RESTRICTED  
  
IP/C/M/86/Add.1/Rev.1  
 
23 November  2017 
(17-6414) Page: 1/51 
Council for Trade -Related Aspects of Intellectual 
Property Rights    
 
MINUTES OF MEETING  
HELD IN THE CENTRE W ILLIAM RAPPARD ON 13  JUNE 2017  
Chairperson: Ms Irene Young (Hong Kong, China)  
Revisiona,b 
The present document contains the statements made during the C ouncil for TRIPS meeting held on 
13 June 2017.  
 
_______________  
 
AGENDA ITEM 1: ELECT ION OF CHAIRPERSON  ................................ ................................ . 3 
AGENDA ITEM 2: NOTIF ICATIONS UND ER PROVISIONS OF THE  AGREEMENT  ..................  3 
AGENDA ITEM 3:   REVIEW OF NATIONAL I MPLEMENTING LEGISLAT ION ......................  5 
AGENDA ITEM 4: REVIE W OF THE PROVISIONS OF ARTICLE 27.3(B)  ...............................  6 
AGENDA ITEM 5: RELAT IONSHIP BETWEEN THE TRIPS AGREEMENT AND 
THE CONVENTION ON BIOLOG ICAL DIVERSITY  ................................ ...............................  6 
AGENDA ITEM 6: PROTE CTION OF TRADITIONAL  KNOWLEDGE AND FOLKLO RE ...............  6 
AGENDA ITEM 7:   NON-VIOLATION AND SITUAT ION COMPLAINTS  .............................  13 
AGENDA ITEM 8: REVIE W OF THE IMPLEMENTAT ION OF THE TRIPS AGR EEMENT 
UNDER ARTICLE 71.1  ................................ ................................ ................................ ..... 19 
AGENDA ITEM 9: REVIE W OF THE APPLICATION  OF THE PROVISIONS OF  THE 
SECTION ON GEOGRAPHI CAL INDICATIONS UNDE R ARTICLE 24.2  ................................  19 
AGENDA ITEM 10: TECH NICAL COOPERATION AN D CAPACITY BUILDING  ......................  19 
AGENDA ITEM 11: INTE LLECTUAL PROPERTY AN D INNOVATION: INCLUS IVE 
INNOVATION AND MSME GROWTH  ................................ ................................ ................  19 
AGEN DA ITEM 12:  INTELLECTUAL PROPERT Y AND THE PUBLIC INT EREST: 
COMPULSORY LICENSING  ................................ ................................ ..............................  34 
AGENDA ITEM 13: INFO RMATION ON RELEVANT DEVELO PMENTS ELSEWHERE IN 
THE WTO  ................................ ................................ ................................ ........................  48 
AGENDA ITEM 14:  OBSERVER STATUS FOR INTERNATIONAL 
INTERGOVERNMENTAL OR GANISATIONS  ................................ ................................ ....... 48 
AGENDA ITEM 15: OTHE R BUSINESS  ................................ ................................ ..............  50 
 
  
                                                
a In English only.  
b This Revision is being distributed to communicate a corrected index on page 2.  IP/C/M/86/Add.1/Rev.1  
 
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INDEX OF THE STATEMENTS MADE  
AT THE MEETING OF COUNCIL FOR TRIPS 13 June 2017*  
 
Argentina  
Non-Violation  ................................ ...... 16 
ARIPO Secretariat  
IP and Innovation - MSME Collaboration  . 34 
Australia  
Biotech, Biodiversity, TK  ......................  12 
IP & Public Interest -Compulsory Licences  48 
IP and Innovation - MSME Collaboration  . 23 
Bolivia, Plurinational S tate of  
Biotech, Biodiversity, TK  ........................  9 
IP & Public Interest -Compulsory Licences  42 
Non-Violation  ................................ ...... 17 
Brazil  
Biotech, Biodiversity, TK  ........................  8 
IP & Public Interest -Compulsory Licences  38 
IP and Innovation - MSME Collaboration  . 31 
Non-Violation  ................................ ...... 16 
Observer Status  ................................ .. 50 
Canada  
Biotech, Biodiversity, TK  ......................  11 
Ip and Innovation - MSME Collaboration  . 26 
Chairperson  
Biotech, Biodiversity, TK  .................  12, 13  
China  
Biotech, Biodiversity, TK  ......................  10 
IP & Public Interest -Compulsory Licences  40 
IP and Innovation - MSME Collaboration  . 33 
Non-Violatio n ................................ ...... 17 
Observer Status  ................................ .. 50 
Colombia  
IP & Public Interest -Compulsory Licences  44 
Ecuador  
Biotech, Biodiversity, TK  ........................  8 
IP & Public Interest -Compulsory Licences  41 
Non-Violation  ................................ ...... 17 
Observer Status  ................................ .. 49 
Egypt  
Biotech, Biodiversity, TK  ......................  10 
Non-Violation  ................................ ...... 18 
Observer St atus ................................ .. 50 
El Salvador  
IP and Innovation - MSME Collaboration  . 33 
European Union  
IP & Public Interest -Compulsory Licences  46 
IP and Innovation - MSME Collaboration  . 19 
Notifications  ................................ .........  3 
Fiji 
IP & Public Interest -Compulsory Licences  41 
Hong Kong, China  
IP and Innovation - MSME Collaboration  . 31 
Notifications  ................................ .........  4 
 
 India  
Biotech, Biodiversity, TK  ........................  6 
IP & Public Interest -Compulsory Licences  37 
IP and Innovation - MSME Collaboration  32 
Non-Violation  ................................ ..... 15 
Observer Status  ................................ .. 48 
Indonesia  
Biotech, Biodiversity, TK  ........................  9 
IP & Publ ic Interest -Compulsory Licences  43 
Observer Status  ................................ .. 49 
Japan  
Biotech, Biodiversity, TK  ......................  11 
IP & Public Interest -Compulsory Licences  45 
IP and Innovation - MSME Collaboration  25 
Non-Violation  ................................ ..... 18 
Kazakhstan  
Review of Legislation  .............................  5 
Korea, Republic of  
Biotech, Biodiversity, TK  ......................  12 
IP & Public Interest -Compulsory Licences  47 
IP and Innovation - MSME Collaboration  34 
Norway  
Notifications  ................................ .........  5 
Singapore  
IP and Innovation - MSME Collaboration  26 
Other Business  ................................ ... 50 
South Africa  
Biotech, Biodiversity, TK  ...................  7, 12 
IP & Public Interest -Compulsory Licences  34 
Non-Violation  ................................ ..... 17 
Observer Status  ................................ .. 49 
Sri Lanka  
Non-Violation  ................................ ..... 19 
Switzerland  
Biotech, Biodiversity, TK  ......................  12 
IP & Public Interest -Compulsory Licences  45 
IP and Innovation - MSME Collaboration  28 
Non-Violation  ................................ ..... 13 
Notifications  ................................ .........  5 
Chinese Taipei  
IP and Innovation - MSME Collaboration  30 
United States  
Biotech, Biodiversity, TK  .................  10, 12  
IP & Public Interest -Compulsory Licences  42 
IP and Innovation - MSME Collaboration  22 
Non-Violation  ................................ ..... 18 
Observer Status  ................................ .. 49 
Review of Legislation  .............................  5 
Venezuela, Bolivarian Republic of  
Observer Status  ................................ .. 50 
WTO Secretariat  
Information of Developments in WTO  .... 48 
Notifications  ................................ ..... 3, 5 
______________________  
* 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/86/Add.1/Rev.1  
 
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  AGENDA ITEM 1: ELECT ION OF CHAIRPERSON  
1.  No statements were made under this agenda item.  
AGEN DA ITEM 2: NOTIFICAT IONS UNDER PROVISION S OF THE AGREEMENT  
2.1 WTO Secretariat  
2.  Under Article 63.2 of the Agreement, the Council has received the following notifications:  
 From Hong Kong, China, Patents and Ordinance Orde r 2017, the Registered Designs 
Ordinance Regulation, the Trademarks Ordinance Regulation 2017 and the Layout -
Design (Topography) of Integrated Circuits Regulation 2017;  
 From Switzerland, a number of notifications which include among others consolidated 
versions of the Federal Law and Ordinance covering the following areas: copyright and 
neighbouring rights; trademarks and indications of source; patterns, designs and 
topographies of semi -conductor products; a number of GI –related ordinances as well as 
the consolidated version of the Federal Law on Agriculture and the Federal Law on 
the Statute and Tasks of the Federal Institute of Intellectual Property as well as the Fees 
Charged by the  Institute. Some of these laws and regulations notified also include 
provisions related to IP  enforcement;  
 From the European Union, the 2006 Directive on the term of protection of copyright and 
certain related rights; certain Commission Regulations in the field of trademarks; the 
2013 Regulation establishing a Common Organizatio n of the Markets in Agricultural 
Products, the  2014 Regulation on the Definition, Description, Presentation, Labelling and 
the Protection of Geographical Indications of Aromatised Wine Products, as well as a 
number of Commission Regulations in the fi eld of  geographical indications ; 
the E-Commerce Directive adopted in 2000; as well as the 2012 Regulation entrusting 
the Office for Harmonization in the Internal Market with tasks related to the enforcement 
of intellectual property rights; and  
 From Norway, the I ndustrial Property Office Act which entered into force on 1 April 2013.  
3.  These notifications are referred to on the revised agenda for this meeting. They are also 
available in the  IP/N/1 -series of documents, and the actual texts of laws are on the Documents  
Online database.  
4.  Furthermore, Kazakhstan has notified its responses to the Checklist of Issues on Enforcement 
shortly before this meeting which have been circulated in the IP/N /6–series of documents.  
No other initial responses or updates to earlier respon ses have been submitted since 
our last meeting.  
5.  To conclude, as regards contact points, we have received information from Myanmar under 
Article 69 for the exchange of information and cooperation on trade in infringing goods. Also, 
Botswana has updated its Article 69 contact points. And again the information on the Members' 
transparency toolkit page has been updated accordingly.  
2.2 European Union  
6.  We did a bit of house -cleaning in our legislation and we went out to look ba ck for any pieces of 
legislation that are intellectual property relevant. We found a number that we had not notified in 
due time. Since there are around 15 pieces of legislation, I will introduce two of them as 
an example: Regulation 251/2014 on Geographical Indications for Aroma tized Wine Products, this 
is a R egulation that stipulates the specifications of aromatized wine products, and protection of 
their geographical indications. It seeks to ensure high levels of consumer protection, product 
authenticity, market transparency and fair competition. It applies to all aromatized wine products 
placed on the market in the European Union whether they are produced in the EU or in 
non-EU countries, and also products produced in the European Union for expo rt. The preceding 
Regulation s dating from 1991, and from 1994, regulating aromatized wine products, proved IP/C/M/86/Add.1/Rev.1  
 
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  successful and , while independent  of these R egulations, market s considerably expanded and there 
was a growth in this area. However , due to technologi cal innovation, market development and 
evolving consumer expectations, it was necessary to update the rules on the definition, 
description, presentation, labelling and protection of geographical indications for these products.  
7.  Regulation 386/2012 on the Es tablishment of the European Observatory on Counterfeiting and 
Piracy created an institution that is producing remarkable work since then. This Observatory had 
already been established de facto in 2009 as an EU -wide network of representatives to support 
the protection of intellectual property rights and help combat the growing threat of IP infringement 
and also as a centre of excellence on information and data relating to the value of intellectual 
property rights and the negative consequences of infringement  thereof. The Observatory was at 
the time intrusive to OHIM which in the meantime became the European Union Intellectual 
Property Office, our agency in charge of registration of trademarks an d designs in June 2012 by 
this Regulation. The R egulation covers the responsibility for a wide range of tasks relating to 
research, communication, and spread of best practices and enforcement of all types of intellectual 
property rights,  thus not limited to the ones that are attached to the EUIPO. In order to carry out 
these assigned tasks, an O bservatory department was formed in late 2012 consisting of three 
main areas: (i) the Observatory operations and projects (ii)  the Academy and (iii) the Chief 
Economist. Thus the Observatory has become fully integrative into the E U IP Office and benefits 
from all the capabilities and resources of this Office. Aligned with the EU IPO Strategic Plan, there 
is an Observatory multi -annual plan which identifies several key initiatives designed to enable it to 
become the centre of excell ence and the central resource for gathering information that will 
facilitate and support the activities of national authorities, EU  institutions and the private sector. 
Here in the broader sense of the term it is not only about right holders but also other  civil society 
sectors and organizations.  
8.  These key initiatives will be executed by the Observatory and/or several resources 
as appropriate , taking full advantage of the synergies created by putting in place representatives 
of all these different interests . European Union policy makers see innovation and creativity 
as a corner stone of economic development. In this context and considering the mission and 
the range of activities defined in Regulation 386/2012 the EU has set three main goals 
for the Observato ry: provide facts and evidence for use in formulation of effective IP policies 
by policy makers; to create tools and resources to sharpen the fight against IP infringement; 
and to raise awareness of intellectual property and of the negative effects of coun terfeiting and 
piracy. The approach to achieve these proposed goals is based on two complementary pillars. 
The first pillar aims at strengthening the efficiency and efficacy of the public -private network that 
makes up the core of the Observatory's function . The second pillar aims at facilitating and 
promoting the  process of cooperation with third countries in order to advance knowledge 
and enhance protection of intellectual property.  
9.  The three goals of the Observatory will be achieved by executing five key initiatives grouped in 
the following lines of action: 1) evidence based contributions and data to enable EU and national 
policy makers to shape effective IP enforcement policies and to support innovation and creativity; 
2) data, tools and databases to supp ort EU and national authorities in the fight against IP 
infringement; 3) knowledge building and learning programmes for enforcement authorities as well 
as for businesses especially small and medium -sized enterprises and on that I will be discussing 
more la ter in the Agenda; 4) campaigns to raise overall awareness of IP value and the negative 
effects of IP infringement; and 5) initiatives to help right holders protect their IP rights both within 
and outside of the European Union. In pursuing these programmes  the Observatory has already 
published a considerable number of studies on intellectual property, on methodology, and 
on economic value.  Therefore, remarkable work has already been done in the last five to six years.  
I believe this is useful because there is an international dimension to the work of the Observatory 
and there is of interest in value to all Members of this Council.  
2.3 Hong Kong, China  
10.  We have recently updated the list of qualifying countries, territories  or areas for meeting 
the international obligations under the Paris Convention and/or the TRIPS Agreement of affording 
the same level of intellectual property protection under four respective legislations concerning 
Patents, Register Design, Trademarks and  Layout -Design (Topography).  IP/C/M/86/Add.1/Rev.1  
 
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  2.4 Switzerland  
11.  Switzerland introduced its updates of notification s according to Article  63.2 of 
the TRIPS  Agreement at the last Council meeting. The update which has been circulated concerns 
amendments made to the Swiss IP legislation between 2012 and January 2017.  
12.  We are referring to our intervention at the last meeting and the summary of the most 
significant develop ments which have been provided.  
2.5 Norway  
13.  The noti fication from Norway relates to the Act on the Norwegian Industrial Property Office 
and the Board of Appeal for Industrial Property Rights. The Act was passed by the Norwegian 
Parliament on 6 June 2012 and repeals the Act on the Norwegian Industrial Proper ty Office from 
1910. From the entry into force on 1 April 2013 new and updated provisions on the purpose and 
tasks of the Norwegian Industrial Property Office and the Board of Appeal and general provisions 
on case handling were modified, however without af fecting the exclusive rights governed by 
the Patents Act, the Trademarks Act and the Designs Act. The Act was translated into English and 
the unofficial translation was published on the homepage of the Norwegian Industrial Property 
Office shortly after the  entry into force in 2013. Due to an error that translation was only now 
notified to the Secretariat.  
2.6 WTO Secretariat  
14.  This brief interim repor t supplements the series of briefings the Council has received over 
recent sessions on this elaborate project, which represents a once -in-a-generation overhaul of how 
we manage TRIPS documentation and how we serve Members in making this information 
accessible and practicably workable. The project, I am glad to report, is in it s late stages, having 
been assisted and guided by the feedback provided by interested delegations, whom we thank, 
and who took part in informal briefing and demonstration sessions and gave us very he lpful 
feedback and suggestions.  
15.  While this is a brief int erim report, we expect to have a significant advance to report at 
the next meeting of the Council . At this stage, the e -TRIPS project has almost completed the full 
digitisation of the entire range of TRIPS -related notification and review materials. We are currently 
in the process of validating and closely checking the thousands of individual records concerned and 
intensively testing the prototype on -line notification tool. We are also preparing a draft 
web gateway that will greatly facilitate access to and use of all TRIPS -related materials by WTO 
Members. We have just secured the necessary ad hoc  resources to take forward the final stages of 
implementation both of data validation and upload of the data onto the information management 
system, on the input si de, and for the development and elaboration of an accessible gateway, 
for the effective use of these data. We are therefore reasonably confident of reaching the final 
stages of the project in the course of this year, and we will be again reaching out to interested 
delegations to consult with us both for demonstrations of the current advanced prototypes and for 
feedback on how to ensure this new facility best meets the practical needs and requirements 
of Members, both Geneva -based delegates and officials i n capital. We certainly welcome 
the interest and involvement of any interested delegations.  
AGENDA ITEM 3:   REVIEW OF NATIONAL I MPLEMENTING LEGISLAT ION 
3.1 Kazakhstan  
16.  We have already transmitted the responses to the US questions and hope that these will be 
sufficient for them.  
3.2 United States  
17.  With respect to the review of Kazakhstan's national implementing legislation, we deeply 
appreciate the efforts made by Kazakhstan to respond to our copyright -related follow -up questions 
and we are further pleased that Kazakhstan has also responded to the Council's Checklist of Issues 
on Enforcement.  IP/C/M/86/Add.1/Rev.1  
 
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  AGENDA ITEM 4: REVIE W OF THE PROVISIONS OF ARTICLE 27.3(B)  
AGENDA ITEM 5: RELAT IONSHIP BETWEEN THE TRIPS AG REEMENT AND 
THE CONVENTION ON  BIOLOGICAL DIVERSITY  
AGENDA ITEM 6: PROTE CTION OF TRADITIONAL  KNOWLEDGE AND FOLKLO RE 
6.1 India  
18.  India is one of the seventeen identified mega bio -diverse countries of t he world. India is also 
rich in 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, which exists in the oral undocumented traditions.  
19.  India has been a major victim of bio -piracy. Pursuant to the ratification of the Convention on 
Biological Diversity (CBD), India developed a comprehensive legislation on biodiversity, including 
a Traditional Knowledge Digital Library (TKDL) database to prevent misappropriation of traditional 
knowledge at international patent offices, so that cases of bio -piracy can be prevented. India has 
signed TKDL Access Agreements with nine international patent offices. While India has pion eered 
the 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, the TKDL 
represented a subset of the universe of available traditional kno wledge. The realm of traditional 
knowledge in areas other than herbal cures and genetic resources was not covered by 
the digital  library.  
20.  While India is undertaking a number of measures at the national level in order to prevent 
misappropriation of genetic resources and/or associated traditional knowledge, the problem has 
an obvious international dimension and needs an international solution in order to be addressed 
effectively. The TRIPS Agreement continues to ignore the numerous IPR -related obligations 
in the CBD which are of interest to the developing countries. The disclosure proposal (IP/C/W/474) 
which was submitted in 2006 was followed up by the submission TN/C/W/52 in June 2008 with 
the support of 109 Members. The latest submission on this issue is con tained in document 
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 membership, 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 bio -piracy, 
further strengthen the credibility of the patent system by facilitating assessment of the novelty 
and inventiveness criteria.  
21.  The Nagoya Protocol of the Convention on Biodiversity (CB D) entered into force 
on 12 October  2014. So far 100 Countries, including India, have ratified the Protocol. According to 
the CBD website, the Access and Benefit -sharing Clearing -House (ABS -CH), which is a platform for 
exchanging information on access and benefit -sharing established by Article 14 of the Protocol, is 
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, five countries (Guatemala, India, 
Mexico, Spain and South Africa) have published 52 internation ally recognized certificates 
of compliance (IRCC) with details of prior informed consent for access to genetic resources and 
benefit sh aring on mutually agreed terms.  
22.  In the 2030 Agenda for Sustainable Development, two targets (SDG 2.5 and 15.6) related 
to genetic diversity and the fair and equitable sharing of benefits. This demonstrates that ABS and 
the Nagoya Protocol are making an important contribution to the conservation of biodiversity 
and sustainabl e economic development for all.  
23.  It would be quite useful to the delegates of the TRIPS Council, if the CBD Secretariat is 
requested to brief the TRIPS Council in October session on the latest developments 
in the implementation of the Nagoya Protocol, including the decisions that were taken IP/C/M/86/Add.1/Rev.1  
 
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  at the December  2016 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 Se cretariat 
in the interest of the large majority of developing countries. We also support Ecuador 's proposal 
for updating the three factual briefs by the Secretariat.  
24.  I conclude by stating that the TRIPS -CBD issue is one of the outstanding implementation 
issues and positive outcomes on outstanding implementation issues are one of the most important 
deliverables of the Doha Round f or the developing countries.  
6.2 South Africa  
25.  In respect of the triplets, we note th at Paragraph 19 of the Doha Ministerial Declaration 
instructs the TRIPS Council to pursue its work programme under Article 27.3b, Article 71.1, and 
paragraph 12 of the Ministerial Declaration, inter alia , "to examine the relationship with 
the Convention of  Biological Diversity and the prot ection of traditional knowledge... " A large group 
of developing countries proposed an amendment to the TRIPS Agreement to introduce 
a mandatory disclosure requirement in patent applications and have sought clear guidance o n this 
matter as part of the modalities decision. The basis of this amendment is contained in TNC/W/59 
which requires access and benefit sharing, prior informed consent and disclosure of the source of 
material when a patent is applied for.  
26.  South Africa is rich with natural resources, being the 3rd most biologically diverse country 
after Indonesia and Brazil. It represents 2% of the world 's landmass, has 10% of the world 's 
plants, 7% of all mammals, birds and reptiles, and 15% of all known marine species. So uth Africa 
is also a Contracting Party to the CBD and has ratified the Nagoya Protocol on Access to Genetic 
Resources and Fair and Equitable Sharing of Benefits Arising from their Utilization in 2013 which 
came into effect in October 2014.  
27.  The ABS legal re gime for South Africa, is contained in Chapter 6 of the National Environmental 
Management: Biodiversity Act No 3 of 2003 which governs bioprospecting and the use of 
indigenous biological resources. This Act regulates inter alia : bioprospecting involving in digenous 
genetic and biological resources; the exportation of indigenous genetic and biological resources for 
purposes of bioprospecting or any other research purpose; and provides for a fair and equitable 
sharing by stakeholders in benefits arising from b ioprospecting;  
28.  South Africa also requires disclosure of the use of traditional knowledge or biological resources 
in patent applications. Section 30 (3A) of the Patents Act No. 37 of 1952 as amended by 
Act No 20 of 2005 requires that:  
"(3A) Every applicant who lodges an application for a patent is accompanied by 
a complete specification shall, before acceptance of the application, lodge with 
the registrar a statement in the prescribed manner stating whether or not the 
invention for which protection is claime d is based on or derived from an indigenous 
biological resource, genetic resource, or traditional knowledge to this effect. " 
This amendment to the Patents Act came into force on 14 December 2007 by proclamation and 
with the publication of Regulations for t he Patents Amendment Act. As a result, every applicant for 
a patent (with the exception of provisional patent applications) filed in South Africa on or after 
14 December  2007 is required to lodge a declaration or statement in respect of traditional 
knowled ge or use of indigenous biological resource, irrespective of the nature of the invention 
sought to be protected. Also in this respect, on 23  March  2016, South Africa issued the second 
internationally recognized certificate of compliance following a permit made available to the Access 
and Benefit -sharing (ABS) Clearing -House.  
29.  Given the extensive (legal) regime that applies in South Africa, we still experience significant 
instances of bio -piracy and misappropriation. National regimes are therefore necessary, but 
insufficient steps to protect traditional knowledge or the use of indigenous biological resources. 
A multilateral system within the context of the TRIPS Agreement that regulates disclosure and 
access remains the best guarantee against misappropriation of genetic resources 
and traditional  knowledge.  IP/C/M/86/Add.1/Rev.1  
 
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  30.  While related negotiations can complement the negotiations of TRIPS issues in the WTO, 
they are not an effective substitute for achieving results in the WTO TRIPS context. 
Other  international fora lack an effective dispute settlement mechanism to ensure compliance with 
the obligations, and there is no certainty that these negotiations will be successful in these fora.  
6.3 Brazil  
31.  Brazil has a well -known position regard ing the promotion of mutual support between TRIPS 
and the CBD. In our view, the best 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  amendment will introduce a mandatory requirement for the disclosure 
of the origin of these resources in patent applications. This would create a multilateral and efficient 
mechanism to combat misappropriation, a concern that remains, especially in develop ing 
countries. At the last session of the TRIPS Council, our delegation referred to two examples of 
patent applications containing genetic resources from the Amazonia region. A mandatory 
multilateral disclosure requirement would enable a clear assessment o f whether those patents 
complied with the legal requirements in the country of origin.  
32.  The disclosure requirement as provided in document TN/C/W/59 will not be burdensome for 
industrial property offices, since they will be simple "check points " in the new system. It would 
create no obligation for the patent examiner to conduct a thorough review of the document 
provided by the applicant.  
33.  A mandatory disclosure requirement will meet the objectives of the CBD and the intellectual 
property system by providing a ppropriate incentives and rewards for traditional knowledge 
holders, in recognition of their contribution to society. It would also contribute to enhancing 
transparency about the utilization of genetic resources and associated traditional knowledge, 
dispel ling questions regarding the misappropriation of valuable national resources.  
34.  For these reasons, Brazil joined China, Colombia, Ecuador, India, Indonesia, Peru, Thailand, 
the ACP Group, and the African Group in supporting the amendment of the TRIPS Agreeme nt with 
the introduction of a mandatory requirement for the disclosure of origin of genetic resources and 
traditional knowledge in patent applications.  
35.  As a means forward, we would like to support the suggestion by India regarding a briefing by 
the CBD Sec retariat in order to illustrate recent developments at the CBD level. We also support 
the updating of the Secretariat 's report on the matter.  
6.4 Ecuador (delivered by Bolivia, Plurinational State of ) 
36.  The distinguis hed colleague from Ecuador could  not attend the meeting this morning so 
I would also like to read out the statement on behalf of Ecuador and then read Bolivia's statement. 
So first on behalf of Ecuador:  My country's position has been expressed repeatedly i n this Council. 
So we would request that in the consideration of the three items concerned  we refer to statements 
made by my delegation in previous meetings.  
37.  I would like to refer to Ecuador's proposal submitted a number of years ago on the possibility 
of the Secretariat preparing an update of the factual notes on the aforementioned topics. Given 
that the last compilation of the ideas discussed was produced in 2006 we believe that updated 
versions of documents IP/C/W/368, IP/C/W /369 and IP/C/W/370 would pro vide us with a  clearer 
idea of what was already discussed for a number of years  with the aim of ensuring that Members 
have an updated picture so that  they can contribute to informing the debate on these issues, thus 
enabling us to move forward in our discu ssions. A consensus has been emerging around that idea 
and we are just waiting for one Member to adopt a more flexible position in order to allow us to 
have that update. So we would call upon that delegation to join the consensus.  
38.  In view of the above, we reaffirm our position that there should be an opportunity to conduct 
discussions on the basis of more detailed information, which could be presented by the Secretariat 
in a neutral manner, without compromising any of the Members' positions. We wish to emph asize 
this, as each Member's position would remain intact and could, moreover, be substantiated by 
further up -to-date information.  IP/C/M/86/Add.1/Rev.1  
 
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  6.5 Bolivia, Plurinatio nal State of  
39.  Bolivia's stance on this matter is well known. Bolivia believes that a development -oriented 
outcome in Buenos Aires should at least include a negotiating mandate on disclosure of the source 
of origin. In this regard, modifying the patent system could disco urage the biopiracy practices that 
we have seen since the TRIPS Agreement was adopted at the WTO.  
40.  In addition to disclosure of the source of origin, it is necessary to include substantive 
provisions that prevent the patentability of life forms and parts th ereof, such as genetic resources, 
and traditional knowledge associated with genetic resources. The possibility of patenting life forms 
and parts thereof was encouraged by the adoption of Article 27.3(b), which, unlike any other 
international rule, has prom oted the undue appropriation of such resources through the patent 
system. This has allowed for an increase in private monopolies on life forms, genetic resources and 
gene sequences, among other things, by merely isolating and characterizing them, which has  
negative consequences for the innovation itself and for scientific research, as well as access to its 
findings. Preventing the patentability of life forms and genetic resources would help to prevent 
biopiracy and would act as a complement to a mechanism f or disclosing sources of origin.  
41.  Document TN/C/ W/59 would be a good basis on which to move ahead with the process in 
this Council, with a view to achieving a tangible pro development outcome at the Eleventh 
Ministerial Conference.  
42.  Our position on observers  is also well known. We believe that the issue of observer status 
must be addressed in a balanced manner, and in its entirety, in order for the representative 
institutions of most Members to have this status. Until now, I had never understood why th ere was  
opposition towards the Secretariat of the CBD and the South Centre having observer status in 
the Organization.  
43.  In conclusion, I would like to reiterate our support for Ecuador's proposal that the Secretariat 
update its factual notes describing relevant de velopments in recent years.  
6.6 Indonesia  
44.  In regard to the triplets  agenda  items , Indonesia would like to reiterate its view that 
the relationship between the TRIPS Agreement and the CBD should be reflected in thi s Council by 
ensuring and maintaining the cohesion, coherence and consistency between the two. These two 
internationally agreed instruments must be implemented in a manner that is mutually supportive 
with respect to their objectives. Since the CBD and the Nagoya Protocol have formed a basis of 
the protection of genetic resources and/or associated traditional knowledge with provisions on 
prior informed consent for access and fair and equitable benefit -sharing, the TRIPS Agreement 
needs to reflect these state d provisions to avoid misappropriation and oblige Members to take 
necessary measures to ensure fair and equitable benefit -sharing. The protection of genetic 
resources is of paramount importance to Indonesia, and we consider that a legal obligation to 
estab lish a mandatory disclosure of origin as a requirement for patent applications will not only 
prevent misappropriation and enhance transparency on the utilisation of genetic resources and/or 
associated traditional knowledge but will also provide greater leg al certainty as to the rights and 
obligations of the providers and users of genetic resources.  
45.  Indonesia would also like to add that we should not delay substantive discussions in this 
Council for reasons that this issue is being negotiated in other fora, such as WIPO. The discussions 
that take place in this Council should reinforce what has already been agreed to at the multilateral 
level such as the CBD and should complement negotiation or discussion in other fora. We believe 
that parallel discussion will  enhance the effort and understanding of achieving a fair and balanced 
trading system with regard to intellectual property. On that note, we would also like to suggest 
that the TRIPS Council meetings not be held coincidently with meetings of the Intergover nmental 
Committee on GRTKF at WIPO. If possible these meetings should be held back -to-back to enable 
our capital -based experts, which for many of us are one person for both fora, to be able to attend 
both meetings. Indonesia will also take this matter duri ng the IGC meeting be held in the same 
week. Last but not least, Indonesia would like to use this opportunity to re -convey its support for 
the proposal by Group of W/52 and of W/59 to revise Article 27.3(b) and Article 29 of 
the TRIPS  Agreement.  IP/C/M/86/Add.1/Rev.1  
 
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  6.7 Egypt  
46.  The protection of biological resources, traditional knowledge and folklore presents 
an important developmental issue for Egypt. In view of the importance of this issue we continue 
to support engagement in full negotia tions on the relationship between the TRIPS Agreement and 
the CBD, which is a critical part of the implementation -related issues as contained in 
the Doha Work Programme. Therefore we urge other Members to engage in this issue of high 
importance to developi ng countries as part of the conclusion of the DDA. Technical discussions on 
this issue have been ongoing for more than 15 years so far. We believe that TRIPS Agreement 
should be amended in order to provide that Members shall require an applicant for a pate nt 
relating to biological materials or associated traditional knowledge to disclose the source and 
the country of origin of the biological resources and associated traditional knowledge used 
in the invention. Furthermore, the applicant shall also provide e vidence of prior consent and 
evidence of fair and equitable benefit -sharing unde r the relevant national regime.  
47.  Finally, we would like to support the proposal to invite the CBD Secretariat to attend the next 
meeting of the TRIPS Council in order to apprais e the Members on the Nagoya Protocol.  
6.8 China  
48.  The relationship between the TRIPS Agreement and CBD is an important issue in the TRIPS 
Council. China always attaches great importance to this issue and participates in  the discussions, 
which are quite useful for clarification. China hopes Members are constructively involved in this 
discussion.  
49.  Regarding the substantial issues, China notes that the majority of Members support to amend 
the TRIPS Agreement so as to ensure the mutual supportiveness between the TRIPS Agreement, 
the CBD and its Nagoya Protocol. China believes that the introduction of a mandatory disclosure 
requirement, and benefit sharing, could prevent misappropriation and erroneous patents. 
And providing the  information concerning the prior informed consent and benefit sharing would not 
be burdensome, while the benefit -sharing arrangement on contractual basis and the database 
solution would not serve the purpose of sufficient protection for genetic resources.  
50.  As to disclosure, China has provided the detailed suggestions on improving the transparency 
on genetic resources' utilization, preventing the misappropriation of genetic resources and 
traditional knowledge, and preventing the grant of erroneous patent in two documents TN/C/W/52 
and TN/C/W/59, co -sponsored by different Members.  
51.  As regards procedure, China believes that the discussion and negotiation in WIPO/IGC would 
not hinder the Members to find a solution in WTO. Furthermore, the Ministers have given 
the Council the mandate to examine the relationship between TRIPS and CBD. Therefore, Members 
should follow the instruction and mandate to work to find a solution. In this regard, to strengthen 
the understanding so as to carry on with the constructive discuss ion in this Council, China supports 
to invite the CBD Secretariat to brief on the Nagoya Protocol. China also hopes that the Secretariat 
could update  the three factual notes.  
6.9 United States  
52.  Regarding geneti c resources, traditional knowledge and folklore, we continue to believe that 
WIPO serves as the best forum to address these issues. As observed by Indonesia, many 
delegates in this room split their time between the WTO and the WIPO this week as WIPO IGC 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. With respect to 
the various requests made today the United States is not in a position to s upport these requests 
but remains open to discussions including bilaterally with delegations, in between and at 
the margins of the TRIPS Council meetings. To that end we look forward to meeting with Ecuador 
tomorrow afternoon and reporting back on any prog ress that may be made.  
53.  As for the relationship between the TRIPS Amendment and the CBD, in past sessions 
of the TRIPS Council a number of delegations noted that they believe that there is a need to avoid 
erroneous patents that involve the use of genetic re sources and related traditional knowledge. IP/C/M/86/Add.1/Rev.1  
 
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  We agree that there is a need to avoid erroneous patents but we disagree that the disclosure of 
origin would help improve the quality of patents, and as noted by India in past sessions 
of the TRIPS Council, tradit ional knowledge and cultural practices can be prior art and would be 
fully taken into account in the patent examination procedures.  
54.  Finally, the United States welcomes the interventions of WTO Members describing their recent 
actions to implement the Conven tion of Biological Diversity and the Nagoya Protocol. We believe 
that all WTO Members can benefit from a better understanding of the policy decisions made by 
the other WTO Members who are party to the CBD or are signatories to the CBD in deciding 
whether t o ratify the protocol or in implementing it. We do not however support the CBD 
Secretariat providing an intervention at this time as we have previously explained.  
6.10 Japan  
55.  With regard to agenda items 4, 5 and 6, thi s delegation would like to reiterate our position 
that it is necessary to seek appropriate ways to deal with the misappropriation of genetic 
resources. This means we should bear in mind that any measures taken must not adversely affect 
the existing intelle ctual property system or hinder the creation of innovations utilizing genetic 
resources and associated traditional knowledge.  
56.  This delegation is firmly convinced that the disclosure requirement would discourage 
industries from conducting research and devel opment activities on biological materials overseas. 
This is the very consequence of the disclosure requirement that Japan has been concerned about. 
Therefore, Japan believes that the disclosure requirement is not an adequate means for dealing 
with such mis appropriation; so therefore, we have to avoid including it in the intellectual property 
system.  
57.  In addition, this delegation believes the WIPO IGC is the most appropriate forum for holding 
technical discussions on IP aspects. The 34th Session of IGC is bei ng held this week. Japan 
remains willing to contribute to discussions on these issues in a constructive manner.  
6.11 Canada  
58.  Canada continues to firmly believe that the TRIPS Agreement and the Convention on 
Biological  Diversity are complementary and that there is therefore no need to amend 
the TRIPS  Agreement in this regard.  
59.  Canada would like to reiterate our view where by matters related to Article 27.3(b) of 
the TRIPS Agreement are an implementation issue as outlined  in the Doha Ministerial Declaration, 
as is also the case with respect to the relationship between TRIPS and the Convention on Biological 
Diversity, and the protection of traditional knowledge and folklore. Canada continues to support 
an approach that prov ides for national flexibility on these matters.  
60.  As noted at previous TRIPS Council meetings, and without prejudice to Canada's position on 
substantive matters, Canada is not opposed from a procedural standpoint to a briefing from 
the CBD Secretariat to the  TRIPS Council, should there be sufficient interest from other Members 
on this matter. Similarly, Canada could also support the update of the three factual notes on 
the TRIPS Agreement and the CBD by the Secretariat. We remain of the understanding that thi s 
would remain a purely factual collating exercise. In both cases, this is without prejudice to national 
positions on these issues.  
61.  Canada would also like to note its continuous support for the important work of the WIPO IGC, 
particularly the discussions u nderway this week at WIPO. Canada remains an active 
and committed participant in this important work and welcomes both the concrete discussions and 
exchange of national experiences at WIPO on these issues.  
62.  Similar to our positions expressed at the IGC and our openness to briefings from the CBD 
Secretariat and the updating of the factual notes by the Secretariat, Canada would welcome 
further detailed presentations by any interested Members containing the latest information on 
the operation and functioning of  their national IP regimes concerning genetic resources and 
traditional knowledge, to inform other Members in this Council. Canada has appreciated similar IP/C/M/86/Add.1/Rev.1  
 
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  presentations on other categories of IP at recent meetings of the TRIPS Council, such as those 
made b y our US and EU colleagues last November concerning their regimes on trade secrets and 
presentations made by a variety of Members under the "IP and Innovation " item in recent years, 
to give but a few examples. We would welcome presentations on national reg imes concerning 
genetic resources and traditional knowledge at future meetings of the TRIPS Council.  
6.12 Australia  
63.  Australia considers the World Intellectual Property Organization's IGC is best placed to 
consider  the complex and important intellectual property issues relating to genetic resources and 
associated traditional knowledge.  
6.13  Switzerland  
64.  As a co -sponsor of document TN/C/W/52, in which a large part of the membership proposed 
modalities language for all three TRIPS issues under discussion, i.e. the GI register and GI 
extension as well as the disclosure of source requirement for patent applications, this delegation 
would like to reiterate its continued intere st in moving this matter forward.  
65.  The TRIPS Council must continue discussing those outstanding implementation issues, 
exchange national and international experiences and engage constructively in finding solutions 
within the mandates given.  
66.  Switzerland also  supports the proposal that the CBD Secretariat informs about and presents 
the Nagoya Protocol to the Council, in whatever mode the Council deems to be appropriate. 
We also support Ecuador 's proposal that the WTO Secretariat updates its factual notes 
on the TRIPS/CBD and GI issues to include the Council 's discussions of the recent years.  
6.14 Korea, Republic of  
67.  On the triplet agenda items, I would like to register our positions expressed in the previous 
Council meetings.  
6.15 Chairperson  
68.  Let me  share with you my observations.  First of all , I am very pleased to know that two 
delegations are having bilateral meetings tomorrow afternoon o n one of the outstanding iss ues. 
I hope that will be a fruitful meeting. If delegations wish to involve me in the bilateral 
consultations, I am always available. And I will also, as I said, reach out to some of you to see 
whether we can find a solution to some of the outstanding issu es. My second observation is that 
unfortunately I think today we cannot agree on the request to update the three factual notes 
prepared by the Secretariat on previous discussions , or for a CBD briefing to be held at a formal 
Council meeting. I have heard o ne delegation suggesting that maybe we should consider a CBD 
briefing in whatever mode that is acceptable to Members. And in that connection I recall that , in 
the last formal meeting of this Council , we have also heard one delegation suggesting that maybe 
the CBD briefing could be organized when the Council meets in an informal mode, for example, as 
a back -to-back session before our next formal meeting. I just want to know if Members would like 
to react to these suggestions.  
6.16 United States  
69.  We do not support the briefing of the CBD Secretariat in informal mode at this time.  
6.17 South Africa  
70.  In respect of the small group meeting which you (the Chair) presided over  last Friday, 
it would be useful if you would be able at our future meetings to give feedback on the discussions 
that we had, I think it would be useful in informing of some of the opinions that have been 
expressed. Specifically on the issue of the briefin g by the CBD, I believe that the proposal was not 
necessarily that it be done in informal mode but perhaps as a side -event to future meetings of this 
Council, so this is also another option that is on the table and that Members could consider.  IP/C/M/86/Add.1/Rev.1  
 
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  6.18 Chairpe rson 
71.  Would anyone like to respond to that suggestion about a side -event not necessarily the 
Council in an informal mode? There does not seem to be any comments on this one, so I will 
further explore with interested delegations about that suggestion and see if w e can come up with 
any ideas for the October meeting  of the TRIPS Council . 
AGENDA ITEM 7:   NON-VIOLATION AND SITUAT ION COMPLAINTS  
7.1 Switzerland  
72.  We would like to confirm that our position has not changed since the last mee ting, 
as summarised in IP/C/M/82/Add.1.  There are a few arguments, however, that opponents of non -
violation complaints under TRIPS, including India, took up in the last Council meeting, which 
we would like to briefly respond to.  
73.  Non-violation claims form a n inherent part of the Dispute Settlement Understanding (DSU). 
They are essential for ensuring the balance of rights and obligations also within 
the TRIPS  Agreement and help secure that legitimate obligations are not circumvented or avoided. 
Non-violation complaints are an instrument which is open to all members, designed to make sure 
that all parties are adhering to their responsibilities.  
74.  The language of Art.  64.1 TRIPS clearly and unequivocally states that:  
"The provisions of Articles XXII and XXIII of G ATT 1994 as elaborated and applied by 
the Dispute Settlement Understanding shall apply to consultations and the settlement 
of disputes under this agreement (i.e. the TRIPS Agreement) except as otherwise 
specifically provided ". 
Thus, the question was never on whether non -violation and situation complaints were to apply but 
rather on the modalities and conditions that would apply to such types of complaints.  
75.  According to Art.  64.2 TRIPS a moratorium of five years was established during which 
situation and non -violation complaints would not apply. Consequently, the intention was clear that, 
once the period of five years had expired, non -violation and situation complaints 
in GATT  Article  XXIII were to be applied.  Further, non -violation complaints are expressly p rovided 
for under Article 26 of the DSU.  The WTO agreements have never excluded non -violation 
complaints from intellectual property matters in general. The moratorium and provisions unde r 
Article 64 TRIPS only concern  non-violation and situat ion complaints  under the TRIPS A greement 
itself.  
76.  The TRIPS A greement does not exclude GATT 1994 from the field of intellectual property, and 
in return, GATT 1994 contains no general exception broad enough to cover intellectual property 
laws and regulations, as indicated  by Matthew Kennedy in his book WTO Dispute Settlement and 
the TRIPS  Agreement: Applying Intellectual Property Standards in a Trade Law Framework 
(OUP 2016).  
77.  Thus, GATT 1994 and TRIPS apply concurrently. This becomes particularly appa rent when 
looking at the TRIPS A greement 's preamble. The first and second clause of the preamble show that 
the intention of TRIPS was to complement GATT, as new additional rules were needed concerning 
the applicability of the basic principles of GATT 1994 and of relevant intel lectual property 
agreements. More so, several agreements in Annex 1A to the WTO Agreement have elements 
in common with TRIPS and can overlap with them. For details I refer to Matthew Kennedy and 
materials of the ne gotiation history of the TRIPS A greement.  
78.  For example, it is evident for the TBT agreement 's scope to overlap with TRIPS due to product 
marking and labelling requirements, which are closely related to the subject matte r of certain 
TRIPS obligations.  Thus, the argument that the TRIPS is a sui gener is agreement distinct from 
GATT and GATS has, in our opini on, no solid ground. The TRIPS A greement forms an integral part 
of the WTO framework as well as the DSU.  IP/C/M/86/Add.1/Rev.1  
 
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  79.  The TRIPS Agreement is a lso a market access agreement. A s was repeatedly pointed out, 
the TRIPS Agreement protects market access for IP -related products and services. The  preamble 
explicitly states that the obje ctive and purpose of the TRIPS A greement is to ensure that measures 
and procedures to enforce intellectual property rights do not undermin e the  legitimate trading 
system.  The Agreement 's Preamble also indicates the expectations that TRIPS negotiators had 
regarding market access for IP -protected goods and services. The objectives outlined in 
the preamble of the agreement were taken from the i nitial mandate for negotiation in 
the 1986 Punta del Este Declaration.  
80.  In the TRIPS negotiating group, various proponents of the agreement stressed the fact that 
the value of trade concessions negotiated under the GATT were being impaired by inadequate or 
excessive protection of intellectual property rights .1 Therefore TRIPS was intended to help reduce 
market distortions that existed prior to its negotiation by establishing adequate minimum 
standards and principles concerning the availability, scope and use  of trad e-related intellectual 
property rights. This is also why we consider any claims according to which non -violation and 
situation complaints are unnecessary and inconsistent with the interests of WTO Members 
to be unfounded.  
81.  What is the purpose of the  non-violation r emedy? We also take the view that 
the establishment of the procedure for non -violation complaints does not primarily aim to prevent 
a tariff concession or specific commitments on trade in services from being adversely distorted by 
additiona l trade measures taken. There are three GATT panel reports which considered 
non-violation claims based on general obligations rather than specific tariff concessions, finding 
that GATT Article XXIII:1(b) is not limited to tariff benefits: The 1985 Panel Re port in European 
Economic Community - Production Aids Granted on Canned fruit, L/5778, not adopted, 
para. 50; 1988 Panel Report on Japan - Semi-conductors , para 82 ; and 1990 Panel Report on 
United States - 1955 Waiver , cited in IP/C/W/212 on page 6 and IP/ C/W/124, Annex 4.  
82.  Establishment of a non -violation claim. The Indian and other delegations have suggested that 
introducing non -violation claims could have a debilitating effect on member 's regulatory policy 
space. We appreciate those concerns. Yet, apart f rom the fact that non -violation complaints are 
regarded as exceptional remedy2, the standards and requirements for bringing forward 
a non-violation complaint are likely to be very high.  
83.  It has been suggested that bringing forward a non -violation complaint principally requires 
the establishment of three criteria.  First, there must be an application of a measure by a WTO 
Member against which such a complaint is brought (1). Here, by virtue e.g. of  Articles 7 and 8 of 
the TRIPS A greement as well as the Paragra ph 6 System, certain measures are per se excluded 
from such complaints. In general terms, the application of TRIPS flexibilities would, as was 
previously outlined by this delegation, most likely to be excluded.  
84.  Were the panel to find that a measure was not  excluded by these provisions or flexibilities, 
in a next step, second it would examine whether there was a benefit accruing to the complaining 
Member (2), and third whether this benefit was being nullified or impaired as a result of 
the application of the  measure (3).  
85.  Apart from the fact that identifying the potential benefit under the TRIPS Agreement  may 
cause substantial difficulty, the requirement of nullification or impairment of a benefit is not 
presumed and must be demonstrated by the complainant on the basis of solid evidence.  
86.  According to Article 64.3 TRIPS, a decision to extend a moratorium can only be agreed upon 
consensus. Thus, further extension of the moratorium under Article 64.2 TRIPS should no longer 
be agreed. While we believe that there is  no need to define specific modalities for NVCs under 
TRIPS Agreement, we remain open for comments and proposals pertaining to the scope and 
modalities for non -violation and situation complaints as well as for the Council to enter into closer 
and more spec ific analysis thereupon.  
                                                
1 Meeting of Negotiating Group of 23 September 1987, Note by Secretariat, MTN.GNG/NG11/3 (8 
October 1987) para. 8.  
2 Decision of the Ministerial Conference on  TRIPS non -violation and situation complai nts (WT/L/842) of 
17 December 2011.  
 IP/C/M/86/Add.1/Rev.1  
 
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  7.2 India  
87.  I would also like to thank the delegation of Switzerland for providing some explanations on 
the issues  raised  by other Members , including India. India's position on the issue of non -violation 
complaints under the TRIPS Agreement remains unchanged.  
88.  In the run -up to the Ministerial Conference in Nairobi it would be worth noting that there is a 
great confluence of interest on making such complaints inapplicable to TRIPS. We are not 
convinced by th e reasons provided by several Members of its place in the TRIPS context. 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 non-violatio n complaints  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  importance of which Ministers reaffirmed through their adoption of the 
Decision on Implemen tation -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 scope 
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 initiate 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 Agreement is, 
in our view, incorrect.  
89.  For some of the comments made by the Swiss delegation, I would like to refer to our 
submission c ontained in document IP/C/W/385/Rev.1 where we have stated why non -violation and 
situation complaints are unnecessary under the TRIPS Agreement.  
90.  The TRIPS Agreement, unlike other WTO agreements, is a sui generis  agreement which is not 
designed to protect m arket access or the balance of tariff concessions but , rather , to establish 
minimum standards of intellectual property protection, which, if abused, may even undermine 
market access.  
91.  Non-violation and situation complaints are unnecessary to protect any bal ance of rights and 
obligations inherent in the TRIPS Agreement, as these are reflected in the Agreement's principal 
obligations and flexibilities, and the Agreement explicitly states that WTO Members are not obliged 
to implement more extensive protection ( Article 1).  They are also  unnecessary to protect market -
access commitments embodied in the GATT or GATS, or any other notion of a balance of 
concessions struck in the Uruguay Round, as these are adequately protected by those agreements 
and other Annex 1 ag reements.  
92.  Rights and obligations in the TRIPS Agreement are best performed through good faith 
application of its provisions, in accordance with established principles of international law 
recognized by the Appellate Body, and do not require recourse to the  legally imprecise notion of 
non-violation and situation complaints.  
93.  In the GATT/WTO legal framework, the establishment of the non -violation procedure aims 
primarily to prevent the 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 or dilution of trade obli gations 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 complaint is an additional tool with which to balance 
the rights and obligations concerning market acces s 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 IPR might facilitate trade and investment, 
the obligations under the TRIPS Agr eement cannot be characterized as market access concessions.  
94.  Serious concerns remain regarding  the debilitating impact that non-violation complaints in 
TRIPS can have on the regulatory policy space of Members, on TRIPS flexibilities , as well as on IP/C/M/86/Add.1/Rev.1  
 
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  increasi ng the  complexity of interpreting the TRIPS provisions. It can not only have a chilling effect 
on Member 's exercise of their IP regimes but also severely restrain the ability of Members to 
achieve other public policy objectives.  
95.  The absence of non -violatio n 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 is sues 
relating to the rights of intellectual property r ight holders versus the legitimate exercise of 
regulatory policy choice by g overnments. Introducing non -violation and situation complaints into 
the TRIPS Agreement is unnecessary and inconsistent with the interes ts 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 without introducing 
the legally uncertain notion of non -violat ion and situation complaints.  
96.  We also wish to reiterate that until there is a consensus on the scope and modalities of 
the applicability of non-violation complaints  to TRIPS, such complaints  should not apply to 
the TRIPS Agreement.  
7.3 Brazil  
97.  Brazil would like to reiterate its understanding that non violation and situation complaints 
should not be applied to the TRIPS Agreement.  While we thank Switzerland for their statement, we 
remain unconvinced by  the arguments presented today.  
98.  For the cases where a Member assesses that the obligations of the TRIPS Agreement are not 
being properly fulfilled by another party, Article 64 of TRIPS unambiguously establishes a dispute 
settlement mechanism which could be  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 and no concrete cases were presented up to date 
by demanders.  
99.  As provided in document IP/C/W/385/Rev.1, concessions under the TRIPS Agreement cannot 
be characterized as "market access " under GATT. The TRIPS Agreement, like other 
WTO agreements, is a sui-generis  treaty designed to establish minimum standards of intell ectual 
property protection. Complaints regarding measures pertaining to market access should be filed 
under relevant provisions of the GATT. The sui generis  nature of intellectual property with regard 
to the standards set in GATT led the negotiators of the  Uruguay Round to the TRIPS Agreement, 
instead of including intellectual property provis ions as amendments to the GATT.  
100.  Furthermore, the fact that no consensus on the matter was reached during the negotiations 
of the Uruguay Round underlines the fact that negotiating parties were not convinced that it would 
contribute to the attainment of the goals of the TRIPS Agreement. The continuous renewal of 
the moratorium since 1999 shows that Members remain unconvinced of any benefit that could be 
brought by the app lication of non-violation and situation complaints . 
101.  In short, the application of such complaints to intellectual property disputes would generate 
systemic imbalance s and reduce the legal certainty of multilateral IP law, a result that would 
conflict with t he very goal of the multilateral trade system. Its necessity has not been established 
by demande urs until this moment, and its application is opposed by the vast majority of 
WTO Members.  
102.  Consequently, we propose that the TRIPS Council recommend to the Ministerial Conference  
that complaints of the type provided for under subparagraphs 1(b) and 1(c) of Article XXIII of 
GATT 1994 shall not apply to the settlement of disputes under the TRIPS Ag reement.  
7.4 Argentina  
103.  Argentina's po sition is very well known on this issue . We re-iterate that non -violation and 
situation complaints do not apply to the  TRIPS Agreement as has already been explained in 
document IP/C/W/385/Rev.1 of which Argentina is a co -sponsor together with a large number of 
other Members.  IP/C/M/86/Add.1/Rev.1  
 
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  104.  Argentina believes that this Council should recommend to the Ministerial Conference that 
complaints provided for in 1 (b) and 1(c) of Article XXIII of GATT 1994 should not be applicable to 
dispute settlement under the TRIPS Agreement, as proposed in the draft decision contained in 
the document IP/C/W/607.  
7.5 Bolivia, Plurinational State of Bolivia  
105.  Like other delegations have also mentioned the Plurinational State of Bolivia believes that 
non-violation and situation complaints do not apply in the context of intellectual property. Along 
with a large majority of Members, B olivia submitted a document IP/C/W/385 with a large amount 
of information and analysis as to why non -violation and situation complaints should not apply to 
intellectual property. Applying such complaints  would have a very negative impact on the capacity 
of each Member to reg ulate in various areas and that i s not acceptable for many Members of 
this Organization. We are not going to repeat the arguments contained in document IP/C/W/385, 
but we would like to reiterate our position that the TRIPS Council should  recommend to the 11th 
Ministerial Conference to adopt a decision that non -violation and situation complaints identified in 
Para 1(b) and 1(c) of Article XXIII of GATT 1994 should not be applicable to the TRIPS Agreement.  
7.6 South Africa  
106.  We thank Switzerland for its intervention in this regard and we place it on record that we do 
not agree with many of the basis of arguments that Switzerland advances, more specifically, in 
respect of the negotiating history. We believe tha t the issue of non -violation complaints is 
necessarily an outstanding issue, unfinished business which was not agreed during the Uruguay 
Round and as a result, the GATT -ability of the TRIPS Agreement vis-à-vis the GATT has always 
been on the table , and the  current  debate around this issue is a confirmation of this. Without 
belabouring the arguments that have been presented in the past this delegation has many times 
indicated that non -violation and situation complaints are unnecessary and should not apply in  
the context of the TRIPS Agreement.  
107.  Specifically, we are further inclined to interpret Article 64.2 to mean that in case 
the moratorium on the application of non -violation and situation complaints is not extended in 
2017, the complaints would not automati cally apply to the TRIPS Agreement. Under a strict 
reading of Article 64.2, these disputes cannot apply until Members agree to the scope and 
modalities of their application in respect of the TRIPS Agreement.  
7.7 China  
108.  Members mig ht recall that in 2015, the Nairobi Ministerial Conference decided to further 
extend the moratorium of the application of non -violation and situation c omplaints under 
TRIPS  Agreement. H owever, until now, the divergence between Members is still observed.  
109.  China appreciates the efforts made by the Chair and Secretariat, and hopes Members could 
constructively participate in the discussion. China reaffirms the position that the non -violation and 
situation complaints are not applicable under the TRIPS Agreement, which has been elaborated in 
document  IP/C/W/385/Rev.1 proposed by 16 Members including China in 2015. China welcomes 
the discussion on this issue in accordance with the decision and mandate given by the  Nairobi 
Ministerial Conference.  
7.8 Ecuador  
110.  As a co -sponsor of document IP/C/W/385/Rev.1, Ecuador believes that this document should 
serve as a basis for discussions on this agenda item for the reasons set out therein. Ecuador's 
position is well known . The TRIPS Agreement does not seek to protect market access, as there is 
no exchange of tariff concessions, but rather that it is a sui generis  agreement that establishes 
minimum standards on the acquisition, exploitation, scope and exercise of intellectual pro perty 
rights. Non -violation complaints are therefore not applicable under the TRIPS Agreement.  
111.  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 1( c) of the GATT 19 94 are not IP/C/M/86/Add.1/Rev.1  
 
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  applicable to the TRIPS Agreement . This is the recommendation that must be made and adopted 
at the Buenos Aires Ministerial Conference.  
7.9 Egypt  
112.  The position of Egypt is well -known with regard to this  agenda item. We continue to believe 
that complaints  of the type identified in Article  XXIII 1(b) and (c) of GATT 1994 are not applicable 
to the TRIPS Agreement. We still believe that the best way to overcome this issue is that 
document number IP/C/W/607 p roposed by Peru should be the basis for our future negotiations 
in this regard.  
7.10 United States  
113.  For the reasons detailed in our previous interventions under this Agenda item the United 
States continues to maintain its position that NVNI disputes should be applicable to 
the TRIPS  Agreement, that they are fully consistent with the TRIPS Agreement and that the 
application of such disputes in this context was the intent ion of the drafters of 
the TRIPS  Agreement.  
114.  We believe that while valid questions have arisen, they are fully and adequately answered by 
the text of the TRIPS Agreement itself and further clarified through GATT and WTO adjudications, 
as we have enumerated in our communications to the TRIPS Council which is bei ng circulated to 
Members as IP/C/W/599, as well as in our recent interventions. The United States has provided 
detailed and extensive analysis in each of our statements under this item over the past several 
years. We have explained the legal basis for such  claims in the GATT and the TRIPS Agreement 
text, the Panel and the Appellate Body jurisprudence involving NVNI disputes, the extensive 
safeguards that exist to protect Members' rights and obligations under the TRIPS Agreement in 
concrete descriptions rega rding how such disputes would work in practice. As we have detailed in 
past interventions, and will share today to respond to remaining concerns of some Members, NVNI 
claims have a long lineage in the WTO and in international trade law generally. The appli cability of 
such claims to the WTO Agreements is the rule, their non -application is the exception. 
The TRIPS  Agreement moratorium is the exception. Some delegates have recently raised concerns 
that NVNI would have a negative impact on TRIPS exceptions. If NVNI has had no negative impact 
on exceptions under GATT, GATS, and the Agriculture, Government Procurement and other 
WTO Agreements, we wonder why NVNI would impact exceptions under the TRIPS Agreement. The 
answer is that there is no evidence that suggest s that such claims would have such impacts. We 
also have heard recently from some delegations that the TRIPS Agreement is not a market access 
agreement thereby rendering NVNI inapplicable as a result. While we have demonstrated copiously 
to the  contrary an d heard good intervention s on this point from our Swiss delegation, we again 
note that such a dialectical or binary view is beside the point. As has been discussed NVNI claims 
have been brought outside of the GATT -context and assessed on the mer its by 
WTO-adjudicative  bodies.  
115.  To conclude, non -violation complaints are fully appropriate in the context of 
the TRIPS  Agreement and have long been part of the WTO and GATT. Such complaints are 
exceptional and infrequent, and subject to existing and clear rules of t he road including numerous 
levels of safeguards to ensure security and predictability with respect to the rights and obligations 
of all WTO Members under the TRIPS Agreement. Non -violation complaints serve an interest of all 
Members which is to assist Members in protecting against measures that nullify or impair 
concessions. Non -violation complaints were part of the balance of rights and obligations in 
the TRIPS Agreement and the time has come to allow for the moratorium on non -violation 
complaints to expire.  
7.11 Japan  
116.  Japan's view on this issue has not changed. Both clarity and predictability should be ensured 
when applying non -violation and situation complaints to the TRIPS Agreement. From this point of 
view, making factual analyses on applicable specific and concrete circumstances of non -violation 
and situation complaints would facilitate examination in terms of the scope and modality of 
non-violation and situation complaints in the area of  the TRIPS Agreement.  IP/C/M/86/Add.1/Rev.1  
 
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  7.12 Sri Lanka  
117.  Sri Lanka would also like to join the majority of Members who sponsored the proposal on 
non-applicability of non -violation and situation complaints under the TRIPS Agreement. My 
delegation 's position is well known and we support a permanent solution by making non -violation 
and situation complaints inapplicable under the TRIPS Agreement. We understand that there is 
a need for Members to reach a definitive agreement in this regard and would l ike to assure 
the fullest cooperation of my delegation in future consultations.  
AGENDA ITEM 8: REVIE W OF THE IMPLEMENTAT ION OF THE TRIPS AGR EEMENT UNDER 
ARTICLE 71.1  
118.  No statements were made under this agenda item.  
AGENDA ITEM 9: REVIE W OF THE APPLICATION  OF THE PROVISIONS OF THE SECTION 
ON GEOGRAPHICAL INDI CATIONS UNDER ARTICL E 24.2  
119.  No statements were made under this agenda item.  
AGENDA ITEM 10: TECH NICAL COOPERATION AN D CAPACITY BUILDING  
120.  No statements were made under this agenda item.  
AGENDA ITEM 11: INT ELLECTUAL PROPERTY A ND INNOVATION: INCLU SIVE 
INNOVATION AND MSME GROWTH  
11.1 European Union  
121.  Allow me to make the first intervention on t his point that we co -sponsored. I t is part of 
a very import ant debate that we have been having for the last five years at least here in this 
TRIPS Council about concrete benefits that intellectual property brings to innovation and we have 
decided now to choose some points that we would discuss with bit more at len gth so in the course 
of two or three sessions to allow more in -depth debate with Members and also give them time to 
collect their e xperiences and to share them with us. In that sense , as well as to help feed 
the debate together with the other co -sponsors , we prepared a short summary of the issues that 
could be discussed under the theme that we have today which is Inclusive Innovation and MSME 
growth. I  will not repeat what is in that paper but instead I would like to share with you 
the intense activi ty of t he EU and of its member S tates in tailoring intellectual property to 
the smaller companies and to those who have fewer resources to manage their research and their 
discoveries and their quality products, so making intellectual property more accessible to a ll. 
So, the crucial role of the  intellectual property in the success of start -ups and innovative MSMEs 
has long been recognized, it allows innovative businesses to appropriate the results of their 
creativity, inventiveness and R&D investment , and creates a n incentive for further investment 
in innovation.  
122.  Recent data  from the EU Intellectual Property Office shows that businesses using IP rights 
perform better and this is particularly true in the case of MSMEs. Recent studies show that in 
the EU these kind s of small companies owing IP rights have almost 32% higher revenue per 
employee than MSMEs that do not. They also expand their work force faster and pay higher 
salaries. Intellectual property is therefore important for smart and sustainable growth. Yet, 
the same data show  that there are few MSMEs , even in the EU , that actually make use of 
intellectual property. The study showed that around 9% of these small companies registered 
intellectual property rights as compared to 36% for larger companies. The study al so gives us 
a view on why many SMEs do not use the intellectual property system, and this is sometimes 
because they are not aware of the benefits of it, they lack the necessary expertise or they find 
some of the procedures too costly. This is why it became  evident for us that there was a need to 
support the smaller companies in accessing, using and exploiting the intellectual property system 
and we have been working on this challenge since then.  
123.  Given that an information and knowledge based economy with str ong innovation 
performance is made up of businesses whose most valuable assets are intangible, all innovative IP/C/M/86/Add.1/Rev.1  
 
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  and creative start -ups and MSMEs need to be aware of the advantages of using IP and the dangers 
of neglecting it. Once pr otected  these rights have  to be managed to generate value and to enable 
innovation to play its true role. A variety of different strategies and supp ort measures are applied 
by EU member S tates in order to encourage and help MSMEs in the use of the IP. For  instance, 
Portugal financ ially helps its MSMEs to register IP rights, not only in Portugal but also EU -wide and 
in third countries. Another example, the UK Intellectual Property Office currently funds 250 audits 
for high -growth businesses engaged with business support programmes r un by the European 
Enterprise Network, the Welsh Government or Scottish Enterprise. This specialized service 
provides an in -depth analysis of a business  IP, including opportunities for increasing revenue , as 
well as any potential risks, together with recom mendations for increasing the value of their 
intellectual property catalogue.  
124.  The Czech Republic provides financing and IP pre -diagnoses services to its MSMEs. This aims 
at providing advisory service on how to efficiently create added value and  protect int angible 
assets ; and is targeted at particular small and medium -sized enterprises and innovative 
companies. A tailor -made analysis will be carried out assessing the state of the protection of 
the intangible assets for these companies. In France,  the Nationa l Institute for IP has been 
developing throughout the years policies of support and financial aid to MSMEs which include 
personalized support for these companies, the provision of services in the form of information 
searches in various IP data basis, train ing adapted to companies, and work in regional partnership 
with innovation development agencies. On the EU side , in our single market strategy of 2015 and 
building on the  experience of these and other Member states, the Commission announced that it 
will co me forward with EU -level measures to support the use of IP by MSMEs. Delivering on that 
commitment , the Commission has now undertaken to put in place a package of IP support 
measures for these companies which will have the effect of improving coordination and consistency 
in addressing sub -optimal use of IP by them across the EU. These measures include, among 
others, streamlining European IP -awareness schemes for MSMEs and providing pre -grant 
assistance, developing an EU online information tool to promote IP  sharing and an IP mediation 
and arbitration network for MSMEs. And third, encouraging the creation of European -level 
insurance schemes for litigation and IP theft. The measures will be delivered on the basis of 
a partnership approach between the relevant Commission services, the EU member S tate 
authorities, the EU IP Office and other relevant stakeholders.  
125.  Let me develop a little bit each of these three points, starting with information and 
awareness. Different initiatives at EU national and local levels e xist to raise awareness on IP, but 
the challenge has been to ensure that messages are streamlined, easily accessible and that they 
address the real business needs of innovative MSME enterprises. The Commission in partnership 
with the EU Intellectual Proper ty Office will streamline IP awareness sc hemes for this type of 
company  and will support exchange of best practices through an EU -coordination platform. 
This will involve the development of a common portal of materials for information and training and 
of common training of trainers. Awareness actions need to be complemented with more concrete 
actions to support MSMEs in the access and use of intellectual property.  
126.  As I mentioned, some member S tates provide individualized advice on the IP potential of 
a forum's intellectual assets within each specific market context. These services that I mentioned 
before , known as IP pre -diagnostic services , can be particularly effective as a way of helping these 
kinds of companies, both to assess the value of their IP asset s and to  include intellectual property 
fully in to their business strategy. The Commission will finance a project of IP pre -diagnostic 
services to be implemented in a coordinated  manner with member S tates and the EUIPO and 
the other stakeholders. It will bu ild on existing experience but will comprise a more thorough 
coverage of such services across the EU. And will systematically consider EU -wide IP rights within 
the whole IP  spectrum.  
127.  In particular, patents are relatively expensive and the patent system can  be complex for 
MSMEs. Today , protecting an invention  throughout the European Union Single M arket can be 
achieved through the European Patent Office, but only at a non -negotiable cost. Pre -grant costs 
and patent at torney fees represent an important charge for MSMEs and start -ups in order to 
market their innovative products and services across the entire EU market. Considering this factor 
we see that with less than 1% of MSMEs own patents in Europe. The Commission will help 
innovative companies and start -ups that want to patent in Europe to use  European patents. A pilot 
project will be launched to finance these companies in requesting and being granted patents. The 
subsidy will cover 50% of the pre -grant costs for European patents as well as a part of attorne y's IP/C/M/86/Add.1/Rev.1  
 
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  fees. This  will support such innovative small companies in the early years in developing their 
innovative products by significantly reducing patent costs. This should also create a cycle to 
facilitate their access to finance and investment. Such an ini tiative could in the future be extended 
to other European IP titles and notably EU trademarks and community designs or the future 
unitary patent , once it is in force. A nd it could cover both private and professional advice , which is 
a main source of expens e for these titles.  
128.  The second area of support to SMEs  is facilitating the use and enfor cement of intellectual 
property. T o get innovative start -ups and MSMEs enterprises to benefit from the  IP system, 
whether by registering rights or by applying other IP protection methods is not enough. Once such 
enterprises  own their IP rights they face subsequent challenges on how to make use of 
the system. With the appropriate tools these companies could generate more income through 
licens ing or sales of their protecte d intellectual property , as well as raise more funds for 
investment. Small businesses , however , will not receive the full value of their intellectual property 
rights if they cannot enforce them when needed. Evidence suggests that enforcing intellectual 
property titles is costly and complex , especially for these kinds of small and medium -sized 
companies and when facing large entities.  
129.  In this context , the previously mentioned Single Market Strategy announced that 
the Commission will pay specific attention to  this type of companies in the context of an on -going 
revision of our enforcement directive. MSMEs need to pay attention not only to their own IP rights 
but also to the IP rights of others. In a knowledge -based environment even IP -savvy companies of 
small dimension need help to find commercial partners. A tool with patent licensing information 
could be very useful to facilitate such partnerships and avoid costly disputes. The Commission will 
therefore work with the network of EU Member states authorities to  develop such a platform for 
knowledge sharing and business matchmaking on technologies covered by current and 
future  patents. This will be done in the course of this and next year.  
130.  The platform will offer organized and comprehensible information, such as know-how, 
key-contractual conditions and partnering in order to facilitate licensing between parties. 
This platform will serve as service to find information on the licensing possibility of patents in force 
in different EU Member states. While all entities  would benefit from such a tool , it would 
particularly help the  smaller companies and start -ups to license in and license out technologies 
across Europe. Also , alternative lighter and faster methods of solving legal disputes , namely 
through arbitration and  mediation , can be very useful for these smaller companies, as 
an alternative to litigation in court. This , in particular , if such arbitration and mediation can be 
provided at an affordable cost. These methods also allow for a more proportionate settlement  than 
simple out -of-court bilateral agreements, w hile the involvement of an experienced IP specialist as 
an independent expert ensures a more equitable outcome. The Commission will strive for 
the availability of mediation and arbitration services covering the whole spectrum of intellectual 
property accessible across the  entire EU and designed in an MSME -friendly way. They will be 
available online and potentially through local intermediaries , for instance , such as chambers of 
commerce and will dovetail with broader legal mediation.  
131.  To conclude, very briefly on the third point that I mentioned , which is work on IP litigation 
insurance: the ability to enforce right s is essential for IP to keep its value, but  as I mentioned 
before, smaller companies do not  neces sarily have the financial or  legal means or even human 
resources to do so. IP litigation insurance , if it was more broadly available for small companies , 
would allow for the sharing or transfer of the financial burden and risks associated with IP 
litigatio n. However, these studies that have been conducted show that the market for insurance 
products for IP litigation has to date been too limited. The Commission will therefore seek to 
encourage insurance companies to enter this market in respect of EU -wide in tellectual property 
titles and will assist innovative micro and small medium -sized enterprises to access such services. 
To this end , a two-year pilot -project on multi -territory patents will be launched , after which the 
initiative will be evaluated and, if appropriate, continues and possibly will be  extended to other IP 
titles.  
132.  With this I conclude my remarks for today . As you can see, there is quite a broad range of 
measures that are being explored in the Europe an Union and together with our member S tates. 
Best practices are being developed and we would be very happy to debate these with colleagues 
here today and also to listen to the experience of the co -sponsors and of all the other Members 
that will intervene on this point.  IP/C/M/86/Add.1/Rev.1  
 
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  11.2 United States  
133.  The United States welcomes this opportunity to share views and experiences on 
the important issue of inclusive innovation and MSME growth. I would like to express thanks to 
Australia, Canada, the European Uni on, Japan, Singapore, Switzerland and Chinese Taipei for 
co-sponsoring this item today.  
134.  We benefitted greatly and appreciated the contributions on inclusive innovation and MSME 
co-operation shared during the last session by so many delegations. The United States is pleased 
that the co -sponsors of this item seem to have identified a theme for the year that enjoys wide -
spread and diverse support among the TRIPS Council Membership and I think this demonstrates to 
the public our commitment to work toget her on i mportant and timely IP issues. As we described in 
our previous intervention, MSMEs are critical to the American  economy. They create jobs, sp ur 
innovation and foster entrepreneurial spirit. One of the ways that US policy makers have 
contributed is by takin g a global perspective to MSME development. This helps ensure growth and 
competitiveness of US MSMEs, so that they may take advantage of the same opportunities 
available to larger companies.  
135.  Today, thanks to advances in technology , it is easier than ever b efore to access the global 
market place. The digital economy is booming, creating new opportunities we could not have 
imagined even a decade ago. With these advances, borders are collapsing often pushing 
companies to go global even before they may feel rea dy to do so. In addition t o understanding 
local markets, intellectual p roperty -landscapes and business practices specific to different 
countries are crucial for MSMEs to successfully enter new markets. Too often , MSMEs find 
themselves unaware of government  and private sector resources and best practices when starting 
and growing their businesses. As evidenced by many of the previous sessions' interventions 
the government can play an important role as a catalyst for the private sector by developing 
ecosystem s for MSMEs, start -ups and entrepreneurs to thrive and become the successful 
businesses of tomorrow.  
136.  With respect to growth, the IP system provides MSMEs and all companies with a confidence 
to invest in themselves as a way t o continuously enhance, refine and distribute a viable product or 
service for the market place. The US Federal Government provides key resources to make sure 
that innovators have what they need to turn a great idea into a successful business and take 
advantage of global opportunities. Th e US Government wants to make sure that US MSMEs have 
knowledge of access to and benefit from existing government resources aimed at realizing 
international opportunities. For example, the Global Innovation Forum  (GIF)  is a non -profit 
organization that par tners with the Department of Commerce to connect businesses, start -ups, 
and development and university leaders with public policy makers to understand the opportunities 
and challenges associated with engaging in the global marketplace in the digital age. K ey points of 
emphasize include securing intellectual property in the early stages of a company and securing 
access to finance.  
137.  GIF identifies and connects the diverse set of stakeholders from executives of multinational 
corporations, start -up CEOs and vent ure capitalists to university leaders, researchers and public 
policymakers and provides thought leadership on issues related to how companies, entrepreneurs, 
researchers and just about anyone can innovate and access global markets in the digital age. 
This programme was created due to the strong demand from the MSME community for the 
government to provide technical assistance on exporting their goods and services. Additionally , 
their incubators and accelerators across the United States help MSMEs scale up, for example , the 
Cambridge Innovation Centre (CIC) in Massachusetts is a shared work environment for MSMEs and 
other companies. This business incubator has a strong track reco rd of success, having hosted 
nascent companies such as Facebook, Paypal, Google Android's development and Amazon.com , 
when they were in their growth phase. CIC's mission is to develop ecosystems that allow 
entrepreneurs to create new products and companies  better and faster. They achieve this by 
providing infrastructure and actively building start -up communities in the premium locations of 
future focus cities.  
138.  Another start -up incubator, 1776, which has roots in Washington D.C., but has since 
expanded inter nationally , connects MSMEs to the information they need to help them build highly 
skilled  businesses through curriculum, to export mentors who can help start -ups to quickly solve IP/C/M/86/Add.1/Rev.1  
 
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  problems, to market  through their partners and to obtain capital through thei r investor network 
and seed fund s. 
139.  In addition to incubator and accelerator networks, regional innovation clusters provide 
MSMEs with three sour ces to foster innovation and in turn  generate growth for individual MSMEs 
and industries. Regional innovation or  industry clusters are geographic concentrations of 
interconnected companies, suppliers, service -providers as well as academic institutions, 
government agencies and other organizations that provide specialized training, education and 
resources. By facilita ting knowledge exchange and the pooling of resources these active networks 
drive innovation and job creation boosting regional and national competitiveness. Building trust 
among the cluster of players is essential for achieving high levels of collaboration  that lead to 
developing, commercializing and bringing innovative products and services to market.  
140.  Strong intellectual property regimes are critical for engendering this trust and collaboration 
and for forming international partnerships. As research over t he past few decades has shown, 
clusters exist in all types of economies and are more prevalent in locations that achieved better 
performance relative to their overall stage of development. They play a fundamental role in driving 
regional economic competiti veness by encouraging higher rates of job growth, wage growth, new 
business formation and innovation in regions they are located in.  
141.  Other US Government programmes are for grants to advance invention in capacity building 
activities in communities across th e country and help stimulate inclusive innovation growth. 
In 2016, 35 organizations including non -profits, institutes of higher  education and 
entrepreneurship -focused organizations from 19 US S tates received nearly $15  million to create 
and expand cluster focus, proof -of-concept and commercialization programmes, and early stage 
seed capital funds, through the Department of Commerce, Regional Innovations' Strategies 
Programme  (RIS) . This programme is a national initiative designed to support the creation of 
centres for innovation and entrepreneurship that increase the rate at which innovations, ideas, 
intellectual property and research are translated into products, services, viable companies and 
ultimately jobs. The divers e group of awardees has reached urban  and rural areas across 
the United States,  including the programme's first investments in historically black co lleges and 
universities in the South, a women -focused early -stage capital fund in Texas, 
a Native  Americans -centered proof -of-concept programme i n Oklahoma and urban innovation hubs 
honing in on fashion technology and social innovation in New York and Louisiana , respectively.  
142.  The RIS programme advances innovation and capacity building activities in regions across 
the country by addressing two essen tial core components that entrepreneurs nee d to take their 
ideas to market : Programmatic support and access to capital. The RIS programme is critical to 
ensuring that entrepreneurs have access to the tools they need to move their ideas and inventions 
from idea to market. One awardee, Biotech Innovation Incorporated, is a non -profit public -private 
partnership in Maryland that supports the progression of early state bio -health technologies and 
companies from research to commercialization. Their project is foc used on harvesting assets in 
the form of technology and ideas from the sources of research, intellectual property and 
entrepreneurial community at large. The grant will allow the organization to review more 
technologies, spur the development of new compani es from the technology, create connectivity 
through our regional industry cluster and, around new opportunities, raise capital, and overall 
provide a unique growth opportunity for early -stage businesses.  
143.  These public -private partnerships are vi tal to the p rocess of discovery, the commercialization 
of new products and to the growth in cities and communities across our country and are necessary 
to create the inventions that could reshape our economy and our way of life. These initiatives 
promote IPR protectio n by providing MSMEs with an innovative ecosystem and the resources 
to help them protect their IPR at an early stage. Strong IP protection is critical in scaling up, 
forming partnerships and ultimately going global. These aforementioned programmes through 
partnerships, education, training and matchmaking provide MSMEs with the  resources needed to 
protect their IP, grow their businesses, create jobs and build a more competitive economy.  
11.3 Australia  
144.  Australia joins other co -sponsors for this discussion today on 'Inclusive Innovation and Micro, 
Small and Medium -Sized Enterprise Growth'. Australia has established a number of IP and IP/C/M/86/Add.1/Rev.1  
 
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  Innovation initiatives to help MSMEs utilize and protect their intellect ual property and to promote 
MSME growth including through scaling up their initiatives, collaboration and commercialization. 
Australia will highlight three programmes today: the IP Mediation Referral Service, an accelerator 
service for SME known as the ON Program and the Entrepreneurs Programme.  
145.  The f irst: Mediation -Referral Service: IP Australia plans to establish a domestic intellectual 
property Mediation Referral Service where IP right holders will be able to access mediation as 
a low cost and affective alternative to resolving IP related disputes. The Mediation -Referral Service 
will consist of a register of qualified, accredited and specialist private sector mediation providers 
listed on the IP Australia Website. The register will provide details on the fees and contact details 
of each listed provider allowing parties to IP -related disputes to engage with mediators. 
IP Australia has also collaborated with the Arbitration and Mediation Center of 
the World  Intellectual Property Organization to develop new r esources that provide alternative 
dispute resolution services online. This new service provides Australian businesses, including 
MSMEs, with improved access to mediation, arbitration and expert determination services, and will 
enable parties to settle IP d isputes in a time and cost -efficient manner.  
146.  The s econd: Australia's publicly funded research institute, the Common -Wealth Scientific and 
Industrial Organization, also known as CSIRO, launched the 'On -Program' in July 2015 to empower 
researchers to play an  active role in the commercialization of service -based technology and help 
restrain researchers and their collaborators to develop practical commercialization and venture 
building skills. In July 2016 ON expanded its eligibility criteria to include all pub licly funded 
researchers, an expansion made possible by A$20 million of additional funding from the  Australian 
government's National Innovation and Science Agenda. This programme consists of a pre -
accelerator aspect known as the ON Prime for innovative res earchers at early stages of investment 
readiness, and a separate national science at technology accelerator –programme known as ON 
Accelerate for innovative researchers closer to commercialization. To date over 130 research 
teams have completed this program me, and 27 universities and a number of government 
departments have partnered with this programme. Participating teams retain ownership of their 
intellectual property. One SME, known as Cardihab, graduated from the first round of the ON 
Accelerator program me in February 2016 , and is one of the many success stories of this initiative. 
This small company uses web and mobile application based technology to enable medical 
practitioners to provide more timely advice in supporting patients with heart disease.  
147.  The third programme is called the Entrepreneurs' Programme. This programme is a flagship 
initiative, operating at an individual firm level, drives growth and competitiveness among SMEs. 
This programme takes 'facilitation first' approach and provides easy to a ccess advice, assistance 
and tailored support to SMEs, including IP support, to help them become more competitive and 
growth focused. It is a flexible programme designed to address the individual needs of SMEs. 
For example when SMEs are seeking to collabor ate with the publicly funded research organization, 
the programme ensures that participants are provided advice in all aspects of this work including 
their IP. The programme operates with a national network of over 130 advisors assisting 
participants drawn  from a wide range of industry groups to ensure participants are provided was 
relevant, tailored and expert support.  
148.  Australia has provided some examples of intellectual property and innovation initiatives that 
are designed to promote sustainable growth of  MSMEs. We encourage other Members to join us 
in sharing national practices.  IP/C/M/86/Add.1/Rev.1  
 
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  11.4 Japan  
Slide 1  
149.  Please allow me to mention that handouts of this short presentation3 can be found just 
outside the entrance of this room. At present, there are approximately 3.82 million companies in 
Japan and 99% of those companies are MSMEs. That is to say, most of the companies in Japan are 
MSMEs. Raising the MSMEs ' awareness on intellectual property will broaden the base of  intellectual 
property. By utilizing intellectual property, MSMEs can develop and local communities can be 
revitalized, which will eventually lead to the economic development of the country. We believe that 
this holds true not only for Japan but also for e very country in the world. In addition, it is a fact 
that MSMEs play an important role in the economic development of their respective countries.  
Slide 2  
150.  First, please look at the pie chart on the left. Although MSMEs account for 99 .7% of the total 
number of companies, as I ment ioned, they filed about only 14%  of all applications. The number 
of foreign patent applications filed by Japanese MSMEs  is also only about 16% . 
151.  Next, please look at the bar graph on the right side. This graph shows the correlation 
between patent possession and operating profit on sales in Japan. MSMEs without patents have 
only 1.8 % in operating profit on sales, while MSMEs with patents have 3.5 %. For comparison, the 
operating profit on sales for large companies is 2.6 % in all indust ries. 
152.  Accordingly, the operating profit on sales by MSMEs with patents is higher than that for large 
companies. Therefore, the fact that companies with patents achieve good business performance 
indicates that intellectual property has a positive effect on corporation results.  
153.  Since there is still a mple room for MSMEs to utilize intellectual p roperty both domestically 
and internationally, it is necessary for the government to accelerate initiatives for strengthening 
intellectual property strategies of MSMEs.  
Slide 3  
154.  One of the measures taken by Japanese government was setting up Comprehensive IP 
Support Service Counters. As shown in the upper left box, there are various issues and problems 
with IP, starting from the planning stage up to developing solid corporate management.  
155.  Accordingly, the Japan Patent Office (JPO) started supporting MSMEs by establishing service 
counters in all 47 prefectures in Japan.  These Service Counters provide full services to assist 
MSMEs with IP issues and problems free of char ge. Persons working at the Counters provide a 
one-stop service to solve problems on the spot.  
156.  Working in cooperation with IP specialists and external organizations, the Service Counters 
provide solutions for highly specialized issues and problems. The IP s pecialists are attorneys -at-
law, patent attorneys, former business persons, designers, brand specialists, and specialists on 
Intellectual Property in foreign countries.  
157.  Recently, the Comprehensive IP Support Service Counters started a new service, which is  
offering consultations on issues and problems with aquaculture, agriculture, forestry and fisheries, 
in cooperation with the Ministry of Agriculture, Forestry and Fisheries. That new service also covers 
Geographical Indications (GI) and plant breeders' ri ghts (PBR) for seeds and seedlings.  
Slide 4  
158.  Lastly, let me explain two examples of MSMEs making use of the Comprehensive IP Support 
Service Counters. This first example was a company that successfully grew its business by utilizing 
IP rights. The company d iscussed its problems with the staff at the Service Counters, trying to 
decide whether to file a patent application or to keep its technology as a trade secret. It wanted 
to protect its proprietary technology the best way possible. The Service Counters pro vided 
guidance and support on a license agreement. As a result, the company was able to obtain 
a patent right and successfully conclude a technical partnership agreement with a manufacturer. 
                                                
3 RD/IP/16 available in English  only. IP/C/M/86/Add.1/Rev.1  
 
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  This is one of the successful examples in which a company grew it s business by utilizing 
the Service Counters.  
159.  The second one is a good example in which a company succeeded in expanding its business 
overseas. The Service Counters helped the company file foreign patent applications and conclude 
a non-disclosure agreement  and a manufacturing licensing -agreement with an OEM in a foreign 
country. This is one of the examples in which an MSME succeeded in filing overseas applications 
and grew its business overseas, by receiving assistance from the Service Counters.  
160.  As these ex amples show, Japan believes that it is vital to implement initiatives to further 
strengthen intellectual property strategies based on MSMEs effectively using 
their intellectual  property.  
11.5 Singapore  
161.   MSMEs make up 99% of the  businesses in Singapore, so facilitating the sustainability and 
growth of the experience is important for our overall economic growth, especially in the context of 
increasingly innovative and creative global economy. The Intelle ctual Property Office of Singapore 
(IPOS) has three initiatives to help MSMEs consolidate their gain by protecting their new ideas and 
products to existing IP frameworks and using these IP rights to access financing and develop 
IP management systems to ena ble their effective use.  
162.  The first initiative is IP Value Lab, collaboration between IPOS and several private equity 
funds to help grow innovative MSMEs with the technology of an IP based business modules into 
globally competitive companies. IP Value Lab d oes this by helping the private equity funds identify 
companies with the best IP and offer strategies for harnessing this IP to gain a competitive 
advantage. It recently partnered with a private equity fund to grow 10 to 15 companies from or 
through Singap ore. One of the first companies to benefit from the scheme is NSP -Tech which 
designed a lancet for a safe and painless blood prick test and blood sampling called Safety Set. 
The key inventive step behind the compact design of Safety Set was its use of a ro tational 
mechanism to drive the lancet with a speed and precision needed to minimize pain. This is a boon 
for patients who need to obtain blood samples regularly , such as diabetics. NSP obtained both 
patent and trademark protection for Safety Set and won n umerous awards for it in 2016 includ ing 
WIPO's IP Enterprise Trophy , IPOS's Award for Technology Patent, the President's Design Award 
and the Unity Best Product Award. NSP is now working on further improving the design of 
the lancet and investing in develo ping new products.  
163.  The second initiative is the IP Financing Scheme which enables companies to gain access to 
debt financing using their intangible assets , such as  patents, trademarks and copyrights 
as collateral. The first such project was approved for Ma sai Group International in June 2016 , and 
enabled the company to monetize its patents and trademark portfolio in order to pursue 
brand  marketing and invest in R&D. Around 25% of Masai's loan would be designated for 
IP protection efforts such as shutting do wn websites selling counterfeit versions of its products. 
MSMEs in Singapore also have access to the Capability Development Grant , which provides 
assistance to MSMEs to deal with costs associated with conducting a udits of IP assets, developing 
an IP management system or conducting IP intelligence activities. While these initiatives are still in 
their nascent stages , they are already helping MSMEs harness innovation to keep pace with 
technological advancements, remain competitive and identify opportuni ties to scale up. We hope 
that over time MSMEs will take a greater interest in the potential offered by the use and 
the protection of their IP for their growth. We hope that our presentation today has been useful 
and we look forward to further discussion a t the TRIPS Council on how Members, particularly 
the developing countries can build up their MSMEs' capacities through an IP innovation initiative.  
11.6 Canada  
164.  According to a 2014 "Survey on financing an d growth of SMEs " conducted by Canada's 
Ministry of Innovation, Science and Economic Development, it was found that SMEs that hold 
formal IP are four times more likely to export, 64% more likely to be fast -growing companies and 
32% more likely to seek fina ncing. It was also determined that larger SMEs are more likely than 
smaller SMEs to innovate and hold IP. Indeed, as the size of the businesses surveyed increased by 
number of employees, so too did the percentage of SMEs that introduced at least one type o f IP/C/M/86/Add.1/Rev.1  
 
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  innovation that held at least one type of IP. For instance, among Canadian businesses with 
between one and four employees just over 34% introduced at least one type of innovation and just 
21% held one type of IP, whereas among those businesses between 10 0 and 499 employees 
the proportions of businesses that introduced at least one type of innovation and held one type of 
IP rose to over 50% and 51% respectively. As well, the number of SMEs in Canada that have 
introduced at least one type of innovation and hold some type of IP protection has increased 
overall in recent years. The number of SMEs that introduced at least one type of innovation and 
held some type of IP protection rose 4% for both of these  indicators, to 42% and 21% 
respectively, since the previ ous survey was conducted for the 2009 -2011 period.  
165.  One of the questions facing policy makers is how to design the IP system to support and 
facilitate the growth of MSMEs. While one of the fastest ways is to boost productivity and grow is 
to innovate, the r esources available for innovation are also tied to a firm's size. This means that 
MSMEs are often constrained in their ability to dedicate resources to innovation, and are therefore 
limited in their ability to grow and compete internationally. In Canada, f or instance, MSMEs make 
up the largest proportion of Canadian firms, but account for proportionally far less R&D spending 
than large businesses. Ensuring that the IP system supports MSMEs, by providing for 
the availability of business services and speciali zed tools, is therefore key to ensuring that small 
businesses have the capacity to grow and compete alongside larger firms.  
166.  In Canada, the Canadian Intellectual Property Office (CIPO) is committed to enhancing its 
IP awareness and education programming to deliver tailored and responsive products, services and 
training to innovators and SMEs. CIPO's IP Education and Awareness Program will extend its reach 
and impact by co -developing programming for and with relevant partners, increasing its regional 
presence , and working with others in the innovation network to market and provide IP education 
and awareness tools to clients. CIPO's IP Education and Awareness Program offers services 
in three areas:  
167.  First, the IP4Business  provides a suite of products designed to  provide businesses with 
the tools and information that they need to better acquire, manage and leverage their IP assets. 
These products and services include IP guides, brochures, videos, an online IP strategy tool, 
training, checklists, fact sheets, and d igital content designed to increase awareness of IP 
in particular high growth -potential markets and sectors.  
168.  Second, CIPO's IP Academy  provides a suite of seminars and training services for 
businesses, partners and intermediaries, including those for speci fic markets and sectors. 
The IP Academy will offer a bank of speakers, massive Open Online Course (MOOC) webinars, 
IP boot camps, (search -a-thons,) case studies, and custom training programs for accelerators, 
incubators, university technology transfer offi ces and more.  
169.  Third, the Program will also support an IPHub , which comprises a network of services, 
including a digital platform, referrals, consultations, and advisory services for participants in the IP 
marketplace.  
170.  In addition, the Government of Canada offers a range of services and programs aimed at 
supporting MSME growth more broadly. For instan ce, Canada's National Research C ouncil 
(the NRC) provides assistance to SMEs through the Industrial Research Assistance Program 
(IRAP), by way of technical and business advisory services to better equip clients to conduct R&D, 
commercialize new products, processes and services, and to access new domestic and 
international markets. The IRAP's industrial technology advisors assist clients at various stages of 
the innovation process to build their innovation capacity, for instance, through technology and 
business assistance, literature and patent searches, and strategic intelligence. IRAP also connects 
SMEs with partner organizations that can provide further assistan ce such as financing, R&D, 
IP services, and technology transfer.  
171.  The N ational Research Council also offers a single access point called Concierge, where SMEs 
can find high -quality, timely advice to help them innovate and grow. Providing free, on e-on-one 
guidance to SMEs, the Concierge service connects SMEs with Innovation Advisors, namely industry 
experts with extensive networks that provide clients with high -quality referrals and services, to 
help SMEs navigate available innovation resources and support pr ograms.  IP/C/M/86/Add.1/Rev.1  
 
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  172.  Another key constraint faced by MSMEs is financing. Indeed, many small business 
entrepreneurs may find themselves unable to dedicate time and resources to pursuing growth 
opportunities such as hiring talent, boosting productivity, or seeking new ma rkets. Moreover, there 
are a number of costs associated with protecting IP, from administrative fees to hiring IP 
professionals such as patent agents. The government of Canada offers a number of resources to 
MSMEs in this regard. For instance, the business  Development Bank of Canada (or BDC), which is 
a federal Crown corporation owned by the Government of Canada, provides financing and advisory 
services with a focus on SMEs. BDC provides a number of financial services to SMEs, such as start -
up financing and  small business loans, as well as BDC's Xpansion Loan  which is designed to help 
businesses realize products that are key to growth, such as expanding their market, investing in 
technology, developing new products, applying for IP protections, and purchasin g IP licenses.  
173.  As well, with a view to encouraging small businesses (and universities) to use the patent 
system, certain CIPO fees for obtaining and maintaining a patent are reduced by 50% for "small 
entities ". Canada's Patent Rules define a small entity a s one that employs 50 or fewer employees 
or that is a university department. In order to take advantage of the reduced fees for small 
entities, applicants must submit a small entity declaration before or at the time of their fee 
payment, if there is not al ready one on file.  
174.  These are just some of the services and programs offered to SMEs in Canada, aimed at 
supporting their growth and expansion. Canada would be pleased to provide additional information 
on any of these services and programs  to other Members upon request.  
11.7 Switzerland  
175.  We thank the co -sponsors for tabling this important topic on the agenda and for allowing 
a further inclusive discussion on the fostering impact that IP can have on MSMEs.  
176.  The question of how IP can contribute to growth of micro, small and medium size enterprises 
could be answered with the question of what the right tools for enabling success and growth are. 
This is a question that has to be asked not only in business  as such, but likewise in sports, music 
or arts in general: Also the most talented athletes and players need the adequate support and 
the right tools to perform at their best. This applies to runner Haile Gebrselassie and tennis player 
Roger Federer, to ja zz pianist and prodigy Joey Alexander or to artist Lucia Fainzilber, they all rely 
on the right equipment and suitable framework conditions.  
177.  It is those conditions and the right tools at hand which allow a player or an MSME to make 
a difference and grow. Such tools complement talent and hard work, and they can be crucial to 
succeed in the market. We will present two examples to illustrate how IP acts as such a tool. And 
how it can be a door -opener for inclusive growth and contribute to future prosperity.  
Example 1: COLIPRI - Colombian -Swiss Intellectual Property Project  
178.  In 2013 Colombia and Switzerland started a fruitful cooperation project. The project overall  
aims to strengthen the use of intellectual property r ights in Colombia, and in particular to 
contribute to higher competitiveness and added value of Colombian products. Colombia 's 
intellectual property s ystem is at an advanced stage. Accordingly, the project focuses primarily o n 
addressing specific requests.  
179.  One of the project's achieve ments is the sup port for local geographical i ndication supply 
chains, both in the food and handicraft sectors. For example, in the past four years the project has 
supported the registration of the so -called Bocadillo veleño guava paste  as a geographical 
indication . Bocadi llo veleño  is Colombia 's most traditional fruit sweet and is produced by MSMEs in 
a very specific region called Vélez. Its distinctive characteristics are based on unique clima tic 
factors and human know -how. 
180.  In 2013, the original product of Vélez was losin g an estimated 51% of market share due to 
copies produced in different regions. Furthermore, its reputation was declining and its name was 
on the verge of becoming generic for this type of sweet. This month, Bocadillo veleño  is being 
registered as a GI in Colombia, after 4 years of preparation work. Thereafter, it will be up to 
the producers of Vélez to enforce their GI from now on. With the GI protection in place, they now 
have a powerful tool to defend their market share and proceed against freeriding and  unfairly IP/C/M/86/Add.1/Rev.1  
 
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  copied products, which amount for an estimated annual USD 12 million on the Colombian 
internal  market.  
181.  IP and in particular , geographica l indications or collective trademarks also can be 
an important tool to enhance local growth potential. All lo cal producers, as long as they produce in 
accordance with the rules established by the specification requirements, get access to a strong and 
well protected marketing asset.  
182.  This is especially relevant for micro and small enterprises, which  lack the necess ary funds for 
marketing their unique products on a wider scale. Moreover, the registration of GIs can also help 
to support more vulnerable population groups such as rural communities and ethnic minorities.  
By better marketing their products, GIs are expected to increase local producers ' income and are 
an important tool for growth. Furthermore, the mentioned project also supports community 
development and capacity building. Thereby, it further contributes to establishing favourable 
conditions for a  business-enabling environment.  
183.  As such, the project supports the Colombian government 's aim to increase competitiveness, 
to diversify its economy and to narrow the income gap between its rural and urban population. 
As a GI publicised by modern ways of promoti on, it  eventually enhances protection abroad, 
in countries protecting GIs, including against unfair competition, and acting as a piece of evidence 
of the protection in a legal action.  
Example 2: Bioburn  
184.  GIs and trademarks primarily protect producers ' efforts and investment over time and enable 
them to market their products. Fur thermore and as is well known, intellectual p roperty plays 
a key role in the development and diffusion of new technologies. To invest in research and 
development, firms and researcher s need to trust that legal certainty is guaranteed and that 
the Intellectual Property System is reliable and the enforcement of their rights works efficiently. 
The right framework conditions facilitate innovation and allow for new technologies to be 
develo ped and made accessible.  
185.  With our second example we would like to highlight how new technologies can improve 
a region 's business environment and growth perspectives. The given example refers to a company 
called Bioburn and how it s technology is used in Uga nda. 
186.  Bioburn, a Swiss enterprise, invented and patented a technical method which allows to 
transform biological waste into biomass very efficiently. Subsequently, consumers can use 
the biomass as fuel. In 2016 , Bioburn started a promising cooperation -project in Uganda. 
The project was also supported by the Swiss Government.  
187.  In rural regions of Uganda, there is a huge potential for biomass fuel. Together with their 
local partners, Bioburn intends to use agricultural waste and turn it into fuel. They experime nted 
with different sorts of agricultural waste. Intensive testing over a long period of time which showed 
that cacao bean and pod waste of farmers seems to be the most suitable resource for efficiently 
producing the fuel. With its local approach, the proj ect can create new value chains. Local 
production in rural regions offers new jobs and income opportunities. And this is not only true for 
well-established companies but especially also for small farmers.  Moreover, because biomass is 
often cheaper than con ventional fuels, the used technology can also contribute to reducing 
ecologically harmful incentives of deforestation. In addition, the fuel 's lower price benefits 
consumers. Bioburn 's patented technology offers significant economic benefits for producers,  
consumers and the economy as a whole. It is of great importance for future prosperity that such 
technologies are being conti nuously developed and diffused.  
188.  And this is where national and multilateral IP -regulation comes into play: it offers necessary 
incentives for research and development since it protects against freeriding, for a limited period of 
time, and at the same time provides the tools for diffusing as well as facilitating the licensing of 
the technology in question. In the case of the Bocadillo veleño  guava paste  it is the GI protection 
system which is an important tool for facilitating the growth of MSMEs, in the case of Bioburn it is 
the patent system doing the same.  IP/C/M/86/Add.1/Rev.1  
 
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  189.  In conclusion, the two examples show how IP has economic effects in various wa ys: First, it 
can build new and strengthen existing value chains. Second, it can contribute to a stable and 
business enabling environment. And thirdly, it can provide the necessary incentives for research 
and development as well as for  diffusion of new tec hnologies.  
190.  Taken together, all these factors contribute significantly to a country 's growth and future 
prosperity. Micro, small and medium sized enterprises often manage their businesses with limited 
financial resources. Accordingly, they especially depend  on favourable business regulation. 
In addition, IP is considered as one key element at the core of innovation. Through these different 
channels IP can generate a supportive environment for MSMEs to grow and prosper; intellectual 
property as a proven tool to enable continued success.  We are looking forward to hearing from 
further delegations about their experience, about MSMEs experience and about policy approaches 
how t o support them.  
11.8 Chinese Taipei  
191.  Our own MSMEs  account for almost 98% of all our businesses. They are the backbone of our 
economy and they have played a  critical role in fost ering our economic development.  What we 
have learnt, however, is that while they display a remarkable capacity for innovation in IP matters, 
when it comes to drawing up IPR strategies or comprehensive patent portfolios, MSMEs 
in particular usually struggle due to a lack of resources and support from IPR professionals. So, in 
order to help MSMEs deal with I PR-related challenges, and to create a more favourable 
environment for IPR development and innovation in general, our governments have offered MSMEs 
support in three key areas - expert advice, financial assist ance, and information services.  
192.  To provide expe rt advice, we have set up the "IP Consulting Centre for SMEs " which makes 
available a range of customized services offered by experts in the form of IP diagnosis and 
strategy planning, in areas such as intellectual property rights, technology, law, 
and market analysis, according to the size and particular needs of the MSME. In this way, MSMEs 
can get help in the R&D stage for patent searches and portfolio strategies, so as to build their 
innovation capacity.  
193.  As far as financial assistance is concerned, we h ave introduced the "A+ Industrial Innovation 
R&D Programme "(or the "A+ Programme "), which provides incentives to businesses applying for 
patents, to encourage them to start building a patent portfolio as early as possible.  
194.  I can give you some hard numbers to illustrate the success of the A+ Programme since 
its launch in 2014. By the end of March this year, 2017, a total of 1,079 projects have been 
approved under the Programme, boosting investments by US$5 ,67 billion and creating 
a production value of over 8 ,68 billion. In addition, by the end of last year, over 9,000 patent 
applications had been made at home and abroad under this Programme. Of these, over 
4,000 patents had been granted - an approval rate of about 45%.  
195.  Furthermore, in order to support MSMEs c onducting overseas IPR litigation or other similar 
actions, we have launched the "Enterprises Overseas Intellectual Property Litigation Loan ", 
providing guaranteed credit to domestic enterprises in the form of a loan for the expenses in 
overseas IPR litiga tion. Loans of up to US$1, 68 million are available depending on the  project, for 
a term of seven years at the most.  
196.  And, finally, a range of information services are made available to MSMEs on request, 
including trends and analysis of patent applications i n specific areas. In addition, there's the "IP 
SME Corner ", a one -stop search platform providing basic IPR knowledge and information 
on government resources in this area. With this platform, MSMEs can improve both their 
understanding of IPR matters and their success in acqu iring patents.  
197.  Most MSMEs today face an urgent need to make better use of patent portfolios in order to 
protect and take advantage of their innovations and R&D results. Our experience is telling us that 
IP is a key component of smart a nd sustainable economic growth and development. We would 
encourage all Members, therefore, to share their policies and experiences in this respect, 
in the interests of inclusive economic development, and MSME growth in particular.  IP/C/M/86/Add.1/Rev.1  
 
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  11.9 Brazil  
198.  Micro, small and medium -sized enterprises (MSMEs) play a major role in social and economic 
policies, representing the majority of companies in almost every country in the world and 
concentrating more than half of all  jobs in both developing and developed countries. Therefore, 
they play a major role in social and economic policies and their participation in international trade 
is an important issue in the WTO agenda.  
199.  In this sense, I would like t o draw the attention of  Member s to the Joint Communication 
circulated during the last session of the General Council WTO regarding the  informal dialogue on 
MSMEs in  this organization. A group of m embers, including Brazil, referred to the importance of 
promoting the participation  of those entities in international trade, pointing out, among other 
things, that one of the obstacles preventing MSMEs from engaging more in export and import 
activities is technological development. Technological development is an issue explicitly mentio ned 
in Article 8 of the TRIPS Agreement, underlining the potential contribution that intellectual 
property might bring to MSMEs. There is , thus, much that can be done in WTO regarding 
this matter.  
200.  Our delegation also wishes to highlight that Brazil, Argent ina, Paraguay and Uruguay just 
circulated the paper JOB/GC/127, in which we indicate areas where the WTO could develop 
measures in favour of MSMEs. In the area of information and transparency, proponents suggest 
that Members afford better access to informa tion for MSMEs in several aspects, including 
procedures related to the acquisition of intellectual property rights.  
201.  Now turning to the invitation of the proponents to share domestic experiences, our National 
Institute of Industrial Property actively engage s with MSMEs in order to disseminate information 
about the steps necessary for obtaining intellectual property protection in Brazil and abroad. 
The INPI also provides an on -line course, elaborated in partnership with WIPO, which brings 
an overview of the l egal requirements for the protection of IP. While the on -line course is not 
specifically directed to MSMEs, data available indicates that MSMEs and individual persons are 
the main users of the course.  
202.  Furthermore, in order to overcome the challenges those companies commonly face, 
the Ministry of Industry, Development and Foreign Trade provides support to MSMEs in a myriad 
of actions, such as the elaboration of a their business plan.  
203.  Lastly, Brazil participates in the CIBEPYME, the Iberoamerican Platform of Industrial 
Propriety which is directed to small and medium companies. The initiative provides easily 
accessible information about the many types of intellectual property, as well as a consulting 
service focused on the concrete needs of small and medium com panies.  
204.  This is not, of course, an exhaustive list of all the actions and we hope it can contribute 
to the discussion.  
11.10 Hong Kong, China  
205.  Hong Kong, China is pleased to share our support me asures to SMEs in relation to IP trading. 
SMEs are the  backbone of our economy; they constitute of 98% of our local business 
establishments and account for about 46% of the total employment in the private sector in Hong 
Kong. The Hong Kong, China (SAR) Government attaches great importance to SMEs and tries to 
provide a business -friendly environment for them. Our Government has been providing 
multi-layered support for them through operating various funding schemes, building the necessary 
infrastructure and p roviding the latest market information and other business advisory services 
in relation to IP trading through relevant government departments and quasi -government 
organizations. The surge in global demand for IP in recent years and increasing international  trade 
in IPRs opened up a  world of new opportunities. IP commercialization is very important to 
the further development of a knowledge -based economy. We saw the potentials here and decided 
to implement a number of support measures in relation to IP trade.  
206.  First of all, our Government has set aside US$3 million as from 2015 to 2016 , for three years 
to suppor t a series of new measures. These include  the provision of free initial consultation IP/C/M/86/Add.1/Rev.1  
 
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  services to raise the IP awareness of SMEs, organizing a sponsoring  IP-related training to help 
SMEs build up their IP manpower capacity, launching an IP manager's scheme to support SMEs in 
building up their manpower capacity on IP management and commercialization, and rolling out 
promotion and public education campaigns.  Our Intellectual Property Department launched 
a dedicated website , in March  2015, to provide a one -stop shop for disseminating IP trading 
information such as types of IP, trading IP, managing IP, protecting IP and many other resourceful 
features. The Intellectual Property Department launched the IP managers' scheme in 2015. 
The scheme aims to assist Hong Kong enterprises, especially SMEs, to build up their IP manpower 
capacity, and to increase competitiveness thro ugh IP management, so as to grasp  
the opportunities brought by IP trading. The scheme encourages enterprises to appoint a sta ff 
member in a managerial position as their in -house IP manager , who will be responsible for 
overseeing the compliance management , exploitation and commercialization of IP assets. Over 
500 SMEs have joined the scheme , as of mid -May 2017. The training  and r esources on IP 
management are provided for the IP managers to carry out their duties within the enterprises. 
The Intellectual Property Department in collaboration with our Law Society in Hong Kong launched 
the IP consultation service scheme in September 20 16, to provide one -on-one free IP consultation 
services to SMEs with a will to raising the awareness of IP  and developing effective 
IP management and commercialization strategies. Advisory areas cover IP registration, IP due 
diligence, IP management and IP  licensing. This scheme is well received by SMEs.  
207.  Last but not least, we have also been reaching out to different in dustries and SMEs such as 
movie and toy  to promote cross-sector IP trading , since the latter half of 2015. And the  responses 
so far have bee n very encouraging. Key players in the respective views have a  better 
understanding of the potentials of the IP and the prospects of cross-sector commercialization.  
11.11  India  
208.  In para 5 of the document (IP/C/W/622), the co -sponsors have selectively quoted from 
the study about the  informal economy, by de Beer, Fu & Wunsch -Vincent (2013: 39) to support 
their position that IP must be considered as a relevant aspect for innovative micro -sized 
enterprises. Ho wever, one of the important observations by de Beer, Fu & Wunsch -Vincent in their 
study about the informal economy, is that formal IP based on exclusions and proprietary 
knowledge is not compatible with the knowledge diffusion  and learning processes of the  informal 
economy which are based on communities, clusters and the exchange of information.  
209.  The co -sponsors of the agenda item "IP and Innovation " have argued 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 
innovation. There have been many studies to show that intellectual property is only one element in 
a larger innovation ecosystem and  IP laws alone do not promote technology development. 
For instance, according to the Trilat eral study by WTO, WHO and WIPO:  
"Patent law is not a stand -alone innovation system. It is only one element of 
the innovation process, and one which can be deployed differently in diverse 
innovation scenarios. Patent law has little bearing on many other factors that lead to 
the successful development of technologies, e.g. the nature and extent of demand, 
commercial advantages gained by marketing and ancillary services  and support, 
commercial and technical viability of production processes, and compliance with 
regulatory requirements, including through effective management of clinical trials 
data." 
210.  The MSME sector in India,  consisting 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 the potential to spread in dustrial growth across the country and can be 
a major partner in the process of inclusive growth.  
211.  To enhance awareness of MSMEs about Intellectual Property Rights (IPRs), the Government 
of India launched a scheme titled "Building Awareness 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 IP/C/M/86/Add.1/Rev.1  
 
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  technology upgradation and enhancing competitiveness. Another scheme entitled "Support for 
Entrepreneurial and Managerial Development of SMEs through Incubators " is operational since 
April 2008 , to assist incubation of innovative business ideas that could be commercialised in 
a short period of time, resulting  in the formation of MSMEs that have distinctive presence in 
the market. More details about these schemes could be found on the website www.msme.nic.in  
212.  A national innovation survey has been conducted during 2011 -12 in  India,  by 
the Department of Science and Technology (DST ). A national report entitled "Understanding 
Innovation: Indian National Innovation Survey " with special focus on MSMEs has been brought out 
by DST. The report is based on the analysis of sample surve y of 9001 firms, largely MSMEs, from 
26 states and 5 Union Territories across various industrial sectors in the country.  
213.  The survey identified many barriers to innovation with regard to MSMEs. Some important 
barriers to innovation include availability of f inance and , in general , the cost of innovation, 
availability of skilled manpower, access to market information and availability of information 
technology, infrastructure, domination of established player s in the market, regulatory 
requirements etc. IPR rel ated issues are not found to be of any concern for the innovation 
activities of the firms.  
214.  I conclude by quoting from our Prime Minister Narendra Modi 's statement during the launch 
of the Mission Innova tion in Paris in November 2015:  
"Our innovation initia tive should be driven by public purpose, not just market 
incentives, including intellectual property. That also means strong public commitment 
by suppliers to developing countries. ... Innovation must be backed by means to make 
it affordable and ensure adoption. " 
11.12   China  
215.  The growth of micro, small and medium size enterprises can contribute to the innovation and 
economic development . A suitable intellectual property system can effectively assist en terprises, 
especially MSMEs. However, China also believes there are many factors contributing to 
improvement of the innovation and development capacity of MSMEs, attention should not be paid 
to the importance of intellectual property rights only.  
11.13   El Salvador  
216.  In El Salvador  the Law on the promotion, protection and development of micro and small 
enterprises  provides that the National Commission for Micro and Small Enterprises (CONAMYPE) 
has ce rtain responsibilities in the area of entrepreneurship, and is in charge of defining, 
formulating, promoting, implementing and coordinating programmes and instruments to promote 
entrepreneurship and the building of an entrepreneurial and business culture, as well as a culture 
of corporate social responsibility and sustainable environmental management.  
217.  The National Registration Centre's Intellectual Property Registry is the administrative 
authority responsible for administering intellectual property rights i n El Salvador. It regulates 
the acquisition, maintenance, protection, modification and licensing of trademarks, commercial 
advertising slogans or signs, trade names, emblems, geographical indications and appellations of 
origin; the registration of patents,  utility models and industrial designs; and the deposit of works 
protected by copyright and related rights. Under the Intellectual Property Law, the Registry is also 
responsible for fostering the dissemination of information on, and promoting awareness of,  
intellectual property right protection.  
218.  For a number of years now, both institutions have assisted MSMEs with intellectual property 
procedures and have helped to implement various support programmes that cover advisory 
services and training in the area of  innovation and intellectual property.  
219.  These programmes include the following:  
 The "Opulencia Pipil "platform: In 2014, CONAMYPE created the Opulencia Pipil  platform, 
with a view to providing support to the artisanal sector by organizing a fashion show IP/C/M/86/Add.1/Rev.1  
 
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  linked to artisanal production and national identity. The funding for this initiative was 
provided by the Special National Telecommunications Administration Privatization 
Resource Fund (FANTEL). The platform seeks to showcase the innovative nature and 
quality of artisanal products made in the country, and to open up new marketing 
channels for artisanal enterprises.  
 The "Un Pueblo Un Producto "("One People One Product ") strategy: This programme 
seeks to promote innovation and creativity through the use of local r esources and 
endogenous development, with a view to enhancing community capacity and improving 
the quality of life of community inhabitants through the development and marketing of 
products originating in their communities.  
 Artisanal development groups: Th is is a CONAMYPE initiative to form associations within 
the artisanal sector with a view to enhancing entrepreneurship, promoting the marketing 
of artisanal products, and encouraging the consumption thereof at both na tional and 
international level.  
11.14   Korea, Republic of  
220.  Korea has  already shared our effort to promote SMEs ' innovation at the APEC level at 
the November TRIPS Council meeting last year . I would like to refer to that intervention which was 
about the project of "Guidebook for SMEs ' IP-Business Cycle "which is to provide APEC Economies 
with standardized SME -friendly IP policies.  
11.15 ARIPO  Secretariat   
221.  From January this year ARIPO has undertaken a number of initiatives to assist its member 
States , which includes workshops organized either solely or in collaboration with other partners , 
especially WIPO, the Japan Patent Office, I ntellectual Property Offices of Member states and 
others. ARIPO's flagship this year is to work with the main intellectual property generators , i.e., 
with the universities and the research and development institutions. In that regard we have 
organized work shops in Sierra Leone,  which is taking place on 14-15 June; and in Zambia, Lesotho 
and Rwanda. We have also organized a number of seminars with universities in our host country , 
Zimbabwe. The main theme of these workshops and seminars is to create awarenes s among 
teachers and students on the importance of intellectual property in universities and research and 
development institutions which will, in turn, assist in the creation and development of MSMEs.  
222.  Furthermore, we have realized that many universities an d research and development 
institutions in ARIPO member states lack intellectual property policy , which defines the effective 
use of intellectual property systems.  
223.  It is against this backdrop that alongside the workshop on awareness creation, ARIPO and 
WIPO are developing a model of institutional intellectual property policy for an effective use of 
the IP system by universities and research and development institutions in Africa,  which among 
others provide guidelines on establishment of start -ups. As mentio ned earlier these are some 
of the highlights of the initiatives that ARIPO has undertaken to assist member states in improving 
the IP systems, but as was the case in 2016, a detailed report will be provided for  2017 
AGENDA ITEM 12:  INTELLECTUAL PROPERT Y AN D THE PUBLIC INTERES T: 
COMPULSORY LICENSING  
12.1 South Africa  
224.  The communication (IP/C/W/630) dated 31 May was circulated at the request of 
the delegations of Brazil, China, Fiji, India and South Africa. The Agreement on Trade -Related 
Aspects of Intellectual Property Rights of the WTO established minimum standards of protection 
that each government has to give to the intellectual property of fello w WTO Members. Each of 
the main elements of protection is defined, namely the subject matter to be protected, the rights 
to be conferred and permissible exceptions to these rights, and the minimum duration of 
protection. WTO Members have the flexibility to  design their national intellectual property systems 
within the minimum standards set by the TRIPS Agreement in cognizance of a country's economic, IP/C/M/86/Add.1/Rev.1  
 
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  developmental and other objectives including public health. The TRIPS Agreement attempts to 
strike an approp riate balance between the interests of rights of holders and users.  
225.  Article 7 of the TRIPS Agreement entitled 'Objectives' recognizes that the protection of 
intellectual property should 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 
the rights and obligations. The search for a balance between the need to pr otect IPRs and to 
provide incentives for R&D on one hand and on the other hand to address concerns about 
the potential impact of such protection on the health sector, in particular its effects on prices, has 
been an important consideration in the WTO's wor k. The TRIPS Council also recognizes that 
the principles of IP protection are based on the underlying public policy objectives.  
226.  Article 8 of the TRIPS Agreement entitled 'Principles' states that WTO Members may, 
in formulating or amending their laws and re gulations, adopt measures necessary to protect public 
health and nutrition and to promote the public interest in sectors of vital importance to 
the socio-economic and technological development, provided that such measures are consistent 
with the  provisions  of this Agreement. Article 8.2 further states that appropriate measures may be 
needed to prevent the abuse of IPRs by right -holders or to resort to practices which unreasonably 
restrain trade or adversely affect international transfer of technology.  
227.  In fu rtherance of the objectives and principles of the TRIPS and enshrined in 
Articles  7 and 8, a number of safeguards or flexibilities have become an integral part of the TRIPS 
framework. These flexibilities can be used to pursue public health objectives. Howe ver, to 
implement these flexibilities action is needed at the domestic level by incorporating them into 
national IP regimes, keeping in mind each country's individual needs and policy objectives. Key 
TRIPS flexibilities include transition periods for LDCs extended by the WTO until 1 January 2033, 
differing IP  exhaustion regimes, refining the criteria for grant of patentability criteria, pre -grant 
and post -grant opposition procedures, as well as exceptions and limitations to the patent rights 
once granted, i ncluding the regulatory review exception or Bolar exception to facilitate market 
entry of generics, compulsory licenses and government use. For pharmaceutical patents, these 
flexibilities have been clarified in and enhanced by the 2001 Doha Declaration on TRIPS and Public 
Health. WTO Members have the flexibility to interpret and implement TRIPS provisions in a manner 
supportive of their right to protect public health.  
228.  Another new flexibility was added by the Doha Declaration which was put into practice 
in 2003 by the WTO with a decision enabling countries that cannot manufacture medicines for 
themselves to import pharmaceuticals made elsewhere under compulsory licenses. In 2005, 
Members agreed to make this decision permanent through the Protocol Amending 
the TRIPS  Agreement which entered into force on 23 January 2017 after two thirds of Members 
had accepted it. The amendment provides legal certainty that generic versions of patent -protected 
medicines can be produced under compulsory licenses specifically for export to countries with 
limited or no pharmaceutical production capacity.  
229.  Many governments have not used the flexibilities available under the TRIPS Agreement for 
various reasons, such as capacity constraints or political pressure from states and corporat ions, as 
mentioned in the UN Secretary General's High Level Panel Report on Access to Medicines. 
Moreover, even where some developing countries used the flexibility available to them under 
the TRIPS Agreement to address public interest objectives through m easures which are fully 
consistent with the TRIPS Agreement, these attempts have been challenged legally, as well as 
politically. Political and economic pressure placed on governments to forgo the use of TRIPS 
flexibilities violate the integrity and legiti macy of the system of legal duties and rights created by 
the TRIPS Agreement as reaffirmed by the Doha Declaration.  
230.  A slew of regional tra de agreements containing 'TRIPS +' standards of IP protection and 
enforcement have the potential to significantly affect the policy space available for effective and 
full use of TRIPS flexib ilities. The most common 'TRIPS +' provisions in free trade agreements that 
affect the pharmaceutical sector are (i) the definition of patentability criteria, (ii) patent term 
exten sions, (iii) test data protection, (iv) the linkage of regulatory approval with patents and 
(v) enforcement of IPRs, including border measures. Such provisions can delay the market ing of 
generics and increase pri ces of medicines. I nvestor -to-state disputes  under regional or bilateral IP/C/M/86/Add.1/Rev.1  
 
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  investment protection agreements are also emerging as significant threats to the use of TRIPS 
flexibilities in the public interest.  
231.  Ironically, the above -mentioned challenges to the use of TRIPS flexibilities to further 
the public interest objectives underlying IP protection  have been occurring in spite of 
the emergence of laws and jurisprudence in developed countries that seek to limit the scope of IP 
protection and enforcement. For exam ple, in the 'Myriad -Genetics' case of 201 3, the US Supreme 
Court had ruled unanimously that naturally occurring genes cannot be patented even if they are 
isolated. In 2003, the US Federal Trade Commission had proposed tightening 
the 'non-obviousness' standard in order to limit the grant of unwarr anted patents. There is 
a growing concern about an imbalance between intellectual property and public interest with 
regard to health technology, for example, patents and related monopoly rights. Without sufficient 
use of balancing exceptions and limitation s to protect the public interest, companies are permitted 
to maintain high prices and exacerbate the crisis of access around the  world where many patients 
cannot afford medicines and force governments with finite health budgets to ration alize care. 
232.  Increased copyright protections create similar problems of access to knowledge goods 
limiting the ability of many people around the world to access print, audio, or visual works 
of education or entertainment that we take for granted. These are only a few e xamples of 
the problem. There is a need to pursue a developmental -oriented approach towards formulating 
IP laws and policies rather than to pursue an iconic classic approach to IP for development.  
233.  More than twenty years after the adoption of the TRIPS Agre ement there is a need for 
discussion in the TRIPS Council on the relationship between IP and the public interest and to 
broaden the understanding of how the IP system can be more responsive to public interest 
considerations. While this issue is very pertin ent for developing countries, it has also been a topic 
of significant policy debate even in developed countries. During the course of meetings of 
the TRIPS Council in this year and later, WTO Members could exchange views and experiences on 
measures within the IP system that they have adopted to promote the public interest, including 
but not limited, to compulsory licensing, patentability criteria, IP and competition, and 
the Bolar exception.  
234.  The sponsors of this communication invite delegations to share the ir experiences on the use 
of compulsory licenses for accessing health and other technologies. Compulsory licensing occurs 
when a government allows someone else to produce the patented product or process without 
the consent of the patent owner. Article 31 T RIPS lays down a set of conditions for issuing 
compulsory licenses of patents. The Doha Declaration on the TRIPS Agreement  and Public Health 
states that "each Member has the right to grant compulsory licenses and the freedom to determine 
the grounds upon which such licenses are granted ". Despite the clarity of this language, WTO 
Members around the world seeking to make use of compulsory licenses as tools to create access to 
affordable medicines have faced various challenges or barriers.  
235.  Some possib le ground s for compulsory licenc es are suggested in Article 5a of the Paris 
Convention, for example, abuse of patent rights, including failure of the patent holder to work 
the invention, and in Article 31 of the TRIPS Agreement, for example, national emergency and 
public non -commercial use. However, this list is not exhaustive. The Doha Declaration on 
the TRIPS Agreement and Public Health confirmed what was already implicit in 
the TRIPS  Agreement that WTO Members have the freedom to determine the grou nds upon which 
compulsory licenc es are granted. They are thus not limited to emergencies or other urgent 
situations, as is sometimes mistakenly believed. A range of grounds have been set out in national 
laws, such as non -working or insufficient working, anti -competitive practices, public interest, 
dependent and blocking patents and government use.  
236.  The sponsors of this communication invite Members to share their national experiences and 
examples  of using compulsory licenc es. The information exchange could serve to enhance 
the understanding of Members on various grounds available fo r the issue of compulsory licenc es 
and the problems faced by Members while using them. We have also circulated guiding questions 
which I summarize as such: what grounds are available in the nation al laws to issue compulsory 
licenc es; what are the difficulties faced by WTO Me mbers in using compulsory licenc es including 
constraints such as insufficient or no -manufacturing capacities; how the measure of compulsory 
licenc e was used by governments to ob tain price reduction form patent holders; and what was IP/C/M/86/Add.1/Rev.1  
 
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  the result of using compulsory licenc es in terms of price and access to affordable products and 
technologies.  
12.2 India  
237.  At the outset, I would lik e to thank the delegations of Brazil, China, Fiji and South Africa who 
are also co -sponsors of this agenda item. We would also support the statement made by 
South  Africa while introducing our submission contained in document IP/C/W/630.  
238.  The TRIPS Agreement  attempts to strike an appropriate balance between the interests of 
rights holders and users. The TRIPS Agreement also recognizes that the principles of IP protection 
are based on underlying public policy objectives. In furtherance of the objectives and pr inciples 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 can be used to p ursue 
public  health  objectives.  
239.  During the 1980s and 1990s, antiretroviral med icines 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 Agreement, including 
compulsory licenses 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 triple therapy could be ma nufactured 
for less than a dollar per day, as compared to the price of standard triple therapy at US $ 10,000 
per patient and year. Indian generic companies made ARV medicines accessible to all those who 
needed the drugs but had previously not been able to afford them.  
240.  As regards compulsory licensing, Article 31 provides Members complete freedom to decide 
the ground s for issue of compulsory licenc es. 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 com pulsory licenses 
are granted.  
241.  There have been many studies that examine the possible grounds for issue of compulsory 
license. For instance, the diversity in the grounds for issue of compulsory license is documented in 
the United States Congressional Resear ch Service Article titled "Compulsory Licensing of Patented 
Inventions " by John R. Thomas, dated 14 January 2014, which mentions that "depending upon 
particular national laws, the grounds for government award of a compulsory license may include: 
(i) circum stances of national emergency or extreme urgency; (ii) where the invention serves vital 
public health needs; (iii) a strong societal interest has arisen in access to the patented invention; 
(iv) the patent owner has failed to practice the patented inventio n in the jurisdiction that granted 
the patent within a reasonable period of time; (v) the patent owner has abused its economic 
power in such a manner as to violate the antitrust laws; and (vi) in circumstances where multiple 
patents held by different owner s cover a particular technology. For example, combination 
therapies, such as triple antiretroviral drugs, may be subject to more than one patent. In such 
cases, if one patent owner refuses to license, then the technology may not be marketed absent 
a compul sory licensing ". 
242.  I would like to share with you briefly the details of India 's law with regard to compulsory 
licensing. Sections 83 to 94 of India 's Patent Act contain detailed provisions regarding compulsory 
licences, including those that generic companie s can apply for, government use licenses, those 
issued in cases of national emergency, extreme urgency and public non -commercial use and 
compulsory licenses for exports.  
243.  India has i ssued only one compulsory licenc e so far. In March 2012, Indian generic 
manufacturer NATCO Pharma  was granted a compulsory licenc e to manufacture Bayer 's drug 
Sorafenib Tosylate (Nexavar) used for the treatment of kidney and liver cancer. Bayer was granted 
a patent and received marketing approval for Nexavar for the treatment of liver and kidney 
cancers in 2008. Bayer would have supplied 200 patients in 2011, which was a little more than 
two percent of the affected population. The primary reason for this abysmally low coverage vis -a-
vis the need was the exorbitant treatment cost of nearly Indian Rs.284.000 (US $4,370) for IP/C/M/86/Add.1/Rev.1  
 
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  a month 's treatment which priced the medicine out of reach of almost all people in India. Patent 
rights cannot be allowed to impede protection of public health.  
244.  NATCO pharma proposed to sell the generic f orm of Nex avar for Rs.8,800 (US $135) a 
month.  The Controller of Patents in India granted a compulsory license under section 84 because 
the TRIPS Agreement allows Members to adopt measures to protect public health and Bayer did 
not meet its duty under the Indian Pate nts Act, as the patented invention was not available to 
the public at a reasonable price, and it was not worked in the territory of India. The Indian Courts 
have upheld the decision of the Controller General of Pate nts to grant a compulsory licenc e to 
NATC O Pharma to manufacture the generic version of Nexavar in India.  
245.  Now, I would like to provide brief details of use of compulsory licences in a few other 
Members. According to an article entitled "Compulsory Licensing of Patented Pharmaceutical 
Inventions: Evaluating the Options " by Jerome H. Reichma n4, the United States threatened Bayer 
with a compulsory license on ciprofloxacin (Cipro) in 2001, which the U.S. intended to stockpile as 
a defence against anthrax. In response, Bayer drastically lowered its pri ce. The Italian Competition 
Law authorities issued compulsory licenses against Merck, on certain antibiotics, for abuse of 
a dominant position in 2005; against Glaxo, for refusal to license a patented migraine headache 
drug in 2006; and against Merck again  for refusal to license a treatment for baldness in 2008.  
246.  In Apple Vs Motorola , filed in the United States District Court for the Northern District of 
Illinois (Eastern Division), Judge Richard Posner, in June 2012, while dismissing with prejudice 
the patent infringement suits, cited the decision in eBay Inc. v. MercExchange, L.L.C. He 
specifically noted that a "compulsory license with ongoing royalty is likely to be a superior remedy 
in a case like this because of the frequent disproportion between harm to  the patentee from 
infringement and harm to the infringer and to the public from an injunction ". 
247.  The September 2016 Report of the UN Secretary General 's High -Level Panel (HLP) states 
that many governments have not used the flexibilities available under the  TRIPS Agreement, 
including compulsory licences, for various reasons, ranging from capacity constraints to undue 
political and economic pressure from states and corporations, both express and implied.  
248.  The HLP Report also refers to Resolution No 2475 by the  Ministry of Health of Colombia that 
was a pathway for issuance of compulsory licence to access Imatinib, in public interest, for 
treatment of Leukaemia. The Report also states that many domestic and foreign parties have tried 
to dissuade the Colombian Gov ernment from issuing a compulsory license as provided by 
the TRIPS Agreement and the Doha Declaration. We request the delegation of Colombia to share 
their experiences in this regard.  
249.  Political and economic pressure placed on governments to forgo the use of TRIPS flexibilities 
violate the integrity and legitimacy of the system of legal duties and rights created by the 
TRIPS  Agreement and as reaffirmed by the Doha Declaration.  
250.  I conclude by quoting the recommendations in the HLP Report on compulsory licence s: 
"Governments should adopt and implement legislation that facilitates the issuance of compulsory 
licenses. Such legislation must be designed to effectuate quick, fair, predictable and 
implementable compulsory licenses for legitimate public health needs, and particularly with 
regards to essential medicines. The use of compulsory licensing must be based on the provisions 
found in the Doha Declaration and the grounds for the issuance of compulsory licenses left to 
the discretion of governments ". 
251.  We look forw ard to hearing other delegations' experiences regarding the use of the TRIPS 
flexibility, i.e. compulsory licensing.  
12.3 Brazil  
252.  I would first like to thank the delegations of China, India, Fiji and S outh Africa who are also 
co-sponsoring this agenda item.  
                                                
4 Published in the Journal of Law, Medicine and Ethics in 2009, 37 (2): 247 -263. IP/C/M/86/Add.1/Rev.1  
 
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  253.  The proposal for inclusion of the item on 'Intellectual Property and the Public Interest' aims 
at spurring the discussion regarding the many facets of IP within the broader socio -economic 
framework o f Members. The complex and complementary relationship between these aspects is 
a topic that merits careful reflection and broad discussion by Members.  
254.  IP addresses the public interest by providing incentives for innovation. At the same time, 
governments ha ve the responsibility of safeguarding the public against its potential negative 
impact, notably on competition. A balanced IP system, therefore, provides powerful incentives for 
innovation with the least effects on the competitive landscape; in economic te rms, it will stimulate 
the pro -competitive dynamic effects of intellectual property while limiting and controlling its 
potential anticompetitive static effects.  
255.  An efficient IP system, by definition, results from a delicate balancing act. There is no 
one-size-fits-all approach. Rather, a flexible policy space is necessary to allow each Member to 
develop and adapt the set of IP regulations more adequate for its individual reality. This is to be 
done, of course, within the boundaries of the internationally a greed objectives, principles and 
standards, to ensure predictability and mutual confidence. One of the tools to reach that result is 
the use of exceptions and limitation to IP rights, an intrinsic element of the law of every Member. 
They serve a number of purposes by conferring the necessary flexibility to guarantee national 
security and to shape public policies to meet, inter alia , development, competition, and health 
surveillance goals.  Therefore, they will generate an increased societal welfare without 
unreasonably prejudicing the legitimate interests of the patent owner.  
256.  In recognition of the underlying public policy objectives of national systems for 
the protection of intellectual property, including developmental and technological objectives, 
Articles 7 and 8 TRIPS contain clear language regarding the relationship between public interest 
and the protection and enforcement of intellectual property rights.  
257.  The discussion under this agenda item has, among its goals, the increase of knowledge 
regarding thos e aspects and the exploration of possible solutions for developing, as well as for 
developed countries.  As an initial effort to broaden the understanding of how the IP system can be 
more responsive to public interest considerations, the proponents would li ke to mention the topic 
of compulsory licenses.  
258.  The ju dicious use of compulsory licenc es assists countries to uphold the delicate balance of 
the TRIPS Agreement. While the topic is commonly referenced to with health issues, compulsory 
licensing can be used  in other cases as well. As we all know, neither Article 31 TRIPS nor Article 5A 
of the Paris Convention contain s any restriction with regard to the ground on which a compulsory 
license may be issued, a view confirmed by the Doha Declaration on TRIPS and P ublic Health.  
259.  Under Brazilian law, right holders may  be subject to compulsory licenc es if they exercise 
patent rights in an abusive manner, or if they engage in abuse of economic power. In the case of 
dependent patents, for instance, anticompetitive behavi our can be established if the holder of 
the main patent fails to reach agreement with the patent holder of the dependent patent on 
the exploitation of the earlier patent.  
260.  We would like to refer to a concrete case in order to further contribute to the debat e. In 
2007, Brazil issued its first and only compulsory licenc e to date, regarding the antiretroviral 
efavirenz, for public non -commercial use. The underlying intention was to guarantee that 
HIV patients received appropriate treatment from the Brazilian Pu blic Health System, as efavirenz 
was used by 40% of all HIV patients in Brazil at the time. Previous to the compulsory license, 
the Brazilian Government engaged with the patent owner in several meetings with the view of 
reaching a negotiated solution. Thos e negotiations, however, did not lead to an agreement 
in terms and conditions adequate for addressing the public interest.  
261.  In conjunction with the procedures necessary for the compulsory license, the Brazilian 
Government initiated the preparation for the p roduction of efavirenz. As we all know, issuing 
a compulsory license is the initial element of a complex process that involves many actors.  
262.  The first step was to comprehensively analyse the invention as disclosed in the patent 
application, clarifying aspec ts of the phases of production. The disclosure of an invention as IP/C/M/86/Add.1/Rev.1  
 
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  mandated by Article  29 of the TRIPS Agreement is an important element of the patent system and 
could be explored in future discussions under this agenda item.  
263.  The second step for the public laboratories responsible for manufacturing the medicine was 
to take advantage of a limitation contained in Article  43, subsection II of the Brazilian Industrial 
Property Law. The Article states that patent rights do not extend to acts carried out by 
[unaut horized] third parties for experimental purposes, in connection with scientific or 
technological studies or researches. It aims at maintaining the incentives for research and studies 
by third parties, thus allowing the progress of science and technology. F urther to those actions, 
the last step required to initiate the production of the medicine under the compulsory license was 
to obtain regulatory authorization from the Brazilian health authority, known as ANVISA. To fulfil 
this requirement, Brazil used ano ther aspect of IP rights, this time related to clinical test data.  
264.  In spite of strictly following the requirements contained in the national and international legal 
framework, the Brazilian Government faced legal disputes in national courts, which were ini tiated 
by the owner of the patent. These disputes, however, were not successful.  
265.  As a result of such efforts by the Brazilian Government, and taking full advantage of legally 
permissible limitations and exceptions, it was possible to substantially reduce t he price of efavirenz 
from US$ 1.59 to US$ 0. 45 per tablet at nominal prices. This helped to ensure the adequate 
provision of medicine to HIV patients who needed to take it on a daily basis to keep the disease 
under control.  
266.  Thanks to successful public pol icies combined with the steady availability of innovative 
drugs, Brazil is able to provide treatment to the vast majority of patients diagnosed with 
HIV/AIDS. Nowadays, among those receiving treatment in Brazil, 90% of them have no detectable 
viral load, a  sign of success of the treatment. This result is only possible with the active 
participation of Government, pharmaceutical companies and patients associations, in line with 
the higher level goals of the IP system.  
267.  The recent entry into force of the Protoc ol Amending the TRIPS Agreement demonstrates 
the need to have mechanisms that preserve at the same time the adequate remuneration of IP 
Rights and the rights of governments to adopt measures necessary to protect the public interest. 
Another recent development of interest is the publication of the United Nations Secretary -General 's 
High Level Panel on Access to Medicines, which contains many recommendations regarding 
the interplay between intellectual property and access to medicines.  
268.  Brazil believes  that respect for intellectual property and efforts to promote the public interest 
in sectors of vital importance to a country's socio -economic and technological development are not 
mutually exclusive. A balanced intellectual property system, with built -in flexibilities as well as 
complementary policies and incentives, is the best way to incentivize innovation in all fields 
of technology.  
269.  We would like to invite other Members to express their views and share their experiences 
regarding the topic, providing a rich discussion which would be beneficial to all countries and  
generate additional inputs to the TRIPS Council.  
12.4 China  
270.  China would like to thank the other co -sponsors for including this important  item on 
the agenda. China attaches great attention to TRIPS and public interest issues. China 's Patent Law 
and implementing regulation have specific provisions on compulsory licensing, which have been 
improved with the later amendments. In 2012, combining  the related provisions, China issued 
the new detailed rules for compulsory licensing for the purpose of easy operation.  
271.  China believes the discussion on intellectual property and public interest should be open and 
inclusive. WTO Members could exchange vie ws and experiences on how to take full advantages of 
TRIPS flexibilities, and effectively solve the public interest problem.  IP/C/M/86/Add.1/Rev.1  
 
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  12.5 Fiji  
272.  Fiji would like to thank the delegations of China, India, South Af rica and Brazil as 
co-sponsors of this agenda item and the submission of document IP/C/W/630. For a small 
economy, the issue of intellectual property and public interest is important and for Fiji, in 
particular, in relation to ensuring that there is access  to medicines for our citizens. The constitution 
of Fiji takes reasonable measures within its available resources to achieve the progressive 
realisation of the  right of every person to health, inter alia , to ensure that the person is not denied 
access to m edical treatment.  
273.  Achieving an effective and efficient functioning health system is a priority for the Fijian 
Government and access to affordable medicines complements this priority. The Government of Fiji 
has put in place a free medical programme for all Fijians. Fiji attaches great importance to 
the TRIPS Agreement. On this note we also believe that striking the appropriate balance between 
the interest of right holders and users is essential. The more markets are available for 
an importing country such as  Fiji to access quality and affordable medicines, the better it will be 
from a socio -economic perspective for its citizens.  
274.  As mentioned by other proponents, Fiji is also of the view that there is a need for discussion 
in the TRIPS Council on the relations hip between IP and public interest. Fiji looks forward 
to learning from the experiences of the membership on the use of compulsory licences in accessing 
health and other technologies in this relation.  
12.6 Ecuador  
275.  Ecuador thanks the delegations of Brazil, China, Fiji, India and South Africa for requesting 
inclusion of this item on the Council's agenda in order to address the critically important issue of 
intellectual property and the public interest a nd the implications of compulsory licensing.  
276.  Article 8 of the TRIPS Agreement mentioned in the proponents' communication refers to 
the fact that Members may 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.  
277.  Taking this principle as a basis and using the flexibilities available under 
the TRIPS  Agreement in its Article 31 to further public interest objectives, Ecuador has had to 
adopt and implement laws providing for compulsory licensing in order to meet legitimate public 
health needs of Ecuador. This prompts me to touch upon my country's experie nce in granting 
compulsory licences so as to give the population broader access to medicines.  
278.  One of the justifiable grounds for issuing this type of licence under Ecuadorian law was to 
regard compulsory licensing as a tool for the Government to break the monopoly on patented 
medicines and be able to import or manufacture equivalent, lower cost pharmaceuticals that have 
no brand name but are just as effective. This ensures that the entire population has access to 
the medicines and treatments they need, strengthens the public health system and enhances 
people's quality of life.  
279.  By means of Executive Decree No. 118, in 2009 the National Government declared access to 
medicines to be a matter of public interest, a decision that enabled Ecuadorian and foreign  
laboratories established in the country to apply for compulsory licensing of patented medicines 
in order to produce and market them domestically.  
280.  With a view to conducting scientific research and developing active ingredients for 
the production of cheaper , generic medicines, the State owned pharmaceutical company ENFARMA 
was created that same year and tasked with providing the comprehensive public health network 
with a timely and efficient supply of essential medicines, as well as contributing to raise 
the percentage of the population with access to medicines for the treatment and cure of diseases.  
281.  The Ecuadorian Intellectual Property Institute (IEPI) has approved nine applications to 
produce mass consumption medicines. The first three licences were issued for the antiretroviral IP/C/M/86/Add.1/Rev.1  
 
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  drugs ritonavir, lamivudine and abacavir, which the Ministry of Public Health supplies free of 
charge for the treatment of HIV/AIDS patients.  
282.  The reason for issuing these licences was that, according to IEPI data, Ecuador has around 
37,000 HIV infected patients and some 700 deaths from the disease are reported each year. 
The data indicate that as a result of compulsory licensing the Ministr y of Public Health has saved 
30-70% on the cost of purchasing these medicines, which have to be supplied by the State.  
283.  In addition to the licences issued for antiretrovirals, licences were subsequently granted for 
etoricoxib (Arcoxia), a drug of proven efficacy in the treatment of acute pain diseases; 
mycophenolate sodium (MYFORTIC), used for kidney transplant recipients; sunitinib, 
an anticarcinogen for the treatment of renal cell carcinoma (RCC) and gastrointestinal stromal 
tumours (GIST); and certolizumab, used to relieve the symptoms of rh eumatoid arthritis the first 
licence to be issued in the ar ea of biotechnology.  
284.  With compulsory licensing the National Government aims not only to achieve a significant 
reduction in the prices of medicines but also to strengthen the country's pharmaceutical industry 
so that the largest possible number of imported drugs can be replaced by domestically produced 
medicines in the future.  
12.7 Bolivia, Plurinational State of  
285.  Let me begin by congratulating the sponsors of this agenda item. T he promotion of 
flexibilities under the TRIPS Agreement is something which has not been sufficiently encouraged in 
the developing world, and we would like to share some thoughts in this respect.  
286.  For different reasons, Bolivia has not had recourse to compul sory licensing. However, we are 
convinced that the use of this instrument deserves greater promotion, particularly, for instance, in 
the case of access to medicines.  
287.  We believe that WTO Members should make full use of the policy space available under 
the TRIPS Agreement to meet the needs of their countries and peoples, and this requires 
the support of the international organizations in the form of capacity building to enable them to 
use these instruments.  
288.  We also believe that governments should adopt and im plement legislation to facilitate 
the granting of compulsory licences to meet legitimate developmental or public health needs.  
289.  We have witnessed on more than one occasion, in the Latin American region, the pressure 
that has been brought to bear on certain countries when they have wanted to use compulsory 
licensing. This reality did not escape the notice of the UN Secretary General's High Level Panel on 
Access to Medicines which, in a report published at the end of 2016, not only encouraged the use 
of compul sory licensing, but also called upon certain countries and the private sector to refrain 
from applying explicit or implicit pressure as well as tactics or strategies that undermine the right 
of WTO Members to use the flexibilities provided for under the TR IPS Agreement. According to 
the High Level Panel , cases of undue political and commercial pressure should be reported 
to the WTO and debated among Members in order to discourage such unwarranted practices.  
12.8 United States  
290.  The United States welcomes the opportunity to offer a few initial observations on the general 
theme of IP and the Public Interes t and the concept paper before us discussing the issue of 
compulsory licensing. The United State s has long held that intellectual property rights protection is 
very much consistent with furthering the public interest and that international cooperation, to 
strengthen and provide confidence in domestic IP systems can help maximise these benefits. 
The co-sponsors' concept paper (IP/C/W/630) suggests that this agenda item will perhaps discuss 
public interest in a way that fails to fully account for the benefits of protecting IP. One potential 
negative effect for the co -sponsors' view of the public interes t could be tha t it discourages 
Members from striving  towards, and upholding robust domestic IP regimes, and therefore denies 
the public the benefits of critical future innovations and creative endeavours.  IP/C/M/86/Add.1/Rev.1  
 
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  291.  Before addressing the topic of compulsory licences,  I would like to respond to one of 
the co-sponsors assertions that 'TRIPS +' provisions and free trade agreements can do a disservice 
to public interest. We would encourage them to consider some of the many benefits that have 
been ascribed to IP protection . For example, a 2016 study analysing the launch of 642 new drugs 
in 76 countries concluded that patent and price regulation regimes strongly effect how quickly new 
drugs become commercially available in different countries. Price regulation delays launch,  while 
longer and more extensive patent rights accelerate it. Furthermore, US Intellectual Property and 
Innovation Policies have not only helped encourage investment in pharmaceutical innovation, but 
have also facilitated the approval and utilisation of ge neric drugs. According to recent data, generic 
medicines account for 89% of all prescriptions dispensed in the United States. I share this 
research to help provide the perspective that IP and patents should not be viewed as intrinsic 
barriers to access. To  properly address barriers to access we must look at factors outside 
the IP system.  
292.  In fact, the most recent estimates are that approximately 85% of medicines under WHO 
model -list of essential medicines are off -patent. Factors that are relevant to the acce ss question 
include pricing and procurement policies, taxes, mark -ups and tariffs and other national policies or 
lack thereof that have ultimately resolved in higher costs for consumers and for health systems. 
Unfortunately, the theme of today's agenda ite m does not explore these critical factors as it deals 
exclusively with the subset of medicines that is patent -protected in the territory.  
293.  Moving on to the issue of compulsory licensing, as affirmed in the Doha Declaration on 
TRIPS  and Public Health, the Un ited States respects its trading partners' right to protect public 
health and, in particular, to promote access to medicines for all and supports the vital role of the 
patent system in promoting the development and creation of new and innovative life -saving 
medicines. Consistent with these views, the United States respects its trading partners' rights to 
grant compulsory licences in a manner consistent with the provisions of the TRIPS Agreement and 
encourages its trading partners to consider ways to address  their public health challenges while 
maintaining intellectual property systems that incentivise the investment and research necessary 
to develop innovative new medicines.  
294.  The United States continues to encourage all WTO Members to promote a stable and 
predictable patent system that can nurture innovation. WTO Members can and should ensure 
supportive environments for innovators to achieve success and make significant contributions to 
innovative growth in their country. Many pharmaceuticals, whether essentia l drugs or not, have 
their origins in countries with strong patent systems. Robust and predictable patent systems 
provide interested parties with incentives necessary to encourage them to invest many years in 
significant financial resources into worthy end eavours without a guarantee of success. Compulsory 
licensing diminishes the exclusivity of the patent grant and undermines the incentive for 
innovation and investment that is a critical compo nent of technological progress.  
295.  A common view of innovative compa nies is that compulsory licences could prevent them 
from re group ing their investments in research and development. When these companies make 
investment decisions, they consider the ability to secure and maintain patent rights in a given 
market. The United States' system permits the use of a patent without the right -holders' 
authorisation only in very rare and narrow circumstances and the US Patent and Trademark Office 
has never issued a compulsory licence. In fact, it does not have the authority to do so. W e urge 
other Members to exercise caution and careful deliberation on issues related to compulsory 
licensing as they have significant implications that could negatively affect investment in R&D for 
the treatments of tomorrow and restrict investment into new  markets. The United States 
welcomes the opportunity to convey our views and we encourage the co -sponsors to seek topics 
that appeal to the diverse array of Member interests and that provide encouragement for 
upholding robust IP systems.  
12.9 Indonesia  
296.  Indonesia supports the proposal made by the delegations of India, Brazil, China, Fiji and 
South Africa on Intellectual Property and the Public Interest. As highlighted by the delegation of 
South Afric a, TRIPS sets minimum standards and allows Members to deliberate further under 
national IP systems by taking into consideration the balance between the interests of right -holders 
and the public. This is particularly vital with regard to public health inter ests. The tendency to 
introduce new obligations and extended protection through regional trade agreements containing IP/C/M/86/Add.1/Rev.1  
 
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  'TRIPS+' standards will affect Member's policy for making use of TRIPS flexibilities and disregards 
the objective that IP should contribute  to the promotion of innovation and transfer of technology.  
297.  Some are of the view that innovation and technology begins with providing an increased 
protection for inventors. But for many developing countries, the capacity of inventors is limited by 
the inac cessibility to data, technology and information needed to further the research and 
development. Therefore, for developing countries it is about such access that results in improved 
capacity as well as affordable prices. The use of TRIPS flexibilities shoul d not be hindered, based 
on the notion that it negates the rights of IP holders. Instead, it should be born in mind that every 
private right comes with the responsibility, particularly where the public is concerned. We should 
refrain from asserting pressur e on any government wishing to apply TRIPS flexibilities and 
exceptions, and resist any attempt to derail from the objectives of the Doha Development Agenda.  
298.  Indonesia, as a country that has adopted a mechanism for implementing flexibilities 
i.e. compulsor y licensing, in its national law, would support the initiative for discussions in this 
Council on the relationship between IP and the public interest. Indonesia would be open to share 
its views and experiences in implementing compulsory licences and discus s with Members how to 
address challenges and potential risk s posed by 'TRIPS+' standards. Like many other countries, 
Indonesia is still facing difficulties in delivering adequate health services and medicines to all of our 
citizens. One of the reasons is d ue to insufficient raw materials and manufacturing capacity. 
But this should not be interpreted as an export potential to a relatively big market which almost 
always results in expensive prices. Instead, governments should be encouraged and permitted to 
implement policies to enable the development of their industries. In accordance with 
the Doha Declaration, we believe that every Member has the freedom to determine the grounds on 
which compulsory licences are granted and that it is not limited to emergency situations, as some 
would have liked to convince us. It is therefore important that governments are induced to take 
measures that help public policy objectives and that this Council contributes to discussions on 
this matter.  
12.10   Colombia  
299.  In Colombia, compulsory licenses are recognized legal instruments in the framework of 
multilateral and bilateral trade agreements, as well as in Decision No. 486 of 2000 of the Andean 
Community. The grounds for g ranting compulsory licenses are: lack of exploitation; reasons of 
public interest, emergency or national security; abuse of dominant position; and 
patent  dependency.  
300.  The procedure for the declaration of public interest is established in the Colombian 
legislation. This procedure begins when the Ministry in charge of formulating and adopting the 
policies of the pertinent sector considers that it is necessary to issue a declaration. The Ministry 
will then compose a Technical Committee of at least one delegate from the Ministry, one from the 
Ministry of Commerce, Industry and Tourism and one from the National Planning Department. This 
Committee has to examine and evaluate the documents submitted, request concepts or technical 
support from other entities, and mak e a recommendation to the Minister on the decision to declare 
the existence of reasons of public interest or not. The recommendation will be made available to 
all interested parties for at least 10 days in order to receive comments. Thereafter, it will be 
forwarded to the Minister along with all submitted comments.  
301.  The resolution issued by the corresponding Ministry or Administrative Department stating 
that there are reasons of public interest that merit the issuance of a compulsory license must 
identify the situation that affects the general interest, establish the circumstances that led to the 
declaration and the reasons why the licence is to be granted. The aspects related to the specifi c 
scope of the compulsory licenc e that will be granted will be dete rmined by the Superintendence of 
Industry and Commerce.  Two applications for declarations of public interest have been submitted 
in order for the State to grant a compulsory license for medicines.  
302.  The first case concerned  Kaletra (HIV/AIDS), in 2008. Sever al NGOs filed applications for 
a compulsory license. The grounds for the request were: the increase in the number of people 
infected; that the consumption of the drug had doubled in the previous year; and that the patent 
of the drug had allowed maintaining  higher prices than under competition. From the analysis 
carried out by the Ministry of Health, it was determined that there were no grounds for declaring IP/C/M/86/Add.1/Rev.1  
 
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  the existence of reasons of public interest in order to grant a compulsory license. However, 
the price control mechanism was utilized and a reference price for the drug was established.  
303.  Glivec (Imatinib)  was t he most  recent experience . As provided by Resolution 2475 of 
14 June 2016, the Minister of Health declared the existence of public interest regardin g Imatinib, 
but not for granting a compulsory licence. The Ministry of Health requested the National 
Commission of Prices of Medicines and Medical Devices to consider applying the regime of direct 
price controls to Glivec, using a general methodology that simulates conditions of competition. 
Imatinib (active substance) is a very effective drug used to treat chronic myeloid leukaemia and 
other types of cancer.  
12.11  Japan  
304.  This delegation believes that sh aring experiences on this matter may be beneficial, as 
long as this is an ad hoc agenda item and an information -sharing session without connection to 
any future negotiation.  
305.  For the purpose of having meaningful discussions, we would like to make two commen ts. 
First, when discussing matters such as intellectual property and public interest, we should make 
a distinction between matters directly related to the Amendment of the TRIPS Agreement; and 
other matters that may need a clear explanation of why such oth er matters need to 
be discussed  here. 
306.  Second, the Doha Declaration, its statements and the resulting amendment of 
the TRIPS  Agreement all rest on an intricate balance. On the one hand there is the need to make 
sure that common drugs become common for every one. On the other hand we have the need to 
protect intellectual property to encourage development of new and effective drugs so that our 
stock of common drugs will continuously be updated. This balance is necessary to meet our 
common objective, which is to  protect public health, as described in Paragraph 3 of 
the Doha Decla ration.  
307.  We would also like to recall the Chair man's Statement JOB (05)/319, which was read out 
prior to the adoption of the Amendment. I quote: "Members recognize that the system that wil l be 
established by the amendment should be used in good faith to protect public health and, without 
prejudice to paragraph 3 of the Article 31bis of the amendment, not be an instrument to pursue 
industrial or commercial policy objectives ". 
308.  Thus, we should  be cautious in determining the scope of discussions when we mention 
compulsory licenses, such as the statement that "they are thus not limited to emergencies or other 
urgent situations "in paragraph 12 of the document submitted by the co -sponsors (IP/C/W/630). 
This might disturb the balance and objective defined by the Doha Declaration and the related 
articles of the TRIPS Agreement. Such arguments would need to be justified based on eviden ce 
and facts, before we are able to have any meaningful discussions.  
12.12  Switzerland  
309.  Due to the recent circulation of the submission, we will keep our intervention brief and may 
come back to th is point at the n ext Council meeting.  
310.  Public interest is a very important topic. The  current system of intellectual property 
protection fully integrates a balance between private and public interests. In their submission, 
the co-sponsors focused on access to medical products. Switzerland would like to highlight that 
access to medical products constitutes one of the main objectives of its health policy, notably with 
regard to its foreign relations.  
311.  We wish to recall that a patent only grants so -called 'negat ive rights' , in other words 
the right to prevent others to use the patent owner 's invention without authorization. A patent 
does not confer a discretionary power over pricing upon its owner. It is inherent to the system that 
investment in R&D and marketing  of innovative medical products are financed via the patent 
system through exclusive rights ' revenues, which in the short -to-medium term may be reflected in 
the prices of medical products. In the long term, however, the patent system constantly nurtures IP/C/M/86/Add.1/Rev.1  
 
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  a pipeline of new generic products. These usually become available after the patent protection 
period has expired and at a lower price.  
312.  As to IP provisions in free trade agreements: reliable and solid rules on intellectual property 
rights provide for the nec essary legal certainty to encourage not only the investment in new and 
better drugs for unmet medical needs, but also to allow for the use of licencing (in and out) of 
technological innovation – of any products, including medical products. In the mid - to long term, 
the IP system plays an essential role with regard to availability and accessibility of medical 
products and is therefore affirmative of the right to health. The Swiss delegation is aware that 
a good intellectual property framework is not the only  requisite for foreign direct investment, but 
one among many others.  
313.  We thank all co -sponsors for tabling this topic. Submission IP/C/W/630 makes reference to 
compulsory licensing. Whilst such licences may be a legitimate tool for very specific circumstanc es, 
Switzerland considers  them as a tool of last resort.  We are, however, aware that the intellectual 
property system is not a panacea for solving all aspects to address the challenge of better access 
to medical products. There may be policy and market fai lures that need to be addressed.  
314.  The Swiss Government provides, for example, technical and financial support to the WHO to 
set up a public observatory where research and development activities are monitored worldwide. 
Our Government further supports a comm ittee for the prioritisation of research needs. Switzerland 
has also given technical and financial support for a voluntary fund to finance priority research and 
development initiatives.  
315.  Funding of the selected innovative demonstration projects remains insu fficient. The Swiss 
matching fund provided to complement contributions from low - and middle -income countries has 
not been fully used by these countries. To date, we have only been able to disburse 
US$700'000 out of US$2 Mio . This is surprising.  
316.  We also inv est in public -private partnerships for the research and development of medical 
products (so -called product development partnerships), especially in the area of poverty - and 
neglected tropical diseases, including Medicines for Malaria Venture (MMV), Drugs f or Neglected 
Diseases Initiative (DNDi) and the Global Antibiotic Research and Development Partnership 
(GARDP).  
317.  Furthermore, this delegation would like to highlight that Switzerland is currently financing 
a feasibility study conducted by the Medicines Pate nt Pool which looks into the challenges 
and opportunities of potentially expanding MPP's business model.  
318.  In summary, instead of advocating the use of compulsory licences, this delegation strongly 
believes in the promotion of initiatives and approaches whic h incentivise research 
and development and, by the same token, improve access to medical products for people in 
low-and middle -income countries. And this is one important example of how the IP system serves 
the public interest.  We believe that building on voluntary and inclusive efforts (such as 
the Medicines Patent Pool, the Global Fund 's e-procurement platform or WIPO Re:SEARCH), rather 
than disincentivising  research into the development of new and better medical products, is the way 
forward and corresponds to the collaborative spirit of the  2030 Agenda for 
Sustainable  Development.  
12.13  European Union  
319.  It is the formally established position of the European Union that a balanced system of 
intellectual property rights which takes into account legitimate interests of users and right -holders 
fully serves the public interest. It is for this reason tha t national and international systems of 
intellectual property rights have been created for well more than 100 years. In the European 
Union, according to Article 17 of the Charter of Fundamental Rights, intellectual property is 
a fundamental right of every European citizen. Additionally we believe that TRIPS provides 
a reasonable balance and its rules and flexibilities allow countries to have a pragmatic and flexible 
approach that can help them to maximize the potential of their own intellectual assets and f urther 
their integration into international trade while achieving broader societal welfare.  IP/C/M/86/Add.1/Rev.1  
 
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  320.  In that sense, today's debate seems to confirm our assumption. In previous interventions, 
we heard a number of stories of how the system has functioned and how it h as been used by 
countries within the extent that is legally permitted to negotiate and to enhance access 
to medicines. This debate will actually confirm that the system is well -suited and it has reached 
a carefully crafted balance. We have also heard count ries that even if they are asking for more 
flexibility they have decided themselves not to use them.  
321.  But let me recall some of the functions of IP. It is known that the primary function of 
an intellectual property right is to permit the right holder to exploit his idea or creation 
in commercial activities, thus contributing to innovation. Other less frequently mentioned benefits 
include, for example, providing guarantees regarding the quality and safety of products. 
Many  counterfeit products place our ch ildren's and citizens' safety or health at risk; for instance 
where vehicles' spare parts or medicines are concerned. Enforcing intellectual property rights 
in respect of such products guarantees at least that the product's origin is known and that 
the products are genuine and safe; whereas counterfeit products often do not comply with the 
applicable safety standards. This is especially true for trademarks but often patent licensing 
contracts for instance also include quality insurance clauses. Would it be in the public interest to 
weaken such safety mechanisms?  
322.  Another benefit of IP is the dissemination of information on innovation. Even where 
a company or a university or an individual does not intend to protect its own invention, its staff 
and researchers can still make use, for instance, of patent information from others. The disclosure 
of the invention to the public is part of the contract to get time -limited protection. Patents are 
the most prolific and up -to-date source of technological information and contain detailed technical 
data which often cannot be found anywhere else. It is estimated that up to 80% of current 
technical knowledge can only be found in patent documents. Moreover, this information is rapidly 
available, as most patent applications are  published 18 months after their first filing. Searches in 
patent literature can be conducted by anyone by using for instance the free -of-charge Espacenet 
patent database. It provides access to more than 90 million patent documents from all over 
the world,  classified by technological areas on the basis of international patent classification. 
Would it be in the public interest to keep all of this information secret instead?  
323.  Additionally, IP rights often play an instrum ental role for small and medium -sized companies 
including start -ups and spin-offs, in trying to convince third parties to provide financing to them, 
to attract  investment, or to grant loans , etc. In the absence of tangible assets, their ideas, 
creativity and innovation are the only assets  that t hese companies will have,  depriving them of 
the possibility to exploit  them. This would clearly not be in the public interest.  
324.  To conclude, let me turn briefly to the issue of access to medicines and the discussion on 
pharmaceutical patents that was mentioned in the last part of the communication. The current 
innovation model based on patents has delivered consistent progress in global public health, 
continuously leading to important new and improved treatments, as well as much extended life -
expectanc y, both in developed and developing countries. Medicines are not created by public 
authorities, but by pharmaceutical industries. As all industries, they need an adequate return on 
investment to finance innovation. The challenge obviously is how to use all  levers available to 
public authorities to promote access to affordable medicines without negatively affecting the R&D 
by the pharmaceutical industries and therefore the availability of new and innovative medicines. 
Like others have mentioned before, let u s also recall that evidence shows that, indeed, there are 
many different significant causes for lack of access to medicines which renders it simplistic and 
misleading to attribute this problem merely to or even principally to intellectual property -related 
aspects. In fact, intellectual property issues seem to play a minor role in the problem, but 
a disproportionately large role in the debate.  
12.14  Korea, Republic of  
325.  I thank the proponents  and other delegations for sharing their experiences which provide 
useful information for the implementation of compulsory licenses.  
326.  Korea is of the opinion that the current TRIPS Agreement with the amendment effective 
since January this year could address  the concerns raised in the High Level Panel Report. Korea IP/C/M/86/Add.1/Rev.1  
 
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  believes that the issue of access to medicines needs a comprehensive approach, as various factors 
other than patents affect access.  
12.15  Australia  
327.  Australia notes the communication from Brazil, China, Fiji, India and South Africa regarding 
Intellectual Property and the Public Interest: Compulsory Licensing. Australia notes existing TRIPS 
flexibilities and welcomes, in particular, the recent  entry into force of the TRIPS Protocol. Australia 
supports full utilisation of TRIPS flexibilities. We are open to hearing the views of other 
Member  States in this regard.  
AGENDA ITEM 13: INFO RMATION ON RELEVANT DEVELOPMENTS ELSEWHE RE IN THE 
WTO  
13.1 WTO Secretariat  
328.  Many thanks for giving the Secretariat an opportunity to provide an update of IPR -related 
issues as they have come up in the most recent Trade Policy Reviews.  
329.  Since the last TRIPS Counci l Meeting in March, the Trade Policy Reviews of Japan, Mexico, 
Belize, Mozambique, Switzerland and Liechtenstein have taken place. I am pleased to report that 
Members continue to substantively contribute to the discussions on TRIPS -related issues during 
these reviews.  
330.  Members continued to engage in a constructive dialogue on a wide range of trade related IP 
issues, including: implementation of the TRIPS Agreement; exhaustion regimes; copyrights and 
related rights; copyright infringement exceptions; protecti on of software; protection of well -known 
and non -traditional trademarks; revocation procedures for trademarks; the protection of 
geographical indications; patent protection for agricultural chemical products; extension of patent 
protection periods; protect ion of undisclosed information and test data; compulsory licences; plant 
variety protection; enforcement of IP rights, online and at the border; functioning of the "piracy 
mailbox "; protection of trade secrets and their enforcement at the border; support f or SMEs using 
the IP system; establishment of technology licence offices at universities; IP dispute resolution 
system; national IP strategies; IP chapters in  regional trade agreements; and  accession to 
the WIPO Marrakesh Treaty to Facilitate Access to Pub lished Works for Persons who are Blind, 
Visually Impaired or Otherwise Print Disabled.  
331.  The Secretariat continues to collaborate on IP -related issues for Trade Policy Reviews and 
the preparation of the DG's Monitoring Reports. As in the past , this update is intended just to give 
Members an overview of the issues that have come up in these reviews for their 
background  information.  
AGENDA ITEM 14:  OBSERVER STATUS FOR INTERNATIONAL INTERG OVERNMENTAL 
ORGANISATIONS  
14.1 India  
332.  India su pports granting of permanent observer status to three intergovernmental 
organizations - South Centre, the CBD Secretariat and the International Vaccine Institute. All  three 
organizations fulfil the requisite criteria laid down by the General Council with re gard to 
Observer  status.  
333.  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 an alysis oriented on various 
international policy areas that are relevant to the protection and promotion of the development 
interests of developing countries, including on IPR issues. They have contributed to the discussions 
in the TRIPS Council like sponso ring a side -event yesterday at the WTO side events on the report 
of the HLP on Access to Medicines. South Centre already has observer status in WIPO, WHO, CBD 
and many other UN bodies.  IP/C/M/86/Add.1/Rev.1  
 
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  334.  The Convention on Biological Diversity (CBD) fulfils all the required p arameters for observer 
ship of the WTO. The WTO Secretariat has observer status at the CBD and regularly participates in 
the CBD meetings. So as a matter of reciprocity, the CBD Secretariat shall be granted 
observer  status.  
335.  We would also like to support th e request from the International Vaccine Institute (IVI) for 
observer status in the Council for TRIPS. The International Vaccine Institute, which was created 
initially as an initiative of the United Nations Development Programme (UNDP), is the world 's only  
international organization devoted exclusively to developing and introducing new and improved 
vaccines to protect the world 's poorest people, especially children in developing countries. 
India requests Members opposing the three organizations to provide a  valid reason for their stand 
given that all the three organizations fulfil the requisite criteria laid down by the General Council 
with regard to Observer status.  
336.  On the request of Nigeria, India is in a position to support only the two African Intellectu al 
Property Organizations, ARIPO and OAPI.  
14.2 South Africa  
337.  As of the last TRIPS Council meeting, there remain  13 pending requests for observer status 
in the TRIPS Council. This delegation believes that pending requests should be assessed on their 
own merit, particularly in respect of the competence and interest that respective organizations 
have in the worl d of the TRIPS Council. South Africa supports,  based on th e aforementioned 
considerations,  the granting of permanent observer status to the South Centre and the  CBD 
Secretariat.  
338.  In respect of the African Regional Intellectual Property Organization, and the Afric an 
Intellectual Property Organization, several M embers have expressed support for these 
organizations to be granted permanent observer status beyond ad hoc status currently enjoyed on 
a meeting to meeting basis and we also support the granting of permanent  observer status to 
these organizations.  
14.3 United States  
339.  The United States' position remains the same and we continue to object to the CBD and 
other organizations that India proposed being included as observers to th e TRIPS Council. 
However, we would be willing to continue our informal consultations with the Chair on this issue.  
14.4 Ecuador  
340.  Ecuador maintains the position it expressed at previous meetings in order to support 
the particip ation of two organizations, the South Centre and the Secretariat of the Convention on 
Biological Diversity, as permanent observers to this Organization.  
14.5 Indonesia  
341.  Indonesia would like to reiterate its position in suppo rting the approval of the request from 
the South Centre and the CBD Secretariat as permanent observers of the TRIPS Council.  
342.  As we all know, the South Centre is an intergovernmental organization that helps developing 
countries combine their efforts and exp erts to promote their common interest in the international 
agenda. It is an independent intergovernmental think tank created to analyse the specific 
problems of developing countries and encourage them to value and share their common 
experiences as well as provide intellectual and policy support for them to act collectively and 
individually including on IPR related matters.  
343.  The CBD, an internationally legally binding treaty with objective to encourage actions which 
will lead to a sustainable future, is often  seen as the key international instrument for sustainable 
development. As one of the WTO objectives is to expand the production of entre -aide in goods and 
services we are allowing for the optimal use of the world's resources in accordance with IP/C/M/86/Add.1/Rev.1  
 
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  the objectiv e of sustainable development. We think that the involvement of the CBD in the WTO 
especially in the TRIPS Council will actually benefit WTO to attain that objective.  
344.  To sum up granting the observer status to both organizations will benefit the progress for  
the discussions that have taken place in TRIPS Council. Its role would contribute to a more 
meaningful participation of developing countries in TRIPS Council discussions.  
14.6 Brazil  
345.  Brazil supports the approval of the reques t from the South Centre and the CBD as a matter 
of priority. The South Centre is an organization that provides imports to the developing countries 
in the course of their activities in Geneva. They combine their efforts and expertise to promote 
common inter est with the developing countries in the international arena. The South Centre 
encourages developing countries to value and to provide intellectual policy support for them to act 
collectively and individually, particularly in the international level. The o rganization has 
an observer status in several international organizations; in the WTO it is an observer  to 
the Committee on Trade and Development. Its f irst request dates back to 1999. I t would 
contribute to a more meaningful participation of the developing countries in TRIPS discussions 
without in any way harming the interest of other Members.  
346.  Regarding the CBD, it is an agreement ratified by as many as 196 parties that represents 
a dramatic step forward in the conservation of biological diversity . Like other permanent observers 
to the TRIPS Council the CBD is directly implicated in a number of items of the TRIPS Council's 
permanent agenda. A specific adding regarding relationship between the TRIPS Agreement and 
the CBD is part of the Agenda for ev ery TRIPS Council meeting. Those questions could greatly 
benefit from the participation of the CBD Secretariat as an observer. To reiterate our view that 
decisions should be made as a matter of priority. We find a delegation currently opposing it to 
presen t reasoning behind its opposition what has not occurred so far.  
14.7 Egypt  
347.  We would like to support the statement of India on the request to grant a permanent 
observer status to both CBD Secretariat and the South Centre.  
14.8 Venezuela, Bolivarian Republic of  
348.  I support all the others that have provided their support to the CBD and to the South Centre 
for them to participate as observers in this Council. We are convinced t hat they will provide value 
added, we feel that this is a good opportunity and will be favo urable for the outcome of our work.  
14.9 China  
349.  China supports that the CBD Secretariat and South Centre be granted observer status, at 
least on an ad hoc  basis.  
AGENDA ITEM 15: OTHE R BUSINESS  
15.1 Singapore  
350.  As mentioned ASEAN organized a lunch panel as part of the UNCTAD E -commerce week on 
27 April. The event was organized because we saw value in trying to f ind synergies between 
the discussions being held in UNCTAD and in the WTO on the development aspect of 
the E-commerce. The Panel on "Can E -Commerce Trade Rules Help MSMES In  Developing  
Countri es?" featured panelists  from the WTO, Singapore, Cambodia, the Global Express 
Association, and the  International Trade Center. The Thai Vice Minister for Commerce Winichai 
Chamchaeng provided opening remarks. The Panel had a broad discussion on the issue including 
on existing WT O rules that apply to E -commerce and the comment types of E -commerce rules 
found in FTAs. The P anel also shared how E -commerce has enabled MSMEs to better integrate into 
the global economy. The Panel also heard that interest in E -commerce cuts across the 
development levels in ASEAN having already committed to some E -commerce disciplines 
for example in the ASEAN Australia -New Zealand FTA. It was also shared that ASEAN Members IP/C/M/86/Add.1/Rev.1  
 
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  were looking to negotiate an  ASEAN E commerce agreement. The documents that we have  tabled 
summarize a reflection and key take -aways from the lunch panel. We look forward to engaging 
constructively with other interested  Members on how to take the work on E -commerce forward.  
 
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