RESTRICTED  
  
IP/C/M/106/Add.1  
 
17 February  2023 
(23-1154) Page: 1/79 
Council for Trade -Related Aspects of  
Intellectual Property Rights    
 
MINUTES OF MEETING  
HELD IN THE CENTRE WILLIAM RAPPARD ON 12-13 OCTOBER AND 15 -16 DECEMBER 2022 
Chair: H.E Ambassador Dr Lansana Gberie (Sierra Leone)  
Addendum  
The present document contains the statements made during the Council for TRIPS meeting held on 
12-13 October and 15 -16 December 2022.  
 
_______________  
 
Contents  
1   NOTIFICATIONS UNDER PROVISIONS OF T HE AGREEMENT  ................................ ........  5 
2   REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION  ................................ ............  13 
3   IP AND COVID -19 ................................ ................................ ................................ ...... 13 
4   REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B)  ................................ ...................  14 
5   RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND  THE CONVENTION ON 
BIOLOGICAL DIVERSITY  ................................ ................................ ................................  14 
6   PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  ................................ ... 14 
7   ANNUAL REVIEW OF THE SPECIAL COMPULSORY LICENSING SYSTEM (PARAGRAPH 7 
OF THE ANNEX TO THE AMENDED TRIPS AGREEMENT AND PARA GRAPH 8 OF THE 
DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON 
THE TRIPS AGREEMENT AND PUBLIC HEALTH)  ................................ ..............................  17 
8   NON-VIOLATION AND SITUATION COMPLAINTS  ................................ .......................  17 
9   REVIEW OF THE IMPLEMENTATION OF THE TRIPS AGREEMENT UNDER ARTICLE 71.1
 ................................ ................................ ................................ ................................ ...... 20 
10   REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON 
GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2  ................................ ....................  21 
11   TWENTIETH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON THE 
IMPLEMENTATION OF ARTICLE 66.2 OF THE TRIPS AGREEMENT  ................................ ... 21 
12   TECHNICAL COOPERATION AND CAPACITY -BUILDING  ................................ ............  28 
13   PARAGRAPH 8 OF THE MINISTERIAL DECISION ON THE TRIPS AGREEMENT 
ADOPTED ON 17 JUNE 2022  ................................ ................................ ...........................  37 
RESUMPTION OF THE COUNCIL FOR TRIPS ON 15 DECEMBER 2022  ...............................  56 
RESUMPTION OF THE COUNCIL FOR TRIPS ON 16 DECEMBER 2022  ...............................  65 
14   INTELLECTUAL PROPERTY AND INNOVATION: ROLE OF IP TO RAISE FINANCE FOR 
START -UPS ................................ ................................ ................................ .....................  65 IP/C/M/106/Add.1  
 
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  15   INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO  ...............  78 
16   OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS
 ................................ ................................ ................................ ................................ ...... 79 
17   ANNUAL REPORT  ................................ ................................ ................................ ..... 79 
18   OTHER BUSINESS  ................................ ................................ ................................ .... 79 
 
  IP/C/M/106/Add.1  
 
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  INDEX OF THE STATEMENTS MADE  
AT THE MEETING OF COUNCIL FOR TRIPS 12-13 OCTOBER AND 15 -16 DECEMBER  2022 * 
 
Argentina  
Non-Violation and Situation Complaints  .. 18 
Para 8 of the MC12 TRIPS Decision  ........  46 
Australia  
Article 66.2  ................................ ........  22 
IP and Innovation – Financing for Start -Ups
 ................................ .....................  70 
Technical Cooperation  ..........................  31 
Bangladesh  
Biotech, Biodiversity, TK  ......................  15 
Non-Violation and Situation Complaints  .. 18 
Bangladesh, on behalf of the LDC Group  
Article 66.2  ................................ ........  28 
Para 8 of the MC12 TRIPS Decision  ........  42 
Technical Cooperation  ..........................  34 
Bolivia, Plurinational State of  
Non-Violation and Situation Complaints  .. 20 
Para 8 of the MC12 TRIP S Decision  ........  46 
Brazil  
Biotech, Biodiversity, TK  ......................  15 
Non-Violation and Situation Complaints  .. 18 
Notification Under Provisions of the 
Agreement  ................................ ....... 9 
Para 8 of the MC12 TRIPS Decision  ........  47 
Canada  
Article 66.2  ................................ ........  26 
Intellectual Property and Innovation – 
Financing for St art-Ups .....................  70 
Non-Violation and Situation Complaints  .. 18 
Para 8 of the MC12 TRIPS Decision  ........  53 
Technical Cooperation  ..........................  32 
Chair  
Para 8 of the MC12 TRIPS Decision 57, 58, 
59, 60, 61, 62, 63, 64  
Chile  
IP and Innovation - Financing for Start -Ups
 ................................ .....................  74 
Non-Violation and Situation Complaints  .. 19 
China  
Biotech, Biodiversity, TK  ......................  17 
IP and Innovation – Financing for Start -Ups
 ................................ .....................  77 
Para 8 of the MC12 TRIPS Decision  ........  47 
Colombia  
Para 8 of the MC12 TRIPS Decision  ........  42 
Egypt  
Para 8 of the MC12 TRIPS Decision 45, 62, 
63, 64 
European Union  
Article 66.2  ................................ ........  21 
IP and Innovation – Financing for Start -Ups
 ................................ .....................  72 
Non-Violation and Situation Complaints  .. 20 
Notification Under Provisions of the 
Agreement  ................................ .. 6, 12 
Para 8 of the MC12 TRIPS Decision  .. 51, 58  
Technical Cooperation  ..........................  28 
 Gulf Cooperation Council  
Technical Cooperation  .........................  36 
Hong Kong, China  
IP and Innovation – Financing for Start -Ups
 ................................ ....................  75 
Non-Violation and Situation Complaints  . 20 
India  
Article 66.2  ................................ ....... 28 
Biotech, Biodiversity, TK  ......................  14 
IP and Innovation – Financing for Start -Ups
 ................................ ....................  77 
Non-Violation and Situation Complaints  . 17 
Para 8 of the MC12 TRIPS Decision  ....... 54 
Indonesia  
Biotech, Biodiversity, TK  ......................  15 
IP and Innovation – Financing for Start -Ups
 ................................ ....................  78 
Non-Violation and Situation Complaints  . 19 
Para 8 of the MC12 TRIPS Decision  ....... 43 
Japan  
Article 66.2  ................................ ....... 25 
Biotech, Biodiversity, TK  ......................  16 
IP and Innovation - Financing for Start -Ups
 ................................ ....................  66 
Para 8 of the MC12 TRIPS Decision  ....... 51 
Technical Cooperation  .........................  33 
Kenya, on behalf of the ACP Group  
Para 8 of the MC12 TRIPS Decision  ....... 41 
Korea, Republic of  
Biotech, Biodivers ity, TK  ......................  17 
Non-Violation and Situation Complaints  . 20 
Para 8 of the MC12 TRIPS Decision  ....... 53 
Malaysia  
Para 8 of the MC12 TRIPS Decision  ....... 42 
Maldives  
Para 8 of the MC12 TRIPS Decision  ....... 41 
Mexico  
IP and Innovation – Financing for Start -Ups
 ................................ ....................  75 
Para 8 of the MC12 T RIPS Decision  ....... 50 
New Zealand  
Article 66.2  ................................ ....... 23 
Technical Cooperation  .........................  33 
Nigeria  
Biotech, Biodiversity, TK  ......................  16 
Non-Violation and Situation Complaints  . 19 
Para 8 of the MC12 TRIPS Decision  ....... 55 
Panama  
Non-Violation and Situation Complaints  . 20 
Peru  
Biotech, Biodiversity, TK  ......................  16 
Non-Violation and Situation Complaints  . 19 
Para 8 of the MC12 TRIPS Decision  ....... 48 
Russian Federation  
Non-Violation and Situation Complaints  . 20 
Notification Under Provisions of the 
Agreement  ................................ ..... 12 
 IP/C/M/106/Add.1  
 
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  Saudi Arabia, Kingdom of  
Notification Under Provisions of the 
Agreement  ................................ ...... 10 
Seychelles  
Notification Under Provisions of the 
Agreement  ................................ ....... 5 
Singapore  
IP and Innovation – Financing for Start -Ups
 ................................ .....................  71 
Para 8 of the MC12 TRIPS Decision  .. 48, 62  
South Africa  
Article 66.2  ................................ ........  27 
Biotech, Biodiversi ty, TK  ................  14, 17  
IP and COVID -19 ................................  13 
IP and Innovation – Financing for Start -Ups
 ................................ .....................  76 
Non-Violation and Situation Complaints  .. 18 
Para 8 of the MC12 TRIPS Decision 37, 56, 
57, 58, 59, 60, 61, 62, 64  
Sri Lanka  
Biotech, Biodiversity, TK  ......................  15 
IP and COVID -19 ................................  13 
Non-Violation and Situation Complaints  .. 18 
Para 8 of the MC12 TRIPS Decision 44, 57, 
61, 63  
Switzerland  
Article 66.2  ................................ ........  25 
IP and COVID -19 ................................  13 
IP and Innovation  
Financing for Start -Ups .....................  65 
IP and Innovation – Financing for Start -Ups
 ................................ .....................  76 
Non-Violation and Situatio n Complaints  .. 18 
Para 8 of the MC12 TRIPS Decision 48, 57, 
60, 61, 65  
Technical Cooperation  ..........................  31 
Chinese Taipei  
IP and Innovation – Financing for Start -Ups
 ................................ .....................  71 
Notification Under Provisions of the 
Agreement  ................................ ....... 9 
Para 8 of the MC12 TRIPS Decision  ........  49 
 
 Tanzania  
Para 8 of the MC12 TRIPS Decision  ....... 61 
Thailand  
Notification Under Provisions of the 
Agreement  ................................ ....... 5 
Tonga  
Notifications Under Provisions of the 
Agreement  ................................ ..... 10 
Ukraine  
Notification Under Provisions of the 
Agreement  ................................ ..... 10 
United Kingdom  
Article 66.2  ................................ ....... 23 
IP and Innovation – Financing for Start -Ups
 ................................ ....................  73 
Non-Violation and Situation Complaints  . 19 
Para 8 of the MC12 TRIPS Decision 54, 58, 
59, 61  
Technical Cooperation  .........................  31 
United States of America  
Article 66.2  ................................ ....... 24 
Biotech, Biodiversity, TK  ......................  16 
IP and Innovation – Financing for Start -Ups
 ................................ ....................  68 
Non-Violation and Situation Complaints  . 19 
Notification Under Provisions of the 
Agreement  ................................ ..... 12 
Para 8 of the MC12 TRIPS Decision 50, 58, 
59, 60  
Technical Cooperation  .........................  31 
Uruguay  
IP and Innovation – Financing for Start -Ups
 ................................ ...............  75, 76  
Para 8 of the MC12 TRIPS Decision  ....... 47 
World Health Organization  
Para 8 of the MC12 TRIPS Decision  ....... 55 
Technical Cooperation  .........................  37 
World Intellectual Property Organization  
Technical Cooperation  .........................  36 
WTO Secretariat  
Information on Relevant Developments 
elsewhere in the  WTO ......................  78 
Technical Cooperation  .........................  34 
 
 
*A record of statements as delivered in the formal session of the Council. Some statements have been lightly 
edited as appropriate to ensure the consistency of presentation.  
  IP/C/M/106/Add.1  
 
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  1  NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  
1.1  Thailand  
1.  Thailand thanks the WTO Secretariat for circulating and assisting us in preparing the notification  
IP/N/ 1/THA/6  referring to the notification of the Ministry of Commerce regarding the determination 
of counterfeit goods and pirated goods as goods prohibited from export, import and bringing in 
transit, which entered into force on 29 July 2022. 
2.  This notification of the Ministry of Commerce was intended to  modernize and streamline the 
legislation and procedures for the determination of counterfeit goods and pirated goods as goods 
prohibited from export, import and bringing in transit, in line with relevant international agreements 
to which Thailand is a par ty including the TRIPS Agreement and the recent Regional Comprehensive 
Economic Partnership Agreement, in order to strengthen border control measures to combat 
intellectual property rights infringement more efficiently. Kindly refer to the notification for  details, 
including the translation of the legislation.  
3.  To conclude, I  would like  to reiterate Thailand 's commitment to fulfilling its obligations under the 
TRIPS Agreement to ensure efficient protection and enforcement of IP rights.  
1.2  Seychelles  
4.  The Seychelles first would like to thank the Secretariat for the assistance provided in processing 
the notification IP/N/1/SYC/11  and IP/N/1/SYC/ O/4. The Seychelles Fair Trading Act, 2022 
(Act 12 of 2022), entered into force on 1 August 2022 and was notified  to the WTO on 29  July 2022 
under Article 63.2 of the TRIPS Agreement (other Laws and Regulations). A little background in the 
notifying text. The Government of Seychelles, through the Fair -Trading Commission, sought funding 
for a consultant to address the  shortcomings of the previous Fair - Trading Acts, following which a 
report with feedbacks were provided, and the draft Fair -Trading Bill was prepared.  
5.  An Independent Fair -Trading Tribunal was set up as an effective redress mechanism for all 
consumer and co mpetition cases and chaired by a chairperson who is a full -time magistrate. The 
investigative powers of the Commission have been enhanced to create a new level of enforcement. 
In that pursuit, this Act repeals the Fair -Trading Commission Act (Cap 267), the  Fair Competition 
Act (Cap 266), and the Consumer Protection Act (Cap 257).  
6.  Seychelles does not foresee any substantial changes in the immediate future, as this new Act will 
give confidence to businesses through the provision of consistent application, enf orcement, and 
adjudication of competition and consumer matters . 
7.  The main elements of the new Act : The Fair-Trading Commission is the central institutional organ 
for the effective administration of the Act.  The Commission is tasked with several functions, including 
enforcing compliance with the Act; advising the Government on laws affecting fair trading, 
competition, and consumer protection, and making recommendations to the Government on the 
actual or likely anti -competitive effects or consumer protection issues that arise out of the 
implementation of the Act.  
8.  It establishes the Fair -Trading Tribunal to d eal with appeals against the decisions of the 
Commission 's complaints of alleged prohibited conduct, applications for breaches of undertakings, 
and applications for the authorisation or permission of proposed mergers recommended by the 
Commission.  The intr oduction of the Fair -Trading Tribunal is not only commendable as a principle of 
best international practice but is also good for democracy and the rule of law.  
9.  In case of consumer protection and fair competition , the Act extensively makes provisions for 
the protection of consumer protection rights. Accordingly, it protects, amongst many others, the 
rights to fair, just, and reasonable terms and conditions, disclosure of information, fair and 
responsible marketing, fair and honest dealing, choice, safety, fa ir value, good quality, and safety 
for the performance of services and supply of goods.  IP/C/M/106/Add.1  
 
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  10.  Regarding fair competition, the Act makes provision for, among others, the abuse of a dominant 
position, restrictive horizontal and vertical practices, mergers, and fac tors to be considered for 
determining the aforementioned practices and market inquiries.  
11.  Offenses and penalties for contravening the provisions of the Act are also clearly specified in 
the Act.  Finally, the Act mandates the minister responsible for trade i n consultations with the Fair -
Trading Commission to make regulations for all matters which are required or necessary to be 
provided for in giving effect to the provisions of the Act.  
12.  Briefly about t he main features of the Act: 
a. it is tailor -made and recogni ses the particular circumstances of Seychelles;  
b. considers tried and tested mechanisms, draws on their successes, and learn s from their 
failures;  
c. provides for the imposition of a fixed penalty in certain cases;  
d. strengthened and included additional enforce ment provisions;  
e. increase in penalty quantum;  
f. introduction of a corporate immunity provision which is an effective tool to fight cartels;  
g. introduc es more provisions into regulations for greater flexibility given the dynamics of 
competition and consumer laws;  
h. exclusion of financial consumer protection from the Bill;  
i. remitting the final decision on mergers in the financial sector to the Central Bank and  
other regulatory financial bodies;  
j. provides for a tribunal rather than a Board of Commissioners for an accessible, effective 
and efficient system of redress for consumers and businesses;  
k. Any decision or order of the Tribunal may be served, executed, and e nforced in the 
same manner as a judgment or order of the Supreme Court under the Seychelles Code 
of Civil Procedure (Cap 213);  
l. provides a mechanism for continuity so that the current unheard cases before the Board 
of Commissioners can be heard;  
m. Introducing  a cap of SCR 5 million on complaints for consumer protection;  
n. Time limitation on bringing complaints to the Commission reduced from three years to 
two years.  
13.  In term of n ext steps, in order to ensure the full functioning of the Fair -Trading Act 2022, new 
regulations are required under the new Act. These regulations are being drafted, and as such, we 
expect they will be available by the end of December 2022.  
14.  In order to ensure transparency, these regulations may be shared with WTO Members at the 
appropriate  time. 
1.3  European Union  
15.  The European Union is pleased to present to you the regulations and measures adopted in the 
area of GIs, and more particularly of GIs concerning the European Union  itself. I am going to hand 
over the floor to two people and I will then take the floor again as we are also going to cover , on 
behalf of Italy and France,  the regulations and laws that have been passed in these two countries. I IP/C/M/106/Add.1  
 
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  now hand over to Mr. Klaus Blan k of the Directorate General for Agriculture of the European 
Commission.  
16.  As regards  the European Union notification  IP/N/1/EU/38:  this is Regulation (EU) 2021/2117 of 
the European P arliament and of the Council of 2 December 2021 amending Regulations (EU) No 
1308/2013 establishing a common organization of the markets in agricultural products, Regulation 
(EU) No 1151/2012 on quality schemes for agricultural products and foodstuffs, Regulation (EU) No 
251/2014 on the definition, description, presentation, labelling and the protection of geographical 
indications of aromatized wine products and Regulation (EU) No 228/2013 laying down specific 
measures for agriculture in the outermost regio ns of the Union . 
17.  The text of the regulations modifies the primary EU legislation on geographical indications in 
the sectors of food, wine and aromatized wines and the EU legislation on traditional specialities 
guaranteed. Regulations (EU) No 1151/2012 on G eographical Indications in the food sector and on 
Traditional Specialities Guaranteed , Regulation  (EU) No 1308/2013 (for the part concerning 
Geographical Indications in the wine sector) and Regulation (EU) 251/2014 (for the part concerning 
Geographical Ind ications in the aromatized wines drink sector ) have been modified. The new rules 
affect the scope, the definitions, the content of the product specification, the procedures for 
registration, amendment and cancellation, the extent of the protection, the lab elling, the use of logo 
and the checks of the Geographical Indications (GI) in wine and food sector. Procedures for 
registration and amendment of Traditional Specialities Guaranteed in the food sector have also been 
modified. The Aromatized Wines GI sector  has been merged into the food GI sector.  The Regulation 
entered into force on 7 December 2021.  
18.  Second, as regards to d ocument  IP/N/1/EU/39  this concerns the Commission Delegated 
Regulation (EU) 2022/891 of 1 April 2022 amending Delegated Regulation (EU) No 664/2014 , 
supplementing Regula tion (EU) No 1151/2012 of the European Parliament and of the Council with 
regard to the establishment of the Union symbols for protected designations of origin, protected 
geographical indications and traditional specialities guaranteed and with regard to c ertain rules on 
sourcing, certain procedural rules and certain additional transitional rules . 
19.  The text of this delegated regulation modifies the existing Commission Regulation (EU) 
No 664/2014, which is the Commission Delegated Regulation of the Regulation  of the European 
Parliament and of the Council (EU) No 1151/2012 on geographical indications in the food sector, 
which has been amended by Regulation (EU) No 2021/2117. In particular, the text concerns specific 
rules for applications for approval of Union amendments and for approval and communication of 
standard and temporary amendments . This Regulation entered into force on 11  June 2022.  
20.  Finally, as regards the notification in d ocument  IP/N/1/EU/40  this concerns the Commission 
Implementing Regulation (EU) 2022/892 of 1 April 2022 amending Implementing Regulation (EU) 
No 668/2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European 
Parliament and of the Council on quality schemes for agric ultural products and foodstuffs . 
21.  The text of that Commission Implementing Regulation  modifies the existing Commission 
Regulation (EU) No 668/2014, which is the Commission Implementing Regulation of the Regulation 
of the European Parliament and of the Counc il (EU) No 1151/ 2012 on geographical indications in the 
food sector, which has been amended by Regulation (EU) No 2021/2117. In particular, the text 
concerns specific rules for applications for approval of Union amendments and for approval and 
communicatio n of standard and temporary amendments, for the use of specific digital system of 
managing the applications and communicating with the Commission, and for the establishment of 
the electronic register.  This Regulation also entered into force on 11 June 2022 . I will now hand over 
to a colleague.  
22.  Good morning , colleagues. It will be me who will present the notification by Italy that I think 
was circulated in the meantime , and Pierre -Yves, my colleague from Brussels,  will then introduce 
after me the French noti fications. So, as regard s the Italian notification , Italy is notifying several 
pieces of legislation affecting IP covering a wide time frame from 2001 until 2020. Some of these 
legislative pieces have been taken recently, to adapt the legislation to techno logical improvements 
or to introduce new digitalized and streamlined administrative procedures for applicants. Other 
instruments were adopted some years ago to improve judicial or administrative procedures or to 
implement EU directives at national level. S ome of the acts notified relate to primary law (laws or IP/C/M/106/Add.1  
 
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  legislative acts), some other s relate to regulations or implementation acts, mainly aimed at 
procedural and operational improvements. The overall objective is to modernize and simplify 
substantive IP rules and procedures in line with the international and European practice and 
standards.  
23.  I will start with the notification IP/N/1/ITA/6 . The most relevant and recent modification took 
place in 2019 with the Ministerial Decree of 13 November , concerning a new examination procedure 
for international applications for patents. This new procedure allows the Italian patent office to 
examine an international patent application designating  Italy as the country of protection. 
Previously, an international application for a patent to be protected in Italy had to be submitted only 
through the European Patent Office. This is an improvement in the application of the "Patent and 
Cooperation Treaty " of WIPO and an additional option for international businesses seeking patent 
protection in Italy.  
24.  The ne xt notification is IP/N/1/ITA/8 . In 2020, the Industrial Property Code of 2005 was 
amended by the Legislative Decree No. 34 of 19 May as regards the historic national brand. The 
procedure introduced in 2019 concerning companies owing historic national brands deciding to 
relocate abroad was repealed, together with the corresponding support fund.  
25.  The next notification is IP/N/1/ITA/7 . A decree of 3 April 2018  established the on -line platform 
named "PAGO PA " for the online payment of the administrative fees related to most administrative 
procedures of the Ital ian Patent and Trademark Office. This makes available a digital  payment , 
whereby before the payment was possible through bank transfer or postal bulletin.  
26.  The next notification is IP/N/1/ITA/4 . In 2003, a legislati ve decree of 27 June established, in 
civil tribunals and courts of appeal, 12 divisions specialized in industrial and intellectual property. In 
2012, the specialized IP divisions were increased to 21. This amendment allows judicial cases 
concerning IP righ ts to be reviewed directly by competent IP judges, speeding up the judicial 
procedure and better serving business interests.  
27.  The next notification is IP/N/1/ITA/9 . In 2001, Italy transposed the EU Directive 1998/71 
concerning the legal protection of industrial designs. National provisio ns dating back to 1940 were 
modified in the substance and in procedures. New definitions of design, industrial model and 
industrial design were introduced, as well as a definition of access to the public. A reference to the 
Locarno international classifica tion for design applications was also introduced. Finally, registration 
requirements and criteria were changed and modernized in line with the EU framework.  
28.  The penultimate  notification is IP/N/1/ITA/5 . In November 2019, a joint ministerial decree was 
adopted: it introduced new procedure s for the registration of new plant varieties and a new method 
to pay the related fee. This implementing decree improved and streamlined the procedures to 
register new plant varieties.  
29.  Last but not least IP/N/1/ITA/3 . In March 2020, Italy enacted a law with provisions for the 
organizati on of the winter olympic and para -olympic games in Milan  and Cortina  d'Ampezzo  in 2026. 
Such law contains also a provision concerning the prohibition of activities of ambush marketing and 
misleading advertising. These activities are prohibited on the occas ion of sport events or trade fairs 
of national or international relevance if they are not authorised by the organising bodies and when 
they are aimed at gaining an economic or competitive advantage. The prohibition aims at preventing 
unfair competition in marketing and advertising during big sport events.  That's all from me and I 
give the floor to my colleague Pierre -Yves.  
30.  Now the regulations and legislation that have been adopted by France, from IP/N/ 1/FRA/2  to 
IP/N/ 1/FRA/17 . I will illustrate these notifications with four laws:  The "Pact" Law No. 2019 /486 of 
22 May 2019 on the growth and transformation of companies and its implementing regulations 
introduce various measures to modern ize and safeguard the intellectual property framework in 
France:  
a. Some measures concern patents: filing of a provisional application for a patent to 
facilitate access to intellectual property, particularly for SMEs and start -ups; creation of 
an opposition p rocedure before the intellectual property office and strengthening of the 
patent substantive examination procedure to ensure greater legal certainty.  IP/C/M/106/Add.1  
 
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  b. Other measures concern trademarks and stem from the transposition of EU Directive 
No. 2015/2436 to approxi mate the laws of the Member States relating to trademarks: 
creation of new types of trademarks (sound, motion (animated) or multimedia); 
changes to the opposition procedure and creation of a procedure for the invalidation or 
revocation of trademarks before  the intellectual property office.  
31.  The second law I would like to present to you is Law No. 2018 /670 of 30 July 2018, which 
transposes Directive No. 2016/943/EU of 8 June 2016 on the protection of undisclosed know how 
and business information against their  unlawful acquisition, use and disclosure.  Order No. 2018 341 
amends the French Intellectual Property Code to ensure that French legislation is compatible with 
European regulations on the unitary patent and the Agreement on the Unified Patent Court.  
32.  Lastly , other legislation notified concerns copyright: Law No. 2019 /775 of 24 July 2019 creates 
a right related to copyright for the benefit of news agencies and press publishers; Law No. 2021 
1382 of 25 October 2021 on the regulation and protection of access to  cultural works in the digital 
age aims to better protect creators ' rights (by providing for a system for blocking or dereferencing 
mirror sites and an ad hoc interim mechanism to tackle sports streaming websites); and 
Order  No. 2021 1518 introduces mandat ory exceptions to copyright in order to allow for text and 
data mining, digital uses of works for the purposes of illustration for teaching, and the preservation 
of cultural heritage. With this, we have finished with the EU notifications, including those f rom France 
and Italy.  
1.4  Chinese Taipei  
33.  The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu would like to make a 
brief introduction of our three notifications circulated rec ently. The first one is IP/N/1/TPKM/33  
(Amendments to the Patent Act) . In compliance with the Patent Linkage System introduced into the 
Pharmaceutical Affairs Act and implemented on 20 August 2019, Article 60 -1 of the Patent Act was 
added to stipulate the legal basis for patent holders to sue generic drug manufacturers that make a 
P4 declaration for patent infringement. The Article also provides that in a case where a patent holder 
does not file a suit within the stipulated time period, the generic drug manufacturer may file a 
declaratory judgment to ascertain whether any infringement has occurred.  
34.  The second one is IP/N/1/TPKM/34  (Amendments to the Copyright Act) . The amendments to 
the Copyright Act were ratified i n response to digital technology advancements that have boosted 
education results, the increasing need for digital school bags, and the objective to digitize collections 
and provide digital services within libraries - promoting knowledge equity and meeting  the needs of 
our current education policy in the digital age.  
35.  The third one is document IP/N/1/TPKM/35  (Amendments to the Copyright Collective 
Management Organization Act) . The amendments to the Copyright Collective Management 
Organization Act were made to ensure smooth operation, i ncreased transparency, and prudent 
management of our collective management system. Provisions added stipulate the need for internal 
controls to manage personnel, finances, operations, etc. within CMOs and set forth the competent 
authority 's supervision mec hanism and the penalty clauses envisaged for the CMOs ' non-compliance 
with its provisions. The amendment has strengthened TIPO 's supervisory and guidance capacity, 
providing it the power to revoke CMOs ' establishment permit and order the dissolution of any  not 
adhering to prudent management practices.  
1.5  Brazil  
36.  Allow me to make a brief introduction of Brazil 's notification IP/N/1/BRA/10 . In general terms 
Law 14200 of 2 September 2021 which has been notified , amends Article 71 o f Law 9279 which is 
the Brazilian Industrial Property Law. This revision is part of an effort from the Brazilian Government 
to update and reinforce our national framework of intellectual property and should be read together 
with other notifications made to this Council such as IP/N/1/BRA /7 and IP/N/1/BRA/8 . The 2021 Law 
that ha s been notified now , regulates the employment of temporary non -exclusive compulsory 
licences on patents under specific conditions, such us during states of national or international 
emergency or public calamity. It further details internal procedures for i dentifying instances where 
compulsory licenses may be applied.  IP/C/M/106/Add.1  
 
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  1.6  Ukraine  
37.  Ukraine would like to present its notification of the Law No 2174-IX adopted to the purpose of 
protecting intellectual pr operty interest of stakeholders during the martial law regime.  We would like 
to reiterate that the martial law was imposed in Ukraine on the 24  February  2022 due to the 
unprovoked and unjustified military aggression by the Russia n Federation  against Ukrain e. It has 
been prolonged for the fourth time because of ongoing escalation of the Russia n Federation 's military 
aggression with the use of terrorist methods by Russian troops in the territory of Ukraine, delivering 
missile s and artillery attacks on our inf rastructure and civilians, holding fake "referenda " in the 
occupied territories of Ukraine and recent announcement of Russia  Federation 's mass mobilization.  
38.  Just last Monday 10 October the whole world had witnessed the unprecedented terrorist attack 
by the Russian Federation.  While more than 80  missiles were launched into 20 cities all over the 
territory of Ukraine. The launch of the Russia  Federation 's war led to disastrous repercussions, huge 
human suffering and losses , adversely affected all economic activities, including in the field of 
intellectual property , causing uncertainty and lack of understanding relat ing to possibilities of proper 
application of established procedures concerning maintenance and requisition of intellectual property 
rights during the war time.  
39.  To protect intellectual property interests of right  holders and applicants, on the 1 April 2022 
Ukraine adopted the above -mentioned Law. It refers to all categories of intellectual property . Its 
provisions provide for peculiaritie s for maintaining the validity, terms of use and enforcement of 
intellectual property rights during and after the state of war.  The Law also suspends  deadlines for 
examination procedures of applications as well as for other actions related to granting of i ntellectual 
property rights during the  martial law regime.  The Law entered into force on the 13  April 2022 . It is  
effective now and it will be in force until  the Russian Federation stops the war once and for all.  
40.  To conclude, we would like to reassure WTO Members that, despite the brutal war launched by 
the Russia n Federation , Ukraine is doing its best to ensure efficient protection and enforcement of 
intellectual property rights , developing the Ukrainian intellectual property system in accordance with 
the international commitments , as well as by improving its institutional capacities.  The government 
of Ukraine will also continuously fulfil its obligation to ensure the transparency of our intellectual 
property  legislation.  
1.7  Saudi Arabia, Kingdom of  
41.  Our delegation does not intend to make any statement about its notification  today but we would 
be happy to receive any question about it.  
1.8  Tonga  
42.  I thank the Council for the opportunity to provide a brief introduction on Tonga 's notification 
under Article 63.2 reference IP/N/1/TON/2  to 10.  This also serv es to update Members of Tonga 's 
notification since the 2 June 2009 reference IP/N/ 1/TON/1 . Amendments to legislation vary from 
minor modifications , such as reaffirming the minister responsible, the short title and commencement 
date, to modifications such as that under the Industrial Prop erty Act to ensure compliance with WTO 
commitments under the TRIPS Agreement.  
43.  Title one: Customs and Excise Management Act [Chapter 11.03 ] (2020 Revised Edition) . First 
notification under the TRIPS  Agreement . In the Act , Section 2 elaborates on the Interpr etation of 
"counterfeit goods " while Section 94  outlines the penalties for importing or selling counterfeit goods.  
44.  Title two: Protection of Layout -Designs (Topographies) of Integrated Circuits Act  
[Chapter  17.13 ] (2020 Revised Edition) . 2020 Revised Editio n includes all amendments made before 
30 October 2020.  Amendments included:  
a. Act 18 of 2002 Amended by Act 5 of 2012  
b. Modification of Short title to commence as of date 30 July 2012  
c. Commencement of Act is 1st September 2008  IP/C/M/106/Add.1  
 
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  d. "Minister " means the minister of labour, commerce and industries modified to read 
"Minister " meaning the minister responsible for commerce; and  
e. "Registrar " means the Registrar of Industrial Property, holding office, under the 
Industrial Property Act 4.  
45.  Title three: Protection of Layout De signs (Topographies) of Integrated Circuits Regulations  
[Chapter 17.13.01 ] (2020 Revised Edition) . Tonga 's notification under 63.2 in 2009 stated that draft 
regulations were still being finalised. This regulation includes all amendments made before 
30 October 2020 and are made under section 21 of the Protection of Layout -Designs (Topographies) 
of Integrated Circuits Act [Chapter.17.13 ]. The Regulations provide for the payment of fees in 
connection with applications for the registration of layout -designs of integrated circuits and matters 
related thereto.  Commencement date of Regulations is 8 December 2009 . 
46.  Title four: Protection of Geographical Indications Act [Chapter 17.12 ] (2020 Revised Edition ). 
2020 Revised Edition includes all amendments made before 30  October 2020 . Amendments 
included:  
a. Act 17 of 2002 amended by Act 5 of 2012  
b. Short title  
c. Commencement date of Act is 1 September 2008  
d. "Minister " means the minister of labour, commerce and industries was modified to read 
"Minister " meaning the minister respo nsible to commerce  
e. "Registrar " means the Registrar of Industrial Property holding office in terms of section 
37 of the Industrial Property Act.  
47.  Title five: Protection of Geographical Indications Regulations Chapter 17.12.01 (2020 Revised 
Edition) . Tonga 's notification under 63.2 in 2009 stated that draft regulations were still being 
finalised.  This regulation includes all amendments made before 30 October 2020 and is drafted under 
section 20 of the Protection of Geographical Indications Act [Chapter. 17.12 ] to provide for the 
payment of fees in connection with applications for the registration of geographical indications and 
matters related thereto.  Commencement  date of Regulations it is 8 December 2009 . 
48.  Number six: Industrial Property Act  [Chapter 17.07 ] (2020 Revised Edition ). Tonga 's notification 
under 63.2 in 2009 stated that an Industrial Property Amendment Bill 2009 was still being finalised.  
2020 Revised Edition includes all amendments made before 30 October 2020 . Amendments 
included:  
a. Act 5 of 2012  
b. In section 2, replace the word "Minister " and its definition with ""Minister " meaning the 
minister responsible for commerce " 
c.  Act 6 of 1999  
49.  Section 46 of the Principal Act is amended:  firstly by inserting the following new subsection as 
subsection (1A)  which  reads: (1A) Notwithstanding subsection (1), the Registration of United 
Kingdom Trademarks Act is deemed to be in force as from 31 January 1997 until the Minister notifies 
in the Gazette a date for regulations under this Act to come into force. " And in sub section (2):  
a. by deleting the commas and words  "on the date of entry into force of this Act, " in line 
1;  
b. by deleting the words "entry into force of this Act " in line 5 and substituting therefor 
the words "the repeal of the United Kingdom Trademarks Act ". IP/C/M/106/Add.1  
 
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  50.  Title seven: Industrial Property Regulations  [Chapter 17.07.01 ] (2020 Revised Edition ). First 
notification . 2020 Revised Edition includes all amendments before 30 October 2020.  These 
Regulations are made under section 44 of the Industrial Property Act [Cha pter 17.07] made on 
8 October 1998.  Amendments included:  
a. Substituted by 2010 amendment Regulation.  
b. The first schedule of the industrial property regulations 1998 is then repealed and 
replaced by the new schedule of payable fees in respect of the matters such as Patents 
and Utility Model Certificates, Industrial Designs, Marks and general.  
51.  Title eight: Copyright Act  [Chapter 17.05 ] (2020 Revised Edition ). 2020 Revised Edition includes 
all amendments before 30 October 2020.  Act 17 of 2002 amended by  Act 5 of 2012.  Amendments 
included:  
a. Modification to the Short title  
b. Commencement date of Act 1 September 2008  
c. Also modified was and I quote "The Minister responsible for copyright may, with the 
consent of Cabinet, make Regulations for the implementation o f the purposes and 
provisions of this Act " was modified to read "Minister responsible for commerce ". 
52.  Lastly, title nine: Protection Against Unfair Competition Act  [Chapter 17.11 ] (2020 Revised 
Edition). 2020 Revised Edition includes all amendments before 3 0 October 2020 . Amendments 
included:  
a. Modification to the short title to commence as of date 30 July 2012  
b. Commencement date of Act modified to 1 September 2008  
53.  Should you have any questions, I kindly ask to provide written questions to submit to capital.  
1.9  Russian Federation  
54.  My delegation did not plan to intervene on this item of the agenda, however I wanted to attract 
the attention that unfounded and misleading political statements mad e by some Members, especially 
artificially integrated in this item agenda one more time, are out of mandate of this TRIPS Council. 
We consider such practi ce inappropriate; they impede the work of the Council. My delegation asks 
you Mr. Chairman to take app ropriate measures.  
1.10  European Union  
55.  The European Union just wanted to support the Ukraine in condemning in strongest possible 
terms the brutal , unprovoked and illegal invasion and war that the Russian Federation  unleashed in 
Ukraine. The recent Russian blind, senseless and terrorist attacks on non -military target s including 
universities and children 's playground s are particularly despicable. Thes e terroristic attacks reflect 
the true nature of what the Russian  Federation calls a "special military operation ". 
1.11  United States of America  
56.  The United States of America also wanted to speak in support of Ukraine. We reiterate our 
condemnation of Russia 's brutal , unprovoked and unjustified war  of aggression against Ukraine. The 
Russian Federation is solely responsible for the catastrophic loss of lives and human suffering in 
Ukraine and for rising threats to food security around the world , particularly in developing countries. 
The United States will continue to support Ukraine 's courageous efforts to defend itself , uphold its 
territorial integrity and protect its population. We c all on the Russian Federation to immediately 
cease  the war , withdraw all of its forces from Ukraine and allow a return to peace and stability.  IP/C/M/106/Add.1  
 
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  2  REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION  
57.  No statements were made under this agenda item.  
3  IP AND COVID -19 
3.1  South Africa  
58.  We note with appreciation, the Secretariat working paper entitled "Innovation and the Patenting 
Activities of COVID -19 Vaccines in WTO Members – Analytical Review of Medicines Patent Pool 
COVID -19 Vaccines Landscape (VAXPAL) ". 
59.  We also would like to thank the Secretariat for hosting a seminar in which it presented the study 
to a broad range of stakeholders including Geneva -based delegates and patent offices. Certainly, 
the feedback we received from the Companies and Intellectual property Commission (CIPC) – which 
is South Africa 's IP office  – is that the presentation was most useful.  Similarly, we also value the 
Secretariat publication entitled "Patent -related Actions Taken in WTO Members in Response  to the 
COVID -19 Pandemic ". 
60.  We would encourage the periodic updating of these important publications to reflect recent 
relevant developments. On this note, a recent review by US-based institution Knowledge Economy 
International (KEI) looked into contracts between the United States Government and private 
companies. This study revealed 62 contracts containing government authorizations to use patented 
inventions without the permission of patent holders. Presentation of such information can provide 
useful best practice for Members.  
3.2  Switzerland  
61.  Just to add our voice to the delegate of South Africa to thank the Secretariat and express our 
appreciation for all the event s and work and publications that they have produced under this 
important topic , so relevant to this Council , and we certainly could support South Africa proposal to 
update these Secretariat publications regularly. I think they assist Members tremendously.  
3.3  Sri Lanka  
62.  Sri Lanka reiterates its position and welcomes both outcomes from MC12 on the TRIPS Decision 
and the WTO response to the COVID -19 Pandemic and Preparedness for Future Pandemics 
document. Particularly, by adopting the WTO response to the COVID -19 pandemic Decision, 
Ministers have clearly highlighted the need for addressing IP -related challenges for expanding 
production and providing equitable and affordable access to all COVID -19 products, including 
vaccines, therapeutics, diagnostics, and other essential medical goods including their inputs, for the 
current and future pandemics.  
63.  We believe that these Ministerial Decisions have re -affirmed the need for a solution on IP th at 
would address the difficulties faced by developing countries in accessing TRIPS flexibilities and 
relevant provisions contain ed therein, so that they could be applied automatically during future 
pandemics, health emergencies and other crises.  
64.  Sri Lanka would like to thank the Secretariat for the compilation of the IP measures in the 
context of COVID -19 imposed by Members, and it is important to flag that these measures highlight 
the need for effective solutions to IP -related challenges in the context of COVID -19, and also in the 
context of Members ' preparedness for future pandemics.  
65.  Such compilation also reveals the obvious inadequacy of the existing flexibilities within the 
TRIPS Agreement to cater for current health emergencies  and reiterates the need for effective 
solutions to be found in case of future pandemics to address an array of challenges, including IP 
measures in the context of C OVID -19 pandemic, in an expeditious manner , as such new solutions 
may go beyond the existing flexibilities provided for in the present WTO Agreements.  
66.  Further, we suggest the WTO Secretariat to compile specific IP measures and tools that can 
facilitate the use of TRIPS flexibilities, including patent landscape reports, early publication of patent IP/C/M/106/Add.1  
 
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  applications etc., and specific instances of use of TRIPS flexibilities in the context of C OVID -19, both 
by developed and developing countries, and finally the country level analysis of the legal status of 
patents and patent applications relating to COVID -19 vaccines, therapeuti cs and diagnostics as well.  
67.  We look forward to continuing our constructive work to fulfil the Ministerial mandates in this 
regard and support this item to remain on the TRIPS Council agenda to allow us to be updated by 
the measures taken by Members.  
4  REVIEW  OF THE PROVISIONS OF ARTICLE 27.3(B)  
5  RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE CONVENTION ON 
BIOLOGICAL DIVERSITY  
6  PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  
6.1  South Africa  
68.  Following your advice , we will not give a not exhaustive statement under this agenda item.  We 
will submit our statement to the Secretariat. We will just perhaps like to recall our request for the 
CBD Secretariat to brief the TRIPS Council as well as our call for the updating of t he notes that you 
made reference to.  
6.2  India  
69.  Traditional medicine has been an integral resource for health across world communities for 
millenia  and remains a mainstay for these communities facing inequities in access  to conventional 
medicines. The sociocultural practices and biodiversity heritages of traditional medicine are 
invaluable resources to evolve inclusive, diverse, and sustainable development. India reiterates its 
long-standing demand of an international enf orceable regime to contain misappropriation. Patents 
should not be granted for existing traditional knowledge (TK) associated with genetic resources. 
Further where TK associated with genetic resources form the basis of scientific development, it is 
important to have disclosure of source or origin of the resource/knowledge along with disclosure 
that the access was on mutually agreed terms. This will not only help address concerns of bio piracy 
but also strengthen and add to the Members ' commitment to transparency mechanism, which should 
not be understood as limited to notification obligations.  
70.  The TRIPS Agreement continues to ignore numerous IPR -related obligations in the CBD which 
are of  interest to developing countries. Despite several submissions like the disclosure proposal 
(document IP/C/W/474 ) submitted in 2006, document TN/C/W/52  submitted in June 2008 followed 
by document TN/C/W/59  in April 2011, calling for a decision to enhance mutual supportiveness 
between  the TRIPS Agreement and the CBD proposed by a majority of the Membership, it is 
regrettable that progress remains elusive. The WIPO  IGC process has also been unable to make 
much progress in these years. Given the enforceability of the TRIPS Agreement , there is a need and 
clear mandate to build the linkage between the TRIPS Agreement and the CBD under the aegis of 
this Council and we must ensure that substantive discussions on the TRIPS -CBD linkage is revived. 
We also reiterate our demand for a formal briefing by the CBD Secretariat in the interest of most 
Members. We also support updating  the three factual briefs by the Secretariat.  
71.  The 2030 Agenda for Sustainable Development Goals (SDGs) calls for promoting access to and 
fair and equitable sharing of benefits arising from the utilization of genetic resources and associated 
traditional kno wledge in Targets  2.5 and 15.6 , we need to expeditiously work towards these goals. 
We wish to share with the Membership steps taken by India in this regard. The Indian Government 
in August of this year has decided to open up India 's Traditional Knowledge and Digital Library 
(TKDL) database to users beyond patent offices. This will enable the TKDL to drive research and 
development, and innovation based on India 's valued heritage across different fields.  
72.  Indian TK offers immense potential to serve national and global needs, by providing societal 
benefits as well as assisting in economic growth. For example, the traditional systems of medicine 
and wellness from our country, namely Ayurveda, Siddha, Unani, Sowa Rigpa, and Yoga are serving 
the needs of  people from India and across the world even today. The recent COVID -19 pandemic 
has also been witnessing extensive use of Indian traditional medicines whose benefits range from IP/C/M/106/Add.1  
 
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  immune -boosting to symptoms -relief to anti -viral activity. Earlier this year , in April, the World Health 
Organization (WHO) established its first off -shore Global Centre for Traditional Medicines (GCTM) in 
India. These demonstrate the continued relevance of TK in addressing the current and emerging 
needs of the world. The decision emphasizes  on integrating and co -opting TK with current practices 
towards enhancing innovation and trade. The TKDL will act as an important source of TK information 
for advancing knowledge and technology frontiers.  
73.  At last, India is committed to continue ou r efforts in building momentum on the issue of TRIPS -
CBD linkage in light of important developments, namely the finalization of the SDGs  and the 
ratification of the Nagoya Protocol.  
6.3  Bangladesh  
74.  On agenda items 4 , 5 and 6, the position of Bangladesh has not changed. In this regard, to 
avoid repetition, I refer to my delegation 's previous statement s delivered at the TRIPS Council 
meeting s. Bangladesh stands ready to engage constructively with Members.  
6.4  Sri Lanka  
75.  The protection of biological resources, traditional knowledge and folklore are important 
development issues for developing countries including Sri Lanka. These three issues are currently 
being discussed in detail at WIPO as well. However, our delegation wo uld also like to support to keep 
these issues on the TRIPS Council agenda, considering the substantial importance of these issues 
for developing countries . In this regard, our delegation stresses the importance of the negotiation 
on the relationship betwee n the TRIPS Agreement and the CBD, as well as the need to protect 
traditional knowledge and folklore.  
76.  Sri Lanka also believes that it is important for the TRIPS Council to give adequate attention to 
address these issues. Against  this backdrop, a formal briefing by the CBD Secretariat on the latest 
developments of the Nagoya Protocol will be useful for Memb ers and we also support updating the 
three factual briefs by the Secretariat on these issues.  
77.  Therefore, considering the mandate from the Doha Ministerial Declaration and the 2030 
Sustainable Development Goals, Targets 2.5 and 15.6, it is our responsibili ty to take these 
discussions forward towards to a meaningful outcome . Sri Lanka stands ready to engage 
constructively with Members on these important issues.  
6.5  Indonesia  
78.  At the outset, we would like to recall our previous statements on agenda items 4, 5, and 6 of 
which our position remains unchanged.  Our delegation further stresses the need to amend 
Article s 27.3(b) and 29 of the TRIPS Agreement in order to prevent misappropriation and misuse of 
genetic resources a nd traditional knowledge through effective and complimentary international 
arrangements.  
79.  On that note, in order to provide us with the necessary information to move forward based on 
evidence, facts, and objective data on this longstanding issue, it would b e in our best interest to 
agree on updating the long overdue Secretariat summary notes and to invite the CBD Secretariat to 
brief the Council on the Nagoya Protocol and its developments . 
80.  Indonesia urge s that we move from this stalemate, starting with an "information session " 
involving relevant organizations, which we will also be doing in other Committees, and we are ready 
to engage constructively with Members on these matters.  
6.6  Brazil  
81.  Brazil 's long -standing positions regarding agenda items 4,5 and 6 remain unchanged to date. 
We remain committed to explore options, alternatives in this Council to discuss the relationship 
between the TRIPS Agreement and the CBD as well as  the possibility of an amendmen t to the 
TRIPS  Agreement that conte mplates a mandatory disclosure requirement of the origin of genetic 
resources in patent applications. A multilateral provision on disclosure would be the most effective IP/C/M/106/Add.1  
 
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  mean s to protect genetic resources as determined by the CBD, increase the legal security of the 
system as a whole , and provide a framework to the rights of countries hosting a rich biodiversity.  
82.  We also take this opportunity to invite Members to engage constructively in the promising 
discussions taking plac e in the WIPO IGC in preparation of a diplomatic conference on that matter.  
6.7  Nigeria  
83.  I wish to recall our previous statements regarding agenda items 5 and 6.  We reiterate the 
importance for Members to engage in dis cussions with the aim to promote traceability and 
requirement of  prior informed consent as well as benefit sharing in respect of any product 
manufactured through the use of genetic components or traditional knowledge and folklore. We 
believe the requireme nt of disclosure contained presently in the TRIPS Agreement remain grossly 
inadequate. Hence the need to improve existing provisions. In addition , we urge Members to 
consider collaborating regionally and internationally, in order to achieve this mutually b eneficial goal. 
We also stand ready to engage constructively on this matter.  
6.8  Peru  
84.  In relation to agenda items 4, 5 and 6, Members are already aware of Peru 's position. However, 
we believe it is important to note that, for Peru, addressing the question of how the implementation 
of the TRIPS Agreement and the CBD can be mutually reinforcing and supportive and is becoming 
increasingly urgent.  
85.  We wish to point ou t that my country has seen a rise in biopiracy cases in recent years. 
According to information provided by the National Anti -Biopiracy Commission (CNB), 248 biopiracy 
cases have been identified in relation to 41 genetic resources of Peruvian origin and ass ociated 
traditional knowledge of indigenous peoples. A quite significant increase was identified in 2021. We 
believe that the disclosure of source requirement would be the most effective way to address the 
international problem of misappropriation of genet ic resources and traditional knowledge. We 
associate ourselves with the request to invite  the CBD Secretariat to brief Members and update its 
factual notes.  
6.9  United States of America  
86.  I think our po sition on these issues are well known as stated in previous meetings. Just to 
streamline our position regarding genetic resources, traditional knowledge and folklore we continue 
to believe that the World Intellectual Property Organization (WIPO)  serves as the best forum to trust 
these issues , and as noted by colleagues , the WIPO IGC is looking at addressing unresolved issues 
and working on a common understanding of core issues using an evidence -based approach and 
examples of national experiences. While the  WIPO  General Assembly recently took a decision to 
convene a diplomatic conference to conclude an international legal instrument related to intellectual 
property, genetic resources and traditional knowledge associated with genetic resources no later 
than 20 24, significant gaps in views, positions and scope of the subject matter remain on these 
topics. The United States will continue to engage in technical discussions at WIPO IGC. With respect 
to the various requests made today , the United States is not in a position to support these requests 
but remains open to discussions including bilaterally with delegations in between, and at  the margins 
of the TRIPS Council meetings.  
6.10  Japan  
87.  Japan 's position remains unchanged. Regarding the proposal to introduce the disclosure 
requirement in the IP system, there is concern that the introduction of such a requirement would 
discourage industries from conducting research and development activities on biological materials . 
88.  In addition, this delegation believes that the WIPO IGC is the most appropriate forum for holding 
technical discussions on genetic resources, traditional knowledge and folklore from the IP 
perspective . Given that detailed discussions have been continuous ly held at the WIPO IGC, we should 
avoid duplication of discussion. The delegation of Japan remains willing to contribute to 
evidence -based discussions on these issues in a constructive and effective manner.  IP/C/M/106/Add.1  
 
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  6.11  South Africa  
89.  I just would like to thank the distinguish ed delegate from the United States of America for 
bringing to our attention the recent decision taken by  the WIPO General Assembly  to convene a 
diplomatic conference on genetic resources. We would like  to reiterate our perspective that 
discussion at the WIPO IGC and this forum are complementary and not  mutually exclusive, and given 
this recent development , the time will be right for the WIPO, as an observer , to brief us on the 
discussions at the IGC  pertaining to genetic resources.  
6.12  Korea, Republic of  
90.  Regarding Article 27 .3(b), our position remains unchanged. With regard to the possible 
alignment of the TRIPS Agreement and the Convention on Biological Diversity (CBD) , we believe 
that TRIPS and CBD have differen t purposes and oversee different aspects. So the amendment is 
unnecessary. Regarding the protection of folklore , we are  of the  position that the WIPO IGC  is the 
right forum  to address these issues to avoid overlapping discussions.  
6.13  China  
91.  China 's position on this issue is well -known and remain s unchanged, we are glad to hear that 
the WIPO IGC  is carrying out work on the se issues, but China still believes that the discussions and 
negotiations carried out at the WIPO IGC do not contradict with Members ' discussion at the WTO.  
6.14  South Africa  
92.  We would l ike to recall our previous statements on these items. As indicated previously, in this 
discussion we often lose the relative importance of the individual components making up the 
'Triplets '. The Doha Ministerial Declaration instructed that the TRIPS Counci l, as part of its work 
programme to review Article 27.3(b) as well as examine the relationship between the 
TRIPS  Agreement and the C onvention on Biological Diversity (CBD)  and the protection of traditional 
knowledge and folklore. These are important mandat ed issues which remain an integral part of the 
Doha Round single undertaking. Biopiracy remains a pervasive problem and the absence of a 
multilateral solution, as applicable under the TRIPS Agreement, national disclosure requirements will 
remain inadequate . Discussions in this forum and those under the auspices of the WIPO IGC are 
complimentary and not mutually exclusive. In this regard, we welcome the progress made at the 
recent WIPO General Assembly where consensus was reached on a diplomatic conference d ealing 
with genetic resources. The WTO Membership would certainly take note of such developments. Our 
delegation would welcome a briefing from WIPO in this regard.  
93.  Similarly, it would be useful for the CBD Secretariat to brief the TRIPS Council on the CBD  and 
other implementation issues under the Nagoya Protocol as well as any new developments. Finally, 
we wish to raise once more, the issue of updat ing the three technical notes contained in 
documents  IP/C/W/368/Rev.1 , IP/C/W/369/Rev.1  and IP/C/W/370/Rev.1 . It would be appropriate 
for the Secretariat to update the information c ontained in these notes in a neutral manner to further 
facilitate discussions among Members.  
7  ANNUAL REVIEW OF THE SPECIAL COMPULSORY LICENSING SYSTEM (PARAGRAPH 7 
OF THE ANNEX TO THE AMENDED TRIPS AGREEMENT AND PARAGRAPH 8 OF THE 
DECISION ON THE IMPLEMENTA TION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON 
THE TRIPS AGREEMENT AND PUBLIC HEALTH)  
94.  No statements were made under this agenda item.  
8  NON-VIOLATION AND SITUATION COMPLAINTS  
8.1  India  
95.  India's position on the issue remains unchanged.  We further reiterate that in our understanding , 
until there is a consensus on the scope and modalities of the applicability of NV SCs to TRIPS, these 
will not apply to the TRIPS Agreement. India is committed to engag ing with like -minded Members 
in making non -violation and situation complaints inapplicable to the TRIPS  Agreement . IP/C/M/106/Add.1  
 
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  8.2  Switzerland  
96.  Just to recall that o ur delegation believes that no additional modali ties are needed for the 
application of such complaints under the TRIPS Agreement next to those already contained in the 
Dispute Settlement Understanding.  This said, our delegation is ready to discuss in a constructive 
spirit any such proposal from Members,  should they consider modalities in addition to those included 
in the Dispute Settlement Understanding necessary.  
8.3  Argentina  
97.  The position of Argentina with respect to non -violation and situation comp laints remains 
unchanged.  In line with the arguments presented in document IP/C/W/385/Rev .1, which Argentina 
co-sponsored together with other Members, these complaints raise systemic concerns and, as 
affirmed in paragraph 57 of this document, complaints provided for under subparagraphs 1(b) and 
1(c) of Article XXIII of GATT 1994 must not be applied to the settlement of disputes under the 
TRIPS  Agreement.  Lastly, my delegation would like to express once again its willingness to hold 
multilateral discussions that can lead to permanent and consensual solutions.  
8.4  Sri Lanka  
98.  Sri Lanka reiterates its support to the Ministerial Decision adopted on 17 June 2022 on the 
extension of the Non -Violation and Situation Complaints Mora torium stipulated under the Article 64.2 
of the TRIPS Agreement until MC13 , which would permit Members to refrain from bringing any 
unintended violations of provisions, including in use of compulsory licences,  of the TRIPS Agreement 
to the WTO dispute sett lement system.  
99.  Sri Lanka 's position on this issue remains unchanged as a co -sponsor of the 
document  IP/C/W/385 . Accordingly, Sri Lanka supports the decision to instruct the TRIPS Council to 
continue its examination of scope and modalities, and to make appropriate recommendations to the 
MC13 and we look forward to working with like -minded Members in making non -violation complaints 
inapplicable to TRIPS and come up with a way forward and a permanent solution for th ese 
long-delayed issue s. 
8.5  Brazil  
100.  Brazil remains open to assess proposals on scope and modalities of NVSCs applied to the 
TRIPS  Agreement. We are ready to discuss any contributions that Members might have that could 
lead to an agreed solution on this topic.  
8.6  Canada  
101.  Canada 's longstanding position on this issue remains unchanged, and notes that the 
availability of NVNI claims under TRIPS would create legal uncertainty for WTO Members. Canada 
recognizes that Members have worked  constructively to arrive at a consensus -based decision on this 
matter as recently as MC12 and encourages the TRIPS Council to continue to similarly engage in a 
constructive manner to identify consensus -based solutions to other important issues facing the 
WTO Membership going forward.  
8.7  Bangladesh  
102.  On non -violation and situation complaints, my delegation is in favo ur of establishing a 
permanent moratorium before MC13. To avoid repetition, I refer to my delegation 's previous 
statements delivered on this issue at the TRIPS Council meetings.  Having said that,  Bangladesh is 
ready to constructively engage with Members on this issue further.  
8.8  South Africa  
103.  It is well established that proponents of the application of NVCs under the TRIPS Agreement 
have not provided concrete examples of the kind of scenarios under which an otherwise 
TRIPS -consistent measure would impair or nullify benefits beyond those  arising from the obligations IP/C/M/106/Add.1  
 
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  set out in the Agreement.  Having said this and as we indicated  previously , we stand ready to discuss 
our ideas with delegations on this matter . 
8.9  United Kingdom  
104.  As this is the U nited Kingdom 's first intervention today, we would like to start by saying that 
as we meet here to discuss issues arising under the global rules -based system, we cannot sit by and 
ignore  the egregious  violations of international law and the UN Charter committed by one WTO 
Member, the Russia n Federation , against another , Ukraine.  
105.  Putin's illegal annexation of regions of Ukraine constitutes  a new low point in Russia 's blatant  
flouting of  international law . The United Kingdom unreservedly condemns this outrageous and illegal 
act. What happens in Ukraine matters to the work of this organization and matters to us all. Russia 's 
actions will prolong the impact on the global economy , have global consequences and  jeopardize 
prospects of peace The U nited Kingdom  and the international community have made it clear to 
President Putin  that his attack  on the Ukrainian people must stop  and that he must withdraw from 
Ukraine and restore regional and global stability . 
106.  On this item, t he United Kingdom would like to state  that given the lack of substantive 
discussion on this long -standing issue preceding the pandemic , the TRIPS Council in October 2021 
made the right decision to extend the NVSC s moratorium until MC13. The Unit ed Kingdom  believe s 
it is important  that the TRIPS Council can  begin substantive discussion on the scope and modalities 
of the NVSCs before MC13.  
8.10  Nigeria  
107.  We wish to recall our previous statements under this agenda item. We take note of the MC12 
Decision adopted on 17 June 2022 to extend the moratorium contained in document  WT/L/1137  
instructing the Council to continue its examination of scope and modalities, and to make 
recommendations to MC13. We remain open to working with other Members to consider modalities 
for the application of non-violation and situation complaints. However, in the absence of any 
proposals, we are of the view that the current moratorium  should be made permanent because  we 
believe that complaints in this context should be made in the case of an actual violation.  
8.11  Indonesia  
108.  Indonesia welcomes the adoption of the Ministerial Decision on June 2022 to extend the 
morato rium to the upcoming MC13.  Indonesia 's position, as in previous meetings, remains 
unchanged. We would also like to reiterate our concerns on the negative impacts that non -violation 
complaints in TRIPS can have on existing TRIPS flexibilities.  Having said t hat, we are ready to discuss 
this issue in order to come up with a way forward and solution on this long -delayed issue. Rest 
assured, Indonesia is committed to engage constructively in the discussion of this matter.  
8.12  Chile  
109.  The latest extension reflects the fact that consensus has not been reached on this matter in 
the past and shines light on the need to continue dialogue and the search for a consensual solution 
to this issue, bearing in mind all its repe rcussions and the link between this moratorium  and others 
within this Organization. Chile, like other delegations, considers that this type of complaint should 
not be applicable at the multilateral level in the context of the TRIPS Agreement, given the lac k of 
legal certainty that it creates for users and creators of the innovation ecosystem.  
8.13  United States of America  
110.  The United States of America remains open to considering specific pro posals from Members 
wishing to further examine the scope and modalities for complain ts of these types.  
8.14  Peru  
111.  Peru's position on this item is also fairly well known. We support a permanent moratorium  on 
non-violation and situation complaints in view of the specific nature of this Agreement and the fact IP/C/M/106/Add.1  
 
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  that to do otherwise could result in inconsistencies between the WT O Agreements by allowing the 
arrangements under the TRIPS Agreement to be challenged or by affecting the functioning of the 
flexibilities contained in the Agreement. However, we are open to considering any proposals that 
Members may submit in order to addr ess their concerns.  
8.15  Russian Fe deration  
112.  The Russian Federation is a co -sponsor of the document IP/C/W/385 . We want to reiterate our 
position that non-violation and situation complaints should not be applicable to the 
TRIPS  Agreement.  
8.16  Bolivia, Plurinational State of  
113.  Bolivia 's position on this issue remains unchanged and I have stated it at previous meetings 
of this Council. We consider that the bene fits derived from the Agreement can be adequately 
protected by applying the letter of the Agreement, in accordance with the principles of international 
law and without introducing a legally uncertain notion, such as the one before us. In no way does 
the mo ratorium jeopardize the flexibility of TRIPS -related  rights and obligations. On the contrary, 
applying non-violation  complaints could put the rights of intellectual property owners at odds with 
the ability of governments to legitimately implement their reg ulatory policies, even limiting their 
sovereign capacity to introduce new social, economic and health -related  development measures. 
We reiterate that there is no precedent for the application of these complaints. Furthermore, no  
concrete examples have been given of instances in which an otherwise TRIPS -consistent  measure 
would impair or nullify benefits, beyond the obligations already set out in the Agreement, so it is  
unnecessary for us to even continue this discussion. However, we remain committed to moving  
constructively towards a definitive and consensual solution before the  MC13.  
8.17  Korea, Republic of  
114.  Our position remains unchanged. We have concern that the application of NVSC o the TRIPS 
Agreement may increase the legal uncertainty given that the legal systems of WTO Members vary. 
However , we will constructively engage with Members to continue to discu ss this matter.  
8.18  Panama  
115.  My delegation joins others in welcoming the Ministerial Decision extending the moratorium  
until MC13 . As other delegations have stated, we believe that it is time to begin discus sions on scope 
and modalities in the TRIPS Council, in whichever format is deemed appropriate, and to issue 
recommendations.  
116.  We must move away from this repetition of statements and on to concrete proposals that allow 
us to start these discussions. We the refore consider it appropriate for the Chair to hold consultations 
with Members that can guide the way forward on this issue.  
8.19  Hong Kong, China  
117.  Hong Kong, China sees it is important that this Council continue its examination of the scope 
and modalities for non -violation and situation complaints cases as mandated in the 
TRIPS  Agreement. We remain open to proposals on how to take forward this discussion.  
8.20  European Union  
118.  The European Union also remains open to hear and discuss any possible solution on this matter 
in the future and ahead of MC13.  
9  REVIEW OF THE IMPLEMENTATION OF THE TRIPS AGREEMENT UNDER ARTICLE 71.1  
119.  No statements w ere made under this agenda item.  IP/C/M/106/Add.1  
 
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  10  REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON 
GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2  
120.  No statements were made under this agenda item.  
11  TWENTIETH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON THE 
IMPL EMENTATION OF ARTICLE 66.2 OF THE TRIPS AGREEMENT  
11.1  European Union  
121.  The European Union and its member States have taken their commitment s under Article  66.2 
of TRIPS Agreement very seriously since the beginning. The Europe an Union and its member States 
provided proof year after year of having promptly and attentively reacted to natural, social, health, 
climate, food and economic changes by implementing projects specifically tailored to the current 
needs of LDCs individually  or their regional organisations.  
122.  The European Union has submitted its annual report which provides a detailed update on EU 
technology transfer programmes, both the European Union and its member States. This document 
was circulated in accordance with the D ecision of the Council for TRIPS in 2003, according to which 
developed country shall submit annual reports on actions taken or planned in pursuance of their 
commitment under Article 66.2.  
123.  Our programmes cover the period from July 2021 to July 2022 and can be found in the 
e--TRIPS Portal. Besides the EU -financed programmes, this year Austria, Czech Republic, Finland, 
Germany, Ireland, Spain and Sweden sent reports to the European Commission on technology 
transfer programmes funded by these countries. The rep ort submitted by the Commission is not an 
exhaustive list of all the technology transfer programmes  provided but gives a vast range of 
examples of these programmes. The report has a total of 123 technology transfer programmes, 
including 24 projects funded by the EU institutions, Horizon Europe mainly, and 99 projects funded 
by the EU member States, notably by Germany.  
124.  Today we would like to focus on three examples of the EU 's and its member States ' technology 
transfer programmes, but please don 't hesitate t o have a look at the report itself when it will be 
translated. So now I give the floor to my colleague Martin, in the room, to present very important 
programmes we managed in the European Union the "E-SHAPE ". 
125.  Thank you, Pierre Yves, and yes indeed I will d escribe three out of the 123 programmes  
included in the EU report. The first is E -SHAPE comprising  showcases of the Group on Earth 
Observations (EO ). The E -SHAPE programme is  driven by the need to develop operational EO 
services with and for the users and to create a conducive environment whereby the strengths of 
Europe are exploited towards addressing societal challenges, fostering entrepreneurship  and 
supporting sustainable development in LDCs. The proposed objectives are:  
a. to develop operational EO services with and for users active in key societal sectors;  
b. to demonstrate the benefits of EO pilots through coordinated downstream exploitation 
of EO data and utilization of existing EO resources;  
c. to promote the uptake of pilots at national and international scale, across vertical 
markets (private and public) and amongst key user communities;  
d. to enable the long -term sustainability of numerous pilots, t heir penetration in public and 
private markets and support their upscaling;  
e. to increase uptake by raising awareness on solutions developed through tailored and 
well-targeted communication, dissemination and outreach activities.  
126.  The proposal aims at setting -up and promoting a sustainable organization dedicated to users ' 
uptake of European EO resources, building on Copernicus and the Group on Earth Observations 
(GEOSS) through the development of co -design pilots (i.e. application -oriented products, services 
or solutions) built on a user -centric approach and delivering economic, soci al and policy value. IP/C/M/106/Add.1  
 
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  Through  the development of 27 pilots organized in seven showcases , it aims  to deliver information 
that will contribute to the three Group on EO engagements : SDGs, Paris Agreement and Sendai 
Framework. The field of technology is the Veg etation -Index Crop -Insurance.  
127.  E-Shape provides a financial service delivery to smallholder farmers in some LDCs with a 
geodata -driven, risk -mitigation insurance product that offers a basic safety net to protect them 
against weather -related perils. The pro vision of the service will be supported by on -site training, 
eSupport to create a long -duration product sustainability and a country -specific independence in 
knowledge and skills. The overall budget is over EUR 15 million.  
128.  The second project is Vaccine Aga inst Schistosomiasis for Africa, a Phase 1 clinical study in 
Burkina Faso and Madagascar. Schistosomiasis is a poverty -related neglected tropical disease, 
impacting one billion people in 74 countries. Science ranked a schistosomiasis -vaccine as one of the 
top-10 vaccines urgently needed. Chemotherapy is the preferred method for schistosomiasis control; 
but the effectiveness of mass -treatment programmes is compromised by reinfection requiring 
regular re -treatment. Schistosoma mansoni,  causing intestinal and hepatic schistosomiasis, and 
Schistosoma haematobium,  causing urinary schistosomiasis, are endemic.  
129.  An efficient vaccine, with long -lasting protection against all schistosomiasis forms, would 
impact disease control. This programme funds clinical developmen t of the SchistoShield® -vaccine 
in Burkina Faso and Madagascar. In baboon studies, SchistoShield® has been effective against all 
major schistosome species. It is the only vaccine candidate having consistently exhibited potent 
prophylactic, anti -fecundity, egg-induced pathology resolving, transmission -blocking and 
therapeutic efficacy. The objectives are manifolds:  
a. to assess the safety/immunogenicity of SchistoShield® in a Phase I clinical study in 
healthy adults from Africa;  
b. to refine and develop a female w orm schistosome human challenge model;  
c. to identify correlates of protection, innate and adaptive immune signatures, gene 
expression and the role of antibodies in the prevention/control of Schistosoma 
infections; and  
d. to foster a global consortium for advanc ing research on schistosomiasis disease burden, 
vaccines and address ing downstream access constraints in resource -poor settings.  
130.  The funding granted allows the clinical development of SchistoShield®. African site research 
capacity will be improved and epi demiological burden data using novel diagnostic techniques will be 
used to advance clinical development to Phase 2 and potential future elimination project. The 
Consortium VASA comprises French public research centres  and private companies.  
131.  And the last ex ample is an agricultural development programme in Burkina Faso  funded by 
Germany . In selected value chains in the programme 's intervention, the famers and micro or SMEs 
should increase their income and improve their nutritional basis through increased and improved 
sustainable production in selected value chains. With this programme , the framework conditions for 
sustainable development of the agricultural sector, in particular , the supported value chains are 
improved and the competencies of producers and ent repreneurs and their organizations in the 
supported value chains are strengthened for an environmentally sound management of their farms. 
Furthermore, the services offered along the value chains of rice, cassava and soybean are 
strengthened and the people supported in these selected value chains have improved their 
knowledge about balanced nutrition and good hygiene.  
11.2  Australia  
132.  Australia was pleased to submit its Article 66.2 report to the Secretariat on 
12 September  2022. We acknowledge the important role that technology transfer plays in supporting 
all WTO Members, particularly LDC Member s, to develop and achieve greater prosperity . 
133.  Australia recognises the need for developed countries to continue to step up our efforts to 
support technology transfer in response to COVID -19 to ensure that LDCs can develop the sovereign IP/C/M/106/Add.1  
 
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  capabilities necessary to manage the impacts and support their pop ulations. Our report focuses on 
Australia 's efforts to help LDCs create the conditions essential to allow the transfer of technology, 
including the technology necessary to assist WTO Members access and administer COVID -19 
vaccines. We would be happy to dis cuss our report further with Member s at the next available 
opportunity.  
11.3  United Kingdom  
134.  The United Kingdom remains committed to implementing Article 66.2 of the TRIPS Agreement 
to promote and encourage technology transfe r to LDC Members. We welcome the opportunity to 
provide insight into one of the projects undertaken by the U nited Kingdom , to promote such transfer . 
135.  The AgriFood Africa project (a part of the wider Global Challenge Research Fund programme) 
is a project to boost collaboration between the U nited Kingdom  and Africa to develop sustainable 
management of food production systems in Africa. This project aims to enhance food security, 
nutrition, and welfare through greater involvement of the private sector, both UK and African, in 
innovation for agriculture and food systems.  For example, through feasibility studies and industrial 
research projects or social science studies into barriers to the adoption of, or investment in, 
technologies and innovations in the agricul ture sector.  AgriFood Africa is delivered through three 
strands:  
a. The first is a technology accelerator programme including Seeding Awards delivered by 
Biotechnology and Biological Sciences Research Council (BBSRC); and industry focussed 
Research and Devel opment and demonstration activities through the Agritech Catalyst, 
which is delivered by Innovate UK. The purpose is to accelerate the transition from 
discovery research to translational development projects by supporting preliminary 
work or feasibility st udies in agri -food technology ; 
b. The second is by linking world -leading knowledge and expertise of academics to 
business --critical projects, through AgriFood Africa Knowledge Transfer Partnerships, 
delivered by Knowledge Transfer Network (KTN) ; 
c. The third is by connecting the U nited Kingdom  and Africa through events, funding, 
information sharing, partnering, and networking to increase the impact of AgriFood 
funded projects and align UK expertise to African challenges, through AgriFood Africa 
Connect.  
136.  Overall, the project aims to fund a portfolio of projects with the potential to accelerate the 
development and scale of adoption of agricultural and food system innovations to address the 
challenges faced by agriculture and food systems in Africa.  
137.  We hope Members found the highlights of this project informative as agricultural development 
is fundamental to achieving many of the SDGs in Sub -Saharan  Africa.  
11.4  New Zealand  
138.  Thank you for the opportunity to speak to New Zealand 's report on the implementation of 
Article 66.2, document IP/C/R/TTI/NZL/2 . New Zealand encourages technology transfer to LDCs 
through various methods, including:  
a. promoti ng an economic environment that enables New Zealand enterprises and 
institutions to transfer technology abroad;  
b. encouraging global trade in goods, services and labour mobility;  
c. facilitating a strong intellectual property environment; and  
d. through various bilateral and regional development programmes.  
139.  At the heart of our technology transfer efforts is the New Zealand  Aid Programme. We see 
technology transfer as fundamental to achieving sustainable development and poverty reduction in IP/C/M/106/Add.1  
 
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  developing countries, through the investment of money, knowledge and skills. With a strong focus 
on the Pacific, New Zealand 's Official Development Assistance (ODA) was boosted in 2018, with an 
additional funding commitment of NZD 714 million, increasing the overall ODA funds to 
NZD 2.218  billion for the period 2018 – 2021. 60% of our ODA went to the Pacific during this period, 
but there a re multiple examples of technology transfer projects beyond our immediate Pacific 
neighbours. To provide a few examples:  
a. in Zambia, New Zealand has undertaken a 7 -year, NZD 7.4 million dairy activity to 
strengthen emerging dairy value chains through knowle dge transfer on animal health 
and dairy business practices. Approximately 600 participating farmers have experienced 
improved yields, reduced costs of production and increased profits.  
b. in Myanmar, Plant and Food Research, a New Zealand Crown Research Insti tute, is 
partnering with Proximity Design, a Myanmar Social Enterprise, in a six -year NZD 7.9 
million project to improve the productivity, income and resilience of smallholder 
vegetable farmers and to reduce post -harvest losses . 
140.  The New Zealand – Africa Ge othermal Facility (NZ -AGF) is a NZD 10.2 million partnership with 
the African Union Commission. Since the 2017/18 financial year , it has provided geothermal 
technical assistance to support the development of the geothermal sector in East African countries.  
It is open to 11 eligible countries including ten LDCs.  
141.  These projects not only directly provide for the transfer of technology and know -how but 
enable commercial operations which attract further technology transfer through partnership with the 
private se ctor. New Zealand remains committed to technology transfer efforts and encouraging and 
enabling enterprises and institutions to further their technological collaboration.  
11.5  United States of America  
142.  The United St ates of America  attributes great importance to this review with respect to the 
obligation under Article 66.2.  Our submission this year, is an update to our 2021 report, detailing 
progress in the past year to program mes aimed to support LDCs in fostering th e necessary 
environment to encourage the effective, voluntary transfer of technology to LDC Members on 
mutually agreeable terms.  The U nited States submission details program mes ranging from 
intellectual property and trade capacity building to the health, l abour, and environmental sectors. 
Similar to previous submissions, this report includes comments from host country governments and 
private sector representatives regarding the value of several program mes listed in the report.  
143.  We believe  that for Article 66.2 of the TRIPS Agreement to function effectively, there must be 
a robust dialogue between developed countries and LDC Members. Strong communication between 
partners is critical to ensur ing targeted incentives remain responsive to the s elf-identified technology 
transfer interests and needs of LDC Members. The United States strives to make this a priority in all 
our engagements with our host government partners around the world and will continue to explore 
ways to improve upon the process  as we go forward.  
144.  Please allow me to mention some elements contained in our 2022 report, highlighting a few 
program me updates.  Health research through biomedical and behavioural  funding activities of U nited 
States agencies , have contributed to technology transfer and research capacity strengthening in 
many LDCs. For new technologies developed by US scientists, NIH licenses biological materials 
and/or patent rights to institutions that can bring products to the market in or for LDCs.  
145.  In Bangladesh, the USAI D MaMoni Maternal and Newborn Care Strengthening Project (MNCSP) 
activity will reduce maternal and neonatal mortality and increase contraceptive prevalence by 
strengthening the capacity of health systems and facilities through the provision of quality mate rnal 
and new-born health care, postpartum planning, and nutrition services. The activity will further 
strengthen new-born care at all levels . In fiscal year 2022, USAID continues to support the 
International Federation of the Red Cross and Red Crescent to increase the resilience of vulnerable 
communities in the Solomon Islands and expand the ability of the Solomon Island Red Cross Society 
(SIRCS) to support  its own  disaster risk management and community -based health program mes.  IP/C/M/106/Add.1  
 
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  146.  The USAID TradeHub supported  exporters in Lesotho with trade enhancing services such as 
organic certifications, and product testing to enhance their competitiveness for entry into the US 
market. Social compliance certification is becoming central to market -entry requirements, with 
buyers increasingly considering humane and ethical factory standards, compliance with national 
laws, and the treatment of garment workers. A private sector partner said, "I would like to thank 
USAID TradeHub for being very supportive to us as we are now doin g a photoshoot of products that 
we are shipping to the US for Amazon ". 
147.  Our report describes over 135 program mes just like these, that shows how the US government 
transforms lives. No report can truly represent every activity that directly or indirectly inc entivizes 
enterprises and institutions for the purpose of promoting and encouraging technology transfer. This 
report attempts to describe the most significant activities and program mes and to convey the 
breadth and depth of efforts by the United States  of America . 
148.  We look forward to further discussing our technology transfer programming  with the LDC 
Member s at the annual workshop and we commend the Secretariat for putting together another 
fantastic workshop during the pandemic.  
11.6  Japan  
149.  The delegation of Japan recognizes the importance of Article 66.2 of the TRIPS Agreement for 
LDCs, taking into account their economic, financial and administrative constraints . From such a 
perspective, Japan is earnestly engaged in improving the busi ness environment for technology 
transfer to LDCs.  
150.  We would like to briefly describe this year 's report on our implementation of Article  66.2, 
document IP/C/R/TTI/JPN/3 . This report consists of four sections, namely : 
a. Activities undertaken by technical cooperation organizations ; 
b. Activities in the field of climate change ; 
c. Activities in the pharmaceutical sector; and 
d. Activities in the field of intellectual property rights.  
151.  This report was submitted through the e -TRIPS submission system and contains an annex 
provid ing detailed information on each activity involving technology transfer to LDCs. Japan 
understands that incentives to enable technology  transfer include a variety of measures such as 
financial support and business environment support, because one of the main o bstacles for 
enterprises and institutions in developed countries to transfer technologies to LDCs is the lack or 
insufficiency of business environment in LDCs. Furthermore, improving the business environment 
helps create incentives that are stable and self -sustainable, which is especially important considering 
that technology transfer often takes time.  
152.  Japan believes that activities in the report contribute to creating a sound and viable 
technological base in LDCs, which will bring about further technology  transfer by enterprises and 
institutions in developed countries.  
153.  Japan will continue to make its utmost efforts to improve the business environment and make 
it even more conducive to transfer technology.  
11.7  Switzerland  
154.  Switz erland 's 2022 report contains an updated list of the measures and program mes that 
Switzerland has implemented to incentivize technology and knowledge transfer to LDCs.  The report 
lists the projects financed by Swiss official development assistance (ODA)  as funded by the Swiss 
Agency for Development and Cooperation and the State Secretariat for Economic Affairs.  
155.  We would like to briefly mention one example of a current project listed in our Article  66.2 
report. This project is called REPIC , a Swiss Platform  for Renewable Energy, Energy Efficiency and IP/C/M/106/Add.1  
 
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  Resource Efficiency Promotion in International Cooperation.  This platform is jointly managed by the 
State Secretariat for Economic Affairs, the Swiss Agency for Development and Cooperation, the 
Federal Office fo r the Environment and the Swiss Federal Office of Energy.  
156.  Its main objective is the transfer of know -how and technologies with the aim of developing 
renewable energies, energy efficiency and resource efficiency, such as solar, wind and geothermal 
energies especially in LDCs.  
157.  Since its launch in 2004, REPIC has supported more than 150 projects in 50 different countries, 
including the following LDCs: Uganda (biomass), Mali (biomass, photovoltaic), Benin (biomass, 
resource efficiency), Nepal  (small hydro), Mad agascar (mall hydro  ), Bangladesh (photovoltaic), 
Senegal (photovoltaic), Zambia (photovoltaic), Haiti (energy efficiency, resource efficiency), Liberia 
(resource efficiency), Tanzania (resource efficiency) and Cambodia.  
158.  Last but not least, we would like t o inform Members that last spring we worked, with the 
Secretariat  - which we would like to thank for its valuable assistance  - on some technical 
improvements regarding the submission of the Article 66.2 reports via the e -TRIPS Submission 
System.  These improvements will ultimately benefit  all stakeholders, including LDCs.  
159.  Switzerland will continue to make all efforts to provide relevant information on the incentives 
it provides under Article 66.2, in a s transparent, consistent, and comprehensible m anner as possible.  
We look forward to participating in the dedicated workshop on Article 66.2 scheduled before the first 
regular TRIPS Council meeting in 2023 , and to  receiving the preparatory information ahead of the 
workshop in order to allow for adequat e preparation.  
11.8  Canada  
160.  Canada is pleased to report on its work under Article 66.2 in providing incentives to enterprises 
and institutions to promote and encourage technology transfer to LDC Members in order to enable 
them to cre ate a sound and viable technological base.  
161.  Canada 's 2022 report on the implementation of Article 66.2 of the TRIPS Agreement 
(document IP/C/R/TTI/CAN/3)  updates on the range of projects and initiatives undertaken by 
Canada over the past year. Before discussing some of the more noteworthy projects included in this 
year's report, we note that Canada 's report on Article 66.2 focuses primarily on non -market projects, 
as financed by Canadian departments, agencies, and institutions, through official development 
assistance (ODA), grant s, and other concessional financings. For instance, Canada provides financial 
incentives in partnership with Canadian educational and research institutions in a range of 
development areas like agriculture and food security, public health, artificial intell igence and 
education, sustainable development, as well as business development and capacity -building for 
SMEs . 
162.  In addition to updates on existing projects, this year 's report includes information on a very 
recent grant program me, Addressing Environmental D egradation in Cox 's Bazar District  in 
Bangladesh , which launched this year and is funded in partnership with the United Nations 
Development Program (UNDP). This project will provide technical assistance and know -how that will 
result in the development of s trategies, policies, and systems to address environmental 
rehabilitation, including the provision of alternative, clean cooking fuel and technology to all refugee 
households. This program me aims to contribute to environmental rehabilitation and long -term 
development of Cox 's Bazar District through  supporting an ecologically sustainable approach in host 
communities and Rohingya refugee camps.  
163.  Another notable project from this year 's report, the Global Fund for Disaster Reduction and 
Recovery - Earth Observat ion Technologies, was launched in collaboration with the Global Fund for 
Disaster Reduction and Recovery, and  is set to fund Earth Observation (EO) technology and data 
collection for use by coastal and Small Islands Developing States (SIDS), regional organ izations, 
and other partners to pursue climate change adaptation and resiliency to extreme weather events. 
In a similar vein, the project Transforming the Market for Stoves and Clean Energy in Haiti launched 
with the United Nations Foundation and in partne rship with Haiti, aims to restructure and boost the 
market for efficient stoves and clean energy in order to protect the environment, improv e the health IP/C/M/106/Add.1  
 
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  of women and children and strengthen women 's economic power within new value chains for 
producing and m arketing stoves and clean energy.  
164.  This year 's report also includes information on Strengthening Public -Private Partnerships in 
Research and Innovation in the Manufacturing Sector in Uganda. Through collaboration between the 
International Development Resear ch Centre and the Uganda National Council for Science and 
Technology, this project supports research and innovation to address challenges facing the 
manufacturing value chains for various industrial products in Uganda through partnerships and 
collaboration s between universities and industry. It aims to contribute towards the reduction of 
technological bottlenecks affecting the manufacturing sector, thereby increasing sector productivity 
and competitiveness.  
165.  Canada would be pleased to provide further informa tion on these and other technology transfer 
projects and program mes contained in Canada 's 2022 report on the implementation of Article  66.2, 
upon request. Canada also invites interested delegations to consult Global Affairs Canada 's 
searchable "International Development Project Browser " for further information on these and other 
initiatives.  
166.  Finally, Canada would also like to take the opportunity to again thank the Secretariat for 
organizing the March 2022 workshop on Article 66.2, and to thank those Members that shared their 
experiences and valuable insights in this area. We look forward to the next workshop on the 
implementation of Article 66.2 and to further discussions with other Members on these important 
issues.  
11.9  South Africa  
167.  I had hope d to take the floor after Bangladesh online  who will be  presenting this on behalf of 
the LDC Group , but first I w ould like to  express our support for the statement  that will be  made by 
Bangladesh on behalf of the LDC Group.  Article 66.2 of the TRIPS Agreement places a legal obligation 
on developed country Members to provide incentives to enterprises and institutions in their territories 
for the purpose of promoting and encouragi ng technology transfer to LDC Members in order to enable 
them to create a sound and viable technological base.  
168.  Fulfilment of the obligation contained in Article 66.2 would contribute to the objectives of the 
TRIPS Agreement, in particular, Article 7 which  posits that "the protection and enforcement of 
intellectual property rights should contribute to the promotion of technological innovation and to the 
transfer and dissemination of technology ". This issue is key , not only in the context of the pandemic , 
but also in relation to longer term and structural issues such as climate change and digitalization. 
The Doha Dec ision on Implementation -Related Issues and Concerns reaffirms the mandatory  nature 
of Article 66.2, as does the 2001 Declaration on the TRIPS Agr eement and Public Health.  
169.  In our view, it is important that the implementation of Article 66.2 should contribute to the 
objectives of the TRIPS Agreement and enable LDCs to develop a sound and viable technological 
base. In order to home in on technology  transfer related activities more precisely, clarification of 
various issues could assist. These include inter alia :  
a. definitional issues around what constitutes technology transfer ; 
b. to what extent incentives provided can be considered additional to official  development 
aid?  
c. the robustness of evaluations undertaken to understand the impact of initiatives that 
have been taken.  
170.  LDCs have raised some of these issues , among others , in document IP/C/W/562 . Subsequent 
submissions by the LDC Group document IP/C/W /664 and document RD/IP/24 . These documents  
are highly  instructive. Our delegation sees great value in meaningfully engaging with these issues 
and stands ready to work with other Members toward full implementation of Article  66.2. IP/C/M/106/Add.1  
 
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  11.10   Bangladesh , on behalf of the LDC Group  
171.  Under this agenda item , Bangladesh delivers this statement on behalf of the LDC Group. The 
LDC Group welcomes the annual reports on the implementation of Article  66.2 and the reporting 
Members ' most sincere efforts to help creat e sound and viable technological base in LDCs.  
172.  Since most of the reports are very recently submitted, we could not go through them in detail. 
After examining these reports, the LDC Group will provide feedback to the respective reporting 
Members very soon. We believe that our last year 's feedback was useful for the reporting Members 
to understand the technology needs and current realities of the technological base in LDCs. In the 
proposed reporting template ( document IP/C/W/668)  we underscore the need for information about 
the specific incen tives, the incentives recipient enterprises and institutions, the specific technology 
that has been transferred and the name of the beneficiary LDC Member. This will help acknowledge 
the substantive contributions of the developed country Members with evide nce and precision.  
173.  While we truly appreciate the initiatives of the developed country Members under Article  66.2, 
we also feel that LDCs  should do some homework focusing their needs and challenges in terms of 
technology transfer. For the forthcoming workshop in March 2023 on the implementation of Article 
66.2, LDC Members are currently working on a self -assessed voluntary survey on their p riorities for 
technology transfer needs. The LDCs thank the IP Division of the Secretariat for extending technical 
support in this regard.  
174.  The LDC G roup welcomes the annual workshop on the implementation of Article 66.2 of the 
TRIPS Agreement as an excelle nt opportunity. We expect that next year 's workshop will bring more 
practical inputs for an informed dialogue between the reporting Members and LDCs. The LDCs hope 
that the technology needs identified by the LDCs will also be prioritized by the developed M embers 
in their forthcoming program mes and schemes on implementation of Article 66.2.  The LDC Group 
stands ready to engage constructively in this regard.  
11.11   India  
175.  India thanks the delegations for their reports and statements made t oday under this agenda 
item. This is a positive obligation on developed country Members that emanates from the 
TRIPS  Agreement and is an important transparency exercise.  
176.  However, much remains to be done under this obligation by the developed country Member s, 
to fulfil their obligation under Article 66.2 in both letter and spirit. There is continued concern that 
reports generally do not focus and often lack information on the incentives that developed country 
Members have provided to their enterprises and in stitutions for promoting transfer of technology.  
177.  Promotion and dissemination of technology transfer becomes more relevant and critical now 
than ever as LDCs have been disproportionately hit by the pandemic and therefore, greater 
transparency, with regard t o the effective technology transfer undertaken would be supportive of 
LDCs' efforts towards building a much -needed technological base and further help them to combat 
the pandemic as well as recover from its aftermath.  
12  TECHNICAL COOPERATION AND CAPACITY -BUILDING  
12.1  European Union  
178.  The E uropean Union submitted its annual report on technical and financial cooperation 
programmes carried out between July 2021 and July 2022 together with the  member States . The 
European Union carried out 14 technical cooperation activities during the reporting period and also 
the member States contributed as well, as I said, France, Sweden, Spain, Denmark, and Germany . 
The programmes covered all IP rights in the TRIPS Agreement and some of the programs were 
multi-annual programs consisting of many activities to the benefit of LDCs and developing countries.  
179.  Today we would like to highlight  to these programmes, and I would like to say as well that this 
report is not exhausting. There are so  many programmes to support and for cooperation in Africa 
not only but elsewhere as well that it is quite difficult to be exhaustive in this kind of report. So, we IP/C/M/106/Add.1  
 
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  will limit ourselves today in talking about two programmes: one is the well-known  by our fri ends in 
Africa is the Afr IPI and the other one is the IP Key in Latin America.   
180.  As regard AfrIPI  programme, AfrIPI is the pioneer Africa -wide EU -funded IP cooperation 
project, which commits joint action between the E uropean Union and Africa to boost intra -African 
trade, and to facilitate African -European investments for economic growth and sustainable 
development. With a budget of EUR 17 million, the project is funded by the European Union and 
implemented by the EUIPO , our agency for IP,  in partnership with  key African continental, regional 
and national institutions such as the African Union Commission, of course, the AfCFTA Secretariat, 
the "Organisation Africaine de la Proprieté Intellectuelle " (OAPI) and the Africa Regional Intellectual 
Property Office (A RIPO).  
181.  The overall objective is to facilitate intra -African trade and African and European investment. 
The Specific Objective is that IPR are created, protected, utilized, administered and enforced across 
Africa, in line with international and European bes t practice and in support of the AfCFTA and the 
African Union 's Agenda 2063. There are 4 outputs  foreseen : 
a. Output 1: Promoting international agreements in the area of IPR and reinforced 
cooperation between the E uropean Union and Africa in order to facilitate fact -based 
AfCFTA negotiations.  
b. Output 2: Strengthening national and regional IP institutions, networks, and tools, for 
more efficient and user -friendly IP protection and enforcement systems.  
c. Output 3: Strengthening the c apacities of Micro, Small and Medium -sized Enterprises 
(MSMEs)/productive sector on the importance and value of IP protection (including GIs) 
in the African society.  
d. Output 4: Implementation of the priority actions identified by the work plan linked to 
the Africa Union Continental Strategy for G Is. 
182.  One part of what we have selected in the multitude of  programmes is covered by AfrIPI , the 
French government and the French companies  - and the French public entities are very active.  
183.  An illustration of the imple mentation of the AfrIPI by the EUIPO agency is the training 
programme for judges. This is a training seminar for judges in the OAPI region, including the sharing 
of experiences and launch of the future case law database of African court decisions in intell ectual 
property matters. A second seminar is currently taking place in Dakar to launch a vast network of 
judges.  
184.  In addition, France is participating in a project being piloted by WIPO. In cooperation with the 
French National Institute for Intellectual Pro perty (INPI) and the OAPI, the French National School 
for the Judiciary (ENM) is implementing this pilot programme for the training of trainers in judge 
academies in the following three countries: Cameroon, Côte d 'Ivoire and Senegal. The aim of the 
program me is to train judge trainers so that each new judge graduating from the judge academy 
can follow the modules on intellectual property. A guide on case law is to be published to accompany 
this project. The modules have been developed by the French ENM in B ordeaux, and ENM trainers 
provide training to the judges selected (two for each country).  The AfrIPI is t he most ambitious 
programme we have on IPR in Africa.  
185.  Now I give the floor to my colleague Mr. Martin Gajda to deal with the IP Key Latin America . 
IP Key Latin America  is the European Commission 's programme to implement the objectives of the 
European  Union in the area of IPR, through international cooperation with Latin American countries. 
Signed between the EU and the EUIPO in 2017, it is co -founded  and implemented by the EUIPO and 
a total estimated cost of EUR 6  million.  
186.  The overall objective of the programme is to promote a level playing field for EU companies 
operating in L atin America  by contributing to greater transparency and fair implementatio n of the 
IPR protection and enforcement system in there. EU businesses will benefit from improved IPR 
protection as well as from the achievement of adequate and effective functioning of IP administration 
and enforcement procedures in L atin America.  IP/C/M/106/Add.1  
 
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  187.  Further more, companies and right -holders should benefit from an increase in the technical 
expertise of L atin American  countries and organizations on how to improve IPR related laws and 
proper implementation of trade agreements with the E uropean Union. EU business es will also benefit 
from enhanced access for EU users to IP information of L atin America  IPO databases, which is crucial 
to their business and IP protection strategies abroad. These will be facilitated by the implementation 
of innovative tools and databas es created by the European Trade Mark and Design Network 
(ETMDN).  
188.  The final beneficiaries will be reached mainly through active involvement of key business 
support and multiplier organizations operating in Europe and L atin America , as well as industry 
representatives and umbrella organisations. At the same time, L atin American  innovative and 
creative business will take due advantage of such improvements in the level of protection and in the 
efficiency of enforcement of IPR which should, to a certain extent , enhance international trade and 
make the economies of the region more attractive to foreign investments.  The programme has 
certain objectives and output and impacts :  
a. First one is a  substantive support for the preparation and development of FTA 
negotiati ons. The expected result of the project is to obtain data and information on 
local IPR legislation, protection and enforcement to assist the European Commission in 
the preparation, negotiation and implementation of FTAs in the region such as national 
or regional case law and the IPR institutional framework and resources.  
b. Another one is t he information collection and strategic analysis to prepare regional 
integration in Central America. Under this result, the project activities provide a detailed 
overview of  the situation regarding IPR legislation, protection and enforcement and the 
capacity and efficiency of the IPR offices and institutions in the relevant countries. 
Encouraging and improving regional cooperation and integration on the processing and 
enforce ment of IPR would support EU businesses operating across the region.  
c. Third impact is t he effective support for IP Dialogue and sub-committees and 
Implementation of FTAs . Appropriate actions are to be delivered in accordance with the 
decisions and indicatio ns that emerge from discussions during the existing and future 
IP dialogues and sub-committees held by the EU with L atin American  countries. The 
Action also proposes interventions that assist the various countries involved in L atin 
America  with obligations  arising from the commitments taken in the context of the trade 
agreements with the EU. The action also includes the provision of ad-hoc support, in 
the form of support activities in relevant IP working groups.  
d. Another output is t he improvement of the IP a dministration and the enforcement of 
practices including the increased use of IP information technology tools and the 
establishment of an enforcement network. The Action is targeting an increased uptake 
of EU IT tools by the local IP offices to improve acc ess to the IP system and to facilitate 
processing of IP applications and registrations. It will also comprise outspreading the 
EU approach in the elaboration of laws and development of best practices directed 
towards ensuring an efficient and transparent a dministration of IPRs. As regards 
enforcement, the action will be based on the development of enforcement networks in 
support of increasing the effectiveness of ICT tools and as well as on the exchange of 
best practices as regards IPR enforcement.  
e. Another  important objective is t he awareness on the importance of intellectual property, 
its protection and enforcement. This outcome  is attained by organising actions directed 
towards the promotion of the understanding of the importance of IP protection from the 
perspective of social and economic development, and to favour foreign investment.  
f. One last objective of this programme, or ou tput rather, is t he improvement of the 
information sharing through information management system (IMS) and document 
repository. In order to ensure a sufficient institutional memory and easy accessibility by 
all interested stakeholders of the documents eman ating from the project (such as 
reports, studies, surveys), an information management system will be set up and a 
document repository created.  IP/C/M/106/Add.1  
 
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  12.2  United Kingdom  
189.  The United Kingdom is committed to sharing its expe riences and knowledge in helping  
Members develop their IP systems.  As an example, we  would  like to talk about a workshop between 
the United Kingdom and Viet  Nam in June 2022, on working together to tackle counterfeit goods and 
piracy, both online and offli ne. This workshop sought to facilitate effective information exchange 
between relevant ministries and agencies in methods and best practice in preventing and combating 
infringement of intellectual property rights (IPRs); to continue to improve the capacity  and 
effectiveness of intellectual property right enforcement; and to lay the foundations to build a 
comprehensive cooperation program on these issues.  
190.  Key sessions covered legal cooperation, where ministries and agencies exchanged and 
contributed specific  ideas on ways to avoid overlapping of functions, duties, and authority.  The 
discussion focused on the challenges of enforcement and various ways countries across the world 
are tackling the problem.  It also focused on communication and education on intelle ctual property, 
resulting in new initiatives to raise public awareness of IPRs by local ministries and departments.  
We are pleased with the outcome of this workshop as a great example of learning from each other 
and how cooperation and sharing of experienc es can benefit Members, contributing to raising IP 
standards globally.  
12.3  United States of America  
191.  The United States continues to believe that a technical cooperation to improve IP protection 
and enforc ement infrastructures it is crucial to countries ' economic development, and it is directly 
linked to contributing to foreign investments and a voluntary private sector  biotechnology  transfer 
in developing countries and to fostering the ability for developi ng country innovators to capitalize on 
their creativity. We look forward to continue d discussions and report in the Council concerning 
technical cooperation of governments and IGOs for the strengthening of IP system s.  
12.4  Australia  
192.  Australia remains committed to promoting and facilitating technical cooperation and 
intellectual property capacity building activities. Australia fulfilled its Article 67 technical cooperation 
commitment through multil ateral, regional and bilateral programmes and activities. Many of our 
activities are focused on developing and least developed countries in the Indo-Pacific region. 
Australia works closely with WIPO and associations of south -east Asian nations (ASIAN) secr etariat 
and other partner to assist developing and least developed countries to build their intellectual 
property capacity and system s. We will be happy to discuss our report further with Member s at the 
next available opportunity.  
12.5  Switzerland  
193.  Our 2022 report document IP/C/R/TC/CHE/3  describes Switzerland 's technical cooperation and 
capacity building activities . Switzerland is pleased to announce that it is currently partner to 12 
technical cooperation bilateral projects across diff erent regions in the field of IP.  Whereas the Swiss 
State Secretariat for Economic Affairs is the main funder of the majority of projects through its 
Global Program for Intellectual Property Rights (GPIPR) set up in 2018, the Swiss Federal IP Institute 
implements the GPIPR.  
194.  Let me please recall that the GPIPR supports developing and least developed countries, as well 
as emerging economies, in developing an efficient and effective system for the protection and 
enforcement of intellectual property rights. Thi s aims to promote economic development s, and assist 
our partners in the implementation of their rights and obligations under the TRIPS Agreement. Two 
examples of specific projects are described in a more detailed manner in our report of this year.  
195.  One proj ect is the Swiss – South African IP Project, which began in 20 20. Among the activities 
that have already been carried out, there have been workshops for patent examiners and collecting 
societies, and a report on the use of compulsory licenses in Switzerlan d for South African 
policy -makers was published. Another report on considerations relevant for the development of a GI 
strategy is underway.  IP/C/M/106/Add.1  
 
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  196.  The other project, which has started this year, is the Tunisian – Swiss IP Project. Its objective 
is to contribute  to entrepreneurs, creators, researchers and producers in Tunisia benefitting from 
effective IP protection. For instance, the review of the laws relating to IP rights is one of the paths 
used to achieve the project 's objective.  
197.  Switzerland continues its ef forts to be a reliable partner in delivering technical assistance in 
the field of IP and to contribute through its technical cooperation projects, among others, to the 
implementation of the 2030 Agenda for Sustainable Development.  
12.6  Canada  
198.  Canada is pleased to have submitted its report on the implementation of Article 67 under 
document number IP/C/R/TC/CAN/2 . Canada 's 2022 report provides an update on Canada 's 
activities concerning IP -related technical and financial cooperation for developing and LDC Members. 
We thank the Secretariat in advance for its efforts in circulating Canada 's report following this 
session.  
199.  Canada undertakes a number of technical cooperation activities at the multilateral, plurilateral 
and bilateral levels, which are outlined in this year 's report. We would like to briefly take the 
opportunity to highlight a few notable activities from the past year. First, in May 2022, the Canadian 
Intellectual Property Office (CIPO) hosted and delivered its annual CIPO -WIPO Executive  Workshop 
on IP Office Management, on management techniques in the delivery of IP services, for senior 
officials from developing countries. Due to the COVID -19 pandemic, this year 's workshop was the 
second to be held virtually over the course of two weeks.  The objectives of the workshop were to 
enhance knowledge and skills in the area of management techniques in the delivery of IP services; 
improve the capacity of IP officials; provide participants with first -hand experience of the nature and 
scope of Canad a's IP expertise, products and services; and provide a forum to exchange ideas and 
experiences with officials from other IP offices.  
200.  In 2021, Canada 's Expert Deployment Mechanism for Trade and Development (EDM) 
completed an activity in Viet Nam to strength en protection of intellectual property rights in Viet Nam. 
This activity supported the IP Office of Viet Nam to implement legal and administrative reforms to 
better enable Viet Nam to fulfil its commitments under the Comprehensive and Progressive 
Agreement  for Trans -Pacific Partnership (CPTPP). The technical assistance had three major benefits 
for officials in Viet Nam by exposing them to : 
a. how sound marks and undisclosed test data for agricultural chemical products are 
protected in Canada;  
b. how IP rights are  enforced by Canadian border officials and through criminal remedies; 
and 
c. tools to raise public and private sector understanding of IP obligations in the CPTPP.  
201.  Additionally, from 2019 -2022, Canada 's International Development Research Centre funded a 
project to strengthen research and policy capacity on critical digital policy issues in Kenya. This 
project is supporting cyber policy research centres to develop a robust policy research agenda that 
addresses all facets of cyber and digital policy, including i nnovation, human rights, and security, and 
the interplay of these issues in the Global South. This project has resulted in the creation of an 
academic, open access, peer -reviewed journal  – the Journal of Intellectual Property and Information 
Technology (JI PIT). 
202.  Also in 2019 -2022, Canada 's International Development Research Centre funded a project to 
strengthen the support the digital rights ecosystem in Latin America by building the capacity of key 
and emerging thought leaders with skills, knowledge, and re sources; addressing critical challenges 
around digital rights; and promoting coordination among funders and organizations.  
203.  Further details on these activities can be found in Canada 's 2022 report, and Canada would be 
pleased to discuss our report with any interested Member. Canada also remains interested in hearing 
views from developing country and LDC Members on the successes and challenges of technical IP/C/M/106/Add.1  
 
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  assistance and cooperation, as well as how priority needs have changed since Members ' TRIPS 
implementati on, and where gaps in technical assistance might remain.  
204.  Canada looks forward to discussing these issues further, with a view to ensuring that our 
technical assistance continues to meet the priority needs and development objectives of its 
recipients.  
12.7  New Zealand  
205.  Thank you Chair for providing the opportunity for New Zealand to speak to our technical 
cooperation activities under Article 67. The report, document IP/C/R/TC/NZL/1 , identifies three 
avenues through which New Zealand provides tech nical cooperation and capacity building to 
develop ing and least developed Members.  
206.  The Intellectual Property Office of New Zealand (IPONZ) provides on -going technical assistance 
on request to developing and least developed countries. New Zealand will cont inue to support future 
work, on request, to improve the intellectual property systems of developing countries. IPONZ hosts 
delegations and study visits from developing and least developed countries to provide practical 
training and knowledge sharing.  
207.  New Z ealand has been a member of the International Union for the Protection of New Varieties 
of Plants (UPOV) since 1981. As we all know, a  key element of UPOV is cooperation between member 
states and the harmonisation of testing and examination activity.  
208.  The A SEAN -Australia -New Zealand Free Trade Area (AANZFTA) mandates a programme of 
technical assistance activities to assist AANZFTA Parties to operationalise and implement the 
Agreement. Until June 2022 this was known as the AANZFTA Economic Cooperation Support  
Programme (AECSP). Projects funded by the AECSP are available to all ten ASEAN member States. 
Numerous projects focus on Intellectual property. Including:  
a. Assistance for ASEAN member States to accede to the Madrid Protocol and implement 
its post-accessio n, facilitating trademark registration regionally and globally.  
b. Projects to strengthen ASEAN member States ' institutional capacity to design and adopt 
a high -quality, consistent, and sustainable approach to patent examination and tailored 
training.  
c. Develo pment of a Regional Intellectual Property Public Education and Awareness 
Strategy and a pool of resources to raise awareness of AANZFTA business communities 
and IP creators about strategic IP management.  
209.  We hope the information provided today and in the report is helpful for Members in 
understanding the work New Zealand does in the implementation of Article 67.  
12.8  Japan  
210.  The delegation  of Japan  would like to briefly describe this year 's report on Japan 's technical 
cooperation, document IP/C/R/TC/JPN/3 , which was also submitted through the e -TRIPS submission 
system. This report consists of the main body and its annex. The main body highlights recent 
technical activities, while the annex lists the details of each activity.  This report categorizes 
cooperative activities into four areas, namely, industrial property, copyrights, plant varieties, and 
border measures.  
211.  As for the industrial property, the Japan Patent Office orga nized 18 training courses for both 
government officials and the private sector in FY2021. More than 300 people attended in total. 
Moreover, based on the JPO 's long history of conducting training courses, alumni associations have 
been established in the tra inees' home countries. The Japan Patent Office continues to support the 
alumni associations by holding follow -up seminars in Asian countries. Japan will continue to make 
its utmost efforts to fulfil its obligation under Article 67.  IP/C/M/106/Add.1  
 
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  12.9  Bangladesh , on behalf of  the LDC Group  
212.  Under this agenda item, Bangladesh delivers this statement on behalf of the LDC Group. The 
LDC Group welcomes the reports under TRIPS Article 67 from the developed country  Members and 
the reports of the Secretariat and other international organizations on the technical cooperation and 
capacity building support to the developing countries. These reports provide information on a wide 
range of program mes and activities customi zed for the beneficiary Members. These program mes are 
critically important for the LDCs.  
213.  We sincerely thank the developed country Members and the international organizations for 
their help and request to continue their valuable support for the developing countries and the LDCs 
including the graduating LDCs. In this regard, we also request delegations to explore the possibility 
of organizing an annual event, similar to TRIPS 66.2 workshop, to discuss the implementation of 
Article 67 of the TRIPS Agreement. We believe that the Secretariat can extend its support and such 
an opportunity will also help Members engage in informed dialogues. The LDC Group stands ready 
for further discussion on this issue with Members.  
12.10   WTO Secretariat  
214.  The Secretariat 's technical cooperation activities have the objective of assisting Members and 
Observers to meet their developmental and other domestic policy objectives, such as innovation and 
industrial policy, health, regulatory aspects , competition policy and environmental protection, 
through the trade and IP regime, in line with their domestic circumstances and priority needs.  
215.  During the review period, the Secretariat 's technical cooperation activities in relation to the 
TRIPS Agreement continued to focus on assisting Members and Observers to understand their rights 
and obligations under the Agreement. Additionally, Members and Observers continued to receive 
tailored assistance regarding notifications and reviews of national leg islation. Activities are 
essentially driven by demand from developing and least developed country Members, as well as from 
governments preparing to accede to the WTO. Partnerships and coordination with other 
intergovernmental organizations and key stakehol ders are, of course, integral to our work and are 
increasingly important and valuable.  Overall, the Secretariat is committed to continue its efforts to 
provide tailored support, subject to Member guidance, in order to respond to your needs and 
priorities.  
216.  Let me say few words about b uilding capacity to respond to the COVID -19 pandemic . A 
particular priority continued to be responding to the needs of Members in relation to the COVID -19 
pandemic response and preparedness. In the spirit of an integrated approa ch to address the 
pandemic, in February the Directors -General of the World Health Organization (WHO), the World 
Intellectual Property Organization (WIPO) and the WTO reaffirmed their commitment to enhance 
support to Members battling COVID -19 and took stock  of a number of initiatives delivered during 
the reporting period. T hose included:  
a. an updated extract of the Trilateral Study entitled "Integrated health, trade and IP 
approach to respond to the COVID -19 pandemic " in October 2021;  
b. the second of a series of  trilateral workshops on Accessing and Using Information 
Resources for the Pandemic Response held in February this year ; and  
c. the launch of the Trilateral  Technical Assistance Platform in April 2022. Th is platform 
provides a one -stop shop that makes availab le the full range of expertise of the three 
organizations, and other partners, regarding the interface of public health, IP and trade 
matters in a coordinated and systematic manner. The objective is to build Members ' 
capacity to effectively respond to the challenges caused by the COVID -19 pandemic.  
217.  To help respond to the continuing demand for interdisciplinary and integrated technical 
assistance on public health, trade and IP, the Secretariat also held a number of global workshops 
related to COVID -19 respon se and pandemic preparedness.  
218.  A brief s ummary of other main activities . In cooperation with WIPO, the WTO organized two 
flagship capacity building activities:  IP/C/M/106/Add.1  
 
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  a. the 17 th edition of the Colloquium for IP Teachers which covered a wide range of IP 
policy and le gal issues, such as IP and public health, IP and e -commerce, IP and 
biotechnology, IP and artificial intelligence, and IP and blockchain, held from 1 to 
12 November 2021; and  
b. the Advanced Course on Topical Intellectual Property Policy Issues to equip gover nment 
officials with the tools to develop and apply domestic policies that contribute to the IP 
development process and the achievement of domestic policy objectives, held from 
28 March to 8 April 2022.  
219.  Another main capacity building activity included the annual workshop on the implementation 
of Article 66.2: incentives for technology transfer to LDCs. In our continuous efforts to improve the 
value and impact of this annual dialogue between LDC Members and developed country Members, 
this year under the guid ance of LDC Members, the Workshop was devoted to specific fields of 
technology transfer critical for sustainable development. The Workshop featured highlights of a WTO 
survey on LDC needs and priorities for technology transfer, as well as a summary of deve loped 
country Members ' annual reports on actions taken or planned in pursuance of their commitments 
under Article 66.2 of the TRIPS Agreement.  
220.  In terms of t echnical cooperation resources , the WTO produced an array of capacity building 
materials. For instan ce, a new book entitled "Trade in Knowledge: Intellectual Property, Trade and 
Development in a Transformed Global Economy " was published in March, the result of a process that 
commenced with a technical assistance workshop which drew together officials and  experts from a 
wide range of developing countries to explore their capacity building needs in this evolving field. It 
complemented the launch of the WTO Trade in Knowledge portal, which provides materials aimed at 
helping policymakers and others keep abre ast of current developments; understand the changing 
patterns of cross -border knowledge flows; and consider the legal, economic and policy dimensions. 
The WTO Secretariat also launched the report "Tackling Illicit Trade in Medical Products: Better 
internat ional co -operation for better health ". And finally, f ollowing from the World Health 
Organization (WHO) , World Intellectual Property Organization (WIPO) , World Trade Organization 
(WTO)  Workshop on Accessing and Using Information Resources for the Pandemic R esponse in 
February, we also  published an Inventory of COVID -19 Information Resources which can be accessed 
on the WTO 's COVID -19 webpage.  
221.  The peer -reviewed academic journal, the WIPO -WTO Colloquium Papers, building on the 
Colloquium series, continued to s trengthen scholarship and dialogue on development and other 
policy issues across the developing world.  
222.  Let me just say few words finally towards  technical assistance generally  at the WTO with TRIPS 
component  just to highlight that the WTO Institute for Tra ining and Technical Cooperation organizes 
many activities that include a significant TRIPS component. During th is reporting period, this 
included two regional trade policy courses, a Virtual Executive Trade Course, a Virtual Introductory 
Trade Policy Cours e for LDCs, an in person Advanced Trade Policy Course for government officials.  
223.  Before closing let me just announce something which has been posted on our webpage this 
afternoon. L et me briefly draw  your attention to a Workshop on Innovation and Access to Diagnostics 
for COVID -19 and Beyond , that will be held on 28 October  2022 from 2pm to 4.30pm . This 
capacity -building activity  will be jointly organized by the WHO, WIPO and WTO secretariats. 
Following a factual introduction by the trilateral agencies to diagnostics, looking at the innovation 
and access landscape from a health, trade and IP perspective, panellists with various backgrounds 
are invited to discuss challenges, opportunities and the way forward  to secure innovation and access  
in this particular area . While primarily targeting the membership of the three Organizations, the 
event is also open to other interested stakeholders. The registration link to attend this fully virtual 
workshop is included in the web announcement that you found as of now while we are speaking on 
our respective web pages.  
224.  I close by encouraging Members to continue to consult with us on priority needs for capacity 
building. We aim to work very closely with Members to ensure that technical assistance, and the 
empirical foundation of that work, continue to respond in a tailored way to their evolving needs and 
priorities, and bolsters capacity to undertake policymaking in IP, trade and related policy fields in a 
practical  and focused manner that supports development goals.  IP/C/M/106/Add.1  
 
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  12.11   Gulf Cooperation Council  
225.  At the outset, I would like to wish you and all participants to the TRIPS Council all the success. 
The overall objective o f the Gulf Cooperation Council (GCC) technical cooperation program mes in 
the field of intellectual property is to contribute to the capacity building of officials from the GCC 
member States and to strengthen their knowledge in many IP technical aspects inc luding the 
protection of intellectual property rights and supporting of invention and innovation.  
226.  The GCC technical cooperation in IP is based on its mandate derived from Article 20 of the 
GCC Economic Agreement which states that "member States shall devel op programs encouraging 
talented individuals and supporting innovation and invention; cooperate in the field of intellectual 
property and develop regulations and procedures ensuring protection of intellectual property rights; 
and coordinate their relevant policies towards other countries, regional blocs and international and 
regional organizations ". 
227.   The technical cooperation activities of the GCC Secretariat General during recent period was 
affected partially in a way or another by the COVID -19 outbreak.  As reflected in the GCC technical 
cooperation activities report for 2022, which undertaken by the GCC Secretariat General covers the 
period from 1 September 2021 to 1 September 2022.  The technical cooperation activities during the 
said period focused on var ious IP aspects such as enhancing the awareness of the intellectual 
property r ights and its policies in the GCC region, cooperation in examination and IT as well as 
supporting innovation and invention, etc. These activities were conducted in the form of wo rkshop, 
on-job training, supporting the participation in international invention exhibitions.  
228.   For example,  cooperation with the World Intellectual Property Organization (WIPO)  continues 
to contribute to the GCC technical assistance efforts in various IP a reas. In this regard, it may be 
worth to mention that the GCC secretariat general,  with the collaboration of WIPO organized a 
seminar for specialists from GCC member States titled "The WIPO virtual seminar on digital data, 
artificial intelligence and their connection to intellectual property " from 22 to 23 of September 2021.  
229.   Also, the GCC Secretariat General,  in coinciding with the International Day of Handicapped 
organized event titled "The Exhibition for Handicapped Inventors " during 3-5 December 2021, in 
order to encourage and support those great people to more innovation.  
230.  Internationally, The GCC Secretariat General has participated to Mal aysia international 
exhibition of inventions. The GCC Secretariat General ambitiously intended  to facilitate the bilateral 
communications between inventors from the GCC States with those around the world and through 
this exhibition . The GCC Secretariat General hosts and supports all inventors from the GCC States.  
12.12   World Intellectual Property Organiz ation  
231.  Thank you for the opportunity to share some information on the World Intellectual Property 
Organization 's technical co -operation activities conducted from September 2021 to Septe mber 2022 
as set out in document IP/C/R/TC/WIPO/3 . 
232.  WIPO remains committed to providing technical assistance to its member States so that they 
may progress on their developmental objectives while observing international intellectual property 
norms. WIPO 's technical cooperation act ivities are needs driven and customized to countries ' 
requirements. The activities also enable WIPO to deliver on its mission to lead the development of 
a balanced and effective global intellectual property ecosystem to create jobs, attract investments, 
drive enterprise growth, and ultimately develop economies and societies for a better and more 
sustainable future.  
233.  As set out in our report, WIPO 's technical co -operation activities address three broad areas: 
policy and legislative advice, IP strategy, and IP  office business solutions. Over the past year, there 
has been an increasing focus on enhancing the capacity of SMEs and young innovators to make 
effective use of IP. This has resulted in initiatives such as online training webinars and expert 
consultation s on IP management and valuation.  
234.  The WIPO academy has continued to strengthen its extensive distance learning programs. 
Notably, the WIPO Academy has broadened the scope of its support to developing and IP/C/M/106/Add.1  
 
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  least-developed countries by focusing on building pr actical IP skills, transforming technical IP 
knowledge to real -world impact. Through new courses such as IP4Youth&Teachers, as well as 
programs on IP for start-ups and for app and videogame developers, WIPO aims to equip 
entrepreneurs, business owners and others with the necessary skills for success.  
235.  Ensuring IP continues to be a powerful tool to respond to global challenges remains a priority 
at WIPO. To support this, WIPO, WTO and WHO launched the Trilateral Technical Assistance Platform 
earlier this year . The objective of this platform is to help member  States  address their 
capacity -building needs in order to respond to the COVID -19 pandemic.  
236.  I would like to thank the Members who have acknowledged the extensive work done by WIPO 
in the area of technical cooperation. I would like to assure all members that WIPO remains committed 
to providing technical cooperation and capacity building programs, which respond to the needs of 
members as they seek to fulfil their TRIPS obligations.  
12.13   World Health  Organization  
237.  I would like to briefly mention that our communication to the TRIPS Council summarizes the 
technical cooperation activities of the World Health Organization (WHO) in the area of public health, 
innovation and intellectual property that have taken place since the last report . The overall objective 
of WHO 's technical cooperation is to strengthen the capacity of developing countries in the areas of 
health innovation, access to medicines and manageme nt of intellectual property.  
238.  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 (GSPA -PHI) as well as other 
relevant resolutions of the World Health  Assembly, including WH A resolution 72.8 on "Improving the 
transparency of markets for medicines, vaccines, and other health products1", WHA resolution 73.1 
on the "COVID -19 response,2 "WHA resolution 74.6 on "Strengthening local production of medicines 
and other health technologies to improve access3" and WH A resolution 75.14 on the extension of 
the time frame of the "Global Strategy and Plan of Action on Public Health, Innovation and 
Intellectual Property " from 2022 to 2030.4 
239.  In resolution 74.6, the S eventy -fourth World Health Assembly emphasized the need to improve 
access to quality, safe, effective and affordable medicines and other health technologies, inter alia , 
through cooperation with, support to and development of voluntary patent pools and oth er voluntary 
initiatives, such as the WHO COVID -19 Technology Access Pool (C -TAP). The resolution requested 
by Dr Ghebreyesus , WHO Director -General to continue to provide technical support, as appropriate, 
upon request, in collaboration with other competen t international organizations, in particular W orld 
Intellectual Property Organization  and W orld Trade Organization , including to policy processes and 
to countries that intend to make use of the provisions contained in the TRIPS Agreement, including 
the fle xibilities affirmed by the Doha Declaration on the TRIPS  Agreement and Public Health in order 
to promote access to pharmaceutical products.5 
240.  WHO, through its Headquarters, Regional and Country Offices collaborates closely with 
relevant international organ izations on topics related to the interface between public health, 
innovation  and intellectual property . We remains committed to provide technical assistance to 
member States at their request.  
13  PARAGRAPH 8 OF THE MINISTERIAL DECISION ON THE TRIPS AGREEMENT ADOPTED 
ON 17 JUNE 2022  
13.1  South Africa  
241.  We thank you for the schedule of meetings to engage on this important issue. The World 
Health Organization has been abundantly clear about the need to deal with the COVID -19 pandemic 
comprehensively. Dr Ghebreysus, Director -General of the WHO, has said, "Vaccines alone will not 
 
1 https://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_R8 -en.pdf   
2 https://apps.who.int/gb/ebwha/pdf_files/WHA 73/A73_R1 -en.pdf   
3 https://apps.who.int/gb/ebwha/pdf_files/WHA74/A74_R6 -en.pdf   
4 https://apps.who.int /gb/ebwha/pdf_files/WHA75/A75_R14 -en.pdf   
5 https://apps.who.int/gb/ebwha/pdf_files/WHA74/A74_R6 -en.pdf   IP/C/M/106/Add.1  
 
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  end the pandemic. " "Many countries need diagnostics, lifesaving therapeutics — including oxygen 
and support for vaccine rollout ". 
242.  The COVID -19 pandemic is ongoing. Health experts have warned that while Omicron 
subvariants  BA.4/5 have  dominated in Europe over the summer, newer Omicron subvariants are 
gaining ground.6 WHO data released last Wednesday showed that cases in the European Union 
reached 1.5  million last week, up 8% from the prior week while hospitalization rates in Europe ha ve 
increased significantly over the past few weeks. It is reasonably foreseeable that this trend will be 
replicated in other regions heading into the winter months.  
243.  As we witnessed in the initial waves of the pandemic, the interconnectedness of the global 
economy rendered the spread and mutation of new variants inevitable. Let us learn from the lessons 
of the past few years and develop a comprehensive response to the pandemic as health experts 
have urged.  
244.  The Ministerial mandate in paragraph 8 of the WTO De cision on the TRIPS Agreement is a 
matter of utmost priority. The 17 December deadline is fast approaching and necessitates that we 
act decisively on this important item that affects people 's lives. The Decision reached at MC12 
demonstrated what we can ach ieve as the Membership when we work together and adopt a 
solution -oriented  approach to issues that affect humanity. The said Decision was a step in the right 
direction, but we must conclude our unfinished business.  
245.  The waiver proponents have provided suffi cient evidence in the documents that have been 
submitted before on the intellectual property barriers applicable to therapeutics and diagnostics, 
including concerns regarding accessibility and affordability. Therefore, we urge all Members to move 
beyond ci rcular Q&A sessions and expeditiously proceed with the decision entailed in paragraph 8.  
246.  As we stated in the General Council last week, the paragraph 8 mandate is clear: the task 
before us is to decide within 6 months on the extension of the WTO Ministeria l Decision on the TRIPS 
Agreement to cover therapeutics and diagnostics. It is not an agreement to renegotiate the text.  
247.  Some delegations have expressed concern about therapeutics with multiple uses and have 
thus called for the products covered by the deci sion to be limited. However, the WTO Ministerial 
Decision contains safeguards to ensure that products produced and supplied under the authorization 
are for COVID -19. This is reflected, for instance, in paragraph 1 which provides that authorizations 
under t he Decision may only be granted, "to the extent necessary to address the COVID -19 
pandemic ". My friend Sherif spent many hours in the green room negotiating those wordings.  
248.  In addition, the treatment options to be availed to patients depend on many factors , such as 
the disease severity, the availability of drugs, routes of administration (only intravenous for 
remdesivir and the monoclonal antibodies), and duration of treatment, among others. Some of these 
treatments can be used in combination (i.e. as for s evere or critical COVID -19) while others are to 
be used as alternatives. The evolution of the virus and patterns of vaccination affect the efficacy of 
therapeutics thus raising the importance of adapting the treatments to local contexts. We caution 
against  an approach that ties the hands of health authorities on the ground and therefore defeats 
the very purpose of the waiver Decision .  
249.  At the TRIPS Council meeting of 19 September, a number of questions were posed to the 
co-sponsors  and we thank delegations for these questions. They are, however, similar to the 
questions that have been repeatedly asked and answered since October 2020. We suggest that 
delegations go back to the submissions that we have already made. However, as we did at the 
informal meeting o n 3 October and in the spirit of constructive engagement, we offer some 
reflections on some of the most pertinent of these recent questions. So I have selected some of 
them and will read them out and give some responses. Two of them read as follows:  
a. In whi ch countries and for which products have the prices been prohibitively high so 
that they have posed a barrier to access?  
 
6 https://www.reuters.com/world/europe/covid -wave-looms -europe -booster -campaign -makes -slow-
start-2022-10-06/.  IP/C/M/106/Add.1  
 
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  b. Do these prices reflect the lower prices that many pharmaceutical companies offer via 
their tiered pricing systems?  
250.  In response we wou ld pos it the following: equitable access means that therapeutics and tests 
are available and affordable for all who need them at the same time everywhere. Currently, many 
therapeutics and diagnostics, which are widely available in high -income countries (HI Cs) are not so 
in low - and middle -income countries (LMICs). Developing countries are kept waiting for donations 
or for companies ' decisions on whether:  
a. to enter into a voluntary licence and the conditionalities that companies impose on their 
voluntary act ions, e.g. geographic limitation;  
b. to donate some products to countries or populations of the company 's choice;  
c. to lower the price to a level and for countries of the company 's choice.  
251.  Clearly this is not a sound public health policy to leave LMICs subjec t to the largess e of 
companies ' decisions.  
252.  There are two important issues related to access to COVID -19 therapeutics and diagnostics:  
a. supply in terms of the quantity of the product available for LMICs to procure ; and 
b. the price. Like vaccines, pharmaceutical companies prefer to supply the high-income  
market where they can sell for higher prices and maximize their profit than in LMICs where 
profit will be less .  
253.  That is why access to therapeutics and diagnostics is repea ting the inequitable situation seen 
in vaccines. For example, as of April 2022, 66% of Merck 's anti -viral medicine ( Molnupiravir) was 
sold in high -income countries.  
254.  Other medicines such as monoclonal antibodies are not available in many LMICs. When 
availab le, the price is prohibitive. For example, Roche 's price of a 600 mg dose of tocilizumab is 
USD 646. The main patent on tocilizumab expired in 2017, yet several secondary patents remain on 
the medicine in a number of LMICs that cause uncertainties about th e potential of production of 
biosimilars. Shortages of tocilizumab have been observed in many countries that have already 
started using it for COVID -19 treatment. It has been documented by Médicins Sans Frontières that 
during the second wave, in one develo ping country7, the distributor ran out of the medicine and not 
a single vial was available in that country for critical patients.  
255.  WHO recommended the monoclonal antibodies (mAbs) casirivimab and imdevimab for people 
at high risk of developing serious COV ID-19 diseases and defined these groups as: a) older age b) 
have immunodeficiency or chronic disease or c) are unvaccinated.8 The medicine is the subject of 
patent applications filed in at least 11 LMICs.  
256.  These medicines are examples where the producing c ompanies dictate supply, allocation, and 
price. Supply is not adequate, and the prices are too high in LMICs. Since the real cost of R&D and 
manufacturing are not known due to a total lack of transparency, it is difficult to assess the prices 
offered excep t in terms of countries ' affordability to purchase. In the case of repurposed drugs it is 
particularly difficult to justify monopoly prices as an incentive for research and development. Many 
LMICs would not consider the current prices of most COVID -19 ther apeutics and diagnostics to be 
affordable.  
257.  Turning to the next question, it is more of a statement than a question: there are many 
therapeutics for which patent rights do not exist, or which are royalty -free. In response, we would 
posit that there are medicines such as dexamethasone that have been produced by generic 
companies in several countries. Generic competition of this medicine has led to lower prices and 
 
7 https://msfaccess.org/tocilizumab -second -drug-ever-recommended -who-covid-19-will-remain -
unaffordable -and-inaccessible .  
8 https://www.who.int/docs/default -source/coronaviruse/poster_casirivimab -and-imdevimab.pdf .  IP/C/M/106/Add.1  
 
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  wider availability. This is precisely the situation that we would like to create for newer therapeutics 
and hence extending the WTO Decisio n of June to therapeutics would be helpful in this regard. There 
are not many royalty -free therapeutics for COVID -19 and, as we pointed out before, treatments that 
are suitable for patients differ and are based on a number of factors.  
258.  Patent barriers affe ct accessibility and affordability. For example, tocilizumab, which was 
mentioned before, is strongly recommended for treating patients with severe and critical COVID -19. 
It is a biological medicine manufactured by a Swiss -headquartered company.9 Tocilizu mab is in fact 
a repurposed drug, having been used for inter alia  rheumatoid arthritis since it was first marketed. 
Its main patents expired in 2017. However, subsequent patent applications for other features have 
been filed leading to the extension of tocilizumab 's patent thicket up until 2028 for some jurisdictions 
in the world.10 These are known as "evergreening " patents. Although Roche voluntarily said that it 
would not enforce its patents in some developing countries and least developed countries, it l eaves 
out key manufacturing countries.11 In South Africa, for example, despite an expert panel finding that 
tocilizumab reduced deaths, the recommendation was for the medicine to not be used because it is 
"not affordable at the current offered price ". The life-saving therapy is largely out of reach for African 
populations at a cost of around 2,000 dollars per patient.12 The cost to manufacture tocilizumab is 
estimated to be as low as 40 dollars per dose of 400 mg.13 Further, the demand for tocilizumab far 
outstrips its limited supply, jeopardising the treatment not only of COVID -19 patients but also those 
who use the drug for the other indications available.14 
259.  Two further questions state as follows: first, there are some COVID -19 therapeutics available 
to developing countries at low prices through voluntary licences including via the Medicines Patent 
Pool (MPP), or tiered pricing. Considering these facts, patent rights are unlikely to be the cause of 
rising prices or restricted access to therapeutics in devel oping countries.  
260.  The second one reads as follows: we need comprehensive information about existing 
collaborations and in particular voluntary licences. For instance, are there countries that would have 
been interested in applying for a sublicence for molnu piravir and Paxlovid but were not able to do 
so because they fall outside the scope of the MPP licence agreements? Which companies from those 
countries, that are eligible for applying for a sublicence, have been rejected in WHO 's prequalification 
phase? Ha ve applications been turned down for other reasons? And in which cases has it been 
possible for low - and middle -income countries to conclude voluntary licensing agreements?  
261.  In response we would say the following: there are only two anti -viral products tha t have been 
recently licensed to the MPP, molnupiravir produced by Merck and a combination drug produced by 
Pfizer. One generic equivalent of molnupiravir received WHO prequalification approval and several 
more versions of both medicines are awaiting appro val. However, these licences have limitations, 
for example, as to the geographical scope. Although the licences allow for manufacturing worldwide, 
they limit where the licensees can supply these products.  
262.  The licences exclude most of Latin America and man y Asian countries from benefiting from 
these arrangements directly. The extension of the June Decision would streamline the process for 
compulsory licensing to allow excluded countries to access lifesaving treatments at affordable prices.  
263.  Outside the MPP,  bilateral voluntary licences between producing companies and generic 
companies lack transparency and have several conditionalities on supplies and geographic allocation. 
For example, a bilateral licensing agreement for remdesivir excluded nearly half of t he world 's 
population from benefitting from price -lowering generic competition.15 
 
9 https://app.magicapp.org/#/guideline/nBkO1E .  
10 See IP/C/W/670 . 
11 In countries where there  is no such waiver of patent implementation, it is reported that Roche has 
kept the price of this therapeutic very high in most countries, ranging from 410 dollars in Australia, 646 dollars 
in India to 3,625 dollars in the USA per dose of 600 mg for COVID -19. 
12 https://www.twn.my/title2/intellectual_property/info.service/2021/ip211011.htm .  
13 https://reliefweb.int/report/world/tocilizumab -second -drug-ever-recommended -who-covid-19-will-
remain -unaffordable -and.  
14 https://msfaccess.org/tocilizumab -second -drug-ever-recommended -who-covid-19-will-remain -
unaffordable -and-inaccessible .  
15 https://www.msf.org/governments -must-support -proposal -waive -coronavirus -covid-19-patents .  IP/C/M/106/Add.1  
 
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  264.  Other medicines, especially monoclonal antibodies, colloquially knows as mAbs, such as 
baricitinib, are not available due to exclusive rights held by the originator.16 The or iginator holds 
patents in more than 50 developing countries, e.g. Latin America, Asia and Africa, which are hit hard 
by the pandemic.  
265.  Problems with access to mAbs are not limited to LMICs. For example, the drug bebtelovimab 
is recommended for immunosuppre ssed patients with COVID -19. It is not available in Europe 
because the company that holds the IP rights refuses to register and market the product for patients 
in Europe.17 This is discussed extensively in an open letter by Michel Goldman, President of the  
Institute for Interdisciplinary Innovation in Healthcare, Université libre de Bruxelles, Belgium. This 
open letter dated is 5 August 2022.18 
266.  Many of these details that we provided today are available in our written submissions 
document IP/C/W/670 -674. We urge delegations to consult these submissions.  
13.2  Maldives  
267.  The Maldives would like to reiterate our commitment to assist in enabling universal, equitable 
and affordable access to COVID19  vaccines, includ ing therapeutics and diagnostics. In this regard, 
we believe it is important that urgent and concrete action be taken by the TRIPS Council to help 
diversify production of COVID -19 vaccines, diagnostics and therapeutics and contribute to improve 
the health and wellbeing  of all people, everywhere around the world.  
268.  The World Health Organization still considers COVID -19 as a pandemic. They have recently 
announced that there are entire regions of the world that are at risk of the pandemic because of 
vaccination  gaps, low rates of testing and sequencing, and lack of access to antivirals. Therefore, 
we believe it is important that diagnostics and therapeutics are made available promptly, in sufficient 
quantities and at affordable prices to meet global demand.  
269.  The Maldives welcomes the schedule put forward by the Chair on 21 September 2022 to 
discuss paragraph eight of the 12th Ministerial Decision on the TRIPS Agreement. We encourage the 
Chair to continue the discussions as planned and also facilitate bilateral mee tings as we now have 
less than three months to come to a decision. In these discussions, we request Members to engage 
constructively in the spirit of cooperation and solidarity, to strengthen the MC12 Decision on the 
TRIPS waiver agreement for the COVID -19 pandemic by including diagnostics and therapeutics.  
13.3  Kenya , on behalf of the ACP Group  
270.  I deliver this statement on behalf of the ACP Group. The ACP Group commends the 
commitment o f Members during the 12thMinisterial Conference and welcomes the Ministerial Decision 
on the TRIPS Agreement with respect to COVID -19 vaccines, and the need to extend this Decision 
to therapeutics and diagnostics.  
271.  It is important to emphasise that COVID -19 remains a health threat to populations, and that 
the use of vaccines is limited in scope in the fight against this disease. Access to therapeutics and 
diagnostics is therefore essential to sustainably address this pandemic. Moreover, the rate of 
vaccinati on in many of our countries is still very low compared to developed countries.  
272.  We have agreed to reach a decision no later than six months after the Ministerial Conference. 
In order to achieve this, it is essential to start serious textual discussions on t he possible contours 
and content of such a decision. To refrain to engage in textual discussions is to choose inevitably to 
reach a negative decision and to close doors and windows to a positive consensus.  
 
16 https://msfaccess.org/latin -america -how-patents -and-licensing -hinder -access -covid-19-treatments .  
17 https://www.thepharmaletter.com/article/weak -demand -leads-lilly-to-withdraw -covid-antibody -in-
europe .  
18 https://www.ft.com/content/36b1d91d -6b0c-453e-b4a0-
37f3d21912e4?accessToken=zwAAAYO8xn4ikc82sdkdawxFPtO0oDfz0 hkS5A.MEUCIQDif6JgTk6nWXumorWb6Hv
IjWbna_iFasMLcQMwq_rIEwIgDVwZ4rJXBB83PJmoEHCKHgq24j0N44Z4MQg4F3X_v1A&sharetype=gift&token=
d2901bba -041a-456c-b04a-32a6acdc3b13 .  IP/C/M/106/Add.1  
 
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  273.  The ACP Group remains firmly confident in the strength of mutually beneficial dialogue and 
calls on all Members to work towards the commencement of formal negotiations on the draft text 
submitted by the co -sponsors. Please be assured of our readiness to work diligently with the other 
parties to advanc e this discussion and to reach a mutually beneficial outcome.  
13.4  Malaysia  
274.  At the outset, allow me to thank Dr Ngozi Okonjo -Iweala , Director -General of the World Trade 
Organization, and you , Chair, for the co llective leadership in this discussion. In the TRIPS Ministerial 
Decision , we view that vaccine equity can be further improved in vulnerable parts of the world in a 
timely manner. We remain cognizant of the role of intellectual property rights in research and 
development. Nonetheless, the COVID -19 experience tells us that addressing the threatening 
pandemic situation now and in the future warrants more comprehensive and decisive interventions. 
Therefore, we will continue to support Dr Ngozi Okonjo -Iweala , Director -General of the World Trade 
Organization and you, Chair, in our endeavour to deliver an inclusive WTO response to the pandemic.  
13.5  Bangladesh , on behalf of the LDC Group  
275.  Bangladesh delivers this statement on behalf of the LDC Group. The LDC Group supports the 
initiative and the presentation by South Africa on behalf of the co -sponsors, which includes the 
LDC Group.  
276.  The LDC Group welcomes the temporary MC12 TRI PS waiver Decision to support the 
production and affordable and timely supply of COVID -19 vaccines with an opportunity to extend 
the decision to therapeutics and diagnostics. This is already a delayed decision after the outbreak of 
the pandemic. We sincere ly hope that the MC12 Decision will help scale up COVID -19 vaccine 
production and make those vaccines affordable for all of us. Without further delay, we must extend 
the Decision to therapeutics and diagnostics as desired by the Ministers. In our understan ding, no 
new conditions are required to extend the same decision resulting from a long negotiation.  
277.  In this regard, the least developed countries (LDCs) thank the TRIPS Council Chair for his 
schedule to facilitate dedicated informal discussions and also ap preciate the oral status report in the 
General Council. The LDCs hope that the TRIPS Chair may kindly continue presenting his oral status 
report in the General Council as the TRIPS Council is yet to complete this work, as instructed by the 
Ministers at MC1 2. 
278.  We urge Members to engage constructively in order to fulfil the mandate of the MC12 Decision 
on the TRIPS Agreement regarding the inclusion of therapeutics and diagnostics. Our Group stands 
ready for further work to agree on a favourable decision as soo n as possible before the deadline 
ends in December 2022.  
13.6  Colombia  
279.  Just after MC12, at our first subsequent meeting before the summer break, Colombia 
expressed its support for the extension of the waiver t o the production and supply of COVID -19 
diagnostics and therapeutics. On that occasion, Colombia further noted that the best alternative 
would be a simple extension of the Decision to the new product category, as a lengthy discussion 
reopening all the argu ments would be extremely complicated.  
280.  Today, we are concerned about precisely that. We have two major concerns about this 
discussion process. The first is that there seems to be an impasse over arguments regarding the 
process. We seem to be reaching a poin t in the discussion where everyone is asking for general 
evidence on the role of IP in innovation, by some, and in access, by others. This is not about resolving 
such a complex and potentially TRIPS Agreement -wide issue. It is more simply an emergency 
redistributive measure, which does not have a general impact but a specific impact on individual 
production chains . The responses are not, and cannot be, general but are always context -specific.  
281.  We are concerned that the focus is shifting from an exceptional m easure to a general 
discussion about the role of IP in access to health, or to innovation. Ideally, we should get back to 
the particular context of this discussion: we need to recognize the seriousness of what happened 
and is still happening, and simply re cognize the political importance in general, and limited to some IP/C/M/106/Add.1  
 
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  countries in particular, of what the limited vaccine waiver could do once extended to therapeutics 
and diagnostics. Moreover, this impasse has immediate consequences for how the WTO and the 
TRIPS Agreement are seen from outside, and their legitimacy, because they will be perceived as 
inflexible, as disconnected, as incapable of contributing effectively to a global problem. We should 
be more strategic, and more specific, collectively recognizin g that this is an exceptional case, and 
adopt a simple extension of the MC12 Decision, as soon as possible.  
282.  If there are no obstacles, then it should be easy to extend the Decision, and if there are 
obstacles, then extending the Decision should be paramoun t. Secondly, we would like to express 
our concern about a particular technical issue. This is the considerable legal uncertainty surrounding 
the licensing processes for the production of therapeutics and diagnostics, as this is the most 
frequently mentione d alternative to extending the Decision in paragraph  8. Indeed, many of you 
have noted that voluntary licensing has been shown to be a swift and effective way to increase 
production and access, without infringing on the rights of patent holders.  
283.  Regardless  of whether this is true or not on a case -by-case basis, which is debatable as South 
Africa has shown, what is indisputable is that all current licensing processes that will allow for 
increased production with conditions are also shrouded in the considerab le legal uncertainty 
stemming from the so -called patent wars. Indeed, there is a patent lawsuit war going on in the 
major markets. There are lawsuits and counter lawsuits  of tremendous importance for vaccines, 
therapeutics and diagnostics. Depending on the  outcome of these lawsuits , patents may immediately 
become an obstacle  to access to vaccines, diagnostics and treatments, as these decisions will have 
an immediate effect on voluntary licensing  schemes . Against this background, both because of the 
specific  and contextual nature of what we are discussing, and because of the problems that are likely 
to emerge with the alternatives, Colombia reiterates its position on a simple extension of the MC12 
waiver Decision.  Let us move forward with your meeting schedul e to achieve this.  
13.7  Indonesia  
284.  Before starting with our statement, I would like to begin by extending our appreciation to the 
Chair for the report at the General Council meeting as well as for setting up a schedule to discuss 
and follow up this much -needed, live -saving outcome of the MC12.  
285.  Unlike the COVID -19 waves we experienced in 2020 and 2021, where a single variant, such 
as Delta, rapidly outpaced all others and spread across the world, vir ologists are currently tracking 
the growth of multiple immune -evading subvariants for these coming months.  
286.  About 80% of people in high -income countries have received at least one vaccine dose 
compared to only 23% of those in low -income countries. Those who  have not been vaccinated are 
facing bigger health risks than those who have. Vaccines are only part of the solution.  
287.  In this regard, therapeutics and diagnostics are inseparable parts of the countermeasures 
devised in the WHO's four-pillar strategy, and h ave been proven to be effective in the prevention, 
containment, and treatment of COVID -19 and subsequent pandemics.  
288.  Dr Ghebreyesus , Director -General of the World Health Organization, once stated that it is 
simply not acceptable that innovative treatments t hat can save lives are not reaching those that 
need them, while manufacturers are posting record high profits. In fact, for both testing and 
therapeutics, the ACT -Accelerator report notes with concern the challenge that manufacturing is 
highly concentrated  and the need for diversification in production, in particular through local 
production.  
289.  The evidence is out there, and to be bogged down by providing evidence in a circular manner 
is to repeat the same mistakes we have made, where it took us 18 months to reach a decision that 
is partial, conditioned, and narrow in scope to respond to COVID -19. Are we going to follow the 
same old pattern or are we going to become an organization that is relevant and responsive in 
addressing this global issue?  
290.  Lastly, no one  is safe until everyone is safe and that means everyone needs access to, and 
the availability to use, if needed, the medical tools to stay safe at affordable prices, which includes IP/C/M/106/Add.1  
 
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  vaccines, tests, and treatments. Indonesia, as always, stands ready to enga ge constructively on this 
issue.  
13.8  Sri Lanka  
291.  The Sri Lankan delegation would like to thank you, Chair, for initiating discussions on the way 
forward on this issue, as this is a very important decision to t ake from a public health perspective.  
292.  We would like to highlight that on 15 June 2021, the Directors -Generals of the World Health 
Organization (WHO), the World Intellectual Property Organization (WIPO) and the World Trade 
Organization (WTO) issued a joint statement in which they underscored their "commitment to 
universal, equitable access to COVID -19 vaccines, therapeutics, diagnostics, and other health 
technologies ". 
293.  Further, on 27 September 2021, WHO, WIPO and WTO jointly organized a workshop which 
addres sed the importance of realizing global equitable access for vaccines, diagnostics, therapeutics 
and other COVID -19 health technologies; mechanisms and processes to support technology transfer 
and intellectual property licensing; and enabling factors and po licies for technology transfer.  
294.  On 29 June 2022, Dr Ghebreyesus , Director -General of the WHO noted "on COVID -19, driven 
by BA.4 and BA.5 in many places, cases are on the rise in 110 countries, causing overall global cases 
to increase by 20% and deaths have  risen in three of the six WHO regions ". 
295.  On 16 February 2022, the International Monetary Fund recognized that "in this environment, 
our best defense is to move from a singular focus on vaccines to ensuring each country has equitable 
access to a comprehensi ve COVID -19 toolkit with vaccines, tests, and treatments ". 
296.  The world is now experiencing an evolution of the COVID -19 pandemic. It is observed that 
antibodies triggered by vaccination are less effective in responding to new variants of the pandemic, 
and even vaccinated people with boosters are vulnerable to multiple infections of new variants. Still 
people continue to die from COVID -19 and new variants of the pandemic due to limited access to 
life-saving treatments in many parts of the world . 
297.  Besides that, the crucial role of therapeutics and diagnostics in controlling COVID -19 is 
undisputed. Diagnostics are critical for effective use of therapeutics. Testing helps to identify new 
COVID -19 variants and to develop effective vaccines and therap eutics. They are recommended 
increasingly by WHO as well as by national strategies as part of test -and-treat strategies.  
298.  However, testing in developing countries, especially in least developed countries (LDCs), 
remains absurdly low. Therapeutics and diagno stics for controlling COVID -19 recommended by the 
WHO are either unavailable or unaffordable for most developing countries, mainly due to significant 
supply constraints and limited numbers of manufacturers, particularly for new therapeutics.  
299.  We fully concu r with the concerns expressed on the low level of daily COVID -19 tests per 
thousand people reported in many developing countries. If I speak of the situation in my country, it 
stands at 0.06% in Sri Lanka as of June 2022. The hospitals are not carrying out  PCR tests on 
suspected cases and they can only rely on rapid antigen tests (RATs) in view of the high cost involved 
in PCR testing, as the government cannot continue to afford and fund the provision of such facilities 
to its population free of charge.  
300.  Such empirical data reveals the imbalance in the area of use of diagnostic tests, as they are 
not easily accessible for low and lower middle -income countries. If these countries had access to 
generic versions of PCR testing kits at affordable cost, then PCR t esting could be increased for tracing 
the positive cases for further treatment. In Sri Lanka, though the daily new confirmed cases due to 
COVID -19 remains at somewhat low levels, the actual situation may reveal a different picture, if we 
can test cases usi ng PCR test methods.  
301.  It is also important to note that the treatment landscape is constantly evolving. Many clinical 
trials are underway and thus no single therapeutic is sufficient. It has been identified that different 
therapeutics are applicable at diff erent stages of COVID -19. IP/C/M/106/Add.1  
 
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  302.  Intellectual property monopolies, especially relating to patents, remain a major barrier to 
scaling up production and to facilitating equitable access. According to WIPO, there are considerably 
more patent filings related to thera peutics than on vaccines, at an approximately 4:1  ratio.  
303.  For some therapeutics, there may not be a need for voluntary licences that are required for 
supply. In some cases voluntary licences exclude supplying many developing countries, and even 
for countrie s included, voluntary licences are subject to various conditions that are often difficult for 
developing countries to comply with. Supply constraints are expected to continue even for products 
for which voluntary licences do exist.  
304.  Therefore, extending the  scope of the TRIPS Decision beyond vaccines to cover therapeutics 
and diagnostics could secure the availability of compulsory licences to override the patent barriers 
to production and export, as equitable and affordable access to therapeutics and diagnos tics still 
remains a massive challenge for developing countries and LDCs. In this backdrop, the Sri Lankan 
delegation would like to re -emphasize that the TRIPS Decision needs to be extended to cover the 
production and supply of COVID -19 diagnostics and the rapeutics.  
305.  Sri Lanka echoes the concerns expressed by co -sponsors of the proposal 
document  IP/C/W/669/Rev.1 , particularly in relation to a lack of clarity on the way forward and 
dragging of the process by some Members, which might delay reaching the final outcome on the 
remain ing Ministerial Decision by the end of 2022.  
306.  It is commendable that the TRIPS Council has already started discussions on this matter and 
aims to make progress, however, we believe that the TRIPS Council should provide clarity on how 
discussions will be tak en forward and accelerated so that a meaningful decision may be taken within 
the stipulated time frame as per the MC12 Decision.  
307.  We believe that studies and reports presented by reputed international organizations working 
on these issues, including WHO and  WIPO and several submissions put forward by the co -sponsors, 
have already emphasized and shown enough evidence through facts and figures to prove the 
importance of addressing IP -related challenges to expanding production and providing equitable and 
afford able access to all COVID -19 products including vaccines, therapeutics, diagnostics, and other 
essential medical goods including their inputs, for the current and future pandemics.  
308.  Substantial discussions have already taken place on this matter during the n egotiations prior 
to MC12 and there is no justification for exploratory factual discussions which can delay the adoption 
of this decision, which contributes to addressing a public health emergency.  
309.  Further, our ministers emphasized this decision by adoptin g the Ministerial Declaration on the 
WTO response to the COVID -19 pandemic and preparedness for future pandemics at MC12 as well. 
Therefore, we urge Members to seriously consider this timeline ahead of us and work positively, 
constructively and meaningfull y to deliver this significant decision within the stipulated time.  
310.  My delegation would continue to engage in all future discussions on this very important file 
constructively, as this matter is about public health of human life on this planet. We would lik e to 
emphasize that any process going forward should be open, inclusive, and transparent and allow all 
Members to be heard.  
13.9  Egypt  
311.  This intervention is going to be very brief and to the point, having heard th e statements made 
by South Africa on behalf of the co -sponsors, Sri Lanka, Indonesia and others, which we support. 
My intervention is based on some of the information that our negotiator sitting next to us, Sherif, 
has provided in the preparations for this  meeting.  
312.  We recall that at a certain point in time when we were negotiating prior to MC12, the 
cosponsors , together with our trade partners, had an agreement. And this is mentioned even in 
written submissions provided by our trade partners. In one of the  submissions in the run up to MC12 
it was acknowledged that therapeutics and diagnostics, together with vaccines, are one of the pillars 
of a comprehensive approach. I am referring to documents that were submitted by the European 
Union, document numbers IP/C/W/680  and IP/C/W/681 . Its preambular part, paragraph number IP/C/M/106/Add.1  
 
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  three sta tes that "recognizing that pandemics affect all countries and therefore require concerted 
global efforts to ensure that all people in all countries have access to safe and effective vaccines and 
medicines as soon as possible ". As you see, it says "medicines ". Reference was made to therapeutics 
in document IP/C/W/680 . Everybody here is aware that the definition of medicines is quite broad 
and comprehensive,  and it may include therapeutics and diagnostics. So, the question today is, has 
this position changed? If s o, then why?  
313.  Again, for the sake of time, and to be brief and practical, I wonder when our trade partners 
will finalize their data and evidence -gathering process and analysis, given that we have a deadline 
that we need to honour. What will happen if we mis s that deadline? This is a question that I am 
posing to the membership, especially our trade partners. What will happen if we miss the deadline? 
Are we ready in this Council to miss the deadline? This is a very important question to answer. My 
delegation i s not ready to miss the deadline. We request our trade partners to provide answers to 
those questions as soon as possible. W e also refer to the answers that we provided to the questions 
in the course of the informal  meeting [of 3 October 2022] . 
13.10   Argentina  
314.  The Argentine Republic wishes to align itself with the statement made by the distinguished 
delegate of South Africa on behalf of the co -sponsors. Our country has faced numerous barriers in 
terms of access  to health technologies during the pandemic, as have many developing and least 
developed countries. This is why we stress the importance of fulfilling the mandate under paragraph 
8 and extending the Ministerial Decision to cover COVID -19 diagnostics and th erapeutics. In doing 
so, we will help achieve more affordable and equitable access. In this regard, I would like to refer 
to the statement made by my delegation at the previous General Council session. The deadline 
stipulated in the mandate expires in less  than two months. We need to move forward in constructive 
debates to fulfil, in due time and form, the multilateral obligation assumed in June.  
13.11   Bolivia , Plurinational State of  
315.  We th ank the delegation of South Africa for the statement made on behalf of the co -sponsors, 
and those made by other co -sponsors, which we support. As we said in the General Council last 
week, we regret that no concrete progress has been made to fulfil the mand ate, adopted by Ministers 
last June, to extend this decision to therapeutics and diagnostics.  
316.  It is our understanding that the pandemic is not yet over, and, although our response to it has 
not only been belated but also limited, it is evident that the pan demic was and is still ongoing, albeit 
in abeyance, otherwise it would have made even less sense to make so much effort to reach a 
consensus. We refuse to believe that those efforts were made only to impress the international 
community and the world. We ma de those efforts because we are truly concerned about human life 
and those who have been impacted the most by COVID -19, the most vulnerable populations.  
317.  Accordingly, ensuring equitable access to therapeutics and diagnostics at fair and affordable 
prices is  an essential part of this response. We could spend another two years discussing whether 
or not intellectual property is a barrier, how to define therapeutics and other countless questions, to 
which answers may not even be found in this room. But the fact remains that the pandemic continues 
and infections are up again, so we need to anticipate our response and increase production capacity 
in the event of an obvious emergency.  
318.  During the pandemic, the high cost of essential medical supplies to combat the dis ease became 
evident, and many countries face major challenges in accessing these medicines and oxygen for 
intensive care, hospitalization and prevention, as well as diagnostic tests, the procedures for which, 
such as those required for the PCR tests, are c omplex, lengthy and costly. As we have said on several 
occasions, in the case of Bolivia, like other developing and least developed countries, the shortage 
of medicines, tests and oxygen was critical, and urgent actions had to be taken to overcome this 
problem. In this context, for example, we stepped up the planning and acquisition of medical supplies 
through the Office for Health Commodities and Supplies (CEASS), an entity overseen by the Ministry 
of Health and Sport, which has allowed health system procu rement to be managed properly and 
ensured that they were used for COVID -19 patients. This shows that there are ways to manage 
these matters at the national level that allow for the controlled use of therapeutics and diagnostics.  IP/C/M/106/Add.1  
 
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  319.  Lastly, we believe it is ur gent to implement our mandate . We therefore ask delegations to 
commit to working in good faith in order to reach a comprehensive response on the basis of the 
adopted timetable and to carry it out in an inclusive and transparent manner, without excluding 
Members ' legitimate interests, so as to give effect to the Decision as soon as possible.  
13.12   Brazil  
320.  Brazil is committed to a robust trade and health framework for the World Trade Organization, 
one that offers meaningful, timely and comprehensive solutions to the COVID -19 pandemic and 
beyond.  
321.  I would like to reiterate our commitment to work under your leadership, Mr Chair , on fulfilling 
the mandate created by paragraph 8 of the Mini sterial Decision on the TRIPS Agreement to extend 
its scope to COVID -19 therapeutics and diagnostics.  
322.  We call on all Members to work together with flexibility and good faith to find common ground 
and reach a balanced outcome, within the agreed timeframe, t hat preserves the integrity of the 
TRIPS Agreement, while improving the relevant dispositions and providing for affordable and 
inclusive access to COVID -19-related products in developing and least developed countries.  
13.13   China  
323.  COVID -19 and its various variants remain a major challenge to the world, in particular for 
developing Members. China, as a developing Member plagued by similar difficulties, fully 
understands the positions of the co -sponsors and firmly sup ports the efforts to increase the 
accessibility and affordability of diagnostics and therapeutics for developing Members. Therefore, we 
call upon the further coordination among Members and relevant international organizations, so as 
to make greater contrib utions to help developing Members fight against the pandemic. China stands 
ready to work with all Members to continue our active and constructive engagement in follow -up 
consultations and pursue an early decision on this issue.  
324.  Meanwhile, we have also noti ced the diversity and complexity of COVID -19 diagnostic and 
therapeutic products. We believe an early and scientific clarification of the product scope would help 
our discussion in a more focused and targeted manner. Again, we would like to reiterate our c oncern 
for the transparency and inclusiveness of the consultation process. The consultation process is aimed 
at implementing the multilateral consensus of MC12; therefore, the whole process should be 
transparent and inclusive. In addition, any possible out come through this process should be 
non-discriminatory  and conducive to helping the world conquer the COVID -19 pandemic at the end 
of the day, so as to highlight the crucial role of the World Trade Organization in this regard.  
13.14   Uruguay  
325.  Firstly, it is important to acknowledge and commend Members who have submitted questions 
on the reasoning behind the extension to the waiver for COVID 19 diagnostics and therapeutics, as 
well as the reasoning behind its possib le implementation. We thank those Members who have tried 
hard to respond to some of them. The intervention by a colleague from South Africa is a good 
example of this.  
326.  In our case, we are particularly interested in access to medicines for medical diagnostic s and 
treatment. We believe that these medicines must be easily accessible in international trade, which 
means that unnecessary distortions, such as export bans and excessive bureaucracy in registering 
new drugs or trade facilitation disciplines, should be  limited as far as possible. Moreover, 
transparency about the availability of these medicines, and having a very clear logic for the trade 
flow of these goods, is key to being able to serve the target populations.  
327.  Thirdly, affordability is a factor that mu st always be given the highest consideration. 
Overpricing and misuse of the law of supply and demand are not welcomed by developing Members, 
and organizations such as the World Trade Organization  (WTO) or the World Intellectual Property 
Organization  (WIPO ) and the World Health Organization  (WHO) must work on this. In this regard, 
we note the event scheduled for 28 October  2022 and will take part online. This is a discussion that IP/C/M/106/Add.1  
 
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  we already had at length in the negotiations prior to the Min isterial Conference on the response to 
the pandemic and on the Decision finally adopted . 
328.  It is still unclear to us how an extension of the TRIPS  waiver currently in force would be 
implemented. In the case of vaccines, we are talking about an easily identif iable product but, in this 
case, it is a whole new, practically unfathomable universe, according to the specialists. We believe 
that a discussion based on questions and comments is vital in helping Members to visualize how this 
extension of paragraph 8 would actually benefit COVID -19 patients in a reasonable time frame. We 
therefore again urge Members to work on practical, easy to achieve and focused issues for the 
benefit of our peoples, in a way that that will ensure we see rapid outcomes.  
13.15   Peru  
329.  Peru wishes to thank those who have already shared questions and answers to shed light on 
this matter. In Peru, we are still engaging in consultations at the internal level to gather information 
for discussion, because  we believe that any decision should be based on current and objective data. 
Given that some Members may share the difficulties that we are facing with respect to the availability 
of data, we suggest considering the possibility of inviting experts from oth er international 
organizations to share with us any statistical information they have that might be relevant to the 
matter at hand so as to provide a better foundation for our discussions.  
13.16   Singapore  
330.  The TRIPS waiver Decision at MC12 has demonstrated Members ' ability to work together and 
exercise flexibility when the time calls for it. As we are faced with a deadline for a decision in 
approximately two months ' time, we should engage in a constructive, pragmatic, and balanced 
manner. Allow me to elaborate.  
331.  In order for us for us to have constructive and informed discussions on the issue, the facts 
and evidence must be clearly laid out on the table. On that note, we thank the proponents for their 
time and effort in responding to the questions posed during the inf ormal TRIPS Council meetings 
which have given us more to reflect upon. Singapore and other Members have highlighted the 
existence of voluntary licences and sublicences for therapeutics such as Pfizer 's oral COVID -19 
treatment under the Medicines Patent Poo l, and Gilead 's Veklury which are available to many low 
and lower -middle income countries. However, we have yet to hear from Members the reason why 
they have not been successful in applying for these licences, and we look forward to receiving a 
response on  this. 
332.  In addition, we must be pragmatic in recognizing that there are other barriers to accessing 
COVID -19 diagnostics and therapeutics which can be addressed domestically and more 
expeditiously. According to an ACT -Accelerator report, these barriers incl ude regulatory bottlenecks, 
the lack of demand forecasting, and low awareness and demand for diagnostics and therapeutics. 
Singapore had pointed out at the General Council meeting last week that our experience with 
vaccines has proven that addressing suppl y side factors would not be sufficient. As governments 
have the authority to address these issues within their jurisdictions, this should be the first recourse.  
333.  In closing, we must take a balanced approach in our discussions to ensure that we do not 
disinc entivize innovation which is critical to fighting future pandemics. This means that the scope of 
diagnostics and therapeutics covered under the extension cannot simply be "any diagnostic or 
therapeutic used to treat COVID -19", bearing in mind that many dia gnostics and therapeutics have 
multiple uses for other diseases. We must not inadvertently undermine the intellectual property 
system by having a broad and undefined scope of diagnostics and therapeutics covered under the 
extension. Singapore remains commi tted to continue engaging constructively and working with 
Members to find a way forward on this issue.  
13.17   Switzerland  
334.  Your process of dedicated informal meetings of the Council is helpful. It provides Mem bers 
with an inclusive venue and the opportunity to exchange views on whether to extend the MC12 
TRIPS  Decision to cover also the production and supply of COVID -19 therapeutics and diagnostics. IP/C/M/106/Add.1  
 
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  While we have made progress, we have not reached a point where  we would be in a position to take 
a decision.  
335.  As my delegation has mentioned in past meetings, including at MC12, we are convinced that 
the intellectual property system is part of the solution to fighting this and future pandemics. IP is 
not a barrier; it  works as a bridge in fact, across which development and manufacturing partnerships 
can connect. This of course is true equally in relation to vaccines as it is in relation to therapeutics 
and diagnostics. Having said this, let me reiterate that my delegat ion is fully committed to engage 
actively and constructively in fact - and evidence -based discussions in this format. We need to get a 
better understanding of the situation on the ground, regarding access to and supply of COVID -19 
therapeutics and diagnosti cs. 
336.  At the last dedicated informal meeting of the Council, we have received a number of  responses 
by the proponents of an extension  to questions posed by Members . In order to facilitate our 
exchange, the delegate of Egypt kindly agreed to share his long an d rather technical statement with 
other delegates. We are looking forward to receiving this and other relevant statements so that we 
can study them in detail. Receiving detailed oral replies in writing in a timely manner will facilitate 
and accelerate our discussion and allow us to make progress . In the same way we therefore also 
request the delegate from South Africa to make available his statement today made in this Council 
in writing so that we can examine the information provided in more detail.  
337.  While w e await this information, allow me to make two preliminary remarks at this point. First, 
several proponents have mentioned in their statements in past and today 's meeting that there is a 
shortage of COVID -19 therapeutics. Factual data recently published on  the situation on the ground 
does not support this. Data from the health analytics company Airfinity shows, for example, that 
Pfizer produces its COVID -19 therapeutic Paxlovid at only 35% of manufacturing capacity, and Merck 
its molnupiravir at a capacity of 45%. More than half of their manufacturing capacity remains idle 
due to a lack of demand for these COVID -19 therapeutics. Reuters reported lagging demand already 
back in April. We would therefore like to ask the proponents to provide us with additional data where 
exactly they meet with a shortage of COVID -19 therapeutics and how far that shortage is actually 
caused by IP barriers.  
338.  Second, we have heard claims that global production capacity needs to be increased so that 
therapeutics and diagnostics can b e produced in sufficient quantities and in the region for the region. 
According to the proponents, the extension of the MC12 Decision to therapeutics and diagnostics is 
necessary because inventors are reluctant to share their IP and do not grant licences f or the 
production of generic versions. However, statistical data again provided by Airfinity highlights that 
this is not actually the case. As of August 2022, 187 voluntary licence agreements for the production 
and distribution of COVID -19 treatments have been signed. Sixty agreements alone were signed 
with Indian generic pharmaceutical companies. The remaining agreements were signed with 
companies in developing countries all over the world, e.g. Viet Nam, Egypt and South Africa.  
339.  Furthermore, via the Medic ines Patent Pool (MPP) sublicences for the production of 
therapeutics can be obtained. molnupiravir and Paxlovid can, for example, be sublicensed in 106 
and 95 countries, respectively. In the case of molnupiravir, already 23 generics companies make 
use of such a licence; in the case of Paxlovid the number stands at 36. For both products, the 
sublicences facilitated by the MPP are granted on a royalty -free basis.  
340.  Against this background, we would like to ask the proponents of an extension  to provide further 
explanations why the production of COVID -19 therapeutics in developing countries and export to 
other developing countries is not feasible and where IP barriers actually exist.  
13.18   Chinese Taipei  
341.  We thank the proponents and thank all Members which have contributed to the discussions on 
this topic. The discussions are very useful. We consider saving lives and health important and we 
are serious on the discussion of the possible extension of the TRIP S Decision.  
342.  We have launched our domestic consultations with stakeholders to find the best way to tackle 
the pandemic in a realistic and practical way and, at the same time, to respect patent rights as much 
as possible. In addition, we have the following suggestions.  IP/C/M/106/Add.1  
 
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  343.  The TRIPS issues with respect to vaccines, on the one hand, and those with respect to 
diagnostics and therapeutics, on the other hand, might not be necessarily identical. Therefore, 
discussions on various aspects to address different concerns in relation to diagnostics and 
therapeutics is not an unnecessary repetition, but is needed to help our discussion move forward.  
344.  Our sincere belief is that clarification of the scope of diagnostics and therapeutics is necessary. 
There are no clear definiti ons for diagnostics and therapeutics in the fields of medicine or medical 
devices. During the past negotiations on the TRIPS waiver discussions, Members had not proposed 
a working definition for discussion.  
345.  Since an extension of the MC12 Ministerial Decisi on on the TRIPS Agreement will be binding 
in nature, we need to be sure about the exact product coverage so as to provide certainty for its 
future application and for the affected and benefiting industries to conduct their business.  
346.  In addition, some COVID -19-related diagnostics and therapeutics have broad and multiple 
uses. They might not be exclusively for the purpose of diagnosis or treatment of COVID -19. From 
this perspective, it could be overly broad and could have unexpected adverse implications if th e 
dual-use products are covered.  
347.  We note that many Members might have encountered problems with diagnostics and 
therapeutics. There might be various factors contributing to these difficult situations. We still believe 
that when the actual problems involved  in supply, production and distribution, as well as the reasons 
why demand is not matched can be identified, Members will be able to come to a conclusion on 
possible extension in a more swift manner. We stand ready to engage constructively in the 
transpare nt, inclusive and evidence - and science -based discussions.  
13.19   United States of America  
348.  The United States of America recognizes that the pandemic is still ongoing. So, in addition to 
our work at the WTO, we are also continuing with our broader efforts to respond to the pandemic, 
including through donations, pilot test and treat programs, and other health and humanitarian 
assistance, to help ensure communities around the world have the resources  that they need.  
349.  We are continuing to conduct our domestic consultations on whether to extend the 
TRIPS  Decision  to cover the production and supply of COVID -19 diagnostics and therapeutics. As 
part of our consultations, we are in the process of gathering i nformation on the use of diagnostics 
and therapeutics to treat COVID -19. We are also gathering information on other related issues, such 
as supply, production, demand, and distribution as they relate to COVID -19 diagnostics and 
therapeutics.  
350.  We support the  ongoing discussions convened by you, Chair, and appreciate your leadership. 
As we continue our consultations, we look forward to continuing to engage with WTO Members.  
13.20   Mexico  
351.  I would like to thank the co -sponsors of document RD/IP/49  for the replies to the questions 
submitted by Mexico during previous meetings. However, we would have preferred the replies in 
writing in order to share them with our capital. In that regard, in order to be able to further analyse 
the is sue with our capital and stakeholders, we would like to seek some more clarity on the replies 
provided on the following points:  
a. Some Members shared the definition of therapeutic product as set out in their 
national legislation. Those definitions are gener al for all diseases, not only for the COVID -19 
virus. Therefore, in order to be able to define the scope of the discussion, we would like to 
know the definition of therapeutic product for the COVID -19 virus.  
b. Also, one of the definitions shared during the l ast meeting included medical 
devices. In this regard, we would like to confirm whether such products are intended to be 
included in the list of therapeutic products.  IP/C/M/106/Add.1  
 
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  352.  During the last meeting, the delegate from Egypt raised an excellent question on how 
intellectual property has facilitated trade in these products. In this regard, we would like to share 
the following information, as one of many examples: since October 2020, work has been ongoing to 
make the therapeutic remdesivir available, also in its generi c version, to 11  million patients 
worldwide. Of these, 7.2 million have been made available in developing and least developed 
countries (LDCs).  
353.  The way to achieve this rapid production and distribution of therapeutics has been through 
voluntary licensing. The manufacturer has entered into a number of voluntary licensing agreements 
with manufacturers of generics to ensure the supply and distribution of the generic product in 127 
developing countries and LDCs. These licences are royalty -free. As another examp le, I would like to 
share that Mexico has been one of the beneficiary countries in the negotiation of voluntary licensing 
agreements, and we are currently producing Pfizer 's therapeutic.  
354.  Mexico is convinced that the intellectual property system is part of the solution to address this 
and future pandemics, as it is a key driver of innovation and investment in technology. We would 
therefore welcome written responses and are committed to participating constructively in all 
discussions.  
13.21   European Union  
355.  Thank you for the discussions and explanations and information that has been provided today 
by various Members. These explanations will certainly be very helpful and will lead us into further 
discussions on this issue and help us in our ongoing internal consultations. The European Union at 
the moment continues its internal consultations both with the EU member States, and by the 
European Commission. We note that some member States are also conducting consulta tions on this 
issue at the national level.  
356.  We have heard some of the explanations, in particular by South Africa today, which were very 
helpful and help us in answering some of the questions that we have, and some of the factors that 
we are looking at as w ell in these consultations. We see that a number of factors affect the complex 
situation on both access and uptake of therapeutics and diagnostics, as already mentioned by 
Singapore earlier: regulatory matters, manufacturing capacity, distribution, funding , the role of 
global, regional and national initiatives to promote equitable access, forecasting and demand issues. 
We believe that all of these factors are important for the evidence -based debate.  
357.  For example, we understand that the demand for products, i n particular therapeutics, is low 
at the moment. It would be important to understand the reasons behind it. We heard the 
South  African delegate mention that some of the products are not available everywhere, including 
in the European Union. These are exact ly the factors that we are considering in our consultations.  
358.  Answering the question by Egypt, posed specifically to the European Union on the 
communication of the European Union to the Council for TRIPS in June 2021: indeed, that 
communication as it was qu oted spoke about vaccines and medicines. We note, however, that this 
communication was an introduction to a draft declaration that the European Union proposed at the 
same time, and the draft declaration concerned the existing TRIPS flexibilities and the ex isting TRIPS 
framework. Namely, it proposed certain clarifications of the flexibilities that are already there and 
available to every WTO Member. The Decision that was agreed in June is of course a different type 
of decision. It is a waiver of an obligatio n of WTO Members. Therefore both the legal basis and the 
legal consequences of that Decision are different from the explanation. I hope that answers the 
question that was posed. Thank you for the discussions and we will continue engaging with all WTO 
Membe rs further in this forum.  
13.22   Japan  
359.  Japan appreciates the efforts made by the Chair and the Secretariat to continuously provide 
us with opportunities to discuss this important matter. Intellectual property right s and the TRIPS 
Agreement play a crucial role in the development of COVID -19 vaccines, diagnostics, and 
therapeutics. According to the Ministerial Decision on the TRIPS Agreement at MC12, Members will 
decide by December on an extension to cover the product ion and supply of COVID -19 diagnostics IP/C/M/106/Add.1  
 
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  and therapeutics. In the consideration of the extension, Japan believes that this discussion should 
be conducted based on evidence and facts.  
360.  We would like to draw your attention to one of the important points, that diagnostics and 
therapeutics are different from vaccines in their nature, distribution patterns, usage and so on. 
Therefore, the extension of the Decision to diagnostics and therapeu tics should be considered in 
light of these facts. Japan appreciates the submission of the room document RD/IP/49  at the last 
TRIPS Council meeting in July for its discussion of this issue. We have studied the arguments 
presented in the document and shared our analyses on the arguments in the in formal meetings held 
twice after the last regular Council meeting. Japan constructively participates in this discussion with 
Members.  
361.  In this context, Japan also appreciates the feedback/explanations from the proponent 
countries in response to questions ra ised by Members in the last informal meeting. Japan would like 
to share with TRIPS Members the factual information we have collected so far: EFPIA (European 
Federation of Pharmaceutical Industries and Associations) published a report titled "Factsheet on 
Covid-19 Therapeutics " on 29 September. Based on Airfinity 's data, this report indicates the 
following:  
a. The production of therapeutics presently exceeds demand;  
b. Many voluntary licensing agreements have been in place for therapeutics; and  
c. Many pharmaceutical companies offer therapeutics at tiered pricing.  
362.  PhRMA (Pharmaceutical Research and Manufacturers of America) also published a report on 
29 September. Based on Airfinity 's data, this report indicates that the quantity of therapeutics 
produced  currently exceeds demand not only in high -income countries, but also in low -income and 
middle -income countries. We should collect and assess these facts reflecting the current situation or 
reality.  
363.  We would like to first discuss therapeutics and then dia gnostics. At the last informal meeting, 
as a response to the question on how intellectual property has been the barrier to access, we listened 
to statements from Members insisting that high prices for products create the barrier to access in 
developing cou ntries. As indicated by the EFPIA 's report, tiered pricing is used in developing 
countries to ensure affordability. In some cases, inexpensive generics are available on the market 
through voluntary licensing. It has been publicly announced that Pfizer 's Paxlovid would be offered 
to low -income and middle -income countries at a non -profit price in cooperation with UNICEF and the 
Global Fund, in addition to the sublicences via MPP, Medicines Patent Pool. This month, a Japanese 
pharmaceutical company also signed  a licence agreement with MPP for the purpose of offering its 
COVID -19 therapeutic drug, ensitrelvir, widely to lower middle -income countries with no royalties.  
364.  In response to the question of how intellectual property is or has been the barrier to access, 
we also heard statements from Members saying that generics are more affordable and accessible 
than expensive original drugs.  
365.  However, without IP protection, there would be less hope for the development of new 
therapeutics for future pandemics, which requi res considerable investment and effort. And if new 
therapeutics are not developed, there would be no generics either. In fact, it is intellectual property 
that incentivizes the development of new therapeutics, facilitates access to generics, and enables 
tiered pricing.  
366.  The room document RD/IP/49  argues in the paragraph on therapeutics that the number of 
patent applications is increasing. This means that many inventions are being produced to combat 
COVID -19. This is evidence that innovation is promoted by intellectual property in the field of 
treatment, and that there is a virtuous cycle of therapeutics development. Another fact is that some 
patents of therapeutics efficacious for COVID -19 have already expired. Given these facts, and 
especially regarding the therapeutics we mentioned above, it can be concluded that patents will not 
cause price increases or access limitations in developing countries.  IP/C/M/106/Add.1  
 
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  367.  We welcome any additional evidence and analyses showing that IP is or has been a barrier to 
access. At the last informal meeting, it was pointed out tha t some countries could not take advantage 
of sublicences via MPP due to the World Health Organization 's strict prequalification  requirement. 
However, our understanding is that the requirement aims to achieve our common goal of delivering 
high-quality and s afe therapeutic products to patients.  
368.  Now we are going to discuss diagnostics. At the informal meeting, it was pointed out that 
patent monopolies were a significant barrier to promoting equitable access. However, as mentioned 
in the room document RD/IP/49 , the foundational patents for the main d iagnostic methods have 
already expired. Therefore, we recognize that not only certain manufacturers with such foundational 
patents, but also other manufacturers can produce COVID -19 diagnostics. In fact, the ACT -A report 
was mentioned at the last meeting, and the report indicates the following:  
a. More than 1,500 new diagnostics for COVID -19 have been commercially available;  
b. Many of the diagnostics are from companies new to the IVD (in -vitro diagnostic) market; 
and  
c. Diagnostics are actually produced locally in several developing countries in Africa and 
South America.  
369.  The report points out that the existing challenges to expanding local production of diagnostics 
include:  
a. Difficulties in recruiting sufficiently skilled personnel;  
b. Unpredictable demand;  
c. Difficu lties being cost competitive with other manufacturers during the start -up period;  
d. Regulatory issues in individual countries, among others.  
370.  If there is any specific evidence or analyses which support the argument that patent rights are 
barriers to access to  diagnostics and therapeutics, and expansion of local production of diagnostics 
and therapeutics, we would like to have them for our review and analysis. Japan continues to 
constructively participate in this discussion.  
13.23   Canada  
371.  Canada is pleased to continue participating in these discussions, and remains committed to 
engaging with all Members on this important matter in the coming months. Canada continues to 
encourage the sharing of any Member experiences in respect of the production and supply of 
COVID - 19 therapeutics and diagnostics, including with respect to any challenges experienced in 
relation to, or arising from, the TRIPS Agreement.  
372.  In particular, we note and welcome the Secretariat 's compilation of questions raised by 
Members at our 19 September meeting, and distributed on 21 September  2022. Canada looks 
forward to continued discussion, including on the basis of these questions.  
373.  Canada remains of the view that ongoing discussions will continue to be aided by an 
evidence -based  exchange on Members ' experiences in responding to the COVID -19 pandemic, in 
order to enhance Members ' understanding of the issues. This discussion would allow the Council and 
the World Trade Organization to contribute to the broa der understanding of the factors affecting the 
production and supply of COVID -19 diagnostics and therapeutics, and thus contribute to our 
collective ability to concretely and effectively address any challenges, not just here at the 
TRIPS  Council but more b roadly.  
13.24   Korea, Republic of  
374.  My headquarters is currently conducting an analysis of the information presented at the 
previous meetings to the extent possible as well as on the current COVID -19-related situation. My IP/C/M/106/Add.1  
 
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  delegation looks forward to participating in fact - and evidence -based discussions with more available 
details.  
375.  One of the priority issues for the ongoing discussions is defining the scope of COVID -19 
therapeutics and diagnostics, as these products involve a broader range of stakeholders and can 
cause a multiple use issue in comparison with COVID -19 vaccines. In this regard, we should continue 
fact and evidence -based discussions with a view to achieving agreeable outcomes on this issue.  
376.  Responding to the current pandemic is of great importance. At the same time, the pandemic 
response needs be in balance with the IP protection system that preserves innovation, which in turn 
will help us in responding to future pandemics.  
13.25   India  
377.  At the outset my delegation would like to thank Dr Ngozi , Director -General of the World Trade 
Organization, who took cognizance of India 's suggestion at the last General Council meeting to host 
a retreat on the paragrap h 8 mandate of the TRIPS MC12 Decision, with a view to expeditiously 
finalizing the extension of the Decision to therapeutics and diagnostics. We hope that Members, as 
well as your kind self, Chair, consider this suggestion positively.  
378.  While the MC12 Decis ion is far from being a perfect one, as it comes too late and offers too 
little, nonetheless, we regard it as a step in the right direction. The Decision helps to lay rest to the 
debate on whether intellectual property is a barrier to equitable and afforda ble access. All Members 
agree that to combat the COVID -19 virus and its ever -mutating strains, a comprehensive strategy 
must be adopted. Apart from preventive measures, test and treat strategies continue to be relevant 
and important to save lives, as peopl e continue to contract the virus and fall sick and also die in 
some cases despite several doses of vaccinations. Testing is not only critical to detect cases, it is 
essential to identify new variants to start building vaccines and therapeutics that can pre vent or 
treat infection and to better understand the scale of infection allowing for expeditious action to be 
taken to break the chain of transmission and contain the spread further. The 12 th meeting of the 
International Health Regulations Emergency Commit tee of the World Health Organization regarding 
the coronavirus disease that met in July 2022 stressed that "access to timely and accurate testing, 
with linkage to clinical care and therapeutics, needs to be maintained ". It further recommended that 
"local p roduction related to therapeutics and diagnostics should be encouraged and supported as 
increased production capacity can contribute to global equitable access to therapeutics ". 
379.  Given the urgency of the mandate we call on Members to consider extending the Decision to 
therapeutics and diagnostics. And in this regard, we thank you for issuing a schedule of meetings of 
this Council to take the discussions forward. I hope that these meetings are optimally used, and 
avoid getting into circular discussions and th e need to provide endless evidence. It is unfortunate 
that questions posed by some non -proponents seeking evidence to prove lack of access to 
therapeutics and diagnostics appear to be insincere and insensitive given that over 6.5  million lives 
have been lo st amidst the acute shortages of masks, ventilators, PPE kits, therapeutics, vaccines, 
diagnostics etc. This was a global catastrophe that we all witnessed, and something that no one can 
deny. Substantive and protracted discussions have been undertaken on this issue since the 
introduction of this proposal in October 2020. In the past two years several documents containing 
comprehensive information and analysis have already been provided by the proponents. Today 
again, under this agenda item, several co -sponsors have made very detailed statements with 
granular details responding to the questions raised and we thank and support those statements 
made by the co -sponsors. I would also like to mention that there were some very poignant questions 
raised by Egypt th at we must all seriously reflect upon.  
380.  To conclude, we hope that all Members work in solidarity and in good faith towards delivering 
on this Ministerial mandate before 17 December 2022.  
13.26   United Kingdom  
381.  The United Kingdom values the discussions taking place in this forum, as WTO Members 
consider whether or not to extend the TRIPS Decision to COVID -19 therapeutics and diagnostics. 
We also acknowledge and appreciate the interventions made on the matter a t informal Council 
meetings, where Members raised pertinent questions that provide a good basis to bring this IP/C/M/106/Add.1  
 
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  discussion forward. We thank proponents for the answers provided so far, including the additional 
details provided today. We look forward to seein g their written responses and we echo calls to share 
statements from today so we can analyse them accordingly.  
382.  We welcome the active engagement from all today including on how the COVID -19 pandemic 
has evolved. The United Kingdom recognizes that COVID -19 is far from over and we need to take 
action to respond to the evolving crisis and to learn for the future. That is why the UK welcomed the 
World Trade Organization 's response to the pandemic from MC12 and why we are engaging actively 
on the pandemic instru ment being developed by the World Health Organization.  
383.  At this Council the discussions need to explore whether there are issues for countries seeking 
to access COVID -19 therapeutics and diagnostics and if these relate to intellectual property. We 
reiterate  that the decision of the membership should be based on facts and evidence. We remain 
committed to engaging openly and constructively, including via bilateral meetings, to assess the 
current situation and ultimately to inform our own deliberation on this m atter.  
13.27   World Health Organization  
384.  World Health Organization member states have indicated even before the pandemic, in the 
World Health Assembly Transparency Resolution, that they are "[s]eriously concerned about high 
prices for some health products, and the inequitable access within and among Member States as 
well as the financial hardships associated with high prices which impede progress towards achieving 
universal health coverage ". 
385.  Now, more than ever, we need to ensure coherence in our response to address public health 
concerns. Despite our distinct mandates, we need to find complementarities and aim to achieve 
global Sustainable Development Goals, in particular the SDG 3 target "to ensure health for all ". We 
are learning from this pandemic how health has a direct impact on all the other development 
dimensions – economic, social and environmental – of sustainable development.  
386.  As you know, since the beginning of the trilateral collabo ration, already in the first version of 
the trilateral study we focused on relevant developments relating to access to medicines and other 
health technologies such as vaccines, medical devices, and diagnostics, due to their importance for 
achieving public health outcomes. We have also included relevant information in the trilateral insert 
on COVID -19 in all these areas because we need a comprehensive approach to deal with the health 
access and innovation challenges. Not only vaccines are important; the "test and treat " strategy is 
vital for the response. Countries are facing challenges to access affordable diagnostics. For medicines 
we have few voluntary licences from key technology holders to scale up manufacturing and respond 
to the needs in countries. Unf ortunately, the scope of these licences is not sufficient; it excludes 
many countries, so WHO calls on the technology holders to expand the scope of these licences to 
facilitate the response.  
387.  These interfaces between public health, intellectual property an d trade have been at the centre 
of international negotiations and policy debates in our three organizations for more than two 
decades. The UN 2030 Agenda for Sustainable Development calls for cooperation to support 
development targets and emphasizes the im portance of research and development and access to 
medicines in accordance with the Doha Declaration. We know how essential innovation is, but at the 
same time we need to ensure that these technologies go to people around the world, in particular 
to develo ping countries.  
388.  Finally, as you probably know, all these elements are at the core of the negotiations of the 
pandemic preparedness and response international agreement taking place at WHO. As some 
delegates stated, the pandemic is not over. WHO remains at  your disposal to provide additional 
information on the need for diagnostics and therapeutics.  
13.28   Nigeria  
389.  We would like to underscore the need to intensify discussions so as to ensure that all Members 
decide on the extension of the waiver agreement on vaccines to therapeutics and diagnostics, as 
indicated in paragraph 8 of the 17 June Decision.  IP/C/M/106/Add.1  
 
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  390.  The COVID -19 pandemic remains a crisis with infections on the rise. According to an ACT -A 
report, without adequate em phasis on testing, treating and vaccines, the global population would 
lose its significant progress in its fight against the disease. In addition, the report stressed that oral 
antivirals can prevent hospitalization and save the lives of patients with the most likelihood of 
developing severe illness. The report clearly identified the main barrier hindering the introduction of 
oral antivirals and attributed it to limited access to the products required and the fact that the 
landscape of treatments and costs is ever changing. Currently, the majority of the known supply 
deals – to the tune of 76% – are concentrated in high -income countries.  
391.  Reports show that manufacturing of diagnostics and therapeutics is still predominantly 
concentrated in specific regions. T here is a need to overcome this challenge by diversifying 
manufacturing activities by facilitating local production. Without comprehensive and adequate access 
to therapeutics and diagnostics in developing countries, the test to treat initiative as currentl y 
applied by some Members would be unavailable to developing countries. It is pertinent to note that 
in terms of therapeutics options for COVID -19, most of the products are either unavailable or 
unaffordable for developing countries.  
392.  The World Health Organ ization has clearly indicated that there ha ve been significant shortages 
of recommended therapeutics, which are not easily accessible to developing countries as a result of 
high costs. The IMF projects that as a result of the pandemic, cumulative global ou tput losses amount 
to almost USD 13.8 trillion through 2024 and therefore advises that the best defence against the 
pandemic will be to shift from a singular focus on vaccines to equipping each country with a 
comprehensive COVID -19 toolkit with vaccines, t ests and treatments. The WHO has also expressed 
disappointment on the existence of inequitable access to COVID -19 treatments, particularly in those 
countries which need these treatments to save the lives of their citizens.  
393.  Regarding therapeutics, there is evidence that intellectual property has posed a barrier to 
access to COVID -19 therapeutics. For Paxlovid, containing the nirmatrelvir compound as 
recommended by WHO for patients with non -severe illness at the highest risk of hospitalization, 
research shows  that patent protection has been sought worldwide by the proprietor Pfizer, 
particularly in developing countries. Therefore, if these patent applications are granted, it will hinder 
generic manufacturing or supply of the compound in the countries where pat ents are granted. For 
the patented Paxlovid, access challenges exist as a result of the high cost. The cost per treatment 
ranges between USD  200-500 in some developing countries, whereas the cost of its generic 
counterpart is only USD 73. The voluntary lic ence agreement with Medicines Patent Pool (MPP) 
signed by Pfizer excludes some developing countries. These same access challenges were also 
identified for WHO -recommended therapeutics, namely molnupiravir.  
394.  Finally, the 17 June Decision has been negotiated and it can apply mutatis mutandis  to 
therapeutics and diagnostics. We recommend the extension of the 17 June Decision to therapeutics 
and diagnostics by Members. We would continue to engage constructively in future negotiations.  
13.29   South Africa  
395.  Apologies for taking the floor again , but we thought it is very appropriate for us to acknowledge 
the very informative presentation that we have just received from the World Health Organization. 
As the only United Nation s institution with the relevant competence and expertise to deal with health 
issues, we place great stock in the views expressed by the institution. We note in particular 
confirmation by WHO about supply shortages when it comes to therapeutics , as we ll as the 
inadequacy of voluntary licensing arrangements.  
Resumption of the Council for TRIPS on 15 December  2022 
13.30   South  Africa  
396.  We have made proposals on the text in para 5. It would be important to ensure that there is 
a true reflection of the issues and the different  positions of Members so, other than to put it in 
binary, then we propose that we put in the second sentence "some Members " instead of "other ". IP/C/M/106/Add.1  
 
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  13.31   Chair  
397.  Is that agreeable? Any objection to that? I think this is probably agreeable. I do not see any 
disagreement. It means only that there is no consensus.  
13.32   South Africa  
398.  Then Chair, with regard to paragraph 7 we believe that paragraph  7 needs to be aligned to 
the mandate of the Ministers and we have proposed a draft that we put forward to the Secretariat. 
It would read as fol lows: "The co -sponsors of document IP/C/W/669/Rev.1  have called for the 
Membership to decide on the extension of the Ministerial Decision on the TRIPS Agreement to cover 
therapeutics and diagnostics in compliance with the Ministerial Mandate in paragraph 8 of the said 
Decision. S eeing no progress in adopting the Ministerial Decision the co -sponsors had no option but 
to reiterate the Decision taken by the Ministers through document WT/GC/W/860 , also known as 
document IP/C/W/694 . Unfortunately, there has been no consensus. " And then we propose also an 
additional paragraph 8 referring to the World Health Organization (WHO) . Then, on your paragraph 
7, we will come back on that depending on the discussions.  
399.  It would be the new paragraph 6. It would not replace paragraph 6 but come before the current 
paragraph 6. And now it will be a new paragraph 9 with the reference to WHO. Of course, we would 
be interested to hear the Members ' views in regards to how it is currently captured and we will be 
flexible, but I think the important issue for us is to capture the role of the WHO.  
13.33   Chair  
400.  Thank you. The floor is open. I have not seen language like this in reports, so I am not sure 
that, to make a value judgement like this, should go into a report of the Council.  
13.34   Sri Lanka  
401.  I have been raising my flag for the last 10 minutes so maybe in the middle of so many 
proposals the Secretariat may not have seen my flag had been raised. Thank you very much for the 
floor and we also fully support the formulation presented by  South Africa on behalf of the co -sponsors 
for what we see now is paragraph 6 and paragraph 8. We fully support those formulations. Now 
Chair, Sri Lanka wishes to make another drafting suggestion: It is to old paragraph 7 - now it is in 
paragraph 8. So, I will now inject the amendments that we wish to present. After the first line please 
add "decide on the extension to cover therapeutics and diagnostics by the 1 st General Council in 
2023". So, I repeat the formulation: in light of the above discussions in t he TRIPS Council will 
continue to decide on the extension to cover therapeutics and diagnostic by the 1 st General Council 
in 2023. That is the formulation that we are proposing here. I think it is for the consideration of the 
Members and I think it is a mo re realistic and pragmatic way to continue this discussion because we 
really need Members ' engagement and also desire to achieve results, so this sense of urgency is the 
reason why we are proposing this formulation.  
13.35   Chair  
402.  Thank you. My intention was not to open the text but to make a decision on the draft text at 
least. But the floor is open for delegations. I think we can give this another open -up to discuss and 
see whether it is agreeable and reach a consen sus. 
13.36   Switzerland  
403.  We appreciate your efforts to come to a conclusion here. As we already mentioned in the 
informal setting, we also have made some suggestions for the improvement of the report. We 
flagged also that we would be flexible and not insist on our changes if there is a consensus  on the 
initial text of the report . Looking at the timing and the fact that we have to agree on a TRIPS Council 
report today, we really wonder whether opening the text is the best way forward. So, we would still 
repeat our offer to join consensus  on the initial or the revised Chair 's text,  but we would want to 
refrain from opening the text and have a drafting exercise at this juncture.  IP/C/M/106/Add.1  
 
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  13.37   Chair  
404.  That would be my preference  too. I had hoped not to re -open the text, quite frankly, but 
delegations d o have the last final say. 
13.38   United Kingdom  
405.  Thanks to you, the Secretariat and the team for all the efforts you put in to come to this text, 
and for the many hours you spent with us in informal discus sions trying to get to a text that fairly 
represents the discussion that we have been having. We just wanted to echo Switzerland 's point: 
the UK also had comments  on the text. It is definitely not the kind of text we would draft if we were 
given the pen. B ut we recognize that in the spirit of consensus , that we need to compromise and 
therefore we have been able to come on board with the text that you originally proposed. Therefore, 
we would like to come back to the original text please.  
13.39   United States of Ame rica 
406.  I am really struggling to understand this exercise. Some language, unfortunately, I do not 
think is appropriate for a draft report. Also, "in compliance with the ministerial mandate " again has 
obviously been read in many different ways, so I do not think it is helpful. If we strip those things 
out, aside from having the specific references to various documents, it is basically saying the same 
thing that it is in the first sentence of p aragraph  5 already. Then, the fact that there is no consensus  
is covered by paragraph 6. So even when you put paragraph 5 in 6 and the existing para 6 in 7, it 
is just again saying the same thing, namely that there are sponsors of something, but it has not  
achieved consensus.  But paragraphs 5 and 6 already say that.  
13.40   South Africa  
407.  We do believe that those elements that are now in the new paragraph 6 are important. What 
we could do to address the concern  that has been raised by the U nited States of America , is to 
maybe have the elements that are in para 6 come immediately after the 1 st sentence of para 5 and 
we are flexible whether the highlighted part would come immediately thereafter or in new paragraph .  
408.  Then, on the suggestion  by Sri Lanka, I guess the highest decision -making body in the WTO 
in between Ministerials  would be the General Council. So, we are also flexible what we say, because 
it cannot be the TRIPS Council that will decide, so it is either "the General Council " or "Members " 
who will decide.  
13.41   Chair  
409.  "Unfortunately there has been no consensus " is very obvious - and has been stated over and 
over again in the text. In any case, I am still unsure whether this is the language to be used in a 
formal report like this.  
13.42   South Africa  
410.  Thank you very much, Chair. We would be flexible on that, Chair. Thank you.  
13.43   European Union  
411.  On our side we have to thank you, Chair, for all efforts in bringing us up to h ere and I hope 
that we will get to a report, ultimately . It is a little regrettable that we see all these efforts by the 
proponents only at this stage – shortly before the end of the meeting – and not on either Monday 
or Wednesday. In any case, just a coup le of initial thoughts and suggestions on the draft, of course 
without prejudice because our preference would be for your original draft. But in the spirit of 
compromise, we see that there are certain formulations we do not understand. It might be that 
English is not my first language like for most people here, but to repeat "the Ministerial Decision " is 
a bit strange. We also think that the words "have no option " are also a value judgement – and we 
saw the flexibility of South Africa on deleting another va lue judgement in the text as regards 
"unfortunately ". We think that "had no option but to reiterate " should be deleted as well, and 
probably replaced by something like "propose the extension of the Ministerial Decision " or something IP/C/M/106/Add.1  
 
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  along these lines. I wi ll not comment on the addition by Sri Lanka yet at this stage, but I think HE 
Ambassador Machado in his previous intervention clarified that we have a problem with the "the 
leading role of the W orld Health Organization (WHO) ". I think he gave a number of reasons why we 
have a problem with that paragraph, so we are very uncomfortable with that provision.  
13.44   United States of America  
412.  Again, I think we have two sentences  saying the same  thing, again with some value judgment  
words that should not be there . If we are just trying t o be more precise, we can work with that . The 
sentence that was in the draft shared on 6 December 2022, "a group of 65 Members " – I understand 
that it is a refere nce to the co-sponsors of document IP/C/W/669/Rev.1 , and that the document 
referenced in that short sentence "tabled  a proposal " that is the WT/GC/W/860 , and there is a 
footnote  that refers to the IP/C/W/694  document . Again, if the des ire is to be clear what the 
documents are and what actions were taken , I think that we can really just consolidate all this into 
one sentence that is factual , maybe to avoid too many clauses . Like "On 6 December 2022, the 
co-sponsor s of IP/C/669/Rev.1  etc. … seeking a decision  on the  extension of the Ministerial Decision 
to cover therapeutics and  diagnostics ". Period.  That is basically it. 
413.  I think the l anguage "in compliance with the  Ministerial mandate " gets us into the question 
that we have been bouncing  around for a long time . So, again, just trying to understand that there 
may be a desire to demonstrate the steps that have been taken – and that is legitimate  – but we 
can do that in a very factual way without getting into these additional wrinkles  that create issues . 
13.45   Chair  
414.  Just on a point of formality, if a Council report is adopted at all. The language "seeing no 
progress in adopting the Ministerial  Decision, the co -sponsors had no option but to reiterate… " - that 
is not language tha t would be  neutral and acceptable. It is a value judgement. It is the position of 
the co -sponsors and not that of the Council. This particular paragraph becomes quite superfluous  in 
light of the rest of the text.  
13.46   South Africa  
415.  We agree with the need to streamline, but we do not believe it is superfluous and we propose 
to properly address the concern of Members that we have been judgment al when we say "had no 
option but to  reiterate ". Let's see if this formulation works : you already have "seeing no progress ", 
so we can rather copy, after "seeing no progress in adopting the Ministerial  Decision, the 
co-sponsors …" and then you take what is "on 6 December 2022 …" and then the rest – "had no option 
but to" – will then be taken out, just to also address the con cern that has been raised by both the 
US as well as the EU.  
13.47   Chair  
416.  "Seeing no progress " is, again, judgmental language. Frankly, it is meant to be a fo rmal report 
by the Council, it is not the report by the co -sponsors. Let 's just have that clear.  
13.48   South Africa  
417.  I thought the problem was the language "there is no option but to reiterate ". I think it is factual 
that we have not made progress, we have not reached a decision within six months, so I do believe 
that that is at least factual . 
13.49   United Kingdom  
418.  I reiterate that our preference would be  to go back to your original language . But just to come 
in on this  "no progress " point: I do  not think i t is a fair reflection of the time, energy and effort that 
this TRIPS Council has put into this discussion . We have seen lots of Members putting forward 
different proposals . We have seen pa pers. We have had an in -depth conversation.  Probably, this is 
the most active conversation since MC12 on any of the files. You are jumping to a judgment call that 
we, as the UK , do not feel is there in terms of reflecting the real effort of everybody in the room that 
has gone into these discussions . IP/C/M/106/Add.1  
 
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  13.50   Chair  
419.  Here is additional proposed  text now and the previous draft that I submitted . Should we give 
Members ten minutes to look at it so see whether this is agreeable for adoption?  
13.51   South Africa  
420.  What it is on the table now does not reflect what I have just said. I do not know whether I 
need to repeat it. I thought it was clear that we are asking that what was in paragraph 5 must go 
down to after "Decision " and then you say "the co -sponsors, on 6 De cember… ". We do believe that 
will then address the concern  of repetition that was raised  and streamline the text. I hope that it is 
clear.  
13.52   Switzerland  
421.  Thank you for putting together what is really mean t by the co -sponsors, in terms of 
amendments to this text. We would just like to echo also the comment made by the United Kingdom 
about the progress made, or not made. I think we have maybe different views on that. Other than 
that, I would just like to rem ind that we also submitted a formal proposal for changes and if we 
continue this discussion, we will then also ask the Secretariat to introduce the changes to the 
different paragraphs that Switzerland had put forward in writing.  
13.53   Chair  
422.  It seems that we have a stalemate again.  
13.54   South Africa  
423.  We have no problem with Members wanting to reflect their positions, not at all, if Switzerland 
believes  that there are aspects that they want to add. Our interest is to ensure that we have a factual 
report that addresses the interest of all Members. So, we do not have a problem with Switzerland 
adding what they believe should be reflected in the report.  
13.55   Switzerland  
424.  My suggestion would be that we make a consolidated document and then we have some time 
so consider it. I think it is difficult to have such a detailed drafting exercise in this setting and as we 
said before, given  also the time -constraint that we are facing. We still have basically a preference 
for your original text.  
13.56   United States  of America  
425.  I will make one last attempt, which probably will no t work. So, you could say: "The co -sponsors 
of IP/C/W/669/Rev.1  called  on the WTO Membership to decide on the extension of the Ministerial 
Decision on the TRIPS  Agreement to cover therapeutics and diagnostics ". Period. And then you 
begin: "On 6 December 2022, the co -sponsors tabled a proposal for the General Council to extend 
the Ministerial Decision through document … etc. ". So, you just keep to the facts.  
13.57   Sout h Africa  
426.  We appreciate the position  of the United States, but we do not think it reflects the sentiment 
that we, the co -sponsors, want to raise. We do believe that what is captured there is factual. Y ou 
know, we have shown enough flexibility in trying to accommodate the concerns that have been 
raised. So in our view , the way it is currently capture s – at least from the co -sponsors ' perspective 
– what should be reflected in the factual report.  
13.58   Chair  
427.  The interpreters will be leaving in 15 minutes, but I would like to suggest that the co -sponsors, 
Switzerland, the United Kingdom , and the United States  of America  may get together and see IP/C/M/106/Add.1  
 
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  whether they  can agree on a language and then come back. Let us take a break of 30 minutes – but 
we have to end this today.  
13.59   Chair  
428.  It seems clear that there is no agreement. There is no consensus  on either version. We do  not 
need to submit a report. So, I thank you all. There will be no formal report to the General Council, 
but I will be reporting under my own name on the state of play.  
13.60   Sri Lanka  
429.  My delegation believes  that you are rushing to make a decision. I think, as the Chair, you 
should give delegations more time. I think we have resolved many more complex issues than this 
during MC12. Give time to the Members to come together and find some common understanding 
and landing zone, rather than rushing  and making your own decision that there is not consensus . I 
think we have a systemic issue in this institution. The chairs are sometimes taking certain decisions 
without looking at the possibility of reaching certain con sensual decisions. So, I think it would be 
good that you – as the facilitator – are coming forward and trying to facilitate Members to come 
together and reach consensual decisions. Otherwise, it will be very difficult for us to reach consensual 
decisions. I appeal to you to give delegations more time rather than rushing to a decision like this.  
13.61   Chair  
430.  I am sorry. More time is what we do not have. And this report is, in any case, not the important 
thing. The im portant thing is that there was no consensus on an extension of the Decision. I think 
this is the most important thing – and this report would simply state that. It is not going to change 
anything fundamentally and we do not have time to continue.  
13.62   South A frica 
431.  We also have a day, even a weekend before the General Council. So, I do not believe that we 
can say we have concluded our work. There is still time to engage. We would agree with Sri Lanka 
that the text where we are now can be circulated to Members to reflect on and we can contin ue our 
discussions. That is the view of the co -sponsors. The 65 co -sponsors.  
13.63   Switzerland  
432.  On the Swiss side we do not have the impression that you are rushing any decision. I think 
you just simply state d the obvious, namely, that it will be very difficult to get any consensus  on a 
report. As others have said, we deplore the fact that the co -sponsors have made the substantive 
and numerous comments  at this very last minute, not allowing others the necessar y time to analyse, 
to consult, and to react to it. This is the situation that we are in, and we do not feel that you rush to 
any conclusion. You just state the obvious.  
13.64   United  Kingdom  
433.  We just want t o come in and echo what Switzerland said about your efforts. I think you made 
a really strong effort in trying to summarize what have a been lots of in -depth detailed discussions 
on this issue and all the submissions  made. We think it will be a shame not t o have a report, because 
we have made so much progress  and we have had such a good discussion. I think from our 
perspective, we do actually think there is a report from the TRIPS Council that has gotten us a long 
way – which is your draft. And exactly as y ou said, there is not very much time left. So to assess,  
to review, and to understand new proposals takes time in all of our systems, which we just do not 
have anymore. The General Council is on Monday, so from our perspective the only one that will be 
possible is the text that you have proposed to us. And if that it is impossible to be taken forward, 
then we understand, and we thank you for all your efforts.  
13.65   Tanzania  
434.  We really appreciate that you are givi ng us an opportunity to engage, and I still believe that  
you will continue to engage to let the Members engage like South Africa just said. Based on the IP/C/M/106/Add.1  
 
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  previous experiences that we have been working - sometimes even also during the weekends – I do 
not see  why we should not do that for this matter, considering the importance of this decision that 
we are going to make. We are just about to agree . I think, like the co -sponsors have said, we give 
more time for Members to consider the proposals that have been a dvanced by the Members, 
particularly the co -sponsors and other Members have been said that they have  not had an 
opportunity to see the language in advance. That makes it more rational to give them more time to 
consider. I would like to reiterate the call o f being given more time. We still have tomorrow, and we 
still have Saturday and Sunday, so we still have those 3 days in my view, and it will be not the first 
time to work on the weekend. We should be extending the same process with the same spirit of 
collaboration towards achieving an outcome which is really text that reflects the understanding of 
the Members. I wanted just to echo the proposal by South Africa.  
13.66   Singapore  
435.  I want just to make three brief points. First, it is not fair to accuse you of trying to rush things. 
I think you have put in tremendous  efforts, and we actually appreciate what you have done and 
what you are trying to do. Second, you have put forward a cl ear path that can take us forward and 
that is to use the draft that you have put on the table, and which is acceptable to the majority – 
large number – of Members. And three, Chair, there is a suggestion that we can work over the 
weekend. My delegation is committed to do it, provided that there is sincerity, a real flexibility, not 
just saying "I am flexible ", but not really moving anything. So, Chair, if that is the understanding 
my delegation is prepared to work, although our preference clearly is to use the path that you have 
given to us, and to use the draft that you have put on the table.  
13.67   Chair  
436.  We have to end this meeting today. My feeling is that it will be difficult to reach consensus  on 
all these new a mendments , and that there is some bad faith on the part of some Members accusing 
me of being the one – and not them – causing a delay in decision. But here is my challenge: I will 
give until 12 noon tomorrow – and if all these elements can be worked out by  then we can have a 
brief Council meeting  to adopt it formally. Such a communication, that there is a consensus  text that 
has been agreed bilaterally between the co -sponsors and other Members can be sent to the 
Secretariat. I will then convene a meeting fo r maybe half an hour, and we adopt it. Otherwise, if we 
do not have that, I will have to report under my own responsibility. Some delegations have so many 
other things to do, and you can blame me all you want – it is fine. Next time you probably have to 
do more vetting of chairs. Thank you all and I hope we do get something from you by noon tomorrow 
so that we can convene a quick meeting.  
13.68   Egypt  
437.  If you can, please, call for a meeting tomorrow at 10  o'clock so we can discuss or reach a 
consensus  on a report . Otherwise, if we only come together tomorrow at 12 noon to find a way, 
where would we do this and when? So if there is a meeting, an informal meeting, even on the level 
of experts to discuss the rep ort even for one or two hours and then we can come up to adopt this 
report, that would be great.  
13.69   Chair  
438.  I disagree .  
13.70   South  Africa  
439.  I think we need to avoid coming up with new procedures not normally done for other issues. 
That is one point. Two, I agree with you that consensus  will be reached if we engage as Members, 
and that should be encouraged. But this new procedure, to say the me eting will be called only if 
there is a consensus  document – we disagree with that because I have not seen that in other 
negotiations whatsoever. So I think the best way forward would be to say you encourage Members 
to speak with each other so that we can have a way forward. Then we can set a time within which 
we need to meet as Members to see where we are and of course hopefully we will be close to each 
other, to have a short meeting. But again, I think it is pre-emptive to say "only 30 minutes " because 
new ideas may come as we engage with each other. And so, I propose that we show that flexibility IP/C/M/106/Add.1  
 
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  to agree on the time to meet, and of course all of us attempt to engage with each other towards 
finding a common ground.  
13.71   Chair  
440.  I meant to say that, if you can have a conversation and reach a consensus , then we can meet 
and adopt it. But we are not going to meet again to have a long conversation with new elements 
who have to be introduced - that it is not going to ha ppen. I am sorry. So, we can certainly circulate 
something to have a meeting sometime tomorrow to make a final decision. But it is just not 
productive to bring in new elements at the last minutes when we are really there to adopt a draft 
document that has gone around for such a long time.  
13.72   Egypt  
441.  I am reiterating my call for a meeting tomorrow, an informal meeting of the Council in the 
morning to meet together and just see a way forward on the report.  
13.73   Chair  
442.  This is not decided on the spot. There are a lot of other issues. In any case, a formal report to 
the General Council is not mandatory. It is not as important as reaching consensus  on extending the 
decision under paragraph 8. This is simply a report, a factual report reflecting on our work . So, it 
shouldn 't be this difficult . Comparing it to MC12 it is not a true comparison. So, if you can meet at 
10 o'clock - I will be not there – hopefully there will be interaction between the co -sponsors and 
others and a new document can be brought to the Secretariat. Then we will convene a meeting and 
see how we can adopt it. We are open to that, but I am not going to be chairing another informal  
meeting.  
13.74   Sri Lanka  
443.  I think we should not be repeating a practice that many facilitators and chairs actually adopted 
during MC12. Some facilitators actually left the Members even to each other. We fortu nately did not 
end up like that in the end. But, Chair, as the Chair of this Council I think you should be there to 
lead these Members to arrive at some consensus . That is a responsibility of a chair, because you 
cannot say "these countries do not agree, t herefore I cannot report ". You know Chair, I think you 
should make all the attempts - we have to really use all options available, because this is an 
important issue, and this is the first of the Ministerial outcomes on that we are supposed to deliver 
some thing. If we fail in this particular first kind of mandate that Ministers have just given us, if we 
fail to deliver something, it will reflect very badly on other outcomes and other engagements, and 
to arrive to such outcomes also will be in jeopardy. So, how do we really believe in a system, if 
within 6 months we fail to even agree on a report? So, as the Chair of this Council I think you should 
be making all your efforts. Maybe you do not have the magic wand to really get everyone on board, 
but at least y ou must make all your efforts to bring Members together and create a platform for 
Members to arrive at consensual language so that you have your report. So therefore, we like you 
to chair the meeting which Egypt has very kindly requested you to convene.  
444.  Now, this is a normal formal committee. If the Secretariat has logistical challenges with 
resources, then I am puzzled as we were assured in the Committee on Budget, Finance and 
Administration (CBFA) that formal committees can be conducted uninterruptedly. This is precisely 
what I have been raising in the CBFA. They are allocating a lot of money on other non -mandated 
committees and meetings, but they do not have logistical capacity and resources to convene a 
meeting, which multilateral ministers have mandate d us to work on. So, I try to understand what 
kind of logistical hurdles there are. We will be raising this again in the General Council. If the 
Secretariat is experiencing logistical hurdles to conduct these meetings, where does this money and 
other capac ity go?  
13.75   Chair  
445.  Thank you. You cannot make the Secretariat the focus on this conversation. The time is not 
right, there are a lot of other issues, other commitments, other logistical issues. It is not the 
Secretariat saying that – it is me. Number two, you are confusing the categories. The important IP/C/M/106/Add.1  
 
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  decision here would have been to extend paragraph 8. Agreeing on a report is not the important 
decision. It is not. So, let 's not confuse all these categories, plea se. Egypt has made a good 
suggestion, but I will not be chairing a meeting. You can ask the Secretariat to organize a room and 
you can have this conversation, and if a consensus  can be reached, we can meet again at a set time 
and adopt the report. The repo rt is not important, it is not mandatory. It would be nice to have, but 
if it is not here it is not a tragic event.  
13.76   South Africa  
446.  I feel you are now abandoning the Members, because I cannot understand  why – when the 
Members are asking for a meeting – the Chair says, I am not there. It is a bit of a challenge. We 
humbly request, Chair, that you reconsider because I think it will set a seriously wrong precedent 
for the Chair to say, "meet on your own ". Then what 's the point of having chairs if we can meet on 
our own. Of course, we will meet on our own in terms of lobbying each other to come to a common 
ground, but a platform has to be provided for Members to engage. Because we probably will meet 
in diffe rent configurations, because we know what the challenge is of the European Union with 
regards to the World Health Organization . So, if we have to discuss about W orld Heath Organization  
we need to engage the E uropean Union. On other issues, with need to eng age the United States  of 
America , on other issue we need to engage Switzerland and the United Kingdom. But for everyone 
to have an appreciation on where the consensus  is emerging among those Members that have 
different positions, a platform is required. We  also disagree with you, Chair, that this report is not 
important. This report is important, that is why we spent time as Members. Otherwise, if it was not 
important, we would not even have engaged. The reason it is important is because if you are able 
to have emerging consensus  here, you are not out of the discussion at the General Council. So, it is 
important in that regard. So, as I said Chair, we ask you to reconsider your position because we do 
believe this is an important issue that affects peoples ' lives and we cannot take it for granted.  
13.77   Chair  
447.  A formal meeting can be called , which I would chair , to adopt whatever it is you may be able 
to agree . I know that most constructive  work can be done when you ta lk to each other.  
13.78   South Africa  
448.  Engaging in this process, you know the dynamics. You had to convene us in informal and 
formal mode to try to get us to a common ground. That is what it is going to get us forward. So 
again, I am asking humbly that you reconsider your position because we need a platform, both 
informal and formal mode, and to do whatever it takes to get us to a way forward.  
13.79   Chair  
449.  I still enc ourage you to have that kind of informal conversation among yourself and see if 
something can be hammered out. I did not say, by the way, that the report is not important. I 
drafted it because I know it is important – but it is not mandatory. There is a di fference in emphasis. 
All these new different elements, newly introduced, mean that there is some bad faith on the part 
of some Members, I regret to say. If you are accusing me of all sorts of things, I think you should 
also take responsibility for the lack of consensus .  
13.80   Egypt  
450.  I am requesting that our call for an informal meeting, that has been rejected twice, be added 
to your report to the Gener al Council under your own responsibility . This is a formal request to call 
for an informal meeting and it has been rejected twice from many Members.  
13.81   Chair  
451.  If I report under my own responsibility, I will deci de myself what goes into that report. Not 
Members. So, I am hoping some kind of meeting can take place and I will call a formal meeting if 
there is agreement, and then we can meet to adopt that report. I thank you all for the very 
constructive engagement t oday. The formal meeting of the Council  for TRIPS  is closed. The Council IP/C/M/106/Add.1  
 
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  for TRIPS takes note of the statements made today and this brings us to the end of today 's resumed 
meeting. The meeting is suspended.  
Resumption of the Council for TRIPS on 16 December  2022 
13.82   Switzerland  
452.  Just a brief statement from Switzerland. We did not oppose the consensus  on this report to 
the General Council although we must say that some elements contained in it remain a little bit 
unclear to us. So, what I would like to be put on the record, to be very clear, is that we have noted 
in the past that there have been differe nt understandings of the meaning of paragraph 8 of the 
Ministerial Decision on the TRIPS Agreement. Switzerland has made its views and its understanding 
of the meaning quite clear in the past, as have others. I just would like to confirm that our 
understan ding of this paragraph 8 will not change, or is not changed, by us joining the consensus  of 
this draft report.  
14  INTELLECTUAL PROPERTY AND INNOVATION: ROLE OF IP TO RAISE FINANCE FOR 
START -UPS 
14.1  Switzerland  
453.  My delegation has the honour to briefly introduce, on behalf of the group of the 'Friends of IP 
and Innovation (FOII) ', the communication contained in doc ument  IP/C/W/692 , titled "Intellectual 
property and innovation  – Role of IP to raise finance for start -ups". The submission is co-sponsored 
by the delegations of Australia, Canada, Chile, the European Union, Japan, Singapore, the Separate 
Customs Territory of Taiwan, Penghu, Kinmen and Matsu, the United Kingdom and the 
United  States  of America.  
454.  During the Council 's lunch break yesterday, the Friends of IP and Innovation organized a n 
event with panel list from WIPO, from WTO delegations and the private sector . It that focused on IP 
and finance, with a focus on start -ups and MSMEs many questions were posed,  and we had a livel y 
debate.  
455.  For start -ups it is a particular challenge to raise enough capital to be able to grow and to reach 
their full potential. IP financing can help in this challenge. In our submission, the following six types 
of IP financing are being examined more closely:  
1. IP-based equity financing  - when partners invest their own money in the company.  
2. IP-backed venture debt  - a newer form of financing for young firms in which IP serves as 
collateral.  
3. Revenue from IP licenses  - the classic method of generating cash flow from IP rights such 
as patents , trademarks or designs. The purchase of a license allows the buyer to use the 
company 's IP. 
4. Royalty securitisation  - in which the IP owner sells an income stream associated with the 
IP for a specified period of time in e xchange for an upfront payment. An example from the 
area of copyright are artists selling rights to future income from their songs or 
photographs.  
5. IP sale -leaseback  - here, IPRs are sold by the right holder to a n investor and then leased 
back from it. For start-ups, this type of IP financing has the advantage of providing 
immediate liquidity.  
6. Finally  - IP insurance  - in which a third party provides upfront capital to the IP owner to 
fund potential IP infringement disputes.  
456.  I will now introduce our own coun try experience with regard to the use of these types of IP 
financing . Switzerland has fared well over the past years in WIPO 's Global Innovation Index when it 
comes to its innovation environment and performance. This said, WIPO 's report points us to areas IP/C/M/106/Add.1  
 
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  where we can further improve. For example, in the category of "Venture capital received ". On this 
background, Switzerland recently conducted a country study on IP financing19, in partnership with 
WIPO . The study brought several insights to light: in order to convince investors, such as business 
angels or venture capitalists, start -ups should present a compelling business case.  
457.  A promising IP portfolio can be one way of doing this or at least an important part of such a 
strategy . In Switzerland, IP financin g is focused on Venture Capital funding. Especially patents are 
frequently used to signal that there is qualitative substance in a young company. This is particularly 
so in the life science sector, but also for clean -tech and ICT start -ups. By contrast, IP  is rarely used 
as collateral in classical debt finance in Switzerland, although the Venture Debt market has grown 
in significance more recently. Even more of a niche in Switzerland 's innovation environment are the 
financing methods of IP insurance and IP sale-leasebacks.  
458.  Let me now present a real-life example of how patents can help in the financing process: The 
Swiss start -up Oxara20 has developed a cement -free admixture -technology that converts waste into 
cement -free concrete and non -fired bricks. Compar ed to conventional concrete, the production of 
so-called "Cleancrete " or "Cleanbrick " (both are registered trademarks of Oxara) leads to 
significantly lower CO2 emissions. For the future, Oxara plans to expand its portfolio with new 
products and patents. O xara has won several grants and awards for its patented technologies. 
According to Oxara, its patent portfolio and IP strategy has been key to attract financing from 
investors, enabling Oxara to take off fast, hopefully into a promising future.  
459.  In order to  encourage the use of IP for financing purposes, it can be helpful to support start -ups 
and MSMEs in establishing an IP strategy. One such support in Switzerland is through coaching 
programs in which start -ups receive expert advice, for example, in relatio n to setting up their own 
IP management. The Innosuisse Start -Up Coaching program21 offers packages for high -tech 
start-ups where they get advice from fellow entrepreneurs and coaches that are experts in relevant 
business areas like finance, commercial law  and, not least, of course, IP.  
460.  Before concluding, I would like to draw delegations ' attention to a high -level conversation 
organized by WIPO entitled "Unlocking Intangible Asset Finance ". This conversation will take place 
in three weeks ' time, on 1 of November. The event will highlight the potential of intangible assets 
for financing to a wider audience from both the public and private sector.  
461.  As for today, my delegation is looking forward to a fruitful exchange among Members. We 
encoura ge others to share experiences they have made with IP financing, challenges encountered, 
lessons they have learned and to pose questions they may have.  
14.2  Japan  
462.  Thank you, Mr Chair and colleagues , for giving us the opportunity to share our experiences 
and national policies regarding this agenda item. First of all, the delegation of Japan would like to 
thank the Swiss delegation for introducing our concept paper. Also, we have prepared co pies of 
today 's presentation22 materials at the entrance please feel free to pick them if you like. As today 's 
theme suggests, we consider IP financing as critically important for start -ups. Today, we would like 
to introduce Japan 's initiatives on IP finan cing. 
463.  The term "IP financing " usually refers to methods or techniques, such as attaching security 
interest in IP or collecting royalties under license agreements on IP rights, which take advantage of 
the value of IP rights themselves in the hopes of moneti zing them. In Japan, however, those 
techniques have not become the mainstream in financing IP. One of the major reasons for this 
situation is that lenders, including banks, hesitate to make loans using IP rights as collateral, since 
traditional asset evalu ation methods that emphasize tangible assets have taken deep root in banks 
- who consequently tend to find less value in intangible assets than they actually are worth.  
464.  Many start -ups in Japan obtain the needed funds through loan financing from banks. 
Difficulties in collateralizing IP rights could bring hurdles for start -ups that do not have substantial 
 
19 See WIPO and IPI (2022 – to be published).  
20 https://oxara.ch/technology/  
21 https://www.innosuisse.ch/inno/en/home/support -for-start-ups/startup -coaching.html   
22 Circulated as d cument RD/IP/50  IP/C/M/106/Add.1  
 
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  tangible assets - particularly IT start -ups - in terms of obtaining smooth funding. Under such 
circumstances, the Japanese government has shifted its strat egy on IP financing from simply 
measuring the value of the IP rights alone, to evaluating what additional value such IP rights bring 
to the business: in other words, evaluating the IP rights in combination with the entire business.  
465.  Given that start -ups do not always have substantial tangible assets, we hope that this 
presentation will be useful for other Members - especially where IP rights have not been sufficiently 
utilized as financial assets, due to the difficulties in evaluating intangible assets.  
466.  The Japanese Government 's initiatives on IP financing consist of two pillars. The first is that of 
the efforts to ensure proper evaluation of companies ' business value by investors and companies 
themselves. These efforts include the revision of Japan 's Corpora te Governance Code in 2021, which 
required businesses to disclose information on IP investment strategies.  
467.  The second pillar consists of efforts to introduce a securitization system that allows the entire 
business value of a company, including IP, to be co llateralized. We will not mention this today, but 
the overview is shown in the last page. This is also an initiative based on the idea of understanding 
the value of IP rights as part of the value of the entire business. Please feel free to contact us for 
further information in this regard.  
468.  Today, I would like to introduce the Japan Patent Office 's initiatives, which are part of the first 
pillar, in terms of facilitating the proper evaluation of corporate value by investors and companies. 
Many banks in Japan  have conducted business feasibility assessments. The purpose is not limited to 
financing, but also includes aspects of business and management support for companies.  
469.  The Japan Patent Office 's primary initiative, "IP Financing Business ", helps banks to pro perly 
assess the business value and the feasibility of their client companies by offering the perspective of 
the IP side, so that banks understand the actual financial state of their clients. Incorporating an 
evaluation from the perspective of IP will enab le both investors and companies to understand a 
company 's genuine business value and its strengths - thereby promoting the utilization of IP. This 
will especially help start -ups that do not have many tangible assets, but do have technological 
strengths, in  terms of achieving smooth financing and expediting their growth.  
470.  Proper value assessment can indicate a company 's room for growth in terms of new businesses 
or new markets, for example, where financing will ultimately be necessary to realize such potentia l. 
In other words, the idea is that banks actively create their own financing opportunities. Most of the 
financing results in Japan have been indirectly linked to such financing. There is one barrier to 
including a technological perspective such as IP, esp ecially patents, in a bank 's business feasibility 
assessment.  Generally, banks are good at understanding a company 's value or status based on 
financial information  - but they may not necessarily have such an understanding of its technological 
capabilities.  In fact, there are very few technical personnel in Japan 's banks.  
471.  In order for banks to provide effective business and management support to client companies, 
it is essential that they understand their clients ' technological capabilities which serve as th e source 
of sales, including IP.  In Japan, small and medium -sized enterprises (SMEs), including most 
start-ups, account for more than 99% of all businesses. There are many manufacturing companies 
with excellent technological capabilities, but at the same t ime, many among them have not fully 
made use of their skills in terms of calling for further investments.  It is necessary for banks to have 
a proper understanding of the excellent technological capabilities of manufacturing companies.  
472.  Based on this backgro und, the IP Financing Business initiative put the focus on SMEs. Under 
this initiative, the Japan Patent Office provides IP business assessment reports and IP business 
proposals for banks and their client SMEs.  These reports provide business feasibility ev aluations 
from a technical perspective. This is done in order to complement the evaluation methods used by 
banks that have difficulty in understanding corporate IP activities, such as technology and 
know -how. It is expected that these reports and existing evaluation methods will complement each 
other, so that stakeholders can understand and evaluate corporate activities more accurately.  
473.  IP Business Assessment Reports cover target companies that assess the relationship between 
that company 's entire business and its IP, such as technology and brand power, which are the 
sources of SME management power. This report is prepared by a research company and experts, IP/C/M/106/Add.1  
 
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  such as patent attorneys and management consultants, who can appraise technical and brand 
power. IP Business Assessment reports are crafted in order to help banks properly understand the 
content and value of IP.  The IP Business Proposal is a report on a target company. In addition to IP 
Business Assessment Reports, such proposals analyse  the business issues and growth potential of 
that company, while also proposing recommended actions for the SME.  Such recommended actions 
usually must be accompanied by management and financial support from the lender.  
474.  Next, I would like to introduce an exa mple, in the form of an actual case study, to show how 
the IP Business Assessment Report can actually be utilized.  There was an SME that was considering 
starting a new business using its technological capabilities.  Its bank knew that the company was 
seekin g to develop a new business but  did not fully understand the relationship between the 
strengths of the company 's technology and its business. Therefore, the bank asked for an IP Business 
Assessment Report.  
475.  The report from the Japan Patent Office revealed t he relevance of the company 's strengths 
and its business. In addition, through interviews conducted by experts with companies in the same 
industry, the report made it clear that although the basic technology was being established, there 
was still no prospe ct of commercialization.  Therefore, the bank proposed that the company proceed 
with joint development through industry -academia collaboration with the research institution that 
the company was collaborating with for some time.  
476.  As a result of the joint deve lopment proposed by the bank, the company was able to complete 
the new product and successfully launch a new business. During this period, financial institutions 
also provided financing for joint development.  In this case the IP business assessment report played 
a key role in promoting financial institutions understanding other companies ' business with the intent 
a proposal industry -academia collaboration and further support through financing.  
477.  The IP Financing Business initiative has been conducted since 20 14, and the results are shown 
on the slide.  There are 216 financial institutions that have utilized the IP Business Assessment Report 
at least once during the 8 years from 2014 to 2021. Since there are approximately 500 regional 
financial institutions in J apan, this means that about 40% of regional financial institutions have used 
the IP Financing Business initiative.  A total of 2,188 people attended IP Financing Business seminars 
and symposiums. In the past few years, we have not been able to hold large -scale events due to 
the COVID -19 pandemic —but such meetings are planned to be held this year.  
478.  The IP Business Assessment Reports have led to financing 88 institutions in 189 cases, totalling  
approximately YEN 9.32 billion. To avoid confusion, this amount doe s not include direct IP financing.  
Although this number of cases is not considerable, we believe that the positive effect for SMEs 
including start -ups were greater than mere monetary figures, since in most cases, financing for the 
companies was provided in  combination with management support from financial institutions.  This 
brings me to the end of this presentation. We hope that today 's introduction will be useful to other 
Members. In addition, the delegation of Japan is looking forward to other Members sh aring their own 
experiences.  
14.3  United States of America  
479.  The United States of America extends our thanks to the Friends of IP and Innovation and to 
Switzerland for the discussion pa per on IP financing and start -ups. I would also like to thank 
everyone who came to the side event yesterday. We had some excellent panel speakers who 
provided different perspectives on IP and financing. It was fascinating to hear from a start -up who 
could provide a first -hand account from small business perspective. Thanks to everyone for your 
great questions during that event.  
480.  New businesses in the United States rely on external debt (including trade credit and bank 
loans) for more than 60% of their initia l funding. The leading sources of start -up equity investment 
are self -financing, friends and family, angel investors, and venture capital.23 
481.  While venture capital is the dominant source of start -up investment, only about one third of 
venture capital invest ment goes to seed and early -stage ventures. In addition to federal programs, 
 
23 SEC.gov | What are the differences in friends and family, angel investors, and venture capital funds?  IP/C/M/106/Add.1  
 
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  state governments also provide significant support to start -ups, with state -level funds that can 
exceed USD 1 billion supporting a variety of grants, loans, and other forms of fin ancing.  
482.  There is very limited data on the use of IP financing and a lack of research in this area. 
However, venture capital is the largest source of start -up financing and is highly responsive to 
start-ups' patent holdings. Surveys of high -technology entre preneurs suggest that less than 40% of 
start-ups hold any patents, but over 80% of venture -backed firms hold at least one patent.24 
483.  IP valuation is a service provided by accounting firms and other smaller boutique firms in the 
private sector. They pitch these services to both IP holders (including start -ups) and to potential 
investors. They also pitch these services to entities involved in litigation surrounding IP.  Education 
of start -ups and investors  and banks about IP financing opportunities take s a variety of forms in the 
United States  of America . There are many varieties of decentralized programs organized and run by 
educational institutions, technology transfer organizations and associations, the US Federal 
Government, and private sector firms. The USPTO 's hub for start -up resources can help address the 
IP challenges specific to start -ups, including securing funding.25 
484.  In addition, the US Small Business Administration (SBA)  works with innovative small 
businesses and start -ups to empower th em to succeed with access to capital, valuable resources, 
business know -how, and the right expertise for each stage of their business lifecycle.  As part of its 
counselling resources, SBA educates small businesses on the importance of and steps to take to 
protect their intellectual property both in the United States and globally.  SBA also works to support 
small businesses through a variety of access to capital programs. Small businesses can explore 
microloans and bank financing, such as loans backed by the U S Small Business Administration.26 In 
addition, it provides education on other funding for small businesses including venture capital and 
crowdfunding.  
485.  Recognizing that we can always do better to support our innovative small businesses and 
start-ups, the Small Business Administration  recently created two new advisory committees – the 
Invention, Innovation, and Entrepreneurship Advisory Committee (IIEAC) and the Investment 
Capital Advisory Committee (ICAC) – to accelerate support for start -ups driving critic al innovation 
across the US and increase small businesses ' access to capital .27 
486.  A challenge is to expand participation in IP, particularly among start -ups. IP holdings provide 
benefits such as adding credibility to start -up business plans that facilitate a ccess to financing; 
however, a relatively small fraction of start -ups hold IP, particularly patents.  Another challenge is to 
monetize IP once obtained. Beyond the classic model in which a start -up becomes a fully integrated 
firm that invents, develops, and  sells products and services, other avenues to obtain financing from 
IP such as selling or licensing the IP are understudied and underdeveloped.  
487.  Increasing knowledge and awareness about start -ups and financing opportunities could be 
helpful, as could furth er research into the needs of start -ups when it comes to IP financing and 
awareness.  Becoming familiar with its own IP assets may be a critical step for start -up seeking to 
use IP -backed finance.28 To that end, one resource is a joint tool called The IP Aw areness 
Assessment, developed under the joint efforts of United States Patent and Trademark Office (USPTO) 
and National Institute of Standards and Technology  which  provides the user an assessment of IP 
awareness, which may be a starting point for an indivi dual or business trying to assess its IP assets.  
The USPTO also notes on its website the comprehensive information provided by WIPO on IP 
valuation and IP -backed financing.  
 
24 Graham, S. J., Merges, R. P., Samuelson, P., & Sichelman, T. (20 09). High technology entrepreneurs 
and the patent system: Results of the 2008 Berkeley patent survey. Berkeley Technology Law Journal, 1255 -
1327. https://www.jstor.org/stable/24120583   
25 https://www.uspto.gov/learning -and-resources/startup -resources   
26 https://www.sba.gov/busi ness-guide/plan -your-business/fund -your-business   
27 https://www.sba.gov/article/2022/jul/29/sba -admini strator -guzman -announces -two-federal -advisory -
committees -accelerate -american -innovation   
28 https://ipassessment.uspto.gov/start.html   IP/C/M/106/Add.1  
 
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  14.4  Australia  
488.  Australia welcomes communication IP/C/W/692  and is pleased to co -sponsor the paper with 
the friends of IP and innovation. We support the sharing of information on the role IP can play in 
raising finance for start -ups. This communication provides a useful overview of the many different 
ways IP can be u sed to help start -ups access much -needed capital. It highlights key institutional 
considerations that can facilitate (or, if they are absent, prevent) the development of a 
well-functioning  financial IP market.  
489.  As an innovative economy, Australia recognises the important role that start -ups play as 
catalysts for growth and acknowledge the challenges that start -ups face in accessing finance, 
particularly in the early stages. Start-ups in Australia face some of the  specific challenges in 
accessing financing that are identified in communication IP/C/W/692 . 
490.  A 2016 report into IP financing in Australia commissioned by Australia 's IP office (IP Australia) 
found that there were no specific innovation -based or IP -based financing products available in 
Austra lia at the time. In Australia, start -ups often require funding from multiple sources – funding 
rarely occurs as a single -lump sum. We have found that equity investment is an important vehicle 
for financing new and innovative high -risk ventures. This can oc cur either through professional 
venture capital firms or 'business angels ' which have niche interests.  
491.  Australia has several policies and program mes to support the commercialisation of innovation 
and technology. Australia has a dedicated debt venture fund which aims to grow companies 
commercialising technological innovation. The Government also encourages venture capital 
investment and angel investment in early -stage companies through tax incentives for investors  
492.  The National Reconstruction Fund (NRF) is a $AUD15 billion investment to diversify and 
transform Australia 's industry and economy and includes support to make it easier to commercialise 
innovation and technology by providing loans, guarantees and equities to drive investments and 
develop capability in the area.  
493.  We look forward to further exchanges with Members on their experiences of IP financing for 
start-ups in particular, on the different sources of financing for start -ups seeking to commercialise 
their innovation;  and ways we can help both start -ups and venture capital to better understand the 
opportunities IP offers as part of a business ' business plan and as collateral for accessing finance.  
14.5  Canada  
494.  Canada would like t o thank Switzerland for drafting the communication for this item as well as 
other Members that are sharing their views and information on this topic today. Canada sees clear 
connections between the development and protection of IPRs by MSMEs and the abilit y to secure 
investment and financing, enhance their growth, facilitate additional innovation, and expand further 
into domestic and international markets. Canada has also identified some opportunities to facilitate 
the capacity of businesses in this area, p articularly MSMEs, and will present on several related 
initiatives today.  
495.  As noted at a past meeting of the TRIPS Council, as part of its IP Awareness and Education 
program, the Canadian Intellectual Property Office has launched an online IP Academy, featu ring a 
suite of information materials and interactive learning resources for businesses and entrepreneurs. 
The IP Academy includes a recently -developed "massive open online course " developed by the 
Canada -based Centre for International Governance Innovatio n on "Foundations of IP Strategy " that 
offers particular value for MSMEs. The IP Academy also includes an online self -assessment IP 
strategy tool for MSMEs which generates a tailored guide with information on what to consider when 
developing their IP strat egies.  
496.  One of many areas covered by this resource is IP -based financing, an area of growing 
importance and potential for innovative companies. As noted in the tool, IP -based financing 
strategies include IP -backed loans, IP royalty securitization, which inv olves the pooling and selling 
of future IP -related income streams in exchange for immediate financing, and IP sale and license -
back arrangements which can involve the sale of IP assets in exchange for immediate financing, 
while retaining the option of usin g the IP assets through a license -back arrangement and potential IP/C/M/106/Add.1  
 
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  option of to buy back the ownership of the IP assets at a fixed price at the end of the license period. 
The IP Academy materials are available online should any other Member wish to consult t hem, share 
with their own stakeholders, or have questions or feedback to share with Canada.  
497.  Additionally, in 2020 the Business Development Bank of Canada, that is to say a federal 
government corporation that supports Canadian businesses through financing  advisory services and 
capital with focus on SMEs launched an IP -backed financing program me for businesses - the first of 
its kind in Canada to provide capital to high -potential companies in knowledge -based industries, 
particularly those who have monetized t heir IP portfolios through product commercialization or 
licensing arrangements, or both. If other Members with similar program mes – or with an interest in 
pursuing similar program mes – have an interest in further discussions with Canada on this 
program me, we would be pleased to follow up and arrange conversations involving our respective 
authorities in this area, in the spirit of continuing to leverage the TRIPS Council as a venue for 
collective policy exchange and learning.  
14.6  Chinese Taipei  
498.  First, t he Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  would like to 
thank the United States of America, Japan and the Swiss for organizing the side event yesterday, 
the discussion was very informative and also shows how IP and finance could assist start -ups and 
SMEs. Returning to today 's agenda item we  would  like to thank Switzerland for preparing the paper. 
We are happy to co -sponsor the paper. According to the Global Competitiveness Report 2019 
compiled by the World Economic Forum, our jurisdiction ranked 4 th in the world in terms of 
innovation capability. While the innovative energy of start -ups is undoubtedly the driving force 
behind a nation 's economic prosperity, start -ups are often faced with a shortage of capital. 
Technology innovation requires long -term capital investment; therefore, our government is  working 
to assist start -ups in utilizing their intellectual property rights to obtain funds and address their 
capital needs at different stages of business operations.  
499.  The main factors that hinder the development of our IP financing market are the lack of  a 
vibrant IP trading market and a credible authority that can undertake the valuation and disposition 
of IP assets for banks. In order to help start -ups secure financing with their IP assets, the Industrial 
Development Bureau of the Ministry of Economic A ffairs has been actively promoting the registration 
and management of intangible asset appraisers and institutions, as well as facilitating intangible 
asset financing.  
500.  The government facilitated a tripartite cooperation between 26 financial institutions, S mall and 
Medium Enterprise Credit Guarantee Fund, and Industrial Technology Research Institute in 2019 to 
increase the guarantee coverage of credit guarantee funds so as to lower financial risks that impact 
financial institutions, which has so far led to m any successful cases of intangible asset financing, 
covering key industries such as biotechnology, medicine, green energy, smart machinery, and 
information technology.  
501.  Ways to effectively assist start -ups in obtaining funds through IP financing to maintain 
business operations and continuous R&D are matters that we must give thought to. We welcome 
Members to share their measures and experiences related to said matter s. 
14.7  Singapore  
502.  Singapore thanks the friends of IP and innovation and  Switzerland for preparing the discussion 
paper which has been insightful for us. Singapore supports the development of a healthy IP  licensing 
ecosystem. When conducted well, IP licensing is a powerful tool to unlock the value of innovation. 
Singapore 's business environment enables innovative enterprises to seek and secure equity 
investment from angel investors and venture capital firm s. In 2019, venture investments rose to 
more than USD 9.8  billion, representing a year -on-year increase of 36%.  
503.  The Intellectual Property Office of Singapore International recently launched a new "IP Start " 
programme for accelerators and early -stage start -ups in September this year. This programme will 
provide free IP advice, training, and resources to start -ups through start -up accelerators and 
incubators based in Singapore, and to support the integration of IP management into the early 
stages of their bus iness.  IP/C/M/106/Add.1  
 
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  504.  This programme will also complement existing efforts by IPOS to overcome the key challenge 
of the lack of IP awareness among start -ups and MSMEs. As shared in previous sessions, IPOS has 
worked with the Singapore Business Federation to provide suppo rt to companies in improving their 
IP literacy and management. IP clinics were also offered to help businesses understand how to 
protect their IP portfolio through the development of an IP strategy. In closing, IP financing for 
start-ups is an often -overlo oked area of work and we are happy that this is being discussed at the 
WTO. We look forward to hearing from other Members experiences.  
14.8  European Union  
505.  The E uropean Union  is pleased to co -sponsor this agenda item together with the other 
delegation s. We thank Switzerland,  in particular,  for the  concept paper which was  high quality and 
for its active role in the drafting of th is document with the other delegations . We also thank , as 
usual,  the U nited States for their full involvement in the coordination of the group and the 
organization also of the side event yesterday.  
506.  Intellectual property rights (IPRs) play an increasingly important role in corporate strategy 
and the intangible ass ets created through innovation represent a major share of the value of today 's 
businesses. The IPRs associated with intangible assets are the legal guarantee for potential returns 
on investment in innovation and a means to get funding, notably in start -ups and early-stage  
companies. The use of IPRs to gain finance is considered an important aspect given that SMEs and 
start-ups encounter difficulties in raising funds from bank loans due to the risks involved, while 
venture capitals ask for a large equity int erest.  
507.  According to certain surveys that we monitor in the European Union the EUIPO SME scoreboard 
2019,  and the most recent one in 2022,  only 13% of SMEs owning IP rights tried to use intangible 
assets to obtain finance: 9% successfully and 4% unsuccessfu lly. Additionally, only 25% of SMEs  
IPR owners have professionally valued their intangible assets, and this drops to 20% for small and 
micro -sized IPR owners.  
508.  According to the  most recent study  2022 Intellectual Property SME Scoreboard, 15 % of SME 
owners o f registered IP rights reported that they had suffered from infringement of an IP right that 
they own . In light of these figures , I have already mentioned this year,  and in light of the information, 
the E uropean Union has developed programmes supporting yo ung entrepreneurs coming from the 
universities favouring the financing of the SMEs or innovative start-ups, most of the time these 
start-ups are created by PhD students.  
509.  The main programme, for PhD student in Europe or elsewhere, there is no discrimination , is 
the Marie Curie Actions. The newest programme , Marie Skłodowska, it is her name, (MSCA Doctoral 
Networks 2022 deadline next 15 November 2022) implements doctoral programmes, creating 
partnerships between universities, research institutions and researc h infrastructures, businesses 
including start-ups of course , and other socio -economic actors from different countries across Europe 
and beyond.  
510.  This action offers training in research -related domains, as well as transferable skills and 
competences relevant  for innovation and long -term employability such as IPR but also 
entrepreneurship, commercialisation of results, communication. Through industrial doctorates, 
doctoral candidates may step outside academia and develop skills in industry and business by bein g 
jointly supervised by academic and non -academic organisations, both of which can be established 
in the same EU Member State or Horizon Europe Associated Country.  
511.  A start -up can also receive support of a technology transfer office in the university. Such  offices 
accompany start -ups and provide the necessary initial guidance and resources, including designing 
the intellectual property strategy and providing help for IP registration. The technology transfer 
offices are organized at EU level within the Europ ean TTO circle | JRC Science Hub Communities , it 
is really easy to find on the net . 
512.  A PhD student with a good business idea would be eligible to apply for Erasmus for Young 
Entrepreneurs. This is a cross -border exchange programme which gives new or aspirin g 
entrepreneurs the chance to learn from experienced entrepreneurs running small businesses in other 
participating countries. The exchange of experience takes place during a stay with the experienced IP/C/M/106/Add.1  
 
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  entrepreneur, which helps the new entrepreneur acquire t he skills needed to run a small firm, in 
particular as regards the IP strategy. The host benefits from fresh perspectives on his/her business 
and gets the opportunities to cooperate with foreign partners or learn about new markets.  
513.  Furthermore, both the E uropean Union and its Member States have a number of general 
programmes to support access to finance, in particular for micro, small and medium companies. 
Under the Single Digital Gateway, such young entrepreneurs can find a number of access to finance 
programmes: Acce ss to finance /Your Europe.  
514.  As regards the EU, the Commission launched in November 2020 the Intellectual Property 
Action Plan to support the EU 's recovery and resilience. The IP Action Plan identified a number of 
priorities, among which one was to promote a n effective use and deployment of IP, in particular by 
SMEs and start-ups. To achieve this priority, the Commission committed to offer financial support 
for SMEs impacted by the COVID -19 crisis, helping them to manage their IP portfolios as well as 
helping  them move towards green and digital technologies  which are our priorities in the European 
Union.  
515.  In the framework of this general Action Plan, the Commission and the EUIPO launched the new 
EU SME Fund on Intellectual Property in 2022, which offers intelle ctual property vouchers for 
EU-based SMEs for post -COVID -19 recovery and green and digital transitions for the next three 
years (2022 -2024). The new EU SME Fund, with its budget of EUR 47 million, offers a great variety 
of services: partial reimbursements of various national fees or costs  for instance. Start-ups need a 
flexible IP toolbox and quick financing to protect their innovations. Hence, for the first time the new 
EU SME fund is now also covering patents. The European Commission 's financial contribut ion, which 
can amount up to EUR 2 million, will be dedicated fully to the patent related services.  
516.  This action , the EU SME Fund , is implemented by the EUIPO through calls for proposals. The 
applications are examined and evaluated based on a first in first out criterion. SMEs with no 
experience in the area of intellectual property are encouraged to apply first for an IP Scan service 
and only subsequently to the other services. The IP Scan service will provide a broad assessment of 
the IP needs of the applica nt SME, taking into account the innovative potential of its intangible 
assets.  
14.9  United Kingdom  
517.  The United Kingdom would like to thank Switzerland for their interesting and informative paper  
on IP financing for start -ups. We also thank Members for helpful information shared so far. The 
United Kingdom  believes that businesses ' ability to access the right type of finance at each stage of 
development is critical to allowing innovators to develop  their ideas and enabling businesses to grow.  
518.  Innovation is a key driver of economic growth, and finances affect every stage of the 
innovation cycle: from idea creation to commercialisation, expansion, and long -term business 
sustainability. Businesses ' innovation finance journeys typically involve progression from the 
founder 's own resources, grant funding, seed equity and later venture, institutional capital, and 
ultimately debt finance.  
519.  However, IP -rich companies with substantial intangible assets can fin d it difficult to secure 
debt finance. A key challenge for innovative businesses is the financial services sector 's 
understanding of the role that IP plays in generating cashflow. To address this challenge, since 2018 
the UK has been working and engaging w ith banks, lenders, investors, accountants, and insurers 
to: 
a. Explore the challenges faced by the financial sector and businesses in using IP as  a 
collateral for lending ; 
b. Explore the barriers financial institutions face in recognising IP as an asset, and ho w 
businesses can use their IP as leverage to access finance.  
520.  We also want innovative, IP intensive businesses to understand how to use their IP to gain 
access to funding.  IP/C/M/106/Add.1  
 
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  521.  To improve awareness amongst start -up businesses of how IP can be used to unlock access 
to finance, the UK offers a range of resources to help new businesses understand and identify their 
IP and incorporate it into their business planning. For example, the  'IP for Investment ' digital toolkit 
was developed to prepare IP -rich businesses looking for equity finance to grow. The toolkit helps 
them to identify and assess their IP assets as part of their overall business strategy and provides 
guidance on their inv estor readiness.  
522.  The UK also offers a range of other digital resources to help businesses with managing, using 
and commercialising their IP. This includes the IP health check diagnostic tool kit for businesses to 
undertake an initial audit of their IP asse ts to identify how to maximise their value, and the Business 
Lifecycle Framework, which provides information aimed at pre -start-up and start -up businesses, 
such as how IP assets can be used for seeking finance. As a part of our commitment to improving 
understanding of IP, the UK is developing a specialist module on IP valuation as part of its IP 
awareness and education work. This will set out some of the key methods for IP valuation, sitting 
alongside a broader package of education resources on topics such as IP management, IP 
commercialisation, and IP in contracts, to improve understanding of the value of IP assets.  
523.  The U nited Kingdom  has also worked with regional business services on IP and access to 
finance, as well as working with financial institutions directly. For example, by including IP within 
regional programmes aimed at supporting early -stage SMEs acquiring equity finance and working 
with finance providers to ensure they direct businesses to relevant IP information and support.  
524.  Financial support is  also available to SMEs to help them to better manage, protect and 
commercialise their IP. The IP Audit scheme provides eligible, innovative high -growth potential 
businesses with funding towards an audit carried out by an IP professional. This in -depth ana lysis of 
the business 's IP helps new businesses to identify how they can make their IP work for them as they 
grow, so they can unlock the value of their IP. Funding is also available to businesses to implement 
the recommendations in their audit report - such as engaging professional services to support IP 
management and commercialisation, including IP insurance and valuation of IP. I hope this 
information has illustrated how the U nited Kingdom  sees IP as a way of unlocking finance for 
start-ups, and our commitment to ensuring that it can be fully used by such businesses.  
14.10   Chile  
525.  Firstly, our delegation would like to thank the co -sponsors for placing this interesting matter 
on this Council 's agenda. Our delegation considers that access to financing through intellectual 
property is crucial for SMEs. Many of the innovators taking their first steps do not have the financial 
track record or collateral needed to access financing via the traditional  routes. This is precisely the 
reason why intellectual property assets can represent a powerful tool available to innovators who 
are seeking to take the next step in their projects.  
526.  Chile has been establishing itself as a business hub for start -ups through  a drive by the State 
and collaboration with the private sector. These projects use a variety of sources to access financing. 
In terms of grants, we would like to highlight the existence of seed capital programmes and the 
"Start-up Chile " accelerator. Inno vators may also access services and capital provided by incubators 
in the earliest stages of their projects ' development. In both initiatives, the provision of grants and 
the incubators, the public sector plays a fundamental role in creating connections an d enabling 
innovative projects to become a reality.  
527.  Accelerators are also increasingly present in later stages of the project, with recent years 
seeing the entry of new actors, which has led to the diversification of the offer in this area. Venture 
capital  and angel investors may also be accessed. In this connection, some actors have decided to 
focus their investment on projects that are particularly strong in terms of intellectual property assets. 
This may be the case in the creative industries sector or f or those products associated with 
commercial patents and/or trademarks that are strong or have potential.  
528.  Nevertheless, the valuation of intellectual property assets remains a significant challenge. The 
difficulties associated with this process mean that t here is still potential that has not yet been fully 
exploited in terms of access to financing, whether it involves using these assets as collateral or other 
alternatives that take initiatives to the next level.  Our delegation considers that it is highly im portant 
to identify potential shared challenges in this area.  IP/C/M/106/Add.1  
 
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  14.11   Hong Kong, China  
529.  We would like to put on record our appreciation to the co -sponsors for the submission as well 
as for organi sing the side event yesterday. Yesterday, we indeed had a lively debate where we 
explored the difficulties faced by start -ups in securing capital due to the lack of hard assets, as well 
as what governments and international organisations could do to promot e IP-backed finance. For 
example, raising IP awareness among start -ups and financial institutions, standardisation of IP 
valuation, review of financial reporting on intangible assets, as well as information sharing. Today, 
we continued to listen with great  interest the different experiences and best practices around the 
world. We will reflect on these and see how we can create a sustainable ecosystem in 
Hong Kong, China  to promote IP financing.  
14.12   Uruguay  
530.  First of all, we welcome the drafting and submission of document IP/C/W/692 , which was 
drawn up by Switzerland and endorsed by a number of other Members that are very active in this 
area. My Ambassador, as Coordinator of the Informal Working Group on MSMEs, had the honour 
and pleasure of presenting the issue of start -up financing based on intellectual property asset 
capitalization, from the public policy standpoint, at yesterday 's lunchtime event moderated by the 
United States. There, we were joined by WIPO and an innovative en terprise from the food sector, 
both of which shared their views regarding technical aspects and the real challenges on the ground.  
531.  After attending yesterday 's event and hearing about some Members ' experiences, it is clear 
that the developing world still ha s a long way to go until the financial system recognizes intellectual 
property assets in a way that is effective from the point of view of risk and potential market gains. 
While some financial institutions are clearly already pioneers in this area, the vas t majority continue 
to operate in a traditional and conservative manner. This is where States need to make an additional 
effort to ensure dialogue between MSMEs and entities with capital available for investment, and to 
perhaps amend domestic regulations a t the central bank level. In this regard, we have found that 
financial regulations promote conservatism when it comes to providing high -risk capital, and this is 
detrimental in situations where an entrepreneur submits a business plan that is based, in many  
cases, on a patent, an industrial design or a trademark. The regulatory machinery should be used 
to ensure that central banks have the assurance they need that credit providers can conduct business 
safely, but without this stifling innovation or the possi bility of financing projects that on the surface 
appear high -stakes.  
532.  In Uruguay, the National Innovation and Research Agency finances and supports business 
projects from their inception and the development of business plans. It provides financing and helps  
businesses to find other sources of capital in the public and private sectors. It is our understanding 
that public policies should provide the initial impetus to encourage central banks, financial 
institutions and, above all, entrepreneurs, so that this i ssue is not a taboo.  
533.  We suggest that this item remain on the Council 's agenda on a permanent basis, so that the 
issue can continue to inspire Members. We also suggest that this issue continue to be discussed in 
the Informal Working Group on MSMEs. Lastly, we invite everyone to participate in the event to be 
held by WIPO on 1 November, which has already been mentioned by my Swiss colleagues.  
14.13   Mexico  
534.  Mexico would like to thank the Friends of Intellect ual Property and Innovation for including 
this item on the agenda, for the document IP/C/W/692 , for yesterday 's event and for their very 
interesting presentations. Mexico recognizes and concurs on the importance of protecting intellectual 
property rights as a key element in enabling start -ups to obtain financing. At present, Mexico does 
not have any similar government programmes owing to a lack of resources and because, outside of 
intellectual property related departments, there is a lack of awareness of the benefits that protecting 
intellect ual property rights can bring to the wider economy.  
535.  However, the Mexican Institute of Intellectual Property (IMPI) provides advice to the general 
public, on a personal and individual basis. Appointments can be requested on the Institute 's web 
page. Moreover, the IMPI carries out campaigns to encourage companies to protect their intellectual 
property rights through tariff reductions, up to 90% for micro -, small - and medium sized enterprises.  IP/C/M/106/Add.1  
 
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  14.14   Uruguay  
536.  In that sense we understand that this agenda item has been proven to be very fruitful and it 
has engaged a lot of Members the side event and the level of attendance that the organizer had it 
was very interesting indeed and it is a dynamic issue t hat help us to apply IP policies on the field in 
our cases. So, it would be our understanding that there is some appetite for this kind of discussions, 
regularly, in this Council and we would like to suggest that we can have this agenda item 
permanently in  our agenda, sometimes with a wider scope sometimes with a more discrete approach 
but the idea of linking IP policy and MS MEs I think that it is very useful for our daily work in this 
Organization.  
14.15   Switzerland  
537.  We would certainly agree in fact that I think we have seen in this Council and in past Council 
meetings under this ad hoc agenda item IP and Innovation much interest by Members and we had 
very rich and useful discussions. I think it does cover a potentially very broad policy area and I think 
useful information and sharing exercise can be very useful so my delegation would cer tainly agree 
to having an agenda item IP and Innovation permanently on the agend a. Let me take this 
opportunity also to thank all those delegations in fact which have today taken the floor and share d 
their experience . I think we had a very useful discussio n and it demonstrated that IP is in fact not a 
means in itself , but in fact a means to an end and an important end – I would say – particularly from 
the prospective of start -ups and MSMEs.  
14.16   South Africa  
538.  We thank the co -sponsor of document IP/C/W/692  for the submission. Our delegation has 
consulted with stakeholders about this submission. The feedback we received is as follows:  
539.  It is important to interrogate the factual scenario in order to provide a realistic reflection of 
what is to follow. Therefore, the following 8 comments are submitted from a South African 
perspective:  
a. Imagine that a young PhD student at a technical faculty of a renowned university comes 
up with a promising invention. Comment as follow - if that is the ca se the university 's 
intellectual property policy would apply and the university rather than the student, 
would be the owner of both invention and resulting intellectual property, she would 
merely be named as inventor and have a share of the profits  
b. Comment  two: thanks to university modules she attended on how to deal with 
intellectual property (IP), she applies for and is granted a patent for her invention. 
Comment to the follows: the university 's technology transfer office would do the 
application. She wou ld never be the one applying. Only a patent attorney can file a final 
patent specification.  
c. Comment three: now, together with the university technology transfer office, she would 
like to bring the invention to market. The comment to the follows: again, quite 
simplistic, the technology transfer office  would do this probably through a spin -off 
company.  
d. Comment four: w hen writing a business plan, she soon realises that the funds she needs 
greatly exceed her family 's and her university 's financial capacity . The comment to the 
follows: a technical university w ould have access to the necessary funds and if not, 
some state entity would assist - in South Africa the technology innovation agency  would 
assist – one example is the D urban University of Technology  which has a University 
Technology Fund which would fund this scenario}.  
e. Comment five: w here can she find funding ? The comment to the follows: the question 
should be , where would the university find such f unding ? That would be the real 
question . IP/C/M/106/Add.1  
 
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  f. Comment six: v arious studies show that young companies that have an active and a 
well-managed IP portfolio to show to potential investors to obtain more funds and grow 
faster than those without.  The comment to the follows: how has she morphed into a 
young company? Again , the applicant would be the university or its spin -off. 
g. Comment seven: s o, if the PhD student from our example seeks IP protection for her 
invention, she will stand a much better chance of finding the necessary funds to turn 
her idea into a business.  The com ment is she would not own the IP.  
h. Comment eight: i n addition to protecting intellectual assets from free riders, intellectual 
property  rights are a potentially useful means of raising money, especially for start -ups. 
In the above example, IP is used as a signal to investors that there is considerable 
substance in the young company. Furthermore, IP can be used as leverage or collateral 
for borrowing, or for sale to prospective buyers through sale -leaseback transactions.  
The comment to the follows: i n theory, it would be good if a start -up could protect its 
inventions/creations with IP. This indeed would give them the opportunity to raise 
funds, set collaborations etc. In our context, the financial services sector is very risk 
averse and as a result, use of IP as security is very uncommon, particularly in relation 
to MSMEs).  Furthermore, it would be good to investigate, whether IP protection  (of 
larger companies) can actually prevent start -ups from exploiting their inventions. In 
some industries , such as complex technologies, the number of patents is so high that it 
is very difficult to get through patent thickets of thousands of patents for a small 
start-up (e.g., mobile industry). To actually get something to the market, a company 
would need to have a portfolio of hundreds of patents to be able to negotiate cross -
licences. So yes, the nice picture of a PhD student inventing something, patent ing it, 
and then developing a successful business sounds like a very good example. But the 
reality may be more complicated.  
540.  The scenario would benefit from taking into account, the reality of university intellectual 
property  policies, Bayh -Dole type legisl ation and the actual practice at universities . That concludes 
the statement.  
541.  With regard to the request  that you are deliberating upon we would certainly need time to 
consult but one element that would be taken into consideration in our consultation would be over 
the inclusion of a mandate d issue such as the Work P rogramme on E-commerce and the 1998 
mandate we have and the contribution of this particular Council . Some delegations may be of the 
view that we should take those into consideration before bringin g a new permanent item.  
14.17   India  
542.  Thanks to the proponents for bringing this agenda item up here and thank you very much for 
your comprehensive presentation and statements and also for hosting yesterda y's event . It was 
quite useful, thank you very much for that. Just to support South Africa 's last comment here that 
today we are also not in the position to be able to say yes or no. We will still need more time to 
consult, whether to make this issue as a permanent standing agenda item.  
14.18   China  
543.  China would like to thank the co -sponsors for their consistent efforts in pushing forward the 
discussion on IP and innovation. We have fully recognized the challenges faced by start -ups due to 
their limitation in scale, assets and other aspects. The discussion on this topic would contribute to 
the exchanges among Members. China would like to share our practices as well.  
544.  First of all, China has been continually improving the IP -related financing legal system, in 
particular, for example, the stipulations and provisions on the pledge of IPRs by the Civil Code of 
the People 's Republic of China; and the measures for the Registration of Pledge of Pate nt Rights, 
etc. All these regulations have formed a solid legal and institutional basis for IP financing to facilitate 
the commercialization of IPs.  
545.  The second is about IP insurance. China National Intellectual Property Administration has 
carried out wide cooperation with insurance institutions in optimizing IP insurance products, services IP/C/M/106/Add.1  
 
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  and business models. By now, there have been 4 categories of insurance, namely liability insurance, 
guarantee insurance, credit insurance and expense compensation insuran ce, covering patent, 
trademark and other IP types. Moreover, China is seeking to widen the financing channels of start -
ups through a new method called 'direct investment of insurance capital ', so as to support their 
innovation and development.  
546.  The third is  our efforts in strengthening IP assessment services. With Asset Appraisal Law of 
the People 's Republic of China as the legal basis, China has established an evaluation system of IP 
intangible assets, which includes basic standards and specific standards f or asset appraisal, as well 
as guidelines for IP asset appraisal. In this manner, the reliability of IP asset appraisal could be 
further improved.  
547.  There are a large number of MEMEs in China, lots of them being starts -up. The guiding 
questions raised by the  co-sponsors point out a direction for in -depth research and discussion. We 
would like to listen to Members ' experiences so as to further the discussion in the future.  
14.19   Indonesia  
548.  Indonesia would also like to thank the proponents for their presentations to today, as well as 
the submissions, and also the side event that was held yesterday, we found it very useful and very 
informative as well. We note the importance of this issue, as well as its complexities. We also note 
that IP and Innovation is also an issue that is very much the focus of many discussions at Word 
Intellectual Property Organization. As such, noting the evolving nature of the issue, as well as taking 
lessons from yest erday in which we have many standing agenda where there were further 
interventions from Members. We are not ready at the moment to agree to the standing agenda of 
this issue at the TRIPS Council.  
15  INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO  
15.1  WTO Secretariat  
549.  As in previous occasions and for Members ' information, the Secretariat will provide a brief 
update of the issues related to intellectual property policy that h ave come up in the most recent 
Trade Policy Reviews. Since our last report during the TRIPS Council Meeting in July, the Trade Policy 
of Republic of Moldova and Mexico took place. During these reviews, delegations engaged in the 
discussions and sought furt her details on:  
a. The domestic implementation of the TRIPS Agreement;  
b. Institutional arrangements for the administration and enforcement of intellectual 
property;  
c. Copyright and related -rights regimes;  
d. Trademark regime;  
e. Protection of geographical indications;  
f. Patent regime;  
g. Enforcement, online and at the border; and  
h. Measures taken in response to the COVID -19 pandemic.  
550.  The Secretariat has also contributed with the chapters on intellectual property for the 
upcoming G20 and WTO -wide Director -General 's monitoring reports. We would like to thank 
Members and Observers that sent information about the measures that were implemented since 
October 2021. These inputs by delegations are essential in assisting the Secretariat to prepare the 
reports in the most acc urate and comprehensive manner. The reports will be circulated in November.  IP/C/M/106/Add.1  
 
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  16  OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS  
551.  No statements were made under this agenda item.  
17  ANNUAL REPORT  
552.  No statements were made under this agenda item.  
18  OTHE R BUSINESS  
553.  No statements were made under this agenda item.  
__________