RESTRICTED  
  
IP/C/M/96/Add.1  
 
16 February 2021  
(21-1273) Page: 1/165 
Council for Trade -Related Aspects of  
Intellectual Property Rights    
 
MINUTES OF MEETING  
HELD IN THE CENTRE WILLIAM RAPPARD ON 1 5-16 OCTOBER AND 10 DECEMBER 2020  
Chair: H.E. Ambassador Xolelwa Mlumbi -Peter (South Africa)  
Addendum  
The present document contains the statements made during the Council for TRIPS meeting held on 
15-16 October  and 10 December 2020. 
 
_______________  
 
Table of Contents  
1   NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  ................................ ........  6 
2   REVIEW OF NATIONAL IMPLEMENTING LEGISLATION  ................................ ..............  12 
3   IP MEASURES IN THE CONTEXT OF COVID -19 ................................ ...........................  13 
4   REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B)  ................................ ...................  16 
5   RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE  CONVENTION ON 
BIOLOGICAL DIVERSITY  ................................ ................................ ................................  16 
6   PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  ................................ ... 16 
7   ANNUAL REVIEW OF THE SPECIAL COMPULSORY LICENSING SYSTEM  
(PARAGRAPH 7 OF THE ANNEX TO THE AMENDED TRIPS AGREEMENT AND  
PARAGR APH 8 OF THE DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6  
OF THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH)  ...........  23 
8   NON-VIOLATION AND SITUATION COMPLAINTS  ................................ .......................  32 
9   REVIEW OF THE IMPLEMENTATION OF THE TRIPS AGREEMENT UNDER  
ARTICLE 71.1  ................................ ................................ ................................ .................  37 
10   REVIEW OF THE APPLICATION OF THE PROVISIONS OF TH E SECTION ON 
GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2  ................................ ....................  37 
11   EIGHTEENTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION  
ON THE IMPLEMENTATION OF ARTICLE 66.2 OF THE TRIPS AGREEMENT  ......................  37 
12   TECHNICAL COOPERATION AND CAPACITY -BUILDING  ................................ ............  44 
13   INTELLECTUAL PROPERTY AND INNOVATION: MAKING MSMES COMPETITIVE - 
MAKING MSMES COMPETITIVE THROUGH INCLUSIVE PROTECTION OF VAR IOUS IPS  ... 56 
14   DULY MOTIVATED REQUEST BY LDCS TO EXTEND THE TRANSITION PERIOD  
UNDER ARTICLE 66.1 OF THE TRIPS AGREEMENT FOR LEAST  DEVELOPED COUNTRY 
MEMBERS  ................................ ................................ ................................ .......................  82 
15   PROPOSAL FOR A WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS  
AGREEMENT FOR THE PREVENTION, CONTAINMENT AND TREATMENT OF COVID -19 ..... 92 IP/C/M/96/Add.1  
 
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  16   WORK PROGRAMME ON ELECTRONIC COMMERCE  ................................ .................  161  
17   INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO  .............  164  
18   OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL  
ORGANIZATIONS  ................................ ................................ ................................ .........  165  
19   ANNUAL REPORT  ................................ ................................ ................................ ... 165  
20   OTHER BUSINESS  ................................ ................................ ................................ .. 165  
20.1   Dates for 2021 Meetings  ................................ ................................ ....................  165 
 
 
  IP/C/M/96/Add.1  
 
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  INDEX OF THE STATEMENTS MADE  
AT THE MEETING OF COUNCIL FOR TRIPS 1 5-16 OCTOBER AND 10 DECEMBER 2020* 
 
 
 
Afghanistan  
Article 66.1  ................................ ........  86 
Angola  
Article 66.1  ................................ ........  86 
Argentina  
Article 66.1  ................................ ........  88 
Non-violation and situation complaints  ... 35 
Waiver - COVID -19 ...........................  104 
Australia  
Article 66.2  ................................ .. 38, 43  
Biotech, Biodiversity, TK  ......................  23 
E-commerce  ................................ ..... 164 
IP and Innovation - MSMES  ..................  62 
Notifications  ................................ ........  8 
Special Compulsory Licensing System  .... 29 
Technical Cooperation  ..........................  46 
Waiver - COVID -19 ...........................  118 
Bangladesh  
Article 66.1  ................................ ........  82 
Article 66.2  ................................ ........  40 
Biotech, Biodiversity, TK  ......................  20 
E-commerce  ................................ ..... 161 
Non-violation and situation complaints  ... 33 
Technical Cooperation  ..........................  47 
Waiver - COVID -19 .....................  96, 154  
Bangladesh on behalf of the LDC Group  
Article 66.1  ................................ .. 83, 91 
Bolivia, Plurinational State of  
Waiver - COVID -19 ...........................  128 
Botswana  
Waiver - COVID -19 ...........................  155 
Brazil  
Biotech, Biodiversity, TK  ......................  19 
IP and Innovation - MSMES  ..................  75 
Non-violation and situation complaints  ... 32 
Technical Cooperation  ..........................  47 
Waiver - COVID -19 ....................  116, 148  
Cambodia  
Article 66.1  ................................ ........  86 
Article 66.2  ................................ ........  44 
Technical Cooperation  ..........................  56 
Canada  
Article 66.2  ................................ ........  41 
Biotech, Biodiversity, TK  ......................  22 
IP and Innovation - MSMES  ..................  69 
IP measures - COVID -19 ......................  15 
Non-violation and situation complaints  ... 36 
Notifications  ................................ ........  9 
Special Compulsory Licens ing System  .... 30 
Technical Cooperation  ..........................  46 
Waiver - COVID -19 ....................  117, 126  
Chad on behalf of the LDC Group  
Article 66.1  ................................ .. 82, 91  
Article 66.2  ................................ .. 40, 44  
E-commerce  ................................ ..... 161 
Special Compulsory Licensing System  .... 26 Technical Cooperation  ....................  47, 54  
Waiver - COVID -19 .....................  104, 130  
Chile  
Biotech, Biodiversity, TK  ......................  19 
IP measures - COVID -19 .....................  13 
Non-violation and situation complaints  .. 34 
Special Compulsory Licensing System  ... 30 
Waiver - COVID -19 .....................  101, 128  
China  
Article 66.1  ................................ ....... 87 
Biotech, Biodiversity, TK  ......................  21 
E-commerce  ................................ ..... 161 
IP and Innovation - MSMES  .................  80 
IP measures - COVID -19 .....................  13 
Non-violation and situation complaints  .. 35 
Special Compulsory Licensing System  ... 28 
Waiver - COVID -19 .....................  105, 138  
Colombia  
Waiver - COVID -19 .....................  108, 154  
Cooperation Council for the Arab States 
of the Gulf  
Technical Co operation  .........................  51 
Costa Rica  
Waiver - COVID -19 ............................  107 
Ecuador  
Biotech, Biodiversity, TK  ......................  22 
IP and Innovation - MSMES  .................  66 
Non-violation and situation complaints  .. 37 
Waiver - COVID -19 .....................  106, 145  
Egypt  
Article 66.1  ................................ ....... 88 
Non-violation and situation complaints  .. 34 
Waiver - COVID -19 .....................  103, 133  
El Salvador  
IP and Innovation - MSMES  .................  71 
Waiver - COVID -19 .....................  108, 146  
Eswatini  
Waiver - COVID -19 ............................  132 
European Union  
Article 66.1  ................................ ....... 89 
Article 66.2  ................................ ....... 43 
E-commerce  ................................ ..... 163 
IP and Innovation - MSMES  .................  64 
IP measures - COVID -19 .....................  14 
Non-violation  and situation complaints  .. 36 
Notifications  ................................ ...... 11 
Special Compulsory Licensing System  ... 32 
Technical Cooperation  .........................  47 
Waiver - COVID -19 .............  109, 135, 160  
Holy See  
Waiver - COVID -19 ............................  119 
Honduras  
Waiver - COVID -19 ............................  119 
Hong Kong, China  
Notifications  ................................ ........  8 IP/C/M/96/Add.1  
 
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  India  
Article 66.1  ................................ ........  90 
Biotech, Biodiversity, TK  ......................  20 
E-commerce  ................................ ..... 164 
IP and Innovation - MSMES  ..................  81 
IP measures - COVID -19 ......................  14 
Non-violation and situation complaints  ... 34 
Special Compulsory Licensing System  .... 28 
Technical Cooperation  ..........................  56 
Waiver - COVID -19 .....................  93, 148  
Indonesia  
Article 66.1  ................................ ........  88 
Article 66.2  ................................ ........  42 
Biotech, Biodiversity, TK  ......................  21 
E-commerce  ................................ ..... 163 
IP measures - COVID -19 ......................  16 
Non-violation and situation complaints  ... 35 
Waiver - COVID -19 ....................  103, 134  
Israel  
Waiver - COVID -19 ...........................  153 
Jamaica  
Waiver - COVID -19 ....................  109, 148  
Jamaica on behalf of the African, 
Caribbean and Pacific States  
Article 66.1  ................................ ........  87 
IP measures - COVID -19 ......................  15 
Non-violation and situation complaints  ... 34 
Japan  
Article 66.1  ................................ ........  90 
Article 66.2  ................................ ........  39 
Biotech, Biodiversity, TK  ......................  22 
IP and Innovation - MSMES  ..................  60 
Special Compulsory Licensing System  .... 29 
Technical Cooperation  ..........................  45 
Waiver - COVID -19 ....................  113, 137  
Japan on behalf of the co -sponsors  
IP and Innovation - MSMES  ..................  56 
Joint United Nations Programme on 
HIV/AIDS  
Waiver - COVID -19 ...........................  121 
Kenya  
Waiver - COVID -19 .............................  95 
Korea, Republic o f 
IP and Innovation - MSMES  ..................  67 
Non-violation and situation complaints  ... 37 
Waiver - COVID -19 ...........................  145 
Malaysia  
Waiver - COVID -19 ...........................  126 
Mali 
Article 66.1  ................................ ........  85 
Technical Cooperation  ..........................  48 
Waiver - COVID -19 ...........................  108 
Mauritius  
Waiver - COVID -19 ....................  108, 139  
Mexico  
IP and Innovation - MSMES  ..................  75 
Notifications  ................................ ........  7 
Mozambique  
Waiver - COVID -19 ....................  117, 147  
Nepal  
Article 66.1  ................................ ........  84 
Waiver - COVID -19 ....................  100, 160  New Zealand  
Waiver - COVID -19 ............................  147 
Nicaragua  
Waiver - COVID -19 ............................  100 
Nigeria  
Article 66.1  ................................ ....... 90 
Biotech, Biodiversity, TK  ......................  20 
IP measures - COVID -19 .....................  14 
Non-violation and situation complaints  .. 34 
Waiver - COVID -19 .............................  95 
Norway  
Waiver - COVID -19 .....................  114, 131  
Oman  
Article 66.1  ................................ ....... 89 
Waiver - COVID -19 ............................  139 
Pakistan  
Notifications  ................................ ........  6 
Waiver - COVID -19 ......................  99, 151  
Peru  
IP and Innovation - MSMES  .................  77 
Philippines  
IP and Innovation - MSMES  .................  73 
Waiver - COVID -19 ............................  100 
Senegal  
Article 66.1  ................................ ....... 87 
Waiver - COVID -19 ............................  107 
Singapore  
IP and Innovation - MSMES  .................  61 
Waiver - COVID -19 ............................  131 
South Africa  
Article 66.1  ................................ ....... 87 
Article 66.2  ................................ ....... 38 
Biotech, Biodiversity, TK  ......................  18 
E-commerce  ................................ ..... 162 
IP measures - COVID -19 .....................  13 
Non-violation and situation complaints….
 ................................ ...............  33, 36  
Notifications  ................................ ...... 11 
Special Compulsory Licensing System  ... 27 
Technical Cooperation  .........................  48 
Waiver - COVID -19 ...............  92, 122, 155  
Sri Lanka  
Technical Cooperation  .........................  54 
Waiver - COVID -19 ......................  96, 129  
Switzerland  
Article 66.1  ................................ ....... 90 
Article 66.2  ................................ ....... 39 
IP and Innovation - MSMES  ............  67, 82  
Non-violation and situation complaints  .. 35 
Special Compulsory Licensing System  ... 30 
Technical Cooperation  .........................  47 
Waiver - COVID -19 .....................  112, 152  
Chinese Taipei  
Biotech, Biodiversity, TK  ......................  21 
IP and Innovation - MSMES  .................  72 
Non-violation and situation complaints  .. 36 
Notifications  ................................ ........  9 
Tanzania on behalf of the African Group  
Article 66.1  ................................ ....... 88 
Biotech, Biodiversity, TK  ......................  19 
E-commerce  ................................ ..... 162 
Non-violation and situation complaints  .. 33 IP/C/M/96/Add.1  
 
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  Special Compulsory Licensing System  .... 28 
Waiver - COVID -19 ....................  106, 154  
Thailand  
Biotech, Biodiversity, TK  ......................  20 
Non-violation and situation complaints  ... 35 
Waiver - COVID -19 ...........................  105 
Tunisia  
Waiver - COVID -19 ...........................  105 
Turkey  
Article 66.1  ................................ ........  89 
Waiver - COVID -19 ....................  102, 131  
Ukraine  
Notifications  ................................ ........  8 
Special Compulsory Licensing System  .... 26 
Waiver - COVID -19 ...........................  140 
United Kingdom  
Article 66.1  ................................ ........  90 
Article 66.2  ................................ ........  37 
IP and Innovation - MSMES  ..................  70 
Notifications  ................................ ....... 10 
Technical Cooperation  ..........................  45 
Waiver - COVID -19 ....................  115, 138  
United Nations Conference on Trade and 
Development  
Technical Cooperation  ..........................  53 
United States of America  
Article 66.1  ................................ ........  89 
Article 66.2  ................................ ........  42 
Biotech, Biodiversity, TK  ......................  21 E-commerce  ................................ ..... 163 
IP and Innovation - MSMES  .................  57 
IP measures - COVID -19 .....................  15 
Non-violation and situation complaints  .. 36 
Notifications  ................................ ...... 11 
Special Compulsory Licensing System  ... 29 
Technical Cooperation  .........................  44 
Waiver - COVID -19 .............  111, 126, 140  
Vanuatu  
Waiver - COVID -19 ............................  161 
Venezuela, Bolivarian Republic of  
Waiver - COVID -19 ......................  99, 139  
Viet Nam  
Waiver - COVID -19 ............................  132 
World Health Organization  
Article 66.1  ................................ ....... 91 
Technical Cooperation  ...............  52, 54, 56  
Waiver - COVID -19 ............................  120 
World Intellectual Property Organization  
Biotech, Biodiversity, TK  ......................  16 
Technical Cooperation  .........................  52 
WTO Secretariat  
Information on Developments in WTO  .. 164 
Non-violation and situation complaints  .. 32 
Notifications  ................................ ........  6 
Special Compulsory Licensing System
 ................................ ...........  …..23, 31  
Technical Cooperation  ....................  48, 55  
Waiver - COVID -19 ............................  125 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_______________  
* 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/96/Add.1  
 
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  1  NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  
1.1  WTO Secretariat  
1.  The Council has received the following notifications from Members  since its meeting on 
30 July 2020. 
Under Article 63.2  
2.  Chinese Taipei has notified regulations governing the filing of patent and trademark applications 
by electronic means, as well as regula tions governing the application for compulsory licences for 
musical works and related royalties.  
3.  Australia has notified a consolidated version of its Patents Act 1990, as well as the Intellectual 
Property Laws Amendment Act 2020, which implements the Produ ctivity Commission Response 
Part 2 and Other Measures.  
4.  Mexico has notified a revision of the Penal Code, as well as a Decree amending the Federal Law 
on Copyright with regard to copyright protection in the digital environment.  
5.  The United States has notified its amended Plant Variety Protection Act and corresponding 
Regulations.  
6.  The United Kingdom has notified over 70 pieces of legislation that represent the evolution of the 
UK law on trademarks and on designs since 1996.  
7.  Pakistan has notified its Geographical Indications Act 2020.  
8.  Myanmar has notified its new Plant Variety Protection Law.  
9.  Hong Kong, China has notified a Copyright Amendment Ordinance which enhances the copyright 
exceptions relating to persons with a print disability in the Copyrigh t Ordinance in order to meet the 
standards under the Marrakesh Treaty.  
10.  Ukraine has notified amendments regarding its patent law reform, as well as amendments to 
strengthen rights to trademarks and designs, and to combat patent abuse.  
11.  Japan has notified a f urther revision to its Unfair Competition Prevention Act of 1993, which 
provides civil remedies against acts of unfair competition with respect to "shared data with limited 
access ". 
12.  Slovenia has notified an Act Regulating Collective Management of Copyright  and Related Rights.  
Under Article 69  
13.  Albania and Slovenia have provided information on contact points for the exchange of 
information and cooperation on trade in infringing goods.  
1.2  Pakistan  
14.  In order to ensure transparency Pakistan notified its newly promulgated law of geographical 
indications (GIs) (Registration and Protection Act, 2020) in document IP/N/1/PAK/3, IP/N/1/PAK/G/1 
as per Article 63.2 of the TRIPS Agreement.  
15.  The GI law provides a  legal and institutional framework which specifies the scope and terms of 
protection, registration requirements, revocation/cancellation mechanism, offences, penalties and 
related matters of GI registration and protection.  
16.  As per the subject law the Feder al Government shall be the holder and exclusive owner of all 
the GIs. It may allow any statutory body, public body, local or provincial administration, government 
enterprise or any government organization to apply for and register the product as a GI as a IP/C/M/96/Add.1  
 
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  registrant. The producers or operators, with the formal assent of the Registrant, shall apply to the 
Registry for obtaining registration as authorized users.  
17.  In Pakistan, a score of products has potential to be protected under the GI law and the subject 
law provides the required legal framework for the same protection. The GI protection will enable our 
producers and exporters to realize the true premiums of our products. Besides, this law is an 
important step to support rural development in the country thro ugh MSMEs and to enhance the 
livelihood of producers and skilled workers.  
18.  Under the subject law, Pakistan GIs will be protected, branded and traded exclusively in the 
international market as Pakistani products. Moreover, the promulgation of GI law provides  a unique 
opportunity to bring together various players of supply chain including producers, traders, exporters 
and government authorities to transform our products into value added market commodities.  
1.3  Mexico  
19.  This delegation is pleased to report to the TRI PS Council that Mexico has amended and 
supplemented various provisions of the Federal Law on Copyright and the Federal Criminal Code, 
and has issued a new Federal Law on Industrial Property Protection . 
20.  This was notified to the Council pursuant  to Article 6 3.2 of the TRIPS Agreement.  
21.  The new Federal Law on Industrial Property Protection notified to the Secretariat and circulated 
in document IP/N/1/MEX/21 ; IP/N/1/MEX/I/15 on the WTO documents website - which will come 
into force on 5 November 2020, repealing  the current Law on Industrial Property - introduces 
significant changes and improvements in various fields of industrial property.  
22.  For instance, with respect to patents, it expressly establishes the "Bolar provision "; updates the 
mechanism for coordinatio n between the Mexican Industrial Property Institute (IMPI) and the health 
authority as regards the marketing authorization process for pharmaceutical products; extends the 
period of validity of utility models; classifies handicrafts as industrial designs a nd strengthens 
regulations in that regard; and clarifies the grounds for declaring patents null and void.  
23.  With respect to industrial secrets, it introduces the concept of misappropriation and exceptions 
thereto, and establishes administrative infringement s.  
24.  With respect to trademarks, it modifies the time used to calculate the validity of registrations; 
reduces requirements for well -known or famous trademarks; eliminates the obligation to register 
the licensing of rights in order to take effect vis -à-vis third parties, inter alia .  
25.  With respect to geographical indications and appellations of origin, it enhances their concepts, 
reinforcing recognition thereof by identifying their individual requirements; specifies their legal 
nature as domestic goods; enabl es Congress to submit a request for a general declaration of 
protection, inter alia .  
26.  With respect to enforcement, it contains changes intended to enforce the law more effectively 
and efficiently, including the possibility of requesting a determination of damage/injury vis -à-vis 
IMPI or the courts without the need for a prior administrative declaration; strengthens the framework 
of border measures and measures for the digital environment; establishes a conciliation mechanism 
as an alternative dispute resolu tion method, inter alia . 
27.  The amendments made to the Federal Law on Copyright, notified to the Secretariat and 
circulated in document IP/N/1/MEX/23 ; IP/N/1/MEX/C/9 on the WTO documents website, were 
mainly aimed at protecting copyright and related rights co ncerning works, performances or 
phonograms existing in digital media, through technological protection measures (TPMs) and rights  
management information (RMI). In addition, the responsibilities of online service providers are 
regulated, and a notification and withdrawal mechanism has been established for materials or 
content protected by copyright or related rights that are transmitted, reproduced or sold online 
without the authorization of right holders. Measures have also been established to prevent misus e 
of the system.  IP/C/M/96/Add.1  
 
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  28.  Lastly, the amendments made to the Federal Criminal Code, notified to the Secretariat and 
circulated in documents IP/N/1/MEX/22 ; IP/N/1/MEX/E/1 and IP/N/1/MEX/22/Rev.1 ; 
IP/N/1/MEX/E/1/Rev.1 on the WTO documents website, introduce penalties  for various 
infringements of copyright or related rights, such as the act of decrypting or decoding encrypted 
programme -carrying satellite or cable signals without the relevant authorization; circumventing, for 
profit -making purposes, TPMs used to protect content subject to rights in the digital environment; 
alteration of RMI without authorization and for profit -making pur poses; as well as recording, 
transmitting or copying, in full or in part, a protected cinematographic work at the time of showing 
at a cinema; among other acts.  
1.4  Australia  
29.  We provided an update on these measures at the TRIPS Council meeting of 30 July 2020  and 
have no further updates.  
1.5  Hong Kong, China  
30.  Hong Kong, China submitted a notification to the WTO on 25 September 2020 in document 
IP/N/1/HKG/37, to notify the TRIPS Council of the commencement of amendments to copyright 
legislation, in accordance with Hong Kong, China 's obligations under Article 63.2 of the 
TRIPS  Agreement.   
31.  The Copyright (Amendment) Ordinance 2020 enhances the copyright exceptions relating to 
persons with a print disability in the Copyright Ordinance (Cap. 528) in order  to meet the standards 
under the Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, 
Visually Impaired, or Otherwise Print Disabled.  
32.  In detail, the Amendments expands the definition of "print disability " in the Copyright Ord inance 
to enable persons with a perceptual or reading disability to use the copyright exceptions provided 
for persons with a print disability. They also make it clear that audio forms of certain copyright works 
(such as audiobooks) may be used in the produ ction of accessible copies for the personal use by 
persons with a print disability. The amended legislation also allows cross -border exchange of 
accessible copies of copyright works for the personal use by persons with a print disability, subject 
to certai n conditions being met.  
33.  The legislative amendments were effective from 26 June 2020.  
1.6  Ukraine  
34.  Ukraine presents its notifications on a number of intellectual property related legislative 
developments, which have occurred recently and aimed at achievement of efficient level of 
intellectual prop erty rights protection.  
35.  The first notification  in document  IP/N/1/UKR/8 presents the Law of Ukraine No 816 -IX "On 
Amending to Certain Legislative Acts of Ukraine regarding the Patent Law Reform " adopted on 
21 July 2020, by the Verkhovna Rada of Ukraine.  
36.  This Law introduces European norms and standards of legal protection of inventions and utility 
models into national legislation, and in part of inventions - the standards according to the Association 
Agreement w ith the EU.  
37.  The Law introduces norms aimed at achieving a balance of interests between the patent 
monopoly and the right of everyone to access to medicines.  
38.  The Law expands the list of technology objects that are not covered by the legal protection, and 
allows to file the objections against applications for inventions after their publication ( "pre-grant 
opposition ") and to recognize administratively the rights to inventions and utility models as invalid 
in the Appeals Chamber ( "post-grant opposition "); it also clarifies the procedure for granting 
additional protection of the rights to inventions (SPC).  IP/C/M/96/Add.1  
 
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  39.  The second notification in document IP/N/1/UKR/9 concerns the Law of Ukraine No 815 -IX "On 
Amendments to Certain Legislative Acts of Ukraine on Strengthenin g the Security and Protection of 
Rights to Trademarks and Industrial Designs and Combating Patent Abuse " adopted on 21 July 2020, 
by the Verkhovna Rada of Ukraine.  
40.  Law № 815 -IX aims at ensuring European norms and standards on the legal protection of 
trademarks and industrial designs, compliance of these standards with the Association Agreement 
with the EU. The Law also aims to combat with so -called "patent abuses ".  
41.  With regard to trademarks, the Law clarifies the grounds for refusal of registration and 
recognition of trademarks as invalid, and strengthens sanctions for infringement of trademarks 
rights.  
42.  With regard to industrial designs – an additional criterion of protection (individual nature) was 
introduced; the possibility of protection of unregistere d industrial designs is provided ( three  years); 
the term of protection of registered industrial designs is established (up to 25 years); the possibility 
of pre -trial revocation of certificates for industrial designs in the administrative order in the Appea ls 
Chamber (post -grant opposition) is provided.  
43.  Ukraine considers intellectual property area as being of great importance to the economy and 
one of the key priorities of the Ukrainian Government.  
1.7  Canada  
44.  Canada wishes to address questions raised by South Af rica at our 30 July 2020 meeting in 
relation to Canada 's presentation of a COVID -19-specific measure, as notified in document 
IP/N/1/CAN/30. As the TRIPS Council may recall, this notification pertains to recent amendments to 
Canada 's Patent Act under Bill C -13 (an act respecting certain measures in response to COVID -19). 
Bill C -13 required the Commissioner of Patents, o n the application of the Minister of Health, to 
authorize the Government of Canada or another specified person to make, construct, use and sell a 
patented invention to the extent necessary to respond to the COVID -19 pandemic. These 
amendments included safe guards to protect the interests of patent holders, for example, ensuring 
that a patent holder received adequate remuneration for the making, using, constructing, and selling 
of the patented invention, placing limitations on the duration of the authorizatio n, and ensuring that 
the patent owner had recourse to the courts if any person authorized acted outside the scope of the 
authorization.  
45.  By way of update, we report that no authorizations have been issued pursuant to this 
amendment, and the powers to seek authorization for third -party manufacturers were in place until 
30 September 2020, as set out in the original 25 March 2020 amendments. Canada wishes to stress 
that these measures were in addition to, and at no time replaced, existing pathways for the 
authorization of the use of a patent under Canada 's Patent Act, which remain in place under Canada 's 
domestic regime.  
46.  Canada remains committed to ensuring that its IP system supports efforts to address COVID -19. 
The Canadian Intellectual Property Office (CIPO)  has, for example, launched a pilot programme  that 
allows accelerated examination of patent applications at no additional cost for inventions related to 
medical products and processes supporting the response to COVID -19. As well, ExploreIP: Canada 's 
IP Mar ketplace, which is a new online resource for businesses to explore licensing and collaboration 
opportunities with public sector patent holders, now features a new "COVID -19-related " category to 
help users find technologies that could help combat COVID -19. Canada looks forward to presenting 
on these IP -related responses to the pandemic in greater detail, under the upcoming agenda item 
"IP measures in the context of COVID -19", later in this TRIPS Council meeting.  
1.8  Chinese Taipei  
47.  In compliance with Article 63.2  of the TRIPS Agreement, we notified the WTO  TRIPS Council of 
our recent amendments to our law. The document numbers are as follows: IP/N/1/TPKM/27, 
IP/N/1/TPKM/28 and IP/N/1/TPKM/29. In brief, the changes are as follows:  IP/C/M/96/Add.1  
 
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  48.  To improve examination quality, the Enforcement Rules of the Patent Act has been revised to 
expressly stipulate that third parties may henceforth submit observations prior to a patent 
examination decision being rendered.  
49.  Amendments have also been made to the Regulations Governin g the Implementation of Filing 
Patent Applications and Services by Electronic Means and the Regulations Governing the 
Implementation of Filing Trademark Applications and Services by Electronic Means. These changes 
will permit applicants to make use of alte rnative methods for electronic transmission of patent and 
trademark applications, provided certain conditions are met.  
1.9  United Kingdom  
50.  Let me start by saying that the United Kingdom considers the WTO notification system an 
essential component of multilatera l trade by promoting transparency between WTO Members  and 
encouraging compliance with agreed WTO commitments.  
51.  As outlined at the TRIPS Council session in February this year, recalling the importance of WTO 
notifications as a pillar of the global trading r egime, we wish to provide WTO Members  with a clear 
picture of the United Kingdom 's IP framework. As we also set out, we plan to do this in batches by 
IP right.  
52.  The first batch of notifications, which you would have seen circulated recently, outline the UK 
legal framework on trademarks and designs and the historic development of that framework.  
53.  At this point, this delegation would like to thank the TRIPS Secretariat for their support 
throughout this process, and to note that the e -TRIPS System made a perhaps otherwise onerous 
task much quicker and easier.  
54.  In the interests of time, I will not introduce each of the 70 plus notifications individually, but 
cite examples that reflect the changing world around us and the importance of ensuring that the UK 
IP system is fit for purpose.  
55.  The United Kingdom  is committed to an effective and balanced IP regime that drives innovation, 
investment, and economic opportunity for the benefit of all.  
56.  Over the period covered by these historical notifications, the United Kingdom has updated our 
IP system in line with technological developments; reflecting policy considerations, to ensure it 
meets the needs of rights holders and the public.   
57.  The United Kingdom places great value in international systems and standards. Illus trating this, 
The Designs (International Registration of Industrial Designs) Order 2018, as set out in document 
IP/N/1/GBR/77; IP/N/1/GBR/D/35 gave effect in the United Kingdom to the provisions of the Geneva 
Act of the Hague Agreement concerning the Inter national Registration of Industrial Designs. It allows 
the United Kingdom to be a designated state, so that going forward, UK businesses have access to 
an international system that allows industrial designs to be protected in multiple countries or regions 
through a single international registration. The more Members  this system includes, the more 
valuable it is for all. Therefore, we encourage all Members  to consider the benefits of signing up to 
the Geneva Act of the Hague Agreement and to other important IP treaties.  
58.  The United Kingdom is committed to taking advantage of technological advances enabling 
administrative systems to stay up to date as the world moves forward. For example, the lack of an 
online system was perceived to be a barrier to registering  designs - so with the Registered Designs 
(Fees) Rules 2016 as found in document IP/N/1/GBR/64; IP/N/1/GBR/D/30 the United Kingdom 
developed a digital service to streamline the design registration process and deliver efficiencies, 
which were passed on to c ustomers in the form of lower fees. As the cost of fees could have been a 
barrier to registering and protecting designs for MSMEs and individuals, the reduced fees for multiple 
applications encourages them to file applications for parts of a design, as wel l as the whole, 
improving their ability to protect the innovative aspects of their products.  
59.  Another area where the system has been made easier for users, was with the Regulatory Reform 
(Registered Designs) Order 2006. This order which can be found in docu ment IP/N/1/GBR/26; IP/C/M/96/Add.1  
 
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  IP/N/1/GBR/D/15, simplified procedures for registration of a design, as well as allowing multiple 
design applications to be made, and making it easier to restore a registration where it had lapsed 
due to non -payment of the renewal fees,  ultimately making the system easier and fairer for users.  
60.  As an example of consistently improving the IP system - To create a more balanced and effective 
system for the registration of national UK trademarks the Trade marks (Relative Grounds) Order 
2007 document IP/N/1/GBR/37; IP/N/1/GBR/T/24  streamlines applications for new UK trademarks, 
and provides a better balance between the rights of earlier trademarks and those of new applicants.  
61.  This also ensures a system which provides a useful, affordable alterna tive for those with 
business in the United Kingdom  to the registration of their mark as a Community trademark.  
62.  The United Kingdom will be submitting a further batch of historic notifications ahead of a 
TRIPS  Council session in 2021. These notifications will focus on legislative changes to the 
United  Kingdom 's copyright and patent regime. The UK delegation is ready to respond to questions 
you may have at this stage. We are also considering providing more details of the legislative changes 
set out in our TRIPS notifications and their functioning within the UK IP ecosystem in a workshop, 
to be organised next year.  
1.10  United States of America  
63.  The United States notes that US plant  variety protection legislation changes are reflected in 
documents IP/N/1/USA/64 and IP/N/1/USA/65.  
64.  The 2018 Farm Bill, Public Law No: 115 -334, Sec tion 10108, of 20 December 2018, amended 
the US Plant Variety Protection Act to add asexually propagated plants, previously not available 
under the Act.  
65.  The final rule revising the US Plant Variety Protection Regulations was published on 
6 January  2020.  
66.  We are glad to report that the US Plant Variety Protection Office now accepts asexually 
propagated plants applications, in addition to those previously available for seeds and tu bers. 
67.  With this broadened scope, in addition to those rights still available under utility patents and 
plant patents, we have further incentivized the development of new and improved plant varieties.   
68.  New varieties, for example those better suited for the environment, pest control, and/or disease 
control, promote agriculture production and food security for an increasing world population.  
1.11  South Africa  
69.  I am just taking the floor to thank Canada for coming back on questions that we raised during 
the last TRIP S Council meeting and just to remind the Euro pean Union that there are still some 
questions and that we would like to discuss with them.  
1.12  European Union  
70.  The E uropean Union would like to read out the replies provided by Hungary to the questions 
raised by South Africa at the last TRIPS Council.  
71.  Question 1 raised by South Africa:  why has the Government of Hungary decided to rely on its 
emergency powers to issue a Government d ecree for public health compulsory licences ? 
72.  Hungary 's reply: in connection with the COVID -19 pandemic, on 11 March 2020, the Hungarian 
Government declared special legal order (State of Danger) that lasted until 18 June  2020. During 
the State of Danger, th e Government may adopt decrees by means of which it may, as provided for 
by a cardinal Act, suspend the application of certain Acts, derogate from the provisions of Acts and 
take other extraordin ary measures.  IP/C/M/96/Add.1  
 
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  73.  The pre -existing compulsory licence regime for public health purposes provided in the Hungarian 
Patent Act (Law No. XXXIII of 1995 on the Protection of Inventions by Patents, hereinafter mentioned 
as "HPA") was based solely on Regulation of the European Pa rliament and of the Council (EC) 
No 816/2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical 
products for export to countries with public health problems (hereinafter mentioned as "Regulation 
(EC) No 816/2006 ").  
74.  Besides th is specific regime under Regulation 816/2006, the Hungarian patent law did not 
provide for a compulsory licence regime for public health purposes. The COVID -19 pandemic, as a 
situation of national emergency, created a risk that holders of patents or supple mentary protection 
certificates valid in Hungary of medical products, active substances, procedures and equipment 
needed to fight the COVID -19 pandemic would not be able to ensure the required supply. Should 
voluntary mechanisms fail, compulsory licences c ould be an option to secure this supply. Therefore, 
a system that would handle domestic public health problems was deemed necessary and swift 
legislative action was required. The special legal order provided the most suitable and fastest 
framework to regul ate the new regime of compulsory licences for public health purposes.  
75.  Question 2 raised by South Africa:  Section 1 .4 of the Decree states the period for which a public 
health compulsory licence is granted shall not last longer than until 31 March 2021. Giv en that the 
COVID -19 challenge is expected to continue for a number of years, and shortages are likely, what 
other provisions exist in Hungary 's patent law that will allow Hungary to issue compulsory or 
government use license to import or manufacture paten ted medical products ? 
76.  Hungary 's reply: the special legal order (State of Danger) was terminated on 18 June 2020, 
and thus Government Decree 212/2020 ceased to have effect on that day. There were no compulsory 
licences  filed for or granted based on the Decr ee. 
77.  Act LVIII of 2020 on Transitional Rules related to the Termination of State of Danger and on 
Epidemiological Preparedness made necessary modifications regarding the termination of the special 
legal order, including the modification of the Hungarian Pat ent Act ( HPA), which came into force on 
18 June 2020. This modification added the provisions on the public health compulsory license system 
to the HPA.  
78.  Question 3 raised by South Africa:  the public health compulsory license  decree allows 
exploitation of patented inventions presumably including importing from other countries. How will 
the opt -out of Hungary as an eligible importing country in connection with the 30 August 2003 and 
Article  31bis mechanism impact the utility of  Hungary 's public health compulsory license decree ? 
79.  Hungary 's reply:  The Government Decree 212/2020 provided for a regime of compulsory 
licences for public health purposes for the supply in Hungary. It did not amend the compulsory 
license based on Regulati on (EC) No 816/2006 (Art icle 33/A of HPA) concerning the compulsory 
licences for export to countries with public health problems. Status of Hungary as an importer under 
Article 31 bis of the TRIPS Agreement has also not changed.  
80.  Question 4 raised by South A frica: what circumstances informed the government 's decision to 
terminate the special legal order (State of Danger) on 18 June 2020?  
81.  Hungary 's reply:  Hungary successfully completed the first phase of the fight against the 
coronavirus, following which Hungary was among the first EU Members  to terminate the special legal 
order. The special legal order served its purpose,  it helped in preventing the pandem ic from reaching 
tragic proportions, because the Hungarian Government could take all the necessary measures in due 
time and could rely on the sacrifice and discipline of the Hungarian citizens. With the stabilisation of 
the epidemic situation, the terminat ion of the special legal order was justified.  
2  REVIEW OF NATIONAL IMPLEMENTING LEGISLATION  
82.  No statements were made under this agenda item.  IP/C/M/96/Add.1  
 
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  3  IP MEASURES IN THE CONTEXT OF COVID -19 
3.1  South Africa  
83.  We thank you for your report on this very important matter, South  Africa would like to join 
others to thank the Secretariat for maintaining a nd updating the list of IP measures that Members  
have taken in respect of COVID -19. We believe it is an important exercise in transparency that this 
item continues to appear on the  agenda of the TRIPS Council meeting. Whereas it is noteworthy that 
many of the measures contained on the list have been verified with the Member concerned but not 
notified.  
84.  It is understandable that it is not always possible to immediately notify such me asures, however 
we would encourage Members  that have taken measures to notify them as soon as possible. My 
delegation has been at pains to emphasise  the enormity of the challenges presented by COVID -19, 
limiting discussions on this  agenda  item only to nati onal measures would not do justice to the interest 
that all Members  have to discuss all systemic and related concerns. It is therefore suggested that 
this agenda  item not be limited only to discussion of national measures but also the broader impact 
that COVID -19 may be having on the IP landscape in general. We need to continue to discuss 
COVID -19 in its broader context. COVID -19 is taking its toll on all countrie s, including in Africa.  
85.  A second wave of the virus has started to engulf various countries with new and stricter 
lockdown measures being reintroduced. What is clear is that the pandemic is here to stay and will 
have long term implications for the IP polic y landscape. As we already indicated, COVID -19 
treatment and vaccines alone will not solve our problems, focusing on individual measures will not 
work, the pandemic requires bold collective action and discussion. Keeping this item on the agenda 
as a broade r platform to share not only national experiences but to talk about the systemic 
implications of COVID -19 for our collective well -being is the most useful way to approach this agenda 
item.  
86.  I am an African, hence my heart and concern are most attuned to wh at is happening on my 
continent, as many of our Members  are reaching their peak or have just passed their respective 
peaks, the long -term consequence of COVID -19 for developing countries cannot be underestimated. 
In the developed world, there is infrastruc ture and capacity to deal with the most immediate impacts 
of the virus, but despite this capacity the loss of life has been staggering. Developing countries have 
even less capacity to deal with the pandemic. Lockdowns for poor nations mean that people cann ot 
work, there is no luxury to telecommute, no ventilators for critically ill patients or financial packages 
to bail of struggling industries.  
87.  The impacts of COVID -19 disproportionately affect developing countries . When Scipio Africanus 
came to Africa dur ing the Punic wars between Rome and Carthage, he uttered the famous phrase: 
Carthago delenda est ! I think in our context it would be appropriate to say 'COVID  delenda est '! We 
can only defeat COVID -19 through collective actions that are inclusive and that targets those who 
are most affected by its impact. This Council remains the best place to have this discussion, we 
therefore would be in favour of maintaining this item on t he agenda and not restricted only to a 
consideration of national IP measures.  
3.2  Chile 
88.  Chile wishes to add its voice to those thanking the Secretariat for preparing a compilation of 
the measures notified to the WTO and ke eping it up to date. Moreover, we wish to commend those 
Members  that have notified their various measures, thereby contributing to transparency, which is 
one of the fundamental pillars of this Organization. In this vein, we consider it extremely useful f or 
Members  to continue notifying the various measures that they a re adopting, as this enables them 
to share experiences while helping other Members  that are assessing potential measures to tackle 
the pandemic.  
3.3  China  
89.  China supports discussing IP measures taken by Members  in the context of COVID -19. 
COVID -19 has highlight ed the importance of global collaboration. We believe that experience -sharing 
and information exchange in an open and transparent way is essential for Members  to learn from IP/C/M/96/Add.1  
 
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  each other so as to come up with better containment measures to the pandemic. In th e 
TRIPS  Council meeting held in July 2020, China briefed the Members hip on its Information Sharing 
Platform for Patents on Epidemic Prevention against COVID -19. This platform for patents is in the 
continuous process of updating and improvement. We are will ing to continue the discussion with 
respect to this important issue.  
3.4  Nigeria  
90.  My delegation would  like to thank you for convening this very important meeting and we would  
like to extend our thanks to the Secretariat  for its compilation of the various measures regarding 
trade-related intellectual property rights in the context of COVID -19, at these difficult uncertain 
times.  
91.  Indeed, we believe that a more constructive discussion should be continued under this agenda 
item because the impact of COVID -19 is still very much affecting our economies , especially in Africa. 
Hence , we are in favour of discussing the impacts of the pandemic in a broader context.  
92.  We note that the li nk provided under this agenda item mostly contai ns, measure taken by 
countries to facilitate IP processes such as amendments to their laws that include safeguards to 
protect the interests of patent h olders, an d provisional IP applications for COVID -related products. 
However, there is need for continuous  collaboration among all Members  in other to cushion the 
negative effects of the pandemic. We encourage that while the focus by most Members  seem s to be 
to develo p an adequate response mechanism, we should not  lose sight of the need to increase access 
to medicines and COVID -related equipment in more vulnerable countries in other to ensure equitable 
access to and fair distribution of all essential health technologies and products to combat the virus.  
93.  Allow me to highlight some of the effects of the pandemic from our national standpoint. The 
COVID -19 pandemic is still affecting the day -to-day life at our capital and has significantly slowed 
down our economy. Developing countries like Nigeria who lack the capacity to produce all the 
required COVID -related medical supplies and equipment depend largely on importation to be able 
to meet demand.  Given the unpredictability of this COVID -19 virus, there is no telling of when there 
will be a cure or vaccine despite some claims out there. In other to rise to these challenges, Members  
should be able to collaborate in other to make these COVID -related drugs and equipment readily 
available as this would also go a long way in improving prospects for a global recovery. Similarly, 
the invocation of TRIPS flexibilities can certainly be beneficial to local manufacturing industries.  
94.  We therefore urge the TRIP S Council to continue in its efforts to play a critical role on 
intensifying its cooperation with the WHO and WIPO on intellectual property and public health in 
other to promote innovation and access to health technologies.  
3.5  India  
95.  We echo and strongly suppo rt the points raised by South Africa and Nigeria. We believe that 
TRIPS Council has a wid er role to play in combatting the COVID -19 pandemic and support this  
agenda  item to be maintained on agenda for a broader discussion beyond the national measures.  
3.6  Euro pean Union  
96.  I would like to thank the Secretariat for compiling this information about IP measures taken in 
the context of COVID -19, and we all know and that other delegations had presented the crisis 
continues. This is very dynamic, unfortu nately it i s still the case and therefore the need for 
collaboration that the whole state continues as well.  
97.  In the same way, we think that there is a need still, of course, a continued need for exchange 
of best practices, an exchange of information on IP measures, that w e have taken already or will be 
taking in the future in this context.  
98.  That is why we would like to very much support the transparency exercise in that regard, we 
will of course have more to say about the response of the COVID -19 situation. We will do so under 
agenda item 15.  IP/C/M/96/Add.1  
 
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  3.7  Canada  
99.  As noted under the agenda item 1, Canada has undertaken a number of IP -related measures in 
response to COVID -19. This includes our previously -notified amendments to the Pate nt Act, as 
outlined in document IP/N/1/CAN/30.  
100.  As well, with respect to IP office measures, pursuant to  the Patent Act, the Trademarks Act, 
and the Industrial Designs Act, the Commissioner of Patents, the Registrar of Trademarks, and the 
Minister of Innovation, Science and Industry, respectively, designated all days in the period 
beginning on 16 March 2020,  and ending on 28 August 2020. The result of designating these days 
was that, if a time period fixed under the Patent Act, Trademarks Act, and Industrial Designs Act in 
respect of any business before the Canadian Intellectual Property Office (CIPO) for doi ng anything 
ended on any of the designated days, that time period was extended to the next day that was not 
either a designated day or a day that was prescribed under the Patent Rules, the Trademark 
Regulations, and the Industrial Design Regulations.  
101.  This meant that all such time limits ending on any of these designated days was extended until 
31 August 2020. To ensure continuity of service, CIPO 's online services also remain available.  
102.  CIPO has also launched a pilot programme  on accelerated examination of patent applications 
at no additional cost for inventions related to medical products and processes supporting the 
response to COVID -19. Applicants can submit a request for accelerated patent examination if: they 
have a new or existing patent application fo r an invention that supports the health -related response 
to COVID -19; and they qualify as a small entity which is a university or a business employing 50 or 
fewer employees.  
103.  Finally, we note that a new "COVID -19 related " category of technologies has been added to 
ExploreIP: Canada 's IP Marketplace, which is a searchable database that showcases an inventory of 
public sector patents held by government, academia or other public sector institutions. ExploreIP 's 
new "COVID -19 related " technology category will a llow IP owners to promote technologies that could 
help in the fight against COVID -19, as well as help interested businesses find and obtain licenses for 
those technologies. At present, ExploreIP 's new technology category includes 58 
COVID -19-applicable tec hnologies from 11 public sector organizations.  
3.8  Jamaica on behalf of the African, Caribbean and Pacific States  
104.  The African, Caribbean and Pacific States ( ACP) Group wishes to commend the Secretariat for 
its important work in facilitating Members ' reporting on the IP measures that have been implemented 
in the context of COVID -19 and we also thank the Members  that have provided updates in this 
regard. Such initia tives contribute greatly to transparency, which is an important feature of the 
multilateral trading system.  
105.  In the context of the COVID -19 pandemic and TRIPS, the ACP Group continues to reiterate 
that the WTO should prioritise improved easier access to me dicines, diagnostics, medical equipment 
and other technologies protected by intellectual property rights, thereby expanding the capacity to 
distribute them globally with the necessary quality and quantity. The WTO has a vital and ethical 
role to play in st riking an acceptable balance between, on the one hand, preserving the health of 
our populations and on the other, saving the lives of our people.   
106.  In this connection, the ACP Group wishes to emphasize that the TRIPS Agreement should 
continue to be interpre ted and implemented in a manner supportive of WTO Members ' right to 
protect public health and, in particular, to promote access to medicines for all.  
3.9  United States of America  
107.  The previous interventions of the United States on agenda  item concerning IP measures in the 
context of COVID -19 stand. In particular, other aspects on the issue of COVID  should occur under a 
dedicated agenda item. This  agenda  item is viewed as an ad hoc  item supported by the Secretariat 's 
compilation of COVID -19 measures regarding trade -related IP Rights.  IP/C/M/96/Add.1  
 
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  108.  As stated previously, intellectual property plays an incentivizing role in combatting this deadly 
pandemic and supporting economic recovery.  
109.  In addition to the initiatives, programme s and other helpful IP -related information from the 
United States Patent and Trademark Office regarding the COVID -19 outbreak, the United States 
Patent and Trademark Office ( USPTO ) recently implemented another programme  to facilitate 
collaboration in the development of COVID  treatm ent and cures.   
110.  The USPTO implemented a deferred -fee provisional patent application pilot programme  and 
collaboration database to promote the expedited exchange of information about inventions designed 
to combat COVID -19. Under this programme , the USPTO pe rmits applicants to defer payment of the 
provisional application filing fee until the filing of a corresponding nonprovisional application. In turn, 
applicants must agree that the technical subject matter disclosed in their provisional applications 
will be  made available to the public via a searchable collaboration database maintained on the 
USPTO 's website.  
111.  Further information on the USPTO 's initiatives on life science technologies can be found on the 
COVID -19 Response Resource Centr e page of the website.  
3.10  Indonesia  
112.  We would also like to extend our appreciation to the Secretariat for the compilation of IP 
measures taken by Members  in the context of COVID -19. 
113.  We see this as good practices in learning from each other on how the COVID -19 can affect the 
IP law landscape . We also share the vi ew of the delegation of South Africa to continue this discussion 
on the impact of COVID -19 on the global IP landscape as we move forward.  
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  World Intellectual Property Organization  
114.  We would like to thank WTO Members  for having expressed interest in having a briefing from 
the Secretariat of the World Intellectual Property O rganization (WIPO) on intellectual property and 
genetic resources, traditional knowledge and traditional cultural  expressions.  Indeed, it is our 
pleasure, in our capacity as an Observer, to brief the TRIPS Council.  
115.  It is my privilege to make such a briefing, under this agenda item, together with my colleague 
Ms. Fei Jiao.  
116.  I recall that the delegation of Zimbabwe at the TRIPS Council meeting in July  2020 had 
graciously referred in particular to one of our publications and it is with this that I would like to start.  
117.  The publication, entitled "Intellectual Property and Genetic Resources, Traditional Knowledge 
and Traditional Cultural Expressions ", was first published by the WIPO Secretariat in 2015. We 
updated it recently in 2020 with a new cover and updates of hyperlinks to other publications and 
resources. The publication mainly consists of three parts: (i) background to the need for the 
protection of  traditional knowledge, traditional cultural expressions and genetic resources, which 
describes some of the key concepts and provides a factual summary of ongoing discussions on the 
objectives and beneficiaries of protection; (ii) options for the intellect ual property protection of 
traditional knowledge and traditional cultural expressions, which covers options within existing 
conventional intellectual property systems and adaptations thereof; and, (iii) the work of WIPO in 
the field of traditional knowledg e, traditional cultural expressions and genetic resources.  
118.  Regarding the work of WIPO, the WIPO Secretariat provides seven services in relation to 
traditional knowledge, traditional cultural expressions and genetic resources.  IP/C/M/96/Add.1  
 
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  119.  One service area of the WIPO Secretariat is the facilitation of the ongoing negotiations of the 
WIPO Intergovernmental Committee on IP and Genetic Resources, Traditional Knowledge and 
Folklore (the IGC). The IGC met for the first time in April 2001 and commenced text -based 
negoti ations in 2010. The full text of the current IGC 's mandate for the 2020 -2021 biennium is 
available online. In short, the IGC will continue to expedite its work, with the objective of finalizing 
an agreement on an international legal instrument(s), without prejudging the nature of outcome(s), 
relating to intellectual property which will ensure the balanced and effective protection of genetic 
resources, traditional knowledge and traditional cultural expressions.  
120.  Due to the COVID -19 pandemic, Members  have just  agreed that IGC 41, which had been 
scheduled to take place in the week of 19 October 2020, has been postponed.  
121.  Now I would like to invite my colleague Ms. Fei Jiao, Programme  Officer, Traditional Knowledge 
Division, WIPO to continue to introduce other of WIPO 's service areas.  
122.  I will briefly introduce you to WIPO 's other six services relating to genetic resources, traditional 
knowledge and traditional cultural expressions1. 
123.  Upon request, WIPO provides policy and legislative information and assistance to re gional and 
national authorities interested in establishing policies, strategies, action plans and legislation. In 
2008, around 70 regional organizations and countries had adopted or were developing such 
legislation, policies,  action plans or strategies. By  2020, that number has doubled to over 140.  
124.  We have developed some tools to support this service, such as:  
a. a compilation of information on national and regional sui generis  regimes for the IP 
protection of traditional knowledge and traditional cultural exp ressions;  
b. a table compiling patent disclosure requirements enacted regionally and nationally;  
c. a collection of codes, guidelines and practices relating to the recording, digitization and 
dissemination of traditional cultural expressions; and  
d. a searchable da tabase of laws and regulations relevant to traditional knowledge, traditional 
cultural expressions and genetic resources.  
125.  WIPO also provides support to indigenous peoples and local communities to facilitate their 
participation in the IGC and other WIPO act ivities. For example : 
a. Indigenous representatives are financially supported by the WIPO Voluntary Fund to 
participate in the IGC negotiations. Each IGC session starts with an indigenous panel where 
indigenous experts can share their views on and experiences with the issues addressed by 
the IGC.  
b. WIPO launched an Indigenous Fellowship Programme  in 2009. By now, nine Indigenous 
Fellows from different regions have benefited from this programme . 
c. WIPO provides scholarships and other support for indigeno us peoples to participate in 
WIPO training activities.  
d. Indigenous peoples and local communities benefit from WIPO 's training and 
capacity -building activities designed specifically for and with them.  
126.  The WIPO Indigenous Entrepreneurship Programme  enables In digenous Peoples and local 
communities to make effective and strategic use of intellectual property in their businesses. The 
Programme  has a practical approach and consists of training and mentoring phases.  
127.  Another WIPO 's service is to provide intellectual  property advice on the documentation of 
traditional knowledge and traditional cultural expressions. A Toolkit on the documentation of 
 
1 The PowerPoint presentation is available in Room Document RD/IP/42.  IP/C/M/96/Add.1  
 
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  traditional knowledge, and a Practical Guide for museums, libraries and archives are among the 
Secretariat 's materials.  
128.  The WIPO Secretariat provides information, practical tools and training related to the 
management of intellectual property in genetic resources and genetic data, such as through a 
forthcoming distance learning course "Intellectual Property and Genetic Resou rces in the  "Life 
Sciences ", and a practical "Guide on IP Issues in Access and Benefit -sharing Agreements ". 
129.  Last but not least, WIPO provides different information resources on intellectual property and 
genetic resources, traditional knowledge and traditio nal cultural expressions. We strongly 
recommend you all to visit our website, where you can find different kinds of materials on a wide 
array of topics.  
130.  One example of the dynamic resources we have developed is a short animation, which tells 
the story of t he fictional Yakuanoi people2 as they work towards protecting their traditional 
knowledge assets. Different language versions, including indigenous languages, are available on 
WIPO 's Youtube Channel.  
6.2  South Africa  
131.  As indicated in our intervention at the la st TRIPS Council, South Africa is in favour of a more 
granular discussion of the th ree agenda item which informally have become known as the 'triplets '. 
I will deal with each of these  agenda  items in turn.  
Review of the Provisions of Article 27.3( b) 
132.  Many developing countries advocate for the amendment of Article 27.3(b) of TRIPS to prohibit 
patents on life forms, this also includes diagnostic, surgical or therapeutic methods for the treatment 
of humans or animals. It also includes the policy flexibili ty not to grant patent exclusivity for the use 
of existing drugs for treatment of COVID -19.  
133.  Countries may want to consider how to consider such exclusions from patentability based on 
current issues of diagnostics and treatment brought up in the context of  COVID -19. Even in countries 
where a new use for an existing drug is in principle patentable, it will not always meet the conditions 
for patent protection, in particular the inventive step which is require d. If these policies are not 
already in place, amen dments to existing laws may take a long time to put into effect. South Africa 
is a non -examining jurisdiction which means that virtually every patent application that is filed, will 
be granted. Between January 2005 and July 2015 , 40,131 patents originating  from all over the world 
which were registered in South Africa, only 4064 of those patents ha d a South African origin.  
134.  We are now attempting to fix this by introducing formal examination as envisage d in our IP 
Policy. The IP Policy sets out a range of pro posals relating to key aspects of patent law that have an 
impact not only on public health but more broadly. In addition to substantive search and 
examination, IP Policy addresses the following issues (amongst others) - patent oppositions, 
patentability cr iteria, parallel importation, exceptions and compulsory licences.  
135.  In the context of COVID -19, this ongoing legal reform will come too late to save even a single 
life where abuses of intellectual property rights lead to barriers to access. The South Africa n patent 
landscape is characterized by the easy grant of patents of dubious quality and value, as well as the 
enforcement of a legal framework that appears to be heavily skewed in favour of patentees. What 
this means in practice is that in exchange for ver y little, market exclusivity is easily granted, and 
maintained, ordinarily at a high cost to society.  
Relationship between the TRIPS Agreement and the Convention on Biological Diversity  
136.  As indicated in your introduction we would once again note our reques t for the update of the 
three factual notes and the request to invite the CBD Secretariat to brief the Council on the 
Nagoya  Protocol to the CBD.  
 
2 https://www.youtube.com/watch?v=3bim1tFE6Tg . IP/C/M/96/Add.1  
 
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  Protection of Traditional Knowledge And Folklore  
137.  South Africa would like to thank WIPO for the presentation, a nd would like to acknowledge the 
proposal by the delegation of Zimbabwe in the July 2020 TRIPS Council meeting to invite the 
organisation to brief the TRIPS Council. We note the outcome of the WIPO Assemblies of Members ' 
decision to renew the mandate for t he IGC for the 2020 -2021 biennium, as well as the work plan for 
the IGC.  
138.  Irrespective of the nature of the outcome and form of instrument envisaged under the IGC 
process  in WIPO , it is our considered opinion that the best way to ensure the proper use of g enetic 
resources and associated traditional knowledge is through an amendment to the TRIPS Agreement 
as set out in document TN/C/W/59 and subject to a legally binding two -tier dispute settlement 
processes as envisaged under the DSU.  
6.3  Chile  
139.  Our country 's position is well -known, and we would simply like to reiterate what our delegation 
has already mentioned under these  agenda  items during past meetings of the Council.  
140.  We would like to thank WIPO for its presentation and entrust them with the successful 
development of programme s and services related to genetic resources, traditional knowledge and 
traditional cultural expressions.  
6.4  Tanzania on behalf of the African Group  
141.  I deliver this statement on behalf of the African Group as an intervention in respect to agenda 
items 4, 5, and 6.  
142.  We would like to thank WIPO for the briefi ng they have provided and our commands on the 
progress being made in WIPO as far as IGC is concerne d. 
143.  Like in our previous statements, we would  like to reiterate the following:  
144.  The TRIPS Agreement need s to incorporate provisions that take into account the protection of 
genetic resources and tradition knowledge and folklore as provided by Art icle 27.3 ( b). The reviewed 
Agreement should stipulate obligations for Members  to prohibit misappropriation of genetic 
resources and traditional knowledge.  
145.  The original owners or custodian of genetic resources and traditional knowledge should 
equitably acquire benefits from right holders.  
146.  The TRIPS Council should cooperate with other relevant institutions particularly WIPO and CBD 
Secretariat and get better insights to advance this work  in the  WTO on this agenda item .  
147.  In order to resume discussions on these issues, we would like to request the Secretariat to 
update the Council in the next meeting about the proposals and the work previously done on these 
agenda.  
6.5  Brazil  
148.  I am taking the floor to  reiterate Brazil 's longstanding position on the issue of the relationship 
between the TRIPS Agreement and the Convention on Biological Di versity.  
149.  We remain convinced that the TRIPS Agreement should be amended to include a requirement 
for the disclosure of  origin of genetic resources in patent applications.  
150.  We believe that a multilateral WTO provision on disclosure is a reasonable and straight -forward 
demand that would provide a concrete response to the rights of countries hosting a rich biodiversity.  
151.  We th erefore invite Members  to reengage in these discussions with a truly constructive spirit.  IP/C/M/96/Add.1  
 
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  6.6  Bangladesh  
152.  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 statement made at t he TRIPS Council meeting on 
6 February 2020. Ba ngladesh stands ready to engage constructively with Members .  
153.  The delegation of Bangladesh thanks the WIPO Secretariat  for their presentation and updates. 
My delegation also supports the proposal of inviting  the CBD Secretariat to provide relevant updates 
at the TRIPS Council.  
6.7  Nigeria  
154.  Our intervention will be in respect of agenda items 5 and 6.  
155.  We thank the delegation of  Zimbabwe for its suggestions under this agenda item. We also 
thank the WIPO Secretariat for its presentation.  
156.  To avoid repetition, I wish to recall previous information provided  by Nigeria on these subject 
matters and we reiterate that the need for the mu tual supportiveness of the TRIPS Agreement and 
the Convention on Biological Diversity cannot be over emphasized. Enhanced corporation of the 
TRIPS Agreement and other relevant international organizations and international instruments 
remain a basic princip le of the TRIPS Agreement. We are in support of the harmonization of the 
TRIPS Agreement in other to be consistent with the CBD. We believe that , in order to develop a 
sound and viable technological base in developing countries and LDCs, any utilization of  genetic 
resources from these regions must involve sustainable use in o rder to conserve biological diversity, 
and must show evidence of a fair and equitable sharing of benefits, as are the principles of the CBD.  
157.  We therefore urge Members  to consider colla borating with each other both regionally and 
internationally, in o rder to achieve this mutually beneficial goal.  
6.8  Thailand  
158.  This statement addresses agenda items 5 and 6.  
159.  Thailand places emphasis on the protection of biological diversity and the rights of indigenous 
communities in their traditional knowledge and folklore. We believe that the protection and legal 
recognition o f those issues are the key ingredients for sustai nable development.  
160.  In this connection, a step towards a truly balanced intellectual property system should be 
promoted as the crucial tool for enhancing not only innovation and development, but also equitable 
benefit -sharing, when genetic resources and ass ociated traditional knowledge are utilized.  
161.  Therefore, we believe that the Amendment to the TRIPS Agreement to be compatible with the 
principles of the CBD and the protection of traditional knowledge would provide a concrete step in 
addressing biopiracy an d misappropriation of associated traditional knowledge. This would also help 
enhance transparency and legal certainty in patent application s and trading systems.  
162.  Furthermore, in relation to procedural matters, we support the WTO Secretariat to update the 
three factual notes on review of Article 27.3(b), the TRIPS Agreement  and the CBD, and the 
protection of traditional knowledge and folklore, and are open to the briefings by the CBD Secretariat 
on latest developments in the implementation of the Nagoya Prot ocol and the WIPO Secretariat on 
the report on the IGC work . 
163.  Lastly, I would like to thank the WIPO Secretariat for the comprehensive presentations and 
also thanks the delegation of Zimbabwe for initiating this briefing.  
6.9  India  
164.  We would like to thank WIPO f or their briefing on the 2020 Report.  IP/C/M/96/Add.1  
 
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  165.  Our po sition on these issues remains unchanged. We reiterate the need fo r an international 
enforceable regime to end the misappropriation of genetic resources and traditional knowledge. The 
TRIPS -CBD linkage is important for all countries as it seeks to address biopiracy. We would also like 
to reiterate the need to move forward in our discussions on these three mandated issues, namely 
the TRIPS -CBD linkage, GI register and GI extension based on the moda lities contained in document 
TN/C/W/52. In this regard, as mandated in paragraph 19 of the Doha Ministerial Declaration, we 
believe that the only mandate that exists to examine the relationship between the TRIPS  Agreement 
and the CBD, as well as protection  of traditional knowledge and folklore is that of the TRIPS Council 
to carry out such discussions. We also support the updating  of three factual notes and the request 
to invite the CBD Secretariat to brief the TRIPS Council.  
6.10  China  
166.  We would like to thank th e WIPO Secretariat for the presentation. In response to the call for 
Members  to present  opinions on the two procedural suggestions, our position remains unchanged. 
As regards the procedur al suggestion , China supports inviting the CBD Secretariat to brief o n the 
Nagoya Protocol. We also wish that the Secretariat could renew the three factual notes.    
167.  Like many previous speakers, China supports amending the TRIPS Agreement to ensure the 
mutual supportiveness of the TRIPS Agreement, the CBD and the Nagoya Protocol. We believe that 
adding disclosure requirement of genetic resources to the process of patent application will help to 
prevent the misappropriation of genetic resources and the granting of erroneous patents. In addition, 
setting up a reason able system for prior informed consent and benefit sharing could ensure better 
protection for genetic resources. Benefit sharing solely based on contractual terms and establishing 
a database on genetic resources are not sufficient.  
6.11  Indonesia  
168.  Indonesia 's position is well -known for agenda items 4, 5 and 6. Indonesia would like to refer 
back to the statements delivered in the previous Council meeting s.  
169.  My delegation would like to reaffirm its position on the great importance of the negotiation of 
relationship  between the TRIPS A greement and the Convention on Biological Diversity, as well as 
the protection of traditional knowledge and traditional cultural expressions.  
170.  We would also like to appreciate your efforts in ensuring that the WIPO Secretariat briefing is 
taking place.  
171.  We thank the WIPO Secretariat for their informative briefing on the work of WIPO in the context 
of promotions and protections of genetic resources, traditional knowledge and traditional cultural 
expressions.  
6.12  Chinese Taipei  
172.  On the issue of the relationship between the TRIPS Agreement and the CBD, we believe that 
there are still some important technical issues that need to be clarified, such as the definition of 
associated traditional knowledge and the trigger for the disclosu re require ments and s o on. My 
delegation would not oppose the request by Members  for a briefing on the current work by the CBD 
Secretariat, provided that the briefing would be helpful in clarifying technical issues and that there 
is sufficient support from Members . 
6.13  United States of America  
173.  We thank WIPO for its presentation.  
174.  The U nited States' position has not changed. Regarding genetic resources, traditional 
knowledge and folklore, we continue to believe that WIPO serves as the best forum to address these 
issues.  
175.  WIPO  IGC is looking at addressing unresolved issues and working on a common unde rstanding 
of core issues, using an evidence -based approach and examples of national experiences.  IP/C/M/96/Add.1  
 
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  176.  The United States will continue to engage in technical discussions at WIPO IGC and looks 
forward to hearing more from the demandeurs  regarding data supporting their position on this issue.  
177.  With respect to the various request s made, 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 Co uncil meetings.  
6.14  Japan  
178.  First, Japan would like to thank the WIPO Secretariat for the briefing on their activities. We 
have discussed this agenda item at length during a series of meetings of the TRIPS Council. This 
delegation, therefore, believes that our p osition is well -recognized among Members , so we would 
like to make our interve ntion brief, highl ighting some major points.  
179.  The delegation of Japan would like to reiterate our position that the Convention on Biological 
Diversity  is by nature not relevant to the intellectual property system. Therefore, we need to seek 
appropriate ways to deal with the utilization of genetic reso urces  (GRs) . This means that we should 
bear in mind that any measures taken must not adversely affect the existing intellectual property 
system or hinder the creation of innovations utilizing genetic resources and associated traditional 
knowledge  (TK). 
180.  This delegation is firmly convinced that to include the disclosure requirement in the IP system 
would discourage industries from conducting research and development activities on biological 
materials. This is the very consequence of the disclosure requirement  that Japan has been concerned 
about. The same holds true for not only developed countries Members but also emerging and 
developing countries. Japan believes that the disclosure requirement is not an adequate means for 
dealing with the utilization of genet ic resources.  
181.  In line with the above -mentioned position, we firmly believe that the protection of GRs, TK 
and folklore should be designed in a manner that both supports creativity and innovation.  
182.  In addition, this delegation believes WIPO  IGC is the most a ppropriate forum for holding 
technical discussions on genetic resources, traditional knowledge and folklore from IP aspects. This 
delegation has been actively contributing to the discussions at the IGC meetings, making various 
proposals, and remains willin g to contribute to evidence -based discussions on these issues in a 
constructive and effective manner.  
6.15  Canada  
183.  Canada would like to thank WIPO for its presentation to the TRIPS Council Members hip. We 
note that Canada 's position is well -known, and would refer  to our previous interventions on agenda 
items 4, 5, and 6 (the "triplets "). 
6.16  Ecuador  
184.  We thank the World Intellectual Property Organization (WIPO) for the briefing on the report 
"Intellectual Property, Genetic Resources, Traditional Knowledge and Traditional Cultural 
Expressions ". 
185.  My delegation 's position is well -known. In this vein, we wish to stress the need for the 
amendment of Article 27.3(b). We also reiterate the need for legal instruments that improve the use 
of genetic resources and protect  traditional knowledge.  
186.  With this in mind, the source of origin of these resources should be taken into account, as the 
unconditional need for prior informed consent and benefit sharing.  
187.  Moreover, we are of the view that the submission of the factual notes  will help us in our 
discussions without affecting the position of each Member.  IP/C/M/96/Add.1  
 
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  6.17  Australia  
188.  Australia also thanks WIPO for the presentation. Australia believes that WIPO IGC is best 
placed as the proper expertise to consider the conflict issues related to IP  and genetic resources and 
association of traditional knowledge and cultural expressions.  
189.  We hope that  Member s will adopt the spirit of compromise when the issue of genetic resources 
is considered . Australia believes that the TRIPS Agreement and the Conve ntion of Biological Diversity 
are fully  consistent  and that the TRIPS Agreement therefore does not need to be amended . Australia 
fully implements our obligations on both agreements which will be at mutually supportive.  
7  ANNUAL REVIEW OF THE SPECIAL COMPULSO RY LICENSING SYSTEM (PARAGRAPH 7 
OF THE ANNEX TO THE AMENDED TRIPS AGREEMENT AND PARAGRAPH 8 OF THE 
DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON 
THE TRIPS AGREEMENT AND PUBLIC HEALTH)  
7.1  WTO Secretariat  
190.  Thank you very much for providing the Secretariat with an opportunity to make a presentation 
on how to use the Special Compulsory Licensing System.3  
191.  To start with it is useful to put the System into context. Where does it come from? Back in 
2001, the Doh a Declaration on the TRIPS Agreement and Public Health identified the probl em of 
Members  with insufficient or no manufacturing capacity in the pharmaceutical sector to make 
effective use of compulsory licensing. This can be found in Paragraph 6 of the Doha  Declaration, 
which also explains why many people still refer to the mechanism as the "Paragraph 6 System ".  
192.  The problem identified by the Doha Declaration is about securing adequate supply of affordable 
generics from third country sources where the needed  products are patent -protected. The difficulty 
does not lie on the importing Member 's side because that Member can issue compulsory licences for 
local production and import under Article 31 TRIPS. It is located on the exporting Member 's side 
because of the  restrictive condition in Article 31(f) which requires compulsory licences to be used 
predominantly to supply the domestic market. Under a normal compulsory licence, only the 
non-predominant part can be exported. This was considered to be potentially a pro blem and explains 
why the System puts in place two distinctive derogations from Article 31(f), as well as a derogation 
from the calculation of remuneration to be paid by the right holder under Article 31(h).  
193.  Let's now look at when to use the System. There is place for use of the System when there is 
insufficient or no local manufacturing capacity in the importing Member to produce the needed 
medicines and this Member therefore needs to rely on imports from a generic supplier in another 
Member. In the export ing Member, the product needed is covered by a patent and the export of the 
non-predominant share of the production which would be possible under a normal compulsory 
licence does not satisfy the need of the importer. Hence, there would be a need to authori ze the 
generic manufacture exclusively for export. This is typically the scenario in which the System could 
be used.  
194.  The following are instances in which the System would not be used. This is the case when the 
potential importing Member has manufacturing c apacity to produce what is needed in terms of 
medicines or pharmaceutical products. On the exporting Member 's side, the System would not be 
used if there is no patent on the products needed by the importer and there would therefore no 
compulsory licence be  required to manufacture for export. The same applies if there is a patent, but 
the standard compulsory license in the exporting Member would be sufficient to satisfy the needs of 
the importing country by exporting the non -predominant share of the producti on. Finally, the System 
would not be used in situations where anti -competitive practices have been determined by judicial 
or administrative processes. Under Article 31(k), this would lift the restrictive condition in 31(f).  
195.  What does the System cover? On the 'disease side ', it covers public health problems affecting 
developing countries and LDCs, especially those resulting from HIV/AIDS, tuberculosis and malaria, 
 
3 The PowerPoint presentation is available in Room Document RD/IP/40. References  to the relevant slides 
are added in brackets.  IP/C/M/96/Add.1  
 
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  but not limited to those. It also refers to other epidemics. On the 'product side ', the System  covers 
all pharmaceutical products, including active ingredients and diagnostic kits which are patented or 
manufactured under patented processes.  
196.  Who can use the System? LDCs automatically qualify as importers under the System. Other 
Members  will have to notify the intention to use the System as importers. We should bear in mind 
that developed countr y Members  opted out of using the System as importers. There is also a group 
of 11 high -income developing countries which voluntarily agreed to use the System o nly in 
circumstances of extreme urgency. And we should also note that this is different from a standard 
compulsory license under Article 31 which can be used by all WTO Members  for local production or 
import of all health and other technologies.  
197.  On the exp orting Member 's side, any WTO Member is entitled to export under the System as 
soon as it has export capacities. Usually, this would require implementation of this form of 
compulsory licence within domestic law, which most WTO Members  with established capa city to 
export medicines have done. The data for worldwide pharmaceutical exports in 2014 for 122 
countries confirm that the share of the total exports covered by WTO Members  with implementing 
legislation amounted to more than 85% of the total pharmaceutic al exports. It can thus be safely 
assumed that the legislative framework enabling Members  with manufacturing capacities to engage 
in exports under the System is in place.  
198.  We now come to the key question of this presentation, i.e. how to use the System? The  use 
consists of four easy steps. The first two are notifications by the importing Member and the exporting 
Member. In addition, the product which is manufactured under the System needs to be clearly 
identified as such through labelling or marking of those  products for the purpose of avoiding trade 
diversion to high income countries so that they will stay in the country that needs the product. And 
finally, the licensee is required to post the details of the shipment(s) on a website to ensure 
transparency ab out what is shipped, the quantity of the shipped product and the distinguishing 
features applied to it, and the destination.  
199.  Let's first look at the notifications in more detail. For LDC Members , the notification would 
provide information about its specif ic needs, including the names and expected quantities of the 
needed products and, if the product is patent -protected in the importing LDC Member, the intention 
to grant a compulsory license or the actual grant of a licence. Alternatively, reference can be made 
to the extended transition period in the pharmaceutical sector which exempts LDCs from the 
obligation to protect such patents.  
200.  Among the points which merit being kept in mind is that the notification merely signals the 
need of the LDC and does not me an a commitment to procure medicines under this System. In other 
words, if the LDC Member finds a more affordable source from which to procure the medicines it 
needs, it does not have to continue the use of the System. There is no need to notify the name o f 
the supplier, nor the expected time frame of supply and use of the medicines. This is an important 
point, because notifying the name of the supplier would unnecessarily limit the range of potentially 
interested candidates who could otherwise engage in su pply of the medicines. So, keeping it open 
to a wide range of potential suppliers is important. Joint notifications can be made by importing 
Members  or a regional organization on behalf of its Members  with their consent. Finally, this 
notification is not needed when pharmaceutical products are imported from another Member under 
the RTA derogation in Article 31 bis(3). 
201.  To illustrate how this would like in practice, let 's take the hypothetical example of Aradia, an 
LDC. Its Ministry of Health, in cooperation with an International procurement programme , 
determined that it needs 15 million doses of 'panaceavir '. It also exercised rights not to protect 
pharmaceutical patents until 2033. All its notification u nder the System therefore needs to say is 
that "Aradia needs to import 15 million doses of panaceavir. " 
202.  For Members  that are not LDCs, two notifications would be required to use the System. The 
first notification is about its intention to use the System as  an importer. It can be made any time, 
also together with the notification of its specific needs. This notification is not needed if the importing 
Member is an LDC or if the import takes place from another Member under the RTA derogation in 
Article 31 bis(3). Again, making the notification does not imply a commitment to procure medicines IP/C/M/96/Add.1  
 
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  under the System. It is just the first step and the Member remains free to get the medicines from a 
different source.  
203.  The second notification is about the importer 's specif ic needs. This has to be made each time 
the System is used by a Member for a particular medical need. It is almost identical to the notification 
requirement for LDC Members  with one difference, i.e. the importing non -LDC Member also has to 
notify that it h as established that it has insufficient or no manufacturing capacities in the 
pharmaceutical sector and how this has been established. The other notes are similar to those set 
out regarding LDC notification requirements.  
204.  How would this look like in practi ce? In the hypothetical case for illustration purposes, Sanatos 
is a developing country. Its Ministry of Health procurement programme  determined that it needs 
30 million doses of 'elixivir '. The country has insufficient manufacturing capacities in the loca l 
pharmaceutical industry. In this case all the notification needs to say is that "Sanatos intends to use 
the System set out in Article 31 bis of the TRIPS Agreement and the Annex and the Appendix to it, 
as an importing Member " and "Sanatos needs to import 30 million doses of elixivir. Sanatos has 
found that its manufacturing capacity in the pharmaceutical sector is insufficient to meet its needs 
for this product, on the basis of 'Pharma Sanatos 2016 ', the most recent report on the 
pharmaceutical sector prep ared by the Ministry of Industry ".  
205.  Optionally, if no patent is in force, the notification could also indicate that "elixivir is not patent 
protected in the territory of Sanatos ". If a patent is in force, the notification would need to confirm 
that "Sanato s intends to authorize use of the subject matter of the patent or patents in force for 
elixivir without the consent of the patent owner in accordance with the provisions in Article  31 and 
Article 31 bis of the TRIPS Agreement ". 
206.  Let's now turn to the notific ation requirements for an exporting Member. It needs to notify the 
grant of a compulsory license and conditions attached to it. What exactly does it need to notify? The 
notification has to include the name and address of licensee; product and quantities fo r which the 
compulsory licence has been granted; importing Member(s); duration of compulsory license; website 
address with information on quantities being supplied and distinguishing features applied to the 
product manufactured for export; and, on an optio nal basis, other licensing conditions and patent 
numbers.  
207.  It is important to note that in the notification that has to be made by any exporting Member 
for every compulsory licence issued under the System, information about details can be replaced by 
a copy  of the compulsory license attached to the notification. The notification has to be submitted 
prior to export. Specific labelling/marking requirements apply to formulated products, active 
ingredients and finished products using such active ingredients. Bef ore the shipment begins, the 
licensee may post information about the shipment on its own website or on a dedicated WTO website. 
This notification is not required if export takes place under the RTA derogation (Art icle 31bis(3)). 
208.  Finally, how to notify? The  preferred option would be the use of the e -TRIPS Notification and 
Submission System. The links in the presentation are active in the room document and can be 
accessed by Members .  
209.  The e -TRIPS platform facilitates entry of each of the three notifications. We would encourage 
Members  to use this facility. Other means of making notifications by email, by fax, or by mail remain 
also available. For Members  wishing to use those options, a Guide to Notifications, including model 
notifications, is available on the WTO webpage.  
210.  The notifications will be circulated by the Secretariat to the TRIPS  Council as a formal 
document and can be accessed either on e -TRIPS or the TRIPS and Public Health webpage, which 
links to the relevant notifications on Documents Online.  
211.  Please note that none of these notifications require approval by a WTO body; that the general 
TRIPS requirements for compulsory license in Article 31 continue to apply such as the requirement 
to first seek a voluntary license by the right holder in normal ci rcumstances; and, as the System is 
about intellectual property, that it does not address any procedural issues relating to, for example, 
procurement of medicines and regulatory approval.  IP/C/M/96/Add.1  
 
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  212.  For those who are interested in more detail, slide 14  provides a list of resources which includes 
very recent material like Annex 3 to the Second Edition of the Trilateral Study. This Annex addresses 
the operation of the Special Compulsory Licens ing System. Also, the Guide to the TRIPS Agreement 
has a module  on TRIPS and Public Health, including a specific section on using the Special 
Compulsory Licen sing System.  
7.2  Chad on behalf of the LDC Group  
213.  Chad is speaking on behalf of the LDC Group, which thanks you for your report. We also thank 
the Secretariat for the  update just provided to us.  
214.  As you recalled, it is  true that the TRIPS  Agreement and public health is a highly important 
matter for LDCs.  
215.  The entry into force of the amended TRIPS Agreement in January 2017 was a historic 
development, building integrally into the Agreement, as you reminded us, a valuable public health 
safeguard for the benefit of developing countries and particularly LDCs, which are extremely fragile 
and vulnerable.  
216.  The amendment provides for medicines to be produced under a special compulsory lic ence, 
for export to countries particularly reliant on overseas suppliers to meet the needs of their patients. 
As you know very well, the health needs in our countries, and especially in the least developed 
countr y Members , are extraordin arily high.  
217.  It is therefore easy to see why this amendment is important as we face this global health crisis 
caused by COVID -19. 
218.  The LDC Group understands the important role that the TRIPS Agreement and public health 
play in relation to COVID -19. Indeed, w e believe that the provisions of this amendment are highly 
relevant to the current global health crisis. The pandemic is an accelerator rather than a complication 
arising from the situation.  
219.  For this reason, the LDC Group is of the view that this issue is particularly important given the 
current pandemic. Focusing on access to medical supplies and saving human lives is therefore our 
overarching concern. We are currently facing difficulties due to the restrictions on travel, market 
access and the movement of  goods. We are struggling to access the tools necessary for tackling the 
pandemic, such as, inter alia , medicines, masks and ventilators.  
220.  This amendment, in our view, is highly valuable and useful in light of the current situation. By 
way of conclusion, yo u reminded us that 33 Members , including LDC Members , are yet to accept this 
amendment. The LDC Group has therefore begun awareness -raising and mobilization activities to 
ensure that the Members  of our Group accept the amendment by the deadline. We believe  that these 
Members  will do so and that it is simply a procedural matter. It is hoped that, by the deadline, this 
amendment will be validated and accepted by those Members  of the LDC Group that have not yet 
done so.  
221.  Once again, this amendment is highly use ful and important for the LDC Group so that we are 
able to easily access medicines and pharmaceutical products. In light of this, it is clear that the 
matter is relevant to the pandemic.  
7.3  Ukraine  
222.  Ukraine expresses its gratitude to the WTO Secretariat for pr eparing a draft report and the 
possibility of taking part in the annual review of the Special Compul sory Licensing System.  
223.  Ukraine follows the discussions on this issue in the TRIPS Council and considers that 
exchanging information and experiences regardin g the imple mentation and use of the System is 
very important and valuable, especially in the context of the COVID -19 crisis. Ukraine welcomes this 
work, hoping that it will ensure the effective operation of the System and encourage all remaining 
WTO Members  to notify their acceptance of the Protocol Amending the TRIPS Agreement.  IP/C/M/96/Add.1  
 
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  224.  Given the situation with the COVID -19 pandemic, it is extremely important for Ukraine to 
ensure greater access to affordable medical products by intellectual property mechanisms, as 
provided in Article 31 of the TRIPS Agreement.  
225.  Ukraine would appreciate hearing about the experience of WTO Members who have used or 
considered using the System, any updated information regarding its implementation into domestic 
legislative and regulatory framework, as well as thoughts concerning the System 's role to address 
the COVID -19 pandemic. Such exchanges of  views, as well as discussions in a broader context of 
the relationship of intellectual property and public health, will help to raise awareness of practical 
possibilities of using the System or its alternatives and related TRIPS flexibilities both among W TO 
Members  as well as with interested agencies in charge of public health matters in their territories, 
and to adopt effective measures necessary to protect public health.  
7.4  South Africa  
226.  The first question I have with respect to the Secretariat presentation refers to the definition of 
a 'pharmaceutical product ' as we find it in the Annex to the TRIPS Ag reement. The last sentence of 
sub-paragraph (a) says "it is understood that active ingredients necessary for its manufacture and 
diagnostic kits needed for the  use would be included ". One interesting question that always comes 
up is that this particular definition does not refer to vaccines. The question I have in context of our 
discussions around COVID -19 is whether or not we are talking about pharmaceutical pr oducts or 
products of pharmaceutical processes. This essentially would also include vaccines — it would be 
good if this point could be clarified.  
227.  The second question is in relation to Members  that have implemented regimes for exportation 
under this System.  And just in terms of the statistics, you indicated that 85% of the worldwide 
exports comes from Members  that have implemented the System into their domestic law. Do we 
have statistics of who those Members  are, i.e. the world exporters, the WTO Members  with 
implementing legislation?  
228.  The last question is in respect of the use by LDCs in an RTA. If I go to the text of Article 31 bis 
and I look at paragraph 3, it says and confirms what the slide says. But it goes on to say that where 
a developing or a LDC Memb er is party to an RTA within the meaning of Article XXIV of the GATT 
1994 and the Decision of 28 November 1979 on Differential and More Favourable Treatment 
Reciprocity and Fuller Participation of Developing Countries, the requirement then is that at least  
half of the current Members hip is made up of countries presently on the United Nations list of least 
developing countries. This creates a more cumbersome requirement for Members  to benefit from a 
producer that may be situated within that RTA. To clarify t hat it is not just any RTA, it is only RTAs 
where at least 50% of Members  are LDCs. According to my calculations, there are only two of these 
currently existing, and both of them are situated in Africa.  
229.  So as indicated I will proceed to read my prepared s tatement, and noting your introduction, 
thanking you for the consultations that you have held. We are also appreciative of the Secretariat 's 
interventions including the excellent presentation.  
230.  The Doha Declaration on the TRIPS Agreement and Public Health, and the Paragraph 6 System 
established under the 2003 waiver, and the Protocol Amending the TRIPS Agreement through 
Article  31, remains a fundamental achievement and a landmark worthy of admiration. Yet, the 
Paragraph 6 System has stood as a monument to go od intentions —pristine and only invoked once 
during the entire time. There is a recognition that the use of the System is overly cumbersome with 
too many conditionalities and procedural prescripts to be useful to Members  with insufficient or no 
manufacturi ng capacity in the pharmaceutical sector.  
231.  Having studied the recently updated trilateral study, it points out that concerns have been 
expressed that the System is overly complex and not practical, and the potential use of the System 
may be deterred by con cerns of political or trade ramifications associated with the use of compulsory 
licences. We agree that the System cannot be a panacea against all eventualities. However, 
conditioning the use of the Paragraph 6 System to time -consuming and overly burdensom e 
procedures does not make for quick action irrespective of the level of development of a country.  IP/C/M/96/Add.1  
 
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  232.  Looking at the System through the lens of COVID -19 quickly reveals of the cracks in its 
construction and application. The System is based on developing coun tries notifying the WTO of the 
general intention to use the System, yet we see that there are many factors that might prevent a 
country from doing so and especially given the COVID -19 circumstances. As we indicated, we remain 
concerned about the apparent p rocedural and legal difficulties that continue to exist under this 
System and we stand ready to continue a discussion on many of these concerns that we have.  
233.  I just wanted to point out that in the context of HIV/AIDS, South Africa being one of the most 
affected countries in the world and so too the African continent, it is estimated that between 1997 
and 2012, 12 million Africans died waiting for enough life -saving drugs to reach the continent. This 
is already during the time when the Doha Declaration on t he TRIPS Agreement and Public Health 
had been issued, the 2003 waiver had been adopted and implemented on a provisional basis until it 
was finally subject to the Amendment of the TRIPS Agreement —yet millions of people still died. 
What are we to make of a S ystem that allows a humanitarian crisis of this magnitude to continue 
without abatement? If this many people died in the genocide or an armed war or conflict there would 
be immediate action. Yet many of these people did not die because they were killed by bullets or 
artillery shelling, they died because they could not access life -saving medicine in a timely manner. 
We ask, will we allow this to continue? I hope not. The WTO must be responsive to the needs of its 
Members , chief amongst them must be counted the poorest and the most vulnerable.  
7.5  India  
234.  We thank the Secretariat for the comprehensive presentation on the use of the Special 
Compulsory Licensing System.  
235.  India attaches high importance to the Doha Declaration on the TRIPS Agreement and Public 
Health, the Paragraph  6 System as established under the 2 003 waiver decision and the Protocol 
Amending the TRIPS Agreement. These provisions provide that the TRIPS Council shall review 
annually the functioning of the Special Compulsory Licensing System with  a view to ensuring its 
effective operation.  
236.  The impracticality and difficulty in using this System should be self -evident in view of the fact 
that since 2007 this System has been invoked only once, despite the existing lack of sufficient 
manufacturing ca pacities in many countries.  
237.  We note that while delivering the presentation, it was mentioned that the process to use this 
System is fairly easy. However, when MSF had actually attempted to use it to export HIV medicines 
from Canada to Rwanda, it had expre ssed some pertinent concerns and I quote, "that the mechanism 
is neither expeditious nor workable and it is so cumbersome and full of red tape that it acts as a 
major disincentive ". The onus, thus, lies on this Council to improve the procedures under this System 
so as to make it efficient and workable. We hope that Members  will engage constructively on this 
important issue.  
238.  Lastly, we congratulate Barbados, Burundi and Niger for accepting the Protocol since the 
sixteenth annual review in 2019 and encourage the 33 Members  who are yet to accept the Protocol, 
to do so expeditiously.  
7.6  China  
239.  China wants to thank the Secretariat for its presentation and the draft report. It is informative 
and very useful. China supports the discussion on flexibilities provided by the TRIPS Agreement and 
the Doha Declaration on the TRIPS Agreement and Public Health, including how to make more 
effective use of the Special Compulsory Licensing System.  
7.7  Tanzania on behalf of the African Group  
240.  The African Group would like to thank the Secretariat, in particular Mr Roger Kampf for the 
briefing that he has provided under this important agenda item. The briefing shares the challenges 
that face potential use of this System in terms of t he bureaucratic processes needed before impor ters 
or exporters engaged in the use of the System. This is an opportunity to reflect on the importance 
on how to make the System work effectively.  IP/C/M/96/Add.1  
 
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  241.  The African Group would like to express ap preciation for the Secretariat 's continued good work 
under this i mportant agenda item, which helps shed light on, among other things, ways of making 
the Paragraph 6 System work.  
242.  We welcome new developments which saw Burundi and Niger accept the Protocol Amending 
the TRIPS Agreement, and we also welcome the commitment o f the delegation of Zimbabwe who at 
their Trade Policy Review a couple of weeks back made a commitment to accept the Protocol 
Amending the TRIPS Agreement.  
243.  These are encouraging developments, particularly in Africa where we have been 
disproportionately af fected by the COVID -19 pandemic that has overstretched our financial 
resources and public health systems. It is, thus, important for Africa to have all the tools at our 
disposal to address the pandemic and build local pharmaceutical manufacturing capacitie s and 
address structural vulnerabilities that arise out of the over reliance on imports of pharmaceutical 
and medical consumables.  
244.  We would like to encourage Members  that do not have ratified the System yet to do so in the 
remaining time.  
7.8  Japan  
245.  This delegation would like to express our gratitude to the Secretariat for making a presentation 
and preparing a draft report so  that we can review the  Special Compulsory Licensing System. We 
welcome this work, hopin g that it will encourage all remaining Member s to notify their acceptance 
of the Protocol.  
246.  This delegation would like to reiterate the importance of access to medicines, which needs to 
be discussed in a broader context, taking into account not only the Special Compulsory Licensing 
System but also va rious other relevant measures and factors such as procurement and tariffs. Japan 
supports the Paragraph 6 System as established under the 2003 waiver decision and the 2005 
Protocol Amending the TRIPS Agreement. The very objective of the System is to suppor t WTO 
Members  in obtaining greater access to medicines, specifically Members  that have either insufficient 
or no pharmaceutical manufacturing capacity. Compulsory licences  are, whether granted under the 
System or not, just one of the potential means that c an be utilized for this objective under an 
exceptional circumstance. Therefore, the System should not be considered as the only solution, but 
rather as just an option we could consider.  
7.9  Australia  
247.  Australia thanks the Council for the Annual Review. As highl ighted in the Review, Australia 
notes that the Secretariat has continued to provide technical assistance, in coo peration with other 
partners, to s upport the effective use of the Special Compulsory Licensing System.  
248.  The Review also notes a number of recent capacity building activities. We recogni ze that these 
activities are a useful way to facilitate the implementation and understanding of the System. 
Australia also commends the TRIPS Council for supporting transparency providing a guide to 
notifications for  the Special Compulsory Licensing System on the WTO website.   
249.  We welcome the joint WTO -WHO-WIPO study on 'Promoting access to medical technologies 
and innovation ', and note that Annex III provides a helpful overview of the Special Compulsory 
Licensing Syst em. We look forward to further efforts to promote transparency and understanding 
for all TRIPS Members .  
7.10  United States of America  
250.  The United States would like to thank the Secretariat for its presentation.  
251.  The United States welcomed the entry into force of  the Protocol Amending the 
TRIPS  Agreement . We welcome the Secretariat 's draft Report and its work throughout the year to 
facilitate and encourage all Members  to notify their acceptance of the Protocol.  IP/C/M/96/Add.1  
 
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  252.  We also congratulate the additional Members  that have  accepted the Protocol since the entry 
into force of the amended TRIPS Agreement.  
253.  While the entry into force of the amended TRIPS Agreement represented an important step in 
promoting our shared goal of facilitating access to medicines, it is only one piece  of the puzzle. For 
example, the WHO has identified numerous considerations, including pricing and procurement 
policies, taxes, mark -ups and tariffs, and other national policies that ultimately result in higher costs 
for consumers and for health systems.  
254.  We encourage Members  to continue to focus efforts to address other salient barriers to access 
while also recognizing the important ro le that intellectual property and international trade 
liberalization play in incentivizing drug development and expanding access to medicines around the 
world.  
7.11  Canada  
255.  Canada considers access to medicines to be a key priority in our ongoing efforts to promo te 
global health and prosperity.  
256.  Canada 's Access to Medicines Regime (or CAMR), which impleme nts Paragraph 6 of the 
Doha Declaration on the TRIPS Agreement and Public Health, is one such measure used in Canada 
to promote access to medicines. Canada  also recognizes  the 2017 entry into  force of the  Protocol 
Amending the TRIPS Agreement which provides countries with an important tool to improve access 
to affordable medicines. As the only country to have exported a medicine pursuant to the temporary 
waiver, Ca nada has always been a strong proponent of the Amendment, and would be pleased to 
share our experiences and lessons learned in implementing our own System with any Member who 
wishes to learn more.  
7.12  Chile  
257.  Our delegation would like to thank the Secretariat fo r the presentation on the use of the 
System, as well as the Annu al Review. Chile congratulates all the Members  that have already ratified 
the Amendment and we commend those that have not done so to do it before the deadline. Chile is 
a strong promoter of t his Amendment and is willing to share its ex periences in how our  country 
ratified the Amendment.  
258.  Our country is open to hearing more cases with empirical evidence in this area, as well as 
surrounding elements such as aspects of public procurement and prici ng that could eventually have 
an effect on access to medicines. Our delegation is open to hearing concrete proposals on this issue.  
7.13  Switzerland  
259.  My delegation would like to first thank the Chair, for your consultations held to prepare the 
review under agenda item 7 .  
260.  I would like to join other delegates to thank also the Secretariat for their technical assistance 
throughout the previous year and fo r the very useful, clear and concise overview of the functioning 
of the 31 bis System and how beneficiary Members  may make use of it. We hope the Secretariat will 
make the presentation available on the WTO 's dedicated webpage, together with the other helpful 
information and the Guide to Notifications facilitating the use of the System.  
261.  The presentation of the Secretariat showed that the use of the 31 bis System by beneficiary 
countries is straightforward. In  contrast, in their interventions India and South Africa called the 
System complex, cumbersome and not practical, citing as evidence that the System has been used 
only once so far. We disagree.  
262.  The Secretariat recalled in its presentation that the purpose  of adopting the System in 2003 
was to extend the TRIPS flexibility of Article 31 of the TRIPS Agreement to eligible beneficiary 
Members  without relevant manufacturing capacity in the pharmaceutical sector. It has not been 
conceived for frequent use. The S ystem applies to eligible beneficiary countries, in a specific case 
scenario and under particular circumstances. There are many instances, where the reasons for a IP/C/M/96/Add.1  
 
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  lack of access to needed medicines in potential beneficiary countries are not related to pate nt 
protection. And it is misleading to imply that the many casualties that today still – and tragically 
enough - result from insufficient and untimely access to medicines would be the result of IP or 
perceived deficiencies in the system provided by Art icle 31bis.  
263.  By making the so -called Paragraph 6 System  on patents and public health permanent in their 
decision of 6 December 2005 and amending the TRIPS Agreement formally by adding Article  31bis 
in its Part II Section 5, Members  have ensured transparency, c larity and legal certainty.  
264.  Should eligible beneficiary Members  meet with concrete problems when actually  making use 
of the System, then it is the Council 's duty to examine these specific difficulties in its Annual Reviews 
and look into how they can be ad dressed best in a practical manner. So far, we have not heard of 
such practical problems.  
265.  We call on those 33 Members  who have not yet accepted the Protocol Amending the 
TRIPS  Agreement to do so now without further delay.  
266.  We were pleased, in this respect,  to hear from the distinguished delegate from Chad on behalf 
of the LDC Group that they will undertake additional efforts to encourage their Members  to accept 
the Protocol before the expiry of the extended deadline, and that he considered the 31 bis System 
to be very useful from the perspective of a beneficiary country group.  
7.14  WTO Secretariat  
267.  We thank the Chair and delegations for their useful inputs into the debate. Let me start with 
the questions which were posed by South Africa, which are very per tinent.  
268.  The first question concerned the definition of pharmaceutical products and whether this 
included vaccines. This  is, of course, a very pertinent question in the current situation, as the 
pandemic is very much about access to vaccines if and when they become  available. As usual, it is, 
however, not for the Secretariat to interpret relevant provisions. I would therefore turn the question 
back to South Africa. Is there any serious concern about vaccines not being included in the definition 
of a pharmaceutical p roduct? Is there any argument being made saying that vaccines are indeed not 
considered to be pharmaceutical products? In relevant WHO official documents, for example, 
vaccines are generally included in the legal definition of a pharmaceutical product. Sim ilarly, the 
WHO Good Manufacturing Practices for Pharmaceutical Products has numerous references to 
vaccines. So, there are indications out there about what falls within the definition of a pharmaceutical 
product. But again the question is: is there really  any concern about vaccines not being included?  
269.  The second question referred to the slide with the statistics about Members  with export 
capacity that have implementing legislation in place, seeking an explanation as to how these 
statistics were put togethe r. These have been taken from industry sources which have records on 
the export of pharmaceutical products on a country -by-country basis. I did compare this data with 
the implementing legislation that is compiled in a Staff Working Paper on the key feature s of 
WTO Members ' implementing legislation regarding the Paragraph 6 System.4 That led to the figures 
you see on the slide concerned. While the data merit being updated, newer figures can be expected 
to confirm the finding that the vast majority of Members  with export capacities have implementing 
legislation in place.  
270.  The final po int was about regional trade agreements and I apologise that the slide may be a 
bit misleading, although I did present it orally in a more concise manner. As the delegate from 
South  Africa has rightly noted, for RTAs to benefit from the easier procedure in  Article 31 bis to 
export medicines to other Members  within the RTA, they need to qualify as an RTA within the 
meaning of Article XXIV of the GATT 1994. The RTA needs to be composed of 50% or more of least 
developed countri es and also the Members  concerned need to share their health problems in 
question. However, I would rather see what has been described as a cumbersome further condition 
to use the System as an additional flexibility. It was built into the mechanism when it was adopted 
 
4 Available at https://www.wto.org/english/res_e/reser_e/ersd201507_e.pdf . IP/C/M/96/Add.1  
 
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  to give additional fl exibility to those who at the time were most suffering from the HIV/AIDS crisis. 
One can therefore also see that particular derogation from a positive angle.  
271.  To conclude, I just wanted to pick up on what our colleague from Chile said, i.e. that there is 
more need for empirical studies and evidence. Indeed, when it comes to the question as to whether 
the procedures are cumbersome and bureaucratic, it would actually be good to hear more about the 
problems and, in particular for least developed countries, the  difficulties to submit a one line 
notification identifying the products and the quantities needed. This call for empirical evidence or 
studies seems therefore pertinent and maybe something to be picked up in our future work.  
7.15  European Union  
272.  The European Un ion would like to use the opportunity for as we  had some technical problems 
under agenda  item 7. I will not be very long but I would  just like to thank the Secretariat for the 
presentation on the sy stem of compulsory licensing  and, of course, for the report, that we fully 
support , and congratulate all the Members  that have accepted  the Protocol since the last review.   
273.  The EU has consistency supported the use were necessary and justified of the flexibilit ies 
provided under the T RIPS Agreement and in line with the Doha Declaration  and with the objective 
of ensuring the access to medicines. W e find this mechanism, very important and key for ensuring 
this access . I will come back to this issue in more detail  when we discuss it under  agenda item 15.  
8  NON-VIOLATION AND SITUATION COMPLAINTS  
8.1  WTO Secretariat  
274.  This is just to say that on 3 September 2020, the Secretariat held another briefing session on 
TRIPS non -violation complaint s at the WTO and remotely through Interprefy.  
275.  As in previous years , this briefing provided information on the origin and application of such 
complaints in the GATT and in the WTO , on the discussions in the context of the TRIPS Agreement , 
and on non-violation and situation complaints (NVSCs) provisions in re gional trade agreements. As 
always, the purpose of Secretariat briefings is to provide factual background information to 
delegations so as to enable them to engage in substantive discussions and to facilitate the Council 's 
consideration of this matter.  
276.  The briefing attracted over 90 participants across the globe and has received very positive 
feedback.  
8.2  Brazil  
277.  There is an extensive consultation process ongoing in the Brazilian Government on the issue 
of Non -Violation and Situation Complaints applied to the TRIPS  Agreement . Several government 
agencies are being consulted, so that we can have as broad a perspective as possible on the matter.  
As we all know, jurisprudence regarding NVSC applied to IP is scarce.  So, we are navigating 
uncharted waters.  
278.  In the past decade or so, we have seen a growing number of NVSC provisions applied to IP in 
regional and bilateral trade agreements. However, we have not seen sufficient litigation referring to 
these provisions.  The lack of concrete cases leads us to an assessmen t exercise that is essentially 
abstract in nature.  
279.  In 2019, South Africa has kindly shared with us a discussion paper on the issue of NVSCs.  The 
paper gives important hints on possible avenues regarding scope and modalities, based on 
contributions made by Members  in the discussions over the last two decades.  The alternatives 
presented in this document, among others, are being considered in our internal assessment.  
280.  In a scenario where the moratorium expired, it would be important for us to guarantee that 
guidelines had been previously agreed by Members  for the application of NVSCs to the 
TRIPS  Agreement, thus avoiding a situation where panels (and the Appellate Body)  had to fill the 
normative gap.  IP/C/M/96/Add.1  
 
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  281.  For us, any solution to this issue must have the Members ' footprint.  
8.3  Tanzania on behalf of the African Group  
282.  I am taking the floor on behalf of the African Group to reiterate our position which is 
well-known. We have been ca lling on Members  that the moratorium on non-violation and situation 
complains be made permanent.  We think that the expiry of the moratorium under Paragraph 2 of 
Article 64 of TRIPS Agreement will not trigger any automatic application of Articles XXIII of 
GATT  1994, as this is conditional to the consensus outcome under Paragraph 3 of Article 64 of the 
TRIPS  Agreement.  
283.  Therefore , we would like to urge Members  that if we have to consider  for the moratorium to 
expire  then we should find a solution . Out of that , we think it would be not possible to trigger the 
application of non -violation and situations complaints in the DSB . 
8.4  South Africa  
284.  As you recalled i n your introduction the TRIP S Council is called to continue its examination of 
the scope and modalities of non -violation and situation complaints on the basis of the General Council 
Decision of 10 December 2019  and, certainly, the next Ministerial date as a working hypothesis 
would bear reference here. Once again we would like to thank the Secretariat for the briefing session 
on 3 September 2020 on the history and evolution of non-violation and situation complaints, 
including some very useful observations by the Legal Affairs Division. South Africa has made 
countless interventions on this subject -matter and has indicated its willingness to cooperate with 
other Members .  
285.  I think Brazil has alluded to the fact that we have in principle a working document with various 
options indicating pos sible scope for the application of non -violation and situation complaints, to the 
TRIPS Agreement, further articulating modalities which have bee n recognized under litigation and 
certainly the dispute settlement understanding , and ending with possible remedies . From that point 
of view, we have not formally shared this with other Members  but we have reached out to especially 
proponents that have mad e the case that non -violation situation complaints should  apply to the 
TRIPS Agreement  and further to understand how these Members  envisage a possible application . I 
think Brazil is correct in indicating that if we do not look at the margins , if we do not ensure that 
there is sufficient guidance to panels who may , in an abstract way , start to think about what the 
intention s of Members  were, we leave open a scenario when non -violation situation complaints , 
should they ever become applicable to the TRIPS Agre ement , are construed more widely and may 
undermine existing right , including issues  around flexibilities.  
286.  So from that point of view, we are ready to share this proposal more widely based on a 
common understanding  that other Members  are willing to conside r this . This is of course without 
prejudice to our position and that position as elucidated by the African Union is , that complaints of 
this kind should be permanently  not applicable to dispute settlement system under the 
TRIPS  Agreement . But nonetheless , I think I also just want to point out that we had previously also 
suggested that it would be useful to clarify what situations Members  would wish to avoid and 
specifically it refers to proponents for the application of non -violation and situation complain ts. So 
which situations, these Members  would seek to avoid having a non -violation remedy applicable under 
the TRIPS Agreement , and on the other hand , as duly pointed out by my esteem  colleague , that a 
non-violation remedy in the TRIPS context will not be s o wide as to have the effect of expanding 
existing TRIPS obligations . Having previously reached out to proponents and a further group of 
Members , we are happy to take this process further and would also be happy to  share – in a without 
prejudice manner  - the initial draft that we had discussed in 2019 . 
8.5  Bangladesh  
287.  The position of Bangladesh on the proposed lifting of the moratorium on non -violation and 
situation complaints is well -known. We are in favour  of establishing a pe rmanent moratorium. To 
avoid repet ition, I refer to my delegation 's statement made at the TRIPS Council meeting on 
6 February 2020. Bangladesh reiterates its readiness to constructively engage with Members  on this 
issue further.  IP/C/M/96/Add.1  
 
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  288.  Bangladesh also suggest that the Chair of the TRIPS Council should facilitate  informal  
consultations on this issue. My delegation also thanks the Secretariat for organizing the briefing 
session on the factual background of NVSC on 3 September 2020.  
8.6  Egypt  
289.  We would like to  align ourselves with the statement delivered by Tanzania on behalf of the 
African Group, and we also welcome the ideas presented by South Africa.  
290.  We wish to reiterate the following . First, we believe that Non -violation and situation complaints 
should not  be applicable to the TRIPS Agreement due to the negative effects they can have on both 
the policy space of Members  and on their ability to use TRIPS flexibilities to increase access to 
medicines and to enhance their capacities to better deal with current and future public health crises.  
291.  Second , we strongly support the continuation of the NV SCs moratorium and making it 
permanent, and we would like to refer in this regard to the reasons explained in document 
IP/C/W/385/Rev.1 which Egypt co -sponsored together  with a large number of other Members . We 
consider this document as a good starting point for a focused discussion on this issue.  
8.7  Nigeria  
292.  We thank the Secretariat for their briefi ng. We look forward to the proposal by any member 
on the examination of scope of application of NV SCs under TRIPS. However, in the meantime, we 
align ourselves with the statements made by the delegation of Tanzania on behalf of the African 
Group. We therefore wish to recall our previous statements under this age nda item.  
8.8  Chile  
293.  Our delegation 's position is well -known among Members . Moreover, we welcome the decision 
made at the last meet ing of the General Council in December 2019 to extend the moratorium.  We 
would like  also to thank the Secretariat for the briefing session organized on September 2020 that 
was very useful.  
294.  In our delegation 's view, both formal and informal talks on this matter at the Council have 
brought to light the existence of different positions concerni ng the conditions and modalities, and it 
is therefore appropriate to continue discussing the various aspects contained in the mandate of 
Article 64 of the TRIPS Agreement. Chile believes that it is vital to continue extending the moratorium 
until a common understanding can be reached on this matter.  
295.  We would appreciate receiving more information on the South African document that has been 
mentioned by the Brazilian delegation as our delegation is not aware of its contents. We believe that 
there could be a m ore inclusive and transparent approach in order to have a more fluid dialogue.  
8.9  India  
296.  Our position on this issue remains unchanged. Such complaints in TRIPS can have a debilitating 
impact on the regulator y policy space of Members  and on implementation of TR IPS flexibilities. They 
will not only introduce legal uncertainty but also severely restrain ability of Members  to achieve 
public policy objectives. We look forward to continuing  working with like -minded Members  in making 
such complaints inapplicable to TR IPS. 
8.10  Jamaica on behalf of the African, Caribbean and Pacific States  
297.  The African, Caribbean an d Pacific States Group (ACP) wishes to underscore the importance 
to WTO Members  of the continued examination of the applicability of non -violation c omplaints to the 
Agreement on Trade -Related Aspects of Intellectual Property Rights (TRIPS). While the views of 
Members  evidently vary, Members  have consistently agreed on the importance of continued 
examination of this issue. This agreement was reflected most recently at the WTO General Council 
meeting in December 2019 .  IP/C/M/96/Add.1  
 
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  298.  The Group takes note of Members ' interventions under this agenda item and recommends that 
the Council keeps the agenda item open and reconvene once further work is sufficiently mature, 
with a view to agreeing on a recommendation to the 12th WTO Ministerial Conference.  
8.11  Argentina  
299.  Argentina 's position on this issue is well -known and, to date, remains unchanged. We believe 
that complaints of this type are no t applicable to the TRIPS Agreement for the reasons explained in 
document I P/C/W/385/Rev.1, which Argentina co -sponsored together with a large number of other 
Members . 
300.  Non-violation and situation complaints in the TRIPS context are unnecessary. They raise 
serious systemic concerns, run counter to the long -term interests of the multilateral trading system 
and upset the delicate balance of rights and obligations in the Agreement.  
301.  We believe it is necessary to continue to explore this matter, and Argentina is ready to pursue 
constructive discussions on this issue with a view to finding an acceptable and permanent solution.  
8.12  Thailand  
302.  Thailand maintains its position that the non -violation and situation complaints should not apply 
to the TRIPS Agreemen t for the same reasons expressed  in previous meetings.  
303.  Thailand agrees with the statements of others that more time is needed for the clarity on the 
scope and limitations of the NV SCs applicability , and that the NV SCs Moratorium should be extended.  
8.13  China  
304.  We would like to thank the Secretariat for organizing an informative and comprehensive 
briefing session on non -violation complaint in early September. It has deepened our understand ing 
in this regard.  
305.  China 's position on this issue remains unchanged. We sha re the view with many Members  that 
non-violation and situation complaints should not be applicable to the TRIPS Agreement.  
306.  We also support continuing the examination of this issue and look forward to the proposal.   
8.14  Indonesia  
307.  Indonesia thanks the Secretariat for organizing the briefing session in early September.  
308.  Indonesia reaffirms its position that apply ing NVSC s to the TRIPS Agreement could result in 
imbalance between the rights of IP -holders, IP users, as well as the public  interest. The absen ce of 
scope and modalities for NVSC would introduce new obligations and raise the standards for 
protection beyond what has been agreed upon.  
309.  Moving forward towards MC12, Indonesia supports a permanent moratorium of NVSC to the 
TRIPS Ag reement. In addition, Indonesia stands ready to engage in discussion s if any Member put 
any proposal on the table.  
8.15  Switzerland  
310.  Switzerland 's position under this agenda item and for the Council 's recommendation is 
well-known.  Our position remains unchanged.  
311.  This statement serves on the one hand to thank the Secretariat for organizing the useful 
briefing session on non-violation nullification and impairment (NVNI) in early September . On the 
other hand, this is to confirm that Switzerland is ready to  examine and discuss any proposal from 
other TRIPS Council Members on modalities for non -violation and situation complaints under the IP/C/M/96/Add.1  
 
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  TRIPS  Agreement, should they consider such modalities necessary in addition to those contained in 
the Dispute Settlement U nderstanding.  
312.  We thank the delegation of Brazil for informing the Council about internal thinking and work 
under way in Brasilia on the issue of modalities that may be submitted to the Council at a later stage  
at the Council meeting . 
8.16  United States of Ameri ca 
313.  The United States ' position on this issue remains unchanged. We reiterate our support for 
allowing the current moratorium to expire so that Members  may bring NVNI complaints in the future, 
as appropriate.  
314.  In the previous TRIPS Council  session , some Members raised concerns over the application of 
NVNI complaints to the TRIPS Agreement. We believe that while val id questions have arisen, they 
are fully and adequately answered by the text of the TRIPS Agreement itself and further clarified 
through  GATT and WTO adjudication, as w e have enumerated in our communication to the TRIPS 
Council in the past as well as in our recent interventions.  
315.  The United States has provided detailed and extensive analysis in each of our statements 
under this  agenda  item over the past several years. As we have detailed in past interventions, NVNI 
claims have a long lineage in the WTO and in international trade law generally. The applicability of 
such claims to the WTO Agreements is the rule; their non -application is the ex ception. The 
TRIPS  Agreement moratori um is the exception.  
316.  We continue to believe that WTO Members  are being deprived of an important tool to enforce 
their rights under the TRIPS Agreement, which is why we support the expiration of the current 
moratorium so  that complaints of this type may be applicable to the TRIPS Agreement.  
8.17  European Union  
317.  The European Union would like to first of all thank the Secretariat for the preparation of the 
technical meeting on this matter which was very useful.  
318.  The EU supported extending the moratorium of 13 December 2017 on not using TRIPS 
non-violation and situation complaints.  However, the EU remains open to hear and discuss any 
possible solutions for the future.  
8.18  Canada  
319.  Canada 's longstanding position on this issue remains unch anged , that the availability of NVNI 
claims under TRIPS would create legal uncertainty for Members . Canada recognizes that the current 
morat orium exists thanks to consensus, and we trust that Members  can continue to discuss these 
issues in a collegial manner, especially in view of the high concentration of Members  with concerns 
in this area. We wish to express our continued interest in participating in any consultations that take 
place on this issue a mongst other interested Members . 
8.19  Chinese Taipei  
320.  We understand that there are concerns among Members  over the applicability of non -violation 
and situation complaints to  the TRIPS Agreement. We are looking forward to substantive discussions 
about the scope and modalities for complaints of this type of dispute applicable under the Agreement.  
8.20  South Africa  
321.  I just wanted to clarify one reference by Chile.  The paper was really  designed to be discussed 
in the context of the BRICS collaboration which we have had for a few years on IP matters. So it  
was really a group paper and the reason w hy this was not more widely shar ed was essentially that 
internally we are also working to try to accommodate some of the elements that are contained in 
that paper. So from that point of view, in the interest of transparency , I would just want to say that 
this is a working document and as soon as we have some consensus elements , that we could extend IP/C/M/96/Add.1  
 
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  this paper further, but as I indicated, this is also no bar to us making this paper available more 
generally , whether it is bilaterally or through any facilitator process. We stand ready to share these 
ideas soon.  
8.21  Ecuador  
322.  Our delegation rei terates its position that these complaints are not applicable under the 
TRIPS  Agreement, given that the scope and modalities for complaints of the types provided for under 
subparagraphs 1(b) and 1(c) of Article XXIII of the GATT should not be applicable to  dispute 
settlement under the TRIPS Agreement.  
323.  Document IP/C/W/385/Rev.1, co -sponsored by Ecuador and many other countries, clearly 
substantiates this position.  
324.  Our delegation will, accordingly, continue to participate actively in the Council 's deliberatio ns 
so as to reach a definitive solution on this matter.  
8.22  Korea, Republic of  
325.  Korea 's position on this  issue has not changed. We are still open to further discussing this 
issue with other interested Members  and we are looking forward to hearing from South Afr ica and 
others about the new proposal on modalities und er this issue.  
9  REVIEW OF THE IMPLEMENTATION OF THE TRIPS AGREEMENT UNDER ARTICLE 71.1  
326.  No statements were made under this agenda item.  
10  REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON 
GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2  
327.  No statements were made under this agenda item.  
11  EIGHTEENTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON THE 
IMPLEMENTATION OF ARTICLE 66.2 OF THE TRIPS AGREEMENT  
11.1  United Kingdom  
328.  The United Kingdom remains co mmitted to implementing Article 66.2 of the TRIPS Agreement 
to promote and e ncourage technology transfer to least developed countr ies. In September, we 
submitted our Annual  Report to the Council, which sets out a number of successful projects 
undertaken by  the UK Government.  
329.  We will provide an update on a project undertaken by the United Kingdom – the 
Commonwealth Marine Economies Programme  (CME).  
330.  Launched in 2016, this UK Government programme  aims to support the marine economies 
(also referred to as blue e conomies) of 17 Commonwealth Small Island Developing States (SIDS).  
331.  In partnership, the programme  develops and implements national Maritime Economy Plans to 
ensure the programme  leaves a lasting legacy.  
332.  The CME Programme  is an integral part of the UK 's effort to protect the health of the world 's 
oceans and promote the growth of blue economies.  
333.  The programme  builds the capacity of the islands to manage their marine resources and 
develop their national maritime economies.  
334.  Capacity and knowledge (through Part nerships, support and training, and technical assistance) 
has been built in areas such as Seabed Mapping, marine data collection, deep -sea environmental 
assessment, mapping of water quality and human health issues.  IP/C/M/96/Add.1  
 
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  335.  Marine economies face common threats and  challenges due to their small size and populations, 
remoteness, narrow economic bases, and high degree of vulnerability to external economic and 
environmental shocks. And while accounting for a tiny fraction of the world 's greenhouse gas 
emissions, are li kely to be among the first to suffer the consequences of global warming.  
336.  Work delivered in support of marine economies since launch includes supporting priority 
clean-up activities and coastal planning in the Solomon Islands and Vanuatu, by helping to ide ntify 
marine litter and pollution hotspots, and working with the Government of Vanuatu to enhance 
hydrographic governance, improving compliance with International Conventions  
337.  This programme  has helped identify the potential of, and develop, marine economi es in a 
sustainable, resilient, and integrated way - promoting growth, innovation, jobs and investment, 
whilst safeguarding healthy seas and ecosystems.  
338.  The U nited Kingdom  looks forward to providing further examples at the workshop on 
technology transfer, which is scheduled to be held in early 2021.  
11.2  Australia  
339.  Australia was pleased to submit its TRIPS Article 66.2 report to the Secretariat on 
18 September  2020. We take our TRIPS Article 66.2 reporting seriously and  are careful to submit 
our reports using the template preferred by LDC Members . 
340.  Our report focuses on Australia 's efforts to help LDCs create the conditions essential to allow 
the transfer of technology . Many of our efforts to promote technology transfer take the form of 
official development assistance . Australia is committed to using development assistance as a catalyst 
to promote economic growth and development.  
341.  We would be happy to discuss our report further with Members  at the next available 
opportunity.  
11.3  South Africa  
342.   We thank Members  that have submitted their reports . As we indicated in the last 
TRIPS  Council meeting , developed country Members  are required to submit information as a matter 
of legal obligation, the wording TRIPS Article 66.2 is quite unequivocal, 'developed country Members  
shall provide… ' The good faith principle also requires that when such information is provided, that 
informa tion should be relevant and comprehensive enough in order to assess whether the legal 
obligation is met. We note from a working paper of the WTO some historical factual data regarding 
the nature of information that was provided by developed country Members  from 2000 onwards. It 
is pointed out that at the request of the TRIPS Council, the WTO Secretariat made a summary of the 
first round of submissions. This summary noted that "It was not possible to distinguish between 
developing countries generally and lea st developed countr ies in most of the information submitted. " 
(page 8). This problem seems not to have been addressed in any concrete way, even in light of the 
Council 's Decision on Implementation of TRIPS Article 66.2 ( document IP/C/28).  
343.  In 2011 , LDC Members  in document IP/C/W/561 proposed a different format for reporting . 
This has been taken up by many Members  but not in a uniform way. In their recent submission , the 
LDC Group asked for another simplification of template to be adopt ed with an app endix that will 
enable a more accurate reflection of the recipients of incentives. As indicate d in that meeting, 
South  Africa supported the premise of the paper as well as the call to clarify fundamental concepts 
- such as "transfer of technology " or "incentives " used in the text of TRIPS Article 66.2. Clarifying 
these matters will help us understand if Members  are actually doing what they had undertaken to 
do. Some of these issues can be taken up in the workshop on TRIPS Article 66.2 which the Secretariat 
is planning as well bilaterally on the basis of the LDC  Group 's proposed template.  
344.  We would be interested to know whether or not further discussions could be held t o incorporate 
some  of the newest ideas that the LDCs have put on the table.  IP/C/M/96/Add.1  
 
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  11.4  Japan  
345.  Even though it is not necessary to mention again, this delegation recognizes the importance 
of Article 66.2 of the TRIPS  Agreement  for LDCs, taking  into account their economic, financial and 
administrative constraints and so on. From such a perspective, Japan is earnestly engaged in 
improving the business environment for technology transfer to LDCs . 
346.  This t ime, this delegation would like to briefly describe this year 's report on our implementati on 
of TRIPS  Article 66.2, document IP/C/R/TTI/JPN/1. The report consists of four sections, namely, I) 
activities undertaken by technical cooperation organizations , II) activities in the field of climate 
change , III) activities in the pharmaceutical sector , and IV) activities in the field of intellectual 
property rights.  
347.  Furthermore, this report has an annex in a spreadsheet format, which provides detailed 
information on each activity involving technology transfer. In this annex, participating LDCs are 
shown  in bold where they are included as parts of beneficiaries.  
348.  Japan understands that incentives to enable technology to be transferred include a variety of 
measures such as financial support and business environment support, because one of the main 
obstacles  for enterprises and institutions in developed countr y Members  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.  
349.  Japan believes that activities in the report contribute to creating a sound and viable 
technological base in LDCs, which will bring about further technology t ransfer by enterprises and 
institutions in developed countr y Members . 
350.  Japan will continue to make its utmost efforts to improve the business environment and make 
it even more conducive to transfer technology. In the coming Workshop to be held early 2021, this 
delegation is willing to introduce our report in detail, and strongly believes that the workshop will be 
a good opportunity to enhance mutual understanding, which will lead to greater cooperation in the 
future.  
11.5  Switzerland  
351.  Switzerland 's 2020 report ( document IP/C/R/TTI/CHE/1) reflects an updated list of the 
measures ad programme s that Switzerland has implemented to incentivize techn ology and 
knowledge transfer to LDCs.  
352.  The report lists projects financed by Swiss official development assistance  as funded by the 
Swiss Agency for Development and Cooperation and the State Secretariat for Economic Affairs.  
353.  Detailed information on the various incentives provided under TRIPS Article 66.2 to enterprises 
and institutions on the territory of Switzerland can be found in our 2020 report.  
354.  As desired by the LDC Group, Switzerland specifically lists all targeted LDC Member(s) for each 
of the 46 projects separately (see annex to the report).  
355.  Switzerland will make maximum efforts in its future reports to provid e relevant information on 
the incentives it provides under TRIPS  Article 66.2 in a manner as transparent, consistent, clear and 
comprehensible as possible.  
356.  We suggest keeping the current reporting format, and will make all efforts to submit 
2021 report th rough the e -TRIPS Submission System, as the TRIPS Secretariat encourages Members  
to do.  
357.  Switzerland will continue to engage in discussions with the LDC Group and remains committed 
to further promoting the technology and knowledge transfer to LDCs.  IP/C/M/96/Add.1  
 
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  11.6  Banglad esh 
358.  The delegation of Bangladesh welcomes the annual reports o n the implementation of the 
provisions of TRIPS Article 66.2 submitted by the developed country Members . The reports p rovide 
the reporting Members ' generous efforts to help create sound and viable technological base in LDCs.  
359.  If examined carefully, some of the reports presented in th is TRIPS Council have listed 
initiatives like organizational reform of revenue authority, financial support to construc tion of an 
academic building, supply of metal silos and hermetic bags, and different training initiatives including 
financial management, trade capacity, human resource management, global value chain, land 
management, project management, organizational man agement, good governance, public 
awareness and so on. Like many LDC Members , my delegation struggles to understand how these 
initiatives can be justified as technology transfer or what technologies have been transferred to the 
LDCs. In addition, most of th ese reports do not clearly offer information on incentives provided to 
enterprises and institutions in the reporting Member 's territory.  
360.  My delegation finds that these reports are a mixture of technical assistance programmes and 
a few technology transfer  initiatives. We sincerely acknowledge that technical assistance 
programme s aimed at enhancing capacities are extremely important for the LDCs. However, these 
reports only fulfil the requirements of TRIPS Article 67 on technical cooperation but do not fully  
satisfy the obligation of TRIPS Article 66.2.  
361.  LDCs always appreciate the contributions of developed count ry Members  and their annual 
implementation reports under TRIPS Article 66.2. During the July 2020 meeting of the TRIPS Council, 
the LDC Group submitt ed a template for annual reporting ( document IP/C/W/664) under 
TRIPS  Article 66.2. The proposed template does not demand any new information and has just 
reorganized the columns and rows of the existing reporting format that developed country Members  
are a lready using following the TRIPS Council decision contained in document IP/C/28 dated 
20 February 2003 and the reportable areas proposed through document IP/C/W/561 dated 
06 October 2011. The main objective of the reporting template ( document IP/C/W/664) i s to specify 
the incentives and the details of the enterprise and institution receiving the incentives from the 
developed country Members  and transferring technology to LDCs.  
362.  The LDC Group believes that the improved template will help simplify reporting pr ocess, 
synchronize the current reporting variations, and acknowledge the substantive contributions of the 
developed country Members  with evidence and precision. During the July 2020 meeting of the 
TRIPS  Council, my delegation requested Members  to examine t he LDC submission in document 
IP/C/W/640 to help specify the meaning of 'incentives to enterprises and institutions ' and the LDC 
submission room document RD/IP/24 to agree on developing an illustrative list of incentives for the 
purpose of technology trans fer to LDCs. My delegation requests the reporting Members  to consider 
using the improved template contained in document IP/C/W/640 for annual reporting from 2021. 
My delegation also expects that the next WTO workshop on technology transfer to LDCs early 2021, 
will serve a good platform for constructive dialogue between developed country and LDC Members  
on the issue of technology trans fer and annual reporting.   
363.  My delegation also thanks those developed country Members  who have expressed willingness 
to engage further and consider using the template. The delegation of Bangladesh stands ready to 
engage constructively with Members . In addition , Bangladesh requests the TRIPS Council to please 
keep the item for discussion in the agenda of  the next meeting of the Council.  
11.7  Chad on behalf of the LDC Group  
364.  I am going to attempt to expand on what has been said by Bangladesh, our TRIPS focal point.  
365.  I would like to begin by thanking Japan, Switzerland, the United States, Australia, the 
United  Kingdom and all the developed country Members  that submitted the updated  report s on 
Article 66.2  of the TRIPS Agreement . 
366.  On behalf of the LDC Group, I also wish to thank South Africa for its relevant briefing on the 
fundamental objective of TRIPS Article 66.2 and what is expected from the operationalization of this 
Article.  IP/C/M/96/Add.1  
 
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  367.  Japan has clearly raised an important concern. I simply wish to reassure our Japanese 
colleague that, with regard to the business environment that he mentioned as an obstacle, the LDCs 
are undertaking many efforts in terms of regulations, the legal framework  and fiscal incentives to 
attract investment and therefore improve the accessibility of information and communication 
technologies (ICT). Our governments  have demonstrated clear political determination to facilitate 
such access and important provisions are in place and will be effectively strengthened.  
368.  We have witnessed how technologically equipped countries are the best prepared to handle 
the current heal th crisis that has led to restrictions on movement and a slowdown of global activity 
and aggregate demand.  
369.  As you can imagine, for highly fragile countries such as ours, the current global health crisis 
has intensified the pressure on us while disrupting o ur progress and development projects. It is 
therefore vital for us to focus on bridging the digital divide. In this respect, the transfer and use of 
technology play an important role in our economic catch -up. This is why the LDC Group is seeking 
the effect ive implementation of Article 66.2 of the TRIPS Agreement on incentives for technology 
transfer. This Article stipulates that developed country Members  shall provide incentives to 
enterprises and institutions in their territories for the purposes of promot ing and encouraging 
technology transfer to LDCs in order to enable them to create a sound and viable technological base.  
370.  In light of this, we are calling on Members  to pay due attention to these matters, which are a 
priority for the LDC Group, and to follo w up on them in line with their obligations under the 
Agreement relating to technology transfer to LDCs.  
371.  It is clear that, in the area of trade, the development of technologies has given rise to trade 
that is today more fragmented and integrated in regiona l and global value chains. Technology has 
enabled many developing countries which were unable to manufacture a whole product to 
nonetheless profit from the wealth created by these products. We need to be more integrated in 
these regional and global value c hains and able to create value added for the products that generate 
the most wealth for our economies, through technology that facilitates processing.  
372.  It is therefore essential for LDCs to benefit from the transfer of technology that facilitates 
processing  and enables us to increase production levels. We also require technology that allows us 
to develop new products using existing domestic resources.  
373.  I wish to conclude by saying that technology transfer remains a key and vital element for LDCs 
to ensure the  successful implementation of our development programme s and projects. We must 
therefore collectively pursue our efforts and ensure that the benefits of new technology are 
harnessed to achieve fair, inclusive and sustainable development with a particular f ocus on the most 
fragile.  
11.8  Canada  
374.  Canada is pleased to take this opportunity to present  an overview of Canada 's most recent 
report on the implementation of TRIPS Article 66.2, which was submitted to the WTO Secretariat in 
October  2020. We thank the Secretar iat in advance for its efforts in circulating Canada 's report 
following this session. As in previous years, Canada 's report has been developed to reflect certain 
criteria requested by LDCs at the October 2008 and October 2010 workshops, as well as the form at 
proposed by LDCs in October 2011, in document IP/C/W/561.  
375.  Canada 's report is divided into two sections: the first provides a broad overview of Canada 's 
approach to the implementation of TRIPS Article 66.2, including on the types of incentives provided 
and the thematic areas under which technology is transferred under this commitment. It also 
presents the range of entities in Canada that administer incentives for the promotion of tech transfer 
to LDCs. The second section includes an annex of ongoing, nota ble projects undertaken in recent 
years, with key details on each LDC -focused initiative, including project overviews, outcomes, and 
contact points. As we have pointed out in previous discussions, Canada 's reporting on Article 66.2 
of the TRIPS Agreement focuses primarily on informal, non -market incentives to promote tech nology  
transfer to LDCs. This includes projects financed by Government of Canada departments, agencies, 
and Crown corporations, in partnership with private enterprises and institutions thro ugh official 
development assistance, grants, and other concessional financing.  IP/C/M/96/Add.1  
 
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  376.  The initiatives outlined in Canada 's 2020 report are varied in nature, and respond to the broad 
range of thematic needs and priorities identified by LDCs in cooperation with Canadian enterprises, 
institutions, and development practitioners. With this in mind, Canada remains interested in he aring 
the experiences and interests of LDC Members  in specific projects and priorities, as well as the 
experiences of other developed country Members , with a view to identifying best practices and 
commonalities. Canada would be pleased to discuss any aspec t of its 2020 Report with interested 
LDC Members , and looks forward to constructive engagement on these important issues, including 
in the context of the TRIPS Article 66.2 workshop in early -2021.  
11.9  Indonesia  
377.  My delegation would like to seek clarifications f rom Australia on the report that put one 
programme  the WIPO Accessible Book Consortium in document IP/C/R/TTI/AUS/1, which stated that 
the benefit of the programme  are Indonesia and Viet Nam. We seek clarifications whether that 
particular programme  is corr ectly put in this report. The report focuses on incentives that are either 
targeted, specifically at LDCs or at the group of countries which includes LDCs.  
11.10   United States of America  
378.  The United States attributes great importance to this review with respect t o the obli gations 
under TRIPS Article 66.2.  
379.  Our 2020 submission  in document IP/C/R/TTI/USA/1 is the second update to our 2018 report, 
detailing programme s aimed to support LDCs in fostering the necessary environment to encourage 
the effective, voluntary transfer of technology to LDC Members . The US submission details 
programme s ranging from intellectual property and trade capacity building to capacity buil ding in 
health, labour , and the environment.  Similar to the last two years ' submissions, this report includes 
comments from host countries regarding the value of several of the programme s listed in the report.  
380.  The United States continues to believe that the effective functioning of Article 66.2 of the 
TRIPS Agreement requires a robust dialogue between developed countries and LDC Members  in 
order to target incentives in a way that is most responsive to the self -identified technology transfer 
interests and needs of LDC Members .  
381.  Please allow me to mention some elements contained in our 2020 report, highlighting a few 
programme  updates.    
382.  Founded in July 2013, the Smart Infrastructure for the Mekong (SIM) programme  offers 
governments participating in the Lowe r Mekong Initiative (LMI) an array of technical advisory, 
capacity -building, and support services related to climate -smart, environmentally sound and socially 
equitable infrastructure, clean energy development, and land and/or water resources use related t o 
sustainable management of the Mekong. Through a multi -agency US government agreement, SIM 
has access to some of the US government 's best engineers, scientists, and technical and policy 
experts to support these activities.  
383.  Under the LMI, the US Departmen t of State supported an October 2018 Information Sharing 
Programme  that brought 13 scientists and practitioners from Myanmar , Thailand, Lao PDR, and 
Cambodia to Houston, Texas , Miami  and Florida. The activity transferred expertise and know -how 
related to e fforts to combat vector -borne diseases, including dengue, Zika, West Nile Virus.   
384.  The group 's itinerary was designed to focus on three common challenges: 1) bolstering 
cooperation between environmental management, public health, and health care; 2) strengt hening 
public outreach to affected communities; and 3) incorporating innovative technologies and 
approaches to model, surveil, and control mosquito vectors. State and local governments are often 
the best places to observe approaches to addressing these cha llenges and to understand how 
programme s work; the group also visited with community and academic partners in each location.  
385.  The activity included transfer of expertise and know -how related to  the distribution of mosquito 
traps and surveillance sites and use of data for effective targeting of mosquito control; creation and 
distribution of multi -lingual, science -based public information products; piloting novel techniques for 
mosquito control, including "smart " (Internet of Things) devices as well as biolog ical, chemical, and IP/C/M/96/Add.1  
 
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  genetic techniques to control mosquito populations; and designing rigorous methods for testing 
effectiveness of novel techniques.  
386.  Results from the activity were used to frame the July 2019 LMI Young Scientist Programme  in 
Vientiane, La o PDR. The programme , which included 33 students and young professionals from 
Myanmar , Thailand, Lao PDR, Cambodia, and Viet  Nam, featured participants from the 2018 
Information Sharing Programme  as speakers and mentors for participants. The theme of the 
programme  was teaching and inspiring participants to build informatics tools to support vector -borne 
disease control in the region. Additionally, participants acquired knowledge related to ideation, 
design thinking, teamwork, and prototyping.  
387.  The programme  evaluations indicate a high level of satisfaction with the programme . Each 
week's content relevancy earned "satisfied " ratings from 75% or more of participants; several of the 
individual modules received "satisfied " ratings from more than 95% of participants.  
388.  A Laotian specializing in Epidemiology at Michigan State University recalled her experiences 
during a memorable field trip in Lao  PDR: "I have been working in public health area, and my work 
has focused just on immunization. I had no idea ab out the severity of Dengue outbreak in Lao  PDR 
before I joined the programme . LMI open my perspective[s] on a very important issues such as 
vector borne diseases control and prevention. I got to meet brilliant entomologist from Cambodia 
and learned from th em how to identify mosquitos. And I got to meet a mathematician from Thailand 
who taught me the principle of machine learning, " she said . 
389.  This and many examples are in our report. We look forward to further discussing our report 
with LDC Members  at the Feb ruary workshop.  
11.11   Australia  
390.  I just wanted to take a moment to respond to the question appointed from  the Indonesian 
intervention , in terms of how we do our 66.2 Report. A number of our intended programme s are 
valuable for activities in both LDCs and other de veloping countries . Rather  than being limited  only 
to LDCs , we have, however, made a deliberate effort to highlight LDCs recipients in our 66.2  report. 
The programme  WIPO Accessible Book Consortium supports both developing Members  and LDC s 
Members . 
11.12   European Union  
391.  The European Union and its Members  take their commitment under TRIPS Article 66.2 very 
seriously and annually provide a detailed update on their respective technology transfer 
programme s. The EU and its Members  provided proof year after year  of having promptly and 
attentively reacted to natural, social, health, climate and economic changes by implementing 
projects specifically tailored to the current needs of LDCs and their regional organisations.  
392.  On 7 October  2020, the EU submitted its annu al report on technology transfer programme s 
carried out between July 2019 and July 2020 by the European Union and EU Members  in favour of 
least developed country Members . Our programme s can be found in the e -TRIPS Portal.  
393.  Beyond the EU -financed programme s, in 2020  Austria, Czech Republic, Denmark, Finland and 
Germany sent reports to the European Commission on technology transfer programme s provided to 
LDCs. The report submitted by the EU is not an exhaustive list of all the programme s provided but 
gives on ly examples of the technology transfer programme s. The programme s cover a wide range 
of sectors, including public health, agriculture, telecommunication, energy and water sanitary 
systems.  
394.  Taking into account the format of this meeting, on the issue of conditions for successful 
technology transfer, including the importance of absorptive capacity of LDCs, we would like to refer 
to our interventions on this topic in previous meetings.  
395.  We will  be ready to present our report more in detail at the workshop organised  in early 2021 
and we stand ready to assist the beneficiary least developed country Members  should they have any 
questions concerning the programme s included in our report.   IP/C/M/96/Add.1  
 
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  396.  As for the  new proposed template from the LDC Group, the EU is open to engage constructively 
in the discussion on the use of the new template and the consequent adaptation of the e -TRIPS 
Portal where it helps promote objectives such as accessibility and searchabilit y. 
11.13   Chad on behalf of the LDC Group  
397.  We would like to thank the European Union for the update on the submitted report. We would 
like particularly to thank the United States for their intervention and in particular the examples that 
have just been given. The example of Cambodia was a fairly  concrete example. The LDC Group is 
looking forward to the examples from the United States at the next workshop to give us more details 
on the examples they have developed , and it would be a great pleasure for us to receive this 
information. It would also b e important for us as LDCs to give feedback o n what was done, what 
obstacles we encountered and what we did not achieved. So the LDC Group also reiterates its call 
on Members  to really effectively implement TRIPS Article 66 .2 on technology transfer which is in the 
interest of all and especially to help the most vulnerable to achieve development goals.  
11.14   Cambodia  
398.  Cambodia would like to take the opportunity to thank all Members who had updated the 
information under the Article 66.2  of the TRIPS Agreement. Specially we thank the United States for 
the programme on technology transfer to Cambodia. I would like to encourage other Members in 
continue in providing incentives for technology transfer because is very helpful for LDCs.  
12  TECHNI CAL COOPERATION AND CAPACITY -BUILDING  
12.1  United States of America  
399.  The United States is pleased to highlight its report under Article 67, contained in document 
IP/C/R/TC/USA/1 on the technical assistance programmes  provided by the US Government 
concerning the protection, utilization and enforcement of intellectual property rights, including 
patents, trademarks and enforcement for developing and least developed countries.  
400.  Although traditional, face -to-face training programme s did not take place from mid-March 
through September 2020, the US Government continued to meet training obligations during this 
unprecedented time through increasing its leverage of various technologies to provide live, online IP 
training. Through these well -attended and well -received distance learning initiatives, US government 
agencies provided tailored content to developed and developing countries and LDCs.  
401.  Our report accounts for more than 195 training, technical assistance, and capacity building 
programme s for four intergovern mental organizations and 160 different countries, including 
developing countries and LDCs in the past year.  
402.  Of these programme s, 53 programme s were provided for over 36 LDC countries, including, 
Afghanistan, Angola, Bangladesh, Benin, Bhutan, Burkina Faso,  Burundi, Cambodia, Chad and 
others.  
403.  Technical cooperation to improve IP legal, administrative and enforcement infrastructure is 
crucial to countries ' economic development and directly contributes to foreign investment and 
voluntary, private sector -led te chnology transfer in developing countries. It also allows developing 
country innovators to capitalize on their creativity.  
404.  US government technical assistance is driven by demand and individual priority needs of 
beneficiary countries. The diversity of needs  and interests identified by beneficiary countries results 
in tailored technical assistance activities on specific areas of interest.  
405.  We look forward to continued discussions on reports in the Council concerning technical 
cooperation of governments and IGO s for the strengthening of IP systems.  IP/C/M/96/Add.1  
 
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  12.2  United Kingdom  
406.  The U nited Kingdom  strongly believes technical cooperation and capacity building efforts are 
essential to support the development of a global IP system for t he benefit of all.  
407.  In document IP/C/R/TC/GBR/1, t he UK has submitted its Annual Report on Technical 
Cooperation in l ine with its obligations under Article 67 of the TRIPS Agreement, and would like to 
share with you some of the work we  have been undertaking together with Brazil, as exemplars of 
our cross -cutting and wide -ranging technical assistance initiatives.  
408.  We have been working closely with Brazil to support them in reinforcing their IP enforcement 
systems and processes, including visits and best practice exchanges of information.  
409.  For example, building on previous engagements with Brazilian authorities and p rosecutors, an 
IP Enforcement expert from the UK Intellectual Property Office and the Detective Superintendent of 
the UK 's Police Intellectual Property Crime Unit visited Brazil in September  2020, together with the 
UK Intellectual Property attaché based in  Sao Paulo, to share UK experiences of tackling IP 
infringement, particularly IP crime such as counterfeiting and piracy.  
410.  During this, we conducted discussions with a wide range of Brazilian enforcement agencies, 
rights holder representatives and governmen t officials in Brasilia, Sao Paulo and Rio de Janeiro, and 
shared approaches to tackling online copyright infringement through voluntary collaboration.  
411.  Wanting to learn from our expertise in tackling online fake goods, Sao Paulo City Hall (which 
has been u ndertaking a series of actions to tackle counterfeiting) in March  2020 signed a 
Memorandum of Understanding with the IPO of the UK which commits both parties to establishing a 
framework under which the participants can develop cooperation activities in the  field of 
IP protection, utilisation and enforcement.  
412.  We have also supported Brazil in improving its management of administrative processes, such 
as rights granting. In February 2020, we launched a project designed to develop a Brazilian 
Intellectual Prope rty Office for the 21st century.  
413.  This three -year project will involve a series of actions to modernise processes and increase 
office efficiency, leading to an improved quality of IP rights granted in a reduced timeframe.  
414.  The project will be delivered thr ough close partnership between the IPO of the UK and the 
Brazilian National Institute of Industrial Property – by implementing targeted interventions that will 
bring the country closer to international standards and practices.  
415.  These are just some examples of our commitment to providing technical assistance to improve 
the intellectual property system for all those who use it. You can find more details of our initiatives 
in the report we submitted, and we would be very happy to answer any further questions.  
12.3  Japan  
416.  This delegation would like to briefly describe 2020 report on Japan 's technical cooperation, 
document IP/C/R/TC/JPN/1. The 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.  
417.  This report categorizes cooperative activities into four areas, namely, industrial property, 
copyrights, plant varieties, and border measures.  
418.  When it comes to industrial property, the Japan Patent Office organized 15 training c ourses 
for both government officials and the private sector in FY2019. More than 250 people attended in 
total. Moreover, based on the JPO 's long history of conducting training courses, alumni associations 
have been established in the trainees ' home countries. The Japan Patent Office continues to support 
the alumni associations by holding follow -up seminars in Asian countries.  
419.  Turning now to copyrights, in FY2018, the Japan Copyright Office, with the support of the 
WIPO, held training courses i n Japan and workshops in Asia - Pacific countries.  IP/C/M/96/Add.1  
 
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  420.  Moreover, Japan provided technical cooperation to developing and least  developed country 
Members  on the protection of plant varieties and border measures.  
421.  Japan will continue to make its utmost efforts to fulfil its obligation under Article 67.  
12.4  Australia  
422.  Australia takes an active rol e in promoting technical cooperation and capacity building in the 
intellectual property field as we have highlighted in our 2020 Article 67 Report, which we submitted 
to the Sec retariat on 18 September  2020. 
423.  From December 2019, a third iteration of the  Australia /WIPO  Funds -In-Trust (FIT) programme 
has supported a range of intellectual property (IP) capacity building activities, which will enable the 
development of IP systems in b eneficiary countries. During this reporting period, the majority of 
activities under the new work plan for the F IT have been scoped or commenced.  
424.  We are pleased to reiterate our commitment to technical cooperation and intellectual property 
capacity buildin g activities.  We would be happy to discuss our report further with Member s at the 
next available opportunity.  
12.5  Canada  
425.  Canada was pleased to submit its annual report on the implementation of Article 67  of the 
TRIPS Agreement to the WTO Secretariat in October.  The 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 . In the meantime, Canada  would like to share a few highlights  of the 2020 report to the 
present meeting . 
426.  During the reporting period, the Canadian Intellectual Property Office ( CIPO) provided patent 
searc h and examination reports, upon request from other WIPO Members , and worked on five 
requests for search and examination reports from Kenya and Trinidad and Tobago. In 
November  2019, CIPO also participated in the Forty -Third Session of the Administrative Co uncil and 
Council of Ministers of the African Regional Intellectual Property Organization (ARIPO) in Monrovia, 
Liberia, to discuss how the Government of Canada works to advance IP and innovation. During this 
meeting, CIPO facilitated a workshop on developi ng an effective national IP Strategy, as well as a 
workshop for the Council of Ministers.  
427.  Also detailed in 2020 report, Canada 's International Development Research Centre (IDRC) has 
launched two new projects dealing with IP -related technical cooperation. F irst, the project entitled 
"Strengthening cyber policy research centres in the Global South " has been undertaken in 
partnership with the Centre for Intellectual Property and Information Technology Law, Strathmore 
University, Kenya, to strengthen research a nd policy capacity on critical digital policy issues. The 
project will help build institutional capacity and sustainability to produce locally -relevant research 
that convenes different perspectives on critical policy issues, and will strengthen the capacit y of 
research centres to inform and influence policy development. Another recent IDRC project, entitled 
"Initiative for Digital Rights in Latin America ", is a three -year collaborative re -granting/funding 
arrangement intended to strengthen and support the d igital rights ecosystem in Latin American 
countries, including Panama. The project will support institutional capacity on digital rights issues, 
including access to knowledge and copyright.  
428.  With respect to discussions in TRIPS Council, Canada remains inter ested in hearing  the views 
of developing country and LDC Member on some of the successes and challenges of technical 
assistance and cooperation in addressing their priority needs. Canada would also be interested in 
hearing how have priority needs changed s ince LDCs ' initial work on TRIPS implementation, and 
where gaps in technical assistance might remain. As well, Canada is interested in Member 
experiences and best practices on the types of technical assistance that have proven most effective 
in supporting the implementation of TRIPS obligations and in using IP to support economic and social 
development.  Canada look s forward to discussing these issues further with a view to ensuring that 
technical assistance continues to meet priority needs and development ob jectives.  IP/C/M/96/Add.1  
 
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  12.6  European Union  
429.  On 7 October 2020, the Europea n Union submitted its annual report on technical and fin ancial 
cooperation programmes  carried out between July 2019 and July 2020 by the European Union and 
EU Members  in favour of developing and least developed country Members , with the objective to 
facilitate the implementation of the TRIPS Agreement. Our programmes  can be found in the 
e-TRIPS  Gateway .  
430.  The EU carried out 40 technical cooperation activities during the reporting period and also the 
EU Members  contributed to the report. The Czech Republic, Finland, France, Germany, Lithuania, 
Portugal and Spain d elivered programmes  in this context.   
431.  The programmes  covered all IP rights in the TRIPS Agreement and some of the programme s 
were multi -annual programme s consisting of many activities to the benefit of LDCs and developing 
countries.  
432.  In the interest of time and due to the format of the meeting, we do not give an overview of 
these programmes , but we are ready to assist developed country Members and least developed 
countries should they have any questions concerning the programmes  uploaded to the 
e-TRIPS  Portal.  
12.7  Bangladesh  
433.  The delegation of Bangladesh welcomes the reports under TRIPS Article 67 from the developed 
country  Members  and the reports of the Secretaria t and other in ternational organizations on the 
technical cooperation and capacity building support to the developing countries and particularly the 
LDCs. These reports provide information on a wide range of programme s and activities customized 
for the beneficiary Member s. These programme s are critically important for the LDCs.  
434.  Bangladesh sincerely thanks the developed country Members  and the international 
organization s for their help and would like to encourage them to continue their valuable support for 
the developing countries and particularly the LDCs and the graduating LDCs.  
12.8  Switzerland  
435.  Simply to conclude on the developed country side, the Swiss technical cooperation and the 
capacity building in the field of intellectual property can be found for the 2020 annual repo rt in 
document IP/C/R/TC/CHE/1. Switzerland is currently partner to ten bilateral technical cooperation 
projects on IP, whereas the Swiss State Secretariat for Economic Affairs is the main funder of these 
projects through its global programme for IPR set u p in June 2018, the Swiss Federal Institute of 
Intellectual Property implements the global programme. The programme supports developing and 
least developed countries as well as emerging economies in developing an efficient and effective 
system for the prot ection and enforcement of IPRs with a view to promoting economic development 
and supporting our partners in their task to implement their rights and obligations under the TRIPS 
Agreement.  
12.9  Brazil  
436.  I would just like to take this opportunity to thank the Unite d Kingdom for their statement on 
the cooperation. Our countries are developing together, this partnership outlines the new moment 
when even Brazil with regard to the modernization of our IP system. We value our partnerships such 
as this and the ones also underway with the United States and France which are examples of how 
countries can work together in support  of the IP systems.  
12.10   Chad  on behalf of  the LDC Group  
437.  Regarding technical cooperation and capacity building, we have followed closely our peers in  
developing countries and other Members  who have taken the floor on these important issues. It is 
true that both technical assistance and capacity building are very important tools. If a country does 
not have the appropriate infrastructure or human capital , it would be difficult to make progress or 
achieve one 's goals despite one 's best efforts or intentions. As the United Kingdom and others have IP/C/M/96/Add.1  
 
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  already underscored, the LDCs consider that technical cooperation and capacity building are crucial 
to achieving  sustainable development, especially for LDCs in these extremely difficult and particular 
circumstances where certain activities have been suspended. Our delegates who should have 
travelled from the capitals have not been able to do so due to the pandemic and so capacity building 
has been curbed, which impacts on our development and our projects.  
438.  The LDCs are requesting that the resources allocated to the Secretariat for capacity building 
and technical assistance be increased in order to meet the growing ne eds of Members , in particular 
those of LDCs.  
439.  The various technical assistance and capacity building programmes  help us not only to comply 
with our obligations but also to make full use of our rights within the multilateral trading system, to 
continue to pa rticipate actively in multilateral trade negotiations and to create new possibilities for 
economic growth and development.  
440.  In conclusion, the LDCs wish to thank the Members  for their continued support, which is 
extremely necessary, useful and important.  
12.11   Mali 
441.  I would al so like to thank all the development partners that he lp Mali, that support us and that 
provide us with very effective assistance. Allow me to give you a few examples. During the COVID -19 
lockdown period, we had young innovators and inventors who developed a number of systems. 
Again, I  am just citing a few ex amples of start -ups that devised innovations for businesses: an 
artificial respirator, a disinfecting portal, an intelligent hand washing apparatus, a negative pressure 
ventilator and mobile applications. These young people only ask to be supported and rec ognized 
because as we saw, the closing of borders has been disastrous for us ; especially for Mali, which is 
landlocked. I reiterate that assistance is necessary  and indispensable to us to help these young 
people through scholarships and funds to multiply t heir ideas and for these inventions to be made 
available in large numbers to hospitals and clinics. This would be very useful and a very good thing. 
This concretely is the type of assistance that young people need. These start -ups do  not have the 
funds but  lack no amount of creativity to make inventions that we needed and used during the 
pandemic.  
12.12   South Africa  
442.  Technical cooperation and capacity building are core functions of the WTO. In this regard we 
would like t o thank the Secretariat for the report on it s activities from 1 October 2019 to 
30 September 2020 contained in  document  IP/C/R/TC/WTO -OMC/1. The e -TRIPS Submission 
System and the e -TRIPS Gateway are useful tools for Members  and we commend the Secretariat for 
training activities and general awareness  around the platforms and their uses. The E -learning 
platform remains an important component of the Progressive Learning Strategy, especially during 
this period of COVID -19. Finally, we would also like to thank the Secretariat for organising the 
technical workshop on COVID -19 in conjunction with the WHO and WIPO. Our thanks also go to the 
ACP that pro posed to hold this workshop in the first place.  
12.13   WTO  Secretariat  
WTO Secretariat Report to the TRIPS Council  
443.  Document IP/C/R/TC/WTO -OMC/1 contains a full report on the technical assistance activities 
in the area of TRIPS that we undertook between 1 October 2019 and 30 September 2020.  
444.  The structure of the report is to give a general overview of the broad trends and then in an 
annex, to give a specific list of activities delivered. There is a review of the overall trends, the 
resources available for technical cooperation and the specifics activities as I mentioned as well as 
contributions to broader technical assistance activities that have TRIPS component. C oordination 
and cooperation with other intergovernmental organizations and other public stakeholders are of 
course important. We emphasize these partnerships and cooperation are integral to our work and 
are increasingly important and valuable. The annex to  the report provides detailed information on a 
number of activities undertaken by the Secretariat during the reporting period.  IP/C/M/96/Add.1  
 
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  445.  The technical cooperation activities, undertaken by the Secretariat under the aegis of TRIPS, 
have the objective of assisting Mem bers and Observers to meet their developmental and other 
domestic policy objectives within the framework of the IP system established by the 
TRIPS  Agreement, and to respond directly to the needs and priorities articulated by the Members 
concerned. A key fe ature is that activities are driven by demand from developing country and least 
developed countries partners, as well as from governments in the process of acceding to the WTO. 
Members and Observers do continue to receive tailored assistance, which include s their participation 
in the transparency work of this Council, which has been stepped up in line with the opportunities 
provided by the e -TRIPS Submission System and the e -TRIPS Gateway, which we hope assist 
Members to track and update notifications and t o make use of the enormous trove of information 
that has been collected over the past 25 years. The e -TRIPS Gateway is expressly labelled a "beta" 
gateway, which means that it is still under development. We are very much reliant on Members to 
provide feedb ack and guidance on how e -TRIPS can be further elaborated and tailored so that as 
practical delegates and as practical capital -based officials, we provide you with an information 
service that meets your practical needs.  
446.  A particular priority in recent mont hs has been responding to the needs of Members in relation 
to the impact of the COVID -19 pandemic.  Overall, in presenting the report, we stress the 
commitment of the Secretariat to continue to respond to needs and priorities of Members, including 
more tail ored support for Members or groups of Members and subject to their guidance. We are 
grateful for guidance from Members regarding past activities, and aim to continue to shape and 
update technical assistance to meet practical needs and priorities.  
447.  Regarding  a few overarching activities in the reporting period that may be of general interest 
to Members, in July 2020, the WHO, WIPO and WTO Secretariats launched the second edition of the 
Trilateral Study, "Promoting Access to Medical Technologies and Innovation : Intersections between 
public health, intellectual property and trade "(www.wto.org/trilate ralstudy2020 ). This publi cation is 
a close collaboration with our valued trilateral partners which catalyses a nd enables ever more 
productive, up to date and practically focused technical assistance for the benefit of Members. We 
report on it under the tec hnical assistance agenda item because it is indeed a critical part of the 
transparency and the substance of ou r technical assistance work in this area of public health, and in 
particular in our cooperation with key partners. From that point of view, we rec ord our deep 
appreciat ion to our colleagues in these cooperating organizations and register our respect for th eir 
distinctive expertise and professionalism, which give an enormous impact to our work together.  
448.  As with the previous edition, this  updated edition of the trilateral study is made available to 
provide a transparent, holistic and broad -based platform for technical assistance in this high priority 
area. The updated edition provides an empirical foundation for policy debate and for informed 
decision making at a critical time for global health. A COVID -19 section at the very start of the 
publication provides a factual overview of the developments and measures taken to address the 
COVID -19 pandemic, which began after the work on the second edition of the study had been 
completed  and was going through formal clearance when this pandemic hit us, and so this was 
prepared as a separate extract as well, which is also available.  
449.  A further general resource is the revised guide to the TRIPS Agreement . We have recently 
updated the gener al, factual and descriptive guide to the TRIPS Agreement, availa ble on the Website 
(www.wto.org/trips -guide ) to take account of recent developments. The same updates will b e 
reflected also in a revised edition  of the standard Secretariat Handbook on the TRIPS Agreement – 
familiar to many delegates in its first edition as the 'green book ' – and this will be published shortly.  
As a foundational resource for all TRIPS -related technical cooperation activities , this u pdated edition 
includes material on current TRIPS issues, both  in this Council and in other multilateral policy 
processes elsewhere, as well as a completely reworked and updated guide to all of the TRIPS 
transparency me chanisms in particular taking accounts of the launch of e -TRIPS and the various 
improvements to the  transparency mechanism that have been implemented recently.  
450.  Finally , I would like to draw your attention to the Colloquium Papers . During the reporting 
period, the WIPO and the WTO Secretariats jointly published the ninth and tenth editions of the 
WIPO -WTO Colloquium Papers , a series of peer -reviewed academic papers resulting from the 
WIPO -WTO Colloquium for IP researchers and teachers. This peer -reviewed publication provides a 
uniquely  represent ative and diverse showcase for emerging IP scholarship from across the globe. It 
aims to stimulate analysis and debate on current IP issues particularly of interest to developing 
countries. It offers an avenue for the dissemination of a broader and more ge ographically diverse IP/C/M/96/Add.1  
 
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  and representative range of scholarship than is common in much of the academic literature on IP 
law and policy. A redesigned platform, very recently organized, provides much easier access to ten 
years of editions of the journal. This s howcases IP research from over 130 scholars from 64 countries 
across the globe , so we see that this is a very valuable supplementary resource for our capacity 
building and outreach work.5 
451.  Finally, concerning recent act ivities in the public health area, as has been touched on several 
times under the previous agenda items, since the entry into force of the Protocol Amending the 
TRIPS Agreement, activities have increasingly focused on implementing the Protocol at the domes tic 
level and supporting the  utilizati on of the Special Compulsory Licensing System as an effective 
procurement tool to ensure access to affordable medicines in line with the continuing guidance given 
by Members in this Council.  As the focus of this work t urns more to addressing practical questions 
in implementing the system, more tailored and focused technical assistance is available to Members 
on request, and we will engage with Members to ensure that technical assistance is ever more 
directed to their pr actical needs,  including if required in dealing with any practical constraints that 
Members encountered with the System as it is currently configured.  A particular feature of our 
technical assistance in general has been to support individual Members in mak ing and tracking their 
notifications and we can therefore similarly provide specific support in relation to notifications under 
this System, given also that this is an area of obvious priority especially at the present time.  
452.  Marking ten years of cooperatio n among trilateral partners, the WTO, WHO and WIPO 
Secretariats, in October 2019 the WTO hosted a technical symposium on 'Cutting -Edge Health 
Technologies: Opportunities and Challenges '. Of course , this was before the outbreak of the 
pandemic, so the oppor tunities and challenges were somehow more broadly based. This symposium 
discussed how scientific progress and advances in health technologies have contributed to 
unprecedented improvements in health outcomes. Equally , we conducted the 15th WTO Trade and 
Public Health Workshop, organized in close collaboration with the Secretariats of the WHO and the 
WIPO, in November 2019. The Workshop covered various policy dimensions with an effect on public 
health and how these relate to provisions of WTO agreements alon gside other relevant agreeme nts 
and treaties. I would mention also that while our key partners in the field of public health are indeed 
our trilateral partners, we benefit enormously from partnership with other multilateral organizations 
and many other sta keholders in civil society and in various areas of industry. And finally, as has 
been mentioned as well, in February 2020, the second Workshop on the Implementation of 
Article  66.2 was convened.  
453.  As I mentioned the work in recent months has focused naturally in responding to the COVID -19 
challenges. There is COVID -19 section in the second edition of the Trilateral Study, "Promoting 
Access to Medical Technologies and Innovation: Intersections between public health, intellectual 
property and trade ". This is also of course available on the websites of our trilateral partners. In 
addition, a wide range of COVID -19-related materials more broadly under aegis of work of WTO is 
available at https://www.wto.org/english/tratop_e/covid 19_e/covid19_e.htm . This covers a wide 
range of material including compilations of COVID -19-related measures undertaken by Members, as 
well as a wide range of other material, including series of information  notes, such as the note on the 
TRIPS Agreement a nd COVID -19. There are materials or activities in the pipeline, including online 
version of the WTO Trade and Health Workshop, a further webpage on TRIPS and COVID -19, as well 
as series of technical assistan ce activ ities increasingly tailored to Members ' demand concerning 
COVID -19 measures.  
454.  The first of these is a workshop which will take place on 21 October; flyers advertising this 
activity are available outside the room. We would certainly encourage delega tes, including 
capital -based officials, to participate in that. A key point there is that the workshop will be quite 
brief; we are covering a lot of ground in this workshop and we are thankfully assisted with the 
excellent cooperation of our colleagues in the WHO and WIPO Secretariats as well as in other WTO 
divisions dealing with substantive matters. Thus, it can only touch on the range of interlocking issues 
that Members do need to consider, hence the title: An integrated health trade and IP approach to 
address the pandemic. It can therefore only survey the landscape.  It is certainly not intended to be 
a definitive or complete guide to policy issues in this area. Why I say this is because we are very 
reliant on Members to take an active part in this worksh op; we hope to  use it as a basis for ever 
 
5 www.wto.org/colloquiumpapers.  IP/C/M/96/Add.1  
 
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  more tailored and responsive technical assistance in this area, and as a chance to gauge and learn 
of Members ' priority needs and requirements in this critical field.  
455.  My closing remarks therefore are to encourage Members to follow that workshop and if it is 
not possible, to contact us and consult with us on priority needs in this critical area. Finally, WTO 
resources will continue the analytical work under way, such as WTO staff working papers. We would 
like to wor k very closely with Members to ensure that technical assistance and also the empirical 
foundation of that work is ever more strengthened at a very critical time for the international 
community and for individual Members.  
12.14   Cooperation Council for the Arab St ates of the Gulf  
456.  At the outset, I would like to wish you and all participants to the TRIPS Council a good health 
in these very hard times.  
457.  The overall objective of the Gulf Cooperation Council (GCC) technical cooperation programme s 
in the field of intellectual property is to contribute to the capacity building of officials from the GCC 
Members and strengthening their knowledge in many IP tech nical aspects which are of high 
importanc e for the protection of int ellectual property rights and support of invention.  
458.  In fact, the GCC technical cooperation is based on its mandate derived from Article (20) of the 
GCC Economic Agreement (2001) which sta tes that "Member States shall develop programme s 
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 r ights; and coordinate their relevant policies towards other countries, regional blocs and 
international and regional organizations ".  
459.  Although the COVID -19 outbreak affected all the works and programme s of the GCC 
Secretariat General, technical cooperation  activities continued to be undertaken during recent period 
with the means at hand and limited programme s.  
460.  As reflected in the GCC Technical Assistance report for 2020, technical cooperation activities 
undertaken by the GCC Secretariat General covers the period from 9 September 2019 to 
9 September 2020.  
461.  Technical assistance activities undertaken by the GCC Secretariat General during the said 
period have been focused on various IP concrete aspects such as enforcement of IP laws, Intellectual 
Property Rights  policies in the GCC region, patent electronic filling, cooperation in IT Systems and 
support of innovation and invention, etc. These activities was conducted in the form of workshop, 
on-job training, secondment or through supporting the participation in C onferences or in 
international IP exhibitions.  
462.  Cooperation with WIPO continues to contribute to the GCC technical assistance efforts in 
various IP areas. In this regard, it may be worth to mention that the GCC Patent Office, with the 
collaboration of WIPO , launches, on 5 December 2019, an electronic platform called "WIPO Publish " 
which allows researchers form the GCC States to access to all patents granted by the GCCPO and 
related  documents.   
463.  The GCC Patent Office continues to contribute to building capaci ty of GCC national Offices in 
examining and filling patent applications. On job -trainings devoted to this IP area continue to be 
organized for examiners from IP national Offices. Two secondments extension were undertaken, one 
year each, for the period Dece mber 2019 – December 2020 in O man and  the State of  Kuwait 
respe ctive IP Offices a iming at examining number of patent applications, including applications filed 
under PCT and sharing knowledge with the examiners of the Oman IP Office.  
464.  The GCC technical coop eration and capacity building programme s has included also other IP 
issues such as enforcement of IP laws and Intellectual Property Rights. On 20 October 2019 in Oman, 
specialists from the GCC Members  participated in an important workshop organized on "GCC and EU 
policies in the field of IPRs " and during which, the GCC Patent Office submitted a working paper on 
the IPRs in the GCC region.  IP/C/M/96/Add.1  
 
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  12.15   World Intellectual Property Organization  
465.  The World Intellectual Property Organ ization (WIPO) undertakes an extensive ran ge of 
technical cooperation activities relating to the implementation of the TRIPS Agreement. Our technical 
assistance to Members covers a wide spectrum of intellectual property (IP) areas, including patents, 
trademarks, copyright, industrial desi gns, and IP enforcement.  
466.  There are three main categories of technical assistance that we provide to governments: policy 
and legislative advice, national IP strategies, and IP office business solutions.   
467.  Based on requests from Members, WIPO provides IP policy and le gislative advice tailored to 
the specific needs and level of socio -economic development of the requesting country.  In this regard, 
WIPO assists Members in drafting new law or amending existing law, as well as advise Members on 
the implementation of flexibi lities contained in international treaties.  
468.  WIPO also assists developing countries and least  developed countries (LDCs) to formulate 
national IP strategies to facilitate the integration of IP into their overall national development and 
public policy.  
469.  In th e category of IP office business solutions, WIPO provides business systems to IP 
institutions in developing countries and LDCs to enable them to participate effectively in the global 
IP system.  WIPO aims to help IP offices deliver better online services re lating to filing systems, IP 
administration, and the digital exchange of data.  
470.  WIPO 's technical cooperation activities also involve numerous projects managed by various 
sectors and divisions at WIPO.  The WIPO Academy 's IP Training Institutions project, for  example, 
assists Members to establish IP training institutions to enable Members to create their own 
self-sustaining IP training infrastructure focused on specific national goals and priorities.  
471.  The disruption caused by the COVID -19 pandemic has posed ch allenges to WIPO 's delivery of 
its capacity -building activities.  In response, WIPO has adapted to new ways of delivering technical 
assistance remotely in virtual formats such as webinars.  From January to August 2020, WIPO 
provided approximately 300 technic al assistance activities online.  A number of activities specifically 
addressed the impact of COVID -19 on different areas of IP.  Moreover, WIPO has taken several 
initiatives to facilitate technical cooperation in the context of stimulating innovation to fig ht the 
pandemic.  These initiatives include the COVID -19 IP Policy Tracker, which provides information on 
measures adopted by IP offices in response to COVID -19; the inclusion of COVID -19 terminology in 
WIPO PEARL, a multilingual portal that enhances the sh aring of scientific and technical terms derived 
from patent documents; and the addition of a new COVID -19 related search functionality in the 
global patent database PATENTSCOPE.  
472.  WIPO is fully committed to continuing its legal and technical assistance to su pport the efforts 
of Members in fulfilling their TRIPS obligations.  
12.16   World Health Organization  
473.  The World Health Organizati on (WHO) takes this opportunity to highlight to the WTO Council 
for TRIPS some technica l cooperation activities that took place since our last report to the Council.  
474.  A recent major development that may be of interest today, in light of the ongoing COVID -19 
pandemic is the Solidarity Call to Action and the establishment of the WHO COVID -19 Technology 
Access Pool (C -TAP). We know tha t no country is safe from COVID -19 until every country is safe.  
475.  To this effect, the Solidarity Call to Action urges the global community to voluntarily commit 
to undertaking urgently needed actions to advance the pooling of knowledge, intellectual property 
and data for key COVID -19 health -related technologies.  
476.  Specifi c actions are outlined for governments, researchers, funders, holders of knowledge, 
intellectual property or data to existing or new therapeutics, diagnostics and vaccines, to make 
voluntary commitments to facilitate their use in research, development, and  manufacturing that IP/C/M/96/Add.1  
 
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  would permit effective technology transfer and early access to key technologies for the detection, 
prevention, treatment and response of COVID -19. 
477.  C-TAP is as a complementary tool to other initiatives, such as the Access to COVID -19 Too ls 
Accelerator (ACT -A) which is a ground -breaking  global collaboration to accelerate development, 
production, and equitable access to COVID -19 tests, treatments, and vaccines.   
478.  The Seventy -third World Health Assembly called to work collaboratively at all l evels to develop, 
test, and scale -up production of safe, effective, quality, affordable diagnostics, therapeutics, 
medicines and vaccines for the COVID -19 response, including, existing mechanisms for voluntary 
pooling and licensing of patents to facilitate  timely, equitable and affordable access to them.  
479.  WHO reaffirms its commitment to support Countries through our technical cooperation 
activities derived from the Global Strategy and Plan of Action on Public Health, Innovation and 
Intellectual Property (GSP A-PHI). WHO collaborates closely with WTO and other relevant 
international organizations to provide technical assistance on topics related to the interface between 
public health, innovation, intellectual property and trade, including the use of TRIPS flexi bilities for 
public health.  
480.  In relation to the second edition of the Trilateral Study on Promoting Access to Medical 
Technologies and Innovation , we would like to draw your attention to the COVID -19 insert which 
provides a factual overview of measures take n to address the ongoing pandemic. This section 
includes refer ences to important initiatives that both developing and developed co untry Members  
and International Organizations are undertaking in relation to intellectual property laws and policies 
to promot e innovation and access to health.  
481.  More ample information on WHO 's technical cooperation activities in relation to IP and health 
can be found in document IP/C/R/TC/WHO/1. We would be glad to answer any questions delegations 
may have regarding these activit ies. 
12.17   United Nations Conference on Trade and Development  
482.  The United Nations Conference on Trade and Development (UNCTAD) Secretariat, through its 
Intellectual Property Unit, located within the Division on Investment and Enterprise, implements a 
work programme  on the development dimensions of IP rights.  
483.  The work programme  is designed to respond to the mandate received from M embers at the 
Ministerial Conference in Nairobi in July 2016, as well as to intergovernmental requests under the 
WIPO Development Agenda and the World Health Assembly 's Resolution 61.21 on a Global Strategy 
and Plan of Action on Public Health, Innovation a nd Intellectual Property. It is partially funded by 
donor governments and institutions.  
484.  Currently, the work programme  targets technical assistance and capacity building in the 
following areas:  
a. Local pharmaceutical production and its linkages with COVID -19; 
b. Designing investment incentives to address anti -microbial resistance (AMR) in Ethiopia, 
Kenya, Uganda and the East African Community;  
c. The role of regional cooperation on Intellectual Property under the African Continental Free 
Trade Area (AfCFTA);  
d. The role of IP in technology and R&D partnerships, and  
e. The role of IP in the digital economy.   
485.  For more details, I refer to UNCTAD 's written submission that is available in the WTO 's e-TRIPS 
submission system.  IP/C/M/96/Add.1  
 
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  12.18   Sri Lanka  
486.   We have studied the WHO ACT Accelerator and we would like to request if this initiative is 
focusing on new diagnostics  and vaccines. It is not clear to us whether this initiative will carry out 
produ ct development or facilitate product dev elopment through the sharing of tools. From t he 
statement we read that is committed to share a more equitable, global access to innovative tools 
for COVID -19 for all. However, why one of the partners in the initiative is the International Federation 
of Pharmaceutical Manufacturers and Associations for transnational pharmaceutical corporations 
which pushes for maximalist intellectual property protection and enforcement without consideration 
to access to affordable medicine. With such setbacks, how does WHO envisage that this mechanism 
that they will br ing us the desired benefits to all of us?  
12.19   Chad on behalf of the LDC Group  
487.  On behalf of the Group of LDCs, I would also like to thank the Secretariat  for the report that 
was presented to us on technical assistance activities and TRIPS related matters, and a ll WTO 
partners.  
488.  The Member of the Secretariat underlined an important point: the idea of tailored assistance. 
I think this is an extremely important topic because we do in fact have specific needs and so assisting 
Members  who have specific needs is crucial for understanding their pr iorities. That was scaled up 
and added to the e -TRIPS system.  I have a few questions for him.  
489.  The first has to do with the arrangement the Secretariat has put in place, for example to allow 
LDCs who are experiencing particular difficulties to familiarize t hemselves with the e -TRIPS system s. 
How do you intend to inform us about this  online platform? You know that LDCs have difficulty 
accessing the WTO online  system s and I imagine the same is true for e -TRIPS, so how can you 
ensure that LDCS will be able to u se these online tools in an effective and efficient manner? 
Otherwise, these tools will not have any meaningful impact for us. 
490.  Another question has to do with the activities of trilateral partners, for example, the WTO, 
WIPO and the WHO  Secretariats . I am of the view that these activities also concern the Trade Ministry 
that deals with WTO matters, the Health Ministry, and the ministries of the Economy, Labour, the 
Digital Economy and Technology. We have focal points in our capitals for these three departme nts, 
so what is your plan regarding trilateral activities in terms of virtual participation of capitals? Are the 
Health, Trade and Digital Economy Ministries also invited to participate in virtual activities?  
12.20   World Health Organization  
491.  Thanks to the delegat e from Sri Lanka for the question, I am happy to respond to your concern 
in relation to the ACT Accelerator.  
492.  The World Health Organization (WHO) believes that in these difficult times it is very important 
that all stakeholders are engaged and believe that all stakeholders  are relevant to solve the crisis 
and that means that not only governments, but funders and also industry , pharmaceutical industry, 
civil society organizations,  all those mentioned  groups, all are relevant and all need to work in a 
collaborative manner to really solve the problem for the world . So ACT Accelerator includes industry 
partners and includes civil society as well.   
493.  Of course , the pharmaceutical industry is very relevant for the development of the new drug 
and the ACT  Accelerator is now very focused on trying to find  the new medic ines, diagnostics,  
vaccines ; we have different pillars  in the ACT A ccelerator . But at the same time, WH O is also calling 
through C-TAP to this complementary tool and the solidarity call to action is calling all researchers, 
pharmaceutical industry ; we are working on a strategy for engagement and with civil s ociety , with 
the private sector in order to facili tate this sha ring of knowledge .  
494.  Of course, the sha ring of knowledge is going to be through C-TAP and the implementing 
partners like  the UN technology, like the Medicine Patent Pool, that are existing tools and we do not 
want to duplicate the efforts that and we are working together with all of them to facilitate the 
sharing . There is a big call from governments that have p articipated in the Solidarity Call to Action 
to share this knowledge, this is data and facilitate the transfer of technology . So this is the main IP/C/M/96/Add.1  
 
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  objective so that there are complementary tools . In parallel t he WHO also thinks that all the other 
mechanisms are important . WHO keeps  also providing technical assistance on other areas like the 
use of TRIPS  flexibilities.  
12.21   WTO Secretariat  
495.  My warm thanks to our colleague, the delegate of Chad, for two very pertinent questions which  
are very much in that spirit  of adapt ing our tools  to respond to the needs of Members .  
496.  On the first point, I acknowledge that for those of us working in Geneva we tend to take digital 
access for granted . The World Wide Web was invented just seven kilometres away in CERN and we 
are very conscious  of the need not to assume that is a privilege enjoyed by all the digital divide 
remains a significant  concern.  
497.  So, in itself , our TRIPS technical assistance and our work with the TRIPS Agreement cannot 
address the digital divide in isolation, of course, b ut this is a theme that we would like to tak e up i n 
the next workshop for LDCs on TRIPS Article 66 .2 in early 2021 to look at practical considerations  
for access to this information for those with the limited access to the Internet . This is an important 
practical question and it is part of the better process that I me ntioned o f adapting and developing 
the platform, so that it is truly accessible . Hence, I would not pre-empt specific proposals or technical 
responses but it is clearly  an important practical m atter that we will address in our work .  
498.  At the same time, we also have had the privilege of sitting with quite a number of delegations 
from across the development  spectrum, to give one -on-one training or familiarity briefings on the 
use of the platform fo r those delegates who are based in Geneva for those who visit. It can be very 
helpful to sit down together and go  through it in a very practical way to take advice . A lot of the 
functionality and the benefits of the system as it is now (and it is still not complete ) is a direct result 
of that valuable insight  from Members right across the spectrum . Thus we would certainly hope that 
this input and guidance continue.  
499.  On the second point concerning trilateral cooperation , I would not mention also the cooperation 
in the field of public  health does go beyond that arrangement , but that is the focus . We would hope 
that among the benefits flowing from trilateral cooperation is that it really does establis h a norm of 
cooperation in this critical area beyond our comfortable silos or areas of  particular expertise and 
competence . One of the practical difficulties that I think every Member government has encountered  
is the inevitable challenge in coordinating a cross different agencies , with different mandates , with 
different core competence s. The essence of our work o n public health, trade and intellectual property 
is to develop ways of coordinating and working in an integrated holistic way with the different 
agencies involved.  
500.  That said , when it comes to public health , from a trilateral point of view we take t he leadersh ip 
of the WHO as the experts on public health matters and  we offer our contributions on TRIPS and on 
trade policy matters, just as W IPO contributes on intellectual property  and related matters . 
Therefore , for all of our activity  - a good example of this could be the workshop on trad e and health, 
which we can hold every year  – it is deliberately targeted at representatives of these diff erent polic y 
communities : public health officials, trade officials and intellectual property officials . A lot of the 
positive feedback we get from participants is exactly that they are able to work together and develop 
a com mon dialogue , a common lexicon w ith those who have been working in other specialized areas . 
So, it is not merely about passing on technical knowledge about the specifics of this or that 
agreement or this or that policy framework, but also  about building the tools for dialogue across the 
areas of expertise . That is really at the very heart  of our program mes, both the trilateral work at 
the international level, but also the  policy support we have tried to give to Member governments .  
501.  The activities that have been referred to are deliberately planned and structured and invited 
indeed  to build up that kind of compensation between areas of expertise . Each specific area of 
expertise is incredibly important, but it is rarely  sufficient in itself and so building that into  great 
holistic  approach is at the core of this programme. As delegates will see, I can talk about this all 
night, but I think we might have remaining work ahead , so I thank you for your patience.  IP/C/M/96/Add.1  
 
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  12.22   India  
502.  We thank the Members and all the Secretariat s for providing details regarding their technical 
cooperation activities. Just a qu ick question I would like to ask to the representative from WHO : if 
she could provide details on how many pharmaceutical manufacturing corporations have committed 
to sharing of intellectual propert y rights and technological know -how under the C -TAP and COV AX 
to the ACT of the Accelerat or initiatives of WHO.  
12.23   World Health Organization  
503.  Thanks for your question to the delegate from India. I just share with you some information 
about C -TAP because my wor k is more focused on the technology access pool. Y ou know that it is a 
recent initiative that has been launched at the end of May . We are working now and we are in 
discussions with several companies or private sector in different areas.  Our implementing partners 
are also in discussion s with some of the m, but we still do not have anything in our website in relation 
to specific commitments. The implementing partners though have already, for example, the open 
COVID  pledge, have already some comm itments from different companies that are registered in 
their own website. We are still working on building this platform in order to collect all the information 
in one place.  
12.24   Cambodia  
504.  Cambodia would like to thank all Members, GCC , WIPO, WHO, UNCTAD and ot hers for their 
report.  In addition, we would like to thank the capacity building provided specially during the 
COVID -19 pandemic. Cambodia has lately benefitted from the training programme on legislation. 
The Government of Cambodia request to continuing pr oviding training to improve capacity and 
knowledge in the field of IP in particular during and after the pandemic.  
13  INTELLECTUAL PROPERTY AND INNOVATION: MAKING MSMES COMPETITIVE - 
MAKING MSMES COMPETITIVE THROUGH INCLUSIVE PROTECTION OF VARIOUS IPS  
13.1  Japan  on behalf of the co -sponsors  
505.  Firstly, on behalf of the co -sponsors of this  agenda  item, this delegation would like to briefly 
introduce the background and some possible discussion points of th is agenda item in accordance 
with the document IP/C/W/667.  
506.  It is widely recognized that micro, small and medium -sized enterprises (MSMEs) play key roles 
in most economies and are important as major sources of innovation, industrial competitiveness and 
international trade. In emerging markets, small com panies, such as start-ups, are able to create 
innovative products and services and to respond quickly to drastic changes in technology and 
industrial structures.  
507.  As the intrinsic value of intangible assets has increased in importance for industry and busin ess 
in recent years, the ratio of intellectual property in overall corporate value also has steadily risen. 
Since MSMEs often face the challenge of obtaining financial support to develop their businesses, 
protection of IPs and developing valuable IP portfo lios may therefore help MSMEs to enhance their 
corporate value and be better positioned to secure funding.  
508.  The competitive features of products and services may be diversified in terms of not only 
technological aspects but also designs and trademarks. In p articular, such technological aspects can 
be protected by patents or trade secrets, and designs may be protected by industrial designs or 
copyright as well as against acts of unfair competition. In any case, business competitiveness is also 
acquired by bra nding strategies that rely on the use of trademarks. Thus, valuable IP portfolios may 
include various types of IP such as patents, designs, copyright, trademarks, and trade secrets.  
509.  However, most MSMEs lack IP awareness, and human and financial resources and experience 
in developing IP strategies, registering IP rights not comprehensively considering their IPs. They 
also lack resources and experience in enforcing against infringement acts based on their IPs.  IP/C/M/96/Add.1  
 
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  510.  Given these circumstances, it would be beneficia l for Members  to share pertinent knowledge 
and experiences on how MSMEs can develop their businesses through building and achieving the 
highest possible quality IP portfolio, composed of various types of IP, and how governments can 
support MSMEs to expand their operations by encouraging building such an IP portfolio.   
511.  In this context, we would like to highlight the competitiveness through registered and 
unregistered IPs, such as patents and trade secrets. Each type of IP has distinct validity requirements 
and provides different forms of protection in terms of time span and scope of the rights conferred. 
Accordingly, it is necessary for industry to select and combine the appropriate measures to protect 
competitive technologies or other intellectual assets. In  this regard, governments can play an 
important role in providing IP education as well as opportunity of access to IP professionals to raise 
companies ' awareness or knowledge regarding distinct features of each IPs and various avenues for 
enforcement. Furt hermore , governments can also support strategic IP portfolio protections and 
enforcement by ensuring both have strong legal structures.  
512.  In addition, we would like to shed light on the importance of the inclusive protection of IP 
rights. It should be empha sized that proportionate IP portfolios consisting of a combination of various 
IP rights should be based on a strategic perspective. Protecting products and services based on 
different types of IP rights effectively protects both business operations and inv estments as well as 
support cooperation.  
513.  Based on the above backgrounds, through this topic, this delegation would like to highlight 
the importance of multi -layer protection through IP portfolios, and discuss how governments can 
support strategic IP protec tion through sharing information under this proposed theme. The possible 
issues to be discussed are included in paragraph 13 in the document.  
13.2  Unites States of America  
514.  The United States welcomes this opportunity to co -sponsor this agenda item and we thank 
Japan for introducing the topic.  
515.  The United States welcomes this opportunity to share views and experiences on the im portant 
issue of Making MSMEs Competitive Through Inclusive Protection of Various IPs.  
516.  As it is the case in many countries, MSMEs are  critical to the American economy. They create 
jobs, spur innovation and foster entrepreneurial spirit.  
517.  Particularly during these troubling economic times caused by COVID , innovation and the 
incentives created by IP systems will be key to pulling countrie s toward global economic recovery.   
518.  How governments can support MSMEs during this period will be important. WIPO 's 2020 Global 
Innovation Index theme of "Who Will Finance Innovation? " - asks a vital question that business and 
policy leaders will need to co nsider during these uncertain economic times. Nonetheless, this 
question should be viewed as a call to action to sustain innovation.  
519.  Taking steps to help foster and increase local innovation should become a key policy response 
to a prolonged downturn. For that to be effective, it will have to go hand in hand with raising 
awareness of, and growing support for, IP - particularly among start -ups and MSMEs.  
520.  With respect to the United States ' experience in this area, the US Government plays an 
important role in promoting the growth and competitiveness of MSMEs by developing ecosystems 
where MSMEs, start -ups and entrepreneurs thrive and become the successful businesses of 
tomorrow.  
521.  The US Government provides key resources, both financia l and educational, to make sure that 
innovators have what they need to turn a great idea into a successful business and take advantage 
of global opportunities.  
522.  These resources include funding provided to small businesses by 11 participating federal 
agenci es through the Small Business Innovation Research (SBIR) and Small Business Technology 
Transfer (STTR) programme s coordinated by the US Small Business Administration.  IP/C/M/96/Add.1  
 
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  523.  Each year, the participating federal agencies are required to allocate about 3 % of their  R&D 
budget to fund these programme s. 
524.  By reserving a specific percentage of federal R&D funds for small businesses, the SBIR 
programme  protects small businesses and enables them to compete on the same level as larger 
businesses.  
525.  The SBIR programme  funds t he critical start-up and development stages and it encourages 
the commercialization of the technology, products, or services, which, in turn, stimulates the US 
economy and local economic competitiveness by encouraging higher rates of job growth, wage 
growt h, new business formation and innovation in those regions.  
526.  Since its enactment in 1982, the SBIR programme  has awarded over USD 40 billion to 
thousands of research -intensive American small businesses. Their contributions have enhanced the 
nation 's defen ce, protected our environment, advanced health care, and improved our ability to 
manage information and data.  
527.  It is well -documented that protection of intellectual property rights is essential for attracting 
additional private investment and product developme nt resources.  
528.  A number of recent studies looked at the value of patents and other intellectual property assets 
to start -ups.  
a. One study found that a patent grant increases a start-up's chances of securing funding 
from venture capitalist by 47%, and of sec uring a loan by pledging the patent as collateral 
by 76%, within three years of the patent grant.  
b. A patent grant also more than doubles the odds of the start-up raising funding from an 
initial public offering. The study concludes that "a patent grant sets  a start-up on a growth 
path through funding that helps transform its ideas into products and services that 
generate jobs, revenues, and follow -on inventions. " 
c. Another study done by the Massachusetts Institute of Technology (MIT) Innovation 
Initiative Lab for Innovation Science and Policy, found that securing a trademark in the 
first year of business and securing patent protection, among other factors, both positively 
correlate with the start-up growth.  
d. A granted patent facilitates bargaining, licensing, an d other transactions which are vital to 
the process of commercialization of new products.  
e. Other recent research found that a start-up's first granted patent puts the company on a 
higher employment growth path, which continues for five years. Start-ups that  received a 
patent showed a 6% increase in employment growth in the first year, with this growth 
differential increasing to about 55 % by the fifth year.  
529.  Equally important for small business are other types of IP protection - trademarks, copyright, 
designs and trade secrets.  
530.  The United States Government , including the United States Patent and Trademark Office 
(USPTO ), has a variety of programme s and initiatives designed to promote innovation, to help 
individual inventors and small businesses to protect thei r IP and to commercialize their inventions.  
531.  Let me briefly discuss some of these programme s and initiatives at USPTO.  
a. USPTO offers patent fee discounts for small and micro entities. USPTO also offers small 
and micro entity discounts on search and prelimin ary examination of international patent 
applications for which the USPTO is the International Searching Authority or International 
Preliminary Examination Authority under the Patent Cooperation Treaty  (PCT) .  
b. USPTO 's Inventor and Entrepreneur Resources web page offers information for start-ups, 
individual inventors and entrepreneurs on the patent and trademark process and offers a 
number of guides and other resources to assist inventors and entrepreneurs in protecting 
their IP rights.  IP/C/M/96/Add.1  
 
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  i. We have the USPTO 's Inventor Assistance Centre  as well as other programmes in this 
area.  
c. The USPTO 's Inventor Assistance Centre  (IAC)  cannot provide a legal opinion or advice , 
or do a patent search . 
d. To further assist MSMEs in commercializing their inventions as well as to aid in the fight 
against COVID -19, the USPTO has launched a Prioritized Examination Pilot Programme for 
small and micro -entities for patent applications that are subject to an applic able federal 
marketing approval for COVID -19 use.  
i. There is also a prioritization examination programme  for marks used to identify 
qualifying COVID -19 medical products and services, helping to bring these critical 
products and services to market more quickl y. 
ii. Also, the USPTO 's Patents 4 Partnerships is a meeting place that enables patent owners 
who want to license their IP rights to connect with the individuals and businesses who 
can turn those rights into solutions.  
iii. The P4P platform will provide entities l ike MSMEs and start-ups that have limited 
resources a valuable tool to match their technologies with interested buyers and 
licensees.  
iv. Another recent patent administrative initiative that would benefit MSMEs and facilitate 
collaboration, is the deferral of provisional application fees in exchange for early 
disclosure of technical subject matter of COVID -19-related inventions on the USPTO 
website, as mentioned under  agenda  item 3.  
v. Further information on the USPTO 's initiatives on life science technologies ca n be found 
on the COVID -19 Response Resource Centre  page of the website.  
e. With respect to intellectual property education, the USPTO offers a number of educational 
resources and conducts a number of educational programme s for small businesses.  
i. For example , on our website, we offer a web -based tutorial and a detailed guide on 
how to conduct a US patent search; a training video on electronic filing; step -by-step 
guides on patent and trademark processes and many other resources.  
ii. We offer six e -modules on int ellectual property protection and enforcement in five 
languages.  
iii. We also regularly conduct webinars on IP -related issues, Expos, training programme s, 
roadshows, public meetings, discussions, many of which are webcasted.  
iv. In helping MSMEs leverage the syne rgistic effects of registered and unregistered IPs, 
we work with other US government agencies to provide training to foreign officials and 
businesses on trade secret protection and enforcement.  
• Like patents, trade secrets are important tools to provide leg al protection for firms 
wishing to protect their valuable IP.  
• In fact, SMEs and MSMEs may rely more heavily on trade secrets than on other 
forms of intellectual property, as the costs of obtaining and maintaining a patent, 
coupled with the costs of patent litigation, can make it more financially viable for 
smaller businesses to depend primarily on trade secrets. Additionally, not all 
innovations are eligible for patent protection.  
• Trade secrets are particularly attractive for MSMEs that have processes and s ervice 
innovations and have kept such business information secret. MSMEs often go the 
trade secret route when the early stages of innovation are critical to their long -term 
success and there are time and cost pressures on the business.  IP/C/M/96/Add.1  
 
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  • The theft of trade secrets adversely affects entities of all sizes, particularly MSMEs. 
The USPTO provides training to foreign officials on the importance of trade secret 
protection laws that enable MSMEs and start-ups to take action against trade secret 
theft. Practical ste ps are also highlighted to businesses to protect their 
commercially valuable proprietary information.  
v. Another valuable resource for MSMEs is the Patent and Trademark Resource Centres  
(PTRCs) which are part of a nationwide network of public, state, and academic libraries 
designated by the USPTO to support the public with trademark and patent assistance.  
532.  Finally, the USPTO 's four Regional Offices located in Detroit, Denver, Dallas and San Jose serve 
the local communities in which they are located, with a special emphasis on universities, individual 
inventors, SMEs and MSMEs.  
533.  These are just some of the examples of IP assistance programme s in the US dedicated to 
helping MSMEs. For those interested in Intergovernmental Organization support, WIPO has launched 
a new initiative for SMEs and MSMEs to undertake a basic diagnosis of their IP assets. WIPO 's IP 
Diagnostic Tool generates a report based on the answers of a business, thereby providin g an 
assessment of the IP assets that a business may have and how it may consider protecting and 
exploiting them as well as the risks to the business in not managing these assets. The Tool can be 
accessed from the WIPO SME website.   
534.  We hope this informatio n provides micro and small businesses with the resources needed to 
protect their IP, grow their businesses, create jobs and build a more competitive and resilient 
economy.  
13.3  Japan  
535.  This delegation would like to share Japan 's experiences and national policies regarding this 
agenda item.  
536.  This deleg ation is of the view that competitive advantages of products and services are derived 
not only from certain technological features but also from various distinctive features, such as 
designs and brands. In addition, e specially in the field of information technology , such as artificial 
intelligence and the Internet of Things, not only information technologies themselves but also data 
themselves are valuable, and the utilization of such data become major sources of compa nies' 
competitive advantages as well. Each of those features and data can be protected as various types 
of IP, such as patents, trade secrets, and copyright. Meanwhile, in corporate business strategies, it 
is essential for companies to establish IP portfol ios that comprehensively and strategically cover the 
various kinds of multiple IPs.  
537.  On the other hand, in order to establish comprehensive IP portfolios that cover various kinds 
of IPs for enhancing business advantages, it is essential for companies to for m an appropriate 
combination of IPs with a better understanding of the characteristics of their individual IPs. In 
particular, most MSMEs are facing the problem of having a tendency to lack knowledge and resources 
needed for establishing such IP portfolios . 
538.  Under such circumstances, Japan would like to introduce Japan 's two initiatives, one of which 
is aimed at supporting establishing comprehensive IP portfolios and the other is aimed at providing 
new IP protection based on the diversification of data utilization. Please refer the room document 
RD/IP/39 as well.  
539.  Firstly, Japan would like to introduce the initiative to support establishing strategic IP 
portfolios. As we mentioned in the beginning, it has become important to establ ish IP portfolios that 
comprehensively cover various kinds of IPs in line with corporate activities. In order to support 
companies in acquiring comprehensive IP rights for effective use in enhancing their business 
activities, the Japan Patent Office is con ducting an initiative of "collective examinations for IP 
portfolios ", in response to co rporate business strategies. Under this initiative, the JPO conducts 
examinations collaboratively on a cross -sectional basis to timely grant multiple IP rights, such as for 
patents, designs, and trademarks, which are associated with the expansion of business activities.  IP/C/M/96/Add.1  
 
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  540.  When conducting examinations under this initiative, applicants explain their business activities 
and strategies to examiners, additionally examiners inter view applicants directly. As a result, 
examiners can gain a full understanding of applicant business backgrounds and their connections to 
their applications. Moreover, the schedule of explanation of businesses, interviews, and launches of 
examination proce dures are coordinated to support companies in acquiring IP rights at their most 
desirable timing.  
541.  Secondly, we introduce the new system to provide comprehensive data protection. The value 
of data has been increasing as major sources of companies ' competiti ve advantages. As a result, 
there is a growing need to establish a framework to transact data in safety and to allow appropriate 
compensations, to the extent commensurate with investments and efforts in creating, collecting, 
analysing, and managing data. M eanwhile, in order to protect data based on conventional copyrights 
or trade secrets, it is necessary to meet certain requirements, such as creativity or maintaining 
secrecy. In this regard, due to the diversification of data utilization, it became necessa ry to establish 
a data protection system which enables the protection of data where creativity is difficult to 
recognize, such as automatically collected data, and to support business models in which data are 
widely shared with others without maintaining s ecrecy.  
542.  In responding to such situations, Japan revised its Unfair Competition Prevention Act in 2018 
to introduce the new data protection scheme, where unlawful actions using certain data are defined 
as unfair competition acts. In this revision, the data  provided to third parties by business operators 
through certain business transactions are protected as "shared data with limited access " 
543.  In detail, among valuable data, the data that meet following three requirements, namely (1) 
Limited provision, (2) Sig nificant accumulation, and (3) Electromagnetic management, are defined 
as "shared data with limited access " In addition, wrongful acquisition, use and disclosure of such 
data are newly defined as acts of unfair competition. Also, as remedies to deal with t hese unfair 
competitive acts, the revision sets rights to claim injunctions and damages against such acts. 
Because of this revision, when the data cannot be protected under the Copyrights Act or as trade 
secrets, but if the data meet certain requirements, such data can be protected as "shared data with 
limited access ", which can become major sources to create new value by sharing with others. 
Moreover, before the revised Act came into effect, Japan formulated easy -to-understand guidelines 
that show specific examples of acts of unfair competition and concepts of the requirements for 
protection of such data under the revised Act. Furthermore, Japan is conducting activities to raise 
awareness for the importance of such data for companies who are unfamil iar with the data protection 
system, including MSMEs.  
544.  In conclusion, establishing comprehensive IP portfolios plays important roles in maximizing 
corporate business values and competitive advantages and in promoting innovations. Accordingly, 
it is indispen sable to us in supporting companies, including MSMEs, to establish comprehensive IP 
portfolios, to include providing a legal and administrative framework. Furthermore, because data 
utilization has become more diversified, when an IP system is established t o comprehensively protect 
valuable data according to the characteristics of and the utilization of the data, such a system will 
help to establish strategic IP portfolios which include protection of data, and can promote innovations 
based on data sharing.  
13.4  Singapore  
545.  Singapore is pleased to co -sponsor this a genda item, and would like to thank Japan for 
submitting this discussion paper on "Making MSMEs Competitive Through Inclusive Protection of 
Various IPs ", which is the second in a series of discussion topics  on how countries and government s 
can support MSMEs via IP rights to make them competitive both in the domestic market and around 
the world. Japan 's paper provides us with a good starting point to discuss the importance of 
multi-layered protection of an MS ME's business through diverse IP portfolios, and how governments 
can support such strategic IP protection. Allow me to share three key points underpinning 
Singapore 's efforts in this regard.  
546.  First, to set a good example, the Singapore Government has consta ntly sought to ensure that 
the agencies that cover IP look at the issues in a broad -based and holistic manner. In past years, 
there was a strong misconception that IP -related matters mostly pertained to legal and technical 
work. There was also little inter face between the various aspects of IP, such that the officers working IP/C/M/96/Add.1  
 
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  on copyright, patents and trademarks for example did not collaborate closely to understand how 
these different rights could interact and impact each other. Within the past few years, th e Ministry 
of Law and the Intellectual Property Office of Singapore (IPOS) have been reorganised to take into 
account the legal, financial, business, technological and research implications of IP rights, and this 
has contributed to the success of Singapore  in building up our status as an IP Hub.  
547.  Second, the Government provides various avenues for MSMEs to improve their level of 
awareness and knowledge regarding the distinct features of the various IP rights and the avenues 
for enforcement of those rights. As a case in point, IPOS and Singapore 's apex business chamber, 
the Singapore Business Federation (SBF), collaborated to roll out the Workforce for IP -Savvy 
Enterprises (WISE) initiative, which aims to help Singapore companies identify new business 
opportu nities and acquire new capabilities through IP. The WISE initiative builds upon the Skills 
Framework for IP launched in 2019 to provide companies with holistic support in improving their IP 
literacy and management. Companies are also equipped with knowledg e and skills to identify new 
business opportunities, protect intangible business assets and minimize risks of costly litigations 
from IP infringements. Specifically, WISE helps companies to build: i) HR capabilities to hire, nurture 
and optimize IP talents  in their companies; ii) business development capabilities through online IP 
courses and consultation to identify potential new opportunities; and iii) networks and knowledge 
on IP at IPOS ' and SBF 's flagship events. Additionally, under IPOS ' wholly owned subsidiary, IPOS 
International, there is a team focusing on providing IP Strategy solutions to enterprises, including 
MSMEs, as well as government agencies, with regard to optimising intangible assets (IA) 
management to drive economic and business growth. IPOS International has made available a free 
online tool, IlluminateTM for enterprise, to help businesses get a quick overview of an enterprise 's 
IP and IA health status. IPOS International also provide IP Strategy advisory, which consists of 
actionable ad vice, frameworks and processes to help enterprises identify, understand and manage 
their IP and IA in a more strategic manner. Lastly, IPOS International provides services in the areas 
of patent analytics and technology scans – these are actionable intelli gence based on review of large 
patent data sets to gain insights into the market and technology trends for R&D decision, identify 
potential new opportunities and learn more about competitors.  
548.  Third, we provide a wide range of training to ensure that MSMEs are continually equipped to 
deal with the needs of a fast -changing world and can make strategic decisions on their IP portfolios 
in an agile manner. The national level skills development framework for IP Launched in 2019 allows 
MSMEs to develop capabilitie s in IP management and commercialisation. This framework provides 
comprehensive information on the career options and skills needed for the various job roles, and 
also the relevant training programme  for the IP sector. It outlines information on the sector , career 
pathways for talent attraction and retention, as well as skills and competencies to support the growth 
and transformation of the sector. This will aid in the upskilling of new entrants and also existing IP 
professionals. In terms of concrete progr amme s, IPOS collaborates with the Singapore University of 
Social Sciences to offer a Master of IP and Innovation Management (MIPIM). In an innovation -driven 
environment, the programme  helps develop the pipeline of IP talents with the expertise to develop 
and align IP strategies to achieve business goals. IPOS International also hosts the IP Academy 
(IPA), which aims to grow a vibrant network of skilled IP and innovation professionals and users 
through quality education.  
549.  This is an important issue which bea rs more focused discussions to share best practices, and 
we look forward to hearing from other Members  on their national experiences.  
13.5  Australia  
550.  Australia commends Japan for their support in preparing the communication an d is pleased to 
be able to co-sponsor it.   
551.  Australia recogni zes the key role that micro, small and medium sized enterprises (MSMEs) 
play in spurring economic growth and development  they are often responsible for innovative services 
and technology, which in turn helps create new jobs  and businesses.  
552.  Intellectual property is integral to these outcomes. The ability to register, protect and enforce 
intellectual property rights is critical.   IP/C/M/96/Add.1  
 
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  553.  Australia recogni zes that MSMEs have been particularly impacted by the global pandemic, 
domestica lly and globally, and initiatives designed to target and support MSMEs in the current 
climate are particularly important . 
554.  MSMEs have worked hard to continue and in many cases transform their operations, whether 
through online deliveries, virtual events or the adoption of new digital platforms . 
555.  This readiness to innovate has been a key factor in Australia 's response to the immediate 
challenges resulting from the COVID -19 crisis and will be central to helping all businesses and the 
global economy bounce back.  
556.  Meanwhile, Australia 's official development assistance continues to support the transfer of 
business information and know -how to least developed countries, which in turn helps MSMEs in these 
economies develop and grow.   
557.  In Australia, small and medium busi nesses, including their owners and employees, are the 
heart of the Australian economy the sector comprises roughly 99.7% of the actively -trading business 
in the country this translates to over two million SMEs powering the economy, according to data 
from t he SME Association of Australia.  
558.  Australia has commenced a review into the accessibility of the patent system for MSMEs. The 
Patents Accessibility Review will consider:  
a. the cost of applications for patents ; 
b. processing times of patents ; 
c. advice provided by t he Australian Government with respect to the patent application 
process ; 
d. awareness of the patent application process ; 
e. the cost and times required to enforce standard patents ; 
f. any other barriers or impediments that prevent Australian businesses filing and obtaining 
patents ; and  
g. Government programme s to assist Australian MSMEs seeking patent protection, including 
protection overseas.  
559.  In 2018 the Australian Government conducted a stakeholder consultation process to better 
understand the needs of innovativ e Australian MSMEs seeking to commercialise their business ideas. 
In 2019 a public discussion paper was released summarising the findings of the consultation, and 
the Australian Government will consider the submissions to this consultation paper in light o f any 
overlapping issues identified by the Patents Accessibility Review.  
560.  The communication asks about the development of IP strategies that reduce the risk of IP 
litigation. For Australia, it is important to create regulatory environments that allow MSMEs to create 
valuable IP portfolios where they can protect their brand and ideas  
561.  By building an enforceable and accessible intellectual property regime, governments can help 
minimise the risk of litigation and help their MSMEs prosper and grow  and we see the commitments 
in the TRIPS Agreement as integral to this.  
562.  The communication also asks about the development of successful IP portfolios. Australia 's IP 
system supports MSMEs to develop portfolios of diverse IP rights, recogni zing that these portfolios 
can h elp MSMEs establish themselves in a market . 
563.  Our portal for small and medium enterprises (found at www.ipaustralia.gov.au/sme -portal ) 
provides a useful resource for MSMEs  looking to better understand the intellectual pr operty system 
and the process involved in developing an IP portfolio.  IP/C/M/96/Add.1  
 
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  564.  The portal provides a detailed case management tool to help MSME 's navigate Australia 's 
patent system, as well as fast track services to  help businesses expedite their IP registration 
applications . 
565.  For example, a father and son team in New South Wales, Australia, developed a system to 
harvest honey directly from the hive without opening it and disrupting the bees. Despite being a 
two-man s mall business, Australia 's patent system allowed the team to quickly protect their idea. 
This allowed the team to launch their product, named Flow -Hive, without extended administrative 
delays, confident that their rights would not be infringed. Flow -Hive q uickly achieved over 
USD 12 million in sales and won Australia 's top design award. Stories like this are made possible by 
simple, easy to access intellectual property rules.  
566.  While it is focused on the Australian market, Australia 's SME portal also provides  webinars and 
workshops designed to educate early -stage businesses on the basics of IP  
567.  These education materials may be useful for a range of MSMEs in different markets and 
jurisdictions, looking to understand the basics of IP protection.  
568.  We look forward t o engaging with Members  on how to support MSMEs develop IP creation and 
management strategies.  
13.6  European Union  
569.  The European Union ( EU) is pleased to co -sponsor this agenda item and thanks Japan for 
having introduced this item. Intellectual  property rights ( IPRs) play a crucial role in catalysing 
innovation and creativity, promoting economic growth and development, creating and growing jo bs, 
improving the quality and enjoyment of our lives.   
570.  Among this multitude of positive contributions, IPRs provide a critical conduit for inclusiveness 
in local and global trade. In particular, IPRs help micro, small, and medium -sized enterprises 
(MSMEs) to channel the potentially boundless contributions of a wide array of innovators and 
creators in different economic sectors and from diverse communities. IPRs also enable MSMEs to 
spur innovation and creativity, to structure partnerships, and to join globa l value chains.  
571.  The key role of intellectual property in the success of start -ups and innovative SMEs has long 
been recogni zed. It allows innovative businesses to profit from the results of their creativity, 
inventiveness and R&D investments, and creates a n incentive for further investment in innovation.  
572.  The European institutions have a number of initiatives in the area of intellectual property to 
support MSMEs. The support the EU institutions provide to MSMEs improves their competitiveness 
and economic pe rformance, mainly through the better management of their IP portfolio.  
573.  Among other activities of the EU and its Members, the EU aims at providing information and 
support for MSMEs through the IPR SME Helpdesk programme  which encourages MSME participation 
in an open international trade framework. There are three IPR SME Helpdesks that were set up and 
funded by the EU in different regions of the world. The Helpdesks provide European MSMEs with 
free, practical, business advice relating to IPR in these regions . More specifically, the Helpdesks:  
a. Provide free information and services in the form of jargon -free first -line confidential 
advice on intellectual property and related issues, plus training, materials and online 
resources.  
b. They raise awareness about IPR matters in the three regions that affect European MSMEs, 
enabling them to make informed decisions.  
c. The services are available to all EU MSMEs, and the Helpdesks are working closely with 
European MSME networks, chambers of commerce and industry association s to provide 
advice on IP and related issues.  IP/C/M/96/Add.1  
 
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  d. The Helpdesks also produce industry and business -focused materials and training tools 
(e.g. IP specific guides, Country IP factsheets, industry specific guides etc.) that address 
IPR issues.  
e. Training events a nd webinars are another important services offered by the three IPR SME 
Helpdesks.  
574.  There are also various other initiatives at EU, national and local level to raise awareness on 
IP, but the challenge is to ensure messages are streamlined, easily accessibl e and that they address 
the real business needs of innovative MSMEs. The European Commission services, in partnership 
with the European Union Intellectual Property Office ( EUIPO ), are trying to streamline European IP 
awareness schemes for MSMEs and support exchange of best practices through an EU coordination 
platform. This involves the development of a common portal, and in the future of common materials 
for information and training, and of common training of trainers.  
575.  Awareness actions are compleme nted with more concrete actions to support MSMEs in the 
access and use of IP. Some EU Members provide individualised advice on the IP potential of a firm 's 
intellectual assets within its specific market context. These services, known as IP pre -diagnostic 
services, can be particularly effective as a way of helping MSMEs both to assess the value of their 
intellectual assets and to include IP in their business strategy.  
576.  The EU Commission services finance a project of IP pre -diagnostic services to be implemented 
in a coordinated manner with EU Members, the EUIPO and other relevant European IP stakeholders. 
It builds on existing experience, but comprises a more thorough cov erage of such services across 
the EU, and will systematically consider EU -wide IP rights within the whole IP spectrum.  
577.  In particular patents are relatively expensive and the patent system can be complex for 
MSMEs. Today, protecting an invention throughout  the EU 's Single Market can be achieved through 
the European Patent Office, but only at non -negligible  cost. Pre -grant costs and patent attorney fees 
represent an important barrier for MSMEs and start -ups to market their innovative products and 
services ac ross Europe. In view of these factors, it is not surprising that only 0.3  % of MSMEs 
currently own European patents.  
578.  The EU Commission services  help selected innovative MSMEs and start -ups that want to patent 
in Europe using European patents. A pilot proje ct was launched to finance innovative MSMEs 
requesting and being granted patents. The subsidies cover 50  % of the pre -grant costs for European 
patents as well as a part of attorney fees. This supports innovative MSMEs in the early years of 
developing their  innovative products by significantly reducing patent costs. This in turn should 
facilitate their access to finance and investment.  
579.  Also, alternative, lighter and faster methods of so lving legal disputes – namely through 
arbitration and mediation – can be very useful for MSMEs as an alternative to litigation in court, if 
such arbitration and mediation can be provided at an affordable cost. These methods also allow for 
more proportionate settlements than simple out of court bilateral agreements, while the in volvement 
of an experienced IP specialist as an independent expert ensures a more equitable outcome.  
580.  The EUIPO has opened up its mediation service, dedicated so far to disputes in relation to its 
procedures. It is now open for trademark and design related  disputes involving MSMEs. The 
Commission services intend to encourage the availability of mediation and arbitration services 
covering the whole spectrum of IP, accessible across the entire EU and designed in an MSME -friendly 
way. Ideally, they should be a vailable online and potentially through local intermediaries (e.g. 
chambers of commerce) and should dovetail with broader legal mediation.  
581.  Many MSMEs suffer from the lack of access to finance. The Commission is also exploring 
developing for IPR -driven sta rt-ups and SMEs a project to help them use IP to access to finance. 
The portal would provide information on sources of funding to be able to benefit from personalised 
IP advice and identify pre -certified experts to provide such advice. The aim is to reduce  the costs 
and raise the quality of advice.  
582.  The advice should improve MSMEs intangible assets protection and commercialisation 
perspectives and the portal should help identify public financial guarantees to funding based on IP. IP/C/M/96/Add.1  
 
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  Such action to reduce MSMEs risk levels should lead to further financing schemes and should increase 
the leverage effect of intangible assets for public  and private investors.  
583.  The ability to enforce rights is also essential for IP to keep its value, but MSMEs do not 
necessarily have the financial or legal means to do so. IP litigation insurance, if it was more broadly 
available for MSMEs, would allow for the sharing or transfer of the financial burden and risks 
associated with IP litigation. However, the market for insurance products for IP litigation has, to 
date, been too limited. The EU Commission services plan to encourage insurance companies to enter 
this market in respect of EU -wide IP titles once the Unitary Patent is available.  
584.  The COVID -19 pandemic has affected nearly all SME s negatively in terms of business activities. 
It is useful to provide more support for them to preserve valuable entrepreneurial capacity that will 
help the recovery.  
585.  For that purpose , the Commission, in r espect of a better  use of IP by SMEs and researcher s, 
is exploring the means to improve the information systems for SMEs, provide strategic advice to 
SMEs, help researchers better use IP and facilitate SMEs use of IP to access to finance.  
Examples from the EUIPO 's programme s to support MSMEs:  
586.  The EUIPO 's actions supporting SMEs are coherent with the Commission 's policy on IP.  
587.  In view of the need to provide more support for SMEs and to use its resources, the EUIPO has 
developed an SME programme  within its new Strategic Plan  2025.  
588.  Noting the urgency to provide help for SMEs because of the crisis triggered by the COVID -19 
pandemic, the EUIPO has accelerated the deployment of actions of its SME programme . 
589.  The EUIPO has started a new SME oriented awareness website, which is int egrated in the EU 
Single Digital gateway.  
590.  This website, the  Ideas Powered for Business hub , has a range of initiatives to support small 
businesses through t he COVID -19 crisis. The hub has information on trademarks and designs geared 
toward businesses. The hub pro vides MSMEs with trademark and design guides, matches with 
pro-bono IP advice, a fast -track online registration tool for trademarks  and designs, lear ning 
resources on the different IP rights, brand building advice and a state of the art e -translation service 
for MSMEs.  
591.  The EUIPO together with the Members  of the  European Trade Mark and Design Network  have 
produced a tool that provides training for small and medium enterprises (SMEs) on the importance 
of intellectual property (IP) rights.   
592.  The European Union Intellect ual Property Office (EUIPO) together with the  European Patent 
Office (EPO)  have developed an  online course  with the basic information on intellectual property 
(IP). 
13.7  Ecuador  
593.  We thank the Members  that have submitted this initiative.  
594.  Ecuador, with a view to stimulating the growth of MSMEs, has made a register of MSMEs 
available to citizens through the Ministry of Production, Foreign Trade, Investment and Fi sheries, 
allowing the owners of small and medium sized enterprises (SMEs) to access benefits and 
programme s offering support in areas such as promotion, growth and development. Registration 
can be obtained throug h the Ministry 's official portal.  
595.  Another state programme  for MSMEs in the area of IP involves the National Intellectual Rights 
Service (SENADI) offering discounts of 50% 90% on registration fees, which facilitates access to 
protection for IP protected int angible assets. Users may access this benefit by filling out the 
corresponding online form available through the SENADI official website.  IP/C/M/96/Add.1  
 
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  596.  Moreover, since August 2020, Ecuador has been running a pilot project for institutions that 
support SMEs. This has bee n implemented by the Ministry of Production and our National IP Office, 
with a view to promoting awareness among national SME support institutions of the importance of 
IP and empowering these institutions with an understanding of IP so that they are able t o advise 
and train SMEs on how to effectively use and manage IP tools to increase their competitiveness. The 
project is being run in cooperation with World Intellectual Property Organization (WIPO).  
597.  Similarly, the national Government enacted the Organic La w on Entrepreneurship and 
Innovation of 2020, the purpose of which is to establish a regulatory framework that encourages 
and fosters entrepreneurship, innovation and technological development, and promotes an 
entrepreneurial culture in Ecuador to strength en the entrepreneur ecosystem.  
598.  Lastly, our national office, SENADI, offers an ongoing training service for entrepreneurs, 
researchers and students, with the aim of disseminating information to boost the registration of 
intellectual property.  
599.  We intend to c ontinue with these training programme s on a regular and ongoing basis in order 
to reach a growing number of entrepreneurs and, above all, keep them up to date on the subject.  
13.8  Korea, Republic of  
600.  To support the IP situation of SMEs, KIPO operates Regional IP  Centres  that provide consulting 
on IPRs and solving IPR -related difficulties. Additionally, SMEs can receive analysis and diagnosis on 
their situation from consultants and experts through the Regional IP Centre . Thereafter, the SME 
are provided with suppo rt to obtain IP strategies necessary for business expansion such as patent 
maps, design maps, and brand development. In 2019, services to support SMEs were carried out 
for 1,471 IP issues and 231 brand development projects. Following the providing of such services, 
IPR applications for patents, trademarks and designs by SMEs have gradually increased, and the 
gap between IP capabilities of large companies and SMEs is expected to reduce.  
Cases of K -Brand Protection in Overseas Markets  
601.  Many times , small and medium -sized enterprises (SMEs) export first in order for early entry 
in overseas markets then recognize the need to secure trademarks afterwards as the volume of 
export increased. Exploiting such situation, foreign trademark brokers can pre-emptively  register 
the trademarks of these brands.  
602.  Compared to large companies with specialized IP departments, SMEs are lacking in terms of 
scale or business experience which also influences their IP capacity. For that reason, SMEs often fall 
short in their  ability to establish IP strategies and respond to IP disputes.  
603.  With the aim of preventing damage caused by the pre-emptive  registration of trademarks and 
protecting the intellectual property rights of Korean companies overseas, the Korean Intellectual 
Property Office (KIPO) currently operates IP -DESK in 15 regions among nine countries where 
frequent intellectual property disputes occur. These IP -DESKs support Korean companies to secure 
overseas trademark rights and cope with infringement disputes. Also, lo cal briefing sessions are 
organized to inform about damages from trademark brokers and strategies for response which will 
help raise awareness on the importance of securing overseas trademarks.  
13.9  Switzerland  
604.  Switzerland would like to  thank Japan for introducing this TRIPS Council  agenda item. We are 
pleased to support both the agenda item and submission  document  IP/C/W/667, together with the 
other co -sponsors.  
605.  We welcome the opportunity to exchange national experiences and to hear abo ut different 
approaches on how to support and strengthen the capacities of micro, small and medium -sized 
enterprises (MSMEs) to make use of and take advantage of intellectual property rights (IPRs) for 
their business activity.  IP/C/M/96/Add.1  
 
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  606.  Compared to large companies, MSMEs face a number of challenges with regard to the use of 
IPRs. Although many such companies are founded on excellent and innovative ideas, just as many 
unfortunately fail. This is because, among other things, they did not or were not able to protect the ir 
IPRs appropriately and effectively, thus putting the innovative potential of their product at risk or 
losing their competitive edge during its marketing. Even if they do, with the IP protection comes 
along the burden to enforce a registered right in cas es of infringement, which requires know -how, 
time and resources, as well.  
607.  In today 's times, protecting an innovative or creative product with a single IPR may no longer 
suffice. The combination of various IPRs, the development of a coherent and sustainable  IP strategy 
as well as the management of a company 's IP portfolio in fiercely competitive markets, is today just 
as relevant for smaller innovative companies as it is for larger ones. Much time, effort and resources 
may be spent on developing a product or  a service. It goes without saying that MSMEs are often 
more constrained by budget considerations compared to their larger competitors. This can have 
various effects. MSMEs often neglect the importance of IP portfolio management. This said, it is also 
important that an IP strategy is guided by a company 's size and capacity. Before investing in any 
kind of IP protection, it is crucial for MSMEs to analyse  the market and assess how best to set up an 
appropriate and effective IP strategy to reap the rewards of  their inventive and creative efforts on 
the market.  
608.  Intellectual property develops dynamically both at the national and international level. 
Accordingly, time and attention need to be dedicated to what new developments may mean for a 
company 's IP strateg y. An awareness and a capacity MSMEs sometimes simply do not have. Although 
a patent, trademark, copyright, design or a geographical indication are IPRs, they all have their own 
characteristics and requirements for protection to be considered in each case individually.  
609.  For this reason, the Swiss Federal Institute of Intellectual Property (IPI) supports MSMEs 
actively and assists companies as concerns know how and the use of IP. For instance, by offering 
trainings to both newcomers and experts, through assi stance in patent searches for inventors, along 
with a free initial consultation on issues concerning patent protection or software copyright protection 
via our IP advisory network. Patent attorneys from both Switzerland and Liechtenstein participate in 
our network, advising MSMEs, as well as individuals, free of charge for up to an hour. There is a 
proverb that says: Many roads lead to Rome – as far as Intellectual property in Switzerland is 
concerned, these roads lead to IPI in Berne . 
610.  In the following, my delegation would like to present an example of a Swiss medium -sized 
enterprise and demonstrate how it has made use of various IPRs to protect its innovative and 
creative products and has thus built and managed an IP portfolio to help it stay at the top of the 
competition in its field of business.  
611.  Caran d 'Ache is a Swiss manufacturing company of drawing and writing instruments, 
headquartered in Thônex, here in the Canton of Geneva. Since its foundation in 1915, Caran d 'Ache 
has been an inspiring example of innovation and creativity. Since its early years, Caran d 'Ache was 
successful and excelled with a number of technological innovations, such as the first mechanical 
pencil, the first watercolour  pencil and the first wax pastel. As concerns their use of IPRs , 
Caran  d'Ache's initial focus for their products was thus on patent protection.  
612.  In later years, not least for reasons of costs involved in building and managing a patent 
portfolio, Caran d 'Ache also opted for relying on trade secrecy for some of its inve ntive steps to 
protect their confidential business and technical information. They had to be aware, however, that 
this form of IPR carries its own risks and requires a number of precautionary measures for it not to 
be lost due to wilful or negligent disclo sure. Caran d 'Ache also started to actively protect their brand 
using various trademarks. This ensured that its brand could not be free -ridden  upon by potential 
competitors. Caran d 'Ache's in-house IP management is in charge, with the assistance of externa l 
IP counsels, of managing the company 's IP portfolio at a global level in its major markets of 
distribution, thus ensuring effective legal protection of their IP.  
613.  Companies like Caran d 'Ache take advantage of the IP system for the protection and marketing  
of their products and brands, often making use of more than just one IPR for a particular product. 
A forward -looking IP strategy for innovative and creative products or services may thus be IP/C/M/96/Add.1  
 
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  multipronged, considering the whole range of IPRs when building a  company 's portfolio, as an 
important component of a company 's overall business strategy.  
13.10   Canada  
614.  Canada  is pleased to co -sponsor this topic and would like to thank Japan for drafting the 
communicat ion on the "IP and innovation " theme of "Making MSMEs competitive through inclusive 
protection of various IPs ", as well as other Members  that are sharing their views and information on 
this topic.  
615.  Canada has presented under this agenda item over a number of years, most recently at the 
Februar y 2020 meeting of  the TRIPS Council where we focused our attention on the importance of 
the trademarks to MSMEs ' competitiveness, growth, and trade performance. We are pleased to 
continue that discussion by considering considerations across the various categories of IP and  how 
they can serve as important tools for MSMEs ' success and growth.  
616.  As my delegation has presented at past meetings of the Council, Canada has been 
implementing a National IP Strategy since 2018 with the overall objective of helping businesses, 
creators,  entrepreneurs and innovators understand, protect, and access IP as key tools for growth. 
I will highlight a few of recent initiatives that are relevant to the themes set out in the 
communication.  
617.  As part of its IP Awareness and Education programme , the Ca nadian Intellectual Property 
Office has launched an online IP Academy, featuring a suite of information materials and interactive 
learning resources for businesses and entrepreneurs. The IP Academy includes a recently -developed 
"massive open online course " on "Foundations of IP Strategy ", developed by the Canada -based 
Centre  for International Governance Innovation, with particular value for MSMEs. The IP Academy 
also includes a customizable web -based guide for MSMEs to develop their own tailored IP strategi es. 
These two voluminous resources are too detailed to replicate through Canada 's intervention but they 
both will help MSMEs grapple with many of the challenges of operating in a competitive business 
environment.  
618.  To give an example of subjects covered by the IP Academy 's resources, IP ownership can be 
a key consideration when starting a new business As an overarching matter, the importance of 
conducting an audit of existing and potential assets by IP category – such as patents, copyright, 
trademarks, indust rial designs, and trade secrets - is a potentially valuable, if often neglected, early 
step for MSMEs. Beyond an audit, MSMEs may consider further options, like seeking professional 
advice for an IP evaluation – an investment which can pay off when dealing  with potential financial 
partners.   
619.  IP-based financing is another area of growing importance and potential for companies. Indeed, 
this is one of the potential benefits of the IP system for MSMEs covered by IP Academy. IP -based 
financing strategies include  IP-backed loans, IP royalty securitization, which involves 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 i mmediate 
financing, while retaining the option of using the IP assets through a license -back arrangement and 
option of to buy back the ownership of the IP assets at the end of the license period. Important 
considerations exist when arranging IP -based finan cing, including the importance of maintaining 
confidentiality, especially for trade secrets and unpublished inventions or designs through 
nondisclosure agreements when dealing with prospective financial partners, as public disclosure may 
jeopardize the suc cess of a patent or industrial design registration.  
620.  A number of financing considerations are also relevant to certain IP categories. For example, 
in the area of patents, to maximize the value of a company 's patent portfolio, IP Academy 
recommends providin g prospective financial partners with both quantitative and qualitative 
valuations of patent holdings and highlighting the importance of the features that the patents 
protect.  
621.  To demonstrate the value of trademarks IP Academy recommends that MSMEs show the  
strength of the marks through registration and market reputation, and willingness to enforce their 
protection to prevent the dilution of their brand.  IP/C/M/96/Add.1  
 
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  622.  Relevant to copyright, to help secure financing or attract financial partners, IP Academy 
advises that MS MEs are advised to highlight the value of their copyrighted material as an IP asset, 
such as through registration as a demonstration of ownership.  
623.  For industrial designs, IP Academy has suggested that MSMEs highlight the value of the 
aesthetic uniqueness o f their products as well as any applications or registrations held, to showcase 
their business 's capacity to develop unique products.  
624.  Finally, to maintain the confidentiality of trade secrets, MSMEs are advised by IP Academy to 
share the outputs of a prot ected asset with investors, rather than the trade secrets themselves. 
Highlighting the existence of trade secrets and their protection may boost the confidence of 
prospective financial partners.  
625.  The IP Academy resources cover further thematic areas, such a s IP considerations across the 
various categories when operating a continued business such as IP asset management and 
prioritization, market monitoring and enforcement of rights, as well as when seeking to export goods 
or services or establishing a presenc e in foreign markets.  
626.  If any Members  are interested in learning more about these resources, I would encourage you 
to do a web search for "IP Academy Canada ". My delegation would also be pleased to share 
information on the development of these and other programme s under our national IP Strategy if 
other Members  are considering similar initiatives to support MSMEs ' competitiveness and growth by 
leveraging the I P system. Canada will continue to listen to similar initiatives undertaken by other 
Members  with great interest, in the spirit of continuing to collectively leverage the TRIPS Council as 
a venue for policy exchange and learning.  
13.11   United Kingdom  
627.  The United K ingdom is pleased t o co-sponsor this paper and would like to thank Japan for 
introducing it.  We also welcome the discussion on this  agenda  item.  
628.  With 99.9% of British companies being micro, small or medium sized businesses, the 
United  Kingdom has always b een a strong supporter of MSMEs as drivers of innovation.  
629.  The United Kingdom is not alone in this; across the globe, MSMES represent 95% of businesses 
and, as is clear from this paper, their significance to the economy is increasingly recogni zed. In 
times  of uncertainty, it is even more important that we look at ways to bolster the capacity of MSMEs 
to support economic recovery.  
630.  The UK considers that an intellectual property system that enables these highly innovative 
enterprises to protect their creativi ty and innovation is crucial to maintaining their competitive edge 
and to supporting and nurturing their continued growth.  
631.  As the founder and Chairman of the well -known UK product Tangle Teezer said, "innovation is 
at the heart of Tangle Teezer and our pr oducts " He has patented his hairbrush in over 30 countries; 
each brush design is protected by design rights and the name Tangle Teezer is also protected as a 
trademark. "Being first to market has been of huge importance, but so has having worldwide IP 
protection… Having IP rights in so many countries makes trying to combat counterfeiters and patent 
infringements much easier. " 
632.  However, while MSMEs are the lifeblood of the UK economy and trade in intellectual property 
is an increasingly important part of UK business activity, it is also often true that many MSMEs have 
only limited knowledge of IP and the impact it may have on their business, and in turn on their 
competitiveness.  
633.  Therefore, the UK Government  is committed to working to increase MSMEs ' ability t o 
understand the impact of IP on their entrepreneurial activities through awareness raising and 
education initiatives. Our ambition is that IP will be taken into account during the  business planning 
process and that businesses understand and take informed decisions about using IP as an asset in 
the UK, and abroad – where our IP attachés support British businesses operating overseas and have 
a major impact on the improvement of the global IP system.  IP/C/M/96/Add.1  
 
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  634.  In practice that means businesses being able to access rele vant IP information and IP 
registration services at the time that it is most pertinent in their development, which can make all 
the difference:  
635.  Such as in the case of These Please who specialise in colourful doorknobs, handles and coat 
hooks. Ashley Flett,  Managing Director of the company says:  
… we continued to see copies of our products being sold without our permission…  
we had a look on the IPO website, read up on what we needed to do, and applied for a 
registered design… we realised we could cover sever al products under the same design. 
This was very attractive to us as it allowed us to expand our range and hold the design 
going forward . 
The design registration has been fantastic… It 's been a low investment with a high value. 
We couldn 't run the business  effectively without it . 
636.  Therefore , our support includes a range of digital tools and guidance designed to provide 
businesses and their advisors with the basic information they need to identify their assets, 
understand how they might protect them and the  options available  to derive value from them. This 
includes online tools to:  
a. help advisors identify assets which may be protected by IP rights;  
b. help businesses identify their own IP while raising awareness and understanding of the 
broader IP system and its benefits;  
c. support businesses in facilitating IP terms within collaborative agreements - to equip UK 
businesses with the skills they need to successfully collaborate whilst taking control of how 
IP is managed and commercialised; and  
d. support IP -rich business es in seeking equity growth funding.  
637.  Another example of the work the UK Government undertakes in this area includes providing 
funding towards audits of small businesses ' intellectual property, carried out by an IP professional, 
to provide clear recommendat ions as to how a business could leverage value out of its IP and how 
to develop an IP management plan to integrate IP assets into wider business strategy.  
638.  The service aims to provide MSMEs with guidance and advice in respect of IP management, 
commercialisa tion and marketing to ensure that they can obtain their IP rights, identify opportunities 
to use them in their wider business strategy and maximise their value.  
639.  Great ideas, properly protected, help MSMEs to compete and to grow. The benefits to be gained 
from using the intellectual property system to increase competitiveness apply to small, young 
companies as well as to larger, more established ones.  
640.  The United Kingdom is committed to ensuring that the intellectual property system can be fully 
utilised to support these aims. We look forward to hearing other member 's experiences of using 
intellectual property to support MSMEs in a similar vein and to learn from these experiences going 
forward.  
13.12   El Salvador  
641.  We thank the delegation s of Australia, Canada, Chile,  the European Union, Japan, 
Republic  of Korea, Singapore, Switzerland, Chinese Taipei, the United Kingdom and the United 
States for submitting document IP/C/W/667. We would like to stress the importance of this exercise, 
since it enables us to hear about and learn from other Members ' experiences and success stories. 
Our delegation wishes to share its experience in relation to the assistance being provided to MSMEs 
so that they are able to build their portfolios and develop thei r intellectual property strategies.  IP/C/M/96/Add.1  
 
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  642.  The Ministry of the Economy of El Salvador, with support from WIPO and in cooperation with 
the National Intellectual Property Office, recently organized two workshops for MSMEs on intellectual 
property. The first worksho p, "Intellectual property for SMEs ", took a pragmatic look at the basic 
aspects of IP, highlighting its benefits for users. The second, "The value of intellectual capital in 
SMEs ", focused on the potential economic benefits that IP management can offer for  businesses. 
These workshops were attended by 40 participants.  
643.  A training session entitled "Marketing and intellectual property " is also being organized in the 
coming days for 143 entrepreneurs and start -ups that participated in the national round of the 
Entrepreneurship World Cup.  
644.  In addition, the Ministry of the Economy, the National Intellectual Property Office (National 
Registration Centre 's Intellectual Property Registry), the micro and small enterprises support agency 
(CONAMYPE) and the export promotion agency (PROESA) are participating in a regional project with 
WIPO on intellectual property and SMEs. This project aims to promote awareness among national 
SME support institutions of the importance of IP and to empower them with IP knowledge so t hat 
they are able to advise and train SMEs on how to effectively use and manage IP tools to improve 
their competitiveness.  
645.  Between July and October, the National Intellectual Property Office organized a series of online 
events at the subregional level (Cen tral America and the Dominican Republic), aimed at boosting IP 
promotion activities during the pandemic. Events included a session on creative industries and 
another on the protection of video games, which involved an analysis of strategies and support 
measures to strengthen this business sector with IP tools.  
646.  The Ministry of the Economy and the National Registration Centre are planning a number of 
activities for next year, both together and individually, relating to support for MSMEs through IP 
tools as pa rt of their strategic plans.  
13.13   Chinese Taipei  
647.  We thank Japan for introducing this topic. MSMEs make up 98% of our entire entrepreneurial 
sector, and although they are behind a large number of creative ideas with significant market value, 
they often lack suff icient resources to enhance competitiveness through IP. To remedy this situation, 
we have introduced several key measures aimed at fostering greater understanding of IP protection 
as well as  its proper application  and management. The following is a brief o verview of our main 
measures and developments:  
648.  The IP Value Maximization Plan for MSMEs is designed to increase awareness about IP rights, 
be it by strengthening business owners ' familiarity with IPRs or highlighting the importance of patent 
analysis. This  is achieved by enabling innovative MSMEs to optimize their IP capabilities and granting 
them access to helpful resources. Providing a comprehensive service platform for such companies, 
the plan makes use of various different strategies, i.e., promotional activities and lectures, digital 
media utilization, telephone consultations, company visits, advisory services and referrals.  
649.  The Chinese Taipei Intellectual Property Management System (TIPS), launched in 2007, has 
also allowed us to implement a plan that  provides enterprises with the resources they need to 
establish their own IP management systems. This has enabled companies to adopt an integrated 
strategy that combines IP, R&D and business goals, thereby enhancing the effective use of IP to 
boost their c ompetitiveness and performance. Since its introduction, this plan has already helped 
more than 2,000 enterprises correctly identify weak spots in their IP management approach, with 
customized improvement recommendations being made in each case. Not only ha s this led to a 
surge in patent applications and quality, it has also increased the number of orders received from 
large manufacturers, as the improved implementation of trade secret protection measures has 
strengthened trust.  
650.  IP and innovation are both es sential for economic growth, a fact that underscores the 
importance of the government 's role in helping MSMEs boost competitiveness through 
comprehensive IP protection measures.  IP/C/M/96/Add.1  
 
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  13.14   Philippines  
651.  The Philippines would like to thank Japan and the co -sponsors of  document  IP/C/W/667 for 
this timely and relevant contribution to the policy discourse on MSMEs and the importance of 
intellectual property right s to sustaining their c ompetitiveness in the global marketplace.  
652.  Like a wide majority of WTO Members , the Philippines has long valued MSMEs as important 
drivers of the domestic economy, comprising 99.5 % of the total number of establishments, of which 
89.9% are micro -enterprises, 9.2 % are small enterprises, and 0.4 % are medium -sized enterprises. 
It has long been a universally accepted truth that a robust, dynamic, and innovative MSME sector is 
critical to achieving our national development goals.  
653.  At the same time, for the Philippines to be able to compete globally, a purp oseful and effective 
national innovation policy is needed to transform the Philippine economy into a knowledge -driven 
and innovative economy. To achieve this, an effective and predictable rules -based regime for the 
protection and promotion of intellectual property rights that benefits not just large multinational 
corporate investors, but also MSMEs in equal measure, would be indispensable.  
654.  The Philippines ' policy environment to support MSMEs has long been a prominent feature of 
the national government 's med ium-term development plans over successive administrations. 
Despite this, MSMEs have not innovated as much as large firms. To encourage MSMEs to invest more 
in innovation, public interventions that are adapted and tailor -fit to their specific needs have pr oven 
to be necessary. To cultivate a culture of entrepreneurship and innovation, ongoing entrepreneurship 
programme s and other support measures for MSMEs implemented by government will be enhanced 
and actively promoted for greater awareness of the importan ce of innovation and IP.  
655.  Under the administration of President Rodrigo R. Duterte, the Philippine Government  made a 
conscious policy decision that a coordinated, seamless, and complete package of enterprise 
assistance for MSMEs can help the development of a vibrant IP culture that supports inclusive growth 
and innovation. Connecting and integrating the key elements and stakeholders of the Philippine 
innovation and entrepreneurship ecosystem is crucial. Several important pieces of legislation were 
enacted to  make the policy environment for MSMEs more conducive to innovation.  
656.  The Philippine Innovation Act (RA 11293), signed into law in April 2019, is expected to 
accelerate the progress of the Philippines ' efforts to build a more innovative economy, starting wi th 
integrating and synchronizing all government agencies ' programme s and projects to link academe 
with the industry through a whole -of government approach to innovation policy. The law also builds 
a strong base for our internet infrastructure, brings scien ce, technology, engineering, and 
mathematics or STEM education to the fore in the curricula of our educational institutions, and raises 
awareness on the IP tools Filipinos can use to maximize the economic returns of their inventions and 
innovative ideas.  
657.  The Innovative Start-up Act (RA 11337), signed also in April 2019, seeks to provide start-ups 
with easy access to funding and other services and capacitate MSMEs to penetrate and operate 
competitively in large international markets.  
658.  Meanwhile, the Personal Property Security Act (RA 11057) establishes IP as intangible property 
that is registrable as collateral for credits/loans that also provides MSMEs an additional option for 
access to finance.  
659.  Coordinated strategies have been implemented to promote the use of IP tools to MSMEs, 
traditional producers, and technical and vocational schools. Such strategies were eventually 
consolidated into the National Intellectual Property Strategy 2020 -2025, an agenda to harness 
intellectual property for innovation, creativit y, and knowledge generation; for entrepreneurship and 
competitiveness; and to achieve public policy goals such as universal access to health care, 
agricultural self -sufficiency and inclusive growth.  
660.  In implementing this strategy, the full panoply of IP too ls should be made more accessible to 
MSMEs to incentivize them to protect their innovations. Utility models, trademarks, collective marks, 
geographical indications, and industrial designs have the potential to address inclusive innovation 
goals.  IP/C/M/96/Add.1  
 
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  661.  Among the major programme s is the Juana -Make-A-Mark Programme  through which the 
Philippine Intellectual Property Office (IPOPHIL ) waives certain fees to MSMEs handled by or 
comprising of a woman entrepreneur or innovator. The IPOPHL expanded the Juana -Make-A-Mark 
programme  to cover women filers for patents, UMs, and designs under the Juana Invent and Juana 
Design.  
662.  The IPOPHIL also implemented the Inventor Assistance Programme  which provides free legal 
advice on patent applications and free basic seminars on patent se arch and drafting, as well as the 
IP Depot, an online marketplace where MSMEs can market their IP -protected products for free.  
663.  Notably, our IPOPHIL will soon partner with our Trade Ministry 's Global MSME Academy to 
assist MSMEs in developing their IP strat egy. 
664.  To improve the innovation performance of our MSMEs, regional inclusive innovation centres  
were established, linking public and private stakeholders together to serve as linchpin of productive 
collaboration between and among industries, universities, g overnment agencies, local government 
units ( LGUs), start-ups, MSMEs, R&D laboratories, S&T parks, incubators, investors, among many 
other agents in the innovation ecosystem.  
665.  There are several other support programme s and priorities for MSMEs include the following:  
a. Strengthening and expanding one -stop-shops for MSMEs, which provide services such as 
certification, licensing, capability training, production, and marketing of products/ 
services; services can be expanded to provide business mentorship, particu larly for 
start-ups, as well as creative and design services that aid in transforming ideas/ prototypes 
into commercially viable products and services;  
b. Establishing regional start-up offices or hubs that can serve as a platform for MSMEs to 
connect and net work with industry experts as well as function as business incubators for 
stakeholders in the regions;  
c. Fostering greater cooperation among actors in the MSME support network (i.e., incubators, 
accelerators, small business development centres , export assist ance centres ) by 
deepening and strengthening their involvement and engagement with stakeholders, 
including industry experts;  
d. Building and/or strengthen MSME partnerships with academe and larger players in industry 
for mentorship programme s for innovation a nd technology -related training programme s 
and activities; and  
e. Strengthening the Start-up Ecosystem Development Programme  (SEDP) and provide 
support programme s and other forms of assistance to start-ups and other Members  of the 
community.  
666.  The Philippine Government  has adopted a combination of strategies to help Philippine MSMEs 
innovate their businesses through the use of IP. These strategies involve programme s that not only 
directly apply IP tools or make such tools more accessible and tar geted, but also programme s that 
indirectly promote a policy environment that is more conducive to innovation.  
667.  Although we still have a long way to go, some progress has certainly been made.  
668.  Recently, the Philippines reached its highest ranking thus far (50 ) in the Global Innovation 
Index for 2020, after placing as low as 100 in 2014. The Philippines together with other three 
economies has made the most significant progress in the Global Innovation Index innovation ranking 
over time.  
669.  We will continue to buil d on this agenda for more inclusive and innovative MSMEs, and will 
continue to look to an effective and responsive intellectual property regime to make this happen.  IP/C/M/96/Add.1  
 
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  13.15   Brazil  
670.  We would like to than k the proponents for the discussion document.  
671.  Micro, small and medium -sized enterprises (MSMEs) are a driving force of economic 
development and employment in most countries. Brazil is no different.  MSMEs represent 95% of 
Brazil 's companies - a universe of six million enterprises.  They also represent 75% of Brazil 's 
exporting companies.  
672.  Just as the proponents of the discussion, we are convinced that intellectual property is a means 
to enhancing the business value and competitiveness of MSMEs, with positive effects on international 
trade.  
673.  Recent surveys condu cted by Brazilian Micro and Small Business Support Service (SEBRAE) 
revealed that intellectual property in general, including trademarks, are still little considered in the 
business strategies of a large number of Brazil 's MSMEs.  These surveys have also sh own that these 
numbers significantly change when companies receive targeted training in IP.  
674.  The Brazilian Government is committed to nurturing an IP culture in Brazil and disseminating 
knowledge on the use and benefits of IP.  
675.  MSMEs and start-ups benefit fr om registration fee reductions and priority of examination in 
Brazil.  This reflects Brazil 's recognition of the importance of the right incentives and tools to engage 
these enterprises in the use of IP.  IP education is one central aspect of our policy towa rds MSMEs.  
676.  For the past years, Brazil 's IP office (INPI) has made partnerships with other public and private 
entities to reach MSMEs of different sectors and provide them with information on a wide range of 
modalities of IP rights.  Examples in this regard  are partnerships developed with the National 
Confederation of Industry, the Brazilian Export Promotion Agency and SEBRAE.  
677.  Beside the development of educational material, activities target capacitation of IP 
professionals and mentorship programme s for MSME s. All these initiatives will be structured within 
Brazil 's Intellectual Property National Strategy.  
678.  Its first draft, elaborated in coordination with key stakeholders from government, private 
sector, scientific community and civil society and in cooperatio n with WIPO, was recently submitted 
to public consultation.  In the aforementioned strategy, MSMEs will have a pivotal role as they are 
directly involved in strategic initiatives related  to competitiveness and capacity -building.  
13.16   Mexico  
IMPI activities in su pport of MSMEs  
679.  Mexico thanks the proponents. The Mexican Institute of Industrial Property (IMPI) has 
proposed making the industrial property syst em available to users, including MSMEs, in an accessible 
and simplified way, and with the required support to enable a greater number of creators and 
entrepreneurs to access such a system, without intermediaries, which will bring down their 
management cost s. The Institute is focussing its efforts on enhancing processes, facilitating access 
to electronic mechanisms and fostering a culture of industrial property in Mexico, with a direct impact 
on MSMEs, which make up the majority of the users of the services offered by IMPI.  
680.  Among the activities that IMPI is undertaking in support of MSMEs , are the following:  
Enhancing IMPI 's electronic services  
681.  From March 2019, IMPI ceased using postal services for all its notifications and procedures 
and switched to using em ail as the main means of communication with users who were still 
processing their documentation over the counter. IMPI now sends emails to notify users of Industrial 
Property Gazette notifications.  
682.  Approximately 110,000 people, including those in MSMEs, wh o each year file for protection for 
their trademark or invention directly at IMPI, have benefitted from this enhancement.  IP/C/M/96/Add.1  
 
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  683.  In August 2019, a one -stop online integrated services platform was launched. This platform 
provides creators and entrepreneurs, partic ularly MSMEs, with the ability to file their requests for 
trademarks and patents entirely online and to sign their documents with their Single Population 
Registration Code (CURP) and an email address. The platform uses intuitive and user -friendly 
language,  sends notifications by email, allows online payments by means of credit cards or electronic 
transfers and provides user guides to explain in clear and didactic terms, step by step, how to use 
the platform to enjoy all of the services offered by IMPI.  
684.  In addition to this electronic services platform, the Institute developed a mobile app which 
provides, amongst other things, user tutorials on how to complete procedures directly, without the 
need for third parties; a survey or quiz to help entrepreneurs ident ify the most appropriate form of 
protection for their intellectual property; and a function that makes it possible to search for 
documents in the IMPI databases by means of a QR code.   
685.  The official IMPI Twitter, Facebook, YouTube and Instagram accounts pro vide free online 
tutorials and courses to help MSMEs and individual users complete the document submission process 
online, without the need for intermediaries.  
Partnership with other local government agencies   
686.  During this new administration, activities dir ectly supporting MSMEs have been carried out in 
partnership with the country 's state governments.  
687.  Over the course of 2019 and so far in 2020, various partnership agreements have been 
reached with the aim of deepening the culture of industrial property rights protection by means of 
knowledge -sharing activities and those which foster the use of the industrial property protection 
system for MSMEs, traders, manufacturers, natural persons and individuals interested in protecting 
their industrial pro perty rights.   
688.  IMPI has carried out specialized consulting and guidance activities on trademark applications 
for MSMEs that are supported by the Secretariats for Economic Development of various States.   
689.  Currently, IMPI is continuing its collaboration with other governments to further develop the 
protection of traditional products from communities of such States, particularly through MSMEs.  
Consulting and training   
690.  IMPI consistently provides specialized consulting in industrial property by means of 
conferenc es, courses, lectures and information booths at various events aimed at Mexican 
entrepreneurs and creators, and events aimed at MSMEs. These activities responded to requests 
and exchanges with various public, private and corporate sector agencies and bodie s. 
691.  The activities carried out throughout the country, mainly aimed at MSMEs, include the 
following:6 
a. Provision  of 2,107  physical or online courses, workshops, diploma courses, lectures and 
lecture series, covering trademark and patent -related topics.  
b. Of note were the continuous courses broadcast live on Facebook Live. The videos of these 
courses are stored on the official IMPI Facebook profile so that entrepreneurs and creators 
can always access them.  
c. Consulting was provided on 110,312 occasions in per son, by telephone and online through 
buzon@impi.gob.mx and social media.  
 
6 As at April 2020.  IP/C/M/96/Add.1  
 
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  13.17   Peru  
692.  The delegation of Peru would like to thank the proponents for bringing this important topic to 
the debate of the TRIP S Council .7 This time I would like to present  the followin g: 
a. MSMEs and intellectual property in Peru - general overview;  
b. Initiatives developed by INDECOPI in favour  of MSMES:  
i. inventions and new technologies  
ii. distinctive signs  
iii. copyright  
c. COVID -19 crisis - INDECOPI 's MSMES reactivation strategy  
MSMEs and intellectual p roperty in Peru - general overview  
693.  In Peru, MSMEs represent 99.5% of the formal companies of which 87.6% are dedicated to 
commerce and services, and the rest of them (around 12.4%) to productive activities (including 
manufacturing, construction, agriculture, mining, and fishing).  
694.  Moreover,  MSMEs embody around 60% of the economically active population. However, high 
rates of informality are the main problem on this sector, since 48.4% of Peruvian MSMEs are not 
enlisted/registered under the Peruvian Tax Administration Office (SUNAT).  
695.  Here we can observe how MSMEs activities can be linked to the different IP tools.   
696.  One of the biggest issues in Peru is precisely the unawareness of IP tools importance and 
benefits such as:  
a. market domain position;  
b. enforcement against copies;  
c. more attractive for investors and shareholders; and  
d. more business opportunities . 
Initiatives developed by INDECOPI in favour  of MSMES  
697.  The National Institute for the Defense of Competition and the Protection of Intellectual Property 
(INDECOPI) is the Peruvian Au thority in charge of the correct function of the market. Its scope of 
protection includes Intellectual Property, Consumer 's Protection, Unfair Competition, Bureaucratic 
Barriers, Dumping and Bankruptcy . 
698.  Regarding Intellectual Property, the Peruvian system is formed by three  Directorates 
Distinctive Signs, Inventions and New Technologies, and Copyright), their correspondent contentious 
commissions and an Intellectual Property Court.  
699.  In markets like Peru 's, MSMEs must resort to innovation, differentiation or IP to compete in 
better conditions. It must be noted that sectors linked to innovation are usually agriculture, farming 
metallurgy and farming, manufacture, basic services, construction, ICTs and technological services.  
700.  There are  some rules that we consid er important for the correct management of IP portfolios 
among SMEs:  
a. IP as a strategic asset ; 
b. Asset Protection ; 
c. IP Information ; 
 
7 The P owerPoint presentation is available in Room Document RD/IP/41.  IP/C/M/96/Add.1  
 
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  d. Asset safeguard ; 
e. IP management ; and  
f. IP access . 
Inventions and new technologies  
701.  The Inventions and New Technologies Directorate h as been designing and implementing an 
integral package that seeks to raise awareness among Peruvian companies about the importance 
and value of the use of IP for the protection of innovations, as well as the strengthen of business 
management in order to in crease their competitiveness.  
702.  This package includes:  
a. IP ROUTE: its purpose is to develop and provide each participating company with a work 
plan to optimize the use and management of intellectual property within the company 's 
organization, based on its str ucture, capacity and the type of business that it operates. It 
is primarily focused on sectors with a greater patenting capacity.  
b. PATENTA EMPRESA: Initiative aimed to evaluate patent viability of innovations developed 
by Peruvian companies and to provide f ree technical support for the filing application.  
703.  The Annual recognition for the commercialization of Patents is a yearly award given to the 
most outstanding success stories of a patented Peruvian invention that has also been commercialized 
in the market.  In this way, the successful experience can serve as an inspiration for other inventors.  
704.  The value of patent information for MSMEs: content development targeted to the Peruvian 
companies in order to facilitate their understanding of different aspects of i ntellectual property.  
705.  Protect your designs: initiative developed to promote the protection of aesthetic  aspects of 
products, and to provide virtual assistance for the filing application.  
706.  Webinars and training programme : programme  developed to educate and raise awareness 
about the most relevant issues related to patents and other industrial property elements. The 
programme  is available free of charge to entrepreneurship centres , business incubators, chambers 
of commerce and all business institutions in Lima  and other regions.  
Distinctive signs  
707.  The Distinctive Signs Directorate has focused its efforts on developing and strengthening the 
existing digital tools to promote the use and protection of IP:  
"Peruanizado " ("Peruanized ") 
708.  Through this tool, users can search for the correct classification of products or services for 
typical Peruvian terms, under the Nice classification. Up to date PERUANIZADO has included 1257 
new Peruvian terms to its database.  
IP Electronic Gazette  
709.  Through this service, INDECOPI automatically publishes trademark and patent applications 
that has passed formal examination. It is free of charge (generating USD 9.8 million in safes up to 
date) and allows procedures to be faster (for trademarks, an average of 35 working days).  
"Busca t u marca " ("Find your brand ") 
710.  Free of charge search tool, BUSCA TU MARCA allows users to online check by themselves if 
the sign they want to register is identical or alike to a previously registered trademark.  
Online Trademark Renewal  
711.  This tool allows user s to renew a registered trademark automatically on a fully digitized 
platform , in addition to obtaining a discount on the renewal fee.  IP/C/M/96/Add.1  
 
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  712.  The Distinctive Signs Directorate have performed several activities (such as webinars, 
interviews, and campaigns) to comm unicate the importance of the use of trademarks to protect 
entrepreneurs ' assets.  
713.  Additionally, INDECOPI has launched the campaign #YoProtejoMiMarca (#IProtectMyBrand) 
which goal is precisely to show, through successful entrepreneur experiences, the importance of 
trademark protection.  
714.  Its main slogan is: "Do not put your dreams at risk, protect the most valuable asset of your 
company, your brand ". 
715.  As you can see promotion measures taken by the Distinctive Signs Directorate allowed 
INDECOPI to communicate its message to more than 17 000 entrepreneurs. Consequently, and 
despite the current pandemic situation, the trademark application ratio has increased from 7566 
applications in the first trimester to more than 12 000 on the third trimest er of the present year.  
Increase on the number of trademark applications during 2020  
716.  In April, due to the government measures taken to face COVID -19, the number of trademark 
applications decreased to less than 1200 applications (64% less than April 2019), then after the 
start of the promotion measures adopted by the Distinctive Signs Directorate, the number of 
applications gradually increased, overcoming the applications filed during July, August and 
September 2019. During September 2020, we reached the num ber of 4523 applications (32% more 
than in 2019).  
Collective marks programme  
717.  Given the nature of collective marks, the programme  seeks to develop associative and 
technical capacities of MSMEs through the use of this intellectual property tool.  
718.  Therefore, the programme  includes the implementation and development of four aspects:  
a. Training: Up to date, more than 4700 trainees . 
b. Technical Assistance on the filing on applications: which includes goods/services 
Classification, formal requirement review, Trademark  searches, assessment on 
registration viability, among others . 
c. Free of charges: Achieving more than  USD 700,000  on savings for more than 30000 
families . 
d. Fast Track system, which allowed collective trademarks to be granted on an average of 38 
working days.  
719.  The Collective marks programme  also includes different digital products such as: QR CODES 
(consumers can access to important commercial information of the trademark owner such as product 
history, contact information, among others)  
Multimedia Publications  
720.  Collective marks interactive map: A catalogue including the registered collective marks by 
regions . 
Certification marks programme  
721.  Another important measure recently implemented by the Distinctive Signs Directorate is the 
Certification Marks Programme  for the economic reactivation of MSMEs.  
722.  According to our legislation, a certification mark shall be understood to be a sign intended to  
be applied to goods or services of which the quality or other characteristics have been certified by 
the owner of the mark.  
723.  In this scenario, through the registration and use of certification marks, the programme  seeks 
to generate economic benefits in favour of:  IP/C/M/96/Add.1  
 
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  a. Authorized MSMEs: who increase their sales due to the use of an IP tool that guarantees 
quality standards and/or compliance with health regulations.  
b. Consumers: who increase their confidence in the acquisition of products and services in 
the market , because they precisely meet the conditions previously described.  
724.  Its TARGET:  
a. Productive/service guilds ; and  
b. Regional/local governments . 
725.  This programme  includes:  
a. Diffusion ; 
b. Technical Assistance on the filing of applications ; and  
c. Fast Track system . 
726.  The Copyright Directorate has implemented the following services to promote the use and 
respect of IP rights:  
727.  Catalogue of Public Domain Works which currently includes 1061 texts available.  
Fight against piracy in the digital environment :  
728.  INDECOPI has perform ed an intense work against digital piracy, for example recently 
suspended the domain of six websites which performed unauthorized broadcast of phonograms.  
729.  It is important to mention that in Peru the fight against piracy and counterfeiting is based on 
a triple approach:  
a. Preventive Approach: We seek to develop and consolidate a culture of respect for IP rights 
among citizens, also raising awareness among the citizenship . 
b. Persuasive Approach: Incentives for compliance with intellectual property rules.  
c. Reactiv e approach: Actions for the control and sanction of acts that violate IP rights . 
COVID -19 crisis - INDECOPI 'S MSMEs reactivation strategy  
730.  The economic consequences in Peru due to COVID -19 has been devastating. According to the 
World Bank Organization, Peruvian GDP will decrease 12% on 2020. Also, six million jobs have been 
lost between April and June 2020.  
731.  To contribute with the economic reactivation of MSMEs, INDECOPI is implementing a  work 
plan to strengthen their competitiveness.  
732.  The work plan includes the participation and cooperation of three areas for the economic 
reactivation: consumer 's protection, bureaucratic barriers and intellectual property . 
733.  With joint actions, the authorities in charge seeks to: build capacities, promote the use of 
different IP tools, ensure quality in service, facilitate market access, and generate an adequate 
environment for innovation.  
13.18   China  
734.  Like many other Members , China  fully recognizes the important roles of MSMEs in boosting 
our national economic development, driving innovation, expanding employment and meeting 
people 's demands. We have taken many measures,  including relevant IP measures, to advance the 
innovation and development in MSMEs.  
735.  First, China implemented the Project of Promoting IP Strategies among Small and 
Medium -sized Enterprises in 2016. In the Project, China National IP Administration (or CNIPA) IP/C/M/96/Add.1  
 
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  together with the Ministry of Industry and Information Tech nology (or MIIT) put forward specific 
measures for improving MSMEs ' IP creation, utilization, protection and management capabilities. 
Pilot policies are carried out among 35 industry parks in 20 pilot cities where MSMEs are 
concentrated. Take a few pilot m easures for example. We provide MSMEs regularly with IP 
information of high quality and low cost. We establish an R&D system for patented technologies 
which allows universities, research institutions to directly place orders with MSMEs. We also launched 
targeted and specialized IP enforcement activities to protect IP of MSMEs.  
736.  Second, China helps MSMEs to optimize IP management  strategy . CNIPA and other 
government authorities issued the national standard on IP Management for Enterprises. As a 
recommended st andard, this document aims to enhance enterprises ' IP management in the whole 
process of project initiation, R&D, procurement, production, sales and post -sales services and to 
improve the quality of innovation in a comprehensive manner. Besides, to assist MSMEs to have an 
accurate understanding and effective implementation of the standard, some provinces in China 
establish service points to offer free consultation services and hold specialized workshops and 
seminars, so that MSMEs could learn more about the  standard, build up IP management systems 
that suit their own needs and support their own development strategies.  
737.  Third, China has made efforts to address the difficulty of MSMEs to obtain IP financing. By 
facilitating IP pledge registration procedures, th e IP pledge and financing system have been 
improved. During the COVID -19, we establish green passages for patent and trademark pledge 
registrations, which immediately process enterprises ' applications for IP pledge and help enterprises 
to get rapid financi ng. In 2019 alone, the total amount of financing deriving from patent and 
trademark pledge in China adds up to RMB 151.5 billion, which has increased by 23.8% compared 
with the year before.  
738.  We are more than willing to hear from Members ' policies and practices.  
13.19   India  
739.  We thank the proponents for their submission  document  IP/C/W/667.  
740.  My intervention under this agenda consists of two parts - first part highlights some of the 
initiatives taken by t he Government of India to enhance awareness of IP rights amon g MSMEs and 
the second pertains to general remarks on some of the elements of the paper.  
741.  In India the MSME sector, through more than 8,000 products, ranging from traditional to high 
tech precisio n items, contributes about 45% to the total manufacturing output and 40% to the 
exports. The MSME sector has the potential to spread industrial growth across the country and can 
be a major partner in the process of inclusive growth. India has undertaken se veral initiatives for 
enhancing the contribution of IP assets in growth and development of MSMEs. The Ministry of Micro, 
Small and Medium Size Enterprises, in 2014, launched Guidelines on Implementation of the Scheme 
Building Awareness on Intellectual Prop erty Rights (IPR) for Micro, Small and Medium Enterprises 
(A Component of National Manufacturing Competitiveness Programme ), which include measures for 
the protecting their ideas and business strategies. This scheme undertakes several activities such 
as or ganizing awareness/sensitization programme s, specialized trainings, assistance in grant of 
patent and GIs, among others. In addition, in 2019, Government proposed a reduction in IPR 
registration fees for MSMEs and start -ups, to encourage more MSMEs to regi ster their IPRs. Various 
roadshows are also being organized on 'IPR and National IP Policy ' to appraise MSMEs about the 
benefits of IP filings.  
742.  I will now switch over to general remarks on the submission . 
743.  The submission mentions - 'Governments can support s trategic IP portfolio 's protection and 
enforcement by ensuring strong legal structures for both patents and trade secrets. '  
744.  In this context, could the proponents explain what do they mean by strong legal structures 
and how will they impact the entry of ne w players in the market? Also, what would be the adverse 
impact of protection and enforcement of strategic IP portfolio on transfer of technology and hence, 
promotion of innovation among MSMEs?  IP/C/M/96/Add.1  
 
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  745.  Could the proponents also explain the meaning of "measures tha t enable the use of digital 
establishment of evidence supporting unregistered IPs "? 
746.  Further, what does the term "synergistic effects of registered and unregistered IPs " signify? 
We believe that synergism in terms of registered and unregistered IP has not b een solemnised under 
the TRIPS Agreement and thereby TRIPS Council is not an appropriate forum for such discussion.  
13.20   Switzerland  
747.  It is merely to thank all delegations for as I found as an exceptionally rich and useful discussion 
and for all the contribu tions that we have heard . Just as one example, I would like to highlight the 
high p resentation of F ernando Cardenas , from INDECOPI, which we fund extremely inspiring, and  
particularly, of course, also the measures that INDECOPI and Peru have undertaken to react to the 
current COVID -19 challenges and their program mes to reactivate a strategy for the benefit of their  
MSMEs . I think that is certainly an initiative that we can learn a lot from . And this, of course, includes 
the questions and comments on our presentations and  submissions by co -sponsors and from India 
and we will revert to respond to these questions as soon as possible at the latest at the next 
TRIPS  Council . 
14  DULY MOTIVATED REQUES T BY LDCS TO EXTEND THE TRANSITION PERIOD UNDER 
ARTICLE 66.1 OF THE TRIPS AGREEMENT FOR LEAST DEVELOPED COUNTRY MEMBERS  
14.1  Chad on behalf of the LDC Group  
748.  I wish first of all to congratulate yo u on the way you have chaired the present session s. 
749.  I wish to make some brief opening remarks, before giving the floor to our focal point, 
Bangladesh, to prese nt our communication.  
750.  The LDC Group has submitted a duly motivated request, to which you referred  earlier, to 
extend the transition period pursuant to Article 66.1 of the TRIPS Agreement, since the current 
transition period granted to the LDC Group, the second such period, will expire on 1 July 2021 as 
you yourself stated a moment ago.  
751.  Furthermore, th e situation of LDCs has remained unchanged, if it hasn 't worsened. Our 
communication also addresses the situation of graduating LDC Group Members.  LDCs represent the 
most vulnerable and weakest segment of the international trade community.  Characteristics of LDCs 
include low per capita income, a low level of human development and structural economic barriers.  
752.  Our countries still face many difficulties in reaching their development goals, even as the 
implementation period for the Istanbul Programme of Action  for LDCs for the decade 2011 -2020, 
adopted by the Fourth United Nations Conference on the Least Developed Countries, is coming to 
an end. It is worth recalling that the COVID -19 pandemic has created more barriers for LDCs to deal 
with. Confinement measure s and the slump in global demand have particularly impacted LDCs that 
are dependent on exports of finished goods. The COVID -19 pandemic will clearly have far -reaching 
implications for the global economy and particularly for LDCs, including those on the pat h to 
graduation.  
753.  In this context, overcoming these economic, financial and administrative constraints and being 
given flexibility to establish a viable technological base, remain vital.  This is what I wanted to say, 
as an opening remark and, with your perm ission, I wish now to let our focal point, Bangladesh, 
present our communication.  
14.2  Bangladesh  
754.  The delegation of Bangladesh endo rses the statement made by Chad on behalf of the LDCs. 
Bangladesh is happy provide further explan ation for the submission  of docum ent IP/C/W/668 
requesting extension of transition under TRIPS Article 66.1 as long as a Member remains in the LDC 
category and for a period of twelve years after the entry into force of a decision of the 
UN General  Assembly to exclude the Member from the least developed country category. And 
nothing in TRIPS Article 66.1 limits the scope of the request that can be made by the LDCs.  IP/C/M/96/Add.1  
 
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  14.3  Bangladesh on behalf of the LDC Group  
755.  Fundamentally the provision lai d down in Article 66.1 acknowledges that the TRIPS Agreement 
may not be conducive to the social and economic circumstances of LDCs and that LDCs need to have 
policy space and flexibility to address their development chal lenges and create a viable technological 
base.  The COVID -19 pandemic has further exacerbated the challenges that the LDCs continue to 
face. It is evident that the COVID -19 pandemic will have far -reaching implications for the global 
economy and especially for LDCs including those on the path to graduat ion.  
756.  Also, looking into the current grim scenario of socio -economic development in LDCs, it is not 
possible to assess when LDCs will be able to overcome their economic, financial and administrative 
constraints. This means that LDCs will need flexibilities  as long as they are under these severe 
uncertainties and as long as they are unable to create a viable technological base. In other words, 
being in the LDC category, they will be unable to overcome the constraints and therefore, they will 
be in continuous  need of the transition period for exemptions as provided under TRIPS Article 66.1 
for a longer duration. The special needs of LDCs and their requirement for maximum flexibility are 
also clearly recognized in the Preamble of the TRIPS Agreement. This means  that the maximum 
flexibility in TRIPS implementation is vital for LDCs. Members  may also agree that LDCs have small 
delegations and it is difficult for them to come to the TRIPS Council  after every fixed duration to 
request and negotiate this extension of  transition with their limited capacities. Therefore, the 
transition period should remain in force for as long a country remains a least developed country.  
757.  LDCs continue to face many difficulties in reaching their development goals, even as the period 
for implementing the Istanbul Programme  of Action (IPoA) for the LDCs for the Decade 2011 -2020 
comes to an end. One of the main targets of IPoA was for half of LDCs to meet the graduation criteria 
by 2020. Members  are aware that there are three  criteria for L DC graduation under the UN 
procedure: Income criterion, based on a three -year average estimate of gross national income ( GNI) 
per capita, Human Assets Index (HAI), and Economic Vulnerability Index (EVI). To be eligible  for 
graduation, a country must reach threshold levels for graduation in two consecutive triennial reviews 
for at least two of the three criteria, or its GNI per capita must exceed at least twice the threshold 
level. T o date, three countries have graduated during this decade. 12 countries have  already met 
graduation criteria and are on the path of graduation. 15 countries have already met at least one 
criterion for graduation. Thus, graduation from LDC status has taken a new momentum. At this point 
in time LDCs need special attention from Members  on the future course after graduation.  In this 
context, it may be pertinent to refer to the 2016 United Nations Conference on Trade and 
Development (UNCTAD) LDC report. It maintains :  
The process of development beyond graduation merits much greater attention, even 
during the pre -graduation per iod — that graduation itself should not be the primary 
focus of LDCs and their development partners, but should rather be viewed as one 
milestone in LDCs ' longer -term sustainable development. Graduation does not 
represent a solution to all the graduating c ountry 's development challenges; neither 
does a new set of challenges emerge out of nothing at this point. Rather, the challenges 
of the post -graduation period are a continuation of those that characterized the 
pre-graduation period . 
758.  The international comm unity has similar views on post -graduation challenges. Accordingly, the 
UN General Assembly in its resolutions 59/209 of 2004 and 67/221 of 2012 called upon 
WTO Members  to allow graduated LDCs the existing special and differential ( S&D) treatment and 
exemp tions available to LDCs for some additional years to help support their transition for smooth 
and sustainable graduation. Positive response s to this call are particularly important for the 
TRIPS  Agreement as LDC graduation criteria does not specifically ad dress economic, financial and 
administrative constraints, which ha ve been considered when  providing exemptions to LDCs under 
TRIPS Article 66.1. As you are aware, implementation of the TRIPS Agreement requires, among 
other things, adequate financial resour ces, administrative capacity, judicial capacity, a legal regime, 
and border measures, which may not be available soon after graduation.  
759.  The LDC Group proposes that an LDC Member , after exclusion from the list of LDCs as per a 
decision of the UN General Assembly , should be provided a transition period of 12 years for 
implementing TRIPS Agreement. This decision, if approved, will genuinely respond to the call that 
Members  recognized at the UN General Assembly.  IP/C/M/96/Add.1  
 
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  760.  The LDCs, therefore, request the Council to ag ree on the draft decision contained in document 
IP/C/W/668 to allow LDCs a transition period as proposed under Article 66.1 of the 
TRIPS  Agreement.  
14.4  Nepal  
761.  My delegation would like to associate with the statements made by Chad and Bangladesh on 
behalf of the  LDC Group and would like to add my intervention as follows:  
762.  Least developed countries represent the poorest and weakest segment of the international 
community and continue to confront structural and developmental constraints and challenges related 
to eco nomic growth, human and institutional capacities and economic vulnerabilities. The unique 
development situation of LDCs is r eflected in their 0.96% share of the world 's merchandise exports 
and 0.71% share of the world 's commercial service exports, while th ey need to feed and care for 
about 13% of the world 's population, with a special responsibility for 31% of the world 's poor.  
763.  LDCs continue to face numerous difficulties in reaching their development goals, as well as in 
the effective implementation of glo bal commitments such as the Istanbul Programme of Action for 
the Least Developed Countries.  
764.  The high degree of vulnerability from which least developed countries suffer, both economic 
and climate shocks, has caused significant setbacks to their progress t owards the achievement of 
the United Nations ' Sustainable Development Goals (SDGs).  
765.  The COVID -19 pandemic has further exacerbated the challenges that LDCs have already been 
facing, as the pandemic threatens to have devastating consequences for their socio -economic 
transformation. Our health systems are unable to cope with increasing numbers of infected people, 
and the economic recovery will be another uphill challenge.  
766.  In this context, without meaningful support and bold policy actions from the internatio nal 
community, achieving the SDGs by the 2030 deadline will likely be out of reach. It is evident that 
the pandemic will have far -reaching implications for the global economy and especially for LDCs, 
including those on the path to graduation.  
767.  LDCs' export s are expected to be severely affected. Primary commodities prices are in decline, 
supply chains disrupted, and the tourism industry is largely at a standstill. LDCs are not able to 
adapt the latest technology to revive their productivity growth, especiall y in the present era of the 
digital economy.  
768.  E-commerce has emerged rapidly in recent times and the pandemic has further accelerated 
its growth. However, there is a huge digital gap between advanced, developing and least developed 
countries. The huge digi tal divide between and within countries, particularly LDCs, has become an 
obstacle to reaping benefits from e -commerce and the digital economy. LDCs lag significantly far 
behind in science, technology and innovation.  
769.  In this context, implementing TRIPS pr ovisions will be much beyond the capacity of LDCs. 
Therefore, we need a continuing exemption from the TRIPS Agreement in order to be able to grow 
economically viable industrial and technological sectors; to consolidate capacity; and to work out 
ways to con nect and gain from the technological value chain. Sufficient policy space becomes 
inevitable to overcome the difficulties faced by LDCs in this pandemic situation. Furthermore, access 
to various technologies, educational resources, and other tools are equa lly necessary for 
development and to curb the spread of the pandemic.  
770.  Essentially the provision laid down in Article 66.1 acknowledges that the TRIPS Agreement 
may not be conducive to the social and economic circumstances of LDCs and that LDCs need to hav e 
policy space and flexibility in order to address their development challenges and to create a viable 
technological base. Therefore, the transition period should remain in force for as long as a country 
remains a least  developed country.  
771.  Similarly, susta inable and smooth graduation is a challenge for LDCs. The challenges of the 
post-graduation period are a continuation of the challenges of the pre -graduation period; therefore, IP/C/M/96/Add.1  
 
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  it is required that LDC -specific flexibilities continue to apply after graduati on, and be phased out 
progressively.  
772.  Hence, all LDCs, including graduating LDCs, would need a further extension of the transition 
period with maximum flexibility. Furthermore, this extension would not restrict any LDC Member to 
undertake an early implemen tation of the provisions of the TRIPS Agreement in view of their 
country 's unique context.  
773.  Additionally, enriched technology transfer from developed country Members to LDCs under 
TRIPS Article 66.2 and other support measures, including those reflected in Article 67 of the 
Agreement, would highly support  LDCs in effectively implementing the TRIPS Agreement.  
774.  In this context, the LDC Group has submitted a duly motivated request for extension of the 
transition period and my delegation would like to call upon all Members to extend your valuable 
support and accord extensions as per our submission.  
14.5  Mali 
775.  Thank you for organi zing this Council meeting.  
776.  The suddenness of the COVID -19 pandemic has brought out the basest of human survival 
instincts. Many Members have taken protectionist measures, which , while temporary, may have 
dramatic consequences for our countries. Restrictions on the export of essential foodstuffs, medical 
and pharmaceutical products and medical equipment, and the introduction of compulsory licens ing 
deprive the poorest members of society of adequate care and means of protection against the virus, 
and all this despite the alarming forecasts issued by the World Health Organization (WHO). These 
restrictive measures, combined with the closing of borde rs throughout the world, have exacerbated 
the adverse effects of the pandemic on LDCs and small vulnerable economies, pushing tens if not 
hundreds of millions of people into a state of precarity and extreme poverty. Land -locked LDCs such 
as Mali have felt the impact of this shockwave even more. Access to affordable medicine and 
vaccines, which should be a universal right, is an immense challenge for our low -income countries. 
LDCs, and even some developing countries, need the provisions of Article 66.2 of th e 
TRIPS  Agreement to be effectively implemented so as to benefit from the transfer of the technologies 
required to produce medicines and vaccines.  
777.  In the 21st century, no country should be unable to care for its citizens; no human being 
should have to face  making the difficult choice between feeding their family or providing them with 
treatment. Unfortunately, this is all too often the case in our countries. The virus has shown us that 
it can spread anywhere, regardless of the level of development, and that  closing borders will not 
stop it. Help us obtain the appropriate resources, the resources we need, by favourably responding 
to the concerns brought before you.  
778.  To conclude, Mali fully endorses and supports the communications submitted by Chad on 
behalf of  the LDCs, as well as the communication submitted by India and South Africa. The waiver 
under Article 66.1 of the TRIPS Agreement should be extended for as long as a Member is an  LDCs. 
We also support the statement just given by Nepal, since we all hope to be able to graduate from 
LDC status one day, although this situation, being in limbo, is not easy. Lastly, the delegation of 
Mali requests that this statement be entered into the record by the WTO Secretariat.  
779.  With the diligence of all Members, I wish to make a small proposal and perhaps backtrack 
slightly. Regarding the workshop that you suggested organizing for the start of February – I don 't 
know whether it was this workshop or another that would focus on our countries – Mali proposes  
that our capitals be invited to an ad hoc  workshop. I think this is better. I was very happy this 
morning to hear many countries describe their domestic provisions in favour of MSMEs, and we 
would have liked to do the same, but I think that our capitals ' presentations on intellectual property 
organizations will give all Members an idea of the huge gap that exists between our countries. We 
hope this request is acceptable.  IP/C/M/96/Add.1  
 
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  14.6  Cambodia  
780.  Cambodia associate s itself with Chad 's statement. LDCs are continuing to face  many difficulties 
and challenges including weak health systems, lack of domestic financial resources, limited human 
capacity, innovation, technology, administrative constraints, and so on and so forth.   
781.  Further to this, the COVID -19 pandemic has substanti ally affected LDCs in many sectors, in 
particular the supply and demand sides. Indeed, the impact of COVID -19 is one of the causes for a 
slow-down in progress in achieving our development goals and the 2030 Agenda for Sustainable 
Development, with only ten  years left.  
782.  To that, we need to build greater resilience and work together to find a good solution through 
the development of trade – both at national and international levels.  We also need to make sure 
that LDCs have maximum policy space, among others, to access various technologies, educational 
resources, and other tools necessary for development. We also need to implement the existing 
mandates to assist LDCs in coping with difficulties and challenges, including the mandate set out in 
Article 66.1 of th e TRIPS Agreement.  
783.  Cambodia, therefore, requests Members to support the adoption of the proposal contained in 
document IP/C/W/668 submitted by Chad on behalf of the LDC Group, for an extension of the 
transition period under Article 66.1 of the TRIPS Agreem ent. 
14.7  Angola  
784.  The Angolan delegation is in line with the statement made by C had and Bangladesh on behalf 
of LDCs.  
785.  LDCs continue to face great difficulties in achieving their development -related objectives, given 
their economic, financial, and administr ative needs and limitations.  
786.  These limitations tend to be aggravated if we consider the current situation of COVID -19, 
which the world and especially LDCs feel doubles difficulties and insufficiencies, not only in matters 
specifically related to health. There is  also a lack of technological equipment for other sectors to 
support development.  
787.  For these and other plausible justifications, we request that the Members of this Council 
deliberate and take a decision in favour of LDCs, in terms of the extension of the t erm (period) 
provided in Article 66.1 of the TRIPS Agreement.  
14.8  Afghanistan  
788.  At the outset, I would like to thank Chad and Bangladesh for delivering the statement on behalf 
of the LDC Group.  
789.  We are all aware of the special needs and requirements, the economi c, financial, and 
administrative constraints of LDCs, and their need for flexibility to create a sound and viable 
technological base. LDCs have not been able to develop their productive capacities, and their 
technological development level has remained low .  
790.  The current unprecedented global public health crisis exacerbated the LDCs ' challenges given 
their vulnerability and lower level of development, low public health care capacities, and their 
capacity to properly navigate their countries ' fight against th e pandemic and recover from it.  
791.  As an LDC, Afghanistan is facing considerable challenges in achieving economic growth and its 
sustainable development goals. We have the capacity and technological constraints which challenge 
the implementation of our TRIPS commitments.  
792.  As we are the latest Member of the WTO, we need the extension in order to acquire the capacity 
and technical expertise, and we, therefore, support the statement and communication made by the 
delegation of Chad on behalf of the LDC Group.  IP/C/M/96/Add.1  
 
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  793.  In conclusion, we urge all Members to consider the challenges and constraints of LDC Members 
and agree with their proposal.  
14.9  Senegal  
794.  My delegation associates itself with the statements made by Chad and Bangladesh and would 
like to refer Members to document IP/ C/W/555 of  27 June  2011. The constraints and needs 
expressed by Senegal in this document, which have been exacerbated by the crisis due to the 
COVID -19 pandemic, are still relevant today and warrant the extension of the transition period under 
Article 66.1  of the TRIPS Agreement.  
795.  We thereby call on Members to give due consideration to the LDCs ' submission.  
14.10   Jamaica on behalf of the African, Caribbean and Pacific States  
796.  The ACP Group w ishes to  thank the delegation of Chad, in its capacity as coordinator of the 
WTO LDC Group, for its recently proposed draft decision for an extension of the transition period 
pursuant to TRIPS Article 66.1, due to expire in July 2021, as outlined in document IP/C/ W/668. We 
also thank the delegation of Bangladesh for their presentation.  
797.  As was the case when these flexibilities were initially agreed, we acknowledge that LDCs 
continue to face certain structural and institutional constraints, which make it difficult fo r them to 
comply with some of the provisions in the TRIPS Agreement. In this connection, we note that this 
proposal by the LDC Group calls for a permanent extension of the transition period under 
TRIPS  Article 66.1 while a Member remains an LDC; and, for 1 2 years from the date of entry into 
force of a decision by the UN General Assembly to exclude the Member from the LDC category.  
798.  LDCs need a continuing exemption from the TRIPS Agreement in order to be able to grow 
economically viable industrial and techno logical sectors, to consolidate capacity and to work their 
way up the technological value chain.  
799.  The ACP Group therefore supports the extension of the LDCs ' TRIPS flexibilities, and the 
statement delivered by Chad on behalf of the LDC Group.  
14.11   China  
800.  China h as always put great emphasis on LDC Members ' concerns. We understand that LDCs 
are confronted with economic, financial and administrative constraints in implementing the 
TRIPS  Agreement. Particularly, we notice that COVI D-19 has posed serious challenges to  LDCs. In 
light of these considerations, China supports this pr oposal of the LDC Group to extend the transition 
period under Article 66.1 of the TRIPS Agreement for LDC Members, as long as the Member remains 
in the LDC category and for a period of 12 years  from the date of entry into force of a decision by 
the UN General Assembly to exclude the Member from the LDC category.  
14.12   South Africa  
801.  South Africa would like thank Chad and Bangladesh f or their  introductory statements and 
Bangladesh for presenting the request by the LDC Group to extend the transition period under 
Article  66.1 of the TRIPS Agreement for LDC Members. We also support the intervention made by 
the ACP Group.   
802.  South Africa unequivocal ly supports the request by the LDC Group under Article 66.1 of the 
TRIPS Agreement, for as long as they remain LDCs, and for an additional period of 12 years following 
their official graduation from the LDC category as determined by the UN General Assembly . 
TRIPS  Article  66.1 recognizes LDCs ' special needs and requirements, the economic, financial and 
administrative constraints faced by LDCs, and their need for flexibility to create a sound and viable 
technological base.  
803.  We note the impact of COVID -19 on t he achievement of the SDG goals, as pointed out by the 
LDCs in their submission and would agree that the COVID -19 pandemic will adversely impact the 
economies of all LDCs, including those LDCs that are on the verge of graduation, due to decline in IP/C/M/96/Add.1  
 
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  exports,  fall in commodity prices, supply chain disruptions and the bleak prospect of an impending 
balance of payments crisis. LDCs can only achieve their productive capacities and thereby establish 
a viable technological base if this extension is granted.  
804.  The up grading and development of a viable technological base takes time and should not be 
subject to specific time limits. South Africa is in support of the request that establishes the extension 
for as long as a country remains an LDC and that an LDC Member may  continue to benefit from the 
flexibilities for an additional 12 years following graduation.  
14.13   Argentina  
805.  Argentina agrees with the arguments set forth in document IP/C/W/668 in support of the 
decision to extend the transitio n period which ends on 1 July 2021  for LDC Members under 
Article  66.1 of the TRIPS Agreement. We therefore support the proposal circulated by Chad on behalf 
of the LDC Group . 
14.14   Egypt  
806.  Egypt supports the statement to be delivered by  Tanzania on behalf of the African Group.  
807.  It is evident that t he COVID -19 pandemic will have far -reaching implications for the global 
economy and especially for LDCs, includ ing those on the path to graduation. In this context we 
believe it is necessary to extend the transition period exempting LDC Members from implem enting 
the substantive obligations under the TRIPS Agreement. Hence we encourage all WTO Members to 
support the proposal by the LDC Group in document IP/C/W/668.  
14.15   Tanzania on behalf of the African Group  
808.  The African Group welcomes the LDC  proposal contained in document IP/C/W/668, namely the 
Extension of the Transition Period under TRIPS Article 66.1 for Least Developed Country Members.  
809.  The TRIPS waiver as enshrined in Article 66.1 of the TRIPS Agreement was provided in view 
of the s pecial needs and requirem ents of LDCs due to their economic, financial and administrative 
constraints, and their need to create a viable technological base. Undisputedly, to date LDCs are still 
facing a similar situation, and even worse with the current COVID -19 situation. A major ity have been 
forced to divert most of their financial resources to procure medication and personal protective 
equipment  to treat the COVID -19 pandemic.  
810.  Despite the previous extensions, the situation of LDCs has not changed to date because key 
structural e conomic challenges remain unaddressed. LDCs still face financial and administrative 
constraints and do not have a viable technological base; and that remains the legitimate grounds on 
which they request a further extension of the waiver. The situation in L DCs will only change once 
they have ably created a viable industrial and technological base as envisioned in Article 66.1 and 
linked to Article 66.2 of the TRIPS Agreement.  
811.  We think it is reasonable to assert that Members have not implemented their obliga tions under 
TRIPS Article 66.2, in a manner demonstrable to assist LDCs in creating a solid technological base – 
a prerequisite criterion for LDCs to implement the TRIPS Agreement.  
812.  Certainly, short transitional periods hinder investors from committing to invest in LDCs, and 
as a result the target is being missed from time to time. It is our view that this time, LDCs should 
be granted an extension sufficient to address the challenges envisioned in the TRIPS  Agreement in 
collaboration with Members, as stated  in TRIPS Article 66.2.  
14.16   Indonesia  
813.  We appreciate the request of LDC Members for the extension of the transition period under 
Article 61.1. We recognize the special needs and requirement of LDCs in facing t heir economic, 
financial and administrative constrai nts. Further, the current pandemic situation has created further 
challenges for LD Cs in facing their public health and economic constraints.  IP/C/M/96/Add.1  
 
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  814.  In this regard, Indonesia supports the extension of the transition period under Article  61.1. of 
the TRIPS Agreeme nt. We also call on Members to extend their support to the extension request.  
14.17   Turkey  
815.  We welcome the LDC Group 's request for an extension of the transition period under 
TRIPS  Article  66.1 in line with the explanation given by the LDC Group.  
816.  Due to financial, economic and structural difficulties, we know that LDCs have been facing 
various problems in complying with the TRIPS Agreement. In addition to this, the challenges of 
COVID -19 make the situation even more difficult. Thus, we totally understand LDCs' need for 
flexibility.  
817.  As it hosted the fourth UN Conference on LDCs in Istanbul in 2011, Turkey leads several 
initiatives to increase the capacities of LDCs and especially to disseminate technology and technical 
know -how for LDCs. In this respect, Tu rkey hosts the UN Technology Bank for Least Developed 
Countries, which aims to help LDCs with building the necessary capacity in intellectual property 
rights, conducting the transfer of technology, and creating innovation.  
818.  As stated in the Marrakesh Agreem ent, the need for positive efforts are vital for the 
development of LDCs. This effort will also provide assistance for LDCs to fully implement the 
TRIPS  Agreement.  
819.  In this respect, we are in favour of the inclusion of a development dimension in IP systems.  
We also believe that it is beneficial for LDCs to have necessary policy space for crafting proper 
protection for intellectual property in their national capacity.  
14.18   United States of America  
820.  The United States thanks the delegation of Chad on behalf of the LD C Group for its submission 
on the Exten sion of the Transition Period under TRIPS Article 66.1 for least developed countries . 
821.  Our delegation is currently studying the proposal and looks forward to further engagement on 
the issue.  
14.19   European Union  
822.  The European U nion thanks the delegation of Chad for the communication submitted on behalf 
of the LDC Group on the ext ension of the transitional period under TRIPS Article 66.1 for 
least developed countries.  
823.  The EU recognizes the economic, financial and admini strative constraints that the 
least developed countries have to contend with on their path to development. We are also fully 
aware of the fact that the COVID -19 pandemic has further exacerbated these difficulties and that 
resources must be put into what is  the common priority around the globe, i.e. dealing with a health 
crisis of unprecedented scale.  
824.  Given this situation, we recognize that least developed countries will need considerably more 
time to implement the provisions of the TRIPS Agreement. The Eur opean Union supports the 
extension of the transitional period under Article 66.1 of the TRIPS Agreement. We stand ready to 
work on the appropriate decision of the TRIPS Council to put such extension into effect.  
14.20   Oman  
825.  This initiative tries to address the st ruggle to contain the spread of the pandemic and provide 
health care services to those affected. The economic cost of the pandemic is huge on Oman in 
addition to the low oil prices. We would like to make sure that we have  access to medicines and will 
be ab le to purchase vaccines at affordable prices or to be able to use the TRIPS flexib ility on 
compulsory licensing.  IP/C/M/96/Add.1  
 
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  14.21   India  
826.  We thank the LDC Group for their submission.  
827.  India has consistently supported the LDCs ' request for an extension of the transition period  
under Article 66.1 of the TRIPS Agreement. It is evident t hat the LDCs need more time to address 
the extensive development and technological challenges facing them, especially when the COVID -19 
pandemic has disproportionately impacted their economies. We,  therefore, support the extension of 
the waiver under Article 66.1 of the TRIPS Agreement for LDC Members as long as the Member 
remains in the LDC category. As the proposal rightly points out the need of a transition period with 
maximum flexibility for gra duating LDCs to build a sound and viable technological base, we support 
the idea that a reasonable period of time should be granted as a transition period for all graduating 
LDCs.  
14.22   Japan  
828.  Japan 's view on this issue is that the following points should be take n into account for the 
discussion.  
829.  Firstly, it should be recognized that IP rights are an important instrument to support economic 
development. The protection of IP rights makes it possible to secure higher investment in research 
and development, which its elf leads to promoting innovation, and encourages foreign direct 
investment and technology transfer. The IP system, therefore, is conducive to promoting economic 
development.  
830.  Secondly, the incentives to take measures for implementing the TRIPS Agreement sh ould be 
considered. It is hoped that the aforementioned points will be taken into account. Japan will continue 
to actively engage in future discussions in order to make a constructive contribution to the issue.  
14.23   Nigeria  
831.  We thank the delegation of Cha d for i ts statement made on behalf of the LDC Group concerning 
their proposal under Article 66.1 of the TRIPS Agreement.  
832.  We would like to underscore the need for LDCs to have the required policy space to essentially 
develop their productive capacities. Th e avail ability of a sound and viable technological base is 
indispensable if they are to overcome the threat to human health, safety and well -being caused by 
the COVID -19 pandemic, as well as the unprecedented and multifaceted effects of the pandemic, 
including th e severe disruption to societies, economies, global trade and travel. Therefore, we 
welcome constructive discussions regarding this proposal.  
14.24   United Kingdom  
833.  The United Kingdom would also like to thank the LDC Gro up for this communication and for 
adding thi s important item to the agenda for the present meeting.  
834.  The UK would like to express its support for LDCs. We note the wide range of policy concerns 
that they face, particularly during this unprecedented time of global pandemic and its impact on 
social and economic well -being. Therefore, we welcome this discuss ion and urge Members to find a 
progressive solution that meets the needs of LDCs, without losing the many successes that have 
already been achieved.  
835.  The UK stands ready to work with and to assist LDCs to ensure that they have the tools 
necessary to enact a nd/or maintain a fit -for-purpose intellectual property framework, and we look 
forward to further discussions on this issue in the future.  
14.25   Switzerland  
836.  My delegation would like to thank the distinguished delegates of Chad and Bangladesh for 
introducing docum ent IP/C/W/668 on behalf o f the LDC Group.  IP/C/M/96/Add.1  
 
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  837.  Switzerland recognizes the challenges faced by LDCs in implementing international obligations 
such as the ones under the TRIPS Agreement. We commend those LDCs who have nevertheless 
made significant efforts and p rogress in implementing their TRIPS obligations.  
838.  Switzerland is convinced that doing so will help LDCs create an enabling environment for 
development through a transparent and rules -based regulatory framework for the protection and 
enforcement of IPRs. Th is, in turn, can help promote inventive activity at the domestic level, 
increased competitiveness at the international level, technology transfer and foreign investment, 
thus contributing to more sustainable development.  
839.  Having said this, Switzerland is a ware of the resource constraints that LDCs still face today 
and that they need flexibility when defining their priorities on how to spend these limited resources.  
840.  Switzerland thus supports, in principle, a further extension of the general TRIPS transition  
period for LDCs, as we did in 2013. As far as the terms for such an additional extension are 
concerned, we are committed to a mutually agreeable outcome that is in line with TRIPS  Article  66.1. 
We are prepared to discuss this further with the LDC Group.  
14.26   Bangladesh on behalf of the LDC Group  
841.  The LDC Group thanks all the Me mbers and observers for their statements. The LDCs thank 
those Members who have supported this submission. The LDC Group also thanks those Members 
who have rais ed some concerns and their w illingness to engage effectively. LDCs will be ready to 
provide furt her clarifications.  
842.  The LDC Group requests the Council to keep this item on the agenda for the next meetings of 
the Council until the issue is resolved. In the meantime, LDCs will engage bilaterally with Members 
concerned. In this regard, the Chair of the TRIPS Council is also requested to kindly facilitate the 
consultations.  
14.27   Chad on behalf of the LDC Group  
843.  I would like to follow up on what my colleague from Bangladesh has just said  and thank all 
the Me mbers that have spoken about our proposal, as well as those that have understood the need 
for this request. I would also like to reiterate what was said a momen t ago about us being fully 
disposed to speaking with any Members requiring further explanations.  
844.  I fully understand the reservations of some Members. I did not see any reservation as being 
indicative of a deadlock, which I am pleased about. We are prepared to continue engaging bilaterally 
with any Members seeking additional infor mation. I would like to stress that it is essential for LDCs 
to obtain this extension.  
845.  As I said in my opening statement, the grounds for this provision and these realities are still 
relevant today. In fact, they have become even more relevant with the eme rgence of the COVID -19 
crisis, and we call on all Members to show flexibility and understanding so that we can ultimately 
find a consensual solution.  
846.  In any event, I would like to thank you on behalf of all members of the LDC Group and to 
endorse the sugge stion put forward by our colleague from Bangladesh to keep this matter for the 
next session.  
14.28   World Health Organization  
847.  Universal Heal th Coverage is a priority for the World Health Organization and is part of the 
Sustainable Devel opment Goals (SDGs). That i s the main reason why WHO has supported requests 
of LDC WTO Members with respect to the extension of the transition  period for pharmaceutical 
products.  
848.  The challenges that remain for LDCs in terms of achieving development goals and structural 
transformatio n, in addition to their high degree of vulnerability in the current pandemic, and not 
only with COVID -19, but as well as for other diseases, oblige WHO to make a statement in support IP/C/M/96/Add.1  
 
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  of the current request from LDCs for an extension of the transition perio d under Article  66.1 of the 
TRIPS Agreement.  
849.  An extension of the transition period would facilitate LDCs ' access to essential treatments and 
build up viable technology bases and manufacturing capacities in these countries. A further extension 
to the genera l exemption from full TRIPS compliance for as long as a country remains an LDC as 
well as a transition period upon graduation from LDC status are critical for the achievement of SDG 
3 related to health. Extending the transition period during the current pa ndemic will facilitate a 
reduction in disparities in, for example, the diagnosis and treatment of COVID -19, that we all witness 
today.  
850.  Finally, not only does the pandemic represent an immense challenge for LDCs but it has 
compromised social and economic de velopment in these countries.  
851.  WHO strongly encourages WTO Members to support the extension requested by Chad on behalf 
of the LDC Group.  
15  PROPOSAL FOR A WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT 
FOR THE PREVENTION, CONTAINMENT AND TREATMENT OF COVID -19 
Council for TRIPS held on 16 October 2020  
15.1  South Africa  
852.  I have the honour to introduce  this proposal on behalf of the delegations of Eswatini, India, 
Kenya and South Africa.  
853.  The COVID -19 pandemic is a clarion call for us to answer to the better angels of our nature. 
High-minded language on solidarity and globa l public goods, however, has n ot been matched by 
tangible steps to share know -how and intellectual property rights to facilitate deep technology 
transfer in the COVID -19 response. Business as usual approaches will not bring back the countless 
lives that were lost, neither will it ensur e that IP barriers to the prevention, containment and 
treatment of COVID -19 will be addressed effectively.  
854.  We have seen this before. At the height of the HIV crisis, prices set for ARVs to treat HIV were 
simply too high and out of reach for many developin g countries. As death rates due to aids plunged 
in rich countries, infected people across the developing world were left to die.  
855.  Our leaders vowed that is would never happen again, the Doha Declaration on TRIPS and 
Public Health reaffirmed flexibilities to  accommodate access to medicines. Even in light of this 
political undertaking and its translation into the Paragraph 6 System, prices of many life -saving 
diagnostics, therapeutics, vaccines and other medical products remain out of reach of most 
governments  and its people.  
856.  In 2004 the highly pathogenic avian influenza H5N1 re -emerged, developed countries had 
priority access, while affected developing countries did not. Within five years another pandemic flu 
(H1N1) emerged and once again rich countries placed  large pre -orders of a vaccine buying almost 
all doses that could possibly be produced. Many countries promised to donate vaccines, most of 
them reneged and moved to secure their own supplies. With COVID -19 history is repeating itself.  
857.  Several months into  this pandemic there are no meaningful global policy solutions to ensure 
access. Given this present context of global emergency, it is important for WTO Members  to work 
together to ensure that intellectual property rights such as patents, industrial design s, copyright and 
protection of undisclosed information do not create barriers to the timely access to affordable medical 
products including vaccines and medicines and/or to scaling -up of research, development, 
manufacturing and supply of medical products e ssential to combat COVID -19.  
858.  All WTO Members  are struggling to contain the spread of the pandemic and provide health 
care services to those affected. Many developed, developing and least developed countries have 
declared a national emergency with the aim to curb the growing outbreak, and as advised by the 
WHO implemented social distancing measures with significant consequences for society and the IP/C/M/96/Add.1  
 
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  economy. Notably, developing countries and least developed countries are especially 
disproportionately affected .  
859.  An effective response to COVID -19 pandemic requires rapid access to affordable medical 
products including diagnostic kits, medical masks, other personal protective equipment and 
ventilators, as well as vaccines and medicines for the prevention and treat ment of patients in dire 
need. Shortages of these products has put the lives of health and other essential workers at risk and 
led to many avoidable deaths. It is also threatening to prolong the COVID -19 pandemic. The longer 
the current global crisis persi st, the greater the socio -economic fallout, making it imperative and 
urgent to collaborate internationally to rapidly contain the outbreak. As new diagnostics, 
therapeutics and vaccines for COVID -19 are developed, there are significant concerns, how these 
will be made available promptly, in sufficient quantities and at affordable price to meet global 
demand. Critical shortages in medical products have also put at grave risk patients suffering from 
other communicable and non -communicable diseases. The rapid scaling up of manufacturing globally 
is an obvious crucial solution to address the timely availability and affordability of medical products 
to all countries in need. The emerging second wave of the disease underscores the importance to 
finding global solu tions that ensure equitable access.  
860.  There are several reports about intellectual property rights hindering or potentially hindering 
timely provisioning of affordable medical products to the patients. It is also reported that some 
WTO Members  have carried out urgent legal amendments to their national patent laws to expedite 
the process of issuing compulsory/government use licenses, as evidenced by the updated Secretariat 
report on national measures taken by WTO Members . Beyond patents, other intellectual pr operty 
rights may also pose a barrier, with limited options to overcome those barriers. In addition, many 
countries especially developing countries may face institutional and legal difficulties when using 
flexibilities available in the Agreement on Trade -Related Aspects of Intellectual Property Rights 
(TRIPS Agreement). A particular concern for countries with insufficient or no manufacturing capacity 
are the requirements of Article 31 bis and consequently the cumbersome and lengthy process for the 
import and  export of pharmaceutical products.  
861.  Internationally, there is an urgent call for global solidarity, and the unhindered global sharing 
of technology and know -how in order that rapid responses for the handling of COVID -19 can be put 
in place on a real time basis. Our joint proposal requests a waiver to be granted to all WTO Members  
so that they do not have to implement, apply or enforce certain obligations related to COVID -19 
products and technologies under Section 1 (copyrights and related rights), 4 (indus trial design), 5 
(patents) and 7 (protection of undisclosed information) of Part II of the TRIPS Agreement. Let me 
stress that the proposed waiver would be applicable only to COVID -19. The waiver is limited and 
does not suggest a waiver from all possible T RIPS obligations, nor does it suggest a waiver beyond 
what is needed for COVID -19 prevention, containment and treatment.  
862.  The waiver should continue until widespread vaccination is in place globally, and the majority 
of the world 's population has developed  immunity . Hence, we propose an initial duration of [X] years 
from the date of the adoption of the waiver.  
15.2  India  
863.  We thank South Africa for its detailed and comprehensive statement. We also thank UNAIDS, 
UNITAID, MSF, other academics, researchers as well as numerous civil society organisations who 
have expressed widesp read support for our proposal.  
864.  Let me also take this opportunity to thank the Secretariat for its report on the 
TRIPS  Agreement and COVID -19. We believe that it is not merely coincidental that this report came 
out the day before, more than six months into  the COVID -19 pandemic. At least our proposal could 
generate enough interest for action now. However, in our view, the measures listed in the report 
are not sufficient for an effective COVID -19 response, which necessitates the need for our waiver 
proposal.  
865.  At the outset we would like to emphasize that this proposal is, particularly important to cater 
for those who have insufficient or no manufacturing capacities in the health products required to 
combat the COVID  crisis. In the past few months, India has su pplied medical products and 
equipment needed in fighting the pandemic to more than 150 countries and resisted the attempts IP/C/M/96/Add.1  
 
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  to corner the supplies by a few countries. We would like to remind the Members  that in a global 
pandemic where every country is affec ted, we need a global solution. And our waiver proposal 
represents an open and expedited global solution to allow uninterrupted collaboration in 
development, production and supply of health products and technologies required for an effective 
COVID -19 respo nse. 
866.  South Africa has very clearly explained the purpose and objective of our proposal. In this 
regard, we want to highlight following points:  
867.  First, there can be no denying the fact that the development of and equitable access to the 
tools – such as diagn ostics, therapeutics, treatments, vaccines etc. – required to fight the COVID -19 
pandemic are limited by IP barriers. It is quite evident from an array of lawsuits filed by private 
companies in different parts of the world for IP infringement on COVID -19 pr oducts. In the past few 
months, we have also seen that IPRs do come in the way of scaling up production of test kit reagents, 
ventilator valves, N95 respirators, therapeutics, fluorescent proteins and other technologies used in 
development of vaccines etc.  
868.  Second, governments across the globe are supporting development of new health 
technologies, in  particular vaccines by pouring billions of USD of public funds into research and 
development. The EU tracker of  pledged resources for access to tests, treatment s and vaccines8 
stands at EUR  16 billion. Therefore, the often -repeated argument that monopoly rights are needed 
to allow the  inventors to recoup their investmen t does not seem to apply in case of development of 
health products and technologies required f or handling the ongoing COVID -19 crisis.  
869.  Third, we have heard from some Members  in the previous meetings that voluntary licenses 
are the most ap propriate solution to scale up manufacturing in response to COVID -19. However, the 
fact remains that not a singl e IP holder has shown willingness to commit to the COVID -19 Technology 
Access Pool (C -TAP) and the ACT -Accelerator voluntary initiatives launched under the aegis of WHO. 
In fact, the representative from WHO in the Council admitted in response to a question  that no 
pharmaceutical company has committed to sharing its IP and technologies in the C -TAP pool since 
its launch more than five months ago. Given the refusal by pharmaceutical industry to routinely offer 
nonexclusive licenses with worldwide coverage to facilitate global access, clearly the solution to 
ending the pandemic does not lie in voluntary licenses.  
870.  Fourth, with regard to existing flexibilities under the TRIPS Agreement, the same are not 
adequate to address the fast -changing landscape of COVID -19. Of particular concern for countries 
with insufficient or no manufacturing capacity is Article 31 bis, which is limited to pharmaceutical 
products, and was not designed to address challenges arising from pandemics of this scale and 
magnitude. Medical device s like ventilators, dialysis machines etc. that are crucial for combating the 
ongoing pandemic, may not be covered under the scope of Article 31 bis. There is a reason why the 
Special Compulsory Licensing system has been used only once. Requirements under t his System 
that exporters and importers have to comply with, are extremely onerous and time -consuming, 
thereby rendering it of no practical utility towards handling the ongoing pandemic.  
871.  Fifth, we have included four sections of TRIPS Agreement namely pate nts, copyrights, 
industrial designs and undisclosed information or trade secrets, in our proposal. This is because the 
health products and technologies like test kits, masks, medicines, vaccines, components of 
ventilators like valves, control mechanisms an d the algorithms and CAD files used in their 
manufacturing are protected by these four types of IPRs. This ensures that our waiver proposal does 
not suggest a waiver from all TRIPS obligations, but only from these specific sections and that too 
only to the  extent the same are essential for effective handling of the COVID -19 crisis.  
872.  Sixth, it may be noted that the waivers granted to LDC Members  with respect to obligations in 
Article 70.8 and 70.9 and their rights under Article 66.1 of the TRIPS Agreement are in no way 
impacted by this proposal.  
873.  Lastly, we want to clarify that the time period of 'X' years does not signify that we are seeking 
a waiver for an indefinite duration. The actual waiver duration will be negotiated and be limited to a 
period that this Council finds necessary to effectively handle the COVID  crisis. Furthermore, the 
 
8 https://global -response.europa.eu/index_en . IP/C/M/96/Add.1  
 
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  waiver will be reviewed annually by the General Council in accordance with the provisions of 
Article  IX (4) of the WTO Agreement. We are flexible with regard to the scope and duration of the 
waiver. We look forward to constructively engage with Members  having any questions or concerns 
regarding our proposal.  
874.  We believe that now is the time for WTO as an organization to rise up to the collective call for 
defeating the pandemic. It will not succeed in its efforts in rebuilding the COVID  affected economies 
unless it acts now to first save those lives that are going t o build these economies. It 's time for 
Members  to take collective responsibility and put people 's lives before  anything else. History will not 
judge us kindly if we do not act immediately to save large scale loss of human life and health and 
allow global d ysfunction to prevail over global cooperation. We hope that Members  will support our 
proposal that will ensure that vaccines and treatments become truly global public goods.  
15.3  Kenya  
875.  Kenya welcomes the proposal from India and South Africa in docum ent IP/C/W/6 69, titled 
Proposal for a Waiver from Certain Provisions of the  TRIPS Agreement for the Prevention, 
Containment and Treatment of COVID -19, and aligns with the statement that was delivered by 
Tanzania on behalf of the African G roup in support of the proposa l. 
876.  The COVID -19 pandemic has had a debilitating effect on the global economy, trade, 
investment, and the social well -being. It has caused a dramatic decline in foreign direct investment 
globally, and the resultant unilateral restrictions on exports and imp orts have drastically affected 
many countries ' ability to participate in international trade. The pandemic has also slowed down the 
pace by many countries to realize their development agenda, particularly the Sustainable 
Development Goals.  
877.  In their effort s to contain and manage the pandemic, many developing countries are facing 
public health challenges, due to restrictions brought about by intellectual property protection. It is 
noteworthy that intellectual property is at the core of the fight against the pandemic and as the 
TRIPS Agreement provides, protection and enforcement of intellectual property should be to the 
mutual advantage of both the producers and users, in a manner that is conducive to social and 
economic welfare, and that ensures the balancin g of rights and obligations.  
878.  The prospects of economic recovery from the pandemic, for most countries largely depend on 
the duration of the health crisis, as well as the effectiveness of the policy interventions that they 
deploy. Countries will therefore have to constantly adjust their interventions as the health situation 
unfolds. Currently, access to the technological innovation and production required to respond to the 
pandemic is curtailed by IP protection and this extends beyond patents, to copyright,  industrial 
designs and trade secrets, which also apply to products and technologies that are urgently needed 
to address the effects of COVID -19.  
879.  Kenya therefore welcomes the proposal by India and South Africa for the TRIPS waiver and 
indeed happy to be a  co-sponsor and looks forward to further in -depth discussion by the Council on 
this submission. Kenya believes that more should be done within the context of the TRIPS Agreement 
to ensure that developing countries of the WTO are able to promptly respond to  the COVID -19 
pandemic through access to vaccines, diagnostics, personal protective equipment and other medical 
technologies.  
15.4  Nigeria  
880.  We commend the delegation of South Africa and India for their joint submiss ion. In the context 
of COVID -19 pandemic, we be lieve the paper has come at the right time.  
881.  My delegation would like to underscore the importance for WTO Members  to work together to 
ensure that intellectual property rights such as patents,  industrial designs, copyright and trade 
secrets do not create ba rriers to the scaling -up of research, development, manufacturing and supply 
of medical products essential to combat COVID -19 while preserving intellectual property rights of 
Members . IP/C/M/96/Add.1  
 
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  882.  Finally, while we are still awaiting instructions from capital in this re gard, we welcome 
constructive discussions regarding this proposal.  
15.5  Bangladesh  
883.  The delegation of Bangladesh thanks the delegation of India and South Africa for this 
submiss ion (document IP/C/W/669). My delegation also supports the statement delivered by Chad 
on behalf of the LDC  Group.  
884.  The submission presents an extremely urgent call during this time of global crisis caused by 
COVID -19 pandemic. The issues of public health should not be seen from a narrow perspective. We 
live in an interdepe ndent and interconnected world. Therefore, a threat to public health in one society 
is a threat to humanity everywhere. Moreover, the pandemic may be primarily a health issue, but 
in the long run this is destroying our employment, investment, mobility, cre ativity, social relations 
and overall economic development. The whole world is suffering. The developing countries, 
particularly the LDCs, are severely and disproportionately affected by the COVID -19 pandemic. 
Members  must act collectively to save societie s and economies from the devastating impacts of the 
pandemic.  
885.  The delegation of Bangladesh requests a favourable consideration of the proposal.  
15.6  Sri Lanka  
886.  First, I take this opportunity to commend you in the effective manner in which you are steering 
this very import Council 's preceding since assumption of your role recently.  
887.  Also let me thank and appreciate immensely India, South Africa, Kenya and other newly joine d 
co-sponsors for presenting their extremely relevant and timely proposal for a Waiver from certain 
provisions of TRIPS Agreement for Prevention, Containment and Treatment of COVID -19. 
888.  At the outset, let me notify Sri Lanka 's strong and unequivocal support  for the proposal 
circulated in document IP/C/W/669 and presented by the co -sponsors.  
889.  The COVID -19 was declared a pandemic by the WHO on 11 March 2020. It is widespread, 
affecting almost all WTO Members . After experiencing a very brief initial period of COVID  pandemic, 
Sri Lanka is now experiencing a second waive, where the epidemiologists and virologists have 
detected the COVID -19 virus, which is more severe in affect than what we experienced before and 
able to spread among large sets of community groups vigorously in a given period. This has 
necessitated the authorities to double their efforts in containing the virus to minimize the health and 
socio-economic impact on our poor population.  
890.  In this situation, ensuring timely access to essential commodities  by overcoming acute 
shortages faced by countries due to high demand and disruptions in the supply chain is critical. 
There is no vaccine or medicine yet to prevent or treat COVID -19. Hence, there is an urgent need 
to speed up development of new vaccines, treatments and diagnostics, at scale, and make these 
widely available.  
891.  An effective response to COVID -19 pandemic not only requires timely access to affordable 
medical products, but access to diagnostic kits, medical masks, other personal protective equipm ent 
and ventilators is also vital. However, as the crises persist, there has been a rapid increase in demand 
with many countries facing acute shortages, constraining the ability to effectively respond to the 
outbreak. Importantly, timely access to affordab le vaccines and medicines for the prevention and 
treatment of patients in dire need is another major concern, as the COVID -19 global crisis deepens. 
Given the disruptions in supply chains and severe shortages, local/regional production is a critical 
soluti on, may be the only solution for small economies such as mine.  
892.  Efforts to contain the COVID -19 spread has led to serious concerns about the impact of IPRs, 
such as patents, industrial designs, copyright and trade secrets on the availability and affordabili ty 
of medical products. Global demand for medical products can only be met with global production of 
products needed to contain, treat and prevent COVID -19. Apart from availability, affordability is IP/C/M/96/Add.1  
 
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  another concern that needs to be addressed, an aspect of which is very important and relevant for 
Sri Lanka.  
893.  In view of the above reasons, Sri Lanka considers that the Proposal is timely and importantly 
necessitated in the current context:  
894.  In the proposal, the co -sponsors are calling for the WTO Members  to agre e to temporarily 
waive certain provisions of the WTO TRIPS Agreement related to the obligations on protection and 
enforcement of patents and other intellectual property rights to support the global COVID -19 
pandemic response.  
895.  In addition to patents, other  forms of IP rights, such as, copyrights, industrial designs, and 
trade secrets can also apply to products and technologies required for responding to COVID -19. This 
necessitates enabling a broader application of flexibilities beyond patents to such other forms of IP 
rights. Accordingly, the proposal requests wavering of specific obligations of the TRIPS Agreement 
on protection and enforcement, namely, (1) patents, (2) copyright and related rights, (3) industrial 
designs and (4) protection of undisclosed in formation during the COVID -19 pandemic.  
896.  As elaborated in the proposal, the waiver would absolve all countries from implementing the 
referred obligations for a limited time period, extending policy space for governments and extending 
freedom to operate to parties without risk of infringing such intellectual property rights, while 
ensuring legal certainty that actions are compliant with WTO TRIPS rules.  
897.  As argued in the proposal, the adoption of this proposal will overcome potential obstacles that  
above categories of intellectual property rights may create to get timely and unfettered access to 
technologies and products needed to address the pandemic. It will not affect, however, the 
enforcement of other categories of rights covered by the TRIPS Ag reement, nor its full 
implementation in relation to matters unrelated to the prevention, containment or treatment of 
COVID -19. Therefore, the adoption of this proposal is critical to ensure availability of medical 
products at affordable price for the preve ntion, containment and treatment of COVID -19. 
898.  Why Sri Lanka supports the proposal:  Sri Lanka 's government total expenditure on health 
sector is around USD 1.32 Billion, which is a share of 1.7% of the total GDP of Sri Lanka in 2019. 
Total bill on import of  medical and pharmaceuticals is USD 552.6 million, which is a share of 2.8% 
of total imports in 2019 and is now on the rise due to the current crisis. At present, 80% of the 
country 's drug requirement is met through imports. At present, Sri Lanka is the la rgest importer of 
drugs in the Asian region and it is high time that Sri Lanka turns the tables in its favour.  
899.  Sri Lanka is a country which is proud of having a universal free medical access programme  
securing free access to health facilities & Treatment for its population, which is also enshrined in its 
Constitution as a fundamental right of its citizens. When the country is inundated with balance of 
payment difficulties exacerbated by the COVID  Pandemic, the Government  is seeking to reduce 
import bills i ncluding the expenditure on medical and pharmaceutical products through other means.  
900.  A disturbing development witnessed by Sri Lanka during the current pandemic is the gradual 
increase of domestic prices of essential medicines sold in the market by the Ph arma Companies 
when our regulatory authorities ' attention has been drawn in containing the spread of pandemic. 
There are investigations going on to these alleged anti -competitive practices by the regulatory 
authorities.  
901.  Recently, Government informed that its plans to increase production with a view to meeting 
the country 's total drug requirement and to ensure the supply of high quality drugs at affordable low 
prices and to enhance the export production capacity of nascent items in COVID -19 product range. 
Sri Lanka has also decided to establish a free trade zone to accommodate such investments in the 
pharmaceutical sector. Through this, the Government is intending to meet at least 50% of country 's 
current pharmaceutical requirements. In terms of the plan, 25  medium and small scale companies 
are prepared to invest USD 300 million to meet the local demand.  
902.  This proposal is, therefore, in line with Sri Lanka 's policy goal for exploring avenues for 
increasing domestic value addition in productive sectors, particu larly by building production capacity 
of Domestic Pharmaceutical and Medical Devices sector.  IP/C/M/96/Add.1  
 
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  903.  Unless there is an unambiguous clarity that any domestic production of COVID -related 
patented drugs and medical devices, PPE products etc can be carried out in Sr i Lanka for meeting 
the domestic demand and with plans to export to third countries, without any IPRs related legal 
impediment, it is highly risky to invest in new ventures if it is otherwise.  
904.  A research institute in Sri Lanka, namely, Sri Lanka Institute of Technology (SLINTEC), has 
ventured in to innovate and commercialize two new products with high export potential in the USA 
and the EU. These products are SLINTEC Swabs and SLINTEC Sterile. The SLINTEC has reverse 
engineered COVID -19 testing swabs and ha s been producing them in -collaboration with the Medical 
Research Institute of Sri Lanka, the Lady Ridgeway Hospital, and Hi -Fashion Holdings Pvt limited.  
905.  It indicates that these items are already under patents and though they are now made in 
Sri Lanka in generic form and intended to be exported under Sri  Lanka brand name, there is a 
likelihood of overriding the patent holders ' rights in the importing countries. Sri Lanka has found 
such new product lines and intends to capitalize on the export potentials, s o that in addition to 
catering to our local demand, Sri Lanka can supply to those countries, who require them to deal with 
the current pandemic, which is going to stay in the world for many years. But, Sri Lanka may not 
be able to export them to those coun tries due to the possible IPRs infringements. If so, it not only 
deprives Sri Lanka generating most vital foreign exchange, but also deprives the countries which 
require them desperately.  
906.  The WTO waiver proposed in the proposal will, therefore, provide th e required legal certainty 
to Sri Lanka in the interim period, until it is able to address those IPRs related legal impediments in 
the long run.  
907.  Currently, Sri Lanka has few provisions in Sri Lanka 's National Intellectual Property Act, No. 
36 of 2003 that  provide such exceptions, particularly Section 86 of the Act, which unfortunately 
bundles the important exceptions provided under 'exhaustion of rights (parallel imports) and 
Compulsory licences  (CL) and offers less clarity in their application.  
908.  Further, Sri Lanka is yet to amend its National Intellectual Property Legislation to introduce 
the complaint provisions necessitated by the Amendment to the TRIPS Agreement (under 
Article  31bis of the TRIPS Agreement), which is overdue. This amendment is particular ly important 
to Sri  Lanka, as it lacks domestic manufacturing capacity and would, therefore, be dependent on 
imports to meet its medical needs.  
909.  Many developing countries, including Sri Lanka may also face legal, technical and institutional 
challenges in u sing TRIPS flexibilities due to the lack of ambiguity in the existing legal provisions. 
This is especially true for countries, such as Sri Lanka that have never utilised flexibilities such as 
compulsory licences  (CL). National patent laws may not even have  the necessary provisions to issue 
compulsory licences  in the public interest or government use licenses.  
910.  In some countries, including Sri Lanka the issuance of compulsory license may not be possible 
until the expiration of three -four years following the g rant of patent. Sometimes, provisions on 
compulsory licensing in national legislation are subject to specific processes and as such the issuance 
of compulsory license may involve lengthy processes that are time -consuming.  
911.  As explained above, a few countri es have introduced or are in the process of introducing 
simplified procedures for issuing compulsory licences  in times of a public health crisis. This however 
may not be an option for Sri Lanka, where legal and technical capacity maybe lacking and the pass ing 
of national legislation is often a very long process.  
912.  In order to support these efforts, Sri Lanka is in the process of carrying out a gap analysis on 
the Sri  Lanka 's existing National IPRs Legislation to ascertain the areas where further improvements  
are necessary to ensure that the production can commence on those products protected under IPRs 
enabling the long -term survival of those investments and projects.  
913.  While the process of amendments will be time consuming on a variety of IP rights that are 
relevant in the fight against COVID -19, Sri Lanka along with other like -minded countries have been 
working on a joint proposal, initiated by India and South Africa, w hich has now been submitted to 
the WTO TRIPS and the General Council seeking a more integrated approach to address the public IP/C/M/96/Add.1  
 
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  health concerns/challenges of COVID -19 pandemic, through TRIPS flexibilities that include other 
various types of intellectual prop erty (IP) rights including copyrights, industrial designs and trade 
secrets.  
914.  The use of TRIPS flexibilities in other areas of intellectual property, beyond patents, is less 
understood at the national level. In fact, in other fields of IP, National IP laws  may not even provide 
for sufficient flexibilities to address issues of access.  
915.  In view of the above forgone and justifiable reasons, Sri Lanka calls for support for the 
multilateral solutions, more particularly this joint proposal which is before us in as suring and 
delivering fair access to COVID -19 treatments for all those in need in the developing countries and 
the LDCs.  
15.7  Pakistan  
916.  Pakistan welcomes the proposal on 'a waiver from certain provisions of the TRIPS Agreement 
for the Prevention, Cont ainment and  treatment of COVID -19' contained in document IP/C/W/669, 
and we thank the co -sponsors for this very important contribution. It is high time that WTO stood 
up and made itself counted in the global fight against the pandemic.  
917.  It is proven that the COVID -19 pandemic presents in ev ery way, a global health emergency. 
This is coupled with a resultant economic crisis. The effects on livelihoods and general health of the 
populations in developing countries in particular, are devastating while health budgets of many 
countries find it dif ficult to sustain availability of highly priced COVID -19 related medical products 
and limited access to diagnostic testing.  
918.  In order to combat the COVID -19 pandemic, we require rapid access to affordable medical 
products including diagnostic kits, medical  masks, other personal protective equipment and 
ventilators, as well as vaccines and medicines for the prevention and treatment of patients. At the 
same time, it is feared that the development, dissemination and public availability of medicines 
including v accines can become subject to monopolistic behaviour of large pharmaceutical firms and 
the global political economy of price premiums.  
919.  In wake of this challenge, there is an urgent call by many for global solidarity for unhindered 
global sharing of technol ogy and know -how; cheap and easy access to medicines and medical 
equipment, and the enhancement of local production capacities of these products for developing 
countries.  
920.  While the TRIPS Agreement contains some flexibilities, many WTO Members  face challen ges 
in using them effectively. The flexibilities are selective, limiting in their scope and application and 
virtually impossible to implement. For instance, Pakistan finds it difficult to implement the 
compulsory licensing provisions due to various limitat ions of time, price, quantity, region of 
production.  
921.  The current pandemic requires collective global action to tackle IP barriers at a more 
comprehensive level. Acknowledging that we are passing through this unprecedented global medical 
emergency, we wish  to echo the concerns raised in the subject proposal and support the waiver. We 
feel that this will ensure adequate and affordable supply of medical products including vaccines and 
medicines, allow scaling -up of research, development, manufacturing and sup ply of medical products 
essential to combat COVID -19 and have an overall positive effect on the ability of developing 
countries to tackle the mounting challenges posed by the pandemic.  
15.8  Venezuela, Bolivarian Republic of  
922.  The B olivarian Republic of Venezuela would like to thank India and South Africa for such a 
necessary proposal at this time and fully supports it.  
923.  Extraordinary situations, such as those resulting from the COVID -19 pandemic, call for equally 
extraordinary decisions. Article IX of the Marrakesh  Agreement provides us with the legal basis for 
this. IP/C/M/96/Add.1  
 
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  924.  The epidemiological report by WHO issued this week states that, from 30 December 2019 to 
11 October 2020, more than 37 million cases of COVID -19 and more than a million deaths were 
reported worldwide. B ut what is most alarming is that, despite all of the collective efforts to try to 
reduce the effects of this pandemic, last week saw the highest number of cases reported in a single 
week to date.  
925.  No one has been spared by this pandemic. All governments are  dealing with the challenges of 
ensuring timely, adequate and affordable access to medicines, vaccines, diagnostic kits and other 
essential medical supplies. This is particularly challenging for many developing countries that are 
dealing with limitations o n the development and expansion of production capacity due to intellectual 
property barriers.  
926.  In the context of this universal emergency and while the pandemic lasts, this waiver is required 
for the benefit of all humanity, since no one can be safe in this  world until we all are.  
15.9  Nepal  
927.  My delegation would like to extend sincere app reciation to the delegation of India and 
South  Africa for their submission.  
928.  While going through the proposal, it seems an appropriate and timely initiative in the context 
of curr ent COVID -19 pandemic. The COVID -19 pandemic has severely devastated the global 
economy where developing especially, least developed countries are suffering most because of their 
limited capacity to cope with the impact of the pandemic. In this context, su fficient policy space as 
per the need of country 's context is essential to overcome the difficulties faced as indicated in the 
submission.  
15.10   Philippines  
929.  The Philippines thanks India and South Africa, Kenya and Eswatini for their proposal document 
IP/C/W/669,  on an issue of profound importance no t just for TRIPS Council Members  but also for all 
participants of the multilateral trading syste m. 
930.  The Philippines has elevated concerns over the COVID -19 global pandemic to the highest 
levels, and has made the effort to eradicate the novel coronavirus one of its highest priorities. No 
less than our Head -of-State, President Rodrigo Duterte, declared at the recent 75th Session of the 
U.N. General Assembly last September that "ensuring universal access to anti -COVID -19 
technologies and products is pivotal in the global pandemic recovery. " 
931.  During the Special ASEAN Summit, our Leaders committed to intensify cooperation to ensure 
adequate provision of medicines, essential medical supplies and equipment, including, but not 
limited to diagnostic tools, personal protective equipment.  
932.  At the recent APEC Ministers Responsible for Trade Virtual Meeting, our Trade Minister 
Mr Ramon  Lopez called for closer cooperation in data gathering and R&D, particularly to strengthen 
health system s and provide access to affordable, high -quality health products, treatments and 
services.  
933.  The WTO has a positive role to play in promoting trade in medical goods and in ensuring 
balance of trade and intellectual property and public health interests. At th e height of the HIV/AIDS 
pandemic, WTO Members  responded by adopting the 2001 Doha Declaration on the 
TRIPS  Agreement and Public Health, which eventually led to a Decision of the General Council on 
30 August 2003 amending the TRIPS Agreement on the Special  Compulsory Licensing System . Like 
other WTO Members , the Philippines would later incorporate this mechanism as part of our national 
law as the Universally Accessible Cheaper and Quality Medicines Act of 2008.  
15.11   Nicaragua  
934.  We thank the proponent delegations for including this agenda item on the proposal for a 
temporary waiver from certain provisions of the TRIPS Agreement . IP/C/M/96/Add.1  
 
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  935.  We consider that this proposal is of great importance amid the current difficulties, since it is a 
meas ure that would offer de veloping countries like Nicaragua timely and affordable access to the 
medical products, medicines, vaccines, inputs and medical equipment necessary for detecting and 
treating COVID -19. It would also provide fair access to medical tec hnologies, which are essential for 
the proper handling of the fight against COVID -19. 
936.  Our Government wishes to take this opportunity to express its support for this proposed 
waiver, based on the content of document IP/C/W/669.  
15.12   Chile  
937.  Our delegatio n would like to thank the proponents of document IP/C/W/669 in which a waiver 
to the implementation of the main obligations cont ained in the TRIPS Agreement is proposed.  
938.  Firstly, I would like to state that as a country, and since the beginning of this Organi zation, 
we have maintained that the objective of intellectual property (IP) is to be a tool for stimulating 
technological innovation, and the transfer and dissemination of technology to the mutual advantage 
of producers a nd users, in a manner conducive to the economic and social welfare of countries, as 
stated in Article  7 of the TRIPS Agreement. In this respect, our country has vigorously defended and 
promoted balanced IP systems which both foster innovation and meet the needs of society as a 
whole.  
939.  This i s why we share the premise that IP should not hinder or impact access to medicines, but 
we understand that the same IP system contains the tools to prevent this situation from happening 
and that there are flexibilities in the system which allow Members  to strike the necessary balance 
appropriate to their own socio -economic reality. Also, and like other Members  we are open to 
analysing which types of conduct may constitute an abuse of IP rights, as well as exploring the 
mechanisms that the Agreement establis hes to rectify such types of situation.  
940.  Specifically, we can announce that, at local level, our country has managed to use the 
flexibilities contained in the TRIPS Agreement, which has resulted in suitable production of generic 
medicines, as well as being an attractive market for marketing latest generation medicines. 
Instances of this include the establishment of an international IP rights exhaustion system, which 
along with our network of free trade agreements, allow us to seek the best prices for a speci fic 
medicine on the world market. As regards our IP legislation, it has maintained the exclusions from 
patentability stipulated in Article 27 of the TRIPS Agreement, as well as introducing a strict and 
thorough examination of patent applications. Additiona lly, this year has seen reforms to the Law on 
Industrial Property with the aim of facilitating the use of the flexibilities contained in Article 31 and 
31bis of the TRIPS Agreement, which are currently before our National Congress.  
941.  At international level, our country was one of the first to support the creation of the Medicines 
Patent Pool and to collaborate on the database that today provides a means of clearly identifying 
when a patent has entered the public domain in such a way as to generate access to t he medicines 
listed therein. Chile, for its part, promoted the recommendations of the World Intellectual Property 
Organization Development Agenda and particularly those listed under Cluster B on the use of 
flexibilities and the public domain, among others.  
942.  Like all WTO Members , Chile has been severely impacted by the pandemic, and to date, my 
country finds itself in an extraordinary constitutional situation with, among other measures, 
restrictions on the movement of people, quarantines and social distancing . The priority is to not only 
ensure that there are beds and medical supplies, including mechanical ventilators, but also that a 
vaccine against COVID -19 is now made available.  
943.  This is why we are working on two fronts. Firstly, in the field of clinical res earch and trials, we 
have forged partnerships with universities and laboratories so as to foster timely access to vaccines 
and upscale scientific capabilities. Secondly, we have increased contact through meetings and 
discussions with the main laboratories which are developing the most promising vaccines and, in 
particular, have reached an agreement with COVAX, a global initiative led by the WHO, the EU and 
associations such as the Bill & Melinda Gates Foundation.  IP/C/M/96/Add.1  
 
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  944.  All the above, despite the repercussions of the pandemic, has enabled a developing country 
such as Chile to show that it is able to seek solutions to current and future problems, and notably 
we have seen a spirit of collaboration emerge between all actors of the health system and of 
innovation given  the nature of the pandemic. We believe that in recent months we have witnessed 
how the most brilliant of minds in the world have searched for solutions to the pandemic. The 
response to the pandemic has involved collaboration between innovative enterprises , universities, 
research centres, SMEs and even independent inventors on a global scale.  
945.  That said, and given the importance of the proposal set forth in document IP/C/W/669, we 
would like its proponents to provide some clarification on its potential impac ts and implementation. 
In this regard, and to evaluate the proposal, we would like for them to clarify the following:  
a. Firstly, we would be grateful if the proponents could provide us with more information on 
specific cases where, in the context of the COVID-19 pandemic, IP has hindered access to 
the vaccines currently being developed.  
b. Secondly, we would appreciate some clarity on the economic impact that the proposal 
would have, as well as whether they may have a prior i identified any type of impact on 
innovation in the medical field.  
c. Lastly, we believe it is important that we better understand how the proponents would 
implement this waiver at local level. Specifically, we would be interested in understanding 
how this waiver would be implemented as regards t he domestic laws of the proponent 
Members , what would the implications be for IP rights already preliminarily granted and 
whether it might impact most favoured nation and national treatment commitments.  
946.  The proposal before us is unprecedented in this Counc il and in that light, we believe it is crucial 
that the above issues be clarified so that we can evaluate what effects the proposal may have, who 
it would benefit and the way in which it could be implemented, if approved.  
15.13   Turkey  
947.  At the outset we would like  to thank India and South Africa for the proposal regarding a waiver 
from certain provision s under the TRIPS Agreement concerning the need for prevention, containment 
and treatment of COVID -19. 
948.  While we note the comprehensive and in -depth nature of the pro posal, we would like to make 
preliminary comments without prejudice to later interventions of our delegation with regard to the 
way forward.  
949.  Turkey has always put not only the health of her citizens but also other countries medical 
needs, at the top of her  policy agenda. We attach great importance to provide affordable health care 
and ensure an equitable access to medicines for everyone.  
950.  COVID -19 pandemic poses a widespread and major threat to the world. And there is not yet 
a vaccine or scientifically pro ven treatment although there are many important studies which are 
ongoing. We have seen that medical equipment, such as ventilators, personal protective equipment 
and medical supplies have been very critical to combat the pandemic.  
951.  In that sense, Turkey v alues close collaboration among the Members  during such difficult 
times. We were in solidarity with many countries in their struggle with COVID -19. Turkey supplied 
medical and personal protective equipment as well as ventilators to over 150 countries and s ix 
international organizations since the beginning of the outbreak.  
952.  As this proposal requires close and thorough coordination among relevant national authorities, 
we need further consultations in Turkey. However, we are ready to engage constructively to ac hieve 
a global strategy so that everyone can better cope with this global health crisis.  IP/C/M/96/Add.1  
 
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  15.14   Egypt  
953.  Egypt aligns itself with the statement to be made by Tanzania on behalf of the African Group, 
and we would  like to  thank  India and South Africa for this timely proposal.  
954.  It is now evident after the difficult times we have been through since the beginning of the 
pandemic, that there are limitations on relying on a "case by case " approach when using the TRIPS 
flexibilities t o address IP barriers in confronting this crisis. We believe that Responding to COVID -19 
effectively requires a collective and global solution that overcomes the restrictions of addressing IP 
barriers on a national level so that countries can collaborate a nd freely share manufacturing and 
supply capacities.  
955.  In this context, we believe that this proposal can provide a very good base for discussions in 
this Council on the role our organization has to play in the current unprecedented global crisis during 
which all governments are facing challenges ensuring timely, sufficient and affordable access to 
effective medicines, vaccines, diagnostics and other essential medical tools.  
15.15   Indonesia  
956.  We thank the delegation of India and South Africa for their proposal for a Waiver from certain 
provision of the TRIPS Agreement for the Preven tion, Containment and Treatment of COVID -19 as 
circulated in the document IP/C/W/669.  
957.  This proposal is timely to open the discussion on our and WTO role in ensuring global s olidarity 
through effort in ensuring equal, affordable, and timely access to PPE, medical equipment, diagnostic 
test, drugs and vaccines for the prevention, containment and treatment of COVID -19.  
958.  This COVID -19 pandemic has become a global threat, not only  for global trade and economy, 
but also to humanity. Global solidarity in combatting this pandemic should materialize in concreate 
action. International organizations should also contribute in a meaningful way toward this effort.  
959.  Fortunately or unfortunat ely (as we could decide later), the TRIPS Agreement as one of the 
most important agreement during global public health crisis, is under our auspices. It is well 
recorded, both in public health papers, journals or writing by United Nations Bodies or Special  
Rapporteur under the UN Human Rights Council, that Intellectual Properties could become a serious 
barrier for combatting public health crisis.  
960.  While the TRIPS Agreement has governed the flexibilities under the patent protection, we have 
been taught that t he barrier for prevention, containment and treatment of COVID -19 pandemic is 
not only posed by patent protection. We share the view that beyond patent, there are lack of 
flexibilities offered, or even known, to ensure those IP protection not become barrier s to combat 
global health crisis.  
961.  This proposal, we believe, will open positive discussion on the limitation and possible solution 
for the TRIPS Agreement in assisting Members  to deal with global health crisis. This proposal would 
also provide assurances f or Members  in taking legitimate immediate measures for protection of the 
public health in the time of crisis, as granted under the Article IX:3 of Marrakesh Agreement.  
962.  The fact that there will be no immediate and adequate of therapeutics and vaccines to de al 
with the COVID -19, has become serious issue that we need to deal. The possible limited 
manufacturing of vaccines from private pharmacy companies, as we learned, has been secured by 
several Members  under private contracts which would create imbalance acc ess to the products for 
others. The waiver, as proposed, hopefully could boost cooperation in research and development 
and scale -up manufacturing of necessary medicines and vaccines to ensure that no Member is left 
behind.  
963.  As the number of infection s is keep rising in every part of the world, we shall all agree that 
there is no global recovery, both in global public health and economy, if some Member s are left 
behind in t he recovery process.  IP/C/M/96/Add.1  
 
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  15.16   Argentina  
964.  We thank South Africa and India for submitting document  IP/C/W/669.  
965.  We see that the world is facing an extraordinary situation due to the pandemic, which requires 
extraordinary solutions t o ensure affordable access to medical products needed for the prevention 
and treatment of COVID -19, within the multilateral  regulatory framework.  
966.  The challenges linked to accessing health products to combat COVID -19 are at the core of the 
multilateral trading system. The matter has permeated the discussions of many forums and was also 
touched upon in the communiqué issued by t he G20 Trade and Investment Ministers, which stressed 
the need to ensure that all countries have access to essential medical supplies and pharmaceuticals, 
including vaccines, at an affordable price.  
967.  In light of the above, my delegation supports the proposa l contained in document IP/C/W/669.  
15.17   Chad on behalf of the LDC Group  
968.  The LD C Group thanks South Africa and all the co -authors for the communication on the 
prevention, containment and treatment of COVID -19 through the proposed measures in the 
framework of th e TRIPS Agreement. We believe that this proposal is a step in the right direction 
given the extraordinary situation in which we find ourselves, which calls for equally extraordinary 
measures.  
969.  It is clear, as we have already mentioned in our committee, that  we must be able to quickly 
and effectively secure the means to tackle and defeat the pandemic, which poses a considerable 
threat to the lives of millions of people worldwide. It is well -known in our countries and in many 
developing countries that we lack sufficient technology and equipment to produce protective 
equipment, treatments and even vaccines.  
970.  We are therefore totally dependent on exports from equipped countries to our countries. In 
the current situation, we are obviously trying to figure out how to obtain masks, hydro -alcoholic gel, 
ventilators, medicines and eventually vaccines as quickly as possible. In the current context, 
everything must be streamlined as much as possible in order to save lives. We need solidarity now 
more than ever.  
971.  The following fact was highlighted in the preamble of the draft decision: the pandemic poses 
a threat not only to human health, safety and well -being, but also has unprecedented and 
multifaceted effects, including the severe disruption to society currently bein g witnessed, disruption 
to economies, disruption to global trade, disruption to travel, and the devastating impact on the 
livelihoods of people. Moreover, the statistics from international agencies, whether it be the WHO, 
FAO or the World Food Programme , in terms of the impact on human lives are getting worse and 
worse.  
972.  The LDC Group considers it appropriate to take a new initiative in terms of flexibility in the 
provisions of the WTO Agreements. With regard to the TRIPS Agreement, flexibility is needed to 
simplify and speed up the provision of medical products accessible to all, in terms of both cost and 
supply, in order to effectively tackle the pandemic. Every country in the world without exception - 
developed countr y Members , developing countries and lea st developed countries - is affected by the 
pandemic.  
973.  Stopping the growing and alarming surge in the pandemic is therefore a matter of global 
urgency. We must ensure that intellectual property rights do not become barriers to the provision 
of affordable me dical products for all and, in particular, for those who need them most and/or are 
ill. 
974.  In conclusion, the LDC Group believes that the intention of the proposal before us is good. We 
would simply like to be able to further discuss the proposal with its co -author at a meeting with our 
Group in order to have some clarification in the coming days and weeks. We are also awaiting 
feedback from the capitals, as the communication has been forwarded to the LDC capitals, where IP/C/M/96/Add.1  
 
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  the proposal is still being analysed. A ll the LDC Group wishes to say about this communication for 
now is that we are open and flexible to discussing the proposal with the co -author.  
15.18   China  
975.  We thank India, South Africa and co -sponsors for presenting this proposal. COVID -19 has 
severely threatene d human life, security and health, dis turbed the function of global supply chain 
and brought great challenges for the normal supply of treatment medicines and relevant medical 
equipment. The joint proposal emphasizes the difficulties faced by developing co untries and LDCs 
and seeks to ensure Members ' timely, equitable and affordable access to commodities in relation to 
the prevention, containment and treatment of COVID -19, especially COVID  medicines and vaccines. 
We would lend our support to exploring this issue at the TRIPS Council.  
976.  China has taken good note of the capacity constraints that developing countries encounter in 
using TRIPS flexibilities such as compulsory licensing, as pointed out by the proposal. China has 
made serious commitment that COVID -19 vaccine development and deployment in China, when 
available, will be made a global public good and developing countries will be our priorities. Earlier 
this month, China joins the COVID -19 Vaccines Global Access Facility, or the COVAX Facility, and 
will take concrete measures to promote the fair distribution of COVID  vaccines, especially among 
developing countries.  
977.  China is willing to discuss access to commodities in relation to the prevention and control of 
COVID -19, including medicines and vaccines under  the framework of the TRIPS Agreement, and 
supports the discussions on possible waiver or other emergency measures to respond to the 
pandemic, which are "targeted, proportional, transparent and temporary ", and which do not create 
unnecessary barriers to tr ade or disruption to global supply chains.  
15.19   Thailand  
978.  Thailand would like to thank India and South Africa and co -sponsors for submitting the 
proposal and providing a comprehensive i ntroduction.  
979.  Like others, we witness the impacts of the COVID -19 crisis on societies, economies , and 
vulnerable groups in developing and least developed countries in the present year and for years to 
come. And we note the importance of strengthening cooperation among c ountries in multilateral 
level to maintain socio -economic stability for sustainable development and to protect public health 
and promote access to medicines for all.  
980.  With respect to the intellectual property measures in the context of COVID -19, Thailand al ways 
recognizes that intellectual property protection is important for the development of new medicines 
and vaccines while understands that the prompt policy responses to utilizing the flexibilities available 
in the TRIPS Agreement for public health at thi s challenging stage is also needed to mitigate the 
impact of the pandemic.  
981.  Thailand has always supported a right balance between IP protection and public interest. 
However, since the proposal presents the broader dimensions on the waiver from the 
TRIPS  Agreement, we, therefore, currently are studying the proposal prudently and may seek further 
clarification from the proponents in the future.  
15.20   Tunisia  
982.  Tunisia thanks India and South Africa for their joint communi cation in document IP/C/W/669 
and supports their  initiative, which aims to provide equitable and affordable access to medical 
products needed for the prevention, containment and treatment of COVID -19. 
983.  Tunisia, which urgently called for international solidarity and secured by unanimous consent 
the adoption, on 1  July 2020, by the UN Security Council of a Resolution on combating the COVID -19 
pandemic, would like to underline the need for exceptional measu res to deal with an equally 
exceptional health, economic and social global situation; as well as the WTO 's decisive role to play 
in promoting such multilateral cooperation to protect international public health at this critical 
juncture . IP/C/M/96/Add.1  
 
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  984.  My country, like a ll countries, has undergone disruptions to its production and trade cycles for 
medical products needed to combat the pandemic and has suffered the consequences, which may 
worsen with this second wave of the virus.  
985.  Tunisia would therefore be open to the pro posal for a "Waiver from certain provisions of the 
TRIPS  Agreement for the prevention, containment and treatment of COVID -19", and in this regard 
would like to highlight the following:  
a. The TRIPS Agreement provides for the use of waivers in cases of approve d exceptional 
situations and this is case of COVID -19, which was declared a global pandemic by WHO.  
b. This waiver is limited to medical products needed for the prevention, containment and 
treatment of COVID -19, and should be time -bound until a vaccine is ava ilable worldwide, 
thereby mitigating its adverse effect on intellectual property rights.  
c. Ten months into the pandemic, a meaningful solution to the health crisis is still not within 
reach, along with persisting inequality in access to the technologies requ ired to deal with 
the pandemic. The solution to dealing with this pandemic, therefore, must be global and 
shared by all.  
15.21   Tanzania on behalf of the African Group  
986.  The African  Group welcomes the joint submission by the delegations of India and Sou th Africa 
contained in document IP/C/W/669 titled Proposal for a Waiver from Certain Provisions of the 
TRIPS  Agreement for the Prevention, Containment and Treatment of COVID -19. The African Group 
is consulting internally and with Capitals  on this joint submission.  
987.  As we have previously expressed at the Informal HOD and General Council meetings, the 
African Group holds the view that the WTO has an instrumental role to play in fostering multilateral 
cooperation that will promote equitable and affordable access to key pr oducts necessary for the 
prevention, containment and treatment of COVID -19. In this connection, and in accordance with the 
Doha Declaration on TRIPS Agreement and public health, solidarity and close cooperation among 
Members  is necessary to ensure that the  TRIPS Agreement does not and should not prevent Members  
from taking measures to protect public health, an important aspect at this critical time.  
15.22   Ecuador  
988.  We thank India and South Africa for introducing this p roposal, on which we wish to make a 
few comment s. 
989.  With regard to the first Article of the proposal, in which it is proposed to waive Members ' 
obligation to implement or apply sections 1, 4, 5 and 7 of Part II of the TRIPS Agreement in relation 
to prevention, containment or treatment of COVID -19, we are  of the view that is approach is, in 
principle, a positive one.  The global health crisis has had a severe impact on countries and may 
require decisions to help them tackle the pandemic, in accordance with international law and 
following the relevant multilateral processes.  
990.  However, Ecuador considers that the proposal needs to offer clearer guidance on, inter alia , 
what are intellectual property developments, the possibility of second uses, and research related 
information.  It is vital to avoi d uncertainties over what would be covered by a waiver.  This would 
prevent any adverse effects on the development of a solution to COVID -19 and avoid setting 
inappropriate precedents.  
991.  Likewise, in our view, the idea of non -compliance with Part III of the A greement on the 
enforcement of intellectual property rights is ambiguous. More clarification is needed on the matter 
to ensure consistency with the principle of protection.  
992.  In this respect, although Ecuador agrees with the urgency and humanitarian aims beh ind the 
proposal from India and South Africa, we are of the view that the initiative needs to be reworked in 
order to address the above -mentioned concerns.  IP/C/M/96/Add.1  
 
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  15.23   Senegal  
993.  My delegation thanks Sout h Africa, India, Kenya and Eswatini for the proposal for a waiver 
from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of 
COVID -19. 
994.  Our delegation understands the grounds for this proposal as reflected in the statements made 
by South Africa and India. We strongly believe that, pursu ant to the Doha Declaration on intellectual 
property and public health, the TRIPS Agreement does not and should not prevent Members  from 
taking measures to protect public health.  
995.  The ongoing and profound health, economic and social crisis around the world,  which impacts 
developing countries and LDCs in particular, is an opportunity for Members  to strengthen cooperation 
and international solidarity to ensure universal access to affordable medicines, equipment and 
vaccines needed for COVID -19 prevention and t reatment.  
996.  The document IP/C/W/669 is being reviewed in my capital, and my delegation welcomes 
constructive discussions on this item on our agenda for this meeting and at the next meeting of the 
Council.  
15.24   Costa Rica  
997.  At the outset, Costa Rica wishes to thank India and South Africa for their proposal, which 
enables us to resume an imp ortant discussion.  
998.  Humankind is currently facing a number of challenges without precedent in recent history. 
Tackling these challenges requires a response that is, above all, solidarity -based, joint, and 
respectful of the law. As societies, our commitment to innovation must be focused on promoting 
scientific research, technological development and the widest possible dissemination of the scientific 
advances drawn from COVID -19. 
999.  As we face this pandemic, we cannot lose sight of the fact that human health is fundamental 
and that our actions must be based on cooperation and solidarity. There can be no doubt that our 
success in these uncertain times will lie in our ability to tackl e the current situation collectively, as 
well as in the acceptance that individual actions will be decisive and impact collective actions.  
1000.   The generation of knowledge on COVID -19 has increased over the past few months. It is 
crucial that these findings are  shared as much as possible so that they benefit everyone, everywhere, 
at the same time.  
1001.   Our country remains firmly committed to the protection and enforcement of intellectual 
property rights, and will continue to promote innovation by recognizing and enfo rcing the rights of 
creators and innovators.  
1002.   Based on this belief, Costa Rica asked the WHO to establish a health technology pool for 
vaccines, medicines, diagnostic methods and any other tools useful in the fight against COVID -19. 
On 29 May, Costa Rica, t he WHO and other WHO Members  launched a "Solidarity Call for Action ". 
This initiative led to the establishment of the C -TAP platform for the open, voluntary and 
collaborative exchange of knowledge, information and intellectual property relating to existing  and 
new health technologies for combating COVID -19. Costa Rica has already shared advances made by 
its own scientists, such as the equine serum protocol, which is currently in the clinical trial phase. 
We strongly but respectfully encourage WTO Members  to voluntarily share their knowledge through 
this platform.  
1003.   Within this Organization, the proper management of intellectual property rights has, in the 
past, enabled us to promote and foster research and development, which are two key elements for 
promoting innovation in the fight against the current pandemic.  IP/C/M/96/Add.1  
 
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  15.25   Mauritius  
1004.   Would like to thank the delegation of South Africa and I ndia for introducing this proposal 
which from our perspective aims at buttressing Public Health. As my delegation indicated at the 
Gener al Council meeting a few days ago, Mauritius will support initiatives that go in the direction of 
upholding Public Healt h. 
1005.   COVID -19 has severely impacted on the National Budget as we seek to preserve Public Health 
whilst at the same time economic growth ha s come to a standstill. Our trajectory towards the 
achievement of the Sustainable Development Goals has been challenged as funds are diverted 
towards efforts aimed at fighting the pandemic.  
1006.   I am sure many countries have been through similar experiences and  in particular Small 
Island developing countries which have felt their vulnerability further exacerbated.  One aspect which 
came to the fore for us during this time was the issue of remoteness, distance from our export 
destinations and our supply chains.  
1007.   Two words will guide us in future when looking at Public Health Initiatives: Affordability and 
Accessibility.  It is from this Perspective that Mauritius supports the Initiative put fo rward by India 
and South  Africa.  It is not that we do not understand the value of Innovation or indeed the efforts 
we need to make to preserve Innovation. But in a situation of war, one needs exceptional measures.  
1008.   We fully support this initiative.  
15.26   Colombia  
1009.   Colombia wishes to thank the delegations of South Africa and India for s ubmitting the 
communication on the waiver from certain provisions of the TRIPS Agreem ent for the prevention, 
containment and treatment of COVID -19. We have always expressed our intere st in making the 
most of the TRIPS Council as a forum for coordination an d constructive discussion among 
WTO Members . 
1010.   We note that there are interesting aspects that may be useful. I should also point out that 
the document is still being reviewed by the re levant authorities in my capital, for which reason we 
will refrain from addressing the content of the proposal. Nevertheless, as we have stated previously, 
I wish to stress that this is a significant discussion, because we consider the interaction between the 
protection of intellectual property rights and public health to be of great importance.  
15.27   El Salvador  
1011.   As is the case worldwide, the COVID -19 pandemic has been a tough and unexpected blow to 
our country. The Government of El Salvador has stepped up its ef forts to support affected sectors 
of the population. Despite intensive and early efforts to prevent the virus 's entry into national 
territory, we were ultimately unable to contain its entry and spread. In addition to the loss of human 
life and the health c risis, the economy has been hard hit and the Government is therefore 
implementing an economic recovery plan.  
1012.   In light of this, we wish to stress the importance that we as a country attach to the 
comprehensive handling and management of the COVID -19 health crisis and of any tool that may 
serve such purposes. We are currently considering the proposal internally.  
1013.   During this analysis, a need for greater clarity on some aspects of the proposed decision has 
arisen. We are therefore seeking to meet bilaterally wi th the proponent delegations in the coming 
days, so that we are able to continue our internal analysis and consultation process.  
15.28   Mali 
1014.   The sudden emergence of coronavirus has brought out humans ' most basic survival instincts. 
Many Members  have taken protect ionist measures that, although temporary, may have dramatic 
consequen ces: IP/C/M/96/Add.1  
 
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  a. Export restrictions on basic foodstuffs, medical products, pharmaceuticals and medical 
equipment;  
b. The imposition of compulsory licences, which, despite the WHO 's alarming projections , 
deprives the poorest of adequate care and the means to protect themselves from the virus.  
1015.   These restrictive measures, combined with the border closures imposed across the world, 
have exacerbated the damaging effects of the pandemic in LDCs and small, vul nerable economies, 
pushing tens, if not  hundreds, of  millions of people into insecurity and extreme poverty.  
1016.   Landlocked LDCs, such as Mali, have been particularly hard hit.  
1017.   Access to affordable medicines and vaccines should be a right for all, yet it represents an 
immeasurable challenge for our low -income countries. For LDCs and even certain developing 
countries, it is vital for Article 66.2 of the TRIPS Agreement to be effectively applied and implemented 
so that we can benefit from the transfer of tec hnology needed to manufacture medicines and 
vaccines.  
1018.   In the 21st century, no country should be left unable to care for its citizens. No human being 
should be forced to make the impossible choice between feeding their family Members  or securing 
medical car e for them. Unfortunately, this is very often the case in our countries.  
1019.   The virus has shown that it can hit anywhere, regardless of level of development. It has 
shown that it cannot be stopped by border closures and does not require an entry visa to trave l. 
Help us, the most vulnerable, to fight it with the right weapons, by redressing the grievances 
expressed in this meeting.  
1020.   In conclusion, Mali fully endorses and supports the communications from India and 
South  Africa, as well as the one submitted by Cha d on behalf of the LDC Group. The waiver under 
Article  66.1 of the TRIPS Agreement should be extended for as long as LDCs exist.  
15.29   Jamaica  
1021.   Jamaica wishes to join other delegations in thanking the co -sponsors of this proposal. It is 
being studied in Capital a nd we will revert with more detailed comments at a later date. 
1022.   Jamaica has not been speared the impact of the COVID -19 pandemic. With an infection rate 
of close to 8000 and 151 deaths, Jamaica sees the discussion of TRIPS and public health as taking 
on an added level of significance.  We have long advocated for the WTO to play a critical role in 
balancing the protection of intellectual property rights on the one hand with affordable and equitable 
access to medicine and other protected health products, esp ecially for developing countries.  
1023.   We do welcome the discussion at this important juncture. We do listen to the views expressed 
and remain of the view that we can find convergence on these issues in a manner that balances the 
interests of access, affordabil ity and the encouragement of innovation.  Jamaica stands ready to 
contribute to this discussion as we seek to manage this global challenge.  
15.30   European Union  
1024.   The European Union fully shares concerns expressed by various Members  about pandemic 
caused by COVID -19 and its devastating im pact on people 's health and wellbeing as well as on 
economic prosperity.  
1025.   Safe and effective diagnostics, treatments and vaccines are crucial in the fight against 
COVID -19. In a global pandemic only broad and equitable access to vacc ines across the globe will 
ensure that the public health crisis can be tackled effectively , including in developing countries that 
have no production capacities or more limited financial resources.  
1026.   We need to find solutions for everyone, whether in the de veloped or developing countries, 
because it is a challenge we face together and because no one is safe until everyone is safe. The 
European Union stands committed to work with all Members  on this global challenge.  IP/C/M/96/Add.1  
 
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  1027.   Researchers and pharmaceutical industry, s upported by public funding, have put 
extraordinary efforts into the development of future treatments and vaccines against COVID -19. A 
well-functioning intellectual property rights system is crucial to ensure that these efforts are 
adequately incentivised a nd rewarded.  
1028.   There is no indication that IPRs issues have been a genuine barrier in relation to 
COVID -19-related medicines and technologies. While we agree that maintaining continued supply of 
such medicines and technologies is a difficult task we all face , non -efficient and underfunded 
healthcare and procurement systems, spike in demand and lack of manufacturing capacity or 
materials are much more likely to have an impact on the access to those medicines and technologies.  
1029.   A well -functioning IPRs system, i ncluding its wide range of exceptions and flexibilities, is part 
of the solution rather than an obstacle. It is our view that we should concentrate on the key current 
challenges:  
a. rapidly developing safe and effective treatment or vaccine against COVID -19;  
b. increasing manufacturing capacity;  
c. keeping global supply chains open; and  
d. ensuring broad and equitable global distribution of treatments and vaccines once they 
become available.  
1030.   We would like to present in more detail how the European Union tackles these challenges.  
1031.   The absolute priority and a major challenge at the moment is t he rapid development and 
rolling out of safe and effective treatments and vaccines against COVID -19. Vaccine development is 
a complex and lengthy process, which normally takes around ten years. The public funding and 
support is contributing significantly t o the development of the future vaccines, potentially within a 
timeframe between 12 and 18 months. However, it is the researchers and the industry with their 
know -how, previous and current investment that will be delivering these new vaccines, including th e 
running of clinical trials in parallel with investing in production capacity to be able to produce millions, 
or even billions, of doses of a successful vaccine. This work must be incentivised and adequately 
rewarded and the IPRs system is one the main ec onomic incentives.  
1032.   We note that public financing of research and development of the innovative treatments and 
vaccines can be subject to certain conditions. For example, the European Commission has published 
a Manifesto for EU COVID -19 research to encourag e recipients of EU funding to make research 
results accessible to all. Recent Horizon 2020 COVID -19 calls have also included a temporary 
obligation to license results on a non -exclusive basis and at fair and reasonable conditions.  
1033.   Once the treatment or the  vaccine is available, the manufacturing of these treatments and 
vaccines at such an unprecedented scale and within an unprecedented timeline is likely to be the 
most problematic issue to be tackled. We should collaborate and assist the pharmaceutical sect or in 
ramping up the manufacturing capacity. To tackle current and future supply side shortages, the 
European Commission signed and continues discussing further pre -purchase agreements that 
incentivise and enable the pharmaceutical sector to build and prep are large -scale production facilities 
once effective treatments and vaccines become available.  
1034.   Being aware of the importance of the global supply chains in the pharmaceutical sector, the 
EU is discussing with some WTO partners a possible WTO 'trade and hea lth' initiative with the aim 
to facilitate global access to affordable healthcare products, including for vulnerable countries 
without appropriate manufacturing capacities. The goal is to make supply chains more resilient and 
diversified and to support eff orts to build strategic reserves of critical equipment. This initiative 
would cover issues such as establishing a scheme of global cooperation in times of health crisis in 
order to remove unnecessary barriers to trade, abolishing tariffs on pharmaceutical and medical 
goods, enhanced transparency and trade facilitating measures.  
1035.   Finally, global collaboration is the only way to overcome a global pandemic. At present, 
international efforts are being made to ensure equitable distribution of affordable vaccines , in 
particular to the most vulnerable populations. To enable broad and equitable global distribution of 
treatments and vaccines, the EU has taken a leading role in the Global Coronavirus Response where IP/C/M/96/Add.1  
 
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  so far nearly EUR 16 billion have been pledged for un iversal access to tests, treatments and vaccines 
against COVID -19 for the global recovery.  
1036.   In collaboration with the WHO, the European Commission is actively supporting the Access 
to COVID -19 Tools Accelerator (ACT -A) and its vaccine pillar – the COVAX Facility. In September, 
the European Commission announced that it would fully participate in t he COVAX Facility for 
equitable access to affordable COVID -19 vaccines everywhere, for everyone who needs them. As 
part of a Team Europe effort, the Commission contributes EUR 400 million in guarantees to support 
COVAX and its objectives in the context of the Coronavirus Global Response.  
1037.   The EU considers that on the basis of the global innovation system, with the necessary IP 
tools such as patent pools and procurement arrangements as the COVAX Facility in place, existing 
and new treatments, and ultimately v accines, can be made available and effectively deployed rapidly 
across the globe.  
1038.   The TRIPS Agreement together with the principles endorsed in the Doha Declaration, is fit for 
purpose and allows for the necessary flexibilities in relation to IPRs protecti on, including in the case 
of a health emergency, such as the COVID -19 pandemic.  
1039.   If all voluntary solutions failed and IP became a barrier to treatments or vaccines against 
COVID -19, mechanisms to overcome it are already available. The EU has consistently supported the 
use, where necessary and justified, of the flexibilities provided under the TRIPS Agreement and the 
Doha Declaration with the objective of ensuring effective access to medicines.  
1040.   In particular, the TRIPS Agreement provides for the possibility , under certain conditions, of 
issuing a compulsory licence for local consumption of medicines and provides for fast -track 
procedures in health emergencies.  The TRIPS Council Secretariat has, regularly and consistently, 
offered its services to any WTO Memb er that sees itself in the need of getting help to manage the 
process of Article 31 bis. This was confirmed in the presentation we saw the previous day.  
1041.   This system is accompanied by other inbuilt TRIPS flexibilities, applying to the various IP 
rights. In a ddition, we note that the least developed countries are exempt from the application of 
the TRIPS  Agreement and, in particular, its pharmaceutical -related provisions.  
1042.   Public health in light of the pandemic is a clear and undisputed priority. No effort must be 
spared to obtain safe, effective and affordable treatments, vaccines, tests and medical devices 
necessary to fight this pandemic and to ensure that these products are equitably distributed on a 
global scale. However, all these efforts must be geared tow ards addressing genuine challenges in 
this pandemic with appropriate solutions.  
15.31   United States of America  
1043.   The United States is committed to working with international partners in identifying practical 
ways both to increase access to safe, effective, affordable and lifesaving medicines  around the world 
and to  support policies that drive the development of new medicines.  
1044.   Intellectual property encourages innovation, incentivizes research and development, and can 
facilitate manufacturing and di stribution, thus helping to expand access to m edicines around the 
world. These core features of intellectual property are necessary for the global community to find 
and develop treatments and cures for this deadly pandemic and to support economic recovery.   
1045.   IP plays a key role in facilitating access to today 's medicines and enables investments in R&D 
that lead s to tomorrow 's cures. IP promotes collaboration that is essential for the rapid development 
of new treatments and cures, particularly during crises l ike COVID -19. 
1046.   We have the shared objective of helping to ensure the swift delivery of potential COVID -19 
therapeutics and vaccines around the globe. We believe that facilitating incentives for innovation 
and competition to develop, test, and produce safe a nd effective therapeutics and vaccines for the 
COVID -19 response, including by respecting intellectual property rights, and supporting industry -led 
collaboration and voluntary knowledge sharing, will best achieve our shared objective.  IP/C/M/96/Add.1  
 
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  1047.   As we have stated in past discussions, IP is an important piece, but ultimately only one piece 
of addressing the issue of access to any potential therapy. We believe that IP has not been an 
obstacle in addressing the pandemic but rather has motivated global efforts to find tre atments and 
cures. Limits to manufacturing capacities and supply chain issues, for example, are of much greater 
concern, especially for vaccines, given the need to provide access to the entire global population. 
We also must be concerned about the pandemic  creating the opportunity for the increase of 
counterfeit COVID -19 pharmaceuticals, which are in and of themselves a threat to health and safety. 
In fact, the perspective that IP is a barrier to access to medicines is often voiced by governments 
that have significant barriers like taxes and tariffs in places that affect access.  
1048.   Where intellectual property rights exist, they can be licensed to companies around the world 
to scale up manufacturing. But if the time needed to get the required regulatory approva ls is too 
long, and other barriers make the cost of products too high, the raw materials or labour needed are 
unavailable, or the market is flooded with counterfeit goods, then safe and effective access to needed 
treatments and equipment would be affected.  
1049.   The United States does not support the waiver proposal of India and South Africa. Weakening 
IP protection and enforcement would be counterproductive to our global fight against COVID  through 
the creation of needed medical technologies and would not addres s the current, main challenges to 
access concerning manufacturing and raw material resources.  
15.32   Switzerland  
1050.   The COVID -19 Pandemic poses an enormous challenge to the global community. The urgent 
need for a new vaccine and effective medical products to combat  the nov el coronavirus is out of 
question.  
1051.   Switzerland fully acknowledges the challenges that come with the current pandemic. In these 
trying times, it is imperative for WTO Members  and all stakeholders, whether public or private, 
non-governmental, scient ists and researchers, to collaborate in close partnership to ensure rapid, 
affordable and equitable access to medical products. So how can we best ensure access at a global 
scale?  
1052.   Under the heading of COVID -19, the authors of document IP/C/W/669 propose a  sweeping 
waiver from the implementation, application and enforcement of most of the intellectual property 
protection that the TRIPS Agreement provides for.  
1053.   Switzerland shares the concern that individual Members  and the international community 
must now do everything that is necessary to ensure affordable and equitable access to 
COVID -related medical products globally.  However, Switzerland does not believe that a TRIPS waiver 
is the right way forward to achieve this goal. On the contrary, we are convinced that such a move 
would have the opposite effects from those looked for.  
1054.   The intellectual property system has been and continues to be a pivotal factor ensuring a 
pipeline of innovative pharmaceutical products, including vaccines to work. It is th e reliable legal 
framework which provides the foundation for stakeholders, for the public and private actors, to 
invest, work and innovate together.  IP rights, and in particular patents, spur stakeholders ' 
interaction, and enable them to share information,  knowledge and data, to aliment the global 
databases, license in and out technology, and to do what is necessary to eventually scale up capacity.  
1055.   Declaring a TRIPS waiver for COVID -19 would mean to put into question the foundation of a 
large part of the in vestments and efforts currently undertaken to research and develop a vaccine 
and medical products against the novel coronavirus. It would risk undermin ing the partnerships that 
bring about first results in the fight against the global pandemic.  Rather, we need to ensure that the 
unprecedented collaboration between all relevant actors, who have come together over the past few 
months to do everything possible to contain the crisis, continues without disruption.  
1056.   This being said, as soon as Research & Developme nt for a new vaccine and medicines against 
the novel coronavirus will succeed, equitable and affordable access to these innovative products 
must be ensured. To meet this challenge, all relevant factors need to be taken into account that IP/C/M/96/Add.1  
 
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  determine access.  It is important that we continue to address the challenges ahead in a holistic and 
sustainable manner, and within the rules -based multilateral trading system.  
1057.   The TRIPS Agreement, strikes the right balance, provides for the necessary means and 
remedies to a llow the use of protected content and products, should voluntary mechanisms fail. In 
such an instance, a country may make use of the flexibilities which WTO Members  confirmed in the 
Doha Declaration on TRIPS and public health.  
1058.   We should avoid sweeping meas ures resulting in a comprehensive revocation of rights for 
the time of the pandemic which would disincentivize efforts underway.  Rather, the collaborations 
and partnerships currently engaged in the search of a new vaccine and medicines against the virus 
must be deployed to work for broad and equitable  access . 
1059.   We need to continue working at the multilateral level and supporting global initiatives. 
Several mechanisms, which facilitate access to medicines and other health technologies to fight 
diseases other t han COVID -19 for the poorest countries, already exist. These are voluntary 
collaborations between the private and public sectors and international initiatives. For COVID -19, 
we should build on the ample experience that is already there.  
1060.   Among the many init iatives under way, I would like to highlight the COVID -19 Vaccine Global 
Access facility (COVAX) and the Gavi COVAX Advance Market Commitment (AMC). These and others 
take IP as an important basis for the cooperation of the participating stakeholders and th eir joint 
endeavour.  
1061.   Switzerland has released CHF 400 million in support of international action in response to 
COVID -19. Working together with partners and the relevant international organizations to find global 
solutions for access and an equitable distr ibution of COVID -19 medical products for all countries, 
Switzerland supports all three pillars of the Access to COVID -19 Tools (ACT) Accelerator. This to 
ensure global collaboration to accelerate and scale up development, production and equitable access 
to diagnostics, treatments as well as a future COVID -19 vaccine.  
1062.   Switzerland further supports international partnership organizations such as Coalition for 
Epidemic Preparedness Innovations (CEPI) or the vaccines alliance GAVI. They have a leading role 
together with the ACT Accelerator in the process, covering the four pillars of access in the response 
to the pandemic.  As part of the holistic response to the challenges we face, we also welcome the 
recent initiatives aiming at facilitating international t rade in essential goods in order to promote 
more resilient and diversified supply chains.  
1063.   To sum up, partnerships, multilateralism, a sound and reliable legal framework and IP 
protection as provided by the TRIPS Agreement are essential for the collaboratio n that we see now 
engage in the process of innovative research and development for a vaccine and effective treatments 
against the novel coronavirus. Switzerland calls on Members  to engage in and contribute to those 
international initiatives and partnership s, which in that collaborative spirit prepare and work towards 
ensuring equitable access.  
1064.   Let's hope for the best, that we will soon have such a new vaccine and safe, medical products 
at our disposal against the novel coronavirus, to fight the pandemic eff ectively together.  
15.33   Japan  
1065.   Japan recognizes the need for all Members  to have unhindered timely access to quality, safe, 
efficacious and affordable diagnostic kits, medicines, vaccines, and essential medical technologies 
for the COVID -19 response.  
1066.   In this re gard, research and development (R&D) activities for medicines and vaccines, which 
would be effective for COVID -19, have been intensively progressing thus far. Each Member needs 
to do their utmost to support research institutes and pharmaceutical companies for development of 
such medicines and vaccines and provide them incentives for such development. In addition, it is 
essential to support the initiatives which allow all Members , including developing countries, to be 
able to readily access these medicines a nd vaccines.  IP/C/M/96/Add.1  
 
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  1067.   We understand that intellectual properties play a central role in providing incentives for 
developing such medicines and vaccines, and relevant medical technologies. If the obligations of 
protection and enforcement of IP rights under the TRIPS  Agreement were waived, incentives for the 
development would be undermined. As a result, this would not only hinder the development of 
medicines and vaccines effective for COVID -19, but also diminish incentive to invest substantial time 
and money in develo ping treatments of infective disease and for the next global health crisis as well.  
1068.   Furthermore, in the midst of this COVID -19 crisis, it should be noted that many companies 
and researchers are working to ensure access to effective medical products and use ful information 
for combatting COVID -19 through voluntary efforts including licensing IPs, waiving their IP rights 
enforcement, publishing scientific data, and providing copyrighted works.  
1069.   Japan is of the view that this proposal does not indicate sufficient grounds that the existing 
framework is not working well. Furthermore, the proposal does not fully explain the necessity for 
waiving any sections of the TRIPS Agreement.  
1070.   Therefore, even though Japan recognizes the need for unhindered timely acces s to essential 
medical products, Japan is not in the position to support this proposal.  
15.34   Norway  
1071.   We would like to thank Eswatini, India, Kenya and South Africa for their proposal. Norway 
attaches great importance to tackling the global health challe nges in t he context of COVID -19, 
including providing access to the necessary medical products f or all. To develop and produce, in 
sufficient amount, all necessary products, whether protected by patents or not, international 
cooperation is crucial and there are many  strategies being employed by governments to achieve the 
best possible outcome.  
1072.   Norway believes that the availability of medicines and other medical products in the context 
of COVID -19 is a very important and multifaceted issue which needs a balanced and coherent 
approach. There is a range of factors weighing in with respect to these issues, at both the 
international, regional and national levels. All aspects should be considered together, not only the 
aspects related to intellectual property.  
1073.   The COVID -19 pandemic is one of the worst health crises that the world has ever faced. 
Everyone is affected, but yet again we see that the most vulnerable and marginalized are 
disproportionately impacted. Testing, treatment and vaccines for COVID -19 should be accessib le for 
everyone as they become available.  
1074.   To achieve this objective of equitable access, Norway is heavily engaged in the 
ACT-Accelerator – or ACT -A. Through this partnership between governments, scientists, businesses, 
civil society, and philanthropists a nd global health organizations Norway is a member of COVAX 
where we have pledged approximately USD 25 million (NOK 230 million) to the COVAX AMC to 
secure fair access to vaccines for low -income countries. Together with President Ramaphosa of 
South  Africa, our Prime Minister Solberg is co -chairing the ACT -A Facilitation Council where we are 
working to raise the necessary political awareness and finances for ACT -A. Equitable access is a top 
political priority for us and we hope to partner with all of you to m ake it a reality.  
1075.   Likewise, the COVID -19 Technology Access Pool (C -TAP) will compile, in one place, pledges 
of commitment made under the Solidarity Call to Action to voluntarily share COVID -19 health 
technology related knowledge, intellectual property and data. Norway supports voluntary 
mechanisms for sharing of patents and we would like to encourage private companies to share 
COVID -19 related knowledge and patents during the pandemic. Some companies have come forward 
with voluntary licenses or pledged not to invoke their patent rights during the pandemic.  
1076.   The TRIPS Agreement provides for minimum standards of IPRs protection, while at the same 
time providing for the possibility of compulsory licensing of patents under the conditions set out in 
the agreement,  which particularly aim at providing flexibility in situations of national emergencies 
and extreme urgency such as the COVID -19 pandemic. Thus, this is already catered for by the 
TRIPS  Agreement.  IP/C/M/96/Add.1  
 
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  1077.   A balanced and coherent approach requires that both the ince ntives for the development of 
new medicines and medical products to tackle COVID -19 provided by the availability of intellectual 
property rights protection – as well as the need for national flexibilities to make exceptions in 
extreme situations, must be t aken into account. The WTO system is in our view already reflecting 
the required balance in this respect.  
1078.   To introduce even further and very broad exceptions related specifically to COVID -19 as 
proposed, seemingly opening for providing no IPRs protection a t all for COVID -19 related products 
under the discretion of national authorities, would mean a setback for the incentives for innovation 
in the field of medicines and medical products related to COVID -19, as well as it would provide legal 
uncertainty with respect to what the relationship would be between such derogation provisions and 
the already existing provisions on compulsory licensing in TRIPS.  
1079.   Against this background, Norway believes that the already existing flexibilities of the 
TRIPS  Agreement are s ufficient, and cannot support the current proposal.  
15.35   United Kingdom  
1080.   The United Kingdom would like to thank Eswatini, Kenya, India and South Africa for 
introducing this agenda item and giving the Council an opportuni ty to discuss this very important 
issue.  
1081.   The UK has long supported affordable and equitable access to essential medicines, including 
in low and middle -income countries. In this vein, intellectual property rights provide incentives to 
create new inventions, such as life -changing vaccines, treatment s, and technologies.  
1082.   The UK believes that a robust and fair intellectual property system is a key part of the 
innovation framework that allows economies to grow, while enabling society to benefit from 
knowledge and ideas.  
1083.   In the current pandemic, we must a cknowledge the IP system is not just made up of rights, 
but it also contains built -in mechanisms to support the sharing and dissemination of innovation and 
creativity. Flexibilities such as limitations and exceptions to IP rights have already proved invalu able 
to the development of digital solutions to support diagnostics and treatment. Text and data mining 
exceptions have been used in initial research into COVID -19, including for tracking and predicting 
its spread and are being used in the search for treat ments.  
1084.   Beyond hypotheticals, we have not identified clear ways in which IP has acted as a barrier to 
accessing vaccines, treatments, or technologies in the global response to COVID -19. 
1085.   A waiver to the IP rights set out in the TRIPS Agreement is an extreme measure to address 
an unproven problem. The UK is of the view that pursuing the proposed path would be 
counterproductive and would undermine a regime that offers solutions to the issues at hand. Rather, 
we should consider how to meet the objectives of prev ention, containment and treatment of 
COVID -19 as set out in the communication.  
1086.   Multiple factors need to be considered to ensure equitable access for all to COVID -19 
vaccines. These include increasing manufacturing and distribution capacity, measures to sup port or 
incentivise technology transfer, ensuring global supply chains remain open, and ensuring that 
effective platforms are utilised to voluntarily share IP and know how.  
1087.   There are existing mechanisms that facilitate the sharing of IP through voluntary licensing of 
intellectual property. Organisations like the WHO are developing initiatives by learning lessons from 
these mechanisms. For example, expanding the mandate of an existing organisation such as the 
Medicines Patent Pool to address needs emerging from COVID -19. 
1088.   The world urgently needs access for all to safe, effective, quality, and affordable vaccines, 
diagnostics, medicines, and other health technologies to enable a n effective response to the 
COVID -19 pandemic, which is why a strong and robust multilateral IP system that can meet this 
challenge is vital.  IP/C/M/96/Add.1  
 
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  1089.   The UK has played a leading role in financing the global effort and working with our 
international and national pa rtners, to identify end -to-end solutions that ensure affordable access 
for all and ensuring no -one is left behind, including the poorest and most vulnerable.  
1090.   For example, the UK has been leading the way in delivering a multilateral solution to 
COVID -19 vac cines, therapeutics, and diagnostics such as by committing GBP 298 million to the 
COVAX Advance Market Commitment (AMC), with GBP 250 million more available as "matched 
funding " if others commit USD 1 billion by December. We urge other Members  to join the COVAX 
AMC in order to secure manufacturing capacity for 92 low and middle -income countries. This will 
support equitable access and will demonstrate that a multilateral response can rise to global 
challenges.  
1091.   We are also committed to collaborat ing with public and private partners in the UK and 
internationally, including exploring voluntary arrangements and approaches such as non -exclusive 
voluntary licensing which promote affordable access for all while also providing incentives to create 
new in ventions, to accelerate development and equitable access in all countries to affordable health 
technologies for responding to COVID -19. 
1092.   We would like to encourage active dialogue between industry and governments to explore 
how best to work together to prev ent, contain and treat COVID -19, including by using 
TRIPS -compliant licensing models in developing countries. While we welcome discussion of this issue 
and acknowledge the concerns of the co -sponsors as set out in their communication, we do not 
consider a waiver of the TRIPS Agreement to be an effective way to achieve the objectives outlined 
in the communication.  
1093.   As we said in the informal consultation on standing TRIPS Council matters, we would be 
happy to participate in a workshop or other event that can support understanding how best the IP 
system can meet the objectives of Members  in relation to COVID -19. 
15.36   Brazil  
1094.   The COVID -19 pandemic is an unprecedented human tragedy, with severe economic 
implications.  
1095.   The Brazilian Government has been working to mitigat e the health and economic impacts of 
the crisis domestically and has strengthened scientific collaboration with international partners in 
the search of possible solutions, such as a vaccine.  
1096.   It is in the interest of all Members  to guarantee adequate access  to medicines and 
therapeutics for the disease. The intellectual property system has been envisaged to strike a balance 
between access and protection, between public and private interest.  And it is our job to make sure 
that the appropriate balance is attai ned. This is not always an easy task. We have crafted a system 
that allows for some carve -outs, for limitations and exceptions, to tackle situations as the one we 
are living.  
1097.   We believe that the TRIPS Agreement provides us with tools and policy space for Members  
to take measures to protect public health.  Brazil has been an historic promoter of TRIPS flexibilities 
and of the right of WTO Members  to use, to full extent, the provisions in the TRIPS Agreement.  We 
therefore believe that solutions can be legitima tely sought within the system.  
1098.   This does not mean that the system is not amenable to improvement, as we have done in 
2003 with the inclusion of the Article 31 bis Amendment to the TRIPS Agreement.  The COVID -19 
crisis is a textbook example of the balance we should strike with the intellectual property system. 
On the one side, we want innovation systems (public and private) to be fully mobilized in the search 
for solutions to the pandemic. On the other, it is necessary that any solution produced be widely 
available.  
1099.   At this point in time, we are not convinced that a waiver to the TRIPS Agreement would 
guarantee us meaningful improvement of access, while it might give the wrong signs to innovators 
and potentially hinder efforts to produce the solutions we need.  IP/C/M/96/Add.1  
 
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  1100.   We should use this opportunity to exchange among ourselves any concrete difficulties faced 
in implementing TRIPS flexibilities for the purpose of prevention, containment and treatment of 
COVID -19, further enhancing our understanding of how limitations and exceptions could serve those 
purposes.  We must also be honest in recognizing that not all difficulties encountered are attributable 
to the agreement itself. They may relate to limitations in national legislation or pertain to a larger 
range of issues that fall outside the scope of the agreement and may impact access to COVID -related 
therapeutics and technologies.  
1101.   Brazil remains open, as usual, to discussing any proposals that aim at improving the 
intellectual property system and its balance of interests in line with the legitimate aspirations of 
Members . 
15.37   Mozambique  
1102.   The delegation of Mozambique would like to welcome and commend the delegations of 
South  Africa and India as well as the co -sponsors for the proposal put forward (documen t 
IP/C/W/669), in view for a waiver from certain provisions of the TRIPS Agreement, for prevention, 
containment, and treatment of COVID -19. 
1103.   COVID -19 is an unprecedented pandemic disease, facing the global community for long, and, 
it continues to challenge the world. It is a fact that it has been disproportionately affecting the 
countries and, due to diversity on the country 's economic and development levels, the responses 
vary from one to another, being more critical in developing and least developed countries due to 
limited capac ity to cope with the pandemic.  
1104.   The calls for solidarity, cooperation and collaborative efforts have been continuously put 
forward in view to help countries to contain, reduce and even eliminate the transmission of COVID -19 
including its elimination as suc h. A lot has been done in view to respond to the above appeals but, 
as it can be seen, given the nature of the COVID -19 pandemic disease; it seems factual that the 
global community is still very far from reaching a stage in which no more lives could be los t as well 
as infections not occurring.  
1105.   This facts show clearly that all that has been done so far is still insufficient to solve the 
problem, and, thus, meaning that a massive involvement is required so as to produce the necessary 
testing materials, vaccin es, medicines, medical equipment and all needed tools and other elements.  
1106.   For our delegation, the proposal in debate is of utmost importance and very timely due to 
the current situation and, it would bring flexibility that would extensively help to update the current 
status of availability and access to the needed medical and technological goods.  
1107.   According to the proposal, the request is objectively addressed, as it foresees a limited 
duration, thus, envisaging to be lasting solely while COVID -19 Pandemic d isease continue to face 
the humanity. Till now, there is no certainty as to when will the vaccines and or certain medical 
drugs be encountered and or approved to be efficient to eradicate COVID -19. Along with the above 
reality, even if vaccines and or othe r medicines are approved, there is no certainty if they are going 
to be accessible, rapidly available and even affordable to all.  
1108.   We totally support the proposal. If accepted and operationalized, it can enable countries to 
substantially contribute to respo nd to internal needs, and help to address the needs that are so far 
not sufficiently responding to the huge, not only current but near future challenging demands.  We 
associate ourselves to the statement made by the Africa Group and others who positively ap preciates 
the proposal.  
1109.   To conclude, our delegation expresses support to the above -mentioned proposal.  
15.38   Canada  
1110.   Canada 's longstanding view is that IP rights can serve as an important incentive to 
innovation, while ensuring that there is an appropriate balan ce between protecting IP rights and 
promoting access to medicines and other health care technologies. Canada remains supportive of IP/C/M/96/Add.1  
 
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  the existing multilateral legal framework under the TRIPS Agreement, which already establishes an 
important balance among the se areas.  
1111.   We note that TRIPS contains important flexibilities for various categories of IP rights under 
the Agreement, and that the Doha Declaration on the TRIPS Agreement and Public Health affirms 
the rights of WTO Members  to make use of flexibilities for  the purpose of protecting public health 
and promoting access to medicines.  
1112.   Canada also reminds that IP rights are only one part of a broad discussion informing the 
availability and accessibility of medicines; indeed, as the Doha Declaration emphasizes, the 
TRIPS  Agreement is part of the wider national and international action to address public health 
problems.  
1113.   With respect to the COVID -19 pandemic, and as a complement to our own procurement 
efforts, Canada has made significant investments to ensure that COVID -19 vaccines, therapeutics, 
and diagnostics are affordable and equitably distributed globally. For instance, Canada is highly 
supportive of the Access to COVID -19 Tools (ACT) Accelerator, which provides a critical platform for 
global coope ration towards the development, production, and distribution of safe and effective 
COVID -19 medical interventions. On 27 June 2020, the Government of Canada committed 
CAD 120 million (or roughly USD 91 million) in support of the activities of the ACT Accel erator. On 
25 September 2020, Canada announced a CAD 440 million (or approximately USD 335 million) 
contribution to the COVAX Facility and Advance Market Commitment (or COVAX AMC), to facilitate 
rapid, fair and equitable access to COVID -19 vaccines for all  countries, regardless of income level. 
As part of this commitment, Canada has allocated CAD 220 million (or approximately 
USD 167 million) to the COVAX AMC to purchase vaccine doses for low - and middle -income 
countries.  
1114.   Canada remains fully available to d iscuss the specific challenges faced by Members  in 
procuring COVID -19 treatments and other related technologies, so that Members  may identify what 
WTO and other avenues would provide the best ways forward, as appropriate and in coordination 
with other effo rts at the WTO, WHO, and other institutions. Canada also remains fully available to 
discuss the specific challenges of Members  in using the Special Compulsory Licensing System  under 
the TRIPS  Agreement, and to discuss Canada 's own experience with this syst em. 
1115.   We are also open to hearing more from proponents of the document IP/C/W/669 proposal on 
the specific problems and gaps that this proposal would seek to address as well as the views of other 
Members . 
15.39   Australia  
1116.   Australia thanks India and South Africa for their communication.  
1117.   Australia recognizes the communication 's concern that COVID -19 represents an 
unprecedented d isruption to the global economy and world trade, and that the world requires rapid 
access to affor dable medical products, including vaccines and medicines.  
1118.   As Prime Minister Morrison made clear at the UN General Assembly the previous month, there 
is a global and moral responsibility on all countries to share a COVID -19 vaccine far and wide . Prime 
Minister Morrison made clear that if Australia finds a vaccine, we will share it, and the Prime Minister 
urged all countries to make that pledge.  
1119.   To this end, Australia has committed USD 80 million to the Gavi COVAX Facility Advance 
market Commitment, which w ill improve access for 92 developing countries to safe, effective and 
affordable COVID -19 vaccines , and we 've committed a further USD 23.2 million for a COVID -19 
Vaccine Access and Health Security Programme  for the Pacific and Southeast Asia; and we have a lso 
invested USD 20 million the development of COVID -19 vaccines in Australia for the greater global 
good and a USD 7.5 million contribution to the Coalition for Epidemic Preparedness Innovations 
which is supporting nine of the leading COVID -19 candidates globally.  
1120.   Australia sees well -functioning and well -understood international trade and IP rules, including 
their flexibilities, as a necessary tool in delivering universal access to COVID -19 medical products IP/C/M/96/Add.1  
 
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  and technologies, such as vaccines after all, the  COVAX Facility is underpinned by international IP 
rules.   
1121.   To this end, Australia cannot support the waiver of Sections 1, 4, 5 and 7 of Part II of the 
TRIPS Agreement  at a time when we must come together to address the complex and broad -ranging 
challenges  posed by COVID -19, this waiver could upend global supply chains, spread uncertainty 
and undermine international rules.  
1122.   Intellectual property plays a key role in incentivising the often costly and timely 
development  of important health products referred t o in the communication . The waiver may 
jeopardise the private investment that has been instrumental in driving a number of vaccines 
towards the final stages of phase III testing.  
1123.   Australia also recognizes that beyond IP rules, other trade -related measures  have an 
important role in helping Members  respond to COVID -19. To this end, we underscore the importance 
of domestic regulations that support the free flow of technology and vital health products, and the 
need to resist disproportionate export restriction s.  
1124.   But Australia acknowledges that international rules must support quick, fair, predictable and 
implementable access arrangements to vital health products, including vaccines  consistent with the 
concerns raised in the communication, we recognize the need  for all Members  to fully understand 
their rights and obligations under the TRIPS Agreement and its flexibilities . To this end, we would 
support the provision of further information to Members  regarding the application of the 
TRIPS  Agreement and its flexibilities.  
1125.   It is Australia 's view that a harmonious, well -functioning and clearly understood international 
IP framework, underpinned by the rules and flexibilities set out in the TRIPS Agreement, is crucial 
in ensuring Members  can ad dress the challenges posed by COVID -19 fairly and in a timely manner.   
15.40   Honduras  
1126.   We welcome the proposal submitted by India and South Africa.  Our country considers that 
such a proposal may  be a good initiative for seeking solutions in light of the current w orldwide 
situation due to COVID -19. 
15.41   Holy See  
1127.   Since this is the first time my delegation is taking the flo or during the current session of the 
TRIPS Council, allow me to begin by congratulating you on your assumption of the Chairmanship 
and by assuring you of the full engagement of the Holy See.  
1128.   Pope Francis has recently reminded us that "a worldwide tragedy like the COVID -19 pandemic 
momentarily revived the sense that we are a global community, all in the same boat, where one 
person 's problems are the probl ems of all. Once more we realized that no one is saved alone; we 
can only be saved together ". As has emerged over the last months, and has been consistently 
recalled by this delegation, "access to affordable medicines no longer represents a challenge just for 
the least developed and other developing countries; it has also become an increasingly urgent issue 
for developed countries ". In the context of the current global emergency, it is important for the 
international community as a whole, and for WTO Member s in particular, to work together to ensure 
that intellectual property rights, such as patents, industrial designs, copyrights and the protection 
of undisclosed information, do not create "barriers to the timely access to affordable medical 
products includ ing vaccines and medicines or to scaling -up of research, development, manufacturing 
and supply of medical products essential to combat COVID -19". 
1129.   A well -designed intellectual property system must balance the private rights of inventors with 
the public need s of society. International intellectual property regulations reflect the premise, as 
stated in the Objectives of the TRIPS Agreement, 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, to the mutual advantage of producers and users of 
technological knowledge and in a manner conducive to social and economic welfare, and to a balance 
of rights and obligations ". These rights n eed to be adequately recognized, insofar as they IP/C/M/96/Add.1  
 
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  compensate investments in time and capital and encourage promising research. Furthermore, such 
rights promote the common good by accelerating the search for solutions that benefit all needy 
persons in the mo dern world. For example, in the pursuit of new medical treatments, special 
protections are needed to ensure that producers are able to recover their massive expenditures on 
research. These protections include the assurance of just wages for scientists and researchers, as 
well as measures to guarantee compliance with regulations regarding product safety. In this regard, 
the protection of intellectual property rights enables the search for solutions to global problems.  
1130.   Nonetheless, it is important to note tha t intellectual property rights are not an end in 
themselves but rather a means to an end. In order to maintain their validity, they must be 
subordinated, therefore, to the requirements of the common good. This requires the implementation 
of control mechani sms to monitor and, when necessary, to correct the logic of the market. As 
St. John Paul II affirmed, the "law of profit alone cannot be applied to that which is essential for the 
fight against hunger, disease, and poverty ". These words continue to ring tr ue. 
1131.   Policies and laws should maintain a perspective focused on the respect and the promotion of 
human dignity, in a spirit of solidarity within and among nations. This means that, while recognizing 
the importance of protecting intellectual property rights,  we should focus on the purpose of such 
rights and strive to avoid the potential negative consequences of the current system, which can arise 
when the aforementioned rights are divorced from their inherent foundation in the pursuit of the 
common good and t he dignity of the human person. When, for example, high -income countries 
excessively protect knowledge based on a rigid assertion of intellectual property rights, this leads to 
an imbalance that must be addressed. Let us not forget that health care should not be subordinate 
to private interests; thus, access to medicines should be guaranteed in accord with the principle of 
non-discrimination and in a spirit of equity, transparency, participation and accountability.  
1132.   As Pope Francis has stated, "what is neede d is sincere and open dialogue, with responsible 
cooperation on the part of all: political authorities, the scientific community, the business world and 
civil society ". In order to promote constructive dialogue that might results in positive action, the 
principles of solidarity, subsidiarity, and concern for the common good must be applied. Solidarity 
would encourage us to be attentive to the needs and concerns of others as much as our own and 
subsidiarity would have us supply the technical expertise and ma nufacturing capacity to those 
communities that otherwise would not have access to them.  
1133.   In the midst of this global health crisis, we are all called to bring generously the best of our 
abilities to tackle the challenges of the current pandemic in all of it s aspects and in every part of the 
world and to look to the future with creativity and hope. In this way, we will succeed in giving witness 
to the concrete solidarity that is indispensable to address the global challenges of our times. Almost 
20 years ago,  WTO Members  agreed to remove an important obstacle to affordable drug imports: 
they waived certain restrictions in the TRIPS Agreement regarding the import and export of generic 
medicines under compulsory license, so as to ensure ready and affordable acce ss to these 
medications.  
1134.   In a similar fashion, given these exceptional circumstances, the TRIPS Council could 
recommend to the General Council, as early as possible, to grant a waiver from the implementation, 
application and enforcement of Sections 1, 4, 5 , and 7 of Part II of the TRIPS Agreement in relation 
to prevention, containment or treatment of COVID -19. 
1135.   Policies and laws should maintain a perspective focused on the respect and promotion of 
human dignity, in a spirit of solidarity within and among nat ions. This implies, inter alia , that, while 
recognizing the value of protecting intellectual property rights, we should focus on the purpose of 
such rights and on the limitations and potential negative consequences of the current system. "It 
would be sad if, for the vaccine for COVID -19, priority were to be given to the richest. It would be 
sad if this vaccine were to become the property of this nation or another, rather than universal and 
for all ". 
15.42   World Health Organization  
1136.   The World Health Organization (WHO) welcomes the India and South Africa proposal that 
helps to highlight the concerns in relation to sharing knowled ge, intellectual property and data to 
promote R&D and affordable access to treatments, diagnostics and vacci nes for COVID-19. The IP/C/M/96/Add.1  
 
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  content of the proposal has been at the forefront of the public discussion since it has been presented 
and r eceived support from several stakeholders and UN Agencies, including UNITAID , UNAIDS the 
Joint UN Programme  on HIV/AIDS.  WHO is hopeful that the TRIPS Council will expeditiously advance 
discussions toward consensus on matters that will facilitate bringing the pandemic to an end.  
1137.   WHO is convinced that collective action and a joint response to COVID -19 is vital for ending 
the pandemic and t o avoid further damage to life, health and the global economy. All effective 
mechanisms to support this cause should be explored and utilized in order to contribute to the 
solution.  
1138.   As mentioned in our previous statements the WHO COVID -19 Technology Access  Pool (C -TAP) 
is one alternative, a voluntary mechanism to facilitate sharing of patents and all other forms of 
intellectual property such as know -how, data, trade secrets, and copyrights, as well as to assist in 
technology transfer necessary to expand the  development and production of existing and new 
technologies needed in the response to the pandemic.  
1139.   Voluntary mechanisms like C -TAP go in parallel with other measures available in the 
TRIPS  Agreement and highlighted by the Doha Declaration to promote pub lic health. The success of 
C-TAP in helping countries respond to the pandemic, will depend on collective political support it will 
receive from Members , so far, 40 countries have endorsed the initiative. Governments and funders 
that are investing resources  on the development of new treatments, diagnostics, and vaccines should 
support encouraging private sector to share the know -how, IP and data through WHO C -TAP to 
facilitate scale -up tools for prevention, detection and treatment of COVID -19.  
1140.   WHO-WIPO -WTO recent Study states that "…each country can tailor its domestic IP system 
to its particular needs and circumstances, including through TRIPS flexibilities. " WHO, in 
collaboration with other international organizations and in line with the Global Strategy o n Public 
Health, Innovation and Intellectual Property (GSPA -PHI), provides, upon request of Members , 
technical support to countries that intend to make use of the provisions contained in the 
TRIPS  Agreement, including the flexibilities recognized by the Do ha Declaration.  
1141.   WHO is closely following the discussions of the TRIPS Council regarding Members  concerns 
to respond to the pandemic and how to enable the use of a broad range of national and multilateral 
strategies to promote global equitable access to COVID-19 health technologies. An unprecedented 
crisis needs an unprecedented response.  
15.43   Joint United Nations Programme  on HIV/AIDS  
1142.   The Joint United Nations Programme  on HIV/AIDS (UNAIDS) takes the floor to support the 
proposal made by the Governments of South Africa and India for a temporary waiver of certain 
TRIPS obligations to facilitate an appropriate response to COVID -19, as it reflects the urgency and 
global hea lth emergency that COVID -19 represents. Its implementation will enable countries to work 
together to establish national and multilateral strategies to promote innovation of, and access to, 
medicines, diagnostics, vaccines, and other health technologies, by  reducing transaction costs and 
eliminating key barriers across the R&D cycle and the supply chain for access to health technologies 
to prevent, diagnose, and treat COVID -19 disease.  
1143.   Global solidarity and shared responsibility have been recognized as funda mental principles 
that guide the UN system response. There is a growing consensus that universal access to health 
care, including COVID -19 health technologies, must be a global public good.  
1144.   In the response to the colliding pandemics of COVID -19 and HIV, U NAIDS has adopted a 
multi-sectoral and people -centred approach, to protect the gains for people living with and affected 
by HIV and drive progress towards the Sustainable Development Goals. The AIDS community knows 
that to tackle public health threats, foc using on inequality is essential – including inequalities in 
access to solutions, whether vaccines, diagnostics or therapeutics.  
1145.   The international community cannot repeat the painful lessons from the early years of the 
AIDS epidemic, when people in wealth ier countries got back to health, while millions of people in 
developing countries were left behind. In the current context, business as usual is the recipe to fail 
in delivering equitable access to COVID -19 treatments for all those in need. Access to heal th is the IP/C/M/96/Add.1  
 
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  human right of everyone, no matter the colour of their skin, the money in their pocket, or the country 
they live in. A range of solutions will be needed in order to ensure equal access and to unlock supply.  
1146.   UNAIDS calls for support for the multi lateral solutions that are on the table and for 
collaboration through fostering transfer of technology and mass -production of COVID -19 tools, using 
a public health lens. This is the basis of the current proposal before this Council.  
15.44   South Africa  
1147.   It has bee n exactly three hours since the last time I took the floor, good evening colleagues. 
It has been a marathon session with many  interventions and discussion.  
1148.   The co -sponsors would like to thank all Members  and observers that had intervened. We have 
heard man y concerns raised by Members  that intervened. Given the time constraints, the 
co-sponsors would like to respond to some of the general elements that have emerged out of the 
discussion. There are more direct questions posed by delegation that could be answe red at a later 
stage and we will reach out to delegations concerned.  
1149.   We want to stress that the protection and enforcement of intellectual property are not 
absolute, Article 8 of the TRIPS Agreement recognizes that countries may adopt necessary measures 
to protect public health. COVID -19 constitutes an unimaginable global pandemic which requires swift 
and bold action. COVID -19 is far from over and there is no certainty as to when effective vaccines 
will be available in sufficient quantities to ensure equit able access. COVID -19 is here to stay, as the 
EU pointed out in their intervention, vaccines take up to ten year to develop.  
1150.   We explained the rationale for our proposal and believe that our proposal demonstrates the 
existence of exceptional circumstance th at justifies our request for a waiver decision, clear terms 
and conditions governing the application of the waiver.  
1151.   The waiver does not imply any change of the substantive treaty obligations; it only 
temporarily suspends their operation of certain provisi ons for a period to be agreed by Members  and 
thus will be time -bound. It has a clearly defined scope related to the implementation, application 
and enforcement of Sections 1 (Copyright), 4 (Industrial Designs), 5 (Patents), and 7 (Protection of 
Undisclosed  Information) of Part II of the TRIPS Agreement which are aspects critical to the 
diagnosis, prevention, containment and treatment of COVID -19. 
1152.   We further clarified that the date on which the waiver will continue to apply until widespread 
vaccination is in  place globally, and the majority of the world 's population has developed immunity 
hence we propose an initial duration of [X] years from the date of the adoption of the waiver. This 
period can be negotiated.  
1153.   We heard the refrain from the EU and others tha t the TRIPS Agreement is fit for purpose and 
its flexibilities are usable without limitation or any problem? We once again contest this this notion.  
Delegations that have taken the floor to condemn this waiver proposal claim that that TRIP S 
flexibilities already include the option to issue compulsory licences  where necessary.  
1154.   The proposal for a waiver on certain IP provisions offers an expedited, open and automatic 
global solution that allows for uninterrupted collaboration in development an d scale up of production 
and supply and that collectively addresses the global challenge facing all countries. Countries should 
continue to use TRIPS flexibilities to safeguard public health, including issuing compulsory licences  
and placing limitations on  or making exceptions to exclusive rights.  
1155.   However, the "case by case " or "product by product " approach required when using 
flexibilities to address IP barriers at the national level could be limiting during the pandemic. Some 
countries also face limitati ons with respect to their national laws, pressures from their trading 
partners, or lack the practical and institutional capacity required to exercise TRIPS flexibilities during 
the pandemic quickly and effectively. The existing mechanisms for compulsory li cences  under 
Article31 and Article 31 bis of the TRIPS Agreement contain territorial and procedural restrictions 
that make the practice of issuing product -by-product compulsory licences  a complex process, making 
it difficult for countries to collaborate. Ar ticle 31 requires that compulsory licences  are issued on a IP/C/M/96/Add.1  
 
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  case-by-case basis and used predominantly to supply domestic markets, thereby limiting the ability 
of manufacturing countries to export to countries in need.  
1156.   Article 31 bis requires that any produc t produced and exported under a compulsory license 
be identified with specific packaging and quantities, which can lead to unnecessary delays in the 
context of COVID -19 where countries need urgent access to medical tools. There is even less 
experience in a reas such as industrial designs, trade secrets, algorithms and copyright, applying 
compulsory licences  to such areas may be legally complicated and novel.  
1157.   Political pressure from two delegations that oppose the waiver proposal have taken action to 
ensure that countries do not use compulsory licences , for example:  
a. EU IP enforcement report 2020, issued right before the COVID -19 pandemic, put a number 
of developing countries, including India, Indonesia, Turkey, Ecuador, under the spotlight 
of criticism for th eir laws allowing the use of compulsory license if patent holding 
companies do not fulfil the obligation of supporting production of medicines locally;  
b. USTR 2020 Special 301 report, issued right in the middle of the COVID -19 pandemic, 
continue to condemn c ountries who improve their laws on compulsory license or make use 
of compulsory  license – countries specifically pressured for their law or their use of 
compulsory license include Chile, Indonesia, Colombia, Egypt, India, Malaysia, 
Russia n Federation , Turk ey, Ukraine, El Salvador.  
1158.   Voluntary Licenses are somehow touted as the solution for COVID -19. 
1159.   IP rights can be exercised by their owners to decide on whether to grant a license or withhold 
from licensing the technology, designs and knowhow required for manufacturing or for further 
developing the products required for COVID -19. By enforcing exclusiv e rights backed by IP, such as 
patents, pharmaceutical companies slow down research and innovation. The use of restrictive 
voluntary license terms limits the catching up and innovation made by generic competitors.  
1160.   Nine months into the pandemic voluntary ap proaches have proven to be insufficient. For 
instance, despite receiving significant public funding of at least USD 70.5 million, Gilead has signed 
secretive bilateral licenses for Remdesivir (a therapeutic for COVID -19 treatment) with a few generic 
compan ies of it choosing that excludes nearly half of the world 's population from its licensed 
territories. Much of Gilead 's supply has also been reserved for very rich nations. As a result, to date, 
most developing countries have barely received any supply of R emdesivir. The prices of Remdesivir 
are also prohibitively high.  
1161.   On the other hand, to date not a single company has committed to the voluntary COVID -19 
Technology Access Pool of WHO. In cases where companies have made such commitments to issue 
voluntary licenses, the lack of transparency of license agreements for products to treat COVID -19 is 
substantial. These initiatives are ad hoc  and are not a sustainable way of addressing IP barri ers. 
1162.   While such companies can limit the production, quantity and export of products produced 
under license to certain geographical areas thereby excluding large parts of the world population. 
Non-profit undertakings are time bound, while such companies wil l decide when they think the 
pandemic is over. If we are serious to address access issues, production cannot be concentrated in 
the hands of only a few manufacturers, in order to scale up production, governments have a critical 
role to play.  
1163.   Various Membe rs have asserted that the waiver proposal will impede innovation and that it 
is improper and ill -conceived on the side of the co -sponsor to bring a waiver proposal at this critical 
time. 
1164.   Never has there been a weaker case for the granting of monopolies.  Governments have been 
funding the development of COVID  drugs and vaccines, and no company is able to meet the global 
demand. In the context of COVID -19, despite the billions of taxpayer dollars invested in R&D, and 
announcements that COVID -19 vaccines should  be considered a public good, no government has 
openly stated committed to this undertaking.  IP/C/M/96/Add.1  
 
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  1165.   Monopoly -based and market -driven R&D in biomedical sector ignores unmet health needs - 
no new medicine was developed for more than 40 years on TB; no effective R& D in addressing 
antimicrobial resistance (AMR) despite of the constant increasing of number of IP – patents granted 
in pharmaceutical sector globally for zero value add.  
1166.   The R&D of drugs is often a joint multi -stakeholder effort, benefitting from signific ant 
amounts of public taxpayer money. For COVID -19, the search for an effective treatment or vaccine 
is a global effort involving by multiple actors – it is not the result of the pharmaceutical industry 's 
efforts alone. Governments and public funding agenc ies around the world have poured billions of US 
dollars of public money to support COVID -19 R&D, especially for drugs and vaccines. However, by 
and large no conditions for access or affordability have been included as a precondition to any of 
that funding.  Governments must attach strings to any public money given for COVID -19 medical 
tools to guarantee that, if they prove safe and effective, they are available to everyone. Some 
Members  have admitted that some conditions had been set on companies, but none o f it goes far 
enough to ensure that IP rights assigned to companies benefiting from taxpayer money do not abuse 
such rights down the line.  
1167.   It was professed by Members  that voluntary cooperative approaches will solve the COVID -19 
crisis through generous ple dges to multi -stakeholder collaborative platforms. We thank the EU and 
other delegations for their generous support for these initiatives, including the donation of vaccines 
and access to COVAX -facility to cooperate in the purchase of future vaccines for t he benefit of 
vulnerable countries.  
a. The co -sponsors agree that global cooperation and collaboration is key to addressing the 
COVID -19 pandemic, initiatives such as the COVAX facility are helpful but insufficient. Our 
waiver proposal is designed to work sy nergistically with such initiatives by enabling the 
rapid scaling of production by multiple producers across many countries, enabling the 
sharing of knowledge and transfer of technology with the aim of addressing the pandemic;  
b. COVAX at best provides very s hort-term, limited access to vaccines. Its approach is not 
sustainable in the medium and long term. The global needs are massive and can only be 
addressed with global sharing of technology, knowledge and related IP. Not by artificially 
limiting competition  and supply which in turn only results in high prices in the medium and 
long term; and  
c. Notably wealthy nations representing just 13% of the world 's population have already 
cornered more than half (51%) of the promised doses of leading COVID -19 vaccine 
candidates9. This creates significant uncertainty for universal access.  
i. The EU together with some other wealthier nations  and regions, have already 
pre-booked more than 51% of the global supply capacity of the potential future 
COVID -19 vaccines – leaving limited share for developing countries and least 
developed countries to share. It is this conduct that has created huge uncertainty to 
the guarantee of u niversal access to COVID -19 medical tools and products.  
d. Global equitable allocation and donation are separate issues from the waiver proposal that 
we put on the table.  
e. While some initiatives such as COVAX is aiming to address the initial shortage of supply  of 
medical tools for COVID -19 treatment and prevention, its effects can be limited due largely 
to the following factors:  
i. The model and the conducts reinforce the deep inequality in the global health 
architecture and do not provide a sustainable solution;   
 
9 https://www.oxfam.org/en/press -releases/small -group -rich-nations -have-bought -more-half-future -
supply -leading -covid-19. IP/C/M/96/Add.1  
 
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  ii. Both the investment to COVAX and donation commitment cannot solve the issue of 
the need to diversify, to the maximum level the global capacity of development, 
manufacturing and supplying COVID -19 medical tools; and  
iii. COVID -19 reveals the deep structural in equality in access to medicines globally, and 
one of the root causes is that IP sustains dominating industry 's interests at the cost of 
lives. 
1168.   We heard some Members  saying that intellectual property is not a hindrance but a help to 
end COVID -19; Suspending  key protections of the TRIPS Agreement would send the wrong message 
to industry investors.  
a. Huge public funding has been poured into R&D for COVID -19 – more than USD 70 billion 
mostly from governments including many developing countries governments; it is 
taxpayers in different countries who have invested the COVID -19 R&D;  
b. People around the world who are taking huge risk of joining in and supporting the 
unprecedented R&D process and clinical trials;  
c. The incentive for people to take substantial risks in supp orting and joining clinical trials 
has nothing to do with IP, but the conscience and common sense of contributing to the 
finding of a cure for all; and  
d. Industry has asked governments to take over their liability and request for indemnity so 
that industry d oes not have to bear the risk but can make all the profit without much value 
add. 
1169.   We also heard that intellectual property has enabled collaboration between 
bio-pharmaceutical innovators and governments, universities and other research partners to speed 
up progress on our most pressing unmet medical needs, however the co -sponsors strongly contest 
this notion.   
a. It is the pandemic – not IP – that has mobilized collaboration of multiple stakeholders;  
b. It is knowledge and skills held by scientists, resea rchers, public health experts and 
universities that have enabled the cross -country collaborations – not IP; and  
c. It is public funding, again, facilitated these collaborations – not IP.  
1170.   I will leave it here in the interest of time and as we indicated at the start of this intervention 
the co -sponsors will reach out to other delegations to address more specific issues and questions 
that may have been raised.  
1171.   It is clear that Member have different opinions regarding the waiver proposal introduced at 
the TRIPS Co uncil meeting, there is a need to discuss this proposal further. According to 
Article  IX.3(b) a request for a waiver shall be submitted to the relevant Council for consideration 
during a period which shall not exceed 90 days. We request that this  agenda  item remain open for 
discussion for the intervening period. This can be done on the basis suspending this agenda item 
and reconvening the TRIPS  Council formally or informally or through consultations that may be 
convened by you or a combination of both modal ities.  
15.45   WTO Secretariat  
1172.   As regards the procedure for waivers, as the delegation of South Africa just mentioned,  
Article  IX.3 of the Marrakesh Agreement provides that in exceptional circumsta nces the Ministerial 
Conference may decide to waive an obligation imposed on a Member by the Marrakesh Agreement 
or any of the multilateral trade agreements.  
1173.   Article IX.3(b) of the Marrakesh Agreement then provides that requests for waivers 
concerning the multilateral trade agreements in Annexes 1.A, 1.B or 1.C – i.e. the TRIPS Agreement 
– shall be submitted initially to the relevant Council, in this case the TRIPS Council, for consideration IP/C/M/96/Add.1  
 
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  during a time period which shall not exceed 90 days. At the end of the time period the relevant 
Council shall submit a report to th e Ministerial Conference.  
1174.   The practice – most of the practice of waivers comes from the Goods Council – has been that 
after the expiry of 90 days the Chair of the relevant Council takes the floor in the General Council 
under the waiver  agenda  item to repo rt that the 90 -day period has expired. In some cases, there is 
a recommendation to the General Council, for instance to adopt the waiver. In cases where there is 
no such recommendation, the Chair of the CTG has often informed the General Council that the 
Council for Trade in Goods will continue its consideration.  
15.46   United States of America  
1175.   The decision -making process for the TRIPS Council is b y consensus and we request that this 
agenda item be suspended for further consultations.  
Resumption of the Council for TRIPS on 10 December 2020  
15.47   Malaysia  
1176.   At the outset, Malaysia would like to thank South Africa and India  for the proposal "Waiver  
from certain provision under the TRIPS Agreement concerning the need for prevention, containment 
and treatment of COV ID-19". Malaysia notes that the objective of the waiver proposal is aimed to 
ease international and intellectual property agreements on COVID -19 vaccines, treatments and tests 
in order to make it available, affordable and in a timely manner.  
1177.   Similar to ot her Members, Malaysia has also experienced the impact of COVID -19 with over 
76,000 cases and 400 deaths. We recogni ze the importance of enhancing cooperation among 
Members at the multilateral level to identify best practices to protect public health and pr omote 
access to medicines for all.  
1178.   With regards to IP measures in the context of COVID -19, Malaysia acknowledges that IP 
protection is essential to the development of new medicines and vaccines. We view that there is 
flexibility accorded by the TRIPS Agre ement. Malaysia continues to promote the right balance 
between public interest and IP protection.  
1179.   At this stage, taking into account the broad nature of the proposal, Malaysia may require 
more time to conduct stakeholder consultation and will seek further  clarification from the proponents 
in the near future, in particular if the existing TRIPS flexibilities are insufficient to address the 
COVID -19 pandemic and the need to provide a clear definition of the threshold for global immunity.  
15.48   Canada  
1180.   Canada is pl eased that Members were able to reach consensus on the status report, and 
indee d as to the next steps in this important discussion.  
1181.   Canada is confident that Members will be able to resolve any concrete obstacles identified by 
Members in an evidence -based and consensual manner.  
1182.   Contrary to some reports, Canada has not rejected this proposal. Indeed, at the October 
meeting of the TRIPS Council, Canada had indicated its interest in hearing about the specific, 
concrete IP challenges of Members in procuring COV ID-19 treatments and other related 
technologies.  
1183.   As Canada has expressed at the October meeting of the TRIPS Council, Canada 's longstanding 
view is that IP rights can serve as an important incentive to innovation, while ensuring that there is 
an appropria te balance between protecting IP rights and promoting access to medicines and other 
health care technologies. Canada remains of the view that the multilateral framework under the 
TRIPS Agreement establishes an important balance in this regard.  
1184.   In particula r, the TRIPS Agreement contains a number of important flexibilities that are 
affirmed under the Doha Declaration on the TRIPS Agreement and Public Health. Canada also notes IP/C/M/96/Add.1  
 
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  that IP rights are only one part of a broad discussion informing the availability a nd accessibility of 
medicines; indeed, as the Doha Declaration emphasizes, the TRIPS Agreement is part of the wider 
national and international legal and regulatory framework to address public health problems.  
1185.   Canada also has a systemic interest in upholding the international rules -based trading system 
with the WTO at its core. Canada is fully available and interested in hearing about concrete 
challenges faced by Members in addressing the pandemic, while noting our very strong preference 
for approach es to any trade issues that work within and leverage the international trading system 
to its full extent.  
1186.   While Canada did hear from a few Members on concrete IP challenges in procuring COVID -19 
treatments and other related technologies, and Canada appreci ates their engagement, no 
regime -level weaknesses, obstacles or inefficiencies that would necessitate a waiver have yet been 
identified. Canada believes that the concerns raised can be addressed through the TRIPS Agreement 
itself and the flexibilities it c ontains, chiefly the mechanisms outlined in Articles 31 and 31 bis. 
1187.   Since October, Canada has heard mostly about concerns in relation to the domestic 
implementation of Article 31, or in relation to Article 31 bis. Canada does not see these concerns as 
sugges tive of issues with the TRIPS regime such that would necessitate a waiver. Canada remains 
the only Member to have used the special compulsory licensing system under Article 31 bis, and can 
thus observe, on the basis of concrete experience, that the system w orked as intended. Canada has 
heard that the Article 31 bis system having been used only once suggests that the system is 
inadequate. Rather, Canada believes that this suggests that the overall TRIPS regime works well, as 
part of the broader international f ramework, and provides Members with sufficient latitude and 
flexibility, such that there has been limited or no need to issue compulsory licences under 
Article  31bis. Canada 's interest in hearing about the specific, concrete IP challenges of Members, 
particularly now in relation to COVID -19, very much remains, as does our longstanding and steadfast 
commitment to balanced international IP rules and to the multilateral framework that the 
TRIPS  Agreement provides to that end.  
1188.   Canada has reviewed the patent la ndscape and other information provided by South Africa 
in document IP/C/W/670, and thanks South Africa for compiling this information. While the 
information provided does give some indications as to the concerns of South Africa and other 
Members, Canada be lieves that more concrete information regarding the specific IP issues faced by 
Members in relation to the TRIPS Agreement, including in respect of the procurement of 
COVID -19-related goods, the establishment of local production of COVID -19-related goods, and the 
use of the flexibilities of the TRIPS Agreement in relation to COVID -19, would be most useful in 
facilitating a constructive, evidence -based discussion, and in fostering mutual understanding. In 
particular, Canada remains interested in seeking clar ification on any IP -related barriers experienced 
by Members related to, or arising from, the TRIPS Agreement, including with respect to the 
implementation of TRIPS flexibilities.  
1189.   On a related note, Canada would like to take this opportunity to present, for  the record, the 
communication from Australia, Canada, Chile and Mexico of 27 November 2020 in document 
IP/C/W/671, and titled Questions on Intellectual -Property Challenges Experienced by Members in 
Relation to COVID -19.  
1190.   There is a need for a comprehensiv e and global response to the pandemic that leverages the 
entire multilateral trading system in supporting the research, development, manufacturing, and 
distribution of safe and effective treatments for COVID -19. This includes key initiatives such as the 
access to COVID -19 tools accelerator and the COVAX Facility, as well as ongoing work in the WTO 
and elsewhere towards safeguarding and protecting global supply chains. These and other 
consensus -based, multilateral solutions represent, we believe, the most ef fective collective response 
to these global challenges.  
1191.   In this spirit, and with a view to promoting further dialogue, and fostering mutual 
understanding and evidence -based discussion, Canada and co -sponsors Australia, Chile and Mexico 
submitted, on 27 No vember 2020, a communication numbered IP/C/W/671 containing a set of 
questions on IP challenges experienced by Members in relation to COVID -19. This communication 
seeks to better understand the nature and scope of any concrete IP barriers experienced by Me mbers 
related to or arising from the TRIPS Agreement such that would constitute impediments to the fight IP/C/M/96/Add.1  
 
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  against COVID -19. The co -sponsors  would welcome any responses to these questions, such as at 
the present meeting of the TRIPS Council or ideally in wri ting as WTO documents. The co -sponsors 
would also be pleased to answer any questions that Members may have on our communication.  
1192.   We look forward to an evidence -based and fruitful discussion of these important issues, and 
also look forward to further exchan ges in the TRIPS Council in this regard.  
1193.   Canada is actively committed to a robust global effort to stop COVID -19 and address its 
devastating health, social, and economic impacts on people across the world. Canada has shown 
strong leadership in this regard,  including through a contribution of CAD 120 million to the access 
to COVID -19 tools accelerator, which Canada co -launched with other world leaders in May 2020, a 
contribution of CAD 220 million to the COVAX Advance Market Commitment to purchase doses for 
low- and middle -income countries, and an investment of CAD 180 million to address the immediate 
humanitarian and development impacts of this crisis, helping communities in developing countries 
mitigate and address the challenges brought about by COVID -19. This funding will support 
programming aligned with international response plans on priorities, such as essential food security, 
nutrition, and education initiatives. This new financial support for international efforts to address 
COVID -19 is in addition to  the CAD 200 million in international development assistance provided by 
Canada to date.  
1194.   Canada remains actively committed to a robust, multifaceted, and global effort to address 
the pandemic, one that draws upon all of the necessary resources and tools av ailable in the 
international rules -based trading system, as well as new mechanisms for global cooperation on the 
procurement of treatments for COVID -19. As equitable, timely, and affordable access to testing, 
treatments, and effective vaccines will be crit ical for controlling and ending this pandemic, we look 
forward to continued engagement with all Members of the international community, including here 
at the WTO, to finding solutions to these global challenges.  
15.49   Chile  
1195.   First, our delegation would like to thank you and the Secretariat for facilitating discussio ns 
on this matter and managing to reach a consensus in the report, which, in our view, has addressed 
the concerns of all delegations.  
1196.   In light of the above, our delegation supports the new text presen ted, insofar as it presents 
the views and discussions that have been conveyed during the formal and informal meetings of this 
Council in a neutral and factual manner.  
1197.   In our view, the report incorporates not only the importance, for Members, of providing 
affordable access to safe, high -quality and effective medicines and vaccines, but also the need to 
address this issue in a comprehensive manner, based on concrete evidence that takes into account 
the use of the flexibilities of the property system and the c oncrete challenges experienced by 
Members in this area, which have been identified by Members during the meetings of this Council, 
as well as in document IP/C/W/671 introduced by the delegations of Australia, Canada, Chile and 
Mexico.  
15.50   Bolivia , Plurinationa l State of  
1198.   The Plurinational State of Bolivia thanks  you and the Secretariat for the efforts made to reach 
a consensus. Also, we thank  India and South Africa for the proposal submitted to exempt 
WTO Members from the obligation to enforce or implement the p rovisions of the Agreement on 
Trade -Related Aspects of Intellectual Property Rights (TRIPS) regarding copyright and related rights, 
industrial designs, patents, and the protection of undisclosed information in the prevention and 
conta inment of COVID -19.  
1199.   The Bolivian Government expresses its support for this proposal and considers that the 
implementation of this initiative will lead to developing countries having more effective and timely 
access to supplies and medicines needed during the pandemic.  
1200.   It shoul d also be noted that Bolivia, like other Member countries, has been working on 
domestic regulations to ensure the effective and urgent application of compulsory licences.  IP/C/M/96/Add.1  
 
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  1201.   We therefore call on all Members of this Council to join forces to implement this pro posal.  
15.51   Sri Lanka  
1202.   My delegation  wishes to flag and particularly want to draw everyone 's attention to the kind 
of support and encouragement received and the solidarity been demonstrated by a considerab le 
amount of inter governmental, non -governmental stakehol ders, including civil society and academics 
towards the very valuable initiatives launched by India and South Africa at the WTO.  
1203.   The most recent and landmark gesture comes in a global petition in which over 900,000 
people from around the world joined toge ther to ask WTO Members to agree to the TRIPS waiver 
for COVID -19 and thus ensure universally accessible and affordable vaccines, treatment and 
equipment around the world.   
1204.   As reported in the WTO Website, this petition is calling for universal access to af fordable 
COVID -19 vaccines has been delivered virtually by Avaaz, a global online citizen movement, to the 
WTO on 9 December 2020. This petition asks all governments, WTO Members and pharmaceutical 
companies to "ensure access to lifesaving COVID -19 vaccine s, treatments and equipment for 
everyone in the world ". 
1205.   In addition, we are also aware, similar petitions, appeals and requests have been presented 
to the governments of many Members, including mine seeking their respective government 's 
intervention in ens uring universally accessible and affordable vaccines, treatment and equipment 
around the world for the COVID pandemic.  
1206.   This reminds me of a similar initiative which the WTO Members launched almost 20 years 
ago, when the HIV -AIDS pandemic became a global h ealth issue. As a delegate who was actively 
involved in the deliberations and negotiations, the then initiative was launched to combat a decease 
who had the ability to spread only through very specific mediums. The Members eventually managed 
to get a moder ate solution through Article 31 bis. This was possible mainly due to the true spirit and 
genuine understanding of each other 's' concerns and issues while placing them in their own shoes.  
1207.   When I compare the today 's situation to the situation then, we are de aling with a virus on 
which there is less information, but having severe and drastic health impact on the all of us and has 
the ability to spread through many mediums and unable to contain it only through one solution, but 
requires a multiple solutions. Th is is amply justified when I remind everyone of the recent statement 
issued by the WHO. I quote  
that only public health measures, not vaccines, can prevent a new surge of COVID -19 
cases as the first vaccines are administered in Britain. Vaccines are a grea t tool, they 
will be very helpful, but the effect of the vaccine in providing some kind of immune 
barrier is still far off . The things that must be done to prevent an increase, an uptick, a 
surge or whatever you want to call it are the public health measur es. 
1208.   Considering this statement, we are to ensure that our populations will have the access to all 
those solutions, the medicine, the vaccine and all the other essential elements to combat this 
pandemic, masques, all devises which is not the only on, the va ccines.  
1209.   So where is our unity and solidarity today and are we attempting to understand each other 's' 
concerns, when we have to deal with an unprecedented global health crisis due to which close to 
around 3% of global population has left this world and their loved ones.  
1210.    We also witness that the Pfizer/BioNTech  COVID  vaccine, two doses of which are requi red 
for full immunity and to be given three weeks apart and claimed to be offering up to 95% protection 
against COVID -19. At this juncture, i t is impossible to know and we will find out only by waiting.  If 
immunity does not last then it may be necessary to  have annual vaccines, as many for flu.  
1211.   All these aspects indicate few guidance to us, one that any vaccine for that matter should be 
available in abundance quantities for the first time as each person requires two doses and they also 
should be available a nnually, as the full immunity period of the first set of doses tend to be limited.  IP/C/M/96/Add.1  
 
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  1212.   Further, this vaccine is being tried and used only in handful of countries, such as the UK and 
Canada, which are rich countries and none of the developing countries appeare d to have managed 
to secure stocks from Pfizer  or Moderna at this juncture.  
1213.   One of the other promising and cost -effective vaccines is the vaccine developed by Oxford 
University and AstraZeneca. This vaccine is crucial to fast rollout as it is much easier to store and 
distribute, because it does not need to be kept at ultra -cold temperatures, but there is still a lack of 
certainty over the effectiveness of this vaccine in the persons, over -55 years of age.  
1214.   This is the vaccine supposed to be used to given t o the WHO COVEX initiative and through 
which low income and lower -middle income countries such as mine tend to benefit from. Sri Lanka 
has therefore placed its sole hope on securing a quantity of this vaccine through this initiative. But, 
we still have ser ious concerns and doubts as to whether we are able to secure the adequate amount 
at the affordable price.  
1215.   It is also important to note that international obligations around the right to health also 
include an obligation to desist from activities affecting  the right to health in other countries. Hence, 
we request those countries who do not want to use the waiver not block the Waiver Proposal, which 
would compromise the fulfilment of the right to health in other, particularly developing and 
least developed, countries.  
1216.   In conclusion, Sri Lanka requests that WTO Members support the adoption of the Waiver 
Proposal, which is critical to expanding the access of medical products vital to the prevention, 
containment, and treatment of COVID -19 in the global South, ot herwise constituting a 
disproportionate burden on women and gender non -conforming people. This is a key opportunity for 
WTO Members to deliver on their promise to battle COVID -19 in the true spirit of multilateralism.  
15.52   Chad  on behalf of the LDC Group  
1217.   Thank you, Madam Chair, for inviting us to attend this mee ting. We believe that all 
WTO Members have a responsibility to support any measures that can facilitate knowledge sharing 
and research. Intellectual property is  given for the prevention, containment and t reatment of 
COVID -19. 
1218.   It is clear that not all WTO Members are at the same level of development. There are 
significant differences in terms of economic progress, technological endowment, and financial 
resources and human resources capacity. This difference in development is also reflected in various 
countries ' market share in world trade. This situation is aggravated by the current pandemic . 
1219.   The WTO is an organization that establishes international trade standards based on rules that 
all Members a re expected to follow; however, not all of them can at the sam e time, as the means 
to do so are not available, especially in developing countries and in LDCs in par ticular.  
1220.   According to the international vaccine alliance, in 2021, the planet will see vacci nes deployed 
on a unprecedented scale and at an unprecedented speed. In the new year, the mobilization to end 
the acute phase of the pandemic and revive economies for a stronger, sustainable and inclusive 
recovery will be strengthened.  
1221.   The only way to miti gate the impact of the pandemic on public health and the global economy 
is to ensure universal and equitable access to vaccines or other treatments against COVID -19, 
particularly for health workers and those most at risk. It is therefore crucial to reach v ulnerable 
populations, such as those in LDCs, and poor communities and to offer them not only vaccination in 
due course, but also treatment, so that no one is left behind.  
1222.   Sri Lanka highlighted the global petition in which thousands of people asked WTO Mem bers 
to accept the TRIPS waiver for COVID -19 and thus ensure universally accessible and affordable 
vaccines, treatment and equipment worldwide. So I think it is clear that the current context calls for 
extreme vigilance: we can see the external pressure an d therefore cannot move at a snail 's pace. 
We must truly move quickly and find common ground on this important matter in order to combat 
the pandemic.  IP/C/M/96/Add.1  
 
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  1223.   Global public opinion cannot understand why we are unable to reach a consensus at the WTO 
on a subject th at clearly reflects consensus. In the LDC Group, we are open to further discussions 
with a view to moving towards a broad consensus on this proposal, which we believe moves in the 
right direction. We are awaiting feedback from our capitals, so that we can share our final position 
on this matter, which we consider to be extremely important, with you and the Members.  
15.53   Norway  
1224.   Let me firs t of all thank you, Chair, for having facilitated discussions on this important topic 
over the last few weeks. I would also li ke to congratulate you on yo ur efforts that resulted in 
consensus on your oral report to the General Council.  
1225.   In relation to the current pandemic, Norway agrees that nobody 's safe until everybody 's safe. 
Ensuring a fair and equitable distribution of vaccin es, diagnostics and medicines should have the 
highest priority. Norway is working hard to make this happen through various international 
cooperative efforts.  
1226.   As to the issue at hand, we have listened carefully to the views expressed by Members in 
both for mal and informal settings. We would like to thank those Members who have presented 
concrete questions to the proponents, and we would like to thank the proponents for their response. 
We consider this engagement to be promising and hope that we can continue  our deliberations in a 
constructive mode.  
1227.   In this context, we would be interested in learning from the proponents whether they are 
considering presenting a revised proposal, given that the chances of achieving consensus on the 
basis of the original propo sal do not seem to be realistic.  
15.54   Turkey  
1228.   I would like to refer to our previous statements d uring both formal and informal meetings of 
the TRIPS Council, regarding the proposal of waiver from certain provisions under the 
TRIPS  Agreem ent for the prevention, containment and treatment of COVID -19. 
1229.   The pandemic that we all have been facing for almost a year now, has increasingly affected 
both global health and economy.  
1230.   The health and welfare of every human being should be our utmost priority. In this regard, 
Turkey has underlined the importance of solidarity and cooperation since the start of the outbreak 
and we have shown it through the very concrete steps taken by Turkey since March 2020.  
1231.   We welcome the recent announcements about the efficacy of some vaccines . There is no 
doubt that the availability of the vaccine to humanity as a whole and its production in adequate 
quantities are as critical as its development. The global effort to vaccines, medical supplies and 
equipment should be equitable affordable and k indly.  
1232.   We have taken note of differing views of the Membership during the recent discussions. We 
also got into touch with the proponents to have a bilateral meeting regarding the proposal. We 
believe that both bilateral and multilateral constructive discussions should continue in 2021.  
1233.   We examined your draft statement to be delivered during the GC on the following week and 
found it to be extremely neutral and factual. Therefore, we fully support it.  
15.55   Singapore  
1234.   Thank  you Chair for reconvening the formal meeting of the TRIPS Council to continue 
discussing this ve ry important issue. Singapore would like to make three points.  
1235.   First, we are heartened by the active and constructive engagement among Membe rs over 
this impor tant issue. In this regard, we note with appreciation the positive conversation among the 
Membership following the circulation of document IP/C/W/671 from Australia, Canada, Chile and 
Mexico. It is a useful document and the exchange of views has helped to shed more light on each IP/C/M/96/Add.1  
 
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  other 's concerns regarding the role of IP in the fight against the COVID -19 pandemic. Members have 
demonstrated a willingness to dive deeper into an evidence -based discussion in order to gain a better 
understanding of the issue. Giv en the multi -faceted and complex nature of this issue and bearing in 
mind that IP represents only one dimension, it is important that Members have the opportunity to 
reflect further and possibly examine first principles. Given the positive trajectory of ou r discussions 
so far, Members will, hopefully, in due course be able to identify concrete, effective and constructive 
solutions. We look forward to participating constructively in these discussions in the coming days.  
1236.   Second, the IP system balances variou s interests, including stimulating innovation and the 
protection of public life and health. It also contains mechanisms to fine -tune this balance when 
needed. Instead of throwing out the baby with the bath water, we should take a clinical approach to 
identify where a problem may lie, diagnose the cause, and collaborate to find the solution as needed. 
In this context, it is worth noting that the current IP system is working to tackle the COVID -19 health 
crisis, including through the rapid development of a va ccine that usually takes years to finalise. 
Ultimately, what is important is that Members recogni ze that we are all working towards the same 
goal of ensuring that the effects of the COVID -19 pandemic are mitigated.  
1237.   Third, taking all these into account, Si ngapore supports the transmission of the short and 
factual report from the TRIPS Council to the General Council, which will enable us to continue these 
important discussions. We thank you Chair, for taking into account Members ' queries about both 
the proc edural and substantive aspects of the report. The constructive efforts of all Members should 
indeed be commended.  
15.56   Viet Nam  
1238.   First of all we would like to thank you and the Secretariat for convening this meeting. We 
would like to thank India, South Africa an d co-sponsors for their proposal for a waiver from certain 
provision of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID -19 as 
circulated in the document IP/C/W/669.  
1239.   Viet Nam always supports solutions to minimize the negative impa ct of IP protection on 
access to pharmaceuticals and medical devices in general, especially the accessibility of 
pharmaceutical products in developing and least developed countries. However, such solutions must 
also maintain incentives for investment in th e research and production of new pharmaceuticals and 
medical devices.  Accordingly, Viet Nam considers that the proposal is necessary to ensure the right 
to access to affordable COVID -19 response products such as pharmaceuticals and medical 
equipment.  
1240.   We ar e of the view that in terms of medical products, the proposed scope of the waiver is 
rather wide and further consideration should be given. Particularly, it would be preferable if a list of 
specific medical products relating to the prevention, containment,  or treatment of COVID -19 should 
be included in the waiver proposal. Furthermore, the application of the waiver to both new 
anti-COVID -19 products that are being researched and experimentally produced, such as vaccines 
and new specific medicines could be a  hindrance to investment into research and development of 
these products. In other words, the application of the waiver may make the pharmaceutical and 
medical device manufacturers less incentive to invest in the research and development of new 
products ag ainst the COVID -19 pandemic.  
1241.   Therefore, in principle, Viet Nam supports the proposal. However, a comprehensive impact 
assessment still needs to be made for the proposal, especially on the investment in research and 
development of new pharmaceuticals to pro tect the Intellectual Property.  
15.57   Eswatini  
1242.   We would like to reiterate what we stated in our previous statement about the unprecedented 
exceptional situation presented by the COVID -19 pandemic which requires decisive actions by 
governments.  We continue to emp hasize the important ro le of the WTO regarding prioritisation of 
improved and easier access to products and technologies necessary to expeditiously respond to the 
negative effects of the virus, including expansion of capacity to produce and distribute glob ally with 
the necessary quality and quantity.  To this extent, the proposed waiver aims to  ensure that IP rights 
do not become a barrier to accessing vaccines, medicines and other treatments and technologies IP/C/M/96/Add.1  
 
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  required in the global fight against COVID -19. In  our view , the waiver – whose  basis is Article IX.3 
of the Marrakesh Agreement  – will allow for a temporary  suspension of the application and 
enforcement of certain IP rights attached to COVID -19-related technologies and products, and if 
granted by the General Council, this will be beneficial to all WTO Members, including developing 
Members, least  developed countries  as well as developed country Members.  
1243.   As already mentioned by other Members, the compulsory licensing mechanism in 
Article  31bis and its terms of application as elaborated in paragraph 2 of the Annex to the 
TRIPS  Agreement are cumbersome and do not  offer an urgent solution to the challenges paused by 
the COVID -19 pandemic. In the same vein, though providing policy space, we do not consider 
TRIPS  flexibilities to be sufficient to address a pandemic of this nature and magnitude.  
1244.   Some delegations have  argued that the IP system provides the necessary incentives for 
development and commercialization of the products.  
1245.   We have addressed this point in significant detail during the informal discussions. It is a fact 
that R&D for emerging infectious diseases has typically depended on public funding and not the IP 
system. And COVID -19 is not different. Billions of public monies have been spent on R&D and 
manufacture of the vaccines. For instance, in the case of Pfizer/BioNtech vaccine, there has been 
USD 546 mi llion of public investment10, and more than USD 6billion has been spent on supply deals. 
It is also reported that Moderna 's R&D is mostly publicly funded , and it has received commitments 
of over USD 1 billion for purchase of the vaccine .11 AstraZeneca has gone so far as to state that the 
development of the vaccine will have no financial implications for the company since "expenses to 
progress the vaccine ar e anticipated to be offset by funding by governments and international 
organisations. "12  
1246.   Given this reality, in a global pandemic, we fail to see the logic of maintaining IP monopolies 
that li mit global supply and competition, and require taxpayers to rep eatedly bear the cost of these 
IP monopolies.  
1247.   To this extent we look forward to the issue taken to the General Council as you have 
mentioned in your report Chair.  
15.58   Egypt  
1248.   I would like at the outset to commend you Madame Chair for the way you are leading the  
discussions and also to commend the proponents and all other Members for their constructive 
engagement on this extremely important issue.  
1249.   I would like to focus my present intervention on four points:  
1250.   First, it is clear that we are facing an unprecedented international crisis that requires taking 
temporary emergency measures in order to save lives as well as to save the global economy from 
the devastating impact of dealing with this pandemic for a longer period of time.  
1251.   Second, the proposed waiver provides a time -limited suspension to certain specific provisions 
during the current global crisis. WTO Members could support the Waiver Proposal and stand in 
solidarity with the rest of the world without applying or using the waiver, if they wish.  
1252.   Third, a country -by-country and product -by-product approach of using the TRIPS flexibilities 
remains limited in addressing IP challenges in this pandemic. The limitations should not be linked 
only to the concerns of some Members or to the evidence they present but should also be linked to 
the severity of the current crisis as well as to the fact that we do not know too much about this virus 
till now.  
 
10 https://assets.oxfamamerica.org/media/documents /A_Shot_at_Recovery.pdf ; 
https://www.reuters.com/article/us -health -coronavirus -eu-pfizer -exclusiv -idUSKBN2800IC ; 
https://www.thesun.co.uk/news/13169692/pfizer -covid-vaccine -cost-uk-600million -ten-oxford -jab/ 
11 https://assets.oxfamamerica.org/media/documents/A_Shot_at_Recovery.pdf  
12 https://www.astrazeneca.com/media -centre/press -releases/2020/covid -19-vaccine -azd1222 -showed -
robust -immune -responses -in-all-participants -in-phase -i-ii-trial.html  IP/C/M/96/Add.1  
 
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  1253.   Lastly, as indicated by Amnesty International: COVID -19 is not only a health and economic 
crisis, but also a human ri ghts crisis and cannot be overcome without true commitment to the 
Sustainable Development Goals (SDG) Principle to "Leave no one behind ". As often repeated this 
year, no one is safe until we are all safe. WTO Members have the opportunity to make a coordina ted 
global decision that can help make this a reality and put an end to this pandemic.  
15.59   Indonesia  
1254.   Thank you, Madam Chair, for conve ning this very important meeting. We also welcome your 
effort s in finalising the TRIPS Council Report to the General -Council, in particular in reflecting the 
factual discussion on the Waiver proposal.  
1255.   Indonesia has followed the discussion with great interest and believe s that the debate over 
the proposal has provide d enlightenment on this important issue. Despite the huge gap among the 
position s of Members, we are of the view that this initiative clearly underline s the deep relation 
between TRIPS Agreements and Public Health.  
1256.   Indonesia would like to reiterate its su pport for the co -sponsors ' proposal for a waiver from 
certain provision of the TRIPS Agreement for the Prevention, Containment and Treatment of 
COVID -19. 
1257.   This initiative offers a different perspective to address global public health crisis by addressing 
one of the core challenges in rapid, equitable and affordable access to health caused by protection 
of intellectual properties to much needed diagnostic kit s, therapeutics, vaccines, and other medical 
equipment to combat COVID -19. This initiative, as we obse rve and analyse , is legal and protected 
under the Marrakesh Agreement.  
1258.   Indonesia would like to add further examples of why intellectual propert y rights pose serious 
barriers to access to health, aside from what has been provided by the co -sponsors and othe r 
Members.  
1259.   The case of access to Remdisivir, as explained by the delegation of Pakistan in the previous 
week, is also experienced by Indonesia. We recently failed to convince Gilead to expand its 
production in Indonesia through voluntary licensing, to addr ess shortages and affordability of the 
medicine. Importing the medicine was factually more costly and difficult to get because of limited 
supply and higher price s for the fulfilment within our region. This selective and secretive production 
agreement is on e of the prime examples on the business -as-usual model.  
1260.   Indonesia also experienced a different case where IP bec ame a serious threat to Indonesia 's 
public health, despite Indonesia 's paramount contribution to the development of H5N1 vaccines.  
1261.   On August 2 006, Indonesia made an unprecedented move by announcing that it will make 
genomic data on bird flu viruses accessible to anyone. Indonesia was of the view that opening up 
global access could be the key to unlocking such vital information as to the origin o f the virus, how 
it causes disease, how it is mutating, the sources of infection, and how to prevent or cure the virus.  
1262.   Despite the fact that, following Indonesia 's move, developing countries have supplied H5N1 
virus to WHO Collaborating Centres for analy sis and preparation for vaccine production, the resulting 
vaccines produced by pharmaceutical companies are in fact unavailable for developing countries 
such as Indonesia.  
1263.   The system behind this unfair practice is closely related to intellectual property protection of 
the vaccines development for pharmaceutical companies that benefitted from the openness of 
Indonesia and other developing countries. It was based on this situation, Indonesia wanted a 
material transfer agreement for each virus sample sent to foreign labs, specifying that the sample 
will only be used for diagnostic purposes and not for commercial gain.  
1264.   Under that proposal, any commercial use of the virus would require prior consent of the 
country providing it. By retaining the intellectual prop erty rights, Indonesia believes, a country could 
allow access to global vaccine stockpiles at an affordable price.  IP/C/M/96/Add.1  
 
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  1265.   The examples we put forward are only a few illustrations that voluntary mechanism or 
business as usual is not enough to address the pandemic. In addition, our example also highlighted 
that IP could become a serious barrier to access to medicine s, while in reverse, transparency and 
global collaboration is the cat alyst and the enabler to enhance access to health.  
1266.   To conclude, when a country, as some organizations inform, can order and secure access to 
vaccines five times than its population, while other countr ies are  struggling to get even the slightest 
part of it,  this only confirms that there is a significant flaw in the business -as-usual model when 
confronting a global pandemic.  
1267.   But maybe, and we significantly doubt it, the enactment of this waiver would not have direct 
impact to access to medicine, vaccines and  other products for treatment and containment of 
COVID -19. But when we are dealing with human lives in scale of this COVID -19 pandemic, it is better 
to err on the side of caution than taking the risk by fully relying on market or voluntary actions.  
15.60   Europe an Union  
1268.   We would like to thank you and all the delegations for the constructiv e engagement on the 
status report which we fully support. In the present statement , the European Union would like to 
make further contribut ions to the discussion but also, for t he record, recall some of the points made 
during the informal meeting the previous week.  
1269.   Universal and equitable access to safe and effective diagnostics, treatments and vaccines is 
crucial in the fight against COVID -19. Achieving this objective is a prio rity of the EU and  this is why 
the EU is leading the Coronavirus Global Response for universal access to affordable COVID -19 
vaccination, treatment and testing. Nearly EUR 16 billion have been pledged so far for universal 
access to tests, treatments, medic al devices and vaccines against COVID -19 and for the global 
recovery.  
1270.   The EU is the main contributor to the COVAX Facility – the international initiative to ensure 
global access to vaccines for COVID -19. It brings together governments, the WHO, UNICEF, 
manufacturers, private sector, civil society and philanthropy and is the best way to ensure that 
high-income countries finance the vaccines and their deployment for low - and middle -income 
countries. Here the key issue is to address the remaining global financ ing needs as underlined in the 
recent G20 Riyadh Leaders Declaration.  
1271.   The challenges that we face are enormous. The manufacturing at huge scale, the distribution 
of vaccines, their storage and even their administering will test our financial capacity, our logistical 
skills and perhaps, most of all, our global collaboration and solidarity in the face of this crisis.    
1272.   We believe that the intellectual property system, with its checks and balances, does not stand 
in the way of these efforts. Indeed, it is part  of the solution to the challenge of universal and equitable 
access to vaccines and COVID -19 treatments.  
1273.   We have already seen it with the development of vaccines – unprecedented work and 
collaboration among governments, pharmaceutical innovators, foundati ons and researchers have 
taken place. We are looking at vaccines being approved within 12 months where normally it takes 
ten years. According to the industry sources, some 1100 potential treatments and vaccines are in 
development. Much of this rapid respon se, like for example the vaccines based on mRNA technology, 
builds on knowledge and research capacity developed over many years with the support of 
intellectual property incentives. We would not be where we are now without the years of this 
research.  
1274.   What is most needed now, beyond developing vaccines, is the ramping up of manufacturing 
of vaccines and the best way of achieving that is by disseminating the technology and know -how of 
those who developed the vaccines through licensing arrangements. Manufactur ing cannot take place 
without the required technology and know -how. In addition, we need these vaccines to be produced 
in a manner that ensures their efficacy and safety. Intellectual property is a key factor in providing 
a framework that enables these arr angements. Developers of vaccines can enter into manufacturing 
agreements, transfer technology and expand production with their licensees. Our main concern is IP/C/M/96/Add.1  
 
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  that suspending the relevant IP rights will not enhance such collaboration and manufacturing but,  
to the contrary, will slow it down or even block it, to the detriment of all.  
1275.   Many pharmaceutical companies have committed publicly and are already working closely 
with governments to ensure that the vaccines will be available and affordable to all who ne ed them. 
We also see agreements on expanding manufacturing capacity, we understand that e.g. AstraZeneca 
entered into agreements with companies in various countries to support the manufacturing, 
procurement and distribution of vaccines. It also entered int o a technology transfer agreement with 
Serum Institute of India to supply doses for low and middle -income countries. We also understand 
that Johnson & Johnson entered into manufacturing service agreements for large -scale 
manufacturing for its vaccines. And  there are other examples, also as regards collaboration to 
increase manufacturing of promising COVID -19 therapeutics.  
1276.   We would like to thank the delegations of South Africa and India for the information provided 
in the course of the consultations and for document IP/C/W/670 from South Africa which we have 
carefully studied. It presents the patent landscape of various anti -viral and other medicines. We are 
grateful to South Africa for explanations given during our last session as to the fact that this 
information was collected for monitoring purposes and the intention was not to infer that the 
existence of these patents amo unts to barriers to access. We will be of course interested to hear 
more as the monitoring progresses. We note also the examples of shortages in supply that occurred 
at the early stages of the pandemic. We understand that these were resolved rather quickly  but are 
of course open to hear more.  
1277.   Without doubt, making sure that there is a continued supply of medicines and technologies 
related to COVID -19 is a difficult task. However, fragile and underfunded healthcare and 
procurement systems, spikes in demand and lack of manufacturing capacity are much more likely 
to have an impact on the access to those medicines and technologies than intellectual property.  
1278.   Having said that, in case intellectual property should become an issue in the context of this 
access, th e international intellectual property system already provides solutions. Patent or any other 
intellectual property protection, such as the protection of test and clinical trial data, is not absolute. 
Intellectual property is a system of checks and balances . The TRIPS Agreement provides for the 
necessary flexibilities such as a possibility to grant compulsory licences – these have been used in 
the past in the context of pharmaceutical products in various countries.  
1279.   The system includes solutions provided spe cifically for emergencies such as this pandemic. 
And these can be used, especially if the companies do not heed the calls for manufacturing at scale 
including with the use of adequate licensing. This includes fast -track procedures where no 
negotiations wit h the patent holder are required and the possibility of granting licences for export to 
countries with no or insufficient manufacturing capacity. Only simple notifications are required to 
put the latter one into effect. It is also possible to dispatch noti fications with regard to many products 
at the same time.  
1280.   During our discussions , problems with domestic implementation of the flexibilities have been 
raised by a number of delegations. We are ready to discuss ways of facilitating the use of these 
flexibil ities. Technical assistance can and should be provided to Members that experience difficulties 
with the implementation and the use of these flexibilities.  
1281.   We continue to have questions on the rationale and the potential benefit of the waiver 
proposed by In dia and South Africa when compared to the approach based on licensing 
arrangements combined with the flexibilities under the TRIPS Agreement. Our main concern is the 
impact this waiver could have on the ongoing private -public partnerships and well as the g lobal effort 
undertaken through the COVAX Facility.  
1282.   In that regard, and in order to facilitate a consensual, constructive and evidence -based 
discussion, we fully support the approach presented in the document IP/C/W/671 submitted by the 
delegations of Aust ralia, Canada, Chile and Mexico and the questions put forward in this document 
as highly pertinent for our discussion.  IP/C/M/96/Add.1  
 
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  1283.   In addition to the questions posed by these delegations, in the spirit of open discussion and 
to foster further exchanges, while appreci ating comments already provided, we would like to invite 
the proponents to:  
a. explain in more detail how concretely the waiver could operate with regard to the vaccine 
production, including the transfer of the required technology and know -how; and  
b. how it wou ld affect the existing licensing mechanisms and the COVAX Facility more 
generally, what would the domestic implementation of the waiver entail and why would it 
be easier to carry out than introducing fast -track procedures for compulsory licensing on 
the ba sis of the existing system?, how the "temporary " nature of the waiver would work, 
with regards to unregistered rights as copyright and with regard to patents and designs - 
should they not be granted if in application stage? If they are already granted, doe s the 
waiver mean that they cannot be enforced? When the application of the waiver is over, 
how do the owners recuperate their rights?  
1284.   The EU believes that the important and complex issues brought up in the context of the 
ongoing discussion merit further r eflection and significant consideration to determine the exact 
nature of challenges faced by Members in addressing COVID -19. It is important to emphasise that 
intellectual property rights are but a part of a broader response to COVID -19 which includes also  
significant investments made by the EU in the COVAX Facility as well as the work undertaken by the 
EU to safeguard global supply chains.  
1285.   Trade policy can support the vaccine delivery by keeping markets open to essential healthcare 
products, avoiding expo rt restrictions and adopting trade facilitation measures. A global crisis 
requires global cooperation. This is the spirit in which the EU and other like -minded WTO partners 
have submitted a proposal to the WTO on the so -called "Trade and Health Initiative " under which all 
WTO Members would jointly agree on a number of actions in response to the current crisis and 
undertake commitments that would contribute to an effective response to any future crisis.  
1286.   The EU is committed to an open and comprehensive dialog ue with all WTO Members to 
explore how the multilateral rules -based trading system can best support universal and equitable 
access to COVID -19 vaccines and treatments. All possible tools should be explored to leverage this 
system to provide for as robust r esponse as possible.  
15.61   Japan  
1287.   Japan believes that ensuring fair and equitable access to  vaccines and medi cal treatments 
entire world is essential to overcome the COVID -19. To achieve this, Japan has been contributing to 
the framework of international multilat eral cooperation to overcome COVID -19 pandemic.  
1288.   On the other hand, Japan still has serious concerns about waiver proposal from India, 
South  Africa and other co -sponsors. This delegation would not repeat our statements that were 
already made, but would like  to point out some important points.  
1289.   First, the proposed waiver would not only undermine incentives for development, but also 
have a negative impact on investment to increase manufacturing capacities for medicines and 
vaccines. The proponents have a scepti cal view on the need of incentives by intellectual properties 
because there is a large size of investment by public funds. However, R&D in the field of infectious 
diseases particularly involves a great risk. For example, even when pharmaceutical companies 
succeed in developing effective medicines or vaccines for a virus, there is always a risk that the 
medicines or vaccines turn to be ineffective due to mutation of the virus. In addition, development 
of medicines and vaccines in a very short term needs a lo t of human resources and financial 
investments. Given such circumstances, it is essential to maximally incentivize pharmaceutical 
companies and research institutes through various measures. Therefore, Members should not 
undermine IP protection, which is th e main driving force for R&D, in order to achieve timely supply 
of new effective medicines and vaccines.  
1290.   Second, the proponents argue that the safety and efficacy of medicines and vaccines can be 
guaranteed under a regulatory framework. However, in order to timely scale up the manufacturing 
capacity of quality and safe diagnostics, medicines and vaccines related to COVID -19, it is essential 
to have effective cooperation among companies, including technology transfers, while appropriate IP/C/M/96/Add.1  
 
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  protection of intell ectual properties is the prerequisite for technology transfers. Especially, building 
strong partnership through voluntary licensing is indispensable for production of quality and safe 
medical products related to COVID -19, which have been recently developed  based on the latest 
technology in a short period of time. On the other hand, this is not always applied to a case that 
medical products have been in the market for a long time and knowledge and technology related to 
them are widely known. In this regard, innovative pharmaceutical companies and generic 
manufacturers clearly state that an effective and balanced intellectual property framework is a key 
factor to enable R&D, accelerate manufacturing scale -up, and facilitate licensing for therapeutics 
and vacci nes. In these circumstances, the waiver proposal would impede such collaboration, and it 
would cause adverse effect to our common goal, which is to deliver quality and safe medical products 
swiftly.  
1291.   Third, the scope and modalities of this waiver are unclea r. The proponents must explain 
clearly what domestic measures the proponents would implement if the waiver were granted and 
how the obligations of TRIPS Agreement would prevent implementing such intended domestic 
measures. In this regard, the proponents in sist that details of such domestic measures should be 
decided by each Member based on its necessity. However, the waiver without any concrete idea of 
its implementation would impose unacceptable uncertainty and unpredictability on the protection of 
intelle ctual property because nobody knows what will happen in such a situation. Such an uncertainty 
would obviously have a negative impact on economic activities for combating COVID -19, including 
investments for R&D and increasing manufacturing capacity of essen tial medical products. 
Furthermore, if each Member were allowed to adopt individualized domestic measures without any 
constraints, pharmaceutical companies would be forced to respond to such domestic measures on a 
country -by-country basis. As a result, the  companies would have difficulties in stably supplying 
medical products worldwide.  
1292.   Finally, the delegation of Japan reiterates the need for all Members to have unhindered and 
timely access to medical products in response to COVID -19. To tackle the COVID -19 pandemic, 
Japan has been strengthening its capacity, in particular, to research and develop vaccines and other 
tools, and to ensure equitable access to those tools. Japan announced its financial commitment of 
approximately USD 300 million to Gavi at the G lobal Vaccine Summit in June 2020, and will 
contribute more than 130 million USD of that commitment for the COVAX Advance Market 
Commitment (AMC), in order to enable lower income countries to reinforce equitable access to 
COVID -19 vaccines. In addition, Ja pan will advance multilateral cooperation schemes such as 
ACT Accelerator and will expand the access to diagnostics through the Global Funds. Japan remains 
committed to combatting COVID -19, together with the international communities.  
15.62   China  
1293.   First of all, w e would like to thank you for proposing the draft r eport and convening this 
meeting. China supports the draft report and we are happy to see the consensus.  
1294.   The COVID -19 pandemic is still widespread. Promoting the availability of COVID medicines 
and vaccines and ensuring equal and timely a ccess to safe and effective medicines and vaccines for 
all Members, especially the developing Members and the LDCs , is still an urgent call for the global 
community.  We are glad that Members share this common goal an d we will take concrete measures 
to promote the availability and affordability of COVID vaccines.  
1295.   For the joint proposal, we still see divergences, and Members also raised some technique 
issues, we are willing to continue the constructive discussion in the  future TRIPS Council meeting.  
15.63   United Kingdom  
1296.   Thanks to the Chair and to delegations for constructive discussions. We are glad that we were 
able to find a compromise acceptable to all a nd we support the proposed wording as a TRIPS Council 
status report to the General Coun cil. We thank delegations of Australia, Canada, Chile and Mexico 
for their communication of 27 November contained in document IP/C/W/671. We find the contents 
of this co mmunication important in regard to building needed evidence base essent ial for our 
discussion. Therefore, the UK supports this communication.  IP/C/M/96/Add.1  
 
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  1297.   We thank to the few delegations that have responded to the questions and call on other 
delegations to do the same in order to be able to move ahead by identifying specific issues and, 
subsequently, possible solutions. We recall our statements delivered on 16 October and 
20 November.  
1298.   The UK reaffirms its commitment to ensuring access for all to safe, effective, quality, and 
affordable vaccines, diagnostics, medicines, and other health technologies to enable an effective 
response to the COVID -19 pandemic. We  remain convinced that we need to search for measures 
and solutions within the current international IP framework. The UK places a great importance on 
this matter,  and we have been engaging in good faith. We believe that discussions on the matter at 
hand h ave not been exhausted in the TRIPS Council and the UK will continue to engage in the 
TRIPS  Council and beyond.  
1299.   In addition to our call on Members to engage and finance the ACT -Accelerator and its vaccines 
pillar COVAX, we have been actively engaging with other initiatives. For example, we are working 
domestically as well as with international institutions and partners to strengthen the value added 
and potential impact of initiatives such as the C -TAP or the Medicines Patent Pool (MPP). More 
specifically, w e are facilitating UK industry and research stakeholder 's awareness of C -TAP, to 
understand how it can add value to the work already underway to respond to COVID -19. 
1300.   We are of the view that the existing IP framework supports research and development for 
new medicines and technologies. Subsequently, voluntary licensing mechanisms as well as 
embedded flexibilities ensure transfer of and access to technology and know -how. Furthermore, 
various collaborative initiatives within the existing IP framework deliver o r have the capacity to 
deliver much needed scale up in a timely manner. We are focused on making sure the innovation 
ecosystem functions to support both innovators and those who need access to innovations at a scale.  
1301.   We continue to engage within and beyond  the TRIPS Council.  
15.64   Oman  
1302.   We share the sentiments of Members on the importance of providing affordable, equitable 
and timely access to COVID -19 vaccines and medicines as a priority. We support the report for the 
General Council that will enable us to contin ue the discussion on this important issue.  
15.65   Mauritius  
1303.   Mauritius is fully aware of the current second way of massive contingent of th e COVID 
pandemic. Our respective countries, while still reeling from the consequences and damage of the 
pandemic on the econ omic and social public from the first phase of infections, will now be facing 
second or forthcoming multiple rounds of contagion. This current situation of uncertainty and despair 
regarding global public health calls for governments to collaborate further.   
1304.   Mauritius believes in international solidarity from developed and developing countries to 
grapple with the consequences of the pandemic and face the same challenge. Saving life needs the 
daily and affordable access to effective medicine, vaccines and oth er essential medical tools. There 
is no doubt that developing countries are removed since, due to their inherent systemic deficiency 
and vulnerabilities, they will lack the capacity to produce on the required large scale medicines and 
public health product s against the COVID pandemic. It is against this background that Mauritius 
reiterates its support to this joint proposal and joint solidarity in calling for flexibilities under the 
TRIPS Agreement for the combating of the COVID -19 pandemic.  
15.66   Venezuela , Boli varian Republic of  
1305.   The Bolivarian Republic of Venezuela wishes to reite rate its thanks to the co -sponsors for this 
much needed proposal at this time, and to express its support for the proposal. The document 
propo sing a waiver from certain provisions of th e TRIPS Agreement for the prevention, containment 
and treatment of COVID -19 is an initiative that deserves to be judged on its merits and further 
analysed in order to address the concerns that have been raised during the round of consultations.  IP/C/M/96/Add.1  
 
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  1306.   We therefor e fully support the proposed steps to be followed and would like to report that 
the matter is being carefully assessed by our authorities so that we may take part in these 
discussions in the most constructive way possible.  
1307.   No doubt, the important and massi ve reaction to this proposal from corporations clearly 
shows the relevance of what we are discussing here today.  
1308.   The eyes of the world are watching us and the global health situation calls for global political 
solutions that can only be achieved through in ternational collaboration, so as to ensure access for 
all, without any restrictions, to medicines and technologies for the prevention, containment and 
treatment of COVID -19. 
15.67   Ukraine  
1309.   Ukraine  expresses  its gratitude  to you M a d a m e  Chair for reconvening  the 
TRIPS  Council  meeting  in formal mode, which together with the previous informal discussions 
provides us with an opportunity to further discuss the Proposal for a Waiver from certain Provisions 
of the TRIPS  Agreement as well as for your effo rts in the discussions.  
1310.   We are also thankful  to India and South  Africa  for their initiative  and call for joint actions  
and global  solidarity  aimed  at putting  in place a collective  response  to COVID -19 pandemic,  as well 
as for the additional  information  that has been provided  in the course  of the last two months.  We 
also highly appreciate constructive engagement  of all Members and  communities  on the topic. We 
also agree on the text of status report and we welcome the adoption in the present meeting.  
1311.   Given the situation with COVID -19 crisis, we reiterate that it is extremely important for 
Ukraine to ensure greater access to affordable medical  products. Ukraine supports statements, made 
under this agenda item, acknowledging that it is i mperative for the WTO Members and all 
stakeholders nowadays to collaborate in close partnership to ensure rapid, affordable and equitable 
access to medical  products.  
1312.   While the Proposal and its possible impact are still being analysed by the Ukrainian inter ested 
authorities and  scientists, Ukraine  will continue  following  the discussions  on this issue within  the 
TRIPS  Council  and we are ready to engage  so as to find  a common  effective  solution and  tackle the 
challenges  posed by  the current  pandemic.  
15.68   United States of America  
1313.   In the las t few weeks, we have seen breakthroughs on vaccines and new treatments that are 
creating a path to effectively fighting the COVID -19 pandemic. There are also encouraging details 
concerning the diverse initiatives of the i ndustry to enhanc e and accelerate a ccess through 
manufacturing and distribution collaborations and networks.  
1314.   All of these unprecedented developments during this relatively short period of time are 
possible in part because of the global IP system. In our vi ew, intellectual property has not been an 
obstacle in addressing the pandemic but rather has motivated global efforts through its incentivizing 
role in R&D to find new treatments and cures.  
1315.   Intellectual property plays a key role in developing partnerships  with respect to 
manufacturing, transportation, and distribution. These partnerships can help to facilitate access to 
innovative products. In particular, voluntary agreements on mutually agreed terms and conditions 
have effectively served to advance access  to key innovations throughout this pandemic.  
1316.   As a result, the United States does not support the proposal of India, South Africa, Eswatini, 
Kenya, Pakistan, Mozambique and the Plurinational State of Bolivia to waive TRIPS obligations in 
connection with pa tents, copyright, industrial designs, and the protection of undisclosed information 
in relation to prevention, containment, or treatment of COVID -19.   
1317.   Given the need to provide the entire global population access to COVID -19 treatments, limits 
to manufact uring capacities and problems with supply chains are currently the most significant 
concerns, especially for vaccines.  We also must be concerned about the pandemic creating the IP/C/M/96/Add.1  
 
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  opportunity for an increase in counterfeit health and safety -related products,  which would harm 
rather than help.  
1318.   The waiver proposal raises many questions given its broad nature. Bilateral meetings have 
helped to begin identifying the many issues the proposal implicates, and we will participate in future 
discussions to better unde rstand and assess the scope, implementation, and impacts of the proposal.  
1319.   With respect to the Council 's status report to the General Council for next week 's meeting, 
the United States supports the compromised language reached. The United States thanks 
South Africa for the communication circulated in document  IP/C/W/670. Patent transparency of 
medical products helps to facilitate innovation and access.  
1320.   A pragmatic approach to use patent transparency to improve access to medicines in general, 
and COVID -19 medical products specifically, is to identify specific problems regarding access to a 
particular medical product and apply effective, targeted solutions , such as licensing agreements 
authorizing generic manufacturing and/or procurement.  
1321.   In fact, in the area of COVID -19 therapeutics, licensing by generics manufacturers already 
exists. It appears that one company has signed non -exclusive voluntary licensin g agreements with 
generic pharmaceutical manufacturers based in Egypt, India and Pakistan to manufacture its drug 
for distribution in 127 countries. The co -sponsors of the waiver proposal are amongst the 127 
countries that will benefit from these arrangeme nts.  
1322.   Other factors that are relevant to the access question include pricing and procurement 
policies, taxes, mark -ups and tariffs and other national policies that result in higher costs for 
consumers and for health systems. In fact, some countries continu e to apply tariffs of up to 20% on 
pharmaceuticals and 10% on vaccines. South Africa 's paper does not explore these critical factors.  
1323.   As the United States has explained during past TRIPS Council interventions, the existence of 
a patent in and of itself is not indicative of an access barrier. The purpose of a patent system is not 
to exclude patients or potential markets. Moreover, we remind delegations that a vast majority of 
older medicines are not patented, yet remain out of reach for many patients.  
1324.   Instea d, South Africa has presented here a "[p]reliminary patent landscape of selected 
priority COVID -19 candidate therapeutics, " which it acknowledges is a "non-exhaustive snapshot. " 
The paper also aggregates some information from certain medicines based on new s article links. 
However, there are limits to the paper as a way to thoroughly understand the current COVID -19 
medical technology area.  Identifying effective strategies to address COVID -19 is a complex 
challenge, requiring systematic analysis based on data  and sound methodology.  We look forward to 
continued discussion on these important issues.  
1325.   The United States thanks the co -sponsors of its communication in document IP/C/W/671. 
The communication contains important fact -based inquires based on the proposal  in 
document  IP/C/W/669.  In particular, we look forward to the response from the proponents on the 
IP challenges experienced that have impeded or prevented the timely procurement of COVID -19 
diagnostics, equipment, therapeutics or vaccines and how those ch allenges are in relation to the 
TRIPS  Agreement. This information would be helpful to understand the perceived TRIPS compliance 
hardships faced by Members such that a waiver for each obligation would be necessary.   
United States ' statement at the  informal  meeting held on 20 November 2020  
1326.   As we stated at the last TRIPS Council meeting, the United States is committed to working 
with international partners in identifying practical ways both to increase access to safe, effective, 
affordable, and lifesaving med icines around the world and to support policies that drive the 
development of new medicines.  
1327.   Intellectual property encourages innovation, incentivizes research and development, and can 
facilitate manufacturing and distribution, thus helping to expand acces s to medicines around the 
world.  These core features of intellectual property are necessary for the global community to find 
and develop treatments and cures for this deadly pandemic and to support economic recovery.   IP/C/M/96/Add.1  
 
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  1328.   Specifically, intellectual property as sists in putting partners and collaborators together with 
respect to research and development, manufacturing and voluntary technology transfer 
arrangements, and transportation and distribution.  These partnerships drive access to innovative 
products and are  facilitated by the intellectual property ecosystem.  
1329.   Intellectual property is an important piece, but ultimately only one piece of addressing the 
issue of access to any potential therapy.  We believe that intellectual property has not been an 
obstacle in a ddressing the pandemic but rather has motivated global efforts to find treatments and 
cures.   
1330.   Given the need to provide access to the entire global population, limits to manufacturing 
capacities and supply chain issues are currently the most significant co ncerns, especially for 
vaccines.  We also must be concerned about the pandemic creating the opportunity for an increase 
in counterfeit health and safety -related products, which would harm rather than help.  
1331.   This proposal to waive TRIPS obligations on patents , copyright, industrial designs, and 
undisclosed information (including trade secrets) in relation to prevention, containment, or 
treatment of COVID -19 would be a broad and unprecedented step.  
1332.   The number of provisions alone that would be waived is worth no ting – if the waiver were 
granted as requested, at least 34 separate paragraphs of the TRIPS Agreement would no longer 
apply.  This is a substantial departure from past WTO waivers.  
1333.   The waiver proposal does not identify any specific measures for which it is  requesting waiver.  
Instead , it states that the listed TRIPS obligations would be waived "in relation to prevention, 
containment or treatment of COVID -19."   
1334.   Based on this language, it is unclear what measures would fall within or outside the scope of 
the waiver.  
1335.   Given the waiver proposal 's broad sweep, it is surprising that the request does not explain in 
detail why compliance with each of the identified TRIPS obligations creates an identifiable and undue 
hardship for Members, such that the waiver of each obligation would be necessary.  
1336.   Turning to the effect of any such waiver, the indefiniteness and breadth of this request – with 
respect to both the provisions that would be waived and the potential measures that might be 
covered – makes it difficult to eva luate the impact the waiver would have on Members ' respective 
commercial interests.  
1337.   The United States recalls the G20 Ministerial Statement of March 30 of this year, which said: 
"We agree that emergency measures designed to tackle COVID -19, if deemed neces sary, must be 
targeted, proportionate, transparent, and temporary, and that they do not create unnecessary 
barriers to trade or disruption to global supply chains, and are consistent with WTO rules. " 
1338.   Following the direction of the G20, the United States wo uld appreciate if the proponents of 
the waiver proposal could provide further explanation to address the following questions:  
Proportionality and Problem Identification:   
1339.   Could the proponents explain how the waiver is a proportionate response to COVID -19? 
1340.   Could the proponents provide data that establishes that the identified TRIPS obligations have 
systematically hindered or blocked the prevention, containment, or treatment of COVID -19? 
Scope:  
1341.   Could the proponents explain how Members would determine whether a measure is "relat[ed] 
to the prevention, containment or treatment " of COVID -19 and thus falls within the scope of the 
proposed waiver?   
1342.   For example, if a measure waives an intellectual property right covering a given product or 
work, would the product or  work have to be directly related to the prevention, containment, or IP/C/M/96/Add.1  
 
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  treatment of COVID -19 in order to fall within the scope of this waiver proposal?  Could the product 
or work be indirectly related?  How indirectly related?  Who would make this determination ?  
Implementation:  
1343.   How is the waiver proposal one that is "targeted " (as noted in the G20 statement), 
considering it implicates the suspension of at least 34 provisions of the TRIPS Agreement?  
1344.   Could the proponents please explain in detail how the waiver would directly resolve issues 
related to COVID -19-related prevention, containment, or treatment in a Member?  
1345.   Do the proponents have any data that would show how such a waiver would demonstrably 
reduce COVID -19 prevalence or impact during the acute phase of the pandemic?  We note that new 
pharmaceutical manufacturing capacity typically cannot be established quickly.   
1346.   How would the waiver of each of the identified TRIPS obligations be implemented by a 
Member?  For example, how would the waiver of obligations related to undisclosed information be 
implemented?  Does each proponent i ntend to implement legislation that would release undisclosed 
information submitted for regulatory purposes?   
1347.   For undisclosed information such as trade secrets, will the proponents suspend their laws on 
trade secret theft?  Have the proponents considered wh ether this would result in an increase in trade 
secret theft?  
1348.   How do proponents plan to suspend rights that exist without formal government registration, 
such as copyrights?  
1349.   If the waiver were to be implemented, how long do the proponents think it will tak e for there 
to be an impact in the prevention, containment, or treatment of COVID -19? What data are the 
proponents relying on to reach this conclusion?  
1350.   How do proponents envision that Members would return to compliance with their TRIPS 
obligations after th e waiver expires?  
Effects:  
1351.   What are the expected impacts on Members ' commercial and economic interests as a result 
of the waiver?  
1352.   What effect do the proponents think that the waiver will have on innovation related to 
products that address the prevention, containment, and treatment of COVID -19? What would be the 
long-term implications for innovators ' willingness to participate in future pandemic response efforts?   
1353.   What are the expected impacts on authors, inventors, and other creators?  
1354.   With resp ect to government funding comments:  
a. There has been significant investment from governments to facilitate and accelerate the 
development, manufacturing, and distribution of COVID -19 vaccines, therapeutics, and 
diagnostics.   
b. However, as a general matter, the  United States and many other governments cannot and 
do not develop these products by themselves. Governments generally do not have the 
required expertise, technical and logistical know -how, manufacturing capabilities, and 
experience in getting products qu ickly to market.   
c. The contribution of the private sector – both financially and in terms of research and 
development, and manufacturing – is essential to the production of these products.  While 
governments may provide aid or funding, the production of thes e products remains a very 
high-risk investment for the private sector.  
d. The intellectual property framework provides the necessary legal and commercial 
incentives to drive private entities to undertake the risk and make the appropriate IP/C/M/96/Add.1  
 
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  investments.  Intellec tual property plays an important role because when private entities 
are able to secure exclusive rights to a product they have developed, they have greater 
certainty about the expected return on their investment and are able to enter into 
partnerships to e nsure efficient commercialization of the product.   
e. Without effective intellectual property protection, the development and commercialization 
of those products would likely not happen in an effective, efficient, and timely way, if it 
happens at all.   
United  States ' statement at the informal meeting held on 3 December 2020  
1355.   Thank you chair for the status report language. We will review and provide potential 
comments by the due date.  
1356.   The United States thanks the co -sponsors of communication IP/C/W/671. We find the 
inquiries to be helpful to the discussion on the proposal and will provide comments for the record at 
the formal meeting next week.  We thank South Africa for its communication IP/C/W/670.  We will 
provide comments for the record at the formal meeting ne xt week.  We thank the proponents for 
their comments this morning.  In particular, we note that we have bilateral discussions tomorrow on 
the proposal for further exchanges on our questions.  
1357.   With respect to some of the comments made by the proponents this m orning, there were a 
couple of points I wanted to address.   
1358.   On the government funding comment, and as the United States noted at the 20 November  
informal, there has been significant investment from governments to facilitate and accelerate the 
development, manufacturing, and distribution of COVID -19 vaccines, therapeutics, and diagnostics.   
1359.   However, as a general matter, the United States and many other governments cannot and 
do not develop these products by themselves.  Governments generally do not have the r equired 
expertise, technical and logistical know -how, manufacturing capabilities, and experience in getting 
products quickly to market.   
1360.   The contribution of the private sector – both financially and in terms of research and 
development, and manufacturing – is essential to the production of these products.  While 
governments may provide aid or funding, the production of these products remains a very high -risk 
investment for the private sector.  
1361.   The intellectual property framework provides the necessary legal and commercial incentives 
to drive private entities to undertake the risk and make the appropriate investments.  Intellectual 
property plays an important role because when private entities are able to secure exclusive rights 
to a product the y have developed, they have greater certainty about the expected return on their 
investment and are able to enter into partnerships to ensure efficient commercialization of the 
product.   
1362.   Without effective intellectual property protection, the development a nd commercialization of 
those products would likely not happen in an effective, efficient, and timely way, if it happens at all.  
1363.   With respect to voluntary licensing and purchasing schemes – both of these are pathways 
that can be the means to provide acces s to relevant products.  Our common objective is to get safe 
and effective products to patients as quickly as possible. The mere existence of a product, especially 
a product to treat a global pandemic, does not do anyone any good if it is not reaching the g lobal 
market. We are all working to get these products to market across the globe through various means 
and without unnecessary delays. Diversity in the deployment of these products facilitates that 
process, while being aware of the enormous raw material a nd vaccine supply demands.  
1364.   The United States supports mechanisms for global efforts to accelerate development and 
access for COVID -19 products that are voluntary, complementary and mutually supportive.  
1365.   Accordingly, intellectual property assists in putting partners and collaborators together with 
respect to research and development, manufacturing and voluntary technology transfer IP/C/M/96/Add.1  
 
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  arrangements, and transportation and distribution. These partnerships drive access to innovative 
products and are facilitated by the intellectual property ecosystem.  
15.69   Ecuador  
1366.   The delegation of Ecuador welcomes the propo sal made by India, South Africa, Kenya, 
Eswatini, Mozambique, Pakistan and the Plurinational State of  Bolivia, whi ch raises the possibility of 
Members waiving certain provisions of the TRIPS Agreement, as part of efforts to prevent, contain 
and treat COVID -19, as set out in document IP/C/W/669.  
1367.   We have taken due note of what has been said about document IP/C/W/669 by the 
delegations that submitted the proposal, at the formal meetings on 15 -16 October, and at the 
informal meetings on 20 November and 3 December in the TRIPS Council.  
1368.   We also welcome the criteria presented by Australia, Canada, Chile and Mexico, which cont ain 
questions on the intellectual property challenges experienced by Members in relation to COVID -19 
in document IP/C/W/671.  
1369.   Against this background, we reiterate what was said at the meeting on 20 November, as 
Ecuador believes that with the flexibilities currently contained in the TRIPS Agreement and the 
principles of the Doha Declaration, the proposals under the initiative set out in document IP/C/W/669 
can be addressed. We therefore see no reason to support this initiative at present.  
1370.   Like other delegati ons, we are committed to observing the obligations set out in the 
TRIPS  Agreement, as well as the flexibilities therein and the Doha commitments. Some are looking 
for a positive balance between intellectual property and public health, which is always impor tant and 
even more so today, during a pandemic like COVID -19, which requires collective action to rapidly 
and effectively develop scientific and technological knowledge related to public health.  
15.70   Korea , Republic of  
1371.   The Republic of Korea  supports the Status Report that you Madame Chair presented in the 
present meeting. The report seems to reflect prope rly the state -of-play of the discussions we had at 
the TRIPS Council.  Korea looks forward to having more constructive, and fact -based discussions at 
the TRIPS C ouncil following year. We also thank Australia, Canada, Chile and Mexico for the proposal.  
1372.   For the sake of times, we would like to ask you and the Secretariat to reflect our statement 
made on 20 November where we shared our views on the proposal by South Africa, India and others, 
and where we should put our efforts to ensure appropriate and easy access to medicines for the 
pandemic.  
Korea 's statement at the informal meeting held on 20 November  2020 
1373.   First of all, the Republic of Korea would like to thank S outh Africa, India and Kenya for the 
proposal. Korea fully shares the concerns over the unprecedented global health crisis resulting from 
the COVID -19 pandemic, in particular the disproportionately adverse impact on developing and 
least developed countries .  
1374.   While we share the concerns of the proponents, at the same time, we are of the view that 
the TRIPS Agreement strikes the right balance between the protection of IP rights and the promotion 
of public health, and provides sufficient flexibility, enabling us to cope with the current challenges 
collectively.  
1375.   It is important to remember that IP rights do not  hinder the efforts to tackle the pandemic – 
they are in fact a vital element in resolving it.  
1376.   In fact a well -functioning IP system can serve as an incentive for the much needed innovation 
that leads to the development of vaccines, treatments and other med ical technologies.  
1377.   Moreover, it is imperative to ensure the supply chain of essential products remains open, 
effective and seamless.  IP/C/M/96/Add.1  
 
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  1378.   However, we also note that an effective IP system and global supply chain for those vaccines 
alone will not be sufficient t o address the problems that the developing and least  developed countries 
are facing.  
1379.   In order to ensure adequate and equitable access to COVID -19 vaccines for all countries 
regardless of their income levels, international cooperation is essential.  
1380.   Seekin g to play its own part in the global cooperation, Korea has continued to support and 
contribute to WHO and related global initiatives. In particular, Korea recently participated in the 
COVID -19 Tools Accelerator (ACT -A) Facilitation Council (Facilitation C ouncil of the Access to 
COVID -19 Tools Accelerator) as a market shaper.  
1381.   As a self -funded participant, Korea fully supports the COVAX Facility - both its underlying 
objectives as well as its model of delivery. Accordingly, Korea has been actively participat ing in the 
discussions to get it off ground as soon as possible as one of the founding members of the Friends 
of the Facility.  
1382.   Korea has been also exploring ways to contribute to the provision of vaccines to developing 
countries through the COVAX AMC.  
1383.   We will continue to work with other like -minded governments and international organizations, 
notably WHO and Gavi, to help launch and operate these mechanisms successfully as early as 
possible.  
1384.   Korea, as the host country, is cooperating closely with the International Vaccine Institute 
(IVI). The IVI aims to support equitable and affordable access to vaccines for the developing world 
by accelerating research and development for critical vaccines.  
1385.   We look forward to working closely with even more countries as partners in the IVI to help 
accomplish its noble vision of making vaccines available and accessible for the most vulnerable 
people around the world.  
15.71   El Salvador  
1386.   We would like to thank you for convening this mee ting to continue this important discussion  
as well as the informal consultations and the report you will present to the General Council.  
1387.   As we stated at the outset of the discussion of this proposal, El Salvador considers the 
comprehensive handling and man agement of the COVID -19 health crisis to b e of vital importance.  
1388.   The Government of El Salvador has stepped up its efforts to support affected sectors of the 
population in terms of health, as well as the harsh economic and social impact that has affected 
most of the population. From the outset, El Salvador has effectively controlled the outbreak of cases 
during the pandemic and is the country with the second lowest number of cases in Central America 
and is among the five countries with the lowest number of cases in Latin America. Even before the 
pandemic had spread to the country, the Government anticipated by taking preventive measures to 
ensure the health and wellbeing of its population.  
1389.   In this context, our country has been analysing the proposal in question in detail and in 
depth, both from a soc ial and health perspective and from a legal perspective. In our case, we have 
a health system that is being modernized, which is making it possible for persons in need to access 
mechanisms for COVID -19 prevention, health care and recovery. Efforts are also  being made at the 
highest political level to give priority access to medicines and treatments to contain this health crisis. 
Moreover, it should be noted that in our legal system, there are already strong institutions that 
afford protection for all areas of intellectual property at the national level, in addition to our 
international commitments in this area, of which we are faithful guarantors.  
1390.   Promoting and incentivizing innovation as a tool for boosting and accelerating our country 's 
development is a to p national priority. El Salvador 's scientific and technological progress and 
modernization are becoming increasingly important in these times of crisis and for economic IP/C/M/96/Add.1  
 
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  recovery. In this context, we find it difficult to reconcile such a broad waiver in the  application of 
intellectual property rights with the objectives that we have set as a country.  
1391.   We believe that, as a result of this discussion, we will have inputs for a practical and in depth 
discussion within the competence of this Council, to improve t he intellectual property system, by 
identifying the specific barriers that some Members have faced during the crisis, to address their 
priorities and to seek solutions within the multilateral system, intensifying dialogue and cooperation 
among Members.  
1392.   We therefore thank the proponents of document IP/C/W/669 and document IP/C/W/771 for 
the opportunity to have this discussion. We hope that, in the near future, our delegation will be able 
to show the Council the progress in innovation as a result of the polic ies that are being implemented, 
as well as its impact on the Salvadoran population in helping us to overcome the COVID -19 crisis.  
15.72   New Zealand  
1393.   New Zealand welcomes and supports  the status report. New Zealand has a systemic interest 
in supporting the interna tional trade systems of the WTO.  We support TRIPS and the balance it 
strikes between allowing access and incentivising investment in innovation, manufacture and 
distribution.  Both sides of this balance are essential to the response to the COVID -19 crisis. We 
cannot have one without the other. New Zealand remains strongly committed to the global, equitable 
distribution of COVID -19 vaccines. We participate in the COVAX Facility and support the COVAX 
Advance Market Commitment that will distribute vaccines to d eveloping countries on an equitable 
basis. We are interested to hear more about the concerns raised by Members and the operation of 
existing flexibilities within TRIPS.  
15.73   Mozambique  
1394.   Thank you very much Mme Chairperson, for the floor, and we thank you for all  your efforts.  
We commend the WTO Secretariat and you , Chair, for organizing this meeting, and we would like to 
reiterate our thanks to Me mbers for the level of engagement and discussion of the proposal for a 
waiver.   
1395.   We agree with your proposals on the ti tle for the agenda item, and also agree with the 
language for the information to be orally presented on the status report, during the General Council.  
1396.   The Doha Declaration on Public Health reaffirms the flexibilities contained in the 
TRIPS  Agreement to ad dress the public health needs of the WTO Members. While some Members 
included TRIPS flexibility in their national laws, many did not, and well positioned countries often 
put political pressure on developing countries against the use of TRIPS flexibilities.  
1397.   As stated several times, the magnitude of COVID -19 pandemic calls for solidarity, cooperation 
and for everyone 's action so as to collectively address the challenge. Public Health is a public good, 
and being so, all governments must be committed to globall y address this issue, as a clear 
demonstration of the commitment to solidarity, through supporting the COVID -19-related waiver 
proposal. We align our statement with the ones presented by the proponents as well as the ones 
presented by the co -sponsors.  
1398.   Agenda 2030 of the Sustainable Development advocates the need to collectively advance, 
and leave no one behind. A positive consideration of the requested Waiver would be a substantial 
contribution for the achievement of the Sustainable development Goals.  
1399.   As LDC, even though we do not have to protect patents, many of us do not have production 
capacity and would require importation of the means to address COVID -19, yet conditionalities 
attached to the use of Article 31 and article 31 bis make the use of such flex ibilities very difficult.  
1400.   We would like to refer to the various petitions that appeal for a positive appreciation and 
consideration of the submission by India and South Africa including the co -sponsors, needless to 
mention them one by one, as they represen t thousands of voices launching appeals, for a positive 
consideration of the above referred Submission.  IP/C/M/96/Add.1  
 
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  1401.   We reiterate that the waiver aims to, on a limited time, thus, temporary, just to facilitate the 
necessary actions to ensure provision and delivery of e ssential medical products, pharmaceuticals, 
technology for diagnostics, vaccines and others, that are so important to save and ensure the 
protection, cure and saving lives.  
15.74   Brazil  
1402.   Brazil joins other delegations in thanking you for efforts in finding a cons ensual wording for 
the TRIPS Council 's report on the waiver proposal.  It rightly points out that delegat ions share the 
common goal of providing access to high -quality, safe, efficacious and affordable vaccines and 
medicines for all.  
1403.   We remain available as usual for constructive discussions on the proposal and related issues 
in the future.  
15.75   Jamaica  
1404.   Jamaica is negatively im pacted by the COVID -19 pandemic. As a result, we welcome the 
general objective of the proposal by India, South Africa and co -sponsors, in ensuring that there is 
access to medicines, vaccines and other items n ecessary to manage the spread of the virus. Our 
goal should be to fin d creative ways to assist WTO Members to get the necessary treatment to their 
populations.  
1405.   We therefore look forward to a constructive engagement on this issue and hope that Members 
are able to agree on an outcome that satisfies their concerns, while facilitating initiatives at the 
national and international levels to tackle this unprecedented p roblem.  
1406.   Jamaica continues its assessment of the proposal in capital, as well as other documents 
circulated on the issue. At the same time, we would welcome a continuation of the dialogue on this 
initiative. We endorse the status report and we welcome its adoption.  
15.76   India  
1407.   Thank you Chair for re -convening TRIPS Council meeting in formal mode to continue 
discussions o n the issue of TRIPS Waiver. We would also like to thank you for your efforts in engaging 
Members over the Chair 's status report to the General C ouncil. We look forward to the discussions 
in General Council on the report. We welcome the Plurinational State of Bolivia as the latest 
co-sponsor to our Waiver Proposal. We also acknowledge the tremendous support by Civil Society 
Organisations for the Wa iver proposal. Rarely has an issue being dealt in WTO, united so many 
disparate aspects of society from developed, developing and least developed countries alike in 
delivering a clear message: to put health first and save lives.  
1408.   At the outset, we would li ke to emphasize that this is not a proposal only for India but for the 
global community at large. India may be having the required manufacturing capacity, the national 
legislations to cater to its needs but we believe that in a global pandemic, where every  country is 
affected, we need a global solution . Global community should not be looking inward at this juncture. 
Though we have repeatedly heard that no one is safe until everyone is safe, yet even the most 
optimistic scenarios today cannot assure access t o vaccines and therapeutics for all, even by the 
end of 2021.  
1409.   All of us witnessed the shortages of essential COVID items, like PPE kits, gloves, sanitizers 
etc. during the initial phases of the pandemic. But the world was able to upscale the manufacturing  
of these items by pooling resources and production capacities and thereby overcome the shortages. 
At present, we need the same pooling of IP rights and know -how for scaling up the manufacturing 
of vaccines and treatments, which unfortunately has not been forthcoming, necessitating the need 
for waiver.  
1410.   Today, we have heard about concrete evidence regarding IP barriers experienced by 
Indonesia. We would like to thank Indonesia for coming forward and explaining such evidence to 
Members and we encourage other Members to also share similar experiences that they would have 
faced.  IP/C/M/96/Add.1  
 
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  1411.   Our waiver proposal represents an open and expedited global solution to allow uninterrupted 
collaboration in development, production and supply of health products and technologies requi red 
for an effective COVID -19 response. The Proposal is targeted and proportionate as it seeks waiver 
for a limited period from four specific sections of TRIPS Agreement, namely patents, copyrights, 
industrial designs and undisclosed information, in so far  as they hinder the production of health 
products and technologies, for prevention, treatment and control of COVID pandemic. Every country 
has been taking extraordinary and unprecedented measures, unheard of before. This includes 
requiring weeks and months  of lockdowns, imposing quarantine, nationalising private hospitals, 
mandating wearing of masks, seeking military help etc. Viewed against that, the waiver is definitely 
a proportionate  response to the problem we are trying to address.  
1412.   It is important that  the interventions by co -sponsors at the previous two informal sessions 
are reflected on record of today 's formal TRIPS Council meeting or are circulated as an IP series 
document as written answers by co -sponsors to the questions raised. We have submitted our 
statements of the informal meetings on 20 November and 3 December for this purpose.13  
1413.   We thank Malaysia, Oman, N ew Zealand  and Viet Nam, who have intervened for the first 
time on waiver proposal. We also thank Sri Lanka, Chad, Egypt, Indonesia, Mauritius, the Bolivarian 
Republic of  Venezuela, Jamaica and the ACP Group and China for their support. We appreciate the 
constructive en gagement by Turkey, Singapore, Ukraine, El Salvador, Norway, Canada, 
United  Kingdom, European Union, Japan, Ecuador, Korea, Brazil and the United States. We would 
like to address some of the additional questions that have been raised by some Members at the  last 
informal meeting, and in the present meeting and also some of the overlapping issues raised in the 
submission document IP/C/W/671, though we would be submitting written answers to all the 
questions raised in the submission, at a later stage.  
1414.   Questio n 1: Some delegations have argued that a waiver will bring great uncertainty to the 
IP system and will impact the incentives, while some others have argued that existing flexibilities 
under TRIPS  Agreement are sufficient to address the pandemic and the wai ver is not necessary. 
Also, there have been questions as to what the national implementation of the waiver will entail.  
1415.   Response: In the situation of unprecedented social, health and economic crisis that we are 
facing today, insufficient supply and inequit able access to COVID -19 health products, heightens the 
sense of insecurity and uncertainty. The existing flexibilities under the TRIPS Agreement were never 
designed keeping in view a crisis of this magnitude and are woefully inadequate in context of 
COVID -19 pandemic. We had explained the rationale behind this argument in significant detail over 
the past meetings. However, I would like to reiterate some points raised earlier in our intervention.  
1416.   Article 31 compulsory licences  are issued on a case -by-case, c ountry -by-country basis 
according to national patent law procedures and practices. It is an impractical option if one takes 
into consideration the need for regional and international collaboration to scale up supply, the need 
to source materials from vario us countries , and the need for economies of scale to make 
manufacturing viable. We have already highlighted the limitations associated with the use of Article 
31bis. Countries that have never utilised compulsory license or the Article 31 bis mechanism will 
have to consider what are the national procedures for doing so, what to do if procedures do not 
exists, who should request this license, who should issue the license, what would be the adequate 
remuneration to be paid, what are the requirements of Article 31bis, can an importing country that 
has not implemented Article31 bis in its national law utilise the provision, what are the Article 31 bis 
requirements for the exporting country, what are the national law requirements in the exporting 
country. Many a time s, countries also have to deal with pressures from other trading partners and 
from pharmaceutical companies while dealing with such issues. Given the urgency to save lives and 
the time it takes to get a compulsory license implemented on ground in most of d eveloping countries, 
use of this flexibility in context of COVID -19 pandemic does not present a viable solution.  
1417.   With regard to the question on national implementation, we have addressed this issue at the 
last informal meetings. National implementation of the waiver depends on a country 's political and/or 
constitutional arrangement. There is no one size fits all approach to national implementation. 
However, once the waiver proposal is approved, emergency, disaster management legislations or 
any other releva nt legislative methodology may be relied upon to provide for executive action to 
 
13 On 15 January 2021 the co -sponsors circulated relevant parts of their interve ntions from informal  
meetings held on 20 November and 3 December 2020 in documents IP/C/W/672, IP/C/W/673 and IP/C/W/674 . IP/C/M/96/Add.1  
 
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  operationalise the waiver at the national level. Implementation of waiver at the national level can 
also be done in the same way as the unprecedented steps, like lockdowns, qu arantine and other 
measures, put in place to curb the COVID spread.  
1418.   In contrast to the waiver bringing uncertainty to the IP system, we are of the view that a 
waiver once implemented will provide greater certainty to manufacturers by providing them freedom  
to operate, and for governments to collaborate to increase supply options. Waiver being sought for 
a limited period and that too only from some specific TRIPS provisions in the context of COVID does 
not increase uncertainty for the IP system. Instead it s hows that in exceptional circumstances, the 
IP system can be flexible and accommodating. On the contrary, a rigid IP system that prioritizes IP 
monopolies and profits over peoples ' lives, would present a greater uncertainty to the world today 
in addressing  the COVID crisis.  
1419.   Question 2: The EU has sought an explanation as to how the waiver could operate with regard 
to the vaccine production, including the transfer of the required technology and know -how and how 
it would affect the existing licensing mechani sms and COVAX in general.  
1420.   Response: In the area of vaccines, there are two primary barriers, patents and protection of 
undisclosed information. Patents are used to protect various aspects of the underlying technology 
as well as the product itself. Document  IP/C/W/670 presented by South Africa, presents a 
preliminary non -exhaustive snapshot of the patent filing and granting status on selected therapeutics 
candidates. As the new vaccines emerge, we are likely to see many more patent applications 
concerning al l aspects of vaccines in the coming months.  
1421.   In addition, manufacturing know -how, test data, and cell lines are needed to facilitate 
diversification of vaccine production. Hence the importance of addressing protection of undisclosed 
information under Artic le 39 of the TRIPS Agreement.  
1422.   The wide range of patents and patent applications as well as exclusivity related to undisclosed 
information creates a complex and uncertain legal environment for scaling up vaccine development, 
production and supply. The waiv er, if granted, would provide potential manufacturers the freedom 
to operate and achieve economies of scale, thereby incentivizing production and supply of 
therapeutics and vaccines  
1423.   We also need to recognize that to date most multinational corporations ho lding COVID -19 
vaccine IP have not shown any willingness to openly license or transfer technologies to all competent 
vaccine developers globally. The pharma industry has objected to participation in WHO 's COVID -19 
Technology Access Pool. Existing licenses are non -transparent, restricted and limited. We have 
addressed this matter extensively in the informal consultations.  
1424.   The waiver is about lifting the legal barrier, it does not preclude the possibility of companies 
agreeing to voluntary licenses. COVAX wi ll also benefit from the Waiver as production will expand 
with more manufacturers engaged in manufacturing. With robust competition, prices can also be 
expected to be substantially reduced.  
1425.   In the present meeting, the European Union has reiterated that tr ansfer of technology and 
know -how should be encouraged through licensing. We would like to know how EU plans to persuade 
pharma companies to enter into transparent, non -exclusive global open licenses, where all 
manufacturers can be engaged without any rest rictions, and also what steps EU is taking to ensure 
full transparency and accountability in the cost of R&D and in licensing agreements.  
1426.   We also look forward to hearing from the Members who have argued against the need of the 
waiver, on the four questions that we had raised at the 3 December meeting, namely:  
a. Do the opponents have any data regarding how the waiver would demonstrably have 
negative impact on Members ' economies, if any?  
b. Public funding has been driving COVID -R&D. In addition, billions of dollars are spent on 
purchasing the vaccine. Given the demand volumes, pharma companies will anyway make 
profits. So why is there a need for IP as an incentive, in a global pandemic situation?  IP/C/M/96/Add.1  
 
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  c. Can the opponents provide data as to how voluntary licensing  approaches and existing 
global cooperation mechanisms, including ACT Accelerator, the COVAX facility and COVAX 
AMC, would be sufficient to address the vaccine requirements of 7.8 billion people in the 
world?  
d. If voluntary mechanisms work, why has the pharmaceutical industry collectively rejected 
participation in the WHO COVID -19 Technology Access Pool (C -TAP)?  
1427.   Like the proponents have provided substantive answers to the questions from other Members, 
in the same way evidence -based specific responses to these questions will enable constructive 
engagement and take us closer to our objective.  
1428.   According to the WHO, nearly one third (32%) of vaccines have fewer than four suppliers. 
We would like to ask the WTO Membership how these limited suppliers will be ab le to cater to the 
needs of 7.8 billion global population and if at all, they can, then after how many months and years, 
after how many more deaths, will everyone get access to vaccines and treatments. These are some 
pertinent questions, which we all need to reflect upon, and that can be answered only through true 
solidarity and global cooperation. Our waiver is the only possible solution to scaling up global 
production to address the pandemic, and considering the urgency of the crisis, we need to take 
time-bound action now rather than limiting ourselves to indefinite debate. We also note the 
COVID -19 and Beyond: Trade and Health initiative by EU, Switzerland, Canada and few others, 
which talks about enhanced preparedness to fight against current and future pandemics. History will 
not judge us kindly if we fail to find an expeditious solution to the current pandemic while claiming 
to prepare for the future ones. We hope the Membership can rise to the demand of this crisis and 
demonstrate that WTO can actually  deliver on timely, equitable and affordable access for all, by 
agreeing to the waiver. World will remember the contribution of WTO during the pandemic for 
generations to come. We now have the opportunity to prove that when the situation demands, WTO 
can indeed deliver. Certainly,  the pace of other ongoing negotiations at WTO that have continued 
for more than 20 years, should not be a benchmark for this proposal.  
15.77   Pakistan  
1429.   Pakistan would like to thank you for convening this meeting and the opportunity to onc e 
again address this issue. At the outset, we would like to confirm that we agree with your proposed 
approach to report the status of our discussions to the General  Counc il in its next meeting. We are 
also satisfied with the content of the report. We must emphasise, that while we are happy to debate 
and discuss the issue at length, this proposal is not one which can be discussed endlessly. When 
human lives are at sta ke, we  must find definitive conclusions to our discussions as soon as possible. 
We would the refore, like to see a logical conclusion of the discussion with hopefully, some positive 
outcomes.  
1430.   We have been discussing this proposal in great detail over the past weeks, and we are 
thankful to all the Members who have engaged positively on this burnin g issue. Along with other 
co-sponsors, we have tried to address each and every concern, question or clarification brought by 
the Members submitted in oral statements or in formal, written communications. In fact, we aim to 
submit a written document contain ing answers to all the questions that we have addressed in 
preceding meetings and those that we will address in the present meeting. Meanwhile, we would 
like to request, that our statements and detailed responses presented during the informal sessions 
of the Council may please be made part of the formal record of the TRIPS Council 's meetings. We 
would be happy to share our previous statements with the Secretariat along with this one.14 
1431.   While on the matter of responses, we would like to take this opportunity  to address one of 
the points raised by a delegation in the last meeting s. A few aspects have already been addressed 
by co -sponsor ed colleagues who have spoken before. It was mentioned, during the informal 
consultations and in the present meeting, that adv ance purchase agreements contributed to 
expanding production calling on companies to use licensing mechanisms to maximise production. 
Reference was made to Astra Zeneca 's license with Serum Institute.  
1432.   In our view, the race to secure vaccine supplies throu gh advance purchase agreements is in 
fact, reinforcing inequitable access to vaccines. Even if production is being expanded, it seems to be 
 
14 On 15 January 2021 the co -sponsors circulated relevant parts  of their interve ntions from informal 
meetings held on 20 November and 3 December 2020 in do cuments IP/C/W/672, IP/C/W/673 and IP/C/W/674 . IP/C/M/96/Add.1  
 
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  for the benefit of a few wealthy nations. As reported openly, all of Moderna 's vaccine and 96% of 
Pfizer/BioNTech 's has been acquired by rich countries. It has also been reported that wealthy nations 
representing just 14% of the world 's population have bought up fifty -three (53%) of all the most 
promising vaccines so far. According to several reports, some countries hav e already made 
arrangements to acquire up to nine doses per person, while among 70 developing or poor countries, 
only one out of every ten people will be vaccinated by the end of 2021 given the limitations of the 
COVAX facility. It is also estimated that m any lower income countries could have to wait until 2023 
or 2024 for vaccination.  
1433.   This situation reveals a lack of global cooperation and solidarity to ensure equitable access 
and allocation. More specifically, IP monopolies are limiting vaccine production  and equitable access. 
Regarding Astra Zeneca 's license, it must be emphasised that the license is limited, and insufficient 
to meet global need. Their pledge to provide doses to developing nations, can only reach 18% of 
the world 's population next year at  most according to estimates. Besides, Astra Zeneca 's CEO has 
reportedly opposed any public sharing of technology and IP.  
1434.   While we appreciate the idea of asking companies to voluntarily license and maximise 
production, the strategy does not deliver access . A recent study on the lessons learned from 
voluntary licensing also demonstrates that IP -holding corporations tend to apply restrictive licensing 
terms such as limited geographic coverage of supply and other conditions that limit the benefits of 
competit ion and global supply. We have already seen this happening during the pandemic. The 
global pharma industry has also objected to participation in WHO 's COVID Technology Access Pool, 
as mentioned by a colleague before.  
1435.   In this situation, perhaps a question needs to be raised: how would countries that argue for 
such licensing arrangements, address companies ' conduct and ensure the availability of 
non-exclusive, global, open licenses on reasonable terms and conditions, where all manufacturers 
globally may be e ngaged and all countries may benefit from supply without any restrictions. Also, 
what steps are those countries taking to ensure full transparency and accountability in the cost of 
R&D and in licensing agreements.  
1436.   The waiver proposal is seeking a limited -time, and limited -scope waiver from certain 
obligations under the TRIPS Agreement only to deal with the global pandemic. The waiver not only 
promises to help large populations in developing countries, but would also allow export of medicines 
and medical equ ipment back to developed countries where poorer segments of their populations 
could also benefit. The present, business as usual approach, on the other hand, could perpetuate 
existing global inequalities even in this unprecedented time.  
1437.   In recent weeks, we  have noted that not only has the engagement on the issue gained 
momentum, the proposal has also been continually gaining wide appeal outside our organisation. 
Global leaders, influential lawmakers, public health experts, leading civil society Members, and  
well-reputed media houses, particularly from developed countries have all come out in support of 
this proposal. Members of the academia, international, governmental and non -governmental 
organisations, and many social and religious groups have all highligh ted the pressing importance 
and merits of the proposal. We are happy to note that even the WTO has covered it briefly in its 
news. We hope the Secretariat will continue to provide due coverage to this most important matter. 
The extensive international cove rage, across developed and developing countries alike, is testimony 
to the importance and validity of the proposed waiver.  
1438.   In conclusion, we would like to thank you and the Secretariat and all Members for their 
engagement and attention to this pressing ma tter. We look forward to continuing our discussions in 
the coming days.  
15.78   Switzerland  
1439.   Switzerland supports the status report to the General Council . My delegation would like to 
thank you, Chair, for the consultations held with the view achieving consensus an d we welcome the 
adoption of the status report by the Council that morning.  IP/C/M/96/Add.1  
 
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  1440.   The discussion in the Council so far shows that Members share the same understanding of 
the extraordinary nature of the crisis that the global community faces due to the COVID -19 
pandemic.  
1441.   Members are united in the objective to undertake all necessary efforts to work as swiftly as 
possible towards global and equitable access to medical products to prevent, contain and treat 
COVID -19.  
1442.   Members disagree that suspending large parts of  the TRIPS Agreement during the pandemic 
would help us achieve this objective. Many think that doing so will actually work against this 
objective.  
1443.   Switzerland is of the view that such a step would indeed be counterproductive. It would result 
in considerab le legal uncertainty at the national and international level. It would thus put into 
question a key component of the basis on which stakeholders currently engage in international 
initiatives and partnerships to make fast and equitable global access to medi cal products against 
COVID -19 a reality.  
1444.   We thank South Africa for its communication in document IP/C/W/670. It is based on the 
assumption that IP will work as a barrier to the access of medical products against the coronavirus. 
However, the communication  presents no convincing evidence that would justify a sweeping 
suspension of large parts of the TRIPS Agreement, rather than, if necessary in a particular case, 
making use of a flexibility already built -into the TRIPS Agreement.  
1445.   We thank also Australia, Ca nada, Chile and Mexico for their communication in document 
IP/C/W/671, in which a number of relevant questions are posed which merit further examination.  
1446.   My delegation thus agrees that this Council continue its discussion, so that the proponents 
and other  Members can answer the questions posed and still open from the three past meetings or 
contained in the communications just referred to.  
1447.   Let me conclude by emphasizing that we need to address this challenge together, in a holistic 
and sustainable manner - and within the rules -based multilateral trading system.  
1448.   Yes, our imminent and most urgent common concern is now how to effectively fight the 
COVID -19 pandemic, causing tragic loss in human lives and enormous economic damage to all our 
countries and to the international community at large.  
1449.   International initiatives underway to work for this collectively are key, such as WHO 's COVAX, 
COVAX Advance Market Commitment or Act Accelerator. Accordingly, we call on all Members to 
engage in these initiatives.  
1450.   As WTO Members, it is also our responsibility to think of the long term consequences of our 
decisions and the impact of our actions on the rules -based multilateral trading system. Were we to 
suspend large parts of a WTO Agreement during this pandemic that emb odies a collective consensus 
for more than 25 years and of 164 countries: What signal would we send to the outside world on 
the reasons of existence of the multilateral regulatory framework, on its utility and reliability? In our 
view, it is essential that  solutions to the unprecedented challenges we face be found within that 
framework - and not by giving up on it.  
1451.   COVID -19 will not be the last pandemic, or virus, or pressing health or other serious problem 
that humanity faces and will have to fight against . We only stand a chance to do so together, in 
close partnership and solidarity, with all the necessary stakeholders involved and on board, and with 
the support of a solid, trustworthy, rule -based multilateral system.  
15.79   Israel  
1452.   On behalf of Israel, we want t o express that we agree with the report 's content to be delivered 
at the upcoming General C ouncil. Regarding our position, we do not want to reiterate our views , 
which were expressed during a previous meeting and in different configurations and so far rema in 
the same.  IP/C/M/96/Add.1  
 
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  1453.   Israel is mindful of the concerns raised by the waiver 's proponents, and we look forward to 
engaging in good faith to address their concerns.  
15.80   Colombia  
1454.   Colombia is taking the floor to once again thank the delegations that co -sponsor ed this 
proposal for bringing this discussion to the TRIPS Council and for their statements, with a view to 
addressing some concerns. As we have reiterated, this is a matter to which Colombia attaches the 
highest importance, even more so in these difficult  times broug ht about by the COVID -19 pandemic.  
1455.   Taking note of the report that would be submitted by you, Madam Chair, to the 
General  Council, we look forward to the continuation of this discussion in this forum in due course.  
15.81   Bangladesh  
1456.   The delegation of Bangladesh we lcomes this meeti ng of the TRIPS Council for the discussion 
of this important issue . My delegation  fully endorses the note that will be taken to the General 
Council the  
1457.   As my delegation stated earlier that the issues of public health should not be seen fro m a 
narrow perspective, since we live in an interdependent and interconnected world. A threat to public 
health in one society puts humanity at risk everywhere and we should work collectively.  
1458.   The ongoing pandemic is primarily a health issue, but this evid ently has far reaching impacts 
on education, human rights, food security and economic development in the long term. 
Unconditional, affordable and timely access to vaccine and other curative measures against the virus 
must be a priority of the time. Product ion and distribution of vaccine and other medical equipment 
for containment, and treatment of COVID -19 should be open to all, so that people of the world - 
irrespective of their development status – can easily access the vaccines and other facilities. The 
TRIPS or any other regulatory framework should not be considered as a hindrance to the most urgent 
needs of the humanity.  
1459.   I will finally thank you for continuing this meeting. The delegation of Bangladesh once again 
requests a favourable consideration of this important proposal.  
15.82   Tanzania on behalf of the African Group  
1460.   We are speaking on behalf of the African Group to reiterate our position which was previously 
stated in the Council. We support the joint sub mission by South Africa, India, and the other 
co-sponsors, in the document IP/C/W/669, whic h, the African Group is supporting. At the moment 
we are still consulting with the view that we will be co -sponsoring.  We want to remind Members that 
the WTO has the responsibility to contribute to the promotion of the equitable and affordable access 
key products necessary for the prevention, containment, and treatment of COVID.  
1461.   From the very beginning, when the spread of the virus started we several times stated that 
this Council has a role to play to ensure that Me mbers can achieve maximum cooperation among 
themselves, among international institutions, private sector to ensure that we get a breakthrough 
of this challenge that we are having and to make sure that whatever is going to be are developed in 
terms of many commands of vaccines it would be available to all. Having said that the 
TRIPS  Agreement it has to ensure to all Members that they are not prevented in any way. They are 
not having difficulties to obtain the vaccines, treatments for the COVID -19. The challe nge that we 
are having at the moment it should be a priority for all Members and that makes the relevancy of 
our Council and the ordinary contribution that we can make at this moment. We want to call for 
solidarity among Members that we can come together t o find a solution that is going to be 
unequivocal.  
1462.   With regards to the proposal, it will be something that will be appreciated actually by the 
global community as to our contribution. We express our support to the proponents of this joint 
proposal.  IP/C/M/96/Add.1  
 
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  15.83   Botswa na 
1463.   Actually my colleague from Tanzania pretty much covered what I wanted to say. But perhaps 
a small addition to support that statement just to emphasise the importance o f this issue, especially 
in view of our country that are quite left out of resources a nd ye t they provide universal access to 
health free of charged to our people. So issues of access and affordability, and the ability to have 
legal health programmes are quite important, and we think that this initiative could go along with 
helping us in th is regard.  
15.84   South Africa  
1464.   Like others we would like to thank you for the report presented this morning which will go 
forward to the General Council, as well as all delegation that worked constructively to make sure 
that this would happen.  At the informal meeting of 20 November and 3 December respectively, 
proponents reverted to questions posed by several delegations. We would like to ask that our 
responses during those meetings be made part of the record of the present formal meeting. I le ave 
the Secretariat to decide how this should be done.15  
1465.   Taken also that there were issues raised by the proponents of document IP/C/W/671, we will 
also in our present intervention come back to some crosscutting issues that were raised in that 
submission , and, as confirmed at the last meeting , we will revert with written responses to the 
questions that were raised by these particular Members.  
1466.   We have also see n new Members took the floor in the present meeting that had not  previously 
spoken and so we are he artened at the level of engagement and also would wish to take the 
opportunity in joining our other co -sponsors to welcome Bolivia to our ra nks. 
1467.   In the present meeting some new issues also arose from interventions including questions 
from various delegatio ns - specifically, the delegation of Norway and Viet Nam – regarding  possible 
modifications of the scope of this waiver. The co -sponsors stand ready to discuss the scope of the 
waiver proposal. I think we also have been open to th ese approaches. We want to  note that in our 
bilateral meetings with many of the Members who may have concerns about the application of the 
waiver , there has always been any principle d objection to look at the language so we welcome this 
development as a positive one.  
1468.   We would also like to thank the United Kingdom for the statement that they made and we 
take good notes of their efforts to explore how products and technologies are quickly made available 
to the WHO 's C-TAP initiative. This is one of the avenues of course that they alwa ys say, our waiver 
supports, and so all efforts are welcomed to scale up reduction and to ensure access to COVID -19 
products and technologies.  
1469.   In the interim , there has also be en noteworthy development in policy guidance that would 
have been issued by some  of our Members, including the European Union.  So we take note of its IP 
action plan and its pharmaceutical strategy, which has direct bearing on our discussions in the 
TRIPS  Council , an issue that I will come back to the little bit later on.  
1470.   We have heard from delegations opposing the waiver proposal have repeatedly suggested 
that voluntary approaches offer the best solution. We have emphasized, the TRIPS waiver proposal 
is supportive of any voluntary licenses issued by companies, however the terms of such licenses are 
often such that they may restrict access or reserve supply only for wealthy nations. Similarly, for 
vaccines, bilateral deals are being signed by pharmaceutical companies with specific governments , 
but the details of these deals remain unknown. Usually these agreements are for manufacturing of 
limited amounts and solely supplying a country 's territory or a limited subset of countries. Ad hoc , 
non-transparent and unaccountable bilateral deals that artificially limit supply and comp etition 
cannot reliably deliver access needed during a global pandemic. These bilateral deals do not 
demonstrate global collaboration but rather reinforces "vaccine apartheid " and enlarges chasms of 
 
15 On 15 January 2021 the co -sponsors circulated relevant parts  of their interve ntions from informal 
meetings held on 20 November and 3 December 2020 in documents IP/C/W/672, IP/C/W/673 and IP/C/W/674 . IP/C/M/96/Add.1  
 
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  inequ ality. Disparity in access is certain to continue un less concrete steps are taken to address 
intellectual property barriers.  
1471.   If what the EU, the US and Japan is suggesting is correct, namely that the IP system is 
responsible for delivery of vaccines in record time , it could fly in the face of the heroic ef forts of 
ordinary people, researche rs, scientists and government support and funding to enable this 
monumental fe at. Not companies , but ordinary people have generously donated the skills and efforts 
to enable global collaboration by participating in vaccin e trials - many in developing countries - 
putting their lives at risk for the greater good of mankind . Yet, the irony does not escape us , these 
very people a denied priority access despite the enormous sacrifices that they have made.  
1472.   We also just want to quickly revert to several questions that were posed as to why the scope 
of the waiver extends not only to patents, but also to trade secrets, copyright and industrial designs 
and also what the evidence is, that the waiver will address these issues.  The co -sponsors presented 
elaborate answers, and so, if delegations want a reference, they could read the statements that 
would have been delivered.  
1473.   Other questions would have also been posed as to how the waiver would resolve issues 
related to COVID -19 preventi on, containment and treatment and what evidence we have to present. 
Similarly, these would have been addressed during the last meeting , but for consistency and perhaps 
impact , I would want to come back on to one or two of these issues.  
1474.   The co-sponsors have been asked which measures would fall within the scope of the waiver 
and whether measures that are indirectly related would also be included within the scope of the 
waiver , and who would make those determinations. We clarified, in our last statement, that the issue 
is not whether a measure is directly related or indirectly related. It is a matter of what is needed to 
prevent, contain and treat COVID -19. Any measure that is not in relation to the treatment of the 
COVID -19 would not be covered  by the scope of the waiver. For instance, a therapeutic for cancer 
treatment would not fall within the scope of the waiver. The waiver proposal is very specific to 
COVID -19, its prevention, containment and treatment; and therefore, is proportionate. Contr ary to 
some of the concerns that we heard in the present meeting. It does not apply to other diseases, 
although we are aware of severe access challenges in other disease areas as well. It does not apply 
to other sectors. We have been particular in excludin g protection of Performers, Producers of 
Phonograms and Broadcasting Organizations under Article 14 of the TRIPS  Agreement , although it 
falls within the ambit of copyright, as it would not be relevant to the prevention, containment and 
treatment of COVID -19.  
1475.   The waiver proposal does not cover all aspects of the TRIPS Agreement, this should be very 
clear. So we cannot agree to broad statements that says that the waiver invalidates large parts of 
the TRIPS Agreement this is not correct and we  have cited exam ples such us the waiver does not 
include GIs, trademarks, layout of integrated circuits etc.  
1476.   We have heard in this meeting, just as a further clarification, issues of safety, quality, and 
counterfeit medicines being raised. I want to clarify once and for all, the waiver request does not 
extend to trademarks and counterfeit trademark goods as defined in Article 51, was referenced to 
footnote 14 of the TRIPS Agreement. The TRIPS provisions in relation to these continue to be 
applicable. I want to emphasize this particular point. The grant of intellectual property or the fact of 
being an IP holder, does not provide any assurances that the protected subject matter is of a 
particular quality, efficacy or safety standard. Even originat or products of multinational  
pharmaceutical companies have been recalled in the past for failing quality standards . Therefore , 
regulatory oversight is required and this shows that the grant of intellectual property ha s nothing to 
do with quality , safety or efficacy.  
1477.   All medical produ ct marketed in a country has to obtain marketing authorization from the 
national medicines regulating authorities or agency. Which provides authorization after quality 
checks. And so the issue of quality of a diagnostic therapeutic or vaccine is determined  by the 
national medicine regulatory authority and not by the IP system as such.  
1478.   At the international level , I want to add that the World Health Organization has a member 
state mechanism that looks at substandard and falsified medical products. So, to con clude on this 
point, we urge WTO Members not to confuse and conflate issues of quality of a product with issues IP/C/M/96/Add.1  
 
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  of intellectual property of medical products. These are separate issues . In the past such conflation 
has led to the seizure of quality generic m edicines by customs authorities  at European ports,  
hindering inter alia  international aid programmes and public health.  
1479.   We have also heard from some countries  that have queried why TRIPS flexibilities and COVAX 
are insufficient to address the challenge s of access posed by COVID. We have addressed this matter 
extensively at the last TRIPS Council. We reiterate that the targets set by A CT-A, including the 
COVAX , is to provide 2 billion vaccine doses (for 1 billion people) to the world by the end of 2021, 
245 million courses of treatment and 500 million diagnostic tests to LMICs (excluding many 
developing countries) in 2021 are insufficient to meet global needs of  the 7.7 billion people of this 
world. As we see vaccine roll -outs in the developed world, we cannot but wonder when equitable 
and timely access will become a reality, with more than 90% of all future production of likely vaccine 
candidates being reserved for rich developed countries.  This cannot be the case.  
1480.   With respect to TRIPS flexibilities, as mentioned in our previous statement, these flexibilities 
have played an important role in promoting access but were never designed to address the access 
challeng es of a pandemic.  In the present meeting we would li ke to revert to a few more questions 
that were raised on 3  December 2020.  
1481.   The delegations of Brazil, EU and Switzerland have referred to IP/C/W/670 and indicated that 
the mere existence of patent or paten t applications does not amount to a barrier. The EU mentioned 
that it would be interested to know more about these medicines.  
1482.   Document IP/C/W/670 presents a preliminary non -exhaustive snapshot of the patent filing 
and granting status o f five selected thera peutic candidates that are under review by the WHO Access 
to COVID -19 Tools Accelerator (ACT -A), under its therapeutics pillar. Due to the interval between 
the time of patent filing and publication, which can take up to 18 months, new patent applications 
that might have been filed this year , may emerge in the coming months.   
1483.   The first table shows  a patent for Regeneron 's new monoclonal antibody REGN10993 and 
REGN10987 , granted in the United States in June 2020, and which expire only in 2040. Information 
on patent applications filed globally should emerge in several months. It is not clear the access 
strategy of Regeneron on this therapy remains unknown.  
1484.   Document IP/C/W/670 also reveals high levels of patent filing and granting on other 
COVID -19 candidates. M erck's Molnupiravir (MK -4482) has primary patent applications filed in at 
least 28 jurisdictions, including two regional patent offices, expiring between 2035 and 2038. Atea 's 
pharmaceutical AT -527 has primary and secondary patents filed or granted in near ly 60 jurisdictions, 
expiring between 2036 and 2038. There are several other candidates we have also looked into. 
Document IP/C/W/670 also presents the patent landscape for Pfizer/BioNTech and Moderna 
vaccines.  
1485.   Patents confers its holder exclusive rights.  With these monopol ies the patent holder is able 
to prevent other competent manufacturers from producing and supplying the patented subject 
matter, as well as to charge exorbitant prices for the se patented medicines, hence hindering the 
timely access to af fordable treatment.  
1486.   The patent landscape as contained in document IP/C/W/670 is merely a warning shot of the 
existing and emerging patent barriers to access and the need for the international community to 
take urgent action to overcome these barriers so t hat supply may be diversified and scaled -up. 
Access to this type of information is critical to ensure further transparency and accountability and 
we have heard , both in the present meeting and in previous meetings , interventions on that point. 
However, at WIPO we have heard that the United States of America has objected to the update of 
WIPO 's review of the existing research on patents and access to medical products and health 
technologies to extend the publication period to up to 2020. In light of the dest ruction brought by 
COVID -19, one wonders what the United States concerns would be regarding the update of this 
report by the WIPO Secretariat.  
1487.   We want to revert to another question which was posed by the EU , regarding the domestic 
implementation of the wa iver, why it would be easier to carry out than introducing fast -track 
procedures for compulsory licensing on the basis of the existing system?  IP/C/M/96/Add.1  
 
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  1488.   Under the TRIPS Agreement, the flexibilities are simply insufficient to address the global 
access challenges that we are facing. In the informal sessions, we have elaborated on this point. 
With respect to fast -track procedure, under Article 31 of TRIPS Agr eement, there is the option to 
issue a compulsory license on grounds of national emergency or other circumstance s of extreme 
urgency , without engaging in prior negotiations with the patent holder. However , in practice, its use 
is dependent on requirements contained in national laws and regulations. Importantly , this 
compulsory license is limited by the condition set in Article 31(f) , that it has to be predominantly for 
the supply of the domestic market, meaning only very limited export is allowed.  
1489.   To expor t, the requirements of Article 31 bis would have to be followed, and this includes 
issuing compulsory licences  in the importing and exporting countries, and compliance with other 
procedures.  The importing country will have to notify the Council for TRIPS, t hat: 
a. specifies the names and expected quantities of the product(s) needed ;  
b. confirms that the eligible importing Member in question, other than a least developed 
country Member, has established that it has insufficient or no manufacturing capacities in 
the pharmaceutical sector for the product(s) in question in one of the ways set out in the 
Appendix to the Annex of the TRIPS Agreement; and  
c. confirms that, where a pharmaceutical product is patented in its territory, it has granted 
or intends to grant a compu lsory licence in accordance with Articles 31 and 31 bis of this 
Agreement and the provisions of the Annex to the TRIPS Agreement.  
1490.   The exporting Member shall notify the Council for TRIPS of the grant of the licence, including 
the conditions attached to it. The information provided shall include the name and address of the 
licensee, the products for which the licence has been granted, the quantities for which it has been 
granted, the countries to which the products are to be supplied and the duration of the l icence. The 
notification shall also indicate the address of the website whereby before the shipment, the licensee 
is required to post information about the quantities being supplied to each destination and the 
distinguishing features of the product(s).  
1491.   Products produced under the licence have to be clearly identified as being produced under 
the system through specific labelling or marking and suppliers should distinguish such products 
through special packaging and/or colouring/shaping of the products thems elves.  
1492.   These are just some requirements of Article 31 bis. National laws may include other 
requirements.  
1493.   These conditions cannot be referred to as a fast -track process. In fact the process of issuing 
CLs will have to be repeated again as more effective me dical technologies enter the market. They 
are also not conducive to achieving economies of scale, which are crucial to motivate large scale 
manufacturing and lower prices of medical products. The current circumstances are especially 
problematic for countri es with insufficient manufacturing capacity.  
1494.   It is a lso worth recalling that Article 31 and 31 bis only address patent barriers while there 
are also challenges with respect to protection of undisclosed information, a barrier which remains 
unaddressed. O ur colleagues have addressed problems surrounding Article 39.3  so I will not go into 
the matter furth er.  
1495.   Further if the waiver is adopted, it is a one -time implementation, and may be achieved 
through executive action. It swiftly addresses all relevant IP barriers. And with its implementation, 
legal barriers to collaboration, development, production and s upply are lifted. A waiver also provides 
legal certainty as to the freedom to operate, economies of scale can easily be achieved and with 
supply expanded, substantial price reduction s may be expected, which may lead to timely affordable 
access.  
1496.   Strangely,  developed countries are placing emphasis on use of TRIPS flexibilities, but why is 
pressure been applied on developing countries for implementing public health safeguards in their 
intellectual property laws and policies, through EU 's annual IP enforcement  report and US ' annual 
"Special 301 Report ", released in the midst of COVID -19.  IP/C/M/96/Add.1  
 
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  Concluding remarks and questions to delegations that have raised opposition to the waiver proposal.  
1497.   At the 16 October 2020 TRIPS Council  meeting , the United States said: "Where intellectual 
property rights exist, they can be licensed to companies around the world to scale up 
manufacturing ". Other delegations have also argued in the same manner. We have few questions to 
these delegations:  
a. If VL me chanisms work, why do various license agreements concluded by various 
companies exclude half of the world 's population from supply and only license to a few 
very specific manufacturers. Why is it that no one knows the full terms of the license?  
b. If VL mecha nisms work, can full details be provided of all voluntary licenses signed with 
companies all over the world to scale -up manufacturing and for global supply . We would 
like to know the full terms of the licenses, with whom these licenses have been signed, 
which countries will be supplied, when will they be supplied etc.  
c. If VL mechanism s work why was Oxford/Astra Zeneca license to the COVISHIELD vaccine 
assigned only to one company in India and a public sector manufacturer in Brazil,  when 
these licenses and technology transfer could have been given to any manufacturer who 
has technical capacity?  
d. If VL works then why are there geographical restrictions in the VL to limit supply to only 
to low - and middle -income countries (LMICs) under the agreements, excludin g supply to 
other developing countries?  
1498.   We are taking note that the issue of classification of countries based on singular criteria such 
as per capita GDP, many times ignores the deep and persistent structural deficits between developed 
and developing coun tries. 
1499.   Some delegations had asked for data regarding how certain obligations have systematically 
hindered prevention, treatment, and containment of COVID -19 so that a waiver is needed. We 
consider the discussion of the current proposal an acknowledge ment of the limitation of the existing 
legal options and the need to provide additional flexibility at the international level. We have 
presented the examples and indications sufficient for Members to consider endorsing the waiver 
proposal, including illustrativ e examples as per our previous interventions. We would like to thank 
Indonesia for sharing its national experiences in this regard. We call on other Members to do the 
same.  
1500.   Improving the readiness of law can be done based on due consideration of the proba bilities 
of events. This has been reflected by a few Members who quickly amended domestic laws to get 
ready based on such probabilities. So, we would like to ask Canada, Germany and Hungary, when 
they decided to swiftly amend national laws to enable quicke r use of compulsory license, what kind 
of data was relied upon at that time demonstrating the necessity of revising the law? We refer to 
the Secretariat note and compilation of COVID -19 measures.  
1501.   TRIPS flexibilities are important to increase access to medi cines and other medical product 
not just in times of pandemics. Why has pressure been applied on developing countries for 
implementing and supporting public health safety in their intellectual property laws and policies. We 
have already indicated the impac t of this actions by the EU  and the US on th ese particular efforts . 
1502.   Several delegations highlight ed TRIPS flexibilities, particularly compulsory license under 
Article  31 and Article 31 bis, as important and need to be used. We recalled how developing countr ies 
have been under pressures and discouraged from using those flexibilities for a long time. The EU 
and Switzerland both highlight the flexibilities as the key measures for Members to use . Does it 
mean the EU and Switzerland will from now on commit not to  pressure developing countries when 
they improve their laws on compulsory license and other TRIPS flexibilities or make use of 
compulsory license s? Would the European Union from now on exclude compulsory license and other 
TRIPS flexibilities from its IP en forcement report? Certainly, the same question could be asked to 
the United  States.  
1503.   We notice the recent IP action plan and pharmaceutical strategy published by the 
European  Commission urges EU Members to use fast track compulsory license and explore 
coordinated compulsory license in EU. In launching the Pharmaceutical Strategy for Europe, Vice 
President Schinas underscored the importance of transparency of R&D costs in ensuri ng access to IP/C/M/96/Add.1  
 
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  affordable  medicines.16 In his remarks to the press on 25 November 2020, Vice -president Schinas 
said,  
Equally important, ensuring affordability of medicines will be guaranteed through 
bolstering transparency on R&D costs and expenditure on me dicines in healthcare 
systems, finding a consensus on costing principles and addressing aspects that impede 
the competitive functioning of the markets impacting on affordability.  
1504.   This principle resonates squarely with our submission to the October 2019 TRI PS Council and 
the WHO Transparency Resolution (WHA72.8). Could the European Union provide more details on 
how it intends to ensure  the "affordability of medicines " through the "bolstering of R&D costs "? 
1505.   The EU IP Action Plan, released on 25 November 2020,  reiterates the exigent need to deploy 
COVID -19 technologies, "not only in Europe but also on a global basis. " 
1506.   To this end, the EU IP plan calls for "voluntary pooling and licensing of intellectual property 
related to COVID -19 therapeutics and vaccines, in  line with the recent resolution of the World Health 
Assembly to promote equitable global access as well as a fair return on investment. " Can the 
European Union elucidate further on how they intend to transform this lofty rhetoric into concrete 
action? The  EU IP Action Plan notes that the Commission is "working on mechanisms that would 
enable and incentivise the rapid pooling of critical IP in times of crisis ". Could the European Union 
please explicate on these mechanisms that would enable the "rapid poolin g of critical IP in times of 
crisis. " 
1507.   Following on from President Ursula von der Leyen 's State of the Union call for the 
establishment of an EU BARDA, the EU 's IP action plan calls for the development of an "effective 
framework for march -in rights, that sh ould guarantee that publicly funded IP is available in case s of 
critical shortages ". Could the European Union please provide details on the design of these march -in 
rights?  
1508.   We would counter the EU's assertion that compulsory licensing should be used as "means of 
last resort and a safety net when all other efforts to make IP available have failed. " Nonetheless, 
could the European Union please provide further details on the EU IP Action Plan 's recommendation 
to EU Members to "establish fast -track procedures t o issue compulsory licences  in emergency 
situations "? 
1509.   The Commission will explore with member  states  the possibility of creating an emergency 
coordination mechanism, to be triggered at short notice when member  states  consider issuing a 
compulsory license. What is the rationale behind this policy decision? Further, how reflects many of 
the concerns that w e have put forward in our waiver proposal.  
1510.   I want to end by thanking all Members who took the floor with very positive interventions. 
As indicated, we will study these interventions more closely and will revert in writing at the 
appropriate time in order t o further answer  questions that would have been posed.  
15.85   Nepal  
1511.   Thank you Chair for convening this meeting and giving me the floor. My delegation would 
like to extend sincere appreciation to the delegation of India, South Africa, and other proponents for 
this submissio n. I would like to reiterate our statement made at the meeting of the TRIPS Council in 
October and would like to support this submission.  
1512.   Furthermore, I would also like to support the report that you presented that morning. My 
delegation would like to req uest all Members to positively consider this submission.  
15.86   European Union  
1513.   I just wanted to thank South Africa for the very specific questions and interest in our 
pharmaceutical strategy and IP action plan, and there  were a lot of  questions for further clarification 
 
16 https://ec.europa.eu/commission/presscorner/detail/en/speech_20_2212 . IP/C/M/96/Add.1  
 
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  and providing more information. We are very happy for the interest in these  initiatives, and of course 
we will provide in the next session an answer to these questions. It would be great to have them in 
writing and hope  that South Africa can provide us with the list of questions in writing because it 
concerns to specific issues on this initiative so that we can respond to them adequately.  
15.87   Vanuatu  
1514.   Thank you Chair for your e xcellent effort in guiding the discussion on an i ssue that is very 
important for all of us , and for the world at th is time. We also are following very closely this 
discussion and we would like to indicate support for the oral report that you have circulated and that 
has been endorsed this morning for the  consideration of the General Council next week. And we also 
welcome the proposal by South Africa and India.  
1515.   We took note of the questions that have been posed by Canada and others on Article 31 . We 
certainly want to encourage further discussion on these i ssues to enable us to find a solution on the 
proposal in question.  
16  WORK PROGRAMME  ON ELECTRONIC COMMERCE  
16.1  Chad on behalf of the LDC Group  
1516.   We have had days of  intense work. The LDC  Group welcomes your leadership, and also thanks 
our interpreter friends for their flexibility. At the same time, we thank our colleagues and friends in 
the Secretariat, the Intellectual Property Division for their support and the doc umentation made 
availa ble to Members to deepen the reflection on the various items on the Council 's agenda.  
1517.   As you have reminded us, and in view of the time available, we prefer to send our statement 
on this  agenda  item to the Secretariat so that it can be recorded in the minut es of our meeting.  
16.2  China  
1518.   China thinks that IP and e-commerce is an important issue and is willing to engage in the 
discussion at the TRIPS Council. China is of the view that the discussion here should follow the 
mandate of the 1998 Work Programme , includin g protection and enforcement of copyright and 
related rights, protection and enforcement of trademarks, and new technologies and access to 
technology. We attach special value to discussing improving developing Members ' access to 
technology. We would also encourage all Members  to share polices, measures, practices and cases 
with regard to intellectual property and e -commerce.  
16.3  Bangladesh  
1519.   The delegation of Bangladesh endorses the sta tement delivered by Ch ad on behalf of th e 
LDCs.  
1520.   Considering the high relevance of electronic commerce, the G eneral Council  in 1998 , in its 
decision WT/L/274 , established a work programme  on electronic commerce and asked the four 
bodies, namely the Council for Trade in Goods, the Council for Trade in Services , the TRIPS Council 
and the Committee on Trade and Development  to examine the issue of electronic commerce in 
relation to the work of their respective jurisdictions and report to the G eneral Council  accordingly. 
Other WTO bodies were also ask ed to inform the General Council of their activities relevant to 
electronic commerce.  
1521.   The delegation of Bangladesh submitted a draft Ministerial decision document 
JOB/GC/152/Rev.1 in 2017. The main objective, among others, was to request the General Council 
to ask the four bodies to conclude the discussions on the work programme  assigned to them and 
report to the General Council .  
1522.   My delegation considers that the su bmission is still valid and should be further discussed to 
implement the General Council 's decision. My delegation also requests that this item should also be 
kept in the agenda for the future meetings of the TRIPS Council . IP/C/M/96/Add.1  
 
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  16.4  South Africa  
1523.   We support inscribi ng this  agenda  item as a standing item , which will be consistent with the 
ministerial mandate and to increase the opportunity for delegations to discuss the importance of the 
work programme  on e-commerce , as well as the impact of the Council decision that extend s the 
moratorium with regard to the application of customs duties to electronic transmissions. 
South  Africa,  in its last submission to the TRIPS Council contained in  document  IP/C/W/666 , has 
argued for TRIPS flexibilities beyond the normal access to medicines and medical technology, which 
still remain under -utilized.  
1524.   We argued that the COVID -19 pandemic requires a more integrated approach to TRIPS 
flexibilities that include various other  types of intellectual property (IP) rights , including copyright, 
industrial designs and trade secrets. The use of TRIPS flexibilities in other areas of intellectual 
property, beyond patents, is less understood at the national level. In fact, in other fiel ds of IP, 
national IP laws may not even provide for sufficient flexibilities to address issues of access. A variety 
of IP rights are relevant in the fight against COVID -19. We referred to various examples where more 
discussion would be needed , including re garding 'big data ' outside the health system. The number 
of recogni zed IP rights have remained constant, however as the digital economy evolves, there may 
be a need to assess to what extent the existing system is capable of dealing with new demands of 
the digital economy. We also raised the use , and the impact of the use , of new technology such as 
3D printing technology.  
1525.   Through these examples , South Africa demonstrated how the interface between IP and new 
technologies such as 3D printing may require a bet ter understand of how a balance may be achieved 
between the interests of rights holders and third parties. More particularly , we pointed to the growing 
importance that trade secrets play in IP protection . We demonstrated a clear need to examine what 
role t rade secrets play during global pandemics. We suggested that now is the time to re -examine 
trade secre cy and its impact on our collective health.  
1526.   The digital economy requires a broader sharing of information to increase global welfare as 
oppose d to only b enefitting a narrow band of beneficiaries and owners of IP rights. The current 
global regime of intellectual property rights is inadequate for serving the purpose of economic 
development and welfare. In a digital environment the discrepancies that exist in  the real world are 
magnified . It is time to think how IP regimes should be retrofitted to ensure that public welfare 
remains at the core of the system , recogni zing that knowledge is a public good. There may be other 
ways of protecting intellectual propert y rights which do not involve traditional tools such as patents 
or copyrights  – we should explore such options. To what extent could centralized open systems 
based on block chain technology promote the open sharing of information and competition without 
undermining the value of innovation and rewarding innovators in a fair and transparent manner.  
1527.   Maintaining this item as a standing item on the agenda of the TRIPS Council will be compatible 
with the high importance that our Ministers have accorded to the 19 98 Work Programme  and will 
also reflect practices that we see in other councils where the 1998 Work programme  is a standing 
item. We hope to introduce various contributions that will advance our discussion and understanding 
of the impact of IP in the context of the digital economy. The importance of building an inclusive and 
development -friendly IP system remains  very high on the agenda of the TRIPS Council specifically , 
and – more generally  – the WTO.  
16.5  Tanzania on behalf of the African Group  
1528.   The African Group welcomes your initia tive to hold consultations on this subject, and on how 
the Council should approach its  mandate. Our interest is to continue discussing the e-commerce 
Work Programme  within the context of the TRIPS Council. We believe that inserting this as a standing 
agenda item in the Council meetings would contribute to the knowledge generation and consen sus 
building on issues at the intersection of intellectual property and e -commerce.  
1529.   While COVID -19 has highlighted the importance of digital connectivity and e -commerce, it 
has brought to light the implications of the digital divide both within and betwee n countries, 
particularly infrastructural gaps to enable e -commerce in Africa, and how to develop it.  IP/C/M/96/Add.1  
 
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  1530.   Furthermore, our countries in Africa aspire to become knowledge -driven economies and such 
ambitions are underpinned by intellectual property and the diffusions of digital technologies, 
including e -commerce.  
1531.   The African Group, therefore, supports that disc ussions continue in this Council with a view 
to explore further relationship between electronic commerce, intellectual property and development 
in a comprehensive manner.  
16.6  United States of America  
1532.   The United S tates remains committed to implementing General Council 's Decision 
WTO/ L/1079 from December 2019.  It called upon Members to reinvigorate the work under the Work 
Programme on electronic commerce based upon the existing mandate  as set out in WT O/L/274. T he 
United States has actively participated in the July 2020 Webinar and open-ended  meeting of the 
Work Programme . 
1533.   We remain open to discussing the issues of e -commerce in the TRIPS Council that fall within 
the mandate of the 1998 Decision. H owever , we pref er that these discussions  be based upon the 
ad hoc proposals of Members and that the e -commerce work programme not be established as a 
permanent agenda item of the TRIPS Council.  Based upon the content of our meetings in recent 
years there has not been suf ficient interest  by Members that would justify a standing agenda item . 
Nonetheless we remain willing to engage on such issues on an ad hoc  basis and urge interested 
Members to circulate  detailed written proposals i n advance  to help other Members prepare  for such 
topics. 
16.7  European Union  
1534.   The Europea n Union considers e -commerce as one of the important topics for future WTO 
work. This is the area where achieving progress could benefit Members hip at large and provide 
tangible results for our economies a nd citizens, both in developed countries as well as  in developing 
countries.  
1535.   The EU supported the General Council Decision of December 2019 to reinvigorate the 1998 
Work Programme  on Electronic Commerce, and remains committed to continue work on the three 
areas that fall under the competence of the TRIPS Council.  
1536.   We do not see a compelling reason to establish the e-commerce Work Programme  as a 
permanent agenda item of the TRIPS Council. The interest in this topic was fluctuating in the recent 
years. We are , however , very interested to engage on these issues on the basis of submissions by 
Members . 
16.8  Indonesia  
1537.   As this is the first time we intervene on this agenda item, we thank the delegation of 
South  Africa for their effort to ensure this item is part of the sta nding agenda of the TRIPS Council. 
We share the view on the need to reinvigorate the mandate of the Work Programme on electronic 
commerce, among other s, in the TRIPS Council.  
1538.   We underline that the Council 's work in 1999 acknowledge d the need for fu rther study to 
understand the novelty and complexity of the intellectual property issues arising in connection with 
electronic commerce.  That statement is never been truer as we are now see ing significant 
technological advancement from the time of our last  work undertaken in 1999. The present context 
clearly provides a greater urgency to ensure a more thorough studies are undertaken.  
1539.   My delegation has great interest in understanding this issue. The interplay between 
intellectual properties protection and t he continu ing inventions of digital technology, such as big 
data, artificial intelligence, and 3 -D printing, could bring significant effect, both to the public policy 
objectives and the attainment of sustainable development goals.  
1540.   We are also following the  debates on the impact of high tech innovation on the economy, 
social order, and public policy. The way big -tech companies shape the social, economic and political IP/C/M/96/Add.1  
 
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  issues bring interest on how we should balance the intellectual properties protection in the  context 
of public policy objectives, which could differ from Member to Member.  
1541.   At this point of time, we would like to learn more from other Members on th ese pertinent 
issues, which hopefully could become good practices and lesson learned. We could probab ly also 
make compilation s of practices at the national level as the basis of further study of the Work 
Programme on e -commerce mandate.  
16.9  Australia  
1542.    Australia recognizes the role of the Work Programme in trying to ensure that IP issues in 
connection with e-commerce  are approach ed in the manner that promotes sustainable development. 
Australia would prefer the discussions on e -commerce continue to proceed on the same basis that 
they have been, so that they only come out  of ad hoc proposals of Members rather than establishing 
a permanent agenda item on the issue. We are thinking this would be the best way to ensure that 
the discussions attract sufficient engagement to be productive . 
16.10   India  
1543.   The 1998 W ork Programme  (WP) on e-commerce mandates the TRIPS Council to examine 
and report on the intellectual property issues arising in connection with electronic commerce. We 
support inclusion of this item as a standing item on the agenda of the TRIPS Council, similar to the 
practice in  all other Council/Committees mandated to discuss issues under the work programme . 
Among other aspects, the work programme mandates the TRIPS Council to examine the issue of 
'new technologies and access to technology '. As the digital sphere undergoes profo und 
transformation, becoming quintessential for almost every domain of day to day life, bridging the 
digital divide through access to digital technologies becomes all the more important.  
1544.   It is also important to explore how developing Members  could make be tter use of e -commerce 
to expand trade and investment opportunities through transfer and dissemination of new 
technologies to businesses including SMEs in developing and least developed country Members , to 
help them better integrate into G lobal Values Chains. We encourage all Members  to share their 
experiences in this regard.  
17  INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO  
17.1  WTO Secretariat  
1545.   As in previous occasions and for Members ' information, the Secretariat will provide a brief 
update of the issues related to intellectual property policy that have come up in the most recent 
Trade Policy Reviews.  
1546.   Since the last TRIPS Council Meeting in July, the Trade Policy Review of Zimbabwe to ok place. 
During this review, delegations sought further TRIPS -related details on:  
a. The implementation of the National Intellectual Property Strategy;  
b. Implementation of the TRIPS Agreement;  
c. Programme s to raise awareness on the importance of the protection of intellectual 
property;  
d. Ratification of the Protocol Amending the TRIPS Agreement; and  
e. Accession to and implementation of WIPO instruments.  
1547.   The Secretariat has also contributed to the G20 and WTO -wide Director -General 's Monitoring 
Reports. The  reports are planned to be distributed before end -November. The WTO -wide report 
covers developments on trade -related aspects of intellectual property rights (TRIPS), including the 
information on developments in domestic legislation and administrative issue s submitted for the 
monitoring exercise by Australia, Azerbaijan, Canada,  Chile, China, Philippines, India, Indonesia, 
Mauritius, the Russian Federation, the Kingdom of Saudi Arabia, Singapore, Chinese Taipei and 
Ukraine.  IP/C/M/96/Add.1  
 
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  1548.   As in the mid -year monitoring rep orts that were circulated in the s ummer, the end -year 
reports also include a sub -section on the specific IP -related measures aimed at facilitating the 
development and dissemination of COVID -19-related health technologies, as well as at relaxing 
procedural requirements and extending deadlines for administrative IP matters. The table containing 
these measures is regularly updated and available on the WTO website, as was discussed earlier 
under agenda item 3.  
18  OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTA L ORGANIZATIONS  
1549.   No statements were made under this agenda item.  
19  ANNUAL REPORT  
1550.   No statements were made under this agenda item.  
20  OTHER BUSINESS  
20.1  Dates for 2021 Meetings  
1551.   No statements were made under this agenda item.  
__________