as soon as possible and urge su ch Members to inform the Council their intended 
timeline for doing so, just like the distinguished dele gate of Thailand did so earlier in this meeting. IP/C/M/80/Add.1 
 
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  129.  Lastly, with respect to the proposal at yesterday's informal meeting on holding a multi-
stakeholder technical symposium on this subject, we are open to consider the proposal provided 
its objective is made clear in written form. At the same time, this delegation believes that we should take full advantage of this annual review to fully understand and identify challenges that 
Members might be facing in utilizing the Paragraph 6 System. 
7.17  United States of America   
 
130.  Thank you for this update regarding the stat us of notifications of acceptance of the 2005 
Protocol Amending the TRIPS Agreement. Since th e last annual review, New Zealand and Australia 
have notified legislation implementing the Sy stem. The United States strongly supports the 
Paragraph 6 System as established under the 2003 waiver Decision, the 2005 Protocol, and the 
2013 General Council Decision to extend the deadline to 31 December 2015 for acceptance of the 
Amendment. 
131.  The United States congratulates those Me mbers identified by the Chairman -- Brunei 
Darussalam, Moldova, Kenya, and Saint Kitts and Nevis, Sri Lanka, Lao PDR, and Iceland – which 
formally accepted the Amendment since the last review. We welcome and encourage the Secretariat's efforts with respect to depositing instruments of acceptance of the Amendment as 
well and encourage other Members to notify their acceptance of the Amendment so that it can 
enter into force. 
132.  With respect to the present status of acceptances, and the indications that a number of 
Members, including the delegation of Thailand, which so indicated today, are actively pursuing 
domestic efforts in order to accept the Amendment, the United States supports the draft TRIPS 
Council proposal to the General Council for a Decision to extend the period for acceptances of the Protocol.  
133.  We would also encourage those delegations th at have expressed criticism of the Paragraph 6 
System under this agenda item to consider furthe r the impact of their interventions on our shared 
efforts to encourage Members to accept this important Amendment. We urge caution regarding 
suggestions that its use indicates flaws in the System. We do not share this view. We also think 
Members should take full advantage of meetings of this Council. If Members have information to share that is relevant to acceptances of the Amen dment, it should be presented at our meetings, 
including the presently, and not held for some future  date at some future event.  The time is now 
to deliver on a decade-old promise on public health. 
134.  As we have explained, there are multiple avenues available for promoting access to 
medicines. The Paragraph 6 System is important, but it is not alone. Appropriate mechanisms for 
transparency, procedural and due process protecti ons, and opportunities for public engagement 
are important in the context of health care systems. Measures, including those that are 
discriminatory, non-transparent or otherwise trade-restrictive, have the potential to hinder access 
to pharmaceuticals and medical devices, and potentially result in reduced access to healthcare due 
to higher healthcare costs.  
135.  We continue to believe that the access to medicines issue is multidimensional. Making 
life-saving medicine available requires transpar ency and a commitment to address measures that 
unduly delay patients from getting the treatments they need. For example, we continue to have a 
great interest in hearing from other delegations regarding their efforts related to trade to facilitate such access. For instance, what measures have been taken by those Members identified in the 
2012 staff working paper entitled, "More Trade for Better Health? International Trade and Tariffs 
on Health Products" as maintaining the highest ta riffs, bound and applied, on medicines, medical 
inputs and medical devices? We recall the Urugua y Round pharmaceutical zero-for-zero agreement 
including the United States and other WTO Members. Are other WTO Members preparing to do the 
same? 
136.  Finally, while we are not in a position to acce pt the proposal due to a lack of information on 
this suggestion, we support the suggestion made by the EU. We also confirm our support for the 
proposal to extend the period of acceptan ce of the amendment for another two years. IP/C/M/80/Add.1 
 
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  7.18  Bangladesh, on behalf of the LDC Group   
137.  I am taking the floor on behalf of the LDC Group. The Paragraph 6 mechanism is a unique 
mechanism to serve the cause of public health an d the LDCs are grateful to the Members of the 
WTO for the Decisions taken in this regard. Ba ngladesh, as LDC coordinator had reminded and 
encouraged the LDC Members concerned to notify  their acceptance. However to find out the 
causes for non-ratification, we may hold formal or informal exchanges of ideas and experiences so that we can understand their causes for delay and we can help the countries if they need any 
technical support or any support for understanding and ratifying this amendment. 
7.19  South Africa   
138.  South Africa is a signatory to the TRIPS Ag reement and one of the countries that played an 
active role in ensuring that the TRIPS Agreement accommodates issues on public health. Hence 
South Africa would like to reaffirm its commitment to improve access to essential medicines in 
developing countries and preserving the spirit and principles contained in the TRIPS Agreement and the Doha Declaration. In this regard, South Africa is currently taking all the necessary steps in 
terms of its constitutional requirements to implement the Paragraph 6 System into its domestic 
legislative framework. South Africa will continue to participate in discussions that aim to improve the efficiency of the Paragraph 6 System. 
139.  Furthermore, South Africa supports all ende avors aimed at promoting and fostering a better 
understanding of the challenges associated with  the effective utilization of the Paragraph 6 
System, including through a dedicated workshop, as  proposed by India and other delegations, and 
wider stakeholder consultation to this end. This delegation wishes to further express its support for 
the extension of the period for acceptance of the Protocol Amending the TRIPS Agreement for a 
further two years. 
7.20  India   
140.  I apologise for taking the floor once again. I would like to restrict my comments to the 
proposal on the technical workshop or symposium. Firstly we would like to thank the delegations who have supported the idea of a technical work shop based on the information provided, but we 
are quite dismayed that a few delegations have opposed the idea of a workshop. The intention of 
India proposing this technical workshop was simple, we are aware of the working of the Paragraph 6 System. This item that has been discussed in the Council for TRIPS and Members 
have aired their views on its practical application and its working. The trilateral study too has 
discussed it and we felt that it is now time to discuss it in a larger setting with multiple 
stakeholders, including representatives from industry, civil society, from international organizations involved in these issues, from public  health experts on an exploratory informal basis 
without any bearing on any decisions. The proposal was just that – to take it forward in terms of a 
trilateral co-operation symposium with WHO, WIPO and WTO which is done every year on different issues. It would, in our opinion, increase Members' understanding on these issues without 
prejudice to the views that each Member has. A number of delegations have opposed this and we 
would like to address the concerns that they have raised and urge them to reconsider.  
141.  Firstly I would like to respond to the EU suggestion that it should be a Member-driven 
approach and could be held in the margins of th e Council and could be based on an information-
sharing basis where it is Member-driven. We do not necessarily disagree with this view, the timing 
of the technical symposium is immaterial, it could be when the next TRIPS Council is meeting or in the margins of the Council, but what is important is that a larger stakeholder involvement of 
different interests and different ideas including industry, civil society and experts would help to 
break this impasse we have seen for the past decade. It has been discussed in the TRIPS Council but it is not just an information-sharing exercise, it would be a sharing of experiences, sharing of 
challenges and sharing of different viewpoints. Wh ile we agree with the EU on holding it in the 
margins of the Council, we urge that this multi stakeholder technical symposium is important to get more views and understanding fo r all Members on this point.  
142.  The second opposition from Switzerland of being premature, we fail to understand when it 
would become mature, because the Paragraph 6 mechanism entered into force in 2003. Since 
then, we have been debating it in the TRIPS Council incessantly, we feel it has become ritualistic IP/C/M/80/Add.1 
 
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  and we feel that it is the right mature time, as many delegations including Brazil have mentioned. 
Switzerland may find that it is premature. This opinion could be stated in the workshop, that it is premature to discuss it, but that should not be a bar to discuss it with other experts.  
143.  We thank Japan for making the point that they are open to consider if the objective is clear. 
I think we have made our objective very clear in the last meeting last year, and again at this 
meeting about the workshop being to tackle Para graph 6 and to see the challenges and problems 
being faced in the context of Paragraph 6. Of course Japan has differ ent views on a broader 
context in which this has to work, and it is free to air that during the symposium. There is no bar 
against Members bringing their opinions, to even suggest speakers; we don't have a list of speakers ourselves. I think that merely because there is a plethora of other ways to handle this doesn't bar a technical symposium on Paragraph 6, so I believe we have addressed to our limited 
ability Japan's objection.  
144.  The US has basically stated that we have different views on how Paragraph 6 should work 
and there are multiple avenues to promote access to medicines. Nobody is making the point that 
holding this technical symposium would change that view. The US could continue to have that view 
and could place that particular view on the agenda  of the symposium, but it would be important to 
discuss that symposium so that we understand be tter how Paragraph 6 could work. The US also 
mentioned that they need more information; we fail to understand what other information we 
could provide. There are topics on the Council agenda for which we have no papers, but we are discussing them without any information. We should be more in a flexible mode of accepting. What we have proposed basically is that Members could come with various suggestions on the agenda, 
on the speakers, on the formats. The Chair could consult in informal mode how it could go, so it is 
Member-driven. I would urge Members who are opposi ng it to reconsider because this is purely a 
symposium on a technical basis, on an informal basis, which would not influence any decision in 
the TRIPS Council.  
7.21  Uganda   
145.  You recall that Uganda submitted its instrument of acceptance in 2010, so I would like to 
e n c o u r a g e  o t h e r s  t o  d o  s o  a s  w e l l .  W i t h  r e g a r d  t o  t h e  p r o p o s a l  b y  I n d i a ,  w e  w e l c o m e  t h e  
suggestion for a multi-stakeholder workshop to better understand, inter alia, why the System is not working well and what the concerns of Members are so as to be able to utilize this instrument. A technical symposium could offer us all an opportunity to find ways for the effective 
operationalization of this instrument. We have noted the different views expressed by Members, 
but we think that Members should not be afraid of an information and experience-sharing session, except of course if the instrument was never meant to be precise, effective and operational like is 
the case for so many S&D proposals currently under review in the CTDSS. 
AGENDA ITEM 8:  NON-VIOLATION AND SITUATION COMPLAINTS Statements made at the meeting on 15 October 2015 
8.1  Peru    
 146.  First of all, Peru wishes to thank the African Group, the African, Caribbean and Pacific (ACP) countries and the LDCs for their support in co -sponsoring documents IP/C/W/607 and IP/C/W/385. 
147.  In my delegation's view, this convergence of interests, highlighted by the fact that the 
documents in question were supported by some two-thirds of the WTO Membership, is a telling 
example of the potential offered by multilateralism. 
148.  These documents reflect a position on the issue of potential application of non-violation 
complaints under the TRIPS Agreement, given the following considerations in particular: 
 Non-violation complaints are unnecessary to protect any balance of rights and obligations 
inherent in the TRIPS Agreement, as these are reflected in the Agreement's principal 
obligations and flexibilities, and the Agreement explicitly states that WTO Members are not 
obliged to implement more extensive protection (Article 1). 
 IP/C/M/80/Add.1 
 
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   In Peru's opinion, the rights and obligations in the TRIPS Agreement are best performed 
through good-faith application of its provisions, in accordance with established principles of international public law. Hence, there is no need for this type of legally imprecise remedy, since the measures that may give rise to non-violation complaints have not even been 
defined. 
 149.  Expanding the non-violation remedy - and with it the right to challenge measures that are 
otherwise consistent with WTO obligations - threatens to: 
 introduce incoherence among the WTO Agreements by allowing something which a WTO 
Member has agreed under the TRIPS Agreement to be challenged on the basis that it could nullify or impair benefits; 
 upset the delicate balance of rights and oblig ations in the TRIPS Agreement by elevating 
private rights over the interests of the users of intellectual property; and 
 limit use of the flexibilities inherent in the TRIPS Agreement which aim 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. 
150.  Given the concerns expressed by Peru and the other co-sponsors of document IP/C/W/385, 
there have been proposals in the TRIPS Council si nce 2002 that the Minister ial Conference should 
determine that non-violation and situation complaints are not applicable under the TRIPS Agreement. 
151.  In line with this position, a draft Decision  (IP/C/W/607) for consideration at the 10th Session 
of the Ministerial Conference has been put forward, stipulating as follows: 
152.   After having examined the issue of the scope and modalities for complaints of the types 
provided for under subparagraphs 1(b) and 1(c) of Article XXIII of GATT 1994, the 10th Ministerial 
Conference decides that those provisions of GATT 1994 shall not apply to the settlement of 
disputes under the TRIPS Agreement. We hope that it will be possible to reach consensus at this 
TRIPS Council meeting. 
8.2  Brazil   
 153.  We thank the delegation of Peru for presen ting the draft Decision on "Non-violation and 
situation complaints" contained in document IP/C/W/607 for consideration at the 10th Ministerial 
Conference, on behalf of all co-sponsors. 
154.  As one of the co-sponsors, we reiterate the understanding that non-violation and situation 
complaints cannot be applied to disputes in the area of intellectual property rights. As we have 
consistently stated, we strongly believe that any development that allows for this kind of complaint in the context of TRIPS would upset the delicate balance of rights and obligations in that 
Agreement, besides risk causing systemic problems for the Organization. With that, I will refrain 
from mentioning all the arguments listed in document IP/C/W/385/Rev.1, circulated in May 2015, since at this stage we believe they have been extensively presented in this Council. 
155.  We want to highlight, however, the significance of the Decisions by the African Group and 
the LDC Group to join the list of co-sponsors of both this document and the draft Decision just 
presented in this session. The addition of th e 43 countries of the African Group and the 34 
countries of the LDC Group makes it even more ev ident that the same position on non-violation 
and situation complaints is shared by the vast majority of the membership. We sincerely hope that 
we are able to agree on the proposed text for the Ministerial Decision, so that the cycle of moratoria can end this year.  
8.3  United States of America   
 156.  For the reasons we have detailed in our previous interventions under this agenda item, we continue to believe that the drafters of the TRIPS Agreement envisioned that non-violation and 
situation complaints should be available under this Agreement.   IP/C/M/80/Add.1 
 
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  157.  We also believe that while valid question s have arisen, they are fully and adequately 
answered by the text of the TRIPS Agreement it self and further clarified through GATT and WTO 
adjudication, as we have enumerated in our communication to the TRIPS Council on 10 June 2014, which was circulated to Members as document IP/C/W/599, as well as in our recent interventions 
on this topic. 
158.  We first wanted to thank the proponents of the draft TRIPS Council Decision regarding the 
applicability of non-violation and situation complaints to dispute settlement under the TRIPS 
Agreement, which is contained in document IP/C/W/607.  We also thank Peru for its clear 
explanation of this proposal this afternoon. For the reasons we will set out today, and which we 
have extensively described in previous TRIPS Council meetings, we are not in a position to support this proposal, or any other proposals for a continued moratorium, at this time. 
159.  Turning to document IP/C/W/385 which was introduced in 2002, while this document was 
resubmitted subsequent to our June 2014 communication, and is commendable for recalling previous iterations of the discourse on this issue, much of the Council's work in this area, 
particularly over the past dozen years, is not reflected and continues to await reflection by the 
proponents of this document. 
160.  We will return to a question we have posed in several meetings of the TRIPS Council and 
would welcome some reflection by those proponents.   
161.  To preface that question, we will recall  the suggestion in document IP/C/W/385 that non-
violation and situation complaints could limit the use of TRIPS Agreement exceptions. We remain unclear how this would be the case. 
162.  With regard to those exceptions, we are interested to hear from other delegations as to why 
such TRIPS Agreement exceptions are vulnerable with respect to non-violation and situation complaints in contrast to the longstanding and harmonious relationship between GATT exceptions 
and GATT non-violation and situation complaints. 
163.  In other words, we continue to look forwar d 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 non-violation and situation complaints on TRIPS Agreement flexibilities.   
164.  Why, for example, would non-violation and situation complaints limit the use of the 
exceptions in the TRIPS Agreement, when non-violation and situation complaints have not been suggested to limit the use of the exceptions under Article XX of the GATT 1994?  
165.  Take the EC – Asbestos  dispute, where the non-violation and situation complaint in no way 
limited the use of the GATT Article XX(b) exceptio n regarding the use of measures necessary to 
protect human, animal or plant life or health.  
166.  As we have mentioned previously, non-violation and situation complaints have been 
available for 63 years, as have GATT Article XX exceptions. Yet, we are not aware of a single 
instance in which a non-violation and situation complaint has imperiled or otherwise limited the 
ability of a GATT or WTO Member to adopt or enforcement measures covered by GATT Article XX. 
167.  In this context, document IP/C/W/385 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 are aware, Article XX covers measures on: 
 public morals; 
 human, animal or plant life or health; 
 products of prison labour; 
 national treasures of artistic, historic or archaeological value; and  
 the conservation of exhaustible natural resources… 
 
168.  To conclude, we believe that the long history of compatibility of GATT non-violation and 
situation complaints with GATT exceptions for measures related to issues, including public morals, IP/C/M/80/Add.1 
 
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  human health, and the conservation of exhaustible natural resources, should go far to allay 
concerns regarding any negative impacts in the context of the TRIPS Agreement.  
169.  Beyond the clear dictates of Article 3.2 of the Dispute Settlement Understanding, which 
provides that "recommendations and rulings of the Dispute Settlement Body cannot add or 
diminish the rights and obligations provided in the covered agreements", the absence of any GATT 
or WTO jurisprudence that suggests that non-violation and situation complaints would impair the ability of Members to use exceptions under any WTO Agreements, whether it be the GATT or the 
TRIPS Agreement, should provide further comfort and dispel such concerns. 
170.  We also maintain our position, confirmed by Article 64 of the TRIPS Agreement, that the 
non-application period will terminate at the upcoming Ministerial Conference, unless consensus is reached to extend it. We are not in a position to join that consensus. 
171.  We reiterate our commitment to finding a wa y out and look forward to continuing to work 
with other delegations to reach that exit.   
8.4  India   
 
172.  I would first like to thank Peru for the proposed draft Ministerial Decision submitted on behalf of the proponents. As Peru has rightly mentioned, there is a confluence of interests in this area 
and as indicated, an overwhelming majority of Members, after a deep study and in-depth 
examination, have supported this position in the TRIPS Council. It is also significant to note that the co-sponsors of this proposal have recently  been joined by the African Group and the LDC 
Group and we thank both Groups which have shown support and recognised the seriousness of the 
issue at hand.  
173.  India believes that there is a great confluence of interests in this regard. There is 
considerable concern over the application of non- violation complaints to TRIPS and there has been 
substantial discussion in the TRIPS Council over the past years, especially in the last year and prior 
to that, on the questions, concerns and challenges that non-violation and situation complaints pose in the TRIPS context. Informal discussions have also been held, both inside the TRIPS Council and 
outside, culminating in this draft Ministerial Decision, which reflects those efforts. As mentioned by 
the Chair on previous occasions, there has to be  an end to the cycle of moratoriums and this 
proposal essentially seeks to end this cycle.  
174.  We do believe that until there is an agreement on the scope of modalities, non-violation 
complaints will not apply in the TRIPS context. The draft Ministerial Decision essentially seeks an 
end to the extension of the moratorium and seeks to make non-violation and situation complaints inapplicable in the TRIPS context. As regards certain comments on how the concerns over non-
violation complaints in the context of TRIPS arise, I think we have discussed this substantially 
earlier in previous meetings and the paper of the proponents clearly lists these concerns. I do not wish to reiterate them. However, especially in the context of TRIPS flexibilities, I think it is well 
known that a dispute, in the context of a non-violat ion complaint, arises when there is no violation 
of the provision of the TRIPS Agreement and that it has a substantial chilling effect on the practice and policy of a Member's IP regime. I think ma ny delegations who have sponsored this draft 
Decision, including India, believe that these have  serious consequences and have proposed this 
draft Ministerial Decision for the consideration of the TRIPS Council.  
8.5  Cuba   
 
175.  Cuba endorses and is grateful to Peru for its statement in support of the proposal. 
176.  We would recall that the application of such complaints in the field of intellectual property 
may give rise to serious difficulties, generate major imbalances between the interests of rights 
holders and public policy considerations, limit the exercise of flexibilities under the TRIPS 
Agreement, and entail practical issues.  
177.  We emphasize that this document is consistent with other documents already submitted, has 
a large number of proponents, and is important in light of the forthcoming Ministerial Conference, 
where it will have to be adopted by the membership as a whole. IP/C/M/80/Add.1 
 
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  178.  We urge that the 10th Ministerial Conference should decide that the provisions of the 
GATT 1994 concerning this type of complaint sha ll not apply to the settlement of disputes under 
the TRIPS Agreement. We call on all Members to endorse and support this draft Decision. We also 
call on Members that reject this Decision to review their position. 
179.  We emphasize once again that the document reflects concerns repeatedly expressed by the 
developing countries in particular, which have not, however, been the only ones to take a stance in 
rejecting the application of such complaints in the field of intellectual property rights. 
180.  Lastly, it would be useful if Members that continue to reject this document could explain in 
which cases they consider such complaints to apply in this field. In this manner they may explain better their position to those who support it today.  
8.6  Canada   
 
181.  We welcome the opportunity to address the important issue of the applicability of the non-
violation and situation complaint remedy to the TRIPS Agreement. Our position on this issue is well 
known and has remained unchanged over the years. In this regard, we wish to refer Members to 
our previous interventions, where we raised conc erns about the applicability of the non-violation 
and situation complaint remedy to the TRIPS Agreement, as well as our previous paper submitted 
to the Council on this issue, in particular document IP/C/W/127.  
182.  Canada stresses its commitment to the TRIPS Agreement and to our work in this Council. 8.7  Indonesia   
 
183.  Indonesia would like to support statements made by Peru, Brazil, India, Cuba and others on 
the inapplicability of non-violation and situation complaints in cases relating to the TRIPS Agreement. As a developing country Member that is trying to tap the full benefits of the system, 
Indonesia is learning and seeking to observe all its commitments in this rule-based organization 
over its highly needed interests to enlarge its pace of development.  
184.  Non-violation and situation complaints would nullify its effort by creating legal uncertainty 
and unpredictability even when all WTO rules and its commitments have been observed and 
followed. The TRIPS Agreement is meant to give a sui generis  protection to IPRs. Non-violation 
and situation complaints will abuse this principle by denying developing countries' and LDCs rights 
to enjoy the flexibilities provided by the WT O for their innovation, health and economic 
development purposes. Discussions on the scope and modalities as a mandatory condition for the 
applicability of this principle can only be define d as an evidence of the inapplicability of non-
violation and situation complaints in the TRIPS Agreement. Accordingly, the vicious circle of 
moratoria should cease. In this regard, Indonesia has urged Members to support the proposal in 
document IP/C/W/607 to enable the Council to recommend to the 10th Ministerial Conference that complaints of the type provided under GATT Article XXIII.1(b) and (c) shall be deemed 
inapplicable to the settlement of disputes under the TRIPS Agreement. 
8.8  Argentina   
 185.  We would like to thank the Secretariat for holding this meeting and Peru for the presentation 
of document IP/C/W/607.  
186.  The position of Argentina on this matter is well known. We would like to reaffirm what we 
have stated on other occasions that non-violation and situation complaints are not applicable to 
the TRIPS Agreement. This is based on the reasons that were put forward in document 
IP/C/W/385/Rev.1, which was co-sponsored by Argentina, together with a large number of Members. I will refrain from repeating the whole list of Members now. I would like to thank the 
African Group, which has joined the co-sponsors of the aforementioned document. We would also 
like to thank the LDCs for their support in this matter. 
187.  Argentina considers that the TRIPS Council should recommend to MC10 that those claims, as 
provided for in paragraphs 1(b) and (c) of Arti cle XXIII of GATT 1994, not be applied to dispute IP/C/M/80/Add.1 
 
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  settlement in virtue of the TRIPS Agreement as proposed in the draft Decision contained in 
document IP/C/W/607. 
8.9  Colombia   
 
188.  I would like first and foremost to thank Peru for having presented this proposal and I would 
like to fully support and endorse Peru's statement. 
189.  Exactly two years ago, at the TRIPS Council meeting held in mid-October 2013, Members 
reached an ad referendum agreement on this is sue. As you may recall, that agreement was to 
extend the moratorium until the 10th Ministerial Conference. 
190.  Two years later, we have been unable to re ach a definitive agreement upon this very theme 
or even one similar to our 2013 agreement, despite the fact that current opinion appears to be 
significantly more in favour of not applying this type of complaint to the TRIPS Agreement. New 
countries have adopted this position and even sponsored the revised version of document IP/C/W/385. We therefore urge Members who oppose the view of the majority to reconsider their 
position and help find a definitive solution to this issue, as proposed in the draft Ministerial 
Decision circulated. 
8.10  Egypt   
 
191.  I will endeavour to be brief in my comments. We would like, first and foremost, to support the proposal voiced by Peru. In our view, non-violation and situation complaints as referred to in GATT Article XXIII.1(b) and (c) should not be app licable to the TRIPS Agreement. It is also 
important for us to recall that without reaching a consensus on the modalities, the system will not 
be effective and will not be applicable. That is the reason why it is my hope that we can support and take this opportunity in MC10 in Nairobi to be decide once and for all that such complaints are 
not applicable to the TRIPS Agreement. 
8.11  Ecuador   
 
192.  I would like also to start out by thanking Peru for their presentation.  
193.  Ecuador has sponsored document IP/C/W/385/Rev.1. Ecuador would like to voice its belief 
that the TRIPS Agreement will not make it possibl e to protect markets, not only through customs 
duties, but this is a sui generis  agreement setting forth minimum standards for the acquisition, 
operation and exercise of intellectual property rights. Ecuador still has a concern that the 
application of non-violation and situation complaints to the TRIPS Agreement could impair the capacity of Member countries to defend their sove reign rights and to limit the capacity of Members 
to put forth new measures that are linked to econom ic development, social, quality of life and also 
many other aspects as well.  
194.  Likewise, we would like to support IP/C/W/607, which is in fact a draft Ministerial Decision 
for consideration at the 10
th Ministerial Conference, by virtue of which a number of countries, 
including Ecuador, consider that the type of co mplaints as in subparagraphs 1(b) and 1(c) of 
Article XXIII of GATT 1994 shall not apply to the settlement of disputes under the TRIPS Agreement. We have not reached a consensus on this matter in discussions to define the scope 
and modalities. In our view, a final Decision should be made at the upcoming Ministerial 
Conference to be held in Nairobi to remove this matter from the agenda of the Council. It will be necessary to derive a lasting solution and we can no longer postpone the Decision because this 
issue has been discussed for a long time.  
8.12  China   
 
195.  China concurs with the views expressed by Peru, Brazil and India and 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. In particular, these type of complaints would bring significant uncertainty into the TRIPS Agreement, which is a delicate balance of 
interests among Members. Moreover, China has noted that many Members are concerned that 
such complaints might undermine the regulatory authority and infringe sovereignty rights. In May IP/C/M/80/Add.1 
 
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  and July 2015, China, together with other Members proposed two documents, namely, "Non-
Violation and Situation Complaints Nullification or Impairment under the TRIPS Agreement (IP/C/W/385/Rev.1) and "Non-Violation and Situation Complaints (IP/C/W/607), which is a draft Ministerial Decision for Nairobi. The Council should recommend to the 10th Ministerial Conference 
that non-violation and situation complaints shall not be applied to the settlement of disputes and 
the TRIPS Agreement. 
8.13  Philippines   
 
196.  The Philippines fully supports the propos al that the TRIPS Council 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.  
197.  Flexibilities embodied in the TRIPS Agreement should be fully preserved, to enable Members 
to exercise their sovereign right to enact domestic laws and measures that pursue national 
policies. We believe that by their very nature, inte llectual property rights are exclusive rights that 
entail a delicate balancing of interests between creators and users, and are not intended to guarantee market access. The principles and object ives of the TRIPS Agreement are clearly set out 
in the provisions, and such minimum standards comprise the entire obligation of Members under 
the Agreement.  
198.  In light of the foregoing, we fully support the proposal that non-violation and situation 
nullification or impairment complaints should not apply to the settlement of disputes under the 
TRIPS Agreement. We also support the call to make the moratorium under Article 64.2 permanent. 
8.14  Thailand
  
 
199.  We would like to express our support for the proposal by Brazil submitted on behalf of 
several co-sponsors, including the African Group. We believe 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, or at least that the moratorium should be extended. 
8.15  Russian Federation   
 
200.  The Russian Federation, as a co-sponsor of documents IP/C/W/385/Rev.1 and IP/C/W/607, 
welcomes new Members to join the position ex pressed in these communications. The growing 
number of like-minded countries in agreement on this issue shows us once again that non-violation and situation complaints are out of place in the TRIPS Agreement. Our delegation 
reaffirms its view that the forthcoming Ministerial Conference to be held in Nairobi should agree 
that the provisions of subparagraphs 1(b) and 1( c) of Article XXIII of GATT 1994 shall not apply to 
the settlement of disputes under the TRIPS Agreement. 
8.16  Nigeria, on behalf of the African Group
  
 
201.  The African Group is a co-sponsor of document IP/C/W/607, which states that non-violation 
and situation complaints shall not apply to the TRIPS Agreement. As far as we are concerned, 
application of non-violation and situation complaints would mean that we shall not be able to use the flexibilities contained in the TRIPS Agreement. Since clearly there is no understanding or 
consensus on this document, the African Group is open to approaches by the Chair so that at least 
non-violation and situation complaints shall not apply.  
8.17  Bangladesh, on behalf of the LDC Group
 
 
202.  The LDC Group is pleased to be a co-sponsor of document IP/C/W/607 submitted by Peru. The LDC Group believes that legal grounds for non-violation and situation complaints under the 
TRIPS Agreement are very weak. Probably that  is why the whole membership unanimously 
extended the moratorium several times. There is no benefit in applying this provision out of 
context and as far as the history and statistics are concerned, we find very few instances where non-violation disputes were brought before th e WTO Dispute Settlement Body with even fewer IP/C/M/80/Add.1 
 
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  records of success for this type of cases. So the past track record does not prove its usefulness. 
Developing countries and especially LDCs are particularly concerned as they enjoy different flexibilities under TRIPS and any one of them could also be a subject of non-violation complaints quite unnecessarily. 
203.  We still cons ider that there are many un certainties as we have no t had a thorough discussion 
of the issues. We further emphasize that Members should in no way consider the TRIPS Agreement as another market access agreement. Furthermore, IP laws and rules in different countries are 
based on sui generis systems, which leave no opportunity to outline non-violation and situation 
complaints under the TRIPS Agreement with the "one size fits all approach".  
204.  Accordingly, we consider that the application of non-violation and situation complaints under 
the TRIPS Agreement would not be reasonable or prudent. 
8.18  Chile   
 205.  We would like to thank the proponents who have sponsored the communications contained 
in documents IP/C/W/385/Rev.1 and IP/C/W/607. We were not one of the co-sponsors of these 
documents. However, we understand nonetheless the arguments that have been put forward and we also attribute value to this proposal that seeks to find a lasting and definitive solution to the 
non-application of non-violation and application complaints within the framework of the TRIPS 
Agreement.  
206.  This position is, in our view, not shared by  all delegations. Therefore, if we are unable to 
reach an agreement, we consider the best way forward would be to extend the moratorium.  
207.  For some time now, we have been listening to different delegations whose positions do not 
favour the renewal of the moratorium, stating that the complaints not based on any violation within the framework of the TRIPS Agreement would become automatically applicable, while Article 
64 requires a consensus. But this would not be the case it seems, so consensus would not be 
reached. Going beyond this position and understan ding the discrepancy that exists, we would like 
to draw the attention of this Council that if there were to be the automatic application of this type 
of complaints to the TRIPS Agreement, this would mean opening up a space for this type of 
complaints to be used more widely in the dispute settlement system. This would be beyond the scope of the TRIPS Council. It is up to the Members to map out the path that is to be followed in this matter. 
8.19  Norway   
 208.  In Norway's view, non-violation and situat ion complaints do not belong under the TRIPS 
Agreement. We support many of the points pu t forward by Peru and other delegations. The 
benefits accruing under the TRIPS Agreement sh ould be understood to be those which were 
specifically described in its various articles. The TRIPS Agreement contains a number of very 
detailed commitments, many of which derive from other multilateral treaties which have been in 
operation for many years. When the TRIPS Agr eement was negotiated under the Uruguay Round, 
negotiators knew very well which rights and obligations were to be given to Members. Hence, applying non-violation and situation complaints to the TRIPS Agreement would be particularly 
difficult and problematic in relation to the principle of legal certainty.  
209.  We are therefore of the view that non- violation and situation complaints should be 
determined to be inapplicable to the TRIPS Agreement. While we are not a co-sponsor, we strongly 
support the content of the draft Ministerial Decision contained in document IP/C/W//607. Should 
no consensus on such a Decision be reached, the Ministerial Conference should extend the present moratorium 
8.20  Bolivia, Plurinational State of   
210.  We would like to thank the delegation of Peru for the draft Ministerial Decision it has 
submitted, which has received the backing of most of the Members of this Organization. IP/C/M/80/Add.1 
 
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  211.  As one of the co-sponsors, I would like to re affirm our support for this draft Decision. I think 
it is a very important issue for consideration at MC10. We would like to reiterate the arguments that we have already voiced on a number of occa sions and which have already been mentioned by 
a number of Members this afternoon. Our position continues unchanged. We consider that 
non-violation and situation complaints are not applicable within the framework of the TRIPS 
Agreement. To conclude, we would call upon those two delegations that have not joined consensus yet to change their position and rally to the position contained in document IP/C/W/607. 
8.21  Hong Kong, China   
212.  We thank the group of like-minded developing country Members for their paper. The issue 
concerning non-violation and situation complaints is a longstanding problem waiting for a solution.   
213.  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. 
214.  Quite a number of delegations have pointe d out the unique nature of the TRIPS Agreement 
before me, namely, that 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 action or inaction on the 
balance that the TRIPS Agreement currently provides before making any decisions. 
215.  Hong Kong, China stands ready to contribu te constructively to the discussions to find a 
solution that is agreeable to the membership.  
8.22  South Africa   
216.  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.  
217.  South Africa recognizes the need for protec tion and enforcement of intellectual property 
rights, however, we believe that the insertion of non-violation and situation complains will be 
inappropriate under the TRIPS Agreement for reasons already set out on in document 
IP/C/W/385/Rev.1. We therefore call on this Council to recommend to the 10th Ministerial Conference that subparagraphs 1(b) and (c) of Article XXIII of GATT 1994 shall not apply to the 
settlement of disputes under the TRIPS Agreement on a permanent basis. 
8.23  European Union   
218.  The European Union is still in the process of finalizing its decision and is making progress in 
this area. However, we must note with some concern that there appear to be two extreme 
positions in this debate. On the one hand, those who defend the non-renewal of the moratorium 
and hence the application of this regime of non-violation and situation complaints, and on the other, an important number of Members who support  a permanent decision that non-violation and 
situation complaints should not apply.  
219.  The European Union is not willing to support either of these two extreme positions. We would 
call, as others have done, such as our colleagues from Chile, for the need to re-examine positions 
of compromise and common sense, such that ther e would be an extension of the moratorium for a 
set period that would allow this debate to continue. 
8.24  Chinese Taipei   
220.  My delegation would like to thank Peru for submitting the proposal contained in IP/C/W/607.  
221.  Regarding non-violation and situation complaints, this matter has already been debated in 
the TRIPS Council for many years. It has been a source of concern on the part of many Members regarding the non-applicability of the regulations within the framework of non-violation and 
situation complaints in the area of TRIPS. If we are unable to arrive at a consensus amongst the 
Members, my delegation would like to see an exte nsion of the moratorium to the next Ministerial 
Conference. We would like to encourage in-depth discussion being held by Members concerning IP/C/M/80/Add.1 
 
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  the scope and the modalities to be applicable within the framework of the TRIPS Agreement at 
upcoming TRIPS Councils. 
8.25  Switzerland   
222.  We thank Peru and the other delegations for co-sponsoring document IP/C/W/607 (and 
IP/C/W/607/Add.1) proposing a draft Decision on "Non-Violation and situation complaints", for 
consideration at the 10th Ministerial Conference. 
223.  However, we are not in a position to support this proposal. Switzerland’s position on the 
issue of non-violation complaints under the TRIPS-Agreement is well known and has not changed 
over the past years. Rather than reiterating ou r arguments supporting our position, we would just 
like to make reference to the unambiguous language contained in Article 64 of the TRIPS Agreement. The Article defines a clear mandate for the Council, and it established a moratorium of 
f i v e  y e a r s .  T h e  p u r p o s e  o f  t h i s  m o r a t o r i u m  w a s  t o  g i v e  M e m b e r s  a  l i m i t e d  p e r i o d  o f  t i m e  t o  
examine the scope and modalities for non-violation and situation complaints to apply under the TRIPS Agreement.  
224.  Twenty years have passed in the meantime and no proposal for specific modalities and the 
definition of the scope of non-violation and situation complaints has been submitted to the Council for examination. No alternative definition of the scope and procedural rules to what the WTO legal 
framework already provides has been made available by opponents for consideration.  
225.  Switzerland has always taken the view that the Dispute Settlement Understanding (DSU) 
provides sufficient guidance, should such a complaint ever be presented to the Dispute Settlement Mechanism under the TRIPS Agreement. Accordingl y ,  w e  d o  n o t  s e e  a  n e e d  f o r  a d d i t i o n a l  o r  
special modalities complementing or replacing the DSU regime and the relevant provision in the 
GATT Agreement. 
226.  The Council should thus in effect recommend to the 10th Ministerial Conference that the 
moratorium expire. Subsequently, non-violation and situation complaints will automatically 
become applicable under TRIPS. Pursuant to paragraph 3 of Article 64, expiration of the moratorium is the sole consequence in the event that there is no consensus among WTO Members 
to extend the same. 
227.  Having said that, I confirm Switzerland’s wi llingness to consider any proposal regarding the 
scope and special modalities in the TRIPS context, should a Member deem special rules desirable. We thank the Chair for his continued guidance, which should allow Members to come to an 
informed decision, in accordance and in compliance with the principles and the mandate of this 
Council defined in the three paragraphs of Article 64 of the TRIPS Agreement. 
8.26  Sri Lanka   
228.  My delegation associates itself with th e statement made by Peru on behalf of the 
proponents.  
229.  As a consequence of the proposal IP/C/W/385/Rev.1 and the reasons stated therein, we 
believe that non-violation and situation complaints should not apply to the TRIPS Agreement and 
the current moratorium should come to an end by the proposed Ministerial Declaration. 
8.27  Korea, Republic of   
230.  My intervention will be brief as our position  on this issue is well known. Our delegation 
echoes the concerns expressed by many other delegations on non-violation and situation 
complaints and supports the extension of the moratorium if Members are unable to reach consensus on this issue. 
8.28  New Zealand   
231.  We would like to contribute New Zealand's perspective on this important discussion. Perhaps 
our views are not widely known, so I apologize if I take the floor for too long. I will try to be brief. IP/C/M/80/Add.1 
 
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  232.  New Zealand maintains its position that non-violation and situation complaints are not 
appropriate in the TRIPS context for reasons that have been well elaborated by Members today and during past Council discussions. These reason s include, firstly, that the TRIPS Agreement 
differs from other WTO Agreements. The non-violation remedy was developed in a context wholly 
different from the TRIPS Agreement as a means of maintaining the balance of concessions made 
during tariff negotiations. The TRIPS Agreement do es not represent such a balance of concessions. 
233.  Secondly, market acess commitments under the GATT and GATS are focussed on agreeing to 
refrain from certain policies that might impede market access. By contrast, the TRIPS Agreement 
contains affirmative obligations on governments to meet certain standards that provide freedom to Members to determine the appropriate method of implementing these obligations within their own 
legal system and in practice to take into account their particular social and cultural context and 
development stages. 
234.  Thirdly, New Zealand is concerned that a non-violation and situation complaint could be 
initiated against a Member because it does not implement minimum standards of IP protection in 
national laws in the way another Member might consider that they should do so. There may be 
scope to initiate a non-violation and situation complaint against a Member who has agreed to TRIPS-Plus standards and free trade agreements on  the basis that these standards have arguably 
undermined expected benefits that should flow fr om TRIPS, especially for users of intellectual 
property rights. These scenarios could only lead to a zero sum game that would bring us back to square one and that would compromise the balance on which the TRIPS Agreement rests. 
8.29  Venezuela, Bolivarian Republic of   
235.  I will be very brief. I would like to express our gratitude for Peru's proposal. As a co-sponsor 
we reiterate our support 
8.30  Japan   
236.  My delegation wishes to recognize the continued efforts made by the Chair and Members in 
advancing the discussion of this issue. We recall that, especially since the extension of the moratorium two years ago, a number of Members have contributed to the discussions on this 
topic, including documents IP/C/W/599, IP/C/W /385/Rev.1 and IP/C/W/607. We welcome those 
efforts. 
237.  Meanwhile, we also recognize that Members have yet to reach consensus on the applicability 
or inapplicability of the scope and modality of non-violation and situation complaints in the area of 
TRIPS. For our delegation, clarity and predictability are of great importance when considering the 
applicability of non-violation and situation complaints to the TRIPS Agreement. 
238.  My delegation has been and is willing to engage in discussions in a constructive and practical 
manner in order to achieve consensus before or at the next Ministerial Conference, just as we did 
two years ago. 
8.31  Nepal   
239.  The delegation of Nepal would like to associat e itself with the proponents of this proposal 
together with other Members. We are of the view that the application of non-violation and situation complaints, which was originally a GATT provision, fits to trade in goods and services, but not in any sui generis  type of system such as TRIPS. Non-violation and situation complaints are 
essentially related to a market access issue. They have less possibility of application with regard to 
TRIPS, which essentially intends to provide minimum protection for IP-related instruments. Application of such complaints in the TRIPS regime will reduce the flexibility and policy space of 
many developing countries in general and the LDCs in particular. This prevents them from 
pursuing developmental goals to the legitimate ex ercise of policy choices in the field of the IP 
regime. 
240.  Against this background, we would like to call upon Members to pay positive consideration to 
forwarding this proposal for consideration at MC10. IP/C/M/80/Add.1 
 
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  8.32  United States of America   
241.  We wish to respond to a recurring theme regarding non-violation and situation complaints in 
order to add further clarity to our position and allay concerns somewhat. This has to do with the concern by some delegations that such complaints would inevitably have a chilling effect on certain 
types of measures adopted by WTO Members, includ ing with respect to their ability to use TRIPS 
flexibilities. 
242.  Yet, it is important to recall that where non-violation and situation complaints have been 
used - and they have been used in the context of the GATT for 63 years, despite some suggestions 
today to the contrary - the ability to utilize such exceptions and to adopt such measures has not been impaired. There has been no chilling effect ,  i n c l u d i n g  t h e  v e r y  t y p e  o f  m e a s u r e s  w e  a r e  
discussing today. So delegates have expressed concerns about their ability to take certain 
measures if non-violation and situation complaints were available, including measures to address 
social public moral-related issues.  
243.  Take, for example, one dispute panel’s description of GATT Article XX(a): 
[T]he term "public morals" denotes standards of right and wrong conduct maintained by or 
on behalf of a community or nation … the content of these concepts for Members can vary in time and space, depending upon a range of factors, including prevailing social, cultural, 
ethical and religious values. 
This description would cover many of the measures identified by some delegations as impaired by 
the supposed chilling effect of non-violation and situation complaints. Yet why, when non-violation 
and situation complaints have not been found to impair or otherwise chill the adoption of such 
measures in the GATT context, would they necessari ly chill the same measures in the context of 
the TRIPS Agreement? 
244.  As one delegation noted, the use of non-violat ion and situation complaints is limited, and this 
should further allay concerns. As noted by WTO adjudicative bodies and borne out by practice, 
these are extraordinary but nonetheless important remedies. But those very bodies, subject to the 
dictates of the Dispute Settlement Understanding (DSU) have been clearly and narrowly confined 
in terms of their scope and ability to interpret a non-violation and situation complaint. Accordingly, 
as we have been encouraged to reconsider, I woul d also respond in kind and like to have some 
kind of historical analysis of the extent to which non-violation and situation complaints have been used – they have been used several times but with no chilling effect and with no limitations on the 
ability of governments to take the kind of measures for which those who have spoken today have 
expressed some concern.  
Statements made at the reconvened meeting on 23 November 2015 
8.33  Peru   
245.  I would like to thank Members for their support of the draft Ministerial Decision tabled in July 
2015 by 17 Members regarding the inapplicability of non-violation and situation complaints to the 
TRIPS Agreement, and especially the LDCs and the African Group who have expressed their 
support for this draft Decision. We would like to make it clear that our position remains unchanged.  
246.  Having said this, we welcome the agreement regarding the recommendation for a Decision 
to be adopted by the tenth Ministerial conference. I would like to express our engagement in the 
future process of consultations that will start after the Nairobi Ministerial Conference. 
8.34  United States of America   
247.  The United States would like to express its support for the draft Decision to extend the 
moratorium on non-violation and situation complaints in the context of the TRIPS Agreement. Of course, our decision to join the consensus is without prejudice to our continued position that non-
violation and situation complaints are fully approp riate in the context of the TRIPS Agreement.  IP/C/M/80/Add.1 
 
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  8.35  India  
248.  India is one of the proponents of docu ments IP/C/W/385/Rev.1 and IP/C/W/607 and has 
consistently supported a permanent solution by making non-violation and situation complaints inapplicable under the TRIPS Agreement. During the last TRIPS Council meeting held on 
15 October 2015, the majority of the membership also supported the draft Decision contained in 
document IP/C/W/607 to make non-violation and situation complaints in applicable under the 
TRIPS Agreement. However, in view of the possibl e consensus emerging only the extension of the 
moratorium for a two-period, we agree to join the consensus for extension of the moratorium and 
on the application of non-violation and situation complaints until the next Ministerial Conference in 2017. 
8.36  Switzerland   
249.  We wish to confirm our support for the proposed Decision. This is, however, without 
prejudice to our position on the substance of this  issue. We remain convinced that no additional 
modalities are necessary to make non-violation complaints applicable under the TRIPS Agreement. 
8.37  Egypt   
250.  We would also like to express our support fior the draft Decision extending the moratorium. 
However, our position is well known. We believe th at the complaints of the type provided for under 
subparagraphs 1(b) and (1(c) of Article XXIII of GATT 1994 are not applicable to the TRIPS 
Agreement. 
8.38  China   
251.  China is a co-sponsor of documents IP/C/W/385/Rev.1 and IP/C/W/607. We believe that 
non-violation and situation complaints are inapplicable under the TRIPS Agreement. However, 
given the circumstances, China would like to join others and express its support for the draft text to extend the moratorium for initiating non-violation and situation complaints under the TRIPS 
Agreement until the next Ministerial meeting in 2017. 
8.39  Korea, Republic of   
252.  We appreciate the support provided by the Chairman and many delegations on this issue as 
well as the Secretariat's contribution. On this issue our position, which is well known, remains 
unchanged. However, we would like to express our support for the Chairman's draft text for the sake of consensus building and will engage in a constructive manner after the Tenth Ministerial meeting in Nairobi. 
8.40  Argentina   
253.  Argentina's position on this item is well known and remains unchanged. However, given the 
current situation, we are in a position to support the draft Decision on extending the moratorium. 
8.41  Ecuador   
254.  I would just like to state that Ecuador is a co-sponsor of documents 3, 5, 6 and 7 and given 
the agreement that has been reached, we can support the consensus for extending the 
moratorium in order to seek possible agreement in future. 
8.42  Japan   
255.  The delegation of Japan recognizes the continuous efforts of the Chair and the Secretariat, 
along with colleagues' contributions to facilitating discussion on this issue. Japan agrees to join the 
consensus. My delegation is willing to engage in discussions on all issues in the TRIPS Council in a 
constructive manner. IP/C/M/80/Add.1 
 
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  8.43  European Union   
256.  The EU position on this particular issue is  well-known so I will not repeat our position. My 
delegation welcomes the Decision reached to extend the moratorium. The European Union as always stands ready to engage in any additional further discussions to follow after Nairobi.  
8.44  Colombia   
257.  Colombia's initial interest was to adopt a Decision to ensure that non-violation and situation 
complaints were not applicable under TRIPS. However, we are aware that, given the current 
context, that is not possible. Accordingly, we ar e in a position to support the consensus and fully 
support extending the moratorium.  
8.45  Brazil   
258.  In May 2015, Brazil presented a communication contained in document IP/C/W/385/Rev.1 
on behalf of a number of co-sponsors and also we are a co-sponsor of the draft Decision presented 
by Peru in document IP/C/W/607. Even though we maintain our well-known position on this 
subject, we would like to express our support for the consensus on this compromise solution for 
the period between this next Ministeria l Conference and the following one.  
259.  We continue to maintain that non-violation complaints can introduce incoherence among the 
WTO agreements and harm the delicate balance of rights and obligations that was agreed in the 
TRIPS Agreement. They could also undermine the national regulatory authority and infringe 
sovereign rights. Further, we consider that they can limit user flexibilities that are an integral part of the TRIPS Agreement. As one of the co-sponsor s of document IP/C/W/385, we consider that a 
consensual draft of scope and modalities is nece ssary for the implementation of non-violation 
complaints in the field of intellectual property rights. Having said that, we can join the consensus 
on this compromise solution and we are ready to continue the discussion after the Ministerial Conference in Nairobi. 
8.46  Sri Lanka   
260.  As a co-sponsor of this proposal, Sri Lanka would like to join the consensus for a Decision to 
extend the moratorium on non-violation and situation complaints. However, my delegation's 
position is well known. Members should seek to fi nd a permanent solution to this issue and they 
should not be applicable under the TRIPS Agreement. 
8.47  Chinese Taipei   
 
261.  My delegation is pleased to join the consen sus to support the draft Decision. As non-violation 
and situation complaints have been a longstanding issue in the TRIPS Council, we look forward to in-depth discussion among Members, in particular with regard to the possible scope and types of 
complaints applicable in the context of the TRIP S Agreement after the tenth Ministerial Conference 
in Nairobi. 
8.48  Malaysia   
 
262.  Malaysia welcomes the compromise by Members and supports the consensus for extending the moratorium for two more years. However, without prejudice to our well-known position, Malaysia looks forward to discussing further the issue of the non-applicability of non-violation 
complaints to the TRIPS Agreement after the Ministerial Conference in Nairobi. 
8.49  Bangladesh, on behalf of the LDC Group   
 
263.  From the perspective of LDC countries, we would have liked to see a permanent non-
application of this provision to the TRIPS Agreement, but as the principle proponents and opponents have reached an understanding, we are happy to join the consensus at this point for an 
extension of the moratorium. IP/C/M/80/Add.1 
 
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  8.50  Russian Federation   
264.  The Russian Federation is a co-sponsor of documents IP/C/W/607 and IP/C/W/385/Rev.1 
and maintains its position regarding the non-applicability of non-violation and situation complaint provisions under the TRIPS Agreement. At the same time, we would like to express our 
appreciation to all parties that took part in the consultations. We would like to join the consensus 
reached by Members. At the same time we agree th at consultations should be held in the future 
and that further work be undertaken with a view to reaching a final agreement. 
8.51  Chile   
265.  Our delegation would like to express its a ppreciation to the Chair, the Secretariat and in 
particular the various delegations for their flexibility in reaching a consensus on this issue. Their positions are well-known on this item and this is the best decision that the Council could adopt as 
the body responsible for this Agreement, given the different positions that have been expressed 
until now. Accordingly, we would like to expres s our support for the consensus. My delegation 
stands ready to continue with discussions with a view to reaching a permanent solution. 
8.52  South Africa   
266.  This delegation is pleased to join the consensus on this issue. However, this is without 
prejudice to our previous position expressed in this Council that non-violation and situation 
complaints are inapplicable to the TRIPS Agreement. 
8.53  Hong Kong, China   
267.  Hong Kong, China is pleased to join the consensus of Members and will continue to work 
with other Members towards a permanent solution after the Ministerial Conference in Niarobi.  
8.54  Nigeria, on behalf of the African Group   
268.  Let me start by thanking the Chair for all the good work done in galvanizing consensus 
around this latest Decision. The African Group welcomes the Decision to extend the moratorium on 
the non-application of non-violation and situation complaints. Accordingly, the African Group is 
therefore happy to join the consensus on this issue. However, our position is well-known. 
Immediately after the next Ministerial Conference there is a need for us to resume work with a 
view to finding a permanent solution on this matter. We will also encourage the next Chair of the 
TRIPS Council to that extent. 
AGENDA ITEM 9:  REVIEW OF THE IMPLEMENTATION OF THE TRIPS AGREEMENT UNDER 
ARTICLE 71.1 
269.  No statements were made under this agenda item 
AGENDA ITEM 10: REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION 
ON GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2 
270.  No statements were made under this agenda item 
AGENDA ITEM 11:  THIRTEENTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE 
DECISION ON THE IMPLEMENTATION OF ARTICLE 66.2 OF THE TRIPS AGREEMENT 
11.1  European Union   
 271.  I would like to very briefly introduce some highlights of our extensive report on technology transfer and to give you a few examples of the programmes and the support that has been put in 
p lac e . I n thi s  ye ar' s  re port we  have  s hown that L DCs  have  b e e n s trong ly s up p orted  by the  EU 
research programmes. We have our European Framework Programme. Pursuant to this programme LDCs received approximately €40 millio n for health projects. Many of the funded 
projects were still on-going in 2014.  IP/C/M/80/Add.1 
 
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  272.  In 2014 the first call of the Horizon 2020 on health was launched. A number of LDCs were 
funded, and they received a contribution of over €7million. These include Bangladesh, Nepal 
Mozambique, Senegal, Uganda and Burkina Faso. A lot of health research and innovation in 2014 
was carried out in the framework and against the background of the Ebola outbreak. Let me give 
you a summary of the main programmes and the related EU contribution. 
The emergency research response 273.  After the declaration of a global emergency in August 2014, the European Commission 
quickly mobilised €24.4million in September 2014 from Horizon 2020, its research and innovation 
programme, via an exceptional procedure. Work  on the funded projects began already on 
1 November 2014. 
274.   Five projects are being funded under this procedure, including a trial of the most advanced 
vaccine against Ebola being developed by GSK with a European Commission financial contribution 
of €15.1 million. This vaccine is already being test ed in humans, with promising results being seen 
so far. Other projects are studying the potential th erapeutic effect on Ebola patients of an existing 
treatment against influenza (favipiravir), plas ma from survivors, and serum from antibody-
producing horses. A further project is working on the transmission of the virus and the clinical importance of its mutations. 
275.  Additionally we have an important partnership which is called the European and Developing 
Countries Clinical Trials Partnership where again th e EU added Ebola to the list of diseases that 
could be covered in this programme and has urged partners to mobilise funding from the participating States to increase the budget from 2014 and 2015 and to coordinate relevant 
research activities. There are more details about this programme on the website that we provide in 
our report. 
276.  We have also programmes from member States. Ireland works with Higher education 
institutions in LDC partner countries. For example, Uganda, Tanzania, Mozambique, Zambia, 
Ethiopia, Malawi, Lesotho, Sierra Leone to implement digital projects. Among others, the establishment of a digital media programme will support the emergence of a sustainable 
indigenous capital media industry in Zambia. The completion of Geographical Information Systems 
database can demonstrate spatial aspects of water and health in Makondo, Uganda.  
277.  We have also reported about HIV/AIDS – connecting public administration, policy and 
communities which includes a workshop planned for early next year to develop shared curricular 
material, and in an e-learning format, which can be used in institutions in, Tanzania and Uganda.  
278.  We also report about UK-financed programmes to support the African Agricultural 
Technology Foundation. We have extended this list of programmes with high values to show that 
the EU continues to translate its obligation into concrete technology transfer and projects that are 
fairly successful and with the cooperation of the recipient countries. 
11.2  New Zealand
2  
 
279.  I will present our report  in more detail at  the Workshop on the Implementation of Article 
66.2 of the TRIPS Agreement, when I will highlight some specific projects which are also outlined 
in our report. These include a regional eye care centre in the Solomon Islands, a Myanmar Dairy 
Excellence Project, the Vanuatu Rural Electrific ation Project, Recognised Seasonal Employer 
scheme (RSE) in which Pacific workers take up seasonal employment in New Zealand's horticulture and viticulture industries. Our report shows that New Zealand's efforts to encourage technology 
transfer to LDCs occur through a variety of ch annels promoting a broad economic environment 
that is conducive to the development of New Zealand enterprises and institutions and enables them to transfer technology abroad. It also en courages trade in goods, services and labour 
mobility. It also facilitates a strong intellectua l property regime. Through New Zealand's bilateral 
and regional development programmes we will work  very closely with Australia and some of our 
key development partners. We would like to thank the Secretariat for arranging the Workshop on Monday, we look forward to presenting on New Zealand's incentives for technology transfers to 
                                               
2 This statement was made under Agenda Item  12, but is relevant to Agenda Item 11. IP/C/M/80/Add.1 
 
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  LDCs and we expect that the Workshop will prov ide a useful opportunity for exchanging views on 
technology transfer issues. 
AGENDA ITEM 12: TECHNICAL COOP ERATION AND CAPACITY BUILDING 
12.1 European Union     
 
280.  I would like to introduce again the some of our activities:  
EU – India Intellectual Property Cooperation 
 
281.  This is a project that will extend from February 2015 to September 2017, involving a EU contribution €1,800,000 and a contribution by our trademark office (OHIM) of €120,000, 
amounting to a total of €1,920,000. 
282.  The Project Components are twofold: (i) tr ademark and design administration services & 
information to the business community aimed at strengthening the capacity of the IP administration in India to deliver quality registration and information services to the business 
community, particularly in the areas of trademarks and industrial designs; and (ii) to enhance the 
capacity of the Indian productive sector to crea te, protect and manage its own brands by using IP 
as a tool for development. 
283.  A second project is one that has been ongoing for many years, but it has had another full 
year, i.e. the EU-ASEAN Project on the Protection of Intellectual Property Rights  - ECAP III , that 
supports the ASEAN IPR Action Plan 2011-2015. Some examples of results include the ASEAN TMclass search tool enabling web access to the ASEAN TMclass database and including search, 
browse and translation functionalities, became fully operational for use by the ASEAN IP Offices in 
March 2015. The ASEAN IP Offices have agreed to make it also open for public use on the web in August 2015.  
284.  This ECAP III programme also included the exchanges of officials, for instance 50 officials 
from the IP Offices of Cambodia, Indonesia, La o PDR and Myanmar improved their knowledge on 
the legal and technical aspects of the Madrid Protocol so they were trained in this area.  
285.  The project also facilitated access through the IP Portal to the common online trademark 
information platform of the ASEAN Member States . There were also a number of exercises in the 
area of designs and geographical indications that you can consult in the information we have provided. 
286.  Passing now to some projects by member States I would like to make reference to a project 
by Austria's IP Office. They organized a training course on patent documentation and information, protection of trademarks and designs, international IP treaties in which Bangladesh  with other 
countries participated.  
287.   France has organized on an annual basis since 2007 courses on GIs, for in total 138 
participants from 43 countries and regional organisations. France also organized several other 
general training courses on intellectual property for LDCs.  
288.  Sweden organized a course for LDCs of th ree weeks in Stockholm and one week in Myanmar 
to enhance the participants understanding of intellectual property rights with emphasis on their contribution for economic growth, trade, and de velopment. It had an audience of around 25 
participants from  countries like Nepal, Bangladesh, Malawi, Lao PDR, Sudan, Rwanda, Uganda, 
Bhutan, Zambia, Mozambique, Tanzania, Cambod ia, Burundi, Sierra Leone and Ethiopia. 
289.  Finally the UK also held several training courses on IP, with participants from Nigeria, 
Jamaica, Kenya, Georgia, South Africa, St Lucia,  Tanzania, Trinidad & Tobago, Egypt and also on 
Trademarks and Design specific for Malaysia, Thailand, Viet Nam, Indonesia, Cambodia, Laos, Burma and the Philippines. IP/C/M/80/Add.1 
 
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  12.2  Australia   
 290.  Australia takes an active role in promoting intellectual property-related technical cooperation and capacity-building as highlighted in our 201 5 report (IP/C/W/610/Add.4). Australia provides 
technical cooperation in various ways to fulfil our commitment under Article 67 of TRIPS. 
291.  As an example of a regional initiative, we work closely with New Zealand and intellectual 
property offices in ASEAN countries on various initiatives under the framework of the ASEAN-
Australia-New Zealand Free Trade Agreement. This Economic Cooperation Support Programme has 
now been extended to 30 June 2018. 
292.  We also continue to be active in support ing relevant multilateral programme. Australia's 
three-year funding commitment under the Australia-WIPO Funds in Trust has been effective, as we 
have highlighted in previous TRIPS Council interventions and in our 2015 Report. 
293.  Since we submitted our 2015 report, Australia announced at the 2015 WIPO General 
Assembly a new investment of $3 million Australian dollars over three years to support a second 
Australia-WIPO Funds in Trust programme. 
294.  The second phase of this programme seeks to  build on the successes of the first programme, 
extend it to new partner countries and expand support for innovative intellectual property 
activities which secure benefits for least develope d and developing country partners. It will also 
support new activities including, for example, on appropriate technologies for developing countries to tackle environmental issues under WIPO Green. 
295.  Furthermore, Australia continues to be a significant contributor to the Global Trust Fund, the 
flagship WTO fund providing trade-related technical assistance activities. In 2015, Australia 
provided a replenishment of over 2 million Swiss Francs. 
296.  In closing, Australia is pleased to have this occasion to reiterate our commitment to technical 
and financial cooperation which facilitates TRIPS implementation. 
12.3  Secretariat   
 
297.  This report on the WTO activities relating to TA in the TRIPS area will be brief. However, 
details are also available in document IP/C/W/608. 
298.  In the first place, I would like to underline that technical cooperation is driven essentially by 
d e m a n d  f r o m  M e m b e r s ,  a s  w e l l  a s  f r o m  c o u n t r i e s  p r e p a r i n g  t o  a c c e d e  t o  t h e  W T O .  G r o w i n g  
diversity of the needs and interests identified by Members has led to increased tailoring and 
focusing of technical assistance activities on sp ecific areas of interest. At the same time, the 
Secretariat has adopted a more holistic approach to its capacity building activities in general, 
putting the TRIPS Agreement and its policy choices into a broader context. This approach takes 
into account the interface between the TRIPS Agreement and other WTO Agreements, such as 
agriculture, TBT and SPS. 
299.  Turning now to individual activities, I would like to focus on Geneva-based activities on IP as 
they represent a large proportion of our technical activities. They are rich in content and serve to 
intensify our collaboration with other relevant international organizations, in particular WIPO and the WHO. They offer good value for money as the cost is, in many cases, shared with partners. 
300.  I am thinking in particular of the flagship joint WIPO-WTO Colloquium for Teachers of 
Intellectual Property from Developing Countries and countries with economies in transition. This activity formed part of the wider Secretariat's approach towards cooperation with the academic 
community in developing countries aimed at local capacity building on WTO matters. The main 
objective of the Colloquium was to update univer s i t y  t e a c h e r s  o f  I P  o n  t h e  a c t i v i t i e s  a n d  
instruments of the WIPO and the WTO with focus on important policy issues under negotiation or 
discussion in the two Organizations. 
301.  Another important Geneva-based activity is the joint WIPO-WTO Advanced Course on 
Intellectual Property. This Course continued to draw on the experience of the Colloquium, and IP/C/M/80/Add.1 
 
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  applied a similar programme structure and pedago gic strategy, but was tailored and focused on 
government officials and public sector policymakers instead of university teachers and researchers.  
302.  Finally, a Workshop on Trade and Public Health was organized in Geneva by the WTO 
Secretariat in close collaboration with the WHO and WIPO. Built on a series of nine workshops on 
intellectual property and public health that ha d been held by the Secretariat since 2005, this 
Workshop was the first ever WTO event to cover a wide range of multilateral trade agreements and their link to the achievement of public health objectives. 
303.  The WTO has also been active outside of Gene va. I am thinking in particular of national and 
regional activities on IP organised all over the world. 
304.  I would also like to mention that a TRIPS module is included in WTO eTraining Courses. 
These are web-based courses for developing country and economies in transition, which are 
provided in English, French and Spanish all-year-round. 
305.  Finally, the WTO Secretariat's technical cooperation in the area of TRIPS includes cooperation 
with other intergovernmental organizations. In particular, the WHO, WIPO and WTO Secretariats 
have continued their trilateral cooperation with a view to fostering a better understanding of the 
linkage between public health, intellectual property and trade more generally. 
12.4 Gulf Cooperation Council   
 
306.  The Gulf Cooperation Council (GCC) for the Arab States of the Gulf is an intergovernmental organization with membership of six developing countries.  
307.  In pursuance to Article (20) of the GCC Economic Agreement which states that "member 
States shall develop programmes encouraging tale nted individuals and supporting innovation and 
invention; cooperate in the field of intellectual property and develop regulations and procedures ensuring protection of intellectual property rights; and coordinate their relevant policies towards 
other countries, regional blocs and international and regional organizations", the GCC Secretariat 
General directs most of its technical cooperation activities to its member States. 
308.  The Cooperation Council for the Arab States of the Gulf started working to amend the "GCC 
Patent Law" to comply with national patents laws of its member States as well as with the 
international agreements. It established the "GCC IP Training Center" in Kuwait which Continuingly organizing training programmes in different IP fields for the benefits of the member States. 
309.  The GCC has also been working on the adopti on of a framework of coordination activities 
between the GCC Patent Office and the member St ates patent offices. The framework includes 
patent policy, patent filing, patent examination, awareness and invention promotion, organizing joint activities, training and human resources, patent information, information technology, and 
international treaties and organizations.  
310.  Since October 2014 the GCC Secretariat General is providing several activities on technical 
cooperation on TRIPS, where they were providing consultation and financial support for the "Gulf 
Inventors Campaign" which is organized by the "Federation of GCC Chambers of Commerce". The 
campaign aims to support GCC inventors as well as  to enhance innovation  in the member States. 
The GCC Patent Office examiners participated in evaluating the inventions by being judges in the 
invention's evaluation committee. 
311.  The GCC Patent Office is sponsoring the participation of inventors from its member States in 
several national and international exhibitions of inventions. The GCCPO participated in the Sixth Technical Meeting organized by Sultan Qaboos University, at Muscat, in the Sultanate of Oman, in 
November 2014, as well as in IENA "International Trade Fair Ideas - Inventions - New Products" , 
at Nuremberg, in Germany, in November 2014. 
312.  The GCCPO also participated in the fourteenth session of WIPO Committee on Development 
and Intellectual Property (CDIP) held  on November 2014, and  in its fifteenth session held in 
April 2015. IP/C/M/80/Add.1 
 
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  313.  The GCCPO also participated in the "7th International Exhibition of Inventions in the Middle 
East", in Kuwait, held in December 2014 as well as  in the sixth student's conference by evaluating 
the students invention, at Jeddah, in the Kingdom of Saudi Arabia, held in February 2015. The GCCPO also Participated in the Forum of "Managem ent of challenges in the field of research and 
innovation", organized by the Gulf Petrochemicals Union in Dubai in March 2015. It also 
participated in the Conference on Challenges in the implementation of IP laws in the Arab Countries" held in Cairo, Egypt, on April 2015. 
314.  In addition, the GCCPO participated in " the Forum on Asian patent information", "East Meet 
West" organized by EPO, in Vienna, Austria, in April 2015. It also participated in Regional workshop on "Benefits from patents examination reports results in other patent offices", organized by WIPO and Egypt Patent Office, in Cairo, Egypt in June 2015. The GCCPO participated in the 
twenty-Second session of the WIPO Standing Committee on the Law of Patents held in Geneva, in 
July 2015. It also participated in workshop on IT for Arab Countries Offices for Industrial Property, 
which was organized by WIPO and Egypt Patent Office, in Cairo, Egypt, in August 2015. The 
GCCPO provided technical support for Kuwait Patent Office by sending expert personnel from 
GCCPO to Kuwait Patent Office, in September 2015. 
315.  In addition to this, the GCC Secretariat Ge neral (GCC IP Training Center) organized in Kuwait 
a number of training courses such as on the Agreement on Trade-Related Aspects of Intellectual 
Property (TRIPS), organized in cooperation with Arab Society of Intellectual Property, in Kuwait, in November 2014 .It organized  also, in cooperation with Singapore IP Academy, courses on Copyright Law in the Current Legislations, in Ma y 2015, as well as on Protection of Undisclosed 
Information and Trade Secrets, in May 2015. The GCC IP Training Center offered also a training 
course on PCT, in June 2016 and on Intellectual Property Basics in June 2016 as well as on Legislation Procedure in Intellectual Property for GCC states, in June 2015.  
316.  The said activities are the beginning of an  ambitious programme aimed at forming the base 
under which the GCC countries intend to protect inventors' rights and their inventions. Therefore, it requires continuous efforts and  follow-up  fr om all concerned parties for the implementation and 
enforcement of national laws and  regulations as well as of international agreements for the 
benefit of development and progress as well as of public interest.  
12.5 UNCTAD Secretariat   
 
317.  The UNCTAD Secretariat through its Intellectua l Property Unit has been implementing a work 
programme on the development dimension of inte llectual property rights. The work programme 
responds to the request by member States at the UNCTAD Ministerial Conference in Doha as well 
as to intergovernmental requests under the WI PO Development Agenda, and the World Health 
Assemblies' Resolution on a Global Strategy and Pl an of Action on Public Health, Innovation and 
Intellectual Property. In implementing the work programme, UNCTAD undertakes research and 
analysis, responds to requests for technical assistance and advises on policy options on the 
interface between investment, trade and intellectual property.  
318.  First, in the area of research and policy analysis, UNCTAD is currently examining the policy 
framework to promote the production of biosimilars in developing countries. UNCTAD is also 
compiling key jurisprudence in intellectual property rights from major jurisdictions in the world as 
an important technical input in informing the management of the interface between IP rights and development. In the area of technical assistance, UNCTAD conducts activities in the integrated 
areas of investment, trade and intellectual property. Technical assistance is provided on a request 
basis and funded by donor governments and institutions. The main focus of the technical assistance activities has been to assist developing countries and LDCs to establish domestic IP 
regimes that facilitate increased access to affordable medicines and where feasible to create local 
or regional pharmaceutical production and supply capacity in cooperation with investors.  
319.  The technical assistance in this area is implemented with the financial support of the 
Government of Germany and originally the Government of the United Kingdom. Funded by the 
German International Cooperation (GIZ), UNCTAD is also examining the coherence of policies in 
developing countries and regions in respect of health, trade and industrial development. The overall objective of this exercise is to assist deve loping countries or regions in building capacity to 
promote policy coherence to ensure that local pharmaceutical production actually increases access 
to medicines. UNCTAD and GIZ pursue this activity on a regional basis in South East Asia and in IP/C/M/80/Add.1 
 
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  the Eastern African Community. In addition, UNCTAD is undertaking similar activities at the 
national level in cooperation with the WHO under the financial support made available by the EU.  
320.  In addition to access to medicines, UNCTAD has been implementing a technical assistance 
programme on IP and diversity with initial financial support from the Government of Germany. The 
programme focuses on the building of local capacity in developing countries to design and enforce 
domestic laws in line with access and benefit-sharing rules under the Convention on Biological Diversity, the Nagoya Protocol and the UN Declar ation on the Rights of the Indigenous People. 
UNCTAD provides upon request by a developing country or a LDC an advisory report on the 
development dimension of intellectual property. The objective of the advisory report is to provide 
well-researched and reasoned advice on the policy, legal and national framework for IP rights, particularly as it relates to important development objectives such as innovation, technology and 
investment. 
321.   The key development issues are usually determined by the requesting countries. UNCTAD's 
technical assistance activities involve a very broad consultation with stakeholders during a fact-
finding mission and an intensive review of the national policies, laws, the bilateral, regional and 
international commitments and also the social-economic indicators of the technical assistance-requesting country. Often the consultation process brings together government entities responsible 
for trade, customs, national development, heal th, finance, science and innovation and related 
policies with the private sector actors.  
322.  UNCTAD's experience in technical assistance has amply demonstrated the financial, 
administrative and economic constraints of LDCs to build technological capacity to promote local 
production of pharmaceuticals and improve access to medicines and related materials. UNCTAD 
welcomes the extension of the transitional period  for the implementation of the TRIPS Agreement 
by LDCs until 2021. UNCTAD also considers it im portant to respond to the request by LDCs to 
further extend the period for the implementation of the provisions of the TRIPS Agreement with 
respect to pharmaceutical products as long as they remain LDCs.  
323.  Last, but not least, an important element of UNCTAD's work is consensus-building amongst 
stakeholders on issues of IP. It provides a forum through its intergovernmental process where 
governments, academia and civil society and the private sector can meet to exchange ideas. For example, UNCTAD on 21 January 2015 organized an ad-hoc Expert Group Meeting on the production of biosimilars in developing countries. More detailed information on UNCTAD's activities 
related to IP as well as a list of activities conducted during the period of November 2014 to 
October 2015 is including in this Council's meeting document IP/C/W/609/Add.4. 
12.6  WHO Secretariat   
 
324.  We seize the opportunity to highlight a number of the World Health Organization's technical cooperation activities that took place since our last report to the TRIPS Council in October 2014. 
325.  One major development that might be of intere st to delegates is the recent revision of the 
WHO Essential Medicines List (EML). This list is an important tool to guide reimbursement decisions, procurement of medicines and the rati onal use of medicines in general. Essential 
medicines are those that satisfy the priority health  care needs of the population. The selection of 
medicines is based on the public health relevanc e of the disease and a comprehensive review of 
available evidence for benefits and harms. 
326.  In April 2015, the WHO Expert Committee on the Selection and Use of Essential Medicines 
added 16 new medicines for cancer, all six newly available innovative oral treatments for 
Hepatitis C and five tuberculosis treatments to the list. The inclusion reflects growing public health needs for example in the area of cancer as well as  the emergence of more effective new innovative 
treatments for example in the area of Hepatitis C. Despite the fact, that the price of a treatment or 
the patent situation are not criteria that are co nsidered by the Committee in its decision-making, 
traditionally the WHO EML included very few patented medicines as most  priority health care needs can be addressed with off-patent medicines. Th e current revision of the list is adding several 
medicines that are still patented in major markets, namely all new oral treatments for Hepatitis C, 
several cancer drugs and two new treatments for multi-drug resistant tuberculosis. By integrating IP/C/M/80/Add.1 
 
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  these new medicines, WHO is underscoring the need for strategies to make these treatments 
affordable worldwide to facilitate equitable access.   
327.  In this context WHO works on providing mo re transparency on the patent situation of 
essential medicines. We published an analysis of the patent situation of seven new hepatitis 
treatments in August 2014 and updated the patent  information on daclatasvir, ledipasvir and 
sofosbuvir in 2015. The patent working papers id entify the most relevant patents and list the 
countries in which these patents have been filed and granted. We will continue to update these 
patent reports. 
328.  To allow health policy-makers to better und erstand the mechanisms linking trade and health, 
WHO published Trade and Health: Towards building a national strategy  in September 2015. The 
book provides a comprehensive overview of issues relevant to the development of a national 
strategy on trade and health. Core evidence is presented to help decision-makers address the key 
challenges to public health, while taking advantage of new opportunities for achieving a higher standard of health, wealth and development. It can be downloaded from our website and you can 
find the link in our report IP/W/609/Add.5. 
329.  In 2015, the WHO Regional Office for Europe launched the report Access to new medicines in 
Europe: technical review of policy initiatives and opportunities for collaboration and research . The 
study explores how European countries are dealing with high spending on new medicines, 
including methods such as restrictive treatment guidelines, target levels for use of generics, and limitations on the use of particularly expensiv e drugs. The study also outlines possible policy 
directions and choices that may help governments to reduce high prices when introducing new 
drugs.  
330.  In July 2015, WHO collaborated with the Ethiopian government in developing and launching 
a National strategy and plan of action for pharmaceutical manufacturing development in Ethiopia. 
The report was launched by the Deputy-Prime Minister  of Ethiopia, in the presence of the Director-
General of WHO as well as many other global an d regional leaders, ministers, ambassadors and 
high-level government officials in July 2015. Under strategic objective 5, the strategy and plan of 
action emphasizes the support for the development of a local cluster for the production of new 
active pharmaceutical ingredients. WHO is now working with the Ethiopian government to establish a mechanism for implementation of the strategy and monitoring of its impact. WHO's local production related technical support  activities ha ve been carried on in Ghana, Tanzania, Kenya, 
Senegal, South Africa and Indonesia.   
331.  These are just a few examples of activities we carried out during the last year. More ample 
information on technical cooperation activities under the WHO programme on public health and 
intellectual property can be found in document IP/C/W/609/Add.5. We would be glad to answer 
any questions delegations might have regarding these activities and send you the reports mentioned by email. 
12.7  WIPO Secretariat   
 332.  WIPO has submitted information regarding it s technical cooperation programmes relevant to 
the TRIPS Agreement for the period October 2014 to September 2015. This submission reports on 
a comprehensive range of cooperation activities to some 157 WIPO Member States reflecting 
WIPO's role as a major provider of intellectual property (IP) related technical assistance. 
333.  WIPO's technical cooperation activities respond to individual needs and requests from WIPO's 
Member States in developing countries, LDCs and economies in transition. This cooperation seeks 
to empower countries to use the IP system as a contributing factor in achieving their national 
development goals, to leverage their participation in the global knowledge and innovation economy 
and to facilitate the use of IP to promote economic, social and cultural development. 
334.  WIPO's work in this regard is informed and guided by the relevant WIPO Development 
Agenda Recommendations, in particular recommend ations under Cluster A on WIPO's technical 
assistance and capacity building. IP/C/M/80/Add.1 
 
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  335.  These activities are undertaken by a range of programmes within WIPO and our submission 
reflects the rich and diverse nature of this support. We wish to inform Members that in addition to our submission to the TRIPS Council, this information is also available on the WIPO website through the WIPO IP Technical Assistance Database (IP-TAD) and in the WIPO Country Profiles. 
336.  I should also like to take this opportunity to express our appreciation to the Government of 
Australia for both the existing Fund-in-Trust and the recently announced new Australia fund in trust agreement.  In addition, I should also like to thank those other government donors who have 
set up funds-in-trust with WIPO to support our work. 
337.  This year marks the 20th anniversary of the WTO and at the same time the 20
th anniversary 
of the Cooperation Agreement between WIPO and th e WTO. This Agreement sets out the enhanced 
cooperation on legal assistance and technical cooperation activities relating to the TRIPS 
Agreement for developing countries, so as to maximize the usefulness of those activities and 
ensure their mutually supportive nature. This has b een an important part of WIPO's work with the 
WTO which has evolved over the years in response to  changing demand and will continue to be an 
important area of collaboration. 
338.  Also related to this, is the work of th e trilateral cooperation between the WTO, WHO and 
WIPO. This has provided an important strengthening of cooperation and practical coordination on 
issues around public health, IP and trade. The trilateral cooperation is intended to contribute to 
enhancing the empirical and factual information basis for policy makers and supporting them in 
addressing public health in relation to IP and trade. 
339.  Finally, WIPO looks forward to its conti nued cooperation with the WTO and in providing 
technical assistance to WIPO and WTO Member States, as well as supporting the work of the TRIPS 
Council. 
12.8  Ecuador  
 
340.  Ecuador wishes to thank the Secretariat for the presentation of document IP/C/W/608 in which the technical cooperation activities carried out by the Organization are described, as well as 
the reports presented by the various Organizati ons. Regarding the report presented by the 
Secretariat of the WTO, although the activities described correspond to the period for second half of 2014 and the first half of 2015, it is worth high lighting the activities carried out in Quito in 
September 2015, organized by the Secretariat, stre ngthening the public and private sector which 
received training on the technicalities entailed in availing themselves of their rights as rights 
holders. We are also grateful for not reducing the funding for these activities.  
AGENDA ITEM 13:  REQUEST FOR AN EXTENS ION 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 
Statements made at reconvened meeting on 6 November 2015 
13.1 Bangladesh, on behalf of the LDC Group   
 341.  First let me take this opportunity to than k all the Members of WTO for contributing towards 
this historic Decision. Extension of transition period for the pharmaceuticals for LDCs under TRIPS 
Article 66.1 may be a mere item under the agenda of the TRIPS Council. But this Decision will assure the LDCs the necessary legal certainty to procure or to produce generic medicines for those 
who need it most, but do not have any access to  it. Our Ministers in 2001 understood well that 
pharmaceuticals are distinct from all other elements of IP and a human being suffering from a deadly disease would not be cured by reading a copyright protected book or by watching a 
copyright protected movie. Human life is something that came only as a gift from heaven and we 
are in no way permitted to endanger it by any means. Our Decision today will help us appear in a good light with regard to our accountability towa rds the humanity. We hope that in the next 17 
years will see the graduation of all LDCs. In the same vein, we expect the General Council to 
expeditiously approve our request for waivers fr om TRIPS Articles 70.8 and 70.9 for the same 
period as has been done in the Decision just adopted today. In the future we hope that the IP/C/M/80/Add.1 
 
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  Member States will show the same compassion when needed to consider any future duly 
motivated request as per TRIPS Article 66.1. 
342.  Today it is my honour to thank you Mr Chairman for your wise guidance along with 
Ambassador Suescum of Panama who enriched our efforts with his precious experience. We 
further show appreciation towards the WTO Secretariat under the Director-General for all the 
logistic and substantive assistance to reach the Decision and not least for guidance even on substantive matters of a technical nature. I thank whole-heartedly our experts who prepared the 
ground for this momentous conclusion and all my co lleagues in the LDC Group. We also gratefully 
recall the invaluable contribution of the civil societies, NGOs, political personalities, think tanks, different private and fellow international organizations from world over who supported and actively moved forward the causes of the LDCs. And it will be remiss on our part if we do not specifically 
mention the contribution and endeavor of Ambassador Michael Punke to reach the understanding. 
We also expect similar pioneering effo rts from him in the coming months. 
343.  I will end by thanking again all the Members of WTO to do more in the near future as they 
have done on this occasion, proving that we can achieve any constructive and beneficial Decision if 
we stand together for our people. I will remind everybody the remark of Martin Luther King Jr.: "We may have all come in different ship s, but we're in the same boat now." 
13.2  United States of America  
 344.  We would like to take this opportunity to confirm our support for the adoption of this Decision and the recommendation of the Waiver Decision to the General Council. Both Decisions 
are the result of several months of productive negotiations among a number of delegations, 
including the ambassadorial-led process between the US and Bangladesh as the LDC coordinator, as well as Uganda as the LDC focal point. We are pleased that we have arrived at an expeditious 
solution prior to the Ministerial, and the extension of the pharmaceutical transition period. We 
would like to thank you Mr Chairman, Ambassador Suescum, for filling in during your absence, the Secretariat and Member, in particular Bangladesh and Uganda, for all of their tireless efforts in 
achieving this result. 
13.3  Uganda   
 345.  The period leading up to this moment has been one of intense activity and reflection. We 
were consciously reminded by the message that Pope Francis delivered to the UN General 
Assembly on 25 September 2015. He said, "[i]t must never be forgotten that political and economic activity is only effective when it is understood as a prudential activity, guided by a 
perennial concept of justice and constantly conscious of the fact that, above and beyond our plans 
and programs, we are dealing with real men and women who live, struggle and suffer, and are often forced to live in great poverty, deprived of all rights. The hour has come when a pause, a 
moment of recollection, reflection, even of prayer, is absolutely needed so that we may think back 
over our common origin, our history, our common destiny. The appeal to the moral conscience of man has never been as necessary as it is today. For the danger comes neither from progress nor from science; if these are used well, they can help  to solve a great number of the serious problems 
besetting mankind".  
346.  Today is a day when we shall look back and say that for a moment the Members in this 
house were joined together by their common heritage to try and address a problem that faces 
many of us living in developed, developing and LD Cs. This is the prevalence of incurable diseases; 
and the cost of medicines in a part of the world where there is more acute need, not least because of the incidence and prevalence of both co mmunicable and non-communicable diseases; but 
largely on account of the level of poverty that still eats at the more than 400 million people living 
in LDCs. The pharmaceutical extension offered as part of the Doha Declaration had a huge positive impact in improving access to affordable treatm ent. With low cost generics; LDC governments, 
donors and the international community have been able to treat more HIV/AIDS patients and also 
make savings on their investment.  
347.  That said however, the treatment gap conti nues to be massive. Overall, at the end of 2013, 
63% of the 10.7 million people living with HIV in LDCs did not have access to ARV therapy. In low 
income countries, 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 IP/C/M/80/Add.1 
 
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  widespread access to vaccines and medicines. Per capita health expenditure in 2013 was a paltry 
$US47. While 50% of all health expenditure in LDCs is out of pocket.  
348.  Which is why, the framers of Article 66.1 had in mind the existence of these factors, and 
they recognized that as a result of our special needs and requirements, our economic, financial 
and administrative constraints - we would require more special and differential treatment to inter 
alia promote and protect the right to health. It is in this spirit that today we see yet again an 
extension granted to afford LDCs the opportunity to  be able to address the various challenges that 
we continue to face. It is no secret that we suffer enormous health burdens, both of communicable 
and non-communicable diseases. The Ebola crisis plagued Sierra Leone, Guinea and Liberia; all LDCs. Can you imagine, the World Bank Group estimated on 20 January, that these three countries would lose at least US$1.6 billion in forgone economic growth in 2015 as a result of the 
epidemic?  
349.  There are only two critical requirements in Article 66.1 that must be met. First, a Member 
must meet the criteria of LDC status; and second ly must submit a duly motivated request. There 
are no further requirements or conditions. There is  therefore nothing in Article 66.1 that prevents 
the granting of an extension for as long as a country remains an LDC, considering that LDC status is not self-designated. To that end therefore there is no logic in requiring LDCs to apply for this 
pharmaceutical extension every few years. As we said before, HIV/AIDS is an incurable disease; 
while cancer requires palliative care. In the past, for a person to be enrolled for ART, they were required to wait until they reach a CD4 count of 250. The new WHO guidelines require that once one is tested positive, they must enroll immediately on ART. Meaning that more and more people 
will require access to ART for a very long time of their remaining life.  
350.  When all has been said and done, when all data and arguments; and legal precedents have 
been argued; a time comes when the lives of m illions of our mothers and fathers who have long 
gone as a result of this disease; when our brothers and sisters, who still rely on the hope of yet 
another pill to live just another day; when our friends and in laws have to get into long queues to pick their pills for the week; when unborn children, at  the risk of catching the disease at birth for a 
crime never their own! A decision must be made. A judgement call has to be taken. We do not 
negotiate as an end in, and of itself, but as a means to an end. This decision, unlike many others has an immediate and positive impact on the lives of real men and women. The reverse has the same equivalent effect. Is it the best outcome we have got? But is it one that would offer the 
g r e a t e s t  a m o u n t  o f  h o p e  f o r  t h e  n e x t  1 7  y e a r s ?  Y e s !  C a n  w e  l i v e  w i t h  i t ?  V e r y  y e s !  W i t h  t h i s  
decision, procurement agencies can supply ARVs without fear of infringement suits. With the dwindling funding in the health sector, donors can make a saving by procuring generic medicines 
for supply to poor countries. The Decision is a beacon of hope to the millions of people living with 
HIV/AIDS who have to pop the pill every morning of the rising sun. 
351.  We recall the promise of H.E Barack Obama, President of the United States of America. In 
his statement to the UNGA with respect to Sustainable Development Goals, he said, "Future 
generations of young people watching today and to morrow will judge us by the choices we make in 
the months and years ahead.  And one of those youn g people is Eva Tolage.  Eva lives in a village 
in Tanzania.  She's 15 years old, and she wrote me  a letter.  She asked me a question that could 
be asked of all of our nations -- "What will you commit to doing…?"  What will you do? And there 
are billions of boys and girls just like Eva.  They 're just like our children.  They have as much 
talent and as much hope for the future.  And they're willing to work hard, and their parents love 
them just as much as we love ours.  And just by the accident of birth, it's so much more difficult 
for them to achieve their dreams as it is for our children.  But in the eyes of God, they are the 
same children.  They're just as important. And so today, I say to Eva and hundreds of millions -- 
billions -- like her:  We see you.  We hear you.  I've read your letter.  And we commit ourselves -- 
as nations, as one world -- to the urgent work that must be done.  To standing with families like Eva's as they work and strive for a better life.  To ending the injustice of extreme poverty.  To upholding the inherent dignity of every human being.  Whatever it takes.  We can't let them 
down".   
352.  It is in that vein, that we join others in endorsing this extension of the transitional period 
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 until 2033.  IP/C/M/80/Add.1 
 
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  353.  In closing, we would like to extend our profound appreciation to all the Members and 
Observers in this Organization, Members of Parl iament and or Congress in the developed world; 
UNAIDS, UNDP, WHO; people living with HIV/AIDS; procurement agencies such as IDA and UNITAID, all the academics, NGOs, civil society organizations; and all activists, who have written 
letters, lobbied, held meetings with key decision makers in various capitals in support of this 
extension. We are profoundly grateful and humbled  by your generosity of love. We also express 
our appreciation to you, Mr Chairman Ambassador Al Otaibi, of the Kingdom of Saudi Arabia; 
Ambassador Suescum of Panama, who was our interim chair; and the WTO Secretariat for all the 
support we received in arriving at this Decision. 
354.  Last but certainly not least, we thank Ambassador Michael Punke and his entire team of 
negotiators with whom we have dealt this issue: Chris, George, Rachel and Debbie. As the Bible 
says in the book of Isaiah: How beautiful upon th e mountains are the feet of him who brings good 
news, who publishes peace, who brings good news of happiness, who publishes salvation, who says to Zion, "Your God reigns." We see you.  We hear you. We ha ve read your letter. 
13.4  Tanzania   
 355.  Let me associate myself with the statements made by the delegation of Bangladesh, on 
behalf of the LDCs and the statement made by th e delegation of Uganda, as a focal point for the 
LDCs on TRIPS issues. At the outset, my delegation would like to thank you personally, Mr. Chairman, for the efforts you have undertaken, particularly in holding Members consultative meetings since the LDCs Group tabled the request on the extension of the transitional period for 
pharmaceutical products.  
356.  In the same vein, we would also like to express our appreciation to all Members for their 
constructive engagement during the consultations with LDCs Group on this very important issue, 
which touches the lives of millions of people. We sincerely appreciate those Members who were in 
the forefront to support the LDCs request which demonstrated their true understanding of the specific health challenges facing the LDCs. Our initial request was a period until graduation. 
However, we do understand the challenges involved in the negotiation process. In this regard, we 
are appreciative of the 17 years which Members have agreed here today as the transitional period for the pharmaceutical products for LDCs. This Decision demonstrates the high value Members 
attach to the importance of ensuring accessible and affordable medicines to save human lives, 
especially in countries where there are immense health challenges from the prevalence diseases. 
357.  It will be recalled that during the last UN General Assembly held in September 2015, 
Members of the United Nations adopted the Sustainable Development Goals and the third goal is 
to fight against health-related challenges for all people on this planet. For this goal to be realised 
in the LDCs the availability of affordable medicines and vaccines becomes very critical. In this regard, this Decision which Members have agreed  here today of extending another transitional 
period for pharmaceutical products for LDCs demonstrates the commitment of the WTO to take 
part in addressing their common goal: the common global challenges. 
358.  The pronounced seventeen years, which means 2016 to 2033 sounds to be very many years, 
but if taken in the context of building a viable technological base and mostly in the health sector, 
they are very few years. Members who have a de veloped health sector, know exactly how many 
years they undertook to be where they are today. In this regard I hope Members in the future will 
take this reality into action and consider any other requests from LDCs should need be there. Once 
again I thank all Members for their constructive engagement and commitments which have led us 
today to the adoption of this important Decision for LDCs. 
13.5  Lesotho, on behalf of the African Group   
 
359.  I am making this brief intervention on behalf  of the African Group. At the outset, the African 
Group welcomes the Decision reached by the TRIPS Council with regard to the extension of the transition period under Article 66.1 of the TRIPS Agreement for LDCs with respect to 
pharmaceuticals. The extension period of the 17 years that LDCs received until 2033 will assist 
LDCs to address the basic requirements for medicines for chronic diseases that include HIV/AIDS, tuberculosis and many others. Public health issues are of high priority for the LDCs and security of 
medicines is of great importance to the lives of the many people. IP/C/M/80/Add.1 
 
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  360.   It is worth noting that this Decision is made without prejudice to the rights of the LDCs to 
seek other extensions, under Article 66.1 of the TRIPS Agreement provided for in paragraph 1 of 
Article 66 of the TRIPS Agreement.  
361.  Let me also take this opportunity to welcome the Decision to grant LDCs unconditionally the 
waivers under Article 70.8 and 70.9 of the TRIPS Agreement with respect to the pharmaceutical 
products until 2033. Let me also, like colleagues who have spoken before, thank and appreciate on behalf of the African Group, other Members of the WTO who are willing to accept the initial request 
by the LDCs for an extension period without an y conditions for LDCs until they graduate. That 
been said, the Group appreciates the efforts and fl exibilities by the WTO membership in granting 
the LDCs an extension for the transition pe riod under Article 66.1 and the waivers under 
Articles 70.8 and 70.9. These decisions will contribute towards the common goal of achieving and 
attaining the recently adopted Sustain Development Goals.  
13.6  Nepal   
362.  At the outset we would like to support the statement made by H.E. Ambassador of 
Bangladesh on behalf of the LDCs and our focal point Uganda and other LDC Members on this 
agenda item. The delegation of Nepal expresses it s gratitude to all WTO Members for their support 
in extending the transition period for LDCs applyi ng to patents for pharmaceutical products up to 
1 January 2033. We are pleased to note that simultaneous agreements from the obligations from 
TRIPS Article 70.8 and 70.9 has given full force to this extension. Further extension of the transition period of applying patents to pharma ceutical products under Article 66.1 and a waiver 
for complying with Articles 70.8 and 70.9 beyond 2015 has been a very crucial issue for the LDCs. 
As Members had agreed this issue is related to the life and death of many people in the LDCs. That 
is why we submitted our proposal for extension in February this year. Our collective efforts have culminated in producing this win-win situation today.  
363.  We think this is an important attainment for LDCs as it exempts them from the obligation to 
comply with the strict, expensive and cumbersome patent requirements for access to life-saving medicines. Similarly, it also exempts them from stringent provisions of Article 70.8 and 70.9 which 
are very burdensome and restrictive for LDCs given the limited administrative and financial 
capacity. We are of the view that the Decision is  significant to support the LDCs from Asia and 
Africa to ensure access to medicines to the poor people and save millions of lives struggling with various communicable and non-communicable diseases in their constituencies. In the meantime 
the extension Decision is expected to provide incentives to potential multinational companies and 
others to invest in the pharmaceutical sectors in the LDCs with a view to providing the most needy and easier access to medicines at affordable prices. In the long run the Decision will enable LDCs 
to be self-reliant in producing life-saving generic medicines. It will help in achieving the goal of 
promoting healthy and decent lives for all which is one of the prime goals of the Sustainable Development Goals.  
364.  At this juncture, we wish to take this opportunity to thank all WTO Members for their good 
understanding in favour of the LDCs. We also express our gratitude to the various international and intergovernmental organizations, civil society organizations, media and others who individually 
or collectively provided moral support to the LDCs' request.  
365.  Finally we think from today's Decision, a positive message has been conveyed throughout 
the world that the WTO can deliver meaningful outc omes in favour of the LDCs. Provided Members 
remain united, share good will and understanding, get constructively engaged and display strong 
political will. We would like to request that the same high speed be maintained in the run-up to 
Nairobi to produce meaningful outcomes and ensure the credibility of the WTO. Lastly we again welcome the Decision and express our commitment to utilise it as a unique opportunity to develop 
our in-country manufacturing capacity in the pharmaceutical sector.  
13.7  Myanmar   
 366.  The delegation of Myanmar associates itself  with the statement made  by the distinguished 
Ambassador of Bangladesh on behalf of the LDCs and also with the statement made by the 
distinguished delegate of Uganda as a focal point.  The delegation of Myanmar would like to extend 
our heartfelt thanks and sincere appreciation to all the WTO Members and all relevant institutions IP/C/M/80/Add.1 
 
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  for their contribution and endorsement on the De cision. The Decision made by Members today is 
really meaningful and reflects the sympathy and understanding of the LDCs. I would also like to extend our heartfelt thanks to all Members for th eir support regarding Article 70.8 and 70.9 of the 
TRIPS Agreement.  
13.8  Barbados, on behalf of the ACP Group   
 367.  The ACP applauds this Decision on this cr itical extension as for Article 66.1 of the TRIPS 
Agreement. As you know, several LDC Members are members also of the ACP Group and we are 
particularly grateful that the membership of the WTO saw it fit to agree to the extension for pharmaceutical products for a period of 17 years. It is important for LDCs to provide pharmaceutical products for the health of their citi zens and the wellbeing of their populations. This 
exemplifies the appreciation by our membership of  the difficulties and hardships of LDCs in the 
area of health, particularly in dealing with communicable and non-communicable diseases, and in shows the understanding of Members of what the pharmaceutical extension means for 
ameliorating their situations. It lifts also the burden of annual anxiety of having to apply every 
year for an extension, and it is clearly a life-ext ending benefit to the populations of the LDCs and 
will have a real sanitary impact on their populations and their health.   
368.  We take note that this extension includes the transition periods with equivalent effect for the 
TRIPS mailbox provisions, including exclusive marketing rights for LDCs. I welcome the application of that extension to marketing rights. ACP memb ers applaud all those involved, especially the 
Chair, the acting Chair, the negotiators, the Secretariat and particularly all the WTO Members 
involved who have supported this extension. 
13.9  Haiti   
 
369.  The Haitian delegation subscribes to the st atement made by Bangladesh on behalf of the 
LDC Group, as well as all the LDC delegations which have proceeded it in taking the floor. We also subscribe to the statement made on behalf of th e ACP. The extension of the transition period 
under Article 66.1 of the TRIPS Agreement with respect to pharmaceutical products, for least 
developed country Members is a key part of the Sustainable Development Goals and it is of particular importance. Certainly the impact of our discussions has gone beyond the scope of TRIPS, and even the WTO in general. Quite clearly to achieve goal 3 on health and wellbeing, LDCs 
need easier access to pharmaceutical products and particularly to affordable medicines. For this 
transition to be implemented up to 2033 is key, and we have seen that with good will, we can 
bring coherence to international public policies and at the same time send out a positive message 
to the millions of people in LDCs who are beset with illnesses such as HIV/AIDS and other 
communicable and non-communicable diseases and give them hope that they will be able to be treated in spite of their abject poverty.  
370.  It is very encouraging to see that the Members who were opposed to this extension have 
been able to join our consensus. The TRIPS Council as a whole has the understanding that the LDCs require greater flexibility, in particular transition periods which will allow them to develop in line with their needs and the needs of their populations to access medicines. The Haitian 
delegation extends its thanks to all those dele gations which have supported the LDC Group. It 
would like in particular to thank the United States, which has shown understanding and flexibility, with a view to accepting the extension of this transition period requested by the LDCs under 
Article 66.1 of the TRIPS Agreement as well as th e waiver request regarding the obligations of 
Article 70.8 and 70.9 of this same agreement. We hope that this will be implemented as quickly as possible. 
13.10  India   
 371.  My delegation would like to thank you for convening this meeting to consider the documents contained in JOB/IP/15 and JOB/IP/16 regarding the extension of the transition period under 
Article 66.1 of the TRIPS Agreement for LDCs with respect to pharmaceutical products and waivers 
from the obligations of Article 70.8 and 70.9 of  the TRIPS Agreement. We have consistently 
supported the LDCs proposal contained in docume nt IP/C/W/605 for extension of the transition 
period without any conditionalities. We are of the view that a extension of pharmaceutical products 
transition period is absolutely critical to provide suppliers, procurers and donors of affordable medicines in LDCs the clarity and certainty to ma nufacture, export and import generic medicines. IP/C/M/80/Add.1 
 
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  372.  While we welcome the compromise Decision, it must be put on record that the LDCs have 
sought for an extension of the transition period under Article 66.1 of the TRIPS Agreement for as 
long as they remain LDCs. The plain reading of the text of Article 66.1 reads "The Council for TRIPS shall, upon duly motivated request by a least developed country Member accord extension 
of this period." We are of the view that the language used in Article 66.1 is mandatory in nature, 
in that it it does not give the TRIPS Council any discretion to deny a request for extension of the transition period or to impose any further conditions on LDCs. We emphasise that the LDCs should 
have been granted a transition period until they  remain LDCs. However, despite the overwhelming 
support for the LDC request from all developing countries and many developed countries, a developed country has negotiated an outcome with the LDCs which is a derogation from the provisions of Article 66.1. This is a matter of systemic importance because despite the express 
provisions of Article 66.1, a different outcome has been negotiated.  
373.  Since the LDCs have already negotiated an outcome with a developed country, and it 
represents the forward movement from the 2002 Decisions, India will join the consensus in 
adopting both the Decisions contained in JOB/IP/15 and JOB/IP/16 regarding extension of the 
transitional period under Article 66.1 of the TRIPS Agreement for LDCs with respect to pharmaceutical products and waivers from the obligations under Article 70.8 and 70.9 of the TRIPS 
Agreement until 1 January 2033.  
13.11  European Union   
 374.  I would like to add the voice of the EU to  those who have welcomed the Decision and the 
progress that has been achieved and has been announced and has been agreed to here today. The 
EU can certainly join the consensus that exists fo r both the extension of the transition period and 
also the waiver of 70.8 and 70.9 obligations for LDCs.  
375.  Although the EU would have been willing to  support the initial proposal as tabled by the 
LDCs, we note that it was in the end only possible to agree on a lengthy waiver period, which, in our view, should provide the necessary legal certainty and policy space for an extended period of 
time.  
13.12  China  
 376.  Concerning economic, financial and administrative questions of LDC Members as well as the 
close relationship between access to certain pharmaceutical products and human life, China hereby 
confirms again its support to the draft Decision on the extension of the transition period under Article 66.1 with respect to the pharmaceutical products, JOB/IP/15 and the draft recommendation 
on waivers from obligations under Article 70.8 and 70.9 of the TRIPS Agreement, JOB/IP/16.  
13.13  Chinese Taipei  
 
377.  On behalf of Chinese Taipei, I would like to subscribe to the other delegations in thanking 
you, Chairman, for your dedication and determination on this matter, and I would like to thank the Secretariat for its efforts over the course of the past few weeks which have resulted in the presentation of these two Decisions to the Council today.  
378.  We acknowledge the key nature of these health related problems and the way in which they 
affect a variety of countries, we would like to stre ss that it is necessary for TRIPS concerns to be 
part of a broader national and international effort if we are to assuage the related problems. We 
are convinced that the multilateral system has cont ributed greatly to wellbeing around the world, 
and that is why we believe that these two Decisions fall in line with the spirit of the TRIPS cause. My delegation fully espouses them. This is an important outcome, which will give Members the 
requisite flexibility to be able to work on efficient and lasting systems. 
13.14  Japan   
 379.  At the outset Japan would like to express its appreciation to the Chair and the interim Chair 
for their guidance on this issue. Our appreciation  also goes to WTO Members constructively being 
engaged in the negotiation process on this matter. This delegation considers that IP rights are conducive to promoting economic development since the protection of IP rights makes it possible IP/C/M/80/Add.1 
 
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  for more investments to be made in the research and development activity which leads to 
promoting innovation.  
380.  As we have underlined on various occasions, we believe that the clear target in the context 
of IP towards the implementation of the TRIPS Agre ement is very important as an incentive. From 
this perspective, Japan supports the proposed Decision and Recommendation including the time-
limited extension of the transitional period and time-limited waiver and hope that the extended 
transition period helps the LDC Members to develop an adequate technological base and also 
encourages the LDC Members to work toward the implementation of the TRIPS Agreement with 
respect to pharmaceutical products. 
13.15  Switzerland  
 
381.  Switzerland would like to join others in welcoming the adoption of these two Decisions by the 
TRIPS Council. When they presented their original request for further extension of the transitional 
period regarding pharmaceutical products, LDCs had expressed two main concerns: ensuring legal 
certainty with respect to the legal environment for the procurement of generic pharmaceuticals in 
LDCs and avoiding provisions linked to the Decision of a further extension which would be unduly burdensome for LDCs. The solution found, with the Decisions regarding the extension of the 
transitional period and the waivers, fully takes into account these two LDCs needs.  
382.  In addition, the Decision with respect to the waivers provides, not only an extension of the 
existing waiver from Article 70.9 but also covers 70.8 as requested by the LDCs. We are glad to see that the solution also fully complies with the Council's mandate in Article 66.1 of the TRIPS 
Agreement. It will enable the TRIPS Council to continue to support LDC Members and to review 
with them their particular situation and challenges regarding access to medicines. This will enable the Council to decide any other appropriate additional supportive measures in the future including 
a further extension of the transitional period if needed.  
383.  Let me end by thanking the LDCs for their continuous engagement with Members in the 
process leading to the adoption of these Decision s and the Chair for his guidance throughout this 
process. 
13.16  Canada   
 384.  Canada would like to join other delegations in thanking you, Chair, as well as Ambassador 
Suescum for your leadership in guiding Members towards this successful outcome on this 
important issue. Canada is a strong advocate for the recognition of the special needs and requirements of least developed country WTO Memb ers. Canada supports this meaningful solution 
as it allows LDCs to address the challenges they face in implementing TRIPS obligations and in 
better integrating within the international trading system. Canada feels LDCs need greater flexibility than other WTO Members to meet their obligations, and we will always play a role in 
working with LDCs to achieve their objectives at the appropriate time. 
385.  What is of particular importance is that th e LDCs receive the necessary support to meet their 
health needs and secure access to medicines in line with their unique set of circumstances. With these principles in mind, Canada is pleased to join the consensus and looks forward to working 
with all Members to further the objectives reflected in today's Decision. 
13.17  Norway   
 
386.  Norway is very pleased with the adoption  of the Decision and recommendation today. The 
result was perhaps not our preferred option, as you know, we fully supported the LDCs request. 
Still, it is a good result, and it is a result that we can all be very proud of, it will give the LDCs the 
flexibility and legal certainty they need for a decent amount of time to come. We would like to 
thank all the Members involved, the Secretariat, the Chair and the interim Chair for the considerable efforts and hard work to achieve a timely result on this extremely important matter. 
 IP/C/M/80/Add.1 
 
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  13.18  Australia   
 387.  Australia welcomes the membership's efforts to reach an outcome that responds to needs of LDC Members, preserves the TRIPS Agreement's integr ity and recognizes that intellectual property 
is a tool for promoting innovation in a manner conducive to social and economic welfare when 
balanced with appropriate public health protection s. Accordingly, we support the extension to the 
transition period and related waivers as reflected in the terms of the draft Decision and draft 
Recommendation for the member ship for adoption today. 
13.19  Brazil   
 388.  Brazil would like to congratulate LDCs, the Secretariat and other Members that took part in 
the negotiations for the final result of the process that led to the draft Decisions on the extension 
of the transition period under Article 66.1 and waiver under the obligations under Articles 70.8 and 70.9 for LDCs with respect to pharmaceutical produc ts. Brazil is among the majority of delegations 
that supported the granting of extensions to LDCs without conditionalities until graduation as 
requested in the document IP/C/W/605, presented by  Bangladesh. In spite of the final result that 
fell short of the objective described in the duly motivated request by LDCs, our delegation 
understands that the result is a compromise solution reached by Members of the Organization. Our 
delegation is ready to support the consensus on adopting both Decisions.  
13.20  South Africa  
 
389.  South Africa would like to join others in applauding the LDC Group on their hard work and 
commitment and in securing an extension on the transitional period on pharmaceutical products. My delegation has always supported the LDCs and their right to medicine, and this Decision is 
certainly a step in the right direction. 
13.21  Holy See  
 
390.  Let me start by thanking all the Members of  the TRIPS Council for this Decision and their 
constructive engagement. 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 that  meet these criteria. 34 of these countries are 
Members of the WTO and only four countries have graduated out of this category.
3  
391.  LDCs are the world's most disadvantaged co untries with the weakest technological capacity. 
With the recovery of the global economy remainin g sluggish and uneven, the LDCs have continued 
to face a challenging external environment during the last biennium. Slow global economic growth, 
which translated into weaker international demand for commodities and a consequent decline in their prices, adversely affected the economic gr owth and export performance of several LDCs. 
Inflows of foreign direct investment (FDI) reache d a record high and remittance inflows continued 
unabated, but official development assistance (ODA ) started to show signs of stagnation. In 2013, 
the current account and merchandise trade balance of the LDCs as a group was weaker. The current account deficit in these countries continued to increase, reaching a historic peak of 
$40billion in 2013, and their merchandise trade deficit also widened, escalating by 29% to 
$21.1billion. According to the 2014 market access study undertaken by the WTO, the share in world merchandise trade by LDCs, during 2013, was 1.24%, with a staggering deficit of 
US$60.6billion. LDCs now find themselves at a cr itical stage of development, and their socio-
economic challenges are massive.  
392.  Access to affordable pharmaceutical products is a prerequisite for LDCs to deal with the 
numerous public health c hallenges that they face. LDCs are home to some of the world's most 
vulnerable people and bear considerable health bu rdens. They face growing burdens of neglected, 
infectious, and chronic non-communicable diseases. UNAIDS reported in its 2015 Gap Report that 
three out of five people living with HIV, and in ne ed of antiretroviral therapy, still do not have 
access to such life-saving and life-prolonging medicines. Many of these people live in LDCs, and 
their numbers will increase dramatically if such co untries are deprived of the price flexibilities from 
which they previously have benefited. Our engagement and our work should continue to be 
inspired by Paragraph 7 of the Doha Declaratio n on the TRIPS Agreement and Public Health in 
                                               
3 Botswana in 1994; Cabo Verde, in 2007; Maldives in 2011 and Samoa in 2014. IP/C/M/80/Add.1 
 
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  recognition of the gravity of the public health problems afflicting LDCs and their acknowledged 
right to maximum flexibility to take steps to ensure access to medicines for all. They disproportionately suffer health risks associated with poverty such as malnutrition, unsafe water and poor sanitation. 
393.  In his recent address to the Congress of the United States of America, Pope Francis 
appealed, "I know that you share my conviction that much more still needs to be done, and that in times of crisis and economic hardship a spirit of global solidarity must not be lost. At the same 
time I would encourage you to keep in mind all those people around us who are trapped in a cycle 
of poverty. They too need to be given hope. Th e fight against poverty and hunger must be fought 
constantly and on many fronts, especially in its causes." 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. 
394.  As already stated by my delegation, a time-limited transition period creates an uncertain 
environment for the producers of affordable medicines, procurement agencies, and donors, as well 
as for LDC governments, all of which 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, and results in especially adverse consequences for the 
scaling up of HIV treatment. However, the Decisi on that the obligations of LDC Members - under 
paragraph 8 and 9 of Article 70 - shall be waived with respect to pharmaceutical products until 1 January 2033, represent a significant step forward. 
395.  In conclusion, with deep interest in addressing these pressing public health needs, securing 
the ability to progressively realize the right to health, and ensuring continuous access to more 
affordable medicines of assured quality, the dele gation of the Holy See hopes that the consensus 
reached on the proposal of extension represents an important sign by the WTO, especially in 
anticipation of the next Ministerial Conference in Nairobi.  The Holy See delegation remains 
confident that a sense of common responsibility, as shown in the Decision adopted, will bring us all 
to support such an extension as an accelerated step toward the human and economic progress of 
LDCs. 
13.22  Chile   
 396.  We would like to express our thanks to the leaders and those who participated in the 
negotiations, in particular we express thanks for their flexibility shown in order to reach an 
agreement on this major issue. We are one of the delegations that supported the initial request by 
the LDCs and we feel that this is an important si gnal that we are giving with this agreement. We 
hope that this spirit will be maintained in the Organization, since we believe that we can do much 
more, in particular, bearing in mind the Sustainable Development Goals for 2030, as mentioned by various other delegations. 
13.23  New Zealand   
 397.  We would like to join others in welcoming the Decision today. New Zealand interprets Article 66.1 in good faith and considers that the LDC made a duly motivated request for its extension. In 
this context, we welcome the consensus Decision to day, and we are especially pleased to arrive at 
this outcome before MC10. 
13.24  Turkey   
 
398.  My delegation would like to join the voices of support and appreciate the sides for reaching the compromise. Turkey always supported the LD Cs, not only for the current issue, but other 
areas.  
13.25  Pakistan   
 399.  We also wish to join others in supporti ng this, and it is one of the most important 
achievements for the LDCs and we congratulate them. IP/C/M/80/Add.1 
 
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  AGENDA ITEM 14:  INTELLECTUAL PROPERTY AND INNOVATION: ENTREPRENEURIALISM 
AND NEW TECHNOLOGIES 
14.1  European Union   
 
400.  It is my pleasure to open the discussion today on IP and innovation. As we have said in the 
past, we value very much, and we consider an important contribution by this TRIPS Council to the discussion to highlight the many positive as pects of IPRs. Today the theme is broad, 
entrepreuneurialism and new technologies, and because in the past we have talked about many 
issues in this area, today I decide to focus on a particular area where the EU industry and rightholders have been very successful, but also  where there is an angle of contribution to 
development. I will focus on the creation of apps , it is a new market, very dynamic, one that is 
extremely interesting. 
401.  As the EU looks to expand and harmonise its digital economy through the newly launched 
Digital Single Market strategy, the mobile games industry is an area of the global tech industry 
where Europe is a global leader and has been driving digital innovation, not just across the 
continent, but worldwide. 
402.  Every day, millions of people throughout th e EU and the world turn on their devices to find 
enjoyment, challenge themselves, and play against their friends on mobile as well as traditional 
game platforms. 
403.  While the mobile games industry is still young, its impact already extends beyond game 
development and spills over to companies and workers in other creative industries, benefitting the 
European digital economy. Furthermore, industry forecasts suggest mobile games will grow at an 
annual rate of more than 10% until at least 2017. 
404.  European mobile app developers capture a large portion of worldwide revenues from mobile 
games. Several of these companies grew from SMEs  to organisations with hundreds of employees 
in the span of less than a decade. Popular games such as Candy Crush Saga (King), Clash of Clans (Supercell), and many others have been create d by European companies and have now become 
international household names. 
405.  More than 90% of the revenues from mobile games come from titles that employ a revenue 
model known commonly as "freemium": this approach  lets people download and play apps for free 
and gives them the choice to pay for extra features through optional in-app purchases. The 
freemium model allows people to try new games without committing any money upfront. The zero 
costs of download also help with international expansion. The digital nature of the marketplace and the reach of app stores allow European developers  to take advantage of global audiences, who 
generate more than 35% of their total revenues. 
406.  Innovations and skills created by the mob ile games industry can fuel Europe's digital 
economy. the European mobile games industry re presents a success story for digital development: 
it has delivered and is expected to continue to deliver positive business and employment impacts. 
The increasing popularity of mobile games impa cts the wider digital economy. Low barriers to 
entry in the industry allow new companies to participate in the growing market. As a result, economies can add jobs and generate tax revenue s. The special needs of games companies and 
other innovative digital players can even create new types of jobs, such as data scientists, 
407.  The industry economic effects are magnified in regional hubs. Hubs and clusters form when 
developers co-locate in areas occupied by other technical companies and wider creative industries. 
London, Berlin, Helsinki, and Stockholm have spawned vibrant hubs that attract talent and capital, 
and boost the broader digital economy. The hubs are not limited to only mobile game developers, as other game companies and creative industries can be a source of talent and creativity. In the 
UK, for example, mobile games companies are often co-located near other creative industries such 
as software, advertising or design. 
408.  The connecting feature of hubs has significant economic benefits. For example, the 
concentration of telecoms, media, and technology industries in London was estimated to contribute 
over £125bn to the UK's GDP. Its tech sector also  generated 27% of the city's job growth between IP/C/M/80/Add.1 
 
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  2009 and 2012. This experience is similar throug hout Europe, where hubs of creative and digital 
industries have led growth of employment and the economy 
409.  This sector is not only about games, and I would like to give also a couple of examples 
where mobile applications produce development-oriented positive output. The European 
Commission through our development services, DG DEVCO, has projects in Zimbabwe use mobile 
applications to improve farmer productivity. One project improves coordination of livestock via 
timely availability of data that truly reflects the situation on the ground by using GPS and IT. 
410.  Another is developing and promoting an ICT platform for marketing and increase in 
production of nutritious foods (cereals and legumes), through crop diversification. It trains farmers in the use of mobile platforms to use marketing info and info on nutrition extension and mobile banking via mobile platforms.  
411.  Another area of interest is that of so called branchless banking. The Technology Programme 
of the Consultative Group to Assist the Poor is  designed to enable access to a broad range of 
financial services such as payments, savings, loans, and insurance for over 30 million poor people. 
Development in information and communication technologies is making it possible for people to 
receive financial services without having to travel long distances to a bank branch and at an affordable cost. Technology – and in particular the ready availability of mobile phones — permits 
banks to make 'last mile' cash management and customer servicing functions such as deposits and 
cash withdrawal available securely through third-party retail outlets such as convenient stores, gas stations, and post offices. This is broadly described as branchless banking because of its strategy for delivering financial services without relying on physical bank branch locations. 
412.  The Technology Programme for branchless banking, supported by UK's Department for 
International Development, the Gates Foundation an d the Consultative Group to Assist the Poor 
(CGAP), will test and scale up branchless bankin g systems in Asia, Africa and Latin America to 
increase access to affordable savings, payments, credit, insurance and remittances services for the 
poor. An estimated 1 billion people with a mobile phone do not own a bank account. Branchless banking can harness the potential offered by new technologies, such as mobile banking, which 
have made it possible for poor people to access financial services without having to travel long 
distances to a bank branch and at an affordable cost.  
413.  So far the programme has helped deliver access to 19 million poor people across 
16 countries in Asia, Africa and Latin America and the Caribbean) through 25 projects.  
Bangladesh, Pakistan, India, Afghanistan, Philippi nes, Mongolia, Ghana, Kenya, Senegal, Uganda, 
Mali, South Africa, Brazil, Mexico, Columbia and Haiti. 
414.  Technologies transferred include new technologies to enable branchless banking, such as 
mobile phones, magnetic stripe or chip cards, and biometric applications. 
415.  We have more examples in this area, all of  these projects require some kind of protection 
through intellectual property, and they are applicable to small markets, to individuals, to all kinds 
of different markets. 
14.2  Australia   
 416.  Australia is pleased to have co-sponsored this TRIPS Council item on  intellectual property 
and innovation with a focus on entrepreneurialism and new technologies. Australia is keen to 
embrace the changes occurring in the global economy from new technologies. We recognise that innovation is critical to our economic prosperity. We wish to encourage a more entrepreneurial 
culture and to play our part in driving global research and innovation. 
417.  We recognise that stronger linkages between  government, providers of higher education, 
science and research institutions and the private sector will help us commercialise good ideas. 
We also advocate the role of appropriate consumer protection in building consumer confidence in 
the use of new technologies. 
418.  In the interests of embracing these changes, the Australian Government is placing science 
and research at the centre of Australia's innovation framework. Initiatives such as Accelerating IP/C/M/80/Add.1 
 
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  Commercialisation and the Industry Growth Centres are designed to improve Australia's 
commercialisation performance. The Industry Growth  Centres are also intended to bring research 
institutions and industry together, improving collaboration and market connections. 
419.  An intellectual property system, as it evolves in response to technological advances, has a 
critical role in enabling innovation and creativity as we have highlighted in our previous TRIPS 
Council interventions under this valuable agenda item. 
420.  Mobile technologies, in particular, continue to transform interactions between the economy, 
society and business, as the EU delegate's presen tation has highlighted so effectively.  This 
transformation is underpinned by a robust mobile ecosystem. A key element of a robust mobile market is competition, which provides a catalyst for the development and adoption of new technologies.   
421.  Governments also have a key role in ensuring a sound policy framework is in place. In 
Australia, that framework extends through a range of initiatives, including spectrum reform and the Public Safety Mobile Broadband. 
422.  In closing, Australia seeks outcomes from the uptake of new technologies that deliver 
certainty to business and consumers while ensuring we maintain the ability to address public policy needs. 
14.3  Chinese Taipei   
 423.  My delegation is pleased to join the Un ited States, the European Union, Australia and 
Singapore in sponsoring the agenda item. We al so very much welcome the contributions from 
other Members on this subject. 
424.  Our ICT design and production industry is wi dely recognized as one of the leading forces in 
the global market today. And, thanks to the proactive efforts of our government, we have a well-
established and sound development environment at home as well. As we kn ow, innovation is key 
to maintaining the competitiveness of our industries, so we are committed to promoting all forms of innovation in our industrial development policies. 
425.  To give you just a few examples of our various activities in this area: our government has 
hosted many professional training courses and competitions to encourage innovation. Here, the goal is to introduce new creative ideas and talents to the ICT industry. The government also provides resources via international partnerships to foster more innovative applications and 
technologies. For 13 consecutive years now we have held a National ICT Competition. This aims to 
seek out innovative works that meet current and fu ture market needs, and then to form and train 
a team to develop them. 
426.  We also have a Cloud Innovation Award to encourage exceptional talents in such areas as 
IoT (so called the Internet of Things), big data, and cloud products and services. The winners are 
given mentorship opportunities to optimize their products and services so as to attract the 
attention of enterprises and venture capital companies. Meanwhile, they are provided with follow-
up professional consulting counselling, such as the business match-up service. 
427.  In addition, we have launched the first Eu rope x Asia (or ExA) Summit, with a view to 
building an exchange platform for the IoT enterpri ses on both sides of the world. And, a TW-USA 
Innovation Forum with the United States will be held soon to provide the opportunity for exchange 
of views to develop IoT. 
428.  The IoT industry has become a key driver of  global trends following the rapid evolution of 
mobile cloud computing, big data and sensing technology. IoT production is expected to reach a 
total value globally of US$26.1billion by 2019. Our government has been helping our industries to grasp the IoT business opportunities and establish a comprehensive development model. It has 
made special efforts to combine our existing ICT advantages with contributions from industry, 
academics, and research institutions to develop smart network patents and system technologies. We have launched several projects - for smart bus standards, smart cloud power management, IP/C/M/80/Add.1 
 
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  high C/P value lighting systems, smart identifica tion services, and a demonstration project on the 
integration of business districts with smart networks. 
429.  The smart identification service project, for instance, which started in 2011, is to help 
enterprises integrate their communication networks or cloud services with the smart identification 
technology in order to develop a new business service model. As of now, a total of 81 local 
enterprises have joined the project to promote coupons, food and beverage services, online 
shopping, travel packages, and a bonus-point exchange. 
430.  The value of the transactions and investment by our services providers associated with this 
project has already reached  a total of US$171.7 million. We have also gained US$14.77 million of investment from foreign and local venture capital companies, generating exports worth about US$5.54 million so far. In the future, the project is expected to create more new services in the 
form of cross-sector collaboration or alliances. It  will also be targeting the emerging markets to 
expand overseas business opportunities. 
431.  I hope this gives you a flavour of the huge importance we attach to innovation in this 
industry. And, I hope I have managed to illustra te the enormous amount of effort and energy 
expended by our government and the private sector  to ensure that our ICT design and production 
industry develops and stays at the forefront of the fast-moving ICT global market.    
432.  We are looking forward to hearing from other delegations about their current policies in this 
regard, and to learning from their own successes and experiences. 
14.4  Singapore   
 
433.  Thank you for the opportunity to share our experience in developing a solid intellectual 
property strategy in communication technology has contributed to innovation and growth in Singapore. The 21
st Century is an IT century – 40% of the world's population is connected to the 
internet, and there are as many mobile subscripti ons in the world as there are people. The rapid 
development in communication technology has created a host of opportunities for businesses and societies worldwide. This is also the case in Sing apore, which is one of the most socially connected 
countries in the world. In 2014 Singapore was ranked first in the world for smart phone adoption, 
with a high usage rate of 85%. This year Singapore tops in mobile data speeds in the South East Asia and Oceania region.  
434.  The evolution of communication technology has made digital platforms a lucrative and 
exciting market for innovators and entrepreneurs. It is no longer viable to ignore the high 
percentage of consumers who would prefer to go online using their smart phones, for example the 
use of mobile phone technology and social media platforms not only reduces the cost of running a 
business, in same case it even allows one to start a business with little capital outlay. New 
technology has also helped businesses mitigate manpower shortages such as through the use of tablet apps for ordering food at bars and restaurants.  
435.  While businesses look to communications technology as a nucleus of current and future 
development, like any product and service, the underlying IP is only as good as its commercial value. Be it patents, trademarks, copyrights or trade secrets or even registered designs, businesses will have to consider whether or not they want protection in more than one country. 
There is also the commercial issue of weighing the advantages of IP protection against the 
preliminary costs of technology development. The info communications industry is increasingly relying upon trade secrets and trademarks as a cheaper and faster means to protect IP in the 
industry. For example Whatsapp and Apple protect their mobile app icons by registering them as 
trademarks.  
436.  Singapore is adapting our IP regime to the new digital era with progressive and forward-
looking policies, for example in the realm of web designs. We have allowed the registration of 
graphical user interfaces (GUIs) as designs under the Registered Designs Act with effect from December 2014. Close to100 GUIs have been registered thus far, including graphical user interfaces ofr display screens of mobile devices an d watches. We have also taken active steps to 
ramp up IP education for businesses. For techno logy-rich infocomm business, our IP Academy is 
running a range of seminars on the subject such as IP risks and protection strategies in relation to IP/C/M/80/Add.1 
 
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  social media, IP as a business tool and the role of IP and software technology industries. Regular 
industry specific IP management seminars called IP consult have been conducted since 2009 to educate and help enterprises better manage the li fecycle of their intellectual assets including 
creation, ownership, protection and commercial exploitation. These seminars were jointly 
administered with trade and industry associations such as the Singapore Manufacturing Federation 
and the Association of Small and Medium Enterprises.  
437.  One example of a company that has benefitted from the IP consult programme is Gurena, a 
leading platform provider for online and mobi le entertainment and communication. Since its 
inception in 2009, Gurena has seen unprecedented growth and currently has a customer base across South East Asia, Chinese Taipei and Hong Kong, China and serves millions of users. In 2010 Gurena launched its first produce, Gurena plus, an online game and social platform for people to 
meet, chat and play games with each other. By combining a communications tool with compelling 
digital content, Gurena invented the business model for online games in South East Asia, and created a platform with network effects. Gurena has taken steps to ensure that its trademark and 
copyright content are properly protected and enforc ed in the market it operates. These are crucial 
as its intangible brand and customer network form  the bulk of the its overall business value. The 
Financial Times valued Gurena at more than US$2.5 billion earlier this year, and Gurena's careful 
protection of trademarks and copyright has undoubtedly played a role in building up its brand 
name. We hope that this presentation has been useful and we look forward to further discussions on how Members, particularly developing countries can support and grow the communications technology sector to relevant IP activities.  
14.5  United States of America   
 438.  The United States very much welcomes th is opportunity to exchange views with TRIPS 
Council delegations on Intellectual Property and Innovation and to focus on the transformative role 
of entrepreneurship and new technologies on economic development. We would also like to thank the Australia, the European Union, and Singapore and Chinese Taipei for co-sponsoring this 
agenda item today. 
439.  IP, innovation and entrepreneurship are intrinsically linked. Our innovators are almost 
always our entrepreneurs, who in turn rely heavily on intellectual property (IP) rights to attract investment, to protect their new technologies from theft, and to generate revenue for future 
research, development, commercialization and employment. Together, IP, innovation and 
entrepreneurship play a critical developmental role. 
440.  Through their new technologies, entrepreneurs not only benefit our consumers, our citizens 
and our societies, they make significant and f undamental contributions to our economies through 
increased employment, knowledge accumulation and diffusion, and contributions to our respective 
GDPs. Academic literature, empirical evidence, and practical experience confirm that entrepreneurs 
are powerful, if not fragile, engines of economic growth. IPR provides entrepreneurs around the 
world with a critical ally amidst the perils of risk and prospects for reward. 
Entrepreneurship 
 
441.  To begin, we will consider today what entrepreneurship is and how it relates to intellectual 
property rights and innovation. We will then turn to the critical, if not catalytic, contributions of 
entrepreneurship to growth and development. Fina lly, from there we will examine several cases 
studies that illustrate this vital relationship.   
442.  So, to start, entrepreneurship is inherently innovative. This link has long been made by 
economists and other commentators. For example, in  his article on "Entrepreneurship in Economic 
Development", Wim Naudé describes Schumpeter's entrepreneurial construct as one that is an 
agent of change or "creative destruction". "A s such the entrepreneur is an innovator".
4  
                                               
4 Naudé, Wim; “Entrepreneurship in Economic Development”; Research Paper No. 2008/20; United 
Nations University, World Institute for Development Economics Research; March 2008; page 3.  See 
Schumpeter, J.A; Capitalism, Social ism and Democracy ; New York: Harper & Row; 1950.  See also 
Schumpeter, J.A.; The Theory of Economic Development ; New York: Oxford University Press; 1961. IP/C/M/80/Add.1 
 
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  443.  Likewise, in their 2011 book entitled Entrepreneurship, Innovation and Economic 
Development , Szirmai, Naudé, and Goedhuys conclude that "the distinction between 
entrepreneurship and innovation is hard to make".5 
444.  Given the significant overlap between entrepreneurs and innovators, it is not surprising that 
entrepreneurs rely heavily on intellectual property rights as well. The United States and other 
delegations have presented copious evidence – including economic analysis, literature on 
innovation and case studies – in support of the importance of IP protection and enforcement for 
innovation. We refer delegations to our interventions in previous TRIPS Council meetings under the 
IP and Innovation  agenda item as well as the item on IP and environmentally sustainable 
technologies. 
445.  The literature on entrepreneurship also conf irms the importance of IPR. For instance, the 
article on "Entrepreneurship in Economic Development" for the World Institute for Development 
Economics Research of the United Nations University concludes that where "property rights cannot be strongly enforced…there will be many individuals with high entrepreneurial ability, but there will 
not be many profitable opportunities to exploit that would result in economic growth."
6 As with 
innovation, entrepreneurship without IP protection is a tremendous resource that may go unrealized. 
Development 
 446.  Turning to economic growth, Szirmai, Na udé, and Goedhuys provide a survey of the 
literature on the relationship between entrepre neurship, innovation and development. Citing 
Verspagen, the authors conclude that "[i]nnovation is central to modern theories of growth and 
development".
7  
447.  Entrepreneurship, conclude these authors, occupies the same core role. As they explain, 
"[t]he study of entrepreneurship opens this black box [of macroeconomic growth]and allows us to 
analyse the …entrepreneurs that are responsi ble for…the development or adoption of new 
technologies… This puts entrepreneurship at the heart of economic growth, development, and 
catch-up ."8  
448.  Turning from the theoretical to the empirical,  we turn to the many ways entrepreneurs from 
around the world have created new technologies that benefit development, whether through generating revenue, creating jo bs, benefiting consumers or protecting the environment. 
Mobile Phone Apps 
 449.  First, we wanted to discuss the mobile phone applications or apps sector as a case study for 
entrepreneurship and new technologies. The app revo lution began in many ways with the decision 
to harness the power of entrepreneurs – in this case external software engineers. As technology quickly improved more people purchased mobile phones. Then, in July 2008, Apple launched The 
App Store with 552 app products; three months later, that number surged to 3,000.
9 
                                               
5 Szirmai, Adam; Naudé, Wim; and Goedhuys, Micheline; Entrepreneurship, Innovation, and Economic 
Development ; Oxford University Press; 2011; page 7. 
6 Naudé, Wim; “Entrepreneurship in Economic Development”; Research Paper No. 2008/20; United 
Nations University, World Institute for Development Economics Research; March 2008; page 27. 
7 Szirmai, Adam; Naudé, Wim; and Goedhuys, Micheline; Entrepreneurship, Innovation, and Economic 
Development ; Oxford University Press; 2011; page 8.  See Silverberg, G.; and Verspa gen, B.; 'A Percolation 
Model of Innovation in Complex Technology Spaces', Journal of Economic Dynamics and Control; Volume 29; 
2005.   
See also  Criscuolo, P.; Narula, R.; and Verspagen, B.; “The Role of Home and Host Country Innovation 
Systems in R&D Internationalisation: A Patent Citation Analysis”; Economics of Innovation and New 
Technology ; Volume 14; 2005. 
8 Szirmai, Adam; Naudé, Wim; and Goedhuys, Micheline; Entrepreneurship, Innovation, and Economic 
Development ; Oxford University Press; 2011; page 10 (emphasis added).  See Gries, Thomas, and Naudé, 
Wim; “Entrepreneu rship and Structur al Economic Transformation”; Small Business Economics ; January 2010, 
Volume 34, Issue 1. 
9 AVC Technologies. IP/C/M/80/Add.1 
 
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  450.  As of 2014, there were close to 700,000 jobs in mobile app development, and over 1 million 
in software development.10 These high-value, knowledge-based jobs involve creating and 
modifying software, analyzing user needs, and developing solutions with the objective of raising operational efficiency.
11 
451.  Today, more than 2 million apps are currently  available that address nearly every facet of 
human need: communications, gaming, multimedia, organization, travel, and utility.12 It is 
predicted that by 2017 mobile apps will be downloaded more than 268 billion times, and generate 
more than $77 billion in revenue.13 And the app revolution is global, with developer entrepreneurs 
innovating for the benefit of consumers around the world. For example, international organizations and government agencies are also leveraging mobile apps to strengthen their development programmes globally.  
452.  Take UNICEF, which in 2014, launched RapidPro, a mobile app platform that helps African 
governments deliver rapid and vital real-time information and connect communities to lifesaving services.
14Here, the app development process relied heavily on local developers in the developing 
world, with the underlying code for RapidPro having been produced through an eight-year process 
of development by UNICEF's global Innovations Lab in collaboration with Nyuruka, a Rwandan 
software development firm.15  
453.  Entrepreneurs are also focusing on addressi ng local needs in health, agricultural and rural 
development, and financial inclusion through mobile technologies. For example, mHealth or "medical and public health practices supported by mobile devices"
16 changes the way healthcare is 
administered and delivered to developing-country populations through the use of technology-
based healthcare alternatives.  
454.  Entrepreneurs in Uganda, for instance, have created apps like Kfree, Matibabu and 
WinSenga, which show how mHealth is a transformative way to deliver health outcomes. Kfree, 
developed by three university students, won the 2014 Community Innovations Award in Uganda 
for its use in aiding the early detection of breast cancer.17 
455.  Matibabu is an app that assists with diagnosis of malaria by using a custom piece that 
connects to the phone.18 And WinSenga replicates the information provided by a prenatal 
ultrasound, whereby a highly sensitive microphone is  used to transmit the foetal heart rate to the 
phone and analyse it.19 Likewise, mobile apps for agricultural and rural development ( m-ARD 
apps) hold significant potential for advancing global development in agriculture.20  
456.  Sri Lankan farmers, for example, are forw arded agricultural commodity prices through a 
platform called Tradenet.21 T h i s  a p p  t r a n s m i t s  u p  t o  f i v e  p r ice alerts for different fruits and 
vegetables from each of three markets covere d by the service, thereby enabling Sri Lankan 
farmers the ability to decide where to sell their agricultural goods for the best price.22  
457.  In Kenya, farmers use the apps DrumNe t and Kenyan Agriculture Commodity Exchange, 
both of which offer online clearinghouses for price negotiations and contract and value-chain 
support.23 Using DrumNet, Kenyan farmers have seen their incomes rise by 32%.24 Mobile money 
apps that integrate financial institutions and mobile money services are also making a difference in economic development and financial inclusion aro und the world. Apps such as M-PESA (Kenya), 
                                               
10 Occupational Employment and Wages, 2014. 
11 Occupational Employment and Wages, 2014. 
12 Number of apps available in lead ing app stores as of July 2015. 
13 Little, 2014. 
14 RapidPro, 2014. 
15 RapidPro, 2014. 
16 World Health Organization, 2011, p. 6. 
17 Muheebwa, 2014. 
18 Ingham, 2014; Uganda Fights Malaria Thro ugh 'Matibabu' App, 2014; Magazine, 2015. 
19 Boyd, 2012. 
20 Zhenwei Qiang, Chew Kuek, Dymond, & Esselaar, 2011, p. i. 
21 Zhenwei Qiang, Chew Kuek, Dymond, & Esselaar, 2011, p. 19. 
22 International Research and Trai ning Centre for Rural Education 
23 Kenya Agricultural Commodity Exchange Ltd. 
24 Emdon, Elder, Petrazzini, & Fuchs, 2014, p. 149. IP/C/M/80/Add.1 
 
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  and Smart Money and G-Cash (Philippines), have attained widespread use.25 In Bangladesh, which 
is quickly becoming a global leader in mobile banking, BRAC Bank's subsidiary bKash accounts for 80 percent of market share.
26  
458.  While IPRs can play a critical role in promoting and protecting such innovation and 
entrepreneurship, IPR infringement can have the opposite effect. For example, in a 2014 case in 
the United States, the U.S. Department of Justice ch arged four individuals for illegal distribution of 
pirated apps in the first case of its kind for uplo ading more than two million copies of pirated apps 
to mobile app platforms between August 2010 and August 2012.27 Similarly, trademark 
counterfeiting is also widespread.  
459.  Perhaps app entrepreneurs put the import ance of IPR protection and the damage of 
infringement best. Take Michael Wong, CEO of Touchpal, which is an app development company in 
China and the first Chinese company to win an international competition – the Global Mobile 
Innovation Award – for app development. Acco rding to this app developer, "many of our 
innovations were not protected; competitors copied our products. This piracy hinders the 
innovator's motivation for creating better products for consumers. So, I think consumers should 
boycott piracy for their own sake." 
Other Case Studies 
 
460.  Of course, the importance of entrepreneur ship and new technologies to economic growth 
extend beyond this case study of the app sector . The contributions of IP to entrepreneur-driven 
growth are felt in many sectors and in many countries around the world. 
461.  Take Simpa Networks, which has developed a green energy solution for under-resourced 
communities in India. Or Wonderbag, a South Afri can SME, that developed a clean, heat retention 
cooking solution that helps prevent smoke inhala tion. We recall our previous interventions on 
these and other entrepreneurs that mobilize IP to deliver to those in need. 
462.  Likewise, social entrepreneurs at Liter of Li ght and Sarvajal use IP to provide light and clean 
water at low cost to impoverished communities. These low-cost/high-impact/IP-intensive 
technologies were not only developed and deployed by entrepreneurs, they also rely on networks 
of local entrepreneurs to service their technologies and diffuse their knowledge. 
463.  And the United States is actively working around the world through capacity building and 
technical assistance initiatives to help support entrepreneurs like these. For instance, our program 
i n  J u n e  o f  t h i s  y e a r  o n  Fostering an Innovation and Entrepreneurship Ecosystem in Tunisia 
featured technology-transfer experts focusing on licensing practices, spin-off creation, IP, investment and marketing of early-stage technologies, valuation of technology, and 
commercialization through university-industry relationships. 
Conclusion 
 
464.  So, to conclude, given that innovation is a driving force for growth, governments must 
endeavor to adopt laws and policies that enable entrepreneurialism. We return one last time to Naudé, who stresses the importance of governme nt engagement to promote the quantity and 
quality of entrepreneurship. To increase the quantity, governments can stress education and raise 
awareness regarding the importance of entrepreneurship. 
465.  Likewise, Naudé explains that "[t]he quality of entrepreneurial ability can be improved 
through incentives that will entice those individuals with the highest entrepreneurial ability to 
become entrepreneurs."
28 Intellectual property rights provide precisely the kind of incentives that 
can enhance the quality of entrepreneurship. 
                                               
25 Mas & Radcliffe, 2010, p. 14. 
26 Chen & Rasmussen, 2014, p. 1. 
27 Department of Justice, 2014. 
28 Naudé, Wim; “Entrepreneurship in Economic Development”; Research Paper No. 2008/20; United 
Nations University, World Institute for Development Economics Research; March 2008; page 35.   IP/C/M/80/Add.1 
 
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  466.  The case studies we have discussed today and previously confirm vividly what the theoretical 
and empirical literature amply demonstrates. Intellectual property rights play a critical role in delivering on the promise of the world's entrepre neurs, whose innovative new technologies fuel 
domestic and international economic growth, and help raise global standards of living. 
14.6  Canada   
 467.  Canada is pleased to discuss its national experiences with respect to entrepreneurialism and 
emerging technologies under the theme of intelle ctual property and innovation. This theme has 
been useful in illustrating the important relationship between the TRIPS Agreement and innovation, something that is useful to bear to in mind when discussing the role of entrepreneurs in the development of emerging technologies. When the TRIPS Agreement was negotiated more 
than 20 years ago, the global economy was in the midst of a global transformation, brought in part 
by new innovation and information and communications technologies. Think, for instance, of the advent of personal computing and electronic mail, technologies that now seem commonplace and 
are woven into the fabric of global commerce and daily interaction. Looking ahead to the next 20 
years, emerging technologies, or what we might call disruptive technologies are similarly creating entirely new fields, as well as new economic and social possibilities, from mobile devices and 
applications to the so-called Internet of Things  as the use of big data, we have heard many 
examples from other delegations. 
468.  To be sure, entrepreneurs pay a significant role in bringing emerging technologies to the 
market, but quite often young firms have a limited awareness of the role that IP plays in 
commercialising their ideas. In an era of global competition, deploying emerging technologies is a 
risky proposition as it is, one that is made all the more uncertain without the IP strategic thinking needed to reap the benefits of innovation both at home and abroad. For entrepreneurs a viable IP 
strategy is therefore important both for identifying and managing their IP assets as well as for 
understanding the legal and regulatory frameworks  by which these assets might be protected and 
enforced.  
469.  Canada has undertaken several initiatives in recent years to assist entrepreneurs and small 
and medium sized enterprises in this regard. For instance, as part of its 2012-2017 business strategy, the Canadian Intellectual Property Office has undertaken a range of outreach efforts to increase knowledge among innovators about the strategic importance of their IP, and to assist 
them in better exploiting these assets. As part  of its targeted customer outreach, CIPO has 
developed tools to assist businesses in identifying their IP assets and setting IP strategies, from its recent IP video series and bank of speakers delivering educational IP presentations to tutorials on 
the competitive advantage of protecting and expl oiting IP and steps for exporting businesses and 
protecting IP abroad. Canada's National Research Council, the NRC also provides assistance for small and medium enterprises through the Indust rial Research Assistance Programme (IRAP). 
IRAP provides technical and business advisory services to SMEs to better equip clients to perform 
research and development, commercialise new pr oducts, processes and services and to access 
new domestic and international markets. IRAP's industrial technology advisors assist clients at various stages of the innovation process to build their innovation capacity in areas such as 
technology and business assistance, literature and patent searches, and strategic intelligence.  
470.  IRAP helps SMEs understand the technology issues and opportunities available to them, and 
provides linkages to the best expertise in Canada. More recently, Canada's department of foreign 
affairs trade and development has also set out to inform and educate businesses on IP, by way of 
its trade commissioner service by providing IP training and tutorials to trade commissioners abroad. Given that these officials work with Cana dian businesses seeking to export their products 
and services to new markets, this initiative aims to help firms better understand the importance of 
sound IP management.  
471.  In conclusion, Canada would note the importance of strategic thinking on IP for SMEs and 
entrepreneurs as they set out to commercialise their ideas in the global economy. As we look 
ahead to the innovation that emerging technologies and entrepreneurialism may bring, it is also 
important to bear in mind the IP frameworks and enabling environments that continue to make this possible. IP/C/M/80/Add.1 
 
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  14.7 Hong Kong, China   
 472.  I would like to thank the European Union, the United States, Singapore, Chinese Taipei and Australia for bringing this item under the "IP and Innovation" series to the meeting again. Hong 
Kong, China is pleased to share our experience in this regard.   
473.  Hong Kong, China is a mature digital economy with one of the most sophisticated and 
advanced telecommunications infrastructures in the world. With the ubiquitous Internet services 
and a tech-savvy community, mobile devices have become an integral  part of our daily lives. Hong 
Kong, China's mobile penetration rate of 228% is one of the highest in the world. With the 
advancement of mobile technology, providing services through mobile channels is gaining currency. Our Government is committed in driving mobile development within the Government, as 
well as in private and non-governmental organisations (NGOs) sector. 
474.  Firstly, it is currently providing over 110 mobile applications (apps) covering a diverse range 
of subjects, including traffic, leisure, health, news, etc. Amongst these, the "MyObservatory" 
mobile app that provides weather information has over five million downloads. "Hong Kong, China 
eTransport", a mobile app that provides real-time traffic information, has well over one million downloads.  
475.  For the private sector, the low thresholds for developing mobile apps have opened up many 
opportunities for startups to kickstart their busi nesses. To encourage the development of startups, 
our Government has put in place support programmes and measures to cater for the varying needs of startup including publicly-funded incubation programmes that provide all-rounded 
support for startups, a one-stop portal named iStartup@HK that provide a comprehensive range of 
startup-related information, as well as a mega startup event, Startmeup Festival, which features an international startup competition and a series of events for the local and overseas startup 
community to meet and connect. 
476.  Many tech startups in Hong Kong, China ha ve made significant achievements in Hong Kong, 
China, and are expanding to overseas. For instan ce, a van delivery business app launched in 2013 
brought in a new ecosystem in logistics and transport industry in Hong Kong, China, which used to 
be heavily relied on radio-calling centres to allocate orders from clients to van drivers. With this app, the lead time between the placement and a cceptance of an delivery has been significantly 
reduced from half an hour to half a minute. We are delighted that this app has recently obtained 
an equity capital of US$10 million (about HK$78 million) from a social network in the Mainland to 
extend its presence in Asia. 
477.  Apart from the Government and private sector, we are also committed to encourage the 
development of mobile apps to support needy grou ps. We have been providing funding support for 
NGOs to develop mobile apps to cater for the special needs of their service recipients including students with special learning needs, persons with hearing impairment and persons beset with 
dementia, etc.  For example, one of the mobile apps developed was designed to assist persons 
with hearing impairment to communicate in sign languages. These mobile apps have received encouraging user feedback and industry recognition. 
478.  Hong Kong, China has a robust intellectual property (IP) protection regime and is well 
positioned to be a premier IP trading hub.  Our creative industries, innovative technologies and IP 
economies benefit from IP trading. For example, IP trading can help acquire background or upstream IP from untapped stock outside of Hong Kong for downstream R&D and product 
development. Likewise, IP trading can assist creative industries by making the most of the creative 
contents generated and exhibit them in the commercial world.  
479.  In March 2013, the Government of Hong Kong, China, set up the Working Group on IP 
Trading (Working Group) to study the promotion of Hong Kong as a regional IP trading hub and 
the specific measures in support. After two years of intensive work, the Working Group released a report in March 2015 with recommendations to furt her promote the development of IP trading in 
Hong Kong, China. 
480.  The recommended action framework comprises four strategic areas, 10 focus strategies and 
28 recommended measures. The Government of Hong Kong, China, accepted the IP/C/M/80/Add.1 
 
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  recommendations, and is working in full swing for implementation. Under Strategic Area (III) 
Fostering IP intermediary services and manpower  capacity, one of the recommended measures is 
to "enhance and promote the use of the Asia IP Exchange (AsiaIPEX) launched by the Hong Kong Trade Development Council (HKTDC), for example to encourage IP exchange, licensing and other 
trading activities". 
481.  Insofar as trading of mobile apps (the corresponding IP rights are predominantly patents) is 
concerned, 12 of them are listed on AsiaIPEX by its strategic partners.  HKTDC also operates the 
"hktdc.com", which seeks to facilitate worldwide buyers to source products and services from 
verified, quality suppliers and manufacturers.  120 mobile apps are currently being featured for trading. 
482.  We are glad to have heard a number of interesting developments on mobile apps and IP 
from members.  Hong Kong, China looks fo rward to more interventions today.   
14.8  India   
 
483.  My delegation would like to thank the delegations of the United States and the European 
Union for tabling an agenda item on "Intellectual Property and Innovation: Entrepreneurialism and New Technologies". No information was provided by the co-sponsors regarding the sub-item 
"Entrepreneurialism and New Technologies". However, we have shown flexibility and engaged 
constructively on this agenda item. I request some Members who are co-sponsors of this agenda item to show similar kind of flexibility in accepting proposals from other Members like holding a technical symposium on the Paragraph 6 mechanism, updating three factual briefs and inviting the 
CBD Secretariat to brief Members on the Nagoya Protocol.  
484.  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 'Entrepreneurialism and New Technolo gies' under the broad theme of Intellectual 
Property and Innovation. In that meeting India pointed out that the word "innovation" appeared just once in the TRIPS Agreement, in Article 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 hold er but it is one of the many tools available to 
the society to achieve technological development, its social and economic welfare and innovation. 
The US Supreme Court in Motion Picture Patents Co. V. Universal Film Mfg. Co. (243 US 502, 
p.511, 1917) found that this court has consistently held that the primary purpose of our patent 
laws is not creation of private fortunes for the owners of patents but is to promote the progress of 
science and useful arts...." 
485.  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 syst em. 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.  
486.  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 about open innovation structures such 
a s  O p e n  S o u r c e  D r u g  D i s c o v e r y  ( O S D D )  m o d e l  o f  I n d i a ' s  C o u n c i l  o f  S c i e n t i f i c  a n d  I n d u s t r i a l  IP/C/M/80/Add.1 
 
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  Research (CSIR), 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.  
487.  The World Health Organisation (WHO) at the 68
th World Health Assemb ly (WHA) adopted the 
'Global Action Plan on Antimicrobial Resistance'. The Action Plan, inter alia , states that most 
pharmaceutical companies have stopped research and development of new antibiotics and calls it 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 afford able access to new medicines, diagnostic tools, 
vaccines and other results from research and development in all countries". 
488.  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. India is committed to maintaining the 
delicate balance of promoting innovation, protecti ng intellectual property rights and meet the 
development challenges by providing a well-balanced and a purposeful IPR regime. 
489.  There are many challenges for undertaking any entrepreneurial activity in a developing 
country like India, especially access to capita l, access to skilled workforce, and access to 
technological knowledge. In September 2014, India has launched the " Make in India" Programme, 
a flagship programme aiming to facilitate investment, foster innovation, enhance skill 
development, protect intellectual property and build state-of-art manufacturing infrastructure. To 
encourage entrepreneurship and to help set up a network of startups in the country, Prime 
Minister Narendra Modi, during his Independen ce Day address on 15 Aug 2015, announced a new 
campaign " Start-up India, Stand-up India". To promote start-ups and entrepreneurship, during 
the year 2015, the Small Industries Developmen t Bank of India (SIDBI), supported by the 
Government, has also launched the Indian Aspiration Fund ( initial corpus of about US$300million), which is a fund of funds that would invest in venture capital funds for meeting the equity requirement of Micro and small enterprises (MSME) start-ups.  
490.  I will conclude by referring to the latest report titled "Start-up India-Momentous Rise of the 
Indian Start-up Ecosystem" by the National Association of Software and Service Companies (NASSCOM) and Zinnov, which was released earlier this week. According to the report, in 2015, 
1,200 new tech start-ups were established in India taking the total to 4,200. A majority of the 
1,200 start-ups are business to consumer and mainly present in three sectors: e-commerce, consumer services and aggregators.  
14.9  Japan   
 491.  This delegation would like to express its appreciation to the United States, the European 
Union and other cosponsors for proposing this interesting agenda item. Japan fully recognizes the 
importance of the role that intellectual property plays in developing new technologies and starting 
new businesses. Japan wishes to take this opportunity to share some of its experience on how we have been encouraging new businesses and promoting the use of intellectual property in 
developing new technologies. 
492.  In 1999, with the aim of promoting new businesses by small and medium enterprises and 
individual entrepreneurs, the Government of Japan implemented a support function called the 
Small Business Innovation Research programme, in short, SBIR. Since then, the SBIR has been 
supporting lots of companies by providing various financial incentives, including subsidies to encourage the development of new technologies, low-interest loans from financial institutions, and reductions in fees for acquiring and maintaining patents. Currently, seven ministries and agencies 
are involved in SBIR and promoting research and development activities in various fields through 
the SBIR programme. IP/C/M/80/Add.1 
 
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  493.  One initiative this delegation believes worth sharing with other Members is the "New Energy 
Venture Business Technology Innovation Programme" implemented by the New Energy and Industrial Technology Development Organization , or NEDO, under the SBIR programme. This New 
Energy Programme is geared to new technologies in the energy field, such as renewable energy 
and untapped energy. The Programme supports small and medium enterprises and venture 
companies in three stages in regard to their promising technologies; and they are feasibility studies, fundamental research activities, and research activities for commercialization purposes. 
494.  The programme also includes providing the companies with expert advice on intellectual 
property strategy. Furthermore, commercialization  of their technologies can be made possible 
through a "business matching forum". It provides a good opportunity for the companies that have new technologies to present them to businesses that are interested in the new technologies. 
495.  Now this delegation would like to touch upon one case demonstrating the important role that 
intellectual property plays in developing new technologies. A Japanese chemical company, Microwave Chemical, by making the most of th e aforementioned "New Energy Venture Business 
Technology Innovation Programme", has been develo ping a new technology to refine biodiesel fuel 
from waste oil by utilizing microwaves. The technology, which enables the recycling of industrial waste oil generated by factories, is expected to be welcomed by the manufacturing industry and 
contribute to the protection of the global environment. 
496.  With regard to this case, this delegation would like to bring two things to your attention. 
First, through this Programme, Microwave Chemical obtained a basic patent for its technology, after consulting with experts on intellectual prop erty strategy. The patent served as a base for 
further development of their technology and gave them a competitive edge in the market. Second, 
the company took part in a "business matching forum" organized under this Programme and successfully secured financial backing from a major venture capital in Japan. Consequently, in 
2014, the company signed a joint development agr eement with a German chemical giant, BASF. 
497.  In summary, Japan attaches great importan ce to the use of intellectual property in 
developing new technologies and starting ne w businesses. Japan continues to develop new 
initiatives in the hope that they can contribute to further promoting innovation and economic 
growth. We hope Members find the information we shared today useful and would welcome other Members' insightful comments on this issue. 
14.10  Switzerland   
 
498.  We would like to thank the United States and the co-sponsors for proposing this agenda item. We associate ourselves with the statements  made by the previous delegations about the 
value of the agenda item for the discussions in this Council. 
499.  We are pleased to share some of the experience in Switzerland and focus on how IP can help 
drive innovation and entrepreneurialism in small and medium-sized companies that only have 
limited resources in terms of capital, staff and research infrastructures and facilities. It is not 
unusual that small companies or individuals come up with ideas which, if the effort is taken to implement them and launch a product or service on  the market, have considerable impact on the 
economy and society, and change the status quo. 
500.  It is these kind of innovations, inventions  and new approaches - thinking out of the box - 
that in a sense attracts imitation and commercial exploitation by others without any personal contribution as soon as the product or service has been developed to commercial viability. This is 
where IP protection and the prevention of unfair co mpetition can prove itself essential, ensuring a 
lasting effect of the small economic operators' activities.  
501.  A reliable legal framework enabling adequate and enforceable IP protection allows the small 
and medium-sized companies to protect their intangible assets, and facilitates a successful 
implementation of their business plan - so they  can market their product and reach potential 
customers. This is often a precondition of monetary return for the time and labor invested, and allows reinvestment in the innovation cycle for improved and new products and services. IP/C/M/80/Add.1 
 
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  502.  SMEs are the backbone of the Swiss ec onomy, the bedrock of our prosperity. While 
Switzerland is very active in different fields of emerging technologies, the backbone of its economy are small and medium-sized enterprises. They account for 99.7% of all Swiss companies and 
provide two thirds of all jobs in Switzerland. SMEs are innovative in various fields, often in areas 
which are not high tech and that are using several aspects of intellectual property rights to further 
their businesses.  
503.  We would like to present three different case studies from Switzerland: CatchMyPain App, 
Atizo Crowdsourcing, and Urban Farmers technology; all of them innovative enterprises active in 
different sectors and different fields of technology, using different types of IP protection for their specific needs.  
504.  The first case we present is CatchMyPain App by sanovation, a pain tracker and community 
app. Mobile application technology has been an emerging technology and grown significantly over 
the last years, and had a prominent impact on the way information is shared between friends, colleagues and within other communities. Almost every mobile user uses mobile applications 
associated with social media, social networking, and social gaming, but also for other issues, such 
as health care. 
505.  Behind CatchMyPain is a young man who suffered from chronic pain for a number of years. 
In search for relieving treatment he had to go through an odyssey of doctors having to repeat the 
same story of his pain history and symptoms every time whilst trying to keep track of what the 
last doctor had prescribed or which therapies ha d proven ineffective. The App was developed in 
2010 while he was still a student. Now, his company is an award winning, energetic Swiss start-up 
based in Zurich. The CatchMyPain App allows for patients to easily track their pain by drawing the 
location and intensity of their pain on a body model using different colors and also making record of the character of the pain, the patient's mood, st ress, fatigue, medication intake and much more. 
This diary allows for much more accurate relaying of information relating to pain towards a doctor 
or medical health care taker, also helping to overcome obstacles such as language barriers. 
506.  At the same time the app brings together people suffering from chronic pain allowing them 
to communicate successful remedies that have worked for them. Furthermore, the app and its 
medical partners are using the anonymised information from the diaries to conduct research and gain new insights. Since 2010 the user community of CatchMyPain has grown to more than 100'000 users worldwide and has won numerous awards. It is in our eyes a prime example for 
mobile application technology in a sector, health care, that is an interest to any society and 
country. 
507.  The growing popularity of mobile applications goes hand in hand with its proclivity to 
imitators and free riders. And this is where IPRs come into the picture. The name of CatchMyPain 
App is registered as a trademark, ensuring that no one can freeride on the success, recognition and image that the app developers have built up by using the same or a similar name. The code 
and the layout of CatchMyPain App are protected through copyright laws – provided that they 
satisfy the conditions for copyright protection - i. e. a unique character -  ensuring that the owners 
of the copyright can prohibit a counterfeit app from using its programme code or appearance, since the user-friendly surface and handling is what makes for the success of such an app. 
508.  The next case we would like to present is a young business called atizo. Atizo was founded in 
2009 and the service they offer is based on th e concept of crowdsourcing that the founder, 
Christian Hirsig, now 31 years old, developed in 2004. He had the business idea while surfing the 
largest crowdsourcing platform in the world - Wikipedia. On the online platform atizo.com 
enterprises can let the atizo community develop new product ideas or find solutions for specified problems. 
509.  This is how it works: enterprises describe what they are looking for in a few words on the 
online platform, e.g. a new product name, a new type of packaging or an idea for a marketing 
campaign. Then the community consisting of 10'0 00 users can share their ideas and solutions. The 
enterprise awards a premium, the amount chosen by the enterprise. This premium is then split 
and awarded to the community members that brought forward the best ideas. This process only 
costs the enterprise the amount of the premiu m (usually between 1000 and 5000 CHF) whilst 
providing them with numerous creative solutions an d - not to be disregarded - material for market IP/C/M/80/Add.1 
 
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  research. The incentive for the users to share their ideas (according to a survey atizo conducted 
together with a Swiss university) is not just the premium that is awarded to the winning ideas but mainly social appreciation and recognition within the community. 
510.  As is well known, a business idea or concept alone is difficult to protect through IPRs. 
Furthermore service providers, such as atizo, do not produce material goods and are therefore 
often classified as non-innovative. Atizo has proved  to be highly innovative though, by having an 
impact on the way enterprises innovate themselves. Branding through the trademark atizo has 
helped to make this innovation visible, communicating its features and providing credibility and 
substance to how the business and its service is perceived. 
511.  Trademarks can in this way – besides their general function of preventing unfair competition 
and assuring consumers that they can rely on a product's or service's expected quality - be a 
means for appropriating monetary returns and other benefits. These can be building the 
enterprise's and platform's reputation, gaining potential clients, new community members and consumer loyalty. 
512.  The third and last case we will present to you today is that of UrbanFarmers Ltd (UF), a 
Switzerland-based technology company building co mmercial food production units in cities. The 
company was established in 2011 as a technology spin-off from the University of Applied Sciences 
in Zurich. UrbanFarmers uses a licensed patent protected Aquaponics technology, owned by the 
Leibnitz-Institute of Freshwater Ecology and Inland Fisheries , that allows for fish and vegetables to 
be farmed in a closed loop system, reducing the use of resources such as water and chemical components for fertilization and water purification by up to 90%. UrbanFarmers' own innovative 
contribution is the development and operation of farms with its software system on empty rooftop 
spaces in urban environments. This gives real estate owners the possibility to rent out otherwise unused rooftop spaces and allows for UF farms to be realized without the need to buy land or real 
estate or build on their own. 
513.  UrbanFarmers is already selling fresh fish and vegetables directly to leading local restaurants 
as well as Migros, Switzerland's largest food reta iler. Such fresh and healthy, locally produced and 
available food contributes to a number of socio-economic issues such as health issues like 
overweight population or malnourished population due to lack of availability of fresh foods, or 
environmental issues like the pollution due to glob al transportation when importing fresh foods, or 
creation of workspaces and perhaps education possibilities. 
514.  UrbanFarmers is a good example of a business making use of and integrating several IPRs 
into its portfolio. For one it profits from a licensed patent protected technology without having invested resources in the creation of that technology. UrbanFarmers is a protected trademark and 
as such helps make the innovation of the UrbanFarmers model visible to clients and helps build a 
reputation which is essential for generating returns, as we explained in the second case study illustrated before. Last but not least the software developed to apply the Aquaponics technology on 
a rooftop or in an urban environment may again be protected by copyright.  
515.  Further information on the presented cases is available on the enterprises' respective 
websites and media reports which can be found on the net.  
516.  We hope that the case studies of national experience presented offer some examples of how 
certain new technologies, which do not necessarily require high tech infrastructure and resources, 
are utilised by entrepreneurs to develop products an d services for the benefit of society. IP rights 
and overall favourable framework conditions promote such personal engagement and investment, 
enable fair competition and allow sustained engagement of economic operators to bring innovative 
products and services on the market. 
14.11 Korea, Republic of   
 
517.  I would like to thank the co-sponsors of this important and interesting agenda item. Korea recognizes the key role of IP in promoting innovation, especially since businesses are becoming more and more dependent on IP in order to provide high-value goods and services. Adopting a 
new national agenda in 2013, Korea has worked to strengthen its IP ecosystem in order to 
encourage new business start-ups with innovative id eas, in particular new types of IP-related R&D IP/C/M/80/Add.1 
 
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  and IP-based financing were set up to help them develop skills and becoming global leaders in the 
IP field.  
518.  One successful outcome of our activities wa s the establishment of the 17 Creative Economy 
Innovation Centres. Each is strategically located to provide coverage across the entire nation. 
These centres assist with the commercialisation and help facilitate the growth of SMEs and venture 
companies. In addition, the government is fosterin g the IPStar company project in order to further 
nurture the potential regional SMEs with impressive growth potential. We further assist these 
business start-ups by providing professional consultations on IP management strategies as well as 
by supporting them in transforming their ideas in to patents through the use of such things as 
customised patent maps.  
519.  It is notable that Korea's annual GDP growth rate almost corresponds with the increasing 
rate in the number of IP applications that Korea has received over the past 20 years, 
demonstrating that IP is the primary engine for industrial and economic development. There are some positive signs in the number of new established legal entities ventures which have surpassed 
80,000 and 30,000 respectively as of this year for the first time since the record began, and that 
of the start-up clubs at universities more than doubled from 1,222 in 2012 to 2,949 in 2014.  
14.12  New Zealand   
 
520.  I would like to thank the United States and co-sponsors of this agenda item. I have heard some interesting stories and examples of the importance of innovation in IP. From our perspective we think high-growth start-up firms play an important role in driving productivity gains, 
commercialising IP and growing emerging sectors. Often start-ups and other new firms exploit 
novel opportunites that have been overlooked by more established businesses, and in doing so they can make an important contribution to economic growth.  
521.  As we have seen, start-ups and new business models are now having a major positive 
impact and this is not just on economic ends, but on social and environmental outcomes, and these firms are often called social enterprises. Ju st to give one example, in terms of a social 
enterprise, most experts believe that the smart ph one has been the most important tool for raising 
standards of living in least-developed areas and for fostering economic development. Building mobile networks for example, in remote locations around the world remains problematic and very expensive, but for instance, Range Networks has helped launched profitable rural cell phone 
services in regions previously uneconomical to set up including in remote areas in Indonesia, 
Zambia, Mexico and a dozen other locations.  
522.  In New Zealand's context, the New Zealand Government has been working to explore 
possible policy tools that can help reshape New Zealand's economy and increase economic growth 
by increasing the number of high growth techno logy-based firms. New Zealand has an incubator 
support programme in place since 2001, which wa s designed to address New Zealand's lack of 
high-growth potential firms by enhancing the survival and growth of these firms via the 
development of high quality incubators. This programme has been successful in catalyzing 
founder-focused business incubators which work with entrepreneurs and build on business propositions and it helps entrepreneur-driven ICT start-up companies become investment-ready 
and globally competitive.  
523.  The Ministry of Business, Innovation an d Employment in New Zealand is supporting an 
accelerated programme which supports the rapi d formation of early-stage ICT and digital 
technology start-ups. The programmes are typically run over three months and prepare start-up 
companies to be investment-ready. They are currently located in different areas of New Zealand, and managed by a few organizations, for instance in Wellington, the capital city, it is under 
Creative HQ, in Auckland it is under the Icehouse. If you visit New Zealand today, you will notice 
that there is a vibrant hub of innovation where many technology start-ups are now global players. Some of the success stories include Zero, which can be considered the Apple of accounting, Vend, the point-of-sale software for retailers, when you go into a store and purchase something it is the 
software that enables the company to process your payments. CarbonScape is a company that 
turns waste from instance sawdust into fuel, through microwave heating. This company uses patented technology to essentially short circuit the carbon cycle and in essence achieve in minutes 
what nature takes millions of years to do. Powerbyproxi is a pioneering wireless charging 
technology where you can charge your mobile phones without a power cord. Carnival Mobile is a IP/C/M/80/Add.1 
 
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  mobile marketing automation for applications. Martin Jetpack produces jetpacks where you can fly 
around and for many of us this sounds very futuristic, but it does exist. Rocketlab that launches rockets into the air and is competing with global  government players in supplementing their space 
programmes in the future. Wynyard Group is a market leader in advanced crime fighting software, 
used by investigations and intelligence operations and government agencies and financial 
institutions and one last example is Pikpok which is one of the leading video game companies in New Zealand with 100million downloads. While I think Angry Birds as a fun game was mentioned, 
you might also like to try Pikp ok's games such as Flick Kick Football and Flick Kick Football 
Legends which was nominated for mobile game of the year in 2014. It has also partnered with Dreamworks Animation to make a game called Turbo Racing Legends. In summary the accelerated programme that I highlighted earlier is just one component of the New Zealand Government's 
support for businesses with high-growth potential that are still in the start-up phase. It 
complements New Zealand's Business Growth Agenda, which is a broad work programme across government agencies to support innovation and growth, and part of the business growth agenda 
includes research and development grants, and seed and venture investment funds. 
524.  Lastly I would also like to note that the enabling and macro-economic environment is also 
very important to serve innovation. It is notable in this regard that New Zealand is ranked second 
in terms of ease of doing business, third in terms of the prosperity index, second in the corruption 
perception index, third in the index of economic freedom, eighteenth in the global innovation index and according to the World Bank it only takes one day to start a business in New Zealand. New Zealand is committed to fostering faster economic  growth by assisting entrepreneurs to develop 
innovative companies that will drive New Zealand's economy into the future. 
14.13  Brazil   
525.  I would like to thank all the co-sponsors for presenting on this agenda item on IP and 
Entrepreneurialism. Our delegation welcomes the debate as it can create the possibility of 
deepening the understanding of features of the intellectual property system related to the 
achievement of the objective of Article 7 of the TR IPS Agreement which states that "The protection 
and enforcement of intellectual property rights 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 an d in a manner conducive to social and economic 
welfare, and to a balance of rights and obligations." At the outset, as it was also stated by other 
delegations, it is important to highlight that patents are far from being the single element driving 
innovation, it is only one in a larger mix of different tools that promote innovation. Having the right infrastructure for innovation, collaboration and research, the flow of ideas among different 
innovation players and access to knowledge are of ten more important ingredients of innovation.  
526.  Even as one element of a larger mix of ingred ients of innovation, in order to play a positive 
role in fostering it, intellectual property must work properly. When this is not the case, IP can work 
counter to innovation and innovators. A patent system that issues an expressive number of low-
quality patents generates uncertainty, and can repr esent an additional barrier to entrepreneurs. 
This scenario was accurately described by Jaffe and Lerner in the book Innovation and its 
Discontent . According to Jaffe and Lerner "the sand in the gears of the innovation machine is that 
companies and individuals must constantly fear that their research and product development may 
come to nothing, because someone is going to assert an as yet unknown or untested patent against them. Further, when such an assertion of patent infringement is made, the uncertainty 
about the ability to defend against that assertion often leads either to abandonment of the 
allegedly infringing technology, or to an agreement to pay possibly unnecessary royalties." Regarding national experiences in supporting entrepreneurialism, in order to allow more time for 
discussion and approval of the extension of waiver s for least-developed countries, I would like to 
refer back to my delegation's previous interventi ons under the agenda items related to innovation. 
AGENDA ITEM 15: INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE 
WTO 
527.  No statements were made under this agenda item. IP/C/M/80/Add.1 
 
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  AGENDA ITEM 16: OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL 
ORGANIZATIONS 
16.1  India  
 
528.  India supports granting of permanent ob server status to three intergovernmental 
organisations- South Centre, the Convention on Biological Diversity (CBD) Secretariat and the International Vaccine Institute. 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. The CBD fulfils all the required parameters for observership of the WTO. The WTO Secretariat has observer status in the CBD and regularly participates in the CBD meetings. So as a matter of reciprocity, the CBD Secretariat should be granted permanent 
observer status.  
529.  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. 
530.  India again urges the Council to positively and expeditiously consider the request of South 
Centre, Secretariat of the CBD and the International Vaccine Institute (IVI) for permanent 
observer status or at least ad hoc observer status on a meeting-by-meeting basis should be granted to them. 
531.  With regard to proposal for granting permanent observer status to ARIPO, OAPI, GCC and 
the EFTA, we are still awaiting instructions from our capital in this regard and we cannot support this proposal at this juncture. However, we supp ort granting of ad-hoc observer status to the 
above IGOs on a meeting-to-meeting basis. 
16.2  Ecuador   
 532.  On this agenda item, my delegation would like to add its voice to India and support the 
participation of South Centre and also the Secretariat of the Convention on Biological Diversity 
should have observer status, or at least be granted ad-hoc observer status. 
16.3  Indonesia   
 
533.  As was stated in the previous Council meeting, Indonesia would like to reiterate its support for granting permanent observer status to the CBD Secretariat and South Centre, to bring their 
positive and valuable contribution to th e work and discussion of this Council.  
16.4  Egypt   
 534.  We would like to associate ourselves with Ecuador and Indonesia. We would like to grant 
observer status to the South Centre and the CBD. 
16.5  Tanzania  
 
535.  We would like to support India and their request for observer status for the South Centre 
and the CBD Secretariat.  
16.6  United States of America  
 
536.  Consistent with our previous position, we can agree to permanent Observer status for ARIPO, OAPI, GCC and EFTA. As for the other requests, we are unable to support those at this time. IP/C/M/80/Add.1 
 
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  16.7  Venezuela, Bolivarian Republic of   
 537.  We add our voice to those countries that have supported the candidature of the South Centre. 
16.8  Brazil   
 538.  The position of our delegation regarding the admissions of new observers is well-known. We 
also support, like Ecuador and India, the admission of the CBD Secretariat and South Centre as 
observers to this TRIPS Council. We understand that they have contributions to the discussions that we have in this forum. Regarding the new proposals to agree the admission of permanent observers at this structure, we still need time to consult on this matter. 
16.9  Nepal   
 539.  My delegation is of the view that several relevant international intergovernmental 
organizations working in the field of intellectual property and natural conservation and particularly 
supporting the LDCs and developing country Members to different means and deeds, are to be given observer status to this Council. In this connection, we ask Members to consider positively to 
extend observer status, permanently, to some intergovernmental organizations, namely the CBD 
Secretariat, South Centre and International Vaccine Institute who have been closely working with us for years in formatting our deliberations more constructively and usefully in the Council. We are of the firm view that their presence and partic ipation in the Council meeting would help them 
further consolidate their respective work in the intellectual property field and encourage them to 
align their works with the WTO TRIPS Agreement. 
16.10  Chairman  
 
540.  As I mentioned in our informal consultation s, there had been support for giving permanent 
status to ARIPO, OAPI, the GCC and EFTA. I heard two delegations say that they needed more 
time for consultation. Let me suggest, that the Council agree, ad referendum , on giving permanent 
observer status to these four organization, ARIPO, OAPI, the GCC and EFTA, giving Brazil and India a period in which they might be able to obtain definite instructions on this, and after which, unless they receive contrary information or instructions that they cannot support, we might 
consider this granting of permanent status as agreed. 
16.11  India  
 
541.  I think I cannot comment on your suggestion, because I need to take instructions from my 
capital. I think we should wait for the next Council meeting to get concrete instructions from our capital. 
16.12  Brazil  
 542.  Perhaps a good suggestion would be to have consultations on this, also taking into account the request of many Members to also have the CBD Secretariat and the South Centre included as 
observers, either as ad hoc observers, or as permanent observers. So we would be willing to join 
to try and find a solution before the Ministerial Conference. 
16.13  Nigeria, on behalf of the African Group  
 
543.  The African Group is a co-sponsor of granting the permanent observer status to ARIPO and OAPI. These are institutions that are responsible for registration of IP in most of our countries. The 
Bangui Protocol for OAPI and the Harare Protocol for ARIPO are the basis for the registration and 
administration of industrial property rights. For us, it is very important, and their work is relevant, not only because it is tied to what is being done here in the TRIPS Council. Of course, I have listened carefully to India and Brazil specifically  the statement made by Brazil saying that they 
needed something on the South Centre, and for th e CBD Secretariat. As African Group, we have 
always supported that the South Centre and the CBD Secretariat be given a permanent or ad hoc observer status. I believe trying to tie these two issues is not going to be helpful for Africa, 
because it means at the end of the day, we did not create this problem, we are supportive of this, IP/C/M/80/Add.1 
 
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  and I would like to ask them to show some flexibility regarding the admission of OAPI and ARIPO, 
because if we are to tie it to the CBD Secretariat, certainly it is out of the hands of Africa.  
AGENDA ITEM 17: ANNUAL REPORT 544.  No statements were made under this Agenda item. 
AGENDA ITEM 18: OTHER BUSINESS 
Contribution of IP to facilitate the tran sfer of environmentally sound technology 
18.1  Ecuador   
 
545.  Ecuador would like to share with you some of the latest updates regarding the proposal that Ecuador made in this Council. Ecuador called for the right to speak on this matter so as to keep the membership up-to-date regarding various actions pertaining to proposal IP/C/W/585, 
presented here in February 2013 and also May 2015.  Since then the country has been working at 
the national level, and also together with other international organizations as well, in order to carry out the second workshop which was slated fo r November of this year. However in order to 
avoid the conflict or clash or with the preparations for the upcoming MC10 in Nairobi, it was 
considered that it would be better to postpone it  and have it in the first quarter of next year. 
Ecuador will continue making its best efforts along the lines of this proposal, and this concerns all 
countries with the contribution of IP to provide technology transfer in order to offset the untoward 
effects engendered by climate change. 
__________