RESTRICTED  
  
IP/C/M/87/Add.1  
 
7 February 2018  
(18-0831) Page: 1/68 
Council for Trade -Related Aspects of  
Intellectual Property Rights    
 
MINUTES OF MEETING  
HELD IN THE CENTRE W ILLIAM RAPPARD ON 19 -20 OCTOBER  2017 
Chairperson: Ms Irene Young (Hong Kong, China)  
Addendum  
The present document contains the statements made during the Council for TRIPS meeting held on 
19-20 October  2017.  
 
_______________  
 
AGENDA ITEM 1: NOTIF ICATIONS UNDER PROVI SIONS OF THE AGREEME NT ..................  4 
AGENDA ITEM 2: REVIE W OF NATIONAL IMPLEM ENTING LEGISLATION  ..........................  6 
AGENDA ITEM 3: REVIE W OF THE PROVISIONS OF ARTICLE 27.3(B)  ...............................  7 
AGENDA ITEM 4: RELAT IONSHIP BETWEEN TH E TRIPS AGREEMENT AN D 
THE CONVENTION ON BIOLOG ICAL DIVERSITY  ................................ ...............................  7 
AGENDA ITEM 5: PROTE CTION OF TRADITIONAL  KNOWLEDGE AND FOLKLO RE ...............  7 
AGENDA ITEM 6: ANNUA L REVIEW OF THE SPEC IAL COMPULSORY LICEN SING 
SYSTEM (PARAGRAPH  7 OF THE ANNEX TO TH E AMENDED TRIPS AGRE EMENT 
AND PARAGRAPH 8  OF THE  DECISION ON THE IMPL EMENTATION OF 
PARAGRAPH 6 OF THE D OHA DECLARATION ON T HE TRIPS AGREEMENT A ND 
PUBLIC HEALTH)  ................................ ................................ ................................ ............  13 
AGENDA ITEM 7: NON -VIOLATION AND SITUAT ION COMPLAINTS  ................................ . 18 
AGENDA ITEM 8: REVIE W OF THE IMPLEMENTAT ION OF THE TRIPS AGREE MENT 
UNDER ARTICLE 71.1  ................................ ................................ ................................ ..... 24 
AGENDA ITEM 9: REVIE W OF THE APPLICATION  OF THE PROVISIONS OF  THE 
SECTION ON GEOGRAPHICAL INDICAT IONS UNDER ARTICLE 2 4.2 ................................  24 
AGENDA ITEM 10: FIFT EENTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF  THE 
DECISION ON THE I MPLEMENTATION OF ART ICLE 66.2 OF THE TRI PS 
AGREEMENT  ................................ ................................ ................................ ...................  25 
AGENDA ITEM 11: TECH NICAL COOPERATION AN D CAPACITY BUILDING  ......................  32 
AGENDA ITEM 12: INTE LLECTUAL PROPERTY AN D INNOVATION: INCLUS IVE 
INNOVATION AND MSME GROWTH  ................................ ................................ ................  41 
AGENDA ITEM 13: INTE LLECTUAL PROPERTY AN D THE PUBLIC INTERES T: 
FOLLOW -UP DISCUSSION ON COM PULSORY LICENSING  ................................ ...............  59 
AGENDA ITEM 14: INFO RMATION ON RELEVANT DEVELOPMENTS ELSEWHE RE IN 
THE WTO  ................................ ................................ ................................ ........................  66 
AGENDA ITEM 15: OBSE RVER STATUS FOR INTE RNATIONAL 
INTERGOVERNMENTAL OR GANIZATIONS  ................................ ................................ ....... 67 
AGENDA ITEM 16: ANNUAL REPORT  ................................ ................................ ...............  68 
AGENDA ITEM 17: OTHE R BUSINESS  ................................ ................................ ..............  68 IP/C/M/87/Add.1  
 
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  INDEX OF THE STATEMENTS MADE  
AT THE MEETING OF  COUNCIL FOR TRIPS 19-20 OCTOBER 2017 * 
 
Argentina  
Non-Violation  ................................ ...... 22 
ARIPO  
Technical Cooperation  ..........................  35 
Australia  
Article 66.2  ................................ ........  28 
Biotech, Biodiversity, TK  ......................  11 
IP and Innovation - MSME Growth  .........  48 
Non-Violation  ................................ ...... 21 
Special Compulsory Licensing  ...............  17 
Technical Cooperation  ..........................  32 
Barbados  
Special Compulsory Licensing  ...............  14 
Bolivia, Plurinational State of  
Biotech, Biodiversity, TK  ........................  9 
Non-Violation  ................................ ...... 19 
Brazil  
Article 66.2  ................................ ........  30 
Biotech, Biodiversity, TK  ........................  8 
IP and Innovation - MSME Growth  .........  56 
IP and Public Interest - Compulsory 
Licensing  ................................ .........  61 
Non-Violation  ................................ ...... 20 
Notifications  ................................ .........  6 
Observer Status  .............................  67, 68  
Special Compulsory Licensing  ...............  15 
Technical Cooperation  ..........................  40 
Cambodia on behalf of LDCs  
Article 66.2  ................................ ........  30 
Canada  
Article 66.2  ................................ ........  29 
Biotech, Biodiversity, TK  ......................  10 
IP and Innovation - MSME Growth  .........  53 
Non-Violation  ................................ ...... 21 
Special Compulsory Licensing  ...............  15 
Technical Cooperation  ..........................  33 
Chile  
IP and Innovation - MSME Growth  .........  54 
Non-Violation  ................................ ...... 21 
China  
Biotech, Biodiversity, TK  ........................  7 
IP and Innovation - MSME Growth  .........  59 
IP and Public Interest - Compulsory 
Licensing  ................................ .........  63 
Non-Violation  ................................ ...... 19 
Notifications  ................................ .........  4 
Observer Status  ................................ .. 68 
Special Compulsory Licensing  ...............  18 
Technical Cooperatio n ..........................  41 
Costa Rica  
IP and Innovation - MSME Growth  .........  55 
Non-Violation  ................................ ...... 20 
Special Compulsory Licensing  ...............  18 
Ecuador  
Biotech, Biodiversity, TK  ........................  8 
Non-Violation  ................................ ...... 21 
Observer Status  ................................ .. 68  
European Union  
Article 66.2  .............................  25, 30, 32  
Biotech, Biodiversity, TK  ......................  10 
IP and Innovation - MSME Growth  .........  46 
IP and Public Interest - Compulsory 
Licensing  ................................ .........  63 
Non-Violation  ................................ ..... 22 
Notifications  ................................ .........  5 
Observer Status  ................................ .. 68 
Special Compulsory Licensing  ...............  14 
Technical Cooperation .....................  33, 41  
Gulf Cooperation Council  
Technical Cooperation ..........................  36 
Haiti  
Article 66 .2 ................................ ........  31 
Haiti on behalf of the LDC Group  
Biotech, Biodiversity, TK  ........................  9 
Special Compulsory Licensing  ...............  14 
Holy See  
IP and Public Interest - Compulsory 
Licensing  ................................ .........  65 
India  
Biotech, Biodiversity, TK  ......................  12 
IP and Innovation - MSME Growth  .........  57 
IP and Public Interest - Comp ulsory 
Licensing  ................................ .........  62 
Non-Violation  ................................ ..... 22 
Notifications  ................................ .........  5 
Observer Status  ................................ .. 67 
Special Compulsory Licensing  ...............  13 
Technical Cooperation ..........................  40 
Japan  
Article 66.2  ................................ ........  29 
Biotech, Biodiversity, TK  ......................  10 
IP and Innovation - MSME Growth  .........  44 
IP and Public Interest - Compulsory 
Licensing  ................................ .........  65 
Non-Violation  ................................ ..... 22 
Special Compulsory Licensing  ...............  17 
Technical Cooperation ..........................  33 
Korea, Republic of  
Biotech, Biodiversity, TK  ......................  13 
IP and Innovation - MSME Growth  .........  44 
Non-Violation  ................................ ..... 22 
Special Compulsory Licensing  ...............  17 
New Zealand  
Article 66.2  ................................ ........  29 
Non-Violation  ................................ ..... 23 
Technical Cooperation ..........................  34 
Nigeria on behalf of the African Group  
Non-Violation  ................................ ..... 18 
Special Compulsory Licensing  ...............  18 
Norway  
Article 66.2  ................................ ........  25 
Notifications  ................................ .........  4 
Technical Cooperation ..........................  32 IP/C/M/87/Add.1  
 
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  Paraguay  
Non-Violation  ................................ ...... 23 
Russian Federation  
Non-Violation  ................................ ...... 22 
Special Compulsory Licensing  ...............  17 
South Africa  
Biotech, Biodiversity, TK  ........................  7 
IP and Innovation - MSME Growth  .........  58 
IP and Public Interest - Compulsory 
Licensing  ................................ .........  59 
Non-Violation  ................................ ...... 19 
Observer Status  ................................ .. 67 
Special Compulsory Licensing  ...............  15 
Switzerland  
Article 24.2  ................................ ........  24 
Biotech, Biodiversity, TK  ......................  11 
IP and Innovation - MSME Growth  .... 41, 59  
Non-Violation  ................................ ...... 20 
Special Compulsory Licensing  ...............  16 
Chinese Taipei  
IP and Innovation - MSME Growth  .........  52 
Non-Violation  ................................ ...... 23 
Notifications  ................................ .........  4 Thailand  
Non-Violation  ................................ ..... 18 
Special Compulsory Licensing  ...............  17 
UNCTAD  
Technical Cooperation ..........................  38 
United States  
Article 66.2  ................................ ........  29 
Biotech, Biodiversity, TK  ........................  9 
IP and Innovation - MSME Growth  .........  49 
IP and Public Interest - Compulsory 
Licensing  ................................ .........  65 
Non-Violation  ................................ ..... 19 
Observer Status  ................................ .. 68 
Special Compulsory Licensing  ...............  14 
Technical Cooperation ..........................  32 
Venezuela, Bolivarian Republic of  
Observer Status  ................................ .. 68 
WHO  
Technical Cooperation ..........................  37 
WTO Secretariat  
Information on Developments in WTO  ... 66 
Notifications  ................................ ..... 4, 6 
Technical Cooperation ..........................  34 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_____________________  
* A record  of statements as delivered in the formal session of the Council. Some statements have been 
lightly edited as appropriate to ensure the consistency of presentation.  IP/C/M/87/Add.1  
 
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  AGENDA ITEM 1: NOTIF ICATIONS UNDER PROVI SIONS OF THE AGREEM ENT 
1.1 WTO Secretariat   
1.  Under Article 63.2. of the Agreement, the Council has received the following notifications:  
 From Norway, the Act Relating to the Right to Employees' Inventions as amended in 
October 2015;  
 From Chinese Taipei,  the consolidated version of the Copyright Act as amended in 
November 2016, the consolidated version of the  Patent Act as amended in January 2017 
and of the Enforcement Rules of the Patent Act as amended in April 2017, as well as the 
consolidated version of the Trademark Act as amended in November 2016 and of the 
Enforcement Rules of the Trademark Act as amended in March 2017; and  
 From China, revised Regulations (i) for the Implementation of the Copyright Law, (ii) on 
the Protection of  New Plant Varieties, and (iii) on Computer Software Protection, all 
adopted in January 2013.  
2.  These notifications are referred to on the revised agenda for this meeting. They are available in 
the IP/N/1 - series of documents, and the actual texts of laws ar e on the Documents 
Online  database.  
3.  Gabon has notified its responses to the Checklist of Issues on Enforcement. No other initial 
responses or updates to earlier responses have been submitted since our last meeting.  
4.  Liberia has submitted information regardi ng contact points under Article 69 for the  exchange of 
information and cooperation on trade in infringing goods. The information on the  Members' 
transparency toolkit page has been updated accordingly.  
1.2 Norway  
5.  The notification of the Employees ' Inventions Act (IP/N/1/NOR/P/9 ) applies to inventions by 
employees in public or private service patentable in Norway. The Act seeks to balance  the right of 
the employer to the work made by employees paid by them and the r ight of the employee to his or 
her inventions. Some of the provisions of the Act only apply if no agreement to the contrary has 
been made between the parties. The Act entered into force on 1 September 1970 whereas its 
latest amendments entered into force o n 1 October 2015. The Act was translated into English only 
now and that's the reason behind this notification.  
1.3 Chinese Taipei   
6.  The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu would like to update 
Members on recent amendments made to our Patent Act, the Enforcement Rules of the Patent Act, 
our Trademark Act, the Enforcement Rules of the Trademark Act, and our Copyright Act.  
7.  With regard to the Patent Act, the grace period for invention and utility mo del patent 
applications has been extended from 6 months to 12 months, and relevant revisions have been 
made to the Enforcement Rules  of the Patent Act accordingly.  
8.  As for the Trademark Act and the Copyright Act, these have been amended to bring them into 
line with a new Chapter on "Confiscation" in the Criminal Code. I should add here that no changes 
have yet been made to the rules governin g the practice of confiscation.  
9.  As for the Enforcement Rules of the Trademark Act, its Schedule has been updated in 
accordance with the 11th edition of the Nice Classification 2017.  
1.4 China   
10.  Three revised Regulations entered into force on 1 March, 2013; namely  the Regulations on 
Computer Software Protection, the Regulations of the People's Republic of China on Protection of 
New Varieties of Plants, and the Regulations for the Implementation of the Copyright Law of IP/C/M/87/Add.1  
 
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  the People's Republic of China.  These revisions aim to enhance the protection of intellectual 
propert y, strengthen the enforcement of intellectual property rights, and maintain fair market 
competition.  
11.  The n ew Regulations for the Implementation of the Copyright Law of the People's Republic of 
China and the Regulations on Computer Software Protection refin e the punishment s of 
administrative penalties and raise the ceiling s of the fine. The new regulation on Protection of New 
Varieties of Plants adjusts the administrative penalty standards and increases the means of 
administrative penalties.  
1.5 India  
12.  We appreciate the efforts made by the European Union on issuance of a "Commission notice 
on the customs enforcement of Intellectual Property Rights concerning goods brought into 
the customs authority of the Union without being releas ed for free circulation including goods in 
transit" (the "Commission notice", see EU Document 2016/C 244/03 of 5 July 2016). India 
considers that while the Commission notice would help in understanding issues that may or are 
likely to arise while applying the Regulation (EU) 2015/2424, it also raises some practical 
implementation issues and legal questions. It is in this regard that we request  from the European 
Union certain relevant documents and clarifications regarding the applicable law:  
i. Can the EU prov ide a list of all the applicable custom laws issued by the EU which could 
be in the form of regulati ons/directives/guidelines etc.?  
ii. Can the EU clarify whether Regulation (EU) No 608/2013 is directed only to goods 
intended and/or suspected of entering into the EU market?  
iii. Does Regulation (EU) No 608/2013 provide any substantive right to an IPR holder or is it 
merely enforcing the existing IP rights? It is also requested that the EU provide a list of 
existing laws/ regulations/ directive/guidelines issued by t he EU governing IPR.  
iv. Are there any IPRs or infringement of IPRs which are excluded from the scope of 
Regulation (EU) No 608/2013? Specifically, please clarify whether goods which are not 
intended for free circulation in the EU market and are also not suspe cted of entering into 
the EU market, are exempted from the scope of Regulation (EU) No 608/2013.  
v. Is it mandatory for goods originating fro m outside the EU to be "released for free 
circulation"  by EU customs authorities before they are placed on the EU mark et? Are 
there any other customs approved use(s) by which goods originating from outside 
the EU may be placed on the EU market?  
vi. Can the EU clarify the factors which are taken into consideration by the EU customs 
authorities while undertaking risk analysis c riteria as provided in recital 16 of Regulation 
(EU) 2015/2424 and recital 22 of Directive (EU) 2015/2436?  
vii. Can the EU clarify whether paragraphs 2.2 and 3.2 of the Commission notice woul d 
apply to medicine(s) as well?  
1.6 European Union  
13.  The EU takes note of the questions from the Indian delegation, since we unfortunately, 
received the questions only a couple of days ahead of the TRIPS Council on a subject involving 
several services of the European Commission. At this mee ting the EU is not in a position to provide 
replies. The EU is compli ant with its TRIPS obligations including those related to enforcement. We 
are not aware of a single recent case in the EU where there was an issue of seizure of legally 
transiting  products which the country just intervening has its main interest, not this time for the 
EU internal market. As India is aware there is an on -going bilateral consultation process on the 
matter  of transit between India and European Union. The EU remains co mmitted to that process.  IP/C/M/87/Add.1  
 
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  1.7 Brazil  
14.  The issue of abuse of enforcement actions of IPRs on goods in transit is unfortunately not 
a new one in this Council. As we all know , in December 2008 , a shipment of generic medicines  
from I ndia with destination to Brazil was unlawfully detained while in transit in the Netherlands. At 
that time, both Brazil and India expressed their full disagreement with the misuse of enforcement 
procedures by right holders, preventing the useful supply of a  life-saving medicine to the Brazilian 
public health system. We will continue to closely monitor the issue and remain open to discuss it 
with the EU.  
1.8 WTO Secretariat   
15.  Colleagues will be aware that the eTRIPS  projec t has been under development for some time 
and that the Secretariat has updated the Council on the progress over several years. I am pleased 
to report that the first major stage is coming close to practical completion, namely an online 
facility for all for ms of notification and submission of review materials relating to the work of 
the Council. I would like to recall the princip les that underline this  project.  
16.  First, this online platform is intended to facilitate existing arrangements , consisten tly with the 
guidance in the TRIPS Agreement itself and in the decisions of this Council regarding notifications 
and review processes. Moreover, it remains an entirely optional tool for Members to use. It doesn't 
replace the existing methods, but we do hope th at it will become much more convenient for 
Members. Among t he objective s of the  project is to make it significantly easier to file notifications.  
Secondly, i t will also be  easier to consult past notifications , including those of your own delegation, 
and to  get up to date as to the state of play.  This is becoming increasingly important as we move 
into twenty -two years of accumulated notifications. Thirdly , the tool will enable delegates generally 
to survey notifications and review materials across the full s weep of agenda items and work of 
the Council.  
17.  The on -line submission gateway is almost ready. In that regard we would like to offer 
Members at the conclusion of this session of the Council a brief demonstration of that tool.  We 
have already had very helpfu l informal consultations with interested delegates making use of the 
tool to road -test it. We thank the  delegations concerned for their guidance and feedback; it has 
helped us shape the tool in the way that will be much more practically useful for delegate s to use. 
The coming months will see, we hope, this tool going on -line for Members to use generally. We 
therefore encourage delegates with impending notifications to get in touch with us and we can 
guide you through its practical use. We hope that this will facilitate your work and perhaps enable 
you to focus less on mechanical and more on substanti ve things. We are quite aware that it is a 
huge workload for delegations to trace up and to submit notifications and our single objective has 
been to make that a n easier task.  
18.  The next stage is to improve the access to the material that has already been submitted. We 
are very conscious that this is a practical difficulty. At the workshop yesterday , concerning 
the implementation of Article 66.2, this was one of the  questions discussed because it is an area 
like several others where there is a very large body of complex documentation . The idea is to 
develop thematic gateways on each of the main topics of interest to the Council . Once again , we 
will be informally consulting with you as to how to make these gateways most useful for you. In 
the coming months, we will reach out to you for consultations on that matter. We very much look 
forward to engaging with delegates on the elaboration of this important tool . Above all , I would 
like to thank those delegates who have sat down with us and helped us develop it.  
AGENDA ITEM 2: REVIEW OF NATIONAL I MPLEMENTING LEGISLAT ION 
19.  No statements were made under this agenda item.  IP/C/M/87/Add.1  
 
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  AGENDA ITEM 3: REVIE W OF THE PROVISIONS OF ARTICLE 27.3(B)  
AGENDA ITEM 4: RELAT IONSHIP BETWEEN THE TRIPS AGREEMENT AND 
THE CONVENTION ON BIOLOG ICAL DIVERSITY  
AGENDA ITEM 5: PROTE CTION OF TRADITIONAL  KNOWLEDGE AND FOLKLO RE 
5.1 China  
20.  The relationship between the TRIPS  Agreement and the CBD is an important issue in the 
TRIPS Council. China always attaches great importance on this issue and participates in the 
discussions which are quite useful for clarification. China hopes that Members constructively 
involve in this  discussion.  
21.  Regarding the substantive  issues, China notes that the majority of Members support to amend 
the TRIPS Agreement so as to ensure the mutual support iveness  of TRIPS Agreement, the CBD 
and its Nagoya Protocol.  
22.  China believes that the introduction of  a mandatory disclosure requirement, prior informed 
consent and benefit sharing  could prevent misappropriation and erroneous patents. And  providing 
information concerning the prior informed consent and benefit sharing could not be burdensome. 
The benefits arrangement on contractual basis and the database solution could not serve the 
purpose of sufficient protection for genetic resources.  
23.  As to the disclosure issue, China has  provided detailed suggestions on improving 
the transparency on genetic resources ut ilization, preventing the misappropriation of genetic 
resources and traditional knowledge, and preventing the grant of erroneous patent s in two 
documents TN/C/W/52 and TN/C/W/59 co -sponsored by different Members.  
24.  As regard to procedure, China believes that  the discussion in  WIPO/IGC could not hinder 
Members from finding a solution  in WTO. Furthermore , Ministers have given the C ouncil  
the mandate to examine the rel ationship between TRIPS and CBD. T herefore, Members should 
follow the instruction s and mandate to work to find a solution. In this regard, to strengthen 
the understanding so as to carry on the c onstructive discussion in this C ouncil, China supports to 
invite the CBD Secretariat to brief on the Nagoya Protocol. China also hopes that the Secretariat 
could renew the three  factual notes.  
5.2 South Africa  
25.  This delegation has indicated in past interventions that the TRIPS Council should continue its 
work progamme on the basis of paragraph 19 of the Doha Minis terial Declaration. In respect of 
the relationship between the TRIPS Agreement and the CBD and the  protection of traditional 
knowledge, a large group of WTO Members have sought to introduce a  mandatory disclosure 
requirement in patent applications. The bes t way to ensure the proper use of genetic resources 
and associated traditional knowledge is through an amendment to the TRIPS Agreement as set out 
in document TN/C/W/59. The TRIPS -CBD issue remains one of the  outstanding implementation 
issues within the co ntext of the Doha Round . 
26.  It is a longstanding request that the CBD Secretariat should be allowed to brief the TRIPS 
Council on developments within the implementation of the CBD, more specifically on the 
implementation of the Nagoya Protocol, which instrument entered into force on 12 October 2014. 
One of the emerging issues under the CBD and the Nagoya Protocol relates to the issue of digital 
sequence information on genetic resou rces. In December 2016, both the  twelfth meeting of 
the Conference of the Parties to the CBD and the second meeting of the Parties to the Nagoya 
Protocol addressed the issue of digital sequence information on genetic resources and decided to 
consider, at t heir next respective meetings, any potential implications of the use of this 
information for the objectives of the CBD and the Nagoya Protocol. It would be useful for the CBD 
Secretariat to brief the TRIPS Council on this is and other implementation issues  under the Nagoya 
Protocol.  
27.  Furthermore, this delegation joins China in respect of the issue of the update of the three 
technical notes contained in documents IP/C/W/368/Rev.1, IP/C/W/369/Rev.1 and IP/C/M/87/Add.1  
 
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  IP/C/W/370/Rev.1. It would be appropriate for the Secretar iat to update the information contained 
in these notes in a neutral manner to further facilitate discussions among Members.  
5.3 Ecuador   
28.  Thank you for your efforts to deal with these long -standing issues and the st eps you have 
taken to enable Members to come to an agreement.  
29.  We wish to reiterate on this occasion our country's position, which has already been 
expressed in this Council. We would therefore ask the Council to refer to the statements made by 
my delegatio n in previous meetings as we discuss the three topics under consideration.  
30.  Specifically, I would like to refer to the proposal put forward by Ecuador in November  2012, 
suggesting that the Secretariat prepare an update of the factual notes on the aforementi oned 
topics. The reason for the proposal was that the last compilation of the ideas discussed was 
produced in 2006. We believe that updated versions of documents IP/C/W/368/Rev.1, 
IP/C/W/369/Rev.1 and IP/C/W/370/Rev.1 would provide us with a clearer idea o f what was 
already discussed a number of years ago, the aim being for Members to have an updated picture 
that could contribute to informing the debate on these issues, thus enabling us to move forward in 
our discussions. As my delegation stated at this Cou ncil's last meeting, consensus on this idea has 
gradually emerged, and the only thing we still need in order for the Secretariat to prepare 
the factual update is for one Member to adopt a flexible position.  
31.  In response to the Chair's call, I would like to report that we have held consultations with 
the delegation of the United States and are confident that, in the near future, we will find 
a definitive solution in respect of this proposal. I wish to stress that the only objective being 
sought is for Members  to have more detailed information, which could be presented by 
the Secretariat in a  neutral manner, without compromising any of the Members' positions. We wish 
to emphasize this, as each Member's position would remain intact and, moreover, more of 
the information conveyed during our debates would be available to us, compiled in 
the Secretariat's updated versions of the three aforementioned documents.  
5.4 Brazil  
32.  Brazil has a well -known position regarding the importance of promoting the neutral support 
between the TRIPS Agreement and the CBD. 
33.  As for many delegations that intervened before  me, we believe that the introduction in 
the TRIPS Agreement of a mandatory re quirement for the disclosure of the origin of these 
resources in patent applications would enhance the transparency regarding the utilization of 
genetic resources and associated traditional knowledge.  
34.  At the national level, Brazil has updated its legislati on 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. The  process for obtain ing authorization was designed with the view of keeping 
efficiency and reducing paperwork, offering a fully electronic system for private parties that wish to 
request authorization.  
35.  The need for action is urgent. In spite of national efforts, biopiracy and  misappropriation of 
traditional knowledge continue to occur. An amendment of the  TRIPS Agreement would ensure 
cooperation between countries, reduce uncertainty for stakeholders and curb illegal activities 
related to the matter. An implementation in the IP system of international rules aimed at the 
protection of biodiversity is feasible and will reinforce the view that IP rules can work for the 
benefit of all countries and stakeholders. As  previously mentioned by China, the database solution 
proposed by som e delegations would fail to offer the full protection necessary for curbing 
biopiracy. We hope to see the necessary measures to prevent biopiracy re flected in the TRIPS 
Agreement.  
36.  We would also like to emphasize the importance of the request that the CBD S ecretariat brief 
this Council on the developments in the Nagoya Protocol adopted in the recent past. IP/C/M/87/Add.1  
 
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  The information provided during this briefing would be of benefit for us all, so we hope that there 
is agreement on this point soon . We therefore support t he suggestion made by China and South 
Africa for inviting the CBD Secretariat to brief us here at the TRIPS Council. We also support the 
update of the  three  technical notes on the matter, considering the many developments that 
occurred at the  international  level since they were produced.  
5.5 Bolivia, Plurinational State of  
37.  The possibility of patenting plants, micro -organisms and animals poses a series of issues for 
my country at different levels: ethical, cultural, economic and others. There are many who 
consider that life is something sacred which should not be dealt with a s a simple commercial 
object and that patents should not be allowed on life forms or part s of them. In commercial and 
trade t erms, the adoption of Article 27.3(b)  not only encouraged biopiracy , but it also promoted 
misappropriation of genetic resources wit h severe and negative impacts for many of our countries. 
We consider that a multilateral agreement is necessary .  
38.  We are also up -to-date with the situation of the renewal of the mandate on the IGC on genetic 
resources, traditional knowledge and traditional  cultural expressions at WIPO , which  will contin ue 
its work for two years or more. T his topic has been discussed at WIPO for more than seventeen 
years without success. We hope that this time efforts will produce  positive res ults. However, for us 
the best f orum to gain an  agreement on this issue is the WTO. We await the outcomes of the work 
at WIPO to see what action we can then carry forward in this Organization in order to avoid 
biopiracy.  
39.  To conclude, I  would like to reiterate that Bolivia also supports t he proposal relating to 
the disclosure of the source of origin, which is in line with Bolivia's proposal to avoid patentability 
of lifeforms or parts of them including genetic resources. We support the proposal of China, 
South  Africa, Brazil and Ecuador fo r the WTO Secretariat to update the factual notes on this topic. 
And we hope that the communications fr om Bolivia from 2010 in IP/C/W/545 and  in 
2011 IP/C/W/554 will be taken into account.  
5.6 Haiti on behalf of the LDC  Group   
40.  The LDC Group believes that the TRIPS Agreement and the CBD should be implemented in 
a mutually supportive manner. The Group therefore considers that the TRIPS Agreement should be 
amended to include a provision making it mandatory to disclose the origin of genetic resources and 
traditional knowledge when filing a patent application.  
41.  LDCs are rich in terms of biodiversity and traditional knowledge. They are often victims of 
bio-piracy. Therefore, the disclosure of the origin of genetic resources and traditional knowledge 
would allow for these dishonest practices to be combatted effectively, and facilitate the sharing of 
the benefits gained from the exploitation of such resources.  
42.  The LDC Group believes that traditional knowledge and folklore must have adequate 
international legal protection. This would contribute to the socio -economic development of 
Members with these resources.  
5.7 United States  
43.  Our position  on these three issues remain s unchanged. Regarding genetic resources, 
traditional knowledge and folklore, we con tinue to believe that WIPO serves as the best forum to 
address these issues.  
44.  WIPO is looking at addressing unresolved issues and working on a common understanding of 
core issues, using an evidence -based approach and examples of national experiences.  
45.  We too k note that the WIPO General Assembly recently agreed on the renewal of the mandate 
of the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, 
Traditional Knowledge and Folklore (the IGC) for the 2018 -2019 biennium, as well as the work 
plan for the IGC for the biennium.  IP/C/M/87/Add.1  
 
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  46.  The United States will continue to engage in technical discussions at WIPO's IGC and looks 
forward to hearing more from the demandeurs regarding data s upporting their position on 
these  issues and appreciate the C hair's work to help facilitate dialogue.  
With respect to the various request made today, the United States is not in a position to support 
these requests, but remains open to discussions, including bilaterally with delegations in between 
and at the margins  of TRIPS Council meetings.  
47.  As we mentioned during the June TRIPS Council, the United States and Ecuador held 
a bilateral discussion following the formal Council meetings to discuss Ecuador's proposal to invite 
the Secretariat to update the three factual n otes. 
48.  We appreciated the delegate from Ecuador's effort to help us better understand the nature 
and scope of this work and will continue our discussions with Ecuador and others intersessionally.  
49.  However, our concerns remain. Specifically, we fear that the resources and efforts required by 
the Secretariat to conduct this work would far surpass the utility to WTO Members given 
the availability of this information to Members.  
5.8 Japan  
50.  We have discussed these three issues for a long time at a series of meetings of the TRIPS 
Council. The delegation of Japan would like to reiterate its position that it is necessary to seek 
appropriate ways to deal with the misappropriation of genetic resou rces. This means we should 
bear in mind that any measures taken must not adversely affect the existing IP system or hinder 
the creation of innovations utilizing genetic resources and associated traditional knowledge.  
51.  This delegation is firmly convinced tha t the disclosure requirement would discourage 
industries from conducting research and development activities on biological materials overseas. 
This is the very result that Japan is concerned about, when it comes to including the disclosure 
requirement. The refore, this delegation believes that the disclosure requirement is not 
an adequate means for dealing with such misappropriation, so therefore, we have to avoid 
including it in the intellectual property system.  
52.  Finally, Japan respects the outcome that came  forth from the WIPO General Assembly last 
week, which is to renew the WIPO/IGC mandate and allow us to continue discussions on these 
important issues among experts. The delegation of Japan believes the WIPO committee is the most 
appropriate forum to addre ss these issues. This delegation will continue to work in this regard in 
a constructive and effective manner using evidence -based approach.  
5.9 European Union   
53.  The EU continues to support that the three TRIPS issues including disclosure of genetic 
resources are addressed together at the WTO. The EU also supports the work of the IGC  related to 
the three separate issues of the genetic resources, traditional knowledge and t raditional cultural 
expressions.  
5.10 Canada  
54.  Canada continues to firmly believe that the TRIPS Agreement and the CBD are 
complementary and that there is therefore no need to amend the TRIPS Agreement in this regard. 
Canada would also like to reiterate its continuous support for the  important work of the WIPO IGC. 
Canada remains an active and committed participant at the  IGC and continues to believe that 
the IGC is the best and most appropriate forum for multila teral engagement on this issue.  
55.  As has been previously noted , the WIPO IGC provides for an important exchange of expert 
views, which are key to accurately pinpoint ing the issues at hand and to identifying 
evidence -based, balanced, appropriate, and mutually beneficial approaches to addressing 
this complex issue. Canada welcomes the concrete discussions and exchanges of national 
experiences at WIPO in this regard. As Canada has previously noted, and without prejudice to our 
position on substantive matters, we are not opposed from a procedural standpoint to a briefing IP/C/M/87/Add.1  
 
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  from the CBD Secretariat to the TRIPS Council, should there be sufficient interest from other 
Members o n the matter.  
56.  Similarly, Canada could support the compilation of the three factual notes on the  TRIPS 
Agreement by the WTO Secretariat. We remain of the understanding that this would remain 
a purely factual collating exercise. In both cases this is without  prejudice to national positions on 
these issues. Similarly Canada would welcome presentations by any interested Members 
containing the latest information on the operation and functioning of the ir national IP regimes 
concerning genetic resources and tradit ional knowledge. To inform other Members in this Council, 
Canada has appreciated similar presentations on other categories of IP and recent meetings of 
the TRIPS Council, such as on IP and innovation, e -commerce and other issues. We would 
welcome presentat ions on national regimes concerning genetic resources and traditional 
knowledge at future meetings of the TRIPS Council.  
5.11 Australia  
57.  Australia considers the WIPO IGC  as best placed to consider the complex IP issues relating to 
genetic resources and associated traditional knowledge. We are pleased that the WIPO IGC will 
continue its mandate and work to progress these issues over 2018 and 2019. In relation to the 
procedural matters , Australia is open to a brief ing by the CBD Secretariat on the Nagoya protocol 
and can be flexible in relation to the Secretariat updating the three factual notes.  
5.12 Switzerland  
58.  In response to the intervention of the distinguished dele gate from Bolivia, Switzerland would 
like to note that we believe there is considerable merit in providing incentives to biotechnological 
inventions through patent protection. We have seen breakthrough innovation in the field of 
biotechnology over the last  few decades for the benefit of society and this seminal technology 
holds many more promises for progress and the wellbeing of mankind.  
59.  We understand the concerns that Members express under the triplet agenda items to be one 
about fairness, transparency an d legal certainty. These are values my delegation shares and 
considers key for the WTO framework to function properly.  
60.  Accordingly, as a corollary to the patentability of biotechnological inventions, Switzerland 
supports the introduction of a non-burdensom e requirement into the TRIPS Agreement to disclose 
the source of genetic resources in patent applications. We consider the Council's technical 
discussion under these agenda items useful to further enhance the understanding of Members 
concerns and views, an d we support the working out of solutions which address the concerns 
expressed and challenges  identified.  
61.  In cooperation with the W/52 coalition, a group of 109 WTO Members, Switzerland has 
submitted modalities proposals for three  outstanding implementatio n issues at TNC level. This 
includes the establishment of a multilateral register for geographical indications, the extension of 
the higher protection for geographical indications for wines and spirits to the products of all 
Members and a  disclosure requir ement for genetic resources and associated traditional kn owledge 
in patent applications.  
62.  Last Tuesday , a group of Members of the W/52 coalition , among which my own delegation,  
organized an open seminar here in the WTO. The  seminar's theme was "Fairness and  transparency 
in Intellectual Property Rights for an  inclusive International Trade".  
63.  Speakers from Cambodia, Cameroon, China and South Africa highlighted how fairness and 
transparency in the use of geographical indications, genetic resources and traditiona l knowledge 
can promote an inclusive development that benefits consumers, producers and local 
communities  alike.  
64.  Representatives from the CBD Secretariat , UNCTAD and WIPO reviewed at the seminar 
the many developments at the national and international level  over the last few years in the fields 
of IP, genetic resources, traditional knowledge and geographical indications. These include, of 
course, the considerable work done in WTO on these issues over the last 20 years, as they are, in IP/C/M/87/Add.1  
 
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  nature, trade -related a spects of IP rights. At Tuesday's seminar, calls were made to the WTO by 
various speakers that the three outstanding TRIPS implementation issues must remain on the 
future WTO work programme in view of finding appropriate solutions for them.  
65.  Our discussion in this Council under the se agenda items can helpfully contribute to 
this objective. Exchange of experience among Members , as Brazil has done today,  is beneficial and 
enhances our understanding of what is at stake and of how the WTO should address best 
the challenges Members face.  
66.  To conclude, Switzerland can support the proposal by China and others that 
the CBD Secretariat be invited to the Council to brief members on the Nagoya Protocol, and we 
can also support Ecuador's proposal to update the factual not es of the Secretariat on 
the discussion on these  three agenda items.  
5.13 India  
67.  India is an ancient civilization with a rich body of traditional knowledge associated with 
biological resources. This traditional knowledge is both coded, as in the texts of Indian systems of 
medicine such as Ayurveda, Unani and Siddha; and non -coded, whic h exists in the oral 
undocumented traditions. India is also one of the seventeen identified mega bio -diverse countries 
of the world . 
68.  India has been a major victim of bio -piracy. Pursuant to ratification of Convention on 
Biological Diversity (CBD), India de veloped a comprehensive legislation on biodiversity, including 
a Traditional Knowledge Digital Library (TKDL) database  to prevent misappropriation of traditional 
knowledge at international patent offices to tackle bio -piracy . India has signed TKDL Access 
Agreement with nine International Patent Offices.  
69.  While India has pioneered TKDL to overcome language and format barriers, the results could 
only be limited. Improving prior art searches through the TKDL was only one part of the solution. 
Further, TKDL repr esented only a subset of the universe of available traditional knowledge and 
the realm of traditional knowledge in areas other than herbal cures and genetic resources was not 
covered by it.  
70.  While India is undertaking a number of measures at the national le vel in order to prevent 
misappropriation of genetic resources and/or associated traditional knowledge, the problem has an 
obvious international dimension. You will agree that such a problem with international ramification 
requires an international solution , to be effective . The TRIPS Agreement continues to ignore 
numerous IPR -related obligations in the CBD which are of interest to the developing countries. The 
disclosure proposal (IP/C/W/474) which was submitted in 2006 was followed up by the submission 
TN/C/W/52 in June 2008 with the support of 109 members. The latest submission on this issue 
TN/C/W/59 in April 2011, which is a draft decision to enhance mutual supportiveness between 
TRIPS Agreement and CBD" has been proposed by a vast majority of WTO Member ship, including 
India.  This proposal seeks amendment of TRIPS Agreement by inclusion of a new Article  29bis for 
disclosure of origin of genetic resources and/or associated traditional knowledge. 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 inventivene ss criteria.  
71.  The Nagoya Protocol  of the Convention on Biodiversity (CBD) entered into force on 12 October 
2014 and 104 Countries, including India have ratified the Protocol, till now. According to the CBD 
website, the Access and Benefit -sharing Clearing -House (ABS -CH), which is a platform for 
exchanging information on access and benefit -sharing established by Article 14 of the Protocol, is 
now fully operational. The ABS Clearing -House is a key tool for facilitating the implementation of 
the Nagoya Protocol,  by enhancing legal certainty and transparency on procedures for access, and 
for monitoring the utilization of genetic resources along the value chain, including through 
the internationally recognized certificate of compliance. So far, nine countries ( Guatemala, India, 
Mexico, Bulgaria, Spain, Kenya, Malta, Dominican Republic and South Africa)  have published 101 
internationally recognized certificate s of compliance (IRCC) with details of prior informed consent 
for access to genetic resources and benefit sha ring on mutually agreed terms.  IP/C/M/87/Add.1  
 
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  72.  In the 2030 Agenda for Sustainable Development, two targets (SDG 2.5 and SDG 15.6) 
related to genetic diversity and the fair and equitable sharing of benefits have been included. 
This demonstrates that ABS and the Nagoya Prot ocol are making an important contribution to 
the conservation of biodiversity and sustainabl e economic development for all.  
73.  It would be quite useful to the delegates of the TRIPS Council, if the CBD Secretariat is 
requested to brief the TRIPS Council on th e latest developments in the implementation of 
the Nagoya Protocol, including the decisions that were taken at the December Meeting at Cancun 
in Mexico. The briefing by the CBD Secretariat would be very important to understand 
the implications of the entry into force of the Nagoya Protocol on the TRIPS Agreement. 
We reiterate our demand for a formal briefing by the CBD Secretariat in the interest of the large 
majority of developing countries. We join China, South Africa, Brazil,  and Bolivia in supporting 
Ecuador's proposal for updating the three factual briefs by the Secretariat.  
74.  I conclude by stating that the TRIPS -CBD issue is one of the outstanding implementation 
issues and positive outcomes on outstanding implementation issue s are one of the most important 
deliverables of the Doha Round for the developing countries.  
5.14 Korea,  Republic of   
75.  Korea would like to reiterate  the positions on these three agenda items it has expres sed in 
the previous Council meetings.  
AGENDA ITEM 6: ANNUA L REVIEW OF THE SPEC IAL COMPULSORY LICEN SING SYSTEM 
(PARAGRAPH  7 OF THE ANNEX TO TH E AMENDED TRIPS AGRE EMENT AND PARAGRAPH 
8 OF THE  DECISION ON THE IMPL EMENTATION OF PARAGR APH 6 OF THE DOHA 
DECLARAT ION ON THE TRIPS AGR EEMENT AND PUBLIC HE ALTH)  
6.1 India  
76.  India welcomes the entry into force of the Protocol Amending the TRIPS Agreement in January 
this year, which is the first amendment to a multilateral treaty  since the WTO Agreement came 
into force in 1995. India attaches high importance to the Doha Declaration on TRIPS and Public 
Health, the Paragraph 6 System as established under the 2003 Waiver Decision, and the Protocol 
Amending the TRIPS Agreement. India was one of the first countries that notified its acceptance of 
the Protocol in March 2007, and we would like to congratulate Members who have deposited their 
instrument of acceptance after the special meeting of the TRIPS Council in January. India has 
always been of the view that the Doha Declaration on TRIPS and Public Health constituted a major 
landmark in the history of the WTO because it recognized the primacy of public health needs and 
the preparedness of organizations to address the problem of access to medicines faced by the poor 
in developing countries. The 2003 Waiver Decision was expected to address public health problems 
faced by Members with insufficient or no manufacturing capacities in the pharmaceutical sector. 
It may have sounded prophetic at  that time, when India voiced certain apprehensions in 
the General Council meeting of August 2003, and I quote "the results accruing from this 
mechanism should not be negated by the creation of cumbersome systems that would lead to 
huge delays in getting m edicines across at reasonable cost to those that needed them or 
discourage Members from using the System for the benefit of the people. In order to make 
the System successful, a  sincere collective effort was required on the part of all Members and the 
entire pharmaceutical industry."  
77.  Regrettably, we have been proven right. The export of HIV/AIDS medicines by the Canadian 
pharmaceutical company Apotex to Rwanda in September 2008 has been the first and only use of 
the System so far. The Trilateral Study by WT O, WHO and WIPO on Promoting Access to Medicines 
and Medical Technologies and Innovation: Intersection between Public Health, Intellectual Property 
and Trade of 2013 highlights some of the issues that need to be addressed for any meaningful 
utilisation of the System. We need to consider those issues carefully so that this measure does not 
remain confined only to paper.  
78.  The UN Secretary -General High Level Panel on Access to Medicines, in its report released in 
September 2016, also recognised that the Paragra ph 6 System is complex and cumbersome. 
It recommended that WTO Members revise the System in order to find a solution that enables IP/C/M/87/Add.1  
 
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  a swift and expeditious export of pharmaceutical products produced under compulsory licence. 
WTO Members should, as necessary,  adopt a waiver and permanent revision of the TRIPS 
Agreement to enable this reform. During an event held on the side lines of the TRIPS Council 
meeting in November 2016, several participants also highlighted that the System was not 
workable in its current  form, and that it was too complex, cumbersome and administratively 
unwieldly for use, and that it was commercially non -viable for companies to supply medicines 
under it. We urge Members to constructively engage on the question of improving the Paragraph 6  
System for making it more workable and more effective so that it can benefit Members with 
insufficient or no manufacturing capacity in the pharmaceutical sector.  
79.  To come to a specific question, some Members who notify their acceptance have not 
incorporate d the System into national law. We encourage these Members to take the necessary 
steps to incorporate the System into their national laws. We also encourage Members who are yet 
to notify their acceptance of the 2005 Protocol to do so by the end of the year . However, I am 
informed that as many as 46 Members are yet to accept the Protocol, and it may not be possible 
for all of them to notify their acceptance in time. We therefore support the extension of 
the deadline for accepting the Protocol by a further pe riod of two years.  
6.2 United States  
80.  The United States welcomed the entry into force of the Protocol Amending 
the TRIPS  Agreement in January of this year. We also welcome the Secretariat's draft report, a nd 
its work throughout the year to encourage all remaining Members to notify their acceptance of 
the Protocol. We congratulate the Members that have accepted the Protocol since the entry into 
force of the amended TRIPS Agreement, namely Oman, Sierra Leone,  Fiji, Saint Vincent and 
the Grenadines and Malawi.  
81.  While the entry into force of the amended TRIPS Agreement represented an important step in 
promoting our shared goal of facilitating access to medicines, it is only one piece of the puzzle. 
We continue to  encourage Members to focus efforts to address other salient barriers to access 
while also recognizing the important roles that intellectual property and international trade 
liberalisation play in incentivising drug development and expanding access to medi cines around 
the world. For example, the WHO has identified numerous considerations including pricing and 
procurement policies, taxes, mark -ups and tariffs and other national policies that ultimately result 
in higher costs for consumers and for health syst ems. 
82.  While we remain disappointed that such a large number of Members have yet to notify their 
acceptance of the Protocol, and urge as many of the remaining to do so before the end of the year, 
we can support the proposal to extend the period of acceptance  for two years.  
6.3 Barbados  
83.  Barbados wishes to take the floor to support a further extension of two years for 
the acceptance of the Protocol Amending the TRIPS Agreement. Barbados is a small developing 
countr y, and as such, we face many challenges, including resource and technical limitations. 
An extension will allow Barbados to continue the necessary process on this important issue.  
6.4 European Union  
84.  The E uropean Union can support the first part of the Indian intervention, praising 
the amendment of the TRIPS Agreement, and we can also support the extension for two years.  
6.5 Haiti on behalf of the LDC Group  
85.  Access to medicines remains an important subject for the group of LDCs, and we attach 
a large amount of attention and importance to the facilitating of access to medicines for vulnerable 
countries. As you know, a number of Members of th e Group, for one reason or another, have not 
yet accepted the Protocol. Taking into account the approaching deadline, the LDC Group is not 
sure that all of its Members will have the time to accept the Protocol before 31 December of this 
year. The LDC Group  therefore seeks a four year extension to allow Members concerned sufficient IP/C/M/87/Add.1  
 
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  time to accept the Protocol. However, the LDC Group would be ready to show flexibility should 
there be a consensus around a two year extension.  
6.6 Brazil  
86.  The Protocol Amending the TRIPS Agreement entered into force last January. We see this as 
a landmark development for the multilateral trading system, showing that trade rules can and 
must contribute to addressing people's needs in poor er countries. It enhanced the legitimacy of 
the WTO and sent a strong message about the capacity of the international community to reach 
consensus decisions. We support that this Organization continues to work towards ensuring that 
the System becomes a pra ctical option for the procurement of medicines in countries without 
industrial capacity. This is provided in paragraph 16 of document JOB/IP/27. During the session of 
the TRIPS Council held last January, we suggested some potential actions that could be ta ken by 
the WTO to assist Members, namely (i) legislative assistance to enable the incorporation of 
the Protocol into Members' national legislation; (ii) awareness -raising activities; and (iii) capacity 
building activities.  
87.  We are very happy to note that th e WTO Secretariat has responded accordingly, and is taking 
concrete steps to assist Members in such an important issue. Brazil is very appreciative of this and 
will do its best to continue supporting those actions by the Organization.  
88.  The document prepared  by the Secretariat also lists 47 countries that are yet to accept 
the Amendment. In spite of active efforts by the WTO Secretariat and WTO Members, it is not 
expected that all those countries complete their domestic procedures before the end of this year.  
It is thus advisable to ensure that appropriate time be granted to enable those Members to finalise 
the necessary legal actions for accepting the Protocol. While, in our view, ideally there should be 
no fixed deadline for the acceptance of the Protocol, w e have heard some Members stating 
a preference for a two year extension. In order to advance the issue, Brazil is in the position of 
joining the consensus of two years for such an extension.  
6.7 Canada  
89.  Canada wo uld once again like to recognize the recent entry into force of the Protocol 
amending the TRIPS Agreement, and would like to acknowledge the leadership of Director -General 
Azevêdo as well as the dedication of the Secretariat in reaching this important mile stone. 
The entry into force of the Amendment is important, not only because this is the first time one of 
the original WTO Agreements has been amended, but, more importantly, because WTO Members 
now enjoy the certainty that the system of compulsory licensi ng envisaged in the Doha Declaration 
on the TRIPS Agreement and Public Health is a permanent and integral feature of the TRIPS 
Agreement. In our view the TRIPS Amendment facilitates meeting one of the key objectives of 
the Declaration, namely promoting acc ess to affordable medicines for developing and least -
developed countries. The Amendment provides countries with another important tool to improve 
access to affordable medicine. As the only country to have exported medicines under the System, 
pursuant to th e temporary waiver, Canada has always been a strong proponent of 
the Amendment.  
90.  In light of this, Canada would support an extension of the deadline for acceptance of 
the Agreement. We see value in a time -limited extension that will create a specific time p oint for 
countries to aim for as they complete their domestic procedures. Canada can support a further two 
year extension, but we are flexible with respect to the number of years that garners consensus in 
this body.  
6.8 South Africa  
91.  South Africa welcomes the entry into force of the Protocol Amending the TRIPS Agreement as 
an important milestone in achieving the flexibilities inherent to the interpretation of the TRIPS 
Agreement. We also note that various Members have still not notified their acceptance of 
the Protocol, and we encourage Members that have not done so, to do so as soon as possible. 
In respect of the time -period for the extension, this delegation is willing to support a fixed period 
of two yea rs. IP/C/M/87/Add.1  
 
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  6.9 Switzerland  
92.  Switzerland welcomed the entry into force of the revised TRIPS Agreement, incorporating 
the Paragraph 6 solution. While the Paragraph 6 mechanism could already be used since 2003 
through  the waiver decision, inserting the new Article 31 bis into the TRIPS Agreement clearly adds 
transparency, clarity and legal certainty. It is also a positive signal illustrating that the WTO and its 
Members are willing and able to recognise relevant public policy challenges and find appropriate 
solutions to them. Switzerland ratified the amendment back in 2006 as the second WTO Member. 
We implemented the special compulsory licensing system in our national legislation in 2008.  
93.  Article 31 bis of the TRIPS Agree ment addresses the particular situation of developing 
countries with insufficient or no manufacturing capacity in the pharmaceutical sector. It removes 
a potential legal barrier for countries without a relevant pharmaceutical manufacturing industry to 
use the instrument of a compulsory license that may have occurred otherwise under Article 31(f) 
of the TRIPS Agreement. The new System was used when Rwanda imported medicines under 
the Paragraph 6 mechanism from Apotex in Canada.  
94.  The Paragraph 6 solution has been criticised earlier by some delegations and certain civil 
society actors as being complex and burdensome. My delegation disagrees with this view. We have 
not heard in the Council's past Paragraph 6 reviews from potential beneficiary Members about 
hurdles that they would have faced when wishing to make use of the mechanism. The WTO 
Secretariat has provided on its website an illustrative guide on how to use the Paragraph  6 
mechanism efficiently, and we believe it demonstrates how straightforward this use can be.  
95.  Claims that the System is not working simply because it has been used only once so far are 
jumping to conclusions. A more likely explanation is that other modalities, instruments or 
mechanisms are just as, if not more relevant and efficient to faci litate access to pharmaceutical 
products, and are being made use of more regularly. In our view, it is wrong to consider 
the Paragraph 6 solution and the new Article 31 bis as a silver bullet  to the access to medicines 
issue. We should avoid raising oversta ted expectations of what the TRIPS Agreement can 
contribute.  
96.  Article 31 bis is a special compulsory license. Compulsory licenses are a flexibility foreseen in 
the TRIPS Agreement. They may be used, provided a number of circumstances are present and 
conditio ns are fulfilled. However, my delegation considers compulsory licences, whether under 
Article 31 or Article 31 bis of the TRIPS Agreement, neither an efficient nor a simple tool to use to 
gain quick access to essential medicines. Compulsory licensing may ov ercome a patent -related 
barrier. However, most of the time, other barriers are present, as well. Lack of infrastructure, of 
diagnostics and health care personnel, insufficient provider or patient knowledge may come into 
play and prevent access. Insufficien t or inexistent public health care, mark -ups by intermediaries 
or customs duties imposed by governments also impact on affordability.  
97.  Pharmaceutical companies, whether R&D originators or generic manufacturers, need financial 
incentives to invest in the man ufacturing of relevant medical products, i.e. a fair return on their 
investment. Even the production of medical products under a compulsory license costs money and 
so does getting the relevant marketing authorisation by regulatory agencies.  
98.  Many countries face challenges related to access to medical products. It is important to 
address these challenges in a holistic and sustainable manner. Switzerland has been a long -time 
supporter of strengthening health systems and sustainable financing, including through  domestic 
resources. Our Government sees this as one of the primary avenues to facilitate access to medical 
products.  
99.  Instead of advocating the use of compulsory licenses, which are by nature contentious in their 
approach, this delegation strongly believes  in the promotion of initiatives and approaches that 
incentivise research and development, add transparency, bring potential partners together to 
make use of synergies and, by the same token, improve access to affordable medical products for 
people in low - and middle -income countries.  
100.  We believe that building on voluntary and inclusive efforts, such as the Medicines Patent 
Pool, the Global Fund's e -procurement platform, WIPO Re:SEARCH, product development IP/C/M/87/Add.1  
 
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  partnerships, such as DNDi, or the recent patent inf ormation transparency partnership 
Pat-INFORMED launched by WIPO and the private sector, are the way forward and correspond to 
the collaborative spirit of the 2030 Agenda for Sustainable Development.  
101.  Switzerland has no comments on the draft report apart fro m expressing our gratitude to 
the Secretariat for preparing it.  
102.  As concerns the further extension of the period of acceptance, my delegation has, as others, 
a preference for a fixed deadline. This corresponds with the  WTO as a rules -based organisation  
guided by procedures and deadlines. However, Switzerland is flexible whether this extension shall 
be for another two or four years and will, in this regard, join Members' consensus.  
6.10 Japan   
103.  The delegation of Japan  welcomes the entry into force of the Protocol Amending the TRIPS 
Agreement and would like to express its sincere appreciation for the efforts by the Chair and 
the Secretariat.  
104.   Regarding to the options of extension of the period of acceptance of the Proto col, this 
delegation supports a two -year extension.  
105.  In addition, the Japanese Government believes that the issue of access to medicines would 
be more effectively dealt with through a more comprehensive approach, based on the accumulated 
understanding and r ecommendations of previous discussions and reports. Accordingly, Japan has 
concerns about making any decisions, reports or discussions on the issue of access to medicines 
based on the UN Secretary -General High Level Panel report.  
6.11 Thailand   
106.  The entry into force of the Protocol Amending the TRIPS Agreement in January reflects that 
the WTO not only contributes to trade liberalization, but also responds to essential needs of 
Members beyond trade policy, particu larly access to affordable medicines. We note that since 
the last Council for TRIPS in June, Malawi and the Russian Federation have accepted the Protocol. 
We would like to congratulate these Members and encourage others to do so.  
107.  Taking into account that t he Protocol is currently open for acceptance until 
31 December  2017, and some Members are currently taking domestic procedures to accept 
the Protocol, which may require time beyond the deadline, we therefore can go along with 
the timeframe that meets the e merging consensus to extend the period of acceptance of 
the Protocol. Thailand therefore supports a two -year extension.  
6.12 Korea, Republic of   
108.  Korea also would like to join in welcoming the entry in to force of the Protocol Amending 
the TRIPS Agreement, and at the same time encourages the 46 Members who have yet to 
conclude their domestic procedures to do so as soon as possible. Korea supports the extension of 
the deadline for two years, even though w e are flexible on the deadlines.  
6.13 Russian Federation  
109.  Thank you for the congratulations on acceptance of the Protocol. We welcome 
the Secretariat's willingness to reflect this fact in the draft rep ort. On the time period, we would 
definitely favour a two -year extension.  
6.14 Australia   
110.  Australia supports the TRIPS Protocol's entry into force earlier this year. It reinforces 
the WTO's ability to deliver  practical development -oriented outcomes. Australia commends 
Members from every region and at every stage of development that have accepted it. Australia 
supports an extension of the period for the acceptance by Members of the Protocol Amending IP/C/M/87/Add.1  
 
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  the TRIPS A greement. We support an extension of two years, but can be flexible on 
a longer  set period.  
6.15 China   
111.  China attaches  importance to TRIPS and public health issues and formally accepted 
the Protocol in 2007. China  supports the extension of the period for acceptance of the Protocol for 
two years, but is flexible and could also accept four years.  
6.16 Costa Rica   
112.  Thank you for organizing consultations around this subject which we found very useful to 
prepare for this meeting. As others, we support the extension of period for acceptance of 
the Protocol. We are flexible regarding the time period. As we seem to see an emerging consensus 
around  two years, we will support it.  
6.17 Nigeria on behalf of the African Group   
113.  The African Group welcomes the entry into force of the Protocol Amending the TRIPS 
Agreement to incorpo rate the waiver decision that was agreed by the General Council. We believe 
that it will provide a predictable flexibility that was enshrined in the Doha Ministerial Declaration on 
TRIPS and Public Health.  
114.  Regarding the extension of the period for the acce ptance of the Protocol for those Members 
who have not yet accepted, of course, as I stated during our last consultations, the African Group 
is in favour of two years. But listening to the LDC Group that has requested four years, 
the African  Group will want  to see a balanced solution in this issue and we are flexible.  
115.  After the extension of the period for acceptance, the Secretariat should continue to reach out 
to Members by informing them of the need for them to accept the Protocol. We also hope that 
the Secretariat will continue to provide technical assistance to those Members who are interested.  
AGENDA ITEM 7: NON -VIOLATION AND SITUAT ION COMPLAINTS  
7.1 Nigeria  on behalf of the African Group   
116.  The views have remained polarized and , to date, the chairs have not been able to bridge  the 
gap. For the  African Group , non-violation complaints are possible in respect of market opening 
commitments for goods and services . However, Members have not yet agreed on whether and how 
such complaints could be used in respect of the TRIPS Agreement. Since the conclusions of the 
Uruguay Round in 1995 to date, we have always de layed  the implementation of non -violation and 
situation complaint s until when  Members are able to agree on its  scope. Since we have not yet 
been able to agree on that, the African Group is of the view that we should extend the moratorium 
at least  until 12th Ministerial Conference.  
7.2 Thailand   
117.  I'd like to thank you for the draft recommendation  on non -violation and situation complaints. 
We believe that the examination of th e scope of modalities for complaints of the types  provided 
under subparagraphs 1(b) and 1(c)  of Article 23 of GATT 1994 should be continued. Th is is to 
strike a  balance between IP rights and public interest and avoid systemic concerns. We  therefore 
support the extension of moratorium on non -violation and situation complaints.  IP/C/M/87/Add.1  
 
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  7.3 China   
118.  In 2015, the Nairobi Ministerial  Conference decided to further extend the moratorium of 
the application of non -violation and situation complain ts under TRIPS Agreement . However, until 
now, the divergence between Members is still observed.  
119.  China appreciates the efforts made by the Chair and Secretariat, and hopes Members could 
constructively participate in the discussion.  
120.  The 11th Ministerial  Conference will be held soon . China reaffirms the position that 
non-violation and situation complain s are not applicable under the TRIPS Agreement, as 
elaborated in the document IP/C/W/385/R ev.1 proposed by 16 Members including China. China 
welcomes the discussion on this issue in accordance with the decision and mandate given by the 
Nairobi Ministerial Conference.  
7.4 United States   
121.  The United States ' position on this issue is well -known. We have had intensive discussions in 
the TRIPS Council this year on a number of topics raised by Members with viewpoints different 
from ours. We hope that our interventions have helped to dispel misperceptions and alleviate 
concerns.  
122.  We will not go into detail on the substance of the merits of allowing NVNI complaints today 
and instead will focus on the pressing issue of considering th e TRIPS Council's recommendation as 
we appr oach Ministerial Conference 11.  
123.  We took note of the informal room document shared by the Chair at the recent informal 
meeting as a suggested text for discussion among TRIPS Council delegates and the United States'  
position on this issue remains unchanged.  
124.  We continue to support allowing the current moratorium to expire so that NVNI Members 
may bring complaints in the future, as appropriate.  As we understand that the text shared by the 
Chair would have the effect of  extending the  moratorium, we are therefore not in a position to 
endorse this text as the basis for a  recommendation of the TRIPS Council.  
125.  Just to be clear, our recommendation is to allow the moratorium to expire.  
7.5 Bolivia , Plurinational State of   
126.  We welcome the availability of th e room  document and are grateful for the consultations that 
you have held on this issue. In Bolivia 's view , NVNI complaints do not apply under the TRIPS 
Agreement , as elaborated in document IP/C/W/ 385/Rev.1 , co-sponsored by  Bolivia. For example, 
NVNI complaints are  not necessary to maintain balance of obligations and responsibilities 
applica ble under the TRIPS Agreement, g iven that these are reflected in the main obliga tions and 
flexibilities of that Agreement. The Agreement explicitly establishes that Members of the WTO are 
not required to apply broader protection. The preamble  and objectives and principles of the 
Agreement consider the development dimension.  Private entities are protected in a sufficient way 
through good faith application of the rights and obligations under the Agreement . Ministers should 
decide  at the 11th Ministerial Conference is that NVNI complaints do not apply to the TRIPS 
Agreement as se t out in document I P/C/W/607 submitted by a group of Member s in 2015 . 
7.6 South Africa   
127.  I refer to our statement at the informal meeting which was held on 16 October 2017.  
128.  In May 2003, the TRIPS Council chairperson had li sted four possibilities for 
a recommendation on this issue: (1) banning non -violation complaints in TRIPS completely, 
(2) allowing the complaints to be handled under the WTO's dispute settlement rules as applies to 
goods and services cases, (3) allowing no n-violation complaints but subject to special "modalities" 
(i.e. ways of dealing with them), an d (4) extending the moratorium.  IP/C/M/87/Add.1  
 
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  129.  Most Members favour banning non -violation complaints completely (option 1) similar to 
the proposal by developing countries under IP/C/W/385, or extending the moratorium (option 4). 
At least one delegation has indicated its preference for o ption 3 – allowing non -violation 
complaints under the TRIPS Agreement . However as my delegation has stated in the past, this 
would be unacceptable for most developing countries and can impair the full use of the  TRIPS 
flexibilities by developing countries.  We reiterate our view that necessarily the proposal on scope 
and modali ties for the applicability of non -violation and situation complaints should cover a 
recommendation that these types of complaints should not be applicable to the TRIPS Agreement . 
In the absence of any consensus on this matter we could support the text to extend this 
prohibition for further two years.  
7.7 Brazil   
130.  Brazil reiterates its understanding that non-violation and situation complaints should not be 
applied to the TRIPS Agreement.  
131.  Article 64 of the TRIPS Agreement unambiguo usly establishes a dispute settlement 
mechanism which was invoked and duly used in cases before the dispute settlement body. Claims 
that the availability of NVSC would prevent Members from evading their TRIPS obligations  are not 
supported by evidence.  
132.  Furthermore, NVSC could threaten the use of flexibilities by Members, in violation of 
Articles  1, 7 and 8 of the TRIPS Agreement. It would jeopardize the use of exceptions and 
limitations for the development of laws and public policies focused on the protectio n of public 
health, among others. This affects the delicate balance of rights and obligations reached by the 
Agreement. It  would also be in violation of the Doha Declaration on TRIPS and Public Health, 
whose paragraph 4 reaffirmed that the TRIPS Agreement does not and should not prevent 
Members from taking measures to protect public health and, in particular, to promote access to 
medicines for all.  
133.  We note that the moratorium has already been extended six times, in addition to the initial 
five-year moratori um. This underlines that Members remain unconvinced by the necessity of such 
types of complaints. Additionally, since the inception of the TRIPS Agreement, no concrete case of 
difficulties faced by Members was presented, showing that the rights and obligat ions of Members 
provided under the TRIPS Agreement are adequately preserved by the current legal framework.  
134.  In short, the application of NVSC to IP disputes would generate systemic imbalances and 
reduce the legal certainty of multilateral IP law.  
135.  Consequently, we propose that the TRIPS Council recommend to the Ministerial Conference 
that NVSC shall not apply to the settlement of disputes under the TRIPS Agreement.  
136.  We welcome the informal room document circulated as a way of assisting Members in our  
discussions. We will carefully consider it in the run -up to the MC11.  
7.8 Costa Rica  
137.  Given the lack of consensus on this matter,  Costa Rica will support the extension of 
the moratorium based on the draft recommendation tha t you have circulated.  
7.9 Switzerland  
138.  At the outset, let me briefly react to a number of earlier interventions that expressed 
concern that non-violation complaints under the TRIPS Agreement could impinge negatively on 
the flexibili ties foreseen in the Agreement.  My delegation has made it repeatedly clear that 
flexibilities provided in the  TRIPS Agreement in fact are part of the rights and obligations in the 
TRIPS Agreement clearly spelled out and does not actually fall und er the scope of non-violation 
complaints.  
139.  NVCs protect the balance of rights and obligations under the WTO Agreements concluded in 
the Uruguay Round. Protecting this balance includes the flexibility provisions foreseen and IP/C/M/87/Add.1  
 
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  confirmed in the TRIPS Agreement.  Recourse to such flexibility is a foreseeable measure and is 
thus not a non -violation situation.  
140.  The position of my delegation is well known.  Article 64 establishes the principle of 
the applicability of NV and SC under the TRIPS Agreement. Para graphs  2 and 3, as an exception to 
the rule spelled out in para graph  1, fix a five-year moratorium during which such complaints shall 
not be applicable. This implies that once the  moratorium lapses, para graph  1 of Article 64 is 
operatio nal and applicable . We consider  this part of the Uruguay consensus and part of the balance 
of rights and obligations agreed at that time.  
141.  When extending the moratorium for another two years at their last Conference in Nairobi, 
Ministers mandated the TRIPS Council to continue its examina tion of the scope and modalities for 
NVC and situation complaints and make recommendations to Ministers at the upcom ing MC.  
142.  Adding to the original five year moratorium the eight extensions, Ministers have given 
the TRIPS Council additional 17 years to exam ine the scope and modalities for NVNI c omplaints in 
the TRIPS context.  
143.  No such modalities have been proposed by Members in all this time. We see thus no merit in 
making a recommendation to Ministers to extend the moratorium again  for a tenth time . 
144.  After the expiry of the moratorium , the DSU will apply  to any case that may arise in the 
future in relation to non -violation complaints under the three WTO Agreements.  
7.10 Australia  
145.  Australia supports the  TRIPS Council making a r ecommendation to extend the moratorium 
on non -violation and situation complaints for at least two years. Australia could support the text 
proposed in RD/IP/19.  
7.11 Chile  
146.  Our delegation would like to thank you for leading consul tations on this important issue. We 
believe that in the WTO context these complaints should not be applied to the TRIPS Agreement. 
We understand that we share this vision with many Members. However, there are some 
delegations that have another vision and h ave even put forward that the moratorium should come 
to an end, given that in their opinion, it would not be necessary to call on specific modalities and 
scope for the application of these complaints in the context of the TRIPS Agreement. We  believe 
that t his discrepancy should be resolved by Members in the context of this Council, as mandated 
according to the TRIPS Agreement, rather than leaving this fundamental decision to the dispute 
settlement system. For these reasons, our delegation calls on Members t o take up 
the responsibility involved in this issue, in order to discuss this matter put forward by you.  
7.12 Canada  
147.  Canada's position on this issue is well -known and remains unchanged. We continue to have 
concerns about the applicability of the NVNI remedy to the TRIPS Agreement and to support 
the draft recommendation.  
7.13 Ecuador   
148.  Thank you for the consultations you h ave held on this topic. As a co -sponsor of document 
IP/C/W/385/Rev.1, Ecuador believes that non -violation complaints are not applicable under 
the TRIPS Agreement. For this reason, we agree with the countries that consider that the scope 
and modalities for complaints of the types provided for under Article XXIII:1(b) and (c) of 
the GATT 1994 are not applicable to dispute settlement. This is the recommendation that must be 
made and adopted at the Buenos Aires Ministerial Conference. We welcome the room document 
tabled and would be able to support it on the understanding that the morato rium be extended in 
accordance with the text proposed by the Chair.  IP/C/M/87/Add.1  
 
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  7.14 Japan   
149.  The delegation of Japan would like to give full recognition to the continuous efforts made by 
the Chair and Members in adva ncing discussion on this issue.  
150.  Meanwhile, this delegation also recognizes that Members have not yet reached a consensus 
on the applicability or inapplicability of, or if applicable, the scope and modalit ies of non -violation 
and situation c omplaints in the area of TRIPS.  
151.  Japan's v iew on this issue has not changed. Both clarity and predictability should be ensured 
when applying non -violation and situation complaints to the TRIPS Agreement.  
7.15 Argentina   
152.  We wish to reiterate our posi tion that non -violation and situation complaints are not 
applicable to the TRIPS Agreement for the reasons set out in document IP/C/W/385/Rev.1, of 
which Argentina, together with a large n umber of other Members, is a co -sponsor.  
153.  In Argentina's view, this Council must re commend to the Ministerial Conference that such 
complaints should not apply to the settlement of disputes under the TRIPS Agreement. However, 
as there is no consensus for that, Argentina supports the moratorium extension included in 
the draft decision that  you have proposed.  
7.16 Korea , Republic of  
154.  Korea supports a Council draft recommendation to extend the moratorium . 
7.17 Russian Federation  
155.  We associate ourselves with the gr oup of Members favoring permanent moratorium on NVS 
complaints.  
7.18 European Union  
156.  The European Union supports extending the moratorium on not using TRIPS non -violation 
and situation complaints. We are currently still analyzing this issue in preparation of MC11.  
7.19 India  
157.  India's position on the issue of non -violation complaints under the TRIPS Agreement remains 
unchanged. In the run up to the Ministerial Conference in Nairobi, there was a g reat confluence of 
interest in making such complaints inapplicable to TRIPS. We do not stand convinc ed by the 
reasons provided by very few  Members its place in the  TRIPS  context.  
158.  While whether the TRIPS Agreement is a market access agreement may or may not  be 
relevant for its applicability, it is clear that the drafters did not unequivocally apply NVCs to TRIPS. 
Article 64.1 of the TRIPS Agreement establishes that GATT Article XXIII applies to the TRIPS 
Agreement except as otherwise provided in Articles 64. 2 and 64.3. Notwithstanding the expiry of 
the time -period under Article 64.2, non -violation and situation complaints only apply to the TRIPS 
Agreement in accordance with the procedure established under Article 64.3. Complying with this 
procedure, the impor tance of which Ministers reaffirmed through their adoption of the Decision on 
Implementation -Related Issues and Concerns, should be a matter of priority for the TRIPS Council. 
The Decision directed the TRIPS Council to "continue its examination of the scop e and modalities 
for complaints of the types provided for under subparagraphs 1(b) and 1(c) of Article XXIII of 
GATT 1994 and make recommendations to the Fifth Session of the Ministerial Conference." It also 
agreed that, in the meantime, Members will not i nitiate such complaints under the TRIPS 
Agreement. Thus, the assertion that the expiry of the time -period under Article 64.2 makes non -
violation and situation complaints automatically applicable to the TRIPS Agreem ent is, in our 
view,  incorrect.  IP/C/M/87/Add.1  
 
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  159.  It is impo rtant to recognize that th e TRIPS Agreement is a unique, sui generis  agreement 
and is distinct from the GATT and GATS, contrary to the assertion made in the US communication. 
In the GATT/WTO legal framework, the establishment of the non -violation procedure  aims 
primarily to prevent tariff concessions or specific commitments on trade in services from being 
adversely distorted by additional trade measures taken. With the gradual evolution of 
comprehensive trade agreements addressing a wide range of issues, it  does not make any logical 
sense to extend the same concern of circumvention/dilution of trade obligations in the context of 
agreements such as the TRIPS Agreement. When it comes to the GATT and the GATS as market 
access agreements, the non -violation compl aint is an additional tool with which to balance 
the rights and obligations concerning market access in the GATT and GATS respectively. 
Fundamentally differing from the GATT and the GATS, the TRIPS Agreement is not "about 
reciprocal market access rights of  governments". While IPRs might facilitate trade and investment, 
the obligations under the TRIPS Agreement cannot be characterized as market access concessions.  
160.  Serious concerns remain on the debilitating impact non -violation complaints in TRIPS can 
have o n the regulatory policy space of Members, on TRIPS flexibilities as well as increasing 
the complexity in interpreting the TRIPS provisions. It can not only have a chilling effect on 
Members ' exercise of their IP regimes but also severely restrain the ability of Members to achieve 
other public policy objectives.  
161.  The absence of non -violation complaints in the TRIPS context does not in any manner 
threaten or dilute the enforceability of TRIPS -related rights and obligations. On the contrary, 
the application of non-violation complaints in the TRIPS context could potentially present issues 
relating to rights of IP  right holders versus the legitimate exercise of regulatory policy choice by 
governments. Introducing non -violation and situation complaints into the  TRIPS Agreement is 
unnecessary and inconsistent with the interests of the WTO Members. Any  benefits arising from 
the Agreement can be adequately protected by applying the text of the  Agreement in accordance 
with accepted principles of international law, and w ithout introducing the  legally uncertain notion 
of non -violation and situation complaints.  
162.  We look forward to work with like -minded Members in making non -violation complaints 
inapplicable to TRIPS. We also wish to reiterate that , until there is a consensus  on the scope and 
modalities of the applicability of NVCs to TRIPS, NVC will no t apply to the TRIPS Agreement.  
163.  We welcome the unofficial room document shared by you. We will carefully consider it in  the 
run up to MC11.  
7.20 New Zealand  
164.  We would firstly like to thank you and the Secretariat for your efforts and the consultations 
that have taken place. New Zealand maintains its position that non -violation and situation 
complaints are not appropriate in the TRIPS context for reasons that we and other Members have 
elaborated on in past Council  meetings . In line with our long -held thinking on this issue , we can 
support the  continuance of the moratorium and the draft recommendation.  
7.21 Chinese Taipei   
165.  We recognize that most Members still have strong concerns over the applicability of 
non-violation and situation complaints to the TRIPS Agreement. My delegation would welcome 
more in -depth and substantive discussions among Members on the scope and modalities relating 
to the application of such complaints under the Agreement.  
166.  On the subject of the recommendation to the MC11, my delegation thanks you and 
the Secretariat for preparing the text proposal. My delegation could go along with the draft 
language on the table.  
7.22 Paraguay  
167.  I would like to record my delegation's support for your proposal and the room document. We 
think that this is a solution that is clear  and concise . Furthermore , my delegation would also lik e to 
work towards a permanent extension.  IP/C/M/87/Add.1  
 
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  AGENDA ITEM 8: REVIE W OF THE IMPLEMENTAT ION OF THE TRIPS AGR EEMENT UNDER 
ARTICLE 71.1  
168.  No statements were made under this agenda item. 
AGENDA ITEM 9: REVIE W OF THE APPLICATION  OF THE PROVISIONS OF  THE SECTION 
ON GEOGRAPHICAL INDICAT IONS UNDER ARTICLE 2 4.2 
9.1 Switzerland   
169.  As foreshadowed at the TRIPS Council meeting in March this year, Switzerland  has submitted 
an update of its responses to the checklist of questions on the protect ion of geographical 
indications. These responses have been available in French in document 
IP/C/W/117/Add.13/Rev.1. since 18  September, and were circulated yesterday in English 
translation.  
170.  Since our first responses were submitted in 1999, many changes have occurred in the Swiss 
legislation on geographical indication s, in order to progressively adapt our legal system to the 
tremendous developments that took place in relation to GIs in the meantime, both at the national 
and international levels. All these c hanges were driven by the intent to combine a flexible and 
simple system with the growing stake of granting an effective level of protection to GIs in the 
context of a  globalized trade.  
171.  Since 1999, the then newly established register for PAOs and PGIs for agricultural products 
and processed agricultural products became fully operational. Practical experience gained with 
the administration of the register over the first couple of years resulted in a number of 
amendments of the initial legal texts, including with regard to the examination of the applications 
as well as the enforcement of the protected GIs. Similarly, a number of case law addressed 
specific situations that were not precisely foreseen by the law. Case law confirmed that 
the opposition procedure in relation to a first decision of registration is effective and can cancel 
this first decision when it is demonstrated that this decision would be detrimental to the interests 
of legitimate users or that the denomination does not fulfil the definition of an appellation of origin 
or a GI.  
172.  On 1 January 2017, a set of changes entered into force regarding the Swiss Law on 
the protection of trademarks and indications of source. This revision is colloquially referred to as 
"Swissness legislation". As far as GIs are concerned, the new legislation has two components: first, 
provisions applying to indications of source in general, including GIs; second, provisions applying 
specifically to GIs.  
173.  The revised Law provides a detailed set of criteria for Swiss indications  of source, applying to 
different categories of goods and services. Unregistered GIs must at least comply with these 
minimal requirements as to the geographical source of raw materials and the place of processing, 
without prejudice to additional criteria t hat might be recognized and enforced by a court. For 
foreign indications of source, including unregistered GIs, the Swiss law refers to the requirements 
fixed in the legislation of the country of origin.  
174.  Regarding GIs, a national system for the registratio n of GIs was introduced also for 
non-agricultural products. Further, indications that are already protected as GIs may , in addition to 
and dependent on this original sui generis  protection, be registered as geographical trademarks.  
175.  This is only a brief summary of some of the main developments and changes in the Swiss 
legislation implementing the protection of GIs under Section 3 of the TRIPS Agreement. 
My delegation will be happy to provide further information on request or answer questions at 
the next C ouncil meeting.  
176.  With our submission, Switzerland responds to the call of the current and past Chairpersons 
to Members to update their relevant information, and my delegation joins you, Madame Chair, in 
requesting those Members which haven't yet submitted t heir responses to the Checklist of 
questions to do so  at their earliest convenience.  IP/C/M/87/Add.1  
 
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  177.  According to the provisions of Art icle 24.2 of the TRIPS Agreement, the TRIPS Council is 
mandated to review the implementation of the protection of GIs under Section 3 of the TRIPS 
Agreement, and this review requires up -to-date information from Members ' national implementing 
legislation . 
178.  Discussing and sharing information on our experiences and legal systems regarding 
the protection of GIs will prove useful for a better com mon understanding of the stakes, challenges 
and solutions in this area of IP. It will also help mutual understanding of each other's systemic 
approaches to protect GIs, will allow us to better understand what is working well in practice and 
help us identif y points of convergence. Switzerland is thus encouraging other Members to provide 
their respective information, so that on this basis, the  Council can lead a  substantive discussion  for 
the mutual benefit of all Members  under this agenda item . 
AGENDA ITEM 1 0: FIFTEENTH ANNUAL REVIEW UNDER PARAGRA PH 2 OF THE DECISION  
ON THE IMPLEMENTATIO N OF ARTICLE 66.2 OF  THE TRIPS AGREEMENT  
10.1 Norway  
179.  Norway would like to thank the Members and the Secretariat for a constructive workshop 
yesterday. We would also like thank the LDCs for their engagement and the questions that were 
posed. We look forward to receiving the  written questions in due time.  
180.  Our report this year focuses on various incentives provided by the Norwegian Agency for 
Development Co -operation – NORAD and the Norwegian Investment Fund for Developing 
Countries , NorFund. We would like to highlight an example of an incentive for technology transfer 
to LDCs, which has bee n particularly successful: the E AF Nansen Programme. T his is a long -
standing partnership between NORAD, the  Ministry of Foreign Affairs, the Norwegian Institute of 
Marine Research and the Food and Agricultural Organizat ion of the United Nations, FAO.  
181.  A central component of the programme is a  Norwegian researc h vessel D r Fridtjof Nansen, 
which has delivered independent data on fisheries resources since 19 75. The programme is part of 
Norway's Fish for Development initiative, and includes research vessel  cruises , scientific services 
and capacity building for rese arch institutions and staff , and scientific underpinning for fisheries' 
management. The goal of the programme is to reduce poverty and to improve food security, 
supporting the  sustainable development goals, the programme specifically supports fisheries' 
authorities in using the data they collect, including those from the Nansen Vessel. These data can 
be used to plan how much can be fished of different species. For instance, the Nansen Programme 
has assisted Myanmar, Tanzania and Mozambique in adopting resea rch-based plans for 
investments in the fisheries sector, and especially for industrial fishing. These countries were 
thereby able to create realistic plans for investments, avoidin g waste of financial resources.  
182.  From 2006 -2016, Norway contributed with abou t 520 million  Norwegian kroner ( crowns ) that 
is roughly €55,4 million to this programme. The next phase will be concluded in 2021 with 
an expected funding of 605 million Norwegian kroner ( crowns ), roughly €64.4 million. We  would 
invite interested Members t o consult the web pages of NORAD and FAO for more  information.  
10.2 European Union   
183.  First I would like to thank the organizers of the workshop yesterday for their engagement to 
this very important subject, and I would also like to thank the LDC members for their active 
participation and the questions they raised yesterday. And I would like to also apologize because 
my presentation will be very long, but this shows that EU's engagement for this subject and for 
the issue of Technology Transfer to LDC countries is very much present.  
184.  This year's report once more confirms that the EU and its Member States take their 
commitments and obligations under Article 66.2 seriously and fulfil them. Both the EU and its 
Member States did  promptly react to natural, social, health, climate and economic changes by 
putting in place projects specifically tailored to the current needs of Least Developed Countries 
(LDCs) and their regional organizations.  IP/C/M/87/Add.1  
 
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  185.  Technology transfer refers to the ways an d means through which companies, individuals and 
organizations acquire technology or know -how from third parties, whether such tech nology is IPR -
protected or not.  
186.  Technology transfer is often one component of a more complex relationship, rather than 
a stand-alone activity. The acquisition by LDCs of a sound and viable technological base does not 
depend solely on the provision of technology or equipment, but also on acquisition of know -how, 
management and production skills, improved access to knowledge sourc es as well as on 
adaptation to local economic conditions.  
187.  The mere transfer of technology without the training of local employees does not enable 
the recipients to achieve the internalization of the provided technology and to reduce 
the technology gap with  developed countries. Several projects put in place by the EU and its 
Member States are accordingly aimed also at providing such training and education.  
188.  One of the most important pre -conditions of technology transfer is the improvement of 
the absorption ca pacity of LDCs. Absorptive capacity can be defined as availability of human 
capital and presence of technological capability and other factors, such as access to finance and 
infrastructure, which helps assimilate and replicate knowledge gained from externa l sources. 
Absorptive capacity is important for diffusion of any knowledge, originating domestically or abroad, 
and thus for determining how technology can contribute to economic transformation and 
"catching -up" of a country. It can also influence technolo gy holders' incentives to promote transfer 
and diffusion of knowledge. Policies aimed at improving absorptive capacity can help technology 
transfer, particularly in least developed countries.  
189.  Aimed at increasing the ability to absorb, internalize  and utilize new knowledge, absorptive 
capacity policies encompass a wide range of measures addressing workforce, organizational  and 
adjustment deficiencies. Increasing the pool of trained workforce able to understand and 
assimilate technology, improving the quality  of higher educational institutions and scientific 
infrastructure as well as of networks between these educational and research institutions and 
enterprises, and better access to finance and efficient institutions, can all have significant impact 
on techno logy absorption and thus  stimulate technology transfer.  
190.  Most projects that deal with sectors such as energy, water, agriculture, governance and 
infrastructure result in transfer of know -how and technology. Moreover, their prolonged duration 
reflects the go al of helping local forces to develop independent systems in the concerned sectors.  
191.  Finally, it should be noted that EU actions usually target groups of countries or regions to 
help sustainable impleme ntation. That is why technology -transfer programmes of the EU and 
Member States target regions including both LDCs and al so other developing countries.  
192.  However, the EU's approach to the allocation of aid and incentives does pay particular 
attention to the situation of LDCs. LDCs have for example access at pref erential grounds to 
research programmes with full funding. In development funds there is a specific focus on LDCs and 
some Member States do also have such programmes specifically dedicated to LDCs.  
193.  Let me highlight a number of projects.  First in the area of Public Health.  
Health programmes  
194.  Among the technology transfer programmes related to health research and innovation over 
the last year, key projects have been those on Ebola and the EU plans to implement quality 
surgical systems for t he benefi t of rural populations in LDCs.  
195.  As for Ebola Virus, the PEVIA (Pan Ebola Vaccine Innovative Approach) Project needs to be 
singled out in the framework of the Innovative Medicines Initiative. Its objective is to develop 
a new second generation of v accines, comprising two complementary and synergistic approaches 
for the design of safe and effective preventive vaccines against multiple Ebola virus strains, ease 
to produce and to deploy in the endemic regions. The PEVIA consortium also aims to develop 
innovative functional analysis tools and in vitro methods to accelerate preclinical and clinical 
development of Ebola virus vaccine candidates and to determine correlates of immune protection IP/C/M/87/Add.1  
 
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  against Ebola virus disease in humans. The targeted LDC countrie s are Benin and Tanzania. 
The project started in June 2017 and will run until May 2023 with a total budget of €18 million.  
196.  Germany has also put in place the "Post -Ebola health system strengthening and epidemic 
prevention" project to increase the resilience  of the health system in Liberia. Germany's 
contribution to the project is worth €7 million . 
197.  To implement quality surgical systems for the benefit of rural populations in LDCs and Low 
and Middle Income Economies, the SURG -Africa project (Scaling up Safe Su rgery for District and 
Rural Populations in Africa) aims at delivering safe, affordable and sustainable essential surgical 
services to rural populations in LDCs and Low and Middle Income Economies. Beneficiary LDC 
countries are Malawi, Tanzania and Zambia.  In each country the total budget for these 4 years -
plans (which started in January 201 7) is around €1 million.  
198.  ZIKAlliance is a new EU initiative to control and prevent the Zika virus. The beneficiary of 
the programme is Cambodia. The purpose of ZIKAllian ce is to contribute to the establishment of 
a multi-centric network of clinical teams in the Caribbean, Central & South America, with research 
sites in countries where the virus has been or is currently circulating (like Africa, Asia, Polynesia). 
ZIKAllian ce is a multinational and multi -disciplinary consortium comprised of 53 partners 
worldwide and coordinated by the French National Institute of Health and Medical Research. 
ZIKAlliance is funded by the European Union's Horizon 2020 Research and Innovation P rogramme. 
The project investigates clinical, fundamental, environmental and social aspects of ZIKA infection. 
In particular, ZIKAlliance will focus on the impact of ZIKA infection during pregnancy and 
the natural history of ZIKA in humans and their environ ment.  
199.  Ireland funds the Royal College of Surgeons Ireland and College of Surgeons of East, Central 
and Southern Africa Collaboration Programme, which aims at improving surgical skills in East, 
Southern and Central Africa. Attention is particularly paid to the training in the following 
specialties : General Surgery;  Orthopaedics ; Paediatrics; Urology; Neurosurgery; Plastic Surgery. 
The program me, which was originally launched in 2013, has been extended until 2020, with 
a current annual contribution of €400.00 0. Burundi, Ethiopia, Malawi, Mozambique, Rwanda, 
Tanzania, Uganda, Zambia, Zimbabwe are the beneficiaries.  
200.  The successful EDCTP2 (Second European and Developing Countries Clinical Trials 
Partnership Programme) continued also this year and keeps contributi ng to the reduction of 
the social and economic burden of poverty -related diseases in developing countries, in particular in 
sub-Saharan Africa, by accelerating the clinical development of effective, safe, accessible, suitable 
and affordable medical interve ntions for poverty -related diseases (vaccines, drugs, microbicides, 
diagnostics), including neglected ones, in partnership with sub -Saharan Africa. This partnership 
targets 32 LDC members. The allocated budget is around €1.9 million . The goals are to maxim ize 
the public health impact of interventions to control malaria in pregnancy through the  translation of 
EDCTP -funded evidence -based global policies to country level policies, improving the impact of 
existing Malaria Products as well as improving HIV prevention and sexual and reproductive healt h 
care in high risk women, etc.  
Environment  
201.  Together with the projects presented in the last edition of this report, which are still ongoing, 
the EU also finances the AFRICAN BIOSERVICES Programme. This is an EU -funded project 
investigating Ecosystem Services in the Greater Serengeti -Mara Ecosystem in eastern Africa. 
The main aim of the project is to understand how the ongoing climate change, human population 
growth and land use change, affect biodiversity and hum an well -being, and use this information to 
derive novel solutions for a future sustainable development. The purpose of this project is to 
identify and develop innovative solutions that would help to mitigate the negative impact of human 
population growth i n Africa on the natural habitat, biodiversity, and ecosystems services. Tanzania 
is the main LDC beneficiary of this project  worth nearly €10 million.  
202.  SafeWaterAfrica Project already started in 2016 but continued also this year. The key 
objective of the pr oject is to improve access to clean water in Africa through research and 
development of an autonomous and decentralized water treatment system for rural and peri -urban 
areas. The project will develop new types of autonomous low -cost and solar powered water  
sanitation systems tailored for the specific needs in the rural areas of South Africa and IP/C/M/87/Add.1  
 
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  Mozambique and operated independently by local communities. Access to safe water through this 
project will reduce health risks. The total requested EC contribution i s slightly less than €3 million.  
203.  In the framework of the Horizon 2020 Programme the FLOWERED Project (de -fluoridation 
technologies for improving quality of water and agro -animal products along the East African Rift 
Valley in the context of adaptation to cl imate change), which has already started in 2016, 
continued in 2017 and keeps contributing to the development of a sustainable water management 
system in areas affected by fluoride contamination in water, soils and food in the African Rift 
Valley countries  (Ethiopia, Kenya, Tanzania), and thus to improve living standards (environmental, 
health and food security) of its population. The total  EC contribution is €3 million.  
204.  The AfriAlliance  project (Africa -EU Innovation Alliance for Water and Climate) continued also 
this year and aims to identify appropriate social innovation and technological solutions for key 
water and climate change challenges, leading to identification and boosting susta inable market and 
investment opportunities in Burkina Faso. The project supports effective means of knowledge 
sharing and technology transfer between Africa and the EU, all with the aim of increasing Africa's 
preparedness to address the vulnerability of wa ter and climate change -related challenges as well 
as to improving water and climate monitoring and forecasting processes and tools in Africa. 
The requested EC Contribution for LDC partner is more than €121.000.  
205.  Germany also funds Promoting Sustainable Aqua culture Development. The purpose of this 
project is to strengthen the sustainably managed aquaculture sector in Myanmar by providing 
alternative technologies that will help to increase catch and production especially of shrimps, which 
are fundamental to th e local livelihoods and nutrition. Germany deployed more than €22 million for 
this 5 years -long-project.  
206.  The United Kingdom funds Unlocking the Potential of Groundwater for the Poor (UPGro), 
a series of projects whose purpose is to improve the evidence bas e around groundwater 
availability and management in Sub -Saharan Africa (SSA). This will enable developing countries 
and partners in SSA to use groundwater in a sustainable way in order to benefit the poor. There is 
increasing evidence that substantial numb ers of rural water supplies in SSA based on boreholes 
with hand pumps are failing within a short time of their installation. The work in the project will 
develop a methodology for unravelling the complex and often interlinked technical, institutional 
and s ocial reasons for this high level of failure. The programme will develop new methodologies 
and technologies that will improve understanding of groundwater resources in SSA. These projects 
will run until 2019 with a total contribution of £12 million.  
207.  As for  climate change initiatives, Germany has launched the Programme for the Support of 
the National Strategy for Adaptation to Climate Change in Mali. The aim of the programme  is to 
increase the resilience of ecological production and social systems in vulnera ble areas of Mali to 
the impact of climate change through reinforced adaptive capacities and innovative, integrated 
adaption approaches. The program me is expected to support the establishment of conditions 
favourable to the emergence of a private sector us ing low -carbon technologies. The program me 
started already in 2014 and will run until December 2019 with a budget of €4.9 million.  
Conclusion  
208.  This overview could only give a couple of hi ghlights of the many technology -transfer projects 
and incentives that the EU and its m ember States have put into place. It makes clear that there is 
a coher ent approach where both EU and m ember States programmes focus on thematic areas to 
tackle LDC specific problems.  
10.3 Australia  
209.  Australia is committed to assisting least  developed countries in the area of technology  
transfers  pursuant  to the Council's decision on the implementation of Article 66.2. We were 
pleased to present Australia's report yesterday at the workshop. It was another import ant 
opportunity to foster continuing dialogue with Members regarding technolog y transfer initiatives 
that benefit LDCs. Australia has attended these workshops since their inception in 2008. They are 
a useful forum for exchanging views and have positively i nfluenced how Australia prepares our 
reports and shares information and we are also looking forward to further work on the e TRIPS 
portal for next year.  IP/C/M/87/Add.1  
 
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  210.  In this year's report IP/C/W/631/Add.1/Rev.1  we outline initiative s to promote and 
encourage technology transfer in a wide variety of fields. Australia recognizes that encouraging 
increased inno vation and technology transfer to high -productivity sectors is a means of helping 
LDC partners create a sound  and viable technolog ical base.  
10.4 United States  
211.  The United States attaches great importance to this review with respect to the obligations 
under Article 66.2.  
212.  Our subm ission this year, IP/C/W/631/Add. 2, details the IP, trade capacity building, training, 
development assistance, educational, financing, entrepreneurship, and infrastructure -related 
programme s, aimed to support LDCs in fostering the necessary environment to encourage 
the effective, voluntar y transfer of technology to LDC Members.  
213.  We will keep our intervention today brief, but encourage interested Members, especially 
LDCs, to review the submission. We enthusiastically support further dialogue in and around 
the TRIPS Council to discuss the sub mission.  
214.  The United States continues to believe that the effective functioning of Article 66.2 of 
the TRIPS Agreement requires a robust dialogue between developed country and LDC Members in 
order to target incentives in a way that is most responsive to the  self-identified technology transfer 
interests and needs of LDC Members.  
215.  We welcomed yesterday's discussion with LDC Members and the Secretariat at the workshop 
which provided a good opportunity to exchange views and we look forward to future opportunities  
to continue this important conversation.  
216.  We welcomed the questions directed towards us in the workshop and look forward to 
responding in writing.  
10.5 Japan  
217.  This delegation would like to thank the Secretariat for organizing yest erday's workshop on 
the implementation of Article 66.2 of the TRIPS Agreement. The workshop helped to advance 
cooperation and enhance mutual understanding between developed country and LDC  Members.  
218.  Japan will continue to make its utmost efforts to improve the business landscape and make it 
even more conducive to transferring technology. This delegation looks forward to working further 
with LDC Members in this context.  
10.6 New Zealand  
219.  New Zealand would like thank the Secretariat for organizing yesterday's Workshop on 
the implementation of Article 66.2 of the TRIPS Agreement. We believe that the Workshop 
continues to enhance mutual understanding between developed country members and 
LDC members. We  think that the Worksh op again allowed for robust and useful discussions and we 
look forward to the next iteration. We would like to thank Bangladesh and Haiti for their questions 
yesterday, we look forward to receiving any written  questions on our Report from LDCs members 
and we will endeavor to respond as soon as possible.  
10.7 Canada  
220.  Canada is committed to providing incentives for the purpose of promoting and encouraging 
technology transfer to least  developed countries. As such, Canada's technology  transfer activities 
were communicated under our annual report pursuing to Article 66.2 of the TRIPS Agreement in 
document IP/C/W/631/Add.3. Canada has engaged in a broad range of institutional and private 
sector actors in pursuing technology transfer acti vities at the multilateral and regional levels, as 
well as through bilateral projects with LDCs. These include bilateral projects in areas such as 
agriculture and food security, vaccine delivery, clean energy and sustainable development, as well 
as support  for entrepreneurs and small and medium sized enterprises working in the digital IP/C/M/87/Add.1  
 
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  environment. We know that the fruitful discussions that took place in the context of the Workshop 
yesterday, and believe that this Workshop continues to provide a good forum f or further 
discussions. We look forward to continuing our dialogue with LDC members, including by replying 
to the questions that were posed yesterday.  
221.  Canada is happy to follow up with any delegation that has an interest in further information 
after this T RIPS Council meeting.  
10.8 Brazil   
222.  We thank the Secretariat for preparing the documents as well as those Member States who 
have submitted their reports regarding the implementation of Article 66.2.  This Article is part of 
the delicate balance that was reached during the Uruguay Round negotiations and has the goal of 
ensuring that all Members benefit from the provisions of the  TRIPS Agreement.  
223.  Regarding the documents themselves, we have an observation concerning  document 
IP/C/W/ 631, whose Section 3 refers to the activities by Japan in the pharmaceutical sector. In 
paragraph 18, the document mentions "substandard/spurious/falsely labelled/falsified/counterfeit", 
also known as SSFFC, as one of the areas of activities. This definiti on of SSFFC, however, is 
outdated. WHO's Seventieth World Health Assembly, held in May of this year, agreed that the term 
to be used from now on is "substandard and falsified medical products". The WHO decision states 
that, in the  context of medical produc ts, the term falsified "adequately includes all the various 
types of deliberate misrepresentation of a medical product in such a way which enables the 
specific exclusion of intellectual property rights".  
224.  Brazil recognizes the dangers posed by such products  and we are committed to the fight 
against their circulation. Nevertheless, we urge delegations to follow the definition reached by the 
WHO, since the use of a standard name will allow for a more thorough and accurate comp arison 
and analysis of reports.  
225.  For further details, I would refer to the WHO document A70/23, Appendix 3, which contains 
the decision regarding substandard and falsified medical products.  
10.9 European Union  
226.  Sometimes issues of transit are raised and I would therefore like to draw Members' attention 
to a recent study by the OECD and the EUIPO  see TRIPS Council document IP/C /W/633/Add.5  that 
sheds light on the origin and trade roots and their transiting related to counterfeits and fake 
products. It also shows that each year counterfeit and fake pharmaceutical products worth alone 
around €16 billion , that is roughly $19 billion, are traded globally. Main destinations of these 
counterfeit and fake pharmaceutical products are Africa, the EU and the US. Unfor tunately, one 
single large South -Asian country's  report is accounting more than 50% of counterfeit and fake 
pharmaceutical products seized by customs worldwide. This study clearly shows that a broader 
debate about actual concrete and evidence -based problem s relating to trade and counterfeit in 
fake medicines , including transit, would be topical.  
10.10 Cambodia  on behalf of the LDC Group  
227.  I would like to thank the WTO Secretariat for organizing yesterday the annual workshop as a 
follow -up activity on the implementation of TRIPS . I take this opportunity to thank developed 
country partners for the ir wide incentive s to promote technology transfer to LDC Members and 
who have answered the LDC Group's questions relating to Artic le 66.2.  
228.  The TRIPS Agreement is a very important trade agreement and its provision ha ve far-
reaching implications as they cover a wide range of areas such as agriculture,  health investment 
and tech nology. The LDCs are still trailing behind  developed and developing countries in terms of 
technology advancements and with limit ed prospects in bridging the gap. To bridge this 
technological gap, it is therefore essential that transfer of technology is facilitated  between 
developed and developing Members and LDCs. In addition to technology transfer , it is also 
essential to transfer knowledge and skills so that it increases the prospect s of LDCs to develop 
local research, instituti ons and appropriate technology.  IP/C/M/87/Add.1  
 
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  229.  Article 66, in particular its paragra ph 2, sets out to provide LDCs with an opportunity to 
develop their own, strong and viable technological base through the  transfer of technology from 
developed Members through the provision of incentives to their enterprises and institutions. LDCs 
have had  the opportunity in previous TRIPS Council meeting s to assess the implementation and 
status of activities undertaken by  developed and developing Members in the context of the 
implement ation of Article 66.2. The LDC Group takes this opportunity to thank Mem bers for 
update d notifications , includ ing from  Australia, Canada, US, Japan, New Zealand, Norway, 
Switzerland and EU. We would like to take this opportunity to urge more developed Members to 
contribute to this on -going effort. It is needless to say that tr ansfer of technology will gradually 
assist LDCs in achieving the UN  SDGs, in particular goals 9 and  17. 
230.  However, we can all agree that more effort is needed to create favourable conditions to 
enable technology transfer to LDCs. In addition, there is a need  for LDC governments  to improve 
policy  coherence between science,  technology and innovation policy and industrial development to 
facilitate transfer. Transfer of technology to LDCs is a key co mponent to our econom ic growth . 
Independent research has proven this time and time again. C rucially, it is also linked to foreign 
direct investment and data, so that LDCs have not been able to attend  the assembly of the  FDI, as 
both developed and developing Members. Finally, Members and all stakeholders who continue to  
pursue effort s are assisting LDCs to be able to build capacity  so that they are able to absorb and 
develop technology that is appropriate for their economy.  
10.11 Haiti  
231.  Haiti thanks the Members who have submitted reports as part  of the review of the 
implementation of Article 66.2 . Haiti also thanks the WTO Secretariat for the workshop held on 18 
October 2017 on the  implementation of Article 66.2 of the TRIPS Agreement. This event was an 
opportunity for the  LDC Group to discuss, w ith the relevant Members, certain points and/or 
omissions made in the  reports presented on the implementation of Article 66.2.  
232.  Haiti does not wish to go over in detail the points discussed during the workshop. 
Nevertheless, it would like to make the following observations:  
 As was the case last year, only eight Members have submitted reports on 
the implementation of Article 66.2 of the TRIPS Agreement;  
 Haiti notes that certain reports or activities mentioned do not reflect the spirit and letter 
of Arti cle 66.2, which establishes that: "Developed country Members shall provide 
incentives to enterprises and institutions in their territories for the purpose of promoting 
and encouraging technology transfer to least -developed country Members in order to 
enabl e them to create a sound and viable technological base".  
 On the basis of the notifications circulated, Haiti observes that certain Members confuse 
the reports on the implementation of Article 66.2 with those on technical assistance 
activities, which are co vered by Article 67 of the TRIPS Agreement. It was also noted 
that a significant number of activities we re carried out in favour of non -LDCs, which has 
nothing to do with the implementation of Article 66.2. Furthermore, it is difficult to 
identify the real  "incentives" granted by certain Members to their enterprises and 
institutions for the transfer of technology to LDCs.  
233.  In conclusion, Haiti would like to ask the following questions:  
 Is there a difference in interpretation, for developed countries and LDCs , regarding 
the concepts of "technology transfer", "incentives" and "sound and viable technological 
base"?  
 Should we therefore ask the TRIPS Council or another competent WTO body to provide 
us with an interpretation of the scope of Article 66.2?  IP/C/M/87/Add.1  
 
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  10.12 Euro pean Union  
234.  Since we have been approached by several delegations concerning  our last intervention, I 
would like to repeat the reference of the document we quoted , namely  IP/C/W/633/Add.5 . It has 
been submitted by the OECD  under agenda item 11 but , given the intervention of Brazil, we also 
found it relevant under the agenda item 10.  
AGENDA ITEM 11: TECH NICAL COOPERATION AN D CAPACITY BUILDING  
11.1 Australia  
235.  Australia takes an active role in promoting technical co -operation and capacity building in IP, 
as we have highlighted in our 2017 Article 67 report IP/C/ W/632/Add.1. Since our last meeting, 
the on -going work of the WIPO -Australia funds and trust programme  has continued to support 
least-developed and developing countries to assess development and implementation of IP 
systems and enhance IP capabilities. We are pleased to reiterate our commitment to technical co -
operation and IP capacity building activities.  
11.2 United States  
236.  The United States is pleased to highlight its report under Article 67 in IP/C/W/6 32/Add. 2 on 
the technical assistance programme s provided by the US Government concerning the protection, 
utilization and enforcement of intellectual property rights, including patents, trademarks and 
enforcement for developing and least developed countries.  
237.  In the past year, our report accounts for more than  145 training, technical assistance, and 
capacity building  programme s for 133 different countries, including developing countries and LDCs.  
238.  Of these 133 countries, 28 programme s were provided for 24 least developed countries, 
including Angola, Bangladesh, Benin, Bhutan, Burundi, Cambodia, Ethiopia, The Gambia, Guinea, 
Lao PDR, Lesotho, Liberia, Malawi, Mali, Mauritania, Myanmar, Nepal, Senegal, Sierra Leone, 
Timor -Leste, Togo, Uganda, Tanzania, and Zambia.  
239.  Technical cooperation to improve IP legal, administrative and enforcement infrastructure is 
crucial to coun tries' economic development that is directly linked to contributing to foreign 
investment and voluntary, private sector -led technology transfer in developing countries and for 
developing country innovators to capitalize on their creativity.  
240.  US Government t echnical assistance is driven by demand and individual priority needs of 
beneficiary countries. The diversity of needs and interests identified by beneficiary countries 
results in tailored technical assistance activities on specific areas of interest.  
241.  We look forward to continued discussions on reports in the Council concerning technical 
cooperation of governments and IGOs for the strengthening of IP systems.  
242.  We appreciate the EU's drawing our attention to the recent OECD report and the information 
it share d on enforcement in response to another Member's inquiry . Customs and transit authority 
provides an important tool to help prevent the proliferation of counterfeit and pirated goods into 
the international market place , given the global scale of trading cou nterfeit and pirated goods, and 
the health and safety risks many of these products propose to consumers . We welcome learning 
about positive steps that Members may be  taking to address this issue at all points in the supply 
chain.  
11.3 Norway  
243.  I would like to give a brief introduction to our report, which is relatively short this year, 
focusing only in one entity – NORCODE, the Norwegian Copyright Development Association, which 
was established in 2007. The association's ob jective is to carry out international development work 
in the copyright field, in order to support the cultural sector in developing countries. In 
collaboration with WIPO , NORCODE has since 2009 every other year organized two -week training 
courses on copyr ight and related rights in Oslo, for 20 participants from developing countries. A IP/C/M/87/Add.1  
 
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  follow -up week is organized approximately half a year later in one of the participating countries. 
The training sessions in Oslo are given by international and Norwegian expe rts on all aspects of a 
well-functioning copyright system. These sessions also include study visits to Norwegian collective 
management organizations and other relevant institutions. The training programme includes inter -
active sessions with group discussio ns, case studies and development of negotiation and 
communication skills. The  programme is conducted in English. More details can be found in our 
report.  
11.4 European Union  
244.  The details of the EU , its member States and the EU Plant Variety Office technical assistance 
activities in LDCs and in developing countries can be found  in the la test submission made under 
TRIPS Article 67 on 15 October 2017. We apologize  for the late delivery  of the reports.  This report 
confirms the commitment of the EU, its member States and the Plant Variety Office to technical 
co-operation and capacity building and shows that the EU has fulfilled its TRIPS obligations. The EU 
remains committed to technology, technical co -operat ion and capacity building projects, and we 
look forward to further engagement with LDCs and the developing countries on that  matter.  
11.5 Canada  
245.  Canada was pleased to submit its annual report on the implementation of Ar ticle 67, which 
provides an update on Canada's activities, concerning IP- related technical and financial co -
operation for developing and LDC members, covering the 2016 -2017 period  (document 
IP/C/W/632/Add.3 ). Canada has undertaken a number of technical co-operation activities at the 
multilateral , plurilateral and bilateral levels. At the multilateral level, Canada works in close 
collaboration with WIPO , as well as the Asia Pacific Economic Co -operation or A PEC, Intellectual 
Property Rights Expert Group (IPEG) , where Canada participates in APAC 's biannual deliberations 
aimed at sharing inform ation and best practices on IP.  
246.  Canada also provides a number of technical co -operation activities, which are mainly 
administered by the Canadian Intellectual Property  Office, Global Affairs Canada, the International 
Development Research Center and the Royal Canadian Mounted Police. Other Canadian institutions 
that receive funding from the Governme nt of Canada, such as the Centre  for Trade Policy and Law 
and the Univers ity of Ottawa are also involved in international technical co -operation efforts. 
We invite the Members to consult the document for further details.  
247.  With respect to discussions on technical co -operation among TRIPS Council Members, 
Canada would once again l ike to thank the Secretariat for convening the WTO Workshop on 
supporting LDCs in making effective use of IPRs, held 10 -11 November 2016. Canada was pleased 
to participate in this discussion and would also like to thank the workshop participants for 
the constructive dialogue during the two -day session. Canada took note of the national 
experiences and sharing of priority needs by developing country and LDC Members at 
the Workshop and remains interested in hearing Member s' views on some of the successes and 
challenges in seeking technical assistance and co -operation t o address their priority needs.  
248.  Canada would also be interested in hearing how priority needs have changed in LDCs initial 
work on TRIPS implementation and whe re gaps and technical assistance might remain. We would 
also be interested in Members ' experiences on the types of technical assistance that has proven 
most effective in supporting the implementation of TRIPS obligations and in using IP to support 
economic  and social development. Canada looks forward to discussing these issues further with 
the view to ensuring that technical assistance continues to meet the priority needs and 
development objectives of its recipients . 
11.6 Japan  
249.  This delegation would like to briefly describe this year's report on Japan's technical 
cooperation. The report consists of the main body and its annex. The main body highlights recent 
cooperation involving technical activities, while the annex lists details of each activity.  
250.  This report categorizes cooperative activities into four areas of IP, namely, industrial 
property, copyrights, plant varieties, and border measures. When it comes to industrial property, IP/C/M/87/Add.1  
 
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  the Japan Patent Office organized 22 train ing courses, designed for both government officials and 
the private sector, in FY2016 and around 300 persons attended in total. Turning now to 
copyrights, in FY2016, the Japan Copyright Office, with the support of the WIPO, held seminars at 
which around 15 0 people attended. Moreover, Japan provided technical cooperation to developing 
and least -developed country Members also for the protection of plant varieties and 
border  measures.  
251.  Japan will continue to make its utmost efforts to fulfill its obligation und er Article 67.  
11.7 New Zealand  
252.  New Zealand was pleased to submit its technical co -operation report for the year 2017 
pursuing to its Article 67 obligations. In this year's report , we highlighted New Zealand's 
engagement with technical co -operation and the bilateral, regional and multilateral realm.  These 
activities were primarily taken up by the Intellectual Property Office of New Zealand, IPONZ, 
the Plant Variety Rights Office and the New Zealand Ministry of Foreign Affairs and Trades 
International Development Group. We welcome any questions and feedback that Members may 
have on our report. New Zealand is pleased to reiterate our commitment to technic al and financial 
co-operation in favour of the developing and LDC Members.  
11.8 WTO Secretariat  
253.  The WTO Secretariat's  annual report (document IP/C/W/634 ) follows the format that we 
recommend for reporting under this item, as it has proved to be most useful in working with what 
is a large amount of detailed information. It consists of an explanatory cover note highlighting the 
key trends in our technical as sistance , and then a table which is easily translated into a database 
giving details of these specific programmes.  
254.  To briefly outline the main trends we have observed, I would first like to mention the entry 
into force of the amend ment to  the TRIPS Agreeme nt in January 2017. This has meant that , while 
our technical assistance in this area will continue to focus on assisting Members and observers to 
understand their rights and obligations under the Agreement, there has been an increasing focus 
on the  impleme ntation of the TRIPS amend ment at the domestic level and fostering the utilization 
of the system as an effective  procurement tool to ensure access to affordable medicines. We are 
looking forward to a regional workshop later this year that will focus exactl y on that practical 
aspect of the amended TRIPS Agree ment.  
255.  Our technical assistance programme is driven by the demand experienced from developing 
country and LDC Members . We would remind delegates to get in touch with us concerning any 
general or specific areas of technical assistance that they might  require so that we can respond 
appropriately within available resources. In view of the  evolving demand, our approach is 
increasingly holistic in charact er, recognizing the interplay between the TRIPS Agreement and 
other elements of the WTO System, including agreements on agriculture, T BT and S PS. Therefore , 
our technical assistance entails ever closer collaboration between vario us divisions within the 
Secretariat . It also involves a close collaboration in planning and programme delivery with our 
collaborating agencies in the multilateral system. Obviously , WIPO is a regular partner and the 
WHO in the area of public health . Partne rs also include a wide range of other organizations in the 
public health area, such as  UNCTAD, UNDP, UNAIDS and the Office of the High  Commissioner for 
Human Rights , as well as a  wide range of civil society and industry organizations to ensure that 
there i s a holistic and coherent view of the interplay between the TRI PS Agreement and public 
health.  A similar approach is taken in other areas of public policy in line with the demand we have  
experienc ed.  
256.  Responding to a consistent demand and feedback from our  colloquium s and advanced 
course s, we are organizing in December a specialized programme on the TRIPS Agreement and the 
national judiciary. This will aim to enhance the capacity of the judiciary on the  policy  and practice 
of disputes and other litigation o n IP matters, particularly those elements distinct to the TRIPS 
Agreement. Nominations for this activity close on 30 October, and we have space for 30 nominees 
from developing and LDC  countries . We would encourage delegates to coordinate as appropriate to 
identify suitable candidates for that programme. I would say that we are very encouraged by the 
response of senior and very authoritative members of judiciary who have agreed to act as IP/C/M/87/Add.1  
 
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  speakers and resource persons for that activity, so it will be well wor thwhile for those participants 
involved.  
257.   In addition, I would like to draw your attention to the forthcoming trilateral symposium, a 
series which has been a mainstay of our technical assistance in the area of the TRIPS Agreement 
and public health . This is the seventh such event convened by the WHO, WIPO and WTO. Typically 
undertaken initially at the level of Director s-General, this is planned to be held on 26 February 
2018 back-to-back with the tentative dates for the first meeting of the Counci l next year. The 
three Director s-General are to attend , and the symposium will look into access to  affordable 
quality medicines and vaccines for all to ensure progress towards universal health coverage and 
the achievement of the SDGs . This activity is very much i n line with the broad trends and 
developments in our technical assistance activities that I have just outlined.  
258.  As ever, we are on hand to respond to specific o r general requests from Members so that we 
can continue to adapt and deliver technical assistanc e in a way that meets their priorities and 
needs.  
11.9 ARIPO   
259.  It is a pleasure and honour for me, on behalf of the African Regional Intellectual Property 
Organization (ARIPO) to address the WTO Council for TRIPS, specifi cally on the technical 
cooperation programmes relating to the implementation of the TRIPS Agreement.  
260.  As you may know, ARIPO is an Intergovernmental Organization that was created with a view 
to pool together resources of its Member States for the promotion,  development and 
harmonization of Intellectual Property laws and policies and to ensure that it contributes to 
the social, economic and technological development of its Member States. To date ARIPO is 
composed by 19 Member States from East, West and Southe rn Africa.  
261.  Pursuant to its mandate, ARIPO organizes activities and programmes either solely or in 
conjunction with its partners. These programmes and activities are mainly aimed at assisting 
ARIPO's Member States in IP matters in order to capacitate Member  States to better use the IP 
system for th e benefit of their populations.  
262.  ARIPO circulated earlier a detai led report as per your request that is found in document 
IP/C/W/633/ Add.4. I will hence not take much time, but I wish to highlight a few achievements  
that we re registered during this year.  
263.  In the course of 2017, the initiatives that were undertaken focused on awareness raising, 
training, improvement of the legal and institutional framework, enforcement and dissemination of 
information on IP.  For the awareness component on IP matters, ARIP O continued roving seminars 
in member States, but this year's flagship was the engagement of the main generators of IP 
rights, i.e. the Universities and Research Institutions. A number of seminars were conducted in 
some Universities (in Sierra Leone, Zambia, Swaziland and another one planned in Rwanda in 
early November) with the objective of raising IP awareness in the universities, colleges and 
research institutions so that they can utilize the system nationally and r egionally for accruing 
economic benefit to the institutions   
264.  In the same vein, ARIPO has conducted a number of seminars on IP in a number of 
universities in the host country.  
265.  ARIPO and the International Confederation of Societies of Authors and Composers ( CISAC) 
jointly organized a Regional Workshop on Strategic Plan for Collective Management Organizations 
(CMOs) with the aim of equipping CEOs of CMOs on how to prepare strategic plan for a better 
management of the their offices.  
266.  In collaboration with WIPO, ARIPO also organized  a symposium on Copyright and Related 
Rights on the theme: Shaping the Copyright and Related Rights System in Africa. The symposium 
brought together copyright offices, collective man agement organizations  in ARIPO m ember States 
and entre preneurs. The finalization of the Copyright Agenda for Africa is among  the outcomes of 
the Symposium.  IP/C/M/87/Add.1  
 
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  267.  ARIPO has also launched a number of publications related to copyright in order to boost 
the knowled ge on this IP component in the m ember States.  
268.  Finally, a comparative study of industrial property laws of m ember States was also 
commissio ned by ARIPO in a view to help m ember States harmonize  their laws.  
269.  ARIPO has limited resources. The above achievements and others that are detailed in 
the report were possible thanks to the cooperation with our strategic partners, specifically WIPO, 
Japan Patent Office, the State Intellectual Property Office (SIPO) of the People's Republic of China, 
USPTO, IP Australia, the Government of the Republic of Kore a, the International Federation of 
Reproduction Rights Organisations (IFRRO), the International Confederation of Societies of Authors 
and Composers (CISAC), the International Federation of the Phonographic Industry (IFPI) , 
NORCODE  and of course the national IP Offices of the ARIPO m ember States . 
11.10  Gulf Cooperation Council   
270.  Let me first thank you for giving me the floor to present GCC Secretariat General's activities 
on technical cooperation in the a rea of intellectual property. In this statement, I would like to 
highlight two distinct but interlinked areas of GCC -SG work on IP related issues when it comes to 
technical cooperation and capacity building:  
 TRIPS Agreement: commitments and implications, covered by the GCC WTO 
Department; and  
 Intellectual Property: technical aspects and implementation in the field, covered by 
the GCC Patent Office.  
271.  As part of the activities of the WTO Department in the GCC Secretariat General devoted to 
raise awareness an d address any lack of knowledge, the department provides on a regular basis 
legal and technical advisory services, organizes specialized workshops and makes available 
publications and brochures for the benefit of relevant administrations and officials in t he GCC 
member States, including in the field of in tellectual property in the WTO.  
272.  In this regard, and as announced during the TRIPS Council session of November 2016, 
the WTO Department has conducted in Manama (Bahrain) on 21 - 24 November 2016 a Workshop 
on ''the TRIPS Agreement and its implications on the GCC member States''. Attended by officials in 
charge of IP issues in the GCC countries and other relevant staff in the GCC Secretariat General, 
the Workshop was designed to raise awareness on the TRIPS A greement, its various 
implementation aspects and the implications of the enforcement of its rules and mechanisms on 
trade and investment. During four days, participants had the opportunity to take part in extensive 
and interactive discussions that have enr iched by presentations of experts from the WTO 
Department and the GCC Patent Office.  
273.  The GCC Department has followed very carefully recent developments in IP in the WTO, 
especially the amendment of the TRIPS Agreement , which entered into force on 23  Januar y 2017 
and made the special compulsory licensing  mechanism to export medicines a permanent part of 
the Agreement. Thus, understanding the implications of such amendment is of great importance 
for IP relevant national administrations and procurement agencie s. That is why the WTO 
Department is preparing, among other activities, a ''Guide'' for publication which will be devoted to 
help relevant IP national Patent Offices and other relevant agencies and officials in the GCC 
countries to raise awareness on the v arious legal and technical aspects of the above -mentioned 
amendment as well as o n the use of ''the Paragr aph 6 System''.  
274.  In addition to its role as a regional patent office for implementing GCC Patent Law, the GCC 
Patent Office (GCCPO) continue s to intensi fy its mutual cooperation programme with GCC national 
patent offices aimed at conducting various activities on technical assistance in the field of patent s 
and enhancing their capacity to contribute to patent enforc ement in the GCC member States.  
275.  In this context, the GCCPO has organized in cooperation with WIPO a workshop on Patent 
drafting in GCC headquarters on 16 - 20 October 2016 for researchers and those concerned with 
inventions. On the same subject, an on -the-job training on patent filing was conduc ted by IP/C/M/87/Add.1  
 
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  the GCCPO in Kuwait IP Office during t he periods 14-17 May 2017 and  24 April - 27 May 2017 with 
the aim of familiarizing formal examiners of Kuwait national IP Office with electronic filing, formal 
examination, granting, p ublishing and customer serv ice. 
276.  On patent examination as such, the GCCPO has conducted four activities during 2017. From 
2 to 15 April 2017 and from 17 to 27 May 2017, the GCCPO has organized an on -the-job training 
in Bahrain on patent examination for the benefit of examiners of Bah rain national IP Office. 
Cooperation activity in formal and substantive examination of patent was organized by the GCCPO 
from 16 April to 15 May 2017 in Oman for patent examiners of Oman national Patent Office. 
Cooperation in patent examination was conduct ed 1 -3 May 2017 in Riyadh (Chamber of 
Commerce) for examiners of the GCC Patent Office, national IP Offices and IP Lawyers as part of 
training programme of the GCC IP Training Centre in cooperation with the Danish Patent and 
Trademark Office. Cooperation i n patent examination was also organized in Qatar from 7 May to 
5 June 2017 for patent examiners of Qatar national IP Office.  
277.  On IP research, the GCCPO has organized , in cooperation with WIPO, a workshop on 
benefiting from published search res ults in GCC he adquarters on 6 –10 November 2016 for 
employees of the  GCCPO and national IP Offices.  
278.  The GCCPO has also provided during the period from 27 February to 12 March 2017 
consultation to Oman IP Authority in restr ucturing its Patent Department.  
279.  As far as IT Systems are concerned, the GCCPO has conducted two cooperation activities: 
one held in Bahra in on 11 –13 July 2017 for IT Team of Bahrain national IP Office with the aim of 
strengthening the IT System and assuring its compatibility with GCC Pat ent Office databases and 
e-filing system. The other cooperation activity was conducted in Kuwait on 2 July 2017 to provide 
employees in Kuwait IP national Office with computers and scanners.  
280.  On patent litigation and dispute settlement, a workshop was organ ized by GCCPO in GCC 
headquarters on 26 –27 April 2017 in cooperation with WIPO for the benefit of members of GCC 
Grievance Committee of patent and law officers of the GCC Patent Office.  
281.  On trademark s and industrial design s, a tr aining event was conducted o n 3–5 April 2017 in 
Riyadh (Chamber of commerce) for employees of the GCC Patent Office, the national IP Offices 
and lawyers.  
282.  Furthermore, GCCPO has participated in ''the Middle East International Exhibition of 
Inventions'' , which was held in Kuwait from 1 5-19 January 2017. The participation of the GCCPO in 
this exhibition included granting a yearly award of SAR 50,000 to the GCC inventors in addition to 
supporting their participation.  
11.11  WHO   
283.  I would like to highlight a  few of our activities contained in our annual report  
(IP/C/W/633/Add.2 ). And I apologize already in advance for a rather lengthy statement. One area 
where the current IP system does not provide enough incentives for investment is in the 
development of new antibiotics. To support progress in this  area, WHO and the Drugs for 
Neglected Diseases initiative (DNDi) have established the Global Antibiotic Research and 
Development  Partnership (GARDP). This not -for-profit research a nd development organization is 
developing new antibiotics addressing public health priorities while endeavoring to ensure 
sustainable ac cess and their appropriate use.  On 4 September 2017, a number of cou ntries and 
foundations pledged €56.5 million to finance GARDP over the next years. The meeting was hosted 
in Berlin by the German Federal Ministry of Health and the German Federal Mini stry of Education 
and Research.  
284.  Over the course of the last year, WHO de veloped a specific work stream on fair pricing. A 
Fair Pricing Forum was held from 10 -11 May 2017 in Amsterdam, the Netherlands in collaboration 
with the Dutch Ministry of Health, Welfare and Sport. The main objective of the  forum was to 
discuss options fo r a fairer pricing system that is sustainable for both health systems and 
innovation. Future work will focus on increasing transparency of prices, production and research & IP/C/M/87/Add.1  
 
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  development  costs, encouraging collaboration between payers as well as providing te chnical 
support to countries in reforming their p rocurement and pricing systems.  
285.  Let me turn to hepatitis C, a viral disease that triggered a lot of debate in the past years . 
Worldwide, approximately 71 million people are living with chronic hepatitis C vi rus infections and 
millions more are newly infected each year. Annually, approximately 400 ,000 people die from 
HCV-related complications. Until 2013, once infected with HCV there was little chance of being 
cured, particularly for people living in low - or m iddle-income countries. Since then, new 
revolutionary treatments can cure chronic hepatitis infections. But these treatments have been 
introduced at high prices, in particular in developed countries, increasing pressure on heal th 
budgets and limiting acces s. 
286.  In 2016, WHO published the first global report on access to these new hepatitis C 
treatments. The report provides the information that countries and health authorities need to 
identify the appropriate treatment, and procure it at an affordable price . The report uses 
the experience of several pioneering countries to demonstrate how countries deal with high prices 
and how barriers to access of treatment can be overcome. It provides information on 
the manufacturers of the WHO recommended new treatments, inc luding where the drugs are 
registered, prices, patent  status and  licence  agreements.  
287.  The new trilateral WHO -WIPO -WTO joint online course on Promoting Access to Medical 
Technologies and Innovation is also under way, which gives an overview of the factors that shape 
access to, and influence innovation of, medical technologies. The course describes how these two 
issues are connected and span the policy fields of public health, intellectual property and 
international trade. In 2016/17 more than 400 students f rom all ov er the world enrolled in 
the course that, very generously,  is regularly run by the WIPO Academy on behalf of the three 
organizations as part of our on-going collaboration.  
288.  On 26 February 2018, WHO, WIPO and WTO will organize their sixth trilatera l symposium in 
Geneva at the WHO Headquarters. The theme this year, as has already been mentioned by 
the WTO Secretariat, will focus on implementation of the Universal Health Coverage and 
Sustainable Development Goals agenda at the crossroads of trade, IP and health policies.  
11.12  UNCTAD   
289.  The UNCTAD Secretariat through its IP unit implements a work programme on 
the development dimensions of IP rights. The work programme is designed to respond to the 
mandate received from member S tates at the Ministerial Conference in Nairobi  in July 2016, as 
well as to the intergovernmental request under the WIPO Development Agenda and the World 
Health Assembly R esolution 61.21 on a Global Strategy and Plan of A ction on Public H ealth, 
Innovation and Intellectual P roperty. The IP unit , located in the D ivision on Investment and 
Enterprise , conduct s research and policy analysis on trade and development aspects of intellectual 
property, facilitates consensus -building and re sponds  to reques ts for technical assistance and 
advises on policy options for successfully integrat ing developing countries into the world economy.  
This document provides an overview of UNCTAD's IP and development related activities during 
the period of November 2016 to O ctober 2017. More information on past activities is available at 
www.unctad.org/ddip  and www.iprsonline.org . 
290.  On a request basis, UNCTAD's IP Unit conducts technical cooperation activities with 
developing countries in the integrated areas of investment, trade and intellectual property. The 
technical assistance activities are partly funded by donor governments and institutions.  
291.  UNCTAD was requested by its Commission on Investment, Technology and  Related Financial 
Issues in 2005  to assess ways in which developing countries can develop their domestic productive 
capability in the supply of essential drugs in cooperatio n with pharmace utical companies. In the 
pursuit of this mandate, UNCTAD implements a work programme on local pharmaceutical 
production, with a view to assisting developing countries and least -developed countries (LDCs) in 
particular, to utilize  IP rights a s tools that facilitate increased access to affordable medicines, and, 
where feasible, to promote domestic and foreign investment to create local or regional 
pharmaceutical production and supply capacities. The programme is supported by the German 
Federal Ministry for Economic Cooperation and Development (BMZ).  IP/C/M/87/Add.1  
 
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  292.  Funded by the German International Cooperation (GIZ), UNCTAD's work programme assists 
developing countries' efforts to promote coherence of policies in respect of health, trade and 
industrial develop ment and ensure that local pharmaceutical production increases access to 
medicines. UNCTAD and GIZ pursue this activity on a regional basis in South -East Asia and 
the East African Community (EAC).  
293.  In 2016, UNCTAD launched its technical assistance programme  on IP, transfer of technology 
and trade facilitation, with the  financial support from the Government of Germany (BMZ). 
The programme focuses on the use of IP regimes for the promotion of technological absorption 
capacities and discusses the use of IP righ ts such as trademarks for trade facilitation.  
294.  IP rights and biodiversity and geographical indications.  In 2011, UNCTAD launched its 
technical assistance programme on IP and biodiversity, with financial support from 
the Government of Germany (BMZ) and in co operation with GIZ. The programme has focused on 
the building of local capacities, in developing countries, to design and enforce domestic trade, 
customs and IP laws in line with access and benefit sharing rules under the Convention on 
Biological Diversity  (CBD), its Nagoya Protocol and the UN Declaration of the Rights of 
the Indigenous Peoples.  UNCTAD has implemented various training courses in developing countries 
in this area, based on its 2014 Handbook on the interface between global access and benefici ary 
rules and intellectual property, and entitled  the convention on biological di versity and the Nagoya 
protocol  intellectual property implications.  An important part of this work concerns the potential of 
distinctive signs such as geographical indications  to promote the use of biodiversity derived 
products and traditional knowledge.  
295.  UNCTAD provides, upon request by a developing country or least -developed country, 
advisory reports on the development dimensions of intellectual property (DDIP). The objective of 
a DDIP report is to provide well -researched and reasoned advice on developing countries' and 
LDCs' policy, legal and institutional framework for IPRs, particularly as it relates to important 
development objectives such as innovation, technology, investm ent, competition, education and 
health. Developing countries specify the key development objectives they wish to examine. A DDIP 
report will take into consideration the socio -economic situation of the requesting country, 
the bilateral, regional and interna tional commitments the target countries have entered into and 
the flexibilities available to them. Based on this analysis, the reports incorporate medium to long 
term recommendations on how governments and other stakeholders could make these frameworks 
more coherent and transparent, with a view to making IP rights contribute to a country's 
sustainable economic and human development goals, and respond to emerging global 
opportunities.  
296.  At the request of the  Ethiopian Government, UNCTAD works closely with the WHO on 
the implementation of the  National Strategy and Plan of Action for Pharmaceutical Manufacturing 
Development (2015 -2025). Staff of UNCTAD's IP Unit frequently participates in capacity -building 
workshops on IP and development issues organized by other  providers of IP -related technical 
assistance. For  instance, UNCTAD was invited by WIPO and WTO to contribute to the 2017 WIPO -
WTO Advanced Course on IP for Government Officials. In April and May 2017, UNCTAD invited 
WTO to make contributions to two multi -stakeholder workshops organized  by UNCTAD i n Senega l 
and Cuba. 
297.  UNCTAD undertakes research and analysis on trade and development aspects of I ntellectual 
Property  and provides advisory reports for developing countries. Currently, UNCTAD is finalizing 
a "Tool Box for Policy Coherence in Access to Medicines an d Local Pharmaceutical Production", in 
collaboration with GIZ. The Tool Box is designed as a quick reference tool for developing country 
policy makers on the various policies related to health, industrial development, trade, investment, 
innovation and IP a nd how they may be used to contribute to local production and access to 
medicines.  
298.  Consensus -building among stakeholders on issues of IP is an important element of our 
programmer's  work. UNCTAD's substantive contributions on the analysis of issues related to 
development and IP have enabled it to become an important forum, through its intergovernmental 
machinery, where governments, academia, civil society and the private sector can meet to 
exchange ideas.  A recent example of UNCTAD's consensus building activ ity is the ad hoc expert 
group meeting on new investment models in health -related recession development the case of 
antibiotics resistance, which we organized on 5 October 2017 at the  Palais des Nations in Geneva. IP/C/M/87/Add.1  
 
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  The purpose of this meeting was to promote  an informal exchange on views of how to promote 
investment to address antibiotic resistance. The meeting was attended by experts from national 
governments, the private sector, civil society and intergovernmental organizations.  
299.  The list of activities for t he period between 1 November 2016 and 15 October 2017 is 
available in our recent  report. For more information on UNCTAD's activities related to IP, please 
visit the UNCTAD website.  
11.13  India   
300.  I take this floor to respond to the document IP/C/W/633/Add.5. Article 67 of the TRIPS 
Agreement  states:  
In order to facilitate the implementation of this Agreement, developed country 
Members shall provide, on request and on mutually agreed terms and conditions, 
technical and financial cooperation in favour of developing and least developed 
country Members. S uch cooperation shall include assistance in the preparation of laws 
and regulation on the protection and enforcement of intellectual property rights as 
well as abuse and shall include support regarding the establishment or reinforcement 
of domestic offices  and agencies relevant to those matters, including training of 
personnel . 
301.  At its meeting on 13 June 2017, the Council had agreed to invite intergovernmental 
organization observers to the Council to update information on their technical and financial 
cooper ation programme relating to implementation of the TRIPS Agreement. In its document 
IP/C/W/633/Add .5, the organization is trying to pass off some study it had conducted as part of 
technical cooperation, which it is clearly not so.  
302.  I also take this opportuni ty to inform that the WHO has assessed Indian National Regulatory 
Authority on nine different functionalities and declared with a maturity level of 4 (the highest level) 
on five functions and maturity level of three  in respect of four other functions. I al so second the  
Brazilian delegate that the terminology Substandard and Falsified Medical Products be used as 
the old terminology "Substandard/Spurious/Falsely -labelled/Falsified/Counterfeit " surfaced from 
a lack of global common understanding, sometimes con fusing the phenomenon of substandard and 
falsified product with protection of IP Rights. 
11.14  Brazil   
303.  We have already referred to the entry into force of the Protocol amending the TRIPS 
Agreement. WTO and its Members s hould work together towards its full implementation, fulfilling 
the expectations of society and stakeholders regarding the benefits of the multilateral trade 
system. We are confident that the expertise of the Organization will prove valuable to that task.  
304.  In that regard, we would like to mention the Regional workshop on Trade and Health that is 
scheduled to be held next November, in Brasília, for the benefit of Latin American countries. This is 
a concrete step in providing assistance to countries for the pr oper implementation of the Protocol. 
Brazil is appreciative of the initiative and we look forward to continuing working with 
the Secretariat on simi lar activities.  
305.  We would also like to comment on the OECD study mentioned in document 
IP/C/W/633/Add.5 regarding goods in transit.  Rules in WTO agreements treat freedom of transit as 
a basic tenet. While Parties may require the compliance of some provisions by goods in transit, 
those rules do not live in a void under the relevant multilateral norm s. Such go ods, for instance, 
shall not be subject to unnecessary delays or restrictions and the procedures shall be reasonable. 
Lastly, Article 51 brings clear requirements to be followed by customs authorities regarding 
the suspension of release of goods, as well a s the relevant legislation that should be considered – 
that is, the law of the  country of importation. Adequate balance should be provided in this matter, 
ensuring the trade of legitimate goods while combatting abusive behavior by right -holders.  IP/C/M/87/Add.1  
 
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  11.15  China 
306.  China believes that document IP/C/W/ 633/Add.5 circulated by the OECD does not concern  
technical co -operation and capacity building and should not be discussed here.  
11.16  European Union  
307.  We think that an activity can clearly be justified as technical assistance if it raises awareness 
about  issues that are happening around the globe , where the IP system does not seem to function 
perfect ly and where this could also be taken up as an incentive to rectify the  problems which seem 
to exist.  
AGENDA ITEM 12: INTE LLECTUAL PROPERTY AN D INNOVATION: INCLUS IVE 
INNOVATION AND MSME GROWTH  
12.1 Switzerland  
308.  Switzerland is  honoured  to co -sponsor agenda item 12 in cooperation with Australia, 
the European Union, Japan, Chinese Taipei and the U nited States . This group of Members 
submitted Communication IP/C/W/635 of 9 October 2017 to provide Members with some  
background information on the topic of "Inclusive Innovation and MSME Trade, as well as to 
propose a number of questions which could guide the Council 's discussion.  
309.  The Council has discussed a diverse range of subtopics under this agenda item over last fe w 
years, from  the role of education and awareness raising, the challenges of innovative start -ups, to 
the role of women or IP & Sports. Today 's proposed topic on IP & innovation is definitely home turf 
for the WTO: inclus ive innovation and  micro, small & medium enterprise ( MSME ) trade. The co-
sponsors propose that Members share their experience s on IP -related measures they have taken 
to support MSMEs in their trade activities, for us all to find out which of these measures work and 
which ones may have not done so.  
310.  What IP strategies and policies have Members considered successful in helping their MSMEs 
to integrate into the global economy and in what sectors could they e xtend their trade exports 
best.? At the outset of our discussion, let me be clear about one thing: No one claims that by 
providing IP protection or ensuring IP enforcement alone would a country 's economy or its MSMEs 
thrive in trade and exports. Clearly, many factors are relevant in that respect and adequate and 
effective IP protection and en forcement are just some among these factors. Thus, IP is just one 
piece of the puzzle. However, it 's an important one. At a Panel event organized yesterday 
afternoon at the WTO by the Friends of IP  & Innovation (FOII) Group of TRIPS Members, we have 
heard this messag e from representatives of MSMEs repeatedly  
311.  The US delegation will in their intervention report in more detail about the panel event and 
particularly the case studies that were presented yesterday by representatives from Government, 
academia and  the private sector.  
312.  As for Switzerland, with your permission, I will ask my colleague for the  purposes of our 
today's discussion to present two Swiss case examples on how MSMEs can use IPRs to maximize 
the potential to develop and grow through trade from their home base into export markets.  
Communication IP/C/W/ 635 refers among others to so called "unique selling points " or "USPs" that 
MSMEs can develop and harvest through making strategic use of IPRs. It won't come as a surprise 
to you that one of our cas e examples will deal with cheese , but we will start with an example 
about drinking water.  
313.  Introduction . We would like to further illustrate those innovation mechanisms and provide 
two specific examples of small Swiss MSMEs which successfully apply IPRs for  business with 
innovative products in international trade.   
314.  How do you find your favorite coffee beans in retail stores, considering a wide variety of 
packaging and labels? For the average consumer they may all  look more or less the same. Should 
you open s ome of the packaging and smell the  beans, taste, maybe chew them?  IP/C/M/87/Add.1  
 
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  315.  How do you distinguish between two cheeses if the only visible and obvious difference is 
the price? Try to smell the product although it is well packaged? How do you know this is 
the product you are looking for and not one which is just similarly packaged to the one you had in 
mind? If you cannot really tell from the label, you may sim ply choose the cheaper product  or 
the more expensive one, if you believe that the higher the price, t he better the product.  
316.  Hence the importance of information. We need further  information about the product 
to decide on our purchase, rather than just rely on our a bility to smell or taste. This illustrates 
the underlying issue of our topic: facili tating MS MEs trade activities, making use of IP.  
317.  It is trust which enables trade. You would not enter a business transaction if you do not trust 
the other side or your business partner. But how to build trust if producers and consumers do not 
have the same level of  information on the traded product?  
318.  In domestic and small markets the level of information may be more balanced. However, at 
the international level, the so -called "information problem " increasingly becomes a major issue. 
Producers, service providers, trad ers, they all need a proper marketing strategy. A strong and well 
protected brand can be crucial for success in trade.  
319.  Property rights are a key tool to create trust. Well -defined property rights clearly reduce 
the lack of trust between trading partners, r educe transaction costs and increase the  information 
symmetry. I P rights are one part of the property rights  system.  
320.  IPRs facilitate enterprises to succeed in global trade. The following two examples focus on 
two main examples of how intellectual property rights support trade activities of MSMEs.  
321.  Example 1: Trunz Water System AG . Switzerland is a small and open economy, on average 
more than 50% of MSME 's turnover results from exports. Thus, let me first present you 
an example of a typical example of an  innovative Swiss SME that is perf orming well in foreign 
markets.  
322.  Trunz Water Systems AG is a small Swiss enterprise which develops, manufactures and 
distributes independent water systems worldwide. Trunz ' aim and motto is "Drinking water and 
electricity an ywhere and anytime ". The company owns different patents for their unique and 
sustainable technology. IPRs enabled Trunz to export their products and expand into foreign 
markets. As their products are highly research -intensive, IP is crucial to protect the company 
against unfair competition and free -riders. It was thanks to IPRs that Trunz Water Systems could 
secure a return on their initial investment, reinvest and step by step develop an innovative product 
of a high quality standard.  
323.  In addition, they make  use of a trademark to differentiate themselves and their products 
from competitors. As was already pointed out in earlier interventions, trademarks are a critical 
instrument in the legal framework, and particularly for internationally operating firms like  "Trunz 
Water Systems ". In their case, trademarks offer the possibility to identify and make a  product 
stand out, flag its quality and maintain the company 's reputation worldwide.  
324.  The company won the Export Award of the Federal Agency "Switzerland Global E nterprise " in 
2012 and is an example which illustrates how a successful national and international IP strategy, 
combined with an international cooperation strategy, can enable MSMEs to reali ze their potential 
for export, or increase their export volume.  
325.  "Trunz Water Systems " is also an example of how IP -protected goods can have positive spill -
over effects for low - and middle -income countries. This is either by way of IP owned by domestic 
companies in those countries, or by way of local trading partners whic h benefit either as part of 
the distribution system being established for the traded product itself or through the  licensing  of 
new technologies to produce bette r products in domestic markets.  
326.  A proper legal IPR framework enhances the incentive for globally operating and trading 
enterprises, ensuring and identifying the quality of their products, protecting the IP and thereby 
allowing for reinvestment in the innovation cycle, for improved, even better products.  IP/C/M/87/Add.1  
 
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  327.  Example 2: Tête de Moine . Our second example illustrates the same with a small number of 
Swiss MSMEs that produce a special kind of cheese, the "Tête de Moine ", and have established it 
as a successful export product. It is an example of ho w trade opportunities can be increased by 
improving the  information flow and trust and how to make an existing product more attractive and 
successful in trade by adding an innovative edge – and why protecting these added values through 
the use of intellect ual property rights is so important.  
328.  Switzerland is known as a country with extensive tradition and experience in cheese 
production. In the case of "Tête de Moine " the historical documents about cheese producing monks 
in the monastery of Bellelay reach bac k to 1192. Historical documents provide evidence of 
continued characteristic features of the cheese, such as its specific taste, the quality and its use 
e.g. as a means of payment.  
329.  Product quality can be built over a short period of time, or can develop ov er time, and may  
be maintained over centuries. Most often, such successful products and services are also the  result 
of a collective effort. The right IP tools can be essential to encourage building up reputation, 
develop exceptional products and maintain their qual ity over a long period of time.  
330.  Trademarks are commonly seen as such a tool or also, in the case in point: geographical 
indications (GIs). The producers of "Tête de Moine " in north -western Switzerland used this tool 
and developed their IP strateg y early on. It is a good example of how a product adequately 
protected by IP grew in national trade and exports.  
331.   "Tête de Moine " not only benefits from a GI, but also from a patent on a device which was 
specifically developed for scraping [ei] the cheese.  The producers ' association recently also applied 
for a geographical trademark to be registered. There are also several word trademarks as well as 
text/picture trademarks registered.  
332.  Geographical indications and trademarks provide consumers additional and trustworthy 
information about the characteristics of a product. They foster trust by better signaling to 
consumers what they can expect from their product. Hence, the consumers ' willingness to pay for 
an innovative and high -quality product.  
333.  "Tête de Moine " is associated with the so -called "Girolle ", a traditional, innovative product, a 
technical device patented in 1981. The idea behind the "Girolle" is running a spi ke through the 
"Tête de Moine " cheese and apply ing a rotating knife to cut, or rather scrape,  it. Thereby, you 
easily produce decorative, mouth -sized pieces of cheese in the s hape a rosette or chanterelle. 
Some delegates hopefully had the opportunity to taste the Tête de Moine on the  occasion of 
the Workshop on "Fairness and Transparency in IP " event at the WTO last  Tuesday.  
334.  Since 1981, when the "Girolle " was commercially launched, sales of "Tête de Moine " have 
increased by an average of 60 tons e ach year. Since the early 1990 s the production has almost 
doubled from 858 tons (in 1990) to 2'386 tons  (in 2016). Roughly 63% of the cheese specialty is 
exported.  
335.  The IP strategy drafted for "Tête de Moine " paid off. As a matter of fact, the "Girolle " won 
a Swiss innovation price in 1986. Sin ce this product was first launched, 2.5 million items of 
the device have been sold. Nowadays, the export figures speak for themselves. It is also thanks to 
an extensive IP strategy that the association "Tête de Moine " was able to increase their export 
value for about 29% since 2006.  
336.  Trademarks and GIs are part of th e "Tête de Moine " story and the remarkable increase in 
export volume of a processed agricultural product.  Trademarks and GIs can provide much added -
value also for producers in low -and middle -income countries. Their economies often have a high 
potential for  trademarks and GI protected agricultural products, with IP increasing MSMEs ' 
international trade opportunities.  
337.  Conclusion . The two different examples show that IPRs can be a main driver of MSMEs trade 
activities and open up new export opportunities. We s ee the following take -aways . First, a stable 
and proper IPR framework in the domestic and foreign country supports MSMEs to step into 
foreign markets and open up new trade opportunities.  Second, IPRs are used to identify quality IP/C/M/87/Add.1  
 
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  and reputation. They contri bute to increase the information levels in general and especially for 
internationally traded goods.  Third, IPRs are a key element and facilitator for trade activities, 
especially for MSMEs, in lo w- and middle -income countries, ju st as in high -income countr ies. 
338.  We are looking forward to hearing from other  delegations about their experience, about 
MSMEs experience, and about policy approaches how to support them.  
12.2 Korea , Republic of  
339.  It is an honour to be given this opportunity to briefly explain to you the contents of 
the guidebook for SMEs ' IP-Business Cycle . The goal of this project was to create a guidebook to 
share experiences concerning IP  business support policies and programmes among co untries. 
The guidebook primarily focuses on IP creation and IP utilization. In a broad view , IP creation has 
six programmes in total in two categories: the  private sector and the public sector ; and IP 
utilization has eleven programmes in total in three cat egories: IP commercialization, IP trade and 
IP valuation.  
340.  In terms of IP creation support in  the private sector, there are three programmes . As the 
starting point to the policies , we have the only programme  of providing support for prior art search 
to enhance  the possibility of acquiring  IP. Then derived from that  come  programme s of subsidy for 
patent acquisition cost to increase SMEs ' IP creation, and support for making client specific patent 
maps  for more  R&D and  commercialization . 
341.  The public sector programmes  aim to promote IP creation in universities and public research 
institutes. One programme matches  patent management  exports to universities and public 
research institutes, to establish IP  infrastructure in such places , and the other provides  support for 
selecting excellent technologies and subsidies for IP acquisition for creating IP of a high quality.  
342.  Proceeding to programmes for IP utilization, the guidebook focuses on those that support IP 
commercialization, IP trade  and IP evaluation. IP commercialization supports the category of 
programmes that cover issues such  as the commercializ ation of SMEs ' IP. Basic programmes 
include , for example, subsidy cost for developing prototypes  of SMEs' inventions such as 3D-
designs  and working mock -ups and preferential purchase by the government. Entering the 
developing phase, the programme of product innovation using IP , works to advise improvement of 
SMEs' products through solutions disclosed in prior art in different technical areas.  
343.  Also within IP utilization is IP trade support to enhance trade of patent technologies. There 
are two programmes for offline  and online patent markets and later more developed programmes 
of IP trade export that procure IP trade and subsidy for consulting o n IP trade. Through IP 
valuation support , SMEs can raise funds for their businesses by using IP -valuation for rules and 
investment. Subsequent to the programme for valuating technological value and business 
feasibility  of IP, the value of IP can be converted to finance through programmes  that support 
guaranteed rules, IP security rules and investment. We hope this guide will become useful for 
developing countries and LDCs and increase their IP capacity.  
12.3 Japan   
344.  The delegation of Japan would like to express its sincere appreciation for the opportunity to 
share Japan's experiences in supporting global business activities of micro, small and medium 
enterprises or "MSME Trade".1 
345.  In addition, this delegation would  like to thank the US delegation for hosting yesterday's side 
event, at which discussions between the panelists from various regions of the world were so 
inspiring that we were able to be more encouraged to disseminate the essen tial role of IP for 
innovati on. 
Slide 1  
346.  Currently, there are about 3.82 million companies operating in Japan and 99.7% of those 
companies are MSMEs. Also, when considering the fact that MSMEs account for 54.6% of the gross 
                                                
1 The representative of Japan made a PowerPoint presentation, av ailable in Room Document RD/IP/20 . IP/C/M/87/Add.1  
 
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  value added of the Japanese economy, this delegation would sa y MSMEs serve as the basis for 
the Japanese economy.  
347.  Meanwhile, the graph at the lower right of the slide shows the number and percentage of 
direct exports from MSMEs in the manufacturing industry. As shown in the graph, the number of 
direct exports from M SMEs has been increasing over the years. However, the percentage of 
MSMEs' exports out of the total production volume still remains at a low level, which accounts for 
only 3.5% in 2013.Thus, this delegation believes that MSMEs have a great potential to dev elop 
through increased international trade.  
Slide 2  
348.  In this slide, this delegation would like to introduce one possible way for MSMEs to expand 
their businesses, and it is to increase their business transactions on a global scale.  In general, 
quite a few MSMEs have technological advantages in very specific fields. Some MSMEs have also 
gained knowledge of niche or unique demands of potential users in neighboring and other foreign 
countries. This delegation believes that by linking these specific technologie s with such niche or 
unique demands, high -quality, new products can be developed. This could facilitate new trade 
transactions by MSMEs and create new markets.  
349.  Please have a look at an example shown in the lower part of the slide. This case involves 
an SME that manufactures food processing machinery in Hokkaido, the northernmost area of 
Japan. That company was able to improve its equipment by making use of its own technology for 
processing marine products, based on the demand for automation in a neighboring  country. 
By developing a business strategy based on the needs of foreign customers and by protecting its 
proprietary IP through obtaining patent rights, the company has been successful in expanding its 
business activities abroad. This delegation believes that such product development and business -
expansion activities enable MSMEs to participate in regional and global value chains, and thus 
contribute to "MSME Trade."  
Slide 3  
350.  However, any business expansions into foreign countries by MSMEs are not so easy. 
We should note that MSMEs have to deal with various risks and overcome many obstacles, in order 
to be involved in business activities abroad.  In particular, when MSMEs expand their business 
activities to foreign countries, there is a  great risk that their technologies and designs could be 
copied. According to the results of a  survey that we conducted on MSMEs, which are shown in the 
figure in the upper left of the slide, 20% of MSMEs are concerned about the risk of expanding their 
businesses to foreign coun tries. They feel that they might suffer damage caused by infringements 
of their intellectual property ri ghts through counterfeit goods.  
351.  In order to avoid such risks, it is essential for MSMEs to obtain IP rights also in foreign 
countries. However, we shoul d also note that MSMEs need to deal with difficulties in managing and 
enforcing the IP rights that they obtained. According to another survey of ours, many MSMEs 
responded that a significant obstacle in managing and enforcing their IP rights is their lack of 
information and knowledge on intellectual property, and their lack of human resources capable of 
managing intellectual property.  
Slide 4  
352.  In this regard, this delegation would like to introduce one of the initiatives that Japan has 
been undertaking to de al with such risks for MSMEs. In Japan, under the leadership of the Japan 
Patent Office and relevant authorities, Global IP Strategy Producers have been placed to support 
MSMEs throughout the country, to help with their IP activities in foreign countries. In fact, 
Producers offer various types of support such as formulating appropriate IP strategies depending 
on individual business circumstances, helping MSMEs to avoid infringements in countries where 
MSMEs are expanding their businesses; and establishing t heir own internal IP procedures to 
prevent technological leaks, etc.  
353.  This slide shows one successful example. It is a case in which an SME that manufactures 
sugarcane harvesting machines planned to sell its products in foreign countries. The company 
consul ted a Global IP Strategy Producer and asked how to negotiate user agreements. Then, based 
on the Producer's advice, the company succeeded in concluding agreements with favorable 
conditions, so as to minimize risks of technological leaks, with a foreign bus iness partner. IP/C/M/87/Add.1  
 
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  The agreements were so successful that, as a result, the company was able to receive additional 
business offers. Now, while consulting Global IP Strategy Producers, the company has been 
advancing its business carefully in terms of managing i ts IP rights, and is planning to increase 
production through licensing and outsourcing in foreign countries.  
354.  This delegation believes that product development based on demand or requirements by 
foreign countries, especially neighboring countries, can signi ficantly contribute to "MSME Trade." 
However, in order for this to happen, it is crucial for MSMEs to make effective use of their IP. 
Governments can help MSMEs by providing customized technical advice on IP management. This 
delegation would like to thank you all once again for giving this opportunity, and sincerely hope s to 
share information with you on ways to implement and improve activities and policies for 
supporting MSMEs.  
12.4 European Union   
355.  First of all we would also like to thank the organizers for yesterday's side event on innovation 
and growth, which I think was a great success.  
356.  Improving the ecosystem for start -ups and scale -ups has direct beneficial effect in driving 
growth and sustainin g employment. Therefore, several Members have already put in place or are 
considering initiatives to create an environment conducive to innovation and entrepreneurship , in 
particular for MSMEs . Given the importance of the MSMEs in the world economy, suppor t has been 
provided by many Members not only to improve the development of their domestic activities, but 
also to encourage small businesses to enter international markets. Furthermore, working in 
partnership with all levels of government, regions and citi es and local communes  and all 
stakeholders (including start -ups and scale -ups themselves) is vital in order to identify and 
implement those measures that can provide support to M SMEs in their trade activities.  
357.  There is a variety of policies and other tools  used by governments to encourage 
entrepreneurs to start a business and to engage in innovative activities, including mechanisms to 
remove barriers for MSMEs, programmes which create new opportunities and support small 
businesses to connect with the right partners or access commercial opportunities,  personalised  
support services, and financial instruments which aim to stimulate MSMEs' access to financing. In 
addition, since IPRs play a crucial role in enabling MSMEs to spur innovation and creativity, whilst  
promoting economic growth, there should be a focus on facilitating SME access to IP, which 
includes actions to coordinate IP support funding schemes for innovative SMEs,  individualised  
support services for the acquisition and use of IPRs, and measures to support IPR enforcement.  
358.  Among other activities of the EU and its Member States, the EU aims at providing such 
information and support for MSMEs through the IPR SME Helpdesk programme , which encourages 
MSME participation in an open international trade fram ework. Since 2015, there are three IPR SME 
Helpdesks that were set up and funded by the EU in different regions of the world. The se 
Helpdesks provide European MSMEs with free, practical, business advice relating to IPR in these 
regions, and it is foreseen that these projects will continue to carry ou t their activities beyond 
2018.  
359.  More specially, the Helpdesks:  
 Provide free information and services in the form of jargon -free first -line confidential 
advice on intellectual property and related issues, plus tr aining, materials and online 
resources.  
 They raise awareness about IPR matters in the three regions that affect European 
MSMEs, enabling t hem to make informed decisions.  
 The services are available to all EU MSMEs, and the Helpdesks are working closely with  
European MSME networks, chambers of commerce and industry associations to provide 
advice on IP and relate d issues.  IP/C/M/87/Add.1  
 
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   The Helpdesks also produce industry and business -focused materials and training tools 
(e.g. IP specific guides, Country IP factsheets, indus try specific guides  etc.) that address 
IPR issues.  
 Training events and webinars are another important service offered by the three IPR 
SME Helpdesks. They organize  both face to face and online trainings which concern IPR 
protection, management and enforcem ent, and that are carefully tailored to the needs of 
SMEs. Each event features an interactive presentation from various IP experts and also 
provides MSMEs with the opportunity to sit down for a free, 20 -minute one -on-one 
advice session with the experts. Mo reover, some of these activities are open to anyone 
interested in protecting their innovations and bu siness es, including of course from local 
companies . 
360.  The key role of IP in the success of MSMEs has long been recognized . Recent data from 
the EU Intellectu al Property Office (EUIPO) show that businesses using IP rights perform better, 
and this is particularly true in the case of MSMEs. MSMEs owning IP rights have almost one third 
higher revenue per employee than MSMEs that do not.2 
361.  A variety of different strategies and support measures are applied by governments in order 
to encourage and help MSMEs in the use of IP, which aim help them achieve a better integration 
into the global economy. However, getting innovative start -ups and MSM Es to benefit from the IP 
system, whether by registering rights or by applying other IP protection methods, is not enough. 
Additional support must be provided to small businesses in order to help them make good use of 
the IP system.  
362.  As a matter of fact, th e IPR SME Helpdesks projects prove how MSMEs are supported in  
being better integrated into the global economy.  
 Very often, users of the services do not have a high level of theoretical awareness of IP 
importance as a business tool or they have erroneous co ncepts about use costs and 
general IP rights' management. Some of them do not even have a comp rehensive IP 
strategy in place.  
 The IPR SME Helpdesks provide  assistance with such things. For example, following 
the advice of the Helpdesks to prepare an IP str ategy and contracts with local partners. 
In the same vein, a large part of companies have decided to register an IPR after 
requesting advice from the regional Helpdesk.  
 The Helpdesks also give the opportunity to local MSMEs in the host countries that 
engag e in commercial cooperation with EU MSMEs to strengthen the links between them 
with regards to the pro tection and enforcement of IPR.  
 By monitoring relevant IPR developments affecting MSMEs in the territories covered by 
the programmes, the Helpdesks are ab le to provide basic support for initial contacts with 
local law enforcement agencies in the host countries.  
 Finally, the Helpdesks support a better integration of MSMSEs into the global economy 
by taking advantage of the potential synergies with other EU i nitiatives (such as the EEN 
Network to promote technology transfer funded under the COSME programme, the IP 
Key projects etc.).  
363.  MSMEs have a key role in the world economy and bring a substantial contribution to 
international growth and employment. In fact,  across the EU28, MSMEs make up 99.8% of all 
enterprises, 57.4% of value added, and 66.8 % of employment.3 MSMEs also have a significant 
social contribution by providing certain benefits, such as more flexible working arrangements.  
364.  However, it is well know n that MSMEs usually have limited resources and management 
capacities, so they are less able than large -scaled enterpris es to engage in global markets.  
365.  By using IP as a business tool, MSMEs can improve the competitiveness and increase their 
revenues. Yet, evidence shows that only around 10% of SMEs have registered IP rights, compared 
                                                
2 Intellectual property rights and firm performance in Europe: an economic analysis (EUIPO, 2015)  
3 Annual Report on European SMEs 2015/2016: SME recovery continues (European Commission 2016).  IP/C/M/87/Add.1  
 
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  to one third of large companies.4 Moreover, small businesses will not be able to receive the full 
value of their IP if they cannot enforce them when need. Therefore, given the important role 
MSMEs play in fostering innovation and growth, it is important to fully unlock their potential with 
the multilateral trading system by making sure they are taking full advantage of their IPRs in order 
to be able to compete with companies big ger and more established than themselves.  
366.  Concretely, one of the export sectors in which MSMEs have been very successful in 
increasing their share of exports thanks to an efficient IP -strategy is the ICT sector.  
 For example, a small European technology enterprise that developed the Near Field 
Communication (NFC) technology , I am sure you all have this in your mobile phones, it 
is also by the way the Apple pay mechanism,  found itself competing against giant 
European and Asian tech companies that had acces sed its inventions and patents, but  
failed to pay their fair dues.  
 The main problem was that few of these tech giants , including Asian and European tech 
companies,  were willing to take the correct licen ce on their extensive patent portfolio 
even though all  these large enterprises were using and profiting from their technology.  
 In general, it is very challenging for an SME to afford the litigation costs  facing such 
large companies  for patent enforcement.  
 Nevertheless, the MSME, with the help of EU Member Sta te public service s supporting 
MSMEs in such case, went through the painful process of litigation against several  large 
companies  and finally winning in litigation.  And this actually helped the company to 
survive;  it was at the brink of not surviving.  
367.  Examp les like this clearly show how IPRs and an efficient IP -strategy supported by public 
policy measures , including the correct enforcement,  can contribute to the promotion of MSME 
competitiveness in global and emerging markets. The small enterprise succeeded to survive by 
taking advantage of IPR protection and the  rule of law.  
12.5 Australia  
368.  Australia joins co -sponsors the European Union, Japan, Switzerland, Chinese Taipei and 
the United States of this discussion today on Intellectual Property and Inclusive Innovation: MSME 
Trade circulated in IP/C/W/635. We thank our colleagues of Switzerland for introducing  this 
agenda item this afternoon.  
369.  In our presentation today, Australia will highlight an example of a small business that has 
successfully relied on our intellectual property and innovation policies to advance its commer cial 
interests including internationally.  
370.  Case study on Stormseal – A recipient of an Accelerating Growth Grant . This business 
developed a product known as Stormseal to respond to natural disasters. Stormseal is a strong 
polyethylene film product that heat shrinks to cover a damaged roof or wall, providing secure 
protection from wind, rain and hail.  Stormseal receive d an Accelerating  Commercialisation  grant 
from the Australian Government through our National Innovation and Science Agenda.  The owner 
came up with the idea for Stormseal after his experience assisting with severe storm damage 
repairs in 2007 when he saw i nsurance claims multiply due to failing tarpaulins.  To develop his 
idea, the owner sought out intellectual property protection in the form of trademarks and patents. 
He said "Successful businesses are valued by the strength of their  IP." Bolstered by the s upport of 
the IP protections and assistance, the owner is now considering entering international markets.  
371.  Our discussions this year regarding intellectual property, inclusive innovation and MSMEs 
have been informative. We now have a greater awareness and a ppreciation for the role and value 
of intellectual property frameworks in relation to MSME collaboration, growth and trade.  We also 
thank all Member States for attending yesterday's side event showcasing real world examples of 
                                                
4 Intellectual property rights and firm performance in Europe: an economic analysis (EUIPO, 2015).  IP/C/M/87/Add.1  
 
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  businesses, universities and others that had relied on intellectual property and been able to access 
global value chains.  
372.  Thank you for the opportunity to present our case study today and to speak to 
the frameworks we consider vital for a flourishing MSME trade. We look forward to hea ring your 
examples.  
12.6 United States  
373.  I would like to thank Australia, Canada, the European Union, Japan, Switzerland, and 
Chinese Taipei for co -sponsoring this item , and all of the delegations that to ok the time to prepare 
interventions on this topic throughout the year; your contributions have given life to this important 
set of issues.   
374.  The United States was pleased to help organize a side event yesterday that examined these 
issues from a variety of different perspec tives, including that of MSMEs. In addition to 
the insightful speakers, one of the highlights was the sushi provided by the Japanese del egation, 
so thank you very much for that.  
375.  The stories of hard work and perseverance in a competitive gl obal environment were 
inspiring and instructive in helping the audience to better understand how policymakers can play 
a helpful role in promoting MSME growth and success.  
 For instance a n official from the Innovation in the Research Contracts & Innovation 
Department at the University of Cape Town and legal counsel from a cutting -edge 
Israeli security firm underscored the increasingly important role that IP protection, 
particularly in those cases, patent protection, plays in attracting ear ly stage capital 
for start -ups. 
 The founder of an Indonesian guitar company helped explain his company's creative 
strategy to invest in brand identity so as to stand out in Indonesia's competitive 
guitar marketplace.  
 Finally, a Colombian official overseeing an effort to prom ote innovative MSME 
development highlighted his agency's impressive efforts to foster innovation and 
creativity as well as helping overcome challenges for these companies to make 
international connections.  
 It was striking to hear how the challenges facing companies in four different regions 
in the world are quite similar to the ones we see facing US MSMEs.  
 Given the common challenges that MSMEs, governments, and other stakeholders 
face, I hope that the following information on US programme s will be benefici al to 
other Members as it is intended to stimulate the growth and trade of MSMEs.  
 The United States' 30 million MSMEs account for nearly two -thirds of net new private 
sector jobs in recent decades. In addition, our youngest companies – those less than 
one year old – have created an average of 1.5 million jobs per ye ar over the past 
three decades.  
 MSMEs that export , tend to grow even faster, create more jobs, and pay higher 
wages than similar businesses that do not.  
 Therefore, the US Government is working to  increase the number of small to 
medium -sized businesses that export by making it easier for them to access federal 
export assistance. That includes expanding access to small business trade financing, 
helping them protect their IPR, and ensuring the most e fficient delivery of services to 
small businesses.  IP/C/M/87/Add.1  
 
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   Additionally, a global focus can help ensure the growth and competitiveness of US 
startups. The US  Government  is committed to give entrepreneurs the tools and 
resources needed to thrive and compete in toda y's global economy.  
 Our federal agencies support entrepreneurs throughout every phase of the business -
life-cycle so that MSMEs can achieve success through the export of their products 
and services around the world.  
USG Matchmaking Programmes  
376.  Various government agencies have a number of services available to small businesses to 
help them grow and eventually, boost exports.  
377.  International business development is a labor -intensive endeavor for any company. And this 
was also something that we heard repeate dly yesterday. The US Commercial Service, part of 
the Department of Commerce, helps to jump -start MSMEs efforts by helping companies to identify, 
screen, and meet prospective partners, agents, distributors, and customers. IP is a crucial 
component in this process.  
378.  The International Trade Administration, with more than 100 offices across the country in US 
Export Assistance Centers and Commercial Service Officers in more than  75 international markets, 
are key sources of business counseling, market research, b usiness matchmaking, trade events, 
and knowledge regarding implications of foreign regulations. The Commercial Services offers the 
experience and services needed to grow international sales of US made products and services. 
Some of the services include:  
 Customized Market Research -answers questions about an overseas market including 
market trends and size, customary distribution and promotion practices, market 
entry requirements, regulations, product standards and registration, key competitors 
and potential  agents, distributors, or strategic partners.  
 International Partner Search programmes provide  US MSMEs with a list of up to five 
agents, distributors and partners that have expressed an interest in their product or 
service.  
 Certified Trade Missions - provid es an effective way for groups of US companies to 
explore business opportunities in overseas markets and meet with agents, 
distributors, government and industry officials and prospective customers.  
 Gold Key Service provides US firms traveling to a foreign market with up to five pre -
screened appointments to establish relationships with potential overseas agents, 
distributors, sales representatives, business partners and other local entities in -
country.  
 The International Buyer Program (IBP) is a joint government -industry effort that 
brings thousands of international buyers to the United States for business -to-
business matchmaking with US firms exhibiting  at major industry trade shows.  
  Other government ag encies provide resources that help MSMEs become export 
ready and help them expand their business abroad.  
379.  For example, the Small Business Association, through their Small Business Development 
Centers (SBDCs) provide an array of technical assistance  
 They serve as key resource partners for helping small businesses become export 
ready through one -on-one con sulting and low -cost training.  
 They organize trade missions, conduct market research, and arrange for meetings 
between paid participants and potential cus tomers.  
380.  The US Trade and Development Agency (USTDA) helps companies create US jobs through 
the export of US goods and services for priority development projects in emerging economies.  IP/C/M/87/Add.1  
 
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  381.  The Minority Business Development Agency (MBDA) is an agency in the US Department of 
Commerce helps create and maintain US jobs by promoting the growth and global competitiveness 
of MSMEs owned and operated by members of the minority communities.  
382.  With a national network of 40 MBDA business centers, MBDA provides minority busin ess 
owners and entrepreneurs with strategic business consulting, procurement matchmaking, capital 
sourcing, bonding and certification services, teaming arrangements and global marketing.  
383.  An example of some MBDA programme s include:  Millenials Entrepreneurs Redefined - This is 
the US Black Chambers Community Economic Development Corporation's Millennials 
Entrepreneurs Redefined program me which provides resources and connects a national network of 
our community's most promising entrepreneurs. The programme  serves diverse millennials 
(aged  18-35) who (a) have not yet started a business but have an innovative idea, or (b) have an 
emerging business with less than $10,000 in capital and/or  revenue.  
384.  There is also the Inclusive Innovation Initiative (I -3) - which is a national outreach effort to 
increase the participation of minority business enterprises (MBEs) and minority -serving institutions 
in the national federal laboratory network. I -3 provides a competitive advantage for under -
represented entrepreneurs and techn ologies.  
Clusters  
385.  In addition to the various matchmaking programme s the US government offers, the USG has 
joined forces with universities and foreign governments to create additional programme s to foster 
MSME growth and trade . 
386.  The US Cluster Mapping Project is a national economic initiative that provides over 50 million 
open data records on industry clusters and regional business environments in the United States to 
promote economic growth and national competitiveness. The project is led by Harvard Business 
School's Institute for Strategy and Competitiveness in partnership with the US Department of 
Commerce.  
387.  Internationally, DOC (EDA) and Harvard University have worked with Mexico, as just one 
example, to create compatible cluster maps  that can be analyzed in a binational fashion to identify 
areas for investment and job creation and enhance regional economic development between 
the United States and Mexico. This tool allows the public and private sectors to better understand 
supply chai n linkages and better assess where to locate new businesses.  
In Conclusion  
388.  Today, more than ever, we see the power and impact new businesses have throughout 
developing communities as MSMEs create jobs, export, improve quality of life, and help define 
the characteristics that make communities alive and unique.  
389.  Looking back on the wealth of experience gained over the course of this year examining 
different factors relevant to MSMEs and Innovation, including through informative interventions by 
delegates and y esterday's side event, a few points stand out:  
 MSMEs represent a critical and treasured component of each of our economies.  
 Virtually all MSMEs have an interest in IP protection and enforcement, whether it be 
through in the areas of patent, copyright, trad emark, trade secrets, or a combination 
of these.  Although awareness of those opportunities through IP vary significantly 
among MSMEs.  
 Governments around the world are increasingly seeking to address the needs of 
MSMEs through targeted programme s focusing o n disparate areas, including 
matchmaking, incubators and clusters, IP technical and legal assistance, and wide -
ranging partnerships.  
390.  As we continue to move forward with these initiatives, it's increasingly important to ensure 
that the fundamental IP polici es that serve MSME and large companies alike are sound so as to IP/C/M/87/Add.1  
 
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  maximize the return on investment of the significant contributions made by governments and 
MSMEs. I look forward to hearing other comments on this topic.  
12.7 Chinese Taipei  
391.  First of all, on behalf of the Separate Customs Territory of Taiwan, Penghu, Kinmen and 
Matsu, I would like to thank the US for organizing the IP and I nnovation seminar yesterday. It i s 
useful to hear voices from private sectors calling governments to take more IP measures to help 
companied to better integrate into global trade.  
392.  Micro, small and medium -sized enterprises (MSMEs) account for about 98% of our 
companies. They are therefore one of the key drivers of eco nomic growth, and have always been 
the backbone of our economy. Despite their particular strengths in terms of innovation and 
creativity, however, for much of the time, MSMEs play only a small part in the supply chains of big 
companies, mainly due to a lac k of knowledge in how to make full use of the IP system. For this 
reason, the participation of MSMEs in export activities st ill remains relatively limited.  
393.  To provide support to MSMEs and make it easier for them to integrate into global markets, 
my delegat ion is very pleased to co -sponsor this proposal. And today, we would like to share with 
WTO Members the results of some of our measures, and in particular our experiences with two 
projects that we have recently carried out.  
394.  The first of these is on "Enhanc ing the Integration of the Business Strategy and Intellec tual 
Property Management System" . Introduced in 2012, this new project is dedicated to helping 
MSMEs to set up their own IP Management System, thereby reducing the relevant IP risks and 
possible liti gation costs as they seek to make inroads into the international market. As an integral 
part of this project, experts make on -site visits to businesses to offer consultation and diagnostic 
services relating specifically to their IP management weaknesses.  In addition, plans are made to 
design and carry out new IP management systems, which are also verified later on -site so as to 
ensure the effectiveness of the plans.  
395.  Over the past three  years, a total of 14 MSMEs have joined the project, and built up their 
own IP Management Systems. This has resulted so far in a reduction in operating costs, indirectly, 
by an  estimated total of US$27 million, and an increase in total output to the v alue of US$1.3 
billion.  
396.  For example, O 'right, a leading local, green, hair -care brand, had previously experienced 
a number of trademark squatting incidents when it tried to push into overseas markets. 
The company joined the project in 2013, and has established its IP Management System since. 
In addition to providing IP training cour ses, the project helped the company to coordinate 
the processes of its different departments, before designing and setting -up its own IP 
management system in the hope of further improving its competitiveness. The company also 
established an IP Evaluation C ommittee, which manages all R&D proposals. As a result of 
the project, the patent quality of O 'right has improved significantly, its number of patent 
applications has doubled, and its products are now sold all over the world, including the U nited 
States, Europe, China, Japan, Republic of Korea , and South East Asia.  
397.  The second project I would  like to share with you is our "Branding Campaign" . This offers 
MSMEs the support and resources that they need when attempting to build or transform brands. 
It provides consultation and diagnostic services to local businesses, specifically on their 
IP portfolios, IP management weaknesses, patent strengths, possible obstacles to patents, and 
patent portfolio strategies, to help them develop high -value and distinct, differe ntiated products 
and brands that are even more competitive globally. To date, the project has encouraged more 
than 10 MSMEs to expand their international patent portfolios, generating licensing fees to 
the value of some US$53 thousand annually.  
398.  Tongtai  Machine & Tool Company, for example, a local company developing high -end 
machine -tools and customized automated production equipment, suffered serious setbacks in its 
attempts at brand globalization, due to patent infringement and trademark squatting when  it tried 
to enter international markets. The company therefore took advantage of the project to receive 
consultation and training assistance on its patent and trademark portfolio, as well as on IP IP/C/M/87/Add.1  
 
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  knowledge in general. Advice and information was provided on key aspects, such as trends and 
developments in technology and patents, to help Tongtai improve its own -brand products. This has 
succeeded in cutting the company 's new product development process by some six to nine 
months, and has helped Tongtai to des ign around and avoid at least five patent claims involving 
high infringement risks, making an annual saving on licensing fees of some US$80 thousand.  
399.  Today, Tongtai has built up a trademark portfolio covering 21 global brands in 16 countries, 
including Swi tzerland, Brazil, and South Africa, as well as countries in the EU and in South East 
Asia, generating an increased output value of about US$1.5 million in real terms.  
400.  To summarize, the IP and innovation strengths of MSMEs definitely play a key role in 
boosting economic growth. It is of crucial importance, therefore, that governments provide support 
to MSMEs and equip  them with comprehensive IP strategies, thereby tapping into their potential 
while expanding trade.  
401.  We would certainly welcome hearing about an y relevant measures and experiences from 
other WT O Members as well.  
12.8 Canada  
402.  Canada is pleased to co -sponsor today's agenda item on IP and Innovation, Inclusive 
Innovation and MSME trade. Canada would also like to thank Switzerland for drafting the  guiding 
communication for today's discussion as well as the co -sponsors and other Members that have 
shared national experiences and insights on this issue so far. We would also note yesterday's 
Friends of IP and I nnovation SMEs –event . We found the interventions by all participants to be 
instructive and pertinent, but found the opportunity to hear the MSME -perspective directly to be 
particularly useful.  
403.  In examining the relationship between small and medium -sized en terprise IP ownership and 
trade, a 2014 survey on financing a nd growth of SMEs conducted by Innovation, Science and 
Economic D evelopment Canada, found that SMEs that hold IP were four times more likely to 
export than those that did not. As well, according to the Canadian Intellectual Property Office, or 
CIPO, 2016 IP Canada report, Canadian IP activity has notably grown in recent years with overall 
global IP rights applications by Canadians growing by  35% from 2005 to 2014.  
404.  With respect to patents, growth a nd applications abroad has been rapid, with 34% more 
patents filed abroad in 2014 than in 2005. More than half of this growth has com e from the use of 
the WIPO patent co -operation treaty by Canadian filers. Particularly, as Canadians continue to 
diversify their export markets by fi ling in multiple jurisdictions.  
405.  Similarly, trademark applications are another key factor in the growing use of IP rights by 
Canadian  firms internationally,  as our applications for industrial design protection in global 
markets. At  the same time however, SMEs often have a low awareness of IP and overlook 
the value of IP protection when seeking to expand into new markets and to access global business 
opportunities. Underutilized IP can translate into potential lost business opportuni ties while fully 
leveraged  IP rights can open the door to new business partnerships, for instance through the sale 
or licensing of IP, creating opportunities for growth, access to foreign markets and 
new investment.  
406.  In this sense, building IP literacy is i mportant to ensuring that SMEs have a sound 
understanding of IP rights when entering foreign markets and can better utilize and leverage their 
IP assets as part of their business and growth strategies. In Canada , CIPO has launched an IP 
awareness and educa tion programme to deliver tailored and responsive products, services and 
training to innovators and SMEs. CIPO's IP awareness and education programme offerings include 
guides, one -pagers and process maps. In addition to seminars and training sessions, they  provide 
business with the tools and information they need to better acquire, manage and leverage their IP  
assets. Seminars and training services for businesses, partners and intermediaries, including those 
for particular markets and sectors, and a suite of network services including referral  consultation 
and support to advisory services is currently in the development stage.  IP/C/M/87/Add.1  
 
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  407.  CIPO also maintains a dedicated webpage for Canadian businesses seeking to learn more 
about managing IP as they prepare to grow their  business in Canada and internationally. This page 
includes advice on learning the basics of IP rules in countries in which exporters are seeking to do 
business, taking stock of IP assets, for instance by building an inventory of IP assets in business 
plans and developing an IP strategy linked to a firm's  export business plan. CIPO's guide also 
includes advice on searching international IP databases in export markets, formal registration and 
protection of IP rights, and information on preventing and remedyi ng IP infringement in foreign 
markets.  
408.  In addition, the government of Canada is building upon CIPO's initiatives to further increase 
the use of IP by businesses to support their growth and competi tiveness. The government of 
Canada also offers a range of pr ogrammes and services  as well as financial support aimed at 
supporting MSME expansion into export markets. For instance, Can ada's Going Global Innovation 
or GGI programme  administered by Global A ffairs Canada 's Trade Commissioner Service, supports 
research ers who aim to commercialize technology by pursuing collaborative, international research 
and development opportunities through partnerships with key players in foreign markets. GGI 
provides assistance to eligible beneficiaries such as Canadian SME and inn ovators by contributing 
up to 75% of eligible expenses for prude pr ojects related to international collaboration. GGI 
provides eligible applicants with up to CAN$75,000, with funding to cover eligible costs required to 
seek international partnerships in fo reign markets.  
409.  More recently, in January 2016, Canada announced the launch of the CanExport, a five -year 
programme  which will provide CAN$50 million in direct financial assistance to SMEs that are 
registered in Canada and that are seeking to develop new export -opportunities, especially in high -
growth emerging markets. Delivered by Global Affairs Canada's Trade Commiss ioner Service in 
partnership with the National Research Council Industrial Research Assistance programme, 
CanExport provides financial support for a wide range of export ma rketing activities. Among 
the eligible expenses covered by CanExport funding, applic ants may use financial assistance in 
respect of IP protection and certification expenses in foreign markets as well as certification fees 
necessary for market access and adaptation and translation of contractual agreements for 
target  markets.  
410.  These are jus t some of the services and programmes offered to MSMEs in Canada and it is 
supporting their growth and expansion into foreign markets. Canada would be pleased to provide 
additional information on any of these services and programmes to other Members upon r equest. 
We would once again like to thank other Members for sharing their national experiences and for 
the productive exchange of ideas on this issue with the view to discussing how IP frameworks can 
be used to support MSME trade in this regard.  
12.9 Chile   
411.  The Ministry of the Economy of Chile has promoted a series of initiatives to increase 
the number of enterprises that incorporate innovation as a strategy for competitiveness and 
productivity, the actions diff ering according to the type of enterprise.  
412.  Starting in 2015, measures were introduced to modernize funding schemes, followed as of 
2016 by initiatives to universalize innovation. During this year and next year, we hope to be able 
to develop a pro innovatio n culture.  
413.  The support programmes include:  
a) support for the patenting of Chilean inventions abroad, strengthening the business plan 
and developing international patenting strategies;  
b) innovation vouchers for SMEs that come up with innovative solutions to productivity and/or 
competitiveness challenges;  
c) innovation prototypes in support of product and process improvements, that would make it 
possible, inter alia, to finance research and development in the areas of technological 
integration, design and constru ction of prototypes;  
d) high technology innovation in support of the development of innovative solutions to 
complex production challenges in relation to knowledge or of a general nature;  
e) finally, aware of the importance of strengthening networks, we have the so called Pymelab 
2017, which aims to foster regional innovation ecosystems by creating regional networks IP/C/M/87/Add.1  
 
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  that bring together local players and promote regional participation in company innovation 
initiatives and projects.  
414.  Chile has a whole range of initia tives to stimulate innovation in the SMEs in order to boost 
their competiveness and productivity through collaborative, open and identifiable innovation 
processes. We hope to be able to share positive results from these initiatives in the short and 
medium term.  
12.10  Costa Rica   
415.  It is clear to Costa Rica that it is necessary to develop and strengthen micro, small and 
medium sized enterprises if it is to maintain and improve the quality of life of all its inhabitants.  
416.  According to the Ministry of the Economy, Industry and Trade, micro, small and medium -
sized enterprises accounted for 93.3% of the country's businesses in 2016.  
417.  SMEs' share of total exports (f.o.b.) in the trade, industry, services and IT sect ors that year 
was 14.8%.  
418.  Integrating intellectual property into SMEs' business strategy is key, as:  
 it adds value, enhancing SMEs' competitiveness by protecting their creations and 
innovations;  
 the designing of logos, products, marks, and so on creates an identity for an SME 
that distinguishes it in the domestic market and facilitates internalization; and  
 intellectual property becomes an asset that can generate financial compensation 
through licensing or the granting of permits.  
419.  For these reasons, various p olicies have been developed to incentivize innovation in SMEs 
and to encourage the protection of patents, marks, etc. through intellectual property education. 
We will discuss some of these programmes now.  
Promoting intellectual property rights as an econom ic asset  
420.  As we have stated, Costa Rica recognizes the importance of innovation as a tool for 
achieving economic growth and social inclusion. It is therefore a priority under the National 
Development Plan5 to bring the innovation programme up to date.  
421.  The M inistry of Science and Technology (MICIT) plays a key role in developing programmes 
to attain the National Development Plan's objectives. It has therefore worked closely with SMEs to 
promote innovation and intellectual property protection. In 2016, 80 trai ning events were 
organized targeting this sector.  
Programme to Support Small and Medium Sized Enterprises (PROPYME)  
422.  Through the PROPYME, the MICIT funds actions and activities aimed at promoting and 
building the management capacity and competitiveness of C osta Rica's SMEs, using technological 
development as a tool for contributing to the country's economic and social development.  
423.  The beneficiaries of this fund are enterprises engaged in projects relating to technological 
development, patents for inventions,  technology transfer, the development of human potential, 
and technological services.  
424.  The fund is competitive and it is possible to receive funding for up to 80% of the project 
proposed.  
                                                
5 https://documentos.mideplan.go.cr/alfresco/d/d/workspace/SpacesStore/cd1da1b4 868b 4f6f bdf8 
b2dee0525b76/PND%202015 2018%20Alberto%20Ca%C3 per centB1as%20Escalante%20WEB.pdf.  
 IP/C/M/87/Add.1  
 
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  Technology and Innovation Centre (CATI)  
425.  The CATI is a  centre  attached to the Registry of Industrial Property that seeks to provide 
Costa Rican inventors and entrepreneurs with information on technology and registration 
procedures with respect to industrial property in order to encourage innovation processes and 
Costa Rica's scientific and technological development.  
The "My Creations Matter" Project  
426.  The five -year "My Creations Matter" project was officially launched in August 2016 and 
consists of an awareness -raising campaign targeting primary and secondary schools a nd 
educators.  
427.  As part of the project, activities are carried out with children and young people in order to 
create a culture of respect for intellectual property rights.  
428.  The project is developed along two lines, one educational and the other informational.  In 
the first, awareness -raising and training workshops for teachers – and corresponding activities for 
the educational community – are held with the aim of conveying to students didactically the basics 
of copyright and related rights.  
429.  The aim of the informational component is to use digital media as a tool for outreach in order 
to communicate interactively with children, young people and educators.  
430.  The implementation of the "My Creations Matter" project demonstrates the Costa Rican 
Government's commit ment to promoting, building and consolidating a culture of respect among its 
citizens by encouraging outreach and raising awareness in this area.  
431.  This is a strategy that will bear fruit in the long term and that, in addition, demonstrates 
the commitment to  innovation.  
12.11  Brazil   
432.  From the outset, allow me to thank the proponents for the initiative and the documents.  
433.  Micro, small and medium -sized enterprises (MSMEs) play a major role in social and economic 
policies of countries. Brazil, alongside different Member States, is working on areas in which 
the WTO could develop measures in favor of MSMES, as provided, among others, in document 
JOB/GC/127.  
434.  Experts point the following barriers to MSMEs interested in eng aging on international trade: 
lack of knowledge regarding legislation from other countries, burdensome requirements and 
procedures, as well as the necessity of  enhancing market intelligence.  
435.  We are open to examining actions to increase participation of MSM Es in international trade. 
One potential way is the development of information platforms targeting MSME s. Such bases 
should contain information that assists MSMEs in their internationalization efforts, for the mutual 
benefit of trading partners by generati ng growth and reducing transaction costs.  
436.  In the last session of the Council, we provided information about initiatives undertaken by 
the Brazilian Government to assist MSMEs. Please refer to the report of that sessio n for additional 
information.  
437.  Brazil fa vors that intellectual property works as a stimulus to innovation, rather than 
a barrier to access to technology. This includes deepening the understanding of features of 
the intellectual property system related to the achievement of the objective set in A rticle 7 of 
the TRIPS Agreement.  
438.  I would also add the importance that IP offices issue patents of high quality that enhance 
legal certainty. Patents of low quality can represent an additional barrier to entrepreneurs, 
something that particularly affects MS MEs. IP/C/M/87/Add.1  
 
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  12.12  India   
439.  There  were some arguments today that increasing patent monopolies would drive greater 
innovation. However, the evidence does not support this assertion. On the contrary, the view 
gaining ground is that increasing patent monopolies would actually stifle innovati on. In fact, many 
of the examples presented today are actually how IP had promoted MSME trade and business 
opportunity and not on how IP monopoly will promote innovation or inclusive innovation.  
440.  Intellectual p roperty is only one element in a larger innovat ion ecosystem and IP laws alone 
do not promote technology development. According to the Trilateral study by WTO, WHO and 
WIPO on "Promoting Access to Medical Technologies and Innovation: Intersections between public 
health, intellect ual property and trade (2013)" page 126,  
Patent law is not a stand -alone innovation system. It is only one element of 
the innovation process, and one which can be deployed differently in diverse 
innovation scenarios. Patent law has little bearing on many other factors that lead  to 
the successful development of technologies, e.g. the nature and extent of demand, 
commercial advantages gained by marketing and ancillary services and support, 
commercial and technical viability of production processes, and compliance with 
regulatory r equirements, including through effective manag ement of clinical trials 
data. 
441.  Joseph Stiglitz, the Nobel laureate, in his 2016 paper on "Industrial policy, learning, and 
development", questioned the benefits of IP and stated that IPR, especially if poorly d esigned, can 
impede innovation and learning. I quote, "There are significant static costs of intellectual property. 
It impedes the use of information and gives rise to monopoly power. Increasingly, the alleged 
dynamic benefits have come to be questioned. I PR, especially if poorly designed, can impede 
innovation and learning. Knowledge is the most important ingredient to production of knowledge, 
and IPR reduces access to knowledge. Moreover, the patent system intervenes with the open 
system that is essential  for the advancement of science. In addition, the patent thicket and patent 
trolls have provided further impediments to research. The patent system even distorts the pattern 
of research, encouraging more research directed at extending market power. These a dverse 
effects are especially significant for developing countries. Successful development entails closing 
the knowledge gap and necessitating access to knowledge. It is even more important in areas of 
health —access to life saving medicines has implicati ons that go beyond the budget."  
442.  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 gove rnment to people at 
all levels.  
443.  MSME sector in India consi sting of 36 million units provides employment to over 80 million 
persons. The sector, through more than 6,000 products, contributes about 8% to GDP besides 
45% to the total manufacturing output and 40% to the exports from the country. The MSME sector 
has t he potential to spread industrial growth across the country and can be a major partner in 
the process of inclusive growth.  
444.  To enhance awareness of MSMEs about Intellectual Property Rights (IPRs), Government of 
India launched a scheme titled "Building Aware ness on Intellectual Property Rights (IPR)" for 
the MSME in August 2008. The scheme enhances awareness of MSMEs about IPRs to take 
measures for protecting their ideas and business strategies, which would also assist them in 
technology upgradation and enhan cing competitiveness.  
445.  A national innovation survey was conducted during 2011 -12 in India by the Government of 
India and the report, based on the analysis of sample survey of 9001 firms, largely MSMEs, spread 
across various provinces and various industrial sectors in the country, identified many barriers to 
innovation with regard to MSMEs, including availability of finance and in general the cost of 
innovation, availability of skilled manpower, access to market information and availability of 
information tec hnology, infrastructure, domination of established player in the market, regulatory 
requirements etc. IPR related issues are not found to be of any concern for the inno vation 
activities of the firms.  IP/C/M/87/Add.1  
 
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  446.  I conclude by quoting from statement made by our Prime Minister during the launch of 
Mission Innovation in Paris in 2015, "Innovation must be backed by means to make it affordable 
and ensure adoption".  
12.13  South Africa  
447.  South Africa has progressively shifted away from dependence on primary resource 
production and commodity -based industries to open up to international trade and to building 
capacity in some knowledge -intensive industries.  
448.  The Ministry of Small Business Deve lopment was established in 2014 marking a turning point 
in history of MSME's and Co -operatives development in South Africa, demonstrating Government's 
commitment to place MSME's and Co -operatives at the  centre  of economic growth and 
job creation.  
449.  In the co ntext of economic growth, MSMEs play an important role as levers for economic 
development. Research undertaken in this respect highlights the fact that generally, an active 
MSME sector creates opportunities resulting in higher volumes of production, employ ment, 
entrepreneurial talents and increases in export of goods  and services . Furthermore, it is noted 
that, in addition to being a lever for increasing economic growth, MSMEs can eventually grow into 
larger firms that are able to contribute to increased em ployment opportunities as they evo lve 
through the business cycle.  
450.  The term MSME covers widely different types of firms. Everything is included, from fragile 
zero growth micro -firms (normally employing up to a couple of workers generating subsistence 
level revenues) to fast growing medium sized firms with up to 250 employees. The role these firms 
play for the developing economy and the challenges they face are often completely different. Micro 
firms often struggle with fluctuating revenues, red tape complexi ty, and lack of knowledge and 
relevant competencies. For medium sized firms, access to sufficient amounts of risk capital, access 
to technology and access to stable electricity sup ply may be more of a challenge.  
451.  South African organizations  are classified a s 'small' when they have fewer than 50 
employees and 'medium' when they have fewer than 200 employees (or fewer than 100 for 
agricultural organizations ). Only 25% of new MSMEs created in South Africa survive the first two 
years of operation. As in most cou ntries across the world, MSMEs play a critical role in economic 
contribution and employment. MSMEs are estimated to contribute 46% of the total economic 
activity and 84% of private employment  in South Africa . Research shows that 68% of all workers 
in South  Africa are employed by small businesses employing fewer than 50 people.  
452.  Innovation in MSMEs lags that involves large enterprises, MSMEs face significant challenges 
in this context. MSMEs tend to have limited resources (financial, human, and physical) and fewer 
systematic management capabilities. Their market penetration is restricted due to the size of their 
organizations , while securing and enforcing IP is challenging due to the costs involved. A lack of 
basic business management and risk management syste m is also relevant  in this regard . MSMEs 
are thus vulnerable when they enter into commercializ ation relationships.  
453.  The Department of Trade and Industry (DTI) supports the export process for MSMEs which is 
driven from a sectoral perspective, and sector stra tegies offer the framework within which exports 
are encouraged and incentivized. The DTI focuses on promoting sectors of the economy that have 
shown the greatest growth potential and marketability.  
454.  In partnership with Provincial Investment Promotion Agenci es (PIPAs) and Export Promotion 
Agencies,  the DTI promotes investment and export activities in targeted markets. It has teams 
operating from regional offices around the world providing market intelligence and identifying 
opportunities for South African com panies, as well as sector specialists offering advice on export 
processes and procedures.  
455.  Export -oriented companies have, in partnership with the DTI, organized  themselves into so -
called Export Councils, which target specific markets. These assist exporter s in reaching their 
targets, and specifically enable small businesses in any sector to access DTI support structures.  IP/C/M/87/Add.1  
 
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  456.  The DTI also provides incentives to exporters – with a special focus on small, medium and 
micro enterprises (SMMEs) and black economic emp owerment (BEE) exporters – through 
the Export Marketing and Investment Assistance (EMIA) scheme.  
457.  I would like to quote just one example of a smal l business that has been able through  
support  access foreign markets and this company is called PlayPump™ . 
458.  The story of this company is essentially that t he idea was first dreamt up by an engineer and 
borehole -driller, Mr. Ronnie Stuiver. As he traveled the country drilling wells, and saw fascinated 
children would crowd round him – most with boundless energy and fe w outlets for play. 
He devised a merry -go-round attached to a simple pump. When children spin the  merry -go-round, 
the attached pump pulls water from the ground. His company later developed and patented 
the PlayPump™ water system.  The word PlayPump™ is regi stered as a trademark throughout 
the world , and has been installed in disadvantaged communities across the African continent . 
459.  Many developing countries with moderate research activities suffer from an innovation void 
because they fail to bridge the gap bet ween knowledge generation and knowledge application. 
The story of PlayPump™ depicts how a small initiative can be very effective in bridging the gap to 
bring basic technology to communities and thus transform the lives of millions of people.  
12.14  China   
460.  China believes that establish ing a suitable IP system can help MSME s participate the global 
trade and can have positiv e effect on development of the M embers' economy and innovation. 
But IP is not the only fac tor influences MSMEs involve in the global trade. Talent, capitals are also 
important, especially for those in the devel oping M embers. China believes that the discussion 
on this issue shall be from a wider perspective . 
12.15  Switzerland  
461.  I would like to thank all the delegations who participat ed in the discussion under this  agenda 
item. We had an extremely rich and broad exchange of experiences , which we found, from our 
perspective, very helpful. I would like to particularly mention the intervention by the distinguished 
delegate of South Africa , who  pointed out challenges and problems that particular ly MSMEs  face in 
getting into trade and really mak ing positive use of intellectual propert y to enhance and grow 
trade in the export potential. I think it is sometimes more the problems and challenges that we 
might need to  look at rather than the top perform ing companies that are running well anyway. 
That is certainly where we can take lessons h ome and we will read in detail the minutes once they 
are out and may come back with other considerations with regard to some o f the interventions 
made today.  
AGENDA ITEM 13: INTE LLECTUAL PROPERTY AN D THE PUBLIC INTERES T: FOLLOW -UP 
DISCUSSION ON COMPUL SORY LICENSING  
13.1 South Africa   
462.  This statement is read on behalf of Brazil, China, India and South Africa. Following 
the circulation of document IP/C/W/630, the co -sponsors introduced "Intelle ctual Property and 
the Public Interest" as a topic for discussion. During the initial discussions, the co -sponsors 
emphasized that WTO members have the flexibility to design their national IP systems within the 
minimum standards set by the TRIPS Agreement,  in cognizance of a  country's economic, 
developmental and other objectives, including public health. The TRIPS Agreement clearly 
recognizes that the principles of IP protection are based on underlying public policy objectives. 
Article 8 of the TRIPS Agreem ent entitled "Principles" states that WTO Members may, in 
formulating or amending their laws and regulations, adopt measures necessary to protect public 
health and nutrition, and to promote the public interest in sectors of vital importance to their 
socio-economic and technological development, provided that such measures are consistent with 
the provisions of this Agreement.  
463.  Article 8 .2 further states that appropriate measures may be needed to prevent the abuse of 
IPRs by right holders, or to resort to prac tices which unreasonably restrain trade or adversely IP/C/M/87/Add.1  
 
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  affect the international transfer of technology. The Trilateral Study of the WHO, WIPO and 
the WTO (2013) point s out that prices of medicines are a critical determinant of access to 
medicines, especially  in countries where the public sector is weak and poor people purchase their 
treatment on the private market (2013:146). It posits that in some developing countries, up to 
80% to 90 % of medicines are purchased out -of-pocket, as opposed to being paid for by  national 
health insurance schemes or pr ivate insurance schemes (ibid).  
464.  In the last session of the TRIPS Council, the co -sponsors invited delegations to share their 
experiences on the use of c ompulsory licenc es for accessing health and other technologies. Some 
delegations indicated t hat the use of compulsory licenc es can assist countries to uphold 
the delicate balance achieved in the TRIPS Agreement, and noted that even though the use of 
compul sory licenc es is c ommonly referenced in respect of health issues, compulsory licenc es can 
also be used in a variety of other situations as well. Various delegations made reference to 
the entry into force of the Protocol Amending the TRIPS Agreement, while the United Nations  
Secretary General's High -Level Panel Report on Access  to Medicine was widely quoted.  
465.  One delegation expressed the view that a balanced system of intellectual property rights is 
one that takes into account legitimate interests of users and right holders an d endorsed the idea of 
intellectual property as a fundamental right of every citizen. The right to health is a fundamental 
part of our human rights and our understanding of a life of dignity and as such the achievement of 
the highest attainable standard of  health is the right of every human being, without distinction of 
race, religion, political belief, or economic or social condition. This is codified in the 1948 Universal 
Declaration of Human Rights. In the same vain, SDG Goal 3 , Target 3.b relating to su pport for 
research and development of vaccines and medicines for the communicable and 
non-communicable diseases that primarily affect developing countries, promotes access to 
affordable essential medicines and vaccines, in accordance with the Doha Declarat ion on the TRIPS 
Agreement and Public Health, which affirms the right of developing countries to use to the full 
the provisions in the Agreement on Trade -Related Aspects of Intellectual Property Rights regarding 
flexibilities to protect public health, and,  in particular, provide access to medicines for all.  
466.  A common theme that emerged from discussions was how g overnments use compulsory 
licenc es to substantially reduce the price of essential medicines while striking a balance between 
the interest of right holders and users. It is however noteworthy that in specific areas, such as 
access to antiretroviral therapy, where substantial progress has be en made, and where substantial 
price reductions for commonly used first -line ARVs have been achieved, prices for second -line 
regimes remain much higher (2013:150). The World Health Statistics 2017 point out that new 
health technologies, such as medicines, vaccines and diagnostics are becoming increasingly 
expensive (2017:19). As one of the co -sponsors pointed out, pubic interest in the achievement of 
inclusive public health goals call on the active participation of governments, pharmaceutical 
companies and patient associations alike. As a result, a balanced intellectual property system, 
through a combination of flexibilities, complementary policies and incentives, guarantee 
sustainable public health outcomes that harness innovation and promotes access to med icines and 
health technologies.  
467.  Given the continued interest that delegations have expressed in the topic of compulsory 
licence s, the co -sponsors have decided to continue an inclusive debate on compulsory licence s. 
Since the last TRIPS Council meeting, sev eral noteworthy developme nts have occurred in 
this area. 
468.  On 6 June, 2017, Judge William Martin Conley, a United States District Judge of the Western 
District of Wisconsin, issued a compulsory licence  allowing Apple Computers to use a patent it had 
infringe d, owned by the Wisconsin Alumni Research Foundation (WARF), in return for an ongoing 
royalty.6 This case follows a long line of cases that seem to suggest that court decisions in 
the United States have allegedly responded to instances of infringement of m edical patents by 
denying injunctive relief, instead granting monetary damages, often in the form of royalty 
payments, what would in effect provide for compulsory licensing. Public interest is often at 
the heart of such decisions.  
                                                
6 In the case of Wisconsin Alumni Research Foundation v. Apple, Inc ., Case: 3:14 -cv-00062 -wmc, (W.D. 
Wis., June 6, 2017).  
 IP/C/M/87/Add.1  
 
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  469.  On 11 July, 2017, the Ger man Federal Supreme Court announced that it had affirmed 
the 2016 decision of the Federal Patent Court to issue a compulsory licence  allowing Merck to 
continue selling its HIV drug, Isentress. The Federal Court shared the assessment of the Federal 
Patent C ourt that a public interest in the granting of a compulsory licence  was credible.  
470.  On 20 September 2017, the Malaysian Department of Health announced that Cabinet had 
authorized a government use compulsory licence  in respect of generics of the Hepatitis C m edicine 
Sofosbuvir. The decision to initiate the Rights of Government was made after the MOH efforts to 
include the drug in the Medicine Patent Pool (MPP)  failed  and price negotiations with patent holder 
were unsuccessful.  
471.  On this basis, I would like to invite the co -sponsors and other delegations to intervene on 
the issues taken up in this statement or any other matter that may be raised in the context of 
compulsory licence s. 
13.2 Brazil   
472.  First we would like to support the statement made yesterday by South Africa.  In the last 
session, Brazil, China, Fiji, India and South Africa circulated document IP/C/W/630, with the goal 
of expanding the discussions on a very important topic for the  multilater al trade system. There is a 
continuous need of increasing knowledge regarding those aspects and the exploration of possible 
solutions for developing as well as for developed countries. Indeed, for all Member States.  
473.  In the first session in which the issue was discussed, some delegations claimed that 
the document did not take into account the benefits of protecting IP and focused only on 
compulsory licenses.  As we have stated before, we do not see those issues as mutually exclusive. 
On the contrary: Brazil u nderstands that the balance reached by the TRIPS Agreement allows for 
ways to address their public health challenges while maintaining intellectual property systems that 
incentivize the investment and research necessary to develop innovative new medicines.  This is 
clearly provided in two of the pillars of the Agreement, namely, Articles 7 and 8, which contain 
the objectives and principles of intellectual property protection under the treaty. In our view, 
a balanced IP system, with built -in flexibilities as well as complementary policies and incentives, is 
the best way to promote innovation in all fields of technology, including the  health sciences. In 
short: a balanced IP system is a much stronger IP system.  
474.  The recent entry into force of the Protocol of Ame ndment to the TRIPS Agreement 
demonstrates the need to have mechanisms that ensure adequate remuneration to intellectual 
property rights holders while allowing governments to adopt measures necessary to protect 
the public interest. The Preamble of the TRIPS Agreement advocates this view, as it recognizes 
"the underlying public policy objectives of national systems for the protection of intellectual 
property, including developmental  and technological objectives".  
475.  We have previously described the process that led  to the single compulsory licenc e issued by 
Brazil, as well as the results achieved by it. More recently, developments in countries from 
different regions have generated increased interest on the matter. As an example, last July 
the Bundesgerichtsh of, Germany's highest civil court, decided to uphold the decision of a lower 
court to grant a prov isional compulsory patent licenc e on Raltegravir, an antiretroviral drug 
ingredient. The producer of that medicine was facing legal threats from the owner of 
the Raltegravir patent, in spite of distributing the drug in Europe for some years. In the course of 
judicial proceedings, it requested a compulsory license based on Sectio n 24 (1) of the German 
Patent A ct. 
476.  Section 24(1) of the German Patent Act lists two conditions for the grant of a compulsory 
licenc e, namely, that the licenc e seeker has, within a reasonable period of time, unsuccessfully 
attempted to obtain permission from the owner of the patent and, second, that the public interest 
calls for the grant of a compulsory licenc e. Based on it, it was decided to grant  a provisional 
compulsory licenc e, allowing the company to continue to distribute the medicine containing 
Raltegravir in the country.  IP/C/M/87/Add.1  
 
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  477.  The Court understood that there is a concrete need of certain  HIV patient group for 
a treatment containing Raltegravir. The use of alternative compounds would entail severe risks of 
adverse effects and a loss of therapy quality, in particular for infants and pregnant women.  
478.  This decision, in Brazil's view, is a good  example of how the IP system provides the basis for 
advancing the public interest without prejudicing the innovative efforts by companies. It also 
shows that this should not be a polarizing issue, as it is of interest to all Member States of this 
organiza tion. 
479.  During  the June session of the Council we heard comments to the effect that access to 
medicines also depends on factors outside the IP system. While this is undoubtedly a complex 
phenomenon that requires a broad range of actions, the mandate of this Council does not include 
tax systems or the physical infrastructure of countries, but intellectual property. Let us focus on 
this issue and its concrete effects in a positive and constructive way, enabling a rich exchange of 
views and experiences that enha nces the mutual understanding of the matter.  
13.3 India  
480.  I would like to  support the statements made by South Africa and Brazil. During the last 
meeting of the Council for TRIPS, many Members, including India, shared their experiences on 
the use of compulsory licensing (CL). We have shared details of provisions in our national law 
regarding compulsory licensing, including the one compulsory licence issued by India so far, i.e., in 
March 2012, Indian generic manufacturer NATCO Pharma was granted compulsory licence to 
manufacture Bayer's drug Sorafenib Tosylate (Nexavar) used for the treatment of Kidney and Liver 
cancer. Since the last meeting of the Coun cil for TRIPS, compulsory licences were issued by 
Germany and Malaysia. I would like to thank the delegations of South Africa and Brazil for 
providing details about these two compu lsory licences issued by Germany and Malaysia.  
481.  The TRIPS Agreement attempts to strike an appropriate balance  between the interests of 
right holders and users. TRIPS Agreement also recognizes that the principles of IP protection are 
based on underlying publ ic policy objectives. In furtherance of the objectives and principles of 
TRIPS enshrined in Articles 7 and 8, a number of safeguards or flexibilities have become an 
integral part of the TRIPS framework. These flexibilities have been clarified and enhanced by 
the 2001 Doha Declaration on TR IPS and Public Health that WTO M embers have the flexibility to 
interpret and implement the TRIPS provisions in a manner supportive of their right to protect 
public health.  
482.  Article 31 provides M embers complete freedom to de cide the ground s for issue of 
compulsory licenc e. The Doha Declaration on the TRIPS Agreement and Public Health has also duly 
confirmed what was already implicit in the TRIPS Agreement – that WTO Members have 
the freedom to determine the grounds upon which  compuls ory licenses are granted.  
483.  During the 1980s and 1990s , the antiretroviral medicines used to treat HIV/AIDS were 
priced beyond the reach of most people who needed them in developing countries. Countries like 
Brazil, Thailand, South Africa and others have used flexibilities under the TRIPS Agreem ent, 
including compulsory licensing  to bring down the price by increasing the supply of generic ARV 
medicines for a fraction of the price of the patented equivalents. Indian generic companies, 
especially CIPLA played an important role by announcing in early 2001 that that triple therapy 
could be manufactured for less than a dollar a day from the price of standard triple therapy from 
US$10,000 per patient/year. Indian generic companies made ARV medicines accessib le to all those 
who needed the drugs but had previousl y not been able to afford them.  
484.  Now, I would like to provide brief details of the compulsory licensing provisions in 
a developed Member, the United States. According to United States Congressional Research 
Service article "Compulsory Licensing of Patented Inventions" dated 14 January 2014, the law in 
the United States permits for t he issuance of compulsory licenc es in a nu mber of circumstances, 
and also allows for circumstances that are argu ably akin to a compulsory licenc e. The Atomic 
Energy Act, Clean Air Act, the Federal Insecticide, Fungicide and Rodenticide Act and Plant Variety 
Protection Act provide for compulsory li censing. Atomic Energy Act allows for compulsory licens ing 
if the invention or discovery covered by the patent is of primary importance in the production and 
utilization of special nuclear material or atomic energy; Clean Air Act contains a similar provisi on IP/C/M/87/Add.1  
 
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  relating to devices for reducing air pollution; and Plant Variety Protection act, Section 44 -"Public 
Interest in Wide Usage " provides for compulsory licensing of seed -bearing plant s that are 
protected by plant variety certificate, a patent -like instrume nt granted by Department of 
Agriculture. The  Bayh-Dole Act offers the federal government "march -in rights," and 28 U.S.C. 
Section 1498 provides the US government with broad ability to use inventions paten ted by others. 
Compulsory licenc es have also been aw arded as a remedy for antitrust violations and a court may 
decline to award an injunction in favor of a prevailing patent owner during infringement litigation, 
an outcome that some observers believe is akin to the grant of a compulsory licenc e. 
485.  September 2 016 report of the UNSG 's High -Level Panel (HLP) states that many governments 
have not used the flexibilities available under the TRIPS Agreem ent, including compulsory licenc es 
for various reasons, ranging from capacity constraints to undue political and ec onomic pressure 
from states and corporat ions, both express and implied.  
486.  Political and economic pressure placed on governments to forgo the use of TRIPS flexibilities 
violates the integrity and legitimacy of the system of legal duties and rights created by the TRIPS 
agreement and as reaffirmed by the Doha Declaration.  
487.  I conclude by quoting the recommendations in the HLP report on Compulsory Licences.  
"Governments should adopt and implement legislation that facilitates the i ssuance of 
compulsory licenc es. Suc h legislation must be designed to effectuate quick, fair, 
predictable and  implementable compulsory licenc es for legitimate public health needs,  
and particularly with regards to essential medicines. The use of compulsory licensing 
must be based on the provi sions found in the Doha Declaration and the grounds for 
the issuance of compulsory licenc es left t o the discretion of governments ." 
488.  I would request the delegations of the European Union and Malaysia to provide details on 
the CL issued by Germany and Malaysia respectively. We look forward to listening from other 
delegations on their experiences on using this important TRIPS fle xibility, compulsory licensing.  
13.4 China   
489.  China attaches great im portance to the TRIPS and public interest issue. China's Patent Law 
and implementation regulation when they were enacted have specific provision of compulsory 
licensing and these provisions have been improved with later amendments. In 2012, in order to 
increase the feasibility of the system, China issued the new  detailed rules for compulsory licensing . 
490.  China believes the discussion on intellectual property and public interests sho uld be open 
and inclusive . WTO M embers could exchange views and experience s on how to take advantages of 
the flexibilities under the TRIPS Agreement, and effectively solve the public interest problem.  
13.5 European Union  
491.  As already explained during the last TRIPS C ouncil the European Union disagrees with 
the underlying assumption in the communication from Brazil, China, Fiji, India and South Africa, 
that there would be a contradiction between the system of IP rights and the  public interests. On 
the contrary, it is the position of the European Union that a balance d system of IP rights which 
takes into account legitimate interests of users and right holders does serve  the public interest. It 
is for this very reason that the national and international systems of international property have 
been created. In  the European Union  according to Article 17, paragraph 2 of the Chart er of the 
Fundamental R ights of the European Un ion, IPR is a fundamental right for every European citizen. 
The European Union further believes that TRIPS generally, although only being minimal standards 
as rightly mentioned in the  communication, provides a  reasonable balance and its rules and 
flexibili ties allow not only least -developed countries a  pragmatic and flexible approach that can 
help Members maximize their potential of their own intellectual efforts and further the integration 
into international trade, while achieving broader societal welfare.  
492.  Intellectual creations need protection if creativity and innovation are to flourish and this is 
the role of IPRs, which plays an important function in promoting and developing the solutions in 
today's global challenges. With regards to protecting innovati on, recognition of the importance of IP/C/M/87/Add.1  
 
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  patent protection keeps growing, for example, statistics from t he European Patent Office show that 
the largest relative increase in patent applications in Europe from 2015 to 2016 can be attributed 
to India. Many of the se patent applications are pharmaceutical applications.  
493.  But let us now turn to compulsory licences and the discussion on pharmaceutical patents as 
mentioned in the last part of the communication from Brazil, China, Fiji, India and South Africa. 
The current  innovation model based on patents has delivered consistent progress in global public 
health continuously leading to important new improved treatments as well as much extended life 
expectancy both in developed and in developing countries. Medicines however  are not created by 
public authorities, but by the pharmaceutical industry. As all industry, it needs an adequate return 
on investment to finance innovation. The challenge is how to use all levels available to public 
authorities to promote affordable acces s to medicines without affecting negatively the R&D by 
pharmaceutical industry and therefore the availability of new and innovative medicines.  
494.  Let us also recall that evidence shows that indeed there are many different significant causes 
of lack of a ccess to medicines. It  is misleading to attribute the problem merely to or even 
principally to IPR -related aspects. In fact, IPR issues seem to play a minor role in the problem, but 
disproportionally large role in the debate. This has also been echoed in the joi nt report from 
the WTO, WHO and WIPO, stating that the lack of access to medical technologies is rarely due to 
a single isolated factor. Additionally, it should be mentioned that currently most medicines on 
the WTO list of essential medicines , i.e. more th an 90% , are available in a generic format, either 
because they were never protected by a patent, or because protection has long expired. Still these 
medicines do not reach all they need, in fact , many countries apply tariffs, taxes and substantial 
mark-ups to medicines and lack an efficient procurement and health care system with a result that 
medicines are not available to the population at le ast not at an affordable price.  
495.  However, the EU has never shied away from a serious and constructive debate on the matter 
in the IPR context and concrete, broad and effective action with the aim of tackling any problem 
related to access medicines. In fact the Global Fund, distributing medicines to patients in need in 
developing countries with diseases such as HIV or ma laria, has been financed by the UN and its 
member States with over €19 billion from 2001 to 2016. For the period 2017 to 2019, the EU and 
its member States will finance the Global Fund with around €17 billion  out of the total of 
€29 billion pledged by all countries. According to the calculation of the Global Fund, this has 
allowed the Fund to save 22 million lives. The Global Fund also cooperates closely with 
the medicines patent pool which receives licences from some of the world's leading innovative 
pharm aceutical companies for free or at a dramatically discounted price. Hence innovation, such as 
the world's latest HIV drugs , can also reach persons in need in places where the country's 
government is not  able to provide universal health care.  
496.  From the outset , the EU has also been at the forefront of the debate on TRIPS and access to 
medicines. In the WTO , the EU has played an active role with the aim of bringing together 
the almost in -reconcilable positions of the opposing sides including on the latest LDC waiver. EU 
has also consistently supported the use, where necessary and justified, of the flexibilities provided 
under the TRIPS Agreement and the Doha Declaration  with the objective of ensuring effective 
access to medicines for the relevant population s. The TRIPS Agreement indeed provides for 
a number of flexibilities that can be used under clear roads and when  there is a real health related 
contrite to industrial policy related reasons. In particular , the TRIPS Agreement provides for 
the possibility u nder certain conditions of issuing a compulsory licence for local consumption of 
medicines. The quoting of the example for the issuing of compulsory licences in line with 
Article  31 of TRIPS , among others a case in Ger many has been mentioned,  actually reas sures that 
the system works and is not as burdensome as often claimed by some.  
497.  Finally, the communication from Brazil, China, Fiji, India and South Africa seems to suggest 
that the IPR provisions proposed in certain trade agreements would restrict access t o medicines 
and no longer enable these countries to produce export generic medicines to other developing 
countries. For the EU these concerns are not founded, in all the trade agreements we are 
negotiating with developing countries. We take into considerat ion the development status and 
public health concerns of our trading partners. Most importantly, we are not asking for provisions 
which would be contr ary to or otherwise undermine the Doha Declaration on the TRIPS Agreement 
and public health. On the contra ry, the provisions on intellectual property we propose include 
an explicit reference to the Doha Declaration so as to ensure that the flexibilities granted by IP/C/M/87/Add.1  
 
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  the TRIPS Agreement especially as regards patents on medicines, can be fully used by 
trading  partners. 
13.6 United States   
498.  First, as a point of order, the United States seeks to confirm that the agenda item "IP and 
the Public Interest" is not a standing agenda item. The Secretariat considers it to be a n ad hoc 
agenda item. As do we.  
499.  Second, as a point of clarification, the delegate of South Africa, representing also Brazil, 
China, and India, mischaracterized a recent US court judgment. The delegate claimed that 
the outcome is a compu lsory licenc e. This is not correct.  The judgment is, in fact, an example of 
a court awarding equitable relief in a case of patent infringement. This is standard practice in 
the United States and in other jurisdictions.  
500.  Such remedies are fully consistent wi th the rule of law, and most certainly are not 
the equivalent of a governmental mechanism for favoring national industri es by granting 
compulsory licenc es to domestic competitors of foreign innovative companies.  
501.  The United States made clear its positions o n compulsory licensing during the last TRIPS 
Council meeting. Our position has been consistent for a very long time.  As we again noted, the 
United States' system permits the use of a patent without the right  holders' authorization only in 
very rare and nar row circumstances. And we repeat, yet again, that the US Patent and Trademark 
Office has never issued a compulsory licenc e. In fact, it does not have the authority to do so.  
502.  We urge Members to exercise caution on issues related to compulsory licensing. Sou nd 
decisions require careful deliberation, and consultation with right holders can offer alternative 
approaches . Decisions regarding compulsory licensing can have significant negative implications, 
including restricting the availability of innovative treat ments in certain markets and limiting 
investment in R&D into the next generation of treatments for all.  
503.  In addition, we share the views of other Members who lamented the narrow focus of the co-
sponsors on the concept of public interest. This is yet another  lost opportu nity for a meaningful 
exchange.  
504.  A great number of benefits accrue to the public as a result of national governments' 
upholding robust IP systems, and managing those systems consistently with the rule of law. 
The United States would be pleased to further explore these benefits in future meetings.  
13.7 Japan   
505.  The delegation of Japan would like to mention that the Doha Declaration, its relevant 
statements, and the resulting amendment of the TRIPS Agreement, all rest on an intricate 
balance. On one hand there is the need to make sure that essential drugs become common for 
everyone. On the other , we have the need to protect intellectual property to encourage 
development of new and effective  drugs so that new essential drugs will continuously be 
developed. This balance is necessary to meet our common objective, which is to protect public 
health, as described in Parag raph 3 of the Doha Declaration.  
506.  The delegation of Japan also strongly believe s that the issue of access to medicines would be 
more effectively dealt with through a more comprehensive approach based on the evidence and 
facts. Accordingly, this delegation would like to stress once again Japan has concerns about 
making any decisions, reports or discussions on the issue of access to medicines based on the UN 
High Level Panel report.  
13.8 Holy See  
507.  Intellectual property benefits public interest by providing incentives for inno vation. 
An efficient IP system can help all countries realize IP's potential as a catalyst for economic 
development and social and cultural well -being. A flexible policy space within the  boundaries of the 
internation al agreed objectives, principles and sta ndards, is necessary to allow each M ember to IP/C/M/87/Add.1  
 
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  develop and adopt more adequately the set of IP regulations for their particular needs and to 
ensure predictability and mutual confidence. Intellectual property as foreseen by Article 7 of the 
TRIPS Agreement sh ould contribute to the promotion of technological innovation and to the 
transfer and dissemination of technology to the mutual advantage of users and producers of 
technological knowledge in a manner conducive to social and economic welfare and to balance 
rights and obligations. To search for a balance between the need , on the one hand , to protect IPRs 
and to provide incentive s for research  and development and the need,  on the other hand , to 
address concerns about the potential impact of such protection in t he health sector, in particular 
its effect on  prices, has been continuously stated by the Holy See at this Council and other fora. In 
line with the objectives and principles of the TRIPS as enshrined in Article 7 and 8 a  number of 
flexibilities have developed  into an integral part of the TRIPS framework and they can be used to 
pursue public health objectives. However, to implement these  flexibilities action is needed in the 
domestic level by incorporating them into national IP regimes, keeping in mind  each country -
specific needs and policy objectives. WTO Members have the flexibility to interpret and implement 
TRIPS provisions in a manner supportive of the right to protect public health. The United Nations' 
High Level Panel on access to medicines in its report to the Secretary General highlighted the 
importance of TRIPS flexibilities and addressing the hope for achievement of 3 Sustainable 
Development Goal s, recommended their use.  
508.  In an era of digitization and globalization the need s of the developing c ountries are even 
more critical. Access to knowledge goods b oth to reach human resources and facilitate economic 
growth is an indispensable requirement for the international system. Developing countries have 
a role to p lay by actively implementing limitati on and exception in a manner that best suits their 
domestic needs, e specially the need to stimulate local creativity. In this sense, the efforts of 
the developing countries to make greater use of flexibilities, limitations and exceptions to 
intellectual pr operty, to advance public policy's objectives in scenarios such as health, education, 
agriculture, food and technology transfer could represent a tremendous step forward. The role of 
limitation  and exception implementing public welfare is a matter of impor tance, not only for users 
of knowledge goods but for creators as well. Without the appropriate balance between protection 
and access, the international IP system totally impoverishes the global public but ultimately it 
undermines its own ability to sustain  and reward the creative enterprise for the long -term future . 
509.  In conclusion, respect  for the exercise of intellectual property rights is clearly subordinate to 
the common good. It serves as a mean s to an end;  it could not be an end in itself. The knowledge 
economy is increasingly evolving into a driving force in the global economy. Thus there is a need 
to protect intellectual property rights as an incentive for innovation and technology creation. Yet it 
is als o important to ensure broad access to technology and knowledge especially for low -income 
countries. The new good s derived  from progress in science and technology are key to world trade 
integration and the use of the flexibilities  by the least developed cou ntries could help them catch 
up and gain international trade competitiv eness.  
AGENDA ITEM 14: INFO RMATION ON RELEVANT DEVELOPMENTS ELSEWHE RE IN 
THE WTO  
14.1 WTO Secretariat  
510.  Thank you for the opportunity to provide  an update of IP -related issues as they have come 
up in the most recent  trade policy reviews. You recall that this has been a regular update in light 
of the  increasing attention paid to IP -related issues in those  reviews. Since the  Council's meeting  
in June, the trade  policy reviews of Nigeria, the European Union, Brazil, Jamaica, Paraguay and 
Iceland have taken place. I am pleased to report that Members continue to substantially contribute 
to the discussions on TRIPS -related issues during those reviews. As Members engage d in a 
constructive dialogue on a wide range of trade -related IP issues, they covered in particular 
copyright and related rights, the determination of royalty rates, trademark protection, 
the protectio n of well -known and service marks, certification marks, geographical indications, 
patents, compulsory licences, data exclusivity, linkage to the  regulatory regime, use and validity of 
supplementary protection certificates, utility models, protection of undisclosed information in trade 
secrets, enforcement measures on -line and at the  border, application of enforcement measures to 
goods in transit, appeal mechanisms, national IP strategies, procedural innovations and the 
granting of IP rights, implications  of judicial rulings , and the ratification of WIPO treaties. In some 
discussions , the status of notifications to this Council was also mentioned.  IP/C/M/87/Add.1  
 
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  AGENDA ITEM 15: OBSE RVER STATUS FOR INTE RNATIONAL INTERGOVER NMENTAL 
ORGANIZATIONS  
15.1 Brazil   
511.  The issue of observer status has a long history in this Council. According to document 
IP/C/W/52/R ev.13, there are currently 13 pending requests from international intergovernmental 
organizations. Those demands should be assessed on their o wn merit, considering the competence 
and interest that those organizations have in the world of the TRIPS Council.  That is why Brazil has 
consistently supported the incorporation of the South Centre and the CBD Secretariat as observer 
to the Council.  
512.  In addition to having observer status in several international organizations, the South Centre 
is an observer to the Committee on Trade and Development in the WTO. Approving its request to 
become an observer at the TRIPS Council . It would contribute to a more m eaningful participation 
of developing countries in the Council . This would not in any way harm the interests of other 
Members or prejudge  their position.  
513.  The CB D is an agreement ratified by as many as 196 Parties . Unlike other permanent 
observers, the CBD is directly implicated in a number of items of the TRIPS Council's permanent 
agenda. A specific item regarding the relationship between the TRIPS Agreement and the CBD is 
part of the built -in agenda of every TRIPS Council meeting. Those discussions could g reatly benefit 
from the participation of the CBD Secretariat.  
514.  Brazil reiterates its view that decisions should be made on the South Centre and CBD 
Secretariat as a matter of priority. We invite the one delegation currently opposing it to present 
reasoning behind its opposition, what so far has not occurred.  
515.  Following consultations with our colleagues from the African Group, Brazil is in the position 
to support permanent observer status to OAPI and ARIPO. We recognize the positive contribution 
they have alre ady provided to the discussions in this Council and we understand that their 
participation as permanent observer status would enhance th is contribution to the Council.  
516.  In the meantime, we would like to stress the necessity of reaching a holistic solution 
regarding the outstanding observer status requests.  
15.2 South Africa   
517.  This delegation thanks the delegation of Brazil for their support to grant permanent observer 
status to ARIPO and OAPI. We believe this is a fundamental step forward and unlocks a 
longstanding impasse, which we believe has n ow reached consensus position.  
518.  Furthermore, we would like to reiterate our previous statements on this matter in respect of 
the fact that any request should be assessed on o wn merit, particularly in respect of the 
competence and interest that respective request would embody very much in line with 
the statement of the distinguished delegate from Brazil , we would also support observer status for 
the South Centre and the CBD Sec retariat.  
15.3 India   
519.  India supports granting of permanent observer status to three intergovernmental 
organizations , namely the  South Centre, the CBD Secretariat and the International Vaccine 
Institute. All the  three organizat ions fulfill the requisite criteria laid down by the General Council 
with regard to Observer status.  
520.  South Centre is an intergovernmental organization with 53 developing country Members 
coming from the three developing country regions of Africa, Asia, and Latin America and 
the Caribbean. The South Centre undertakes research and analysis oriented on various 
international policy areas that are relevant to the protection and promotion of the development 
interests of developing countries, including on IPR issue s. South Centre already has observer 
status in WIPO, WHO, CBD and many other UN  bodies.  
521.  The Convention on Biological Diversity (CBD) Secretariat fulfills all the required parameters 
for observership  of the WTO. The WTO Secretariat has observer status at the CBD and regularly 
participates in CBD meetings. So as a matter of reciprocity, the CBD Secretariat sh all be granted 
observer status.  IP/C/M/87/Add.1  
 
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  522.  We would also like to support the request from the Internationa l 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 dev oted exclusively to developing and introducing new and improved 
vaccines to protect the world's poorest people, especially ch ildren in developing countries.  
523.  India requests M embers opposing the three organizations to provide a valid reason for their 
stand g iven that all the three organizations fulfill the requisite criteria laid down by the General 
Council with regard to O bserver status.  
524.  On the request of Nigeria, India is in position to support only two African intellectual p roperty  
organizations, ARIPO and  OAPI.  
15.4 China   
525.  China supports that the CBD Secretariat and South Center should be granted observer 
status, at least on an ad hoc basis.  
15.5 Ecuador   
526.  Ecuador supports the comments made by se veral delegations that WTO observer status, or 
at least ad hoc observer status, should be granted to the South Centre and the Secretariat of 
the Convention on Biological Diversity.  
15.6 Venezuela , Bolivarian Republic of  
527.  My delegation supports the statements  by Brazil, Ecuador, and other delegations, with 
regard to the inclusion of South Centre as an observer to the TRIPS Council.  
15.7 United States   
528.  Our position  remains the same. To be clear, the United States has consistently objected to 
the CBD, South Centre, and International Vaccine Institute being included as observers in 
the TRIPS Council. We are pleased to continue our informal consultations with the Chair  on this 
issue. 
15.8 European Union  
529.  We can go along with the proposal to invite the CBD Secretariat on an ad hoc basis 
whenever the relationship between the CBD and the TRIPS Agreement is on the agenda. We 
support the grant of Observer status to the African Regional Intellectual Property Organization, the 
African Intellectual Property Organization , the C ooperation Council of the Arab States of the G ulf 
and the Eu ropean Free Trade Association. We stand to be convinced as to the  competence and 
direct  interest of certain other organizations requesting observer status in matters relating to the 
trade -related aspects of intellectual property rights, and we welcome the  flexibility shown by some 
Members on the two African organizations.  
15.9 Brazil  
530.  We would like to go on record thanking you  for your  very active work during those months in 
facilitating the discussion, and we would like to tha nk you and recognize that this considerably 
facilitate s our work in this Council.  
AGENDA ITEM 16: ANNU AL REPORT  
531.  No statements were made under this agenda item.  
AGENDA ITEM 17: OTHE R BUSINESS  
532.  No statements were made under this agenda item.  
 
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