RESTRICTED  
  
IP/C/M/77/Add.1  
 
19 February 2015  
(15-1010)  Page: 1/90  
Council for Trade-Related Aspects of 
Intellectual Property Rights    
 
  MINUTES OF MEETING 
HELD IN THE CENTRE WILLIAM RAPPARD ON 28-29 OCTOBER 2014 
Chairperson: Ambassador Mothusi Palai (Botswana) 
Addendum 
The present document contains statements made during the Council for TRIPS meeting held on 
28-29 October 2014.   
_______________ 
 
Subjects discussed 
INDEX OF THE STATEMENTS MADE AT THE MEETING OF THE COUNCIL FOR 
TRIPS  28-29 OC TOBER 2014 ........................................................................................... 2
 
AGENDA ITEM 1: NOTIFICATIONS UNDE R PROVISIONS OF THE AGREEMENT .................. 4  
AGENDA ITEM 2: REVIEWS OF NATION AL IMPLEMENTING LEGISLATION ...................... 10  
Review of the national implementi ng legislation of  Tajikistan .................................................. 10 
Review of the national implementing legislation of the Russian Federation ................................ 12 
AGENDA ITEM 3: REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B) ............................. 12  
AGENDA ITEM 4: RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE 
CONVENTION ON BIOLOG ICAL DIVE RSITY .................................................................... 12  
AGENDA ITEM 5: PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE ............. 12  
AGENDA ITEM 6: REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE 
IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE 
TRIPS AGREEMENT AND PUBLIC HE ALTH ....................................................................... 23  
AGENDA ITEM 7: NON-VIOLATION AND SITUATION COMPLAINTS ................................. 34  
AGENDA ITEM 10: TWELFTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE 
DECISION ON THE IMPLEMENTATION OF ARTICLE 66.2 OF THE TRIPS AGREEMENT ................................................................................................................... 5 2
 
AGENDA ITEM 11: TECHNICAL COOPER ATION AND CAPACI TY-BUILDING ..................... 56  
AGENDA ITEM 12 INTELLECTUAL PROPERTY AND INNOVATION: PROMOTING 
AWARENESS; CASE STUDIES .......................................................................................... 59  
AGENDA ITEM 13: CONCERNS WITH RESPECT TO MEASURES RELATED TO PLAIN 
PACKAGING OF TOBACCO PRODUCTS AN D THEIR COMPATIBILITY WITH THE 
TRIPS AGREEMENT ......................................................................................................... 76  
AGENDA ITEM 15: OBSERVER STATUS FOR INTERNATIONAL 
INTERGOVERNMENTAL ORGANIZATIONS ....................................................................... 87  
AGENDA ITEM 17: OTHER BUSINESS .............................................................................. 89  IP/C/M/77/Add.1 
 
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INDEX OF THE STATEMENTS MADE AT THE MEETING OF THE COUNCIL FOR TRIPS  
28-29 OCTOBER 2014* 
 
Argentina  
Non-violation, 42 
Australia  
Article 66.2, 52 Biotech, Biodiversity, TK, 21 
IP and Innovation, 74 
Review of Para. 6, 27 Tobacco plain packaging, 81 
Bahrain, Kingdom of  
Notifications, 5 
Bangladesh  
Article 66.2, 55 
Biotech, Biodiversity, TK, 17 
Non-violation, 46 Other Business, 89 
Technical cooperation, 58, 59 
Bangladesh on behalf of the LDC Group  
Article 66.2, 54 Other Business, 89 
Bolivia, Plurinational State of  
Biotech, Biodiversity, TK, 16 Non-violation, 43 
Brazil  
Biotech, Biodiversity, TK, 14 IP and Innovation, 75 Non-violation, 36 
Observer status, 87 
Review of Para. 6, 25 
Canada  
Biotech, Biodiversity, TK, 19 
IP and Innovation, 71 Non-violation, 44 
Review of Para. 6, 27 
Tobacco plain packaging, 84 
Chairman  
Review of Para. 6, 34 
Chile  
Biotech, Biodiversity, TK, 16 Innovation and IP, 68 
Non-violation, 43 
Review of Para. 6, 23 
China  
Biotech, Biodiversity, TK, 14 
Non-violation, 41 Observer status, 88 Review of Para. 6, 25 
Chinese Taipei  
IP and Innovation, 73 Non-violation, 44 
Review of Para. 6, 26 
Colombia  
Biotech, Biodiversity, TK, 17 
Non-violation, 40 
Notifications, 5 
  Cuba  
Biotech, Biodiversity, TK, 15 
Non-violation, 40 
Review of Para. 6, 25 Tobacco plain packaging, 79 
Dominican Republic  
Tobacco plain packaging, 77 
Ecuador  
Biotech, Biodiversity, TK, 18 
IP and Innovation, 66 
Non-violation, 40 Other Business, 89 
Egypt  
Biotech, Biodiversity, TK, 18 Non-violation, 46 
Review of Para. 6, 29 
El Salvador  
IP and Innovation, 74 
European Union  
Article 66.2, 52 
IP and Innovation, 61 Review of Para. 6, 28 
Technical Cooperation, 58 
Tobacco plain packaging, 82 
Honduras  
Tobacco plain packaging, 80 
Hong Kong, China  
IP and Innovation, 72 Non-violation, 47 
India  
Biotech, Biodiversity, TK, 12 IP and Innovation, 69 
Non-violation, 38, 51 
Observer status, 87 Review of Para. 6, 24 
Indondesia
 
Non-violation, 51 
Indonesia  
Biotech, Biodiversity, TK, 18 
Observer status, 88 
Tobacco plain packaging, 79 
Japan  
Biotech, Biodiversity, TK, 20 
IP and Innovation, 67 Non-violation, 42 Review of Para. 6, 28 
Korea , Republic of  
Biotech, Biodiversity, TK, 21 Non-violation, 43 
Notifications, 5 
Mexico  
IP and Innovation, 69 
Montenegro  
Notifications, 4 
  IP/C/M/77/Add.1 
 
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  Nepal  
Article 66.2, 54 Biotech, Biodiversity,TK, 22 Non-violation, 47 
New Zealand  
Article 66.2, 53 Biotech, Biodiversity, TK, 19 
Non-violation, 45 
Tobacco plain packaging, 82 
Nicaragua  
Tobacco plain packaging, 81 
Nigeria  
Non-violation, 47, 51 Observer status, 87, 88 
Norway  
Tobacco plain packaging, 84 
Panama  
IP and Innovation, 67 
Notifications, 7 
Peru 
Biotech, Biodiversity, TK, 16 
Russian Federation  
Notifications, 6 Review of Legislation, 12 
Switzerland  
Biotech, Biodiversity, TK, 21 IP and Innovation, 59 
Non-violation, 46 
Review of Para. 6, 28 
Tajikistan  
Review of Legislation, 10 Uganda on behalf of the LDC Group  
Biotech, Biodiversity, TK, 15 Review of Para. 6, 23 
Ukraine  
Tobacco plain packaging, 76 
UNCTAD Secretariat  
Technical cooperation, 57 
United States of America  
Article 66.2, 54 Biotech, Biodiversity, TK, 22 IP and Innovation, 63 
Non-violation, 34, 48, 51 
Observer status, 88 Review of Legislation, 12 
Review of Para. 6, 26 
Uruguay  
Tobacco plain packaging, 84 
Venezuela, Bolivarian Republic of  
Biotech, Biodiversity, TK, 19 Non-violation, 35, 48, 51 
WHO Secretariat  
Review of Para. 6, 32 
Tobacco plain packaging, 85 
WIPO Secretariat  
Review of Para. 6, 31 
WTO Secretariat  
Notifications, 8 
Review of Para. 6, 29 
Technical cooperation, 56 
Zimbabwe  
Tobacco plain packaging, 80 
 
  
_______________ 
  
 
   
 
  
 
  
 
   
 
  
 
  
 
  * 
A record of statements as delivered. Some statements have been lightly edited as appropriate to ensure the 
consistency of presentation.  IP/C/M/77/Add.1 
 
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 AGENDA ITEM 1: NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT 
1.1 Montenegro   
 
1.  Montenegro has amended the Trademark Law in order to regulate, more precisely and in more detail, certain phases of the registration of trademarks procedure. At the same time, Montenegro 
has also amended the Trademark Law in relation to  the judicial protection procedure in instances 
where a trademark holder's rights are infringed.  In particular, Montenegro has developed an inspection control procedure, introducing misdem eanours in instances where a trademark holder's 
rights are infringed. These amendments were based on the EU acquis.   
2.  As one of its greatest achievements, the Trad emark Law permits the rendering of a decision on 
the partial refusal of an application for the registration of a trademark in relation to certain goods or services, provided there are valid grounds for refusing the trademark registration.  
3.  The Law refines the grounds for refusing trademark registration; it also refines the exclusive 
rights of the trademark holder, and the process of review, when there is opposition to the 
trademark registration.  
4.  Furthermore, the Law prescribes a number of provisions relating to: the procedure for the 
annulment of a trademark, the grounds for the annulment of a trademark when that trademark has been registered contrary to the provisions of the Law (as it relates to the grounds of absolute or relative refusal of trademark registration); the time limits for filing a claim for annulment, and 
persons authorized to file a claim.   
5.  Moreover, the Law introduces the possibility of revocation of a registered trademark in 
instances where a trademark holder, without a justified reason, fails to actually use their 
trademark for the goods or services for which that trademark was registered. However, such 
revocation can only be issued when there has been no use of a trademark for an uninterrupted period of five years, measured from the date of registration or from the date that the trademark 
was last used. The Law also provides a number of other specific grounds for revocation relating to 
the act or omissions of the trademark holder, including grounds relating to misleading the public on the type, quality and geographical origin of the goods or services.  
6.  Provisions of the Law regarding proceedings before the competent court (in the case of 
trademark infringement) prescribe in detail the measures that the court shall take, including the 
scope of the measures to ensure the termination of acts infringing the trademark, as well as the measures to ensure the prohibition of such or similar acts in the future, which may result in the 
payment of a fine. The Law also contains provisions regarding the removal, seizure and destruction 
of the products which infringe the trademark, as well as provisions regarding compensation of damage and publication of the final verdict, by which the claim has been approved in part or as a 
whole.  
7.  Additional achievements of the Law include de tailed provisions regarding the type of provisional 
measures that may be imposed at the request of the trademark holder, when it is likely that the trademark has been infringed or that there is an imminent threat of infringement.  
8.  Finally, the Law regulates: the imposition of provisional measures without notifying the 
opponent of the securing; processes for the securing of evidence, including the obligation to provide information on the origin and distribution channels of products which infringe the 
trademark; and processes for the payment of monetary compensation to the trademark holder as 
an alternative measure if the implementation of the measures requested by the trademark holder would cause disproportionate harm to the defendant.  
9.  In line with Montenegro's commitments in the process of accession to the European Union, 
exhaustion of exclusive trademark rights extends to  the EU territory from the date of accession of 
Montenegro to the European Union. IP/C/M/77/Add.1 
 
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  10.  An integral part of the amendments to the Trademark Law consists of the provisions on the 
inspection control procedure and misdemeanours in the case of unauthorized use of a trademark.  
11.  To conclude, we think that Montenegro, by these amendments, aligns itself better with the 
WTO rules and the relevant provisions. Also let me use this opportunity to reaffirm our 
commitment to the WTO, and also my delegation 's engagement on the work of this body. 
1.2 Bahrain, Kingdom of   
12.  Further to document IP/N/1/BHR/5, circulated on 21 April 2014, Bahrain has submitted a 
revised notification in IP/N/1/BHR/5/Rev.1, circul ated on 2 September 2014, updating the original 
notification with the unofficial English translation of its main IP laws and regulations under Article 63.2 of the TRIPS Agreement. The unofficial English translation can be found at the footnote of the revised notification. We would also like to thank the Secretariat for preparing a corrigendum 
(IP/N/1/BHR/5/Rev.1/Corr.1) informing Members of the correction referring to the Arabic version 
of Law No. 16 of 2006 amending Law No. 16 of 2004 with respect to geographical indications. If there are any questions or enquiries regarding this notification, we would kindly ask that Members 
submit them in writing. 
1.3 Colombia   
13.  Colombia has issued Decree No. 1873 of 29 September 2014 regulating adjustment of patent 
duration through restoration of the patent term. Pursuant to Andean Community regulations and 
its trade agreements, the Colombian Government has enacted legislation to protect inventors by compensating them in the form of additional time for any unwarranted delay in the patenting procedure. 
14.  The new Decree will prevent patent protection from being affected by any delay in the issuing 
of a patent and provides for compensation in the form of time granted to the inventor. In other words, in the event of failure to observe the statutory term of the patent, each day of 
"unreasonable delay" in the patent procedure is compensated by one additional calendar day of 
protection of the invention, counted from the last day of the patent term. Colombia will officially notify this Decree to the Secretariat. 
1.4 Korea, Republic of   
 
15.  The Delegation of the Republic of Korea is very pleased to present briefly its domestic laws 
and regulations regarding Article 31 of the TRIPS Agreement, which pertains to other uses without 
authorization of the right holder, and Paragraph 6 of the Doha Declaration on the TRIPS 
Agreement and Public Health, which we previously notified on in document IP/N/1/KOR/P/7. 
16.  To follow the TRIPS Agreement and the Decision on the Implementation of Paragraph 6 of the 
Doha Declaration on the TRIPS Agreement and Public Health, which was adopted in 2003, we 
amended, in 2005, the Korean Patent Act and Provisions regarding the expropriation and 
implementation of the patent right.  
17.  Article 107 of the Korean Patent Act specifies when working patented inventions non-
commercially is possible both for the interests of the public and the exportation of medicines to 
other countries for treating widespread diseases. Specifically, a person intending to work a 
patented invention may request KIPO's commissioner to award the establishment of a non-
exclusive licence; it can be provided in cases where there is no agreement between the person 
who wants to use the patent and the patent owner, or where a consultation is impossible to 
arrange. However, the person may request an awar d even in the absence of a consultation if the 
patented invention is to be worked non-commercially in the interest of public welfare. 
18.  Regarding the expropriation and implementati on of patent rights when other use without 
authorization of the right holder is necessary for the interests of the public, on 30 November 2005, 
Korea added some related provisions to the Presidential Decree, and we then amended these 
provisions slightly in 2010. IP/C/M/77/Add.1 
 
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  19.  In regard to requests for the import of patented medicines produced via the compulsory 
implementation of the patented invention in orde r to treat widespread diseases, as pursuant to 
Article 107, the import requirement is met whenever there is a lack of manufacturing capability for 
producing the aforementioned medicines in our country. 
20.  Moreover, anyone who intends to apply for an award pursuant to Article 107 of the Patent Act 
shall state the name of the country that intends to import the medicine, in addition to the name and quantity of the medicine referred to in the written request, and submit them along with the 
following: a document showing that the importing country intends to import the medicines from 
the part who requested the award, a proper assess ment of the economic value of medicines in the 
importing country, etc. These documents will be used to prove that the medicines being imported will be used to treat diseases that threaten the health of the majority of the importing country's 
citizens. 
21.  However, the Republic of Korea has not yet undergone the act of awarding the establishment 
of a non-exclusive license for the public health, because no such cases that meet the relevant 
criteria have been brought to our attention yet. 
1.5 Russian Federation   
 
22.  In accordance with its obligation under Article 63.2 of TRIPS Agreement, the Russian 
Federation has made a notification on changes in the Civil Code of the Russian Federation. The reference number of the document is IP/N/1/RUS/0 /2/Add.2. The notification contains the text of 
Federal Law No 35-FZ as of 12 March 2014 on amendi ng part one, two and four of the Civil Code 
of the Russian Federation and certain legislative acts of the Russian Federation.  
23.  Part of the law has entered into force on 12 March 2014, major amendments have entered on 
1 October 2014, several provisions will enter into force in 2015. Changes were made in numerous 
articles of the Civil Code related to acquisition of intellectual property rights as well as its 
enforcement. We want to note briefly some of them.  
24.  Patent Rights - In order to reinforce the lia bility of infringers the new Article 1406.1 will grant 
the author or other right holder in cases of in fringement, the right to require the payment of 
compensation from the infringer instead of reimbursement of injury. This provision comes into force on 1 January 2015.  
25.  Industrial Designs - The requirements for state registration of industrial designs were 
changed. A new procedure was established for the extension of the term of patent for an industrial 
design while maintaining the overall validity of th e patent in twenty-five years (Article 1363 of the 
Civil Code). The extension may be carried out every five years. 
26.  As for the inventions, a number of changes ar e introduced in order to protect the interests of 
investors and other parties interested in the use of the invention.  
27.  Trademarks and service marks - Changes concerning the legal protection of trademarks were 
introduced in Article 1483 of the Civil Code, which establishes the grounds for refusal of state 
registration of a trademark.  
28.  Appellation of origin of goods - In order to  improve the legal protection of appellations of 
origin of goods, the public authorities will control the availability of the special characteristics of 
goods, registered as an appellation of origin, and the maintenance of these characteristics in 
future. 
29.  Copyright and related rights - In order to facilitate the perception of the work by persons with 
disabilities the list of actions that can be performed without the owner's consent and without 
payment of remuneration was amended by "audio description" and by "sign language translation". 
Finally there are some amendments in the Area of protection of IPR on the Internet. Article 1260 
identifies an Internet site as translation or co mpiled work. The author of such compiled work has 
an author's right to its compilation. At the same time, Companies' names, in case of use on the Internet, receive the right to be protected under exclusive rights of a legal entity.  IP/C/M/77/Add.1 
 
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  These are only some of the amendments. As ment ioned earlier all the amendments are listed in 
our notification document.  1.6 Panama  
 
30.  The main objective of Panama's trade policy is to coordinate and take action to promote the country's economic and social development through a national foreign trade strategy that seeks to 
establish Panama as an engine of regional growth, facilitated, inter alia , by the adoption of 
international standards that enable the country to generate competitive advantages. 
31.  In view of the foregoing, Panama amended its intellectual property legislation and notified the 
following laws: 
 Law No. 61 of 2012 amending Law No. 35 of 1996 on Industrial Property; 
 Law No. 63 of 2012 amending Articles of Law No. 23 of 1997 on Guidelines for the 
Protection of New Varieties of Plants; 
 Law No. 17 of 2012 adopting the Budapest Treaty on the International Recognition of the 
Deposit of Microorganisms for the Purposes of Patent Procedure; 
 Law No. 21 of 2012 adopting the Patent Cooperation Treaty (PCT); 
 Law No. 24 of 2012 adopting the Trademark Law Treaty (TLT) and the Regulations 
thereunder; 
 Law No. 25 of 2012 adopting the International Convention for the Protection of New 
Varieties of Plants of 1961, revised at Geneva on 19 March 1991. 
32.  Relevant aspects to be highlighted include the following: 
 Trademarks: 
 
 Electronic payment: Collection by electronic payment of fees and charges in the context of 
the trademark registration and renewal process; 
 Alternative dispute settlement methods: Possibility of settling industrial property disputes 
using alternative methods such as conciliation, mediation and arbitration; 
 Multi-class trademarks/Security: Possibility of filing a single registration application covering 
a number of classes under the Nice Classification/Possibility of using a trademark as security for a financial transaction; 
 Registrability of olfactory and sound marks: Registration of smells and sounds; 
 Enhancement of criminal penalties for infringement. 
 Patents: 
 
 Establishment of the Patent Cooperation Treaty (PCT) mechanism; 
 Non-voluntary licences: In the event of national emergencies, the Government can 
expropriate a patent for the duration of the situation. In specific situations, this would 
mean the Government taking decisions withou t the consent, albeit while respecting the 
rights, of the patent holder; 
 Supplementary protection: Introduction of the po ssibility of extending the term of protection 
of a patent in the event of delays in granti ng the related rights (with the exception of 
pharmaceutical products); IP/C/M/77/Add.1 
 
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   Exceptions to patent rights: Panama established limited exceptions to patent rights provided 
that certain conditions, which generally coincide with public health emergencies (WTO TRIPS Agreement), are met; 
 Development of data protection for both pharmaceutical and agricultural chemical patents. 
 Industrial designs: 
 
 Extension of the term of protection from two to three years. 
 Geographical indications: 
 
 Establishment of legislation governing geographical indications given that these were 
previously not clearly defined by law; 
 Clarification of the scope of the rights derived from geographical indications, indications of 
source and appellations of origin; 
 Establishment of a judicial opposition mechanism. 
 New plant varieties: 
 
 Adaptation of domestic legislation to the pr ovisions of the 1991 Act of the International 
Convention for the Protection of New Varieties of Plants (UPOV); 
 Extension of protection to breeders of new plant varieties; 
 Promotion of plant breeding activities to raise seed and plant quality; 
 The new amendment is aimed at enhancing the competitiveness of the agro-industrial 
sector. 
33.  This new legal framework seeks to continue to promote Panama as a foreign-investment 
friendly country with a free-market model, where rules and disciplines are adopted in the context 
of the globalization of the world economy in order to guarantee right holders standard rules and an 
efficient and effective enforcement mechanism in the various international arenas, with a view to enhancing and improving competitiveness. 
1.7 WTO Secretariat   
 34.  The Council has had on its agenda for some time the question of timeliness and completeness of notifications and other information flows. This was initially put on the agenda as a separate item 
following a request by the Chair of the General Council in 2009. Several updates were given since 
then and it was later agreed by the Council that this matter would continue to be addressed under the regular agenda item on notifications. Th e report in 2009 prepared by the Secretariat 
(document IP/C/W/543) was a summary of the state- of-play at that stage, an overview of the 
notification procedures and a summary of the notifi cations of that had been received by that date. 
As we are now approaching five years from that point and we are preparing for the implementation 
of a more modern IT-based means of working with this information, it is probably timely to review 
the state-of-play; we are indeed in the process of updating that document.  
35.  The basic approach established by this Council for notifications under TRIPS – agreed nearly 
20 years ago, in 1995 (document IP/C/2) - was that Members would notify their laws and 
regulations without delay, normally 30 days after the entry into force of the relevant measure for 
that Member. Subsequent amendments of laws in  the field of intellectual property, would be 
notified 30 days after the entry into force of am ended laws, or after 60 days if a translation was 
needed. Also the guidelines provide that Members may choose to notify laws even in advance of 
the entry into force of the relevant parts of TRIP S on a best-endeavours basis. They also provide 
some provision for a brief description of relevant laws: indeed the kind of information that has just 
been provided to the Council by several Members. I would note that this is becoming increasingly 
useful as the pattern of notifications we are re ceiving generally no longer concerns the primary IP/C/M/77/Add.1 
 
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  law, for example, a Member's patents act or the trademarks act as such, but rather amendments 
to or revisions of that law;  it can be difficult, if one is not an expert, to grasp the importance of an amendment to a patents act without a brief description that helps us understand what has been amended.  
36.  To review the current state-of-play, 133 Members have made notifications of laws and 
regulations under TRIPS. Some 113 have provided answers to the Enforcement Checklist which the 
Council established in 1995 as part of the notification process. The Members notifying laws include 
a number of LDCs which are not obliged to notify  at this stage, but are following that best 
endeavours guidance referred to earlier. In the most  recent notifications, the practice varies very 
widely – we have received  some updated notifications this year, but in some cases the most recent 
notification was in 1996 despite a wide range of activity since then. 19 Members have not made an 
update since 1999 and 89 have not made an update since 2009 when the last review took place. 
On average the most recent notification was received in 2005. The pattern of notifications received varies considerably, ranging between 1 and 25 separate notifications with an average of 5 per 
Member. Overall 56 Members have made one initial notification, and none since then.  
37.  We do see a very wide variation of experience  in the process of notifying laws and regulations. 
As a Secretariat we have been turning our minds to how to make this a more straightforward 
exercise. The request from the General Council was to enhance the timeliness and the user-
friendliness of the system. Given that the system was established in 1995, we all have developed more modern ways of working with this kind of  data, and indeed we have updated the Council 
from time-to-time on the progress towards a more user-friendly tool, so that Members can notify 
with less paperwork, with less uncertainty about th e exact procedure. This has led to a proposal 
for a voluntary reporting tool supplementing the existing WIPO-WTO Portal which is itself an 
optional reporting tool. This reporting tool would enable us to capture the data more clearly, and it 
would clarify what Members have to provide when they are notifying laws. This would reduce time 
for Members, in particular, in verifying and clarifying the notifications received, because this does still constitute a very active role for the Secretariat to ensure the correct handling of notifications. 
If we did have an established reporting format, that would certainly simplify that process for 
Members notifying their laws. In addition, it would streamline the handling of data, and enable us to have a more consistent format for reporting to the TRIPS Council. At the moment, there is considerable variation in the documents' structure, and the content of the documents that are 
circulated under this item, reflecting the great di versity of approaches that Members have taken. 
So this would make it easier to track, to understand the state-of-play, particularly as we enter a distinct phase in the implementation of TRIPS wher e it is decreasingly about the implementation of 
the initial portfolio of laws and increasingly about the kind of updates and amendments that we 
have just heard about from a number of Members. In particular, this would lead to facilitated access for the laws themselves, while, at the moment, it can be tricky to track down and access 
the notified laws, a number are in very lengthy pdf documents - in some cases still image pdf 
documents which are very difficult to use as legal texts. We are working to capture that backlog. We do hold paper records, paper files of these documents, but so far we have had literally no requests to make use of that resource, so clearly the preference is for a more user-friendly online 
arrangement. This would apply also to the questionnaires and the enforcement checklist which are 
agreed as part of the notification and review functions of the TRIPS Council: again we are working to develop more modern, identifiable online versions of those materials. I should stress that none 
of these developments affect in any way the content or the nature of the obligations or the 
procedures for notifications or the review process. It is simply to make sure that we can capture and work with the data in a way that is more suited to the way in which everyone works with data 
today, rather than the paper-based approach that was appropriate nearly 20 years ago. 
38.  So the plan is to develop a prototype over  time, guided by feedback from Members at a 
practical level to make sure that it is a workable tool. At this stage we would be inviting interested Members to make use of the prototype which will be  available shortly to update their notifications. 
We hope very much that this will assist in the pr ogressive transition of this important area of our 
work to a more modern information management system for the wide and extensive amount of TRIPS-related data that we are working with. We ho pe that this will lead to a more accessible and 
more user-friendly resource for Members to make use of as the TRIPS Agreement approaches its 
20
th anniversary. IP/C/M/77/Add.1 
 
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  AGENDA ITEM 2: REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION 
Review of the national implemen ting legislation of Tajikistan 
2.1 Tajikistan  
 
39.  On behalf of Tajikistan, as one of the most recent members of the WTO, it is my pleasure to 
present today our national legislation in the field of intellectual property; we really appreciate WTO 
members' questions. In accordance with the obligations arising from the TRIPS Agreement, 
Tajikistan has submitted the necessary notification, which represents the basis for the review of 
the national intellectual property legislation. 
40.  By the Resolution of the Govern ment of the Republic of Tajikistan № 242 from 28 May 1993, 
the National Center for Patents and Information under the Ministry of Economic Development and 
Trade was established, in order to deal with one of the priority activities - protection of the state's 
interests in the field of industrial property and the c oordination of inventive activity in the country.    
41.  In January 1994 the Republic of Tajikistan became a member of the World Intellectual 
Property Organization. According to the Declaration of the Republic of Tajikistan concerning the 
most important international agreements in the fiel d of industrial property Tajikistan recognizes 
their effect in its entire territory.  
42.  The specialists of the National Center for Pate nts and Information took part in drafting of the 
Eurasian Patent Convention, to which the country accessed according to the Act of Accession 
signed by the President of the Republic of Tajikistan on April 1995. 
43.  Currently, six laws regulating the protection of intellectual property are in force in the 
Republic of Tajikistan, notably the following:  
1. The Law on Inventions;  
2. The Law on Industrial Designs;  
3. The Law on Legal protection of Integrated Circuits;  
4. The Law on Trademarks and Service Marks;  
5. The on Geographical Indications; 
6. The Law on Copyright and Related Rights.    
 
44.  Considering the importance that WTO membership has for its Members, in the process of amending the existing intellectual property related legislation, special emphasis was placed on 
harmonization with the TRIPS Agreement. In addi tion, questions, remarks and suggestions given 
to Tajikistan by Members during the accession process of Tajikistan to the WTO have been taken into account. Tajikistan has also focused its activities on harmonization with provisions of other relevant international treaties and agreements in the field of intellectual property. 
45.  Desiring to quickly integrate into the international community and to pave the way for foreign 
investments, the Ministry of Economic Developm ent and Trade had developed an action plan of 
activities aimed at full compliance with the TRIPS Agreement. 
46.  Tajikistan is a member of the following conventions and treaties: 
i. Paris Convention for the Protecti on of Industrial Property   
ii. Convention Establishing the World Intellectual Property Organization  
iii. Agreement on Trade-Related Aspects of Intellectual Property Rights  
iv. Madrid Agreement Concerning the International Registration of Marks  
v. Protocol Relating to the Madrid Agreement Concerning the International Registration 
of Marks  
vi. Nice Agreement concerning the International Classification of Goods and Services for 
the purposes of the Registration of Marks  
vii. Locarno Agreement Establishing an International Classification for Industrial Designs  IP/C/M/77/Add.1 
 
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  viii. Patent Cooperation Treaty ( РСТ),  
ix. Strasbourg Agreement Concerning the International Patent Classification  
x. Budapest Treaty on the International Recognition of the Deposit of Microorganisms 
for the Purposes of Patent Procedure  
xi. Nairobi Treaty on the Protection of the Olympic Symbol  
xii. Geneva Act of the Hague Agreement on the International Registration of Industrial 
Designs  
xiii. Eurasian Patent Convention  
xiv. Berne Convention for the Protection of Literary and Artistic Works  
xv. Universal Copyright Convention  
xvi. Convention for the Protection of Producers of Phonograms against Unauthorized 
Duplication of Their Phonograms 
xvii.  International Convention for the Protection of Performers, Producers of 
Phonograms, and Broadcasting Organization (the Rome Convention) 
xviii.  WIPO Copyright Treaty  
xix. WIPO Performances and Phonograms Treaty  
xx. International Convention for the Protection of New Varieties of Plants (UPOV) 
47.  Tajikistan has established an institutional framework for the effective enforcement of IPRs. 
Authorities responsible for the enforcement of IPRs are primarily: Customs Administration, Police Administration, Administration for Inspection A ffairs, the Commercial Court, Courts of General 
Jurisdiction and the Prosecutor's Office. Tajikistan is committed to further strengthening 
institutional and administrative capacities in order to ensure effective protection of IPRs. 
48.  We believe that Tajikistan has created an intellectual property system that gives everyone a 
chance to take advantage of its provisions and to  use opportunities in business and trade. The use 
of IPRs based on law will help in the creation of new jobs, affect the well-being of society, 
encourage development of the skills of the popula tion and protect those who put new products and 
services in the market. All these factors should make Tajikistan attractive to foreign and domestic 
investors. 
49.  However, Tajikistan is aware of the need fo r additional work and further reforms in order to 
valorize the benefits that intellectual property provides. 
50.  Tajikistan recognizes the following as strategic goals that would contribute to the further 
development of intellectual property: 
• Improved enforcement of intellectual property rights; • Increasing economic growth through effective use of intellectual property; 
• Improvement of methods of acquiring and managing intellectual property; 
• Better business and public understanding of th e use and the value of intellectual property, 
as well as the importance of the enforcement of IP rights; 
• Improvement and modernization of information systems in terms of intellectual property 
issues. 
 
51.  Having said all of the above, our opinion is that Tajikistan has met the standards set by the 
TRIPS Agreement, and that Tajikistan's legislation on protection of IPRs is in compliance with the 
provisions of this Agreement. IP/C/M/77/Add.1 
 
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  52.  In conclusion, we believe that Tajikist an has significantly amended and improved the 
legislation on protection of IPRs, and that the development of the IP system was not limited to the requirement of the binding international agreemen ts. These efforts prove Tajikistan's will and 
determination to build and operate an effective syst em for the protection of intellectual property in 
order to facilitate the development of its economy. 
53.  I want to reiterate Tajikistan's intention to cooperate with all WTO Members, especially with 
those who have interests in Tajikistan's IP market, and those who desire to share their 
experiences in implementing the commitments an d obligations under the TRIPS/WTO framework. 
54.  As mentioned by the Chair, we recently received the questions posed by the delegation of the 
US regarding the review of the implementation of the TRIPS obligations. We appreciate these 
questions. Since we just received these questions a few days ago, we have not had the 
opportunity to study them carefully. Therefore, I would like to ask the Council to allow us to send 
these questions to our IP experts in capital an d prepare our responses before the next TRIPS 
Council meeting in February 2014. 
Review of the national implementing legislation of the Russian Federation 
2.2 United States of America   
 
55.  We do not have anything to add at this point,  other than to extend our interest in this further 
discussion with respect to some additional questions. 
2.3 Russian Federation   
 
56.  We would like to thank the delegation of the United States for presenting additional questions 
for our replies. They will be duly transmitted to the relevant authorities in Moscow for responses as quickly as possible. 
AGENDA ITEM 3: REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B) 
AGENDA ITEM 4: RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE 
CONVENTION ON BIOLOGICAL DIVERSITY 
AGENDA ITEM 5: PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE 
5.1 India   
 57.  We have been extensively discussing these agenda items for many years. During the course 
of the discussions, many Members have not only  highlighted the misappropriation of genetic 
resources and traditional knowledge but have also proved beyond doubt that such misappropriation and granting of wrongful patent s is possible because of the inadequacy of the 
TRIPS Agreement to address these issues. 
58.  India is one of the seventeen identified mega bio-diverse countries of the world. With only 
2.4% of the world's land area, India accounts for 7-8% of all recorded species, including over 
45,000 species of plants and 91,000 species of anim als. India is rich in traditional knowledge 
associated with biological resources. This traditional knowledge is both coded, as in the texts of Indian systems of medicine such as Ayurveda, Un ani and Siddha; and non-coded, which exists in 
the oral undocumented traditions. 
59.  In the past, there have been several instances of misappropriation of genetic resources and/or 
traditional knowledge. India has been a major victim of biopiracy. Pursuant to the ratification of the CBD, India developed a comprehensive legislation on biodiversity, enacted Biological Diversity 
Act in 2002 and notified Biological Diversity Rules in 2004. This Act gives effect to CBD provisions, 
including those relating to Access and Benefit Sharing (ABS). In 2003 the National Biodiversity Authority (NBA) was set up. All matters relating to requests for access by foreign individuals, 
institutions or companies, and all matters relating to transfer of results of research to any 
foreigner are dealt with by the National Biodiversity Authority.  IP/C/M/77/Add.1 
 
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  60.  The Government of India has also develope d a Traditional Knowledge Digital Library (TKDL) 
database for (i) preservation of traditional kn owledge; (ii) prevention of misappropriation of 
traditional knowledge by breaking the language and format barriers of traditional knowledge systems, and providing access of these knowle dge systems to patent examiner(s) in five 
international languages i.e., English, German, French, Spanish and Japanese, for establishing the 
prior art; and (iii) creation of linkages with modern  science to initiate active research projects for 
new drug discovery and development, based on the time-tested traditional knowledge systems, 
leading to more affordable health care for the poor. 
61.  The TKDL database has been created to prev ent misappropriation of traditional knowledge at 
international patent offices so that cases of bio- piracy can be prevented. India has already signed 
TKDL Access Agreement with (i) European Patent Office (February 2009), (ii) United States Patent 
& Trademark Office (November 2009), (iii) Canadi an Intellectual Property Office (September 
2010), (iv) German Patent Office (October 2009), (v) United Kingdom Patent & Trademark Office (February 2010) and (vi) Intellectual Property, Australia (January 2011). TKDL references as prior 
art have led to significant strides towards achieving the goal of preventing misappropriation of 
Indian traditional knowledge. This includes cancellation of grant of two patents, withdrawal of 75 patent applications, amendments/modifications of claims in 32 applications, and 
rejection/cancellation of two applications.  
62.  While India has pioneered the Traditional Knowledge Digital Library (TKDL) to overcome 
language and format barriers, the results can only be limited. Improving prior art searches through the TKDL is only one part of the solution. Further,  the TKDL represents a subset of the universe of 
available traditional knowledge. The realm of traditional knowledge in areas other than herbal 
cures and Genetic Resources is not covered by the TKDL. While India is undertaking a number of measures at the national level in order to prevent misappropriation of genetic resources and/or 
associated traditional knowledge, the problem has an obvious international dimension and needs 
an international solution in order to be addres sed effectively. The TRIPS Agreement continues to 
ignore the numerous IPR-related obligations in the CBD which are of interest to the developing 
countries.  
63.  The disclosure proposal (IP/C/W/474) which was submitted in 2006 was followed up by the 
submission TN/C/W/52 in June 2008 with the supp ort of 108 countries. The latest submission on 
this issue "Enhancing mutual supportiveness between TRIPS and CBD" (TN/C/W/59) has been 
proposed by a vast majority of WTO Members.  A mandatory disclosure requirement in patent 
applications to include disclosure of origin and evidence of Prior Informed Consent (PIC) and Access and Benefit Sharing (ABS), w ill, in addition to combating biopiracy, further strengthen the 
credibility of the patent system by facilitating  assessment of the 'novelty' and 'inventiveness' 
criteria, and contribute to ensuring that the pate nt system does not issue bad patents. Erroneous 
patents, even if they existed temporarily were harmful for third parties.   
64.  The Nagoya Protocol of the CBD entered into force on 12 October 2014. By providing legal 
certainty on the use of genetic resources and associated traditional knowledge, and by strengthening the opportunities for fair and equitabl e sharing of benefits arising from their use, the 
Protocol will create incentives to conserve biodiversity, and sustainable use of its components, and 
further enhance the contribution of biodiversity to sustainable development and human well-being. 
According to the press release issued after the first Meeting of the Conference of the Parties 
serving as the meeting of the Parties to the Nago ya Protocol (COP MOP-1), held in Pyeongchang, 
Republic of Korea, from 13 to 17 October 2014, decisions that were adopted include mechanisms 
to ensure compliance with the Protocol, measures to assist institutional capacities in developing countries, and a strategy to raise awareness of the international instrument.  
65.  There is now an urgency to discuss the Nagoya Protocol under this agenda item, especially 
after its entry into force this month. We therefore reiterate our demand for a formal briefing by the 
CBD Secretariat in the interest of the large majority of developing countries.  
66.  We would like to reiterate that the TRIPS- CBD is one of the outstanding implementation 
issues and positive outcomes on outstanding implementation issues are one of the most important 
deliverables of this round for the developing countries. I would like to conclude by quoting from paragraph 2 of the Doha Ministerial Declaration: "The majority of the WTO Members are 
developing countries. We seek to place their needs and interest at the heart of the Work IP/C/M/77/Add.1 
 
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  Programme adopted in this Declaration." The TRIPS-CBD is one such issue which is very important 
for developing countries and needs a speedy resolution. 
5.2 Brazil   
 
67.  Brazilian position on the relationship be tween the TRIPS Agreement and the CBD is well 
known. We attribute priority to the full implementation of a mutually supportive relationship between the IP system and the benefit sharing syst em arising from the use of genetic resources. 
Since our last meeting in June, two different developments in other international fora should have 
an impact on our discussions today: (1) the entry into force of the Nagoya Protocol which falls under the United Nations CBD; (2) the decision on the WIPO-IGC work programme for 2015. 
68.  After decades of negotiations, the Nagoya Protocol on Access and Benefit-Sharing entered into 
force on 12 October 2014, expanding possibilities fo r the international equitable sharing of benefits 
of the world's biodiversity. 
69.  The Protocol establishes clear rules for accessing, trading, sharing and monitoring the use of 
the world's genetic resources. By establishing this  framework, the Protocol seeks to ensure that 
genetic resources are not used without the prior informed consent of the countries that provide them, and that the communities that possess the traditional knowledge associated with the use of 
these resources also enjoy the benefits of sharing them with the rest of the world. 
70.  Regarding other Intellectual Property fora, it is important to mention that the 2014 WIPO 
Assemblies, that took place last September, co uld not reach consensus on a work programme for 
the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional 
knowledge and traditional cultural expressions (the IGC).This recent outcome highlights the central 
role of WTO as a forum capable of providing a cont ribution of the international IP system to the 
effective implementation of the internatio nal access and benefit sharing (ABS) system. 
71.  Having said that, Brazil would like to state once again its support to the proposal enshrined in 
document IP/C/W/59. It is important to emphasize that in the proposed mechanism to preclude the misappropriation of genetic resources and associated traditional knowledge, the patent offices 
would be nothing more than a check-point to collect and transmit information. Therefore, it would 
not, in any way, represent a burden to the national systems of IP. 
72.  We also support the proposal to update th e three factual documents on the discussions taking 
place in the Trips Council, as proposed by the Dele gation of Ecuador and the invitation to the CBD 
Secretariat to brief Members on the developments in that forum related with the establishment of 
an international ABS system, as proposed by the Delegation of India. We also support the approval of the request by the CBD Secretariat to take pa rt in TRIPS Council meet ings as an observer. 
5.3 China   
 73.  According to the mandate, the Council is instructed to examine, inter alia, the relationship 
between the TRIPS Agreement and the CBD. It is well recognized that TRIPS-CBD has been an 
important outstanding issue at the TRIPS Council. Therefore, Members should work effectively in order to resolve the matter. The fact that the relevant issues are being discussed in other fora does not and should not hinder the work here. 
74.   China supports amending the TRIPS Agreemen t with the purpose of introducing a mandatory 
disclosure requirement of the origin of genetic resources and/or traditional knowledge into patent applications. This position is co-held by the majority of Members and can be found in documents 
TN/C/W/52 and TN/C/W/59. The proposed solution can contribute to prevent the misappropriation 
of genetic resources and the grant of erroneous pate nts due to the lack of information, to improve 
the transparency of the utilization of genetic resources, and to enhance legal certainty. 
75.  China does not think it would be burden some for the patent applicant to provide the 
information concerning prior informed consent and access and benefit sharing, especially considering the legitimate objective pursued by  the system. The contractual arrangements or 
database solution proposed by some Members are not enough for the protection of genetic 
resources.   IP/C/M/77/Add.1 
 
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  76.  China is considering starting the domestic procedure to accept the Nagoya Protocol. Once 
again, China would like to support inviting the CBD Secretariat to make presentations on the Nagoya Protocol, from a perspective different from  WTO Members. China woul d also like to support 
the suggestion on the update of the three summ ary notes by the Secretariat, as it did on 
non-violation and situation complaints in 2012.  
5.4 Cuba   
 
77.  Cuba supports the review of the relation ship between the TRIPS Agreement and the CBD and 
the protection of traditional knowledge and folklore; these are mandated negotiating issues as well as implementation issues. 
78.  Cuba emphasizes its concern over the failur e to reach consensus at the close of the WIPO 
General Assemblies last September, leaving a dangerous question mark as to the future of the 
Intergovernmental Committee and its negotiations. 
79.  In any event, we reiterate that any results achieved in the WIPO framework will come in 
addition to, and not exclude the need for, an  amendment of the TRIPS Agreement. We draw 
attention to the proposals submitted in 2006 and 2008, which provide a good basis on which to work. 
80.  Once again, we ask that consultations be held with the CBD Secretariat, as Ecuador has 
requested, and that it be invited to give a briefing at the WTO. We also recommend working more closely with other international agencies such as UNCTAD, WIPO and the FAO; this would, moreover, be in keeping with the WIPO Developmen t Agenda. It is important to encourage greater 
synergies between the various organizations conc erned. We emphasize the importance of the 
Nagoya Protocol's entry into force. 
5.5 Uganda on behalf of the LDC Group   
 
81.  I take the floor, on behalf of the LDC Group to  highlight some of the issues of interest to the 
LDC Group in the current discussion relating to  the review of Article 27.3(b) of the TRIPS 
Agreement, which have been highlighted in previous sessions of this Council. 
82.  The review of the provisions of Article 27.3(b)  has been a long standing item on the agenda of 
this Council, yet no substantial progress has be en made towards meeting that mandate despite 
the emphasis placed on this issue by our Minist ers during the fourth WTO Ministerial Conference 
held in Doha in 2001. 
83.  The LDC Group maintains that the review of Ar ticle 27.3(b) is an important aspect of the work 
of this Council. We need to build on progress made since discussions resumed in 1999 and bring 
this work to finality sooner rather than later. 
84.  The position of LDCs remains unchanged. These are aspects that should not be subject to 
patent protection. 
85.  It will equally be important to maintain the flexibility on the form of sui generis  regime 
developed for the protection of plant varieties base d on individual country systems and needs. This 
we believe will contribute to improving the food se curity situation of indigenous people by ensuring 
that their inventions are protected and access to seed is guaranteed.  
86.  Regarding the relationship between the TRIPS Agreement and the CBD, the LDCs appreciate 
the work that has gone into these discussions, including the parallel process undertaken by the 
Director General to narrow the differences among Members. 
87.  For LDCs, biodiversity is a mainstay and important source of livelihood for the majority of 
populations living in rural areas in most LDCs, and yet this remains an area where we continue to experience undue disadvantage when it comes to benefit sharing. 
88.  The benefits derived from the appropriation of biological resources by multinational 
corporations have barely been shared with the communities concerned. This continues to be a IP/C/M/77/Add.1 
 
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  matter of concern to LDCs. It requires urgent attention with a view to finding a lasting solution, 
within the multilateral setup, that will addr ess the hardship faced by these communities. 
89.  LDCs maintain that inserting a mandatory requirement in the TRIPS Agreement on disclosure 
of country of origin of the genetic resource and the associated traditional knowledge used in the 
invention is the only effective way forward.   
90.  Additionally, patent applicants should demo nstrate that they have obtained prior informed 
consent from competent authorities in the country of origin of the genetic resources and the 
arrangements entered into to facilitate the sharin g of benefits arising from the appropriation of 
such resources and or traditional knowledge. 
91.  It is disheartening to note that these issues  have been on the table at the WTO and at WIPO 
and yet no solution is in sight in both organizations. What we now see, is a prolonged and 
perpetual impasse due to the polarity of views of Members on the issues under discussion. What 
we thought would result in the closure of discussi on on the issues under consideration, after the 
DG-led process resulted into a consolidated document (TN/C/W/59) has since gone quiet. The 
process at WIPO equally does not give any hope that a solution would be found soon. We need to 
invigorate the work on this issue and close the remaining gaps which in our view can be doable with political will. 
5.6 Plurinational State of Bolivia   
 92.  As on many other opportunities, we have stated that the review of paragraph 27.3(b) is a pending matter in the TRIPS Council and this is something that should be part of the work 
programme that should be adopted by this year in order to eliminate any artificial difference 
between microorganisms and life forms and orienting towards prohibition of patentability of life forms and their parts. This is a review which is a part of 27.3 itself; as also paragraph 19 of the 
Doha Declaration recommends the TRIPS Council to conduct its work programme in the context of 
the review provided for in Article 27.3(b). A number of reasons would support this review, for example, an increase in bio-piracy since the adoption  of this Article, patentability of life forms has 
a series of concerns for many countries and cultures. We should also specify that over the past 
20 years there has been a series of regulatory deve lopments that would call for a review of this 
provision.  
93.  As stated previously by Brazil, the WTO is the most relevant forum to take up this issue, as 
well as the issue relating to the relationship between the CBD and the TRIPS Agreement. All the 
more so, now that the WIPO negotiations are blocked and the issues should normally come back to this Organization. This is a matter which should also be on the WTO's December Work Programme 
as a matter of priority.  
94.  Furthermore we reiterate our support for Ecuador's proposal that the Secretariat paper be 
updated, taking up new rules-based developments internationally such as the Nagoya Protocol 
which will be useful in the Council's work. We would encourage you, Mr Chairman, to continue your 
consultations to help u to move towards this objective. We would also like to support India, Cuba, and many other countries in urging that the CBD Secretariat be able to attend a session of this Council, so as to report on the entry into force of the Nagoya Protocol.  
5.7 Chile   
95.  It is very important that account be taken of  developments that have taken place in other fora 
of interest such as WIPO. We are grateful for the information, and the various points of view that 
have been expressed. We believe that WIPO continues to be the appropriate place for a continued 
discussion on this issue. 
5.8 Peru   
96.  As other delegations have stated, my delega tion would like to stress that between the last 
Council meeting and this one, there has been a substantive change taking place linked to these agenda items, that is the entry into force of the Nagoya Protocol on Access to Genetic Resources in October 2014 following its ratification by 51 parties to the Convention, including Peru. Convinced IP/C/M/77/Add.1 
 
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  that the loss of biodiversity will have a serious impact on the protection of resources and that the 
protection of these resources and eradication of poverty are essential prerequisites for sustainable development, Peru has decided to ratify the CB D Convention in 1993. Since then my country has 
been working nationally and locally so as to implement and enhance conditions for an effective 
protection of biodiversity; services and functions provided for are needed in a number of 
ecosystems for the protection of the population. Peru has also been promoting and disseminating 
the benefits of biodiversity creating a national commission in order to ensure implementation of 
the Convention on Biodiversity and a strate gic plan for biodiversity 2011-2020 and related 
instruments. We have a national biodiversity action plan and other related policies. Peru has also been actively participating regionally and globally in defence of biodiversity. In our view this is the cornerstone for sustainable development. 
97.  I would like to stress the huge potential that the Nagoya Protocol offers in supporting 
sustainable development in our countries as it do es provide for a framework of mutual confidence 
amongst users, providers and local communities and indigenous communities. This is a milestone 
in the governance of biodiversity, not only due to  access and benefit sharing, but also because this 
contributes to preservation and sustainable use of  resources. Furthermore, it also establishes a 
principle of equity for the countries supplying these resources, particularly indigenous and local 
communities. In the light of the recent entry into force of this international instrument, we believe 
now it is time to look at this agenda item and the work being done in this Council. We do support the CBD's participation and, as this is a cross-cutting issue, we believe that it is important that we repeat an invitation to WIPO. As other colle agues have stated, we have heard about what 
happened in the recent General Assemblies and as opposed to what others have stated, Peru also 
believes that it is important that this issue also be dealt with at the WTO. Finally, I would like to support the proposal made by Ecuador.  
5.9 Bangladesh   
 98.  My delegation supports the statement made by Uganda on behalf of the LDC Group. Our 
well-known position is essentially based on the enshrined objectives as laid down in TRIPS and the 
CBD. We believe mutually supportive and harmon ious implementation of TRIPS and the CBD can 
only ensure the fulfilment of the objectives. 
99.  On Art. 27.3(b), our concerns and position are also known to all and we stand ready to 
contribute in a constructive manner.  In this rega rd, we take note of the Chair's sincere efforts and 
truly appreciate that. 
100.  As regards to the patentability of life forms, Let me restate that it is against the set 
standards of morality and ethics; and hence we ca nnot support pursuing such a route for the trade 
and making trade-related gains.  
101.  We also believe that genetic resources, traditional knowledge and folklore are absolutely 
sovereign to states. Hence, we are supportive of a comprehensive disclosure mechanism with prior 
informed consent for safeguarding the legitimate  right of and ensuring benefit sharing to the 
people. 
5.10 Colombia   
 
102.  As other Members know, Colombia is in favour of negotiating rules to establish legality of access as a prerequisite for engaging in research for and the development of any invention in the 
biotechnology field and the use of biological and/ or genetic resources or associated traditional 
knowledge, and the demonstration of such legality of access in a patent application for the product or process involved. 
103.  We accordingly urge Council members to move forward with their work under the Doha 
mandate, which aims to ensure that the TRIP S Agreement and the CBD are implemented in a 
manner that is mutually supportive and does not run counter to their respective objectives. We also consider that the proposed invitation for the CBD Secretariat to attend this Council remains 
standing, especially in view of the Protocol's entry into force. IP/C/M/77/Add.1 
 
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  104.  Colombia also emphasizes that the issues relating to IP and genetic resources are as 
critically important in the WTO as they are in WIPO. The circumstances affecting WIPO since the outcome of the Assemblies last September should pr ompt us to move ahead with our work within 
the WTO framework, while pursuing our endeavours to achieve positive results in the WIPO 
context. 
5.11 Ecuador   
 
105.  My delegation would like once again to confirm its position regarding the need to review 
Article 27.3(b) on what is understood by patentable subject matter, and in this respect we join the delegations which consider that patents for all life forms or parts thereof should be prohibited. Anything that endangers or negatively affects the life forms of peoples or cultures cannot be 
considered a tradable good that may be the subject of inventions and thus patentable. 
106.  On several occasions Ecuador has expressed, in this Council, its position regarding the 
relationship between the TRIPS Agreement and the CBD, and we reiterate once again the need for 
multilateral legal instruments to improve the use of genetic resources, associated traditional 
knowledge and traditional cultural expressions,  and to give them effective and adequate 
protection. There is a need to establish legal mech anisms to provide for disclosure of the source of 
origin, prior informed consent and access and equitable benefit sharing. 
107.  Ecuador believes in the consultations being undertaken by the Chairman under a mandate 
from this Council to enable the CDB Secretariat to provide information on the outcome of the Nagoya negotiations on the establishment of a Protocol on Access to Genetic Resources. We 
consider, however, that new elements are needed to facilitate his task. This is why my delegation 
has suggested that the Secretariat prepare a comp ilation of the discussions and proposals over the 
past eight years. 
108.  We all agree on the principle of transparency  in the negotiations, and this proposal is a new 
element that could be considered as a contribution to our progress on this issue. 
5.12 Egypt   
109.  We would like to associate ourselves with Ec uador, India, Brazil, China and others. In order 
to eliminate any kind of repetition we would like to refer to our statement during the previous meetings of the TRIPS Council. However we would like to highlight three points: first, the protection of biological resources, traditional knowledge and folklore is of high priority and 
importance for developing countries. In addition it represents also a critical part of the Doha Work 
Programme. Secondly, we are ready to engage with other Members in serious negotiations in order 
to reach an agreement which could provide Members with the right to require the applicant for any 
patent related to biological resources and traditional knowledge to disclose the source and country 
of origin. He should also provide evidence of prior consent and fair and equitable benefit sharing. Finally, we welcome any kind of endeavours from th e Director General to continue consultations on 
the relationship between the TRIPS Agreement an d the CBD. Such consultations should aim to 
invite the CBD Secretariat to brief WTO Members on the Nagoya Protocol and other related matters. 
5.13 Indonesia   
110.  Indonesia would like to reiterate its view regarding this matter and the importance of 
ensuring cohesiveness of these two international instruments. Our delegation believes it is prevalent that the implementation of the TRIPS Agreement and the CBD be carried out in manner 
which is mutually supportive and does not run counter to their respective objectives. 
111.  For this purpose, Indonesia believes that special attention should be given to the objectives, 
definitions and principles of the TRIPS Agreement, the CBD, and the Nagoya Protocol, in particular 
its provision on prior informed consent for access and fair and equitable benefit sharing. The 
discrepancy of these provisions in the TRIPS Ag reement with the CBD and the Nagoya Protocol 
creates contradictive approaches in implementa tion. The TRIPS Agreement does not prevent a 
person from claiming patent rights on an invention based on genetic resources and associated 
traditional knowledge (GRTK) and does not oblige States to take necessary measures for fair and IP/C/M/77/Add.1 
 
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  equitable sharing of benefit. Meanwhile, the CBD and the Nagoya Protocol require prior informed 
consent for access and fair and equitable benefit sharing for any invention based on GRTK. These contradictions leave room for misappropriat ion and the grant of erroneous patents. 
112.  Indonesia, as a proponent to document TN/C/W/59, remains consistent with its view on the 
urgency the mandatory disclosure requirement to be included in the TRIPS Agreement. Indonesia 
further emphasizes that the disclosure requirements in Article 29 of the TRIPS Agreement are incomplete without the disclosure of origin of genetic resources and associated traditional 
knowledge. Including a mandatory requirement for the disclosure of origin would enhance 
transparency about the utilization of GRTK. 
113.  Indonesia believes it is essential that we address this issue in order to ensure that GRTK are 
utilized in an appropriate manner that ensures the fair and equitable benefit sharing through 
mutually agreed terms in accordance with the objectives of the CBD and the Nagoya Protocol. 
5.14 Venezuela, Bolivarian Republic of   
114.  We would like to support Bolivia as to the need for a review of Article 27.3(b) of the 
TRIPS Agreement. The Venezuelan Constitution also prohibits the patenting of any life form. 
In fact, all Bolivia is asking for is compliance with what is stipulated in that Article, namely that the provisions therein shall be reviewed four years after the date of entry into force of the 
TRIPS Agreement; so this Council is lagging behind  on that mandate, and this would be the time 
to do something about it. 
5.15 New Zealand   
 
115.  New Zealand agrees with the views expre ssed by many Members about the importance of 
preventing the misappropriation of genetic resources and associated traditional knowledge. And at a broader level, we have a systemic interest in preventing the granting of erroneous patents. 
Measures that contribute to high quality patent examination are important to ensuring the health 
and integrity of the patent system. 
116.  New Zealand considers there is a significant degree of common understanding amongst 
Members over these high level objectives. But there is still much disagreement over the 
appropriate policy responses that would best achieve these objectives.  
117.  New Zealand's domestic policy is still evolving in this area. But we are committed to 
engaging constructively in relevant international fora to address these important issues.  
118.  The WIPO IGC has been undertaking a detailed consideration of the relationship between 
intellectual property and genetic resources, as well as traditional knowledge and traditional cultural expressions, and has been working on the text of an international instrument or instruments on 
the protection of these three subject matters. Wh ile the process in the WIPO IGC might currently 
be stalled, we are confident that it will resume, and our delegation remains committed to that process.   
119.  New Zealand continues to believe that the WI PO IGC is the appropriate forum to discuss in 
detail issues relating to the protection of traditional knowledge and genetic resources because it is able to look at these issues in a holistic and coordinated way. New Zealand is an active and constructive participant in the IGC, and is committed to the fulfilment of the IGC mandate. 
120.  New Zealand's view is that it will be important to ensure that appropriate political attention 
is given to supporting this process in the WIPO IGC so that it may resume.  We do not consider that a change of forum will solve the issues that  are currently stalling progress on this subject 
matter. 
5.16 Canada   
 
121.  From the outset, Canada has participated actively and constructively in the work of the 
WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional 
Knowledge and Folklore. We are trying in the best of faith to find solutions to the important but IP/C/M/77/Add.1 
 
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  difficult issues that are being addressed by th e Committee, solutions that are consensual and 
pragmatic enough to enjoy the kind of broad support on which their success depends. 
122.  We are therefore deeply disappointed at th e developments that took place at the recent 
session of the WIPO General Assembly as a result of which the Committee may not meet in 2015. 
Canada has stressed several times that an "all or nothing" approach to the work of the Committee 
would be ill-advised, and regrettably, our view has now been borne out. We do not see how this situation can possibly bring anyone closer to a positive outcome of any kind. Let us be clear: 
notwithstanding its well-known positions, Canada deplores this apparent suspension of the 
Committee's work, which is cert ainly not what it wanted. 
123.  Yes, multilateralism takes time. The Intergovernmental Committee is faced with distilling 
188 different national approaches to produce a single common commitment to solutions that work 
for everyone, in areas that are absolutely fundamental, and all of this in uncharted waters. 
These issues are complex and multidisciplinary, and involve a variety of interests that have to be reconciled. In the circumstances, it can take quite long for an international consensus to emerge. 
However, a positive and successful multilateral ou tcome can only be the result of as broad as 
possible a compromise, and will certainly not be ac hieved by skipping stages and rushing things. 
124.  To those who might conclude that the Interg overnmental Committee is dead and that we will 
have to try to obtain a result here at the WTO, Canada would stress that the only way to settle any 
disagreement, at WIPO or at the WTO, is th rough concrete discussions and the exchange of 
national experiences, and we cannot postpo n e  t h i s  a n y  m o r e  t h a n  w e  c a n  s w e e p  o u r  
disagreements under the carpet in the hope that th ey will settle themselves without the inevitable 
technical negotiations. 
125.  The fact is that several very simple questions addressed to the Intergovernmental 
Committee by a number of delegations including Canada have remained largely unanswered, 
particularly with respect to the national experiences of those of us who offer sui generis  protection 
of genetic resources, traditional knowledge and trad itional cultural expressions. We fail to see how 
any change of forum would remedy this situation, and consequently we see no interest or 
justification in doing so. Canada remains firmly convinced that with WIPO's expertise in the 
intellectual property area and with the extensive, committed and representative participation of the different interest groups involved, including experts on the issues addressed, the Intergovernmental Committee is more likely to inspire the kind of concrete and frank technical 
discussions that are needed to move forward on these issues. We reaffirm our commitment to 
pursuing the work of the Committee with a view to  identifying mutually advantageous solutions to 
the important issue of the protection of genetic resources, traditional knowledge and traditional 
cultural expressions. 
126.  Canada is ready to work as a committed partner alongside all those who wish to return to 
the Intergovernmental Committee and pursue our discussions to that end. 
5.17 Japan   
127.  This delegation believes that our position on  this long-discussed and crucially important issue 
is well-recognized among Members, so we would like to make our intervention brief and concise.  
128.  First of all, our delegation would like to re iterate our position that an appropriate approach 
should be taken to prevent the misappropriation of genetic resources, traditional knowledge and 
folklore. Also, the approach we take should ensure that no adverse effects are imposed on the existing intellectual property system and that innovation is not hindered.  
129.  Particularly, regarding the mandatory disclosure requirement, our delegation believes that 
such a disclosure requirement can impose undue burden on applicants and also cause legal 
uncertainty about the patent system itself. The consequence of this would be that innovation, 
which utilizes genetic resources and associated traditional knowledge, will be discouraged.  
130.  Regarding the discussion at the WIPO IGC, the recent WIPO General Assembly could not 
agree upon the work programme of IGC for next ye ar. Nevertheless, Japan still believes that WIPO IP/C/M/77/Add.1 
 
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  is the most appropriate forum for technical discussions on these issues. Japan remains willing to 
contribute to discussions on these issues in a constructive manner 
5.18 Korea, Republic of   
131.  Considering that Korea joined the CBD and it hosted the conference of the CBD a few weeks 
ago, we believe that the spirit of fair and equitable benefit sharing arising from the use of GRTK 
should be respected. 
132.   However, in regard to its purpose and goals, the TRIPS Agreement differs from the CBD as 
well as the Nagoya Protocol. Therefore, amen ding the TRIPS Agreement is not necessary for 
achieving the purpose of the CBD. We believe that these agreements could be respectively 
implemented in a mutually supportive manner sinc e they deal with different subject matters. 
133.   Moreover, the IGC of WIPO is currently undertaking detailed discussions of aspects of IP 
related to genetic resources, traditional resources, and traditional knowledge. We think that the 
IGC of WIPO is the most appropriate forum for discussing GRTK in details 
5.19 Australia   
134.  Australia regards the current flexibilities under the TRIPS Article 27.3(b) as sufficient to allow 
Members to take decisions on the patentability of life forms in accordance with national policies, and we regard it to be appropriate to retain th ose flexibilities. Regarding the relationship between 
TRIPS and the CBD, as we have said at previous  TRIPS Council sessions, we consider the TRIPS 
Agreement and the CBD to be consistent and Australia fully implements its obligations under both agreements which we view as mutually supportive.  
135.  We are a signatory to the Nagoya Protocol, and the Australian Government is currently 
undertaking internal processes to consider its ratification. A broad-based consultation has just 
been completed, which will inform any decision on a possible ratification.  
136.  Australia is an island continent with diverse biological resources and a unique and vibrant 
indigenous culture. We seek to protect genetic resources and the traditional knowledge of 
indigenous people while retaining legal certainty in the IP system. We regard WIPO to be the best place to consider the complex intellectual property issues related to genetic resources and 
traditional knowledge. WIPO Member States have analysed a wide range of complex IP issues, not 
only the specific proposals on disclosure of orig in of traditional knowledge and genetic resources 
advanced in the TRIPS Council. While we share the disappointment of many delegations that the 2014 WIPO General Assembly was not able to agree on an IGC programme, we welcome the 
progress that has been made in the IGC, especially over the last two years due to the commitment 
and flexibility of Member States. We wish to see WIPO Member States stay the course and see this 
important substantive work programme through to its conclusion. The break in official meetings 
this coming year will allow countries to reflect upon their positions and strategies and we hope 
return to the 2015 WIPO General Assembly with a genuine commitment to finalising these negotiations to achieve a meaningful, balanced and deliverable outcome. 
5.20 Switzerland   
 137.  Together with the extension of the protection  for geographical indications, the relationship 
between the TRIPS Agreement and the CBD is one of the two outstanding implementation issues 
that has been under negotiation in the Doha Round for almost 13 years now. The 108 proponents 
of the submission in TN/C/W/52 of which Switzerland is one, have proposed modalities language and offered solution of how the three TRIPS issues in the Doha Round can actually be brought to a 
solution. Switzerland deplores the outcome at the recent WIPO General Assembly with regard to 
the work plan of the WIPO IGC. Switzerland considers the work done in WIPO and in WTO as complimentary. Here at the WTO we need to find wa ys to continue the vast amount of work that 
has already been done, and achieved in the DG -led process. In the meantime, when the 
horizontal process is not clear yet how we can move forward, my delegation supports that we have a fact-based and informed discussion under these th ree agenda items. In that respect, Switzerland 
can also support the proposal to invite the CBD Secretariat to inform the Council at one of its next 
sessions about the entry into force of the Nagoya Protocol.  IP/C/M/77/Add.1 
 
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  5.21 Nepal   
138.  The delegation of Nepal aligns itself with th e intervention made by Uganda on behalf of LDC 
Group, Bangladesh and other like-minded Members on this subject matter. 
139.  The delegation of Nepal cannot support the use of life forms from plants and animals and 
patenting of them. As such review of the Articl e 27.3 (b) of the TRIPS Agreement is essential to 
protecting against the harmful and unethical effects in different spheres of life and nature, my delegation is against patenting of life forms. 
140.  On the relationship between the TRIPS Agreement and the CBD, we underscore the need of 
cohesiveness between these two agreements. It is ou r firm belief that states have the full right 
and authority to protect and preserve their genetic resources, traditional knowledge and folklore. Countries deserve full right to take economic advantage of genetic resources and traditional 
knowledge through legal provisioning as seems to be appropriate. At present, the small bio-diverse 
countries are victims of misappropriation of their genetic resources, traditional knowledge and folklore. To protect them from being deprived further we emphasize that traditional knowledge 
must be given due legal recognition and protection . In light of this, we demand that the TRIPS 
Agreement should be modified with a view to re quiring that patent applicants for biological 
material, provide information on source and the country of origin of biological resources and the 
traditional knowledge used in the invention. Provisions related to mandatory disclosure 
requirement if included in the TRIPS Agreement will contribute to preventing misappropriation of genetic resources and associated traditional knowle dge, as well as improving transparency in the 
utilization of genetic resources and associated traditional knowledge.  
141.  Furthermore, we are of the view that pate nt applicants must also provide proof of prior 
informed consent and benefit sharing with authorities and/or the relevant persons of the relevant national origin. This obligation of information will assist in reducing the number of patents granted 
erroneously or through bio-piracy.  
5.22 United States of America   
142.  We associate ourselves with the statements made by the delegates from Chile, New Zealand, 
Canada, Japan and Korea, with respect to the sentiment that WIPO remains the appropriate forum 
for these negotiations. We have heard certain delegations this morning express concern here today at the inability to reach an agreement for a mandate for the second year of WIPO IGC for 2014 and 2015, and for that reason the WTO should step in and continue those negotiations. We 
have also heard from a few Members who suggest that we should attempt to have substantive 
negotiations on Doha-related issues in this resp ect. Of course, while we look forward to these 
agenda items, and continue to do so in the future in the TRIPS Council, and will engage 
constructively on these items, we do not support the resumption of Doha negotiations on these 
issues or DG consultations as Members may have suggested this morning.  
143.  In this regard we re-state our view that it cannot be business as usual on Doha-related 
issues when trust has been fundamentally shaken  regarding the implementation of understandings 
under the first critical Bali milestones. Moreover we do not believe that the inability of WIPO to 
agree upon a work programme should lead the WTO to take on the work of the WIPO IGC. Of course we, as everyone has stated this morning, are disappointed that the General Assembly was 
unable to agree upon its work programme so that the IGC could continue its work. The United 
States has worked proactively to have a work pr ogramme for the second year of the mandate and 
suggested a work programme in June and worked throughout the General Assembly to agree upon 
a series of meetings and work that would allow th e IGC to continue its work next year. However, 
the Assembly could not come to any agreement. We note that the text being considered by the WIPO IGC did not merely have hundreds of brackets, but also reflects some fundamental gaps in 
principle.  
144.  Substantial work still needs to be done, not only on draft texts but on key concepts. We also 
believe that, based on a real exchange of idea s at WIPO, these gaps can be narrowed. But the 
appropriate place for that conversation, as others have mentioned, is WIPO, and we hope that the 
narrowing can continue there in 2016. Finally, and to confirm the Chair's statement at the IP/C/M/77/Add.1 
 
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  beginning of these items, the US is not in a posi tion to support the request for the update of the 
three WTO Secretariat papers, or the CBD Secretariat briefing. 
AGENDA ITEM 6: REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE 
IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS 
AGREEMENT AND PUBLIC HEALTH 
6.1 Chile  
  
145.  Our country gives this issue high importance. As the report states in JOB/IP/11, Chile 
deposited its ratification instrument during the course of 2013. We commend countries that have decided to implement the Protocol which creates a quorum for its entry into force. As the report 
states, this is not a panacea to resolve all issues of public health. It is part of a larger programme 
that includes other important aspects that have an impact on innovation and access, like 
infrastructure, financing mechanisms that are supporting innovation, inter alia.  
146.  However, although it is necessary to develop national programmes to make progress in this 
area, it is also important to emphasize that the Paragraph 6 System is the only flexibility of the 
TRIPS Agreement that is specifically devoted to the participation of two countries at least to enable that Members with difficulty to make effect ive mandatory licensing under the Agreement can 
effectively use them. We believe that this quality of effort is important today. Our delegation would 
like to stress the importance of the role of th e mechanism as a political sign agreed between 
Members that reflects the importance that this Organization places in the promotion of access to medical technology and innovation as a key area of public health overlapping with intellectual 
property. Our country is happy to participate in the various initiatives, dialogue bodies that may be 
developed in this area. 
6.2 Uganda on behalf of the LDC Group   
147.  I make this statement on behalf of the LDC Group. It is no secret that LDCs have limited 
capacity to manufacture medicines. Access to affordable medicines by our people continues to remain a prominent public health concern relating to TB, HIV/AIDS and malaria. It is a matter of 
life and death. We have a recent eye-opener in this regard – the Ebola outbreak has given us a 
clear message on our capacity constraints and immense limitations. You will recall that Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health clearly recognized the gravity of the problem and instructed the Council to find an expeditious solution.  
148.  Accordingly, Members adopted a decision in this regard (WT/L/540 and Corr. 1 of 
September 2003) to facilitate the legal coverage of importing medicines. However, this decision was marred by so many unnecessary burdensome conditions. Getting recourse through this 
decision was time-consuming. This is disconcerting in view of the life and death situation of our 
patients. Despite the multiple difficulties and without manufacturing capacity, only one of our members has invoked the provisions under this in strument. Failing to respond appropriately and 
quickly is thus a collective shame for all of us. As such we join our voice to those who have called 
for the review of this decision with a view to simplifying the instrument to address our concerns. Further, the adoption of the General Council Deci sion WT/L/641 in 2005 in order to respond to 
difficulties experienced by countries with no or insufficient manufacturing capacity was an 
important milestone.  
149.  However, we are concerned that the process of accepting the TRIPS amendment seems to be 
taking longer than it took to negotiate and arrive  at a decision in 2005. Surely, if all are concerned 
about easing the difficulties faced by millions of people across the globe, with these global public 
health concerns the question is where is that true commitment to the cause of those who are suffering? Consultations have been held to get a se nse of where the difficulties lie, for completing 
the formality of depositing an instrument of ratification. Seminars have been held, and continue to 
be held on this topic, yet progress is taking place at a snail's speed.  
150.  We cannot afford to wait any longer before  the amendments are affected. All of us have a 
collective responsibility to ensure that the TRIPS Agreement works for those faced with a public 
health concern, just as much as private rightholders are enjoying the benefits of protection offered IP/C/M/77/Add.1 
 
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  under this Agreement. We therefore call upon Memb ers who are yet to deposit their Instrument of 
Acceptance to do so. 
6.3 India  
 
151.  India attaches high importance to the Doha  Declaration on the TRIPS Agreement and Public 
Health, the Paragraph 6 System as established under the 2003 waiver decision and the Protocol. The Paragraph 6 System is also the first ever proposed amendment to the WTO Agreement in the 
form of the 2005 Protocol Amending the TRIPS Agreement. India had notified its acceptance of the 
Protocol in March 2007. We would like to congratulate Uruguay, Botswana, Turkey and the Central African Republic for depositing their instruments of acceptance of the Protocol during the last year.  
However, in spite of the fourth extension of the period for acceptance until 31 December 2015, 
only 53 Members have accepted the Protocol so far. The fact that there is still a long way to go for 
it to enter into force, as acceptance by two thirds of the membership is required, is not a positive signal. Therefore, we urge other Members to notify their acceptance of the 2005 Protocol 
Amending the TRIPS Agreement for it to enter into force. We would like to appreciate the 
Secretariats of WTO and WIPO for providing technical assistance for the process of entry into force of the amendment, and also for the implemen tation and use of the Paragraph 6 System.  
152.  India has always been of the view that the Doha Declaration on the TRIPS Agreement and 
Public Health constituted a major landmark in th e 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 countri es. Along with several other Members, India had 
worked relentlessly on the Doha Declaration and the Decision. The Decision was expected to 
address the public health problems faced by Members with insufficient or no manufacturing capacities in the pharmaceutical sector. It may have sounded prophetic at that time when India 
voiced certain apprehensions in the General Council meeting of August 2003. India sounded a 
word of caution and while expressing hope that "t he results accruing from this mechanism should 
not be negated by the creation of cumbersome systems that would lead to huge delays in getting 
medicines across at reasonable cost to those that  needed them or discourage Members from using 
the system for the benefit of the people. In order to make this system successful, a sincere collective effort was required on the part of all Members and the entire pharmaceutical industry." 
Regrettably, we have been proven right. The export of HIV/AIDS medicines by the Canadian 
pharmaceutical company Apotex to Rwanda in Se ptember 2008 was the first and only use of the 
system so far. 
153.  The trilateral study by WTO, WHO and WIPO on "Promoting Access to Medical Technologies 
and Innovation: Intersections between public health , intellectual property and trade" (2013) has 
summarised the diverse observations of the WTO Members on whether the Paragraph 6 System is fulfilling its intended objectives into six points as follows: 
i. "By 2012, the System was only used once, and it took three years before the shipments 
in question proceeded. The System is too complex and administratively unwieldy for further use, and a multi-stakeholder workshop is needed in order to discuss the operation of the System. It is essential to clarify whether constraints on its use were built into the 
System, thus necessitating its reform, or whether such constraints were a consequence 
of how individual countries chose to implement it. 
ii. Potential users of the System may be deterr ed by concerns about political or trade 
ramifications associated with the use of compulsory licensing. 
iii. The Canada's Access to Medicines Regime (CAMR) was successfully utilized, and only a 
very small portion of the three-year time period was taken up with procedures associated 
with the System. Much of the time that el apsed between the regulatory review of the 
medicine in question and the actual shipments was attributable to other factors. 
iv. The limited use of the System is not an appropriate measure of its success, as no 
delegation demonstrated evidence of obstacles to its use when such use was required. A 
single case demonstrated that the System could work when necessary, and that it could 
play a supportive role in the wider effort to improve access to essential medicines, given that alternative ways of procuring the needed medicines are often available. IP/C/M/77/Add.1 
 
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  v. The System is not a panacea to solve all public health related problems. Rather, it is part 
of a broader picture which includes other important aspects that have an impact on innovation and access, such as infrastructure, tariffs, innovative financing mechanisms, partnerships and cooperation (including at the regional level), and regulatory 
frameworks. 
vi. Implementation of full patent protection fo r pharmaceutical products in India, coupled 
with the approaching expiry of transition periods in LDCs, could make it more difficult in 
the future to procure generic versions of new medicines. Under such circumstances, the 
Paragraph 6 System might assume a greater significance." 
154.  The TRIPS Council has been reviewing the mechanism for the last several years. My 
delegation feels that the review mechanism has beco me ritualistic in nature and will not serve any 
purpose if we go on repeating similar questions and get similar replies as summarized by the 
trilateral study done by the WTO, WIPO & WHO.  The implementation of the Paragraph 6 System 
involves several stake holders and our discussions would not be effective if we restrict the 
discussion to this level. 
155.  It is pertinent to mention here that the WTO, WHO and WIPO are holding a technical 
symposium on "Innovation and access to medical technologies: challenges and opportunities for 
middle income countries" on 5 November 2014 at the WTO in Geneva. As part of the trilateral 
cooperation between the WHO, WIPO and the WTO on innovation and access to medicines, we 
request these Organizations to organize a dedicate d workshop involving all stakeholders to expand 
the scope of the discussion on the question of making effective use of the Paragraph 6 System, 
including alternatives to it. 
6.4 Brazil  
 
156.  We associate ourselves to the statements delivered by Chile, Uganda and India. In 2001, all 
Members recognized that WTO Members with insufficient or no manufacturing capacities in the 
pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. In response to this ch allenge, the Council for TRIPS developed the 
Paragraph 6 System to implement one solution to access to medicines. Since the System was 
established, only one country benefited directly from it.  
157.  In light of the fact that we have not witnessed any usage of the System in the last six years, 
it is valid to raise the question of whether Members feel entitled to use the System as an 
instrument of public policies towards universal access to health.  Uganda, on behalf of the LDC 
Group, reminded us all of the high stakes pres ent at the full implementation of the System. 
158.  We should not deny the fact that there is a relationship between IP and access to medicines. 
In this sense we would like to support the prop osal by the delegation of India to expand the 
discussion on the subject of the effectiveness of the Paragraph 6 System to a broader public of 
stakeholders. A workshop would be a good initiative in this direction. 
6.5 Cuba  
 159.  Cuba is in favour of an open-ended workshop on the Paragraph 6 System, to which all 
interested parties would be invited; the time has come to review the problems of the System, as 
the delegations of Uganda and India have requested. 
160.  This is independent from the acceptance of the Protocol, which does not in itself resolve the 
problem of ineffectiveness of the system. 
6.6 China  
 161.  By waiving Members' obligations under Arti cle 31(f) of the TRIPS Agreement, the System 
aimed to address the public health problems faced by Members with insufficient or no 
manufacturing capacities in the pharmaceutical sector. IP/C/M/77/Add.1 
 
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  162.  Unfortunately, the System has been used only once so far, and it is not easy to assess 
whether it has achieved its objectives. The very limited use does not mean that the developing country Members do not face public health problems anymore. According to the trilateral study on "Promoting Access and Medical Innovation - Intersections between Public Health, Intellectual 
Property and Trade" prepared by WTO, WHO and WIPO, tuberculosis and HIV/AIDS are among the 
leading causes of death in middle-income countries, and people in low-income countries predominantly die of infectious diseases. This indicates that the problem of public health and 
access to medicines is still a big challenge for many Members. 
163.  Therefore, the review is necessary. It is important to carefully examine the reasons behind 
the limited use, identify the difficulties faced by Members in using the System, and find possible 
ways of improving it. We support the proposal to hold an open-ended workshop. The inputs from 
all stakeholders, including experts, non-governmental and intergovernmental organizations, would 
contribute to achieve greater transparency, prom ote a holistic understanding of the issues, and 
identify the possible solutions to the current situat ion. We take note that these kinds of workshop 
took place from time to time in other WTO committees, and we do not see any rational for some 
Members to oppose such a workshop.  
6.7 Chinese Taipei  
 
164.  Our delegation would like to thank you for the informative briefing on the current development of the Paragraph 6 System. 
165.  I would like to draw your attention to the fact that the elements contained in the Decision on 
the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public 
Health, and the draft amendment of TRIPS Article 31bis have already been introduced in our 2011 Patent Act. 
166.  Public health problems afflict many developing and least-developed countries, especially 
those resulting from Ebola and other new and serious epidemics. We would like to highlight the need for the TRIPS Agreement to be part of the wider national and international action to address 
these problems. It should be also emphasized th at the TRIPS Agreement does not and should not 
prevent Members from taking measures to protect public health and, in particular, to promote access to medicines for all. My delegation suppo rts the Paragraph 6 System and encourages other 
Members to notify their acceptance of the amendment so that it can enter into force. 
6.8 United States of America  
 167.  The United States strongly supports the Paragraph 6 System as established under the 2003 
waiver decision and the 2005 Protocol. The United States was the first WTO Member to accept the 
amendment in 2005. We also welcome the latest General Council decision of 26 November 2013 which extended the deadline for acceptance of the amendment to 31 December 2015. We also 
welcome and congratulate Botswana, the Central African Republic, Turkey and Uruguay who have 
formally accepted the amendment this year. We welcome and encourage the Secretariat's efforts 
with respect to depositing instruments of acceptance of the Amendment as well. We join Uganda in encouraging other Members to notify their acceptance of the Amendment so that it can enter into 
force. Finally, we wanted to highlight the Secretariat's good efforts in this regard, and draw 
delegates' attention to the WTO TRIPS webpage where Members can find a link to an illustrative guide to notifying under the Paragraph 6 System which we find to be quite helpful. As we have 
explained, there are multiple avenues available for promoting access to medicines, the 
Paragraph 6 System is important of course, but it is not alone.  
168.  There are many mechanisms to overcome barriers, and such barriers of course include tariffs 
and non-tariff barriers. Measures including those that are discriminatory, non-transparent or 
otherwise trade-restrictive have the potential to hinder access to pharmaceuticals and medical devices and potentially result in reduced access to healthcare due to higher healthcare costs. 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 health-care 
institutions and to patients. Moreover unreasonable regulatory approval delays and non-transparent reimbursement policies can create uncertainty or ambiguity about when a new drug or 
medical product can enter into the market and thereby discourage the development and marketing 
of such new drugs and other medical products. The criteria, rational and operation of such IP/C/M/77/Add.1 
 
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  measures are often non-transparent and not fully disclosed, contributing to this uncertainty. 
Appropriate mechanisms for transparency, procedural and due process protections and opportunities for public engagement are important in the context of health care systems. We continue to believe that the access to medicines issue is multidimensional; making life-saving 
medicines available requires transparency and a commitment to address measures that unduly 
delay patients from getting the treatments they need.  
169.  Finally, to the extent that a delegation has requested a TRIPS Council decision today on a 
workshop, as this is a new proposal and on whic h we have received no advance notice, including 
a t  y e s t e r d a y ' s  i n f o r m a l  m e e t i n g ,  w e  w i l l  n e e d  t o  r e v e r t  t h i s  r e q u e s t ,  i f  i t  i s  a  r e q u e s t ,  b a c k  t o  capital. 
6.9 Australia  
 
170.  We welcome this opportunity to discuss the Paragraph 6 System, which we strongly support. We agree with others who have pointed out that the TRIPS Protocol is not a panacea to improve 
public health, and Australia, in that regard supports many international measures to improve 
access to medicines, including through the WHO Pandemic Influzena Preparedness Framework for sharing of influenza viruses and access to vaccines and other benefits. We also support other 
things like the efforts to increase access to quality medicines and other technologies in our region 
through co-chairing the Asia Pacific Leaders Malaria Alliance. The Australian aid programme will also invest AUS$30 million per year in health and medical research, including product development partnerships for medical technologies. We were pleased to accept the TRIPS Protocol in 2007 and 
would like to join those who congratulate Trinidad and Tobago, the Central African Republic, 
Turkey, Botswana and Uruguay on their acceptance of the Protocol since this issue was last discussed in the Council, and we certainly join in encouraging others who have not yet accepted 
the Protocol to do so. Legislation to implement the TRIPS Protocol is currently before the 
Australian parliament. On the question of a workshop on access to medicines, we would welcome a workshop on the effectiveness of the Paragraph 6 System that is sufficiently broad to allow a 
meaningful and frank discussion of access to medicines issues by including participants from 
industry and NGO stakeholders, and by covering related issues, other than intellectual property, 
such as government procurement, supply chains and the role of gender. 
6.10 Canada  
 
171.  As Canada has previously said, while the Paragraph 6 System is a useful tool, it should not be regarded as a panacea for the complex problem of access to medicines. Indeed, medicines are 
one of the many components of health systems, th e price of medicines is one of the many factors 
affecting access to those medicines, and intellec tual property is one of the numerous factors 
influencing the price of medicines. The impact of intellectual property rights on access to 
medicines, on the price of those medicines and on health care in general is proportionate to the 
role played by intellectual property in relation to other factors affecting the price and availability of medicines, including infrastructure, health systems,  regulations, distribution and administration of 
medicines, in addition to customs tariffs and other taxes applicable to them. 
172.  Indeed, it is our understanding that a quarter of Members eligible for the Paragraph 6 
System without notification under paragraph 1(b) of the Decision of 30 August 2003 continue to 
impose import tariffs on medicines at rates of up to 15%, or even 25%. The situation is 
comparable for other eligible Members. Moreover, a 2011 study by the WHO and the Dutch NGO 
Health Action International shows that many Members that are eligible for the Paragraph 6 System apply different taxes on medicines in addition to port, customs clearance, transport and/or 
inspection charges, at rates ranging from 5 to 34 %, on top of customs tariffs where they exist. 
Another study by the same two organizations, published in 2014, reveals that increased distribution charges can push up the price of medicines by another 17 to 84% in relation to the manufacturer's price in low- and middle-income countries, regardless of the patent status. 
173.  In other words, we think that tariffs, taxes and charges on medicines can neutralize, at least 
in part, the beneficial effects of the flexibilities we have given ourselves, which is tantamount to lifting a barrier to exportation and availability on  the one hand while erecting barriers to access to 
medicines on the other. IP/C/M/77/Add.1 
 
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  174.  This being the case, we cannot examine either the Paragraph 6 System or intellectual 
property in isolation from the other issues affecting access to medicines. Canada would like to note that according to a United Nations report published in 2014, even essential generic medicines are available in only 55% of public sector health facilities in low- and middle-income countries. In 
other words, the absence of a patent on a particular medicine is no guarantee of its availability; 
hence the need to examine all of the factors that im pact access to medicines, as well as all of the 
supply mechanisms. In this connection, Canada would like to underscore the importance of 
voluntary licences, including those obtained throug h the Medicines Patent Pool, as well as pooled 
supply systems such as those used by the East African Community. We would be happy to discuss 
the experiences of importing Members eligible for the Paragraph 6 System in this respect, and more generally, the supply mechanisms they advocate and the challenges those mechanisms 
would involve. 
175.  We reiterate that Canada's Access to Medicines Regime that implements the Paragraph 6 
System, clearly functions well in its current form , and meets the requirements and parameters laid 
down in the Doha Declaration on the TRIPS Agreement and Public Health. The Canadian Access to 
Medicines Regime is just one of many aspects of Canada's firm commitment and leadership when it comes to access to medicines and public health for the least-developed and developing 
countries. 
176.  Let me conclude by calling upon all Members that have not already done so to deposit their 
instruments of acceptance of the Protocol Amending the TRIPS Agreement. 
6.11 Japan  
 
177.  Firstly, this delegation would like to reiterate the importance of access to Medicines, which needs to be discussed in a manner so that not only the Paragraph 6 System but also various other 
elements are taken into consideration, such as procurement and tariffs. The very objective of the 
System is to support WTO Members in obtaining greater access to medicines, specifically Members who have either insufficient or no pharmaceutical manufacturing capacity. Compulsory licenses are 
just one of the means available to achieve this objective; and therefore, the Paragraph 6 System 
should not be considered as the only solution, but rather as an option we could consider. 
178.  Secondly, we need to understand and analyse the specific concerns of potential importing 
Members who would or who might use the Paragraph 6 System. We hope that these Members will 
share their concerns and experiences with us. We believe that it would be beneficial for this 
Council to hear specific comments by potential importing Members.  
179.  Therefore, this delegation is of the view that it is premature to hold any workshop at this 
moment, as proposed by some Members. Instead, this delegation believes that we should take full 
advantage of this annual review to collect concre te practical examples, particularly based on the 
list of topics for discussion prepared by the WTO Secretariat in 2011. 
6.12 European Union  
 180.  I will be very brief on this point, because I think it is a subject that has been discussed many times here, and there is not a lot of novelty. Furthermore, I think that our Canadian colleagues 
just captured exactly what we wanted to say, so for the sake of making of a short intervention, I 
would reiterate what Canada mentioned. Intellectual property is only one of the items that have an impact on access to medicines. We spend an excessive amount of time discussing this, while 
overlooking other trade-related issues that have an enormous impact on access to medicines. I 
think by doing we are not rendering a service to th is very important issue of getting medicines to 
people who need it. 
6.13 Switzerland  
 181.  I would like to react to some of the criticism that we have heard in the discussion in the Council this morning on the Paragraph 6 System. Some Members have said that the System has 
not fulfilled its objective of addressing the access to medicines problem of potential beneficiary 
countries. It is important to recall in this context that the mandate in the Doha Declaration on the TRIPS Agreement and Public Health as well as the solution eventually found was not, and could not IP/C/M/77/Add.1 
 
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  have been, to solve the access to medicines problem for countries without manufacturing capacity. 
The mandate was merely - but importantly - to put all WTO Members on a level playing field with regard to the use of compulsory licences as a policy tool provided under the TRIPS Agreement. The Paragraph 6 System has achieved this objective,  as is evidenced by the Rwanda-Canada case.  
182.  This is not to say that my delegation considers the grant of a compulsory licence as a good 
or even easy-to-use tool to be applied and implemented to facilitate access to medicines in a specific situation of a health need. In practice, the grant and implementation of a compulsory 
licence may pose a number of problems and challenges which can render it burdensome and 
inefficient as a tool, not allowing for the quick a ccess to medicines required. But this may be true 
for any compulsory licence, whether granted under the Paragraph 6 System or not. 
183.  Having said this, what the Paragraph 6 System did achieve is that it allows all WTO Members 
to make use of this policy tool. The mere possibility of doing so may be the biggest benefit of the 
System, as it improves a Member's negotiating po sition vis-à-vis manufacturers in the case of a 
public health situation where a particular medicine is required and still under patent protection. 
This may be one of the very reasons why, in practice, the Paragraph 6 System has not been used 
more often. 
184.  Regarding the criticism that the mechanism is burdensome and complicated, in our annual 
reviews since 2003, we have not heard from potential beneficiary countries any specific and real 
case evidence of problems they have encountered  when they wanted to make use of the System. 
In this context it is also recalled that the sa feguards under the Paragraph 6 System are mainly 
geared to avoid diversion of medicines produced under a special compulsory licence. They shall 
make sure that these medicines actually reach th e beneficiary country rather than being diverted 
for commercial purposes to othe r, more affluent markets. 
185.  My delegation does therefore not agree with others who said that our annual review has 
become ritualistic, nor do we see any merit of inviting external stakeholders to the Council's 
discussion before we have heard from potential beneficiary Members what difficulties they may have encountered when they actually had wanted to make use of the Paragraph 6 System. 
6.14 Egypt  
 186.  Egypt does support India's proposal that a workshop be organized to discuss this subject. Such a workshop would be useful in helping us to identify the real problems in this System and 
what hinders developing countries and least developed countries in using it. 
6.15 WTO Secretariat  
 
187.  As in the past, we are taking the opportunity to update Members on the work done by the 
Secretariat in the field of technical cooperation dealing specifically with the Paragraph 6 System, but also more broadly concerning intellectual property and public health, in view of the way in 
which technical cooperation in this field is undertaken. 
188.  The three partner organizations, the Secretariats of the WHO, WIPO and the WTO, have 
continued their trilateral cooperation in the field of intellectual property, trade and public health 
with a view to fostering a better understanding of the linkage between those three policy domains 
and to enhance the mutually supportive implementation  of policies in those areas. This means that 
we increasingly work together to coordinate, desi gn and carry out capacity building activities in 
this area. This work is undertaken on the foundation of the trilateral study which has already been 
referred to by delegations. 
189.  The study, "Promoting Access to Medical Te chnologies and Innovation", was launched last 
year as a shared platform for technical assistance and capacity building for policy makers in those 
areas of policy spanning the intersections of public health, trade and intellectual property. It 
includes specific material on the background an d implementation of the Paragraph 6 System of 
special export licences for medicines. The System has been continuously addressed at almost all of our major technical cooperation activities in the past period under the review. In particular, it was 
covered by the 11
th Joint WIPO-WTO Colloquium for Teachers of Intellectual Property and the 
6th Joint WIPO-WTO Advanced Course on Intellectual Property for government officials; it was IP/C/M/77/Add.1 
 
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  covered in more detail in the 9th Annual Workshop on Intellectual Property and Public Health 
organized by the WTO itself.  
190.  This workshop was held in December 2013, in close collaboration with our colleagues in WHO 
and WIPO. The goal was to draw together each organization's particular expertise in a 
complementary manner and to put into practice the comprehensive coordinated approach outlined 
in the trilateral study. The workshop was accordingly a direct follow-up to the study and followed its content in practice. The study itself often served as starting point for the presentation and 
discussions at the workshop. Further, as with pa st workshops, the emphasis was on hearing a 
diversity of views, practical experience, and po licy perspectives. This workshop covered a wide 
range of issues, including the intellectual property and TRIPS issues specifically relating to the Paragraph 6 System, but also other areas of intell ectual property law and the provisions and the 
flexibilities within the TRIPS Agreement. The brea dth of stakeholders taking part as experts and 
speakers included a range of officials from the three partner organizations, but also experts from elsewhere in the international system and the United  Nations system, as well as representatives of 
industry, the philanthropic sector and civil society organizations, with a view to providing a 
rounded view of the issues at the crossroads between intellectual property and public health. 
191.  Building on the series of joint policy symposia that the three organizations have held, the 
most recent hosted by WIPO in July last year on medical innovation and changing business 
models, the three organizations will be convening the fourth in this series of trilateral technical symposia on 5 November 2014. It will focus on "Innovation and Access to Medical Technologies - Challenges and Opportunities for Middle-Income Countries". The idea is to focus on the concept of 
middle income countries. The chief economists of WI PO and WTO will be joined by the Director of 
Health Systems Governance from WHO for a discussion  on the policy significance of middle income 
countries in general in relation to innovation and access issues. The following session will turn to 
the innovation dimension, concerning how to measure the innovative capacity in the medical 
sector in middle income countries and looking at the factors that are behind the success in innovation in those countries, as well as at overall trends. Discussions will then turn to the 
challenge of ensuring access to medical technologies and the kind of policies, initiatives, measures 
that have been explored in those areas by middle income countries. The emphasis as in the past is 
to draw on practical experience, a breadth of perspectives from those working in the field who can bring to the Geneva policy community a broader understanding of their practical activities and 
programmes, as well as on the policies and the initiatives in middle income countries.  
192.  The series of workshops on Intellectual Property and Public Health has proceeded for 10 
years and has been progressively broadening in scope from a specific focus on TRIPS and 
intellectual property issues to address the broade r trade and health aspects as well. The eleventh 
w o r k s h o p  i n  t h i s  s e r i e s  w i l l  b e  h e l d  i n  G e n e v a  f r o m  2 4 - 2 8  N o v e m b e r ,  o n c e  a g a i n  i n  c l o s e  collaboration with the Secretariats of the WHO and WIPO. It will closely track the trilateral study as 
a foundation for inclusive, comprehensive and holistic capacity building in this area. 
193.  Intellectual property, TRIPS and public health, as well as the Paragraph 6 System, have also 
been regular items at other training activities su ch as regional and advanced trade policy courses, 
the Geneva Week programme for non-resident delegations, as well as a number of national 
workshops. The WTO Secretariat has also offered ad hoc advice to Members upon request. This 
information has included specific advice on the Paragraph 6 System, including the process for acceptance of the Protocol of Amendment of the TRIPS Agreement. Here, we have been able to 
assist along the lines of previous discussions in the TRIPS Council identifying the specific steps that 
are needed for acceptance of the Protocol. A numb er of Members have taken the step of accepting 
the Protocol without any domestic implementing le gislation. It is clearly not a prerequisite for 
acceptance to pass domestic legislation: the instrument of acceptance of the protocol entirely 
focuses on signalling legal agreement that other Me mbers are entitled to use the System if they so 
wish. We see different experiences in terms of accepting the TRIPS amendment on the one hand, 
and practical steps to implement the System in domestic law on the other hand, with Members 
treating these generally as distinct steps. This distinction has been usefully clarified in 
conversation with a number of Members. This agenda item also has links to the first agenda item, on notifications under the TRIPS Agreement: ther e has been significant amount of legislative 
activity among Members to implement, but we are aware that not all of this legislation has been 
notified.  Up to date notification of such implementing legislation is one element that could help inform our work on the System.  IP/C/M/77/Add.1 
 
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  194.  Finally, concerning the acceptance process, as directed at a previous session of the TRIPS 
Council, the Secretariat has prepared a model notification of acceptance: this is available online, and we can share a copy with any interested delegation. The key point is that this is a very straightforward and simple document, and the procedure is not complex. The instrument of 
acceptance simply has to be executed by someone with the requisite authority in the government, 
such as the minister for foreign affairs. 
6.16 WIPO Secretariat  
 
195.  During the period from November 2013 to September 2014, WIPO provided legislative and policy advice on patents that referred to or included considerations regarding paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health as follows: 
At the request of eight Member States, the WIPO Secretariat prepared comments on draft 
laws which included reference to, or implemen ted, paragraph 6 of the Doha Declaration. 
In the framework of legislative assistance on patents, matters related to health policies, 
including paragraph 6 of the Doha Declaration, were also addressed in the context of two 
missions that were undertaken to capitals and two consultations that took place in WIPO headquarters in Geneva.  
Legislative implementation of patent law matters, including the international legal 
framework provided by the TRIPS Agreement, was addressed in the following seminars or 
meetings: 
i. WIPO Sub-Regional Workshop on Patent  Law and Policy, Santiago, Chile, 3-4 
December 2013; 
ii. WIPO National Workshop on Patent Policy and its Legislative Implementation, Santo 
Domingo, Dominican Republic, 29-30 April 2014; and 
iii. WIPO Regional Seminar on Issues of Patent Protection for Medicines, Bishkek, Kyrgyz 
Republic, 28-29 May 2014 
WIPO staff participated in WTO Seminars, where the topic of patent-related flexibilities, 
including paragraph 6 of the Doha Declaratio n on the TRIPS Agreement and Public Health 
has been dealt with, as follows: 
i. National Seminar on the WTO TRIPS Agreement, Addis Ababa, Ethiopia, 12-13 
November 2013; 
ii. WTO National Workshop on the TRIPS Agreement, Naypyidaw, Myanmar, 20-21 
November 2013; 
iii. WTO National Seminar on Public Policies concerning the TRIPS Agreement, El 
Salvador, San Salvador, 21-23 January 2014; 
iv. WTO Workshop on the TRIPS Agreement and IP related matters, Port Louis, 
Mauritius, 5-7 March 2014; 
v. WTO Annual Workshop on IP and Public Health, Geneva, 10-13 December 2013; and 
vi. WIPO-WTO Colloquium for Teachers of IP, Geneva, Switzerland, 16-27 June 2014. 
196.  WIPO's legislative assistance is consistently based on the multilateral legal framework. More 
recently, a number of national authorities in charge of drafting laws have so ught advice from WIPO 
regarding how to use the available multilateral flexibilities so as to accommodate particular 
national interests that are specific to their countries. Since Paragraph 6 of the Doha Declaration is part of those flexibilities which are considered by several countries as part of their access-to-
medicine policies, this issue is regularly cove red by WIPO legislative and policy assistance. IP/C/M/77/Add.1 
 
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  197.  The following is an update on WIPO Re:Search: 
 As reported to the TRIPS Council in October 2013, WIPO Re:Search is a platform launched 
by WIPO with the participation of the public and private sector. Its purpose is to catalyze more research for Neglected Tropical Diseases (NTDs), malaria, and TB through the sharing 
of IP assets between researchers in this field. NTDs, malaria and TB affect more than one 
billion people globally, and usually affect the most disadvantaged populations in developing 
countries. To generate more investment in innovation directed at these diseases, WIPO 
worked with public and private sector partners and created WIPO Re:Search in 2011. Its 
purpose is to create a new mechanism to facilitate the sharing of IP assets between public and private sector partners. For example, private sector companies have large libraries of pharmaceutical compounds and related information, but they are not generally investing 
substantially in NTD research. Yet, this information could be valuable to researchers that are 
focusing on these diseases. WIPO Re:Search was launched on 26 October 2011, with about 30 members, including pharmaceutical companies, research institutions and a range of 
public and private entities as members.   
 To date, WIPO Re:Search has more than trip led its membership, with 92 members currently. 
 Importantly, WIPO Re:Search has more than 17 members from the African continent, 
representing the public and private sectors, and academia. 
 14 new Members, including a major private sector  company, have joined since our report to 
the TRIPS Council in 2013. 
 Over 79 collaborations have been initiated, and more are in development. There were 
approximately 30 in October 2013. 
 Four scientists, from Egypt, South Africa, Nigeria, and Cameroon have completed research 
sabbaticals at WIPO Re:Search Members in Switzerland, India, and the United States. A fifth 
scientist, from Ghana, will return to the University of California, San Francisco, USA, to 
complete the second half of his sabbatical. This programme, funded by the Government of 
Australia, has become one of the most successful examples of capacity building and 
knowledge transfer facilitated by WIPO Re:Searc h.  The programme is likely to be extended 
in 2015. 
 An additional example of technical assistance  and capacity building provided by WIPO 
Re:Search is the upcoming Intellectual Property Management Workshop organized by WIPO 
with the financial support of the Government of Australia in November 2014.  Fifteen 
scientists from a range of African countries will benefit from this programme, which is one of the 'supporting services' of WIPO Re:Search. 
The WIPO Re:Search website ( http://www.wiporesearch.org/ )  provides further information. 
 
6.17 WHO Secretariat  
 
198.  We seize the opportunity to present under th is health-related agenda item a number of the 
WHO's technical cooperation activities that took place since our last report to the TRIPS Council. 
199.  The overall objective of WHO's technical c ooperation in the area of public health and 
intellectual property is to strengthen the capacity of developing countries in health innovation, 
access to medicines and management of intellectual  property. Countries should prioritize public 
health interests in the formulation of national policies and legislation on trade and intellectual 
property.  
200.  WHO's technical cooperation is based on its mandate derived from the Global strategy and 
plan of action on public health, innovation and intellectual property, as well as from other relevant 
WHO resolutions. For example, Resolution WHA67. 6 on the prevention, diagnosis and treatment of 
viral hepatitis requested the Director-General "to assist Member States to ensure equitable access to quality, effective, affordable and safe hepa titis B and HCV treatments and diagnostics, in IP/C/M/77/Add.1 
 
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  particular in developing countries". In 2014, contri buting to the implementation of this resolution 
was one of the main activities in the area of public health and intellectual property. 
201.  The WHO's 2014 Guidelines for the screening, care and treatment of persons with hepatitis C 
infection state that more than 185 million people are infected with the hepatitis C virus worldwide. 
Of these people, 350 000 to 500 000 die each year. HCV infection can be cured, but most people 
infected with the virus are unaware of their infection and thus do not seek timely treatment. Several medicines are available to treat hepatitis C, but treatment duration is long, involves 
weekly injections, and side effects are considerable. With the development of new direct-acting 
antiviral medicines, the treatment landscape is rapidly changing. These new antivirals are expected to reach cure rates of more than 90% in persons with hepatitis C virus infection across different genotypes, with fewer side effects and a shorter duration of treatment. Prices for these 
new treatments however are extremely high, in particular in developed countries, but remain out 
of reach for many patients in developing countri es as well. WHO has advised a number of Member 
States on how to establish national hepatitis programmes that cover all aspects reaching from 
prevention, to diagnosis and treatment, including on how to access the new treatments at 
affordable prices. Options include local production where patents have not been filed or granted, license agreements, price negotiations and compulsory licenses.  
202.  To identify their best options to increase access to and affordability of these new antiviral 
treatments, countries need clarity about the pate nt status of the medicines. Therefore, in 
September 2014 the WHO Secretariat published an analysis of the patent situation of seven new hepatitis treatments. This corresponds to the ma ndate provided by the WHO Global strategy and 
plan of action on public health, innovation and in tellectual property that requests WHO to support 
efforts to determine the patent status of health products. The patent working papers identify the most relevant patents with respect to the seven medicines and list the countries in which these 
patents have been filed and granted.  
203.  Generic competition is the single most effect ive means to drive prices down. In this respect 
the UN/WHO programme on prequalification has played a key role in ensuring the quality of mostly 
generic products, in particular for international procurement programmes for HIV. The 
prequalification programme ensures the quality and sa fety of all prequalified medicines, vaccines, 
diagnostics, and active pharmaceutical ingredients, in particular for international procurement programmes. Its mission is to make quality priority medicines available for all those in need. Given 
that many generic manufacturers from developing countries are not submitted to stringent 
regulatory control, prequalification is essential to allow for the widespread export of generic products from these manufacturers. WHO has thus decided to expand the programme to include 
hepatitis C and B treatments and, in September 20 14, has issued the first call for expressions of 
interest for hepatitis C and B treatments. 
204.  In the area of HIV, the new WHO Technical Report on Access to antiretroviral drugs in low 
and middle-income countries examines global tren ds in prices of antiretroviral treatment and 
assesses how WHO treatment guidelines have influe nced the uptake of different formulations. It 
describes the current constraints limiting the use of  second-line, third-line and pediatric treatment, 
and explores how the quality of an tiretroviral treatment can be secu red and in-country distribution 
can be improved. The report includes chapters on the role of intellectual property in access to 
treatment, on prices, quality assurance, increasing global demand as well as on supply chain management.  
205.  Developed from the consultation on access to  HIV medicines in middle-income countries held 
from 10 to 12 June 2013 in Brasilia, Brazil, WHO published the report "Increasing access to HIV treatment in middle-income countries: Key data on prices, regulatory status, tariffs and the 
intellectual property situation". The paper provides information on the prices paid by 20 middle-
income countries for adult and pediatric formulations of antiretroviral treatments recommended by WHO. It links pricing information with an analysis  of the intellectual property situation of the 
selected medicines taking into account existing license agreements as well as compulsory licenses. 
It also includes data and general information on a number of other determinants of prices and 
availability of ARVs, including tariffs, mark-ups and taxes as well as the regulatory status. The data shows that middle-income countries are a heterogeneous group and that procurement prices 
vary widely. Middle-income countries supported by the Global Fund to Fight AIDS, Tuberculosis 
and Malaria pay low prices for first-line and many second-line treatment regimens, comparable to IP/C/M/77/Add.1 
 
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  those paid by low-income countries. Other middle-income countries pay higher prices, especially 
for newer second-line and third-line treatments sourced from originator producers. 
206.  More ample information on technical cooperation activities under the WHO programme on 
public health and intellectual property can be found in document IP/C/W/603/Add.1. We would be 
glad to answer any questions delegations might ha ve regarding these activities and send you the 
reports mentioned by email. 
6.18 Chairman  
 
207.  Let me thank the three Secretariats of WI PO, WHO and WTO for the information they have 
shared with the Council. They clearly enrich the knowledge and the discussions in the Council. As we wrap up this part of the discussion, let us recognize the fact that there has been a diversity of 
views expressed on this matter so far, and that clearly there is still a divergence of views, 
especially in relation to some of the proposals that have been made, such as the organization of a workshop. Clearly we have not been able to reach agreement on that issue and may therefore 
have to continue to discuss amongst ourselves and explore the issue further in order to see 
whether any progress can be made in that area. So we leave that part with the understanding that we don't have an agreement on that particular proposal.  
AGENDA ITEM 7: NON-VIOLATION AND SITUATION COMPLAINTS 
7.1 United States of America   
 208.  We look forward to the opportunity to discuss the topic of non-violation and situation 
complaints under the TRIPS Agreement. 
209.  As delegates recall, the United States submitted a communication to the TRIPS Council on 10 
June 2014, which was circulated to Members as IP/C/W/599, to facilitate the Council's intensified 
discussions on non-violation complaints. Our position, as described, rests on three pillars: first, 
non-violation complaints are fully consistent with the TRIPS Agreement and the WTO Agreement 
as a whole; second, sufficient guidance already exists through GATT and WTO panels and 
Appellate Body recommendations and rulings to guide the application of such complaints in the 
context of the TRIPS Agreement; and third, whil e Members have raised valid questions over the 
years, each of those questions has answers found  in the text of the TRIPS Agreement and the 
WTO Agreements and relevant GATT and WTO dispute settlement findings.  
210.  We wanted to focus our intervention today on this third pillar and address some of the 
questions raised by certain delegations and the answers that are already found in the WTO legal text and the Dispute Settlement Body recommendations and rulings. For example, some Members 
suggest that non-violation complaints would be at odds with the balance of rights and obligations 
in the TRIPS Agreement. This view is fundamenta lly at odds with the TRIPS Agreement itself. We 
believe that considerable guidance already exists that provides many assurances on this point with 
respect to non-violation complaints.  
211.  Article 64.1 of the TRIPS Agreement clearly st ates: "The provisions of Articles XXII and XXIII 
of GATT 1994 as elaborated and applied by the Dispute Settlement Understanding shall apply to 
consultations and the settlement of disputes under this Agreement except as otherwise specifically 
provided herein." (emphasis added) 
212.  It is difficult to accept the view of some delegations that non-violation complaints are not or 
were not envisioned by the drafters of the TRIPS Agreement as applying to the Agreement. In fact, 
such intent is explicit in Article 64.1 of the TRIPS Agreement.  
213.  Some Members have also suggested that non-violation complaints are limited to tariff or 
market access disputes and that the TRIPS Agreement is not such an agreement. We see no such 
limitation and no such distinction. Regarding any limitation to market access disputes, GATT and 
WTO adjudicative bodies have been clear.  
214.  In the EC Asbestos dispute, for example, the Appellate Body rejected the defending parties' 
argument that the principle could only be applied to "commercial measures", noting that "the text IP/C/M/77/Add.1 
 
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  [of Article XXIII.1(b) of the GATT] does not dist inguish between, or exclude, certain types of 
measures" from its application. GATT Article XXIII.1(b) is not limited to tariff benefits. Non-violation complaints are not limited to tariff benefits.  
215.  In the Korea - Procurement dispute, the Panel recognized the difference between 
"traditional" non-violation complaints based upon concessions and "non-traditional" complaints, 
such as those based upon negotiations under the WTO Agreement on Government Procurement. In that dispute, the Panel provided for great flexibili ty in the required elements for a non-violation 
claim and adopted a different test to apply non-violation complaints in the context of government 
procurement negotiation, rather than pursuant to a tariff concession. 
216.   Moreover, in our view the TRIPS Agreement is a market access agreement. As stated in its 
Preamble, the TRIPS Agreement is intended "to reduce distortions and impediments to 
international trade … and to ensure that measures and procedures to enforce intellectual property 
rights do not themselves become barriers to legitimate trade".  
217.  The standards and procedures established are for the identification, grant and enjoyment 
and enforcement of private rights in most cases. In a similar manner, the Agreement on Technical 
Barriers to Trade or the Agreement on the Application of Sanitary and Phytosanitary Measures establish minimum requirements that government s must meet before imposing limitations on 
goods that may be sold in their markets based on health, environmental or other factors. 
218.  Finally, it is important to emphasize what non-violation complaints will not do. While non-
violation complaints will protect Members from the intentional evasions of obligations under the TRIPS Agreement, it should be stressed that these claims will not under mine the ability of any 
Member to implement legitimate social, economic development, health, environmental and cultural 
policies. Here again, we recall Switzerland's intervention at the February 2014 meeting of the TRIPS Council, where our esteemed Swiss colleagu e stated:  " A number of delegations in their 
interventions today referred to their concern as to the potential impact of the application of non-
violation complaints on their rights and obligations under TRIPS and more particularly the flexibilities contained in the Agreement. Let me be cl ear on this important point: It is our firm view 
that a non-violation complaint cannot be brought against another Member for utilizing a flexibility 
foreseen 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.  After all, they were written into the Agreement, 
agreed by all Members and, as far as pertaining to public health, also confirmed in the Doha Ministerial Declaration on the TRIPS Agreemen t and Public Health of 14 November 2001."
1 
219.  The United States would welcome examples from Members where the existence of non-
violation and situation complaints under other agreements have manifested the concerns expressed here in the TRIPS Council.  
220.  While the TRIPS Agreement is an important agreement touching on many important issues, 
it is not exclusive in that regard. And yet we ha ve not seen such concerns manifesting under the 
GATT or GPA or other Agreements, where non-violation claims are applicable. 
221.  To conclude, for these reasons as well as for those outlined in our recent communication, we 
continue to believe that the drafters of the TRIPS Agreement envisioned that non-violation and 
situation complaints would be available. 
222.  We also believe that while valid question s have arisen, they are fully and adequately 
answered by the text of the TRIPS Agreement it self and further clarified through the GATT and 
WTO adjudication. 
7.2 Venezuela, Bolivarian Republic of
  
 
223.  Together with other Members, Venezuela has co-sponsored document IP/C/W/385 of 
30 October 2002 explaining the reasons why these cases are considered inapplicable to the 
                                               
1 IP/C/M/75/Add.1, para. 169. IP/C/M/77/Add.1 
 
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  TRIPS Agreement. We also believe that it is time to put an end to the extensions that have been 
granted at each of the Ministerial Conferences and to close this item on the Council's agenda for 
once and for all on the grounds that such cases are inapplicable. 
224.  It is also clear that this Council has not been given examples showing the scope and the 
modalities of these types of complaints as esta blished in Article 64.3 of the TRIPS Agreement. 
Regarding the proposal by the United States, we also recall that under Article 64.3, any decision in 
this respect must be made by consensus, and th e consensus is leaning towards those of us who 
consider that such cases are not applicable, so we do not really see how an agreement can be reached on the basis of that proposal. 
225.  It should be remembered that in the WTO, consensus is a principle, and the only exception 
that has been provided for with respect to negative consensus is in the case of the establishment 
of a panel in the Dispute Settlement Body, when the second time around, the Member concerned 
does not accept its establishment. 
226.  If we were to accept what the United States has proposed, not only would we be 
jeopardizing the principle of consensus, which is  something we are not prepared to accept, but 
exactly the same would apply to Article 27.3(b), where there is no reference to consensus, but 
rather, it is clearly stipulated and accepted by all Members that the subparagraph shall be 
reviewed as a matter of course four years after the date of entry into force of the Agreement. 
227.  The same could be said for the end of the moratorium in the case of Electronic Commerce, 
not to mention the Doha Round, for which clear compliance deadlines had been established. To 
mention just one example, the modalities for further commitments, particularly in an area of such 
importance for the developing countries as agriculture, should have been established by 31 March 2003 under Article 14 of the Doha Declaration. 
228.  Our legal instruments are a single whole and cannot be interpreted partially at the 
convenience of the parties; still less can any interpre tation that is made be contrary to a principle, 
if only because the principles form the foundation of these instruments and must apply horizontally 
to everything that stated therein. In this case, it is the principle of consensus that the 
United States is flouting in its proposal. 
229.  We therefore invite the United States and Swit zerland to join what really is the consensus 
among the majority of members and put an end to this issue, which is inapplicable to intellectual  
property. 
7.3 Brazil   
 
230.  Brazil as Venezuela, are co-sponsors of document IP/C/W/385. In this regard we share some 
of the same views, but at the outset I would like to thank the delegation of the United States for 
its efforts in preparing document IP/C/W/599 aimed at clarifying its position on the application of 
non-violation and situation complaints to IPRs. The document seeks to provide answers to 
questions raised since the beginning of this debate. My delegation are co-sponsors, alongside 13 other countries of document IP/C/W/385 and for this reason we were pleased to see our document referenced in the US submission on pages 1, 5, 7 and 8. Document IP/C/W/599 seeks to 
clarify five concerns raised by our submission. I will try to address these elements. 
231.  A first element is that in the view of the United States the TRIPS Agreement does not differ 
from a market access agreement. Unlike the GA TT and the GATS, the TRIPS Agreement does not 
involve an exchange of concessions. 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, the obligations contained in the TRIPS 
Agreement cannot be characterized as market access concessions in the same way as obligations 
under the GATT or the GATS. The results of WTO market access negotiations are recorded in the respective GATT and GATS schedules but not in the TRIPS Agreement. Indeed, in some cases, IPRs may undermine market access. Article 8, for example, explicitly notes that domestic 
measures may be needed to prevent the resort to practice which unreasonably restrain trade. That 
that remedy has been applied under the GATT does not render it appropriate for the TRIPS Agreement. IP/C/M/77/Add.1 
 
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  232.  A second element is that the United States does not believe that the availability of 
non-violation measures will raise systemic concerns. As part of a second undertaking, WTO obligations apply cumulatively and so a measure consistent with one WTO Agreement, for example, the GATT, can still be found to nullify an impaired benefit under another, for example 
TRIPS. Similarly, the response that Article 3.2 of the Dispute Settlement Understanding will 
prevent the Dispute Settlement Body from adding to or diminishing the rights and obligations 
under existing WTO Agreements begs the question and fails to recognize that applying non-
violation complaints to the TRIPS Agreement amounts to establishing a new call for action under 
the TRIPS Agreement. In the absence of clear ar guments to the contrary, the concerns that non-
violation complaints may give rise to incoherence among WTO Agreements remains. 
233.  A third element is that the United States  understands the availability of non-violation 
complaints to protect Members from intentional evasions of obligations under the TRIPS 
Agreement, while preserving the ability of any Member to implement social, economic development, health, environmental and cultural po licies. Following the text of the United States, 
because there are a number of ways to implement so cial and cultural policy goals, a Member may 
take this element of non-violation complaints into consideration when crafting measures to protect these goals.  
234.  Non-violation complaints would require one WTO Member to compensate 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 that may also undermine the Agreement's flexibilities, including in the area of public health, and could affect 
the enjoyment of WTO Members' sovereign rights to  develop new laws to protect public interest.  
235.  We also note that unlike the GATT and the GATS, the TRIPS Agreement fails to protect 
measures designed to achieve important national policy goals, such as health or the environment 
through a general exception. These measures are lik ely to be placed at a further disadvantage if 
open to challenge from non-violation complaints.  
236.  A further element of the US document is that the good faith application of the Agreement's 
provisions will not in all circumstances fully protect Members in the same way that the availability 
of non-violation complaints will. 
237.  Brazil considers that non-violation complaints are not the best way to protect benefits arising 
from the Agreement. We have yet to hear argu ments why the provisions of the TRIPS Agreement 
are not sufficiently flexible to address the concerns raised by Members who support such a 
remedy. We believe that, rather than on relying on the legally imprecise notion of non-violation, a focus on the text of the Agreement supported by other principles of international law, is the 
preferable approach. According to Article 3.2 of  the DSU, one of the purposes of the dispute 
settlement system is to clarify the provisions of the Agreement covered by the DSU, in accordance 
with the customary rules of interpretation of public international law. According to Articles 26 and 
31 of the Vienna Convention, all treaties must be  interpreted in profound and good faith. These 
principles of international law already require the bona fide reasonable application of the TRIPS Agreement by all WTO Members. This requiremen t is sufficient to guarantee any benefits 
embodied in the TRIPS Agreement and obviates th e need for a recourse to the legally imprecise 
and uncertain notion of non-violation complaints.  
238.  A fifth element raised is that according to  the US document, GATT panels and the Appellate 
Body have conducted analyses that provide appropriate guidance on the applicability and use of 
non-violation complaints. Where additional questi ons remain, according to the US paper, dispute 
settlement continues to be the mechanism to furthe r clarify provisions of the covered agreement, 
including Article 64. 
239.  In our understanding, applying non-violation complaints to the TRIPS Agreement introduces 
legal uncertainty that may exacerbate the diffic ulty faced by WTO Members when responding to 
the claims of other Members. The number and complexity of claims facing WTO Members are likely to increase, making it more difficult for them to defend their interests against challenges by more 
powerful Members. It may also be argued however, that the traditional requirements, as well as 
GATT practice, do not provide a clear indication of how the remedy will play out in the TRIPS 
context. Already, the potential for bringing non-violation complaints has been cited in a number of IP/C/M/77/Add.1 
 
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  bilateral consultations concerning IPRs and so the views that the remedy would not give rise to an 
influx of complaints should be  viewed with extreme caution. 
240.  In the light of the discussions today and the points raised by the US document, our position 
remains unchanged. We consider that non-violation complaints should be deemed inapplicable to 
the TRIPS Agreement. 
7.4 India   
 
241.  India would like to express its thanks to the Chair for initiating the discussion on non-
violation and other situation complaints under the TRIPS Agreement today. India associates itself with the statements made by Venezuela and Br azil which raise fundamental concerns on the 
applicability of non-violation complaints under the TRIPS Agreement. 
242.  We thank the United States for circulating a communication on this issue in June 2014 
(IP/C/W/599), which seeks to summarize the relevant provisions of the GATT 1994, the TRIPS 
Agreement, and the Dispute Settlement Understanding (DSU), relevant GATT and WTO panel and 
Appellate Body reports, and responses to issues raised by other WTO Members regarding the applicability of non-violation complaints under the TRIPS Agreement. The US paper fails to 
address, in India's view, the fundamental conc erns that India and several other WTO Members 
have raised with regard to non-violation complaints under the TRIPS Agreement. India will be submitting a detailed paper outlining and reiterat ing the fundamental concerns with respect to 
non-violation complaints under the TRIPS Agreement. 
243.  In today's meeting, however, India would like to reiterate its position on non-violation 
complaints under the TRIPS Agreement, while also addressing some of the issues raised by the United States. In this context, it is important to note that the elements highlighted in submission 
IP/C/W/385 made in 2002 are of critical relevanc e. The submission provides details of our 
systemic concerns and reasons why there should be no application of non-violation and situation complaints to the TRIPS Agreement. We have contended that non-violation complaints can upset 
the delicate balance of rights and obligations in the TRIPS Agreement. This can also limit use of 
the flexibilities inherent in the TRIPS Agreement to secure objectives relating to public health, nutrition, transfer of technology and other issues of public interest in sectors of vital importance to 
socio-economic and technological development.  
244.  India would like to address some of the poin ts raised by the United States under three broad 
pillars:  
Firstly, the nature of the TRIPS Agreement:  
245.  As stated by Brazil, 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 framew ork, 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 ad ditional trade measures taken. With the gradual 
evolution of comprehensive trade agreements addressing a wide range of issues, it does not make any logical sense to extend the same concern of circumvention/ dilution of trade obligations in the 
context of agreements such as the TRIPS Agreemen t. When it comes to the GATT and the GATS as 
market access agreements, the non-violation complaint is an additional tool with which to balance the rights and obligations concerning market  access in the GATT and GATS respectively. 
Fundamentally differing from the GATT and th e 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.  
Secondly, The issue of flexibility under the TRIPS Agreement:  
246.  The Preamble to the TRIPS Agreement reco gnizes the inherent policy flexibility of WTO 
Members when it states that the TRIPS Agreement recognizes "the underlying public policy objectives of national systems for the protection of intellectual property, including developmental 
and technological objectives." It is widely ac knowledged that the TRIPS Agreement put in place 
global minimum standards for IPRs, and left room for policy flexibilities for WTO Members to enact IP/C/M/77/Add.1 
 
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  their laws, so long as they meet the TRIPS minimum standards. We are concerned that the 
application of non-violation complaints would not only threaten to undermine regulatory authority, but would infringe sovereign rights. Flexibilities that the TRIPS Agreement provides would be severely curtailed by non-violation complaints. A Members' rights to introduce new and vital socio-
economic, health, environmental and cultural meas ures, including the measures taken on the basis 
of the Doha Declaration on Public Health, would be severely curtailed and would undermine the enjoyment of WTO Members' sovereign right to de velop new laws to protect public interest. Any 
measure under Article 8 would thus encourage unilateral pressure and speculative claims to force 
countries to raise protection beyond minimum requirements or to refrain from using TRIPS-consistent measures. Inevitably, non-violation complaints will make it harder for Members to rely on the agreed text of the TRIPS Agreement.  
247.  The United States in its communication is of  the view "that the availability of non-violation 
complaints will protect Members from intentional evasions of obligations under the TRIPS Agreement, while preserving the ability of any Member to implement legitimate social, economic 
development, health, environmental and cultural policies. Non-violation complaints will only be 
successful if they could not have been foreseen when the Uruguay Round negotiations were underway. Because there are a number of ways to implement social and cultural policy goals, a 
Member may take this element of non-violation complaints into consideration when crafting 
measures to protect these goals." India's concern with this reasoning of the US communication is that any intentional evasion of a TRIPS obligation can be challenged as a violation of that obligation itself; and there is no need for the 'non-violation' route to address the same. India's 
concern is that what is more likely to be questioned in a non-violation complaint is the exercise of 
available policy flexibility. In fact, the US communication admits as much in the same paragraph when it implies that what is likely to be questioned in a non-violation complaint is the manner in 
which policy objectives are sought to be achieved. It notes that "because there are a number of 
ways to implement social and cultural policy goals, a Member may take this element of non-
violation complaints into consideration when crafting measures to protect these goals." Thus, the 
concern of curtailment of flexible policy spac e provided by the TRIPS Agreement through the 
applicability of non-violation complaints is a genuine and serious one.  
Thirdly, the issue of inadequate guidance: 248.  The issue of inadequate guidance on non- violation complaints under the TRIPS Agreement 
continues to be a cause of concern. The US commu nication states that GATT and WTO panels and 
the Appellate Body have provided extensive guidance regarding non-violation complaints. However, the nature of non-violation complaints being an "exceptional remedy" does not address 
the fundamental inappropriateness of the remedy itself in the context of the TRIPS Agreement. 
The United States has also argued that non-violation complaints will be successful only when these could not have been "foreseen when the Uruguay Round negotiations were underway". The 
practical effect of this approach could be to require developing countries to compensate for 
measures that adversely affect foreign holders of  IPRs, and that were not foreseen during the 
Uruguay Round. Such an approach would arguably bring within its fold a large number of national laws and domestic measures, and may undermine the TRIPS Agreement's preambular goal of 
ensuring maximum flexibility in the domestic implementation of laws and regulations. Thus, we 
remain concerned about the ambiguities in the applicability of non-violation complaints to the TRIPS Agreement. 
249.  To conclude, Article 64.1 of the TRIPS Agr eement establishes that GATT Article XXIII applies 
to the TRIPS Agreement, except as otherwise prov ided in Articles 64.2 and 64.3.  Notwithstanding 
the expiry of the time-period under Article 64.2, non-violation and situation complaints only apply 
to the TRIPS Agreement, in accordance with the procedure established under Article 64.3. 
Complying with this procedure, the importance of which Ministers reaffirmed through their adoption of the Decision on 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 
Ministerial Conference." It also agreed that, in the meantime, Members will not initiate such 
complaints under the TRIPS Agreement. Thus, the assertion that the expiry of the time-period 
under Article 64.2 makes non-violation and situation complaints automatically applicable to the TRIPS Agreement is, in our view, incorrect.  IP/C/M/77/Add.1 
 
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  250.  India calls on all Members to seriously reflect on the concerns expressed in communication 
IP/C/W/385 of 2002 and should join the consensus th at complaints on the grounds of nullification 
or impairment of the type identified in Article XXIII:1(b) and (c) of the GATT 1994 be determined 
inapplicable to the TRIPS Agreement, in the interest of the stability and certainty of the 
multilateral system. 
7.5 Cuba   
 
251.  Cuba supports the statements by the delegati ons of India, Brazil, and Venezuela. We share 
the view, that these types of complaints are not ap plicable to intellectual property, and we request 
that it be prohibited or, if it is not, that the moratorium be maintained, although we would prefer 
the prohibition option. 
252.  We note the relevance and validity of document IP/C/W/385 of October 2002, which 
provides sufficient reasons for determining the inapplicability of this type of complaint. This 
particular proposal, and not only the one submitted most recently, needs to be discussed. 
253.  We thank the United States for its proposal contained in document IP/C/W/599 and have a 
few preliminary comments to make: 
254.  The document does not take into account that the moratorium in Article 64 precisely reflects 
the lack of consensus on the application of such complaints in the TRIPS context; the purpose of 
the moratorium was actually to examine modalities for complaints of this type, and this has not been done so far. 
255.  The document also fails to explain how su ch complaints will protect TRIPS concessions or 
why the standards of the Agreement are inappropriate for safeguarding the obligations it contains. It does not address the panels' and the Appellate Body's lack of experience with regard to these 
complaints or the developing countries' concerns. Such complaints may give rise to legal 
uncertainty, which would increase the difficulties  already facing many Members when they take 
legal or factual measures relating to intellectual property. The developing countries do not have 
the resources to make full use of the dispute settlement system. 
256.  Lastly, the developing countries would derive no benefit whatsoever from the application of 
such complaints, which might yet further reduce  the space available for framing policies and 
implementing their intellectual property legisl ation in a balanced and development-oriented 
manner. 
7.6 Ecuador   
 
257.  Ecuador's view is well-known inasmuch as complaints in the absence of violations and other 
situations raise fundamental concerns which make their application unnecessary.  
258.  My delegation maintains its position, for whatever may be said to the content in document 
IP/C/W/599, that the TRIPS Agreement is a sui generis  agreement that is not intended to protect 
market access or the balance of tariff concessions as is the case with other Agreements, but rather to establish minimum standards of intellectual property protection. 
259.  Ecuador, like other countries, drew attention to these concerns in document IP/C/W/385 of 
30 October 2002. As can be seen, over 12 years have gone by and the issue is still being 
discussed, though the countries defending the proposal have been unable to provide any justification for the need for such a provision in the TRIPS Agreement.  Accordingly, in our view, 
this Council should reach a definitive decision to remove the issue from the agenda and declare a 
full moratorium. 
7.7 Colombia   
 
260.  As announced at the Council's previous session, Colombia now offers its comments on the document circulated by the United States at the time and on the general discussion that took place 
on this topic (IP/C/W/599). IP/C/M/77/Add.1 
 
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  261.  Colombia is concerned about the potential implications of applying the following elements of 
the document in relation to the body of obligations laid down in the TRIPS Agreement: 
 As regards the content of paragraph 2.1, what should be understood by "nullified" and 
"impaired" in this context? What constitutes an "indirect benefit"? 
 As regards paragraph 3.5, Colombia is conc erned about how "protection of a reasonable 
expectation" would be determined. 
 Paragraph 3.8 contains the legally undetermined and subjective term "reasonable 
anticipation". What would be considered reasonable anticipation? 
262.  Furthermore, it is important to note that the elements of a non-violation remedy under the 
GATT, such as "measures", "benefits" and "compe titive relationship", cannot automatically be 
applied to the TRIPS Agreement, as stated in th e document. Such elements are at odds with the 
aim of the Agreement, which is to establish a minimum standard of protection for WTO countries. 
Past discussions show the lack of clarity that aris es where this type of complaint is applied to 
intellectual property, revealing large gaps that co uld generate legal uncertainty if the remedy were 
to apply to any specific situation. 
263.  Colombia disagrees with paragraph 2.3 of the document, which states that "after five years, 
those provisions would apply to the TRIPS Agreement".  It does not share this view because 
Article 64.2 stipulates that subparagraphs 1(b) an d 1(c) of Article XXIII of the GATT 1994 shall not 
apply for the purposes of assessing the scope and modalities for such complaints. Moreover, it is impossible to ignore that most Members have stated their preference for a full ban on non-violation complaints under the TRIPS Agreement. 
264.  Colombia reiterates the position set forth in document IP/C/W/385 that introducing 
non-violation and situation complaints in the TRIPS Agreement may give rise to incoherence among the WTO Agreements by "allowing something which a WTO Member has agreed to accept in 
one part of the single undertaking (e.g. the GATT or the GATS) to be challenged on the basis that 
it could nullify or impair benefits in another area (e.g. TRIPS)". 
265.  The US document does not adequately ex plain the subsidiary nature of non-violation 
complaints. Likewise, where the document states that this is an exceptional remedy, it is difficult 
to understand how this would be ensured and how frivolous action, i.e. use of this tool without any actual grounds for complaint, could be prevented.  Because of the nature of the TRIPS Agreement, 
there is no need for an exceptional remedy beyond the provisions already laid down in the 
Agreement. 
266.  Lastly, Colombia reiterates that non-violatio n complaints should not be included in the scope 
of the TRIPS Agreement. 
7.8 China
  
 
267.  First of all, China would like to support the view expressed by the previous developing 
country Members. 
268.  Regarding non-violation complaints under the TRIPS Agreement, most Members take the 
position that they should be banned. In particular, the systemic concerns and reasons of 
non-application are detailed in document IP/C/W /385 and have been mentioned by some previous 
speakers. When the Council discusses this issue, these options and positions should be borne in 
mind and be fully taken into account.  
269.  With respect to the US communication of 10 June 2014 (IP/C/W/599), China would like to 
provide the following comments: 
270.  In Part 2 (especially in paragraph 2.3), the United States contends that it is clear, according 
to Article 64 TRIPS, that non-violation complaints shall apply to TRIPS after five years following 
the establishment of the WTO, and that the nego tiators clearly envisioned the application of 
non-violation complaints to TRIPS. In our view , the United States fails to read the three IP/C/M/77/Add.1 
 
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  paragraphs of Article 64 in a holistic manner and recognize that the initial five-year moratorium 
was provided by negotiators to examine the scope  and modalities. This means that there was no 
agreement on whether non-violation complaints are appropriate for TRIPS, and if allowed, the extent to which such complaints should be allowed and the modalities that have to be followed. Its 
application depends on the approval by the Minist erial Conference as provided in Article 64.3 of 
TRIPS. So long as there is no agreement on the scope and modalities of non-violation complaints, it cannot be said that Article 64 of TRIPS mandates the application of non-violation complaints to 
the TRIPS Agreement. 
271.  In Part 4.1 (especially in paragraph 4.3), the United States states that the TRIPS Agreement 
is a market access agreement and it cites the obje ctive of TRIPS provided in the Preamble as its 
basis. Indeed, although the TRIPS Agreement is form ally an element of international trade law, it 
draws heavily on, and builds upon, the established heritage of international intellectual property 
(IP) law. The TRIPS Agreement is quite different from other Agreements under the framework of the WTO, such as the GATT or GATS. It should be  noted that the TRIPS Agreement, unlike market 
access agreements, does not involve an exchange of rights and obligations where concessions are 
made in exchange of concessions received. Even assuming that TRIPS was a market access agreement, it would not support the application of non-violation complaints. For example, under 
GATS, a so-called market access agreement, the application of non-violation complaints is only 
limited to the "benefit it could reasonably have  expected to accrue to it under a specific 
commitment of another member under Part III" of  the GATS, but not all parts of the GATS. The 
TRIPS Agreement does not include a similar part to Part III of the GATS.  
272.  In Part 4.3 (especially in paragraphs 4.11), the United States states that it does not believe 
that non-violation complaints under TRIPS will  introduce incoherence and upset the balance 
between various WTO Agreement. Under Article 3.2 of the Dispute Settlement Understanding 
(DSU) the DSB cannot add to or diminish the rights under the covered agreements. However, 
applying non-violation complaints to TRIPS will amount to establishing a new cause of action under TRIPS. Considering that TRIPS does not include a general exception clause to protect measures 
designed to achieve important national policy goal s, we should be very careful to maintain the 
balance between the rights and obligations under  the TRIPS Agreement. The application of non-
violation complaints will limit the use of the flexibilities outlined in the Agreement to secure objectives relating to public health and other issues of public interest.  
273.  Our comments above focus on some paragraphs of the US communication and it shall not 
be understood that we agree with other para graphs. China believes that the application of  
non-violation and situation complaints under the TRIPS Agreement is not appropriate. 
7.9 Japan   
 
274.  This delegation would like to thank again the United States for its communication contained 
in document IP/C/W/599, which helps Members to gain a deeper understanding of various views that have been expressed at this Council. In addition, my delegation would also like to extend its thanks to the United States for the detailed presen tation of this communication, with a particular 
focus on issues of concern to Members states. 
275.  Japan's view on this issue is the same as that which it has expressed repeatedly; namely 
that both clarity and predictability should be ensured when applying non-violation and situation 
remedies to the TRIPS Agreement. To this end, it  would be helpful and conducive to facilitate the 
examination of the scope and modality of non-viol ation and situation complaints in the area of 
TRIPS, by making factual analyses of specific and concrete circumstances in which non-violation 
and situation complaints should be available. 
276.  This delegation has been and is willing to engage in discussions at this Council in a 
constructive and dedicated manner. 
7.10 Argentina
  
 
277.  The delegation of Argentina would like to thank the United States for submitting document 
IP/C/W/599, which is still being examined by my country's authorities.  IP/C/M/77/Add.1 
 
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  278.  Without prejudice to more detailed comments at forthcoming meetings, we wish to underline 
two key issues. First, Argentina maintains the position expressed in document IP/C/W/385 and considers that the non-violation and situation complaints identified in Article XXIII:1(b) and (c) of the GATT 1994 are not applicable to the TRIPS Agr eement. Secondly, the expiry of the time-period 
under Article 64.2 does not make non-violation and situation complaints automatically applicable 
to the TRIPS Agreement. 
279.  As noted in document IP/C/W/385, Article 64.1 provides that Article XXIII of the GATT is 
applicable 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 will only be applicable to the TRIPS Agreement in accordance with the procedures established in Article 64.3. 
7.11 Chile
  
 
280.  On this point we see that there are diffe rent views among Members. This strengthens the 
position that we have always had on this, namely , regarding the need to maintain and extend the 
moratorium. 
7.12 Bolivia, Plurinational State of   
 
281.  Bolivia shares the concerns expressed by In dia, Venezuela, Brazil, Cuba, Ecuador and others 
who have expressed their view that this GATT fe ature does not apply to TRIPS. We are still 
analysing the document presented by the United States, but we have some preliminary reactions to share with Members of the TRIPS Council. We note that the document presents a series of 
notices based on case-law, particularly the GATT, an agreement oriented toward market access of 
goods, where the concept of advantage has a conno tation different to the TRIPS Agreement, which 
through its own nature, limits competition. In addition, it should be noted that the TRIPS 
Agreement was not negotiated under the reciprocal concessions principle, but rather the concept 
of monopolies.  
282.  A mechanism of this type would generate legal uncertainties when countries need to use 
TRIPS flexibilities. A regulation or law oriented towards safeguarding political, social or public 
needs might be subject to complaints despite the flexibilities provided for under the Agreement. 
These, among others, are many elements that are not clarified by the US submission and have to 
be analysed in greater detail in the part of Ar ticle 64.3 and the document presented by the United 
States does not cover as a prerequisite to preparing recommendations. 
283.   Bolivia considers that non-violation complaints are not applicable in the context of TRIPS for 
the reasons that were included in document IP/C/W/385, of which Bolivia is a co-sponsor. 
Therefore, the recommendations to the next Minist erial Conference, should be that non-violation 
and situation complaints are incompatible with the TRIPS Agreement, and should be taken off the agenda of this Council. 
7.13 Korea, Republic of    
 
284.  First I would like to thank the US delegation for preparing the communication contained in 
document (IP/C/W/599) in June and its explanatio n today.  Korea found that this document is 
comprehensive and informative on the issue of non-violation and situation complaints. However, Korea's position on this issue remains the same as before. Our domestic stakeholders are very keen on this issue and have serious concerns. Korea would like to avoid reiterating the same 
arguments and concerns made by other Members today, which Korea shares.   
285.  In short, Korea still believes that non-violation and situation complaints are inconsistent with 
the basic characteristics of the TRIPS Agreement. A pplying them to TRIPS will result in ambiguity 
regarding its scope, potentially raising concerns over misuse or abuse considering the nature of 
intellectual property.  Therefore, Korea does no t recommend applying non-violation and situation 
complaints to the TRIPS Agreement. IP/C/M/77/Add.1 
 
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  7.14 Chinese Taipei   
 
286.  The situation of non-violation and situations complaints has always been discussed in the 
TRIPS Council. This is a subject which is considered to be extremely complex, including many 
aspects to take into consideration. The concept of  these complaints is authorized if a government 
can demonstrate that it was deprived of a given advantage because of a measure taken by 
another government or because of another existing situation. The purpose is to preserve a balance 
of advantages established during multilateral negotiations. Communication IP/C/W/599 submitted 
by the United States does provide answers to the concerns as to the application of non-violation 
and situation complaints under the TRIPS Agreement.  
287.  We are very pleased to have the opportuni ty of an in-depth discussion with Members, 
particularly as regards the scope and modalities applicable in the context of the TRIPS Agreement. My delegation is thus favourable to these discussions held in a constructive spirit and is very 
pleased to continue the discussion within the Council. 
7.15 Canada   
 
288.  Canada is once again pleased to contribute to our important discussion on the applicability of 
non-violation and situation complaints to the TRIPS Agreement. In this context, we wish to thank 
the United States for its thorough communication on the matter, dated 10 June 2014 and numbered IP/C/W/599. 
289.  While Canada wishes to recall our interventions made at our February and June meetings, as 
well as our prior communications on the matter and that still reflect our overall position, we would like to make certain specific comments regard ing the US June 2014 communication, as well as 
discuss some other considerations. 
290.  First, Canada believes that any determination on the applicability of non-violation and 
situation complaints to the TRIPS Agreement requires careful analysis and a shared understanding 
as to what constitutes, for the purposes of the TRIPS Agreement, a "benefit" such that could be 
nullified or impaired by the otherwise permissible actions of a Member. Canada wishes to reiterate 
its view, expressed at our February meeting and on several occasions before, that the term "benefit" remains largely undefined and therefor e lacks an objective meaning, such that the 
application of non-violation and situation complaints in the TRIPS context could lead to 
uncertainty. With Members' differing views on th e nature of IPRs, non-violation complaints as 
applied to the TRIPS Agreement could cut both ways. In addition, we continue to believe that, for 
the purposes of the TRIPS Agreement, the "benef it" concerned consists primarily of the right 
conferred on the right holder to prohibit unauthorized use, and that this "benefit" does not include anticipated economic returns, because otherwise the NVNI remedy would disrupt the balance on 
which the IP system must rest. As we have previo usly stated, in IP/C/W/127, a panel adjudicating 
a challenge based on non-violation and situation complaints would have to establish a definition of "benefit" (referred to in the chapeau of paragrap h 1 of GATT Article XXIII) in a TRIPS context and 
do so almost in a void, which goes beyond the desirable mandate of the dispute settlement 
process. 
291.  Secondly, Canada notes that in its communica tion, the United States recalls that the Dispute 
Settlement Understanding provides for a "mutually satisfactory adjustment" in the resolution of 
non-violation, which differs from the more stringent measures it applies to "regular" disputes. 
Regardless, Canada remains concerned that Members could nevertheless feel compelled to withdraw any given measure at issue if only to avoid the litigation of non-violation complaints, 
which could effectively compromise or create a chilling effect on the capacity of Members to 
implement or introduce certain fiscal or regulatory measures. This is alluded to in the United States' communication, which notes that "there are a number of ways to implement social and cultural policy goals".  
292.  Thirdly, the United States argues in it s communication that "the TRIPS Agreement is a 
market access agreement" as a justification for the application of non-violation complaints to the TRIPS Agreement. Canada would respectfully submit  that it remains unconvinced that this is the 
case. Canada does not believe that the Agreement on Government Procurement, or GPA, supports 
the arguments of the United States in favour of th e applicability of non-violation complaints to the IP/C/M/77/Add.1 
 
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  TRIPS context. The GPA is certainly a market access agreement, since it addresses the conditions 
for competition in government procurement markets, and includes concessions roughly analogous to tariff concessions. Therefore, the GPA is an agreement of the kind of which the benefits could more readily be nullified or impaired by some otherwise compliant measure, and therefore become 
the subject of a non-violation complaint. In that respect, the GPA has, in our view, decidedly more 
commonalities with the GATT, for example, than it has with the TRIPS Agreement. 
293.  In our view, therefore, the TRIPS Agreemen t is not a market access agreement, although 
this does not mean that it is not of trade interest – on the contrary – but rather, as we have 
stated, again in IP/C/W/127, that it is "not principally concerned with questions of market access and does not include a commitment to a certain level of market access". Canada notes that in Korea – Procurement the United States was unsuccessful in convincing the panel of its non-
violation [and situation?] claim under the GPA, regardless of whether it was considered as a 
traditional or non-traditional non-violation [and situation] claim.  Canada therefore questions the relevance of the panel report in Korea-Procurement in this context. 
294.  Even if one were to agree, as per the United States' communication, that the scope of non-
violation complaints is not limited to quantifiable tariff concessions, these complaints still relate – in the limited corpus of cases before us – to at least very specific concessions, the likes of which 
do not exist in the TRIPS context. Absent such concessions, and particularly specific ones, Canada 
thus continues to question what would be the sour ce and nature of any "reasonable expectation" – 
a concept that finds its roots in goods market access – in the TRIPS context.  In our view, this again relates to the definition of "benefit" for th e purposes of the TRIPS Agreement. In Canada's 
view, non-violation complaints cannot be readily adapted to the very different context of the TRIPS 
Agreement. 
295.  To conclude, while we continue to believe that  it is difficult to assess the degree of liability 
that would arise from the application of non-violation complaints to the TRIPS context and that this 
could lead to constraints on domestic policy-making, Canada wishes to stress its strong commitment to the TRIPS Agreement and its implementation, as well as to our discussion of these 
important matters. 
7.16 New Zealand   
 296.  New Zealand thanks the United States for its paper submitted in June, setting out its position 
regarding the application of non-violation and situation complaints under the TRIPS agreement. 
We appreciate the comprehensiveness of the report, and the level of attention that clearly went into its preparation. 
297.  This said, New Zealand continues to believe that such complaints are not appropriate in the 
TRIPs context.  As we have heard from many Members today and in past Council discussions, the TRIPS Agreement is different to other WTO agreements.   
 The non-violation remedy was developed in a context wholly different from the TRIPS 
Agreement as a means of maintaining the ba lance of concessions made during tariff 
negotiations. The TRIPS Agreement does not represent such a balance of concessions. 
 Market access commitments under the GATT and GATS are focused on agreeing not to use 
certain policies that might impede market access. By contrast, the TRIPS Agreement 
contains affirmative obligations on governments to meet certain standards, but provides freedom to Members to determine the appropriate method of implementing these obligations 
within their own legal system and practice and to take into account their particular social 
and cultural contexts and developmental and technological objectives.   
298.  Like others, we believe it is important that we find a resolution to this issue before our tenth 
Ministerial Conference, as requested by our Ministers in Bali. To that end, we will need to step up 
discussions and we urge all Members to support efforts to achieve this over the coming year.   IP/C/M/77/Add.1 
 
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  7.17 Bangladesh   
 
299.  My delegation would like to express its appreciation to the United States for its contribution 
aimed at clarifying the concept of non-violation and situation complaints. In the last Council we 
made clear our position on this issue and we are still of the same view.  
300.  However, in addition to the specific difficulties and challenges flagged by my previous 
speakers, let me share some general comments on the issue.  
301.  Our fundamental understanding is that TRIPS is not a market access agreement. The 
negotiator in the Uruguay Round designed it such as to provide a minimum level of territorial protection to intellectual property for Members. Its operation is also unique and quite different 
from any other WTO Agreements.  While some othe r agreements are explicit about facilitating 
market access and concessions, TRIPS provides for a minimum level of protection and flexibility with a view to achieving socio-economic objectives. Therefore, drawing any parallelism, to our best 
judgment, does not fit with the context of TRIPS.  
302.  As such, we do not see any scope for a non-violation and situation complaints in a 
sui generis  system such as TRIPS, where the nature and scope of obligations allow Members to 
determine the level of protection according to their legal system and practices. 
303.  From the systemic point of view, this will infuse huge legal uncertainty in the system. Hence, 
we do support a further moratorium.  
7.18 Egypt   
 
304.  Egypt would like to refer here to docume nt IP/C/W/385, of which Egypt is one of the 
proponents. The position of Egypt is well known. Egypt fully supports the concern of previous 
speakers that this system is not applicable to the TRIPS Agreement. In fact we believe that the 
relation of the type identified in Article XXIII. 1(b) of GATT 1994 is inapplicable to the TRIPS 
Agreement. 
305.  We would like to refer here to two points: firs t, both paragraphs 1 and 3 of Article 64 should 
be read together in order to understand if non-violation complaints would be directly applicable to the TRIPS Agreement or not. In our understanding, in order for non-violation complaints to be applicable under the TRIPS Agreement, the scope and the modalities should be first agreed and 
approved by all Members; second, we would like to  refer to the point raised by India, Canada and 
others that the TRIPS Agreement is not a market access agreement. We would like to highlight that such a distinction should be made between goods and IPRs which are, as we say in French, "le 
droit incorporel" and that both are totally different. That is why we believe that the moratorium 
should be renewed at the tenth Ministerial Conference
. 
7.19 Switzerland   
 
306.  In view of the comprehensive communication  submitted by the delegation of the US in 
IP/C/W/599 at the last Council, I will keep my dele gation's intervention brief. In many points, I 
can make reference to the rationales set out in the US communication, including the historical context of non-violation complaints and case law under the GATT Agreement.  
307.  The underlying concern of many Members is that non-violation complaints extend the 
protection granted by TRIPS. Let me confirm my  delegation's view that the purpose of non-
violation complaints is not more extensive protection, rather, their objective is to protect the integrity of the Agreement.   
308.  Let me further recall my delegation's standpoint that non-violation complaints cannot be 
used to challenge any measure that is permissible under a TRIPS flexibility. These flexibilities were negotiated and agreed during the Uruguay Round and reaffirmed for health-related matters in the 
Doha Declaration on the TRIPS Agreement and Public Health. IP/C/M/77/Add.1 
 
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  309.  Non-violation complaints, in our view, are an extension of the established international 
principle of good faith. In that role, non-violation complaints provide added predictability and security to Members under the TRIPS Agreement just as they do under GATT and GATS.   
310.  Let me take up a consideration and a comparison made by the delegation of Venezuela in 
their intervention today. They compared paragraphs  2 and 3 of Article 64 with the built-in review 
in Article 27.3(b), concluding that a consensus is needed among Members for the moratorium on 
non-violation complaints  under TRIPS to end ju st as a consensus would be needed to revise 
Article 27.3(b) under the built-in review. This is not so. Under Article 27.3(b), Members are simply 
mandated to review the provision four years after the entry into force of the TRIPS Agreement.  
311.  Paragraphs 2 and 3 of Article 64 TRIPS, however, provide, through a five year moratorium, 
for a time-limited exception of lodging non-violation complaints in the TRIPS context under the 
WTO dispute settlement procedures. The purpose of the moratorium was to give Members the 
possibility to examine whether, in relation to the scope and modalities of non-violation complaints under TRIPS, specific additional guidelines are required under the Dispute Settlement 
Understanding. Accordingly, paragraphs 2 and 3 of Article 64 are based on the principle of the 
applicability of non-violation complaints to TRIPS, providing, however, providing additional discussion time through the five year moratorium, before such complaints may be lodged. 
Accordingly, if paragraphs 2 and 3 of Article 64 TRIPS require any consensus, it is not the 
consensus on the applicability of non-violation complaints under the TRIPS Agreement, but to further prolong the time-limited moratorium.    
7.20 Nigeria   
 
312.  The position of the LDC Group is well known on  this issue. The African Group is of the view 
that the TRIPS Agreement sets minimum standards on the protection of IPRs, as opposed to the 
exchange of concessions under the GATT Agreement.  Therefore we believe the application of non-
violation complaints will erode the flexibilities contained in the TRIPS Agreement and the application of non-violation complaints will further unbalance the TRIPS Agreement by elevating 
private rights over the interests of the users of intellectual property. It will also give rise to 
systemic concerns such as incoherence among WT O Agreements and it will constrain developing 
countries' vital, social and economic goals. It will also give rise to legal uncertainty for WTO Members. Finally, I would like to underline that there are countries that are still in transition 
regarding the implementation of the TRIPS Agreemen t and therefore have little experience with its 
application.  
313.  Finally, having listened to the interventions thus far, it is clear that non-violation complaints 
are not applicable and the TRIPS Council should agree on the non-application thereof. 
7.21 Hong Kong, China   
 
314.  I would like to start by joining others in thanking the United States for their efforts in 
preparing document IP/C/W/599. The topic of non-violation and situation complaints is a longstanding item in this Council. The numerous interventions made at the previous Council meetings are testimony to the importance that Members attach to this topic. In our view a 
sustainable IP regime must have the right bala nce, a balance between the interests of right 
holders and users and a balance between predictabi lity and flexibility. Members must recognize the 
unique nature of the TRIPS Agreement. Experience from other WTO Agreements is of course of 
great reference value, though we must be very careful in trying to apply it to the TRIPS context. 
As a number of delegations have pointed out before me, the TRIPS Agreement is a minimum standards agreement and it does not address market access per se. Before Members take any 
decision, we have to think about the implications of our action or inaction on the balance that the 
TRIPS Agreement currently provides. It is important for Members to engage in ongoing dialogue. Hong Kong, China stands ready to contribute co nstructively to the upcoming discussions on the 
way forward on the homework we have to deliver to Ministers by 2015. 
7.22 Nepal   
 315.  The delegation of Nepal would like to join its voice with Bangladesh, India, Egypt, Nigeria 
and other developing country members who expressed their deep concern regarding this agenda 
item. We welcome the decision taken by ministers in Bali last year to extend the moratorium on IP/C/M/77/Add.1 
 
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  non-violation and situation complaints with respect to TRIPS. In our understanding the application 
of non-violation and situation complaints, which is originally a GATT provision, is consistent only in trade in goods but not in any sui generis  system such as TRIPS. Their application in the TRIPS 
regime will reduce the flexibility and policy space of many developing countries in general and 
LDCs, in particular, and prevent them from pu rsuing their developmental goals through the 
legitimate exercise of policy choices in the IP regime. Accordingly, we are unable to support any 
proposal put forth by any Member to bring TRIPS non-violation and situation complaints issue 
within the ambit of WTO dispute settlement. We support the continuation of the moratorium on 
this issue. 
7.23 Venezuela, Bolivarian Republic  of  
 
316.  I wanted to respond to our friend from Switzerland. We fully agree with Switzerland that 
both cases, Article 27.3(b) and Article 64, are enti rely different. By way of example, we refer to 
the principle of consensus where in both cases there is a Ministerial mandate and in neither case 
has it been possible to reach an agreement, due to the fact that we have a basic principle of 
consensus which we have not managed to achieve in either case. 
7.24 United States of America   
 
317.  Thank you to all colleagues who have intervened under this item. This may be perhaps precedent-setting and we thank you for the close attention you have given to our paper. Obviously we have spent a great deal of time demonstrating our conviction with respect to this issue and we 
very much appreciate and extend our thanks for yo ur detailed review of this paper. Perhaps I will 
try to take each in turn to respond to these various issues. We will start with the issue of consensus and then we will move through the questions that I was able to record, and perhaps 
there will be more to come back with at our next meeting.  
318.  Several delegates have mentioned the issue of consensus, the novel concept of a majority 
and how there could be consensus under Article 64.3 of the TRIPS Agreement itself. We certainly 
agree with all delegations that consensus is a critical issue. Consensus is required of course to 
extend the moratorium, should we not reach consensus on the application of non-violation complaints before the next Ministerial Conference. It is our position supported by the text that 
non-violation complaints shall be fully available to Members to bring. The TRIPS Agreement is 
unambiguous on this point.  
319.  Article 64.1 states clearly that non-violation complaints shall apply to consultations and 
dispute settlement under the TRIPS Agreement, subject to Articles 64.2 and 64.3. Article 64.2 
established a five-year period of non-application for such disputes, which was until 1 January 
2000. Finally Article 64.3 provides that during the five-year non-application period, the TRIPS Council shall examine the scope and modalities for non-violation complaints and submit its 
recommendations to the Ministerial Conference. And "[a]ny decision of the Ministerial Conference 
to approve such recommendations or to extend the [non-application] period … shall be made only be consensus". 
320.  This provision is consistent with the consensus-based nature of the WTO as an institution.  
Non-violation complaints shall apply after the five-year period, unless pursuant to Article 64.3, 
"the Ministerial Council agrees to extend by consensus". And that "by consensus" is important – consensus in the traditional sense. While that consensus was reached most recently in 2013 to 
extend the application period, consensus is required to extend it again. 
321.  Likewise, consensus is required to approve any recommendation on the scope and 
modalities. Here consensus has not been reached. That does not mean, however, that the failure 
to reach consensus on such recommendations alters the TRIPS requirement to reach consensus on 
extending the non-application period. 
322.  Some delegations suggest that the failure to reach consensus on such recommendations 
renders the requirement to reach consensus to extend the non-application null and void. This is 
inconsistent with the clear language of Article 64 and would lead to a perverse result. In other 
words, the consensus requirement for extension does not simply vanish, because the consensus requirement for recommendations is not met.  IP/C/M/77/Add.1 
 
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  323.  Thus, it is clear that the non-application period will terminate at the next Ministerial 
Conference, unless consensus is reached to extend it. And where consensus to extend is not reached under Article 64.3, Article 64.1 is clear - non-violation complaints apply to the TRIPS Agreement.  
324.  With regard to the points raised by certain delegations with respect to possible incoherence 
between other WTO Agreements and the TRIPS Agreement, we would welcome some examples of concerns in that regard. We have heard general expressions of concern and would like to have 
some specific examples so that we can help to allay those concerns. Clearly today non-violation 
and situation complaints exist under the GATT and several WTO Agreements, and we have yet to see how that incoherence manifests itself as non-violation and situation complaints have been applied throughout the history of our organization, in fact prior to the history of the WTO in the 
GATT era.  
325.  In terms of the concerns about the foreseea bility test developed through panel and Appellate 
Body rules and recommendations, I think we have some questions there. First, we want to confirm 
that the measure itself did not have to exist at the time of the Uruguay Round. Rather the 
question is foreseeability.  
326.  And then there was a similar question raised with respect to the provisions of the TRIPS 
Agreement themselves being flexible enough to address this concern that the United States and 
others have raised. We agree that there are sufficiently flexible provisions in the TRIPS Agreement to accommodate measures that were entered into force following the Uruguay Round. Those themselves can capture what was foreseeable at the Uruguay Round. Accordingly, we believe that 
these provisions are flexible and have lived up to the expectations of Members.  
327.  We also heard some comments with respect to good faith. One delegation suggested that 
perhaps a non-violation and situation complaint is unnecessary, because good faith exists as a 
fundamental provision of international law under th e Vienna Convention, on the Law of Treaties for 
example. I think we agree with Switzerland in this regard. One additional point that I would note here is that equating non-violation and situation complaints as identical to or fulfilling the same 
objectives as the good faith requirement in international law would nullify Article XXIII(b) of the 
GATT, which is inconsistent with international law. Accordingly, if you are saying that if a delegation would suggest that non-violation and situation complaints equate with good faith, then why does the GATT contain a non-violation provision? This has been borne out in multiple panel 
rulings to the process. So this is something that differs slightly from good faith and does more 
than merely fulfil a principle of international law. So we still have questions there. 
328.  Several delegations have highlighted the difference between the TRIPS Agreement and the 
GATT as an agreement reflecting the balance of  concessions and we are looking forward to 
additional specificity in this respect. Here we too have some questions and would welcome some further clarity on this issue. Clearly the GATT itself is more than simply a compendium of tariff 
concessions. The GATS is more than simply tariff schedules, as many of you who have highlighted. 
There are actually substantive and binding rights  and obligations that are embodied in those 
agreements as well, which apply to WTO Members as parties to those agreements. That is the same as the TRIPS Agreement. So we continue to question this sort of dichotomy that is 
developing. 
329.  Further, we have a question about the supposition that non-violation and situation 
complaints are only permissible or should only apply to agreements that may include, but are not 
limited to, a balance of concessions in exchange of perhaps tariff offers.  
330.  Thus, we have some other concerns that non-violation complaints might be used with 
respect to flexibilities under the TRIPS Agreement. We do not think that is particularly founded and 
would welcome some kind of explanation or citation with respect to existing practice under the 
GATT, where that might be the case. Certainly there is nothing inherent about a non-violation claim that would in any way suggest that it would be targeted only to exceptions. Again we would refer Members back to the GATT where non-violatio n and situation claims are perfectly permissible 
and have been so for quite a long time. The GATT, as many Members know, contains a general 
exceptions provision. Article XX provides for several measures that in many ways address the concerns that Members have raised today, namely measures that are necessary to protect public IP/C/M/77/Add.1 
 
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  moral, human, animal or plant life or health, and measures relating to the conservation of 
exhaustible natural resources. We would welcome any observations or further data from delegations that have seen how non-violation and situation complaints that are perfectly legitimate under the GATT have somehow conflicted with or imperilled the general exceptions provision, 
which achieved many of the objectives identifi ed by Members today, which we fully support.  
331.  There was some reference to legal uncertainty. Again, we are not clear about that. There is 
nothing about non-violation claims that are more or less uncertain than any other provision in the 
TRIPS Agreement. They were written into the text of the Agreement, and to the extent that they 
require elaboration and clarification, panels do that, subject to, as we have said, DSU Article 3.2 and 3.5, which provides, we believe, sufficient safeguards to allay concerns of Members which they rightly have. 
332.  With respect to power and unilateralism, it is claimed that non-violation complaints would 
somehow enhance the power of some and not of others. This would be a claim available to all Members. It is completely equitable in its application.  
333.  In terms of an influx of cases and disputes, that  is certainly inconsistent with practice so far.  
The Secretariat has been quite helpful in producin g a chart of the number of cases and especially 
the number of cases that have actually prevailed. There is no evidence really to suggest, at least 
in terms of actual practice, that there would be an inundation or influx of these types of claims.  
334.  With respect to sovereignty, it is claimed that non-violation complaints would somehow 
affect the sovereign right of nations. Again, I think we are looking for some more clarity. That is obviously a matter of concern if we believed it were  the case. We do not. Again, our question is 
whether we can have some more understanding how GATT Article XX.III does not imperil the 
sovereignty of Members, but this one would in some specific way.  
335.  One delegation raised a question about the meaning of reasonable expectation. It is a 
standard that has some subjectivity to it. And that is certainly the case but it is also been tackled 
several times by panels in the Appellate Body. Sufficient guidance is there already. If we were to scour our laws, we would find similar subjective standards in our national court systems. We have 
all individually and collectively here at the WTO ag reed to such subjective standards in the past 
and so we are not quite sure about that specific concern. Again, we would certainly welcome more elaboration in that area. 
336.  There was a new interesting concept brought up today, namely, the idea that non-violation 
complaints would not upset the rights and obligations, however, they would create a new cause of 
action. We welcome that perspective. And, of course , that cause of action would be available to all 
Members. And thus there must be no discriminatio n or distinction between who would be able to 
apply them and certainly who would be subject to them. Certainly the United States could be 
subject to them. 
337.  Moreover, allow me to reiterate that, with regard to the application by panels, they cannot 
alter the right and obligations of concessions. A cause of action would indeed be created, when 
that was envisioned by the drafters of the Ur uguay text and the TRIPS Agreement and certainly 
one that has gone into effect in the TRIPS Agreement. But again, Articles 3.2 and 3.5 of the Dispute Settlement Understanding still prevail. Panels, in applying this new cause of action, and 
finding recommendations and rulings with respect to any possible cause of action, would still be 
limited. So the net result, the end of any kind of panel or Appellate Body proceeding in this area would therefore still be fundamentally constrained, as are all panel and Appellate Body 
recommendations and rulings by the fundamental te nets agreed to by consensus by all Members. 
And that would still apply here as well.  
338.  Finally, with respect to the Government Proc urement Agreement and the analysis there. I do 
not think we quite see that analysis, the particular novel reading of a panel decision that would 
suggest that if a claim is not successful, the Panel's findings on that claim are inapplicable. That is a novel reading of panel and Appellate Body repo rts in our view, so I think we perhaps should 
engage in a further conversation about that approach. IP/C/M/77/Add.1 
 
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  339.  That was my initial effort to respond to the questions and comments that were raised today. 
We are happy to engage bilaterally and look forwar d to finding a resolution to this issue at our 
next meeting.  
7.25 Venezuela, Bolivarian Republic of   
 
340.  I thank the delegate of the United States for his very lengthy explanation. Rules are not cast 
in stone. Situations can change as can interpretations. I think an obvious proof of this is the Doha 
Round. If we were to accept what is stated by the United States regarding the interpretation of Article 64, that non-violation complaints automatically apply after a five-year period, then this would have to be based on a principle of consensus. It would be necessary for us to ask for the 
elimination of all of Article 64 as it runs counter to the principle of consensus. I was not in 
Uruguay. I don't know that happened 21 years ago, bu t what is true is that the consensus that did 
exist in 1994 does not exist today. It would therefore be necessary that this request be sent up to 
the next Ministerial Conference as the consensus of 21 years ago on Article 64 has changed. There 
is no point in continuing such discussions. And it would make much more sense, since the United States and Switzerland state that there would not be any main modifications. Why do we need to 
do something that causes so much concern to so many Members when we want to have a more 
productive and calm multilateral system? 
7.26 Nigeria   
 
341.  Let me thank the delegate of the United States for the explanation given. Of course, we have 
listened carefully to his explanations. The issue of  Article 64 is very clear that non-violation and 
situation complaints will not apply until after five years; but of course in the interim there needs to 
be agreement on scope and modalities, which has not been agreed. Accordingly, at least as far as 
we are concerned, the moratorium will continue to subsist until there is consensus on the scope and modalities. Having listened to these explanations, as a developing country we fail to see why 
the current TRIPS provisions are inadequate for the protection of IP standards and as an African 
country that is having problems with access to me dicines we fail to see how the application of non-
violation complaints is going to benefit Members. 
7.27 Indonesia   
 
342.  Indonesia would like to support statements made by Venezuela, India, Brazil and others. We believe that the application of non-violation and situation complaints will create legal uncertainty 
and unpredictability. It could limit authorities to introduce or adopt necessary and legitimate 
measures which are considered essential or vita l to social, economy, health, environment and 
development. The application of such complaints would also limit the use of flexibilities provided in 
the Agreement. We, therefore, are of the view th at non-violation and situation complaints should 
not be applicable to the TRIPS Agreement. 
7.28 India    
 
343.  We would like to thank the United States for its detailed explanation. On the point of 
consensus, we would like to support Nigeria and Venezuela on their reading of Article 64 as a 
whole and not a selective reading of the sub-paragraphs. Article 64.3 makes it very clear that if 
there is no consensus on the scope and modalities,  the same principle applies. Accordingly, the 
automatic application of a non-violation situation would be dependent on the consensus reached 
on scope and modalities. So I think a holistic reading of Article 64 is mandatory.  
7.29 United States of America   
 344.  We continue to have perhaps a difference of view about how Article 64 works. We have 
identified Article 64.1, 2 and 3 in our analysis and hope this will be shared by other Members. With 
respect to Article 63, and paragraph 3 of Article 64 in particular, it is clear that there is the obligation with respect to consensus for extending the moratorium, which is correct and moreover, 
our colleague from Nigeria referred to our succe ssive agreements by consensus to extend the 
moratorium. Thus, in order to extend the moratorium, consensus is required, which is a separate legal obligation. I think that legal analysis would stand up to quite heavy scrutiny from any other 
obligations that may exist in that provision.  So that certainly stands on its own two feet until that IP/C/M/77/Add.1 
 
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  consensus is no longer reached. And that is a clear provision, an operative provision and one that 
remains obviously available. And so we look forward to that. 
345.  With respect to the development issues, we welcome the conversation with the delegation of 
Nigeria and others to understand exactly ho w this could be for improvement and serve 
development ends as well. And we look forward to further clarifications from those Members and 
others about how existing non-violation and situation provisions and GATT Article XX somehow do not raise those same concerns. Because certainly from our view, in our perspective go to those 
very same measures  that protect developing countries and certainly developed countries and all 
Members and LDCs and protect those Members and why is this threat non-existent under the GATT, under the GATS and every other WTO Agreement. And why only in this agreement. It is unclear yet. We would like more information about how those exceptions and flexibilities do not 
apply somehow in the GATT context but do here. 
AGENDA ITEM 10: TWELFTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION 
ON THE IMPLEMENTATION OF ARTI CLE 66.2 OF THE TRIPS AGREEMENT 
10.1 Australia   
346.  Australia is certainly committed to assisting least developed countries (LDCs) in the area of 
technology transfer, pursuant to the Council's De cision on the Implementation of Article 66.2 of 
TRIPS. We would like to thank the Secretariat for organizing the annual workshop on this issue, in 
which we participated yesterday, as we have done since their inception in 2008.  We find the workshops a very useful forum for exchanging views and they have positively influenced how we prepare our reports and share the information.  
347.  In this year's report, IP/C/W/602, we offer an update on the support we provide to promote 
and encourage technology transfer to LDCs in a wide  variety of fields. This ranges from agricultural 
productivity, climate change adaptation and mitigation through to security, improved health 
outcomes, mineral extraction and water resources development. The report also highlights the 
breadth of our cooperation with partners in the field to promote and encourage technology 
transfer, ranging from our LDC partners to other donors to research and education institutions. As 
our report notes, we appropriately use a broad definition of technology transfer covering IP 
embedded in transferred goods and services, the dissemination of business information and know-
how, on which a product, process or service is based, and the dissemination of knowledge and skills through training and education. Further detail on the particular initiatives can be found in the 
report, and was the subject of our presentation at yesterday's workshop. 
10.2 European Union   
 
348.  The European Union attaches great importance to this issue and is a major contributor as 
reflected in our quite detailed and substantial report. Today, I would like to refer in detail to some of these projects that are very important in ar eas like climate change, treatment of water, and 
treatment of some diseases. One of them, EartH2Ob serve, is a project that will support efficient 
and globally consistent water management an d decision-making by providing comprehensive 
multi-scale water resource observations at a local, regional, continental and global level. LDC Members that are recipients of this project are Ba ngladesh and Ethiopia and the EU contribution is 
in the range of €9million. The technology that is transferred with this project includes processed 
satellite images and in situ data containing information on all components of the water cycle, which are freely downloadable. There are also applications of local and global hydrological models. 
These are also transferred for free.  
349.  But we have also projects with countries like India, where we have launched a pilot initiative 
on water-related challenges. Just to give you two examples of projects in this area: firstly, the 
ECO India project, aims to develop innovative, cost-effective and sustainable approaches for 
producing portable water and treating waste water at the community level, focussing in particular on oceanic water-stressed regions in India. Th is project consortium represents a world class 
interdisciplinary research team from several institutes and SMEs in Europe, India and Israel.  
350.  The Nawaech project seeks to develop natural water systems and treatment technologies to 
cope with water shortages in urbanized areas in In dia. It aims to explore, assess and enhance the IP/C/M/77/Add.1 
 
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  potential of natural and technical water treatment systems to improve their performance and 
reliability to cope with water shortages.  
351.  Another project called "Preface" is about enhancing the prediction of tropical Atlantic climate 
and its impacts. Again it is a project with a budg et of approximately €9million and the beneficiary 
countries are Angola, Namibia, South Africa, Cap Verde, Morocco, Senegal, Benin, Ivory Coast and 
Nigeria. This project seeks to assist our African countries which are bordering the Atlantic and who 
strongly depend on their ocean and may be affected by tropical Atlantic climate in general. Its 
goals are to reduce uncertainties in our knowledge of the functioning of tropical Atlantic climate, to 
improve climate prediction and the quantification  of climate change impacts in the region, to 
improve the understanding of the cumulative effect s of the multiple stresses of climate variability, 
greenhouse-induced climate change and fisheries on marine ecosystems and ecosystems services. 
In addition, it seeks to assess the social-economi c vulnerabilities and evaluate the resilience of 
Atlantic African fishing communities to climate-driven ecosystem shifts and global markets. In order to meet these goals the project brings toge ther European and African expertise. The target 
regions include areas more affected by climate change and by its consequences. This project has 
very practical results that involve considerable technical knowledge, IP-protected items and a considerable transfer of technology.  
352.  I would also refer to a project concerning a low-cost mosquito-contamination device for 
sustainable malaria mosquito control targeting, in particular, Tanzania, with a budget of €1.5million.  
353.  Another project, COSMIC is the community-based scheduled screening and treatment of 
malaria in pregnancy for improved maternal and infant health: a cluster-randomized trial. The 
budget for the recipient countries, Burkina Faso and Benin is approximately €700,000 and €566,000 respectively. This project aims to develop low-cost intervention to deal with malarian 
pregnancies. It seeks to educate community-healt h workers and consumers to improve the use of 
rapid diagnostic tests. It involves pharmaceutical companies as well. You can find more information about this on the website that is mentioned in our report.  
354.  In addition, we have programmes dealing with renewable energies in Latin America, in 
particular a programme called EURO-SOLAR. This programme proposes a new approach to traditional rural electrification projects by mainstreaming renewable energy. This involves linking power generation to a series of goals, incl uding improvements in education and health, 
development of productive activities, skilled bu ilding within the community; and it also has a 
gender focus. The kit, which is designed for this EURO-SOLAR programme, is wholly based on renewable resources and has a neutral impact on the environment, therefore ensuring the 
sustainability of the development model. Systems of  this kind are a good alternative in isolated 
rural communities where direct connection to the electricity grid is not viable for technical or economic reasons. Some key figures for this project: it has improved the living conditions of 
300,000 people by linking isolated communities an d providing them with electric energy; it has 
eight beneficiary countries in Latin America; it has a total budget of €36million, 80% financed by the European Union. It involved 3,000 Internet-c onnected computers, 500 satellite antennas, and 
2,500,000 square metres of solar panels.  
355.  I could go on and on. I think these projects  deserve that people know about them. But for 
the sake of the schedule I will stop here today, but I would really ask people to have a look at the information we provided and to have this in consideration when we see so much criticism about 
how TRIPS falls short of its ambitions in providin g for technology transfer and capacity building. 
10.3 New Zealand   
 
356.  Like others, New Zealand attaches great importance to this process under Article 66.2.  
New Zealand's report this year provided an update  on the range of incentives by New Zealand to 
encourage the transfer of technology to LDCs, ra nging from support for government administrative 
systems and training, to water management and electrification initiatives. 
357.  New Zealand would like to convey its thanks to the Secretariat for arranging yesterday's 
workshop on the implementation of Article 66.2 of the TRIPS Agreement, which again proved a IP/C/M/77/Add.1 
 
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  useful opportunity to discuss New Zealand's incentives for technology transfer to LDCs, and a 
helpful forum for exchanging views on technology transfer issues. 
358.  We appreciated the thought that went into the preparation of the questions posed during the 
review by LDC Members, and reiterate that New Ze aland will endeavour to respond to these in the 
near future. 
10.4 Nepal   
 
359.  Technology and innovation are key factors in addressing developmental needs of many poor 
and LDC Members in the IP regime. In order to enab le LDCs to reap due economic benefit from the 
intellectual property sector, they need to have a sound and viable technological base, which is very 
often beyond their capacity to afford.  In light of this, incentives to be provided by developed 
country Members to enterprises and institutions in their territories for the purpose of promoting 
and encouraging technology transfer to LDC Member s in line with TRIPS Article 66.2 are of great 
significance and relevance. Yesterday, we attend ed a dedicated workshop on this issue, where 
several delegations made presentations of their reports submitted to the Secretariat.  
360.  We are glad to note that developed countries have been increasingly extending their support 
in the field of technology transfer through vari ous means. For that we extend them our sincere 
appreciation. However, as there remains some overlapping between TRIPS Article 66.2 and 67 in 
their reporting, we encourage the reporting country Members to be more specific while preparing their submissions under TRIPS Article 66.2 next year and distinguish it from the reporting of Article 67 which talks about technical and financial cooperation.  
361.  We would also like to underscore the need of adopting and applying a uniform template by 
all developed Members while reporting on this issue for the sake of simplicity, uniformity and reducing paper cost. In this regard, the template submitted by Angola in October 2011 on behalf 
of LDC Group would be a solid piece of document to  be considered by all Members and later on to 
be adopted by developed country Members while reporting on Article 66.2. Finally, we encourage Members to extend their support further in the field of technology transfer to LDCs in the days to 
come so that LDCs can develop a sound technologi cal base to enjoy the benefits derived from the 
IP sector. 
10.5 United States of America   
 
362.  We also want to join others in being very clear about the strong importance the United 
States places on this process with respect to the obligations under Article 66.2 and most importantly thank LDC Members and the Secretariat for organizing yesterday's workshop. The 
workshop offered an opportunity for a very good  e x c h a n g e  o f  v i e w s  a n d  w e  f o u n d  i t  t o  b e  
extremely constructive, and welcome several very important questions raised, which exhibit a great deal of work on behalf of LDC Members,  for which we are looking forward to engaging 
intensively on an ongoing basis. We described in  great detail yesterday our eleven areas of work, 
from climate change to health and many other areas, where we are working to promote and undertake the things that our esteemed colleague from Nepal just mentioned. 
10.6 Bangladesh on behalf of the LDC Group   
 
363.  Let me first speak on behalf of the LDC group. The LDCs are pleased to note that we are now at the twelfth annual review of Article 66.2 of th e TRIPs Agreement, in line with the Decision 
adopted by Ministers in Doha in 2001. 
364.  But shall we pause and ask why are we here? Article 66, in particular is the centre of the 
delicate balance that was struck in the TRIPS Agreement.  Those who came before us in Uruguay, 
concluded this agreement bearing that point in mind. You will recall that in a couple of days, we 
shall be celebrating another anniversary of th e WTO Agreements: however, anniversary after 
anniversary we are still standing still with respect to building a sound and viable technological base. The faithful implementation of the obligat ions under Article 66.2 would respond to that 
objective and purpose for which it was crafted.  IP/C/M/77/Add.1 
 
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  365.  That said, we would like to thank those developed countries that have continued to provide 
reports to the TRIPS Council on incentives they ha ve provided to their enterprises and institutions 
in their territories, with a view to promoting and encouraging transfer of technology to LDCs, in 
order to enable our countries to create a sound and viable technological base. 
366.  It ought to be acknowledged that we have come a long way in this process and LDCs are 
pleased to note the improvements made by some dele gations to their reports.  As is known to all, 
the purpose of this review is threefold: first, to provide Members with an opportunity to pose 
questions in relation to the information submitted and request additional information; second, to 
discuss the effectiveness of the incentives provided in promoting and encouraging technology transfer to LDCs in order to enable them to create a sound and viable technological base; and third, to consider any points relating to the oper ation of the reporting procedure established by the 
Decision. 
367.  It is important to recall that we had a fr ank exchange of views during the workshop held 
yesterday, 27 October 2014 on this subject. Th ere is common understanding among all those that 
have participated in this process that reports not only have to be submitted, but their format has 
to be such that the information is digestible to the recipients of such support.  
368.  We also observed that some Members had made an effort to follow the structure that we had 
proposed in our submission IP/C/W/561, to make  the reporting system structured and simple. 
Others are yet to get there. 
369.  The reports are very informative and help ful to understand the programmes Members have 
been offering to us.  We got the reports very recently and had little time for an in-depth analysis. 
H o w e v e r ,  o n  a  p r e l i m i n a r y  r e a d i n g ,  w e  f o u n d  s o m e  t o  b e  d i f f i c u l t  t o  s o r t  o u t  t h e  e l e m e n t s  a s  
envisaged in the TRIPS Council decision contained in IP/C/28. 
370.  Most importantly, there was extremely limited indication or specific mention of the "incentive 
regime" that Members have put in place. Nonethele ss, we raised some questions for clarification. 
We hope Members will respond to them in writing. 
371.  Finally, a common understanding on what cons titutes technology transfer still eludes us. 
Developed countries have elected a very broad view of what technology transfer means. Contrary 
to the understanding of the LDCs, and in fact, shared understanding by our Uruguay round negotiators. Our view is for the Chair to facilitate a process to address this gap with a view to harmonization of this understanding. 
10.7 Bangladesh   
 372.  Let me start by aligning my delegation with the statement I just made. Implementation of 
Article 66.2 is of prime importance to us. In the Uruguay Round, the LDCs assumed the onerous 
responsibilities of the TRIPS Agreement hoping that building up a sound and viable technological base through the effective and meaningful implem entation of Article 66.2 would gradually advance 
us toward fully embracing the TRIPS Agreement. 
373.  There is ample political guidance and support in place, along with the procedural decision in 
this council contained in document IP/C/28. However, we are yet to hear clearly about any "incentive regime" put in place by the developed Members.  
374.  I do thank the developed country Members which submitted their reports. As these have 
been made available very recently, we need some reasonable time to analyse them and also reserve any further comment for a future time. I do  also appreciate the wide ranging support by 
developed country Members, as demonstrated in their reports, in our pursuit of achieving social 
and economic goals. 
375.  All, in this house, would agree that the type and nature of the report is of critical importance 
for efficient monitoring of implementation. Th e Doha mandate and the TRIPS Council decision 
IP/C/28 provided further guidance on the report ing format and substance. However, from the 
submitted reports, it is extremely difficult to identi fy and sort out activities that are specific to the 
obligation under Article 66.2 due to the absence of a common structure and format. IP/C/M/77/Add.1 
 
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  2.  As such, we would particularly appreciate information on the incentive regime put in place, 
along with other elements as contained in paragraph 3 of document IP/C/28. 
AGENDA ITEM 11: TECHNICAL COOPERATION AND CAPACITY-BUILDING 11.1 WTO Secretariat   
 
376.  Under the previous agenda item we reported specifically on technical assistance in the public health area, so this report is a more general update on our activities relating to technical 
assistance in the TRIPS area. The details are found in document IP/C/W/600, so this report simply 
focuses on a few broad highlights and trends. 
377.  The overarching consideration is that technical cooperation remains driven essentially by 
demand of Members, as well as those countries in the process of accession to the WTO. We are 
seeing a diversity of needs and interests that Members identify in this process. This in turn creates 
a need increasingly to tailor and focus technical assistance activities on specific areas of interest or specific sectoral policy issues. This is particularly the case in national and regional workshops. At 
the same time, again driven by demand and the feedback we receive, we are working towards a 
more holistic approach to capacity-building activities with the goal of putting the TRIPS Agreement and the policy choices within the TRIPS framework into their broader operational context. That in 
turn leads to a greater collaboration, both within the Secretariat with other areas of expertise, but 
also with a wider range of international partners and experts who take part in our activities.  
378.  This approach is manifested particularly in the flagship Geneva-based activities: last year 
saw the sixth in the series of WIPO-WTO advanced courses for government officials on intellectual 
property. Again the approach here was to strength en policy capacity and understanding of the IP 
framework generally and the TRIPS Agreement with in that framework, while examining specific 
current policy issues that are of interest to the participating government officials. 
379.  A similar approach has been taken with what  was the eleventh in the series of WIPO-WTO 
Colloquia for Teachers of Intellectual Property from Developing Countries. The aim is to enhance research and teaching capacity, so that the indigenous capacity of developing countries to work 
and educate on IP issues is accordingly strengthened. And the focus here again has been on both 
the overall international framework but also on current policy issues.  
380.  A particular progress there has been in developing the Colloquium Papers as an academic 
journal, thereby strengthening the capacity of the participating academics and enabling them to 
build their academic credentials as part of the Colloquium. 
381.  We have already touched on the other flagship Geneva event, which is the series of 
workshops on public health, and so I turn to  the workshop on realizing the developmental 
objectives of the IP system: LDC priority needs for technical and financial cooperation that was 
held in June 2014. The focus of this activity was under the general provision of Article 67 on technical cooperation and the ongoing technical cooperation programmes of the WTO itself, but 
also our partners, WIPO in particular, for the benefit of LDCs. The focus was, in particular, on 
improving the coordination of responses to the pr iority needs identified by LDCs and ensuring a 
better matching of supply and demand of technical and financial assistance, so that it does match the priority needs identified by LDCs, taking account of their own priority sectors and 
developmental objectives.  
382.  The workshop was a very practical process. It looked at a number of practical questions, in 
particular, the utility of needs assessment and how they fit into the broader process of planning 
and executing development cooperation activities, the specific challenges of responding to 
individual priority needs that least developed country Members have identified and communicated, and the accessibility and relevance of information provided. This refers in particular to the 
extensive reporting on technical assistance activities, as well as communications by LDC Members 
about their priority needs, how to improve the mana gement of that information again, so that it 
becomes a more practical planning resource without the information being locked in the documents themselves and facilitates improved coordination and above all delivery of technical 
assistance to LDC Members.  IP/C/M/77/Add.1 
 
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  383.  A further issue that has been discussed in previous sessions of this process also included the 
possibility of establishing a dedicated fund to re spond to LDC needs. The workshop itself was part 
of a series of activities undertaken under the broader guidance of the LDC Group, and in particular responding to a specific request made by the LDC Group in the TRIPS Council. This has included a 
series of three Geneva-based workshops, as well as  regional workshops in the past. Accordingly, it 
fits into that broader process.  
384.  I think that is all the details we need to share at this stage but obviously we have more 
details in the report that has been filed. I would simply conclude by mentioning that the 
Secretariat report has adopted a particular format of an introduction covering the general trends and highlights and then including the details of ea ch activity in a separate table. We are very 
grateful to our technical cooperation partners, a number of whom have adopted a similar format. 
This is part of the experimental process of deve loping a coherent, optional framework for reporting 
the details of these activities. This would lend itself to a more workable information management system and we should be able to report back to the Council in the course of next year about how 
this can be turned into a more accessible and more user-friendly means of consulting this very 
important information about technical cooperation activities and the available programmes in this area.  
11.2 UNCTAD Secretariat   
 385.  Responding to the mandate received from member States at the UNCTAD Ministerial Conference in Doha, as well as to inter-governmental requests under the WIPO Development 
Agenda, and the World Health Assembly's Resoluti on WHA 61.21 on a Global Strategy and plan of 
action on public health, innovation and intellectu al property, the UNCTAD Secretariat, through its 
Intellectual Property Unit, implements a work pr ogramme on the development dimensions of IPRs. 
UNCTAD undertakes research and analysis on trad e and development aspects of IPRs, responds to 
requests for technical assistance and advises on policy options on the interface between investment and intellectual property for a successful integration of developing countries into the 
world economy. I will provide you with a brief overview of UNCTAD's main areas of IP-related work 
in respect of technical assistance, research and policy analysis, and consensus-building.  
386.  First, in the area of technical assistance, UNCTAD conducts activities with developing 
countries in the integrated areas of investment, tr ade and intellectual property. These projects are 
on a request basis and are funded by donor gove rnments and institutions. In the pursuit of a 
mandate from its Commission on Investment, Technology and Related Financial issues, UNCTAD, since 2006, has been implementing a programme on IPRs and local pharmaceutical production and 
supply capacity of essential medicines with the financial support of Germany and originally the 
United Kingdom. The overall objective of the programme is to assist developing countries and least developed countries to establish domestic IP regimes that facilitate increased access to affordable 
medicines and create local or regional pharmaceutical production and supply capacities in 
cooperation with investors.  
387.  Funded by the European Union, UNCTAD in cooperation with the World Health Organization 
as the lead agency, is examining coherence of policies in selected developing countries in respect 
of health, trade and industrial development. The ov erall objective of this exercise is to assist 
developing countries in building capacities to promote such coherence to ensure that local pharmaceutical production increases access to medi cines. UNCTAD is conducting fact finding and 
subsequent capacity building activities in selected  countries with the potential to serve the African 
market.  
388.  Since 2011 UNCTAD has been implementing a technical assistance programme on IP and 
biodiversity with the initial financial support from the Government of Germany. The programme 
focusses on the building of local capacities in developing countries to design and enforce domestic trade, customs and IP laws in line with access and benefit-sharing rules under the CBD, its Nagoya Protocol and the UN Declaration of the Rights of Indigenous Peoples.  
389.  UNCTAD produces, upon request by a developing country or a least developing country 
advisory reports on the development dimensions of intellectual property, in short DDIP. The 
objective of a DDIP report is to provide well researched and reasoned advice on developing 
countries' and LDCs' policies and institutional framework for IPRs, particularly as it relates to IP/C/M/77/Add.1 
 
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  important development objectives such as innovation, technology, investment, competition, 
knowledge and education, and health. 
390.  Developing countries specify the key development objectives they wish to examine. In 
addition, a DDIP report will take into consideration the bilateral, regional and international 
commitments the target countries have entered into  and the flexibilities available to them. Based 
on this analysis, the reports incorporate medium to long-term recommendations on how governments and other stakeholders could make these frameworks more coherent and 
transparent, with a view to making IPRs contribute to a country's sustainable economic and human 
development goals and respond to emerging global opportunities.  
391.  The aim is to present an analysis and recommendation designed to promote innovation and 
technology transfer as well as a pro-competitive and transparent domestic IP system.  
392.  Finally, UNCTAD 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 2014 WIPO-WTO Advanced Course on IP for Government 
Officials. Second, in the area of research and policy analysis, UNCTAD in 2014 published its 
handbook on the interface between global access and benefit-sharing rules and intellectual property entitled "The Convention on Biological Diversity and the Nagoya Protocol Intellectual 
Property Implications". It is available on the UNCTAD website and was presented to the Twelfth 
Conference of the Parties to the CBD in the Republic of Korea earlier this month.  
393.  The Handbook provides an overview of th e international framework on IP and access and 
benefit sharing. It also analyses in detail issues such as disclosure of source or origin and 
additional tools, positive protection of traditional knowledge, the use of distinctive signs and 
private contract law.  
394.  Last but not least, consensus building amongst stakeholders of IP is an important element of 
UNCTAD's work. It provides a forum through its inter-governmental machinery where 
governments, academia, civil society and the private sector can meet to exchange ideas. For example, UNCTAD and UNAIDS jointly organized an event investing in sustainable and universal 
access to medicines at the UNCTAD World Investment Forum in Geneva on 14 October of this 
year. More detailed information on UNCTAD's activities related to IP as well as a list of activities conducted during the period of October 2013 to October 2014 is included in this Council's meeting documentation.     
11.3 Bangladesh   
 395.  Thank you to the Secretariat and the UNCTAD for those very informative reports. But I must 
confess that due to our physical constraints and time limitation, we were unable to fully explore 
the Secretariat report. Therefore, we will come back on the report at a future time. 
396.  I do recognize such activities are distinctly useful for us. As such, we do encourage the 
Secretariat to gear up further this process for our benefit. We are very appreciative of hearing that 
a further holistic approach is now under active consideration. In this regard, we would prefer a bottom up approach and are ready to constructively engage in designing the activities so that these fit to our exact time-based needs. 
11.4 European Union   
 397.  We note that a lot of the comments and discussions we have had here focus on the format 
and on how the information must be presented. That is very important, particularly in terms of 
accessibility of this information to third parties. And we are well aware that it is difficult for third parties to access this information and to produce studies that actually reflect the truth and fairly 
depict the contribution of some Members. In that sense it is very important that information is 
more  ac c e s s ib le . W hat is  mis s ing  in t his  d e b ate  and  what we  would  l i ke  to have  als o i n future discussions is the feedback or discussion on how these programmes are relevant or how they are not working for the recipient countries. I think that has nothing to do with the format. IP/C/M/77/Add.1 
 
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  398.  Yesterday I mentioned a couple of programmes and this is just giving an example. I 
mentioned a programme where there is work done with Bangladesh to see the impact of waters and the tides in their territory. We would certainly like to hear from the recipient countries concerning their experiences. And for this one does not need a different formatting. It is a 
p r o g r a m m e  t h a t  i s  t h e r e .  I  a m  s u r e  t h a t  B a n g l a d e s h  i s  v e r y  a w a r e  t h a t  i t  e x i s t s .  I t  w o u l d  b e  
appreciated if one day we could have a brief discussion about how this works.  
399.  We mentioned another programme for the treatment of malaria in pregnancies in African 
countries. Again, we would be interested to know. These programmes related to malaria are 
examples of how one can promote access to heal th with something that does not necessarily 
involve pharmaceutical patents. There are many things that can be done in the area of malaria, prevention etc. that do not involve pharmaceutical patents. We would like to know if these have a 
positive impact or not. 
400.  This is the reason why in my recent interventions I have been focussing so much on the 
details. I think we would very much like to know and to talk about the concrete programmes and 
maybe a bit less about Excel tables. 
11.5 Bangladesh   
 
401.  I am just hearing from my EU colleagues and definitely we are ready to share our 
experience. This is a generic comment: I believe ev ery project has a positive impact and will have 
that certainly. But here we are discussing about reporting something and not about impact. Anyway, we are ready to discuss it at an appropriate time. 
AGENDA ITEM 12 INTELLECTUAL PROPERTY AND INNOVATION: PROMOTING 
AWARENESS; CASE STUDIES 
12.1 Switzerland   
 
402.  It is a pleasure and an honour for me to introduce this agenda item and to co-sponsor it with the delegations of the United States and the European Union. 
403.  In my statement, I will make reference to yesterday's innovation fair organized in the Atrium 
of the WTO building by the Delegations of Mexico , United States, European Union and Switzerland. 
We will present a case example of a successful innovation partnership among a number of stakeholders of the Swiss innovation landscape. Representatives of the relevant companies and 
institutions from that case study participated at the fair yesterday.  
404.  I wished that the timing of the Council's discussion would have allowed us to deal with this 
agenda item yesterday, as it would have been poss ible then for interested delegates to go to the 
fair and speak with the participants and exchange views and learn about their experience and 
know-how in the field.   
405.  This was the objective of the four WTO Members when they agreed to organize the 
innovation fair: to give TRIPS delegates the oppo rtunity to meet with people who are working as 
practitioners in the real world of innovation. Events like the innovation fair can thus add a third dimension to our sometimes two-dimensional discussions in the TRIPS Council to provide us with a more practical approach to the role of intellectual property in the innovation process. 
406.  It is important that we, as TRIPS delegates, have an understanding of the situation, the 
challenges, the needs and concerns that innovators face to ensure that we carry out our work here in the TRIPS Council properly and in a well-informed manner. 
Innovation cycle 
407.  Genuine innovation is rarely accomplished by a single person on its own. There are often 
several parties involved, each playing its part to help turn ideas into reality. Some stakeholders 
are not even creators, but act as partners to the inventors; some act as facilitators, providing both 
a launch pad from which the inventor can spring as well as a structure to support one or another specific step of an innovators journey.  IP/C/M/77/Add.1 
 
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  408.  I would now like to present a case example of an innovation process in Switzerland and first 
introduce the four stakeholders who play a role in it and who were, as mentioned, also present at yesterday's fair.  
EMPA  
409.  The first is the Swiss Federal Laboratories for Materials Science and Technology (EMPA). 
EMPA is a research and services institution for material sciences and technology development. EMPA's research and development activities focus on meeting the requiremen ts of industry and the 
needs of society. EMPA works together with industry partners conducting applications-oriented 
research and assists with the practical implementation of new ideas. 
IPI 
410.  The second is The Swiss Federal Institute of Intellectual Property (IPI). The Institute is the 
Swiss Government's federal agency for all matters concerning intellectual property. As such, it is 
also the point of contact for customers that want to apply for and protect industrial property rights, such as patents, trademarks or designs.  
CTI 
411.  Thirdly, the Commission for Technology and Innovation (CTI) is the Swiss Confederation's 
innovation promotion agency supporting research & development projects. One such project is the 
provision of training programmes for start-up founders as part of the "La Forge" innovation park in 
Lausanne, which was introduced by this delegation at the last Council meeting in June.  
Katadyn 
412.  Finally, the company Katadyn, which is one of the world's leading manufacturers of individual 
water purification systems and products. The technologies developed by Katadyn, have a wide 
ranging application and have been utilized by international relief organizations, local communities and individuals across the world.  
The case of the ceramic filter 
413.  At the Swiss stand at yesterday's fair, the cooperation and interaction among these four 
stakeholders was illustrated with a case study of the development of ceramic filter membranes. 
The ceramic filter is used to treat water and ensure that it is safe to drink; traditional filters often 
let microscopic viruses through, while those that did not were very expensive to produce.  
414.  Katadyn wanted to find a way to lower the costs and raise the manufacturing capacity for 
such filters while retaining their quality and effectiveness. As an SME, Katadyn did not possess all 
the necessary know-how or the resources to carr y out the research required to design a new 
technology all on their own.  
415.  Therefore, Katadyn formed a partnershi p with EMPA who could provide the expertise 
unavailable to Katadyn to develop the necessary technology. Once the innovative technology was 
developed, a patent application was submitted to the IPI to protect the use of this innovation and secure the benefits for both partners. At this stage, the Commission on Technology and 
Innovation, the CTI, joined in as a partner of the innovation process, providing resources as well 
as advice and support, to facilitate bringing the innovative product from the laboratory stage to the market. 
416.  Thus, the research that went into this product was conducted over several years with the 
involvement of a number of actors, all contributing in different ways to overcome the various 
hurdles that may occur at the different stages of the innovation process.  
417.  Five years later the success of the project meant that Katadyn once again needed to upgrade 
its production process and once again is looking to work with its partners in the innovation chain to 
enable this to happen successfully.   
Conclusion  
418.  This case example demonstrates that the innovation process can be enhanced and promoted 
through partnerships. That is an important lesson, and one that applies equally in developing and developed countries.  IP/C/M/77/Add.1 
 
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  419.  Intellectual property rights play a key role in helping such partnerships to function well and 
facilitate working together at the various stages of the innovation process. They help ensure that each partner receives a fair share of the result of  the innovation process they contributed to. Also, 
IPRs help build trust and confidence for a well-w orking partnership, by providing certainty and 
transparency about the ownership and protection  of the innovation, enabling the legally safe 
transfer and sharing of such ownership throug h the share of benefits among the innovation 
partners. 
420.  TRIPS Delegates who did not have the opportunity yesterday to visit the Swiss stand and 
talk to the stakeholders represented there, but are still interested in the details of the case Switzerland just presented, are invited to let me  k n o w .  W e  w i l l  t h e n  s e n d  y o u  a  c o p y  o f  t h e  
Factsheet in electronic format.  
421.  Finally there is another opportunity today fo r delegates interested in innovation issues and 
the role of IPRs. Co-sponsored by the United St ates, the European Union and Switzerland, a panel 
event will take place during the lunch break. Seven entrepreneurs and innovators from a wide 
range of WTO Members will present their own experi ence, give advice and present case studies on 
the role of IPRs in their innovative ventures.  
12.2 European Union   
 
422.  I would like to share some reflections on the importance of innovation to development. I will start by asking some questions: how will we tackle challenges like climate change, energy supply, the scarcity of resources and the impact of demo graphic changes? How will we improve health and 
security and sustainably provide water and high-quality, affordable food?  
423.  In Europe, we believe that innovation plays a key role in responding to all these questions. 
The European Union has assigned a central role to innovation to underpin the smart, sustainable 
and inclusive growth of the Europe 2020 strate gy. Innovation is about promoting growth and 
ultimately benefiting societies. Innovation is not just research or technology  development and its applications. It encompasses both research-driven and innovation in business models, design, 
branding and services that add value and respond to people's needs. It is about building and 
changing the whole system: products, processes, ma rkets and organizations. It is about reaching 
the users, involving the suppliers as well as the consumers everywhere across borders, across 
sectors and across institutions.  
424.  Innovation is also about inclusiveness. Achieving the objective of transformative economies 
and societies requires the involvement of different actors in the innovation cycle, academia, public 
and private sector, civil society etc. In this perspective, not only major companies are important 
but also small and medium enterprises in all sectors and the social economy and the citizens 
themselves, often referred to as social innovation matter.  
425.  Cooperation through the innovation chain, including international cooperation, between 
countries as is the case here is also very important. In this context, the relevance of innovation 
also in relation to sustainability is evident. The sustainability agenda puts people at the centre and 
calls for working together to promote inclusive economic growth, social development and environmental protection. Europe 2020 also ackn owledges the potential contribution to green 
economy to achieving sustainable development. A re cent report by the Green Growth Best Practice 
initiative assessed the lessons from experiences of pursuing green growth across all levels of government and all regions. It pointed at green innovation policy, and labour market and skilled 
development policies as a prerequisite to a transition to green growth in many countries. This 
highlights that a green transformation requires more than technological innovation and needs to be complemented with open, social and financial innovation.  
426.  Finally, this report illustrates a clear payoff of government investment in green innovation as 
government investment in green research and development successfully translates into development and commercialization of breakthrough green technologies.  
427.  Let me now address the role of innovation and technology for the implementation of 
sustainable development goals. The creation of a favourable policy environment should include 
reforms to tackle fragmentation, modernization of education systems at all levels and capacity IP/C/M/77/Add.1 
 
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  building in countries that still lag behind in the innovation chain. This requires enhanced 
cooperation between science and businesses and increased international cooperation in research and innovation by opening national research programmes. The UN's sustainable development goals also recognize the importance of research and innovation for agriculture and food security, 
clean energy, vaccines and medicines. In this cont ext, research cooperation among countries will 
be central to ensure the co-creation of solutions as well as knowledge sharing. Ultimately this would favour the access to and ownership of the search results generated by all the actors 
involved.  
428.  The discussion often concentrates on the tr ansfer of technologies through trade and gives 
relatively less attention to the transfer of knowledge and know-how that is possible through research cooperation. Innovation also entails a different use or application of existing technologies. 
Research and innovation cooperation is often more important than commercial aspects of the 
technology transfer process in the field of promis ing, but less mature technologies or technologies, 
that need to be adapted to local conditions. By jointly identifying areas of research and innovation 
cooperation, it is possible to set the basis for technology facilitation. Also the exchange of 
knowledge between regions of the world confronted with similar problems can contribute to create 
economies of scale that are important for technological deployment.  
429.  The EU research programmes are among the most open in the world and promote 
cooperation with non-European countries, both industrialized and emerging economies and also developing countries. Also taking into account their different research capacities through these programmes the European Union has supported a number of sustainable development-related 
projects and international cooperation activities in different areas and across different disciplines, 
ranging from sustainable development governance to  sector-specific activities. Also Horizon 2020, 
the new framework programme for research and i nnovation recognizes the need for increased 
international efforts and enhanced science policy dialogue. Sustainable development is an 
overarching objective of Horizon 2020.  
430.  In recognition of the importance of knowledge  circulation, open access has been identified as 
a means to improve knowledge circulation and thus innovation. On this basis, open access will be 
mandatory for EU-funded research results, including publications and also on a pilot base, data, which will be produced with funding from Horizon 2020.  
431.  To conclude I would like to make a reference to yesterday's very successful event, the 
innovation fair, and to point out what we consider several of the most interesting elements that we 
saw there. 
432.  For instance, the European Patent Office had a stand, which included a number of studies 
that I have mentioned in previous interventions that I think bring absolutely crucial information to 
the debate about intellectual property and its ro le in the dissemination of environmental-related 
technologies. These studies were available there and some more were announced, so I hope you 
had the opportunity to see that part; the stand also gave us the opportunity to present the 
winners of the European Inventor award and their inventions.  
433.  The 2014 European Inventor award winners include very relevant inventions for developing 
countries. Let me give you a few examples. A new anti-tuberculosis drug invented by the Belgian 
researcher Koen Andries and his team is nearly twice as effective as a traditional treatment at 
eradicating tuberculosis in patients. It cures the disease just after eight weeks. These researchers extracted the molecule that cuts off the supply of  energy to tuberculosis bacteria after a short 
time. The drug can be successfully administered to treat even the multi-resistant form of the 
disease and has the potential to cure up to 8 million people affected across the globe. 
434.  Another example is the pharmaceutical company, Janssen Pharmaceutica, which hopes to 
start the third test phase for a medication this year, so that in about six years it can be introduced 
all over the world. There are particular needs for such medication in countries like South Africa, 
India and China. Although this antibiotic has on ly been approved in the United States, Europe, 
South Korea and Russia, it can already be administered in exceptional cases, if there is an ethical 
commission agreeing to it. This means that this drug has already saved lives in South Africa.  IP/C/M/77/Add.1 
 
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  435.  We also saw several inventions in the area of water purification, including one by Danish 
entrepreneurs. This invention of a Danish team of chemists makes it possible to process water in its purist form without consuming large amounts of expensive energy. We saw another project by a small Austrian company that has a mechanism which, with the help of ultraviolet checks, ensures 
that water is purified.  
436.  We saw a very interesting Braille tablet by a Hungarian inventor that is destined for the 
visually impaired. We also saw so many other projects. It is a bit unfair that I cannot name them 
all but I think that colleagues will agree that this was a very interesting event and a very positive 
experience.  
12.3 United States of America   
 
437.  Today's agenda item on IP and innovation , and promoting awareness with case studies is 
intended to complement the first ever WTO innova tion fair, which took place yesterday in the WTO 
Atrium. We hope that delegates and the Secretariat have had the opportunity to visit the fair and 
learn from the many participating inventors. 
438.  The fair, together with this item, reflec t the critical importance of raising awareness 
regarding innovation and the enabling environment needed to stimulate innovation, including 
research and development, education, financing, partnerships, absorptive capacity and IPR 
protection and enforcement. Without public awaren ess of the many keys that unlock the potential 
of innovation, including IPR, innovation remains confined, its potential remains fettered and out of reach of those seeking to make a difference and to improve lives.  
439.  For this TRIPS Council meeting, we wanted to take a proactive approach to reflect in our 
deeds outside of the Council what we have been discussing inside the Council. We have endeavoured to build a bridge of awareness between what we do here as governments and what 
innovators do beyond the walls of the WTO. So that the former can better assist the latter. For us 
this bridge is the innovation fair. This event underscores and reaffirms the relevance and importance of these issues and our discussions on them, not only locally in our domestic markets, 
but globally for all beneficiaries of innovation, not only as a policy discourse but as a real world 
imperative.  
440.  In our efforts to have the courage of our convictions, in our intervention this morning action 
will take centre stage with words playing a su pporting role. And there has been a tremendous 
amount of action, not only by the featured innovators, but by many delegations and others, to 
develop this idea. Like so many innovative ventures, the invention fair itself has been a truly intensive collaboration, involving a proliferation of good ideas and a tremendous amount of hard 
work.  
441.  Of course we want to thank the fair's co-sponsors, the European Union, Mexico and 
Switzerland and of course, with respect to the panel discussion this afternoon, Lithuania, too, as 
well as the many delegations from around the world, whose innovators are represented at the 
innovation fair, and who themselves have worked  extremely hard to put this event together. 
442.  To set the stage, I note that some have enquired about the link between trade, IPR and 
innovation. For us, this relationship is quite clear. The WTO is positioned at the crossroads of 
global commerce and international law. Trade serves as one of the key conduits for innovation, 
and plays a fundamental role in voluntary technology transfer and know-how diffusion. Innovation is a priority as well as an imperative for all countries.  
443.  Its benefits are indeed not only economic, such as job creation and economic growth and 
development, but social as well, as they can provide solutions to local needs, and improve quality of life and its enjoyment. To secure these bene fits, intellectual property is one of the key 
mechanisms to protect the promise of innovation and to combat the challenges we all face. This 
was confirmed yesterday by the fair and its many and diverse exhibitors.  
Innovation themes 
444.  We want to turn to introducing the innovators themselves that have travelled from around 
the world to feature their achievements. And we want to do so in the context of our ongoing IP/C/M/77/Add.1 
 
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  discussions, including on national innovation policies, university research, innovation incubators, 
small and medium-sized enterprises as well as gr een technology, sports, low-cost innovation and 
social entrepreneurship.  
445.  The innovation fair therefore is not an isol ated event but weaves together the many concepts 
we have discussed previously and will continue to discuss in this Council. As delegates will recall, 
in our past meetings under this agenda item, WTO Members have shared their national experiences on a range of topics covering the life  cycle of innovation, which are reflected at the 
fair. For example, several national and regional IP  offices such as the European Patent Office, the 
Swiss Federal Institute of Intellectual Property (IPI), Lithuania's Patent Office and the U.S. Patent and Trademark Office, as well as WIPO and the WTO, were represented at the fair to describe various national innovation models.  
446.  In past meetings, we have also discussed early stage university research and innovation 
partnerships that can lead to start-ups and spin-offs. Such partnerships are exemplified by RUCONBAR rubberized concrete noise barriers designed  in Croatia out of disposed end-of-life tyres 
and developed and patented at the Faculty of Civil Engineering in Zagreb. 
447.  And we have recently explored national incubator innovators, that shelter those innovative 
start-ups and spin-offs to help them. Several incubators, accelerators, and other innovative 
platforms, as well as numerous start-ups also featured prominently at the fair, such as 
Innoventures in Egypt, the Mexican Institute of In dustrial Property, Lithuania's Agency for Science, 
Innovation and Technology, and the City of Knowledge in Panama.  
448.  The presence of small and medium-sized ente rprises is also pervasive. Take for example, 
Ateknea, which is a Hungarian enterprise providing business and technological excellence to SMEs 
to develop their ideas into profitable innovative solutions; CrowdAnalyzer, an Egyptian start-up with a big data analysis solution; and REO systems, a French start-up, with a patent showing that 
even in curtains there is innovation. 
449.  The innovation fair also has big companies: Thales, a French company that specializes in 
open innovation and has a patent portfolio of more than 15,000 applications; Columbus 
Superconductors, an Italian company mobilizing superconductor technology for health and 
environmental response; Takram Design Engineer ing from Japan that among many other things 
has developed the water bottle for decades to come; a leading Japanese confectioner that has redesigned confection to reflect day and time of nutritional needs of each moment during the day. 
And of course there was Sound Candy from Turkey that has developed a candy that activates not 
only our taste but sound, smell, touch and sight senses.  
450.  The innovation fair also placed a heavy emphasis on green technology, which has been a 
consistent innovation theme here in the TRIPS Council. Several companies exhibited 
groundbreaking and sustainable technologies to address pressing environmental challenges. These 
include the ECO-SANDWICH® from Croatia, which is a prefabricated wall panel utilizing recycled 
construction and demolition waste and mineral wool. It achieves multiple environmental 
objectives, including the 20-20-20 goals of a 20% increase in energy efficiency, a 20% reduction of CO2 emissions and a 20% increase in the use of renewables by of course 2020. In addition, we 
are pleased that WIPO was available to particip ate with presentations on WIPO GREEN and WIPO 
Re:Search. 
451.  Finally, returning close to home here in Switzerland as our Swiss delegate just explained, 
Katadyn has established individual water purification systems and products, which I must say, are 
quite popular in the United States. 
452.  We also wanted to touch in more detail on  two of the themes that have been discussed here 
in previous Council meetings. And those are sports and low-cost innovation.  
Sports Innovation 
453.  Regarding sports, Nike was among the exhibitors featuring in its innovative approach. As an 
innovator, Nike exemplifies the profound role innovation and creativity play in the sports sector, and the importance of intellectual property to that sector. And this is not limited only to Nike's 
efforts to get us to cross the finish line faster or putting the puck in the net more frequently, but IP/C/M/77/Add.1 
 
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  also in promoting sports at the grass-roots level, including promoting youth, sports, and sports for 
women, indicative of the importance of intellect ual property to Nike. The company has over 8,000 
trademarks in over 205 countries, and its patent portfolio was ranked number one by the Wall Street Journal.  
454.  Like in other sectors, intellectual property is a critical asset that is monetized to further 
promote athletic endeavours. Broadcasting monetizes copyright, branding and sponsorship monetize trademarks, and the use of new technologies monetizes patents and trade secrets.  
455.  That revenue which intellectual property helps to create, in turn, helps to advance sport. The 
question for Nike is not why innovate or whether to seek IP protection for its own sake, but how to put IP into action to promote innovation for the sake of sport.  
456.  Innovation and the IPRs that secure it are means to the end of benefiting sport, including 
athletes and spectators alike, through providing safer and better equipment, supporting athletes 
and teams, heightening the thrill and excitement  of competition, and setting new records.  
457.  Intellectual property is not only a key feature of Nike's innovative-orientated business model. 
It is critical to the sustainability of sports teams, both big and small, international and local, for the 
ability to catalyse the creation and improvemen t of sports equipment, and to supporting and 
inspiring the next generation of athletes. 
Low-cost innovation and social entrepreneurialism 
458.  Finally, we wanted to conclude with several innovation fair participants that epitomize low-
cost innovation and social entrepreneurialism.  
459.  The first is the Helioz WADI ultraviolet measurement device from Austria that literally 
visualizes the process of solar water disinfection , and which is solar powered and operates without 
the use of any chemicals. According to sources, 80 % of all illnesses and deaths caused by diseases 
in developing countries derive from insufficient or contaminated drinking water supply. Over 50% 
of all hospital beds in developing countries are occupied by people who suffer from disease caused 
by contaminated water.  And it is always the most vulnerable who have to pay the highest price. Each year, 1.5 million children under the age of five die because of unsafe water. This is equal to 
around 4,000 children every day. The water disinfection tool developed by Helioz has the potential 
to save millions of lives.  
460.  Turning to Hungary, engineers there have developed a high tech interactive solution 
mentioned by my European counterpart for visually impaired persons that contributes to the 
promise of iPad-like uses for persons with visual impairments.  
461.  And finally, Johnson & Johnson development in China and India, which is also featured at the 
fair, echoes the same theme regarding the importance of need-driven and use-conscious 
innovation. Take Johnson & Johnson's work designed to increase access to high quality medical 
devices, including knee replacement kits for use by un-served patients in India and China that reflect not only advances in technology, but also the anatomical and ergonomic characteristics of 
its specific users. Johnson & Johnson's initiative provides devices to the under-served surgeons 
that are relevant to their needs and simple to use. 
462.  These are not only cutting-edge products that improve the lives of patients in two countries.  
The researchers, doctors, manufacturers, and others  involved in the creation and production of 
these products are integrated at every stage of th e innovative life cycle, so that these products 
meet local needs, address local challenges, and serve all those who use them. 
463.  To conclude, the innovation fair is a maker space. It is an enabling environment. It is an idea 
accelerator. The TRIPS Council can be all of these things too. In our view, the innovation fair and 
the TRIPS Council are not so very different. They may use different means but can promote the same end, that of innovation.  
464.  Our discussions in the TRIPS Council are meant to raise awareness about what promotes 
innovation and what hinders it. One country's experience may be relevant to others for their own innovative objectives. Your governments may ask what policies, practices and programmes have IP/C/M/77/Add.1 
 
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  led to the kinds of technologies we see at the innovation fair, or that have yet to be imagined. Our 
discussions in the TRIPS Council may provide some of those answers. But like all innovation, while it is imperative, it is not inevitable. While risk is certain, reward is not.  
465.  As we have demonstrated here in the Council, and the innovation fair exhibitors have 
confirmed, IPR is critical to responding to that imperative and to managing that risk. 
466.  We look forward to hearing from delegates today about their efforts to raise awareness 
about innovation. We invite you to go to the Atrium and visit the innovation fair, if you have not 
already done so. In addition, we want to take th e opportunity to note again the panel event taking 
placing in room S3. 
12.4 Ecuador   
 
467.  In relation to the case studies being pres ented under this agenda item, the Republic of 
Ecuador would like to inform Council Members about the country's efforts in the area of innovation and its relationship with intellectual property. 
468.  Ecuador's aim is to build a social knowledge economy. To this end, it has developed an 
inclusive Social Innovation System that seeks to coordinate the academic and production sectors so that innovations deriving from learned society can develop into products or services that are 
both necessary and useful for society. 
469.  This Social Innovation System comprises coordinated and correlated rules, policies, 
instruments, processes, institutions, bodies and individuals from the social knowledge economy, with a view to generating science, technology, innovation and creativity as fundamental elements 
that bring value and wealth to society. 
470.  The System's objective is to link the knowledge sector with the production sector, so that the 
research and development generated in learned society results in innovations that meet society's 
needs. The vision is one of a dynamic and consol idated system that will link together learned 
society, businesses and companies, with a view to providing services and tools that enable 
Ecuador to develop innovative undertakings that help to change the production matrix. 
471.  Ecuador understands innovation to mean the creative and collaborative process through 
which a new or significantly improved value added product, service or process is introduced, which modifies and creates new social behaviours with regard to problem solving, improving individual or collective capacities, meeting society's needs, and effectively exercising rights. It seeks to 
generate social, economic, cultural and technological impacts that promote living well. 
472.  In this context, the National Secretariat for Higher Education, Science, Technology and 
Innovation focuses on providing support for innovative undertakings, defined as actions aimed at 
developing a new or significantly improved product or service, the most important factor of which 
is the use of knowledge generated on the basi s of research processes, experimental and 
technological development or science based creative processes. 
473.  To this end, through the National Secretariat for Education, Science, Technology and 
Innovation, Ecuador will offer specialized services to promote innovative undertakings. These services consist of activities relating to the de velopment of ideas with market potential, market 
surveys, prototype production, business model de velopment, intellectual property management, 
networking, investment and financial portfolios, and the provision of shared physical spaces. 
474.  Its main project will be to implement a search and support plan for innovative research 
activities or undertakings called the Ideas Bank . This programme will be implemented through a 
virtual platform, the aim of which is to develop projects and ideas with innovative potential and 
facilitate their implementation with a view to meeting the needs and demands of society and the production sector. To meet this objective, the Ideas Bank seeks to create collaborative networks of 
actors related to science, technology, innovation, the production sector, and society in general, 
with a view to promoting synergy and fostering an environment that makes the development of innovation possible. IP/C/M/77/Add.1 
 
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  475.  The Ideas Bank accepts projects from any person, team or institution that has an idea with 
innovative potential, i.e. potential new or significantly improved goods or services that can be incorporated into the production sector. Once registered, the person, team or institution will be able to upload details of their project with innovative potential, with a view to accessing the 
services that are offered by the Ideas Bank to de velop ideas and transform them into innovations. 
These services include the accreditation and linkag e of spaces for the development of innovative 
projects which combine infrastructure with mentoring services. An idea remains in the 
development stage until it is converted into an innovative undertaking through advice and 
technical assistance. 
476.  These services will promote responsible sci entific research, technological development and 
social innovation, with a view to ensuring the tran sition from an exclusive production matrix based 
on the extraction of finite resources to an inclusive and democratic production matrix based on the 
intensive use of infinite resources, i.e. knowledge, creativity and innovation. 
12.5 Panama   
 
477.  We would like to thank the delegations of the United States, Switzerland and the European Union for including this item on the agenda. Panama recognizes that innovation is a key 
engine of economic growth and promotes pub lic policies geared to fostering innovation. 
478.  This year, Panama ranks third amongst countries of the Latin American and Caribbean region 
in the Global Innovation Index 2014. Our main areas of strength include infrastructure, innovation linkages, knowledge absorption, creative goods an d services, and online creativity. There are still 
many areas in which we can improve and conti nue supporting and promoting innovation and the 
use of intellectual property, but we are committed to improving our performance in the areas of principal concern and strengthening our position in those where we have shown that we have 
a competitive advantage. 
479.  Panama works through public institutions such as the National Secretariat of Science, 
Technology and Innovation (SENACYT), whose main  task is to transform science and technology 
into tools for the country's sustainable developm ent. Its projects and programmes are focused on 
enhancing Panama's scientific and technological de velopment, and thereby bridging the inequality 
gap and promoting equitable development, so as to improve the quality of life of our citizens. 
480.  In the private sector, our Government provides incentives and support through legislation 
and private initiatives such as the City of Knowledge, a knowledge management platform focused 
on boosting the innovative and competitive capacities of the users who share the campus. 
481.  The business accelerator programme of th e City of Knowledge provides motivation and 
awareness-raising for users to undertake new projects, beginning with a phase of advice on 
development and opportunities and ending wi th a phase of resource mobilization and 
internationalization. The business accelerator offers entrepreneurs a suitable environment for 
consolidating their business ideas and facilitating the necessary competitive leap to strengthen the 
operational aspect of their activity. The City of Knowledge is participating in the innovation fair taking place today in the atrium, and we invite you to visit and learn a little more about this Panamanian innovation incubator model. 
12.6 Japan  
 482.  First of all, this delegation would like to  extend its congratulation for the great success of 
yesterday's innovation fair and express its gratit ude to the European Union, Switzerland and the 
United States for their efforts in jointly proposing this agenda item. Japan appreciates this opportunity to share its experience on how we have been raising awareness on intellectual 
property. We believe that our experience in prom oting awareness is useful for other Members.  
483.  My delegation recognizes the importance of promoting awareness on IP as a means of 
encouraging innovation and facilitating economic activities worldwide. In this regard, Japan has 
been making various efforts to promote awareness on IP from two different perspectives that are 
related in some respects. They are how to encourage SMEs to make full use of the IP system, on 
the one hand, and how to raise awareness on IP in the general public, on the other hand. IP/C/M/77/Add.1 
 
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  484.  With regard to SMEs, my delegation would like to make a brief remark about two initiatives 
designed to encourage SMEs to utilize IP. In 2011, the Japan Patent Office established IP Comprehensive Support Counters in 57 cities in Japan. These Counters provide comprehensive support on a variety of IP issues all in "one stop", so to speak. For example, they give free 
consultations, mainly to SMEs, on how they can f ile patents, create design and brand strategies, 
license IP, protect their IP against counterfeits, and expand their businesses overseas. These Support Counters responded to more than 148,000 inquires in fiscal year 2013.  
485.  The Japan Patent Office also published a booklet entitled "2014 Collection of Outstanding 
Companies Utilizing Intellectual Property Rights", in February 2014. This booklet is distributed as 
hard copies nationwide and is also available on the Japan Patent Office's website. It gives best 
practices implemented by 139 SMEs, showing how they  utilized their proprietary IP successfully in 
their businesses. These best practices serve as useful references to other SMEs, and encourage 
them to protect and disseminate their own creative technologies utilizing IPRs as leverage.  
486.  I will now speak about the initiatives that were focused on the general public. In order to 
raise further awareness on counterfeit products, the Japan Patent Office has been conducting an 
"Anti-Counterfeiting Campaign" every year since 2003, providing educational material such as videos on the Internet as a means of informing the public of the risks associated with purchasing 
counterfeit products.  
487.  With regard to piracy, the Manga-Anime Guardians Project was launched with the mission to 
bring "genuine creations" to Manga-Anime fans all over the world. To achieve this objective, the Ministry of Economy, Trade and Industry, METI, is working on the measures, not only to take down 
pirated copies of Manga and Anime from the online  space, but also to create a scheme to guide 
fans to legitimate sites and to promote awaren ess on copyright among viewers and consumers. 
Through these initiatives, the METI aims to supp ort and expand the fan base of Manga and Anime 
and to popularize the idea of making proper compensation for creative works. Also noteworthy is a 
special promotional short movie "Thanks, friends", which consists of "Thank You" footage from selected masterpieces of Japanese Manga and Anime. Please visit and watch this special movie. 
488.  Lastly, we would also like to explain about the "WIPO Manga Competition", which was 
organized by the WIPO Japan Office under the sponsorship of the Ministry of Foreign Affairs and the Japan Patent Office. The manga, or cartoon, that won the competition is published on WIPO's website both in English and Japanese. The useful material in manga format informs readers about 
the risks and dangers of counterfeit products, in a clever, eye-catching, and easily understandable 
way.  
489.  Japan remains committed to raising awareness on IP in various ways and supporting 
innovation. We would be pleased to share more in formation in this regard with other Members.  
12.7 Chile   
 
490.  We would like to thank the co-sponsors of this agenda item, and those who convened the 
first innovation fair at the WTO. This activity is the first time that the organization has opened its doors to the public on the basis of a Member-driven initiative, which we hope will be kept up over 
time as a regular activity of the organization. 
491.  In the case of Chile, the National Institute of Intellectual Property created in 2009 wants us 
to contribute to the development of the economy through stimulating entrepreneurship, innovation 
and creativity. This is on the basis of a clear commitment to protect industrial property, as well as 
to disseminate our technological legacy in all the available information.  INAPI has shared with us 
through experiences of Chilean inventors who have worked in the institute and have dared to pursue their dreams, protecting their creations through invention patents. These were documented 
in videos, exposed at the fair. They are a tangible proof of the incentive for innovation and 
industrial property in this aspect. They provide a direct contribution to our society which can generate products which favour health and sustainable development with a direct impact on the quality of life. IP/C/M/77/Add.1 
 
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  12.8 Mexico   
 492.  The innovation fair, as mentioned by other co-sponsors, was extremely successful. It is certainly the first public event of its kind organized at the WTO. Other delegates who have 
preceded me in taking the floor have already mentioned sufficient details about the fair, and the 
real impact and the result of protection of intell ectual property such as a new water bottle, a water 
purification system, superconductors or adapting a special prosthesis in a certain region. Mexico 
showed a video on the history of IP protection in Mexico since 1821 and provided brochures about 
procedures to obtain protection of patents and trad emarks from the Industrial Property Institute of 
Mexico. 
12.9 India   
 
493.  My delegation would like to thank the dele gations of the European Union, Switzerland and 
the United States for tabling this agenda item.  
494.  Let me just recall our intervention when  the agenda item on Intellectual Property and 
Innovation was first introduced in the TRIPS Council. Our statement is still relevant when we are discussing 'Promoting Awareness; Case Studies' under the broad theme of Intellectual Property 
and Innovation. In that meeting, India pointed ou t that the word "innovation" appeared just once 
in the TRIPS Agreement, in Article 7, which stat es that "intellectual property rights should 
contribute to the promotion of technological inno vation and to the transfer and dissemination of 
technology," not for the sake of innovation itself, but "to the mutual advantage of producers and 
users of technological knowledge and in a manner conducive to social and economic welfare, and 
to a balance of rights and obligations." Thus th e TRIPS Agreement makes it very clear that the 
purpose of the intellectual property system is no t solely to protect the commercial interests of the 
intellectual property holder, but it is one of the many tools available to the society to achieve 
technological development, social and economic welfare and innovation.  
495.  According to Petra Moser, Patents and Innovation: Evidence from Economic History, Journal 
of Economic Perspectives—Volume 27, Number 1—Winter 2013—Pages 23–44: 
 "Overall, the weight of the existing historical evidence suggests that patent 
policies, which grant strong intellectual property rights to early generations of inventors, may discourage innovation. On the contrary, policies that encourage 
the diffusion of ideas and modify patent laws to facilitate entry and encourage 
competition may be an effective mechanism to encourage innovation." 
 
496.  Innovation should not be viewed within the narrow prism of intellectual property monopolies, 
but framed within a holistic, knowledge ecosystem that includes open innovation, open knowledge 
approaches and the de-linkage of R&D costs from product prices. According to the WTO, WHO and 
WIPO Trilateral study, Promoting Access to Medical 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 te chnologies, e.g. the nature and extent 
of demand, commercial advantages gained by marketing and ancillary services 
and support, commercial and technical viability of production processes, and 
compliance with regulatory requirements, including through effective management of clinical trials data." 
 
497.  The Trilateral Study also highlights that innovation in medical technologies for neglected diseases suffers from market failure as conventional IP-based incentives do not correspond to the nature of demand for treatments of these diseas es. To overcome the market failure of the IP 
system for neglected diseases, the Trilateral Stud y mentions open innovation structures such as 
the Open Source Drug Discovery (OSDD) model of India's Council of Scientific and Industrial Research (CSIR), collaborative research such as WIPO Re:Search Sharing Innovation in the Fight 
Against Neglected Tropical Diseases. The study also talks about the concept of delinking the price 
of the final product from the costs of R&D by 'push' mechanisms, such as grant funding and tax IP/C/M/77/Add.1 
 
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  credits for investment in R&D and by 'pull' mechanisms that offer rewards for the final outcome of 
R&D of certain products. 
498.  The Executive Office of the President of the United States, President's Council of Advisors on 
Science and Technology (PCAST) published a repo rt to the President on combating antibiotic 
resistance in September 2014. According to the report, antibiotic-resistant infections are 
associated with 23,000 deaths and two million illnesses in the United States each year and estimates of annual impact of antibiotic-resistant infections on the US economy is about 
US$55-70 billion. The report states that market failure is the reason for the inadequate state of 
antibiotic development, as the economic return on developing new antibiotics is currently too low to elicit adequate private investment and innovation. The report also suggests 'push' and 'pull' mechanisms to incentivize the development of new antibiotics. One of the pull mechanisms 
suggested is 'delinking' antibiotic usage from revenues:  
"A variety of incentive models have been proposed, including user licences, 
lump sum prizes, patent buy-outs, and payments to hold drugs in strategic 
reserve. These models would provide reduced risk to potential developers (the 
economic reward is defined), reduced risk to users (their cost is contained), and would allow the resulting antibiotics to be managed as a strategic resource 
so as to preserve their effectiveness for critical uses. In addition, these models 
would not create incentive for a drug maker to increase sales of the antibiotic in order to make more money. (Page 39)"  
499.  As part of the trilateral cooperation between  the WHO, WIPO and the WTO on innovation and 
access to medicines, we request these Organizations to organize a symposium on "New Business Models for Fostering Innovation and Access: Innovation Inducement Prizes and Open Source 
Development Models." 
500.  With regard to the awareness programmes on IP and Innovation, India declared the decade 
of 2011-2020 as the Decade of Innovation. The spirit of innovation has to permeate all sectors of 
the economy from universities, business and government to people at all levels. The future 
prosperity of India in the new knowledge econom y would increasingly depend on its ability to 
generate new ideas, processes and solutions, and the process of innovation would convert knowledge into social good and economic wealth.  
501.  In India, many Government in stitutions at centre and state le vel, industry organizations, and 
non-governmental organizations are involved in creating awareness about intellectual property. Due to lack of time, I will restrict myself to IP awareness programmes of only two institutions: the 
Patent Facilitation Cell of the Department of Science and Technology; and the Intellectual Property 
Office. 
502.  The Patent Facilitating Centre (PFC) was set up by the Department of Science and 
Technology at the Technology Information Forecasting and Assessment Council (TIFAC) in 1995. 
The Patent Facilitation Centre, along with its 26-satellite Patent Information Centres (PIC's) in various states and 71 intellectual property cells at various state universities create awareness about intellectual property rights among the people through awareness seminars, workshops, 
lectures, talks, exhibitions and publications. 
503.  The Indian Intellectual Property Office has undertaken extensive outreach programmes for 
the last several years for promoting IP awaren ess in the country. In the year 2013-14, the 
Intellectual Property office focused on the promotion of IP in the industrial clusters related to 
specific fields of technology. In the current financial year, the Intellectual Property Office, in association with the Industry Associations, is conducting a series of specific awareness 
programmes on intellectual property. These are two-day programmes, of which the first day will 
be used to impart awareness to local industry and government department officials, while the 
second day will be devoted to creating awareness about intellectual property in the academia. The programmes will specifically target students, research scholars, lecturers and professors, micro, 
small and medium enterprises (MSMEs), and start-ups and government officers. IP/C/M/77/Add.1 
 
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  504.  I would like to conclude by stating that there is no direct correlation between 'Intellectual 
Property and Innovation' and that countries have to define the path depending on their level of socio economic development. 
12.10  Canada   
 
505.  Canada is pleased to discuss this agenda it em as part of the ongoing theme dealing with IP 
and innovation. These agenda items have been usef ul in illustrating the significance of the TRIPS 
Agreement in spurring innovation. 
506.  The Canadian Intellectual Property Office (CIPO) is responsible for administering Canada's 
system of IP rights. Their 2012-2017 Business St rategy includes a focus on better understanding 
customers' innovation and IP needs, as well as undertaking targeted outreach to ensure that the 
IP system supports innovation in Canada.  
507.  In light of this mandate, CIPO has engaged in targeted outreach efforts to promote a better 
understanding and knowledge of IP among small an d medium-sized enterprises (SMEs) in Canada, 
and has expanded its IP awareness strategy to add the education sector as a target group.  
508.  One initiative that assists in public awareness of IP in Canada is CIPO's IP Case Studies 
programme. IP Case Studies are teaching tools for colleges and universities designed to 
demonstrate the strategic value of IP to students. They aim to give students a baseline knowledge 
of IP, foster classroom discussion of the use of IP  in the inventive process, and explain how IP can 
be a competitive advantage in business. These teaching tools are designed to reflect realistic career situations for students, particularly those studying engineering, science, business, and 
industrial design. Since the launch of the IP Case  Studies project in September of 2009, CIPO has 
delivered over 500 IP case studies to universities and colleges across the country, primarily in science, engineering and business faculties. CIPO has successfully delivered sessions at more than 
70 post-secondary institutions across Canada. The IP case studies are also acknowledged as being 
of high quality with educational institutions from over ten countries having approached CIPO to ask permission to use them, including institutions in the United States, the United Kingdom, France 
and Chinese Taipei. 
509.  Another outreach activity involves IP info rmation sessions that are delivered to SMEs and 
post-secondary institutions through a collaborative  effort by CIPO and the Intellectual Property 
Institute of Canada. These sessions aim to provide SMEs and post-secondary institutions with a 
better understanding of the best IP options releva nt to their particular situations. In 2012–2013, 
322 IP information sessions were conducted for the business and post-secondary communities across Canada.  
510.  CIPO has been helping Canadian businesses to make more effective use of IP assets and 
information by reaching them through events, seminars, and its website and call centre. CIPO is also working very closely with key intermediary organizations engaged within the innovation 
ecosystem in Canada. For example, one-day IP training sessions have been provided to business 
advisors working with exporters, including over  250 Trade Commissioners from the Department of 
Foreign Affairs, Trade and Development.  
511.  In February and March 2014, Industry Canada hosted a national series of roundtable 
discussions with business leaders and leading IP pr actitioners to discuss IP and identify actions 
that could be taken to further support investment and innovation in Canada. Overall, roundtable participants expressed a general view that Canada's IP system is sound and well administered. 
However, they also pointed to a number of challenges they face in using the IP system. Small and 
medium enterprises in particular indicated they find securing IP rights costly, complex and time-consuming, and called for greater IP awareness-raising initiatives and information tools to help 
them build their IP expertise. In response, a series of workshops were also held across Canada in 
2014 on the importance of developing an iron clad integrated IP strategy at the firm level.  Workshops were well received by industry. Industry  Canada is currently examining what additional 
initiatives could be developed to meet this need. 
512.  Additionally, since June 2012, CIPO has held multiple roundtable consultation meetings with 
nearly 200 innovative SMEs and university Technology Transfer Offices across Canada. These IP/C/M/77/Add.1 
 
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  meetings provided an opportunity to meet with  innovators to understand their needs, their 
expectations, and the barriers they face in effectively using and leveraging IP to support their business goals. The insights on the requirements of innovators and the innovation cycle in which 
they operate are now driving CIPO's priorities and performance goals. 
513.  Economic prosperity in a global economy is driven by new ideas and knowledge-based 
industries.  Public awareness of IP is essentia l to ensure that businesses, governments, and 
educational institutions understand that an effective IPR regime is a crucial incentive to foster 
innovation and creativity, attract new investment, and stimulate economic growth. 
12.11  Hong Kong, China   
 514.  I would like to start by thanking the Europe an Union, Switzerland and the United States for 
bringing this item under the "IP and Innovation" series to the meeting again. To Hong Kong, 
China, promoting awareness in IP and innovation is an interesting and important subject. We are 
more than happy to participate in related discussions. 
515.  Innovation technology and the cultural and creative industries are important drivers of our 
economy. Both the stakeholders and government have contributed considerably to their sustainable development. 
516.  Innovation technology has seen rapid growth in Hong Kong, China in recent years.  Between 
2001 and 2012, our gross R&D expenditure had grown by an average of 7% annually, to about US$2 billion.  During the same period, the number of R&D personnel more than doubled, to over 
25,000.  Since 1999, the Government has supported  more than 4,000 projects with approximately 
US$1.1 billion from the Innovation and Technology  Fund. In the wake of previous successes, we 
are increasing funding for SMEs and universities.  We are also expanding the hugely popular Hong Kong Science Park – its Phase 3 will have a strong focus on green technologies. 
517.  Hong Kong's cultural and creative industries  contribute to about 5% of the GDP and provide 
more than 200,000 jobs. The Government has set up the US$ 41 million Film Development Fund and the US$77 million CreatSmart Initiative to provide financial support for producing small-to-
medium-budget films, nurturing talents, faci litating start-ups, and promotion and market 
expansion in such sectors as film, music, design, architecture, advertising, publishing and digital 
entertainment. Public resources are also available for nurturing local art groups, talents and administrators, and promoting art in schools and the community. In 2014-15, the related 
expenditure is expected to be about US$450 million. 
518.  From the above you can easily identify the usual enabling factors: strong R&D capabilities, 
vibrant talent pools, outstanding infrastructure, world-class universities and training institutes, and 
funding support. What is not so visible but equally, if not more, important is an enabling 
innovative environment in society and a robust IP rights protection regime. 
519.  We consider that promoting awareness of  innovation and IP rights among the public, 
especially children and young people, is a prio rity because as rights holders, they should 
understand their interests and how to protect them; and as users, they should know how to enjoy IP without infringing upon the interests of others. 
520.  At different stages of school education, we introduce to students from different perspectives 
the concept of intangible property and the value of  IP rights and the need to respect them. When 
the y re ac h a more  s e nior le ve l , we  as k s tud e nts  to look at I P  rig hts  from the  p e rsp e c tive  of a consumer. As a sensible consumer, the student has to think about not only value for money and 
consumer rights, but also issues such as environmental protection and IP rights. 
521.  Outside the curriculum, we also organize school visits and education initiatives, such as the 
Interactive Drama Programme to arouse the students' interest. We also use other interactive 
channels such as seminars, competitions and music shows. 
522.  For the business community, we organize semi nars and exhibitions with a view to helping 
them, especially SMEs, to understand the importance  of protecting their IP rights and know more 
about innovation and IP management. IP/C/M/77/Add.1 
 
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  523.  Among the general public, we promote innovati on and IP rights protection through posters, 
public lectures, TV advertisements and the website of the Intellectual Property Department. In 2014-15, more than US$1.2 million has been earmarked for organizing public education and awareness programmes for IP rights protection. 
524.  Intellectual property is an ever-evolving area and we have been improving our IP regime to 
catch up with the latest trends.  To ensure our IP rights protection regime is more robust and up-to-date, we are looking into an "Original Grant" Patent System and have recently introduced the 
Copyright (Amendment) Bill 2014 to the Legislative Council. Together with other new support 
measures being developed for trade enabling, IP cr eation and exploitation, intermediary services, 
promotion and education, we hope these initiatives will help consolidate and enhance Hong Kong's position as the premier IP trading hub in the region. 
525.  We are glad to have heard a number of insp iring ideas in this room. Hong Kong, China looks 
forward to more interventions today and further discussions in future. 
12.12  Chinese Taipei   
 
526.  Our delegation would like to join others in thanking the European Union, Switzerland and the 
United States for adding this item to the Agenda, and for their introduction to the subject. We are 
very happy to share our own experiences with Members in the perspective of how we raise 
awareness of IPR protection and promotion. 
527.  First of all, we must bear in mind that ed ucation plays a vitally important role in changing 
people's behaviour. We believe that both educators and students can help to reduce the growing 
prevalence of copyright piracy and trademark counterfeiting simply by learning more about the 
whole subject of IPRs themselves, and by spreading the word that respecting IPRs is in everyone's interest. 
528.  For this reason, my government recently launched the "Action Plan for the Protection of 
Intellectual Property Rights on Campuses" and the "Industry Academy Cooperation Plan". We have been making a considerable effort to raise awareness among teachers and students of the need 
for, and the importance of, IPR protection and promotion. 
529.   I should like to describe to you, some of the main elements of this Action Plan, and how it 
has been working so far:  
530.  Each university has been asked for specific details of the IPR Protection and Innovation 
Programme. These are important criteria in the Ministry of Education's decisions as to the size and 
destination of budgets allocated to both public and private universities. 
531.  Each public and private university and college has been asked to ensure that on-campus 
compliance with IPRs is in place, and to actively promote the use of legally published textbooks 
only. On-campus businesses that provide copy services must be informed that they are not permitted to engage in copyright piracy, and this must also be stipulated in all contracts with off-
campus businesses that provide such services.  
532.  Management internal control systems an d mechanisms for campus copying are to be 
established as well. 
533.  The Ministry of Education has asked each university to submit a report each year of the 
results from its implementation measures on this matter. These self-review reports are to be 
published online for public scrutiny, and they will become one of the criteria used for institutional evaluation.  
534.  The Ministry of Education has placed the issu e of IPR protection and innovation promotion on 
the agenda of the several conferences of Univer sity and College Presidents, Deans of Academic 
Affairs and other similar annual conferences. It has also asked universities and colleges to step up 
their efforts to promote and implement the two action plans. IP/C/M/77/Add.1 
 
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  535.  Lastly and the most important, my Government recognizes the growing importance of 
innovation and entrepreneurial activity in the new era of the knowledge economy. To face the 
challenge of global economic change and competition, we realize the necessity to further the development of a high-quality environment for IP innovation on campuses. 
536.  We launched the Industry Academy Cooperation Plan to facilitate the transfer of technology 
among academies and entrepreneurs. 
537.  Since 2002 we have established six regional industry-academia cooperation centres, 
providing assistance to a total of 90 (technological) universities/colleges. Last year, the 
US$230million investment in such cooperation resulted in the granting of 2,344 patents and US$5.6million in technological transfer.  
538.  This year we organized a series of information meetings on successful patent portfolios to 
help industries learn more about patenting trends in targeted fields, improve patent application 
quality, and develop strategies for coping with patent litigation across borders. With emphasis on information communications, green energy, and biopharmaceuticals, the series offered courses by 
patent examiners and industry representatives, with the aim of strengthening industrial 
competitiveness, spurring development and transition in the industry.  
539.  In addition, we provide training courses for university technology transfer institute 
personnel, strengthening their R&D capability and applicability. 
540.  As Nelson Mandela said, "Education is the most powerful weapon which you can use to 
change the world." We are convinced that IP education will increase awareness of and respect for IPRs, and will effectively and noticeably reduce  copyright infringement. Through education, we 
believe we can also promote a greater sense of appreciation for creation in our society.  
12.13  El Salvador   
 
541.  Our delegation would first like to thank the proponents for placing this item on the agenda 
and also thank the delegation of Switzerland for the organization of this first innovation fair in the WTO. 
542.  Our delegation would not like to miss this opportunity in indicating our pleasure and 
admiration for the reports submitted by two Members, Ecuador and Panama, and I would refer first of all refer to Ecuador's presentation. I note that they have taken a step forward through the creation of an academy within the system for social innovation. My delegation will be holding 
bilateral contacts with Ecuador, so as to know more about this initiative.  
543.  With regard to the information from the delegation of Panama, we would like to extend to 
them our congratulations on the important ranking they have achieved in the Innovation Index 
and also for the work being done in Panama. El Salvador is fully aware of the benefits of this. We 
were very pleased to hear how they take the innovator by the hand through the full steps of a project, which becomes a reality on the ground. And we would like to thank Panama for this 
report, which will help to guide us in our own domestic innovation policies we may be 
implementing.  
12.14  Australia   
 
544.  I would like to echo the comments made by  previous delegations and thank the proponents 
for bringing forward this agenda item and also th e organizers and participants of the innovation 
fair, which is an excellent initiative. 
545.  Innovation is critical to the growth of our economy. It makes our economy more competitive 
and creates investment. In recognition of this, Australia was pleased to launch the hosting of the 2014 Global Innovation Index in Sydney in July. Th is Index, co-published by the World Intellectual 
Property Organization, Cornell University and INSEAD Business School, looks at how economies 
around the world support innovation. We commend this study to those who have not yet had the opportunity to review it. IP/C/M/77/Add.1 
 
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  546.  As highlighted at the launch, Australia's experi ence is that four features within its IP system 
have been important in supporting innovation. Fi rstly, striking a balance between encouraging 
innovation and ensuring equitable access to new technologies, products and services. Secondly, providing investors with an opportunity to recoup the investments necessary to bring ideas to the 
marketplace. Thirdly, ensuring that innovators can obtain the rewards from their research and 
development and can fund further research. Finally, promoting further innovation through access to information, new technologies and content. 
547.  We have also found that Australian businesse s that innovate are three times more likely to 
export and 18 times more likely to increase th e number of export markets targeted than those 
that do not.  
548.  We also recognize the importance of leveraging innovation occurring outside of Australia. As 
a net importer of intellectual property, Australians need access to the creative works and 
inventions of our trading partners and our approaches also support this need. 
549.  In closing, Australia is committed to supporting innovation and ensuring that we both have 
access to the innovation of others and enable Australians to contribute to the pool of innovative 
and creative ideas. 
12.15  Brazil   
 
550.  Brazil would like to thank the delegations of the United States, the European Union and Switzerland for proposing this agenda item and welcomes the debate on IP and innovation: promoting awareness; case studies. Raising awaren ess of the tools offered by the IP System to 
incentivize innovation is a very important goal of public policies.   
551.  At the outset, as it was also stated by other delegations, it is important to highlight that 
patents are far from being the only element drivin g innovation. They are only one in a larger mix 
of different tools that promote innovation. Having the right infrastructure for innovation, 
collaboration on research, the flow of ideas among different innovation players, and access to knowledge are often more important ingredients of innovation. 
552.  My first comment is that any in-depth discussion on this topic must be based on the 
realization that the granting of exclusive intellectual  property rights can only be justified to correct 
a potential failure in the markets of technology and knowledge. 
553.  That correction of situations of market failure entails costs for society. By establishing 
monopolies, however provisional they may be, protection of intellectual property can impair 
market efficiencies in allocating production factors and resources. To compensate for the possible costs of misallocation, the intellectual property system demands, in return for the granting of 
exclusive or monopolistic intellectual property rights, full disclosure of the know-how of the 
protected invention, in such a way that society as a whole may benefit from it and build upon it. 
554.  This essential trade-off to the patent system has another component: to be able to apply for 
protections, inventions must be, according to Article 27 TRIPS, novel, useful and non-obvious. Not 
all innovations or inventions should be entitled to patent protection. This is clear enough. However, what exactly should be protected and how to translate the three conditions for patent application in Article 27 into national legislation and regulations remains one of the most divisive issues 
whenever one discusses the current international patent  system. 
555.  Against this background, the greatest challenge for public policymakers in any country is 
arguably how to design a theoretically "optimal" IP system that would be capable of generating 
incentives for investment in innovation, while at the same time minimizing losses caused by the 
granting of IP rights. 
556.  Having said that, our delegation would like to mention one sucessful case study of innovation 
and its interesting relation with the IP System. In 2003, a group of Silicon Valley engineers 
founded a company to develop electric vehicles. Today, after only 11 years since its start, that company employs more than six 6,000 workers. IP/C/M/77/Add.1 
 
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  557.  One of its success stories is a sports car that can go from 0 to 60 mph, 0 to almost 
100 km/h  in 3.7 seconds and travel for 245 miles or almost 400 km per charge. 
558.  In 12 June, one day after the conclusion of our last TRIPS Council, the CEO of the company 
made public he would radically change the IPR policy in order to foster the access to their 
technologies and expand the usage of electric vehicles. They started an open-source policy aimed 
at strengthening the position of that automotive company and spreading the usage of their technologies. According to the words of the CEO: 
"(...) we felt compelled to create patents out of concern that the big car 
companies would copy our technology and then use their massive manufacturing, sales and marketing power to overwhelm us." 
 
Still according to him: 
 
"Technology leadership is not defined by patents, which history has repeatedly shown to 
be small protection indeed against a determined competitor, but rather by the ability of a 
company to attract and motivate the world's most talented engineers." 
 
559.  With that, we would like to state once ag ain that national policymakers have over their 
shoulders the responsibility of creating the necessary balance in the IP system that can foster innovation, avoid unnecessary barriers to trade and incentivize the adoption of the latest technologies. In performing this task, it is necessary to bear in mind the experience of innovators 
and their interaction with the patent system. 
AGENDA ITEM 13: CONCERNS WITH RESPECT TO MEASURES RELATED TO PLAIN 
PACKAGING OF TOBACCO PRODUCTS AND THEIR COMPATIBILITY WITH THE TRIPS 
AGREEMENT 
13.1 Ukraine   
 
560.  As you are aware, my Government, together with the Governments of Honduras, the 
Dominican Republic, Cuba and Indonesia, is currently involved in a WTO panel litigation process relating to Australia's tobacco plain packaging me asure. This month, Ukraine and the four other 
Complainants have filed their first written submissions, which have now been received by the 
Panel, Australia and the many Third Parties.  The Chairperson of the Panel, in a public 
communication dated 10 October 2014, informed the Dispute Settlement Body that it does not 
expect to issue its final report to the parties before the first half of 2016. 
561.  Even as this dispute has progressed, a number of WTO Members are reportedly in various 
stages of the process of implementing plain pa ckaging laws, prohibiting without any individual 
assessment the use of validly registered trademar ks on lawfully available products. This Council 
has heard concerns on previous occasions rega rding the measures proposed by New Zealand, 
Ireland and the United Kingdom.  In addition to  these Members, the Government of France has 
recently discussed the imminent development of  its own proposal for the "neutral" or plain 
packaging of tobacco products.  Finland also appears to be considering a similar proposal.   
562.  As we previously stated in this Council and as elaborated upon in our submission to the WTO 
Panel, which many of the Members present here toda y will have received, we are of the view that 
plain packaging measures are incompatible with a number of fundamental principles of trademark 
protection as embodied in the text of TRIPS Agreement.   
563.  Plain packaging measures deny trademarks th e ability to fulfil their essential function to 
distinguish products which makes trademarks what they are – functional rights. 
564.  Distinctiveness is the primary criterion for obtaining trademark protection precisely because 
trademarks are to be used on products or in relation to services to identify and distinguish products. 
565.  It is not the nature of the product to which the trademark is to be applied but the nature of 
the individual trademark that is to determine its protected status. IP/C/M/77/Add.1 
 
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  566.  Trademarks are private and exclusive rights, whose scope of protection and power of 
enforcement, depend on the actions of the trademark owner alone. 
567.  Trademarks are to be protected "as is" and any encumbrances on their use must be limited, 
so as not to impair the essential distinguishing nature and function of trademarks. 
568.  Plain packaging measures go against all of these principles.  They are based only on the 
nature of the product; they seek to destroy di stinctiveness; they prevent the trademark from 
performing its function; and they reduce the scope of protection and enforcement below the 
guaranteed minimum level. 
569.  Importantly, these measures do not apply a case-by-case assessment of the affected 
trademarks, which could have justified certain encumbrances and could have formed the basis for invalidating certain trademarks or preventing th eir use.  Indeed, the TRIPS Agreement provides 
Members ample flexibility to adopt measures that affect particular trademarks if the specific 
trademarks raise public policy concerns, for exam ple because they are deceptive, misleading or 
otherwise individually problematic from a public morals perspective.  There is broad authority 
under the TRIPS Agreement to refu se registration, invalidate registration or prevent the use of 
individually problematic trademarks.  However, absent such individual assessment, the very substance of the trademark right cannot be impaired. 
570.  Further, Ukraine's claims do not relate to the broad range of tobacco control measures in 
force in Members like Australia such as advertising bans, graphic health warnings and bans on certain product descriptors that are demonstrated to be misleading.  Effective tobacco control is not under threat as a result of our challenge of Australia's measure. 
571.   Although legally of lesser importance to the TRIPS issues, it is important to note that the 
evidence to date – now nearly two years after full implementation of the measure in Australia – proves that, in any case, the measure is not working, is not apt or likely to work and is actually 
counterproductive.  The only impact the Australian plain packaging measure appears to be having 
is to distort the normal market dynamic by enco uraging consumers to "down-trade" from premium 
products to low-priced, low-quality alternatives or even to illicit products.  In short, the important 
role that trademarks play in ensuring fair competition and allowing product differentiation that 
stimulates international market penetration is distorted for no good reason. Trade and competitive opportunities are being harmed while there is no or  a negative contribution to public health or 
tobacco control goals. 
572.   Ukraine therefore requests those Members that are considering similar measures to reflect 
on these points and to allow the WTO Panel the necessary time to conduct its objective assessment of the factual and legal arguments presente d by the parties in this dispute.  This ruling 
will be able to guide Members in respect of their legal obligations under the TRIPS Agreement and 
is worth taking into consideration before finalizing any plain packaging proposals. 
13.2 Dominican Republic   
 
573.  The Dominican Republic fully shares Ukraine's concerns about WTO Members possibly following Australia's example and implementing pl ain packaging measures for tobacco products.  
Together with Ukraine, Honduras, Indonesia an d Cuba, the Dominican Republic is currently 
challenging Australia's tobacco plain packaging measures on the grounds that they are inconsistent 
with WTO Members' obligations under the TRIPS Agreement and the TBT Agreement. The Dominican Republic recently filed its First Written Submission with the Panel. 
574.  Australia's plain packaging measures do not regulate tobacco usage, and instead prevent 
tobacco producers from using their trademarks and GIs to perform their basic functions.  In other words, the measures do not target tobacco usage directly, but rather attempt to do so indirectly 
by undermining the intellectual property rights that Australia has specifically agreed to protect in 
accordance with its WTO obligations. 
575.  In bringing this dispute, the Dominican Republic underscores that it shares Australia's 
objective of reducing smoking. The health cons equences and attendant social costs of tobacco 
consumption are considerable.  The WTO covered agreements permit a Member to adopt tobacco IP/C/M/77/Add.1 
 
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  control measures that effectively promote and protect public health, if the Member observes 
certain fundamental principles. Those fundamental pr inciples ensure that measures that are trade-
restrictive and that diminish intellectual property protection have sufficient justification on public health grounds, protect the commitments WT O Members have made to one another, and 
safeguard the security and predictability of the multilateral trading system. Pursuant to these 
fundamental principles, measures that are trade-restrictive and undermine the protection of intellectual property rights must contribute to their purported public health objectives, and there 
must not be less restrictive, and reasonably av ailable, alternative means to achieve the same 
objectives. 
576.  Plain packaging is not consistent with thes e fundamental principles.  In our First Written 
Submission, we methodically analysed the nearly two years of real-world empirical data now 
available on the impact of Australia's plain pack aging regime on smoking behaviour.  The results 
are unambiguous. Contrary to predictions by plain packaging proponents, plain packaging has failed to reduce smoking. 
577.  Instead, as confirmed by the same re al-world empirical data, plain packaging has 
undermined the vital role played by trademarks an d geographical indications in the marketplace. 
These intellectual property rights serve to create competitive opportunities in the marketplace, 
enabling firms to differentiate competing products, signalling quality and reputation to consumers. 
Under a plain packaging regime, differentiation is no longer allowed, and market diversity is replaced by commoditization, with price the only me aningful factor that can be used to compete. 
Thus, plain packaging has resulted in significant damage to the ability of companies to compete 
with each other. 
578.  The real-world empirical data confirm that these market-distorting effects have occurred in 
Australia: since the introduction of plain packag ing, the market has been distorted as consumers 
have increasingly shifted to cheaper tobacco products.  This is particularly detrimental to the 
competitive opportunities of our premium tobacco producers, which can no longer signal the unique quality and reputation they have carefully built over decades of investment.  
579.  To understand how plain packaging affects consumer behaviour, the Dominican Republic has 
also sought the views of academic experts from various fields, including marketing, psychology, and medical science. None of these experts was su rprised by the results of the empirical data. 
Based on their particular expertise, they have ex plained, in expert statements provided to the 
Panel, that plain packaging is an ineffective means to reduce smoking initiation, increase smoking 
cessation, or reduce smoking relapse.   
580.  Finally, the Dominican Republic has asked two groups of academic experts on research 
methodology to assess the rigour of the evidence ba se offered by proponents of plain packaging.  
Independently, these two groups of experts have concluded that the studies relied on to justify 
plain packaging fail to meet the most basic standards of methodological rigour and, accordingly, to 
produce reliable results.       
581.  In sum, based on the evidence presented to  the Panel, it is clear that plain packaging 
destroys our producers' intellectual property rights and undermines their competitive opportunities, without providing any concrete benefits  to public health.  If plain packaging is not 
working as intended to promote public health, th ere can be no basis for its radical interference 
with trademarks and geographical indications, and with trade in affected tobacco products.  This is only further confirmed by the fact that there are other effective means open to regulators to 
reduce smoking in ways that are WTO-consistent.  The Dominican Republic has identified several 
such means for the Panel.    
582.  For all these reasons, the Dominican Republic urges WTO Members to restrain from further 
considering the adoption of plain packaging of tobacco, or of any other product harmful to health, 
until the WTO has ruled on whether this radical measure is compatible with Members' obligations under the TRIPS Agreement and the TBT Agreement. WTO Members should not have recourse to a measure that violates their WTO obligations, while failing to achieve legitimate health objectives.  IP/C/M/77/Add.1 
 
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  13.3 Cuba   
 583.  We thank Ukraine and the Dominican Republic  for bringing this item once again on the 
Council's agenda. It is very important for Cuba, as one of the complainants in the ongoing 
proceedings concerning the plain packaging measure, to reiterate its concern over the negative 
impact of the Australian regulations and related dr aft legislation that might be adopted by other 
Members. 
584.  These are sui generis measures that could set a dangerous precedent and be extended to 
other products. The plain packaging measure dilutes the distinctive features of tobacco product brands. It also makes it difficult for consumers to identify these products, thus nullifying the functions of a trademark. 
585.  In view of the foregoing, we ask Members to  refrain from adopting any such measures until 
the current case has been concluded. Cuba reiterates its commitment to public health and to measures adopted for its protection, as long as these are not abusive or excessive. 
586.  Furthermore, we would like to draw attention to the fact that the top ranking in 
Interbrand's 2014 report on brand value is held by a figurative brand logo. This kind of logo cannot, however, be used in a plain packaging context, where only denominative brand logos can 
be used. 
13.4 Indonesia   
 587.  Indonesia appreciates Ukraine's initiative to bring this issue to today's Council meeting. 
Indonesia has a very strong interest in the Plain Packaging case because the measures threaten 
the export interest of tobacco producing countries. 
588.  Indonesia's cigarette industry accounts for approximately 1.66% of Indonesia's total gross 
domestic product. It is the second largest in dustry in Indonesia and supports the employment, 
both directly and indirectly, of approximately 6.1 million people, including tobacco and clove 
farmers and factory workers. More than half of Indonesia's citizens live in rural areas where 
agriculture and cigarette industries are the main sources of income. Indonesia exports its 
cigarettes all over the world and exported approximately US$700 million in tobacco products in 2013. Indonesia brings this dispute to protect its interests in these exports.  
589.  Most countries, including Indonesia, recognize that tobacco use in various forms can lead to 
disease and in some cases premature death. However, just because tobacco use is bad does not 
mean every form of tobacco control is good. Thus Members must honor their WTO obligations. 
590.  Indeed the WTO provides wide latitude to  Members to pursue legitimate public policy 
objectives such as smoking prevention. In fact, even though the Australia Tobacco Plain Packaging 
Panel of Indonesia with other complainants has been established, none of the complainants in the Plain Packaging dispute in this regard are challeng ing Member's right to restrict the advertising of 
tobacco products, labeling requirements, point-of-sale restrictions, mandatory health warnings, 
and the numerous other measures to reduce the consumption of tobacco products and lower smoking prevalence rates within its borders. However, the plain packaging measures are not in conformity with some WTO Agreements.   
591.  In particular, Indonesia is not challenging the requirement of plain packaging measures to  
display graphic health warnings on 75% of the fr ont surface, 90% of the back surface, and large 
portions of the side surface. In fact, Indonesi a recently adopted its own set of rules requiring 
graphic health warnings on tobacco products. 
592.  However, studies by multiple researchers using a range of data sets and different analytical 
approaches have failed to find any empirical ev idence that plain packaging measures implemented 
by a certain Member are reducing the prevalence of smoking in the general population or among 
youth, who were predicted to be particularly affect ed by plain packaging.  After nearly two years of 
plain packaging, there is zero ev idence from any of the available survey data that plain packaging 
is having a positive impact on consumer behavior. Plain packaging has failed to bring about the IP/C/M/77/Add.1 
 
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  declines in tobacco prevalence predicted by its pr oponents. It is not working and is not likely to 
work.  
593.  Against this background, Indonesia argued that plain packaging measures violate no fewer 
than seven provisions of the TRIPS Agreement, among others but not limited to the provisions of 
Articles 2.1, 15.4, 16.1. 16.3, 20, 22.2(b) and Article 24.3.  
594.  Indonesia urges other Members in the process of introducing similar measures to reconsider 
their intention until the disputes are solved. We would also like to request those Members to 
evaluate alternative measures which are more effective in achieving the health objective, and 
more importantly, consistent with WTO rules.  
595.  Indonesia appreciates the opportunity to pres ent its views on the plain packaging regime and 
its consistency with numerous provisions of the TRIPS Agreement. 
13.5 Honduras   
 596.  Honduras shares the concerns expressed by Ukraine and others that other WTO Members 
may seek to follow Australia's example in adopting plain packaging measures for tobacco products. 
As Members are aware, Honduras is currently challenging Australia's plain packaging measures together with four other complainants. On 8 Octo ber 2014, Honduras and other complainants filed 
their first written submissions to the panel. Honduras has clarified that the dispute is not about 
whether smoking is dangerous, nor whether it affects public health. Honduras regulates tobacco and shares the goal of reducing tobacco consumption.  
597.  An unprecedented instrument, Australia's plain packaging measure removes brand imagery 
and registered trademarks from a legally sold pr oduct. Honduras has submitted expert evidence 
and empirical data from the Australian market conf irming that plain packaging is an experiment 
that has failed to change consumer behaviour. The data show that plain packaging has not 
reduced smoking, but has led to a so-called 'downward substitution' effect, meaning that 
consumers replace higher-price brands by chea per brands. The removal of trademarks and the 
resulting downward substitution breaches the TRIPS Agreement, particularly with respect to 
producers of high-price products that have invested significant resources into building up 
trademarks.  
598.  Honduras fully shares Australia's objective to reduce smoking prevalence. However, 
Honduras considers that the plain packaging measure is more trade restrictive than necessary to 
fulfil this legitimate objective, in violation of its obligations under the TBT Agreement, since less 
trade-restrictive alternatives are available. 
599.  Honduras notes that the panel needs to deliberate upon the arguments and evidence 
submitted by the co-complainants, and eventually by Australia, in order to make its decision 
whether Australia's measure complies with its WTO obligations. Honduras urges other WTO Members not to consider adopting plain packaging for tobacco products while the panel is still 
considering the WTO consistency of such a measure. 
13.6 Zimbabwe   
 600.  My delegation would like to associate itse lf with the concerns ex pressed by Ukraine, the 
Dominican Republic, Cuba, Indonesia, Honduras an d others with respect to measures related to 
plain packaging of tobacco products and their incompatibility with the TRIPS Agreement.  
601.  Zimbabwe has, in different fora, including the DSB, already stated its clear position on the 
plain packaging measures ostensibly introduced to  protect the health of consumers. We wish to 
reiterate that these measures appear to be inconsistent with Article 16.1 of the TRIPS Agreement, because Australia and other proponents of plai n packaging are preventing and are seeking to 
prevent owners of registered trademarks from en joying the rights conferred by a trademark.  
602.  Zimbabwe also considers plain packaging measures to be inconsistent with Article 20 and 
other Articles of the TRIPS Agreement because th ese measures undermine the use of trademarks 
for tobacco products in the course of trade through special requirements, which are detrimental to IP/C/M/77/Add.1 
 
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  trademarks' capability to distinguish tobacco products from one undertaking from tobacco products 
of other undertakings.  
603.  Tobacco farming is a major economic activity and source of livelihood for many families in 
developing countries such as Zimbabwe. Tobacco contributes significantly to our country's GDP. It 
therefore stands to reason that the plain pack aging measures will impact negatively on our 
national economic performance and employment, as well as undermine efforts towards alleviation.  
604.  In light of the restrictive effect of plain packaging measures on trade and the serious 
economic implications on tobacco-producing countries like my own, we are concerned that these 
measures are detrimental to trade in our countries. And as previously stated,  including during the meetings of the DSB, these measures are not compatible with the TRIPS Agreement. 
13.7 Australia   
 
605.  Australia notes the continued interest of other Members in its initiative to require the plain packaging of tobacco products. We would like to take the opportunity to acknowledge again the 
significant amount of support we have received for this important measure. As other Members are 
aware, panels have now been composed to hear the disputes regarding Australia's plain packaging 
measures. As the matter is currently subject to dispute proceedings, it would not be appropriate to 
comment further.  However, I would take the oppo rtunity to comment on remarks that have been 
made so far about how countries should wait until the outcome of the dispute is settled before implementing their own plain packaging measures. Australia's plain packaging measure is a legitimate measure which is consistent with Australia's obligations under the WTO Agreement. It is 
again inappropriate for complainants of the WTO dispute currently underway against Australia to 
invoke those proceedings in an attempt to delay or discourage other Members from developing or implementing their own legitimate measures. 
606.  Australia reiterates its strong support for Members that are taking measures to legislate for 
the mandatory plain packaging of tobacco produc ts. The important steps made by New Zealand, 
Ireland, United Kingdom and France in tobacco control demonstrate that efforts to delay the 
adoption of tobacco plain packaging have not been successful.  
607.  Australia looks forward to continuing our support of countries as they proceed with the 
development and implementation of their own to bacco plain packaging measures. As we have 
consistently stated, Australia is of the firm view that Members have the right to take measures 
necessary to protect public health, while complying with relevant international treaty obligations, 
including the TRIPS Agreement. 
608.  Tobacco plain packaging is a legitimate  measure designed to achieve a fundamental 
objective - the protection of human health. The tobacco plain packaging measure is endorsed by 
leading public health experts, as well as the World Health Organization and is supported by 
extensive peer reviewed research, reports and studies. 
13.8 Nicaragua   
 609.  Nicaragua also shares Ukraine's concerns with regard to the plain packaging of tobacco products and associates itself with the statements made by the delegations of Cuba, 
Dominican Republic, Honduras and Indonesia, countries which together with Ukraine are currently 
involved in a trade dispute with respect to pl ain packaging measures adopted by Australia. 
610.  On more than one occasion, Nicaragua has st ated that it recognizes the legitimate right 
of governments to protect the health of their populations, which is also a priority for my country. 
Accordingly, the Government of Nicaragua has signed and ratified important international instruments aimed at ensuring and protecting the health of its population. However, Nicaragua 
reiterates its concern at measures of the kind adopted by Australia and which other Members are 
seeking to adopt, measures which, under the pretex t of protecting health, could be used to place 
inordinate restrictions on trade by infringing the intellectual property rules of the WTO and other international forums. IP/C/M/77/Add.1 
 
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  611.  As a tobacco producing and exporting country, Nicaragua has a substantial commercial 
interest in this case, given the potential economic and social impact of this type of measure on my country, and urges Members to refrain from adopting measures such as plain packaging for tobacco products until this case has been resolved  in accordance with the rules established by the 
competent international organizations. 
13.9 New Zealand    
 
612.  New Zealand would like to record its support for the decisions and consideration of the 
introduction of plain (or standardized) packagin g requirements for tobacco and tobacco products 
by Australia, Ireland, the United Kingdom and France. 
613.  The TRIPS Agreement recognizes the fundam ental right of Members to implement measures 
necessary to protect public health and provides the necessary flexibilities for Members to do so.  
All of our Ministers agreed in the Doha Declaratio n on the TRIPS Agreement and Public Health that 
"the TRIPS Agreement does not and should not prevent Members from taking measures to protect 
public health" and affirmed that "the Agreemen t can and should be interpreted and implemented 
in a manner supportive of WTO Members' right to protect public health". 
614.  New Zealand believes that it is possible for Members to implement a tobacco plain packaging 
regime that is consistent with all of their WTO obligations and their commitments under the WHO 
Framework Convention on Tobacco Control. 
615.  There is an extensive and growing body of in ternational research that establishes that plain 
packaging, as part of a comprehensive tobacco control programme, will contribute to the objective 
of improving public health.  To date, we have not seen any credible evidence that proves 
otherwise. 
616.  New Zealand's Smoke-free Environments (Tobacco Plain Packaging) Amendment Bill remains 
draft legislation, and will need to be complement ed by implementing regulations.  New Zealand's 
legislative and regulatory process allows ample opportunity for New Zealand to take into account the dispute settlement process in relation to Austra lia's plain packaging measures, before finalizing 
and implementing our plain packaging measures.   
13.10  European Union   
 617.  The European Union would like to make the following statement regarding the draft 
legislation on standardized packaging for tobacco products recently proposed by the Republic of 
Ireland and the United Kingdom.  
618.  The European Union would like to note that tobacco products have recognized harmful 
effects on human health. It notes in this sense that pursuant to Article 8.1 TRIPS Members may, in 
formulating or amending their laws and regulations, adopt measures necessary to protect public health, provided that such measures are consistent with the provisions of this Agreement. 
Article XX(b) of the GATT 1994, although not dire ctly applicable to TRIPS obligations, similarly 
emphasizes the importance of public health by justifying measures "necessary to protect human 
health". The Doha Declaration on the TRIPS Agreement and Public Health stresses that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public 
health.  
619.  Finally, Article 20 TRIPS states that the use of a trademark in the course of trade shall not 
be unjustifiably encumbered by special requirements.   
620.  In order to protect public health, WTO Members may, for example, introduce provisions 
providing for the standardization of the packag ing of tobacco products, provided that these 
provisions are justified on grounds of public heal th, are proportionate and do not lead to arbitrary 
discrimination or disguised restrictions of trade, including with regard to the trade-related aspects 
of intellectual property rights. Any such measures would be compatible with WTO obligations. 
621.  On 17 June 2014, the Irish Public Health Standardized Packaging of Tobacco Bill 2014 was 
notified to the TBT Committee under the reference G/TBT/N/IRL/1. The draft Irish bill aims to IP/C/M/77/Add.1 
 
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  further reduce smoking prevalence in Ireland by reducing the attractiveness of tobacco products, 
especially among young people. The measures are a response to the packaging design strategy 
developed by tobacco companies in recent years, which are aimed at young people, including young women. The notified draft forms the latest trend of a comprehensive range of tobacco 
control legislation already in placed in Ireland, aimed at decreasing tobacco consumption. Amongst 
other measures in existing Irish law, there is comprehensive smoke-free legislation in place, a ban on tobacco advertising and sponsorship and a ban on the display of tobacco products in shops. In 
addition, all tobacco products placed on the market must display combined text and graphic health 
warnings. Certain types of sale promotions are prohibited. The smoking of tobacco products in 
vehicles where children are present will also be prohibited by a law to be enacted by the end of the year.  
622.  In addition to the draft bill, Ireland ma de available through the TBT notification an 
explanatory memorandum that details the rationale of the measure and its expected health impacts, a regulatory impact analysis and seve ral scientific studies on the impact of plain 
packaging on smoking prevalence.  
623.  In parallel with the WTO notification, Irelan d has also notified the measure to the European 
Commission in accordance with internal EU requirements for notification of draft national technical 
regulations under Article 8(1) of Directive 98/ 34 EC and under Article 24(2) of the Tobacco 
Products Directive 2014/40/EU. Ireland received reactions and comments from other EU member States within the framework of the internal notification procedure. Those comments are currently being analysed and considered by the Irish authorities.  
624.  On 3 September 2014, another draft regula tion on standardized packaging of tobacco 
products 2014 was notified to the TBT Committee. This is the UK draft regulation on standardized packaging of tobacco products. It aims to furthe r reduce the smoking prevalence in the United 
Kingdom by discouraging uptake of tobacco use by young people, encouraging and supporting 
tobacco users who want to quit, and reducing peop le's exposure to second-hand smoke. It forms 
the latest strand of a comprehensive range of tobacco control legislation already in place in the 
United Kingdom aimed at decreasing tobacco consumption. Under existing legislation, there is 
already a ban on advertising tobacco products to the general public, a ban of tobacco sponsorship to sports and cultural events, and companies are forbidden to give out free samples of tobacco. Picture warnings on tobacco products are required  in the United Kingdom. The sale of tobacco 
products from vending machines is prohibited and as of 2015, tobacco displays in all shops will be 
prohibited. 
625.  In addition to the draft regulation, the United Kingdom made available through the TBT 
notification an explanatory memorandum that details the rationale of the measure and its 
expected health impacts, an impact assessment and several scientific studies on the impact of 
plain packaging on smoking prevalence. In paralle l with the WTO notification, the United Kingdom 
has also notified the measure to the European Commission, in accordance with internal EU 
requirements for notification of draft national te chnical regulations. The draft is currently being 
analysed within the framework of the internal notification procedure,  
626.  The UK Government is continuing to consider the full range of issues relating to standardized 
packaging of tobacco raised through a public co nsultation concluded in August 2014. No final 
decision has been made by the UK Government on whether to proceed with standardized packaging of tobacco products. IP/C/M/77/Add.1 
 
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  13.11  Norway   
 627.  As previously stressed, both in this Council and in other fora, public health and tobacco control are topics of particular interest to Norway. In our view, it is within the rights of each WTO 
Member to adopt measures which are necessary to protect public health, as long as the measures 
chosen are consistent with WTO Agreements. Plain packaging of tobacco products is a 
recommended measure under the Framework Convention on Tobacco Control. It is Norway's 
opinion that the Framework Convention and rele vant WTO Agreements are mutually supportive 
and that it is possible to implement measures intended to regulate the packaging of tobacco 
products in line with both sets of binding obligations. 
628.  Therefore Norway would like to see more support to WTO Members concerning their rights to 
introduce this kind of measure in consistency with its WTO obligations to fulfil their obligations 
under the Framework Convention in order to protect public health. 
629.  Finally, we agree with others that the ongoing DSB case should not have any bearing on 
Members adopting measures in favour of public health. 
13.12  Canada   
 
630.  Canada continues to take an interest in the numerous developments surrounding the plain 
packaging of tobacco products. We recognize the challenge involved in applying tobacco control 
measures that have never been implemented before. We also recall the statement we made on the issue at our meeting inFebruary 2014 (see paragraph 531, p. 72 of the minutes circulated in 
document IP/C/M/75/Add.1) in which we stressed our interest in questions relating to the 
interpretation of the flexibilities provided for by  the TRIPS Agreement. We are following the dispute 
settlement procedures that were recently initiated and look forward to participating in those 
procedures as a third party. 
13.13  Uruguay   
 
631.  Uruguay would like to thank the delegations of Ukraine and the Dominican Republic for 
introducing this item on our agenda. We also asso ciate ourselves with the statements of Australia, 
New Zealand and Norway and are grateful for the information provided by the delegation of the 
European Union on the plans which are being st udied in Ireland and the United Kingdom.  
632.  Uruguay would like to restate, as it did at the meeting last February under this same agenda 
item, its position regarding the legitimacy of th e measures relating to the plain packaging of 
tobacco products under the WTO rules and the TRIPS Agreement in particular. 
633.  Protection of public health clearly falls under the sovereign authority of states, and 
accordingly, every country is entitled to legislate in the public interest. This has been recognized 
by all WTO Members. 
634.  We wish to point out in this connection that  Article 20 of the TRIPS Agreement provides that 
the use of a trademark should not be "unjustifi ably" encumbered by special requirements. Hence 
the implementation by states of measures desi gned to control tobacco consumption in their 
territories because of its devastating health, so cial, economic and environmental consequences 
cannot be considered contrary to the Agreement. 
635.  Lastly, we would recall that paragraph 4 of the Doha Ministerial Declaration on the TRIPS 
Agreement and Public Health states that th e Agreement can and should be interpreted 
and implemented in a manner supportive of WTO Members' right to protect public health. IP/C/M/77/Add.1 
 
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  13.14  WHO Secretariat   
 636.  Thank you for the opportunity to address the Co uncil on this critical public health issue.  
Tobacco Epidemic  
 
637.  As WHO has previously stated in this forum, tobacco use is one of the greatest threats to public health the world has ever faced, and the single most preventable cause of death in the 
world today. Globally, tobacco consumption kills nearly six million people a year through both 
direct use and the deadly effects of second-hand smoke - more than 70% of whom reside in low- 
and middle-income countries.  
638.  Tobacco also represents the leading modifiable risk factor in the fight against the growing 
epidemic of non-communicable diseases. NCDs, primarily cancers, diabetes, cardiovascular and 
chronic lung diseases, currently account for 63% of all deaths worldwide. These diseases kill an astounding 36 million people each year, with nearly 80% of deaths occurring in low- and middle-
income countries.  
639.  As necessary tobacco control measures continue to be implemented in developed countries, 
the tobacco industry, through aggressive marketing and interference practices, shifted some time 
ago its focus to new markets in the developing world. As a result, tobacco-attributable mortality is 
rapidly increasing in developing countries, and, by 2030, more than 80% of the world's tobacco deaths will occur in low- and middle-income countries. Given that smoking causes 30% of all cancers, including greater than 70% of all lung cancers, 40% of chronic respiratory diseases, and 
nearly 10% of all cardiovascular diseases, it is a critical moment in the global effort to curb the 
tobacco epidemic for the introduction of necessa ry public health interventions under the WHO 
Framework Convention for Tobacco Control (WHO FCTC), like the measure under consideration 
here.  
Economic Costs of Tobacco  
 
640.  The economic costs of tobacco use are as equally devastating as the public health costs. 
Though the tobacco industry routinely cites the economic contribution of tobacco, the reality is that tobacco use puts an enormous financial burden on countries, in addition to the fact that tobacco and poverty are inextricably linked at the individual level. Nationally, the costs of tobacco 
use encompass increased health-care costs, lost pr oductivity due to illness, premature death, and 
widespread environmental damage. Thus, as tobacco consumption rates and tobacco-related illnesses increase in developing countries, so do tobacco-related health care costs. Additionally, 
conservative estimates suggest that tobacco's more than US$500 billion drain on the world 
economy exceeds total annual health expenditures in low- and middle-income countries.  
641.  The economic burden of NCDs, with tobacco representing the largest risk factor, is also 
staggering. Recent macroeconomic simulations suggest that, over the next two decades, 
cardiovascular disease, chronic respiratory disease, cancer, and diabetes, will cause a cumulative output loss of more than US$30 trillion, representi ng 48% of global GDP in 2010. This in turn will 
push millions of people across the planet below the poverty line. Because NCDs will result in long-
term macroeconomic impacts on labour supply, capital accumulation and GDP worldwide, with the 
consequences most severe in developing countries, strong public health interventions, such as the 
standardized packaging measure under deliberation here, are relevant in addressing both health 
and economic concerns. 
United Nations High-level Meeting of the General Assembly on the Prevention and Control of Non-
communicable Diseases  
 
642.  At this point I would like to draw the attention of the distinguished delegates here to the fact that the impact of tobacco and NCDs on both pu blic health and country economies was highlighted 
at the United Nations High-level Meeting of the Genera l Assembly on the Prevention and Control of 
Non-communicable Diseases , held in September 2011 in New York. There, the UN General 
Assembly, comprised of Heads of State, adopted a Political Declaration which recognized the fundamental conflict of interest between the to bacco industry and public health, and wherein 
Member States unanimously committed to advancing the implementation of multisectoral, cost-
effective, population-wide interventions in order to reduce the impact of NCD risk factors. IP/C/M/77/Add.1 
 
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  643.   WHO is of the view that the implementa tion of standardized tobacco product packaging 
represents a legitimate and effective tobacco control measure, and is fully in line with the spirit and intent of the outcome of the UN High-level Meeting, and is in accordance with international legal obligations under the WHO FCTC.  
644.  I kindly refer to my colleague to el aborate on this point about the WHO ECTC. 
Relevant WHO FCTC provisions  
 
645.  We are grateful for this opportunity to pr ovide information to the TRIPS Council on the WTO 
Framework Convention on Tobacco Control or FCTC. 
646.  As observed at previous meetings of th is body, the WHO FCTC was negotiated under the 
auspices of the WHO in response to the globaliz ation of the tobacco epidemic, and the treaty has 
been in force since 2005. Like other international legal instruments, States that are party to the 
FCTC undertake certain obligations pursuant to it. The number of States that are Party to the Convention has risen to 179 - in fact, only 12 of the current 160 WTO Members are not Party to 
the FCTC.  
647.  The FCTC contains a number of provisions th at are relevant to the issue of standardized 
packaging of tobacco products.  
 Article 3 of the FCTC sets out the collective objectives of the Parties in negotiating the 
Convention, including "to protect present and future generations from the devastating health, social, environmental and economic consequences of tobacco consumption and exposure to tobacco smoke ...".  
 As noted during previous sessions of this body , the FCTC sets out in Article 5 the general 
obligations of Parties, including, inter alia, the obligation to "develop, implement, periodically update and review comprehensive multisectoral national tobacco control strategies, plans 
and programmes in accordance with" the FCTC. It is through the implementation of such a 
comprehensive multisectoral approach that the tobacco control measures contained in the FCTC are most effective.  
 Article 11 of the Convention requires Parties to adopt and implement effective measures in 
respect of the packaging and labelling of toba cco products, including health warnings and 
other appropriate messages. Article 11 has consistently remained one of the articles of the Convention attracting the highest implementation rates among Parties, with stronger 
measures being gradually implemented.  
648.  According to the most recent Party reports on implementation, 101 of 130 Parties reported 
that they have banned descriptors on packaging and labelling that were misleading, deceptive or 
likely to create an erroneous impression of the product, and 114 Parties reported that they have 
adopted policies requiring tobacco product packaging to carry health warnings describing the harmful effects of tobacco smoke. In addition, 111 Parties have introduced measures to ensure 
that health warnings are large, clear, visible and legible.  
649.  Another specific provision of the FCTC that has been previously noted in this Council is 
Article 13, which requires Parties to undertake a comprehensive ban of all tobacco advertising, promotion and sponsorship. That comprehensive ban must be read in light of the broad definition 
of "tobacco advertising and promotion" which, according to Article 1(c), "means any form of 
commercial communication, recommendation or action with the aim, effect or likely effect of promoting a tobacco product or tobacco use either directly or indirectly." The Guidelines for the 
implementation of Article 13 include "packaging and product design features" on the indicative list 
of forms of advertising, promotion and sponsorship.  
650.  Again, the most recent Party reports indicate that 91 Parties have introduced a 
comprehensive ban on tobacco advertising, promotion and sponsorship. Further, 90 Parties 
reported that they prohibit tobacco product packaging from carrying advertising or promotion, including design features that make such products attractive.  IP/C/M/77/Add.1 
 
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  651.  The respective Guidelines for the implementa tion of Articles 11 and 13 were both adopted by 
the consensus of the Parties, and each recomm ends that Parties should consider adopting 
standardized or plain packaging measures.  
652.  Further, Article 2 addresses the relationship  between this Convention and other agreements 
and legal instruments. It states that "In order to better protect human health, Parties are 
encouraged to implement measures beyond those re quired by this Convention and its protocols, 
and nothing in these instruments shall prevent a Party from imposing stricter requirements that 
are consistent with their provisions and are in accordance with international law."  
Relevant WHO FCTC COP decisions  
 
653.  The governing body of the Convention, the Conference of the Parties or COP, has also 
adopted a number of decisions to reflect their priorities in this important area.  
654.  At its 4th session in November 2010 the COP adopted the Punta del Este Declaration 
(Decision FCTC/COP4(5)) regarding public health policy, international trade and the activities of 
the tobacco industry. The Punta del Este Declaration reiterates the firm commitment of Parties to 
the FCTC "to prioritize the implementation of health measures designed to control tobacco 
consumption" and "their concern regarding action s taken by the tobacco industry that seek to 
subvert and undermine government policies on tobacco control". In relation to the Parties' rights 
to adopt measures to protect public health, the Punta del Este Declaration makes specific reference to Articles 7 and 8 of the TRIPS Agreement, as well as to paragraphs 4 and 5(a) of the Doha Declaration on the TRIPS Agreement and Pub lic Health, adopted by the 4th session of the 
WTO Ministerial Conference in November 2001.  
655.  Most recently, at its 6th session earlier this month, the COP adopted the Moscow Declaration 
(Decision FCTC/COP6(26)) which calls on Parties to "strengthen collaboration on tobacco control" 
and "to accelerate the full implementation of the WH O FCTC at national levels" in view of the need 
to reduce the global burden of non-communicable diseases. At the same session, the COP adopted a decision (FCTC/COP6(14)) on highlighting the importance of international cooperation in the 
"Protection of public health policies with respect to tobacco control from commercial and other 
vested interests of the tobacco industry".  
656.  Thank you very much for this opportunity to provide additional information on the WHO 
FCTC to the Council for TRIPS.  
AGENDA ITEM 15: OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL 
ORGANIZATIONS 
15.1 Nigeria
  
 
657.  I think in view of the update that we received  by the South Centre, should they be admitted 
on an ad hoc basis. I think that would go a long way because we all know the good work that the 
South Centre has been doing, in order to at le ast help developing countries use the IP system.  
15.2 Brazil   
 
658.  I would just like to second the proposal made by my colleague from Nigeria. In our 
intervention on CBD issues I also recalled our proposal that the CBD Secretariat be admitted as an 
observer to the TRIPS Council on an ad hoc basis.  
15.3 India   
 
659.  We align ourselves with the statement made by Nigeria and Brazil for granting observer 
status to the South Centre and Brazil fo r granting observer status to the CBD. 
660.  We would also like to support the request from the International Vaccine Institute (IVI) for 
observer status in the Council for TRIPS. The International Vaccine Institute, which was created initially as an initiative of the United Nations Development Programme (UNDP), is the world's only 
international organization devoted exclusively to  developing and introducing new and improved IP/C/M/77/Add.1 
 
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  vaccines to protect the world's poorest people, especially children in developing countries. 
Established in 1997, IVI operates as an independent international organization under a treaty signed by 35 countries and the World Health Organi zation. The Institute conducts research in more 
than 20 countries in Asia, Africa and Latin America on vaccines against enteric and diarrheal 
infections, Japanese encephalitis, and dengue feve r, and develops new and improved vaccines at 
its headquarters in Seoul, Republic of Korea. 
661.  India again urges the Council to positively and expeditiously consider the request of the 
South Centre, the Secretariat of the Convention on Biological Diversity (CBD) and the International 
Vaccine Institute (IVI) for observer status. Until then, ad hoc observer status on a meeting-by-meeting basis should be granted to them. 
15.4 China   
 
662.  China would like to echo the previous sp eakers. TRIPS CBD is an important issue at the 
TRIPS Council meeting. It is regretful that the CBD Secretariat is not an observer. China continues 
to support that the CBD Secretariat should be grante d observer status at least on an ad hoc basis. 
It also is important to grant observer status to the South Centre. 
15.5 Indonesia   
 
663.  Indonesia would like to join Nigeria, Brazil, India and China to reiterate our support in granting observer status to the CBD Secretariat and the South Centre to the Council. Both institutions are well known in undertaking important works on the issue related to IPRs as well as 
their connection to the development interest of developing Members. We do believe that their 
participation in this meeting will bring a positive and valuable contribution to the work and discussion of this house. 
15.6 United States of America   
 664.  The United States is not in a position to support these requests for observer status at this 
time. 
15.7 Nigeria   
 665.  Regarding the South Centre, I think the request was made some time ago and of course the 
same delegation did mention that they would require some time to get back to us. I would ask the 
Chair to continue with his consultations or to initiate consultations to see if we could at least have consensus on the South Centre. We all know what the South Centre is all about, and it has been 
assisting developing countries in IP issues among others. So I believe it is a south-south 
cooperation where countries undertake research analysis on oriented issues regarding development. Accordingly, I believe it would be of crucial importance for this Council to grant the 
South Centre that request. So I will ask the Chair to undertaken consultations, in particular on the 
South Centre issue. 
15.8 United States of America   
 
666.  Thank you to the delegation from Nigeria. Our position remains the same with respect to the 
request for observer status. However, we would be happy to participate with Nigeria and with the Chair and others in any consultations on this issue. We are happy to participate in consultations on 
the requests that have been identified here today, on  all three, if that is of interest to others. But 
our substantive position with respect to all three remains the same, which is we are not in a position to support. IP/C/M/77/Add.1 
 
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  AGENDA ITEM 17: OTHER BUSINESS 
17.3 Contribution of IP to facilitate the tr ansfer of environmentally sound technology 
 
17.1 Ecuador   
 
667.  My delegation wishes to comment on the work being carried out on an issue that has been 
referred to repeatedly in various meetings of this Council since 2013, namely intellectual property's contribution to facilitating the transfer of environmentally rational technology. 
668.  As this Council is aware, in 2013 Ecuador submitted its proposal on this issue, which has 
been the subject of an active and interesting discussion. Being as this is a serious matter for Ecuador, and on the basis of the discussion that has taken place, it has been considered necessary 
to gather further information and to continue reviewing this issue at national level and with the 
other countries and organizations concerned. 
669.  In this light, Ecuador wishes to inform the Members of this Council that it is currently 
engaged in a consultation process and that it will keep this body duly informed of any progress  
made in this respect. 
17.4 Extension of the transition period under Article 66.1 of the TRIPS Agreement for 
Least developed country Members for certain ob ligations with respect to pharmaceutical 
products 
 17.2 Bangladesh on behalf of the LDC Group  
 
 
670.  I am speaking on behalf of the LDC Group. Yo u are aware that LDCs represent the poorest, 
weakest and most vulnerable group of the community of nations. With poverty touching all aspects 
of life, the population in LDCs is suffering from, and is highly susceptible to, different forms of diseases. As a result, there are many other associated challenges such as access to medicines and 
health services. 
671.  Our Ministers in Doha recognized the gravity of the public health problems afflicting many 
developing and least developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. They also agreed that the TRIPS Agreement did not and should not 
prevent Members from undertaking measures to protect public health.   
672.  While reiterating their commitment to th e TRIPS Agreement, they affirmed that the 
Agreement could and should be interpreted an d implemented in a manner supportive of WTO 
Members' right to protect public health and, in particular, to promote access to medicines for all. 
673.  We thank the Members for adopting the decision contained in IP/C/25 and WT/L/478. 
However we would like to note that these decisions are due to expire in 2016. This is 
notwithstanding the fact, not only do we not have a sound and viable technological base, but we 
are also perpetual victims of epidemics such as the Ebola outbreak that has caused disaster among some of our Members.  
674.  We are working on a proposal, which we hope to submit by the next meeting of this Council. 
We would like to request the Council to take note of our intervention and include this item on the 
agenda for our next meeting. It is our strong and firm belief that Members will respond positively to our humanitarian call. 
17.3 Bangladesh  
 
 
675.  I would like to make a small statement on behalf of Bangladesh. Let me align ourselves with 
the statement made on behalf of the LDC Group. 
676.   Today's WHO presentation was very enlightening in helping us to further understand 
another dimension of socio-economic importance. In the same vein, we would also appreciate a 
WHO presentation on disease profile, prevalence and access to medicines from the perspective of IP/C/M/77/Add.1 
 
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  public health, focusing particularly on LDCs. This presentation would help us to concentrate further 
to factual discussion in our future meetings. 
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