RESTRICTED  
  
IP/C/M/83/Add.1  
 
30 January 2017  
(17-0571) Page: 1/97 
Council for Trade -Related Aspects of  
Intellectual Property Rights  
  
  Original: English  
 
  MINUTES OF MEETING  
HELD IN THE CENTRE WILLIAM RAPPARD ON 8-9 NOVEMBER  2016 
 
Chairperson : Ambassador Mero ( Tanzania ) 
 
Addendum  
The present document contains the statements made during the Council for TRIPS meetings held 
on 8-9 November  2016. 
 
______________ _ 
 
Subjects discussed  
AGENDA ITEM 1: NOTIF ICATIONS UNDER PROVI SIONS OF THE AGREEME NT ..................  5 
AGENDA ITEM 2: REVIE WS OF NATIONAL IMPLE MENTING  LEGISLATION  ........................  9 
AGENDA ITEM 3: REVIE W OF THE PROVISIONS OF ARTICLE 27.3(B)  .............................  14 
AGENDA ITEM 4: RELAT IONSHIP BETWEEN THE TRIPS AGREE MENT AND THE 
CONVENTION ON BIOLOG ICAL DIVERSITY  ................................ ................................ .... 14 
AGENDA ITEM 5: PROTE CTION OF TRADITIONAL  KNOWLEDGE AND FOLKLO RE .............  14 
AGENDA ITE M 6: REVIEW UNDER PA RAGRAPH 8 OF THE DEC ISION ON THE 
IMPLEMENTATION OF PA RAGRAPH 6 OF THE DOH A DECLARATION ON THE  
TRIPS AGREEMENT AND PUBLIC HEALTH  ................................ ................................ ....... 21 
AGENDA ITEM 7: NON -VIOLATION AND SITUAT ION COMPLAINTS  ................................ . 30 
AGENDA ITEM 8: REVIE W OF THE IMPLEMENTAT ION OF THE TRIPS AGR EEMENT 
UNDER ARTICLE 71.1  ................................ ................................ ................................ ..... 37 
AGENDA ITEM 9:  REVI EW OF THE APPLICATION O F THE PROVISIONS OF THE 
SECTION ON GEOGRAPHI CAL INDICATIONS UNDE R ARTICLE 24.2  ................................  37 
AGENDA ITEM 10: FOUR TEENTH ANNUAL REVIEW  UNDER PARAGRAPH 2 OF  THE 
DECISION ON THE IMPL EMEN TATION OF ARTICLE 66 .2 OF THE TRIPS 
AGREEMENT  ................................ ................................ ................................ ...................  37 
AGENDA ITEM 11: TECH NICAL COOPERATION AN D CAPACITY -BUILDING  .....................  43 
AGENDA ITEM 12: INTELLECTUAL PROPERT Y AND INNOVATION: RE GIONAL 
INNOVATION MODELS  ................................ ................................ ................................ ... 50 
AGENDA ITEM 13: THE UNITED NATIONS SECRE TARY -GENERAL'S HIGH -LEVEL 
PANEL REPORT ON ACCE SS TO MEDICINES  ................................ ................................ .... 74 
AGENDA ITEM 14: INFO RMATION ON RELEVANT DEVELOPMENTS ELSEWHE RE IN 
THE WTO  ................................ ................................ ................................ ........................  91 IP/C/M/83/Add.1  
 
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  AGENDA ITEM 15: OBSE RVER STATUS FOR INTE RNATIONAL 
INTERGOVERNMENTAL OR GANIZATIONS  ................................ ................................ ....... 92 
AGENDA ITEM 16: ANNU AL REPORT  ................................ ................................ ...............  94 
AGENDA ITEM 17: OTHE R BUSINESS  ................................ ................................ ..............  94 IP/C/M/83/Add.1  
 
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  INDEX OF THE STATEMENTS MADE  
AT THE MEETING OF CO UNCIL FOR TRIPS 8-9 NOVEMBER  2016*  
Argentina  
Non-violation , 34 
ARIPO Secretariat  
IP and innovation – Regional models , 73 
Technical cooperation , 45 
Australia  
Article 66.2 , 40 
Biotech, Biodivers ity, TK , 20 
IP and innovation - Regional models , 52 
Other business , 96 
Review of Para. 6, 27  
Technical cooperation , 43 
UN HLP on Access to Medicines , 83 
Bangladesh  
Biotech, Biodiversity, TK , 18 
Non-violation , 34 
Observer status , 94 
Review of Para. 6, 25  
UN HLP on Access to Medicines , 80 
Benin, on behalf of the LDCs  
Article 66.2 , 41 
Bolivia, Plurinational State of  
Biotech, Biodiversity, TK , 15 
Non-violation , 36 
Observer status , 94 
UN HLP on Access to Medicines , 85 
Brazil  
Biotech, Biodiversity, TK , 16 
IP and innovation – Regional models , 71 
Non-violation , 34 
Observer status , 92 
Other business , 96 
Review of Para. 6, 24  
UN HLP on Access to Medicines , 76 
Canada  
Biotech, Biodiversity, TK , 17 
IP and innovation – Regional models , 61 
National implementing legislation , 12 
Non-violation , 36 
Notifications , 5 
Other business , 94 
Review of Para. 6, 24  
UN HLP on Access to Medicines , 81 
Chile  
IP and innovation – Regional models , 72 
Other business , 95 
UN HLP on Access to Medicines , 83 
China  
Biotech, Biodiversity, TK , 16 
Non-violation , 34 
Observer status , 94 
Other business , 95 
UN HLP on Access to Medicines , 78 
Colombia  
Biotech, Biodiversity, TK , 17 
IP and innovation – Regional models , 72 
Non-violation , 32 
Technical cooperation , 45 
 Cuba  
Observer status , 94 
Dominican Republic  
IP and innovation – Regional models , 64 
Ecuador  
Biotech, Biodiversity, TK, 14  
Non-violation , 32 
Notifications , 6 
Observer status , 93 
UN HLP on Access to Medicines , 79 
Egypt  
Biotech, Biodiversity, TK , 15 
IP and innovation – Regional models , 71 
Non-violation , 33 
Observer status , 93 
UN HLP on Access to Medicines , 80 
El Salvador  
IP and innovation – Regional models , 63 
European Union  
Article 66.2 , 37, 42  
IP and Innovation - Regional models , 50 
National implementing legislation , 10 
Review of Para. 6, 26  
UN HLP on Ac cess to Medicines , 82 
Guatemala  
Biotech, Biodiversity, TK , 20 
IP and innovation – Regional models , 72 
Gulf Cooperation Council  
Technical cooperation , 46 
Holy See  
UN HLP on Access to Medicines , 86 
India  
Article 66.2 , 42 
Article 66.2, 42  
Biotech, Biodiversit y, TK, 14 
IP and innovation – Regional models , 67 
Non-violation, 33, 37  
Observer status , 93 
Review of Para. 6, 23  
UN HLP on Access to Medicines , 74 
Indonesia  
Biotech, Biodiversity, TK , 19 
Observer status , 94 
UN HLP on Access to Medicines , 80 
Japan  
Article 66.2, 41 
Biotech, Biodiversity, TK , 20 
IP and innovation - Regional models, 56  
National implementing legislation , 12 
Non-violation , 35 
Other business , 96 
Review of Para. 6, 27  
UN HLP on Access to Medicines , 84 
Korea, Republic of  
Biotech, Biodiversity, TK , 20 
IP and innovation – Regional models , 62 
Non-violation , 36 
Other business , 96 
UN HLP on Access to Medicines , 85 IP/C/M/83/Add.1  
 
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  Mexico  
IP and innovation – Regional models , 63 
Notifications , 6 
Other business , 97 
Technical cooperation, 43  
Moldova, Republic of  
Notification s, 7, 8 
New Zealand  
Article 66.2 , 41 
National implementing legislation , 13 
Norway  
Biotech, Biodiversity, TK , 19 
UN HLP on Access to Medicines , 85 
Pakistan  
Non-violation , 37 
Observer status , 94 
Panama  
Review of Para. 6, 30  
Peru  
Biotech, Biodiversity, TK , 19 
IP and innovation – Regional models , 69 
Non-violation , 35 
Russian Federation  
IP and innovation – Regional models , 69 
Non-violation , 34 
UN HLP on Access to Medicines , 80 
Singapore, on behalf of ASEAN  
IP and innovation – Regional models , 68 
South Africa  
IP and innovation – Regional models , 64 
Non-violation , 36 
Review of Para. 6, 25  
UN HLP on Access to Medicines , 77, 86, 91  
Switzerland  
Article 66.2 , 41 
Biotech, Biodiversity, TK, 17  
IP and innovation – Regional models , 54 
Non-violation , 32 Review of Para. 6, 2 8 
UN HLP on Access to Medicines , 83 
Chinese Taipei  
IP and innovation – Regional models , 60 
National implementing legislation , 12 
Non-violation , 36 
Other business , 97 
Review of Para. 6, 27  
UNAIDS Secretariat  
UN HLP on Access to Medicines , 89 
UNCTAD Secretar iat 
Technical cooperation , 48 
UN HLP on Access to Medicines , 89 
United States  
Article 66.2 , 41 
Biotech, Biodiversity, TK , 21 
IP and innovation – Regional models , 57 
National implementing legislation , 9 
Non-violation, 30, 36  
Observer status , 93 
Other busine ss, 94 
Review of Para. 6, 29  
Technical cooperation , 44 
UN HLP on Access to Medicines , 80, 91  
Uruguay  
IP and innovation – Regional models , 65 
Venezuela  
Observer status , 94 
WHO Secretariat  
Technical cooperation , 47 
UN HLP on Access to Medicines , 87 
WTO Secre tariat  
Article 66.2, 42  
Information relevant elsewhere in WTO , 91 
Notifications , 5, 7  
Review of Para. 6, 21  
Technical cooperation , 44 
UN HLP on Access to Medicines , 90 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
___________________  
* A record of statements as delivered  in the f ormal session of the Council . Some statements have been lightly 
edited as appropriate to ensure the consistency of presentation.  IP/C/M/83/Add.1  
 
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  AGENDA ITEM 1: NOTIFICATIONS UNDER PROVISIONS OF THE AG REEMENT  
1.1 WTO Secretariat  
1.  Under Article 63.2 of the  TRIPS  Agreement, th e Council has received the following notifications :  
 Mexico - a Decree Amending and Su pplementing Various Provisions o f the Industrial 
Property Law and a General Declaration on the Protection of the Appellation o f Origin "Cacao 
Grijalva ";  
 
 The Former Yugoslav Republic of Macedonia -  its Law on Copyright and Related Rights , the 
Law on Industrial Property  and the  Law on Customs Measures for Protection of IPRs and 
related application forms;  
 The Kingdom of Bahrein -  updates on its main laws and r egulations  regarding trademarks, 
trade secrets, geographical indications, patents and utility models, industrial designs and 
integrated circuits, including Decision No.  65 for the year 2016 issuing the Executive 
Regulations fo r the GCC Law on Trademarks.  
 Croatia - notified a set of new and updated legislative measures, including amendments to 
the Trademarks Act and Regulations, Regulations on Industrial Designs, Bi -Laws and 
Protected Designations of Origin, Protected Geographi cal Indications, and Guaranteed 
Traditional Specialities of Agricultural Products and Foodstuffs etc. These notifications were 
listed on the agenda for this meeting. In addition, they are also available in the IP/N/1 
series of documents and on the Document s Online database.  
2.  Since  the circulation of the revised draft agenda, the Council has also received a couple of 
other legislative measures:  
 Brunei Darussalam -  the Patent Order 2011 and the Patent Rules 2012, the Plant Varieties 
Protection Order 2015, an d the Industrial Design Rules 2014;  
 Republic of Moldova - laws on the protection of trademarks, industrial designs, plant 
varieties and inventions, the Law on the State Agency for IP, the Law Ratifying the 
Agreement between the Government of the Republic o f Moldova and the European Patent 
Office (EPO) on Validation of European Patents, the Law Amending and Supplementing 
Certain Legislative Acts and the Law on Vineyards and Wine;  
 Canada - an Act to amend the Copyright Right Bill  C-11; and from Mexico, the De cree 
regarding the Acceptance of the Marrakesh Treaty to facilitate access to published works for 
persons who are blind, visually impaired or otherwise print disabled. Finally, Madagascar has 
notified its Project for a National Innovation Policy and Strate gy in the Field of Industrial 
Property. These notifications will also be made available in the IP/N/1 series of documents. 
In addition, Guyana has submitted information regarding contact points under Article  69 for 
the exchange of information and cooperati on on trade in infringing the goods.  
1.2 Canada  
3.  Canada is pleased to present notification IP/N/1/CAN /17, which provides background on recent 
amendments to the Copyright Act under Bill C -11, An Act to Amend the Copyright Act ( access to 
copyrighted works or other subject -matter for persons with perceptual disabilities). Bill C -11 
received Royal Assent and entered into force on 22  June 2016.  
4.  Bill C -11 amended the sections of the Copyright Act that set out exceptions for persons w ith 
perceptual disabilities (for instance, sections 32 and 32.01 of the Act, as well as new 
section  32.02). This includes amendments in the following areas:  
 Amendments to permit the making of large -print books: the Copyright Act now 
provides that users can  make large print books, subject to applicable safeguards, 
such as commercial availability limitations.  IP/C/M/83/Add.1  
 
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   Reduced restrictions on exporting accessible materials: the Copyright Act now 
provides that organizations in Canada can continue to export adapted mater ials to 
any country, subject to safeguards (for instance, commercial availability), but no 
longer includes the limitations in relation to the nationality of authors. Canada's 
previous exception permitted the sending of accessible format copies to any count ry, 
but limited such exports to a Canadian author's work or the work of an author from 
the destination country.  
 Safeguards to protect the commercial market for materials in accessible formats: 
safeguards ensure that publishers who choose to make their book s available in 
accessible formats can sell them in the marketplace, while not imposing 
unreasonable burdens on non -profit organizations acting for the benefit of persons 
with print disabilities.  
 Exceptions relating  to the circumvention of technological pro tection measures: the 
Copyright Act has now been clarified to ensure that users may circumvent 
technological protection measures (TPMs or "digital locks ") for the purpose of 
benefiting from the exceptions for the perceptually disabled. Also, the limitation  that 
the TPM cannot be unduly impaired has been removed. In place of the "unduly 
impair " limitation, the providing of a circumvention service or device would need to 
be done solely for the purpose of benefitting the perceptually disabled.  
 The amendments t o Canada's Copyright Act under Bill C -11 were designed to enable 
Canada to  accede to the World Intellectual Property Organization (WIPO) Marrakesh 
Treaty to Facilitate  Access to Published Works for Persons Who Are Blind, Visually 
Impaired, or Otherwise Pri nt Disabled (or "Marrakesh Treaty "). Canada acceded to 
the Marrakesh Treaty on 30 June 2016.  
5.  Canada is pleased to note that, as the 20th country to ratify or accede to the Marrakesh  Treaty, 
the Treaty has now come into force  intern ationally as of 30 Septem ber 2016.  
1.3 Ec uador  
6.  We want to be as informative as possible and , for the minutes, inform  Members that we will 
shortly notify  the WTO an information document on the laws on intellectual property in accordance 
with Article  63 of the TRIPS  Agreement. The laws and regulations which will be notified will be on 
the agenda of the Council 's next meeting .  
1.4 Mexico  
7.  This delegation is pleased to inform the TRIPS Council that we have recently reformed the Law 
on Industrial Property and also issued a declaration regarding the appellation of origin of Cacau 
Grijalva . The reform and the declaration have been notified to the Secretariat and were published 
on the website . The changes  allow our system to be m ore transparent and to be in compliance 
with international law.  
8.  The opposition procedure came into force in Mexico on 30 August 2016 and it was presented 
directly to the Industrial Property Institute of Mexico  through the Madrid System. This means that 
any person can oppose the registration of a trademark up to one month after the publication. The 
Mexican Office will thus have more elements to carry out a deeper analysis . This  will ensure that 
there is greater certainty for the users of the system.  
9.  Regard ing the General Declaration, this allows for protection under the appellation of origin for 
Cacau Grijalva in accordance with the established Law on Industrial Property. This is produced in 
11 municipalities in the region known as Grijalva in the South-East of Mexico.  
10.  Furthermore, a Decree on the Promulgation of the Marrakesh Treaty  to Facilitate Access to 
Published Works for Persons Who Are Blind, Visually Impaired or Otherwise Print Disabled  was also 
notified to the Secretariat  (IP/N/1/MEX/14 of 4 Novembe r 2016) . The Decree wa s published in our 
Official Journal  and came into force  on 30 September  2016. IP/C/M/83/Add.1  
 
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  1.5 Republic of Macedonia   
11.  Thank you for providing me an opportunity to present to the Council some additional 
information about the notified laws by my country. The notified Law on Industrial Property replaces 
the previous law from 2002. The main reason for the adoption of the new law  is to further align  it 
with the legislation of the European Union in this area, in creasing the efficiency of the system for 
the protection of industrial property and encourag ing creativity and innovation in the Republic of 
Macedonia. There are two notices in the law I would like to mention. First, the introduction of 
simplified procedur es to apply  for patents or trademarks. Second, the introduction of the 
possibility for affording citizens to act as representatives in the area of industrial property in the 
Republic of Macedonia.  
12.  The notified Law on Copyright and Related Rights replaces t he previous law from 1996. The 
main reason s for the adoption of the Law are to clarify the  language used in the previous law and 
to further align the national legislation with the European Union legislation  in this area. There are 
three main notices in thi s Law. First, the types of the rights protected by this Law are clearly 
distinguished. Second, collective management of copyright is regulated. Third, protection and 
affirmation of the national heritage of  the Republic of Macedonia is addressed.  
13.  The notifi ed Law on Customs Measures for the Protection of IPRs replaces the previous law 
from 2005. The structure of the Law is aligned with the European Union's Regulation No. 608/2013 
applicable from 1 January 2014 and addresses the weaknesses in the previous law  identified 
during the previous ten -year implementation period . The main goal of the adoption of the Law is 
further improvement of the institutional framework and administrative capacity of the Customs 
Administration of the Republic of Macedonia for apply ing selective control  measures  in the area of 
IPRs. Some of the new notices in the Law are the following: identification of the goods exposed to 
risk of counterfeiting  is improved by clarifying the characteristics of the goods and related 
documentation;  cooperation with right owners and their representatives is improved by specifying 
the manner of mutual exchange of information and abolishing the fees for processing of the 
request from the customs section; customs to customs cooperation is improved by regul ating the 
manner of exchange of information with the Customs Authorities in third  countries; risk 
management system of the customs administration in the Republic of Macedonia is further 
improved by regulating the manner of exchange of information with the customs authorities of 
third countries  and by regulating the contents and administration of existing IPR -related service 
databases as part of the Customs Declaration processing system: the issue of small consignment 
of counterfeit goods is regulated and th e provisions related to the extraction of counterfeit goods 
are improved.  
14.  We should further note that there are several amendments to all the above -mentioned laws 
since their adoption and related notifications are under preparation.  
15.  The Republic of Macedon ia is fully dedicated to the protection of intellectual property in this 
context. The Republic of Macedonia works continuously on the improvement of the international 
framework and the capacity for law enforcement, improvements of the cooperation with econ omic 
operators and business associations as well as cooperation between the competent national and 
international authorities.  
1.6 WTO Secretariat   
16.  Since our update at the last session of the Council on the project to improve the timeliness 
and completeness of notifications and other information flows – the so -called "eTRIPS " information 
management system – the Secretariat held on 26 July 2016 an informal demonstration of the 
eTRIPS online notification web tools. We use d this informal demonstration as an occasion to 
showcase the prototype online notification web tools under development and to collect your 
valuable feedback.  
17.   In addition, since our last update, some interested delegates have met with us on an informal 
basis to essentially test the prototype. For us, this was an extremely fruitful exercise as we were 
able to gain a better understanding of a prospective user's experience and needs – and we  have 
taken comments and questions into consideration for the prototyp e's continued development. In 
that light, we express our thanks to those delegations for their guidance.  IP/C/M/83/Add.1  
 
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  18.  We would encourage any interested delegates to get in touch with us on an informal basis in 
order to test the system and offer any feedback or suggesti ons. 
19.  Also, as there is generally an increase in the volume of notification and other review materials 
during this time of year, we would encourage delegations preparing to submit notifications or 
review materials to reach out to us informally. During this interim stage before the online 
notification web tools become available, we have practical arrangements that should make it easier 
for you to make these submissions.  
20.  In close cooperation with our IT colleagues and software developer, we are continuing to 
make technical and functio nal improvements to the eTRIPS S ystem with the aim of making the 
online notification web -tools more robust and intuitive, and the data more accessible and 
transparent.  
21.  Further, we are continuing to transform TRIPS "legacy document s" into workable data by 
identifying data points and sorting information into spreadsheets.  
22.  Early in the New Year, we plan to consult with any interested delegations on the search tools 
and user interface.  
23.  We remain available to provide ad hoc briefings o r demonstrations on request to any 
delegation, in particular delegations preparing to submit notifications or reports to the Council.  
1.7 Moldova, Republic of  
24.  On behalf of the Government of the Republic of Moldova , I would like to draw your attention 
to eight notifications presented by our Government to the Council for Trade -Related Aspects of 
Intellectual Property Rights. The Law of the Republic of Moldova, No. 57 of 10 March 2006 on 
Vineyards and Wine, establishe s the legal, economic and social basis in the sector of viticulture 
and wine -making regulations arising in the activity of production, processing and marketing of 
propagating and planting material, commodity  of wines, grapes, wines and other musts, and 
wine-based products.  
25.  We would like to draw your attention to the Law ratifying the Agreement between the 
Government  of the Republic of Moldova and the European Patent Organization and V alidation of 
European Patents from April 2015. The Law ratifies the Agree ment between the Government of the 
Republic of Moldova and the European Patent Organization and Validation of the European Patents 
conclud ed on 16 October 2013. Another Law from July 2015 amending and supplementing another 
Law from 7 March 2008 under the p rotection of inventions. the new law of July 2015 is Amending 
and Supplementing the Law of the Protection of Invention from March 2007 to 2008 by 
establishing the validation procedure of European Patent Application and European Patents and 
improving and ad justing to above normative acts.  
26.  Another law is the new Law from July 2014 on the State Agency for Intellectual Property of 
the Republic of Moldova establishing the legal framework, legal status, main activities, principles 
and directions, functions, due rights and obligations of the State Agency on Intellectual Property. 
The coordination of the activity within the Agency is founding economic and financial activity as 
well as its basic activities and intellectual property.  
27.  Another notification presented to  the Council is the Law on the Protection of Trademarks 
which stipulate that it is amending to different laws from 2015 and 2012 -2014 as well. These 
modifications and consolidations of certain legal texts in the intellectual property field in order to 
comp ly the regulatory framework which in force through the provisions of the previous law from 
2014 and the State Agency on Intellectual Property of the Republic of Moldova.  
28.  The other one is the Law on the Protection of the Plant Varieties. Several amendments  and 
the adoptions of these Law. The last one is on the minimum tariffs of copyright royalties as well. 
This document sets out the minimum tariffs of copyright royalties which are mandatory for all 
major persons and legal entities that explore the artistic  and scientific works in the Republic of 
Moldova regardless of their type of ownership and management. It lays down the rules and 
remunerations to authors for publication of literary, musical or scientific, educational, technical IP/C/M/83/Add.1  
 
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  creations for industrial e xploitations, works of plastics, decorative and applied. The act also 
established the unique tariffs of copyrights royalties for artistic works created on demand of the 
purpose of presenting it for the public performance and for the right to prepare it for  the public 
performance communication demonstrations and other forms of exploitation.  
AGENDA ITEM 2: REVIEWS OF NATIONAL IMPLEMENTING LEGISLA TION  
2.1 United States  
29.  As you can tell from my previous in tervention, we are quite eager to intervene under this 
item. The United States welcomes this opportunity to introduce the US Defend Trade Secrets Act, 
which was signed into law on 11  May 2016.  
30.  Before summarizing the key aspects of this new law, we will fir st provide a brief context 
regarding the rationale underlying this law, including the priority placed in the United States on 
defending trade secrets against misappropriation.   
31.  The 2013 Administration Strategy on Mitigating the Theft of US Trade Secrets a rticulated this 
priority unequivocally:   “Trade secret theft threatens American businesses, undermines national 
security, and places the security of the US economy in jeopardy. These acts also diminish US 
export prospects around the globe and put American jobs at risk. ” 
32.  Trade secrets are vital intellectual property assets held by innovators. Protection of those 
assets against theft and misappropriation is essential to foster innovation and promote economic 
growth. In fact, for some companies a core aspect o f their success is based on the ability to 
protect their trade secrets.  
33.  As one commentator describes the value of trade secrets and the importance of their 
protection against theft:  "In the Information Age, your trade secrets – a new technology, a 
business  plan, insights extracted from data analytics – define your competitive advantage. And 
because business is global, competition can emerge anywhere, at any time. Not just success, but 
survival requires vigilance and careful management. Those how know how to  protect and exploit 
the most important secrets can quickly leverage their business to profitability and dominance; 
while those who fail to recognize this new reality are doomed. " 
34.  Generally speaking, trade secrets are information that has value by virtue o f not being 
generally known , has value to others who cannot legitimately obtain the information , and is 
subject to reasonable efforts to maintain its secrecy.  They can include formulas and recipes, 
techniques for manufacturing products, product designs, te chnical data, and several other 
categories of information.  Trade secret theft is estimated to result in annual losses to US 
innovators in the range of hundreds of billions of dollars. Th ose losses have been linked to reduced 
innovation and slowing economic  growth. In certain scenarios, the nature of the trade secret theft 
is that a victim does not know about the theft right away, allowing the thief to get greater lead 
time to benefit from the secret. " 
35.  According to the Report of the Commission on the Theft o f American Intellectual Property: 
"our intellectual property here is about $5 trillion. Of that, approximately $300 billion – about 6% - 
is sto len over the networks per year ", which has been described as "the greatest transfer of wealth 
in history ". 
36.  And th e negative impact of trade secret theft is global, and many countries and international 
organizations are engaging intensively in efforts to combat trade secret misappropriation, as we 
will hear this morning as well as tomorrow at lunch at the trade secret s side event.  
37.  The OECD, for example, has issued two in -depth trade secret studies. The first study by 
Mark Schultz and Douglas Lippoldt, entitled "Approaches to Protection of Undisclosed Information 
(Trade Secrets) " (30 January 2014) takes stock of the ava ilable legal protection for trade secrets 
in a broad sample of countries.  
38.  The second study, also by Schultz and Lippoldt, entitled "Uncovering Trade Secrets – An 
Empirical Assessment of Economic Implications of Protection for Undisclosed Data " (also 2014),  IP/C/M/83/Add.1  
 
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  considers the relationship of the stringency of the protection of trade secrets to relevant economic 
performance indicators. The study finds a positive association between the stringency of trade 
secrets protection and the key indicators of innovation and  international economic flows.  
39.  In the context of the United States, trade secret law has developed over time, using a variety 
of legal frameworks to redress theft, and to implement Article 39(1) and (2) of the TRIPS 
Agreement. The US framework has evolved to the adoption of specific statutes addressing trade 
secret theft and economic espionage.   
40.  The Defend Trade Secrets Act of 2016 amends Section 18 of the United States Code, 
Section  1836, the Economic Espionage Act, to establish a private civil cause of a ction for the 
misappropriation of trade secret s.   
41.  A national civil private cause of action for trade secret theft is intended to provide busi nesses 
with a uniform, reliable  and predictable way to protect their valuable trade secrets anywhere in the 
countr y. The law defines a trade secret as covering all forms and types of financial, business, 
scientific, technical, economic, or engineering information, whether or not and how stored, 
compiled, or memorialized physically, electronically, graphically, photogr aphically, or in writing if: 
the owner thereof has taken reasonable measures to keep such information secret; and the 
information derives independent economic value, actual or potential, from not being generally 
known to, or not being readily ascertainable  through proper means by, another person who can 
obtain economic value from the disclosure or use of information.  
42.  With respect to remedies, the law provides for an ex parte  seizure remedy, which "enable[s] a 
trade secret owner under limited, controlled con ditions, to proactively contain a theft before it 
progress es and the trade secret is lost ". The law "balances the need for efficient recovery of a 
stolen trade secret with the rights of defendants and third -parties ".  
43.  Additional remedies for the misappropr iation of a trade secret under the law include injunctive 
relief and damages (i.e., actual loss to the plaintiff, unjust enrichment to the defendant, 
reasonable royalty where damages cannot readily be determined, and double damages for wilful 
and malicious  theft).  The law provides for the award of reasonable attorney 's fees to a prevailing 
defendant if a claim of misappropriation is made in bad faith, or to a prevailing plaintiff if the trade 
secret was wilfully and maliciously misappropriated.   
44.  The Defend  Trade Secrets Act was supported by a broad range of industries and also enjoyed 
strong, bi-partisan support in both houses of the United States Congress.  
2.2 European Union  
45.  Let me also briefly give  you an overview of the framework and then of the content of our 
recently adopted Trade Secrets Directive. Companies invest in acquiring, developing and applying 
know -how and information. This investment in intellectual capital has an impact on their 
compe titiveness and innovative performance in the market and therefore on their benefits and 
motivation for continuing innovation.  
46.  This valuable know -how and business information that is intended to remain confidential is 
what we know as a trade secret.  
47.  As the US mentioned, this covers a wide range of information, which extends beyond 
technological knowledge to commercial data such as information on customers and suppliers, 
business plans and market research and strategies.  
48.  Trade secrets play an important role i n protecting the exchange of knowledge between 
businesses, in particular SMEs and research institutions in the EU in the context of research and 
development and innovation.  
49.  The ex -post evaluation of the 7th EU Research Framework Programme concluded that 6 4% of 
the projects report no patenting activities and 60% of the projects opted for secrecy as intellectual 
property avenue. This shows how often trade secrets are the tools that are used by small 
companies, companies who do  not have extensive financial re sources, that do  not have lawyers at IP/C/M/83/Add.1  
 
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  their disposal to protect their intellectual property and opt for a more economical and more 
effective model to keep some information confidential.  
50.  This is one of the main reasons  why the EU considered it necessary to a dopt the Trade 
Secrets Directive  and harmonize the protection of undisclosed know -how and business information 
to the extent of civil litigation because that is the area for which we have clearly established 
competence. It was not possible at the current s tage to adopt similar legislation for criminal 
infringement and criminal litigation regarding the theft of trade secrets. The Directive was adopted 
on 8 June 2016 and , as is often the case in Europe, is subject to a n implementation  period by 
national legis lation , as it is not directly applicable. It requires each Member State to adopt its own 
laws that put in place the system ; Member States  will have until 9 June 2018  to do so .  
51.  Before the adoption of the Trade Secret s Directive there was great diversity of  systems and 
definitions in E uropean Union Member States as regards the treatment and the protection of trade 
secrets. This new Directive brings legal clarity and a level playing field to all European companies. 
It applies to all companies operating in Eur ope. It also helps to increase their interest in the 
development of research and innovation activities.  
52.  The recently adopted Directive sets out rules for the protection of trade secrets and 
confidential information of companies  who are operating in the Eur opean Union . It lays down 
common measures against the unlawful acquisition, use and disclosure of trade secrets, and aims 
at ensuring the smooth functioning of the E uropean Union's  internal market.  
53.  It is also intended to have a deterrent effect against the  illegal disclosure of trade secrets 
while at the same time  fundamental rights and freedoms or the public interest, such as public 
safety, consumer protection, public health, environmental pro tection and mobility of workers are 
not undermined.  
54.  While the Directive provides for measures preventing the disclosure of information to protect 
the confidentiality of trade secrets, the new measures fully ensure that investigative journalism 
can be exercised without any new limitations, including with regard to the p rotection of journalistic 
sources. The directive is in compliance with the EU's Charter of Fundamental Rights, which 
preserves freedom and pluralism of the media.  
55.  There will also be no limitation to employees' use of the experience and skills honestly 
acquired in the normal course of their employment. Furthermore, the autonomy of social partners 
and their rights to enter into collective agreements is not affected by the implementation of the 
new mechanisms . 
56.  The new D irective introduces that persons acting in good faith that reveal trade secrets for the 
purpose of protecting the general public interest, commonly known as "whistle -blowers ", enjoy 
adequate protection. Trade secrets protection does not apply in cases in which the objective was 
to reveal miscond uct, wrongdoing or illegal activity, provided that the respondent acted for the 
purpose of protecting the general public interest.  
57.  In accordance with the new legal framework, EU Member States have to provide for the 
measures, procedures and remedies necess ary to ensure the availability of civil redress against the 
illegal acquisition, use and disclosure of trade secrets. These have to be fair, effective and 
dissuasive. They must not be unnecessarily complicated or costly, nor ma y they entail 
unreasonable ti me-limits or unwarranted delays.  
58.  The Directive also set outs that trade secret holders are entitled to apply for remedies in case 
of damages following cases of illegal appropriation of documents, objects, materials, substances or 
electronic files containi ng a trade secret or from which a trade secret can be deduced.  
59.  Also the legislation introduces mechanisms for the removal from the market of goods 
manufactured on the basis of a trade secret that was illegally acquired. The Directive puts in place 
mechanis ms to ensure that where necessary, confidentiality of trade secrets is preserved during 
the course of and after the legal proceedings.  Actually, we found it was often the case that a 
company that  had suffered the misappropriation of its trade secret s and t hen went to court to 
make its right prevail, the court was not equipped to address these kinds of cases and often the IP/C/M/83/Add.1  
 
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  company ha d no option, but to rev eal its trade secrets . This was fairly illogical and an 
unreasonable process. We have therefore introduce d mechanisms that equip courts to judge these 
cases with the necessary level of confidentiality so that the company does not suffer twice this 
prejudice, first by some illegal means and then by court proceedings. That is a very important 
element of the Dir ective. For the rest I will let you have a more detailed assessment but these are 
the main points I wanted to make today.  
2.3 Chinese Taipei  
60.  The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  is pleased to introduce 
information on our trade secrets legislation. The first version of a Trade Secrets Act entered into  
force in 1996. It only provided stipulations on civil liability. This was in consideration that the 
Criminal Code already provides stipulations on crimes involving illegal disclosure of commercial 
and industrial secrets. As many Members have recently modernized their systems of trade secrets 
protection there were c alls for amendments from the corporate sectors that had witnes sed and 
been victims of trade secrets infringement.  
61.  Stakeholders expressed their concerns about  potential misappropriation of R&D results and a 
compromised global competitive edge. As such, they demanded that the act include a criminal 
liability to effecti vely deter infringement and strengthen protection and create an environment that 
safeguards fair market competition. Th e amendment quickly responded to the needs of 
stakeholders.  
62.  The current Trade Secrets Act comprise s a total of 16 articles and it entere d into force in 
2013. The act has been amended to enhance protection, deter crimes, safeguard R&D resource s 
and maintain fair competition.  
63.  Both the US and the EU mentioned that in today's economy information and know -how 
representing the result of R&D inv estments, creativities and business initiative have become the 
key for developing and maintaining competitive advantage. We look forward to further cooperation 
in creating a healthier business environment with other Members. It will enable innovators to 
protect and benefit from their know -how when engaging in collaborative innovation.  
2.4 Japan  
64.  The delegation of Japan would like to express our gratitude to the United States for sharing 
information on their "Defend Trade Secrets Act ". Leakage of confidential information on essential 
technologies can cause significant damage to inventors and innovators, so the delegation of Japan 
strongly believes that it is important to enhance protection against trade secret i nfringements.  
65.  Based on this recognition, Japan has revised its Unfair Competition Prevention Act in order to 
enhance both criminal and civil measures that are designed to prevent sig nificant damage caused 
by trade secret infringements.  
66.  As the delegation of  Japan reported at the Council meeting this March, this revision 
strengthens protection against trade  secrets infringements by raising fines and imposing heavier 
penalties. Additionally, the revision also expands the scope of protection against trade secre t 
infringements. Th e delegation of Japan believes continuous efforts in this area are essential in 
order to combat trade  secret infringements . 
2.5 Canada  
67.  Canada would like to thank the United States, the Eu ropean Union, Chinese Taipei and Japan 
for the interesting presentations on their regimes for the protection of trade secrets and is pleased 
to respond to their interest in presenting on the systems in place in other Members.  
68.  Canada has a strong regime fo r the protection and enforcement of trade secrets. For example, 
the 2014 OECD study titled "Uncovering Trade Secrets - An Empirical Assessment of Economic 
Implications of Protection for Undisclosed Data ", as was noted by my United States colleague, 
establi shed a "Trade Secrets Protection Index " that ranked Canada's overall regime second among 
the 37 major economies that were assessed in the study.  IP/C/M/83/Add.1  
 
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  69.  In Canada, trade secrets protection and enforcement has roots in contract, equity, tort, and 
property law, both  at the federal level as well as at the sub -level provincial level. While Canada 
does not have a single federal trade secrets act, trade secrets are addressed in several pieces of 
federal legislation. For instance, Canada's Security of Information Act crim inalizes economic 
espionage, including through the theft of trade secrets. The communication of a trade secret to 
another person, group or organization, as well as the acts of obtaining, retaining or destroying 
trade secrets "to the detriment of Canada's e conomic interests, international relations or national 
defence or national security " are considered criminal offenses under Section 19 of that Act. As 
well, Section 9(3)(b) of the Personal Information Protection and Electronic Documents Act 
establishes the  framework for the protection of commercial confidential information by the 
Government of Canada. Several other pieces of federal legislation address the treatment of 
commercial confidential information of business es with which the Government of Canada int eracts 
in its operations , for example,  the Access to Information Act,  the Canadian Space Agency Act, the 
National Energy Board Act  and the Telecommunications Act.  
70.  Civil c auses of action for pursuing trade secret enforcement in Canada stem primarily from 
contractual liability,  such as a breach of an employment contract or tort law, such as unjust 
enrichment or breach of a  fiduciary duty. In terms of remedies, the Canadian system generally can 
provide a range of  measures that include: preliminary and permane nt injunctions (as long as the 
trade secret remains  secret);  injunctions to  eliminate wrongful head starts;  destruction of 
infringing materials; compensatory damages; orders to protect the confidentiality of trade secrets 
in litigation; and ex parte  emerge ncy search measures. Defences to trade secret actions  can 
include independent creation, reverse engineering and in some cases the public interest  of the 
defence . 
71.  In conclusion, I would just like to once again thank the United States and European Union for 
bringing this item forward. We think this is an area that has been a little bit understudied in terms 
of international discussion. We were pleased to be a part of the discussion today.  
2.6 New Zealand  
72.  Thank you to those other Members who have shared information about their regimes so far. 
New Zealand also appreciates this opportunity to share New Zealand law on trade secrets.  
73.  New Zealand provides comprehensive civil protections and criminal sanctions fo r 
misappropriation and use of trade secrets.  
74.  Comprehensive civil protection is available by means of common law for confidential business 
information and technical information where reasonable efforts are taken by the holder of the 
information to keep it c onfidential. Protection extend s to situations where information is imparted 
to third parties in confidence.  
75.  The Crimes Act 1961 provides for a term of imprisonment of up to five years for 
misappropriation of a trade secret, with the intent to obtain any fi nancial or economic advantage 
or indeed to cause loss to any other person.  
76.  Finally we would just l ike to echo those  Members who have already spoken acknowledging the 
benefits of trade secret protection. Particularly, we  would also like to underline a recen t OECD 
study of trade secret protection. This showed across Membership a positive and statistically 
significant relationship between the protection of trade secrets and certain aspects of economic 
performance . IP/C/M/83/Add.1  
 
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  AGENDA ITEM 3: REVIEW OF THE PROVISIONS OF ART ICLE 27.3(B)  
AGENDA ITEM 4: RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE 
CONVENTION ON BIOLOGICAL DIVERSITY  
AGENDA ITEM 5: PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  
5.1 Ecuador  
77.  Ecuador's position on the se three matters appear s in the record of earlier TRIPS Council  
meeting s. I will refer more specifically to our request now. We would like the Secretariat to update  
the factual notes on these issues  since the documentation we have now dates back to 2006. W e 
feel that by updat ing documents IP/C/W/368/, IP/C/W/369/Rev.1 and IP/C/W/370/Rev.1 , we 
would have a clearer understanding of our discussions over the years. We need to have updated 
documentation available in order to underpin our discussion on these issu es and make headway. 
We regret that we have not had the time to discuss this matter with the United States and to get a 
full understanding of the US  concerns, but we look forward to exploring constructive discussions 
with them.  
5.2 India   
78.  As Members are well aware, we have been extensively discussing the three agenda items for 
many years. However it is important  to note that they  remain  of utmost priority to us. During the 
course of the discussions, many Members have  not only highlighted the misappropriation of 
genetic resources and traditional knowledge, but have also proved beyond doubt that such 
misappropriation and granting of wrongful patents is possible because of the inadequacy of the 
TRIPS Agreement to address  these issues.  
79.  India has been a major victim of biopiracy . 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) da tabase , to prevent misappropriation of traditional 
knowledge at international patent offices , so that cases of biopiracy can be prevented. India has 
signed TKDL Access Agreements with nine International Patent Offices.  
80.  While national measures have been ta ken in order to prevent misappropriation of genetic 
resources 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 a submission TN/C/W/52  in June 2008 that was support ed by  109 Members. The 
latest submission on this issue TN/C/W/59  in April 2011, which is a draft decision to enhance 
mutual supportiveness between TRIPS Agreement and CBD , has been proposed by a vast majority 
of WTO Membership, including India. This proposal seeks amen dment of the TRIPS Agreement by 
inclusion of a new Article 29 bis for disclosure of origin of genetic resources or associated 
traditional knowledge. A mandatory disclosure requirement in patent applications to include 
disclosure of origin and evidence of p rior informed consent and access and benefit sharing, would, 
in addition to combating biopiracy, further strengthen the credibility of the patent system by 
facilitating assessment of the novelty and inventiveness criteria.  
81.  The Nagoya Protocol of the CBD en tered into force on 12  October  2014. So far , 89 countries, 
including India,  have ratified the Protocol. According to the CBD w ebsite, the Access and Benefit -
Sharing Clearing -House (ABS -CH), which is a platform for exchanging information on access and 
benef it-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, four countries (Guatemala, India, Mexico and South 
Africa) have published 38 internationally recogni zed certificate s of compliance with details of prior 
informed consent for access to genetic resources and benefit sharing on mutually agreed terms. 
Countries, organizations and stakeholders can now refer to the ABS Clearing -House to find IP/C/M/83/Add.1  
 
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  information on how  to access genetic resources or associated traditional knowledge in specific 
countries and on ABS more generally.  
82.  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 have been included. This 
demonstrates that ABS and the Nagoya Protocol are making an important contribution to the 
conservation of biodiversity and sustainable economic development for all. Furthermore, the 
second meeting of the Conference of the Parties serving as the meeting of the Parties to the 
Nagoya Protocol on Access and Benefit -Sharing will be held in Ca ncun, Mexico from 
4-17 December  2016.  
83.  We would like to reiterate that i t would be quite useful to the delegates of the TRIPS Council, 
if the CBD Secretariat is requested to brief the TRIPS Council at its first session next year on the 
latest developments in the implementation of the Nagoya Protocol, including the decisions that 
would be taken at the December Meeting at Cancun in Mexico. The briefing by the CBD Secretariat 
would be very important to understand the implications of the entry into force of the Nagoya 
Protocol for the TRIPS Agreement. We reiterate our demand for a formal briefing by the CBD 
Secretariat in the interest of the l arge majority of developing countries. We also support Ecuador' s 
proposal for updating the three factual briefs by the WTO S ecretariat.  
84.  I conclude by stating that the TRIPS -CBD issue is one of the outstanding implementation 
issues and positive outcomes regarding  outstanding implementation issues are one of the most 
important deliverables of the Doha Round for the developing countries.   
5.3 Egypt  
85.  Since there is no change in our position I don't wish to take up too mu ch of this meeting's 
time. I will simply refer to the statement that we made at our earlier meeting and I would like to 
have it appear on the record of this meeting. (See previous IP/C/M/ 82/Add .1 paras 92-94.) 
The protection of biological resources, tradit ional 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 negotiations on the relationship between the TRIPS 
Agreement and the Convention on Biologic al Diversity, which is a critical part of the 
Implementation -Related Issues and Concerns as contained in the Doha Work Programme. 
Therefore, we urge other Members to engage in this issue of prime importance to developing 
countries, as part of the conclusio n of the DDA.  
 
Technical discussions on this issue have been ongoing for almost a decade so far. We believe 
that the TRIPS Agreement should be amended in order to provide that Members shall 
require an applicant for a patent relating to biological materials  or associated traditional 
knowledge to disclose the source and country of origin of the biological resource and the 
associated traditional knowledge used in the invention. Furthermore, the applicant shall also 
provide evidence of prior informed consent an d evidence of fair and equitable benefit sharing 
under the relevant national regime.  
 
Egypt continues to encourage the engagement of the Director -General in his mandated 
consultative process on the relationship between the TRIPS Agreement and the Conventio n 
on Biological Diversity. We look forward to the outcome of this kind of con sultations, and we 
request all M embers to constructively engage therein, taking into consideration that this 
issue is one of high priority for developing and LDCs. 
 
5.4 Bolivia, P lurinational State of  
86.  With respect to these agenda items, we would like to refer to two questions. First  of all, as we 
have often said, the consideration of 27.3(b) of the TRIPS Agreement is  a matter for this Council, 
as provided under Article 19 of the Doha Declaration. This is a matter that should have us consider 
doing away with the patentability of lifeforms. There are ambiguities in the Article now which lead 
to difficulties as some coun tries allow for the patentability of isolated genetic resources. 
Furthermore, the patentability of lifeforms or parts thereof is a matter of great concern for many IP/C/M/83/Add.1  
 
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  world cultures and peoples. They consider that this is unacceptable as lifeforms should not be 
patentable.  
87.  Another issue to which we would like to refer has to do with the disclosure of origin which we 
consider to be of great importance as a way of avoiding the biopiracy of genetic resources . This is 
what we have  addressed  in the submission cont ained in TN /C/W/52 of 2008 and the draft Decision 
of 2011. Bolivia considers that the Buenos Aires Ministerial  Conference  could make a genuine 
contribution to this Organization's consideration of these issues. We therefore feel it would be 
useful to have i nformal discussions on this matter with a view to have it discussed at the 11th 
Ministerial  Conference . 
88.  We would also like to express our support for the updating of the factual notes in documents 
IP/C/W/368, IP/C/W/369/Rev.1 and IP/C/W/370/Rev.1 . We would  also be grateful for an informal 
briefing by the CBD Secretariat at this Council. These are initiatives that would help us move 
forward on these issues.  
5.5 Brazil  
89.  Brazil has a well -known position regarding the i mportance of promoting mutual support 
between TRIPS and the CBD as  detailed in document TN/C/W/59 and enhanced transparency in 
the utilization of genetic resources and associated traditional knowledge . The introduction in TRIPS 
of a mandatory requirement f or the disclosure of origin of these resources in patent applications is 
an important objective. A multilateral and mandatory disclosure would be the most effective way 
to address the misappropriation of genetic resources and traditional knowledge. This wo uld require 
patent applicants to disclose the country of origin of a biological resource and provide evidence of 
compliance with prior informed consent and benefit -sharing. It would also contribute to patent 
examinations by providing additional information  to patent offices. These, however, would not be 
overloaded with extra work since they would be just checking points in the new system.  
90.  As stated in document IP/C/W/59, "the disclosure requirement in Article 29 of the TRIPS 
Agreement is incomplete without  the disclosure of origin of genetic resources and/or associated 
traditional knowledge ". A mandatory disclosure requirement in patent applications will also 
contribute to enhance transparency about the utilization of associated traditional knowledge. This 
will not only ensure compliance with the CBD , but also accomplish one of the primary purposes of 
any intellectual property regime, namely, providing appropriate incentives and rewards to 
knowledge holders in acknowledgment of a benefit to society as a whol e. For these reasons, Brazil 
joins China, Colombia, Ecuador, India, Indonesia, Peru, Thailand, the ACP Group and the African 
Group in supporting the Amendment to the TRIPS Agreement with the introduction of a mandatory 
requirement for the disclosure of ori gin of genetic resources and traditional knowledge in patent 
applications.  
91.  Finally, we would also like to support the proposal from Ecuador to update the factual 
briefings of the discussions we have had over the years in this Council.  
5.6 China  
92.  It is well recognized that the relationship between the TRIPS and CBD has been an important 
outstanding issue at the TRIPS Council . China suggests that Members should work jointly and 
effectively to find a solution for this m atter.  
93.  Regarding the substantial issues, to ensure mutually support between the  TRIPS Agreement, 
the CBD and  its Nagoya Protocol, it is necessary to amend the TRIPS Agreement with the purpose 
of introducing a mandatory disclosure requirement of the origin  of genetic resources and 
traditional knowledge into patent applications, as co -held by the majority of Members and can be 
found in documents TN/C/W/52 and TN/C/W/59. The proposed solution can contribute to prevent 
the misappropriation of genetic resources  and traditional knowledge, to prevent  the grant of 
erroneous patents,  and to improve the transparency of the utilization of genetic resources. 
Considering the legitimate objective pursued by the system, China does not think it would be 
burdensome for the patent applicant to provide the information concerning prior informed consent 
and access and benefit sharing. The contractual arrangements or database solution proposed by 
some Members are still far from  providing sufficient  protection for genetic resource s. IP/C/M/83/Add.1  
 
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  94.  The ongoing discussions and developments in the negotiations at the WIPO Intergovernmental 
Committee (IGC) should not prevent Members from seeking solutions here in the WTO. In 
accordance with the mandate given by Ministers, wh o had instructed the Counc il to examine, inter 
alia, the relationship between the TRIPS  Agreement and the CBD, Members shall work effectively 
in order to resolve the matter. China would like to support inviting the CBD Secretariat to brief on 
the Nagoya Protocol at the TRIPS Counci l. Such a brief will improve Members' understanding o f the 
protection of genetic resources,  and also  facilitate cooperation between WTO and oth er 
international organizations. C hina also would like to request that the three factual notes 
(IP/C/W /369/ Rev.1, IP/C/W/ 368/Rev.1, IP/C/W/370 /Rev.1) be updated, so as to enable 
constructive debates among Members . 
5.7 Canada  
95.  In light of the discussion that took place during the informal mode, I think I will keep it brief 
by sa ying that on the so -called substantive matters, Canada's existing position remains 
unchanged. In terms of what we described as procedural issues, for the record, I want to reiterate 
that Canada does remain open to the holding of a briefing by the CBD Secre tariat in the TRIPS 
Council. That is whether during formal or informal mode, should there be sufficient interest from 
other Members and Canada is also open to the proposal for the Secretariat to update the 
compendium of documents on the relationship betwee n the TRIPS and the CBD. This is of course 
without prejudice to our national position on the substantive matters which remain unchanged at 
this time.  
5.8 Colombia  
96.  With reference to items 3, 4 and 5 on our agenda , Colombia, a biodiverse nation, would 
support measures to cover the  disclosure of  origin of genetic material and traditional knowledge. 
This would support  the sustainable use of biodiversity and the cultural diversity of our people.  
97.  This is a matter that could only be dealt with through the agreement to international rules and 
standards that would be in keeping with the principles in CBD. The only way to have an intellectual 
property system that is truly inclusive is to ensure that we agree to solutions th at suit all 
Member s. We must therefore ensure that we cover issues of particular importance to developing 
countries and LDCs.  
98.  Furthermore, I would like to stress that  while this is a matter that is discussed in other fora, 
such as  in WIPO and its relevant bodies, we must recognize that we are dealing with two different 
sorts of fora here . We must acknowledge  that each organization has a very different mandate 
which leads to differences in position.  
99.  We must ensure that we bear this in mind and recall why it  is that we find ourselves 
discussing intellectual property issues in this Council . Otherwise, we could simply say that all of 
this comes under WIPO's remit. These are not issues that we can avoid. We must recognize the 
importance of agenda items 3, 4 and 5 when it comes to international trade and we do need to 
recognize the need for laws that protect biodiversity that are applicable to all.  
5.9 Switzerland  
100.  Under the review of Article 27.3(b), Switzerland advoc ates that inventions in the field of 
biotechnology deserve patent protection. We believe that this is a field of technology which holds 
many promises for mankind. Accordingly, it needs also the incentive of patent protection in order 
to attract sufficient investments.  
101.  As a corollary of our position, we listened to the concerns by other Members here in  the 
TRIPS Council as far as the risk of misappropriation of genetic resources or traditional knowledge 
is concerned if biotechnological inventions are patent ed. Let me be clear, according to Switzerland, 
the TRIPS Agreement and the CBD are mutually supportive. Having said that, Switzerland is also 
of the view that a non -burdensome disclosure requirement in the TRIPS Agreement will enhance 
transparenc y of genet ic resources and traditional knowledge and inventions and corresponding 
patent applications. Such transparency is relevant to help access beneficiary systems put in place 
by Members at the national level to work effectively and more efficiently. Such trans parency is IP/C/M/83/Add.1  
 
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  ultimately also supportive again of the TRIPS Agreement  and the patentability of biotechnological 
inventions.  
102.  You asked in the informal part of our discussion on the three agenda items how to resolve 
this issue. In fact, a large group of Member s have proposed a way forward on how to solve this 
issue in TN/C/W/52 in 2008 in their submission of modalities proposals. These proposals span 
disclosure of source and geographical indications which are the two outstanding issues and that 
have in fact bee n discussed in the WTO for the last 15 years. Clearly, these issues are of great 
interest to  the overwhelming majority of WTO Members  and therefore remain on the agenda for 
future discussions.  
103.  As far as now our work in the TRIPS Council is concerned, we be lieve that your creative 
effort of bringing new elements into our discussion, in particular  your proposal of partitioning our 
discussion in a formal and informal discussion, should allow us to have an informal briefing by the 
CBD Secretariat to this Counci l. We also believe that the factual notes of the Secretariat certainly 
can be supportive of our discussion and therefore we also support an update of these factual 
notes. Clearly, we would not want to have the Secretariat do unnecessary work. I believe the  
update should really include only novel elements that have been brought forward in this Council, 
but that certainly would help us as a basis for future work.  
5.10 Bangladesh  
104.  As per existing domestic laws on pa tents and also on moral and ethical grounds, we do not 
support patenting  of lifeforms. We would like to further clarify our position as expressed in  our 
previous statement in the last Council. We consider that the resources of the nature like plants and 
animals should not be appropriated by any individual or corporate body. However, if these gifts of 
nature are exploited for commercial benefit then this benefit must be shared with the concerned 
population. A simple declaration that we will enter into a bene fit-sharing agreement with God will 
not be sufficient here.  
105.  We believe that the genetic resources and associated traditional knowledge are integral parts 
of the rights of the States of the indigenous peoples. Just like protection of any other sovereign 
interest, genetic resources, traditional knowledge and folklore of any population must be 
safeguarded from any form of misappropriation which denies the very benefit to its own rightful 
owners and holders. The most effective way to ensure misappropriation is  the implementation of a 
disclos ure requirement with the introduction of prior informed consent on mutually acceptable 
terms.  
106.  The relationship between TRIPS  and the  CBD has been a critical implementation issue for all 
of us. This is important for the devel oping countries and especially for LDCs to ensure health, food 
security and livelihood of the local communities. The benefit s accrued from these resources are 
vital, especially for LDCs to achieve the Sustainable Development Goals. 
107.  Both the TRIPS Agreement  and the CBD with the Nagoya Protocol uphold the promotion of 
innovation for the development and the people and for the socio -economic environment 
irrespective of the levels of development . We consider that these two instruments are 
complementary to each o ther. 
108.  The CBD had particularly provided for the establishment of legitimate rights of genetic 
resources . It is only normal that patent applicants disclose their source of invention if they access 
and use a particular genetic resource of which they are not the rightful owner. The disclos ure 
requirement  is also consistent with the transparency principle that we are trying to strengthen in 
the multilateral trading system and will help reduce the number of application of patents and 
biopiracy.  
109.  We hope that the mandate provided for in paragraph 19 of the Doha Declaration and 
reinforced in subsequent Ministerial Declarations will be implemented in an early and constructive 
manner. In this connection, briefings from the CBD Secretariat would benefit all the Members hip of 
WTO and we thank those developed country Members who supported this idea at this Council 
today.  IP/C/M/83/Add.1  
 
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  5.11 Peru  
110.  The delegations of Bolivia, Colombia, Bangladesh and others who have already spoken have 
said that dev eloping countries feel very strongly about the need to disclose  the origins of genetic 
material. This is in the interest of development and protection of resources. This is a question that 
requires a multilateral solution. That is why we have a process tha t is parallel to that in WIPO 
where  we have had meetings, one on genetic resources, for instance, and there is going to be 
another meeting on 28 November dealing once again with these resources.  
111.  We really hope that we are going to be in a position in the c ourse of future meetings to deal 
with matters pending, particularly from a technical point of view. It is increasingly clear that these 
matters pending have to do with WIPO texts that have been under negotiation for some time now . 
They are of a political n ature and this is a matter that could be resolved in a diplomatic 
conference. We would stress that we have been working on these matters that are still pending 
and we do think that this is a matter that will be dealt with soon in WIPO.  
112.  I would finally like  to take the opportunity to express support for the proposals made by 
Ecuador and India, particularly with respect to the suggestion that the Secretariat invite the CBD 
Secretariat to an informal meeting here with us in order to brief us. We would certainl y be in 
favour with our holding of ongoing consultations on this matter in the hope of finding a solution 
under your Chairmanship.  
5.12 Indonesia  
113.  Indonesia's position has not changed. Our delegation views the is sue of the relationship 
between the TRIPS Agreement and the CBD as well as the protection of traditional knowledge and 
folklore under these agenda items of great importance. It is essential that bold steps be taken by 
all Members to address the matter in a  concrete and fruitful manner for substantive progress to be 
made within the WTO. Indonesia emphasized the need for coherence and consistency of the TRIPS 
Agreement and the CBD. Implementation of the two international instruments needs to be 
mutually suppo rtive  of their respective objectives . 
114.  To this end, our delegation believes that we should focus on the objectives, definitions and 
principles of the CBD and also the Nagoya Protocol , in particular, the provisions of prior informed 
consent for access and f air and equitable benefit -sharing. This set the foundation for the protection 
of genetic resources and associated TK. However, Article 27.3(b) of the TRIPS Agreement does not 
oblige Members to take necessary measures for fair and equitable sharing of benef its as required 
by the CBD and the Nagoya Protocol. Such inconsistency allows room for misappropriation and 
misuse which would defeat the purpose of the CBD and the Nagoya Protocol. Most WTO Members 
are also members of the CBD and many of us are also membe rs of the Nagoya Protocol. We should 
harmonize the TRIPS with the CBD and the Nagoya Protocol as a coherent and unified international 
legal system.  
115.  Given the fact that the protection of genetic resources, traditional knowledge and folklore is 
very crucial for developing countries, such as Indonesia, we would like to reiterate the urgency of 
enhancing the discipline of  a mandatory disclosure requirement. We view that a legal obligation to 
establish a mandatory disclosure requirement in patent applications is  important to prevent 
misappropriation of genetic resources. Such a requirement will also ensure transparency and 
efficacy of the patent system. Our delegation views that a mandatory disclosure requirement can 
provide a greater legal certainty for the IP s ystem itself.  
116.  Our goal can only be achieved through sincere cooperation and partnership among all 
stakeholders. Hence, Indonesia invites other Members to strengthen their commitment and 
stimulate further dialogue to accomplish the desired results. The req uest of some Members to 
invite the CBD Secretariat to brief this house should be supported.  
5.13 Norway   
117.  For the record, let me just state that for the substantive matters, Norway supports the 
amendment of the TRIP S Agreement to introduce a mandatory obligation to disclose the origin of IP/C/M/83/Add.1  
 
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  genetic resources and traditional knowledge in patent applications. To this effect, we had 
submitted a proposal in 2006 in document IP/C/W/473 which should still be on the table.  
118.  On the procedural matters, Norway would also be open to having a briefing from the CBD 
Secretariat here at the TRIPS Council and the updating of the factual notes.  
5.14 Australia  
119.  Following the renewal of the manda te of the World Intellectual Property Organization's 
Intergovernmental Committee on Intellectual Property, Genetic Resources, Traditional Knowledge 
and Folklore as agreed by WIPO Members last October, WIPO is best placed to consider the 
complex intellectua l property issues relating to genetic resources and associated traditional 
knowledge.  
120.  As we have said at previous TRIPS Council sessions, Australia considers the TRIPS 
Agreement and the CBD as consistent. Australia fully implements our obligation under bot h 
Agreements which we view as mutually supportive.  
121.  In relation to the procedural i tems, Australia is open to the proposal that the Secretariat be 
requested to update the three factual notes  
5.15 Japan  
122.  With regard to agenda items 3, 4 and 5, the delegation of Japan would like to reiterate our 
position that it is necessary to seek appropriate ways to deal with the misappropriation of genetic 
resources. This means that we  should bear in mind that any measures taken sh ould not adversely 
affect the existing intellectual property system or hinder the creation of innovations utilizing 
genetic resources and associated traditional knowledge.  
123.  This delegation is firmly convinced that the disclosure requirement would discourage  
industries from conducting research and development activities on biological materials overseas. 
This is the very consequence of the disclosure requirement that we have been concerned about. 
Therefore, this delegation  believe s that the disclosure requirem ent is not an adequate means for 
dealing with such misappropriation and should not be included in the intellectual property system.  
124.  Concerning these issues, this delegation believes the WIPO IGC is the most appropriate 
forum for holding technical discussio ns on IP aspects. The 32nd Session of  the IGC is scheduled 
later this month. Japan remains willing to contribute to discussions on these issues in a 
constructive manner . 
5.16 Korea, Republic of  
125.  The dele gation of Korea maintains the same positions on these agenda items which we have 
reiterated many times at previous meetings of this Council.  
126.  Our delegation would also like to concur with the position expressed by the previous 
speakers that the WIPO is the appropriate forum to deal with these issues . 
5.17 Guatemala  
127.  For my delegation, biodiversity and traditional knowledge are of utmost importance because 
we have a large wealth of these kinds of resources . Despite the fact that this is being discussed in 
other fora, it is extremely relevant and it should be debated in this Council regarding the relation 
between TRIPS and the CBD. Therefore, we could explore mechanisms to ensure that we have 
greater protection of fol klore and traditional knowledge. We agree with previous delegations and 
would like to invite the Secretariat of the CBD to debrief us on the development of these issues so 
that these discussions can allow us to move forward in our debates.  IP/C/M/83/Add.1  
 
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  5.18 United Sta tes 
128.  Regarding genetic resources, traditional knowledge and folklore, we join Australia, Japan and 
Korea in their belief that WIPO serves as the best forum to address these issues. The WIPO -IGC 
continues to ad dress these issues using evidence -based approaches and examples of national 
experiences.  
129.  We take note of the interventions of a few delegations this morning that provided their own 
factual updates regarding work in both WIPO and the Convention on Biologica l Diversity. With 
respect to the various requests made today, the United States is not in a position to support those 
requests, but remains open to discussions including bilaterally with delegations in between and at 
the margins of the TRIPS Council.  
130.  In that spirit, we welcome Ecuador's interest in bilateral consultations which we are eager to 
engage in constructively.  
AGENDA ITEM 6: REVIEW UNDER PARAGRA PH 8 OF THE DECISION  ON THE 
IMPLEMENTATION OF PA RAGRAPH 6 OF THE DOH A DECLARATION ON THE  TRIPS 
AGREEMENT  AND PUBLIC HEALTH  
6.1 WTO Secretariat   
131.  We have observed a steady rise in the rate of acceptances of the Protocol Amending the 
TRIPS Agreement in the course of this year. As you have noted, Mr Chair, to date alrea dy 
15 Members have accepted the Protocol in this year alone. It is worth observing that if it were not 
for the very welcome fact of new Members acceding to the WTO in this period, the Protocol would 
have already entered into force some time ago earlier thi s year.  
132.  We are providing technical assistance on request to Members who are in the process of 
accepting the Protocol – and a number of Members have told us that they are at the final stages of 
their domestic processes. We are at the disposal of any delegat ion or Member who would need 
practical support in the acceptance process. As a very general observation, it often takes Members 
by surprise how straightforward and simple the process is. It is not a difficult procedure and we 
have the necessary model instr uments of acceptance to facilitate the process.  
133.  The other aspect of the report concerns technical assistance for implementation. Document 
IP/C/W/618 is the regular annual report of the Secretariat's technical assistance activities in the 
area of TRIPS in general. We will be introducing that report briefly under that separate item later 
in this meeting. However, as for previous annual reviews of the Paragraph 6 System, because this 
has been a matter of particular focus and particular attention for technical  assistance, we give a 
more focused update under this agenda item.  
134.  In general, TRIPS flexibilities with specific reference to public health have long formed a 
consistent element of our technical assistance activities. A strong impetus in this direction wa s 
given by the Doha Declaration on the TRIPS Agreement and Public Health; this flows through to 
the practical level of technical assistance in the TRIPS area.  
135.  This element of TRIPS implementation is also extensively covered in the Trilateral Study 
publishe d jointly by WHO, WIPO and the WTO in 2013, which includes specific material on 
flexibilities for health and in particular the System of compulsory licences for export of medicines 
(also known as the "Paragraph 6 " System).  
136.  This mechanism has also been a fo cus of an annual series of Workshops dealing with TRIPS 
and Public Health since 2005. These Workshops were conceived as cross -cutting programmes 
directed at a blend of health, trade and IP officials. As this series evolved over the years, it 
maintained cov erage of the key issues concerning medicines, innovation and access to medicines 
from a TRIPS perspective, especially the use of TRIPS flexibilities. In addition, because of the 
demand received from Members, it provided an increasing focus on public health  policy within a 
wider range of disciplines, including the human rights dimension.  IP/C/M/83/Add.1  
 
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  137.  Specifically looking at the use of TRIPS flexibilities and the implementation of the 
Paragraph  6 System of compulsory licensing for export, these capacity -building Workshop s have 
evolved in line with progress in the domestic implementation of the System in many Members. In 
recent years, many more Members have introduced export provisions into their laws to facilitate 
the System as a tool for export. Accordingly, more recentl y, the Workshops have turned from 
looking at legislative implementation towards a more detailed look at how to make effective use of 
this additional procurement tool in practice so that affordable medicines do reach patients.  
138.  The most recent session of th ese series of Workshops, the WTO Workshop on Trade and 
Public Health, was held here in Geneva in October. The Workshop included updated capacity -
building material on making effective use of special compulsory licences for export as a 
procurement tool for m edicines. This material was tailored exactly for the mix of public health, 
trade and intellectual property officials that took part in the Workshop. The feedback and practical 
guidance provided by those officials will, as ever, guide us in updating and imp roving our technical 
assistance activities and programmes to enhance its practical relevance.  
139.  Some of the general points that we have made in the Workshop are touched upon in an 
annex to the Secretariat report ( IP/C/W/618 ). This notes as an important rece nt development that 
the significant increase in pharmaceutical exporting countries that are putting in place the 
necessary legislation to use the System for export. This has gone literally from one Member, at the 
time of the first use of the System, to ove r 52 today. By informal estimates, the System now 
covers about 80% of current global medicines export capacity. It also mentions that the practical 
context of the System is such that it applies when the best option for access to a medicine is 
production es pecially for export under a compulsory licence in a foreign country. It need not apply 
for instance when lower cost medicines are available by other means through regular generic 
production, voluntary licensing , or when some of the production under regular  compulsory licences 
could be exported. For example, if a compulsory licence is applied to serve a relatively large home 
market this production could, in principle, also be used to serve also a smaller export market.  
140.  A key element in the use of the System  concerns notifying expected demands for medicines. 
It was noted that this could be done early in the procurement process, so as to open up a wider 
range of potential suppliers and potentially enable the pooling of demand by different Members 
with similar needs. Notification under the System could also be used at this early stage to identify 
all possible sources of supply so as to ensure the most competitive and sustainable range of 
options for access to medicines.  
141.  The important point of economies of scale  has been considered and discussed. The need for 
economies of scale was foreseen in the design of the System and would clearly be a factor when 
the needs of relatively small populations are concerned. On that note, it was observed that the 
System makes it clear that an export compulsory licence can serve the needs of multiple Members. 
When countries do share the same needs and the same constraints, for example, in the same 
region, this could be an opportunity to pool demand so as to use the System more effe ctively. This 
would be especially effective if their regulatory requirements were similar or compatible, for 
example, through the WHO prequalification programme.  
142.  Discussion has also covered how the System could be used as part of efforts to build local 
production capacity, especially when this would enable one country 's production to serve several 
countries in the same region, enabling economies of scale and thus lower cost, and to support 
more sustainable production of medicines.  
143.  The Workshop on Trade an d Public Health also considered the human rights dimension of 
access to medicines with a participation of a range of international organizations, including the 
Office of the United Nations High Commissioner for Human Rights. The Secretariat of the UN 
Secre tary General's High -Level Panel on Access to Medicines presented the Panel Report which will 
be the subject of a separate agenda item in this session of the Council. We would like to record our 
warm gratitude to our colleagues from across the multilateral system for their invaluable 
contributions to this essential capacity -building dialogue.  
144.  Participating experts in the procurement field and other related fields explored a range of 
practical questions in the course of the Workshop discussion on the use of the System. They 
mentioned the need for awareness -raising of the practical possibilities of use of this mechanism IP/C/M/83/Add.1  
 
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  within domestic agencies and other programmes responsible for medicines procurement. More 
generally, they also looked at the practicalities of  situating the System as an integral part of 
procedures for access to medicines, including procurement processes and other processes such as 
needs identification, procurement policies and the regulation of medicines for safety and efficacy. 
Other points ra ised by the experts included the possible choices for effective implementation of the 
System at the domestic and regional levels and, in particular, how to make the System more 
streamlined in its practical use in those countries that are most likely to be producers and 
exporters under the System. Further points discussed concerned the information needs of potential 
importing countries about potential sources of supply and how to facilitate the forecasting of 
expected needs which in turn would enable early n otification under the System and more capacity 
to aggregate demand of similar needs.  
145.  A final point that has come up in a range of our activities concerning this matter is a 
question of economic viability, or commercial sustainability, given the significanc e recognized in 
the System of boosting economies of scale, how to use the System for greater predictability for 
potential suppliers, and the pooling and aggregation of demand so as to ensure that its use is 
commercially sustainable for producers seeking to  export under this System.  
146.  We look forward to continuing cooperation with multilateral partners on our capacity building 
work in this area and again warmly thank our colleagues for their invaluable contributions to this 
work.  
6.2 India   
147.  India attaches high importance to the Doha Declaration on Public Health, the Paragraph 6 
System as established under the 2003 waiver decision and the 2005 Protocol Amending the 
TRIPS  Agreement. India had notified its acceptance of the Protoco l in March 2007. We would like 
to congratulate Papua New Guinea, Peru and Belize who have deposited their instruments of 
acceptance of the Protocol since the last TRIPS Council meeting held in June 2016. So far, over 
64% of WTO Members have submitted their  instruments of acceptance for the TRIPS Protocol and 
five more Members have to submit their instruments of acceptance for entry into force of the 
2005 Protocol Amending the TRIPS Agreement.  
148.  We have always been of the view that the Doha Declaration on TRI PS and Public Health 
constituted a major landmark in the short history of the WTO because it recognized the primacy of 
public health needs and the preparedness of the Organization to take up the problems faced by the 
poor in developing countries. Along wit h several other Members, India had worked relentlessly on 
the Doha Declaration and the Decision. The Decision established a framework for special 
compulsory licences, which is an additional flexibility aimed at enabling exports of medicines to 
WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector. 
However, the export of HIV/AIDS medicines by the Canadian pharmaceutical company Apotex to 
Rwanda in September 2008 has been the first and only use of the System so far.  
149.  The sid e event which was held today to discuss the challenges and problems associated with 
this Paragraph 6 Mechanism and the comments by experts has broadened our understanding on 
aspects related to the Paragraph 6 System, especially as regards its implementatio n so far, the 
challenges and opportunities involved, as well as the ways of improving the System to make it 
effective and meaningful.  
150.  Ms. Yuanqiong Hu from Medicines Sans Frontiers said that her organization had requested 
the HIV/AIDS medicines from Canad a to supply Rwanda, but it had taken three years for the 
whole process to deliver because there were delays associated with regulatory approval, as well as 
discussions with patent holders which took a lot of time. At the same time, the HIV/AIDS 
medicines w ere available and supplied by Indian generic companies before Rwanda accorded 
supplies from the Canadian company Apotex.  
151.  The representative from Canada who spoke at the side event confirmed that the regulatory 
approval had taken close to six months, as co mpared to one year under the normal procedure, to 
ensure the quality, safety and efficacy of the drugs. The company had made losses and had 
supplied the tablets at a very cheap rate. He was also informed by some companies that they 
would never venture into  providing medicines under this special compulsory licensing scheme.  IP/C/M/83/Add.1  
 
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  152.  Mr. Denis Broun, the representative of CIPLA, shared the experiences of a generic producer 
to manufacture under the System. There was no way to achieve economies of scale because of the 
limited quantities of medicines to be procured by the importing countries. He also noted 
requirements like special labelling and markings and the need for the generic company to host a 
special website and to pay remuneration to the patent holder. According  to him, there was so 
much red tape built into the System that it was difficult for the Paragraph 6 Mechanism to achieve 
its intended purpose. Unless the procedures were simplified, his company would never use the 
System.  
153.  Ms. Suerie Moon, Director of Rese arch, Global Health Centre, Graduate Institute of 
International and Development Studies opined that this was not a good System. It should be 
renegotiated before it entered into force as it was not workable. She also said that patenting in 
exporting countri es like India was on the rise. In her view, the Paragraph 6 System needed to be 
made more workable for it to be used by countries.  
154.  Based on the experts opinion at the side event held today, we reiterate our concern that the 
Paragraph 6 System is too comple x, cumbersome and administratively unwieldy for further use. I 
conclude by quoting the recommendation on the special compulsory license mechanism by the 
UN Secretary General's High -Level Panel on Access to Medicines in its report released in 
September. The  recommendation was also endorsed by many experts at the side event. 
Recognizing the Paragraph 6 System as complex and cumbersome, the UNSG High -Level Panel on 
Access to Medicines has recommended that "WTO Members should revise the Paragraph 6 Decision 
in order to find a solution that enables a swift and expedient export of pharmaceutical products 
produced under compulsory licence. WTO Members should, as necessary, adopt a waiver and 
permanent revision of the TRIPS Agreement to enable this reform. " 
6.3 Brazil  
155.  The Paragraph 6 System represents the recognition of the importance of international 
solutions for public health emergencies. In the Doha Declaration, Members of the WTO recognize 
that countries with insufficient or no  manufacturing capacities in the pharmaceutical sector could 
face difficulties in making effective use of compulsory licences under the TRIPS Agreement. The 
System that implements the Decision has only been used once in 13 years. According to the 
Report of the UN Secretary General's High -Level Panel on Access to Medicines, "some note that 
multilateral health financing has removed the need for resource constraint countries to use it. 
Others argue that it is too complex to be used. The only time the mechanism was used it proved to 
be complex and cumbersome and serious questions remain as to its effectiveness. More than 
ten years after WTO Members agreed to transform the temporary waiver into an amendment of 
the TRIPS Agreement, the amendment is yet to be accept ed by two -thirds of the WTO Members. 
At a time of increased political commitments to enhance local pharmaceutical production in 
developing countries, attention should be paid to incorporating an efficient easy -to-use compulsory 
licensing provision into dom estic legislation ".  
156.  We would like to highlight the importance of this periodic review of the implementation of 
the Paragraph 6 Mechanism which will become even more necessary after the entry into force of 
the TRIPS Amendment. We were glad to be co -sponsor s of the South Centre initiative to host a 
side event to the TRIPS Council on the subject. We had the opportunity to hear from 
representatives from industry, government, non -governmental organizations and academia their 
assessment of the System. We will co ntinue to contribute constructively to discussions on the 
improvement of the System.  
6.4 Canada   
157.  Providing access to medicines to populations in need is one of the key priorities of our 
Government. Canada is a global leader  in supporting partnerships such as the Global Fund to Fight 
AIDS, Tuberculosis and Malaria, the Global Drug Facility, and Gavi, the Vaccine Alliance, which 
strengthen health systems and provide targeted programming to increase access to medicines and 
vaccines.  
158.  Canada hosted the Fifth Replenishment Conference of the Global Fund to Fight AIDS, 
Tuberculosis and Malaria in Montreal on 16 -17 September 2016. Canada pledged $804 million, for IP/C/M/83/Add.1  
 
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  2017 to 2019, to the Global Fund, an increase of 23% over its previous commitment of 
$650 million for 2014 -2016. Canada is the 6 th largest donor to Gavi, the Vaccine Alliance, having 
pledged $520 million for the 2016 -2020 period bringing Canada's contribution to over $1 billion 
since 2002.  
159.  In addition, Canada has introduced t ax incentives for donations of medicines to developing 
countries. The Government of Canada's Donations of Medicine Eligibility Program ensures that only 
Canadian charities with sufficient expertise can participate in this scheme.  
160.  Canada's Access to Medicin es Regime (CAMR), which implements Paragraph 6 of the Doha 
Declaration on the TRIPS Agreement and Public Health, is another measure Canada uses to 
promote access to medicines. Canada continues to believe that CAMR is a useful and effective tool 
to enhance access to medicines in the specific circumstances the System was designed to address. 
Last year, Canada amended the list of medications covered by CAMR to add three new 
antiretroviral drugs. Canada notified this amendment to the TRIPS Council in June 2016.  
161.  I mention all of these programmes to illustrate that the Government of Canada takes a 
holistic approach to promoting access to medicines. Our view is that only by addressing all of the 
factors affecting access to medicines can we end the tragedy of people  suffering from treatable 
illnesses.  
162.  To this end, Canada is open to having a discussion of how best to promote access to 
medicines that considers all relevant factors. We would caution against treating certain factors, 
such as IP rights, in isolation, as d oing so would risk overlooking effective tools to promote access. 
Canada looks forward learning more about the views of other Members on this issue, including 
with respect to Member experiences, challenges, and other considerations.  
163.  We consider it essentia l that the Protocol Amending the TRJPS Agreement be brought into 
force as soon as possible. We are only a handful of countries away from that goal and Canada 
urges all Members who have not already done so to accept the Protocol without delay.  
6.5 Banglades h  
164.  We thank the WTO Membership for this historic decision; they deserve every accolade for 
this. The intention to help developing countries which lack the necessary capacity to produce 
medicines is both honest and genui ne. We thank Members who have recently accepted the 
amendment and hope that the remaining five ratifications that are needed for the entry into force 
of this amendment of the TRIPS Agreement will soon be deposited.  
165.  During the side event today, we have lear nt about different limitations which hinder the 
widespread  use of the System. After the entry into force, we may find suitable ways to overcome 
the administrative and supply side constraints so that this wonderful mechanism is utilized and not 
wasted. This  would pave the way for future necessary amendments of the TRIPS Agreement that 
our Members advocate for other important issues.  
6.6 South Africa  
166.  The Doha Declaration stresses that TRIPS can and should be interpreted  and implemented to 
support the right to health and promote access to medicines for all. The Sustainable Development 
Goal target of achieving universal health coverage by 2030, requires strong government and 
international leadership to effectively implemen t access to essential medicines.  
167.  South Africa notes that the number of notifications required for the entry into force of the 
Protocol Amending the TRIPS Agreement is now fewer than ever. We would encourage all Members 
who have not yet done so to deposit t heir notifications in order for the Protocol to enter into force. 
This will mark a significant landmark toward the realization of access to essential medicines.  
168.  As the sources of generic drugs are substantially depleted over time, the most effective 
metho d by which a country with insufficient or no manufacturing capacity may obtain certain 
medicines at competitive prices is through the use of the Paragraph 6 System. In addition, the 
Paragraph 6 System may prove to be increasingly important for HIV/AIDS pat ients who need to IP/C/M/83/Add.1  
 
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  shift to second -line or third -line treatments. Studies indicate that at least 22% of people on 
treatment would have to switch over to second -line treatment within a five -year period. 
Second - and third -line treatments are substantially mor e expensive, costing up to four to eleven 
times as much as first -line treatments. For these treatments and other widely patent protected 
treatments, the Paragraph 6 System may prove to be an important mechanism for obtaining a 
bulk of the medicine at a com petitive price.  
169.  Having said this, it is indeed not the end of the story since the Paragraph 6 System has been 
reviewed since 2004. During this time a rich debate has emerged between Members regarding 
their experiences of the use of the System. This review  mechanism continues to provide Members 
with an opportunity to exchange their views and to devise ways to make the System more 
effective. As already  mentioned by India and Brazil, the side event hosted this afternoon (of which 
South Africa is a co -sponsor) , clearly outlined many criticisms associated with the Paragraph 6 
System including the length of time it takes to use it. Procedural and other substantive 
complexities make it difficult to effectively use the System, while many developing countries face 
severe political pressures when they consider using it. Raising these criticisms is not an attempt to 
undermine the System, but is indeed an attempt to fully understand the challenges that countries 
face when they want to use it.  
170.  The review should not be a n opportunity for delegations to repeat longstanding arguments. 
Our focus should be to ensure that the System does not remain a flexibility that is consigned to a 
piece of paper, but to move forward to a substantive review of the System and its functioning , 
including through the more systematic collection and sharing of information. The world has 
changed since the System was first introduced. Many more factors now influence its operation, 
including the introduction of many so -called access initiatives that are likely to limit the need to 
use the System; the steady increase in the number of voluntary licences that can make its use 
redundant; while developments under RTAs may further erode the actual use of the System.  
171.  In concluding, we further note that the Report of the United Nations Secretary -General's 
High-Level Panel on Access to Medicines, recommends that WTO Members should revise the 
Paragraph 6 decision in order to find a solution that enables a swift and expedient export of 
pharmaceutical products pr oduced under special compulsory license. South Africa looks forward to 
hear other Members'  views in this respect and remains available for any further discussion on the 
points raised in the High -Level Panel Report.  
6.7 European Union  
172.  The European Union believes that the entry into force of the Protocol will be an important 
signal that will ensure a legally secure, predictable, effective and sustainable solution for those 
countries wishing to use the TRIPS flexibilit ies to get affordable medicines.  
173.  Therefore, the European Commission will continue to encourage and work with the remaining 
WTO Members so that they accept this Protocol and allow the amendment of the TRIPS Agreement 
to enter into force as soon as possible .  
174.  We have much appreciated a series of side events regarding this issue, including the one we 
assisted today. We are pleased to note that, as we pointed out a number of times, these events 
are extremely useful to have discussions about the issues that are  addressed more formally here 
in the TRIPS Council. They are very valuable and allow good debates with people from the outside, 
with other stakeholders, and to hear different opinions.  
175.  We certainly appreciate clarifications that were presented today accord ing to which the 
Paragraph 6 System is very much a last resort option which is most useful at the end of a long list 
of alternatives. Alternatives like the ones that were mentioned by my colleague of South Africa a 
few minutes ago, but also negotiating alt ernatives.  
176.  That takes us to another event that we consider extremely valuable for the debate, i.e. the 
Workshop that was organized by the Secretariat. We participated with pleasure and a lot of 
interest. The part of the Workshop that I assisted was very v aluable. We saw presentations of 
issues that have not been raised today and that are rarely raised in this venue, including how 
countries use the Paragraph 6 System as a negotiating mechanism. This takes us back to the fact IP/C/M/83/Add.1  
 
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  that it is a last resort mechani sm. We heard experiences of officials saying how in the discussion 
process with a right holder the possible use of this mechanism was there as an additional strong 
negotiating tool and how in most cases, and increasingly so in recent years, this had led to  a good 
agreement with the right holder without necessarily triggering the formal steps of the mechanism.  
177.  This being said, in Europe we have put in place legislation for this already in 2007. It has 
never been used so it is very difficult to assess. I see  with some surprise how people are so certain 
that the System does not work based on only one case of use. In Europe, as far as we are aware 
because compulsory licences are managed at Member State level, there was never any attempt to 
use this System. We t herefore  wonder how people can state that it is burdensome and impossible 
to use. This debate is maybe a little bit more complex than it is sometimes presented and certainly 
proposals to review the Paragraph 6 System are way too premature at this stage.  
6.8 Australia  
178.  Australia supports the TRIPS Protocol's entry into force as soon as possible. This will benefit 
Members by providing a permanent legal basis for countries to import medicines to address their 
public health n eeds if they have limited capacity to produce those medicines. The Protocol's entry 
into force will reinforce the WTO's ability to deliver practical development -oriented outcomes.  
179.  Australia commends Members from every region and at every stage of developme nt that 
have already accepted  it. We welcome the recent acceptances of the Protocol since the previous 
TRIPS  Council meeting by Papua New Guinea, Belize and Peru.  
6.9 Japan  
180.  The delegation of Japan would like to reiterate t he importance of access to medicine, which 
needs to be discussed in a broader context, taking into account not only the Paragraph 6 System 
but also various other relevant measures and factors such as procurement and tariffs.  
181.  Japan supports the Paragraph 6 System as established under the 2003 waiver decision and 
the 2005 Protocol Amending the TRIPS Agreement. The very objective of the System is to support 
WTO Members in obtaining greater access to medicines, specifically Members that have either 
insufficient  or no pharmaceutical manufacturing capacity. Compulsory licenses, whether granted 
under the Paragraph 6 System or otherwise, are just one of the potential policy tools that can be 
utilized for this objective. Therefore, the Paragraph 6 System should not b e considered as the only 
solution, but rather as just an option we could consider.  
182.  Lastly, we need to understand and analyse the specific concerns of potential importing 
Members who  would or who might use the Paragraph 6 System. Japan hopes that these Memb ers 
will share their concerns and experiences with us. Japan believes that it would be beneficial for this 
Council to hear specific comments by potential importing Members.  
6.10 Chinese Taipei   
183.  My delegation thanks the WTO Secretariat for the excellent work done on the draft report on 
this subject.  
184.  My delegation strongly supports the System provided for under Paragraph 6 as it was 
established by the 2003 Waiver Decision and the 2005 Protocol. We would like to congrat ulate 
Peru, the Republic of Tajikistan and other Members who formally accepted the amendment this 
year. We would also like to say how much we welcome the Secretariat's efforts aimed at ensuring 
that instruments of acceptance of the amendment are deposited.  
185.  Finally, we wish to take the opportunity to highlight the positive efforts made by the 
Secretariat in this respect. We would draw delegates' attention to the WTO webpage which is 
devoted to the TRIPS Agreement where Members can find a link to a guide on n otifications under 
the System laid down in Paragraph 6. We certainly found that guide very useful.  
186.  We would like to stress how important it is that we ensure that the TRIPS Agreement fits into 
the broader  framework which exists nationally and internationa lly and which is aimed at dealing IP/C/M/83/Add.1  
 
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  with public health problems. We should also underline the fact that the Agreement does not stop 
Members from taking measures which are aimed at protecting public health and in particular 
taking measures which would promote  access to medicines for everyone.  
6.11 Switzerland  
187.  I would like to add the thanks from my delegation to my neighbour who has just intervened 
and to the Director -General and to yourself and the WTO Secretariat for all  your efforts to secure 
the necessary number of acceptances of the Protocol during this year. We certainly commend 
those 15 WTO Members who have completed their acceptance procedure so far this year.  
188.  We also thank the WTO Secretariat for holding its 12th W orkshop on Trade and Public 
Health, as noted in its annual report in document IP/C/W/618, as a capacity -building Workshop to 
raise awareness about the System and to help Members make effective use of it.  
189.  Switzerland was among the first WTO Members to put in place the necessary legislation to 
enable the System at the national level and use of the mechanism for export. According to 
information available from the WTO Secretariat, more than 52 WTO Members have done so by 
today covering about 80% of current med icines export capacity. This was done on the basis of the 
waiver solutions agreed in 2003, and in spite of the fact that the TRIPS Amendment has not yet 
entered into force. This demonstrates the commitment and the support of WTO Members for the 
use of the Paragraph 6 System. In the Paragraph 6 Review in the TRIPS Council, Members have 
confirmed this political support and encouragement for use of the System.  
190.  I would like to refer to two points that have been mentioned by preceding speakers. One was 
the comp lexity and cumbersomeness of the System that was claimed. However, in our 
recollection, in past reviews in this Council of the Paragraph 6 System, we have not heard, at least 
not from potential beneficiary Members, of cases where the System needed to be us ed, but was 
not used or dropped because it was too complex, or that the process of making it proved to be not 
workable at any specific stage of the System.  
191.  When we look at the System it seems quite straightforward. The WTO Secretariat is assisting 
Members who may want to use the Paragraph 6 System very helpfully through all the information 
and the special dedicated website on the WTO site. Notifications certainly should not pose a 
problem.  
192.  Concerns were raised with regard to the need of having to mark medi cines that are produced 
under special compulsory licence. Switzerland has argued in earlier reviews that such special 
marking of medicines is in the very interest of the potential beneficiary country because it will 
ensure that the medicines produced under  such a special licence reach the people who need these 
medicines.  
193.  Also, the requirement for the generic producer under such a licence to put up a website has 
been described as cumbersome. However, I believe hosting a website for a generic manufacture 
capable of actually assisting under this System should not pose an unsurmountable hurdle 
nowadays.  
194.  Having said this, compulsory licences are as such not an easy and quick -fix solution to 
address the broader problem of sustainable access to affordable medicin es – whether in 
developing countries or any other WTO Member. Implementing a compulsory licence, and again I 
refer to normal or special compulsory licences even once granted, pose their own challenges. A 
generic manufacturer needs to be found who is ready,  willing and available to produce the 
medicine needed and the quantities needed within a short time -period at an affordable and 
competitive price and at the required quality and safety standards. This demonstrates that a 
compulsory licence is never a quick -fix solution and this cannot be remedied by the Paragraph 6 
System or by revising it for that matter.  
195.  Also, the fact that the System has only been used once so far was taken as evidence that the 
System is not workable. However, I believe it is important to note, as stated by the EU, that the 
Paragraph 6 System does not have result in the grant of an export licence. One of its key benefits 
is to give all WTO Members, including those without manufacturing capacity in the pharmaceutical IP/C/M/83/Add.1  
 
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  market, the negotiati on leverage when they need to address a specific public health problem and 
to negotiate with potential manufacturers the price and any delivery conditions for receiving the 
needed medicine. That was the very basis of the mandate that Ministers gave the TRI PS Council in 
the Doha Declaration on the TRIPS Agreement and Public Health. Their intention was to ensure 
that this policy flexibility that was identified and confirmed in the Doha Declaration would be 
available to all WTO Members equally.  
196.  The case of Can ada-Rwanda was the first one and was not an easy one. Always when you do 
a thing for the first time, you learn lessons. Therefore, we do believe that the Paragraph 6 Review, 
within this Council, is extremely beneficial for Members to exchange and share exp eriences made, 
raise concerns so that all can learn for any next use of the Paragraph 6 System.  
197.  We have also heard that in many cases the Paragraph 6 System might not have been 
needed since medicine  was available from a country or manufacturer in a countr y where this 
medicine was still available off patent. It has also been mentioned in that context that in the future 
this might be less often the case. In my delegation's view, this only raises the importance of the 
Paragraph 6 System in the future. Therefo re, we very much welcome the discussions in this 
Council under the Paragraph 6 Review so that we can learn how to make this System and its 
application in practice more useful to potential beneficiary countries.  
6.12 United States  
198.  The United States fully associates ourselves with the delegation and the intervention from 
Switzerland. We also want to thank the Secretariat for the update regarding the status of 
acceptances of the 2005 Protocol Amending the TRIPS Agreeme nt. 
199.  The United States strongly supports the Paragraph 6 System as established under the 
2003 waiver decision and the 2005 Protocol.  
200.  The United States congratulates the significant number of countries who have formally 
accepted the amendment since last year 's review. This is a significant achievement. We encourage 
other Members to notify their acceptance of the amendment so that it can enter into force.  
201.  Finally, again, we want to welcome the Secretariat's efforts, I think Chinese Taipei also 
referred to it, and draw delegations' attention to the WTO TRIPS webpage where Members can find 
an "Illustrative guide to notifying under the Paragraph 6 System. " This is quite a helpful document. 
We have taken a look at it. It is easy and it is very understandable so we commend the 
Secretariat's work in this regard and join Chinese Taipei in that respect.  
202.  There are multiple avenues available for promoting access to medicines. The Paragraph 6 
System is of course important, but it is not alone. As raised through the Public Health Workshop 
held at the WTO the week of 17 October as referenced by the European Union, there are many 
mechanisms that governments can use to promote access. Such improvements are the building 
blocks for a sustainable healthcare system. These include, as cited in the October  Workshop:  
 strong and effective procurement systems and processes;  
 supply chain management, including reliable data regarding actual demand;  
 improvements in notification systems and coordination with producers;  
 strong and efficient r egulatory control of assured quality of medicines;  
 eliminating retail mark -ups through more efficient distribution and dispensing 
systems;  
 advance policies that combat substandard and spurious, falsely labelled, falsified; or  
 counterfeit (SSFFC) medicinal products that displace innovative and generic drugs; 
and 
 eliminating taxes and tariffs.  
 
203.  For example, taxes or tariffs may be levied - often in a non -transparent manner - on 
imported medicines and the increased expense associated with those levies is then passed directly 
to healthcare institutions and patients. For example, in a review of tariffs as applied and bound on 
medicinal products, we see ranges of 25% to 40% on tariffs at the border with respect to 
pharmaceutical products. We see applied levels of 10% or 7.5% but that is not the end of the IP/C/M/83/Add.1  
 
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  analysis. We see an additional 13% by some Members added as other duties and taxes creating an 
applied rate of 21% on pharmaceuticals.  
204.  We continue to believe that the access to medicines issue is multidimensional.  Making 
lifesaving medicines available  requires transparency and a commitment to address measures that 
unduly delay patients from getting the treatments they need.  
6.13 Panama  
205.  As one of your predecessors, Chair, who has ha d many opportunities to speak with on this 
matter, I would like to urge Members just as the Director -General has to ratify this Amendment. 
The map that you showed on the screen is very revealing and is very interesting in the sense that 
if we look at the c ountries which still have to ratify we see that most of them are in fact developing 
countries. The other countries are economies in transition if I am not mistaken. This was a 
measure that was promoted by developing countries to the benefit of developing c ountries. I 
believe that we as developing countries need to make a big effort to achieve this as soon as 
possible to ensure that we reach the necessary number of ratifications so that the measure can 
come into force. We will spare no efforts just as those who came before us did not either. This is 
an important measure as has been said by many. To be honest I have never understood the 
reason behind the delays other than perhaps a lack of understanding regarding what the 
ratification process involved.  
206.  The Sec retariat has made a lot of effort providing technical assistance and I would like to 
congratulate the Secretariat for all these efforts. Perhaps the most important detail that a 
government can take into consideration and which can inform the decisions made  by delegations 
and authorities is that acceptance of the Protocol does not mean a change to national legislation. 
What it does is accept that other Members of the WTO can use this mechanism. In other words, 
this could be a very simple decision, a very sim ple instrument because there is always the 
possibility of drafting a more complex national law within domestic legislation in order to apply it, 
but this is not necessary. This could be a subsequent step after acceptance.  
207.  Once again,  I would like to thank the Secretariat and I would like to thank all our 
predecessors who have fought very much for this measure. I hope that we will achieve the 
necessary number of acceptances.  
AGENDA ITEM 7: NON-VIOLATION AND SITUAT ION COMPLAINTS  
7.1 United States  
208.  We continue to believe that the drafters of the TRIPS Agreement envisioned that non-
violation and situation nullification and impairment (NVNI) complaints should be available  under 
the TRIPS Agreement . 
209.  We also take this opportunity  to confirm that while the moratorium on NVNI disputes under 
the TRIPS Agreement was extended in December 2015 for an additional two years, the 
United  States continues to maintain its long -held and firm position that NVNI disputes should be 
applicable under 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 of the drafters of the 
Agreement.  
210.  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 GA TT and WTO adjudication s, 
as we have enumerated in our communication s to the TRIPS Council, which was circulated to  
Members as IP/C/W/599, as well as in our recen t interventions.  
211.  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 TRIPS Agreement texts, the Panel and Ap pellate Body jurisprudence involving 
NVNI disputes, the extensive safeguards that exist to protect Members ' rights and obligations 
under  the TRIPS Agreement, and concrete disciplines  regarding how such disputes would work in  
practice.  IP/C/M/83/Add.1  
 
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  212.  Today, we will explor e a new dimension of our rationale for supporting NVNI claims under 
the TRIPS Agreement, which we consider provide additional legitimacy for such claims on the basis 
of their long -established provenance in the WTO as well as in pre -cursor international  
organizations.  
213.  Our review this morning of the negotiating history, as well as the treatment, of  NVNI claims 
in other WTO Agreements, in our view conveys a clear and unequivocal intent of the  TRIPS 
Agreement negotiators that NVNI claims are not only appropriat e under the Agreement,  but also 
beneficial to all Members.  
214.  NVNI claims date back at least as far as the League of Nations. As in the GA TT and WTO, the  
origin of this concept was to combat protectionism, whether through tariffs or non -tariff measures. 
Out o f this concern, growing support emerged to address "indirect protection ". The result was the 
"equitable treatment clause ", which addressed the scenario in which a  measure does not "result in 
an infringement of terms of the treaty ", but is , nevertheless, of "a nature as to  have the effect of 
nullifying or impairing any object of the treaty ". 
215.  After being memorialized in the League of Nations, the same concept appeared in the  
negotiations of the International Trade Organization (ITO) Charter. Article 30 of the  Commercial 
Policy chapter of the ITO Charter covered "any measure adopted by any other  Member, whether or 
not it conflicts with the terms of this Chapter, [that] has the effect of  nullifying or impairing any 
object of this Chapter ". 
216.  While the ITO Charter was not ultimately ratified, the General Agreement on Tariffs and  
Trade did enter into force in 1947, which included Article XXIII:1(b) on NVNI. As we have  
explained, NVNI and GATT Article XX on exceptions have existed harmoniously for the past  
69 years.  
217.  When the WTO came into being in 1995, NVNI was incorporated in numerous ways.  First. 
the WTO Dispute Settlement Understanding (DSU) confirmed the availability of  non-violation 
complaints horizontally in all WTO Agreements. This was demonstrated not only in Article 3.1 of 
the DSU , but also DSU Article 26.1 which explicitly incorporates GATT Article XXII 1.1(b) on NVNI 
into the DSU.  
218.  The application of NVNI claims to specific WTO Agreements was confirmed  by panels and the 
Appellate Body , including in the panel in the Korea - Procurement  dispute, which recognized that 
NVNI complaints are not limited to tariff concessions.  
219.  Second, NVNI was explicitly incorporated into some WTO Agreements for immediate  
application. This is true, for example, with in the GATT 199 4 and the General Agreement on Trade 
in Services  (GATS). Members can find the NVNI claim under Article  XXIII.3 of GATS.  
220.  Finally,  other WTO Agreements provided for the application of NVNI claims, after a  
temporary exclusion  or transition period. This is the cas e with Article 13(a)(iii) of the  WTO 
Agreement on Agriculture and with Article 64 of the TRIPS Agreement.  
221.  NVNI claims have a long lineage in the WTO and in international trade law  generally as we 
have outlined today. The applicability of such claims to the  WTO Agreements is the rule; their 
non-application is the exception. The TRIPS Agreement  moratorium  is the exception.  
222.  And we have yet to hear an explanation as to why the moratorium  is appropriate in the 
context  of the TRIPS Agreement, but not other WTO Ag reements. The lack of NVNI under the 
TRIPS  Agreements has created incoherence between the WTO Agreements. It is the application of  
such claims to the TRIPS Agreement that would end such incoherence.  
223.  We continue to await a single example in the context of a ny other WTO Agreement where  
NVNI is present evidencing the concerns articulated by some in this Council regarding why  NVNI 
claims should not be present under the TRIPS Agreement.  
224.  If NVNI has had no negative impact on exceptions under the GATT, GATS, and t he 
Agriculture, Government Procurement and other WTO Agreements, why would NVNI impact  on IP/C/M/83/Add.1  
 
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  exceptions under the TRIPS Agreement? We have yet to see any suggestion that suc h claims 
would have such impacts.   
225.  To conclude, non -violation complaints are fully app ropriate in the context of the  TRIPS 
Agreement, and have long been part of the WTO and the GA TT and its precursors . Non -violation 
complaints serve an interest all WTO Members share, which is to assist Members  in protecting 
against measures that nullify and impair concessions. Non -violation complaints were  part of the 
balance of rights and obligations in the TRIPS Agreement. The time has come to allow  the 
moratorium on non -violation complaints to expire . 
226.  With respect to your proposal regarding a Chair's upda te document which would be factual 
or one so produced by the Secretariat, we would be open to such a docu ment.  
7.2 Ecuador  
227.  As a co-sponsor of IP/C/W381/Rev.3, we consider that this needs to be the document on 
which we base ou r discussions on this matter.  
228.  We believe that the TRIPS Agreement does not address  access to markets because it does 
not deal with tariffs. In fact, it establishes minimum standards for intellectual property rights. 
Therefore, non -violation complaints can not be applied within the TRIPS  Agreement. That is why we 
agree with the countries who believe that the modalities in paragraphs 1 (b) and (c) of Article XXIII  
of GATT 1994 cannot be applied to TRIPS dispute s.  
7.3 Colombia  
229.  We would like to reiterate our position : non-violation complaints are not a violation and can 
therefore not  be taken into consideration in TRIPS, as the Agreement  does not affect access to 
markets or tariffs. All it does  is to establish minimum standards  for the protection of intellectual 
property.  That is why our country believes that , within the TRIPS  Agreement,  using non -violation 
complaints could also have an impact on the predictability of the multilateral trading system.  
230.  As regards  the broader  internat ional context, our country has been request ed for these kinds 
of complaints to be included in the trade agreement with the United States.  We need to bear in 
mind, however,  that the balance reached within the multilateral system is very different compared 
to that in bilateral agreements because the two legal regimes are independent. That is why 
Colombia would like to maintain the enforcement of this  type of complaint in the agreement with 
the United States.  
231.  We understand that there is a need for Members to r each a definitive agreement on this kind 
of complaints . Nonetheless, we believe that , having heard the debate on the modalities of NVNI  
complaint s, in which th ese can be applied, our position is that such complaints  cannot be applied 
to TRIPS . 
7.4 Switzerl and  
232.  Let me first thank the US delegation for their presentation shedding light on the historical 
background of NVNI  complaint s in the WTO and how they have been applied smoothly so far in the 
WTO system.  
233.  The purpose of m y intervention is to recall  our statement in the informal part of our 
discussion also in the formal discussion. In particular, I referred to our openness of your proposal 
that you or the Secretariat submit a paper to the Council with factual information on  scope and 
modalities for NVNI complaints in the WTO.  
234.  With regard to the substantive position, I w ill not  take much time of the Council. Our position 
is well -known from earlier Council meetings. It is the TRIPS Agreement itself that guides this 
Council and  binds us as concerns the question of applicability of NVNI complaints under the TRIPS 
Agreement. After the moratorium in Article 64 , these complaints shall be applicable and this was 
the position and the agreement by the WTO Members at the end of the Urug uay Round when in 
fact they subscribed to Article 64.  IP/C/M/83/Add.1  
 
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  7.5 Egypt  
235.  The position of Egypt is well -known . We continue to believe that violations of the t ype 
identified in Article XXIII. 1(b) and (c) of GATT 1994 are not applicable t o the TRIPS Agreement. 
We really believe that the best way to overcome this issue is to take  document IP/C/W/607 as the 
basis for our future negotiations in this regard . 
7.6 India  
236.  India supports the statements made by Colombia,  Egypt, Brazil and China. India is a 
co-sponsor of documents IP/C/W/385 /Rev.1 and IP/C/W/607. India's position on the issue of non -
violation complaints under the TRIPS Agreement remains unchanged. In the run up to the 
Ministerial Conference in Nairobi, the re was a great confluence of interest on making such 
complaints inapplicable to TRIPS. There was also a draft Ministerial Decision in this regard.  
237.  We do not stand convinced by the reasons provided by a couple of Members of its place in 
the TRIPS context. W hile whether the TRIPS Agreement is a market access agreement may or may 
not be relevant for its applicability, it is clear that the drafters did not unequivocally apply NVCs to 
TRIPS. Article 64.1 of the TRIPS Agreement establishes that GATT Article XXIII  applies to the 
TRIPS Agreement except as otherwise provided in Articles 64.2 and 64.3. Notwithstanding the 
expiry of the time -period under Article 64.2, non -violation and situation complaints only apply to 
the TRIPS Agreement in accordance with the proced ure established under Article 64.3. Complying 
with this procedure, the importance of which Ministers reaffirmed through their adoption of the 
Decision on Implementation -Related Issues and Concerns, should be a matter of priority for the 
TRIPS Council. The Decision directed the TRIPS Council to "continue its examination of the 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 Minis terial 
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 automatica lly applicable to the TRIPS Agreement is, 
in our view, incorrect.  
238.  It is important to recognize that the TRIPS Agreement is a unique, sui generis  agreement 
and is distinct from the GATT and GATS, contrary to the assertion made in the US communication. 
In the GATT/WTO legal framework, the establishment of the non -violation procedure aims 
primarily to prevent the tariff concessions or specific commitments on trade in services from being 
adversely distorted by the additional trade measures taken. With the grad ual 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 obligations in the context 
of agreements such as the TRIPS Agreement. Whe n 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 access in the GATT and GATS respectively. 
Fundamentally differing from the  GATT and the GATS, the TRIPS Agreement is not "about 
reciprocal market access rights of governments ". While IPRs might facilitate trade and investment, 
the obligations under the TRIPS Agreement cannot be characterized as market access concessions.  
239.  Serious  concerns remain on the debilitating impact non -violation complaints in TRIPS can 
have on the regulatory policy space of members, on TRIPS flexibilities as well as increasing the 
complexity in interpreting the TRIPS provisions. It cannot only have a chilli ng effect on Member’s 
exercise of their IP regimes, but also severely restrain the ability of Members to achieve other 
public policy objectives.  
240.  The absence of non -violation complaints in the TRIPS context does not in any manner 
threaten or dilute the enfo rceability of TRIPS -related rights and obligations. On the contrary, the 
application of non -violation complaints in the TRIPS context could potentially present issues 
relating to rights of intellectual property right holders versus the legitimate exercise of regulatory 
policy choice by governments. Introducing non -violation and situation complaints into the 
TRIPS  Agreement is unnecessary and inconsistent with the interests of the WTO Members. Any 
benefits arising from the Agreement can be adequately protect ed by applying the text of the 
Agreement in accordance with accepted principles of international law, and without introducing the 
legally uncertain notion of non -violation and situation complaints.  IP/C/M/83/Add.1  
 
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  241.  We note that there is a moratorium on the applicability o f such complaints until the next 
Ministerial Conference and we look forward to work with like -minded countries in making 
non-violation complaints inapplicable to TRIPS. We also wish to reiterate that until there is a 
consensus on the scope and modalities o f the applicability of NVC s to TRIPS, they will not apply to 
the TRIPS Agreement. With regard to the US suggestion of a proposal on updating the factual note 
on non -violation complaints, w e do not support the idea. We can only agree if Ecuador's proposal 
on updatin g the three factual notes on TRIPS -CBD and others is agreed.  
7.7 Bangladesh  
242.  On this issue our position is known and consistent. We are not disputing the basic premises 
of NVNI  complaint s under other different cond itions, but we believe that these complaints are not 
applicable to the TRIPS Agreement which is not a pure market access agreement per se. since this 
idea has reasonable merit, the whole WTO Membership and the Ministers established and then 
extended the mo ratorium repeatedly. This should be made permanent under the TRIPS 
Agreement . The proposal contained in IP/C/W/607 can be a good point to start our future actions 
and negotiations.  
7.8 China  
243.  We appreciate very much your kind e fforts on this issue. The Nairobi Ministerial Conference 
decided to further extend the moratorium of the application of non -violation and situation 
complaints under the TRIPS Agreement. During the Council meetings after that, debates on this 
issue continue d, but divergence was observed.  
244.  In May 2015, China, together with 16 other Members, proposed the document 
IP/C/W/385/Rev.1. It provides detailed background information and concerns. We believe that 
non-violation and situation complaints are not applicable  under the TRIPS Agreement, and would 
like to engage in discussion s according to the Decision and Mandate given by Ministers . 
7.9 Argentina  
245.  Argentina's position on this matter is well -known and remains unchanged. We feel th at 
complaints that are not based on a violation and other sorts of situation complaints are not 
relevant to the TRIPS Agreement as is established in document IP/C/W/385/ Rev.1 which was 
co-sponsored by my country along with a number of other Members of this  Organization.  
7.10 Russian Federation  
246.  The Russian Federation, once again, would like to reiterate its position that non -violation and 
situation complaints should not be applicable to the TRIPS Agreement. As it wa s mentioned earlier 
by numerous delegations there are several grounds that justify such approach of non -applicability 
of non -violation and situation complaints in the context of intellectual property. The TRIPS 
Agreement, unlike other WTO Agreements, is no t designed to protect market access or the balance 
of tariff concessions, but rather to establish standards of IP protection, which, if abused, may even 
undermine market access. The application of non -violation complaints under the TRIPS Agreement 
could up set the delicate balance of rights and obligations in this Agreement, and could also limit 
the use of the flexibilities outlined in the Agreement to secure objectives relating to public health 
and other issues of public interest. Our position, as the posit ion of the majority of WTO Members, 
was clearly pointed out in document IP/C/W/385/Rev.1. Like other delegations, we think this 
document should serve as a basis for discussions on this issue. Our delegation welcomes any 
constructive discussion on the issue  and welcomes delegations to share any new views.  
7.11 Brazil  
247.  As everyone here knows, Brazil is a co -sponsor, alongside many countries, of the document 
just mentioned by the distinguished delegate of Russia, IP/C/W/385/Rev.1. Unlike the GATT and 
the GATS, TRIPS does not involve an exchange of concessions and it remains unclear how 
non-violation complaints would apply to minimum regulatory standards that protect private 
property rights. While IPRs may, in some cases, facilitate international trade and investment, 
TRIPS obligations cannot be characterized as market access concessions in the same way as IP/C/M/83/Add.1  
 
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  obligations under GATT or GATS. TRIPS for the first time  regulated  intellectual property within the 
framework of a major negotiati on on trade rules. It is only natural that the resulting instrument 
would have distinctive characteristics in the acknowledgement that not everything that applies to 
trade in general applies to intellectual property.  
248.  The United States, please correct me i f I am mischaracterizing your views, does not seem to 
believe that the availability of non -violation measures will raise systemic concerns. In Brazil's view, 
the response that Article 3.2 of the DSU will prevent the Dispute Settlement Body from adding to 
or diminishing the rights and obligations under existing WTO Agreements fails to recognize that 
applying non -violation complaints to TRIPS is tantamount to establishing a new course of action 
under these Agreements. In the absence of clear arguments to the contrary, the concern remains 
that non -violation complaints may give rise to incoherence among WTO Agreements.  
249.  The United States also seems to understand that the availability of non -violation complaints 
will protect Members for intentional evasion of obli gations under TRIPS while preserving the ability 
of any Member to implement social and economic development policies, because in their view – 
and again please correct me if I am mischaracterizing – there are a number of ways to implement 
social and cultura l policy goals. The Member may take this element of non -violation complaints 
into consideration when prep aring measures to protect these goals.  
250.  Non-violation complaints would require WTO Members to compensate one another for 
measures that adversely affect foreign holders of IPRs and that were not foreseen during the 
Uruguay Round. Such an approach would arguably cover a range of domestic measures, may 
undermine the Agreement's flexibilities – including in the area of public health, and could 
jeopardize WTO Members' sovereign rights to develop new laws to protect the public interest.  
251.  Brazil understands non -violation complaints are not the way to protect the benefits arising 
from the Agreements. We have yet to hear arguments as to why the provisions of TRIPS are not 
sufficiently flexible to address the concerns raised by Members who support such a remedy. We 
believe that rather than relying on the legally imprecise notion of non -violation, a preferable 
approach would be to focus on the text of the Agreement su pported by recognized principles of 
treaty interpretation.  
252.  To conclude, TRIPS is a unique and permanent balancing act with Article 1 clarifying that the 
Agreement provide s for minimum standards , while Article 7 and 8 determine that it should be 
implemente d with a view to ensuring a balance o f rights and obligations and bearing in mind the 
protection of public health and nutrition. We are convinced that accepting non -violation complaints 
would nullify this delicate balancing act. This , indeed , would be the true nullification or 
impairment.  
7.12 Japan  
253.  Japan's view on this issue has not changed. Both clarity and predictability should be ensured 
when applying non -violation and situation complaints to the TRIPS Agreement. From this point of 
view, making factual analyses on specific and concrete circumstances in which non -violation and 
situation complaints should be available would facilitate examination o f the scope and modalit ies of 
non-violation and situation complaints in the area  of the TRIPS Agreement.  
254.  This delegation has been and is willing to engage in discussions at this Council in a 
constructive and dedicated manner.  
7.13 Peru  
255.  It has been recalled by many Members today  that, on the way to Nairobi , a group of 
Members submitted a document on a draft Decision stating that this type of non-violation 
complaints  do not apply to the TRIPS Agreement which is sui generis . These proposals in 
IP/C/W/385/Rev.1 and  IP/C/W/607 are still on the table. Let me reca ll that while this position is 
not supported by some Members, as has been mentioned by one delegation, the majority of this 
Council  is supporting it.  IP/C/M/83/Add.1  
 
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  7.14 South Africa  
256.  We take the floor once again to reiterate our positi on and that is that from the last 
intervention it has not changed. South Africa believes that the insertion of non -violation and 
situation complaints will not be practical under the TRIPS Agreement.  
7.15 Chinese Taipei  
257.  My delegation would like to inform the Council  that in 2012, document IP/C/W/349 
concerning non -violation and situation complaints was drawn up by the Secretariat. This is a very 
useful  document  to better understand the situation with respect to this mat ter. Since 2013, the 
United States, Peru, Brazil and other Members have also made proposals on this same question. In 
order to facilitate discussion on this matter, particularly with respect to the scope and modalities 
relating to the TRIPS Agreement, I ha ve a recommendation to make. I would urge the Secretariat 
to revise the note that I have just referred to in order to ensure that we all have a full 
understanding of the situation.  
7.16 Korea, Republic of  
258.  Our delegation shares the same concerns expressed by the previous speakers on the issue of 
NVSC. Since we have not h eard any new arguments to change our solid position, our position on 
this issue remains the same . 
7.17 Canada  
259.  Our posi tion on this issue is well -known, and remains unchanged. We continue to have 
concerns with the applicability of the NVNI remedy to the TRIPS Agreement.  
7.18 Bolivia, Plurinational State of  
260.  Bolivia woul d like to join those delegations which have indicated that non -violation 
complaints are not relevant to the TRIPS Agreement. We would also like to say that we consider 
that document IP/C/W/607 is the best working document for us to use to make some headway  on 
this matter.  
7.19 United States  
261.  I wanted to come back on a few points and respond to the helpful invitation by a couple of 
Members with respect to a few issues.  
262.  First, with respect to the text of the TRIPS Agreement , obviously the United States very 
much welcomes a precise textual analysis. Of course, we are drawn immediately to the text of 
Article 64.1 which states unequivocally, clearly and unambiguously that Article XXIII of the GATT  – 
including NVNI disputes  - shall apply to the TRIPS Agreement. Then of course we have Article 64.2 
which provides a temporary transition period of five years and then we have Article 64.3 which 
provides for an examination and possible recommendations as well as an adoption by the 
Ministerial Conference of recommendations if those emerge as well as any extensions of the 
transition period under Article  64.2. So when delegates say – and perhaps we are not hearing the 
precision – when they say that NVNI claims shall not apply or do not app ly to the TRIPS 
Agreement, that  is obviously inconsistent with Article 64.1 of the TRIPS Agreement so we do of 
course welcome encouragement to look back at the text.  
263.  To the extent that some delegations have concerns regarding the application and that  is why 
we are under an extension of a moratorium – that is perhaps a nuance and a slightly different 
position – and we understand that.  
264.  With respect to systemic concerns raised by one delegation , and perhaps that  is with respect 
to flexibilities provided under  the TRIPS Agreement, here again there is ample precision  to be 
made.  Existing modalities, not only under the WTO Agreements, but also under Panel and 
Appellate Body jurisdiction provide a very clear three -part test on exactly how any NVNI claim 
would safe guard the continued ability to use flexibilities under the TRIPS  Agreement . We the IP/C/M/83/Add.1  
 
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  statement made by the Swiss delegation  very instructive  which explained that a non -violation 
complaint cannot be brought against another Member for utilizing a flexibility f oreseen in the 
TRIPS Agreement. One of the necessary conditions that the complaining party must demonstrate 
is that the offending measure could not have been foreseen. That a Member may make use of a 
flexibility provided in the TRIPS Agreement is, just as any other right under the TRIPS Agreement, 
foreseeable by other Members.  
265.  Finally, with respect to legal precision, we again welcome the call and want to answer the 
questions with respect to the justifications under law hop ing to reassure Members about the 
safeguards for the use of NVNI complaints. Here again they are copious. Under the Dispute 
Settlement Understanding we have mentioned Article 3.1, Article 3.2, Article 3.5 and Article 26.1 
which all provide overlapping safeguards with respect to the rights and obligations which include 
exceptions and flexibilities under the TRIPS Agreement. Of course, as I have mentioned, we have 
Panel and AB jurisprudence in this area as well as other indications in other agreements of how 
these would be used in practice an d have been used in practice with respect to NVNI complaints.  
266.  Finally, we would just merely thank Chinese Taipei for its proposal and we would also 
support that proposal.  
7.20 Pakistan  
267.  Discussions continue on this topic and the US delegation has just stated that there are areas 
which need to be looked into . But the delegation of Pakistan has held the view and of course we 
are in support of the majority view that for now at least the moratorium should continue because 
we are t alking and as far as the understanding of the majority of the countries have expressed 
here is concern of two areas of legislation. TRIPS provides within itself a degree of autonomy to 
deal with some of these issues regarding non -violation and we would lik e to adhere to that 
principle essentially.  
268.  However, as has been the view expressed here and in a number of meetings in the past, this 
is an ongoing discussion, but until we have some very convincing material to the contrary, we 
would like to reiterate our  position that we support the moratorium until the next Ministerial 
Meeting and we can continue exploring this to see how we can address this issue.  
7.21 India  
269.  As India stated earlier, we do not support the proposal. We can onl y accept the proposal if 
the equal proposal on updating the three factual briefs on TRIPS CBD and other issues is accepted.  
AGENDA ITEM 8: REVIE W OF THE IMPLEMENTAT ION OF THE TRIPS AGR EEMENT UNDER 
ARTICLE 71.1  
No statements were made under this Agenda ite m. 
AGENDA ITEM 9:  REVI EW OF THE APPLICATIO N OF THE PROVISIONS OF THE SECTION 
ON GEOGRAPHICAL INDI CATIONS UNDER ARTICL E 24.2  
No statements were made under this Agenda item.  
AGENDA ITEM 10: FOURTEENTH ANNUAL RE VIEW UNDER PARAGRAPH  2 OF THE 
DECISION ON THE I MPLEMENTATION OF ART ICLE 66.2 OF THE TRI PS AGREEMENT  
10.1 European Union  
270.  Our concrete efforts cost a lot of money to our taxpayers. They deserve to receive some 
highlight. So I would like to state that t his year's repor t once more confirms that the EU and its 
Member States take their commitments and obligations under Article 66.2 TRIPS seriously and 
fulfil them.  IP/C/M/83/Add.1  
 
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  271.  Technology transfer , provided in this report, refers to the ways and means through which 
companies, individua ls and organizations acquire technology or know -how from third parties,  
whether such technology is IPR -protected or not . 
272.  Technology transfer also takes place via training and education. This is actually crucial for 
transfer of know -how. It includes trainin g of university graduates, exchanges of qualified staff, 
joint research projects. This is as important as transfer via buying or licensing of IP rights.  
273.  Technology transfer is often one component of a more compl ex project, rather than a 
stand -alone activi ty. Most projects that deal with sectors such as energy, water, agriculture, 
governance and infrastructure result in transfer of know -how and technology.  
274.  The acquisition by LDCs of a sound and viable technological base does not depend solely on 
the provisi on of technology or equipment, but also on acquisition of know -how, management and 
production skills, improved access to knowledge sources as well as on adaptation to local economic 
conditions.  
275.  In our efforts to encourage and promote technology transfer, as governments we are limited 
by two factors: first, we do not own the vast majority of such technologies. It is clear that the 
private - and particularly the commercial - sector is nowadays the main source of technologies. 
Second, we cannot force the priv ate sector to transfer its technologies. Incentives can therefore 
only take the form of encouragement, promotion and facilitation of projects which are part of a 
global and comprehensive approach to development.  
276.  Finally, it should be noted that EU actions  usually target groups of countries or regions. The 
reason is because the EU strongly supports regional integration  – this will be part of our 
subsequent point of the Agenda. This  fosters better understanding and political and economic links 
between neighb ouring  countries. This is why we do not have LDC-specific technology transfer 
single programme s at EU level.   
277.  However, our approach to the allocation of aid and incentives does pay particular attention 
to the situation of LDCs. LDCs have , for example , access at preferential grounds to research 
programmes with full funding. In development funds there is a specific focus on LDCs  
278.  Some Member States do have such programmes specifically dedicated to LDCs.  
279.  The overview I will give to you now will show that ther e is a coherent approach where both 
EU and Member States programmes focus on thematic areas to tackle LDC specific problems. I will 
focus mainly on two area , i.e. health programmes and programmes that have a direct impact on  
the environment.  
280.  Starting with  the first. One of the key activities for health research and innovation during the 
period of reference  were the projects on Ebola and the results of these projects will directly benefit 
LDCs.  
281.  The overall objective of the EBODAC (EBOLA vaccine Deployment,  Acceptance & Compliance) 
is to develop a communication and engagement strategy including the development of appropriate 
technology and tools in order to maximize Ebola vaccination impact in the targeted populat ion. The 
targeted LDCs for this programme are Liberia, Sierra Leone and Guinea. The total budget is more 
than €23 million .  
282.  We have another programme called EbolaMoDRAD. T he overall aim of EbolaMoDRAD is to 
develop and deliver rapid field diagnostic tool(s) that will significantly increase the capaci ty to 
handle the current Ebola Virus Disease (EVD) in West Africa and also futu re outbreaks. The 
targeted LDC M embers are Senegal, Guinea, Sierra Leone, Liberia, Guinea -Bissau, and Gambia. 
The EbolaMoDRAD I nitiative will generate several diagnostic tools, important scientific research 
and data. One of the main objectives of the programme is to disseminate the knowledge 
generated by and available to the consortium to public health bodies, outbreak management 
teams and local hospitals in West Africa. It will also contribute to the education of the responsible 
entities and clinical staff in non -endemic countries in terms of outbreak management and clinical 
aspects of the disease. The total contribution is €4.3 million.  IP/C/M/83/Add.1  
 
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  283.  Senegal is the beneficiary LDC Member of a project that evaluates the efficacy of the 
antiviral drug Favipiravir, which has proven activity against many RNA viruses in vivo and in -vitro 
including Ebola, in order to prevent the further spread of the epidemic. The allocated fund is 
€135,000 .  
284.  The Second European and Developing Countries Clinical Trials Partnership Programme  
(EDCTP2 ) will contribute to the reduction of the social and economic burden of poverty -related 
diseases in developing countries, in particular in sub -Saharan Africa, by accelerat ing the clinical 
development of effective, safe, accessible, suitable and affordable medical interventions for 
poverty -related diseases (vaccines, drugs, microbicides, diagnostics), including neglected ones, in 
partnership with sub -Saharan Africa. This par tnership targets 32 LDC Members. The allocated 
budget is around €1.9 million and the beneficiaries are Gambia, Mali, Malawi, Kenya, Rwanda, 
Tanzania, Uganda and South Africa. The goals are to maximize the public health impact of 
interventions to control ma laria in pregnancy through the translation of EDCTP -funded evidence -
based global policies to country level policies, improving the impact of existing Malaria Products as 
well as improving HIV prevention and sexual and r eproductive health care in high -risk women, etc.  
285.  I will just mention very briefly a few further public health -related projects . We provide a 
funding of more than €450,000 in Mozambique to design a v accine that will induce a 
broad -ranging immune response to Mycobacterium Tuberculosis called the Project on Eliciting 
Mucosal Immunity to Tuberculosis.  
286.  We also have the  European HIV Vaccine Alliance (EHVA), which is a EU  platform for the 
discovery and evaluation of novel prophylactic and therapeutic vaccine candidates . It contributes 
to a successful vaccine that would have a greater effect on reducing the overall HIV burden within 
a community in Tanzania, Uganda and Mozam bique.    
287.  To mention a project sponsored by one of our Member States, the  UK's Government funds 
product development partnerships (PDPs) which work  on a specific technology and disease area - 
to develop new health technologies for diseases of poverty. The h ealth technologies acceded 
include: new diagnostics for malaria, sleeping sickness, tuberculosis; new drugs for malaria, 
neglected tropical diseases (NTDs); and new vaccines for meningitis and diarrhoeal diseases. The 
duration of the project is a period of  11 years ( 2010-2021) and the total funding for the research 
is around £350 million.  
288.  I will now mention some projects related to the environment. In the framework of the 
Horizon 2020 Programme , which is our very broad research -based programme at the EU le vel, the 
FLOWERED Project is  about  de-fluoridation technologies for improving quality of water and agro -
animal products along the East African Rift Valley in the context o f adaptation to climate change. 
This project aims to contribute to the development of  a sustainable water management system in 
areas affected by fluoride contamination in water, soils and food in the African Rift Valley countries 
(Ethiopia, Kenya, Tanzania), and thus to improve living standards (environmental, health and food 
security) of its population. The total E U contribution is almost €3 million.  
289.  The SafeWaterAfrica Project: for this programme, the key objective of the project is to 
improve access to clean water in Africa through research and development of an autonomous and 
decentral ized water treatment system for rural and peri -urban areas. The project will develop new 
types of autonomous low -cost and solar powered water sanitation systems tailored for the specific 
needs in the rural areas of South Africa and Mozambique and it will b e operated independently by 
local communities. Access to safe water through this pro ject will reduce health risks. The total 
requested EC contribution is slightly less than €3 million.  
290.  There are other projects in the framework of Horizon 2020 that aim at developing and field -
testing a range of sustainable technologies that will provide a ffordable access to safe water to 
remote and vulnerable communities in Africa and elsewhere, like the WATERSPOUTT Project. The 
requested EC Contribution is €3 million.  
291.  The VicInAqua project which is an i ntegrated aquaculture based on sustainable water 
recirculating sys tem for the Victoria Lake Basin  develops a sustainable combined sanitation and 
recirculating aquaculture system for wastewater treatment and reuse in agriculture in the Victoria 
Lake Basin area.   IP/C/M/83/Add.1  
 
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  292.  The AfriAlliance project which is the Africa -EU Innovation Alliance for Water and Climate 
aims to identify appropriate social innovation and technological solutions for key water and climate 
change challenges, leading to identification and boosting sustainable market and investment 
opportunities in B urkina Faso. The project supports effective means of knowledge -sharing and 
technology transfer between Africa and the EU, all with the aim of increasing Africa's preparedness 
to address the vulnerability of water and climate change -related challenges as we ll as to improve 
water and climate monitoring and forecasting processes and too ls in Africa. The requested EC 
contribution for LDC partner s is around  €121,000.  
293.  Global trends in population growth and rising economic prosperity will increase the demand 
for energy, food and water, with more severe impact in fast -growing economies, such as in several 
African countries. The constraints on water, energy, and  food could hamper economic 
development, lead to social and geopolitical tensions, and cause lasting environmental damage. 
The DAFNE project stands for Use of a Decision -Analytic Framework to explore the water -energy -
food Nexus in complex and trans -boundar y water resources systems of fast growing developing 
countries  – sometimes when you see the objectives of these programmes you understand the 
challenge of finding an acronym. It applies an innovative integrated water management approach, 
tailored to local conditions, to water management in specific basins, operational water 
management across different countries, identification of vulnerabilities, improved local capacity 
and increased social and economic well -being within the study areas. The project activit ies range 
from monitoring, development of indicators and scenarios, modelling, development of decision 
support systems and interaction with stakeholders and policymakers to negotiation exercises and 
simulations. The beneficiaries are Mozambique and Zambia.  The total requested contribution is 
almost €3.5 million .  
294.  Again concluding with  a programme supported by our Member States, I would like to refer to 
the United Kingdom funding of the Sustainable Crop Production Research for International 
Development. In t he framework of this project grants are given to eligible research institutions. 
Each project includes at least one partner from the UK and one from a developing country. The 
approach aims to build scientific capacity in Burkina Faso, Kenya, Ethiopia, Sout h Africa, Tanzania, 
Uganda, Bangladesh, India and the Philippines. The project aims to ultimately deliver crop 
varieties more resistant to biotic and abiotic stress to poor farmers in the beneficiary countries. It 
provides an important contribution to the development of new technologies for specified staples, 
and generates sustainable and long term capacity building i n agriculture research. The UK's  
Biotechnology and Biological Sciences Research Council provided £3  million to this project.  
295.  So these are som e of the programmes that we have in our very extensive submission. We 
believe that they are fairly representative of the serious commitment that we undertake with 
respect to this WTO obligation.  
10.2 Australia  
296.  Australia is committed to assisting LDCs in the area of technology transfer, pursuant to the 
Council's decision on the implementation of Article 66.2.  
297.  We were pleased to present Australia's report yesterday at the Workshop. It was another 
important opportunity to foste r continuing dialogue between Members regarding technology 
transfer incentives that benefit LDCs.  
298.  Australia has attended these Workshops since their inception.  They are a useful forum for 
exchanging views, and have positively influenced how Australia prepa res our reports and shares 
information.  I won't go into detail this afternoon of the report, but in this year's report available 
online, we outline initiatives to promote and encourage technology transfer in a wide variety of 
fields.  
299.  Australia recogniz es that encouraging increased innovation and technology transfer to high 
productivity sectors is a means of helping our LDC partners create a sound and viable 
technological base . IP/C/M/83/Add.1  
 
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  10.3 United States  
300.  The United States attache s great importance to this review with respect to the obligations 
under Article 66.2 of the TRIPS Agreement. We, like others before us, join the chorus of support 
for the Workshop which was held yesterday where we had very concrete discussions about priori ty 
issues to LDC Members.  
301.  Our submission this year is an update to last year's comprehensive report detailing the IP, 
trade capacity, training, development assistance, educational, financing, entrepreneur and 
infrastructural -related programmes aimed to sup port LDCs in fostering the necessary environment 
to encourage the effective voluntary transfer of technology to LDC Members.  
302.  The United States continues to believe that the effective functioning of Article 66.2 of the 
TRIPS Agreement requires a robust dial ogue between developed countries and LDC Members in 
order to target incentives in a way that is most responsive to the self -identified technology transfer 
interests and needs of LDC Members.  
303.  We welcome yesterday's discussion, as we mentioned, and we believ e it provides an 
opportunity to continue the exchange and to further address important questions.  
10.4 Switzerland  
304.  We will not introduce our report in this Council, but refer to our intervention we made 
yesterday. This is  just a brief intervention joining other delegations to thank the Secretariat for 
organizing yesterday's Workshop on the Implementation of Article 66.2 of the TRIPS Agreement.  
305.  The meeting allows the reporting Members and beneficiary  LDCs to take  up specifi c 
discussion point s and review substance contained in the report s in a more informal framework 
than we have here in the TRIPS Council .  
306.  Switzerland also thanks again the LDCs for their engagement and for their questions raised 
with respect to our updated r eport which experts will respond to in due course.  
10.5 Japan  
307.  Japan would like to thank the Secretariat for organizing yesterday's Workshop on the 
Implementation of Article 66.2 of the TRIPS Agreement. The Workshop advance d cooperative 
activities and enhance d mutual understanding between developed country Members and LDC 
Members.  
308.  Japan will continue to make its utmost efforts to improve the business environment and 
make it even more conducive to transfer technology. This delega tion looks forward to working 
further with LDC Members in this context.  
10.6 New Zealand  
309.  Similarly to other delegations, New Zealand would like to thank the Secretariat for organizing 
the Workshop yesterday where New Zeala nd presented our report detailing our activities related to 
Article 66.2 . We think that it was a good, robust and useful discussion and we look forward to the 
next iteration.  
10.7 Benin, on behalf of the LDCs  
310.  On behalf of the LDC Group , I would like  to take this opportunity to thank the eight partner 
countries which have reported on their activities on this matter. We welcomed yesterday's 
Workshop. It gave us the opportunity to have an exchange of views and  to get much information 
from our partners. By the same token, our partners had the opportunity to exchange information 
with us and to hear what different people are doing. We are most grateful to our partners who 
work with us and provide us with support i n the whole area of the transfer of technology.  IP/C/M/83/Add.1  
 
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  311.  I would furthermore like to say the following: we took the opportunity to put some questions 
to our partners and as they have said there were some questions put to us and the replies are 
ready. They have alre ady been sent out and I do hope that they will be available to our partners 
shortly. We would like to take this opportunity to invite developed countries that have not yet 
submitted their Annual Report to follow the example of the eight partner Members wor king with 
us. It would be most useful for LDCs if other countries were to report. We eagerly await such 
reports as we find them extremely useful.  
312.  In conclusion, and this is particularly for the attention of the Secretariat, it would be most 
useful for thes e reports to be available in the WTO's official languages. That will make it much 
easier for us to work with our capitals. This time around we did have a lot of difficulty in 
responding to all of the reports because most of them were in English and not all  the LDCs are 
English -speaking. We would be grateful if the Secretariat could help us avoid such problems in the 
future. This is what th is delegation wishes to say on behalf of the LDC Group and we would like 
once again thank you for having led yesterday's  Workshops so well.  
10.8 India  
313.  The report submitted by the European Union shows  some projects which they have done in 
India also. I think the mandate as per Article 66.2 is limited to LDCs.  I strongly object to  include 
India as an LDC in the list of beneficiaries of some specific programmes so I request the European 
Union to delete references to India in the report and resubmit their report.1  
314.  I also propose that in the future the Secretariat should go through the report properl y. In 
many reports I have seen also programmes which are only specific to some of the developing 
countries and not to LDCs. The mandate is limited to LDCs  only. They are showing some of the 
programmes which they are doing as developing countries in this re port so I urge the Secretariat 
to properly go through the reports and ensure that such things will not be part of the report that is 
specific to LDCs.  
10.9 European Union  
315.  We would like to thank my colleague from India.  It is indeed accurately spotted. It is just to 
be sure that, as I told in the presentation, the programmes that we have are not necessarily 
specifically tailored for LDCs. Often they cover regions so when we are describing the report we 
are mentioning whi ch are the countries that are beneficiaries from this report and on occasion the 
programmes may include countries obviously that are not LDCs. To be perfectly clear, is it just to 
remove India from the report or from the list of countries that benefit from  this assistance?  
10.10 India  
316.  My point was that there should not be any reference to developing countries in the report 
which are specific to LDCs because the mandate is very clear. They should only submit a report 
about  technol ogy transfer to LDCs. Also they are showing India in the column of LDCs. I strongly 
object to such kind of reporting.  
10.11 WTO Secretariat   
317.  We are very conscious that it is not least because we had to process all thos e words too. We 
are conscious that this a lot of information that is difficult to get access to and that is unfortunately 
the reason why it is not available at the moment in all working languages – simply because it is a 
very large translation task . Noneth eless the  reports  will be issued as soon as possible in all WTO 
working languages.  
318.  However, the idea that we are moving towards an online platform, exactly as the Chair has 
mentioned, should mean that the reports will be easier to prepare and submit, will be quicker to 
process and will be easier to consult and translate so that the flow of information should be much 
                                                
1 Secretariat note: These comments refer to the advance copy of the European Union's Report on the 
Implementation of Article 66.2 TRIPS that was circulated in Room Document RD/IP/12. A revised and final 
version of the report is being circulated in document IP/C/W/616/ADD.7.  IP/C/M/83/Add.1  
 
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  easier and more rapid in terms of access to even the translated versions. The fact that Members 
have taken a lot of trouble to format the repor ts in a tabular form has been enormously helpful 
and will help us transition towards a more workable system . We are very grateful for Members for 
helping us in that regard.  
319.  Furthermore, as was mentioned this morning, we will be working towards developing a  
portal or a gateway that Members can use to consult, to access this information and for those who 
have a particular interest in this area or other areas, we would be delighted to sit down with them 
at a quieter time to get their guidance on what is most u seful in terms of accessing this material.  
320.  Finally as the delegation of Benin has mentioned, on behalf of the LDC Group, there are a 
number of questions taken on notice at the Workshop yesterday . I have been asked to quickly 
mention that we will be circul ating those questions directly to the Members concerned and would 
invite them to reply to the questions. In discussions yesterday, it looked like a reply sometime in 
January might be feasible. That would enable us – or you as delegates – to have a look at the 
answers in time for the discussion at the next TRIPS Council meeting. So I just wanted to clarify 
that that was the informal agreement reached at the Workshop yesterday.  
AGENDA ITEM 11: TECHNICAL COOPERATIO N AND CAPACITY -BUILDING  
11.1 Australia  
321.  Australia takes an active role in promoting technical cooperation and capacity -building in 
intellectual property as we have highlighted in our Article 67 Report (IP/C/W/617/Add.1).  
322.  We are also strongly committed to suppor ting least developed and developing countries in 
identifying their indiv idual priority needs and mobiliz ing resources to implement the TRIPS 
Agreement.  
323.  Of note, we have achieved effective results under the first phase of our Australia -WIPO 
Funds in Trust a rrangement.  
324.  In the ASEAN region we assisted Cambodia and Laos accede to the Madrid Protocol. Further 
to this, w e have continued our work with Myanmar and Kiribati to draft their National Intellectual 
Property Strategies.  
325.  The second phase of this program me seeks to build on the successes of the first, to extend it 
to new partner countries and expand support for innovative intellectual property activities which 
secure benefits for LDCs and developing country partners.  Australia will report on these activitie s 
next year.  
326.  We are pleased to once again reiterate our commitment to technical cooperation and 
intellectual property capacity -building activities.  
11.2 Mexico  
327.  We appreciate being able to contribute to this agenda  item regarding one of the technical 
cooperation programmes which is most relevant to the Government of Mexico, i.e.  the support 
system for patent applications and management for Central American countries and the Dominican 
Republic known as CADOPAT. CADOPAT i s a service through which the Mexican Institute of 
Industrial Property provides assistance to the national officers of industrial property in Latin 
America, the Caribbean. Currently there are petitions for providing support regarding patents 
which have an equivalent in Mexico as well as those which do not have an equivalent in our 
country. The CADOPAT System aims to facilitate the exchange of information by analysing patents 
and providing a report on the patent applications or regarding information on any o ther request. 
Initially the participants of this office included seven countries of Central America, but we have 
also had a further seven countries who have joined including ARIPO from Africa. We have now 
dealt with 1,890 petitions in total since 2007.  IP/C/M/83/Add.1  
 
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  11.3 United States  
328.  The United States is pleased to highlight its report under Article 67  contained in document 
IP/C/W/617/Add.5 , on the technical assistance programmes, provided by the United States 
Government, co ncerning the protection, utilization and enforcement of IPRs for developing and 
LDCs. In this respect, we also welcome Mexico's intervention to describe its engagement on this 
issue as well which we find to be very much welcome.  
329.  In the past year, our repo rt accounts for more than 142 training, technical assistance and 
capacity -building programmes to over 4,975 participants from 108 different countries , including 
developing countries and LDCs. Of these nearly 108 countries, 19 programmes were provided for 
25 LDCs, including Bangladesh, Benin, Bhutan, Burkina Faso, Cambodia, Central African Republic, 
Ethiopia, Gambia, Guinea, Haiti, Lao PDR, Lesotho, Liberia, Malawi, Mali, Mauritania, Mozambique, 
Myanmar, Nepal, Niger and Senegal, Togo, Uganda, Tanzania and Z ambia.  
330.  Technical cooperation to improve IP legal, administrative and enforcement infrastructure is 
crucial to economic development that is directly linked to contributing to foreign investment and 
voluntary private -sector led technology transfer in develop ing countries and for developing country 
innovators to capitalize on their own creativity. The US Government technical assistance is driven 
by demand and individual priority needs of beneficiary countries. The diversity of needs and 
interests identified by  beneficiary countries results in tailored technical assistance activities on 
specific areas of interest. We look forward to the technical discussion on the reports in this Council 
concerning technical cooperation of governments and of intergovernmental or ganizations for the 
strengthening of IP systems.  
11.4 WTO Secretariat  
331.  I will be brief since I am sure all delegates have already had a chance to read document 
IP/C/W/618 which is our annual summary of technica l assistance  work. It has a descriptive cover 
note and an annex ed table of all the relevant activities that were delivered in the reporting period. 
I will therefore just confine myself to a few general observations about the overall trends.  
332.  Firstly, the f ocus remains on assisting Members and observer countries to understand the 
rights and obligations that flow from the TRIPS Agreement. With an increasing attention to the 
way that different Members have applied and made use of policy options under the TRIPS  
Agreement , it becomes driven by empirical information about policy choices, but is equally 
addressing a wider range of areas of policy. This is because our activities are very much based on 
feedback from the participants themselves, particularly the gover nment officials that take part in 
our training programmes and other TA activities. A strong signal indicates  that they look for 
understanding of how the TRIPS Agreement and the policy options within the TRIPS Agreement 
relate to other areas of policy. An o bvious example is health , discussed already today , as well as 
innovation, industrial policy, regulation, competit ion policy and the environment, as well as related 
areas . We are adapting the programmes accordingly in order to  respond to that feedback and 
evolving demand.  
333.  This also means that the partnerships with other organizations , while always a part of our 
work, becomes increasingly important. In particular , the cooperation with the WHO and WIPO in 
connection with IP trade and public health  has been me ntioned , but that is by no means an 
exclusive activity . I would highlight the growing and more intensifying partnerships that we have 
with other international organizations and other partners, industry partners, non -governmental 
organizations, civil societ y and regional organizations, forming part of a holistic approach to 
technical assistance and ensuring that there is a necessary breadth of expertise and experience. 
This respond s to the practical demand that we experience from the participants in our 
programmes.  
334.  Therefore, I would conclude by mentioning with particular appreciation the contributions and 
the excellent partnership that we have enjoyed with a range of our partners in the multilateral 
sphere in recent activities. These have included UNAIDS, U NCTAD, UNDP, UNCCC, UN Office of the 
High Commissioner for Human Rights , UPOV, WHO, WIPO and WCO. The list of other partners , 
including regional players, civil society and private  sector actors , would take much more time to go 
through . I would conclude sim ply by expressing our great appreciation for that cooperation and IP/C/M/83/Add.1  
 
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  the way that it enriches and strengthens the TA activities. The activities remain demand -driven 
and focused on the practical context that our Members put to us for technical assistance . We will 
continue to apply TA activities in response to that demand.  
11.5 Colombia  
335.  Colombia would like to share its recent experience on this item regarding technical 
cooperation received from some international organizat ions, such as WIPO and the World 
Economic Forum , regarding strengthening its IP System. We would like to highlight the 
programmes which have bene established to promote innovation and registration through the IP 
system. We would like to share the Colombian  experience on this item.  
336.  We would also like to highlight the efforts made by institutions. One of the programmes we 
would like to mention is the programme created by the Government for support centres for 
technology and innovation to increase access to in formation as well as  to promote the use of this 
information for innovation and economic growth. This programme which has been led by the 
Government of Colombia, as well as WIPO, has promoted access regarding patents and other 
resources which have been publ ished nationally and internationally. This programme has led to the 
creation of centres supporting technology and innovation. We have 23 of these centres in 12 main, 
large and medium -size cities. We currently have 19 agreements  with different institutions,  such as 
research centres and universities to strengthen our work in innovation.  
337.  Finally, we would like to highlight that this work on innovation has allowed us to strengthen 
our patent applications and this has been done with the support of the World Eco nomic Forum and 
WIPO as well as other programmes. We would also like to point out that Colombia, with Morocco 
and the Philippines, has been selected for a pilot programme on this matter. These were the issues 
that we wanted to share with the Council.  
11.6 ARIPO  Secretariat   
338.  As you may be aware, ARIPO was created to pull resources of its Members States for the 
promotion, development and harmonization of intellectual property laws and policies and to ensure 
that they contribute to the social, economic and technological development of its Member States. 
To date, ARIPO is composed of 19 Member States in Africa.  
339.  I wish to bring on record some remarkable achievements in the ARIPO system with regard to 
technical coop eration programmes relevant to TRIPS which ha ve been achieved either solely or 
with the support of some cooperating partners. It is worth highlighting at this juncture that due to 
the limited resources at the organization the initiatives were possible due to the support and the 
involvement of other partners. We therefore wish to highlight that WIPO, Japan Patent Office, 
USPTO, IP Australia, the Government of the Republic of Korea, IFRRO  and other national IP offices  
of the ARIPO Member States were our strat egic partners.  
340.  The initiatives that we have undertaken focused on awareness -raising, training, 
improvement of the legal and institutional framework, enforcement and dissemination of 
information on IP. One of the main challenges for the successful implement ation of the IP System 
in Africa is the lack of awareness of the important role that IP plays in harnessing and rewarding 
human creation for the social, cultural, economic and technological development. It is on this 
backdrop that ARIPO took to run roving seminars in each Member State. Since its inception this 
initiative covered 15 countries and directly benefited more than 2,000 participants.  
341.  ARIPO also views IP training of paramount importance. Since 2006 ARIPO has hosted an 
academy. In 2008 a mas ter of the group programme was introduced in collaboration with the 
WIPO Academy and the Africa University located in Zimbabwe. The programme graduated since its 
inception 221 students from 25 African countries. A new MIP programme will be launched with the 
Kwame  Nkrumah University in Ghana early next year.  
342.  ARIPO also provided technical assistance to Member countries to strengthen and improve the 
legal and institutional framework . It hosted a number of officials in its headquarters to capacitate 
them on the admin istration of IP Systems.  IP/C/M/83/Add.1  
 
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  343.  Finally, the organization has also launched a number of publications related to copyright in 
order to boost the knowledge on this issue in the Member States. With all these initiatives, ARIPO 
intends to assist Member States in impr oving their IP systems and to better harness its potential 
for the development of their countries. A more detailed on tabular form was made available for the 
delegates.  
11.7 G ulf Cooperation Council   
344.  Let me first recall that the G ulf Cooperation Council  Secretariat General is coordinating the 
member States common work on intellectual property, including the implementation of the TRIPS 
Agreement and the follow -up of the various common efforts made to com ply with national laws in 
the various IP fields as well as with the international agreements.  
345.  As far as technical cooperation is concerned, the GCC Secretariat General is acting through 
its WTO Department, the GCC patent Office (GCCPO) and the GCC Intellec tual Property Training 
Centre (IPTC) to provide the GCC member States, on a demand -driven basis with various legal 
consultancy and technical assistance.  
346.  The WTO Department, created as part of the GCC Secretariat General structure to follow up 
and coordinat e WTO affairs, is called for providing legal consultancy and specialized workshops as 
technical assistance to the responsible administrations and officials in the GCC member States, 
including in the field of the TRIPS Agreement.  
347.  In this regard, the WTO De partment intends this year to conduct a Workshop on ''the TRIPS 
Agreement and its implications for the GCC member States'' to be held from 21-24 
November  2016 in Manama, Bahrain. This event will be organized for the benefit of officials in 
charge of IP iss ues in the GCC member States and other c oncerned responsible s in the 
GCC Secretariat General. The Workshop is designed to explain the TRIPS Agreement, its 
implementations for the GCC member States and the impact of the enforcement of its rules and 
mechanis ms on trade and investment in the region.   
348.  In the framework of building practical linkages and dialogue with regional organizations as 
high priority for its programme of regional trade policy capacity building, the WTO Secretariat has 
invited kindly the G CC Secretariat General to contribute to the T rade Policy Course organized by 
the WTO in Muscat, Oman, later this year, through a presentation on the GCC work in the field of 
intellectual property, and the GCC Patent Office activities in particular. Thus, i t is for us a big 
honour and great pleasure that the GCC will take part in such important programme of technical 
cooperation and capacity building conducted by the WTO Secretariat.  
349.  In addition to its role as a regional patent office for implementing GCC P atent Law, the GCC 
Patent Office has built a mutual cooperation program me with GCC national patent offices with the 
aim of conducting various activities on technical assistance and developing capacities in the field of 
patent s, as well as enhancing their a bility to contribute to th e enforcement  of patents  in the 
GCC member States.   
350.  In this context, the GCCPO has conducted during 2016, for employees of the GCC Patent 
Office and national IP Offices, three training courses on ''Substantive Examination Procedu re'' in 
cooperation with  the Egyptian Patent Office and the State Intellectual Property Office of China, in 
preliminary, advanced and on -job levels, in the GCC headquarters (Riyadh) respectively on 
13-17 March 2016, 20 –24 March 2016 and 24 –28 April 2016.  
351.  The GCCPO has also organized in cooperation with WIPO two Workshops in the GCC 
headquarters (Riyadh). The first one on ''Patent Cooperation Treaty (PCT)''  was held from 
25-26 May 2016 , with the aim of familiarizing the participants with the various aspects  of the PCT, 
while the second, held from 16th  to 20th  October 2016, focused on ''Patent drafting'' for the 
benefit of officials of the GCC Patent Office and national IP Offices.  
352.  In addition the GCCPO organized in cooperation with Bo ehmert and Bo ehmert a training 
program me for the benefit of the GCCPO Grievance Committee on "litigation system in European 
Patent Office and German Patent Office " held in the headquarter of the GCC Intellectual Property 
Centre " in Kuwait on 29-31 August 2016.   IP/C/M/83/Add.1  
 
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  353.  The GCCPO is al so intending to organize very soon two workshops , one in cooperation with 
WIPO on ''Examination work sharing program: the benefits of published search results'' to be held 
in Riyadh from 6 to 10 November 2016, for officials of the GCC Patent Office and nat ional IP 
Offices, and the second in Abu Dhabi on 10 November 2016 on ''Creativity and Innovation'' for the 
benefit of officials concerned in the GCC member States.   
354.  On the other hand, the GCCPO has participated in ''the Middle East International Exhibitio n 
of Inventions'' which was held in Kuwait from 16 to 19 November 2015. The participation of the 
GCCPO in this exhibition included granting an yearly award of 50,000 SAR to the GCC inventors in 
addition to supporting their participation.  
355.  The GCCPO has supp orted also inventors from the GCC member States those taken part in 
''the Geneva International Exhibition of Inventions '' held on 13 – 17 April 2016, where the GCC 
Patent office along with inventors from the GCC member States have opened up doors of 
commu nication with those concerned in Europe and the world.  
11.8 WHO Secretariat   
356.  We welcome the opportunity to present WHO 's activities on technical cooperation in the area 
of public health and intellectual propert y. In this intervention, we would like to highlight two areas 
of our work: fostering R&D into new antibiotics and increasing access to hepatitis C treatment.  
357.  On 14 October 2016, the Centre Hospitalier Universitaire Vaudois announced that it was 
facing an o utbreak of vancomycin -resistant enterococci bacteria. Vancomycin is one of the few 
antibiotics that is still effective at treating methicillin -resistant staphylococcus infections, which are 
both common and dangerous. The hospital quarantined affected patie nts and took infection -control 
measures, including shifting surgeries to other hospitals in the region, to prevent the transmission 
of the resistance genes to other more deadly bacteria that are already resistant to nearly every 
other antibiotic.  
358.  This is o nly one episode, but it illustrates the growing problem of antimicrobial resistance. 
The WHO has taken a leading role in combating the rise of such resistance, including on how to 
foster the development of new antibiotics.  
359.  Together with the Drugs for Negl ected Diseases initiative, the WHO launched a new initiative 
known as the Global Antibiotic Research and Development Partnership. This new joint venture 
aims to develop new antibiotic treatments, promote their responsible use and ensure equitable 
access of  these antibiotics. In collaboration with WHO, it will identify R&D gaps and launch projects 
to fill those gaps.  
360.  Over €2 million of seed funding has been secured from the Governments of Germany, the 
Netherlands, the United Kingdom, South Africa and  Switzerland, as well as from Médecins Sans 
Frontières. The Partnership will work closely with all global stakeholders in  antibiotic R&D to 
develop new antibiotic treatments, including pharmaceutical and biotechnology companies, start -
ups, academia, civil society and health authorities. The aim is to have at least two projects that 
address urgent global health needs ready fo r implementation by the end of 2016 and two more by 
the end of 2017.   
361.  Trade law and intellectual property policies are part of the ongoing discussions about how to 
combat antimicrobial resistance. Last month, the WHO, WIPO and WTO held a joint, trilateral  
symposium on antimicrobial resistance. The goal was to highlight the importance of global 
cooperation in fostering innovation of new antibiotics, assuring access to needed antibiotics, and 
promoting antibiotic stewardship.  
362.  Let us turn now our attention t o another area of work . When the new Direct Acting Antivirals 
(DAAs) were first approved for Hepatitis C treatment in 2013, there were widespread fears that 
their high price would put them out of reach for the more than 80 million people with chronic 
Hepatitis C infections worldwide. The new medicines have few side effects and can cure the 
disease  for more than 90% of patients within three months. But at the initial high entry prices of , 
for example US$84,000  in the United States , the drugs were unaffordabl e even in many high -
income countries.  IP/C/M/83/Add.1  
 
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  363.  Nonetheless, a new WHO report, the Global Report on Access to Hepatitis C Treatment: 
Focus on Overcoming Barriers, released in October 2016 shows how a range of low - and middle -
income countries  – including Brazil, Egyp t, Georgia, Indonesia, Morocco, Nigeria, Pakistan, 
Philippines, Romania, Rwanda, Thailand and Ukraine – have been successful in getting drugs to 
people who need them using a series of access strategies supported by the WHO and other 
partners.  
364.  As the report  documents, voluntary license agreem ents have allowed more than 
100 countries to procure the new Hepatitis C drug from a range of generic providers. In addition, 
the non -filing or denial of patents based on patent oppositions filed by civil society have al lowed 
for some local production. Egypt, for example, has driven down prices from an initially negotiated 
price o f US$900 in 2014 to around US$ 170 for a three -month course of the new treatment today 
buying from local suppliers.  
365.  There are still huge differe nces between what countries are paying. Among middle -income 
countries wh ich have no access to generic versions, the price for a three -month treatment of 
sofosbuvir and daclatasvir varies greatly. Costs range from US$9,400 in Brazil to US$79,900 in 
Romania.  Some middle -income countries such as Brazil have opted for price negotiations. Using 
TRIPS flexibilities is another option and is described in more detail in the report.  
366.  High-income countries use various forms of price controls, but the study shows that t hose 
efforts have met with mixed success. High costs have led to treatment rationing in some countries, 
including in the European Union, where current pricing levels do not allow for treating the whole 
affected population. The new WHO Report that presents detailed information on prices of originator 
and generic treatment, where the different drugs are patented and where they are authorized for 
the market , will help create the market transparency needed to support country efforts to increase 
access to DAAs a nd will contribute to the implementation of the Global Health Sector Strategy on 
Viral Hepatitis that aims at eliminating hepatitis as a public health threat by 2030.   
367.  I still have a couple of printed copies left and whoever leaves me his card, I would be happy 
to send over a PDF . You can also find the link to the report in our detailed report on our activities 
that is available as a WTO document.  
11.9 UNCTAD  Secretariat   
368.  The UNCTAD Secretariat through its in tellectual property unit implements a work programme 
on the development dimension of IPRs. The work programme is designed to respond to the 
mandate received from Member States at the Ministerial Conference in Nairobi in July this year , as 
well as the inter governmental request under the WIPO Development Agenda and the World Health 
Assembly Resolution 61/21 on a Global Strategy and Plan of Action on Public Health, Innovation 
and Intellectual Property.  
369.  UNCTAD conducts research and policy analysis on trade and  development aspects of IP, 
facilitates consensus -building and respon ds to requests for technical assistance and advises on 
policy options on successfully integrating developing countries into the world economy.  
370.  As far as technical cooperation is concerned , on a request basis, UNCTAD conducts technical 
cooperation activities with developing countries in the integrated areas of investment, trade and 
IP. The technical assistance activities are partly funded by donor governments and institutions and 
can be div ided into the following programmes:  
(1) IPRs, local pharmaceutical production and supply capacity of essential medicines. UNCTAD 
implements a work programme on local pharmaceutical production with a view to assisting 
developing countries and LDCs, in parti cular to utilize IPRs as tools that facilitate increased access 
to affordable medicines and where feasible to promote domestic and foreign investment to create 
local and regional pharmaceutical production and supply capacities. For example, UNCTAD, at the 
request of the Ethiopian Government, works closely with WHO on the implementation of the 
National Strategy and Plan of Action for pharmaceutical manufacturing development 2015 -2025. 
The programme is supported by the German Federal Ministry of Economic Coop eration and 
Development ;  IP/C/M/83/Add.1  
 
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  (2) Policy coherence for local pharmaceutical production. Funded by German International 
Corperation  (GIZ), UNCTAD's work programme assists developing countries' efforts to promote 
coherence of policies in respect of health, trade  and industrial development and ensure that local 
pharmaceutical production increases access to medicines. UNCTAD and GIZ pursue this activity on 
a regional basis in South -East Asia and the East African Community. Last week, UNCTAD provided 
substantive inp uts and policy recommendation s at the first  international high -level multi -
stakeholder workshop  on promoting pharmaceutical sector investment in the East -African 
Community region in Nairobi, Kenya which was organized by the EEC Secretariat ;  
(3) IPRs and t echnology transfer. In 2016, UNCTAD launched it s technical assistance programme 
on IP, transfer of technology and trade facilitation with the financial support from the Government 
of Germany. The programme discusses the use of IPRs, such as trademarks , for trade facilitation. 
In addition, it focuses on the use of IP regimes for the promotion of technology absorption 
capacities. For example, UNCTAD , in cooperation with the National Agency for Industrial Property 
of Benin,  organized in Cotonou a national work shop on IP, technology transfer and access to 
medicines  in May 2016;   
(4) IPRs and biodiversity. UNCTAD's technical assistance programme on IP and biodiversity has 
focused on the building of local capacities in developing countries to design and enforce do mestic 
trade, customs and IP laws in line with access and beneficiary rules under the Convention on 
Biological Diversity, the Nagoya Protocol and the UN Declaration of the Rights of the Indigenous 
People. For instance, UNCTAD, in cooperation with the Intel lectual Property Office of the 
Philippines in May 2016 in Manila, organized a national workshop on the interface of IPRs, 
biological diversity and traditional knowledge ; 
(5) Development dimension of IP, DDIP and other advisory reports. UNCTAD provides this  open 
request by a developing country or LDC advisory report on the development dimension of 
intellectual property, DDIP. Developing countries specify the key development objectives they wish 
to examine. A DDIP report will take into consideration the socio -economic situation of the 
requesting country, the bilateral, regional and international commitments the target countries 
have entered into and the flexibilities available to them. Based on this analysis, the report 
incorporate s medium to long -term recomme ndations on how governments and other stakeholders 
could make these frameworks more coherent and transparent with a view to making IPRs 
contribute to a country's sustainable economic and human development goals and respond ing to 
emerging global opportuniti es; and  
(6) C ooperation with other providers of IP -related technical assistance. Staff of UNCTAD's IP unit 
frequently participates in capacity -building workshops on IP and development issues organized by 
other providers of IP -related technical assistance. For instance, UNCTAD was invited by WIPO and 
WTO to contribute to the 2016 WIPO -WTO Advanced Course on IP for Government Officials. In 
September 2016 , UNCTAD invited WHO, WIPO and WTO to make contributions to a multi -
stakeholder workshop organized by UNCTA D, UNDP and South Africa's Department of Trade and 
Industry  (the dti)  in Pretoria, South Africa, on a proposed IP consultative framework. UNCTAD also 
participated in a Workshop organized by WTO and the DTI on the same topic.  
371.  As far as research and policy a nalysis is concerned, UNCTAD undertakes research and 
analysis on trade and development aspects of IP and provides an advisory report for developing 
countries. Currently UNCTAD is finalizing a guide to policy coherence for access to medicines and 
local phar maceutical in collaboration with German International Cooperation. The guide is designed 
as a quick -reference tool for developing country policymakers on the various policies related to 
health, industrial development, trade, investment, innovation and IP, and how they may be used 
to contribute to local production and access to medicines.  
372.  Finally, consensus -building among stakeholders on issues of IP is an important element of 
the programme's work. UNCTAD participated as a member of the expert advisory grou p to the 
United Nations Secretary -General High -Level Panel Report on Access to Medicines. UNCTAD in 
collaboration with UNAIDS, the African Union and GIZ organized a round table discussion on 
supporting access to medicines and industrial development in Afri ca investing in domestic 
pharmaceutical manufacturing on 21 July 2016. In Nairobi, on the side of the UNCTAD  Conference 
in July  were investment forums. Representatives of the private sector, investors, civil society and 
government s participat ed in the roun d table. At the end of the event, UNCTAD's Secretary -
General, Dr. Mukhisa Kituyi , UNAIDS Executive Director, Mr. Michel Sidibé, African Union IP/C/M/83/Add.1  
 
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  Commissioner for Trade and Industry, Mrs. Fatima Acyl , Cabinet Secretary of the House Ministry of 
Kenya, Dr. Cleop a Mailu, and South Africa's Minister of Trade and Industry, Dr. Rob Davies, signed 
a statement on investment in access to medicines. The joint statement affirms the signatories ' 
commitment to facilitate investment in local pharmaceutical production in Afri ca, particularly for 
the manufacture of anti -retroviral medicines in support of SDG3 which targets providing access to 
essential medicines for all, SDG9 to advance innovation and domestic technology development and 
SDG17 to foster international cooperation  and policy coherence.  
373.  An entire list of activities for the period between 1 November 2015 and 15 October 2016 is 
attached to document IP/C/W/614/Add.1.  
AGENDA ITEM 12: INTELLECTUAL PROPERT Y AND INNOVATION: RE GIONAL 
INNOVATION MODELS  
12.1 European Union  
374.  Today under this point of IP and innovation which has produced so many interesting debates 
and interventions in the past, we are proposing a new subject: regional innovation models . I will 
focus o ur presentation today, to a large extent, on the most in -depth and most developed and 
most complex and broad experience in this area which is the intellectual property and innovation 
system of the European Union itself. It is an example of where 28 countri es came together and 
shared quite an extensive variety of mechanisms from legislative to jurisprudential to 
administration and granting of IP rights. Towards the end of my presentation I will also mention a 
couple of other very interesting, very successful  regional models of sharing innovation resources, 
but I think this is really an issue where we could talk for several sessions because it has such a 
variety of angles to tackle it. If I also can remind colleagues that this afternoon during the 
lunchbreak w e will have a side event co -sponsored by some of the countries that are also 
co-sponsoring this point which will build upon the discussion we had yesterday on trade secrets . 
375.  The European Union strongly supports regional integration in the area of intellect ual property 
and innovation, because it fosters better understanding and political and economic links between 
neighbouring countries. The EU has put in place many successful models for regional innovation, 
both in terms of legislation, jurisprudence and th e management of IP rights, since the European 
Union itself is an excellent example for regional integration.   
376.  We have put in place laws which are harmonized to a great extent in the area of intellectual 
property, which ensure legal certainty and predictab ility for business and right  holders, as oppose d 
to legal fragmentation along national borders. Our European Court of Justice plays also an 
important role in ensuring the consistency of the EU law by interpreting it to make sure it is 
applied in the same w ay in all EU member States. National courts of EU member States are 
required to ensure that EU law is properly applied, and when they are in doubt about the 
interpretation or validity of an EU law, they can ask the European Court for clarification  through a 
mechanism called "preliminary ruling ". The same mechanism can be used to determine whether a 
national law or practice is compatible with EU law. Infringement proceeding s can be started 
against a national government for failing to comply with EU law. The legal harmonization and the 
uniform jurisprudence ensure  that, in the EU's territory, the law is applied and interpreted 
consistently so that it provides legal certainty to operators.   
377.  One of the recent examples for regional innovation in the EU is the un itary patent and the 
establishment of the Unified Patent Court. The unitary patent is a legal title that will provide 
uniform protection across 26 EU countries. The new EU law will also set up a Unified Patent Court 
that will offer a single, specialized pa tent jurisdiction. The payment and management of the 
renewal of the patents, as well as the registration of the patents and the related rights will be 
managed centrally by the European Patent Office with respect to the territory of the participating 
member  States . These new EU laws will improve the framework conditions for business to innovate 
by creating a unified patent system across the  EU.  
378.  The unitary patent protection will  make it possible for inventors, be they individuals, 
companies or institutions , to protect their invention in 26 EU countries on a one -stop-shop basis by 
submitting a single patent application. After the patent is granted, there will be no need to validate 
it in each country, which will save time and money for the applicants. Unitary  patent protection will IP/C/M/83/Add.1  
 
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  make the existing European system simpler and less expensive for inventors. It will end complex 
validation requirements and drastically limit expensive translation requirements in participating 
countries. By reducing the translation  and publication costs, simplify ing the maintenance of 
patents – their renewal  – and simplifying the registration of transfers, licensing agreements and 
other rights the unitary patent will attract more foreign direct investment to the EU and thus 
contribu te to growth and jobs. It is also expected to stimulate research, development and 
investment in innovation. Unitary patent protection will also protect inventions better than the 
current system. Due to the prohibitive costs involved in the national validat ion of European 
patents, many inventors currently only patent their inventions in a handful of countries. This 
makes inventions less valuable as the lack of protection in other countries allows them to be 
copied more easily. The unitary patent will increas e small and medium -sized enterprises ' access to 
patent protection  and also  increase the scope of patent validations and knowledge dissemination. 
Easier and cheaper access to patents in Europe will result in an increased number of innovative 
SMEs. SMEs have  a major role in job creation  since they ensure two-thirds  of private sector jobs. 
The increase in the number of new business es, therefore, can be expected to have a positive 
impact on job creation. This enhanced integration will have a positive impact als o on consumers' 
access to goods and services. A better integrated market ensures better cross -border trade and 
facilitates fight against counterfeit goods.  
379.  The Unified Patent Court will have exclusive jurisdiction for the enforcement of unitary 
patents. Th e UPC will hear actions related to infringement of unitary patents, counterclaims for 
revocation, revocation actions, actions for provisional and protective measures and injunctions, 
actions against decisions of the EPO relating to unitary patents and acti ons for damages or 
compensation from provisional protection by published applications. This will provide a more 
efficient and cost -effective system as patents will not need to be enforced separately in each 
State, as is the case today . The UPC will create a consistent and uniform patent jurisprudence and 
guarantee more expeditious proceedings and more predictability in patent litigations. The UPC will 
have local, regional and central divisions and an arbitration and mediation centre, which will 
contribute t o the expeditious settlement of legal disputes and makes the system more accessible 
for its users. The Training Centre of the UPC guarantees that its future judges will be equally 
highly qualified throughout the contracting states, which is the preconditio n of a uniform and 
predictable jurisprudence.    
380.  The European Union Intellectual Property Office is another example for the regional 
management of intellectual property rights. The European Union Intellectual Property Office 
(EUIPO), which was known as OHI M until 23 March 2016, was created as a decentralized agency of 
the European Union to offer IP rights protection to businesses and innovators across the EU and 
beyond. Since its inception, its core business has been the registration of EU  trademarks and 
registered Community designs, which are valid throughout the European Union. The Office also 
carries out examination, registration, opposition and cancellation procedures for EU trademarks 
and examination, registration and invalidity procedures for Registere d Community Designs. All 
decisions adversely affecting a party to proceedings can be appealed to the Boards of Appeal of 
the Office.  
381.  In order to further support IP right holders, the Office engages in a wide range of 
cooperation and convergence activities  with other IP offices. However, its work at EU level also 
extends to the harmonization of registration practices and the development of common tools, in 
cooperation with national and regional IP offices throughout the EU -28, users and other 
institutional partners. Together, this is the so called European Trade Mark and Design Network, 
working together to offer users a similar registration experience, be it at national or at EU level.  
382.  The EUIPO also hosts the European Observatory on Infringements of Intell ectual Property 
Rights. The Observatory brings public and private stakeholders together in the fight against piracy 
and counterfeiting. For the EUIPO, this has meant becoming an active participant in the next stage 
of the intellectual property lifecycle wh ich is  helping to secure the results of creativity and 
innovation.  
383.  Concerning the management of plant variety rights, the Community Plant Variety Office 
merits attention. This is a European Union agency, which manages a system of plant variety rights 
across the 28 member States. The CPVO provides EU -wide protection for new plant varieties, 
which is a cost -effective, fast and efficient way for breeders to protect their new plant varieties. 
The core task of the CPVO is processing of and taking decisions on a pplications for Community IP/C/M/83/Add.1  
 
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  plant variety rights. Furthermore, the CPVO either directly or by its Administrative Council, advises 
the Community institutions, Council and Commission, and the EU member States on Plant Variety 
Rights legislation and related pol icy areas. The CPVO furthers effective plant variety protection 
through awareness -raising activities designed to foster respect for plant variety rights and 
encourage the development of enforcement tools. In UPOV, the International Union for the 
Protection  of Varieties of Plants, the CPVO plays a prominent role. It also supports research and 
development activities aimed at improvement of the DUS testing methods.  
384.  Another area of regional integration in the EU is the harmonized law on geographical 
indication s. The EU operates three systems for the protection of geographical indications, for wines 
(aromatiz ed wines), spirit drinks and for agricultural products and foodstuffs. These were created 
to provide uniform protection for GIs throughout the European Unio n. The European Commission 
operates the E -Bacchus database which consists of the Register of designations of origin and 
geographical indications of wines protected in the EU, the DOOR database for agricultural products 
and foodstuff and the E -Spirit Databa se for the spirits. These electronic databases make the EU GI 
systems transparent and searchable.  
385.  These are only some examples of the regional mechanisms we have in place . It is not 
surprising that we reiterate here the EU support  to other  regional innova tion models all around the 
world. I would like to highlight a couple of them. The African Regional Intellectual Property 
Organization and the African Intellectual Property Organization are also successful examples of 
regional cooperation of their contracti ng members. The EU supports the work of ARIPO, because it 
promotes the development of intellectual property laws appropriate to the needs of its members, 
establishes common services and training schemes, and assist s its members in the acquisition and 
devel opment of technology and the evolving of common views on intellectual property matters. 
ARIPO developed the Harare Protocol on Patents and Industrial Designs, which has 17 contracting 
members , and the Banjul Protocol on Marks, with 9 contracting members,  and these legal 
instruments introduced harmonization to a certain extent, which helps business to protect and 
enforce in an easier and more effective manner their  IP rights in the territory of the contracting 
members. OAPI also plays an important role in th e regional integration of its members by 
protecting industrial property rights, disseminating technical information and providing training on 
IPRs. The OAPI syste m with its uniform legislation, the Bangui Agreement, with a common office, 
centralized proced ures and single IP titles, ensures more predictability and cost -effectiveness for 
the IP intensive industries . 
386.  These are only a couple of examples. There are several more that we follow and support with 
considerable interest . I look forward to hearing the contributions that the co -sponsors and other 
Members may have on this issue.  
12.2 Australia  
387.  Australia is pleased to have co -sponsored discussion in this TRIPS Council on regional 
innovation models. Aus tralia is keen to actively contribute to a diverse range of regional innovation 
models and share in the outcomes they bring.  We recognize that innovation is critical to our 
region's economic prosperity. We acknowledge the role that regional engagement and  regional 
systems play in underpinning this important outcome.  
388.  Connections made and maintained through regional innovation models between 
governments, education, science and research institutions and our private sectors will help to 
create new and lasting connections, further economic diversification and share ambitious trade and 
sustainable development outcomes.  
389.  The Australian Government has placed regional models at the centre of its domestic 
innovation strategy, the National Innovation and Science Agenda . As part of this Agenda, Australia 
is establishing Landing Pads in San Francisco, Tel Aviv, Shanghai, Berlin and Singapore. Landing 
Pads will provide Australian market -ready start -ups, many with IP rich ideas, with an operational 
base in these regional in novation hot sports. Emerging Australian companies will gain access 
international expertise, international supply chains and the global market. All Landing Pads will be 
operational by the end of this year.  IP/C/M/83/Add.1  
 
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  390.  Australia also places a high importance on innovat ive programmes within the region. For 
example, on 4 November  2016, the Australian Government announced $3.2 million of funding for 
a new programme: the Regional Collaborations Programme.  
391.  The Regional Collaborations Programme is designed to enable Australi an researchers and 
businesses to strengthen links with their counterparts across the Asia-Pacific region and to develop 
innovative products and solutions to shared challenges.  
392.  Funding multi -partner activities that facilitate greater strategic engagement an d 
collaboration between industry and researchers in science, research and innovation will help to 
reduce barriers and promote open collaboration throughout the Asia -Pacific in developing 
innovative solutions to issues of regional and national significance.  
393.  This investment will also build research capability across the region and establish enduring 
and significant networks between Australia and other key economies. In turn, this will increase 
Australia' s science and research credentials, creat e jobs and tap into international expertise.  
394.  The Australian Government has developed Source IP, a tool which aims to promote 
Australian research internationally by identifying collaborations and licensing opportunities. Source 
IP is a digital marketplace for sharing inf ormation, indicating licensing preferences and facilitating 
contact for IP generated by the public research sector in Australia.   
395.  One local example of Source IP’s success is the collaboration between the Australian tech 
start-up company "Forcite Helmet Sy stems " with the Australia n based University of New 
South  Wales, based on technology that was discovered through Source IP.  
396.  IP Australia is also working to connect Australian public sector innovators to other regions by 
promoting patents listed on Source IP  with a number of sites o verseas, including the major 
UK patent marketplace, and the Danish Patent and Trademark Office.  
397.  IP Australia has engaged all 40 Australian universities, the full panel of Australian Medical 
Research Institutes and Cooperative Rese arch Centres, and the business community to participate 
in the project.   
398.  As a final example, I would like to showcase the good work of the regional based Intellectual 
Property Committee for the ASEAN -Australia -New Zealand free trade agreement, the ANNZFTA . 
399.  The membership of the AANZFTA constitutes one of the most dynamic regions in the world. 
The IP Committee formed by this agreement provides an opportunity for Members to identify and 
address areas of common interest. For example, it is the launch pad for IP Australia’s Regional 
Patent Examination Training Program . The  RPET, as it is commonly known, helps to enhance the 
consistency and quality of patent examination in participating offices, enabling them to improve 
their examination methods to meet internat ional standards. For businesses, this improvement in 
examination standards creates greater confidence in file patent applications in the region and to 
transfer technology across borders.  
400.  The RPET Program h as been internationally recogniz ed by receiving a Gold and Silver Award 
at the 2016 Brandon Hall Group Excellence Awards held in the United States.  
401.  To conclude, the Australian Government actively engages in regional innovation models in a 
number of ways. Examples presented today have included regional inn ovation models that  are 
integral part of Australia' s domestic innovation program me, collaborative program mes to firstly 
connect innovators within the Asia -Pacific region and secondly to connect Australians with other 
regions and finally the positive work o f the IP Committee facilitated through our regional free trade 
agreement.  
402.  We have welcomed this discussion today and encourage others to join us in sharing national 
experiences and practices . IP/C/M/83/Add.1  
 
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  12.3 Switzerland  
403.  Please  first be prepared for a little excursion to calculation  and this is a lawyer as your guide : 
what speaks in favo ur of regional innovation models? It  is quite simple: 1 is just 1. In IP and 
innovation, however , 1 and 1 is 3!  
404.  What do we mean  by this: innovation, and thus also the creation of IP, is, in almost all 
instances, a collaborative process, in which "the whole is greater than the sum of its par ts". 
Transposed to a government' s efforts to create a prosperous environment for IP and  innovation, 
this is a wake -up call to use regional innovation models as a key ele ment in its innovation 
strategy.  
405.  Intellectual property rights play an eminent role in facilitating the process of regional 
integration. IP protection and the availability of effec tive means of enforcement provide countries, 
companies and individuals with the legal certainty they need to confidently and securely trade their 
IP products and services across national borders. Such legal security is an important factor when a 
company co nsiders setting up a regional value chain. For exa mple, when establishing a 
multi-country manufacturin g line. This is only promising  if IPRs are respected throughout the 
whole production and supply chain. Without this, companies will be reluctant to outsou rce their 
production to other countries , transfer or share technology with foreign companies for the 
purposes of research, development or supply partnerships. Accordingly, IP protection is one 
ingredient , among many others, of course , needed to strengthen regional economic ties.  
406.  The following are examples of regional innovation models in which Switzerland participates. 
Inherent in the approach suggested by the topic we discuss today is that, geographically, we refer 
to "our" region. There is , thus, an obvi ous emphasis on examples from Europe. We request 
Members not to misunderstand this as a bias, particularly following after the EU intervention which 
had this focus as well.  We will present, however, our experience from a non-EU-member State 
perspective. It is very clear to us that the Council will only gain the bigger picture by adding and 
comparing the experience and examples of innovation models shared by Members from other 
world regions.  
407.  Let me start with a success story of a Pan -European innovation coo peration: the European 
Patent Organization of wh ich Switzerland was a founding m ember in 1977. The operational heart 
of the organization is the European Patent Office (EPO). The EPO 's core activity is the examination 
of patent applications and the grant of  European patents. In addition, EPO provides patent 
information and training services to lawyers, patent office staff, judges and other interested 
parties. Its participation in the EPO results in significant benefits for Switzerland and its inventors, 
for example,  in terms of the possibility to receive patent protection with one application i n up to 
38 European countries, but also as far as timeliness and affordability of patent granting in Europe 
is concerned, by offering free first -class international pat ent information, harmonized patent 
quality and not least efficient use of financial and human resources due to a single, centralized 
application and examination process. EPO member States also benefit from technical cooperation, 
be it among EPO Member Stat es, or with IP partners worldwide. Key partners in that respect are, 
of course, also other organisations in charge of regional innovation systems . ARIPO, OAPI and the 
Eurasian Patent Office come to mind among others.  
408.  The Patent Union between Switzerland a nd Liechtenstein is an example of a bilateral 
innovation model between two neighbo uring countries. In 1978 the two countries concluded, in the 
framework of their Customs Union Treaty, a bilateral Treaty on the Protection Conferred by Patents 
for Inventions . They now form a unitary territory for the purposes of patent protection. This means 
that a patent valid in Switzerland is automatically valid in Liechtenstein. Neither country needs to 
be designated individually. Based on the successful experience made i n the patent area, 
Switzerland cooperates and coordinates with Liechtenstein its legislative work also in a number of 
other IP areas.  
409.  When thinking about IP and regional innovation models, universities and research centres  
have an important role to play. Euresearch is a network agency mandated by the Swiss 
Government to provide targeted information, hands -on advice and transnational partnering related 
to European research and innovation programmes. The network is composed of a Head Office in 
Bern and Regio nal Offices at each University and the two Swiss Federal Institutes of Technology in IP/C/M/83/Add.1  
 
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  Zurich and L ausanne. In cooperation with the  EU's Horizon 2020 Program me for Research and 
Innovation, Euresearch mobilized for example support to develop a vaccine against  Ebola. In this 
three -year project, the healthcare c ompany GSK and a Swiss University Hospital (Centre 
Hospitalier Universitaire Vaudois - CHUV) contribute to the development of the vaccine with their 
expertise and by making their infrastructure available for clinical trials. In this case of regional, 
institutionalized cooperation, IPRs facilitate and thus promote the research and development of an 
innovative vaccine by ensuring that each partner gets its return on investment and a fair share of 
its profits  made .   
410.  SwissCore, the Contact Office for European Research, Innovation and Education, completes 
the work conducted by Euresearch and is the liaison office in Brussels. It acts as bridge between 
Swiss and European knowledge institutions. The Human Brain P roject (or HBP) is such a flagship 
project, a large ten -year scientific research programme that aims to build a collaborative scientific 
research infrastructure to allow researchers across the globe to advance knowledge in the fields of 
neuroscience, compu ting, and brain -related medicine.  Funded largely by the European Union, the 
HBP is coordinated by the École Polytechnique Fédérale de Lausanne, Switzerland. It is self -evident 
that, in order to be able to smoothly collaborate, the many partners of that  giant science and 
research project, need a detailed contractual agreement on the management and sharing of IPRs 
that each of them creates and contributes to the joint venture.   
411.  The European Organization for Nuclear Research (CERN) may serve as another regio nal 
innovation model. As you may know, CERN 's laboratories are situated at the Franco -Swiss border 
near Geneva. Its scientists use the largest particle physics laboratory in the world, including 
particle accelerators and the impressive large hadron collide r. Intellectual property rights and 
technology transfer play an important role in this regional innovation collaboration. The CERN put 
in place an IP policy and a dedicated Technology Transfer Office which take s care of the 
management of CERN 's inventions and the organi zation’s intellectual property rights, promoting 
the transfer of technology. The 2016 Global Innovation Index calls CERN a successful and 
exemplary regional innovation initiative. The scientific achievements reached at CERN, however, 
are not only important for the European region, but make substantive contributions to the 
international scientific community. And to society as a whole, as we know.  Sir Tim Berners Lee 
World Wide Web had the CERN as its birthplace. An invention that can be called  – albeit a bit 
euphemistically - a by-product of the CERN regional innovation project.  
412.  Switzerland is convinced that regional innovation can benefit tremendously from cooperative 
business models, such as public private partnerships. Such partnerships can play an important role 
in driving innovation, not only domestically, but also regionally and internationally. Public private 
partnerships enable to pool resources, form new industry clusters and create space outside the 
government structure that allows inn ovation to flourish. Such cooperation is crucial to facilitate 
inventions and transform them into real innovation, meaning, innovative products actually sought 
after in the market. This is key in an environment where competition is fierce.  
413.  Swissnex is a pl atform which promotes such private public partnerships for the sake of 
bilateral and regional cooperation for innovation. Swissnex is a science and technology network 
which connects Switzerland to innovative hubs in key regions of the world.  It is an  initiative by the 
Swiss Government, managed by the State Secretariat for Education, Research and Innovation 
(SERI) in cooperation with the Federal Department of Foreign Affairs (FDFA) . There are currently 
six regional Swissnex branches worldwide, in Boston, San  Francisco, Singapore, Shanghai, 
Bangalore and Rio de Janeiro. Each regional Swissnex agency promotes public -private or private -
private ventures between Swiss companies and those in the respective region, reaching out to 
academics, policy -makers and others  stakeholders. The network also relies on science and 
technology counsellors  based in 20 Swiss Embassies around the world. Since its creation in 2000, 
Swissnex has become an important player in Switzerland as a link for Swiss companies to foreign 
science a nd innovation markets. Intellectual property rights are a crucial aspect in the 
management of these public -private ventures promoted by Swissnex. They form the legal 
framework that enables such cross -regional innovation schemes to prosper.  
414.  In conclusion, w e note that successful regional innovation models require cooperation not 
only at all levels of government, but also between the public, academic and private sector. The 
countries of a region can help facilitate and support innovation cooperation among the mselves 
through reliable intellectual property protection systems, which promote rapid diffusion of 
knowledge, best practice and skills within a geographic area, providing added value for all IP/C/M/83/Add.1  
 
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  stakeholders participating in innovation partnerships. The benef its are not limited to the economy 
of an individual country, but have many positive regional spill -over effects.    
415.  We look forward to hearing the experience of other Members with innovation models in other 
world regions, about lessons they learne d and que stions they may have.  
12.4 Japan  
416.  Today, the delegation of Japan will make our presentation based on the PowerPoints slides 
and the handout that has been made available in  the back of this room.2 
417.  Today, the  delegation of Japan would like to share our views and experiences in intellectual 
property and regional innovation. Our ultimate goal here is not only to initiate regional innovation 
but also to ensure its continuity . Japan would like to propose a system to ensure sustained 
regional development.  
418.  This approach tries to promptly incorporate the views and needs of industry through 
consultations and support not only by the governments involved but also by representatives from 
the industries in both countries.   
419.  By starting from a network covering two countries, our Partner and Japan, and then further 
expanding it to include neighbo uring countries, Japan believes we can effectively create a network 
covering the whole region.  
420.  The specific topics to be discussed for the initiatives are ways to activate regional innovation 
such as by advancing and supporting (1) research and development, (2) human resource 
development, (3) improvements in financial systems and support, (4) improvement in business 
matching capabilit ies, and (5) intellectual property protection. Japan believes that appropriately 
protecting and utilizing intellectual property are the keys to forming the basis for an innovative 
business environment.  
421.  As an example of promoting regional innovation, I woul d like to explain our support for the 
Southeast Asian region.  
422.  The line graphs on the top of the slide, "Foreign direct investment from Japan to East Asia " 
and "Changes in ASEAN -Japan Trade Amounts ", clearly show that Southeast Asia has rapidly 
become one of our most important partners.   
423.  In this region, we first started with various bilateral cooperative initiatives such as the 
Vietnam -Japan Joint Initiative (since 2003) and Myanmar -Japan Joint Initiative (since 2013).  
424.  Building upon such bilateral initiati ves, the ASEAN Region and Japan have started the 
ASEAN -Japan Public -Private Dialogue on New Industries, a reg ional cooperative framework, 
in 2014. With the involvement of industry representatives in addition to government officials, the 
potentials and chal lenges of new industries have been discussed, leading to initiatives for raising 
awareness on innovation in industry and increasing cooperation among businesses.  
425.  As I mentioned on the second slide, one initiative to encourage regional innovation is to 
appropriately protect and utilize intellectual property.  ASEAN, under its own initiative, set four IP 
strategic goals with different ways for increasing competitiveness and productivity, which is shown 
here. 
426.  The ASEAN IPOs -JPO IPR Action Plan was developed in order to support initiatives for those 
goals listed on the previous slide.  
427.  On 19 July 2016, the 6th Japan -ASEAN Heads of Intellectual Property Offices Meeting was 
held in Bali, Indonesia, between ASEAN IP Offices and the Japan Patent Office (JPO).  
                                                
2 See Room Docum ent RD/IP/14.  IP/C/M/83/Add.1  
 
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  428.  At the m eeting, the "ASEAN IPOs -JPO IPR Action Plan 2016 -2017" for the fiscal year 2016 
was formulated. At the same time, Japan confirmed that it will further contribute to building IP 
infrastructure based on new challenges in every country while strengthening sup port for human 
resource development  and the ASEAN Region countries'  accessions to international treaties.  
429.  Specifically, the following items were agreed:  
a. Holding training courses on patent examination guidelines as one means for 
formulating/revising patent examination guidelines . 
b. Sharing expertise on the Madrid Protocol and Hague Agreement as a means to enable 
ASEAN Region countries to accede to international treaties.  
c. Sharing methods used to train examiners in Japan, sharing expertise on quality 
management  in terms of examination and managing examination practices, and further 
sharing expertise on h ow to make use of other offices'  examination results, which are 
means for developing human resources and managing examination practices  
430.  Concerning cooperation on  human resource development, for example, the JPO welcomed 
5,137 trainees from 75 countries and 5 regions and sent 587 experts to 36 countries and 
one region.  
431.  Japan hopes that the initiatives on the IP system shown here will help to improve the 
landscape f or promoting regional innovation and develop an attractive and dynamic business 
environment not only for overseas investors but also for domestic industries. Japan also expects to 
see innovation further expand to other regions . 
12.5 United States  
432.  The United States welcomes this opportunity to co -sponsor this item on IP and Innovation: 
Regional Innovation Models. We thank Australia, European Union, Japan, Switzerland, and Chinese 
Taipei  for also co -sponsoring this item. 
433.  Specifically, our focus today is on regionalism, including the relationship between  regional 
IPR treaties and institutions, and regional innovation networks. Regional integration has  come to 
provide a transformative feature of the inno vation landscape.  
434.  Such regional innovation is proliferating, in pa rt, as the result of IPR initiatives that have 
emerged out of a variety of regional undertakings , such as customs unions,  regional IP 
organizations, and plurilateral trade agreements.  
435.  This m orning, we will consider two significant and mutually reinforcing elements: the 
emergence  of regional IPR systems; and the growth of regional innovation networks.  
436.  Turning first to regional IPR systems, these are both numerous and diverse.  Some regional 
systems have a mandate focused exclusively on IPR s, while others have comprehensive 
competence  over IPR s among many other disciplines. Some include institutions and other services, 
such as  examination and registration  of specific IPRs , while others are govern ed by regional IPR 
commitments , the implementation of which is carried out by relevant national authorities.  
437.  These varied regional models provide a wealth of examples whose practical experience with  
norm -setting, cooperation and creative solutions for maxi mizing limited resources we believe are  
instructive for this Council.  
438.  However, while different models proliferate, they do share common features and objectives, 
which  benefit not only the country parties of such regional systems, but also right holders and  the 
peoples of theses region more broadly. These benefits include leveraging shared resources, 
work-sharing,  increasing efficiencies, reducing costs, developing common standards, diffusing  
knowledge, and coordinating technical assistance, capacity -buildin g and awareness -raising.  IP/C/M/83/Add.1  
 
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  439.  Today, we will touch on but a few of these copious regional systems.  Take ARIPO, for 
instance, where its members have adopted several regional treaties addressing  specific IPR 
standards, including the Harare Protocol on Patents and  Industrial Designs with 18  regional 
parties , and the Banjul Protocol on Marks with nine regional pa rties. These agreements  provide 
substantive IPR rules and create institutions for the examination and protection of regional  
intellectual property  rights.  
440.  For example, under the Harare Protocol, the ARIPO Office is empowered to receive and 
process  patent and industrial design applications on behalf of States pa rty to the Protocol. 
Applicants need  only file one application, and can designate anyone of the Hara re Protocol 
Contracting States in  which that applicant wishes the invention or industrial design to be accorded 
protection.  
441.  The Gulf Cooperation Council provides another model of regionalism, where IPR constitutes 
one of many substantive  issues provided un der the overarching mandate of this Organization that 
consists of six countries.  
442.  The GCC Trademark Law, for instance, contains binding legal provisions governing 
opposition,  cancellation, and publication of trademarks as well as enforcement rules. Likewise , the 
GCC Patent Law, which established the GCC Patent Office, acts as a unified filing system. Under 
this system, applications granted within its system automatically impart protection in all six GCC  
member countries.  
443.  Likewise, APEC, which is principally an economic and trade forum consisting of  21 member  
economies  in the Asia -Pacific region , has recognized that IPR protection and enforcement is a key 
factor for promoting  foreign trade and investment, as well as for boosting economic development.  
444.  In pursui t of this objective, APEC economies have established the Intellectual Property Rights  
Experts' Group (IPEG), with the aim  to ensure adequate and effective protection, through 
legislative,  administrative and enforcement mechanisms, of IPRs in the Asia -Pacific region based 
on the principles of the TRIPS Agreement and other related agreements.  And, of course, an 
extensive network of hundreds of Regional Trade Agreements has developed,  which provide for 
specific rules governing IPR protection and enforcement be tween the agreement  parties. 
445.  Building bridges between regions, including through RTAs, further extends the value and 
benefits  of IPR regionalism. The IPR provisions of trade agreements can provide a critical enabling  
environment for innovation not only wit hin a region, but across regions.  
446.  The fabric of IPR regionalism, therefore, consist s of numerous and varied strands, often  
overlapping with other regional initiatives and furthe r woven together with national and  
multilateral law and practice, including wit h respect to TRIPS Agreement implementation. Such  
regional work is further  complimented and enhanced by a wide array of other initiatives, including  
between regional IPR authorities.  
447.  Exemplifying such initiatives are the Patent Prosecution Highway and the Global PPH, which  
provide significant benefits for both national authorities and patent applicants, including by 
reduc ing costs, time, duplication and workload, while increasing efficiencies through simplified  
documentation requirements and reuse of search  and examination results as part of patent  
application process.  
448.  Turning to R egional In novation Networks , regional IPR systems, such as those we have 
discussed, can provide the foundation and  scaffolding to build regional innovation networks. These 
networks  can consist of universities and  research laboratories, financial institutions and regional 
development banks, private sector  activity, public -private par tnerships, and innovation clusters.  
449.  Take Stanford University's Institute for Innovation in Developing Economies, which launched  
innovation cent res in West and East Africa. For example, in May 2016, the first group of business  
leaders selected by Stanford Seed gathered in Nairobi to begin a 12 -month process led by  
Stanford Graduate School of Business facult y. Aimed at driving sustainable growth in the 
East-African region through private -sector -led development, the Seed program me is training  IP/C/M/83/Add.1  
 
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  entrepreneurs from Kenya, Tanzania, Rwanda, Uganda, and Ethiopia through a yearlong,  
interactive, educational journe y based at Seed's regional cent re in Nairobi.  
450.  Likewise, the Massachusetts's  Institute of Technology's Centr e of Bits and Atoms has 
partnered  with the Advanced Manufacturing Technology Strategy (AMTS) implementation unit of 
the Government of South Africa to ro ll out ten Fabrication Laboratories, or "FabLabs ", around the  
country, providing disadvantaged communities with opportunities in the design, testing and  
fabrication process.  
451.  Regional Development Banks also feature prominently in the enabling environments o f 
regional  innovation. For example, the Asia Development Bank provided initial funding for IPEX, 
Cleantech Asia, which provides clean technology matching, advisory and deal facilitation services  
in Asia. IPEX works with technolo gy owners world wide, and tec hnology users or project  developers 
in Asia to facilitate clean technology transactions.  
452.  Likewise, the Inter -American Development Bank financed PROSUR, a harmonized IP system 
in South America among Argentina, Brazil, Chile, Colombia, Ecuador, Paraguay, Per u, Suriname 
and Uruguay. Under this initiative, common software for interconnection of domestic IP offices has  
been adopted, and a tool for cooperation in patent examination and a common regional form for  
filing trademark app lications ha ve been developed.  
453.  In the area of climate change, the Global Environment Facility has approved funding for four 
Climate Technology Transfer and Finance Centr es, which are housed at  multilateral development 
banks in Africa, Asia, Central Asia, Europe, and Latin America and t he Caribbean.  
454.  Finally, innovation clusters - which are geographic clusters of interconnected companies,  
suppliers, service providers, as well as academic institutions, government agencies and other  
organizations - are emerging as a powerful regionally -based engine for economic growth and  
development that relies heavily on strong underlying IPR protection and enforcement systems.  
455.  The United Sates Economic Development Administration (EDA) plays a leading role in 
promoting  innovation clusters in the United Sta tes and building bridges with such clusters in other 
regions.  
456.  EDA's Partnership Planning program me works with regions to develop Comprehensive 
Economic  Development Strategies (CEDS), while it's Office of Innovation and Entrepreneurship 
leads the  Regional I nnovation Strategies Program me to spur innovation capacity -building activities 
across  clusters  in the United States.  
457.  And E DA's work extends beyond US regions to Latin America broadly, including pursuant to 
the Memorandum of Cooperation with the Organizatio n of American States on Competitiveness,  
Innovation and Entrepreneurship in the Americas.  
458.  In conclusion, these are but a few of the numerous initiatives and trends  exemplifying the 
emerging power of regionalism to deliver the benefits IPR in a manner that  compliments national 
and multilateral  lPR and innovation efforts.  
459.  These case studies speak volumes regarding practical and creative solutions regarding the  
administration of IPR laws and institutions to reduce costs and burdens, share work, avoid  
duplicati on, and pool resources, whether  they be financial resources or know -how. 
460.  Regionalism is particularly valuable when we consider efforts to implement the TRIPS  
Agreement. Many WTO Members have looked to their own regions as the principle vehicle for  
TRIPS Ag reement implementation, and many othe r WTO M embers look to regional institutions as  a 
key interlocutor for capacity building and technical assistance with respect to such  implementation.  
461.  And, of course, regionalism cannot be forgotten when considering the drivers of innovation.  
There exists a strong and inextricable link between regional  lPR systems and regional innovation  
networks.  IP/C/M/83/Add.1  
 
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  462.  In other words, to be engines of economic growth, our regions cannot be the  innovation 
clusters we need them to be without str ong and effective IPR systems to sustain  them. As 
confirmed in the 2016 G20 Communique:  "To achieve innovation -driven growth and the creation of 
innovative ecosystems ... we  emphasize the importance of open trade and investment regimes to 
facilitate innova tion through Intellectual Property Right (IPR) protection. " (2016 G20 Communique, 
paragraph 12) . 
12.6 Chinese Taipei  
463.  My delegation  is pleased to join the United States and other Members in sponsor ing this 
agenda item. We are very pleased to have the opportunity of sharing our own experiences with 
fellow Members and of being able to learn from the best practices of other Members at the same 
time. We fully identify with the observation made by the de legate s of the United States and other 
sponsors that innovation transcends boundaries and has become increasingly regional in nature. It 
provides a transformative feature of the innovative landscape.  
464.  My Government keeps promoting innovation to foster indus tries' growth and facilitate 
transregional IP cooperation, but first I will share my Government's effort for the start -ups. The 
innovative start -ups have become remarkable worldwide. Until now, we have already established 
more than 160 incubations to promo te business incubation, facilitate SMEs growth and seek for 
emerging business opportunities.  
465.  Allow me to take the Kaohsiung Software Incubation Center  - or KSIC for short  - as an 
example. KSIC provides one -on-one assistance in technology and business opera tion to fortify the 
venture capital and investor network and to search globally for business opportunities for the 
incubation centre. A wide -range incubation service to start -ups in different phases is provided. In 
recent years, we have successfully attrac ted many start -ups to enga ge in development ranging 
from cloud service, big data, mobile application to IOT technology.  
466.  Since 2007, we have been extending international incubation cooperation from emerging 
markets to Europe and the U nited States, integrati ng resources available in local governments, 
universities and business associations to assist domestic companies in exposing them to business 
opportunities, cooperation, investment and the technology around the globe.  
467.  Furthermore, a platform located in Tha iland, Viet Nam and Indonesia was established in 
2015 which was designed to provide public and private resources to achieve better integration in 
worldwide incubation resources for companies. In addition, we annual ly host Chinese Taipei's 
International Inv ention Show And Techomart , or INST for short, to promote international 
collaborations, technology transfer and IP circulation. We sincerely welcome Members to join this 
great event in INST next year.  
468.  As far as regional cooperation is concerned, we also es tablished the policy framework, such 
as Patent Prosecution Highway known as PPH, Patent Priority Documents Exchange, known as 
PDX, and bio -deposit to enhance cooperation with our regional partners. In terms of PPH, we have 
cooperated with the US, Japan, Sp ain and the Republic of Korea. In our PPH with US , which was 
launched in September 2011, we have received 1,467 requests as of the end of October 2016. Our 
PPH with Japan began in May 2012 and, so far, we have received 2,095 requests. The PPH 
mechanism has  proved to be 6.6 times better than the ordinary procedure and unquestionably 
much more efficient.  
469.  Let me move onto PDX with Japan and the Republic of Korea through exchanging priority 
documents electronically among the patents' request. Both patent office s are benefiting by saving 
time and cost by streamlining procedure s when filing patents in another Member. In addition, the 
PDX enables patent examiners to acquire files online promptly which helps expedite examination 
and reduce red -tape. 
470.  We also establis hed a bio -deposit cooperation programme with Japan which is based on the 
Budapest Treaty and commenced on 18 June 2015. For applica nts in both Members, it brings an 
advantage to depositing the biological material in the designated depository in their own M embers 
to solve problems such as the instability of repeatedly deposited materials and relevant costs.  IP/C/M/83/Add.1  
 
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  471.  We have also been active in the exchanges with examiners from international counterparts. 
These exchanges enabled us to step up our patent and trademark  examination quality.  
472.  In conclusion, we acknowledge the emergence of regional intellectual property system s and 
the growth of regional innovation networks. We would like to point out that today's discussion 
could lead to a consideration of the result of re gional experiences that may serve as models for 
future innovation policies and practices.  
12.7 Canada  
473.  Canada is pleased to present on the "IP and innovation " topic on regional innovation models.  
474.  As the C ouncil may be aware, innovation is a key priority for Canada. The Government of 
Canada recently embarked on an inclusive Innovation Agenda, with a view to building Canada as a 
global centre for innovation. For instance, as part of this ongoing agenda, the Government of 
Canada's March 2016 Budget proposed to provide up to CAD$2 billion over three years for a new 
PostSecondary Institutions Strategic Investment Fund, as well as up to CAD$800 million over 
four years, starting in 2017 -2018, to support innovation  networks and clusters.  
475.  As global trade becomes increasingly organized along global and regional value chains, 
research and innovation are often correspondingly designed around networks and clusters at the 
global and regional levels. Rather than innovating  in isolation, collaboration is taking place across 
national borders. For instance, many Canadian companies are part of the same supply chain and 
work within regional clusters with counterparts in North America, such as the Windsor -Detroit auto 
supply chai n, the Ontario -Ohio manufacturing belt, the Vancouver -Seattle clean technology sector, 
and the Toronto -Waterloo high -tech corridor which has strong ties with Silicon Valley in the 
United  States.  
476.  In view of this regionally integrated trading environment, th e Government of Canada has 
undertaken a number of initiatives, including with regional partners, to encourage collaboration 
across national borders. In North America, Canada is collaborating with the United States and 
Mexico on the North American Competiti veness Work Plan (NACW), which includes fourteen 
initiatives to improve supply chain efficiency, enhance innovation and economic development, and 
undertake stakeholder consultations and outreach. Established in 2013, the latest iteration of the 
NACW was la unched at the June 2016 North American Leaders' Summit, with a number of new 
initiatives for women entrepreneurs, clean energy partnerships, collaboration on cybersecurity, 
and new connections among North American communities to promote economic developmen t. For 
instance, Canada, the United States, and Mexico have agreed to promote "cluster asset mapping ", 
an activity that helps policymakers, businesses, and other stakeholders improve their 
understanding of a region's economic strengths and opportunities. T hese maps identify clusters of 
interconnected companies, suppliers, and institutions, helping businesses expand their labour and 
supply chains while supporting effo rts by local governments and economic development agencies 
to build and attract new industri es. As part of this initiative, Canada has officially announced its 
intention to develop a National Cluster Mapping Portal. Also through the NACW, North American 
Leaders recently committed to advancing a North American Clean Energy Partnership Initiative t o 
support the development of linkages among clean technology companies, with a focus on small 
and medium -sized enterprises, and to promote the use and export of North American clean energy 
and environmental technology.  
477.  Canada also recently hosted the sixth  Americas Competitiveness Exchange on Innovation 
and Entrepreneurship (ACE), from 25 September to 1 October 2016. Organized by the 
Government of Canada and the Government of Ontario, in collaboration with the US Department of 
Commerce and the Organization of American States, the ACE brought together key officials from 
across the hemisphere to visit Canadian incubators and accelerators, universities, and research 
facilities, and to share best practices and innovative approaches to entrepreneurship, build 
networks and partnerships, and foster regional competitiveness.  
478.  Also in the North American region, in 2015, the patent offices from Canada, the 
United  States, and Mexico began a one -year pilot  project  to implement requirements aligned with 
those of the Global  Patent Prosecution Highway (PPH) in each office, to streamline the process for 
applicants to obtain patent rights. The PPH is a patent office -patent office cooperation framework IP/C/M/83/Add.1  
 
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  which allow s applicants seeking patents in PPH partner offices to obtain corr esponding patents 
faster, more efficiently, and with improved quality. As part of the 2016 NACW, Canada, the United 
States, and Mexico have agreed to further North American PPH collaboration. For instance, on 
6 July 2016, the Canadian Intellectual Property  Office (CIPO) announced a two -year extension of 
the PPH agreement with the Mexican Institute of Intellectual Property.  
479.  In addition to the North American region, Canada has developed formal science and 
technology relationships and partnerships with establi shed and emerging innovation networks 
around the world. For instance, Canada has developed a framework for international collaboration 
through science and technology agreements with a number of bilateral partners, including in 
Asia-Pacific, Europe, Latin A merica and Caribbean regions. These agreements serve as guidelines 
for Canadians to effectively partner and work with partner countries to increase international 
science and technology capacity. A related initiative, the Canadian Technology Accelerator, or  CTA, 
provides high -growth, market -ready Canadian companies support to access global markets and 
entrepreneurship services within the information and communications technologies (lCT), life 
sciences, and clean technologies. Managed by the Canadian Trade Co mmissioner Service, the CTA 
provides support for Canadian technology SMEs to access global market opportunities in 
nine cities, including key ICT, life sciences, and clean technology markets.  
480.  In addition, CIPO supports innovation through its efforts to mod ernize its services in order to 
help businesses in Canada improve how they access the Canadian IP system and leverage their 
IP rights. Such efforts will facilitate ease of doing business not only in Canada but regionally and 
globally as well, as Canada ali gns itself with international IP standards and filing systems.  
481.  Canada is also an active participant in regional economic forums, such as Asia -Pacific 
Economic Cooperation (APEC), and particularly, the Intellectual Property Experts Group (IPEG), 
which aims,  among other things, to deepen the dialogue on IP policy, exchange information on the 
current status of IP rights protection and administrative systems, and study measures for the 
effective enforcement of IP rights. During the August 2016 IPEG meeting in L ima, Peru, Canada 
presented on a number of recent IP -related legislative developments in Canada, and also gave a 
presentation on the Royal Canadian Mounted Police Canadian Anti -Fraud Centre's "Project 
Chargeback " initiative (which Canada also recently pres ented on in the TRIPS Council context, and 
also at the WIPO Advisory Committee on Enforcement).  
482.  As noted, Canada is in the process of developing an inclusive Innovation Agenda, as a 
government -wide plan to promote innovation across the economy. Given the r ole that 
collaborative arrangements play in innovation, not only nationally but also in the form of regional 
research networks and clusters, we remain very interested in hearing about the regional 
experiences and practices of other Members, and look forwar d to their interventions on this issue.  
12.8 Korea, Republic of  
483.  I would also like to thank the United States and other co -sponsors for this initiative and their 
interesting presentations.  
484.  Korea has long recognized the importance of regional cooperation in regard to IP for 
economic growth and innovation. Hence, the Korean Government has carried out various projects 
to harmonize and standardize IP polices at the regional level, particularly in t he Asia -Pacific region, 
to make easier the collaboration  between regional IP innovators and to facilitate the emergence of 
regional networks.  
485.  In this regard, our d elegation wants to share an ongoing project carried out by the Korean 
Government, which we be lieve has potential to contribute to the emergence of regional intellectual 
property systems, and the growth of regional innovation networks.  
486.  Currently, t he Korean Intellectual Property Office (KIPO) is carrying out a project called the 
"Guidebook for SME s’ IP-Business Cycle, " which is funded jointly by APEC and the Korean 
Government.  
487.  The core aim of this project is to provide governments with standardized SME -friendly IP 
policies. To achieve this aim, the KIPO has been stock -taking the IP polices maintai ned by a IP/C/M/83/Add.1  
 
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  number of countries, including APEC and non -APEC members, by surveying and interviewing 
SMEs, academics and policy -makers. Based on the results of the stocktaking, the KIPO has 
analysed  the best IP policy practices and categorized them by policy a rea as well as level of 
economic development and IP environment in a given country. Now, as the final step, the KIPO is 
standardizing the policy practices to make a guidebook for governments seeking to design IP 
policies that are in line with their economi c situation and the degree of demand among SMEs on IP 
innovation policies.  
488.  The Korean version of the guidebook will soon be published, while the English version will be 
published, hopefully before the end of this year. Once it is published, it will be cir culated among 
APEC members. Our delegation looks forward to having another opportunity to share the results of 
this project in the future.  
12.9 Mexico  
489.  This agenda item is a good opportunity for us to talk  about the importance of regional 
integration in the area of intellectual property. Mexico has developed a number of instruments 
which provide for integration and also will allow us to benefit from other countries' experiences. 
This will enable  us, in turn , to allow others to benefit from our successes. Of the recent examples 
of a regional integration that have involved us I could mention, for instance, the Technical IP 
Group of the Pacific Alliance which involves offices from Chile, Colombia, the National Institute for 
the Defence of Competition and the Protection of IP of Peru as well as the Mexican IP Institute. 
These groups have a number of technical tools including a list of harmonized terms and regional 
expressions. This list of harmonized terms and re gional expressions provides us with an 
opportunity to harmonize a list of expressions relating to goods and services that do not appear in 
the NICE classification. This allows us to provide certainty to the users of the IP systems of 
countries that are mem bers of the alliance. They can thus  ensure that expressions are recognized 
and accepted by competent authorities when they are included in trademark applications that are 
submitted outside their country of origin.  
490.  We also have the pilot programme for acce lerated patent processing. This allows for a patent 
examination to be carried out in an effective way and makes it possible for  those applying for a 
patent to have their applications dealt with in good time.  
491.  There is another regional initiative I would lik e to refer to , that is the Latin American 
Programme for Intellectual Property which is known as IBEPI. This is part of our regional 
cooperation programmes. Its goal is to ensure that intellectual property is promoted as a tool for 
development and integrati on of companies in the region. The countries involved are Argentina, 
Brazil, Colombia, Costa Rica, Cuba, Ecuador, Spain, Mexico, Paraguay, Peru, Portugal, the 
Dominican Republic and Uruguay. IBEPI develops an exchange of experience and best practices 
among  the participating  IP offices in order to ensure that we can all make best use of the 
resources available to us.  
12.10 El Salvador  
492.  We would like to thank the proponents for placing this item on the a genda, which gives us an 
opportunity to share the Central American experience.  
493.  Central American countries have very similar legal frameworks for intellectual property and 
have been using a harmonized manual on patent examination since 2007 and a harmonized  
manual on trademark registration since 2014. This facilitates trade between the countries of the 
region and with countries outside the region and is also conducive to developing common 
strategies for the promotion of innovation at Central American level.  
494.  The region has set up a ministerial forum to discuss and promote innovation and intellectual 
property initiatives. Every two years since 2010, the Ministers for the Economy, Trade and 
Industry of the Central American countries and the Dominican Republic ha ve been meeting to 
discuss and adopt a variety of projects, with support from WIPO. This forum has proved highly 
important for the development of intellectual property and innovation in Central America and the 
Dominican Republic. It has also led to the con solidation of various initiatives and projects. The 
Central American countries have thus, inter alia, adopted IP policy strategies, established the CATI IP/C/M/83/Add.1  
 
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  CARD network of Technology and Innovation Support Centres (TISC) in the Central American 
region and the  Dominican Republic, drawn up a project to promote the use of intellectual property 
for small enterprises, and are carrying out an economic impact study of intellectual property in the 
region, with support from WIPO and other institutions.  
495.  The next Ministe rial Meeting will be held in Panama City in 2017, to evaluate the 
development and impact of these projects and initiatives and to present the results of the 
economic impact study, which will be critical for the adoption of appropriate initiatives for the 
promotion of innovation in the region and the evaluation of those currently under way.  
496.  Further initiatives are continuing to emerge and are taking on a regional dimension, such as 
the one  that will be  introduced by the distinguished delegat e of the Dominica n Republic; and 
intellectual property offices in Central America and the Dominican Republic are sharing projects 
and good practices.  
12.11 Dominican Republic  
497.  My delegation would like to thank the Members for including this agenda item in this Council 
and we would like to share the experience that we have carried out in the Dominican Republic in 
the area of IP and innovation which might show a sub -regional mission. In April this year, as the 
distinguished delegate of El Salvador said, the Dominican Republic took on the governance  of 
appropriate technology, innovative solutions for daily life. This was fostered by the WIPO, the 
National Intellectual Property Office of the Dominican Republic with t he assistance of the Korean 
Intellectual Property Office, KIPO. We carried out workshops in the provinces and we invited the 
academic circles, polytechnics and the universities to participate in this forum.  
498.  We were looking at the agro -industrial sector. O n 22 April, we had an award ceremony in 
which the ten best projects were presented. The Dominican Republic offered to share its 
experience in the organization in this first competition to the countries of Central America so that 
they could be replicated in  other countries. We hope that this will have a positive impact in the 
efforts being carried out by the Central American countries in fostering national innovation 
networks at the national and regional levels.  
12.12 South Africa  
499.  We thank the co -sponsors for introducing the topic of regional  innovation models as part of 
the theme  on intellectual property and  innovation. South Africa, together with partners from the 
African region  and other internatio nal partner has embarked on collaboration that  seeks to expand 
locally developed technologies. This is  based on a national innovation strategy that coordinates 
partnerships  between state departments, private companies and other social  partners. For this 
purpose we have tu rned our gaze to the heavens.  
500.  As a man of science, I am certain you share certain existentialist questions that many 
millions of other people pose,  such as why are we here or  where did we come from. According to 
the Soshongo people of Central Africa, before we existed there was only darkness, water and the 
great  god Sumba. One day Sumba, in pain from a stomach ache, vomited  up the sun. The sun 
evaporated some of the water, leaving land, still  unwell he vomited the moon, the stars and the 
leopard, the crocodile,  the turtle and finally humans. Sounds familiar?  
501.  South Africa is building the Karoo Array Telescop e, in the current iteration called the 
MeerKAT, which  is a precursor instrument for the Squ are Kilometer Array instrument , but in its 
own right is amongst the largest and most powerful radio  telescopes in the world. The MeerKAT is 
being constructed adjacent to the  site proposed for the SKA  - in short - near the small town of 
Carnarvon in the  Northern Cape Pr ovince. The first time the MeerK AT telescope turned  its eye s 
towards the sky, it discovered more th an 1,200 galaxies that  were previously unknown in a remote 
corner of the universe where only  70 galaxies were known to exist before. It will also be the first 
time that a group of  African countries, under the African Very Long Baseline Interferometry  (AVN) 
project, will host this ki nd of scientific infrastructure which I am presenting about.  
502.  It is hoped the further development of the Meer KAT technology will also  assist in preparing 
local indus try for deeper participation in the  international Square Kilometre Array (SKA) project IP/C/M/83/Add.1  
 
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  once the  construction phase begins in 2018. To this end, SKA has a growing  intellectual property 
register and has begun the commercializ ation process es for four technolo gies, namely, the SKA 
Reconfigurable  Architecture Board (SKARAB), the Real -time Transient Analyser  (RTA), IRONHIVE 
which is a robust, high speed, low cost high -performance  computing solution, and the DSS which 
is a robust, low -cost data storage solution.  
503.  The SKA, of which a global project consists of South Africa and nine Member  countries, will 
join approximately 100 organisations and companies from 20 countries to participate in the design 
and development of the SKA.  
504.  The SKA is being developed in two phase s, between 2018 and the late  2020s. When fully 
operational, the SKA will comprise a forest of 3 ,000 dishes spread across several countries that will 
allow astro nomers to  peer deeper into space in unparalleled detail. It will have a discovery  
potential that is ten times greater th an the most advanced modern  instruments and will explore 
exploding stars, black holes, dark energy  and traces of the universe's origins some 14 billion years 
ago. 
505.  The programme will help develop international competiveness  of Africa n scientists and is 
closely linked to, as I have already indicated, t he African Very Long Baseline Interferometry (AVN) 
project which is a network of capable radio telescopes being constructed across the  African 
continent, hosted by the eight SKA African p artner countries.  The telescopes will form part of a 
global network and are intended to  prepare the African partners to play their part in hosting the 
SKA. Amongst the endeavours that this particular project seeks to stimulate, it is to ensure the 
transfer  necessary and appropriate skills and knowledge in  African partner countries to build, 
maintain and operate radio  telescopes . Good progress has thus far been  made in growing the 
readiness to host  SKA-2 in conjunction with  partner count ries, such as Botswan a, Ghana, Kenya,  
Madagascar, Mauritius, Mozambique, Namibia and Zambia.  
506.  To this end, the A frican Ministerial Forum has been created and will convene to annually 
assist progress that  has been made in respect of the implementation of the project and to provi de 
political and strategic leadership. Amongst the matters that will be discussed by this forum include 
human c apacity development and institutional capacity -building, technology transfer, Big Data 
Africa and strategic partnerships and funding.  
507.  A concept p roposal  for establishing high performance computing in each  of the SKA African 
partner countries was also accepted.  I think I will stop here and I thank Members for their 
attention.  
12.13 Uruguay  
508.  I woul d like to thank the proponents of this agenda item for i ntroducing it. We would like to 
take this opportunity to share our views on the way in which a country like Uruguay sees science, 
technology and innovation (STI) policies and the relevance it has give n to cooperation policies at 
regional and international level.  
509.  In recent years, Uruguay has chosen to open up to the world, seeking to adjust its 
production matrix to meet the challenges of the information society. Likewise, institutional and 
cultural cha nges are under way to enable the country to take an active part in an increasingly 
globalized, interconnected and diverse world.  
510.  In Uruguay, promotion of research and innovation activities is the responsibility of the 
National Research and Innovation Agenc y (ANII), which was established in 2007 and has the 
following three main thrusts:  
a. Promotion of productive innovation: by creating and consolidating a system in support of 
business innovation, bolstered by funding and learning of best practices; and by 
promoting entrepreneurship and building up a network of incubators and tools to foster 
the creation of new enterprises. ANII support is targeted towards dynamic projects 
aimed at achieving high growth rates.  IP/C/M/83/Add.1  
 
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  b.  Promotion of research: by creating the National Res earcher System (SNI), which 
classifies and brings together all researchers in Uruguay to optimize capabilities and 
efforts; and by supporting specific research projects and programmes linking up to 
international networks. Research in Uruguay seeks to achie ve global integration.  
c. Creation of advanced human capital: by developing MA and PhD level scholarship 
programmes for students; and by concluding reciprocity agreements and arrangements 
aimed at incorporating such resources in Uruguayan society as scholars hip recipients 
return to the country.  
511.  "Uruguay Innovador " (Innovative Uruguay) remains one of the pillars of the Government's 
country strategy, based on the understanding that "there is no development without innovation " 
and that the way to achieve integra tion in the new knowledge economy is to build endogenous 
innovative capabilities.  
512.  Review of the past ten years : we may well have addressed the question of innovation at a 
late stage - the institutional changes to promote innovation began in 2005 - but we h ave closely 
and permanently incorporated it, learning from international experiences and drawing on our 
country's cultural traditions.  
513.  The approach taken consisted of four pillars: reform of the legal framework; effective 
regulation; creation of the ANII, and provision of resources. All of this was achieved through cross 
party consensus that ensured continuity as a State policy and not simply as a government 
measure.  
514.  As far as international cooperation is concerned, this set of policies is hampered by the same 
difficulties as those faced by all our countries, namely the isolation in which every form of STI 
cooperation is initiated and implemented, always in parallel with all global cooperation efforts.  
515.  It is necessary to promote an enabling environment for  innovation and science as critical 
tools for achieving sustainable global development; this requires us to agree on a new dimension 
of international cooperation.  
516.  I should now like to mention some of the successful innovation experiences at regional and 
bilateral level.  Experience  Description : exchange of evaluators   exchanged with Argentina and 
Mexico; Call for researchers and enterprises together with Argentina; Cooperation with the 
FAPESP, a s part of cooperation with the FAPESP in 2015, management of a t rilateral fund with the 
United Kingdom and Brazil; Evaluator exchange service  , exchange of evaluators with Paraguay, 
Ecuador, Panama and Mexico; s upport for the creation of the National Scholarships System (SNB) 
and the National Researcher System (SNI)  Support in establishing the SNB and the SNI for 
Paraguay's CONACYT . Scientifi c Cooperation Agreement w ith Mexico's CONACYT; Interinstitutional 
Cooperation Agreement with Paraguay's CONACYT; Cooperation Agreement with Peru's 
CONCYTEC; Agreement with Panama's SENACYT; Agreement with Argentina's  MINCyT and 
CONICET; Agreement with the São Paulo Research Foundation (FAPESP), State of São Paulo, 
Brazil.  
517.  In Uruguay's case, even after a decade of sustained growth and a record of indicators such 
as those mentioned ea rlier, there are still structural shortcomings and weak nesses to be 
overcome.  
518.  In short, w e believe that international cooperation has a strategic role to play in Uruguay's 
transition to a sustainable development model, by supplementing national resources with capacity 
building, technology transfer, regional cooperation programmes, triangular cooperation, and 
scientific cooperation scholarships, agreements and programmes in critical areas or focusing on 
high impact policy issues.  
519.  We note the progress made t owards a form of cooperation that goes beyond aid based 
cooperation, involving local stakeholders and moving away from the model of straightforward 
transfer of resources; we recognize and support the trend towards cooperation for sustainable 
development ra ther than cooperation for economic growth.  IP/C/M/83/Add.1  
 
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  12.14 India  
520.  My delegation would like to thank the delegations of the European Union, Japan, 
Switzerland, the United States and others for tabling an agenda item on IP and Innovation: 
Regional Innovation Models.  
521.   Innovation is only one element in a larger innovation ecosystem and IP laws alone do not 
promote technology development. According to the Trilateral study by WTO, WHO and WIPO on 
Promoting Access to Medic al Technologies and Innovation: Intersections between public health, 
intellectual property and trade (2013) "(Page 126),  "Patent law is not a stand -alone innovation 
system. It is only one element of the innovation process, and one which can be deployed 
differently in diverse innovation scenarios. Patent law has little bearing on many other factors that 
lead to the successful development of technologies, e.g. the nature and extent of demand, 
commercial advantages gained by marketing and ancillary services an d support, commercial and 
technical viability of production processes, and compliance with regulatory requirements, including 
through effective management of clinical trials data. "  
522.  The trilateral study also highlights that innovation in medical technologi es for neglected 
diseases suffers from market failure as conventional IP -based incentives do not correspond with 
the nature of demand for treatment  of these diseases. To overcome the market failure of the IP 
system for neglected diseases, the trilateral st udy mentions about open innovation structures such 
as Open Source Drug Discovery (OSDD) model of India' s Council of Scientific and Industrial 
Research (CSIR)  and collaborative research such as WIPO Re:Search Sharing Innovation in the 
Fight Against Neglecte d Tropical Diseases. The study also talks about the concept of delinking price 
of the final p roduct from the costs of R&D by "push" mechanisms such as grant funding and tax 
credits for investment in R&D and by "pull" mechanisms that offer rewards for the f inal outcome of 
R&D of certain products like milestone or end prizes.  
523.  India declared the decade of 2011 -2020 as the Decade of Innovation. The spirit of innovation 
has to permeate all sectors of economy from universities, business and government to people at 
all levels. India has announced a new national IPR policy in May this year to stimulate a dynamic, 
vibrant and balanced IPR system in India to: foster creativity and innovation and thereby, promote 
entrepreneurship and enhance socio -economic and cultura l development;  and focus on enhancing 
access to healthcare, food security and environmental protection, among other sectors of vital 
social, economic and technological importance.  
524.  Coming to the Regional Innovation Models, I  will focus only on regional tra de agreements 
(RTAs). A number of mega-regional trade agreements and other regional trade agreements 
promoted by a few developed countries in recent years have done away with several flexibilities 
provided under the TRIPS Agreement and the Doha Declaration  on Public Health. Moreover, many 
developing countries who are parties to such RTAs have been forced to accept standards of 
protection and enforcement of IPRs that exceed the standards under TRIPS Agreement. The TRIPS 
plus provisions in the many RTA s lengthen, broaden, and strengthen patent -related monopolies on 
medicines, which delay the entry of cheaper generic drugs and could adversely impact the 
availability of affordable medicines to people in the developing countries.  
525.  In this regard, the UN  SG High -level Panel on Access to Medicines in its report released in 
September this year, made the following observations on the impact of RTAs on access to health 
technologies:  
"Since the TRIPS Agreement came into effect, bilateral and regional free trade agreemen ts 
concluded by several governments have progressively expanded and deepened patent and test 
data protection on health technologies. Such policies further exacerbate policy incoherence by 
narrowing the options provided by the TRIPS Agreement and Doha Decla ration for governments to 
ensure that intellectual property protection and enforcement does not undermine their human 
rights obligations and public health priorities. A number of provisions found in bilateral and 
regional FTAs exceed the minimum standards for intellectual property protection and enforcement 
required by TRIPS Agreement. These provisions may impede access to health technologies, 
including those requiring governments to ease standards of patentability, drug regulatory 
authorities to link marke ting approval to the absence of any claimed patent and  the requiring of 
test data exclusivity instead of test data protection, to list a few.  IP/C/M/83/Add.1  
 
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  The recent Trans -Pacific Partnership Agreement, which is yet to come into force, is emblematic of 
a new generation  of bilateral and multilateral trade and investment agreements which includes 
"TRIPS -Plus" provisions that progressively ratchet up intellectual property protection and 
enforcement. This new generation of trade and investment agreement often includes dispu te 
settlement mechanisms that establish arbitration processes outside the national courts and allow 
private firms to challenge national laws for depriving them of future profits. Other provisions 
restrict government ability to regulate pharmaceutical price s and reimbursement mechanisms. 
Such provisions significantly reduce the scope of measures that national governments can use to 
pursue public health priorities and fulfil the right to health. Ensuring that future trade agreements 
do not interfere with poli cies that guarantee the right to health for all is essential for resolving the 
incoherence between trade agreements and the human right to health. " 
526.  The UN  SG High -level Panel on Access to Medicines recommended that "Governments 
engaged in bilateral and reg ional trade and investment treaties should ensure that these 
agreements do not include provisions that interfere with their obliga tions to fulfil  the right to 
health. As a first step, they must undertake public health impact assessments. These impact 
asses sments should verify that the increased trade and economic benefits are not endangering or 
impeding the human rights and public health obligations of the nation and its people before 
entering into commitments. Such assessments should inform negotiations, b e conducted 
transparently and made publicly available. "  
527.  I conclude by quoting from o ur Prime Minister Narendra Modi' s statement during the launch 
of the Mission Innovation in Paris in November 2015 : 
"Our innovation initiative should be driven by public pu rpose, not just market incentives, including 
on intellectual property. That also means strong public commitment by suppliers to developing 
countries. That will make clean energy technology available, accessible and affordable for all. 
Innovation must be ba cked by means to make it affordable and ensure adoption. " 
12.15 Singapore, on behalf of ASEAN  
528.  I am making this statement on behalf of Brunei, Cambodia, Lao  PDFR, Malaysia, Singapore , 
Thailand Viet Nam to share on ASEAN's experience in developing our IP capacity and becoming an 
innovation friendly region.  
529.  ASEAN which is composed of ten countries in South -East Asia has always placed emphasis 
on innovation as part of  its vision towards an ASEAN economic community. We recognize the 
critical role that innovation plays in driving economic growth. This is encapsulated in the A sian 
Economic Community B lueprint 2025 which aims to build a competitive, innovative and dynamic 
ASEAN through improv ing areas such as productive driven growth, innovation, research and 
development and technology commercialization.  
530.  ASEAN's regional cooperation in IP dates back to 1995 when the ASEAN Framework 
Agreement on Intellectual Property Cooperation was signed. Th e Agreement recognizes the 
important role of IPRs in the context of TRIPS and the flow of investment among ASEAN members 
and has helped ASEAN members to improve their gains from the ASEAN FTA. Since then, ASEAN 
IP cooperation has expanded beyond that of ju st tapping on interregional trade. The ASEAN 
Working Group on IP Cooperation or AWGIPC is the main body driving IP cooperation in ASEAN 
and aims to transform ASEAN into an innovative and competitive region through the use of IP by 
improving the regional fr amework of IP policies and institutions. For instance, the AWGIPC has 
promoted accession of ASEAN members to international IP treaties. Most ASEAN Members have 
already acceded to WIPO's Patent Cooperation Treaty and further accessions to the Madrid 
Protoco l and HEX System are planned by 2020.  
531.  Another important area of work under the AWGIPC is that of harmonizing the region's IP 
framework through the establishment of provisional IP platforms. So far, two such platforms have 
been established. The first is ASE AN TMview which was developed by ASEAN IP offices with the 
help of the EU. ASEAN TMview promotes transparency and information access by allowing 
stakeholders free online access to information on trademark registrations and application in 
participating ASEA N countries.  IP/C/M/83/Add.1  
 
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  532.  The second is the ASEAN Patent Examination Corporation or ASPEC which was launched in 
June 2009. The ASPEC facilitates patent filings by businesses across the region by having ASEAN 
IP offices share their search and examination results, thereb y expediting the patent application 
process. ASPEC operates in English and is free of charge for the applicant.  
533.  The fruits of this effort are already emerging. For example, the ASPEC has received 
154 requests to date – all of which have been granted. In ad dition, while non -resident filing still 
make up the majority of patent output from the region, ASEAN's regional innovation indicators are 
also on the upswing having grown by nearly 40% in the last three years. ASEAN has also 
increased its share of the worl d scientific literature by 170% between 2006 and 2015. As the 
world's largest market and sixth largest economy, there is still a wealth of untapped potential in 
ASEAN and room for greater economic growth through innovation and IP.  
534.  As an Asian economic comm unity, ASEAN members will continue to work together to create 
the best enabling environment that will spur innovation and growth and ultimately deliver a better 
quality of life for our people.  
12.16 Peru  
535.  We are members of the Pacific Alliance and we  would like to add to and comple ment what 
Mexico has said on this matter. We are also involved in the technical group activities dealing with 
IP within the Pacific Alliance and we are also involved in the list of harmonized terms and regional 
expressions which is aimed at strengthening the intellectual property and its benefits to countries 
in the Alliance. The idea is to provide system users with access to information and services 
provided by the competent bodies.  
536.  The countries that are members of this Alliance are committed to pursuing these endeavours 
in order to help users and to work towards the development of the region as a whole.  
12.17 Russian Federation  
537.  The Russian Federation would like to thank the co -sponsor s of Australia, the European 
Union, Japan, Switzerland, Chinese Taipei and the United States for inclu ding the topic regarding 
the regional innovation models on the agenda of this TRIPS Co uncil meeting.  
538.  Considering that in the framework of this topic it is planned to discuss two aspects, such as 
emergence of regional systems of intellectual property and development of regional innovation 
networks, we would like to share the following.  
539.  As for the formation of regional rules for  the protection and enforcement of IPRs please note 
that, for example, in the framework of the Commonwealth of Independent States (CIS) , the 
Intergovernmental Council on the Issues of Legal Protection and Enforcement of  Intellectual 
Property (MGSIS) favours regional rules for  the protection and enforcement of intellectual property 
rights.  
540.   MGSIS is formed in accordance with the Agreement on cooperation in the field of legal 
protection and enforcement of intellectual prop erty and creation of Intergovernmental council on 
the issues of legal protection and enforcement of intellectual property of 19 November 2010.  
541.   In the area of formation of common regional rules and approaches in the field of intellectual 
property , MGSIS c arries out the following functions:  
a. - coordinating joint activities of member states on creation, development and 
enhancement of mechanisms for legal protection and enforcement of intellectual 
property;  
b. - facilitating exchange of legal, normative, methodic al and other information;  
c. - developing recommendations on creation of systems for enhancing efficiency of legal 
protection and enforcement of intellectual property, combatting production and IP/C/M/83/Add.1  
 
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  distribution of counterfeit products and improving mechanisms to protect industrial 
property rights, copyright and related rights;  
d. - preparation of proposals on cooperation development on the issues of legal protection 
and enforcement of intellectual property for consideration by the Council  of heads of CIS 
governments and by the bodies of sectorial cooperation of CIS;  
e. - developing proposals on legal and normative regulation of relations among the 
member states in the field of legal protection and enforcement of intellectual property.  
542.  Regarding  the development of regiona l innovation networks , we would like to mention the 
Interstate Programme of Innovation Development of the CIS Members for the period up to 2020. 
In accordance with the Council of CIS Heads of Government decision the innovation Foundation 
"Skolkovo " is appo inted as operator of this program me.  
543.  The main objective of the Programme is the creation of an interstate innovative space that 
combines the capacity of national innovation systems. In order to achieve the objectives of the 
Programme , the Programme activi ties are aimed at addressing  the following challenges : the 
development of interstate cooperation in the sphere of innovation;  mobilization and development 
of scientific and technological capacity;  formation of a system of staffing for interstate innovation  
cooperation;  co-efficient use and development of innovation infrastructure;  development of system 
of interstate innovation regulation.  
544.  The implementation of the Programme goals forms a regional network integrating the 
activities of government, academic an d private organizations, including the CIS institutions in the 
financial and banking, legal, and scientific areas.  
545.  The implementation of the Programme allows to reach the community of institutions, 
principles and mechanisms of realization of the state sci entific -technical and innovation policy, the 
harmonization of government program mes, standards and requirements for the formation and 
implementation of international innovative projects, the consistency of the law governing the 
operation and development of  national systems of innovation, combined with equal opportunities 
to use the results of scientific and technological activities in the interests of CIS Members, their 
citizens and the Commonwealth as a whole.  
546.  In the c ourse of implementation of the P rogram me, seven  innovative projects implemented 
by scientists from at least three states of the Commonwealth w ere funded by the CIS members in 
2015, of which four projects are already under implementation. In 2016 , 47 projects have been 
submitted for the status of the participant of the Programme . Approximately 100  projects -
participants are expected under  the program me in 2017.  
547.  Taking into account that the P rogram me provides for the participation of teams from at least 
three CIS countries, the progress of its imp lementation shows the increase in the integration of the 
region's innovation community, development of cooperation and, as a consequence, requires the 
creation of legal conditions for joint work.  
548.  Within the framework of the Programme there is  a CIS Counci l of Young Scientists and 
intergovernmental working groups on the commercialization of innovative projects and technology 
transfer, which interact with the integrated structure of the CIS financial and business 
organizations, in particular the CIS Finance and Banking Council and the CIS Business Centr e. 
549.  Thus, the implementation of the Program me, in addition to the development of cooperation 
among scientists, creates conditions for the establishment of joint small and medium enterprises 
working in the field of innovation. For example, 20 companies participating in the project 
"Skolkovo " have already carried out joint ventures or joint use of the results of  their intellectual 
activity.  
550.  The status of Operator of the Program me allows the "Skolkovo " Foundation to  attract project 
participants from the CIS countries and to assist project participants in the commercialization of 
their researches. Currently, several CIS Members decided to place some prospective researchers 
from their countries on the t erritory of the innovation cent re "Skolkovo ". Thus, we could say that IP/C/M/83/Add.1  
 
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  the complex of the activities mentioned above creates the innovative space where young scientists 
and researchers could c ommercialize their inventions.  
12.18 Brazil  
551.  Brazil welcomes the inclusion of this subject on the agenda of the TRIPS Council. As we all 
know, innovation is closely related to intellectual property and, as more and more policymakers 
worldwide are coming to realize, to trade as well. We  believe that this TRIPS Council, by 
addressing these three issues in a coherent way, could provide valuable contributions to the design 
of effective, national and regional innovation policies. In its efforts to overcome the effects of the 
severe economic crisis, Brazil is focusing on innovation as a tool to increase productivity and 
improve standards of living. One of the challenges now facing us is how to ensure that the solid 
scientific production which has been growing for decades results in more and mo re innovative 
solutions  responsive  to the country's problems. We are convinced that, along with universal high -
quality education and other elements, a balanced and effective IP System in line with the 
objectives set forth in Article 7 of TRIPS is key to ac hieving the sustainable innovation 
environment.  
552.  We are also attempting to add ress the innovation imperative by increasing international 
cooperation and partnerships. Most notably, Brazil's research institutions in such areas as 
agriculture, public health, climate and others have been partnering with their counterparts in other 
MERCOSUR and Latin American countries. Embrapa, Brazil's agricultural research centre, along 
with its counterparts in Paraguay and Uruguay, developed computer programs aimed at the 
management of genetic resources. In addition, Fiocruz, Brazil's public health research foundation, 
has partnered with Argentina for the production of yellow fever vaccines.  
553.  Later this month, Brazil will be hosting the ninth Academic Meeting on Intellectual Property, 
Innovation and Development, co -sponsored by our Industrial Property Institute and with the 
participation of Latin American and Caribbean countries.  
554.  Brazil is also an active member of the Community of Portuguese Language Countries. We 
have been c onducting a long -standing cooperation with African nations such as Mozambique, 
Angola, Cape Verde and Sao Tome - again, focusing on agriculture and public health. In addition, 
Brazil and Portugal have just agreed, about two days ago, to a partnership for s etting up the 
Azores International Research Centre - AIR Air Centre – which will house space observation 
facilities, a lab for monitoring atmospheric radiation as well as centres for oceanography and 
fishery studies.  
555.  As a member of the BRIC, Brazil has bee n supporting initiatives aimed at fostering increased 
research and development partnerships with Russia, India, China and South Africa. Among other 
initiatives, we have been discussing the creation of a joint agricultural research centre as well as 
program mes for the prevention of disaster in coastal regions.  
556.  To conclude, Brazil's other international partnerships for innovation, notably with the 
United  States, Canada, EU countries, Switzerland, Japan and other nations, are outside the 
purview of this discus sion on regional innovation models while the initiatives I mentioned are 
concrete with encouraging results so far. We have a lot more to do. We look forward to continued 
discussions in the TRIPS Council and elsewhere to share experience with other countrie s and 
regions.  
12.19 Egypt  
557.  I would also like to thank the United States, the EU and other co-sponsors  that proposed the 
inclusion of this item on the agenda of our meeting.  
558.  It had not been my intention to intervene or to ask for the floor, but because the subject 
under discussion - namely the importance of innovation in regional strengthening and how the 
different regions have succeeded in promoting innovation in their territory - is such an important 
one, I felt I should make a few comments.  IP/C/M/83/Add.1  
 
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  559.  As we see it, this subject cannot be addressed without taking account of the different levels 
of development of each region and the difference in progress and development in each country.  
560.  For instance, according to the 2014 UNCTAD report on Transfer of Technology and 
Knowledge Sharing for Development, in 2011, 67% of patent applications in the world were 
registered in the developed countries, while only 3.2% were registered in the lower middle income 
countries. None were  registered in the LDCs.  
561.  The report also highlights the importance of technology transfer in promoting innovation in 
the developing countries and the LDCs. These technology transfers take place through various 
channels: international trade, direct investme nt, licensing, movement of persons.  
562.  Moreover, the UNCTAD Technology and Innovation Report 2015 points to the low 
participation of African countries in world exports of high technology products: in 2014 they 
accounted for no more than 0.3% of total exports of such products from the developing countries.  
563.  For all of these reasons, we believe that we should continue to discuss this subject under 
Article 66.2 on technology transfer, particularly to the LDCs, and Article 67 on technical 
cooperation.  
564.  We also propo se the organization of a joint workshop between the TRIPS Council and the 
Committee on Trade and Development on: the role of technology transfer in fostering innovation; 
cooperation and technical assistance; and how they can contribute to the development o f the LDCs 
and the developing countries.  
12.20 Chile  
565.  We are pleased that you are conducting our proceedings, and wish to thank those who 
proposed that this item be placed on the agenda. Innovation, as inde ed other areas, is increasingly 
developed in a cross border context, which means that the topic of regional innovation models is 
highly relevant. Delegations have been invited to share their experiences, and it has been very 
interesting to listen to Member s outlining their different perspectives.  
566.  We thank the delegation of Mexico for expanding on the initiatives and projects that are 
being developed in the context of the Pacific Alliance's Technical Working Group on Intellectual 
Property. These initiatives,  as mechanisms for cooperation between industrial property offices, are 
very useful and beneficial in strengthening our systems, and are designed to stimulate and 
promote regional innovation.  
12.21 Guatemala  
567.  We would like to thank the sponsors of agenda item 12. My delegation would like to support 
what was said by the distinguished delegate of El Salvador. We welcome these sorts of initiatives 
outlined by that delegation as they play a key role. This is  a way of providing inputs to 
governments when it comes to their innovation policies. All of this serves to strengthen or set up 
an IP System that in turn promotes economic development.  
568.  Guatemala is a part of a number of regional initiatives on these ques tions and this has given 
us the opportunity to become involved nationally in developing our IP Systems. We feel that it is 
very useful for us to discuss these matters here in the TRIPS Council. Our discussions provide us 
with the opportunity to hear from o ther regions on these issues.  
12.22 Colombia  
569.  We would like to take the opportunity to congratulate the proponents of this agenda item. 
Like Peru, Chile and Mexico, we would like to highlight the work t hat has been done in recent years 
under the work of the auspices of the Pacific Alliance. As already has been said, there is good work 
being done by the technical IP group of that Alliance. This group has worked with others in our 
governments in order to p romote and develop a number of tools of use to the uses of our regional 
intellectual property systems and this is of help regionally and nationally. This technical group has, 
among other things, developed a harmonized list of terms and regional expressions  and has also IP/C/M/83/Add.1  
 
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  developed a pilot project for accelerated patent registration. The list of terms and regional 
expressions has allowed us to develop terms that reflect regional expressions covering products 
that might be included in patent applications. These  are terms that might not be included in the 
NICE System. This is of help to the IP Systems of countries in the region. It means that they are 
familiar with the terms and regional expressions and in a position to recognize them and therefore 
have been acce pted by competent bodies when they appear in trademark applications that are 
registered outside the country of origin.  
570.  The pilot project for the accelerated system for patent granting in the Alliance allows our 
different IP offices to benefit from work car ried out by others when it comes to patent 
examination. It allows patent applicants to have their patent applications processed as fast and 
effectively as possible.  
571.  The work being done by these four IP offices is a way of promoting the best international 
practices when it comes to regional cooperation and the development of IP Systems in the 
countries making up the Alliance.  
12.23 ARIPO  Secretariat   
572.  I thank the co -sponsors o f this item for intro ducing it.  ARIPO is one of the regional offices 
with 40 years of history and experience. One of the mandates of ARIPO which was set 40 years 
ago is to support its members in the acquisition of IP based technologies. This mandate is 
translated today in assi sting Member States in their quest for transfer of technology and promotion 
of innovation.  
573.  Promoting innovation requires first and foremost the existence of a legal framework that 
protects IPRs related to innovation. The Harare Protocol provides protection  at the regional level of 
patents, utility models and industrial designs . To date, 18 member States  are part of this Protocol . 
We have also the  Banjul Protocol  which provides a system for the protection to trademarks and  ten 
member States  participate in th is Protocol . It similarly requires well -functioning IP offices. ARIPO 
offers a very efficient mec hanism of protection of rights at the regional level. With regard 
specifically to patents, the system provides a substantive examination mechanism that ensures  
grant of strong and reliable patent. ARIPO has also been very active in supporting the national IP 
offices to improve their systems of administration of intellectual property rights. Patents that 
cannot be examined at the national level due to lack of cap acity are examined by ARIPO at the 
regional level. This service is offered for free to countries in view of their Membership to the 
organization.  
574.  In 2015 the Arusha Protocol was adopted by the member States for the protection of  new 
plant varieties. We ex pect to see th is Protocol enter into force soon.  
575.  Further, ARIPO has been training national officers to better deal with applications in their 
offices. In collaboration with WIPO and USPTO, it conducted training programmes to develop skills 
in examination p rocedures and patent drafting. With IP Australia and the Australian Patent Office 
(APO) we have also trained our examiners to further strengthen our capacity to grant high -quality 
patents that meet international standards. ARIPO has organized a number of o ther initiatives in 
the promotion of innovation at ARIPO and in the Member States. A conference was organized last 
year on "utility models " with the view to promot ing its use to facilitate small -scale innovation in 
Africa.  
576.  I would like to highlight here th e support that we received from the Republic of Korea, 
through  KOICA, Korea's Internati onal Cooperation Agency , which funded the activity of our ICT 
system to the sum of  $6 million . This  allowed us to digitize our operations and to be one of the 
offices th at offers e -services, namely e -filing, e -searches and e -payment, for the benefit of our 
member States and users. ARIPO also facilitates access to technological information through 
patent searches and monographs, providing a patent landscaping in specific t echnological areas 
relevant to the continent. With such initiatives, ARIPO assists researchers and innovators to avoid 
"reinventing the wheel " and fast -tracking their innovation initiatives.  
577.  ARIPO is also collaborating with a number of Universities in Ghan a, Mozambique and 
Zimbabwe in creating awareness among researchers on the importance of using IP to add value to IP/C/M/83/Add.1  
 
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  their work. To that aim , ARIPO offers a p ackage which includes awareness -raising initiatives 
targeting researchers, development of internal IP policies and the establishment of technology 
transfer offices in those institutions. It is our belief that this package will allow university and 
research institutions to use IP as a tool to turn research outputs into IP assets which will ultimately 
genera te revenue and promote a linkage with industry, thus promoting innovation in the continent.  
578.  Finally, I am eager to share with you the ongoing preparations of the IP Conference on 
Innovation jointly organized by ARIPO and WIPO which will take place in Harar e on 8-9 December 
as a final act of the current cohort of the Master Degree on IP.  
AGENDA ITEM 13: THE UNITED NATIONS SECRE TARY -GENERAL'S HIGH -LEVEL PANEL 
REPORT ON ACCESS TO MEDICINES  
13.1 India  
579.  At the outset, I would like to thank  the delegations of Brazil, China and South Africa who are 
also co -sponsors of this agenda item.  
580.  In November 2015, the United Nations Secretary -General, Mr. Ban Ki -moon, convened a 
High-Level Panel (HLP) on Access to Medicines with the objective "to review and assess proposals 
and recommend solutions for remedying the policy incoherence between the justifiable rights of 
inventors, international human rights law, trade rules and public health in the context of health 
technologies ". The H igh-Level Panel was co -chaired by Ms. Ruth Dreifuss, former President of 
Switzerland,  and Mr. Festus Gontebanye Mogae, former President of Botswana. The High -Level 
Panel was comprised of 15 eminent individuals with an understanding of a broad range of lega l, 
commercial, trade, public health and human rights issues central to promoting innovation and 
access to technologies. Their work was supported by a 25 -member Expert Advisory Group 
constituted from academia, the private sector, civil society and relevant United Nations and 
international organizations, such as the World Trade Organization.  
581.  The HLP deliberations were informed by and benefited  from a broad consultative process, 
which included a generous response to a public call for contributions that netted 182 submissions, 
many of which were of high quality. Hearings and Global Dialogues were held in London and 
Johannesburg in March 2016 to examine the proposals and incorporate the views and inputs from 
concerned parties and affected communities. On 14 Septe mber 2016, the United Nations 
Secretary -General’s High -Level Panel on Access to Medicines released its Final Report. The HLP, 
inter alia, made recommendations on Intellectual Property laws and access to health technologies, 
especially on (i) TRIPS flexibil ities and TRIPS -plus provisions and (ii) and p ublicly -funded research.  
582.  Before going into the specific recommendations of the HLP, I will briefly state about the 
flexibilities in the TRIPS Agreement. The TRIPS Agreement established minimum standards of 
protection that each government has to give to the Intellectual Property of fellow WTO Members. 
The TRIPS Agreement tried to strike an appropriate balance  between the interests of right  holders 
and users. 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 and in a manner conducive to social and economic welfare and to a 
balance of rights and obligations. The search for a balance between the need to protect IPRs to 
provide incentives for R&D on the one hand and, on the other hand, to address concerns about the 
potent ial impact of such protection on the health sector – in particular its effect on prices – has 
been an imp ortant consideration by the TRIPS Council . 
583.  The TRIPS Agreement also recognizes that the principles of IP protection are based on 
underlying public poli cy objectives. Article 8 of  the TRIPS Agreement entitled "Principles " states 
that WTO Members may, in formulating or amending their laws and regulations, adopt measures 
necessary to protect public health and nutrition, and to promote the public interest in  sectors of 
vital importance to their socio -economic and technological development, provided that such 
measures are consistent with the provisions of this Agreement. Article 8(2) further states that 
appropriate measures may be needed to prevent the abuse o f IPRs by right holders, or t he resort 
to practices which unreasonably restrain trade or adversely affect the international transfer of 
technology.  IP/C/M/83/Add.1  
 
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  584.  In fur therance of the objectives and p rinciples of TRIPS enshrined in Articles 7 and 8, a 
number of safegua rds or flexibilities have become an integral part of the TRIPS framework. These 
flexibilities can be used to pursue public health objectives. However, to implement these 
flexibilities, action is needed at the domestic level by incorporating them into  the national IP 
regime, keeping in mind each country' s individual needs and policy objectives. Key TRIPS 
flexibilities include transition periods for LDCs which has been extended by the WTO last year until 
1 January  2033, differing IP exhaustion regimes (intern ational exhaustion allows parallel 
importation of patented products from other countries where they are the cheapest), refining the 
criteria for grant of a patent which is called patentability criteria, pre -grant and post -grant 
opposition procedures, as we ll as exceptions and limitations to patent rights once granted, 
including regulatory review exception which is also called the "Bolar" exception , to facilitate market 
entry of generics, compulso ry licences, including through the Paragraph  6 mechanism and 
government use. For pharmaceutical patents, these flexibilities have been clarified and enhanced 
by the 2001 Doha Declaration on TRIPS and Public Health , i.e. that WTO Members have the 
flexibility to interpret and implement the TRIPS provisions in a manner supportive of their right to 
protect public health.  
585.  Although the TRIPS Agreement provides a substantial degree of flexibility to WTO Members, 
the full utilization of these flexibilities is in the hands of relevant Member s. However, many 
developing countri es are constrained by limited technical capacity to make full utilization of the 
TRIPS flexibilities and therefore they need appropriate technical assistance from relevant 
multilateral organizations in order to fully utilize the TRIPS flexibilities from th e perspective of 
specific sectors of their economies such as agriculture, manufacturing, public health, environment, 
etc. Moreover, even where some developing countries have used the flexibilities available to them 
under the TRIPS Agreement to address publ ic interest objectives through measures which are fully 
consistent with the TRIPS Agreement, these attempts have been challenged legally as well as 
politically. A slew of regional trade agreements containing TRIPS plus standards of IP protection 
and enforc ement have the potential to significantly undermine the effective and full use of the 
TRIPS flexibilities. Investor -State disputes under regional or bilateral investment protection 
agreements are also emerging as a major challenge to the use of TRIPS flexi bilities in the public 
interest.  
586.  Against this background, the recommendations of the HLP, especially on (i) TRIPS flexibilities 
and TRIPS -plus provisions and (ii) publicly -funded research are very important with regard to 
access to health technologies.  
587.  We also made the copies of the HLP report available at the back of the room. Interested 
Members can collect the report. Now I will read the recommendations of the HLP report starting on  
page 27 of the report:  
"TRIPS flexibilities and TRIPS -plus provisions: W orld Trade Organization Members should commit 
themselves, at the highest political levels, to respect the letter and spirit of the Doha 
Declaration on TRIPS and Public Health, refraining from any action that will limit their 
implementation and use in order  to promote access to health technologies. More specifically:  
a. (a) WTO Members should make full use of the policy space available in Article 27 of the 
TRIPS Agreement by  adopting and applying rigorous definitions of invention and 
patentability that curtail the evergreening  to ensure that patents are awarded when 
genuine innovation has occurred.  
i. (i) The United Nations Conference on Trade and Development (UNCTAD), the United 
Nations Development Programme (UNDP), the World Health Organization (WHO), the 
World I ntellectual Property Organization (WIPO) and the World Trade Organization 
(WTO) should cooperate with one another and with other relevant bodies with the 
requisite expertise to support governments to apply public health -sensitive 
patentability criteria.  
ii. (ii) These multilateral organizations should strengthen the capacity of patent 
examiners at both national and regional levels to apply rigorous public health -
sensitive standards of patentability taking into account public health needs. " IP/C/M/83/Add.1  
 
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  b. (b) "Governments shou ld adopt and implement legislation that facilitates the issuance of 
compulsory lice nces. Such legislation must be designed to effectuate quick, fair, 
predictable and implementable compulsory licen ces for legitimate public health needs, 
and particularly wit h regards to essential medicines. The use of compulsory licensing 
must be based on the provisions found in the Doha Declaration and the grounds for t he 
issuance of compulsory licenc es left to the discretion of governments. " 
c. (c) "WTO Members should revise t he Paragraph 6 Decision in order to find a solution that 
enables a swift and expedient export of pharmaceutical products produced under 
compulsory license. WTO Members should, as necessary, adopt a waiver and permanent 
revision of the TRIPS Agreement to en able this reform. " 
d. (d) "Governments and the private sector must refrain from explicit or implicit threats, 
tactics or strategies that undermine the right of WTO Members to use TRIPS flexibilities. 
Instances of undue political and commercial pressure should  be formally reported to the 
WTO Secretariat during the Trade Policy Reviews of Members. WTO Members must 
register complaints against undue political and economic pressure, and take punitive 
measures against offending Members. " 
e. (e) "Governments engaged in bilateral and regional trade and investment treaties should 
ensure that these agreements do not include provisions that interfere with their 
obligations to fulfil the right to health. As a first step, they must undertake public health 
impact assessments. T hese impact assessments should verify that the increased trade 
and economic benefits are not endangering or impeding the human rights and public 
health obligations of the nation and its people before entering into commitments. Such 
assessments should infor m negotiations, be conducted transparently and made publicly 
available. " 
588.  On publicly -funded research , the report recommends that : 
a. "Public funders of research must require that knowledge generated from such research 
be made freely and widely available throu gh publication in peer -reviewed literature and 
seek broad, online public access to such research.  
b. Universities and research institutions that receive public funding must prioritize public 
health objectives over financial returns in their patenting and lice nsing practices. Such 
practices may include publication, non -exclusive licensing, donations of intellectual 
property and participation in public sector patent pools, among others. Sufficient 
incentives must be in place in these practices to make it attract ive for developers to 
underwrite the cost of bringing a product to market at affordable prices that ensure 
broad availability.  
c. Universities and research institutions that receive public funding should adopt policies 
and approaches that catalyse innovation and create flexible models of collaboration that 
advance biomedical research and generate knowledge  for the benefit of the public. " 
589.  To conclude, we encourage Members to share their views on the recommendations of the 
HLP at this session of the TRIPS Counci l. Further, at the subsequent sessions of the TRIPS Council, 
we, along with likeminded countries, would also introduce other agenda items on TRIPS 
Flexibilities  to share their exp eriences  – especially how they are  using the TRIPS flexibilities to 
address p ublic policy priorities, in particular, related to public health.  
13.2 Brazil  
590.  Brazil is pleased to be a co -sponsor, alongside  with China, India and South Africa,  of the 
agenda item on the United Nations Secreta ry-General's High -Level Panel Report on Access to 
Medicines.  
591.  The HLP on access to medicines was established to implement one of the recommendations 
of the Global Commission on the HIV and the law. This Commission, as many will remember, was 
comprised of e minent authorities and chaired by the former Brazil President, Fernando Henrique IP/C/M/83/Add.1  
 
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  Cardoso. On 19 November 2015, UN SG Ban Ki -moon  announced the creation of the High -Level 
Panel on Innovation and Access to Health Technologies. In outlining its mandate, the S ecretary -
General guided the panellists to "review and assess proposals and recommend solutions for 
remedying the policy and coherence between the justifiable rights of inventors, international 
human rights law, trade rules and public health in the context of health technologies ". The HLP 
was co -chaired by the former President of the Swiss Confederation, Ru th Dreifuss  and by the 
former President of Botswana, Festus Mogae. Its final report was released last September as we all 
know and some of  its recommendat ions are directly related to the TRIPS Agreement. One of these 
calls for WTO Members to commit at the highest political levels to respect the letter and the spirit 
of the Doha Declaration on TRIPS and Public Health refraining from any action that will limi t their 
implementation and use in order to promote access to health technologies.  
592.  More specifically, it recommends: (1) WTO Members should make full use of the policy space 
available in Article  27 of the TRIPS Agreement by adopting and applying rigorous de finitions of 
invention and patentability that curtail the evergreening to ensure that patents are only awarded 
when genuine innovation has occurred ; (2) enhanced cooperation among The United Nations 
Conference on Trade and Development (UNCTAD), the United Nations Development Programme 
(UNDP), the World Health Organization (WHO), the World Intellectual Property Organization 
(WIPO) and the World Trade Organization (WTO) and with other relevant bodies with the requisite 
expertise to support governments to appl y public health -sensitive patentability criteria; (3) it also 
recommends these multilateral organizations to strengthen the capacity of patent examiners at 
both national and regional levels to apply rigorous public health -sensitive standards of 
patentabili ty taking into account public health needs; (4) governments should adopt and 
implement legislation that facilitates the issuance of compulsory licences. Such legislation must be 
designed to effectuate quick, fair, predictable and implementable compulsory l icences 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 licences left to the discretion of governments; 
(5) governments and the private sector must refrain from explicit or implicit threats, tactics or 
strategies that undermine the right of WTO Members to use TRIPS flexibilities.  
593.  Brazil has a strong commitment to the improveme nt of public health in our country and in 
our region. To increase the bargaining power of governments in the acquisition of essential 
medicines, Brazil has established in 2015 a regional system of procurement for lifesaving drugs. 
This arrangement with the  participation of most South American countries is one sort of innovative 
mechanism s aimed at helping countries to cope with high prices of pharmaceuticals.  
594.  Engaging in the discussions of recommendations by the HLP might allow Members to 
consider  differen t aspects of the relationship between access to medicines and the patent system. 
Brazil is convinced that the balanced and effective IP System would go a long way towards 
facilitating access to essential medicines without in any way infringing on market pr inciples.  
595.  We all know access to medicines is a challenge for most countries whether least developed, 
developing or developed. We present these views in the spirit of dialogue, convinced that they are 
in the interest of everyone without exception and encour age the whole Membership to work 
constructively towards achieving the goal of universal access to medicines.  
596.  Brazil understands it is important for the TRIPS Council to pay due attention to the issues 
and recommendations raised by the UN SG HLP. We would b e most interested in the continuation 
of this discussion in the next TRIPS Council session as well.  
13.3 South Africa  
597.  On 28 October 2016, the delegations of Brazil, China, India and South Africa, circula ted 
document IP/C/W/619. This document places the U nited Nations Secretary -General' s High -Level 
Panel Report on Access to Medicines on the agenda of the TRIPS Council. The Panel 's mandate was 
"to review and assess proposals and recommend solutions for reme dying the policy incoherence 
between the justifiable rights of inventors, international human rights law, trade rules and public 
health in the context of health technologies ". IP/C/M/83/Add.1  
 
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  598.  The High -Level Panel recommendations call for WTO Members to commit to respect t he WTO 
Doha Declaration on the TRIPS Agreement and Public Health and to refrain from any action that 
would limit its implementation. The Panel recommends that countries should make full use of the 
flexibilities enshrined in the TRIPS Agreement, and use the  policy space available in Article 27 of 
TRIPS Agreement "by adopting and applying rigorous definitions of invention and patentability that 
are in the best interests of the public health of the country ", including amending laws to curtail the 
ever-greening  of patents and awarding patents only when genuine invention has occurred. 
Governments are also called to adopt and implement legislation facilitation the issuance of 
compulsory licences.  
599.  The Report further notes that many governments have not used flexibi lities available under 
the TRIP S Agreement for various reasons , ranging from capacity constraints to undue political and 
economic pressure form states and corporations, both express and implied. The Panel concludes 
that political and economic pressure plac ed on governments to forgo the use of TRIP S flexibilities 
violates the integrity and legitimacy of the system of legal rights and duties created by the TRIPS 
Agreement and reaffirmed by the Doha Declaration.  
600.  The Panel also recommends that governments engag ed in bilateral and regional trade and 
investment treaties should ensure that these agreements do not include provisions that interfere 
with their obligations to fulfil the right to health. It points out that provisions found in RTAs may 
impede access to h ealth technologies, including those requiring governments to ease standards of 
patentability, drug regulatory authorities to link marketing approval to the absence of any claimed 
patent and the requiring of test data exclusivity instead of test data protec tion, to list a few.  
601.  It is with interest that this delegation notes the contribution of the Netherlands to the 
"Lancet Commission on Essential Medicine s for Universal Health Coverage ". Ministers Ploumen and 
Schippers note in their contribution to the repo rt that, inter alia, and I quote  "Steps need to be 
taken to bolster the safeguards in the TRIP S Agreement. The Netherlands is campaigning for these 
safeguards to be maintained in negotiations on free trade agreements with developing countries. 
We will inte nsify our efforts to prevent so -called TRIPS Plus provisions in free trade agreements 
that are being negotiated by the EU and other high income countries. In this respect we agree with 
the recommendations of the UN High -Level Panel on Access to Medicines t hat governments and 
private actors must abstain from retaliatory threats that undermine the right of WTO Members to 
use safeguard measures. "  
602.  The High -Level Report highlights various issues that affect access to essential medicines 
including the use of fle xibilities recognized by the TRIPS Agreement. It notes that flexibilities are 
not exceptions but fully fledge d rights recognized in the TRIPS Agreement. The Report is a rich 
repository and reference document which we intend to use as a reference point to c onduct further 
discussion in the TRIPS Council regarding issues that are pertinent and relevant to its mandate. 
We would welcome further dialogue and contributions from other Members.  
13.4 China  
603.  China is pleased  to be  a co-sponsor o f this item. The United Nations Secretary -General's 
High Level Panel Report on Access to Medicines gives various recommendations to promote 
innovation of health technology, strengthen access to medicines and secure public health. These  
recommendations provide valuable reference information for Members when discuss ing IP and 
public health related issues in the WTO, as well as the establishment of their national systems.  
604.  As a global problem, public health is one of the most important elem ents in the UN 2030 
Agenda. The issue of public health has attracted great attention from global leaders. In  the "G20 
Leaders' Communique Hangzhou Summit ", G20 leaders specified the serious threat by 
antimicrobial resistance (AMR) to public health, growth and global economic stability, and they 
committed to promote prudent use of antibiotics and take into consideration huge challenges of 
affordability and access of antimicrobials and their impact on public health. Following the 
guidelines by G20 leaders, a joint technical symposium was held by WHO, WIPO and WTO on 
25 October to discuss how to foster antimicrobial access and how to formulate trade policy in 
support of such access.  IP/C/M/83/Add.1  
 
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  605.  WTO Members are entitled to take full use of those flexibilities identified und er the TRIPS 
Agreement and  the Doha Declaration on TRIPS and Public Health, in order to promote access to 
medicines and secure public health. In this regard, China would like to share with Members some 
of its views and practices.  
606.  In the context of TRIPS, a fter the adoption of the Protocol Amending the TRIPS Agreement 
by the General Council, China launched its domestic approval proce dure and ratified it in 
October  2007. China was the 13th Member to accept the Protocol. We hope that Members who 
have not ratif ied the Protocol could complete such acceptance as soon as possible, with a view to 
achieving  our joint efforts, our spirit of collaboration and our commitment to overcome public 
health problems.  
607.  In the domestic context, China has been using compulsory lic ensing, parallel imports and  the 
Bolar exception to promote access to medicines and secure public health. These instruments are 
fully permissible under TRIPS and the Doha Declaration on TRIPS and Public Health. For example, 
there is a specific provision of  compulsory licensing in China’s Patent Law and implementation 
regulation. When the Patent Law was amended in 1992, 2000 and 2008 respectively, the provision 
was further improved according to  the Paris Convention, the TRIPS Agreement and the Protocol 
Amend ing the TRIPS Agreement. In 2012, China combined the provisions on compulsory licensing 
and Public health related compulsory licensing together, and issued new detailed rules for  the 
application, review, approval and termination of compulsory licensing, ma king it operate more 
smoothly . 
608.  We note that, due to different domestic IP regimes, WTO Members may have different views 
and positions on the report. We also take note that, even members of the High -Level Panel did not 
agree on each part of the report. Howe ver, we would like to call upon Members to take this 
opportunity to exchange views and practices on how to make better use of the flexibilities under 
the TRIPS Agreement and  the Doha Declaration on TRIPS and Public Health, as well as other 
international or  national instruments if available, and on how to better serve our global efforts to 
secure public health and promote access to medicines . 
13.5 Ecuador  
609.  Ecuador would like to thank Brazil, China, India and Sout h Africa for having requested that 
this item be included on our agenda. Access to medicines is a matter of importance to all countries 
and in particular for developing countries and LDCs.  We therefore welcome the High -Level Panel 
Report on this matter requ ested by the UN Secretary -General. The Panel did refer to the TRIPS 
Agreement and its flexibilities and in particular to the need for governments to ensure that they 
have legislation covering compulsory licences in order to ensure that people have access t o 
medicines.  
610.  I would like briefly to refer to my country's experience of compulsory licences in order to 
ensure access to medicines. In 2009 through Decree 118, our Government declared that access to 
medicines was a matter of public interest. The Decree me ant that domestic and foreign labs were 
able to request for compulsory licences for medicines in order to manufacture them and sell them 
domestically. Following research and the development of principles for the development of generic 
low-cost medicines, w e then set up ENFARMA , a corporate body that is responsible for ensuring 
that people have access to medication which they need to treat their illnesses. EIP , our intellectual 
property office , did adopt compulsory licences  covering such medications , includi ng anti -
retroviral s. The Ministry of Public Health provides  these medications  at no cost for the treatment of 
patients suffering from HIV/AIDS. These licences were granted because EIP data indicated that 
there were some 37 people with the virus that causes  HIV/AIDS. As a result of seeing this data 
and with the compulsory licences some 30% to 70% savings were allowed for the Ministry in the 
purchase of this medication. In addition to the licences for anti -retrovirals, we subsequently had 
licences for medicat ion for the treatment of other diseases causing acute pains and this, for 
instance, involved diseases requiring kidney transplants and then also medication for dealing with 
kidney cancer and gastrointestinal tumours and medication against arthritis  which  was one of the 
first licences granted for a biotechnology produced drug. As a result of these measures, it is the 
hope of our Government that there will be significant savings when it comes to providing 
medication. This will also serve to strengthen our med ical services and allow us to replace the 
imported drugs with domestically produced medication.  IP/C/M/83/Add.1  
 
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  13.6 Egypt  
611.  We would like to thank Brazil, India, China and South Africa for proposing this item on the 
agenda of ou r meeting today. As raised by the four countries, the report of the United Nations 
Secretary -General High -Level Panel on Access to Medicines contains a very important 
recommendation for both developing  countries  and LDCs. Therefore, we urge the TRIPS Counc il to 
start studying the way to implement those recommendations especially the one regarding the 
proposed cooperation between the UNCTAD, UNDP, WIPO and WTO in order to support the 
governments to apply public health -sensitive patentability criteria.  
13.7 I ndonesia  
612.  Indonesia welcomes and supports the inclusion of the UN SG HLP report on access to 
medicines as a dedicated agenda item for the TRIPS Council. We thank the proponents for their 
initiative. We believ e the report is line with the Doha Declaration on the TRIPS Agreement and 
Public Health and will enrich discussion and support the betterment of the TRIPS Agreement. We 
also note that the report was created to achieve  the public health objectives  as mandat ed by the 
2030 Agenda for Sustainable Development. Indonesia will be studying the report and is looking 
forward to discussing the report in the coming TRIPS Council.  
13.8 Bangladesh  
613.  Let me join others in th anking the proponents India, Brazil, China and South Africa for 
proposing this agenda item today. The delegation of Bangladesh welcomes the report of the UN SG 
HLP on access to medicines. Bangladesh benefited immensely from the flexibilities under the TRIP S 
Agreement. We could guarantee production and availability of affordable medicine s to our huge 
population of 160 million. We have developed a reasonably viable technological base for 
production of lifesaving drugs. So we wholeheartedly support the calls a nd effort to ensure access 
to medicine and support the recommendations of the HLP to make essential medicines available to 
all.  
13.9 Russian Federation  
614.  The Russian Federation would like to thank  the delegations of Brazil, China, India and 
South  Africa for inclusion of this topic on the agenda of the TRIPS Council meeting.  
615.  We attach great importance to the issue of access to medicines, which needs to be discussed 
in a broader context, taking into ac count not only the Paragraph 6 System , but also various other 
relevant measures and factors.  
616.  The Russian Federation welc omes the sharing of delegations'  views on the recommendations 
of the High Lev el Panel as well as delegations'  experiences in using the TRIPS flexibilities to 
address public policy priorities, in particular, related to public health.  
617.  As for the Paragraph 6 of the Doha Declaration on the TRIPS  Agreement  and Public Health 
that we mentioned in our statement, the Russian Federation is currentl y accelerating the internal 
process and taking all the necessary steps in terms of our constitutional requirements for 
accepting the Protocol Amending the TRIPS Agreement and aims to accept the Protocol in the near 
future.  
13.10 United States  
618.  As the United States explained in its statement on 16 September in response to the HLP 
report, we are committed to working with international partners in identifying practical ways both 
to increase access to safe, ef fective, affordable and lifesaving medicines around the world and to 
support policies that drive the development of new medicines.  
619.  We are therefore deeply disappointed by the report which detracts from, rather than 
advances, those critical objectives. As t he United States made clear in its submission to the Panel 
in February 2016, the narrowly focused mandate of the Panel was flawed and unlikely to lead to IP/C/M/83/Add.1  
 
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  outcomes that adequately address this complex issue. The result includes conclusions that further 
this narrow perspective raising fundamental questions regarding the legitimacy of its conclusions.  
620.  It is equally regrettable that the Panel worked under the presumption of "policy incoherence " 
between IPRs, international trade liberalization and human rights w hile failing to properly 
recognize the important role that these systems play in incentivizing drug development and 
expanding access to medicines around the world. IPRs and trade are essential to medical 
innovation which is fundamental to promoting public health. We believe that we can both increase 
access to medicines and support innovation for the development of new and improved drugs for 
the world's most critical health challenges. Indeed, there can be no access to drugs that have not 
been developed.  
621.  Support for innovation is essential. In this respect, we note the concerns raised by the 
several panellists who have practical experience in managing medicine research and development 
that taking forward the recommendations of the Panel could have significant , unintended and 
negative consequences. The Panel has now concluded its work and missed a key opportunity to 
provide practical observations regarding the complex issues surrounding access to medicines. The 
report instead offers only a narrow perspective on  a subset of those issues and articulates divisive 
policies that, if implemented, could severely undermine the innovation critical for the development 
of medicines and health technologies as well as private sector, university and government -funded 
research . This divisive approach does not provide the consensus necessary.  
622.  The United States supports the right of everyone to the enjoyment of the highest attainable 
standards of physical and mental health. While we recognize the importance of access to 
medicines , we note that countries have a wide array of policies and actions that may be 
appropriate in promoting the progressive realization of the right to the enjoyment of the highest 
attainable standard of physical and mental health and regret that this perspect ive is not reflected 
in the report.  
623.  We are also concerned with the Panel's mischaracterization of additional aspects of 
international human rights law. Regrettably the Report's narrow focus has caused it to overlook 
the advancements made by innovative eco nomies around the world. Robust IP policies, founded in 
the United States and other economies, support the development of innovative, new treatments 
that save and improve lives around the world. The rules -based international trade system 
eliminates trade b arriers that drive up costs of medicines for governments and patients. Efforts to 
fund drug development and patient treatment programmes in developing countries, including 
those sponsored by the United States, have made significant contributions.  
624.  The Unit ed States Government remains committed to advancing access to existing and new 
medicines, including by supporting innovation through robust IPR -protection and working with 
public and private stakeholders to find new solutions to the world's pressing public  health 
challenges.  
13.11 Canada  
625.  The Government of Canada considers access to medicines for poor and disadvantaged 
populations to be a key priority in our ongoing efforts to promote global health and prosperit y. 
626.  Canada reported on our broad array of programmes promoting access to medicines on 
several occasions yesterday and during the Article 66.2 Workshop on Monday so I will refrain from 
repeating these for a fourth time during this TRIPS Council session.  
627.  Canada welcomes the attention that the Report of  the UN Secretary -General's  High-Level 
Panel  on Access to Medicines has drawn to this important issue since it was released on 
14 September.  
628.  However, Canada will require further time to consider this detailed re port and its  various 
recommendations.  
629.  For Canada, such recommendations touch on a variety of complex domestic policies, laws 
and regulations related to intellectual property, health and pharmaceuticals, which fall under the  IP/C/M/83/Add.1  
 
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  responsibility of several Federa l Government departments and agencies  who are collectively 
studying the Report . 
630.  Canada is pleased to be part of the discussion today and to learning more about the views of 
other Members that have established their national positions on the HLP Report.  
13.12 European Union  
631.  The European Commission takes note of the contribution provided by the Report of the 
United Nations Secretary -General's High -Level Panel on Access to Medicines.  
632.  The work conducted by  the Panel started from an assumption that there was "policy 
incoherence between the justifiable rights of inventors, international human rights law, trade rules 
and public health ". As the European Commission already indicated in its written contribution t o the 
Panel, it does not share this assumption , inter alia , because IPRs are also listed in our Charter of 
Fundamental Rights as being one of them.  
633.  The Commission shares the Report 's acknowledgement that there are many reasons "why 
people do not get the h ealthcare they need, ranging from: under -resourced health systems, a lack 
of sufficiently qualified and skilled healthcare workers, inequalities between and within countries, 
exclusion, stigma, discrimination and exclusive marketing rights ". Other importan t problem s are 
global medicines shortages and stock -outs.  
634.  This is why , in its written contribution to the Panel, the Commission encouraged it to adopt a 
holistic approach to the problem of access to medicines that could result in a valuable contribution 
to the wider debate.  
635.  However, due to its limited mandate, the High -Level Panel has focused its proposals 
exclusively on addressing an alleged conflict between a research and development model that 
partially relies on IPRs and the possibility of providing af fordable medicines. In doing so, it has 
missed an opportunity to advance more balanced, comprehensive and workable solutions to the 
problem of access to health. The Commission would also highlight that no conclusions could be 
reached with the support by al l Members of the Panel, as demonstrated by the dissenting opinions 
attached to this Report., which are no less than nine.  
636.  The European Union is committed to increasing access to affordable medicines and to find ing 
solutions to the world's pressing public h ealth challenges and inequities. In line with the 2010 
Communication and Council Conclusions on "the EU role in Global Health ", the EU pursues a 
rights -based approach to health. Strengthening all areas of a health system, including the 
availability of qual ified health workers, the provision of affordable medicines and the adequate 
financing of the sector, is central to moving towards universal health coverage with quality health 
services accessible and affordable for all. The quality and integrity of the ph armaceutical 
distribution chain is also essential to improving public health.  
637.  The challenge is to strike the right balance between the need to promote and finance the 
research of new and better medicines for all, ensuring that medicines are accessible and  affordable 
to those in need, while guaranteeing the sustainability of health systems. We believe that these 
goals are not contradictory and must be pursued jointly.  
638.  The current innovation model, including the role of trade related to IP, has delivered 
consistent progress in global public health, leading to key new and improved treatments as well as 
much extended life expectancy, both in developed and developing and least developed countries. 
This model already integrates a variety of tools such as incenti ves for innovation based on 
intellectual property, on public and private financing and awards or on public research. Such 
variety is necessary to address situations where there is a functioning market and those where 
there could be market failures.   
639.  The R eport underplays the fact that the development of new drugs requires significant 
investment and long -term research, coupled with clinical trials and regulatory approval 
procedures. The exclusive right conferred by a patent is an important incentive for inn ovator 
pharmaceutical companies to make the necessary investments into that research and IP/C/M/83/Add.1  
 
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  development. Without incentivizing the innovator pharmaceutical companies to invest in research, 
the sustainable development goal of ensuring healthy lives and promoti ng well -being for all, 
including achieving universal health coverage, would be severely undermined.  
640.  Several of the issues covered in the Report's recommendations are addressed in EU 
legislation, as well as EU and Commission policies and actions, including at multilateral level. To 
name a few examples: the Commission is a major funder of research and innovation for poverty -
related and neglected diseases and for new antibiotics. In the previous intervention yesterday, I 
took your time and bored you with my ex haustive reading of these programmes, but there was a 
reason for that. We are talking here about concrete issues and concrete programmes helping 
countries sitting in this room and financed by real money. At the WHO, the EU supports the 
implementation of th e WHO global strategy and plan of action on public health, innovation and 
intellectual property, including the development of the Global Observatory on Health Research and 
Development. In the area of trade, the EU ensures that its free trade agreements are  consistent 
with the Doha Declaration and it has supported the extension of the drug patent exemption for 
LDCs. As part of its health policy, the EU adopted new legislation to ensure that all clinical trials to 
be conducted in the EU will be registered in a publicly access ible EU database (Regulation (EU) No 
536/2014).  
641.  However, several other recommendations in this Report are not in line with the EU rules and 
practices and thus cannot be supported. This is, in particular the case for the proposals to revise  
the Paragraph 6 Decision or the areas of the TRIPS Agreement relating to patentability criteria , as 
well as  the recommendation  to create additional structures at UN level on the issue of health 
technology innovation and access  for mechanisms to supervise the functioning of other 
international organizations .     
642.  To conclude, I would just like to say that a ny future activities at the UN level or at the WTO 
regarding these issues should be conducted on the basis of a much broader understanding of the 
complex issues involved.  
13.13 Chile  
643.  We thank the delegations of Brazil, China, India and South Africa for including this item on 
the agenda. The report deals with matters that are very relevant to our countries, relat ing as they 
do to access to medicines, especially for developing countries. We thank those who have 
expressed substantive views on the subject. Our delegation is currently reviewing the report and 
its recommendations.  
13.14 Australia  
644.  Australia notes the communication from Brazil, China, India and South Africa requesting the 
inclusion of a discussion on the United Nations Secretary -General’s High Level Panel Report on 
Access to Medicines at this meeting. The A ustralian Government is currently considering the report 
and its recommendations from a broad, whole of government perspective. Australia is interested to 
hear the  views of other Members today.  
13.15 Switzerland  
645.  Switzerland attaches great importance to improving access to medicines, strengthening 
global health research, protection of intellectual property and promotion of human rights. These 
are priorities for Switzerland and  are stipulated as explicit goal s in its Health Foreign Policy. Based 
on this policy and the 2030 Agenda for Sustainable Development, Switzerland participa tes in many 
programmes and initiatives aimed at improving access to medicines, particularly in low -income 
developing countries.  
646.  We no te that the Report of the United Nations Secretary -Generals High -Level Panel on 
Access to Medicines (HLP) was not mandated by UN Member States, but commissioned by the UN 
Secretary -General.  
647.  The issue of access to medicines is a complex one. Switzerland thu s regrets that in light of 
the comprehensive and integrated nature of the 2030 Agenda for Sustainable Development, the IP/C/M/83/Add.1  
 
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  mandate of the High -Level Panel was very narrow in scope and presumes as a starting -point policy 
incoherence between IPRs of inventors, i nternational human rights law, trade rules and public 
health. This limits the utility of the Report's analysis. To implement the title of the Report 
promoting innovation and access to health technologies, the mandate should have incorporated a 
more holisti c approach.  
648.  The Report makes a number of useful proposals , some of which are currently being explored 
in the competent international organizations, among which the creation of a publicly accessible 
database with patent information status, or ideas on how t o deal with publicly funded research.  
649.  Switzerland, however, takes a different view with regard to the Report's recommendations 
related to IPRs. The Report fails to fully recognize the key role that IPRs play in incentivizing 
research and development of new  medicines. Governments are free to use the flexibilities 
contained in the WTO TRIPS Agreement. However, a systematic weakening of IPRs, as several 
recommendations in the Panel's report suggest, will discourage medical innovation and thus not be 
conducive but risk to  be prejudicial to the goal of better access to medicines.  
650.  In this context, we would have welcomed a more thorough analysis of existing initiatives and 
approaches which promote research and development and, by the same token, improve access to 
medical products for people in low - and middle -income countries. We believe that building on 
voluntary and inclusive efforts, such as the Medicines Patent Pool or the Global Fund's 
e-procurement platform, instead of denouncing the IP System , is the way forw ard and corresponds 
better to the collaborative spirit of the 2030 Agenda for Sustainable Development.  
651.  The Report also seems not to take adequately into account all the work that  competent 
international organiz ations and their members  have already undertak en or are currently 
undertaking with regard to addressing the access to medicines issue.  
652.  With the now-impending entry into force of the Paragraph  6 Amendment of the TRIPS 
Agreement , we reviewed yesterday one of the key contribution s of the WTO: t he new Ar ticle 31 bis 
puts all WTO Members on a level playing field in the use of the TRIPS flexibility as contained in 
Article 31 of the TRIPS Agreement.  
653.  We refer more particularly to WHO's extensive work on access to medicines , including  the 
Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property and the 
follow -up work based on the Report of the Consultative Expert Working Group on Research and 
Development on Coordination and Financing for Neglected Diseases.  
654.  My delegation also recalls the Trilateral Study of WHO, WIPO and the WTO on Promoting 
Access to Medical Technologies and Innovation. The Trilateral Study contains a comprehensive and 
robust presentation of the many factors, including those relating to IP, that matter when 
examining the challenges of access to medicines and when looking for possible solutions for them.  
655.  Proposals to establish further parallel processes or duplicate such work are not helpful. We 
should concentrate on concrete outcomes of the said work already u nder way in the competent 
organiz ations to which Switzerland is strongly committed . 
13.16 Japan  
656.  The delegation of Japan believes that careful consideration should be given to the High -Level 
Panel R eport.  
657.  Japan would like to clarify our position that access to medicine s is indeed an important issue. 
In order to address the issue, the Japanese Government has been working on important projects 
through working with the United Nations Development Program me (UNDP) and  collaborating with 
the Global Health Innovative Technology (GHIT) Fund. This includes support for R&D activities 
involving pharmaceuticals for developing countries and capacity building to improve administering 
policies on health.  
658.  Nonetheless, while the H igh-Level Panel has set a goal to reach "fundamental solutions " for 
the issue of access to medicines, its mandate seems to be narrow, focusing only on so -called IP/C/M/83/Add.1  
 
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  "policy incoherencies between the justifiable rights of inventors, international human rights l aw, 
trade rules and public health in the context of health technologies ".  
659.  This delegation believes that the issue of access to medicines could most effectively be dealt 
with by taking a more comprehensive approach including enhancing government policies f or 
medicine prices, eliminating taxes and tariffs imposed on essential drugs and rectifying anti -
competitive practices and so on. In other words, our experiences with previous efforts have 
identified multiple factors other than intellectual property that h ave a strong correlation to a major 
part of this issue. Our approach should focus on these factors. Furthermore, Japan would like to 
point out that the recommendation of this report neither reflects  the opinions of, nor has been 
endorsed by, Members workin g to solve the issue by supporting global health.  
660.  In conclusion, this delegation is of the view that the issue of access to medicines could most 
effectively be dealt with  through  a more comprehensive approach , including enhancing 
government policies for m edicine prices, eliminating taxes and tariffs imposed on essential drugs 
and so on. In other words, our experiences with previous efforts have identified much proven 
factors as IP that has a strong correlation to a measured part of this issue. Our approach  should 
focus on these factors.  
661.  Furthermore, Japan would like to point out that the recommendation of this Report neither 
reflects the opinion of, nor has been endorsed by Members working to solve the issue by 
supporting global health.  
662.  In conclusion, thi s delegation is of the view that the issue of access of medicines should most 
effectively be dealt with  through  a more comprehensive approach based on the accumulation of 
previous discussion and reports, such as a joint research conducted by WHO/WTO/WIPO.  
13.17 Korea, Republic of  
663.  Korea is still in the process of interagency discussions, as this Report covers a variety of 
issues and makes a number of comprehensive recommendations. Before that, our del egation 
would like to share our preliminary opinion.  
664.  First, Korea believes that the protection of IPRs and public health, including access to 
medicines, are compatible with each other. The two values can be pursued in a balanced manner. 
Second, Korea suppo rts the current IP norms under the TRIPS Agreement in principle. Third, we 
are open to discussions on this issue.  
13.18 Bolivia, Plurinational State of  
665.  We would like  to thank the deleg ations of Brazil, China, India and South Africa for having 
tabled this agenda  item at the TRIPS Council. Access to medicines is of the highest priority for my 
country. For this reason, even though we continue to analyse the content of the Report of the UN 
SG HLP on access to medicines, as many will recall, the HLP had the participation of experts of 
worldwide  reputation  representing developing and developed countries. Their participation is quite 
democratic in that regard. Many of their findings are consist ent with findings in the WHO in the 
past years, such as the Red Book of 1998 or the outcomes of the Committee on Public Health and 
IP in 2002 or the 2012 Report. So we attach great importance  to this Report and the findings of 
this HLP and we hope to analy se it further in this Council.  
13.19 Norway  
666.  Norway attaches the greatest importance to tackling global health challenges including 
providing access to affordable medicines for all. My authorities in capital ha ve not had the 
opportunity to analyse the Panel Report in detail, but we have a few preliminary comments.  
667.  It seems to us that the Panel Report does not give a fully representative picture regarding 
the role of patents and related IPRs in providing access t o medicines. The R eport seems to focus 
too narrowly on negative aspects, but the system is also contributing to bringing new medicines to 
the market.  IP/C/M/83/Add.1  
 
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  668.  The problems with access to medicines are very complex, with a range of factors weighing 
in, both at the i nternational and national levels. We recogniz e that Members may have different 
views on the role of the patent system. A narrow focus on negative aspects of the system only is 
not conducive. In our view , we need  to take a broader perspective. We do reserve  the right to 
come back to this item with more detailed comments at a later stage.  
13.20 South Africa  
669.  Given the fact that many delegations have indicated that they are still considering the 
content of the  Report and will revert to it at a later stage, we would like to request that this item 
be continued at the next meeting of the TRIPS Council.  
13.21 Holy See  
670.  The initiative of the UN Secretary -General echoes  the concern expressed by the Holy See 
regarding agreements on IP and access to medicines and essential health care. The achievement 
of a stronger balance between the protection of the right of inventors, international human rights 
law and public health ob jectives is clearly foreseen in Sustainable Development Goal 3: to Achieve 
Universal Health Coverage (UHC). This is a unique moment in history. Ensuring the success of the 
SDGs, including an end to the epidemics of AIDS, tuberculosis, malaria and neglected  tropical 
diseases and combating hepatitis, water -borne and other communicable diseases will require 
global solidarity and partnership, especially in times of diverse and demanding global challenges.  
671.  As the UN Secretary -General has stated, in spite of all  the efforts and the promising results 
from the Millennium Development Goals, millions have been left behind; consequently, member 
States have agreed on the Sustainable Development Goals targeting the year 2030.  
672.  In the Encyclical Letter, Pope Francis reca lls the troubling extent of exclusion in our world. 
He says "there is little in the way of clear awareness of problems which especially affect the 
excluded. Yet, they are the majority of the planet's population, billions of people (...) ".  
673.  Access to afford able medicines no longer represents a challenge just for the LDCs and other 
developing countries; it has also become an increasingly urgent issue for developed countries.  In 
particular, States find themselves unable to combat antimicrobial resistance. Mor eover, developing 
countries are confronted with a serious lack of new medicines, even as public health budgets are 
constrained worldwide.  
674.  As we are all aware, health is a fundamental human right, essential for the exercise of many 
other rights, and it is n ecessary for living a life in dignity. The realization of the right to health 
should be a fundamental goal of national policies and programmes, regardless of respective 
economic, social, cultural, religious or political contexts.  
675.  Access to essential medic ines, which satisfy the priority health care needs of the population, 
is a key component of the right to health.  Since essential medicines must be selected with due 
regard to disease prevalence and public health relevance, evidence of clinical efficacy an d safety, 
and comparative costs and cost -effectiveness, they should be available at prices that are 
affordable both to individuals and local communities. Thus, if we are to put in place policies that 
reflect human dignity and a human rights approach we mus t confront and remove barriers, 
address questions of affordability, and particularly, temper a disproportionate and exaggerated 
demand for profits. Through dialogue, which represents the best way to confront the problems of 
our world and to seek solutions that are truly effective, we can contribute towards the building of a 
better world and a better future for coming generations. Three helpful principles for such dialogue 
are: solidarity, subsidiarity, and concern for the common good.  
676.  The Report of the High -Level Panel represents a point of departure from which we could start 
to discuss remedies and correct the misalignments and policy incoherencies between the individual 
and corporate rights of inventors, innovators or manufacturers and broader human rights .  
677.  As stated by Pope Francis: "Interdependence and the integration of economies should not 
bear the least detriment to existing systems of health care and social security; instead, they IP/C/M/83/Add.1  
 
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  should promote their creation and good functioning. Certain health iss ues … require urgent political 
attention, above and beyond all other commercial or political interests ". 
13.22 WHO  Secretariat   
678.  Thank you very much for giving WHO the opportunity to share our feedback o n the Report of 
the High -Level Panel on Access to Medicines.  
679.  In 2016, the UN Secretary -General convened the High -Level Panel on Access to Medicines 
"to review and assess proposals and recommend solutions for remedying the policy incoherence 
between the jus tifiable rights of inventors, international human rights law, trade rules and public 
health in the context of health technologies ". WHO was not part of the Secretariat to the Panel, 
but the Organization had the opportunity to participate in discussions thr ough membership in the 
Expert Advisory Group, and made two submissions to the Panel, one jointly with UNIDO focusing 
on local production.  
680.  The HLP issued its Report on 14 September 2016, and its conclusions are sobering. "Millions 
of people continue to suff er and die from treatable conditions  … because of a lack of access to 
health technologies ". Pharmaceutical research still focuses disproportionately on the treatment of 
diseases that are common in the developed world, neglecting those that primarily afflic t the 
world 's poor.  
681.  The Report thus echoes conclusions of previous reports done under the auspices of the WHO, 
which draw attention to disparities in the R&D system and lack of access to essential medicines.  
682.  I will go through the different recommendations , in particular those that are directly 
addressed to WHO and share with you information on relevant WHO activities and future plans . Let 
me start with the recommendations on IP laws and access to health technologies .  
683.  The Report reiterates many recommendat ions that can be found in in the WHO Global 
Strategy and plan of action on public health, innovation and intellectual property. Many of its 
recommendations are  also in line with a number of WHO resolutions, including those that 
encourage WTO Members to mak e full use of TRIPS flexibilities. Consistent with its mandate, WHO 
will cont inue to provide support to its m ember States  – upon request, and in coordination with 
other intergovernmental organizations – on implementing and using TRIPS flexibilities to faci litate 
access to essential medicines.  
684.  The Panel recommends that UNCTAD, UNDP, WHO, WIPO, and WTO should cooperate with 
other relevant bodies with the requisite expertise to support governments to apply patentability 
criteria that are sensitive to public h ealth concerns. We welcome that recommendation; indeed, we 
are already working closely with our UN partners  and WTO . Most recently, we have joined WTO, 
WIPO and UNCTAD to provide advice to the South African Government as it rethinks its intellectual 
proper ty policy. In 2007, ICTSD, UNCTAD, and WHO published draft guidelines on how to bring a 
public -health perspective to bear on the examination of pharmaceutical patents. We will continue 
to work closely with our partner agencies and entities that have releva nt expertise, including 
national or regional patent offices.   
685.  I will now turn to the recommendations with respect to publicly -funded research. Here too, 
we applaud the recommendations of the Panel that public funding should be better  targeted to 
support p ublic health needs. We also agree that the fruits of that publicly financed research should 
be made as widely available as possible.  
686.  WHO shares the view of the Panel that new incentives for R&D of health technologies are 
needed. The Report positively ackno wledges two recent major WHO initiatives: the Global 
Antibiotic Research and Development Partnership a joint venture of WHO and the Drugs for 
Neglected Diseases initiative, which we presented yesterday, as well as the R&D Blueprint, a global 
strategy and p reparedness plan that fosters R&D activities with respect to pathogens with 
pandemic potential. The aim of the Blueprint is to accelerate the development of effective tests, 
vaccines and medicines to save lives, prevent large scale epidemics and minimize s ocio-economic 
disruption of an outbreak.  IP/C/M/83/Add.1  
 
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  687.  The Panel furthermore urges the UN Secretary -General to initiate a process for governments 
to negotiate global agreements on the coordination, financing and development of health 
technologies, including a binding R &D Convention that delinks the cost of R&D from end prices to 
promote access. The Panel thus reiterates the main recommendation of the WHO Consultative 
Expert Working Group on Research and Development: Financing and Coordination (CEWG). The 
Panel is optimi stic that an R&D treaty has "increasingly gathered support " since it was first 
proposed by the CEWG. An R&D treaty has indeed earned strong support from civil society 
organizations, and may be again discussed in the coming months in WHO Governing Bodies' 
meetings.  
688.  In the framework of the follow -up to the CEWG, WHO member States have taken action to 
improve priority -setting and coordination of R&D activities. They have requested the WHO 
Secretariat to establish a Global Health R&D Observatory to provide dat a on R&D activities and 
allow the identification of R&D gaps. Once gaps are identified, priority -setting will be undertaken 
by a new, independent WHO Committee on R&D Coordination that w ill be established in the 
first quarter of 2017. The Observatory and t he new R&D Coordination Committee will be discussed 
by the upcoming Executive Board meeting in January 2017.  
689.  Under the chapter on governance, accountability and transparency the Panel calls on 
governments to review the situation of access to health techno logies in their countries in light of 
human rights principles and to strengthen the national level policy and institutional coherence 
between the different policies by establishing national inter -ministerial bodies. The latter reiterates 
a recommendation o f the WHO Global Strategy.  
690.  With respect to multilateral organizations, the Panel recommends setting up an independent 
review body to assess progress on health technology innovation and access under the 2030 SDG 
agenda. The Panel also recommends establishin g an interagency taskforce to work towards 
increasing coherence among international organizations. WHO jointly with WIPO and WTO has 
already established a trilateral working group on questions pertaining to access to medicines, 
leading to increased coheren ce and collaboration among the three organizations. An informal all -
agency discussion on trade, health, and intellectual property policies is planned for December 2016 
in Geneva.  
691.  With respect to R&D, production, pricing and distribution of health technolog ies, we welcome 
the call of the Panel for more transparency of production and R&D costs, including contributions of 
the public sector. The Panel also calls for an expansion of the WHO Global Price Reporting 
Mechanism, which has already been expanded to inc lude hepatitis C. WHO will consider expanding 
the GPRM to include more patented essential medicines. However, it is not practically feasible to 
establish a database of all prices worldwide of all patented and generic medicines in the public and 
private sec tor; given that many prices currently are not transparently available , it may not be 
meaningful. WHO has already moved forward on assessing the production cost of essential 
medicines which will allow procurement agencies to better assess their performance and contribute 
to the overall objective of transparency.  
692.  The WHO supports the Panel 's recommendation to require the disclosure of unidentified data 
from all completed and discontinued clinical trials, regardless whether the results are positive, 
negative, neutral, or inconclusive. The WHO 's Clinical Trials Registry Platform is one of the 
international instruments facilitating such disclosure.  
693.  With re spect to the recommendation on p atent information, we again fully support the move 
toward more transparency.  WHO has published a number of patent reports  – including  on 
Hepatitis  C. In enhancing transparency, however, it is important to draw on the experience of 
other organizations that work in this area in order to meet the needs of particular users. Efforts 
should be made to build on existing databases, in particular the one managed by the Medicines 
Patent Pool, to avoid duplication of effort and ideally create a one -stop shop for the public -health 
community.  
694.  I would like to end my intervention by reiterating W HO's commitment to continue to work at 
the intersection of public health, trade and intellectual property, in collaboration with all relevant 
partners.  IP/C/M/83/Add.1  
 
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  13.23 UNCTAD  Secretariat   
695.  UNCTAD recently reco mmended to UN Secretary -General Ban Ki -moon to consider 
endorsement of the Report of the HLP. As a member of the Expert Advisory Group to the HLP, 
UNCTAD was involved in the expert discussions that fe d into the HLP Report. UNCTAD also 
provided comments on the first draft of the Report.  
696.  The Report makes recommendations in three separate but interrelated areas: first, IP laws 
and access to health technologies; second, new incentives for research and development of health 
technologies; and third, government a ccountability and transparency. Within the context of its 
mandate, UNCTAD's technical expertise resides mainly within the first of these areas. The bulk of 
UNCTAD's contributions during the technical discussions with the Expert Advisory Group to the HLP  
related to IP laws and access issues.  
697.  On IP laws and access to health technologies, the HLP recommends the full use of flexibilities 
inherent in the WTO TRIPS Agreement as reiterated in the WTO Doha Declaration on the TRIPS 
Agreement and Public Health. UNCT AD's advisory and capacity -building work over the past ten 
years shows that this flexibility, such as the recourse to strict patenting requirements, set ting out 
exceptions to patent rights and the availability of compulsory licences play an important role in 
promoting generic competition and thus affordable  prices.  
698.  According to our research, many of those countries that  now enjoy a fully developed 
pharmaceutical sector in the past relied on many of those flexibilities that the HLP Report 
recommends in orde r to strike a balance between investors' rights and the realization of certain 
development objectives.  
699.  The HLP recommendations underlined the UN's commitment to the realization of Sustainable 
Development Goal 3 which in its target expressly refers to the goal of providing "access to 
affordable essential medicines and vaccines in accordance with the Doha Declaration on the TRIPS 
Agreement and Public Health which affirms the right of developing countries to use, to the full, the 
provisions in the Agreement o n Trade -Related Aspects on Intellectual Property Rights regarding 
flexibilities to protect public health and in particular provide access to medicines for all ".  
700.  On new incentives for research and development of health technologies , the HLP Report 
recommen ds increased investment by governments in health technology innovations to meet 
needs such as neglected tropical diseases and antimicrobial resistance.  
701.  The Report refers to various ongoing initiatives in this regard and underlines the need to 
develop new a nd innovative sources of financing public policies in line with the Addis Ababa Action 
Agenda.  
702.  The Report is not limited to public funding, but underlines the untapped opportunities for 
increasing private sector funding. The recommendations provide import ant support to efforts that 
seek to identify innovative opportunities for both public and private sector funding for health and 
R&D. UNCTAD is willing to contribute its vast experience in investment policy -making and 
technology issues in this regard.  
703.  Finally, on governance accountability and transparency, the HLP Report calls for increased 
collaboration among UN agencies to improve coherence in technical cooperation activities related 
to public health, as well as to monitor the implementation of the HLP's recommendations. 
UNCTAD, in the delivery of its technical cooperation activities on investment and IPRs as it relates 
to trade and development, already corporates to a large extent with other agencies, such as 
UNAIDS, UNDP, WIPO, WHO and WTO. UNCTAD welcom es the HLP Report recommendation to 
increase interagency coordination.  
13.24 UNAIDS  Secretariat   
704.  On behalf of UNAIDS and UNDP who played the role of Secretariat of the HLP, we would like 
to thank Br azil, China, India and South Africa for bringing this issue for the consideration of the 
TRIPS Council. The HLP had very limited time to deliberate on its recommendations . I thank 
UNCTAD and W HO for their interventions because they covered very well the fa ct that the Panel IP/C/M/83/Add.1  
 
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  viewed the recommendations on existing initiatives that are also member States driven. I think 
that, as was very well presented by my colleague from WHO, the Panel built upon the Global 
Strategy on Intellectual Property, Public Health fro m WTO and also the recommendations from the 
CEWG, but I would like to call the attention to the intervention from the Holy See in terms of the 
pace of implementation of the initiatives that to have in the future.  
705.  In the area of HIV/AIDS , for instance, we s till have 54% of the people living with HIV wh o 
are not accessing medicines that exist. There is a problem in terms of access. Of course, IP is not 
the only problem. Trade is not the only problem. I would like to call your attention as well to the 
recent l aunch of the Report from the Lancet  Commission on Access to Medicines that could cover 
other aspects of the access to medicines equation , including yesterday's  article from the Minister 
of Foreign Affairs of the Netherlands commending the recommendations f rom the HLP as well and 
saying that the recommendations from the Lancet Commission and the recommendations of the 
HLP are complementary , as they complement other existing initiatives.  
706.  I think South Africa's suggestion to continue the discussion is very im portant and I would 
like to invite you to come to the next Programme Coordinating Board meeting when this discussion 
will happen once again in December . I invite you to talk with your colleagues sitting on the Board  
and you are welcome to bring the trade p erspective to this discussion.  
13.25 WTO Secretariat  
707.  In the interest of transparency, we wanted to update the Council on the WTO Secretariat's 
input to the HLP process. As with other agencies, the WTO  Secretariat was invited to take part on 
the Expert Advisory Group and, in the course of doing so , was invited by the HLP to provide 
background information to assist the Panel in its work. Our background note is actually available 
on the website of the HLP  for some time, but there are hard copies also available at the back of 
the room. The important point, of course, was that this background note was prepared just at the 
level of Secretariat ; it was  not presented as representing an official view of the WTO or its 
Members, but was a technical input based on the experience of the Secretariat, particularly in its 
technical cooperation work in this area and above all in its cooperative work with other agencies in 
this field.  
708.  The key points covered included the significance of coherence for public health ranging from 
the international legal framework to concrete practical initiatives and ensuring there are positive 
feedback loops between each of those distinct levels. It noted the significance of the Doha 
Declara tion on the TRIPS Agreement and Public Health as a kind of blueprint for coherence and 
described how this has helped to catalyse coherence in the work of the WTO itself, but also in its 
work with diverse partners. There was a focus based on practical exper ience on building national 
capacity for informed and coherent policy -making and in particular building national capacity for 
assessing and applying policy options within the broader policy options and flexibilities within the 
broader TRIPS framework. The b ackground note refers to the WTO Secretariat experience of 
technical cooperation in partnership with other agencies . It is noted that the HLP Report mentions 
areas where that could continue.  
709.  Another general observation is that we are looking at a moving t arget. The challenge of 
developing and implementing effective and equitable policy measures for innovation and access , 
being dynamic by its very nature, evolving with the disease burden, involving with progress and 
technology and the diversification of inn ovation systems , has led to the observation that there 
would be sustained benefits from encouraging inclusive cross -cutting policy dialogue across the 
multilateral system . This  enable s mutual learning, cooperation and coordination to meet the 
challenges ly ing ahead as well as policy coherence supported by a stronger empirical foundation 
through greater transparency and accessibility of data and efforts to enable policy responses to be 
based on an integrated approach to health, trade and IP data.  
710.  The note t hen refers then, for example, to the significance of the Sustainable Development 
Goals as a framework for coherence , as well as  the experience with the Doha Declaration on TRIPS 
and Public Health as a blueprint for coherence with a discussion of its cataly sing effect on our 
technical cooperation and our support for our Members in reviewing and developing national 
approaches for policy options and flexibilities - looking at, in particular, the work done in IP/C/M/83/Add.1  
 
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  partnership with other international organizations, such as the Trilateral Symposium and the 
Trilateral Study that ha ve been mentioned.  
711.  The background note describes in a practical sense the different forms of policy coherence 
and the way they fit together at the different levels including from the interna tional level through 
to the very practical level – the level of specific initiatives and the role of specific programmes and 
initiatives and everything in between those two levels.  
712.  Finally, it describes the value of coherence in trade policy settings as a  means of providing 
an enabling environment for the application of TRIPS flexibilities and how trade policy choices can 
enhance the effect of TRIPS flexibilities in practice . Given the particular focus of many 
presentations to the HLP, it refers  to the sig nificance of enforcement measures and the balance 
concerning enforcement measures that are provided for in the TRIPS Agreement, the role of 
competition policy, as referred to in the TRIPS Agreement itself and compulsory licensing as a key 
area of discussio n and analysis. In particular, the note discusses  the role of compulsory licensing in 
international trade , as well as a specific background on the practical implementation of what is 
described as the trade -related compulsory licence – that is the special c ompulsory licences for 
export under the Paragraph 6 System  - and offers some practical observations on the 
implementation of that mechanism in the contemporary access to medicines environment.  
13.26 United States  
713.  Just a very brief point of clarification. Perhaps a question through you to the South African 
delegation with respect to their request for a continued discussion of this item. I wanted to clarify 
whether or not that was a request for an ad hoc ag enda item for the next TRIPS Council or 
something else?  
13.27 South Africa  
714.  Since the item configured as an ad hoc item, the intention is to continue in this particular 
mode.  
AGENDA ITEM 14: INFORMATION O N RELEVANT DEVELOPME NTS ELSEWHERE IN THE  
WTO  
14.1 WTO Secretariat  
715.  At the last session of the Council under this item we provided a brief update on recent 
developments concerning trade -related a spects of IPRs taking place elsewhere in the WTO, 
specifically in the parallel work of the TPR mechanism. In the context of our technical overhaul of 
the information services provided to Members, reported already to this session of the Council, we 
are look ing to ways of making existing information more readily available and useful for Members. 
This includes ways of making available cross -cutting information from other processes in the WTO 
relevant to the general area of trade -related aspects of IPRs. It is part of the broader effort of 
making information available to Members in a manner that is more suited to contemporary ways of 
working with information rather than relying necessarily on documents alone. As background 
therefore, we provide a further update on these developments for the information of delegates.  
716.  This brief outline does  not seek to cover all of the many areas of trade -related IP measures 
and experiences that have been reported in recent TPRs. There is simply too much and too diverse 
a wealth o f information to cover in a brief report. So we will focus on those areas that have been 
of particular interest in the TPR mechanism where Members have sought further information from 
each other , put questions to each other concerning their domestic measur es.  
717.  So in the four months since the last report, since the June meeting of this Council, 
nine Members have gone through the TPR process . These nine reviews have covered a very wide 
range of trade -related aspects of IPRs and related measures. We therefore provide just an 
overview by heading of those areas covered. One area has been the approach to exhaustion 
regimes, the application of international exhaustion in the domestic legal system. In the field of 
copyright and related rights, the measures discussed  include copyright and copyright registration 
and management organizations, the use of copyright statutory licences, State accreditation for IP/C/M/83/Add.1  
 
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  collective copyright management. In the area of trademarks the discussions have covered 
trademark invalidation proc esses, the protection of well -known trademarks including regional 
arrangements for such trademark protection. Geographical indications have also been discussed in 
these review processes. In the patent field, a number of measures and mechanisms have been 
discussed. These include expedited screening and examination of green technology patents, 
patentability criteria more generally, compulsory licensing of patents, patent fees and other 
aspects of patent administration. There has been consideration of trade se cret protection and test 
data protection under  the TRIPS Agreement, as well as measures to address anti -competitive 
practices relating to the IP licensing.  
718.  Concerning administration and enforcement of IP, discussions have covered enforcement 
measures – both online and at the border – adjudication procedures, judicial review of 
administrative decisions, preliminary injunctions and other aspects of judicial process , as well as a 
range of other elements of the administration and enforcement framework for IP i ncluding the 
establishment of a specific IPR court. Other areas have included a discussion of the coverage of 
IP royalty payments in customs evaluation methodologies.  
719.  More generally, the reviews have also covered national policies and strategies aimed at 
fostering innovation and promoting the use of IP as a tool for economic growth. This is just an 
incomplete sample of those areas that Members themselves have shown an interest in the TPR 
process. This is not intended to suggest anything , but may  be of backg round interest to delegates 
working on these issues. While the information is available in the TPR documentation, we 
acknowledge that it can sometimes be difficult to trace this systematically . If there is any interest 
on the part of any individual delegat ion, we would be happy to sit with them and point them to the 
relevant material. As I stress this is really just for the background information of Members.  
AGENDA ITEM 15: OBSERVER STATUS FOR INTERNATIONAL INTERG OVERNMENTAL 
ORGANIZATIONS  
15.1 Brazil  
720.  I would like to state our official position on this matter of observers based on the instructions 
of the capital which I am representing here today. Brazil's position on this topic, as we listened five 
minutes ago, is well -known. We support the approval of the request from the South Centre and 
the CBD Secretariat as permanent observers of the TRIPS Council as a matter of priority.  
721.  The South Centre is the intergovernmental organization that helps developing countries 
combine their e fforts and expertise to promote their common interest in the international agenda. 
As we all know , it was established by an intergovernmental agreement in 1995. The South Centre 
is one of those organizations that helps mitigate the asymmetry in access to q ualified human 
resources between country members. 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 experience and provide intellectual and policy support for them to act collectively and 
individually. We do not, in developing countries, always count on the high -level expertise at the 
necessary numbers to address all complex issues of international trade and particularly IP with all 
its ramifi cations. It is a matter of justice to ensure that, to the extent possible, all WTO Members 
enjoy a level playing field as far as IP expertise is concerned.  
722.  Brazil, in its participation in the TRIPS Council and in all other multinational fora, is 
motivated by a spirt of fairness and dialogue – not of confrontation. Nothing in our experience 
shows that the South Centre is any different. The South Centre has an observer status in several 
international organizations, in the WTO, as you know, it is an observer t o the Committee on Trade 
and Development and as my colleague, Rodrigo, just mentioned here, the first request of observer 
status of the South Centre of the TRIPS Council dates back to 1999.  
723.  On the South Centre my final words are a question. What are we af raid of? The South Centre 
would be an observer not a policy setter. It would contribute to a more meaningful participation of 
developing countries in TRIPS Council discussions without in any way harming the interests of 
other Members.  IP/C/M/83/Add.1  
 
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  724.  With your permission a few words about the CBD. The Convention on Biological Diversity 
ratified by as many as 196 countries represents a dramatic step forward in the conservation of 
biological diversity, the sustainable use of its components and the fair and equitable sharing of 
benefits arising from the use of genetic resources. My country is proud to have played a key  role, 
as we all know, when the CBD was adopted at  the Nairobi Conference in May 1992  and was then 
opened for signatures for the first time at the R io Earth Summ it in June of the same year.  
725.  In every TRIPS Council meeting, Members discuss the relationship between the TRIPS 
Agreement and the CBD. It is our understanding that discussions in this Body could greatly benefit 
from the participation of the CBD Secretariat  as an observer. Unlike other permanent observers, 
the CBD is directly implicated as we just saw in a number of items o n the TRIPS Council 's agenda.  
726.  In summing up, Brazil reiterates its view that the decision should be made regarding  the 
South Centre and t he CBD Secretariat as a matter of priority.  
15.2 United States  
727.  In light of the late hour, I will be concise. The United States strongly supports the permanent 
observer status of ARIPO, OAPI, GCC and EFTA. We are not i n the position to support the request 
from any other delegations at this time.  
15.3 India  
728.  India supports granting of permanent observer status to three intergovernmental 
organizations  - South Centre, the CBD Secretariat and t he International Vaccine Institute. We 
support the statement made by Brazil with regard to  the South Centre and  the CBD Secretariat.  
729.  The 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 helps the countries of the South to develop common points of view 
and to work together on major development policy -related issues, including on IPR s..  The South 
Centre already has observer status in WIPO, WHO, CBD and many other UN bodies. It played an 
important role in our side event on  the Paragraph 6 Mechanism  and is a  co-sponsor of the original 
discussion on the agenda item on  the review of the Paragraph 6 Mechanism in the TRIPS Council .  
730.  The Convention on Biological Diversity (CBD), as my colleague from Brazil mentioned, fulfils 
the criteria . The CBD  has been ratified by 106  countries. The WTO Secretariat has observer status 
at the CBD . I similarly request that CBD Secretariat has an equal right to participate in 
deliberations in the TRIPS Council as an observer.   
731.  The International Vaccine Institute (IVI) is an institute created by UNDP . It is the world’s 
only international organization devoted exclusively to develop ing and introducing new and 
improved vaccines to protect the world’s poorest people, especially children in developing 
countries.  
732.  As requested earlier, if you see the guidelines set by the WTO for including international 
intergovernmental observers, under  which provision  are some Members objecting to these 
organizations? They should specify  it. What is the guideline under which they can object? They 
should be clear instead of giving a one line  response . They should specifically state so we can also 
know th e reason for the objection.  
15.4 Ecuador  
733.  Ecuador maintains the position that it has already given. We support the participation of 
South Centre and the CBD Secretariat as permanent observers of this Organization. If not 
Permanent Observer, they should be granted ad hoc observer status.  
15.5 Egypt  
734.  Like Ecuador, we would like to associate ourselves with the statements made by Brazil and 
India in order to grant the observer status to both the CBD  Secretariat and the South Centre.  IP/C/M/83/Add.1  
 
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  15.6 Bolivia, Plurinational State of  
735.  I would like to briefly give you our position. We support observer status being granted to the 
South Centre and the CBD Secreta riat. 
15.7 China  
736.  China supports that the CBD Secretariat and the South Centre be granted observer status, at 
least on an ad hoc basis . 
15.8 Venezuela  
737.  We would like to state briefly for the r ecord that we would like to join the list of those 
countries which have requested that both organizations be granted  observer status.  
15.9 Indonesia  
738.  Indonesia's position on this issue has not changed. We support the grant ing of observer  
status to the South Centre as well as to the CBD Secretariat.  
15.10 Bangladesh  
739.  The position of Bangladesh has not changed. We support the request for observer status for 
the South Centre and the CBD Secre tariat.  
15.11 Cuba  
740.  Like others, we would like to say that we support the South Centre and the CBD Secretariat  
being granted observer status.  
15.12 Pakistan  
741.  Pakistan would also like to place on  record its support for granting of observer status to the 
South  Centre and the CBD Secretariat.  
AGENDA ITEM 16: ANNUAL REPORT  
742.  No statements were made under this Agenda item.  
AGENDA ITEM 17 : OTHER BUSINESS  
17.1 United States  
743.  We have a fairly parochial request with respect to the 31 October date and would request 
perhaps a delay or something a bit earlier given that most of us will be with our kids on that day.  
17.2 Canada  
744.  Further to our f ormal communication in document IP/C/W/613 and our presentation at the 
June 2016 meeting, as well as Canada's broader joint communication on the Work Programme on 
Electronic Commerce in document JOB/GC/97 /Rev.3, Canada would like  to continue discussion on 
the Work Programme, with a view to considering how this issue might be advanced at the TRIPS 
Council. We would also like to thank the Secretariat for circulating the addendum to Canada's 
communication in document IP/WC/616/Add.1 in advance of this meeting.  
745.  Canada continues to have an interest in discussing the e -commerce work programme within 
the TRIPS Council. We have been consulting with other Members since our June 2016 meeting, but 
we have not reached a significant consensus around how discussions to ad vance the work 
programme in the TRIPS Council could best be framed or indeed whether there is sufficient 
appetite around the Membership to pursue the discussions. In light of this we are going to be IP/C/M/83/Add.1  
 
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  continuing to consult with Members over the coming weeks to inform our approach on this issue in 
the 2017 TRIPS Council meeting . We would also invite other interested  Members to share their 
views on this matter here today.  
17.3 China  
746.  China made a brief statement on its e -commerce d evelopment at  the last TRIPS Council 
meeting . The fast growth of e -commerce in China benefits from innovative technologies, new ideas 
and novel business models. It brings unprecedented trade and investment opportunity for SMES, 
lowers costs  and facilitates  their integration into global value chain.  
747.  It has been well recognized that access to technologies is vital for developing members to 
expand their trade and investment opportunity through e-commerce. On September 2016, in the 
"G20 Leaders' Communique Han gzhou Summit ", G20 leaders reaffirmed the "G20 Digital Economy 
Development and Cooperation Initiative ",  and stressed  the need  to foster favourable conditions 
for its development and to address the digital divide, including through expanded , better and 
affordable broadband access, flow of information for economic growth, trust and security, while 
ensuring respect for privacy and personal data protection, investment in the ICT sector, 
entrepreneurship, digital transformation, e -commerce cooperation, enhanced  digital inclusion and 
development of micro, small and medium -sized enterprises (MSMEs).   
748.  China believes that, discussions on e -commerce in the TRIPS Council should follow those 
above -mentioned guidelines and focus on how to improve the abilities of devel oping country 
Members to utilize information and communication technologies (ICT) and on how to facilitate 
cross-border e -commerce. We welcome Members to share their views and practices in this regard.  
749.  Regarding Canada's proposal to continue discussion on e-commerce in 2017, our view is that 
the discussions are still very preliminary. Despite of Members' interests show n at the last meeting, 
we think the understanding of relevant aspects of e -commerce, such as the overlap with IPRs and 
the exact meaning of t he e-commerce work program me in the  TRIPS Council, are still quite 
limited.  
750.  Therefore, China suggests that the issue be discussed on an ad hoc basis at each TRIPS 
Council meeting, in a balanced manner and from a broader perspective. Any steps or actions in  the 
future should be made by consensus.  
17.4 Chile  
751.  We would like to thank the delegation of Canada for having made the presentation at the 
last meeting and for the addendum that has just been made. We find this an interesting  proposal 
and we are considering the proposal made that there be a dialogue on e -commerce. We would also 
like to thank the Secretariat for the document that was prepared for the  dedicated discussion  on e-
commerce  in document JOB/GC/73/Add.1 . We note that t he Secretariat mentioned that the TRIPS 
Council , based on the Canadian proposal, renewed discussions on TRIPS and e -commerce with 
respect to trade in goods protected by IPRs , as well as in relation to the protection of the 
technology that allows for e -comm erce.  
752.  We are aware of the fact that twenty  years have passed since the first report was made to 
the TRIPS Council on the work programme on e -commerce in document IP/C/18 of 30 July 1999. 
The analysis in that rather old document is still relevant. It says  that "Members of the Council are 
of the view that the novelty and complexity of the intellectual property issues arising in connection 
with electronic commerce are such that further study is required by the international community to 
better understand the issues involved. " Over the last 20 years, the whole question of digitization 
which has led to the Internet has reduced barriers to entry into international trade . This has 
allowed for more people to play a part in the global economy today. Digitization and  the 
opportunities afforded by e -commerce also raise interesting challenges to IP. In this respect, it is a 
consideration of our delegation that we do need to refer to all of the IP dimensions involved here 
and we have to include exceptions and limitations  which might constrain players when it comes to 
fair access and also those which allow for readier trade undertakings based on the tools afforded 
by e-commerce.  IP/C/M/83/Add.1  
 
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  753.  Exceptions and limitations have a role to play in e -commerce . That is why they must appear 
on the agenda when we discuss these issues. We are interested in Members' views on this matter 
and we would like to state that Chile is still considering the approach and form that such debates 
on e-commerce and IP should take nowadays. This is particularly  so in the light of the need to see 
the best possible way to ensure that we have a balanced approach to any discussions of this 
subject  matter . 
17.5 Australia  
754.  Australia notes Canada's communication regarding the Work Programm e for Electronic 
Commerce and the continuing interest in the TRIPS Council in discussing related themes in 
meetings to be held in 2017.   
755.  Australia sees value in sharing national experiences and practices on e -commerce issues in 
the TRIPS Council and will consider each e -commerce and IP theme on a case -by-case basis as 
each is brought forward next year.  
756.  Australia would also like to ensure that there is no duplication of work undertake n in 
committees of other organiz ations, for example, the World Intellectu al Property Organization.  
757.  We look forward to working with Canada to discuss possi ble themes for discussions on 
e-commerce within the TRIPS Council in 2017 . 
17.6 Japan  
758.  Given the increasing importance of e -commerce in our econo mic activities, Japan would 
expect to see an increase also in the variety of issues that relate to intellectual property in coming 
years. Thus, Japan also believes that it is beneficial to share the experiences and practices of 
Members in relation to e -commerce and IP protection . 
17.7 Korea, Republic of  
759.  I thank Canada for bringing the issue of IP and e-commerce to the attention of the Council. I 
also thank the other Members for sharing their views on this issue.  
760.  Korea believes that e -commerce has an increasing role in international trade and hence an 
ever greater bearing on development. It is therefore important for us to continue discussions on 
this topic. As announced in the previous meeting, MIKTA, a grouping of Mexico, Indonesia, Korea, 
Turkey and Australia hosted a Workshop on E -Commerce in July to exchange views on the WTO's 
role in developing e -commerce.  
761.  Since then, a series of active discussions have taken place regarding this issue in various 
committee meet ings at the WTO. We have seen that a number of concerns have been raised by 
some Members, particularly by LDCs. In this re gards, Korea appreciates Canada' s efforts to reflect 
on themes which may be of interest to not only developed members but also least d eveloped and 
developing Members with respect to IP and e -commerce.  
762.  In conclusion, Korea supports the idea of placing an ad hoc discussion item on the agenda 
during the 2017 meetings of the Council. And , Korea hopes to continue contributing to the 
discussions regarding e -commerce.  
17.8 Brazil  
763.  Brazil had made an intervention at the previous meeting stating our interest in the debate of 
e-commerce. I would like to thank Cana da for raising once again the issue. We would just like to 
inform Members that Brazil will hold a seminar in the afternoon of 11 November – this Friday . We 
will have the Head of our Corporate Office  to discuss  with Members aspects related to 
e-commerce, co pyright and the digital environment. We would like to see all Member s and experts 
with us on Friday to share their views and ideas from a technical point of view.  IP/C/M/83/Add.1  
 
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  17.9 Chinese Taipei  
764.  We welcome the proposal by Canada  on this item , as we are well aware  that being online 
and using digital technology increas es competitiveness of business as well as other opportunities in 
the domestic and the foreign markets. According to the Connected World, the internet econom y in 
G20 c ountries by 201 6, is expected that almost half of the global population will be internet -users 
and the internet econom y in the G20 countries will reach US$4.23 trillion. The scale of th ese 
number s shows that no business can ignore the internet  any longer . 
765.  There are several reasons why IP is important to e -commerce and the e -commerce is 
important to IP. E -commerce , more than other businesses , often involves selling products and 
services that are based on IP and its licensing. IP is important because the thin gs of value that are 
traded on the internet must be protected. Using technology security systems and IP law to avoid 
theft or freeriding which can destroy businesses .  
766.  Trademarks are an essential part of an e -commerce business  as brand name s, customers  
trust and good will are essential elements for such  business and should be protected by the 
Trademark Act and Unfair Competition Law. My Government will be happy to continue discussions 
on this issue and to learn from the vast practice and the experience of o ther Members in tackling 
the problems of online counterfeit goods and trademark infringement s next year.  
17.10 Mexico  
767.  My delegation welcomes Canada's proposal as others who have spoken before me this 
afternoon . The whole que stion of e -commerce  is of high importance for Mexico and , like others , we 
have carried out some activities related to e -commerce . We will therefore be very interested in 
future activities around this subject.  
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