 RESTRICTED  
  
IP/C/M/95/Add.1  
 
2 October 2020  
(20-6719) Page: 1/67 
Council for Trade -Related Aspects of  
Intellectual Property Rights    
 
MINUTES OF MEETING  
HELD IN THE CENTRE WILLIAM RAPPARD ON 30 JULY 2020  
Chair : H.E. Ambassador Xolelwa Mlumbi -Peter (South Africa)  
Addendum  
The present document contains the information provided  during the Council  for TRIPS meeting held 
on 30 July 2020 . 
 
_______________  
 
 
Table of Contents  
1  ELECTION OF CHAIRPERSON  ................................ ................................ ........................  5 
2  NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  ................................ .........  5 
3  IP MEASURES IN THE CONTEXT OF COVID -19 ................................ ............................  11 
4  REVIEW OF NATIONAL IMPLEMENTING LEGISLATION  ................................ ...............  21 
5  REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B)  ................................ ....................  21 
6  RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE CONVENTION ON 
BIOLOGICAL DIVERSI TY ................................ ................................ ................................  21 
7  PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  ................................ .... 21 
8  NON-VIOLATION AND SITUATION COMPLAINTS  ................................ ........................  26 
9  REVIEW OF THE IMPLEMENTATION OF THE TRIPS AGREEMENTY UNDER  
ARTICLE 71.1  ................................ ................................ ................................ .................  31 
10  REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON  
GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2  ................................ ....................  31 
11  TECHNICAL COOPERATION AND CAPACITY -BUILDING ................................ .............  31 
12  LDC GROUP PROPOSAL ON THE IMPLEMENTATION OF ARTICLE 66.2 OF THE  
TRIPS AGREEMENT  ................................ ................................ ................................ .........  35 
13  INTELLECTUAL PROPERTY AND THE 1998 WORK PROGRAMME ON ELECTRONIC 
COMMERCE  ................................ ................................ ................................ .....................  40 
14  INTELLECTUAL PROPERTY AND PUBLIC INTEREST: BEYOND AC CESS TO  
MEDICINES AND MEDICAL TECHNOLOGIES TOWARDS A MORE HOLISTIC APPROACH  
TO TRIPS FLEXIBILITIES  ................................ ................................ ...............................  48 
15  INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO  ................  65 
15.1  Dispute Settlement Developments Relevant to the TRIPS Agreement  ...................  65 
15.2  TRIPS Amendment  ................................ ................................ ................................  65 IP/C/M/95/Add.1  
 
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  15.3  IPR-Related Issues in Trade Policy Reviews and the Director -General's  
Monitoring Reports  ................................ ................................ ................................ ........  65 
16  OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL  
ORGANIZATIONS  ................................ ................................ ................................ ...........  66 
17  OTHER BUSINESS  ................................ ................................ ................................ ..... 66 
17.1  Annual Review of the Special Compulsory Licensing System  ................................ . 66 
17.2  18th Annual Review under Parag raph 2 of the Decision on the  
"Implementation of Article 66.2 of the TRIPS Agreement"  ................................ ............  67 
17.3  Other Planned Activities for the Benefit of LDCs  ................................ ...................  67 
17.4  Date of Next Meeting  ................................ ................................ ............................  67 
 
  IP/C/M/95/Add.1  
 
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  INDEX OF THE INFORMATION PROVIDED   
AT THE MEETING OF COUNCIL  FOR TRIPS 30 JULY 2020 * 
 
 
 
Argentina  
Non-violation and situation complaints  ... 28 
Australia  
COVID -19 ................................ ...........  19 
IP and e -commerce  ..............................  47 
IP and Public Interest  ...........................  60 
Notifications  ................................ ..........  6 
Bangladesh  
Biotech, Biodiversity, TK  .......................  22 
Implementation of Article 66.2  ..............  40 
Non-violation and situation complaints  ... 27 
Technical Cooperation  ..........................  31 
Bangladesh on behalf of the LDC Group  
Implementation of Article 66.2  ..............  35 
Brazil  
Biotech, Biodiversity, TK  .......................  21 
COVID -19 ................................ ...........  14 
Non-violation and situation complaints  ... 26 
Canada  
Biotech, Biodiversit y, TK .......................  26 
Implementation of Article 66.2  ..............  39 
Information on Developments in WTO  .... 66 
IP and e -commerce  ..............................  46 
IP and Public Interest  ...........................  57 
Non-violation and situation complaints  ... 29 
Notifications  ................................ .... 7, 11 
Chile  
COVID -19 ................................ ...........  15 
IP and e -commerce  ..............................  46 
IP and Public Interest  ...........................  53 
Non-violation and situation complaints  ... 28 
Technical Cooperation  ..........................  34 
China  
Biotech, Biodiversity, TK  .......................  23 
COVID -19 ................................ ...........  15 
Implementation of Article 66.2  ..............  38 
IP and e -commerce  ..............................  46 
IP and Public Interest  ...........................  54 
Non-violation and situation complaints  ... 28 
Colombi a 
IP and Public Interest  ...........................  54 
Ecuador  
COVID -19 ................................ ...........  17 
IP and Public Interest  ...........................  60 
El Salvador  
COVID -19 ................................ ...........  16 
European Union  
Biotech, Biodiversity, TK  .......................  26 
COVID -19 ................................ ...........  19 
Implementation of Article 66.2  ..............  39 
IP and e -commerce  ..............................  43 
IP and Public Interest  ...........................  58 
Non-violation and sit uation complaints  ... 29 
Notifications  ................................ .... 7, 11 
Hong Kong, China  
Notifications  ................................ ........  11 India  
Biotech, Biodiversity, TK  .......................  24 
COVID -19 ................................ ...........  16 
Implementation of Article 66.2  ..............  37 
IP and e -commerce  ..............................  43 
IP and Public Interest  ...........................  56 
Non-violation and situation complaints  ... 27 
Indonesia  
Biotech, Biodiversity, TK  .......................  25 
COVID -19 ................................ ...........  17 
Implementation of Article 66.2  ..............  39 
IP and Public Interest  ...........................  52 
Non-violation and situation complaints  ... 29 
Jamaica on behalf of ACP Group  
Non-violation and situation complaints  ... 30 
Japan  
Biotech, Biodiversity, T K .......................  26 
Implementation of Article 66.2  ..............  39 
IP and Public Interest  ...........................  64 
Notifications  ................................ ..........  9 
Kenya  
Biotech, Biodiversity, TK  .......................  25 
Non-violation and situation complaints  ... 30 
Malaysia  
IP and Public Interest  ...........................  54 
Mexico  
Notifications  ................................ ........  10 
Nepal  
Implementation of Article 66.2 ..............  35 
Nigeria  
Biotech, Biodiversity, TK  .......................  24 
COVID -19 ................................ ...........  14 
Implementation of Article 66.2  ..............  36 
IP and e -commerce  ..............................  48 
IP and Public Interest  ...........................  51 
Non-violation and situation complaints  ... 27 
Russian Federation  
COVID -19 ................................ ...........  16 
Saudi Arabia, Kingdom of  
Notifications  ................................ ........  10 
South Africa  
Biotech, Biodiversity, TK  .......................  22 
COVID -19 ................................ ...... 11, 20  
Implementation of Article 66.2  ..............  37 
IP and e -commerce  .........................  40, 48  
IP and Public Interest  ......................  48, 64  
Non-violation and situation complaints  ... 30 
Notifications  ................................ ..........  8 
Technical Cooperation  ..........................  32 
Sri Lanka  
IP and Public Inter est ...........................  63 
Switzerland  
Biotech, Biodiversity, TK  .......................  25 
COVID -19 ................................ ...........  20 
Implementation of Article 66.2  ..............  38 
IP and e -commerce  ..............................  47 IP/C/M/95/Add.1  
 
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  IP and Public Interest  ...........................  61 
Non-violation and situation complaints  ... 29 
Chinese Taipei  
IP and Public Interest  ...........................  57 
Notifications  ................................ ..........  9 
Tanzania on behalf of the African Group  
Biotech, Biodiversity, TK  .......................  21 
Implementation of Article 66.2  ..............  37 
IP and Public Interest  ...........................  53 
Non-violation and situation complaints  ... 27 
Technical Cooperation  ..........................  34 
Thailand  
Non-violation and situation complaints  ... 28 
Notifications  ................................ ..........  9 
Unite d Kingdom  
IP and Public Interest  ...........................  57 
United States of America  
Biotech, Biodiversity, TK  .......................  26 
COVID -19 ................................ ...... 18, 21  
Implementation of Article 66.2  ..............  38 IP and e -commerce  ..............................  45 
IP and Public Interest  ...........................  62 
Non-violation and situation complaints  ... 29 
World Health Organization  
IP and Public Interest  ...........................  64 
Technical Cooperation  ..........................  33 
World Intellectual Property Organization  
Technical Cooperation  ..........................  33 
WTO Secretariat  
Information on Developments in WTO  .... 65 
Notifications  ................................ ..........  5 
Technical Cooperation  ..........................  32 
Zimbabwe  
Biotech, Biodiversity, TK  .......................  23 
Implementation of Article 66.2  ..............  37 
IP and e -commerce  ..............................  45 
IP and Public Interest  ...........................  55 
Non-violation and situation complaints  ... 29 
Technical Cooperation  ..........................  34 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_______________  
* A record of statements as delivered in the formal session of the Council . Some statements have been 
lightly edited as appropriate to ensure the consistency of presentation.  
  IP/C/M/95/Add.1  
 
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  1  ELECTION OF CHAIRPERSON  
1.  No statements were made under this agenda item.  
2  NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  
2.1  WTO Secretariat  
2.  The Council  has received the following notifications from Members  since its meeting in 
February  2020:  
Under Article  63.2 
3.  The Europ ean Union has notified  
a. Regulations relating to the implementation of the Regulation on the European Union 
trademark; and  
b. a Regulation and a Council  Decision relating to the European Union 's accession to the 
Geneva Act of the Lisbon Agreement on Appellations of Origin and Geographical 
Indications.  
4.  Japan has notified consolidated versions of its Design Act, Patent Act, Trademark Act , and 
Copyright Act.  
5.  Mexico has notified its declaration of protection of the denomination of origin "PLUMA ". 
6.  The Kyrg yz Republic has notified Government  decrees, regulations and rules relating to 
traditional knowledge, and to patenting rules for selection achievements, electronic computer 
programmes  and databases.  
7.  Chinese Taipei has notified its Trade Secrets Act.  
8.  Canada has notified Bill -13, providing for certain measures in response to COVID -19.  
9.  Thailand has notified consolidated versions of its Trade Secrets Act, the Copyright Act and the 
Trademark Act,   
10.  The Kingdom of Saudi Arabia has notified its amended Copyr ight Law and related implementing 
regulations.  
11.  Hungary has notified a Government  decree on public health compulsory licences and transitional 
rules regarding epidemiological preparedness.  
12.  Hong Kong, China has notified an amended trademark Ordinance and its  National Anthem 
Ordinance of 2020.  
Under Article  69 
13.  Belize, Qatar, the Kingdom of Saudi Arabia, and Tonga have provided information on contact 
points for the exchange of information and cooperation on trade in infringing goods under Article  69.  
14.  Chile ha s notified a contact point for technical and financial cooperation under Article  67. 
15.  Let me briefly say that some of the above -mentioned notifications are also included in the list 
of IP-related COVID -19 measures. This non -exhaustive list of IP related measures is compiled and 
maintained by the WTO Secretariat from official sources and from Members ' inputs. The most recent 
inputs were received from Greece , Switzerland , and the Russia n Federation . It represents an 
informal situation report and an attempt to provide transparency with respect to measures related 
to IP taken in the context of the COVID -19 crisis. The list is updated continuously, and the most 
recent version can always be accessed on the WTO website.  IP/C/M/95/Add.1  
 
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  16.  Let me also draw your attention to the follow ing two developments in the area of documentation 
procedures:  
a. A new document series has been created for the circulation of Members ' reports to the 
TRIPS Council . The IP/C/R/[MEMBER]/ - series from now on comprises reports and reviews 
submitted by individua l Members  to the TRIPS Council  from 2020 onwards. This includes 
reports and responses relating to geographical indications (TRIPS Article  24.2), 
biotech nology  patenting and related issues (TRIPS Article  27.3(b)), incentives for 
technology transfer (TRIPS Article  66.2), and technical cooperation (TRIPS Article  67). 
b. The second development relates to the administration of reminders by the Secretariat 's 
Central Registry of Notifications (CRN). The CRN sends out annual reminders to Members  
identifying unfulfilled annual notification obligations across all WTO agreements. In the 
context of TRIPS, the notification obligations under Article s 63.2, 67, and 69 - namely to 
notify legislation, responses to the Checkl ist of Issues on Enforcement , and information 
on contact points, are ongoing obligations which require action whenever new legislation 
enters into force, or when the contact point details change. In light of this, CRN reminders 
will from now on be sent to all Members  covered by these obligations - indicating that 
these notification obligations apply "as appropriate ".  
17.  By sending such regular reminders, CRN invites Members  covered by these provisions to 
regularly verify that they are up to date  with their on going notification obligations under 
TRIPS  Article  66.2, Article  67, and Article  69. 
2.2  Australia  
18.  Australia is  not listed under this agenda item. We submitted a notification on 24 July, after the 
agenda was circulated, and I would like to take this opportunity to briefly outline the notification.  
19.  In response to recommendations in the Productivity Commission 's report on its review of the 
Austr alian IP system, certain amendments were made to Australia 's crown use and compulsory 
licensing measures. These amendments came into effect on 27 February 2020.  
20.  Neither of the amendments apply to compulsory licensing for export purposes.  
21.  The crown use prov isions were amended to improve and clarify their operation, specifically to:  
a. make it clear that crown use can be invoked for the provision of a service that any 
Commonwealth, State or Territory Government  has the primary responsibility for providing 
or fun ding; and 
b. require that Government s first seek a negotiated outcome with the patentee, such as a 
licence to use the patent.  
22.  The requirement to first attempt to negotiate does not apply in an emergency.  
a. if negotiation is unsuccessful, or access to a patented invention is required in an 
emergency, Ministerial approval for invoking Crown use must be sought.  
23.  If approved, the patentee must be notified of the reasons for the decision. The reasons must 
be given to the patentee prior to exploitation under th e Crown use provisions, or if an emergency, 
as soon as practicable.  
24.  The compulsory licensing provisions were amended to replace the 'reasonable requirements of 
the public ' test with a 'public interest ' test when the Federal Court considers an application f or a 
compulsory licence.  
a. The court is also required to consider the public interest when specifying the terms of the 
licence, including remuneration.  IP/C/M/95/Add.1  
 
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  2.3  Canada  
25.  On 25 March, Canada amended its  Patent Act  to expand the authority of the Commissioner of 
Patents, on the application of the Minister of Health, to authorize the Government  of Canada or 
another specified person to supply a patented invention to the extent necessary to respond to the 
COVID -19 pandemic.  Canada has notified thi s measure under document IP/N/1/CAN/30.  So far, no 
authorizations have been issued pursuant to this measure.  
26.  This amendment empowers existing manufacturing capacity to address market failures as 
necessary; for example, when the patent holder is not in a po sition to produce the invention for use 
in Canada or if demand exceeds supply during a health care emergency.  
27.  These amendments include safeguards to protect the interests of patent holders; for example, 
including ensuring that a patent holder receives adeq uate remuneration for the use of the patent 
and placing limitations on the duration of the authorization.  
28.  Canada would continue to welcome timely notifications on similar measures taken by other 
Members  as well as concerning any compulsory license authorizations on patented inventions related 
to COVID -19 before the next meeting of the TRIPS Council .  
2.4  European Union  
29.  The European Union has notified two acts concerning EU accession to the Geneva Act of the 
Lisbon Agreement. The first act is:  
• Regulation (EU) 2019/1753 of the European Parliament and of the Council  of 
23 October  2019 on the action of the Union following its accession to the Geneva Act of the 
Lisbon  Agreement on Appellations of Origin and Geographical Indications  
30.  This Regulation ensures the legal framework for effective participation of the EU in the 
WIPO  Lisbon Uni on after the EU 's accession to the Geneva Act. It lays down rules allowing the EU to 
exercise the rights and to fulfil the obligations laid down in the Geneva Act, on its behalf and on 
behalf of the Members  which ratify or accede to that Act.  
31.  In particular , it provides that, as a rule, Members  may request the European Commission, as 
the Competent Authority under the Geneva Act, to register in the International Register under the 
Geneva Act GIs that originate in their territory if these are protected and reg istered under EU law.  
32.  The Regulation also sets out a procedure for the assessment of geographical indications  (GIs) 
of third country origin for which protection in the EU under the Geneva Act is sought. Moreover, it 
contains transitional provisions for ap pellations of origin originating in EU Members  and already 
registered under the Lisbon Agreement as well as for appellations of origin originating in a third 
country and registered under the Lisbon Agreement before the accession of the Union to the 
Geneva  Act. 
33.  The second act is:  
• Council  Decision (EU) 2019/1754 of 7 October 2019 on the accession of the European Union 
to the Geneva Act of the Lisbon Agreement on Appellations of Origin and Geographical 
Indications  
34.  This Decision of the Council  of the European Union contains the Council 's authorisation for 
accession of the EU to the Geneva Act. It also authorises Members  to ratify the Geneva Act or accede 
to it. 
35.  The EU has also notified a delegated and an implementing regulation on trademarks, which 
were adopted in 2018 (Delegated Regulation 2018/625 and Implementing Regulation 2018/625). 
The delegated regulation updates and simplifies EU trademark applications. The implementing 
regulation updates and replaces implementing rules on t rademark applications.  IP/C/M/95/Add.1  
 
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  Hungary  
36.  The notified Government  Decree on public health compulsory licences for exploitation within 
Hungary created the possibility to issue a public health compulsory licence for exploitation within 
Hungary. The Government  Decree la id down the preconditions to issue a compulsory licence in an 
emergency public health situation, like the current COVID -19 pandemic. The Government  Decree 
implements Art 31 of the TRIPS Agreement . The Government  Decree ceased to have effect and its 
content  was incorporated into Hungary 's patent law. Hungary notified also another law that amended 
the mentioned provisions.   
2.5  South Africa  
37.  We thank the Secretariat for the overview of notifications received under this agenda item. As 
rightly pointed out some of the notifications overlap with the list of verified measures which was 
published by the Secretariat. South Africa wishes to raise some questions on COVID -related 
notifications under agenda item 2. We look forward to study ing Australia 's notification and the short 
explanation of the amendment. Also, the intervention from Canada has been well noted. We have 
some further questions regarding Canada 's notification. The EU also discussed the notification of 
Hungary about which we  also have some questions. For brevity I will focus only on a few questions 
and submit the remainder in writing.  
Canada: document IP/N/1/CAN/30 (Canada: Laws and Regulations)  
a. Does the scope of the amendment allow compulsory licenses to be sought by the Minister 
of Health for purposes of importing generic versions of patented medical products to 
respond to public health emergencies?  
b. The amendment limits the duration of the comp ulsory licenses  to a maximum of one year. 
As is now apparent, pandemics and other public health emergencies can go on for much 
longer, how will Canada address this gap? Can the compulsory licenses  be renewed or can 
the Minister of Health reapply for a new compulsory licenses  to cover the same products ? 
Would this not disrupt access during an emergency?  
c. Do patent holders have the right to apply for an injunction or any other relief that may 
halt implementation of the compulsory licenses  sought by the Minist er of Health?  
d. Why has Canada limited the right of a Minister of Health to apply for and be granted a 
compulsory license  only in situations of public health emergencies ? How will the 
Minister  of Health address patent challenges in other situations of public  health need in 
Canada?  
Hungary: document IP/N/1/HUN/3 (Hungary: Laws and Regulations  
38.  The TRIPS Agreement  reaffirmed by the Doha Declaration on TRIPS and Public Health recognize 
that each WTO Member has the right to grant compulsory licenses  and the freedo m to determine 
the grounds upon which such licenses  are granted. The right to issue compulsory license s, be it to 
address public health or any other national concern , should be a common feature in national patent 
legislation.  
a. Why has the Government  of Hung ary decided to rely on its emergency powers to issue a 
Government  Decree for public health compulsory licenses ? 
b. Section 1(4) of the Decree states the period for which a public health compulsory license  
is granted shall not last longer than until 31 March 2 021. Given 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 s to import or manufact ure patented medical products ? 
c. The public health compulsory licenses  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 ? 
d. What circumstances informed the Government 's decision to terminate the special legal 
order (State of Danger) on 18 June 2020?  IP/C/M/95/Add.1  
 
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  2.6  Chinese Taipei  
39.  In compliance with Article  63.2 of the TRIPS Agreement , we notified the WTO  TRIPS Council  of 
our recent amendments to the Trade Secrets Act in documents IP/N/1/TPKM/26. In brief, the 
changes are as follows:  
a. This amendment introduces a "confidentiality order for prosecutorial invest igation " system 
to strengthen protection of trade secrets during investigation proceedings. A person who 
violates a confidentiality order shall be liable to imprisonment for a maximum of three 
years. The new law will prevent trade secret leakage during inv estigation, increase 
corporations ' willingness to file a lawsuit, and enable prosecutors to effectively and quickly 
conclude their investigations.  
2.7  Thailand  
40.  Thailand is pleased to inform the TRIPS Council  that we have submitte d three notifications 
through the e -TRIPS platform in compliance with Thailand 's obligations under Article  63.2 of the 
TRIPS Agreement . The document reference numbers are IP/N/1/THA/3/R ev.1, IP/N/1/THA/4, and 
IP/N/1/THA/5. We would like to briefly explain some key amendments in the laws.  
41.  First, the Trade Secrets Act 2002 was amended in relation to the appointment and the duties 
of the Trade Secrets Board members  and the penalty imposed on the controller of trade secrets and 
the revealed  of facts  obtained or known from the performance of work more appropriate in  the 
current situation. The amended provisions came into force on 6  February 2015.  
42.  Second, the Copyright Act 1994 which was amended as follows:  
a. - The Copyright Act (No. 2) B.E. 2558 (2015), which came into force on 4 August 2015, 
introduced the amendments to the Copyright Act 1994 on provisions related to rights 
management information (RMI), technological protection measures (TPMs), liability 
limitation of internet service providers (ISPs), and other provisions with an aim to enhance 
efficiency of copyright system particularly in the digital environment.  
b. - The Copyright Act (No. 3) B.E. 2558 (2015), which came into force on 6 April 2015, 
introduced  the amendments related to the prohibition of, and penalties for, illegal 
recording of movies in movie theatres  (anti-camcording provisions), and copyright 
exceptions beneficial to disabled persons.  
c. - The Copyright Act (No. 4) B.E. 2561 (2018), which came into force on 11 March 2019, 
introduced the amendments to comply with the Marrakesh Treaty to Facilitate Access to 
Published Works for Persons Who are Blind, Visually Impaired, or Otherwise Print Disabled.  
43.  Third, the Trademark Act 1991 which was amended as  follows:  
a. - The Trademark Act (No. 2) B.E. 2543 (2000), which came into force on 30 June 2000, 
revised certain aspects of trademark registrability, the cancellation and related 
procedures, the collection of publication 's fee, and the composition, power and  duties of 
the Trademark Board.  
b. - The Trademark Act (No. 3) B.E. 2559 (2016), which came into force 28 July 2016, 
expanded the scope of trademark protection and amended the provisions of the relevant 
part of this Act to conform with the Protocol Relating t o the Madrid Agreement Concerning 
the International Registration of Marks (Madrid Protocol).  
44.  Thailand will continuously fulfil its TRIPS notification obligation to ensure accessibility and the 
transparency of our intellectual property system.  
2.8  Japan  
45.  This delegation  is pleased to inform the Council  that Japan recently amended its Patent Act, 
Design Act, Trademark Act, and Copyright Act. We would like to take this opportunity to briefly 
explain some major points of the amendment s. IP/C/M/95/Add.1  
 
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  46.  Firstly, the Patent Act was amended to enhance the patent litigation system. The amendment 
enables the ability to determine proportional damages beyond the scope of rights  holder 's 
production/sales capacity that are the sum of equivalence for licensing fees . In addition, the 
amendment clearly states that the court can consider the amount that would be determined if 
negotiations were made on the premise of patent infringement in calculating the amount of damages 
for the amount equivalent to the licensing fee.  There are similar amendments in the Design and 
Trademark Acts. 
47.  Secondly, the Design Act was amended to enhance the design system. The scope of protection 
is expanded into "graphic images not recorded or displayed on Article s" and "building exterior and 
interior design ". Additionally, the related design system, which allows the registration to be granted 
for a design even if the design is similar to one the applicant has previously filed an application for, 
are enhanced to protect designs con tinuously developed based on one consistent concept. Precisely, 
related designs can be registered within ten years of the initial principal design application. That had 
been limited to before the publication of the design bulletin for the principal design which was about 
eight months from the application of the principal design. In addition, provisions have been reviewed 
with the aim of consecutively protecting designs that are similar only to related designs. Also, the 
protection period for design rights a re expanded from 20 years from the registration date to 25  years 
from the application date.  
48.  Finally, the Copyright Act was amended in order to be compatible with the Beijing Treaty on 
Audiovisual  Performances. In addition, the amended Copyright Act, which introduces the 
compensation scheme that teachers can use works in online lessons without permission of copyright 
owners in principle, was to come into effect within three years from the date of promulgation, 
May 25 2018. However, the Government  implemented  this Act in this April, a year earlier than 
initial ly planned, in order to meet needs for remote education due to COVID -19. The compensation 
in this fiscal year is free.  
49.  The Government  of Japan will continuously fulfil its obligation to ensure the accessi bility and 
the transparency of the Japanese IP system.  
2.9  Saudi Arabia, Kingdom of  
50.  IP is a key factor for the future development of Saudi Arabia 's economy, and Vision 2030 
stipulates targets that are directly ena bled by IP. In line with this, I would like to inform you that 
the Kingdom of Saudi Arabia has recently submitted two notifications to the TRIPS Council  
concerning replacement s of Saudi laws that had been notified previously under Article  63.2 of the 
TRIPS  Agreement .  
51.  Saudi Arabia 's Council  of Ministers amended the Saudi Copyright Law, introducing two changes:  
• First, replacing the Ministry of Culture and Information with Saudi Authority for Intellectual 
Property; and  
• Second, regarding the decision -making function under the Copyright Law, replacing the 
Minister with the Board of Directors of the Saudi Authority for Intellectual Property. As a result, 
the Article  currently reads: "Decisions of the Committee shall be made by majority vote, which 
shall be endorsed by the Board of Directors ".  
52.  Thus, the adoption of the decisions issued by the Committee must be approv ed by the Board of 
Directors of the Saudi Authority for Intellectual Property, and no longer involve Ministerial approval. 
The Board is composed of a President and 15 Members  of both Government  and private sectors.  
2.10  Mexico  
53.  This delegation  is pleased to inform the Council  for TRIPS that Mexico has issued a general 
declaration on protection of the appellation of origin "Pluma ". 
54.  The declaration has been notified to the Secretariat and published on the WTO website in 
document IP/N/1/ MEX/20 -IP/N/1/MEX/G/9.  IP/C/M/95/Add.1  
 
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  55.  The general declaration provides for the protection of the appellation of origin "Pluma ", in 
accordance with the Law on Industrial Property, in order to protect coffee products, in particular the 
fruits of coffee plants of the specie s Coffee  arabica, primarily of the varieties Typica and L. Pluma 
Hidalgo, which are grown in 30 municipalities in the state of Oaxaca, including the municipality of 
Pluma Hidalgo.  
2.11  Canada  
56.  Canada will answer South Africa 's questions  that they will provide  in writing. Canada wish es to 
make clear at this point that the COVID -19 specific measure that we have notified is in addition to 
Canada 's existing compulsory licenses regime. It does not replace the existing regime, t. It is 
design ed to address this particular  issue that we had. The notified measure is itself part of the 
broader set of measures that are otherwise not IP measures that aim at preventing shortages 
resulting from COVID -19 and demonstrate s taking leadership in this regard .  
2.12  European Union  
57.  We would  also like to ask the delegation  of South Africa to provide the questions in writing and 
we will provide the most precise answers in writing . 
2.13  Hong Kong, China1 
58.  Pursuant to Article 63.2 of the TRIPS Agreement, Hong Kong, China submitted two notifica tions 
IP/N/1/HKG/35 and IP/N/1/HKG/36 to the WTO Secretariat on 3 July 2020.   
59.  The first notification is related to amendments to the Trademark Ordinance with a view to 
making essential procedural rules for implementing the Protocol Relating to the Madrid A greement 
Concerning the International Registration of Marks in Hong Kong, China, and empowering local law 
enforcement agency to enforce the criminal provisions under the Trademark Ordinance.  
60.  The second notification is related to a consequential amendment to the Trademark Ordinance, 
following the enactment of the National Anthem Ordinance. The amended law prescribes that a 
trademark shall not be registered if it consists of or contains the national flag or emblem of China, 
or the regional flag or emblem of Hong Kong, China.  
3  IP MEASURES IN THE CONTEXT OF COVID -19 
3.1  South Africa2 
61.  More than 16.5 million cases and 650 thousand deaths of COVID -19 have been confirmed 
globally. The global community is facing an extraordinary challenge. No country has been spared 
the devastating effects of COVID -19. The h ealth and human toll are substantial and expected to 
continue to grow.  
62.  In this context we recall Resolution of the World Health Assembly WHA 73.1 of 19 May 2020, 
which recognize s that the COVID -19 pandemic has a disproportionately heavy impact on the poor 
and the most vulnerable, with repercussions on health and development gains, in particular in 
low-income countries. It further calls on cooperation between multilateral organi zations and other 
stakeholders and the World Health Organization ( WHO) Director General to identify and provide 
options that respect the provisions of relevant international treaties, including the provisions of the 
TRIPS Agreement  and the flexibilities with in the Doha Declaration on the TRIPS Agreement  and 
Public Health, to be used in scaling up development, manufacturing and distribution capacities 
needed for transparent , equitable and timely access to quality, safe, affordable and efficacious 
diagnostics, therapeutics, medicines, and vaccines for the COVID -19 response. South Africa 
 
1 The delegation of Hong Kong, China  requested at the meeting, that for reasons of time, its full 
statement be included in the record of the meeting . This record may thus contain elements that were not 
spoken at the meeting.  
2 The delegation of South Africa requested at the meeting, that for reasons of time, its full state ment be 
included in the record of the meeting . This record may thus contain elements that were not spoken at the 
meeting.  IP/C/M/95/Add.1  
 
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  welcomes the launch of the Trilateral Study on Access to Medical Technologies and Innovation but  
notes it is very thin on the issues related to COVID -19. 
63.  The list of verified mea sures prepared by the Secretariat already indicate some steps taken by 
Members  and supplemented by views Members  will express during this TRIPS Council  meeting and 
further meetings. A further step in concretizing this commitment is to hold a workshop as re quested 
by the ACP Group which will give Members  and other participants an opportunity to further discuss 
IP challenges with respect to access and to explore approaches to deal with COVID -19 in the context 
of intellectual property rights.  
64.  Curbing the pand emic and limiting the social and economic fallout is dependent on an 
unprecedented timely roll out of sufficient quantities of medical supplies to all countries in need 
including masks, personal protective equipment, ventilators, diagnostic kits as well as  therapeutics 
and vaccines as they are identified. This requires global solidarity to transfer technology and 
massively scale -up manufacturing globally. At present there are vast shortages of medical products 
within a country as well as between developed a nd developing countries . In light of possible second 
waves of the coronavirus, countries must take measures to ensure that they are able to restock 
medical products that will be needed to fight the virus.  
65.  The WHO estimates that at least 500 million tests are needed over the next 12 months in 
low- and middle -income countries.3 Testing if deployed in a timely way could contribute to saving at 
least nine million lives and avert at least 1.5 billion COVID -19 infections. The challenge with testing 
is to develop new rapid diagnostic tests and to scale up the production of such reliable, affordable 
tests to a volume sufficient for all countries to access them. Similar shortages can be seen with 
respect to person al protective equipment and ventilators. Bloomberg reports that the world demand 
for ventilators is ten times the current supply capacity.4 Manufacturing ventilator parts for e.g. using 
e.g. 3D printing raises a number of intellectual property issues such  as patents, industrial design 
and copyright.  
66.  The challenge of intellectual property is most apparent in the area of therapeutics. Several of 
the therapeutics under investigation do have patents granted or pending in many countries. A recent 
case that has  widely been reported is remdesivir, approved in several jurisdictions as preliminary 
results showed that it shortened the recovery period. Earlier this month, it was reported that Gilead 
had agreed to supply the U nited States its projected production for the next three months, raising 
concern about supply of remdesivir to other countries. Gilead has entered into  nine licensing 
agreements with generic manufacturers from three  countries for the supply to 127 countries.5 These 
limited, non -transparent exclus ive licenses seem to be an attempt to contain competition by creating 
an oligopoly.6 Generic manufacturers globally that can contribute to expanding global supply have 
been excluded. The lack of transparency, and accountability in the present dire times i s extremely 
worrying and dangerous. It is an indicator of the IP and access challenges ahead of us, that the 
WTO Members  need to address effectively and swiftly. On the subject of vaccines, there are already 
news reports of intellectual property disputes t hat could hinder the development and production of 
COVID -19 vaccines.7 We observe with great apprehension the rush by developed country Members  
to sign deals to gain preferential access to vaccines, leaving many countries behind. Vaccine 
nationalism may address short term political demands of a country but drastically falls short of what 
is required to contain this pandemic. World leaders from th e North and South have referred to a 
vaccine as a global public good, that should be fairly and equitably available globally, leaving no one 
behind. Now is the time to put it into action.  
 
3 WHO COVID -19 ACT Accelerator Technical Update and Virtual Press conference of 26 June 2020 
<https://www.who.int/docs/default -source/coronaviruse/transcripts/act -accelerator -technical -update -and-
press -briefing -26th-june.doc x?sfvrsn=b88700e1_0 > 
4 Bloomberg (2020), World Ventilator Demand Now 10 Times What 's Available, Says Maker , 
<https://www. bloomberg.com/news/articles/2020 -03-25/world -ventilator -demand -now-10-fold- what-s-
available -says-maker. > 
5 See < https://www.gilead.com/purpose/advancing -global -health/covid -19/voluntary -licensing -
agreements -for-remdesivir > 
6 See < https://www.latimes.com/world -nation/story/2020 -07-01/gilead -patent -limits -access -to-covid-
19-drug-remdesivir > 
7 See < https://twn.my/title2/intellectual_property/info.service/2020/ip200704.htm ; 
https://www.fiercebiotech.com/biotech/moderna -stock-sinks-as-patent -case-spurs -concern -for-covid-19-
vaccine > IP/C/M/95/Add.1  
 
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  67.  The challenge before us is to produce an effective vaccine to meet the needs of the world 
population of 7.8 billion in as short a time frame as possible. This will require the sharing of 
knowledge and technology of successful vaccines so that the widest distribution at lowest cost can 
be achieved. Even the European Parlia ment Resolution entitled "The EU 's public health strategy 
post-COVID -19" which was adopted on 10 July 2020 acknowledges its importance as it calls for 
"maximum sharing of COVID -19 health technology -related knowledge, intellectual property and data 
to the b enefit of all countries in the context of WHO 's Technology Access Pool (C -TAP).8 It also calls 
for strong support for the WHO 's C-TAP, while incorporating collective safeguards in favour of the 
public regarding public funding, such as transparency, access ibility and affordability clauses and 
non-exclusive licences for exploitation of final products, in all current and future calls for funding 
and investment. It further calls for enhanced dialogue with third countries and the issuance of 
compulsory licences  in the event that such countries do not share their vaccines or therapeutic 
knowledge.9  
68.  In a July 2020 paper, MSF documented how exclusive rights and monopolies granted to 
pharmaceutical corporations, resulting in high prices and blocking generic compet ition has had a 
negative effect on MSF 's medical actions in different countries. This has affected that ability of 
countries to provide access to treatment of HIV/AIDS, tuberculosis, hepatitis C and cancer for 
patients who need them. Beyond access to pharm aceuticals and biosimilars, the effects of patents 
have also hindered the introduction of affordable vaccines in developing countries, with the focus on 
pneumococcal conjugate vaccines (PCV) and human papillomavirus vaccine (HPV).10 The 'fair shot ' 
report found that the patents increase uncertainty, costs and delays in competition resulting in high 
prices for low -and-middle income countries. We cannot afford a similar scenario when dealing with 
COVID -19. In short, we are of the view that the W orld Trade Organization  should be cognizant of IP 
obstacles across essential medical products needed to contain the pandemic and take urgent steps 
to address these barriers in a comprehensive manner. The WTO  TRIPS Agreement  does provide a 
number of flexibilities that may be utilized by Members  to overcome IP obstacles. In anticipation of 
such barriers, some WTO Members  have undertaken urgent changes to national patent legislation 
to make it easier to issue compulsory license s. However, there are a number of challenges:  
69.  Firstly, IP barriers go beyond patents, and often flexibilities in other intellectual property such 
as industrial designs, copyright and trade secrets is often less understood and implemented 
nationally.  
70.  Secondly, developing countries  may face legal, tech nical and institutional challenges in using 
TRIPS flexibilities . This is especially true for countries that have never utilized flexibilities such as 
compulsory licenses.  
71.  Thirdly, when an exporting country is producing under a compulsory license mainly fo r export, 
the mechanism established by the 30 August 2003 decision, and later translated into an amendment 
of the TRIPS Agreement  as Article  31bis, would be applicable. T his mechanism waives the condition 
in Article  31(f) that a compulsory license should b e predominantly for the supply of the domestic 
market. However, experience in using this mechanism is largely non -existent. In 2006, Medecins 
Sans Frontieres  (Doctors without Borders) attempted to use the procedures to export HIV medicines 
from Canada to R wanda but it concluded that the mechanism is neither expeditious nor workable. 
We also note that implementation of the Article  31bis mechanism at a national level is rather limited 
or may not achieve its intended objectives.  Further some countries have opt ed out of using this 
system as importers, which may pose a challenge to access.  
72.  Several voluntary initiatives have emerged since the outbreak of COVID -19 including pledges 
and voluntary licenses. Some of these are commendable, but these are ad hoc  initiat ives, simply 
inadequate to systematically and comprehensively address IP barriers. IP holders of essential 
technologies may also decide not to participate in such initiatives.  
73.  The World Health Organization has launched the COVID -19 Technology Access Pool (C-TAP) 
calling IP holders to voluntarily issue global non -exclusive licenses or to voluntarily surrender 
 
8 European Parliament  https://www.europarl.europa.eu/ doceo/document/TA -9-2020-0205_EN.html .  
9 Ad par. 8.  
10 The full text of MSF report 'A fair shot for vaccine affordability: understanding and addressing the 
effects of patents on access to new vaccines ' is available from: < https://msfaccess.org/fair -shot-vaccine -
affordability > IP/C/M/95/Add.1  
 
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  intellectual property rights, to facilitate the widescale production, distribution, sale and use of such 
health technologies throughout the world. How ever, to date no company has committed to doing so. 
Instead limited, exclusive and often non -transparent voluntary licensing seems to be the preferred 
approached and these are insufficient to address the needs of the current COVID -19 pandemic.  
74.  "Business as usual " approaches are simply inadequate to tackle COVID -19. We need to consider 
new bold measures that will comprehensively and expeditiously address IP challenges. The following 
approaches can be considered:  
75.  Members  must explore international collabor ations and binding commitments to facilitate the 
open sharing and right to use technologies, know -how, data and global non -exclusive rights to use 
and produce COVID -19 medical products.  
76.  Members  must take policy and legislative measures to ensure that pate nts and other intellectual 
property do not erect barriers to access to medicines, diagnostics, vaccines and medical supplies 
and devices. This includes addressing evergreening of patents by restricting the grant of secondary 
patents on known medicines and excluding from patentability second medical uses as being mere 
methods of treatment in terms of Article  27 of the TRIPS Agreement . Members  are encouraged to 
take measures to facilitate the local manufacturing or import of essential medical supplies, device s 
or technologies including diagnostics, medicines and vaccines.  
3.2  Nigeria  
77.  My delegation  will like to thank you , Chair , for convening this very important meeting and we 
would like to extend our thanks to the Secretariat for its time ly compilation of the various measures 
regarding trade -related intellectual property rights in the context of COVID -19, at these difficult 
uncertain times.  
78.  Allow me to highlight the effects of the pandemic from our national standpoint. COVID -19 is a 
supply chain and demand shock. My Government  is introducing fiscal and monetary measures to 
stabilize demand and  prevent mass business failure and job loss as is  the case with many 
government s. Our MSMEs and other firms are currently adversely affect ed by a trade finance shock. 
Developing countries like Nigeria who lack the capacity to produce the required COVID -19-related 
medical supplies and equipment depend largely on importation to be able to meet demand. Given 
the unpredictability of this COVID -19 virus, this pandemic may remain with us for a very long time 
as there are no effective vaccines or cure as of yet. In o rder to rise to these challenges, countries 
should be allowed to tap into each other 's growth as this would also go a long way in impro ving 
prospects for a global recovery. Similarly, the invocation of TRIPS flexibilities can certainly provide 
certain subsidies to local manufacturing industries.  
79.  Furthermore, access to medicines ha s been a long -standing issue for our country due to the 
high cost of patented drugs , and this is heightened by the COVID -19 pandemic. We call for deeper 
and honest collaboration among countries and the relevant international organizations as was agreed 
at the W orld Health Assembly  to fight this common problem.  
80.  We note that the link provided under this agenda item mostly contains among other things, 
measure s taken by countries to facilitate IP processes. However, there is need for continuous 
collaboration among all Members  in order to cushion the negative effects o f the pandemic. We 
encourage that ; while the focus by most Members  seem s to be to develop an adequate response 
mechanism, we should not lose sight of the need to intensify in a parallel process our efforts to 
develop an effective vaccine and to increase ac cess to medicines and COVID -related equipment , 
especially in more vulnerable countries. We may wish to recall the recent resolution on COVID -19 
adopted by the W HA which , among other things , calls for the intensification of efforts to control the 
pandemic, and for equitable access to and fair distribution of all essential health technologies and 
products to combat the virus. It also calls for an independent and comprehensive evaluation of the  
global response, including, but not limited to, the World Health Organization 's performance.  
81.  As we have mentioned in our previous information provided , we underscore that the mandate 
of the TRIPS Council  includes the monitoring of the operation of the Agr eement, and to ensure the 
balance of rights. We therefore urge the TRIPS Council  to play a critical role on intensifying its 
trilateral cooperation with the WHO and W orld Intellectual Property Organization  on intellectual IP/C/M/95/Add.1  
 
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  property and public health in o rder to promote innovation and access to health technologies not 
undermining the moral right to benefit sharing.  
3.3  Brazil  
82.  Brazil 's most relevant  COVID -19 measures related to intellectual property rights are listed on 
the World Trade Organization 's compilation, available on its website.  
83.  These are two initiatives  undertaken by our intellectual property office.  
a. The first refers to the creation of a COVID -19 technology landscape observatory.  The aim 
is to provide innovators with information on existing technologies that might be useful for 
preventing, diagnosing or treating COVID -19.  
b. The second measure listed is Brazil 's intellectual property office decision t o prioritize the 
examination of patent applications related to the fight against COVID -19. 
84.  Both initiatives  can also be found in the WIPO COVID -19 IP Policy Tracker, where other 
information on the operation of our intellectual property office during the pa ndemic is available.  
3.4  China  
85.  At the informal session held on 19 June  2020, Members  recognized the importance of IP -related 
measures in response to COVID -19 and the unique role the TRIPS Council  could play in this regard. 
In the complied list of IP measures in the context of COVID -19, China has confirmed two measures.  
86.  The first one is the Notice on Time Limits for Handling Affairs Regarding Patents, Trademarks 
and Layout -Designs of Integrated Ci rcuits under the impact of the COVID -19 pandemic, which has 
clarified and provided relief measures for parties exceeding the time limits for handling IP -related 
affairs. This Notice applies to all stakeholders across all countries and regions affected by t he 
COVID -19 pandemic . The purpose is to effectively protect their legitimate rights and interests.  
87.  The second measure, the one my presentation focus es on, is the Information Sharing Platform 
for Patents on Pandemic Prevention against COVID -19, which has b een developed by the China 
Patent Information Centr e in February 2020 under the guidance of the China National Intellectual 
Property Administration (CNIPA). The Platform has provided professional and public welfare patent 
information assistance and services for stakeholders to carry on research related to COVID -19 
pandemic prevention and control. It has also made contributions to strengthening international 
coopera tion and information sharing by means of providing comprehensive and technical patent 
information related to COVID -19. 
88.  As you can see, this is the website and home page of the Platform  
(https://ncp.patentstar.cn /en). 
89.  The Platform is built on the basis of the China Patent Research System (CPRS), which was also 
developed by the China Patent Information Centre . We selected more than 7000 patent documents 
in the key areas of technological innovation related to "fighting against COVID -19" from the database 
of CPRS. According to their technical relevancy and degree of importance, these patent documents 
are divided into nine first-level branches,  35 second -level branches and 78 third -level branches. 
They cover the wide s pectrum of technical fields including treatment medicines, prophylactic 
medicines, detection and diagnosis reagents, medical instruments, etc.  
90.  When you access this Platform, you will find its bilingual interfaces : one is Chinese and the other 
is English. Take this document as an example. The Platform provides detailed information o n the 
patent documents, such as its bibliographic data, full -text, claims, specification, and legal status. It 
is also possible to downl oad the file.  
91.  The Platform integrates functions of retrieval, online translation, communication feedback, etc. 
The database affiliated to the Platform has been updated regularly. The Platform can be accessed 
for free without prior registration. The statist ics show that, as of 26 July 2020, the Platform has 
received visitors from more than 60 countries and regions with 238,148 hits in total.  IP/C/M/95/Add.1  
 
- 16 - 
 
  92.  If you have any further questions or would like to get more information about the Platform, 
please contact us through the contact information shown on the screen  
(email:  fuwubu@cnpat.com.cn , phone: +86 -10-61073090) . 
3.5  Chile  
93.  Once again, Chile wishes to thank the Secretariat for preparing a compilation of the measures 
notified to the W orld Trade Organization  in relation to the pandemic. We consider it extremely useful 
for Members  to notify the various measures introduced, as this enables them to share their 
experiences while helping other Members  that ar e assessing potential measures to tackle the 
pandemic.  Chile's IP office has taken measures to make deadlines more flexible, and my delegation 
hope that the Secretariat will keep the list of measures up to date . 
3.6  India  
94.  As visible from  various interventions, a number of countr y Members , both developed and 
developing, have adopted measures to enable government s to overcome IP barriers in case they 
constrain access to the goods required for handling the COVID -19 pandemic.  
95.  The rising incidence of COVID -19 requires all countries, particularly developing and least 
developed countries  which are disproportionately a ffected by the pandemic, to be able to procure 
and/or manufacture products required for diagnosis, treatment and prevention of COVID -19. 
Intellectual property rights over such products can constrain countries ' ability to rapidly procure, 
produce and supply  such goods at the required scale at affordable prices.  
96.  The COVID -19 crisis is a powerful reminder of our inter -connectedness, and the need for a 
coordinated, global strategy to overcome this unprecedented global public health crisis. No country 
is reliab ly insulated from this highly contagious virus, as long as it persists anywhere in the world. 
While the disease has no preventive vaccines at the moment, more than 100 candidate vaccines are 
in various stages of development. Similarly, many medicines are b eing tried for treating this disease. 
Though a safe and effective vaccine may still be few months away, countries are already competing 
to lock in assured access, which may drive up prices and crowd out others who may find it difficult 
to access it at affo rdable prices.  
97.  WTO Members  need to work together in the TRIPS Council  to ensure that IP rights do not block 
access to critical technology required for rapid scaling up and augmenting the manufacturing 
capacity for medicines, vaccines, equipment and  treatm ents required for an effective response to 
COVID -19. In this regard, we also support the suggestion by the ACP Group for a workshop on IP 
and COVID -19. 
3.7  El Salvador  
98.  With regard to information concerning the COVID -19 pandemic, we would like to thank the 
Secretariat for all its efforts to make relevant information available to Members . El Salvador has not 
taken any specific emergency measures pertaining to intellectual property, however, the running of 
our National I ntellectual Property Office was affected by the general suspension of terms and 
deadlines because of the closure of Government  offices. This information was included on the 
World Intellectual Property Organization 's COVID -19 IP Policy Tracker webpage, a li nk to which has 
also been included on the W orld Trade Organization's  website. We would like to report that the 
Decree on the state of emergency in the country expired on 15  July 2020, which meant that terms 
and deadlines resumed as of 16 June 2020. On the same date, the Office's intellectual property 
services, including the processing of applications, also resumed under special conditions. We will 
shortly be sending this information in writing to the WIPO Secretariat, so that it can update its 
important COV ID-19 IP Policy Tracker tool.  
3.8  Russian Federation  
99.  My delegation supports the inclusion of this topic to the Council agenda, and thanks South Africa 
for this initiative. In the context of the pandemic it is importan t to have an open, transparent and 
balanced discussion  of IP measures related to the pandemic  in our Council . The Russian Federation IP/C/M/95/Add.1  
 
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  thanks the Secretariat for establishi ng and maintaining the dedicated web resource . It is a very 
useful and easy to use instrument  for all Members . 
100.  We would like to share with Members  some of the measures taken by the Government  of the 
Russian Federation and the Russian Federal Services for I ntellectual Property related to the 
COVID -19 situation.  
101.  The first measure was the creation of a special information section in the official internet site 
of the Russian Federal Institute for Intellectual Property, which contains information on patents 
relevant in the context of a pandemic (patent documents submitted by both domestic and foreign 
right holders) .  
102.  The second was the creation of a special news section on the official internet site of the Russian 
Federal Service for Intellectual Property "Patent of the week " to promote inventions which represent 
technical solutions related to the fight against COVID -19. 
103.  The third was the Decision of the Russian Federal Service for Intellectual Property on 
accelerated consideration of applications for invent ions and utility models in the field of technologies 
for combating viruses and associated diseases (pneumonia) without charging an additional fee.   
104.  During the period from 15 April to 17 May, a system of full electronic interaction was applied 
between the R ussian Federal Service for Intellectual Property and applicants.  
105.  The fifth is under Government  Resolution of 20 June 2020, time limits for the applicant 's 
opportunity to perform actions related to the legal protection of intellectual property (including th ose 
related to the payment of patent and other fees) was extended at the request of the applicant until 
31 December 2020.  
3.9  Indonesia  
106.  We would like to thank the delegation  of South Africa for bringing this agenda item and would 
like to support the statement made by the delegation  of South Africa . 
107.  We also would like to thank the Secretariat for providing important updates on Members ' 
measures related to trade and intellectual property rights in relation to COVID -19. We see this as a 
positive contribution which share s good practices in providing transparency and predictability.  
108.  We believe that the COVID -19 pandemic warrant s more specif ic information on Members ' 
measures related to flexibilities under the TRIPS Agreement . Whether there are possibilities for the 
Secretariat to provide more updates and information in this section, we believe it would be beneficial 
for Members .  
109.  In addition , we understand that the TRIPS Agreement  together with the TRIPS Council  could 
play an important role in assisting access to technology, medical equipment, therapeutics, and 
vaccines for COVID -19 could be available in a timely, equitabl e and affordable man ner. 
110.  Hence, we believe that the work of this Council  is more crucial than ever to enhance 
cooperation with other international organization s and provide a better understanding to its Members  
on the importance of cooperation and flexibilities in TRIPS Agree ment, including through workshops 
or other means available that may be undertaken by this Council . 
3.10  Ecuador  
111.  Ecuador wishes to report on the work carried out in relation to intellectual property measures 
adopted in the context of the COVID -19 pandemic.  
112.  Through the National Intellectual Rights Service (SENADI ), Ecuador has set up a website 
providing information on technologies used to treat and prevent COVID -19. IP/C/M/95/Add.1  
 
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  113.  The aforementioned site contains: Government  measures and official information issued by 
national bodies within their areas of competence; and details  concerning the health measures taken 
following the declaration of a state of emergency in Ecuador.  
114.  It also includes information generated at the international level regarding the pandemic, which 
has been sourced from information sharing platforms and tech nological bulletins prepared by 
international bodies and national intellectual property offices.  
115.  Ecuador has also been involved in preparing the PROSUR Bulletin on Patents in the 
Public  Domain for Technologies to Combat COVID -19. 
116.  This information is includ ed in the list of intellectual property measures in the context of 
COVID -19 drawn up by the Secretariat.  
117.  SENADI prepared an Information Bulletin on patents related to COVID -19, which contains 
useful information related to technologies  to fight COVID -19. 
3.11  United States of America  
118.  With respect to general comments on IP measures and COVID -19, intellectual property 
encourages innovation, incentivizes research and development, and manufacturing and distribution. 
These cor e 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.  
119.  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 and effective t herapeutics 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.  
120.  As we have stated in past discussio ns, 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 treatments 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 government s 
that have significant ba rriers like taxes and tariffs in places that affect access.  
121.  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 approvals 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.  
122.  With respect to United States Patent and Trademark Office (USPTO) relief and initiatives due 
to COVID -19 noted on the WTO website, and as noted in the June informal, t he USPTO considers  
the effects of coronavirus to be an "extraordinary situation " for affected patent a nd trademark 
applicants, patentees, re -examination parties, and trademark owners. Therefore, it has announced 
certain relief in the form of extended deadlines, a new prioritized patent examination pilot 
programme for smaller applicants for COVID -19-related treatments,  and resources offered to 
applicants as the COVID -19 situation continues. The USPTO also announced a COVID -19 prioritized 
trademark examination programme for certain medical products and services.  
123.  For example, the USPTO launched the  COVID -19 Response Resource Center  to provide 
improved access to USPTO initiatives, programmes , and other helpful IP -related information 
regardi ng the COVID -19 outbreak, including links for consumers and healthcare workers to report 
COVID -19-related counterfeiting and fraud to various regulatory and law enforcement agencies, as 
well as tips for identifying counterfeit products.   IP/C/M/95/Add.1  
 
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  124.  In addition, the USPTO has launched  Patents 4 Partnerships , which is an IP marketplace 
platform for licensing opportunities for patent owners who want to license their IP rights to 
individuals and businesses who can turn those rights into solutions to address COVID -19. 
125.  Further information  on these measures can be found on the W orld Trade Organization  webpage 
and W orld Intellectual Property Organization  COVID -19 IP Policy Tracker.  
126.  The USPTO has also, with other US Government  agencies, launched virtual capacity building 
programmes  for customs, police, health regulators, prosecutors and judges focused on combatting 
counterfeit and fraudulent goods related to COVID -19. These goods include personal protective 
equipment (PPE), face masks, disinfectants, hand sanitizer, test kits and medicine.  
127.  With respect to a workshop request, the situation of COVID -19 is rapidly changing. Before a 
decision can be made on this matter,  it is important to consider the intended audience, the topics, 
the necessary expertise, and the objective of such a web -based meeting.  
3.12  European Union  
128.  It is clear that broad and equitable access to existing and new treatment s, and ultimately 
vaccines, will be key to tackle the present public health crisis, including for developing countries that 
have no production capacities or more limited financial resources. The E uropean Union will provide 
more comments on this crucial issue under agenda item 14.  
129.  The EU notified two IP measures that were taken in the context of the COVID -19 pandemic. 
Measures were also notified by Germany, Hungary, Italy and Greece.  
130.  The European Union Intelle ctual Property Office ha d extended the deadlines for trademark and 
design matters. This decision concerned all time limits in each proceeding before the EUIPO that 
would have expired between 9 March and 30 April  2020.  
131.  The European Committee for Standardiz ation and the European Committee for Electrotechnical 
Standardization, in collaboration with their Members , agreed to make freely available certain 
copyrighted European standards for certain medical devices and personal protective equipment.  
Germany  
132.  An am endment to the German Act on the Prevention and Control of Infectious Diseases in 
Humans granted the German Parliament the competence to determine the existence of an "epidemic 
situation of national significance ". In such a situation, the Federal Ministry for Health (instead of the 
Cabinet) is authori zed to issue orders under the German Patent Act, allowing faster proceedings.  
Italy  
133.  The Italian Patent and Trademark Office has extended the deadlines for administrative 
proceedings for trademarks, patents, de signs and models.  
Greece  
134.  Greece also notified measures related to time limits in IPR administrative procedures.  
Hungary  
135.  Hungary  notified its new legislation on compulsory licenses also under the COVID -19 
measures.  
136.  As the crisis persists, the situation is dynamic and additional notifications can be expected, 
especially as regards deadlines for administrative proceedings related to  intellectual property rights.  
3.13  Australia  
137.  Consistent with the 18 May WHA resolution, Australia recognizes the need for universal, timely, 
and equitable access to essential  health technolog ies and products  consistent with the IP/C/M/95/Add.1  
 
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  TRIPS  Agreement . Australia stresses the vital role of IP in incentivizing the often costly and timely 
development of important health products, including vaccines . In this time of crisis , the 
TRIPS  Agreement should support quick, fair,  predictable and implementable access arrangements 
to vital health products . We recognize the need for all Members to understand their rights and 
obligations under the TRIPS Agreement , including its flexibilities. To this end , we support the 
provision of i nformation to Members  regarding key articles of the Agreement. It is our view that a  
harmonious, well -functioning and clearly understood international IP framework , underpinned by the 
TRIPS Agreement and the rights of IP holders , is crucial to ensuring that Members can address the 
challenges posed by COVID -19.  
138.  We support efforts by the TRIPS Secretariat to increase transparency around best practices 
during these unprecedented  times . We note the World Intellectual Property Organiza tion has 
established a Policy Tracker to monitor IP -related relief measures introduced by IP offices across the 
world.    
Australia 's IP-related measures  
 
139.  On 22 April 2020, IP Australia put in place a streamlined process to provide extensions of time 
to ass ist customers impacted by the COVID -19 outbreak. Under the streamlined process, extensions 
of time of up to three months are available free of charge. Customers can simply tick a box in 
IP Australia 's eServices system to declare that they are unable to meet a deadline due to disruptions 
from t he COVID -19 pandemic. No further documents need to be uploaded and the extension of time 
fee will be automatically waived.  
140.  The relief measures will be continued until at least 31 August 2020.  Customers will be provided 
with at least one week 's notice prio r to the measures ceasing.  
141.  These streamlined, free extensions apply to most of IP Australia 's fees but not to renewals.  
142.  Around 1500 requests for extensions of time were received through eServices from 
22 April 2020 to 21 July 2020 (1204 trademarks, 255 pa tents, 18 designs).  Most requests have been 
granted with some still under consideration.  
143.  A trademark service that provides free support and assistance for businesses impacted by the 
COVID -19 pandemic has also been established.  The service provides informat ion about trademark 
registration in the current environment. Our assistance does not guarantee registration of their 
trademark nor does it offer business or legal advice. For business and legal advice, customers will 
continue to be encouraged to contact an  intellectual property attorney or a business advisor.  
3.14  Switzerland  
144.  As a great supporter of transparency, Switzerland would like to thank the Secretariat for this 
compilation of measures.  
145.  Switzerland recently sent an update to the WTO Secretariat, informing that the premises of its 
IP Office are open again for visitors since early June. We thank the WTO Secretariat for updating the 
respective table on its website accordingly.  
146.  Switzerland attaches great importance to questions r elated to access to medicines, in 
particular in times of a crisis. In this respect, we believe that cooperation is important and that a 
voluntary approach is most effective. I will, however, come back on this in more detail under agenda 
item 14.  
3.15  South Afri ca 
147.  This is just a very quick response to some of the issues that have been raised and then just a 
request to have this agenda item stand over ou r next meeting which is scheduled for October. South 
Africa attaches high importance to the protection of intellectual property rights and from this point 
of view, intellectual property rights are important in creating the right incentives for rights holder s 
to benefit the right level of protection is something which is specified by the TRIPS Agreement . IP/C/M/95/Add.1  
 
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  148.  We also have to understand that when right holders exercise these particular rights , they have 
to respect various parameters in the TRIPS Agreement  as recogn ized generally in IP systems 
worldwide. I want to remind colleagues that Article  7 of the TRIPS Agreement  addresses this issue . 
It reads that "protection and enforcement of intellectual property rights should contribute to the 
promotion of technological in novation 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. "  
149.  In this context,  we raise the possibility of IP rights being a barrier to access. We welcome the 
intervention by the United States and recognize the importance of the private sector in ensuring that 
innovative solutions are found to this pandemic. But it is not only the p rivate sector which guarantees 
success in this regard. We have seen massive financial support from government s to develop various 
technologies and now , for example , vaccines for COVID -19. We have seen earlier in July 2020 that 
a private company , Gilead , had agreed to supply the U nited States for a projected production for 
the next three years of a drug called remdesivir. This raises concern about its supply to other 
countries. Gilead has entered into nine licensing agreements with generic manufacturers of three 
countries to supply 127 other countries. These limited non -transparent exclusive licenses seem to 
be an attempt to contain competition by creating an oligopoly . Generic manufacturers globally that 
can contribute to expanding global supply ha ve been excluded. The lack of transparency and 
accountability in the present dire times is extremely worr ying and dangerous. It is an indicator that 
if IP and access challeng es ahead of us are not addressed, many WTO Members  would fall short of 
the requirement to create the right conditions for access, products and technologies to address the 
COVID -19 pandemic.  
150.  On this basis , I ask that the discuss ion of  this particular issue  be continued and be held over 
to the next TRIPS Council  meeting in October.  
3.16  United States of America  
151.  The United States would like to comment concerning South Africa's request that this agenda  
item be held over to the next meeting in October. The U.S. would ask whether this would be an 
ad-hoc agenda  item for the TRIPS meeting, and accompanied by detailed information, per the rules 
of procedure, for the fall meeting . 
4  REVIEW OF NATIONAL IMPLEMENTING LEGISLATION  
152.  No statements were made under this agenda item.  
5  REVIEW OF THE PROVISIONS OF ARTICLE  27.3(B)  
6  RELATIONSHIP BETWEEN THE TRIPS AGREEMENT  AND THE CONVENTION ON 
BIOLOGICAL DIVERSITY  
7  PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  
7.1  Brazil  
153.  Brazil is taking the floor to restate  its position in this matter.  
154.  We remain convinced that the TRIPS Agreement  should be amended to include a disclosure 
requirement of origin of genetic resources in patent applications.  
155.  We believe that such amendment would allow for a harmonious legal coexistence between the 
provisions related to the acquisition of intellectual property rights (especially in relation to patents) 
of the TRIPS Agreement  and the obligations of the Convention on Biological Diversity (CBD).  
156.  We would also like to inform that the Nagoya Protocol on Access and Benefit -sharing was 
recently approved in Brazil 's Chamber of Deputies and should soon be analy sed by our Senate.  IP/C/M/95/Add.1  
 
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  157.  The imminent conclusion of B razil's accession to the Nagoya Protocol reinforces the need, from 
our perspective, of a solution that leaves no doubt or grey areas about the compatibility and 
complementarity between of the two instruments.  
7.2  Tanzania on behalf of the African Group  
158.  Our intervention will be in respect of agenda items 5, 6, and 7. The African Group would like 
to reiterate its long -standing view and position regarding the inseparable relationship between  TRIPS 
Agreement  and the Convention on Biological Diversity, and our call for the TRIPS Council  to 
cooperate with CBD Secretariat, in order for the TRIPS Agreement  to remain relevant and 
meaningful , particularly for developing countries . 
159.  Also, the African Group would like to reiterate the following:  
a. TRIPS Agreement  must be reviewed to take into consideration the need for protection of 
traditional knowledge and folklore as provided by Art 27.3 (B).  
b. The Agreement need s to ensure the benefits  to be shared between patent holder s and the 
custodian s/ original owner s of genetic resources and traditional knowledge.  
c. The Agreement should state clearly the obligations of Members  in ensuring their 
legislations  and state measures  to prohibit misappropri ation of genetic resources and 
traditional knowledge.   
d. Article  29 of the TRIPS Agreement  could be amended to include a mandatory equit able 
sharing and disclosure requirement of sources of genetic resources and traditional 
knowledge involved in the claimed invention.  
160.  Therefore, the Africa n Group would like to urge Members  to get back into discussion and 
particularly in considering documents TN/C/W/52 and TN/C/W/59 which had attracted significant 
support of Members  from diverse configurations and backgrounds which can serve well as a basis of 
our discussion going forward. Therefore, we urge the TRIPS Council  to collaborate with regional and 
international organizations such as the CBD Secretariat, to remain relevant to its Members . 
7.3  Bangladesh  
161.  On agenda items 5, 6, and 7, the position of Bangladesh has not changed. In this regard, to 
avoid repetition, I refer to my delegation 's statement made at the TRIPS Council 's meeting on 
6 February 2020.  
162.  Bangladesh stands ready to engage constructively wit h Members . 
7.4  South Africa  
163.  It has become a practice to address the three agenda items together under the rubric of the 
'Triplets '. However, in this discussion we often lose the relative importance of the individu al 
components making up the 'Triplets '. The Doha Ministerial Declaration instructed the TRIPS Council  
as part of its work programme to review Article  27.3(b) as well as to examine the relationship 
between the TRIPS Agreement  and the Convention on Biological Diversity , and the protection of 
traditional knowledge and folklore. These are legitimate outstanding implementation issues which 
remain an integral part of the Doha round single undertaking. In recent times Paragraph  31 of the 
Nairobi  Ministerial Declaration (WT/MIN(15)/DEC) reaffirmed the strong commitment of all Members  
to advance the negotiating on the TRIPS issues under the work programme of the Doha Ministerial 
Declaration.  
164.  South Africa believes that the debate in re spect of the Article  27.3(b) is not a static one. 
South  Africa requires disclosure of the use traditional knowledge or biological resources in patent 
application s under  Sections 30 (3A) of the Patents Act No. 37 of 1952  as amended by Act No. 20 of 
2005. Despite this requirement and various legislative approaches to curb biopiracy, the problem 
continues to grow. In the absence of an internationally agreed and enforcement system, as 
applicable under the TRIPS Agreement , national disclosure requirements are of  limited effect due to 
the territorial application of intellectual property rights.  IP/C/M/95/Add.1  
 
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  165.  South Africa is a non -examining patent country; any complete patent application that is filed 
and meets with the formal requirements (fees and correct forms) of the Patents Act will therefore 
be granted. The practice of non -examination gives rise to the po tential of abuse, as patentees count  
their 'rights ' safe in the knowledge that the general public does not understand the concept of 
non-examination and that IP litigation is expensive and time consuming. Between January 2005 and 
July 2015, 40,131 patents originating from all over the world were registered in South Africa ; only 
4064 of those patents ha ve a South African origin. 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 o f proposals 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, patentabili ty criteria, parallel importation, exceptions and compulsory 
licences. The South African 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 very little, market 
exclusivity is easily granted, and maintained, ordinarily at a high cost to society.  
166.  In respect of the relationship between the TRIPS Agreement  and the  Convention on Biological 
Diversity and the protection of traditional knowledge, a large group of WTO Members  has sought to 
introduce a mandatory disclosure requirement in patent applications. The best way to ensure the 
proper use of genetic resources and associated traditional knowledge is through an amendment to 
the TRIPS Agreement  as set out in document TN/C/W/59.  
167.  In line with our previous information provided , it would be useful for the CBD Secretariat to 
brief the TRIPS Council  on the CBD and other implementation issues under the Nagoya Protocol as 
well as any new developments.  
168.  We wish to raise once more the issue  of the update of the three technical notes contained in 
documents IP/C/W/368/R ev.1, IP/C/W/369/Rev.1 , and IP/C/W/370/Rev.1. It would be appropriate 
for the Secretariat to update the information contained in these notes in a neutral manner to further 
facilitate discussions among Members . 
7.5  Zimbabwe  
169.  The Government  of Zimbabwe reiterates its previous information provided  on this agenda item. 
As a signatory to the Convention on Biodiversity , Zimbabwe attaches great impo rtance to its 
international obligations under the CBD. We join other delegation s in calling for the harmonisation 
of the TRIPS Agreement  to the CBD as we are of the view that the TRIPS Agreement  does not 
prevent a person from claiming patent rights on an i nvention based on a genetic resource or 
traditional knowledge.  
170.  Recalling Paragraph  19 of the Doha Ministerial Declaration of 2001, and reiterating that 
Section  33 of the Constitution of Zimbabwe inculcates a right to culture for our people, it states, 
"The State must take measures to preserve, protect and promote indigenous knowledge systems, 
including knowledge of the medicinal and other properties of animal and plant life possessed by local 
communities and people. " 
171.  The TRIPS Agreement  is indifferent to acts of biopiracy and obligations under the CBD in 
respect of prior informed consent and benefit sharing for accessing  biological resources. 
Furthermore, the TRIPS Agreement does not require patent applicants to disclose origin of GR and  
TK used in a claimed invention.  
172.  It is therefore our considered declaration that the TRIPS Agreement  be amended to introduce 
for a mandatory disclosure requirement of the country or source of origin of GR or associated TK. 
The argument that this issue shou ld be dealt with in another organisation, being the 
World  Intellectual  Property Organisation (WIPO) is redundant as none of the WIPO treati es and 
discussions deal with trade -related aspects of intellectual property.  
173.  The delegation  of Zimbabwe has noted tha t WIPO has recently published a study entitled, 
"Intellectual Property and Genetic Resources, Traditional Knowledge and Traditional Cultural 
Expressions. " We propose that this Council  consider inviting WIPO to brief Members  on its findings 
as this and othe r studies by the Organisation could benefit us immensely in our discussions.  IP/C/M/95/Add.1  
 
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  7.6  China  
174.  China's position remains unchanged in  two joint proposals TN/C/W/52 and TN/C/W/59 . We 
believe that benefit sharing solely based on contract ual terms and establishing a database on genetic 
resources are not sufficient protection measures. Instead, prior informed consent to access and fair 
and equitable benefit sharing ensure better prote ction for genetic resources.  
175.  I also recall three procedural suggestions made by my delegation to the TRIPS Council meeting 
in February 2020 . 
7.7  India  
176.  We recall our detailed interventions on these long -standing agenda i tems in the previous 
TRIPS  Council  meetings and  reiterate the need for 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 addre ss biopiracy. We need to move forward in our 
discussions on these three mandated issues, namely, the TRIPS -CBD linkage, GI Register and 
GI Extension based on modalities contained in document TN/C/W/52.  
177.  Paragraph  19 of the Doha Ministerial Declaration manda tes us to examine the relationship 
between the TRIPS Agreement  and the CBD, as well as the protection of traditional knowledge and 
folklore. The TRIPS Council  has regrettably failed to fulfil this mandate for almost 20 years now.  
178.  India would also like to reaffirm that the TRIPS Council  is the appropriate forum to discuss this 
issue due to the fact that much of the misappropriation is a consequence of trade, and lack of legal 
enforceability of an outcome through the WIPO IGC process . It is unfortunate that the same countries 
who pressed upon the discussion of IP issues in WTO at one time are now unwilling to engage in 
WTO on an issue of critical importance to developing countries and showing us the door to WIPO.  
179.  We also support a bri efing by the CBD Secretariat on the latest developments in the 
implementation of the Nagoya Protocol and updating of three factual briefs by the Secretariat on 
these issues.  
7.8  Nigeria  
180.  Our intervention will be in resp ect of agenda items 6 and 7.  
181.  I would want to recall previous information provided  by Nigeria on these subject matters and 
we reiterate that the need for the mutual supportiveness of the TRIPS Agreement  and the Convention 
on Biological Diversity cannot be o ver emphasized. Enhanced corporation of the TRIPS Agreement  
and other relevant international organizations and international instruments remain a basic principle 
of the TRIPS Agreement . We are in support of the harmonization of the TRIPS Agreement  in other  
to be consistent with the CBD.  
182.  Traditional communities continue to be negatively impacted as a result of the illegal 
exploitation of their biological resources or associated traditional knowledge. My delegation  is of the 
view that in order to develop a so und and viable technological base in developing countries and 
LDCs, any utilization of genetic resources from these regions must involve sustainable use in other 
to conserve biological diversity, and must show evidence of a fair and equitable sharing of be nefits, 
as are the principles of the CBD. In other to achieve this, we advocate for the creation of a database 
and registration system to be maintained by the users of this genetic resources, traditional 
knowledge and folklore and which therefore contain v aluable information as to the origin, source 
and contact details of the inventor that is accessible to the world. This will go a long way in upholding 
transparency and build trust among WTO Members . 
183.  As has been proposed in past African Group proposals, Article 29 of the TRIPS Agreement  
ought to be given more force to include traceability and a prior informed consent from the source, 
in respect of any product manufactured from the utilization of genetic components or traditional 
knowledge and folklore. In ot her words, full disclosure of the origin and source of any genetic 
resource or associated traditional knowledge should be made in exchange for patent protection. We 
call upon our trade partners who are users of the GRTKF to foster strategic collaborations with IP/C/M/95/Add.1  
 
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  relevant countries towards developing a mechanism where the patent applicants in their respective 
countries will be mandated to disclose the actual source of any genetic material or TK utilized by 
them during the manufacturing of their products. This will go a long way in the administration of 
benefit sharing with the original owners.  
184.  The full disclosure requirement will not only be beneficial to Nigeria in terms of access to 
benefit sharing, but it will also , on the other hand, improve the quality of our substantive patent 
examination, which will in turn ensure the validity of patent grants in our country.  
185.  Finally, we urge Members  to consider the collaborating with each other both regionally and 
internationally, in other to achieve this mutually beneficial goal.  
7.9  Kenya  
186.  The protection of biological resources, traditional knowledge and folklore is an important 
developmental issue and of particular interest to many Members . In this regard, Kenya fully supports 
the examination of the relationship between the TRIPS Agreement  and the Convention on Biological 
Diversity (CBD), as the TRIPS Council  was mandated by Paragraph  19 of the 
Doha Ministerial  Declaration.  
187.  Kenya believes that TRIPS Agreement  and the CBD should be implemented in a manner that 
is mutually supportive and does not run counter to their respective objectives. We therefore consider 
that the TRIPS Agreement  should be amended to incorporate a provision for Members  to require 
that a pa tent application involving the utilization of genetic resources and/or associated traditional 
knowledge, should disclose the source and country of origin of the biological resources and the 
associated traditional knowledge, in accordance with the CBD. In a ddition, there should also be a 
requirement of evidence of prior consent and equitable benefit sharing under the relevant national 
law.  
188.  We believe that to develop a sound and viable technological base in developing countries and 
LDCs, any utilization of l ocal genetic resources must be in a sustainable manner in order to conserve 
biological diversity.  
189.  Finally, Kenya continues to encourage the engagement of the Director -General in his mandated 
consultative process on the relationship between the TRIPS Agreem ent and the CBD. We look 
forward to the outcome of these consultations and encourage other Members  to engage 
constructively in the process, considering that this issue is of high priority for developing countries, 
since they are often victims of bio -piracy . These dishonest practices must be combated effectively 
to facilitate the sharing of the benefits gained from the exploitation of such resources.  
7.10  Switzerland  
190.  In the interest of time, I will not repeat Switzerl and's position that has not changed. I hereby 
refer to previous statement of my delegation  under these three agenda items.  
7.11  Indonesia  
191.  My delegation  would like to reaffirm its position on the great importance on the negotiation of 
relationship between TRIPS Agreement  and the Convention on Biological Diversity, as well as the 
protection of traditional knowledge and folklore.   
192.  We also reiterate our posi tion that Article  27.3(b) and Article  29 of the TRIPS Agreement  does 
not provide any legal obligation for Members  to take all necessary measures for fair and equitable 
sharing of benefits as required by the CBD and the Nagoya Protocol. This legal omission provides a 
room for misappropriation and misuse of genetic resources and traditional knowledge that, in the 
end, defeat the purpose and objective of the CBD and the Nagoya Protocol.  
193.  Substantive discussions of this issue should not be delayed simply becaus e it is being 
negotiated in other fora, such as WIPO. The discussions to take place in this Council  should reinforce 
what has already been agreed at the multilateral level, such as CBD, and should complement IP/C/M/95/Add.1  
 
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  negotiations/discussions in other fora. We belie ve that parallel discussions will enhance effort and 
understanding in achieving a fair and balanced trading system with regard to intellectual property.  
194.  Indonesia believes that it is timely for the Council  to give simultaneous and adequate attention 
to address the issue towards a common goal to ensure that GRTKF are protected in an appropriate 
manner.  
7.12  Canada  
195.  With respect to the relationship between the TRIPS Agreement  and the Convention on 
Biological Diversity, Cana da continues to believe that TRIPS and the CBD are complementary, and 
that there is therefore no need to amend the TRIPS Agreement  in this regard.  
196.  On the protection of traditional knowledge and folklore, Canada welcomes the ongoing work 
of the WIPO Inter government al Committee on Intellectual Property and Genetic Resources, 
Traditional Knowledge and Folklore (IGC). In particular, the IGC has served, and continues to serve, 
as an important venue that brings together the necessary technical expertise and views , to identify 
evidence -based, balanced, and mutually beneficial approaches to these issues.  
197.  Canada has been an active and committed participant in the work of the IGC, and welcomes 
the concrete discussions and exchanges of national experiences in that venu e, which remain key to 
considering the issues at hand.  
198.  Furthermore, Canada regrets the postponement of substantive discussions at the IGC and 
looks forward to the prompt resumption of the IGC 's important work in a mutually agreeable manner.  
7.13  United States o f America  
199.  The United State s' position has not changed,  and we refer to previous information provided  in 
the TRIPS Council  on the subject.  
7.14  European Union  
200.  The position of the E uropean Union has not changed. We refer to our previous information 
provided  on these matters.   
7.15  Japan  
201.  The position of Japan is unchanged. We firmly believe that the protection of GRs, TK and 
folklore should be designed in a manner that supports both creativity and innovation.  
8  NON-VIOLATION AND SITUATION COMPLAINTS  
8.1  Brazil  
202.  As this is a formal TRIPS Council meeting, I would like to present some of the views we have 
shared with Members in previous informal encounters.  
203.  Brazil believes that the TRIPS Council should seek the completion of the mandate assigned t o 
it by Article 64.3 of the TRIPS Agreement, which refers to this Council's obligation to present 
recommendations on scope and modalities of the application of subparagraphs 1(b) and 1(c) of 
Article XXIII of the GATT.  
204.  This issue has been on the agenda for more than 20 years now, depriving this Council of 
precious time and energy to pursue other objectives. The moratorium determined by Article 64.2 
TRIPS played a fundamental role during the consolidation process of the Agreement, and fruitful 
discussions were undertaken during this past 20 years.  
205.  We believe it is now time to move towards more concrete directions. Brazil has always the 
larger picture in mind – the context of WTO reform – and how we could, as Members, make our IP/C/M/95/Add.1  
 
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  contribution to this ef fort. There are elements that could bring us together in these discussions and 
facilitate an agreeable and reasonable outcome.  
206.  We are convinced that a balanced and thoughtful decision on scope and modalities of non -
violation and situation complaints (NVSCs ) would bring clarity and concrete guidance, further 
consolidating and reasserting the use of flexibilities provided for in the TRIPS Agreement. Finally, 
for Brazil, a mature and balanced treatment of NVSCs could even shed a light on negotiations to 
improv e the dispute settlement system.  
207.  We have been engaging with Members in this past month and we plan to continue this exercise 
in the months to follow. We welcome your views and contributions.  
8.2  Tanzania on behalf of the African Group  
208.  As it will be recalled, in December 2019 Members reaffirmed their commitment to continue 
with the exercise of examining the scope and modalities for the application of non -violation and 
situatio n complaints and make recommendations to the MC12 as mandated in Article 64.3 of 
TRIPS  Agreement. However, our firm view is that the moratorium of non -violation and situation 
complaints should be made permanent in order to ensure Members' rights to TRIPS f lexibilities are 
fully utilised.  
209.  Moreover, it is our understanding that expiry of Paragraph 2 of Art. 64 of the TRIPS Agreement 
(the moratorium), will not trigger automatic application of Article XXIII of GATT 1994 in dispute 
settlement, as any outcome is  conditional on consensus under paragraph 3 of Art. 64 of the TRIPS 
Agreement.  
8.3  Bangladesh  
210.  The position of Bangladesh on the proposed lifting of the moratorium on non -violation and 
situation complain ts is well -known. We are in favour of establishing a permanent moratorium.  
211.  To avoid repetition, 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 Me mbers on 
this issue further.  
212.  In addition, my delegation would welcome an informal session on information sharing in this 
regard. Bangladesh also looks forward to hearing about Brazil's proposal on focused discussion.   
8.4  Nigeria  
213.   We align ourselves with the information provided by the delegation of Tanzania on behalf of 
the African Group and wish to add a brief comment regarding this agenda item.  
214.  My delegation wishes to thank the Chair and the Secretariat  for their continued work in trying 
to work out the modalities for the applicability of non -violation and situation complaints as mandated 
by the General Council, and we also welcome the extension of the moratorium on NVCs on 
10 December 2019, however, we note that this is not a permanent solution. My delegation reiterates 
that in the absence of any agreeable modalities as of yet, our position remains that non -violation 
and situation complaints under Article XXIII subparagraph 1(b) and 1(c) GATT should not be allowed 
to apply under the TRIPS Agreement, as this may result in preventing our policy makers from 
effectively utilizing the flexibilities available in the TRIPS Agreement . Specifically , this may restrict 
our power to make regulations and policies for public health with the aim to increase access to 
medicines.  
215.  In terms of a possible way forward, we propose that the TRIPS  Council recommend to the 
upcoming Ministerial Conference that non -violation and situation complaints should not be allowed 
to apply under the TRIPS Agreement. We believe that it is time for all Members to suggest concrete 
direction on this issue going forward. However, we are happy to engage with the Chair and other 
Members to find an amicable solution on this issue. We continue to thank you, Chair, and the 
Secretariat for their continued work.  IP/C/M/95/Add.1  
 
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  8.5  India  
216.  India's position on the issue of non -violation complaints under the TRIPS Agreement remains 
unchanged. Serious concerns remain on the debilitating impact that non -violation complaints in 
TRIPS can have on the regulatory policy space of Members and on TRIPS flexibilities, thereby 
increasing the complexity in interpreting the TRIPS provisions. These complaints can not only have 
a chill ing effect on Member's exercise of their IP regimes but also severely restrain the ability of 
Members to achieve public policy objectives.  
217.  The absence of non -violation complaints in the TRIPS context does not in any manner threaten 
or dilute the enforceabi lity of TRIPS -related rights and obligations. As such, any benefits arising from 
the Agreement can be adequately protected by applying the text of the Agreement in accordance 
with accepted principles of international law, without any need for introducing t he legally uncertain 
notion of non -violation and situation complaints. Introducing such complaints into the 
TRIPS  Agreement is, therefore, unnecessary.  
218.  India looks forward to working with like -minded Members in making non -violation complaints 
inapplicable  to TRIPS. We also wish to reiterate that until there is a consensus on the scope and 
modalities of the applicability of NVCs to TRIPS, NVCs will not apply to the TRIPS Agreement. We 
also look forward to the proposal by Brazil.  
8.6  Thailand  
219.  Thailand would like to reiterate that our position on this issue remains unchanged. We believe 
that non -violation and situation complaints should not be applicable to the TRIPS Agreement. It is 
important to strike an a ppropriate balance between IP rights protection which provides incentives 
for the creation of IP and innovation, and the TRIPS flexibilities which allow Members to achieve 
their legitimate interests.  
220.  We, therefore, strongly support the continuation of the NVC moratorium, at least until the 
12th WTO Ministerial Conference. Thailand is willing to engage in future discussions with a view to 
finding a common understanding and making the NVC moratorium permanent.  
8.7  China  
221.  Like many others, China believes that non -violation and situation complaints should not be 
applicable to the TRIPS Agreement and wishes that the Membership could achieve a consensus on 
the non -application. Specific arguments have been presented i n the joint proposal 
document  IP/C/W/385/Rev.1 submitted by many Members including China. We also look forward to 
Brazil's proposal.  
8.8  Argentina  
222.  Argentina's position on this issue is well -known and, t o date, remains unchanged. We believe 
that complaints of this type are not applicable to the TRIPS Agreement for the reasons explained in 
document IP/C/W/385/Rev.1, which Argentina co -sponsored together with a large number of other 
Members.  
223.  Non-violation a nd 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.  
224.  We beli eve 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.  
8.9  Chile  
225.  Our delegation's position is well -known among Members. Moreover, we welcome the decision 
made at the General Council meeting in December 2019 to approve the extension of the moratorium.  IP/C/M/95/Add.1  
 
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  226.  In our delegatio n's view, both formal and informal talks on this matter have brought to light 
the existence of different positions concerning the conditions and modalities applicable to this type 
of complaint, and it is therefore appropriate to continue discussing the var ious 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.  
8.10  Zimbabwe  
227.  The Government of Zimbabwe reiterates its previous information provided on this agenda item. 
We recall Article 67 of the TRIPS Agreement which requires developed country Members to 
implement technical cooperation initiatives for developing an d least developed countries (LDCs) to 
implement the TRIPS Agreement.  
228.  In light of the Coronavirus disease (COVID -19), at no time in the history of the World Trade 
Organisation has it been more necessary for all Members to be cognisant of their rights to exe rcise 
limitations and exceptions provided by the TRIPS Agreement. We urge developed country Members 
to uphold the spirit and purpose behind this provision.  
8.11  Switzerland  
229.  My delegation's position unde r this agenda item and for the Council's recommendation is 
well-known.  
230.  For the sake of brevity, I thus confine myself to confirming that Switzerland is ready to 
examine and discuss any proposal from other Members on modalities for non -violation and situati on 
complaints under the TRIPS Agreement, should they consider such modalities necessary in addition 
to those contained in the DSU.   
8.12  Canada  
231.  Canada's longstanding position on this issue remains unchanged:  the availability of NVNI 
claims under TRIPS would create legal uncertainty for Members.  
232.  Canada recognizes that the current moratorium exists thanks to consensus, and we trust that 
Members can continue to discuss these issues in a collegial manner, especia lly in view of the high 
concentration of Members with concerns in this area.  
233.  We wish to express our continued interest in participating in any consultations that take place 
on this issue amongst other interested Members.  
8.13  United States of America  
234.  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 ap propriate.  
235.  While we remain of the view that the text of the WTO Agreements and dispute settlement 
rulings provide Members with sufficient guidance on the application of NVNI disputes to the TRIPS 
Agreement, the United States remains open to considering sp ecific proposals from Members wishing 
to further examine the scope and modalities for complaints of these types.  
8.14  Indonesia  
236.  Indonesia reaffirms its position that applying NVSCs to intellectual propert y could result in an 
imbalance between the rights of IP holders  and IP users, as well as the public interest. The absence 
of scope and modalities for NVSCs would introduce new obligations and raise the standards for 
protection beyond what has been agreed u pon.  
237.  Moving forward for MC12, Indonesia supports the permanent moratorium of NVSCs for the 
TRIPS Agreement. However, we will engage if any Member put s any proposal on the table.  IP/C/M/95/Add.1  
 
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  8.15  European Union  
238.  As Members will know, the European Union supported extending the moratorium of 
13 December 2017 on TRIPS non -violation and situation complaints.  
239.  However, the EU remains open to hear and discuss any possible solutions for the future, 
including proposals on scope and modalities. We are ready to engage constructively in these 
discussions.  
8.16  Jamaica on behalf of ACP Group  
240.  The ACP Group wishes to congratulate you on your assumption of y our role as the Chair of 
this very important Council and to reassure you of the Group's support during your tenure.  
241.  The moratorium provided for under Article 64.2 of TRIPS has played an important role during 
the conclusion of the TRIPS Agreement. This pro vision avoided the hasty use of a device on which 
further discussion was needed, as well as afforded time for more clarity in Members' positions.  
242.  The ACP Group wishes to underscore the continued importance to WTO Members of the 
examination of the applicabi lity of non -violation complaints to the TRIPS Agreement. While the views 
of Members may vary on whether to allow for such complaints, Members have consistently agreed 
to continue examination of this issue; most recently at the WTO General Council meeting i n 
December 2019, where Members agreed to:  
take note of the work done by the Council for Trade -Related Aspects of 
Intellectual Property Rights pursuant to the Ministerial Conference decision of 
13 December 2017 on "TRIPS Non -violation and situation complain ts" 
(WT/L/1033).  
243.  Members further agreed that the TRIPS Council would:   
continue its examination of the scope and modalities for complaints of the types 
provided for under subparagraphs 1(b) and 1(c) of Article XXIII of GATT 1994 and make 
recommendations to the 12th Ministerial Conference. It is agreed that, in the meantime, 
Members will not initiate such complaints under the TRIPS Agreement.  
244.  Consistent with this General Council Decision, the ACP Group 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 twelfth Ministerial Conference.  
8.17  Kenya11 
245.  The examination of the scope and modali ties for non -violation and situation complaints made 
pursuant to the TRIPS Agreement, as envisaged by Article 64.3, should also involve an examination 
of whether such complaints should apply to the TRIPS Agreement, and if so, to what extent.  
246.  We believe th at the agreement by Members on the moratorium should be viewed without 
prejudice to the question on the availability of such complaints to the TRIPS Agreement. This is a 
matter that ought to be determined in the course of the examination of scope and modal ities by the 
TRIPS Council.  
247.  We are, therefore, of the view that the Ministerial Conference should grant a moratorium to 
the effect that non -violation and situation complaints shall not be applicable to the TRIPS Agreement 
until the issue of scope and moda lities is resolved by consensus. In the meantime, we urge the 
TRIPS Council to carry out its mandate under Article 64.3 and as reiterated in subsequent Ministerial 
Decisions.  
 
11 The delegation of Kenya requested at the meeting, that for reasons of time, its full statement be 
included in the record of the mee ting. This record may thus contain elements that were not spoken at the 
meeting.  IP/C/M/95/Add.1  
 
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  8.18  South Africa12 
248.  The po ssibility of bringing complaints on otherwise GATT -consistent measures was introduced 
into the GATT 1947 to address situations where the concessions or benefits obtained in a tariff 
negotiation could be easily frustrated by non -tariff measures, such as dom estic subsidies, that the 
GATT 1947 did not regulate. As the original GATT did not require Contracting Parties to make 
substantive commitments on many such non -tariff measures, non -violation complaints were 
introduced as a remedy that could address any imp airment of the benefits of tariff concessions as a 
result of such measures.  
249.  Thus, the basic function of Article XXIII:1(b) was to protect expectations that arose out of 
tariff concessions negotiated by parties to the GATT. It was to ensure that a GATT Cont racting Party 
could obtain compensation, or a right to the compensatory or retaliatory withdrawal of concessions, 
where another Contracting Party introduced a measure subsequent to the negotiation of a tariff 
concession that frustrated the achievement of t hose concessions. In effect, non -violation complaints 
are a fall -back remedy designed to prevent circumvention of GATT obligations through measures 
that are not themselves GATT -inconsistent. We should however note that the non -violation remedy 
is an "excep tional" remedy. There has been no successful recourse to the non -violation remedy in 
any of the WTO disputes in which Article XXIII:1(b) has been invoked. In over 70 years of the 
existence of multilateral trading system, reports were adopted by the GATT Co ntracting Parties in 
only the remaining three out of the eight cases.13 Even in those disputes in which non -violation 
complaints have been successful, there was agreement by the parties involved that it was an 
exceptional remedy to which "a cautious approach" should be taken.14 
250.  This experience with non -violation complaints in  GATT/WTO jurisprudence suggests that the 
evolution of the multilateral trading system, and the expansion in the provisions of WTO Agreements 
regulating non -tariff measures, may have had the effect of making non -violation complaints largely 
redundant as a remedy. Nonetheless, my delegation is not a proponent of the application of NVSCs 
and the proponents of the application of such complaints under the TRIPS Agreement have not 
provided concrete examples of the kind of scenarios under which an otherwise TRIPS -consistent 
measure would impair or nullify benefits beyond those arising from the obligations set out in the 
Agreement. Thus, as we previously suggested, it may be useful to clarify what situations proponent 
Members wish to avoid by having a non -violation  remedy available under the TRIPS Agreement and, 
on the other hand, to ensure that a non -violation remedy in the TRIPS context would not be so broad 
as to have the effect of expanding the existing TRIPS obligations.  
9  REVIEW OF THE IMPLEMENTATION OF THE TRI PS AGREEMENT UNDER ARTICLE 71.1  
251.  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  
252.  No statements were made under this agenda item.  
11  TECHNICAL COOPERATION AND CAPACITY -BUILDING  
11.1  Bangladesh  
253.   The delegation of Bangladesh welcomes the reports on technical cooperation and capacity 
building under Article 67 of the TRIPS Agreement in favour of the developing countries and th e LDCs, 
from the developed country Members and other international organizations and the report of the 
Secretariat. These reports provide us information on a wide range of programmes and activities 
 
12 The delegation of South Africa requested at the meeting, that for reasons of time, its full statement 
be included in the record of the meeting . This record may thus contain elements that were not spoken at the 
meeting.  
13 See Report of the Working Party on Australia - Ammonium Sulphate, Panel Report on Germany - 
Sardines and Panel Report on EEC - Oilseeds I.  
14 See, for instance, EEC - Oilseeds I, where both the US and the Europ ean Community made statements 
to this effect.  IP/C/M/95/Add.1  
 
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  customized for the beneficiary Members. These programmes a re critically important particularly for 
the LDCs.   
254.  Bangladesh sincerely thanks and encourages the developed country Members and the 
international organizations to continue their valuable support for developing countries, LDCs and the 
graduating LDCs.  
11.2  South Africa  
255.   We wish to thank the Secretariat for its ongoing commitment to assist developing  countries 
to make maximum use of the multilateral system. Due to COVID -19 the cooperation and capacity 
building activities may have been affected as reported by ITTC in its briefing to the CBFA. Face -to-
face training in most cases have been postponed until the next fi nancial year while some online 
activities have taken place. South Africa attaches importance to the use of the online mode during 
this time to continue technical cooperation and capacity building. Technical assistance and capacity -
building must always resp ond to Members' needs, at this time many Members may have a need for 
technical assistance and capacity building to respond to the COVID -19 pandemic. In the context of 
the Biennial Technical Assistance and Training Plan 2020 – 2021 (WT/COMTD/W/248/Rev.1), 
emphasis has been placed on improving eLearning programmes. Expanding access to materials is 
also envisaged under the plan, this would be valuable for the public at large.  
11.3  WTO Secretariat  
256.   Also on behalf of my  colleagues from WHO and WIPO, I am pleased to share some excellent 
news with you: on 29 July, the second edition of the Trilateral Study on Access to Medical 
Technologies and Innovation has been presented to the public in a virtual launch event. Together 
with video messages by the three Directors -General, the publication is now available on each 
organization's webpage.  
257.  Encouraged by the strong and positive feedback that the study has received since its initial 
launch in 2013, we trust that the second editi on will make its contribution to an informed policy 
debate about what is needed to foster innovation that is responsive to pressing needs and to secure 
equitable access to essential medical technologies. Its aim is to build capacities in Governments to 
deal with those and other challenging questions.  
258.  For this purpose, the revised study addresses all the key determinants for innovation and 
access to vital medical technologies, from research to development to manufacturing and delivery 
to those in need. And i t maps out the close and complex linkages between health, intellectual 
property and trade.  
259.  To do so, this new publication draws practical lessons from experience, including from our joint 
technical assistance activities, with the interaction of those dist inct policy dimensions. It sets them 
within the broader perspective of the human rights dimension and the Sustainable Development 
Goals.  
260.  What is new in the revised edition? We have seen numerous significant developments since 
2013 that are covered by the n ew publication. To give you a few examples: efforts have stepped up 
to achieve universal health coverage. The fast -evolving pattern of the disease burden and emerging 
global threats to public health pose new challenges, as demonstrated by the current pande mic. 
Antimicrobial resistance pushes us to adapt existing innovation models. And we have also addressed 
the emergence of new health technologies, an increasingly diverse medical technologies sector, and 
strengthening innovative and production capacity in d eveloping countries.  
261.  The second edition offers an improved empirical foundation for informed priority setting, 
resource allocation and policy decisions, through the integration of more comprehensive and 
accessible data on prices, access, patents and trade.  This said, the Study is descriptive, aiming to 
build a firm empirical foundation for policymaking, rather than endorsing or advocating any particular 
approach.  
262.  What has the WTO in particular contributed to this revised edition? Among many other things, 
contributions include a detailed analysis of trade in health technologies, based on a completely IP/C/M/95/Add.1  
 
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  revised methodology to measure trends in trade in health products; second, a detailed analysis of 
provisions in FTAs which bear on innovation and access in the pharmaceutical sector; and finally a 
comprehensive review of the role of competition law and policy for the public health sector.  
263.  I should mention that the main text of the Study was completed before the outbreak of the 
COVID -19 pandemic. To take due accou nt of the unprecedented challenges, we have opted to add 
a section providing a factual overview of the developments and measures taken to address this 
extraordinary public health crisis. As many of the issues that have arisen during the pandemic are 
not ne w, the purpose of this section is to guide the reader to those parts of the Study that provide 
essential background on those issues. This ensures its practical relevance to today's most urgent 
needs. So, while the section on COVID -19 may appear to be thin,  the fact is that responses to the 
pandemic span such a wide range of technical areas that nearly every section of the Study is of 
relevance to the global response to COVID -19. 
264.  The pandemic has brought into sharp relief the fundamental need to co -operate i nternationally 
and to bring together diverse areas of expertise to effectively address global health challenges.  
265.  I would therefore like to use this opportunity to address our special thanks to colleagues and 
friends from WHO and WIPO, as well as the many c olleagues from the WTO and other key 
stakeholders for their excellent collaboration and the significant contributions they have made to 
this publication.  
266.  Let me conclude with a brief quote from the DGs' foreword: "Global collaborative efforts are 
required now more than ever before" - it is in this spirit that we have launched the Trilateral Study.  
11.4  World Health Organization  
267.   This is to present the second edition of the trilateral study promoting access  to medical 
technologies and innovation – intersections between public health, intellectual property and trade.   
268.  As you may know, the three organizations have been working closely together to support 
global endeavours to improve health outcomes, to strengt hen the capacity of developing countries 
to respond to needs in the areas of health innovation, access to health, and intellectual property. 
The objective of the trilateral study is to provide an up -to-date platform for sharing practical 
experience and und erstanding of a wide range of policy instruments. We count on this document to 
support and inform the ongoing technical cooperation and policy discussions, in particular at a time 
when the world grapples with the multi -dimensional challenges of the respons e to the COVID -19 
pandemic.  
269.  The COVID -19 pandemic is a tragic and powerful demonstration of the importance of 
innovation and access for public health. Innovation is essential, but it is only part of the answer to 
this pandemic. Together, we must all ensure  that vaccines, diagnostics and therapeutics for 
COVID -19 are global public goods, not more reasons that more people are left behind.  
270.  The trilateral study integrates lessons from diverse experiences regarding how public health, 
IP, trade and competition ru les all interact with each other in the broader context of the human 
rights dimension of health and the united nations' sustainable development goals. We tried to include 
comprehensive and accessible data and information on prices, access, patents and lice nsing.  
271.  The insert at the beginning of the study summarizes issues that have come up in the context 
of COVID -19, the pandemic has brought extraordinary challenges to peoples' health, economies and 
societies at large. Countries are also seeking at extraordi nary solutions to respond.  
272.  Global collaborative efforts are required now more than ever before to respond to challenging 
situations, not only for COVID -19 but also for other diseases, like HCV, cancer, HIV, etc.  
273.  WHO pledges continuing commitment for furt her collaboration among our three agencies, 
together with other UN agencies, the private sector, funders, and civil society organizations, whose 
insights have contributed much to the study, only this will support our work towards the shared 
objectives of u niversal health coverage, better health outcomes for all, fulfilment of the Sustainable IP/C/M/95/Add.1  
 
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  Development Goals (SDGs) and, first and foremost, the design of effective and lasting responses to 
public health crises.  
11.5  World Intellectual Property Organization  
274.  I am pleased to join my colleagues from WHO and WTO and to add a few words on the second 
edition of the trilateral study.  
275.  Since the launch of the first edition of the study in 2013, consider able relevant work has been 
undertaken in WIPO that has informed the update of the study.  
276.  For example, comprehensive studies have been prepared for, and have been discussed in, the 
WIPO Standing Committee on the Law of Patents (SCP), particularly under the  agenda item patents 
and health. These include studies on: The Role of Patent Systems in Promoting Innovative Medicines, 
and in Fostering the Technology Transfer necessary to Make Generic and Patented Medicines 
available in developing countries and least d eveloped countries (SCP/21/8); Constraints faced by 
developing countries and least developed countries (LDCs) in making full use of Patent Flexibilities 
and their lmpacts on Access to Affordable Especially Essential Medicines for Public Health Purposes 
in those Countries: (SCP/26/5 and SCP/27/6); and the Feasibility Study on the Disclosure of 
International Non -proprietary Names (INN) in Patent Applications and/or Patents (SCP/21/9 and 
SCP/28/5).  
277.  The WIPO Global Innovation Index 2019 Creating Healthy Lives – The Future of Medical 
Innovation has informed the sections on economics of innovation and access to medical technologies.  
278.  At the same time, patent information systems have made significant progress and we now 
have much more sophisticated search tools to f ind relevant patent information, for instance through 
useful features in the WIPO Patentscope database.  
279.  The new WIPO Standard ST.27 (Recommendation for the exchange of patent legal status data) 
aims at improving worldwide availability, reliability and comp arability of patent legal status data and 
we hope that the acceptance of this recommendation by patent offices leads to an improved 
understanding about patent legal status events across different jurisdictions.  
280.  There is, of course, much more in the study, such as updated and enhanced sections on 
copyright and trademarks. The study is comprehensive, and it takes a holistic perspective when it 
presents the intellectual property system in its health and trade contexts. Importantly, the study 
benefits fr om the expertise and close collaboration of the three Secretariats.  
281.  The COVID -19 pandemic requires that we stand together in solidarity and collaborate. The 
work done by the three Secretariats to produce this second edition is a small, and successful, 
instance of such collaboration.  
282.  We trust that this second edition of the trilateral study shall have many readers.  
11.6  Chile  
283.  Chile considers that these types of tools are those that allow Members to better understand 
the complexities between intellectual property, trade, public health and give them greater clarity 
when taking public policy measures in these areas.  
11.7  Zimbabwe  
284.  Zimbabwe thanks the WTO, WHO and WIPO for the publication and for the interventions made.  
11.8  Tanzania on behalf of the African Group  
285.   The African Group would like to register its appreciation to Members who have timely 
submitted their annual reports in relation to the implementation of Article 67 of the 
TRIPS  Agreement. On this note, we call other Members that have not yet done so, to do.  IP/C/M/95/Add.1  
 
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  286.  Similarly, we would like to urge developed country Members to continue to adhere to the 
obligation of providing u pon request the needed financial and capacity building support to developing 
countries and least developed countries. We would also like to encourage intergovernmental 
organizations such as WIPO, WTO, UNCTAD, ITC and others, to intensify capacity building activities 
on IP management and transfer of technology.  
12  LDC GROUP PROPOSAL ON THE IMPLEMENTATION OF ARTICLE  66.2 OF THE TRIPS 
AGREEMENT  
12.1  Bangladesh  on behalf of the LDC Group  
287.  On th is agenda item, the delegation  of Bangladesh makes this statement on behalf of the LDC  
Group . For time constraint, I am not going into the detail for which I particularly refer to the 
information provided  by Chad and Bangladesh at the TRIPS Council  on 6 February 2020.  
288.  LDCs always appreciate the contributions of developed country Members  and their annual 
implementation reports under TRIPS Article  66.2. However, many reports do not clearly give 
information on incentives provided to enterprises and in stitutions in the territory of the developed 
country Members . Instead, these reports contain a mixture of technical assistance programmes  
under Article  67 and a few technology transfer initiatives under TRIPS Article  66.2.  
289.  The LDC Group's proposal  contain ed in document IP/C/W/664 contains a template for annual 
reporting under TRIPS  Article  66.2. This may be noted that the proposal is built on the room 
document RD/IP/37 circulated on 5 February 2020 , which was basically developed from Members ' 
feedback. In this regard, the LDC Group acknowledges the contribution of the participating 
delegates, from the LDC and developed country Members , and their capital -based colleagues who 
provided suggestions on improving the annual reporting process during the WTO worksh ops on the 
implementation of TRIPS Article  66.2 held in 2019 and 2020.  
290.  The current proposal is self -explanatory. The proposed template does not demand any new 
information that developed country Members are already providing in the annual reports following  
the TRIPS Council  decision contained in document IP/C/28 dated 20 February 2003 and the existing 
reporting format proposed through document IP/C/W/561 dated 6 October 2011. T he proposed 
template has just reorganized the columns and rows of the existing re porting format to bring clarity 
and simplification. The additional contribution in the new template is the appendix, expected to 
specify the incentives and the details of the enterprise and institution receiving the incentives from 
the developed country Me mbers  and transferring technology to LDCs. It is also possible to adjust 
and accommodate this template with the e -TRIPS Gateway . The proposed template with appendix 
is expected, as has been stated in the proposal, to help simplify reporting process, synchronize the 
current reporting variations, and acknowledge the substantive contributions of the developed 
country Members  with evi dence and precision.  
291.  It may also be noted that LDC Group earlier submitted  a proposal ( document IP/C/W/640) 
dated 16 February 2018 requesting the TRIPS Council  to specify the meaning of 'incentives to 
enterprises and institutions '. The LDC Group further s ubmitted a room document RD/IP/24 dated 14 
June 2018, to discuss and agree on developing an illustrative list of incentives for the purpose of 
technology transfer to LDCs. Till date there is no agreed list of incentives, however, many reporting 
Members  are currently following the non -exhaustive illustrative list, as contained in RD/IP/24, as a 
guide while submitting annual reports. LDC Group sincerely appreciates those Members . The Group 
also encourages Members  to actively engage in discussion to specify th e illustrative list of incentives 
to technology transfer to LDCs.   
292.  To create a sound and viable technological base in the LDCs, the LDCs need support from the 
developed country Members . This is also a commitment of obligatory nature for the developed 
count ry Members . The LDC Group invites Members  to reflect on the annual reporting template for 
TRIPS Article  66.2 contained in t he proposal and explore further how to utilize this template for 
future reporting purpose. Members  are also encouraged to discuss and  deliberate on the meaning 
of incentives and develop an illustrative list of such incentives for the purpose of annual reporting 
under TRIPS Article  66.2.   
293.  In this regard, the LDC Group stands ready to engage constructively with Members .  IP/C/M/95/Add.1  
 
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  12.2  Nepal   
294.  My delegation  would like to associate with the statement made by Bangladesh on behalf of the 
LDC Group.  
295.  Among the various provisions of special and differential treatment laid down in the WTO laws, 
TRIPS Article  66.2 with specific provision of technology transfer to LDCs has become an important 
and more relevant in the context of technology led world economy  of the 21st century.  
296.  In this context, my delegation  would like to extend sincere appreciation to all developed 
country Members  for their support and cooperation through various means of technical assistance.  
297.  I would like to recall the various initiative s and efforts towards implementation of the 
TRIPS  Article  66.2 provision and its reporting mechanism.  
298.  The LDC Group has made three submissions over time to make the reporting mechanism clear 
and uniform under this Article .  
299.  My delegation  appreciates the annual reports by developed country Members  and the 
engagement of those Members  in the reviews and workshops devoted to the TRIPS Article  66.2 
implementation.  
300.  The clear objective of TRIPS Article  66.2 in terms of implementation is to prom ote and 
encourage transfer of technology in LDCs so that we can develop a sound and viable technological 
base.  
301.  However, there is still gap between the spirit and letter of the TRIPS Agreement  mandate and 
its real implementation while providing assistance to LDCs under TRIPS Article  66.2.  
302.  Further clarification on incentive as per the spirit of the provision, its modality and coverage 
of enterprises and institutions to collaborate may also be required to facilitate the implementation 
effectively.  
303.  LDCs subm itted a room document of an illustrative list, RD/IP/24, containing possible 
incentives that resonate for LDCs and could indicate what to provide and what to report to the 
TRIPS  Council .  
304.  My delegation  would like to thank Switzerland for its report in 2019  indicating that the LDC 
illustrative list served as a guide.   
305.  We believe that the responsibility to provide incentives may falls on the developed country 
Member Government  and not on the private sector entities and enterprises. Therefore, it may need 
a clear mechanism of incentivizing enterprises and institutions in developed country Members  to 
motivate them to transfer technology in LDCs.   
306.  My delegation  would like to extend sincere appreciation to all developed country Members  for 
their continued support to LDCs and expect further enriched cooperation in future particularly in 
technology transfer under Article  66.2 of the TRIPS Agreement .  
12.3  Nigeria  
307.  We support the proposal provided  by Chad on behalf of the LDC Group on the implementation 
of Article  66.2 of the TRIPS Agreement , and we would like to highlight that in view of the economic, 
financial and administrative constraints of the LDCs and also their need for flexibility to create a 
viable technological base, we urge our developed country Members  to continue in their efforts in 
providing incentives to enterprises and institutions in their territories for the purpose of promoting 
and encouraging technology transfer to least developed  countries  so as to fulfil their mandate under 
Article  66 of TRIPS . Particularly, we underscore the importance ensuring that the notification under 
TRIPS Article  66.2 is done in a transparent and inclusive manner, and it is made in the proposed 
format whic h is fit for purpose on behalf of the LDC Group.  IP/C/M/95/Add.1  
 
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  308.  Furthermore, we thank the developed country Members  in their technical support to developing 
and least developing countries already provided, and we urge our developed country partners to 
deepen their kind technical and financial cooperation and collaborations in favour of developing and 
least developed countries  in fulfilment of their obligations under Article  67 of the TRIPS Agreement  
to assist our government s regarding the establishment and reinforcement of domestic IP offices and 
capacity building. However, we urge that such assistance should be made in a manner that is fit for 
purpose in accordance with the specific requirements of the beneficial countries so as to adequately 
facilitate the implementatio n of this Agreement . 
12.4  Tanzania on behalf of the African Group  
309.  The African Group  thanks the LDC Group for th e proposal contained in document IP/C/W/664 
which relate s to the implementation of Art icle 66.2 of the TRIPS Agreement . We would like to 
commend Members  who have consistently provided reports in relation to the implementation of the 
provision. However, LDCs have on several occasions expressed their concern that the majority of 
reports lack s the direct relevance to the implementation of Art icle 66.2 which oblige s developed 
country Members  to provide incentives to enterprises and institutions in their territories for the 
purpose of promoting and encouraging technol ogy transfer to LDCs, in order to enable them to 
create a sound and viable technological base.  
310.  On this note, the Africa n Group supports the LDCs ' proposed reporting template for 
consideration and adoption by the Council ; and we urge other Members  to positi vely consider it.  
12.5  Zimbabwe  
311.  The Government  of Zimbabwe reiterates its previous information provided  on this agenda item. 
We support and appreciate the proposal ( document IP/C/W/664) presented by the Delegation  of 
Chad on behalf of the least developed countries  (LDCs) Group.  
312.  We believe that this proposal is in line with the 2001 Doha Ministerial Decision on 
Implementation -Related Issues and Concerns. Members  agreed that the  TRIPS Council  would put in 
place a mechanism for ensuring the monitoring and full implementation of the obligations.  
313.  There is need for specificity in the reports submitted in terms of TRIPS Article  66.2 with clear 
terms of reference and measurable outcome s. The current unsystematic approach in the compilation 
of the reports makes it very difficult for the Council  to monitor compliance with this Article . 
314.  We call upon Members  of the Council  to recall that technology transfer is an essential element 
of Articles 7, 8 , and 66.1 of the TRIPS Agreement. Support for this proposal would go a long way in 
fulfilling our obligations.  
12.6  South Africa  
315.  Thank you to LDC Group and the African Group. Transparency is an import ant aspect of the 
mandate of this organisation. The simplified template will go a long way in facilitating the work of 
this Council  and comply with the Doha Declaration. The appendix is an important addition in this 
paper and will enable a more accurate re flection of the recipients of incentives. We would also agree 
that the definition of 'incentives ' should be agreed so as to enable a better understanding of what 
types of measures will constitute such incentives.  
12.7  India  
316.  Article  66.2 of the TRIPS Agreement  mandates that the developed country Members  provide 
incentives to their own enterprises and institutions in their territories for promoting and encouraging 
technology transfer to LDCs.  
317.  In this regard, India supports the LDC Group 's proposal, which suggests templates to provide 
details on the speci fic enterprise receiving the incentives and transferring technology to LDCs. The 
LDC Group believes that proposed templates will help simplify the reporting process, synchronize 
the current reporting variations, and acknowledge the substantive contribution s of developed IP/C/M/95/Add.1  
 
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  country Members  with evidence and precision and improve overall transparency in the context of 
this important provision.  
12.8  China  
318.  We would like to thank the LDC Group for tabling the proposal. China  believes that developed 
country Members  should continue to take active measures to encourage enterprises and institutions 
to transfer their technolog y to LDC Members  in accordance with the Article  66.2 of the TRIPS 
Agreement , thus to help the LDC Members to create a sound and viable technological base.   
12.9  United States of America  
319.  The United States continues to support a robust dialogue between developed country Members  
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 . 
320.  It is q uite an undertaking each year to take stock of the program mes we report to the 
TRIPS  Council . The relevant agencies or entities involved in the program mes are identified. As you 
can see from our recent reports, there is not one coordinating body that undertakes these 
program mes. We therefore view it best to continue to implement these program mes and these 
reports as we have.  
321.  We are always willing to meet with interested Members  to discuss ways to ensure that our 
program mes and reports are as helpful as  possible.  
12.10   Switzerland  
322.  Switzerland thanks the LDC Group for presenting document IP/C/W/664.  
323.  A series of workshops and extensive discussions have taken place over the past years in which 
developed country  Members  have discussed with their LDC counterparts how to best adjust the 
contents and format of their reporting under 66.2 to the needs and preference of the LDC Group.  
324.  Developed country Members  have undertaken considerable efforts to respond to those 
proposals when writing or revising their reports.  
325.  We are still in the process of examining the LDC document. Switzerland is open to look into 
additional proposals from the LDC group, as long as we can accommodate them.  
326.  As a preliminary reaction to the pre sented document, it seem s to this delegation  that this is 
not the case with at least some of the additional information that is now asked by the LDC Group 
from developed country Members   
327.  As document IP/C/W/664 recalls, the obligation of developed country M embers  under Article 
66.2 is to provide incentives to enterprises and institutions in their territories so that these 
enterprises and institutions may, if they wish to do so, transfer their technology to LDC Members .  
328.  Developed country Members  have, howeve r, no obligation under Article 66.2 to ensure that 
the enterprises and institutions on their territory make use of these incentives or actually transfer 
their technology to LDCs. This is the autonomous decision of each enterprise and institution.  
329.  Informat ion as to what company or institution transferred what technology to which 
LDC country Member is not information that developed country Members  regularly have at their 
disposal. Nor may they demand companies and institutions to systematically provide such 
information under Article 66.2, not least because such information may qualify as business 
confidential information.  
330.  That said, Switzerland wi ll make maximum efforts in its future reports  to provide information 
on the incentives it provides under Article 66.2 in a manner as transparent, consistent, clear and 
comprehensible as possible.  IP/C/M/95/Add.1  
 
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  12.11   Canada  
331.  Canada  would like to thank Chad and the LDC Group for circulating communication  document  
IP/C/W/664 on the proposed new template for annual reporting under Article  66.2 of the 
TRIPS  Agreement  and welcomes further discussion on this topic.  
332.  Canada continues to enc ourage constructive dialogue on the implementation of 
TRIPS  Article  66.2, including through the recent annual workshops on this topic, which have allowed 
for an in -depth exchange between least developed country (LDC) and developed country Members  
on incent ives for the purpose of promoting and encouraging technology transfer to LDC Members  in 
order to enable them to create a sound and viable technological base.  
333.  In addition to the valuable discussion on technology transfer incentives and LDC needs and 
priorit ies, we have also benefitted from hearing LDCs ' views on how to refine and enhance the annual 
reporting template, in order to ensure that information on technology transfer is conveyed in a clear 
and user -friendly format.  
334.  Canada is open to hearing proposal s from LDC Members  on revising the reporting template in 
this regard, and notes that we currently follow the template previously proposed by the LDC Group 
in document IP/C/W/561.  
335.  As Canada will be preparing its annual report on the implementation of TRIPS Article  66.2 in 
the coming weeks, we would propose that any discussion on a standard reporting template be 
finalized as soon as possible, to facilitate our timely reporting on this important issue.  
12.12   Japan  
336.  Regard ing the proposal of a standardized reporting format, it should be noted that the content 
itself of the report is an important element and it would vary depending on the type of project by 
each Member. From this point of view, the format for reports should be flexible to accommodate the 
varying types of contents. This delegation  will continue to contribute to discussions on this matter.  
12.13   Indonesia  
337.  Indonesia thank s the LDC Group for this proposal. We support the proposal and believe it is 
useful for synchronizing and simplifying reporting process under Article  66.2 of the 
TRIPS  Agreement . This proposal will also enhance transparency in WTO as called on by many 
Members  in other com mittee/ Council  meetings.  
12.14   European Union  
338.  The EU thanks the delegation s of Chad and the Group of Least Developed Countries  for having 
submitted this communication on a new proposal for a template for annual reporting under 
Article  66.2 of the TRIPS Agreement .  
339.  The EU and its Members  take their commitment under Article  66.2 of the TRIPS Agreement  
very seriously and annually pr ovide a detailed update on their respective technology transfer 
programmes. The EU and its Members  provided proof of having promptly and attentively reacted to 
natural, social, health, climate and economic changes by implementing projects specifically tail ored 
to the current needs of LDCs and their regional organisations.  
340.  The EU has always supported efforts to simplify the reporting process and to synchronise the 
reports in order to guarantee their user -friendliness and broad accessibility by LDCs. The EU and its 
Members  have been using the previous template provided by LDC s from the moment it was officially 
submitted to the TRIPS Council  by the LDC Group. Motivated by the aim of improving the reporting 
process even further, in 2019, the EU started using the e -TRIPS Portal developed and promoted by 
the WTO Secretariat.  
341.  As Members  will know, the e -TRIPS Portal guarantees the full harmonisation of the reports as 
well as accessibility and searchability for LDCs and others. The EU intends to continue using the 
e-TRIPS Portal, also for the preparation of its next submission in 20 20.  IP/C/M/95/Add.1  
 
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  342.  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 a nd searchability. We would like to 
make a couple of comments regarding the proposed template.  
343.  Technology transfer refers to the ways and means through which companies, individuals and 
organisations acquire technology or know -how from third parties, irrespe ctive of whether such 
technology is IPR -protected or not.  
344.  More often than not, technology transfer is just one component of a more complex project, 
rather than a stand -alone activity. The acquisition by LDCs of a sound and viable technological base 
does n ot depend solely on the provision of technology or equipment, but also on acquisition of know -
how, management and production skills, improved access to knowledge sources as well as on 
adaptation to prevailing local economic conditions.  
345.  Therefore, factors s uch as training and education of university graduates, exchanges of 
qualified staff, and joint research projects must accompany the buying or licensing of IP rights 
related to the transferred technology. Relevant literature tells us that the mere transfer of technology 
- without the training of local employees - does not enable the recipients to achieve the 
internalisation of the technology provided and to reduce the technology gap as compared with 
developed country Members . Accordingly, several projects im plemented by the European Union and 
its Members  are aimed at providing such training and education.  
346.  It also warrants highlighting that the EU actions usually target groups of countries or regions. 
The reason is that the EU strongly supports regional integr ation. That is why our technology transfer 
projects sometimes target regions including both LDCs and also other developing countries.   
347.  The EU proposes that any discussion on revised or new template takes these issues duly into 
account. The EU stands ready to discuss the matter further.  
12.15   Bangladesh  
348.   The LDC Group thanks the delegation s of Nepal, Tanzania, Nigeria, Zimbabwe, South Africa, 
India, China, and Indonesia for their support to the LDC proposal. The Group also thanks the 
delegation s of U nited States, Switzerland, Canada, Japan, and EU for their encouraging words and 
willingness  to engage with LDC Members  on this issue.  
349.  The LDC Group welcomes the proposal from developed country Members  and looks forward to 
engaging constructively for deciding the illustrative list and the reporting template for future 
reporting.  
13  INTELLECTUAL PRO PERTY AND THE 1998 WORK PROGRAMME ON ELECTRONIC 
COMMERCE  
13.1  South Africa  
350.  The Work Programme on Electronic Commerce (WT/L/274) in Paragraph  4.1 provides that "the 
Council  for TRIPS shall examine and report on the intellectual property issues arising in connection 
with electronic commerce. The issues to be examined shall include:  
• protection and enforcement of copyright and related rights;  
• protection and enforcement of trademarks; and  
• new technologies and access to t echnology. " 
351.  In order to reinvigorate the 1998 Work Programme on Electronic Commerce in line with the 
General Council  Decision of December 2019, this delegation  proposes an intensification of 
discussions under Paragraph  4.1 of the Work Programme. Since this  area of engagement is 
mandated, the TRIPS Council  should inscribe this agenda item as a standing item on the agenda.  
352.  This will facilitate a deeper discussion of issues that could be based on a catalogue of themes 
that could be agreed by Members . Initially the issue of electronic commerce was a standing  agenda  IP/C/M/95/Add.1  
 
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  item on the TRIPS Council ; Members  should return to this practice.15 Members  are encouraged to 
submit further proposals, share information and national experiences, pointing out how the 2030 
Sustainable Development Goals may be achieved through an effective framework for technology 
transfer.  
353.  Intellectual property can have an impact on development so the link between intellectual 
property  (IP) and development, as well as the relationship with t he various SDGs , needs to be 
mainstreamed into the discussion of the TRIPS Council . In order to meet the SDGs, new technology 
needs to be harnessed and accessed by developing countries and LDCs.  
354.  The U nited Nations Conference on Trade and Development  Digital Economy Report of 201916 
captures the transformative effect of digital technologies as follows: "The world economy is 
transforming fast as a result of the rapid spread of new digital technologies, with major implications 
for Agenda 2030 on Sustainable Development. Greater levels of digitalisation of both economies and 
societies are creating new means for tackling global development challenges; however, there are 
risks that digital disruptions will favour mainly those that are already well pr epared to create and 
capture value in the digital era, rather than contribute to more inclusive development. " At the cusp 
of this digital revolution are technologies such as key software -oriented technologies such as 
blockchain, data analytics and artificial intelligence.  
355.  The rapid deployment of smart devices and digital interfaces to 3D printing, wearables, 
automation, robotics and cloud computing are all contributions to a notable digiti zation of the world 
economy, a trend which has been accelerated by COVID -19. In this context the digital divide impedes 
the participation of developing countries in digital value chains, while digital transformation is 
disrupting traditional sectors with severe socio -economic consequences.  
356.  On this basis UNCTAD concludes that: "The current trends of new technologies being 
concentrated in a few countries and controlled by relatively few companies have implications for the 
ability of both developing and developed country Members  to participate in the technological learning 
processes needed to catch up and thrive in the digital economy.17  
Discussion  
357.  The preamble of the TRIPS Agreement  emphasizes the underlying policy objectives of national 
systems for the protection of intellectual property, including developmental and techno logical 
objectives. These objectives should be read in conjunction with Article s 7 and 8 of the 
TRIPS  Agreement . The Secretariat in its Background Note on the Work Programme on Electronic 
Commerce18 recognize s that "[t]he traditional objectives of the syst em as reflected in the current 
international norms, including in the TRIPS Agreement , would appear to remain valid even in 
'cyberspace '."19 
358.  Article  7 of the TRIPS Agreement  provides a context to interpret access to technology by 
emphasizing that the protec tion and enforcement of IPRs 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 that is conducive to 
social and economic welfare, and to a balance of rights and obligations.  
359.  In order to industrialize, it is clear that developing countries would need more access to 
technology ; however, it is also clear that as many developing countries pursue industriali zation, they 
do so in the context of an international IP regime that is more constrained than it was in the 
19th century. The Agreement on Trade -Related Aspects of Intellectual Property Rights (TRIPS) 
establishes extensive standards of IP protection that are almost without exception legally binding on 
all WTO Members . 
 
15 WTO Secretariat Background Secretariat Note: The Work Programme on Electronic Commerce 
Addendum IP/C/W/128/Add.1 of 15 May 2003, ad par. 8.  
16 UNCTAD/DER/2019 ad p. 1.  
17 UNCTAD (2019) ad p. 21.  
18 IP/C/W/128 of 10 February 1999.  
19 Ibid ad  par.13, p. 3.  IP/C/M/95/Add.1  
 
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  360.  Furthermore, Article  8 recognize s the right of WTO Members  to adopt national measures to 
promote public interest in sectors of vital importance to their socio -economic and technological 
development subject that such measures are 'consistent ' with the TRIPS Agreement . When 
considering consistency of measures, the in -built TRIPS flexibilities need to be taken into acco unt 
across the entire spectrum of the TRIPS Agreement . It is also important to take account of the 
cross-cutting impact of proposals in other WTO bodies or plurilateral initiatives that may impact 
intellectual property rights.  
361.  Some Members  have proposed d isciplines to prohibit national localization requirements and 
government s' access to data ; this may have unintended consequences for settled practices in 
Members ' IP regimes and affect exceptions and limitations that are well -established under the TRIPS 
Agreement . The link between localization and IP is not clear and since it is silent on the implications 
for trade secrets on transparency of algorithms and access to copyright ed works in the digital 
economy, these issues should be approached with caution.  
362.  A South Centre paper20 posits that "…localization requirement policies, which are in full 
compliance with WTO provisions and which may also have national security implications, are se en 
as a trade barrier per se , they may substantially impede the development of certain data -intensive 
industries and also favour those who already hold large amounts of data. " 
Summary  
363.  Article  7 broadly captures the need for balance between private property  rights and public 
interest in respect of socio -economic and technological development. This links the TRIPS Agreement  
directly with the 2030 SDG s and requires the promotion of technological innovation, transfer and 
dissemination in a manner that will achi eve the SDG s.  
364.  Further bolstered by Article  8 and Article  66.2 of the TRIPS Agreement , technology transfer is 
central to address development issues, including the digital divide. Both demand and supply side 
issues are covered in these provisions, with TRIPS Article  66.2 imposing a mandatory obligation on 
developed country Members  to provide a favourable environment and incentives to their enterprises 
and institutions to promote transfer of technology to LDCs.  
365.  On the other hand, Article  8 recognize s demand -side imperatives that allow Members  to 
promote public interest in sectors of vital importance to their socio -economic and technological 
development.  
Questions  
366.  Questions that can frame the discussion under this agenda item include:  
1. How can except ions and limitations, including compulsory licenses in the IP system, be used as 
tools to ensure that the patent system contributes to the promotion of innovation in a competitive 
environment and to the dissemination and transfer of technology, meeting the  objectives of the 
system and responding to the public interest at large? What are Members ' experiences in this regard?  
 
2. Article  40.1 of the TRIPS Agreement  recognize s that some licensing practices or conditions  
pertaining to intellectual property right s, which restrain competition, may have adverse effects on 
trade and may impede the transfer and dissemination of technology. Read with Article  40.2, 
Members  may address adverse effects of anti -competitive practices through appropriate measures. 
Such measu res may also be applied to digital platforms that could potentially use their dominant 
position to restrain competition, including through the use of intellectual property rights. How can 
more effective access to technologies , especially in the digital economy , be secured for developing 
and least developed countries  in an inclusive way?  
 
367.  In closing, I would like to stress that technology transfer is not only associated with Art. 66.2 
but is a theme that should be taken account in every aspect of the TRIPS Agreement  and specificall y 
 
20 Policy Brief No.62: Intellectual Property and Electronic Commerce: Proposals in the WTO and Policy 
Implications for Developing Countries (June 2019), p. 5 et seq . IP/C/M/95/Add.1  
 
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  in how we enable the environme nt for developing and least -developed countries to have access to 
appropriate technologies in order to overcome the developmental divide . 
13.2  India  
368.  We thank the delegation  of South Africa for their timely intervention on crucial issues 
pertaining to intellectual property in connection with electronic commerce. The submission rightly 
notes that the 1998 Work Programme on Electronic Commerce mandates the TRIPS Council  to 
exam ine and report on such issues. In fact, e-commerce regularly featured on the agenda of 
TRIPS  Council  meetings from 1998 to June 2003, and the Council  had also produced three reports 
to the General  Council  on this issue. We, therefore, support the request b y South Africa to inscribe 
this issue as a standing item on the TRIPS Council  agenda.  
369.  The rapid deployment of digital technologies has increased substantially during the COVID -19 
crisis, indicating that the ongoing digitalization possesses new means of tac kling global development 
challenges. However, the pace of such digitalization is different in different trading economies. 
Therefore, it is imperative that the requisite technology is made available to the developing and least 
developed countries  so as to create a level -playing field. Discussions on e-commerce will lack 
meaning if the gaping digital divide, partly arising out of lack of access to technologies and furthered 
by the pandemic, continues to exist.  
370.  The TRIPS Agreement , in consonance with Article  7 and Article  8, enumerates several 
flexibilities. These flexibilities are not limited to a particular sector or technology. It remains open 
for Member countries to utilize these flexibilities as per their socio -economic conditions. However, 
India has had very limited experiences in this regard. As of now, India has not invoked any such 
flexibilities in the case of e -commerce.  
371.  The advent of e -commerce has  led to erosion of geographical boundaries, and has facilitated 
the entry of buyers and sellers in markets from around the world. The ongoing digitalization of the 
economy, however, is also throwing certain specific challenges in respect of competition pol icy. In 
this regard, the paper from South Africa rightly points out that Article  40.1 of the TRIPS Agreement  
recognizes that some licensing practices or conditions pertaining to intellectual property rights, which 
restrain competition, may have adverse eff ects on trade and may impede the transfer and 
dissemination of technology, and read with the provisions of Article  40.2, Members  may address the 
adverse effects of anti -competitive practices through appropriate measures which may also be 
applied to digital  platforms.  
372.  It is of utmost importance for developing countries to adopt e -commerce and IP policies that 
are mutually supportive and in line with their developmental goals and policy specificities. Therefore, 
we support the suggestion to maintain this issu e as a standing item on the TRIPS Council  agenda.  
13.3  European Union  
373.  The EU and its members  take note of the communication submitted by South Africa on 
operationali zing technology transfer in the context of Article s 7, 8, 40 and 66.2 of the 
TRIPS  Agreement . 
374.  The EU considers e -commerce as one of the important topics for future WTO work. This is the 
area where achieving progress could benefit the m embers hip at -large and provide tangible results 
for our economies and c itizens, both in developed country Members  as well as in developing 
countries.  
375.  The d igital economy has developed remarkably in the past decades. Our practices have 
evolved accordingly to capture those developments, but only limited progress has been achiev ed in 
the WTO.   
376.  The EU also supports the General Council  Decision of December 2019 to reinvigorate the 1998 
Work Programme on Electronic Commerce and is ready to continue and intensify work on the three 
areas that fall under the competence of the TRIPS Council. IP/C/M/95/Add.1  
 
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  377.  As to the issues raised in the communication by South Africa, the EU believes that voluntary 
technology transfer has the capacity to boost international economic relationships. Therefore, it is 
an important tool that helps foster innovation and devel opment. It can create win -win situations in 
international business.  
378.  A reliable and predictable system of protection and enforcement of IPR s is a necessary 
condition for technology transfer to occur on market -based and voluntary contractual terms and 
there fore a key driver of technology transfer.  
379.  Licensing plays a crucial role in promoting the dissemination and further development of 
technologies by licensees, thereby facilitating the commerciali zation of innovative products.  
380.  Enforcement of IPRs provides f or transparent procedures that permit effective action against 
infringement of IPRs as well as the opportunity for review of final administrative decisions by a 
judicial authority.  
381.  The p atent system is a key driver of innovation and research also in the ar ea of the digital 
economy. Patents are an important and up -to-date source of technological information, which often 
cannot be found elsewhere.  
382.  The disclosure requirement set out in Article  29.1 of the TRIPS Agreement  allows innovators 
and researchers , including in developing countries and LDCs , to access this information and to reach 
the same knowledge level , as well as to continue the momentum with further technological 
development of the patented technology.  
383.  Besides disclosure, there are many ways to support technology transfer, notably collaboration 
and links between researchers and industry, transparency on licensing conditions or special support 
to SMEs. The EU 's Research & Innovation Framework Programmes are good examples of initiatives 
promoting c ross-border collaboration, including with non -EU countries in different sectors, also 
e-commerce.  
384.  The EU and its members  also contribute and implement numerous cooperation and capacity 
building projects to support the services trade and the development of  regulatory frameworks under 
the Aid for Trade programmes, including with regard to digital solutions.  
385.  The EU has presented this and other initiatives in more detail in the context of exploratory 
discussions on supporting the digital capability of busines ses and consumers that are taking place 
in the Council  for Trade in Services.  
386.  It is also important to underline that in many cases access to technologies in the field of 
electronic commerce is dependent on issues outside the IP regime, such as lack of ins titutional 
capacity to absorb technologies, preferences of local suppliers, infrastructure deficiencies and 
restrictions on inward technology.  
387.  Competition law and intellectual property systems are not contradictory, but complementary 
systems of law, which  both strive to further welfare and growth. The TRIPS Agreement  recognize s 
the possibility of the application of competition policy measures while setting clear limits , as such 
measures have to be consistent with the provisions of the TRIPS Agreement . 
388.  Comp etition policy plays an important role in controlling and sanctioning anti -competitive 
market behaviour in any sector, including the area of electronic commerce.  
389.  Abusive IPR -related conduct , as any other abusive practices, can violate competition law and 
can be considered an anti-competitive practice, but only in clearly defined circumstances, and 
provided that all rigorous legal requirements are met.  
390.  At the same time, the number of competition cases that are related to the use of the intellectual 
propert y framework clearly underscore that it is not the IPR system as such that raises competition 
issues. In fact, competition issues which are related to the use of the IP framework originate from 
the unlawful conduct of companies, which go against the objecti ves of the IPR system. For example, IP/C/M/95/Add.1  
 
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  contractual clauses that lead to allocating markets or customers or restricting the exploitation of the 
licensee 's own technology.  
391.  Finally, we would like to emphasise that existing international cooperation in the field  of 
competition, for example the International Competition Network, facilitates the dissemination of 
expertise and best practices and has a large potential to strengthen the fair and appropriate 
enforcement of competition law and contribute to better funct ioning of the markets around the globe.  
13.4  Zimbabwe  
392.  The delegation  of Zimbabwe extends its appreciation to the delegation  of South Africa for the 
submission of document IP/C/W/665 on "Operationalizing Technology Transfer in the Context of 
Article s 7, 8, 40 and 66.2 of the TRIPS Agreement ". 
393.  Zimbabwe believes that the emergence of the coronavirus disease of 2019 ( COVID -19) makes 
it incumbent upon us to resuscitate a conversation on intellectual property (IP) in e -commerce. The 
emergence of new technologies has added a new dimension to the worl d of IP, particularly in artificial 
intelligence, blockchain, and digitali zation.  
394.  The only way in which we can face the existential threats we face in climate change, health 
and other hazards is to harness technology for our common benefit.  
395.  We support the proposal to restore on the agenda of the Council  the agenda  item on 
"Intellectual Property and the 1998 Work Programme on Electronic Commerce ". 
13.5  United States of America  
396.  The United States  thank s South Africa for its paper.  
397.  Under the Work Programme on Electronic Commerce, the TRIPS Council  is to examine the 
protection and enforcement of copyright and related rights as well as trademarks and new 
technologies and access to technology .  
398.  While there i s renewed attention on the Work Programme, the TRIPS Council  has never really 
stopped focusing on the issues identified by it. Indeed, ensuring widespread access to new 
technologies through protection and enforcement of copyrights and related rights and tr ademarks is 
at the very core of the work this Council  does.  
399.  Presentations by developing countries  and numerous international organizations in other 
bodies, such as the Working Group on Trade and Transfer of Technology, have emphasized roles of 
both develop ed and developing economies in ensuring access to technology. Developed country 
Members  have discussed their extensive capacity building programmes  and technology transfer 
initiatives, including as related to intellectual property protection and enforcemen t, designed to build 
the absorptive capacity of developing countries and LDCs. Meanwhile, Members  have recognized the 
important role of the developing economy in creating an environment conducive to technology 
transfer. In particular, international organiz ations such as the World Bank, the United Nations 
Conference on Trade and Development , the O rganization for Economic Cooperation and 
Development  and the U nited Nations Food and Agriculture Organization have emphasized the 
importance of investment protection, removal of trade barriers to technology and strong intellectual 
property protection in creating an environment in which technology transfer can thrive.  
400.  In light of this background, as called for by the Work Programme on Electronic Commerce, thi s 
Council  should focus on how the TRIPS Agreement  ensures protection and enforcement of copyright 
and related rights as well as trademarks, and how that protection and enforcement relates to new 
technologies and access to technologies. Accordingly, the que stions South Africa poses to frame the 
discussion, narrowly focused as they are on abusive anti -competitive practices and the measures 
government s may seek to use to remedy such specific, fact -dependent behaviour , constrain this 
mandate. An appropriate exa mination would focus on the application of the TRIPS Agreement  to 
new technology, and how protection and enforcement of intellectual property rights can promote 
access to technology.  IP/C/M/95/Add.1  
 
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  401.  We do not support adding this issue as a standing agenda item. Nothing pr events Members  
from raising this or any issue in particular meetings.    
13.6  Canada  
402.  Canada thanks South Africa for circulating document IP/C/W/665 on the topic of intellectual 
property and the 1998 Work Programme on Electronic Commerce.  
403.  Canada takes note of the 1998 mandate of the Work Programme, as outlined in document 
WT/L/274, which identified TRIPS as one of several relevant bodies to examine the trade -related 
aspects of e -commerce. As directed by ministers in tha t document, the TRIPS Council  shall examine 
and report on IP issues arising in connection with e -commerce, including: protection and 
enforcement of copyright and related rights; protection and enforcement of trademarks; and new 
technologies and access to t echnology.  
404.  As Members  of this Council  may recall, in May 2016, Canada proposed, under document 
IP/C/W/613, an exchange of national experiences in these areas, with a view to informing our 
respective policy efforts at the intersection between IP and e -comme rce, and to help Members  
understand emerging developments in this area.  
405.  As e-commerce continues to rapidly develop internationally, with implications for IP protection 
and enforcement, and pursuant to ministerial direction on this topic, Canada remains ope n to sharing 
national experiences in these areas.  
406.  We take note of the specific IP topics set out in the 1998 Work Programme, and would 
encourage an exchange of national experiences in these areas. For instance, in 2017, Canada 
presented on an innovative la w enforcement initiative on e -commerce and trademark rights, entitled 
"Project Chargeback ", and would similarly be pleased to share its experiences on the other IP topics 
contemplated by ministers at a future session.  
407.  Given that these topics often involve coordination across domestic government  ministries, we 
would also encourage that topics for discussion be notified in advance of TRIPS Council  meetings, to 
facilitate our engagement and sharing of national experiences on these important issues.  
13.7  Chile  
408.  We wish to thank the delegation  of South Africa for submitting this document and for 
facilitating discussion on the existing relationship between intellectual property and electronic trade 
as provided for under the General Council  mandate of 2019 and the Work Programme on 
Electronic  Commerce.  
409.  In Chile 's view, Article s 7 and 8 of the TRIPS Agreement  make it clear that intellectual property 
is not an end in itself, but a tool for development. Accordingly, the minimum standards of protection 
and flexibilities provided for in the Agreement e nable Members  to establish or adapt intellectual 
property systems in line with their own national realities, favouring and safeguarding their areas of 
particular interest in an appropriate manner.  
410.  Chile believes that the work of this Council  in the area of  electronic commerce should entail 
sharing experiences and best practices so as to further our understanding of how Members  have 
used IP in conjunction with electronic commerce to strengthen SMEs and other businesses. Sharing 
experiences and best practices  will lead to a better understanding of how IP and electronic commerce 
interact and how policies aimed at fostering the use of IP for development are implemented in this 
area. 
13.8  China  
411.  China would like to thank South Africa for  the proposal . As IP enforcement in the digital 
environment has been emphasized a lot in the past, South Africa provides us with the perspective 
of IP and development in the digital era. We recall that the General Council  adopted the Work 
Programme on Elec tronic Commerce in September 1998 and mandates Members  to discuss issues 
related to electronic commerce in the General Council  and four WTO bodies, including the TRIPS IP/C/M/95/Add.1  
 
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  Council . The Work Programme mandates the TRIPS Council  to examine new technologies and access 
to technology. It also requires the Committee for Trade and Development to take into account the 
needs of developing countries , including the use of information technology.  These issues are all 
related to IP and deve lopment in the digital era.  
412.  In recent years, we have witnessed a rapid development of electronic commerce around the 
world. E -commerce effectively helps enterprises, especially medium and small -sized enterprises , to 
reduce the cost of participating in the globalization process and provides more commercial, trade 
and investment opportunities for enterprises so that they can better integrate into the global supply 
chain. The COVID -19 pandemic further highlighted the importance of e -commerce to the global 
economy. 
413.  Meanwhile, we recognize that the challenges brought by e -commerce and new technologies 
have aroused worldwide attention. It is important to explore how developing countries  could make 
better use of e -commerce to expand trade and investment opportuniti es. China thinks that we should 
work to increase developing countries ' involvement in world trade through appropriate measures 
and access to digital technologies on commercial terms, especially in a digital environment.  
13.9  Australia  
414.  Australia recognizes the role of the 1998 Work Programme in seeking to ensure IP -related 
issues arising in connection with electronic commerce are approached in a manner that promotes 
sustainable development.  
415.  Efforts to reinvigorate the 1998 Work Programme should be done in a manner that does not 
duplicate the work of the TRIPS Council  or WIPO, but rather supports existing obligations (i.e. TRIPS 
Article  66.2 reporting).  
416.  We recognize  the importance of continuing to create conditions that encourage voluntary 
technology transfer which is mutually beneficial and supports global development.  
13.10   Switzerland  
417.  Switzerland thanks the delegation  of South Afric a for introducing its submission.  
418.  E-Commerce is a topic Switzerland attaches much importance to. We believe that the World 
Trade Organization  has a central role to play in shaping a legally safe and reliable international 
regulatory framework that is cond ucive - and adequately responds - to the exponential growth that 
we have seen in e-commerce over the last two decades.  
419.  My delegation  agrees that the objectives of the TRIPS Agreement  as set out in its Article  7, 
including the balance of rights and obligat ions, apply to intellectual property protection in both the 
analogue  and the digital environment.  
420.  As in analogue  business, adequate and effective IP protection and enforcement is instrumental 
in e-commerce, whether it concerns goods or services. Switzerla nd is thus happy to participate in a 
discussion of the Council  on e-commerce from the perspective of trade -related aspects of intellectual 
property rights.  
421.  We agree that the General Council  mandate must guide us in this discussion. This mandate 
has however, in our view, its limits . The General Council  instructs the TRIPS Council  to examine the 
e-commerce -relevant aspects of the protection of copyrights and related rights as well as of 
tradem arks and enforcement against their infringement, which in the world of e -commerce means, 
above all, counterfeiting and piracy activities.   
422.  With its reference to new technologies and access to such technology, the General Council  
recognizes in its mandate t hat the protection and enforcement of IPRs in e -commerce matters not 
only for copyright and trademarks, but also for patents, utility models and designs.  IP/C/M/95/Add.1  
 
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  13.11   South Africa  
423.  Thanks to Members  who intervened. Just noting a fe w points that have been made. As this 
particular submission focuses on new technologies and access to technology, it does not undermine 
previous discussions. The main focus of previous discussions was on counterfeit s, piracy, 
technologies to enforce partic ular types of technologies and IPRs , etc. From that point of view , we 
see that our discussion is complementary and we certainly agree with China that the issue of access 
to technology and the link to development is something that we need to take into accou nt. In terms 
of the timing of the communications, we agree th ey should be made available ahead of time , given 
the constraints that one face s in the current scenario and the limitations that many developing 
countries face during this difficult time. Going forward , proposals related to the 1998 Work 
Programme w ill be made available in good time. We are also encouraged by the intervention of many  
Members  and the introduction of certain ideas that we could explore.  
424.  I believe that the impact on SMEs , for example , is noteworthy given the fact that the digital 
revolution primarily reduces the cost of doing business . But whether or not SMEs, especiall y from 
developing and least developed countries , may benefit from this reduction of costs is certainly an 
open question. But if I go back , for example , to the Trilateral Study (this has become somewhat of 
a bible for me, the 2013 version in particular since I have not had the opportunity to look at the 
updated version yet in any amount of detail ), I believe that the cross -cutting issues that were 
brought up previously will benefit from the update d study. This will enable us to certainly make 
proper linkages  between issues as we always recognize  that the topic of technology transfer is not 
as simple as its seams . We recognize  from our previous interventions that there are both demand 
and supply constrain ts, and any legitimate system must be enforceable , transparent and predictable. 
But in any system where there are differences in levels of development and capabilities , we must 
take advantage of the flexibilities to assist developing and least developed count ries. The submission 
also focuses on possibilities to use flexibilit ies in a pro -development way in order ensure that we do 
have a level playing field for every Member to benefit from digital technology and to ensure that 
IPRs do not become a barrier to th e equal access and enjoyments of the benefits of the digital 
revolution.  
13.12   Nigeria  
425.  Let me start by thanking the delegation of South Africa for this very informative paper while 
we are still considering the proposal at capita l, we would like to state our preliminary observations 
of some similarities of some of the elements of the paper with our national approach in 
operationalizing technology transfer under the TRIPS Agreement.  
426.  We are of the view that the discussions around t he 1998 work programme on e -commerce 
should be continued. We also agree with Paragraph 4 of the proposal which implies that intellectual 
property can impact on development, therefore it is pertinent to foster discussions on this regard at 
the TRIPS Council . The need for developing countries ' and LDCs ' access to new technology cannot 
be overemphasized.  
427.  Furthermore, we agree, as was provided under Article 7 of the TRIPS Agreement , that the 
protection and enforcement of intellectual property rights should con tribute to the promotion of 
technological innovation and to the transfer and dissemination of technology in other to ensure the 
balance of rights.  
14  INTELLECTUAL PROPERTY AND PUBLIC INTEREST: BEYOND ACCESS TO MEDICINES 
AND MEDICAL TECHNOLOGIES TOWARDS A MORE  HOLISTIC APPROACH TO TRIPS 
FLEXIBILITIES  
14.1  South Africa  
428.  A main focus at the WTO has been how to facilitate access to medicines in the context of the 
Doha Declar ation on TRIPS and Public Health. The Amendment to  the TRIPS Agreement  entered into 
force in 2017. In the usual way, the term 'TRIPS flexibilities ' has been emphasised in the context of 
access to medicines and medical technology through compulsory licenses  or Government  use and 
even in that context remains under -utilized.  IP/C/M/95/Add.1  
 
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  429.  The High -Level Panel Report on Access to Medicine observes that: "…WTO Members  retained 
important public health flexibilities that can be used to adapt their intellectual property law, policies 
and practices to meet human rights and public health objectives. These include the ability to 
determine patentability criteria, issue compul sory licences, authorise parallel importation, apply 
general exceptions and employ competition laws to limit and remedy the abuse of intellectual 
property rights in domestic legislation. "21 In this regard, there are still a significant number of 
countries that do not make full use of available flexibilities under the TRIPS Agreement .  
Towards an integrated approach to TRIPS flexibilities  
430.  The use of TRIPS flexibilities to address a public health concern is usually seen as a matter 
concerning patents. However , the COVID -19 pandemic requires a more integrated approach to 
TRIPS flexibilities that include other various types of intellectual property (IP) rights including 
copyrights, industrial designs and trade secrets. The use of TRIPS flexibilities in other are as 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. A 
variety of IP rights are relevant in th e fight against COVID -19.  
431.  The COVID -19 crisis created the need to produce essential equipment and medical supplies, 
there is a growing need to be able to manufacture essential medical devices such as masks, 
ventilators and other personal protective equipment. As the debate over COVID -19 moves beyond 
medical issues, the nature of the pandemic requires non -medical approaches to detect, diagnose 
and trace the coronavirus. Studies have found that levels of neutralizing antibodies against 
SARS -CoV-2 remain high for a few weeks after infection, but t hen typically begin to wane.22 So far, 
only one infectious disease comparable to COVID -19 in its broad geographic distribution has been 
eradicated : this disease is smallpox.  
432.  According to GAVI, even if eradication of COVID -19 is ultimately technically feas ible, it will 
likely be extremely  challenging.23 It cautions that given the uncertainty around the technical 
feasibility of eradicating COVID -19, the global community also needs to plan for the possibility that 
COVID -19 will be in global circulation indefinitely. In the absence of prophylaxis through a vaccine 
and more effective treatments, non -medical measures have been an important priority in d ealing 
with the devastating impacts of COVID -19. 
433.  Other goods  and services that are needed to tackle the epidemic include protective equipment 
such as masks, face shields, and hand sanitizers. Such equipment and material remain in critical 
shortage in many countries around the world. Many WTO Members  lack domestic manufacturing 
capacity and would be dependent on imports to meet their medical needs.  
434.  When an exporting country is producing under a compulsory license mainly for export, the 
mechanism established  by the 30 August 2003 decision, and later translated into an 
Amendment  to the TRIPS Agreement  as Article  31bis, would be applicable. This mechanism waives 
the condition in Article  31(f) that a compulsory license should be predominantly for the supply of 
the domestic market. It should be noted that the implementation of the Article  31bis mechanism at 
a national level is very limited and may not achieve its intended objectives.24 In any event, many 
developing countries  may also face legal, technical and inst itutional challenges in using TRIPS 
flexibilities. This is especially true for countries that have never utilized flexibilities such as 
compulsory licenses.  
435.  The World Health Organization has launched the COVID -19 Technology Access Pool (C -TAP) 
inter alia  calling on intellectual property holders to voluntarily license such rights on a "non-exclusive 
and global basis to the UNITAID -established and supported Medicines Patent Pool and/or through 
other public health research and development mechanisms, consortia or initiatives that facilitate 
 
21 Report of the United Nations Secr etary-General 's High -level Panel on Access to Medicines - Promoting 
innovation and access to health technologies (2016) , at p. 22.  
22 Ling Ni, Fang Ye, Meng -Li Cheng et al Detection of SARS -CoV-2-Specific Humoral and Cellular 
Immunity in COVID -19 Convalesce nt Individuals  Immunity 52, 971–977, June 16, 2020.  
23 See the GAVI Vaccine Alliance < https://www.gavi.org/vaccineswork/could -covid-19-ever-be-
eradicated >  
24 WIPO CDIP/5/4 Annex II Categories of Different  Provisions on Specific Flexibilities:  
<https://www.wipo.int/edocs/mdocs/mdocs/en/cdip_5/cdip_5_4 -annex2.pdf#page=1 > IP/C/M/95/Add.1  
 
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  global and transparent access; and/or voluntary non -enforcement of intellectual property right s, as 
appropriate, during the COVID -19 pandemic, to facilitate the widescale production, distribution, sale 
and use of such health technologies throughout the world ". However, to date no company has 
committed to doing so. Instead limited, exclusive and oft en non -transparent voluntary licensing is 
the preferred approached of pharmaceutical companies, which will be insufficient to address the 
needs of the current COVID -19 pandemic.  
Some Examples  
 
Example 1: Big data outside of the health system  
 
436.  Smartphones, mobile data, artificial intelligence, databases and algorithms have been used in 
the COVID -19 pandemic to leverage the detection and control and control of the virus. Different 
types of IP rights are relevant to protect AI algorithms, some may be protected  by copyright and 
trade secrets while other technology is protected by patents while database rights and trade secrets 
may also be relevant.  
437.  While these approaches help with efforts to contain the spread of the virus, they can raise 
issues about  the right to privacy and personal freedoms. National security concerns may also arise 
in the context of Article  73 of the TRIPS Agreement . 
Example 2: 3D printing technology  
 
438.  During this COVID -19 outbreak, an Italian hospital ran out of ventilator valves (which cost 
USD 11,000 each) and their regular supplier could not produce them on time. A duo after scanning 
an existing valve, 3D printed replacement valves which only cost about USD 1 each, saving ten lives 
as of the time of the Article .  
439.  According to a news report,  the original manufacturer was actually approached by the duo in 
hopes to ask for the valve 's blueprints in an urgent attempt to save them time and produce the 
valves to instantly save the critical COVID -19 victims but they were declined.25 The pair then 
proceeded  to manufacture the replicas by manually measuring the valves and 3D printing three 
different versions to see which one worked best.  
440.  According to another news report, "potential legal and medical issues have stopped Fracassi 
from d istributing the digital design file more widely, despite receiving hundreds of requests for the 
3D-printed valves ".26  
441.  Following this case, a law firm warned "…manufacturers should be aware of the complex 
intellectual property issues concerned with this 3D  printing technology. Parts such as valves or other 
medical devices and equipment are capable of protection by patent and/or registered design. 
Unregistered design rights and copyright will also apply to the part itself and/or the digital model or 
CAD file . Some or all of these rights might apply in respect of a single component ".27  
442.  The firm cautioned "In scanning a component such as a valve, and manufacturing a part using 
3D printing equipment, there is a risk that this action will infringe an existing pa tent, design or 
copyright which protects the component, leading to an injunction or claim from the rights holder for 
damages or other remedies (such as delivery up of infringing parts) ".28 Furthermore the firm advises 
that any person or company intending t o manufacture parts using 3D printing should carry out some 
due diligence to identify:  
• who ultimately holds the intellectual property rights in the component;  
• whether the part is protected by patent or registered design; and  
• whether the rights holder is willing to permit the parts to be manufactured in return for a 
small or nominal royalty for the wider public benefit; and  
 
25< https://www.techtimes.com/articles/248121/20200317/maker -ventilator -valves -threatens -sue-
volunteers -using -3d-printedcoronavirus.htm > 
26 <https://www.forbes.com/sites/ amyfeldman/2020/03/19/talking -with-the-italian -engineers -who-3d-
printed -respirator -partsfor -hospitals -with-coronavirus -patients -for-free/#1529841378f1 > 
27https://www.shoosmiths.co.uk/insights/articles/3d -printing -social -responsibility -vs-legal-risks 
28 Ibid. IP/C/M/95/Add.1  
 
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  • whether any regulatory approval is needed for supply of the parts.  
443.  This case clearly demonstrates the interface between IP and new tec hnologies such as 3D 
printing and may require a better understand of how a balance may be achieved between rights 
holders and third parties. More collaborative approaches have been achieved through various pooling 
mechanisms for access to medicines, this i s also true for more generic IP pledges that covers a broad 
range of equipment, software, network and device applications useful in healthcare, containment, 
tracking, diagnostics, emergency response and social distancing. Such approaches nonetheless are 
limited and may require action on the side of national authorities to ensure access to such 
technologies where pledges or voluntary licenses cannot be secured on commercially reasonable 
terms.  
Example 3: Trade Secrets  
 
444.  Trade secrets encompass vast quantitie s of information needed to discover, test, create, and 
manufacture diagnostics, treatments, and vaccines.  
445.  Potential trade secrets include manufacturing processes, test data, medical formulas, and 
more. For vaccines and other biologic medicines, cell lines,  genomic information, and other biological 
material can also be held as trade secrets. Data about the effectiveness of medicines and vaccines 
are trade secrets. Even so -called negative information — information about what does not work — 
can be a trade sec ret. 
446.  Article  39.2 of the TRIPS Agreement  requires Members  to protect undisclosed information,  
which is secret, has commercial value and has been subject to reasonable steps to be kept secret. 
Both voluntary and compulsory licenses, though common in other forms of IP are unusual in trade 
secrets.  
447.  Professor  David. S Levine29 posits that: "Clearly, t here should be times when trade secrecy 's 
ability to lock down information gives way to broader national and international information sharing 
concerns. If there were ever a case for re -examining trade secrecy 's unquestioned dominance, a 
public health cris is on the scale of COVID -19 would be the time. " He concludes by saying: "What 
seems initially like a narrow issue involving intellectual property law and innovation may actually be 
a critical barrier to our ability to rapidly, effectively, affordably, and safely solve the COVID -19 
pandemic. The time is now to examine, and re -examine, trade secrecy 's hold on information and 
our collective health. "30 
Questions  
 
1. To what extent are TRIPS flexibilities embedded in areas outside patent protection well 
understo od? If so, how are Members  implementing such understandings in their national and 
regional laws?  
 
2. What are the likely difficulties that Members  may face in dealing with a changing technology 
landscape where embedded IP rights may affect the dichotomy between IP rights as private rights 
and the public interest dimensions recognize d in the TRIPS Agreement ? 
 
3. What are the benefits and limitations of initiatives such as voluntary licenses and pledges to 
access much needed technology to deal with the COVID -19 pandemic?  
 
4. Are there circumstances where trade secrets can be shared more broadly? If so, what are those 
circumstances? Would national or in ternational health pandemics fall within this category?  
 
14.2  Nigeria  
448.  In response to the questions framed after paragraph 20 of  the proposal, the applicability of 
the exceptions and limitations of the TRIPS Agreement  particularly compulsory license may be a 
 
29 'Covid -19 should spark a re -examination of trade secrets ' stranglehold on information. '  
< https://www.statnews.com/2020/07/10/covid -19-reexamine -trade -secrets -information -
stranglehold/ > 
30 Ibid. IP/C/M/95/Add.1  
 
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  useful tool in ensuring that the patent system contributes to innovation and technology transfer, 
where Government s put in pla ce policies that are against patent non-use and technology 
suppression. However, our country experience is such that it is difficult for such a tool to spark 
innovation as many private parties lack the technological know -how and the financial capacity to b e 
able to finance such innovations which if achieved could foster development in Nigeria.  
449.  Under the Patent Act of Nigeria, a flexibility exists for compulsory licensing system that serves 
to promote a balance between patent protection and public interest.  Nigeria is also working on a 
national policy and strategy which links the other parts of the economy with IP.  
450.  Another application of the TRIPS exceptions is the provision of fair use. Nigeria , as a common 
law nation , authorizes fair use as is provided for in our laws to include any use that is for personal 
consumption or for educational purposes. This provision is contained in our Copyright Act and aims 
at promoting innovation.  
451.  We reserve our right to come back on thi s agenda after due consideration from capital. We 
are also willing to hear other member`s experiences and approach under this agenda item.  
14.3  Indonesia  
452.  We thank the delegation  of South Africa for coming up with this important communication. We 
see this as timely reminder on the importance of WTO in discussing the implication of IP rights over 
the broad range of products, technology and medical supplies that desperatel y needed for 
responding to COVID -19 Pandemic.  
453.  Most of our domestic IP regimes were crafted with compartmentalized approach. In doing so, 
IP rights laws, excluding patent and maybe trade secret, does not include flexibilities that could 
address public healt h policy objectives.  
454.  This is also true with regional trade agreement s. The IP chapter s are among the most delicate 
issues in the negotiation process. In fact, the inability to narrow the gap of interest in IP matters, 
made some of our regional trade agree ments omit the IP Chapter completely in favour  of 
TRIPS  Agreement .  
455.  There is room for improvement in understanding and incorporated flexibilities provided by the 
TRIPS Agreement  in national laws of Members , especially for developing countries . The 
Doha Declaration on the TRIPS Agreement  and Public Health reaffirms the right of WTO Members  to 
protect public health. While the interpretation of this Declaration is covering all spectrum of IP -rights, 
the application of this principle is inadequately understood at national level.  
456.  The coverage of intellectual property rights protection for products, medical supplies, 
technology, therapeutics, and vaccines during this COVID -19 pandemic is indeed broad. The 
delegation  of South Africa rightly pointed out some cases that highlighted the potential impediment 
mass production of products and technologies highly needed by Members . In addition, we also note 
increasing legal disputes involving IP -rights on vaccines development that could further complicate 
vaccines developm ent that badly needed.  
457.  There are two issues that we would like to share in addressing question number two.  
458.  First, given the scale of infection of COVID -19 globally, scaling -up production of products, 
technology, medicines, and vaccines will be a key issu e in ensuring no countries left behind in access 
to health for COVID -19. The absen ce of effective global cooperation in ensuring collaboration in 
IP-rights, make s the scaling -up production depends solely in the industry 's policies and strategies.  
459.  Second, even if some Member has enabling law to ensure application of flexibilities of patents, 
there are no guarantee s of straightforward production due to the fact that a patented product or 
technology could consist of several IP -rights.  
460.  We are pleased to learn from the WHO vaccines landscape that many developing -countr y 
Member s are also in advance stage s of developing vaccines for COVID -19. At the same time, 
cooperation  between developing countries  in ensuring mass production is also increasing.  IP/C/M/95/Add.1  
 
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  461.  But we understand that we are still facing huge limitation s in access for advance d technology, 
therapeutics drugs, even vaccines, despite such cooperation. We are hopeful that v oluntary licensing 
scheme s, as initiated by a few international organizations  could help narrow down  these challenges. 
However, as this scheme mostly lean s into the premise of global solidarity from multi -stakeholders, 
certain barriers, including possible decreasing incentive s from monopoly of supply, make voluntary 
IP pool a wishful thinking.  
462.  On the issue of trade secret s, we believe that Article  39 Paragraph  3 of the TRIPS Agreement  
provide s legal justification on disclosure of trade secret s where there is a necessity to protect the 
public. We are convinced that protection of the public also includes  national and global pandemic.  
463.  However, to ensure  the effective implementation, national IP l aw must also regulate the 
submission of undisclosed test or other data as part of condition of approving the marketing of 
certain products.  
14.4  Chile  
464.  We wish to thank Sou th Africa for including this  agenda  item. Chile wishes to reiterate that 
the TRIPS Agreement  is based on intellectual property not as an end in itself, but as a tool for 
development. The minimum standards of protection and flexibilities envisaged in the Ag reement 
therefore enable Members  to establish or adapt intellectual property systems in line with their 
national realities, ensuring an appropriate balance at local level between IP rights and obligations.  
465.  Chile continues to encourage the use of flexibilit ies when designing balanced intellectual 
property systems that act as a tool to foster innovation while addressing the needs of society as a 
whole. In the case of the COVID -19 pandemic, we have witnessed how all of mankind has joined 
forces to address and overcome COVID -19 as a shared problem.  
466.  At the multilateral level, Chile and other Members  have agreed on initiatives such as the 
WHO's C-TAP and the expansion of the Medicines Patent Pool 's mandate, which encourage voluntary 
approaches to ensure that in th e future we do not face the same problems that occurred at the 
beginning of the year and that continue to affect many Members . We have also seen how this 
pandemic has inspired an innovation exercise at the global level, one that is not necessarily based 
exclusively on IP, but rather on solidarity.  
467.  In Chile, the pandemic has generated an important discussion at the legislative level on the 
use of the various flexibilities of the TRIPS Agreement , and we are therefore interested in engaging 
in dialogue to shar e experiences of how IP has fostered innovation in the different areas mentioned 
in South Africa 's document and in others, and of how flexibilities have been used to address problems 
such as the one we are currently facing.  
14.5  Tanzania on behalf of the Africa n Group  
468.  The African Group thanks South Africa for their paper contained in document IP/C/W/666 as 
communicated by South Africa. We think this communication comes at a critical time when 
discussions on TRIPS flexibilities are more relevant than ever, considering the situation 
WTO Members  are going through in relation to COVID -19. 
469.  The African Group has on several occasions re iterated the importance and need to intensifying 
discussions on TRIPS flexibilities particularly in line with the fight against COVID -19. The Group has 
been calling for solidarity and cooperation to ensure that treatment for COVID -19 is accessible and 
affordable to the world as a public good. In this connection, we recognize  that the TRIPS Council  has 
a significant contribution to play in the achievement of this objective.  
470.  COVID -19 has exposed the deficiencies of our public health systems, particularly for the 
developing and LDCs. For instance, Africa has been overdepend ent on imports of medicinal and 
pharmaceuticals, a situation that has subjected our public health systems to syste mic vulnerabilities, 
which were fully exposed during COVID -19 outbreak when global supplies fell short on essential 
medical supplies such as ventilators, diagnostic devices, protective gears and equipment (PPEs) and 
medicines.  IP/C/M/95/Add.1  
 
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  471.  It is against this backgroun d that the African Group has raised its concerns on the COVID -19 
impact and  outlined them in document WT/GC/219 and TN/C/20. With our submission, together with 
that by South Africa, we believe we can meaningfully contribute to discussions on the COVID -19 
impact and the requisite trade policy tools to build our capacities and support our resilience to crises 
such as COVID –19. 
14.6  Colombia  
472.  Colombia is very interested in t his discussion. We consider it a priority for Members  to 
coordinate on how to address the implementation of the flexibilities provided for in the TRIPS 
Agreement , while continuing to uphold the principles established in the Agreement and seeking 
alternativ e measures that safeguard public health, without disproportionately and unduly affecting 
intellectual property rights.  
473.  More specifically, regarding the use of the exceptions provided for in the TRIPS Agreement , 
Colombia has, until now, been able to address  its public health requirements through direct dialogue 
with intellectual property right holders. In this way, we have managed to find solutions jointly and 
consensually, without any need to use the flexibilities provided for in the TRIPS Agreement . 
474.  The cu rrent global health crisis is a different scenario, however. Colombia cannot rule out the 
possibility of implementing the various TRIPS flexibilities in the future, particularly in the context of 
a health crisis such as this one, where it has become necess ary to safeguard the primary objective 
of protecting public health.  
475.  Nevertheless, Colombia reiterates its commitment to respect intellectual property rights, and 
we reiterate that if it becomes necessary to use the flexibilities provided for in the TRIPS Agreement , 
the country will remain committed to complying with the principles set forth in that Agreement, and 
do its utmost to strike a balance as regards the measures taken.  
14.7  China  
476.  Once again, we appreciate South Africa 's proposal. C OVID -19 seriously threatens human 
health and safety, causes huge negative effects to the functioning of global supply chain and poses 
grave challenges to the normal supply of relevan t medicines, medical equipment and PPEs. China 
thinks that in the current situation, Members  are fully entitled to utilizing flexibilities in the 
TRIPS  Agreement  and the Doha Declaration on the TRIPS Agreement  and Public Health to maintain 
public health.  
477.  In China 's domestic laws, patent is the major field where TRIPS flexibilities are employed to 
ensure access to medicines and medical technologies. China 's Patent Law has a special chapter on 
compulsory licensing . It stipulates that in emergency or extraordi nary situations, or for public 
interest objectives, the Chinese patent administrative agency can issue compulsory licensing of 
inventions and utility models. In 2012, China issued Measures for Compulsory Licensing for Patent 
Exploitation and operationalize s the application and granting procedures of compulsory licensing. 
Besides, China 's Patent Law also allows parallel imports.  
478.  China always holds the view that a right balance should be achieved between IP right holders 
and public interest. The protection of  IP rights should go in parallel with legitimate use of TRIPS 
flexibilities. We support an open and inclusive discussion of IP and Public Interest so that Members  
can freely exchange views and experiences in utilizing TRIPS flexibilities.  
14.8  Malaysia  
1. To  what extent are TRIPS flexibilities embedded in areas outside patent protection well 
understood? If so, how are Members  implementing such understandings in their nat ional and 
regional laws?  
479.  TRIPS flexibilities as to the method of implementing TRIPS obligations allow WTO Members  
different ways to transpose into national law that the TRIPS Agreement  simply articulate but does 
not define. For example, in the field of en forcement the TRIPS Agreement  allows WTO Members  to 
resort to their own legal system and practices to implement enforcement obligations.  IP/C/M/95/Add.1  
 
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  480.  TRIPS flexibilities with regard to standards of IP protection in Malaysia include exceptions and 
limitations provided for, but not limited to, under the copyright and industrial property laws in 
Malaysia. For example, copyright protection incorporate flexibilities where it allows exceptions for 
visually and hearing -impaired  people.  
2. What  are the likely difficulties that Members  may face in dealing with a changing technology 
landscape where embedded IP rights may affect the dichotomy between IP rights as private 
rights and the public interest dimensions recognize d in the TRIPS Agreement ?  
481.  The relevant IP laws on protection of technology provide sufficient flexibility in dealing with a 
changing landscape where embedded IP rights may affect the dichotomy between IP rights as private 
rights and public interest.  
482.  The main challenge is generally  to strike a balance in providing an IPR s framework tha t can 
assure adequate protection of IPRs that is not considered, as under - or over -protection of IPRs which 
may undermine the larger economic strategy of a country. However, in certain circumstances, t here 
may be cases in which private interests in IPRs must be subordinated to more compelling public 
interests. Many countries , for example , are facing increasing social and financial difficulties a 
consequence of public health and epidemic disease.  
483.  Anothe r difficulty that Members  may face in dealing with a changing landscape is that the 
impact of IPRs itself is dependent on the types of technology. For example, the role of IPRs in the 
process of development in the pharmaceutical industry is very different to the role of IPRs in the 
mobile phone industry.  
3. What are the benefits and limitations of initiatives such as voluntary licenses and pledges 
to access much needed technology to deal with the COVID -19 pandemic?  
484.  When patent holder companies issue volun tary licences for patented medicines, they enable 
other manufacturers to develop generic versions of these medicines. This helps to support supply, 
increase affordability and improve access to ensure an inclusive and sustainable healthcare to our 
wider soc iety. In Malaysia 's view, the limitation of voluntary licensing which is based on countries 
economic developments. Due to COVID -19, many countries are faced with challenges in addressing 
the high cost of medicine s and technolog ies required in mitigating th is pandemic.  
485.  Malaysia welcomes discussion among WTO Members  on the implications of intellectual 
property rights  over the technologies and products required for mitigating COVID -19 pandemic with 
the aim of ensuring that IP rights including patents, industr ial designs, copyright and trade secrets 
do not create barriers to scaling up research, development  and supply of technologies necessary to 
mitigate COVID -19.  
4. Are  there circumstances where trade secrets can be shared more broadly? If so, what are 
those  circumstances? Would national or international health pandemics fall within this 
category?  
486.  WTO Members  have a considerable flexibility to define which situations trade secrets can be 
shared, provided that such situations are consistent with the WTO TRIPS  Agreement .  
14.9  Zimbabwe  
487.  Zimbabwe extends its appreciation to the delegation  of South Africa for submission of the 
document IP/C/W/666 on "Intellectual Property and Public Interest: Beyond Access to Medicines and 
Medical Technologies Towards a more holistic approach to TRIPS flexibilities. " 
488.  Zimbabwe believes that the emergence of the Coronavirus disease 2019 ( COVID -19) makes it 
incumbent upon us to re -invigorate the discussion on intellectual property and public health. The 
search for a COVID -19 vaccine and treatment is of utmost importance and it is necessary for 
Members  to be cog nisant of the limitations and exceptions open to them to ensure universal access 
to quality and affordable treatment once a suitable vaccine is found.  IP/C/M/95/Add.1  
 
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  489.  Zimbabwe has noted that discussions on TRIPS flexibilities and access to medicines have 
largely delved on  limitations and exceptions to patent rights. We are aware of the efforts by 
pharmaceutical companies to protect their medicines through trade secrets as opposed to patents.  
490.  We have also noted the increased reliance by pharmaceutical companies on other for ms of IP 
such as trademarks and industrial designs to protect medicines. Therefore, this proposal is essential 
for Members  to fully explore the limitations and exceptions which are afforded by the TRIPS 
Agreement  to the full spectrum of IP.  
491.  We call upon al l Members  to support this very important proposal and look forward to 
participat ing in the ensuing discussions.  
14.10   India  
492.  We thank the delegation  of South Africa for thei r submission.  
493.  The TRIPS flexibilities have stood out as important policy space for Member Countries to enable 
them to create an IPR s regime that ensures compliance with the obligations set out in the Agreement 
while taking into account their developmental priorities. These flexibilities include fair use exception 
(copyright), research exceptions (copyright and patent), compulsory licensing (patent), parallel 
import, transition periods for developing and least developed countries . While patent law flexibilit ies 
are widely discussed owing to the fact that they deal with the extremely sensitive area of public 
health, deliberation on flexibilities in other IP areas has been somewhat limited.  
494.  As rightly pointed out by South Africa in its communication, battling with a pandemic like 
COVID -19 requires a more integrated approach to TRIPS flexibilities in all IP regimes including those 
in copyrights, industrial designs and trade secrets etc. Ongoing COVID19 crisis further highlights the 
urgent need to initiate discus sion and deliberation on the flexibilities available in these IP regimes.  
495.  India has incorporated some of the flexibilities outside the patent protection regime that come 
within the scope of TRIPS Agreement  in its domestic legislations. For example, the pr ovisions related 
to fair use, statutory licensing and compulsory licensing in Indian Copyright Act, 1957 and parallel 
imports under Indian Trademark Act 1997.  
496.  However, the changing technology landscape with embedded IP rights have led to new 
challenges. Em erging technologies like 3D printing, artificial intelligence and their wide use in 
response to C OVID -19 outbreak, including in manufacturing of ventilator valves, the AI algorithms 
used in identifying the outbreak and modelling travel patterns, screening passengers and predicting 
possible reinfections - may be protected by IP rights other than patents, like copyright, trade secrets, 
database rights underlying importance of flexibilities in those IP areas.  
497.  The COVID -19 pandemic is an unprecedented crisis, which continues to cripple economies. Its 
impact is particularly disastrous for the developing and least developed countries , as they lack 
requisite tools such as strong economy and medical infrastructure to counter the crisis. As these 
countries lack the capability to develop high end vaccine at short notice, the need for technology 
transfer and dissemination of necessary undisclosed information, trade secrets and sharing of patent 
has intensified. Due to lack of legal enforceability, the success of vo luntary licenses and pledges will 
ultimately depend on the goodwill of IP holders. Moreover, as the voluntary licensing agreements 
are kept secret and their terms and conditions are un -known, large markets may remain unserved 
and monopoly situations could continue. More transparency in this regard would help in balancing 
the issue of IP rights and affordability.  
498.  Members  need to deliberate upon how broader sharing of information under the trade secret 
regime can help in addressing a global health pandemic o f the scale of COVID -19. In this regard, it 
is important to note that Paragraph  1 of Article  39 of the TRIPS Agreement  sets down the context in 
which the protection to undisclosed information needs to be provided. The context is to ensure 
against unfair co mpetition as provided under Article  10bis of the Paris Convention which mandates 
Members  to provide effective protection against acts of competition contrary to honest practices in 
industrial or commercial matters.  IP/C/M/95/Add.1  
 
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  499.  In conclusion, we believe that further di scussion on the flexibilities available in various 
IP regimes under TRIPS Agreement  is required so as to counter the pandemic.  
14.11   Chinese Taipei  
500.  We understand t hat according to Article s 7, 8, and 13 of the TRIPS Agreement , besides patent 
protection, there are flexibilities among WTO Members , in formulating and amending respective laws 
and regulations to adopt measures necessary to protect public interest as well as provide limitations 
or exceptions to copyright and related rights.  
501.  Hence, given the impact of COVID -19, students may be kept out of schools due to temporary 
school closure. We have drafted amendments to the Copyright Act to provide limitations and 
excep tions in relation to the use of works for distance learning in order to protect significant public 
interests such as knowledge dissemination and cultural development.  
502.  As pointed out in the Doha Declaration on the TRIPS Agreement  and Public Health in 2001, 
the Agreement can and should be interpreted and implemented in a manner supportive of 
WTO Members ' right to protect public health. Particularly, as the COVID -19 is still raging, it is worth 
placing emphasis and deep thinking by all WTO Members  as to how to more holistically use the 
TRIPS Agreement 's flexibility to balance between safeguarding IPR s protection and the interests of 
public health.  
14.12   Canada  
503.  Canada would like to thank South Africa for circulating document IP/C/W/666, under the 
ad hoc agenda item of "Intellectual property and the public interest ", on the topic of acc ess to 
medicines and TRIPS flexibilities.  
504.  The discussion of these issues is particularly timely, as all countries are working to develop 
effective treatments for COVID -19.  
505.  Canada 's longstanding view is that the multilateral framework under TRIPS, as well as the 
flexibilities affirmed under the Doha Declaration on the TRIPS Agreement  and Public Health, already 
establish an appropriate balance between protecting IP rights and promoting access to medicines.  
506.  Ensuring this appropriate balance will remain import ant as the timing and availability of 
promising COVID -19 treatments and other technologies becomes clearer in the months ahead.  
507.  Canada also reminds that IP rights are one part of a broad discussion informing the availability 
and accessibility of medicines and relevant technologies. As the Doha Declaration emphasizes, the 
TRIPS Agreement  is part of the wider national and international action to address public health 
problems.  
508.  With respect to TRIPS flexibilities more specifically, Canada is always open to sha ring its own 
national experiences and lessons learned in implementing the Paragraph  6 system, as well as on our 
more recent amendments to Canada 's Patent Act, as notified earlier this session, under document 
IP/N/1/CAN/30.  
509.  Similarly, we continue to be inte rested in learning more about the practices of Members  in this 
area and  invite other Members  to share their national experiences in this regard.  
14.13   United Kingdom  
510.  We would like to thank South Africa for introducing this agenda item and giving the Council  an 
opportunity to discuss this important issue.  
511.  Intellectual pro perty rights provide incentives to create and commercialise new inventions, 
such as life -changing vaccines. They keep innovators innovating, creators creating and investors 
investing.  IP/C/M/95/Add.1  
 
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  512.  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.  
513.  Multiple factors need to be considered to ensure equitable access for all to COVID -19 vaccines. 
These include increasing manufa cturing and distribution capacity, measures to support or incentivise 
technology transfer, ensuring global supply chains remain open, and ensuring that effective 
platforms are utilised to voluntarily share IP and know how.   
514.  There are existing mechanisms th at facilitate the sharing of IP. For example, expanding the 
mandate of an existing organisation such as the Medicines Patent Pool to cover COVID -19.  
515.  The UK has long supported affordable and equitable access to essential medicines, including 
in low and mid dle-income countries.   
516.  The world urgently needs 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.  
517.  The UK has played a leadin g role in financing the global effort and working with our 
international and national partners, to identify end -to-end solutions that ensure affordable access 
for all, such as such as mechanisms to support the voluntary sharing of IP and know -how, 
manufact uring at scale and ensuring no -one is left behind, including the poorest and most 
vulnerable.  
518.  We are committed to collaborating with public and private partners in the UK and 
internationally, including exploring voluntary arrangements and approaches such a s non -exclusive 
voluntary licensing which promote affordable access for all while also providing incentives to create 
new inventions, to accelerate development and equitable access in all countries to affordable health 
technologies for responding to COVID -19.  
519.  We encourage active dialogue between industry and government s to explore how best to work 
together to facilitate access to medicines, including TRIPS -compliant licensing models in developing 
countries.  
14.14   European Union  
520.  The EU would like to thank South Africa for introducing this agenda item.  
521.  The world quickly needs to develop and deploy effective diagnostics, safe and effective 
treatments and vaccines, whic h are available and accessible everywhere, at an affordable price. This 
is the only way to make sure we can jointly defeat the virus.  
522.  It is clear that broad and equitable access to existing and new treatments, and ultimately 
vaccines, will be key to tackle  the present public health crisis, including for developing countries that 
have no production capacities or more limited financial resources.  
523.  It is with this objective in mind that the EU has led "The Coronavirus Global Response " pledging 
initiative with the WHO and global partners to accelerate the development, production and 
deployment of vaccines, diagnostics and therapeutics, and to strengthen national health systems 
against COVID -19. The EU has also led the work on a Resolution on COVID -19 Response, a dopted 
by the 73rd World Health Assembly on 19 May 2020. This resolution represents a strong commitment 
of the global community to international cooperation in fighting the pandemic and ensuring access 
to COVID -19 treatments and vaccines.  
524.  Global cooperatio n is essential to accelerate the development and scale -up the production of 
safe, effective, quality diagnostics, medicines and vaccines for the COVID -19 response, including 
through arrangements with industry and existing mechanisms for voluntary pooling o f rights and 
licensing.  IP/C/M/95/Add.1  
 
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  525.  Pooling of rights and other voluntary licensing arrangements allow to accelerate the 
development of diagnostics, medicines and vaccines for COVID -19 and scaling up their production. 
These mechanisms benefit everyone as they drive bo th access and innovation.    
526.  The TRIPS Agreement  provides various avenues to address potential IP matters in the case of 
health emergencies should voluntary mechanisms fail, not only with regard to patents, but also with 
regard to other IP rights. These inc lude general clauses on exceptions or provisions on compulsory 
licensing.  
527.  In the European Union these provisions are implemented either at regional or national level. 
For example, the areas of copyright, trademarks, designs and trade secrets are largely h armonised 
at regional level, including provisions on exceptions and limitations. On the other hand, the granting 
of compulsory licences in the area of patents is regulated at national level - each EU Member State 
has relevant legislation and is able to iss ue a compulsory licence at national level.  
528.  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 medicin es.  
529.  We also recall that the TRIPS Council  Secretariat has, regularly and consistently, offered its 
services to any WTO Member that sees itself in the need of getting help to manage the process of 
Article  31bis of the TRIPS Agreement .  
530.  The innovation model, based on patents, has delivered consiste nt progress in global public 
health, continuously leading to important new and improved treatments as well as much extended 
life expectancy, tackling the global health challenges humanity faced so far. The EU considers that 
on the basis of the current syst em, with the necessary IP tools and arrangements in place, existing 
and new treatments, and ultimately vaccines, can be made available and effectively deployed rapidly 
across the globe.  
531.  A well -functioning ecosystem for the protection and enforcement of in tellectual property rights 
remains a crucial incentive for innovation, the research and development of new vaccines, medicines 
and treatments.  
532.  Let us also recall that evidence shows that indeed there are many different significant causes 
of lack of access  to medicines. It is no different in the case of COVID -19. There are no simple 
solutions to the current crisis. We need the necessary expertise in production of new treatments or 
vaccines, we need sufficient manufacturing capacity and access to resources n eeded to produce such 
treatments or vaccines.  
533.  It is the view of the European Union that in order to ensure equitable and affordable access to 
the required treatments and vaccines, we must work collaboratively with industry and with each 
other, incentivise innovative solutions to COVID -19, ramp up manufacturing capacity and pool 
resources.  
534.  There is another aspect in the fight with COVID -19 that we would like to highlight in this 
discussion.  
535.  A report by Europol titled 'Viral Marketing – counterfeits, substan dard goods and intellectual 
property crime in the COVID -19 pandemic ' shows that organised crime groups quickly adapt to the 
new trade environment and find their way to infiltrate the legitimate supply chain of pharmaceutical 
products and equipment. A study  of the European Union Intellectual Property Office and the 
Organisation for Economic Cooperation and Development on Trade in counterfeit pharmaceutical 
products shows the economic and social costs of trade in fake medicines and the threat to public 
health . 
536.  The surge in demand for anti -COVID -19 products poses heightened risks to public health, 
because fake and substandard products, such as unproven and fake treatments, test kits and 
medical equipment and supplies – masks, ventilators, gloves, etc. – have flooded the market and 
this is bound to g et worse when the new COVID -19 treatments and vaccines will be available.  IP/C/M/95/Add.1  
 
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  537.  Due to the global nature of these crimes, global cooperation is necessary.  
538.  Public health in light of the pandemic is a clear and undisputed priority. No effort must be 
spared to ob tain effective and affordable treatment, vaccines, tests and medical devices necessary 
to fight this pandemic and to ensure that these products are safe for our citizens. These efforts have 
to be sustained for as long as needed.  
14.15   Ecuador  
539.  Ecuador wishes to thank the delegation  of South Africa for including this agenda item. Its 
inclusion is timely in a context where we should be joining forces and coordinating activiti es to re-
establish  our present and future global health security.  
540.  We wish to reiterate our commitment to the Doha Declaration on the TRIPS Agreement  and 
Public Health (the amendment to which entered into force in 2017), which contributes by ensuring 
that Members  have the right to protect public health and, in particular, to promote access to 
medicines for all.  
541.  Examining the issue raised by South Africa will most certainly help us to better understand the 
extent to which different forms of intellectual prope rty rights allow or prevent access to the various 
types of technologies and products needed to tackle COVID -19. 
542.  The need for access to treatments, diagnostic methods, and medical devices and supplies, as 
well as the search for a vaccine, are concerns that must be taken into consideration by the 
international intellectual property system.  
543.  It is important to take into account that the flexibilities set out in the Agreement are not limited 
to patents, and we must therefore consider all the various forms of int ellectual property in order to 
address this issue in a holistic manner.  
544.  In this context, adopting a multilateral cooperative approach that seeks to foster innovation, 
creation and technology transfer will ensure that the intellectual property system consti tutes a key 
tool for providing answers to countries in their efforts to combat this pandemic.  
14.16   Australia  
545.  Australia thanks South Africa for its communication.  
546.  Consi stent with the 18 May World Health Assembly COVID -19 response resolution, Australia 
recognize s the need for universal, timely and equitable access to essential health technologies and 
products, consistent with the TRIPS Agreement . 
547.  Australia stresses the vital role of IP in incentivising the often costly and timely development 
of important health p roducts, including vaccines we continue to believe that voluntary pooling and 
licensing initiatives that respect private rights are effective tools in driving innovation and facilitating 
widespread access.  
548.  We also wish to highlight ongoing international i nitiatives to finance, access and equitably 
distribute COVID -19 treatments and vaccines in a manner that respects international IP rules and 
the rights of IP holders and note that close and practical collaboration between Members  will be 
critical to achiev e this.   
549.  In accessing the personal protective equipment and other tools necessary to address 
COVID -19, Australia reminds Members  that beyond intellectual property rules, it is other 
trade -related measures have an important role to play in supporting widesp read access for example, 
APEC and the G20 have already made a number of commitments on the need to maintain trade in 
essential goods and Australia underscores the need for all Members  to continue to guard against 
protectionism and support open supply chain s.  
550.  In this time of crisis, the TRIPS Agreement  should support quick, fair, predictable and 
implementable access arrangements to vital health products we recognize  the need for all Members  IP/C/M/95/Add.1  
 
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  to understand their rights and obligations under the TRIPS Agreemen t, including its flexibilities to 
this end, we support the provision of further information to Members  regarding key Article s in the 
Agreement.  
551.  It is Australia 's view that a harmonious, well -functioning and clearly understood international 
IP framework, u nderpinned by the TRIPS Agreement  and the rights of IP holders, is crucial in 
ensuring Members  can address the challenges posed by COVID -19. 
14.17   Switzerland  
552.  We than k South Africa for their submission. The question of access to medicines and medical 
technologies is particularly relevant in a crisis such as the COVID -19 pandemic.  
553.  Switzerland is committed to ensure global equitable access to COVID -related medical products 
including vaccines.  
554.  Considering the global toll which the pandemic has already claimed, all the suffering and the 
heavy impact on each country 's and the world 's economy, there is no doubt that the international 
community and Government s face a unique challenge these days.  
555.  How can we enable and ensure access to COVID -19 relevant technologies?  
556.  In spite of the magnitude of the challenge, there is also some light, albe it it may not yet be 
the light at the end of the tunnel.  
557.  The pandemic triggered an unprecedented collaboration between major actors who have come 
together at the international level to do everything possible to contain the crisis and, inter alia , 
provide t he medical technology needed.  
558.  The intellectual property system is one of the key components leading to access to quality of 
medical products. The IP system has contributed to making this extraordinary and continued 
collaboration effort at a global scale po ssible.  
559.  Partnerships, whether private -private or public -private, are essential to developing a vaccine 
and effective treatments against the novel coronavirus.  
560.  Within a reliable overall legal framework, IP is a foundation for stakeholders, for the public 
and private actors, it spurs their interaction and makes them willing to share information, knowledge 
and data, to aliment the global databases, license in and out technology, and to do what is necessary 
to scale up capacity.  
561.  The latter will be the crux when it comes to specific COVID -19 technologies and a vaccine in 
particular, and when ensuring populations ' access.  
562.  Multilateral and global initiatives such as the COVID -19 Vaccine Global Access facility (COVAX) 
and the Gavi COVAX Advance Market Comm itment (AMC) will consider IP issues as part of the 
negotiation package with private providers.  
563.  South Africa raises the question of the dimension of TRIPS flexibilities in the current pandemic. 
We agree with South Africa that the aspect of IP relating to COVID -19 and public health issues 
certainly go beyond patent rights, and goes beyond medical products in the strict sense.  
564.  Switzerland acknowledges countries ' right to use the TRIPS flexibilities as they were reaffirmed 
in the Doha Declaration on TRIPS and public health . 
565.  However, measures disincentivising efforts and investment undertaken by relevant 
stakeholders, including in R&D, we should clearly avoid.  
566.  We firmly believe that measures need to build on voluntary approaches and that promoting 
the use of ex ceptions and limitations of rights will rather hamper technological, as well as any other IP/C/M/95/Add.1  
 
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  kind of, innovation efforts. Voluntary measures, and especially voluntary licenses, are preferable 
because they are faster, provide legal security and are as such mor e promising approaches than 
coercive measures. There is ample proof of success of such partnership -based approach, from 
looking back before th e present  year, and a fortiori now during the COVID -19 crisis over the past 
months in 2020.  
567.  The various platforms such as the ACT -Accelerator, the COVAX facility (and the Gavi COVAX 
AMC are important evidence of this. They are the results of this collaborative approach.  
568.  The Medicines Patent Pool (MPP), promoting voluntary licensing, is another example of a 
platform th at successfully builds on voluntary approaches, where several companies manufacture 
the respective product at reduced price; without weakening the patent law and without 
compromising the quality of the products.  
569.  IP protection lies at the heart of a functio ning innovation cycle and remains key for the health 
system. In this time where we need to confront the coronavirus, collaboration will be more important 
than ever to deliver on the high expectations our people have. IP is part of the solution to overcome 
this challenge.  
570.  Besides all the efforts undertaken at the international level and by the international 
community, government s have an important role to play by investing into their public health system 
and the infrastructure needed to ensure a fair and equ itable access to essential medical products.  
14.18   United States of America  
571.  Intellectual property encourages innovation, incentivizes research and develo pment, and 
manufacturing and distribution. 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.  
572.  Innovation is complex and ris ky, as we are witnessing with respect to the development of new 
COVID vaccines and treatments. Intellectual property rights are necessary to promote innovation in 
the face of that risk. Moreover, intellectual property rights help to ensure that there is a robust 
innovative ecosystem in place that encourages all relevant actors to participate in the complex 
process of drug discovery for new and improved treatment options in the future  
573.  Investment in research and development for innovative products has contrib uted to powerful 
improvements in public health outcomes, and IPR s has played a key role in facilitating this 
innovation, including more than 550 new therapies developed since 2000.   
574.  Support for innovation and intellectual property is essential, and there c an be no access to 
drugs that have not been developed.  
575.  In fact, in this crisis, many right  holders have voluntarily pledged or given access to intellectual 
property, whether it be access to key scientific journals or open source designs for personal 
prote ctive equipment, or design specifications for ventilators.  
576.  In addition, the USPTO 's platform Patents 4 Partnerships lists COVID -19 related inventions 
that are available for licensing to individuals and businesses. To date, there are over two hundred 
inven tions listed.  
577.  As we have stated in past discussions and under agenda item 3, IP is an important piece, but 
ultimately only one piece , of addressing the issue of access to any potential therapy. We believe that 
the IP system has not been an obstacle in addressing the pandemic but rather has motivated global 
efforts to find treatments and cures.  
578.  As affirmed in the Doha Declaration on TRI PS and Public Health, the United States respects its 
trading partners ' right to protect public health and, in particular, to promote access to medicines for 
all and supports the vital role of the patent system in promoting the development and creation of 
new and innovative lifesaving medicines.   IP/C/M/95/Add.1  
 
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  579.  Consistent with this view, the United States respects the rights of its trading partners to grant 
compulsory licenses, in a manner consistent with the TRIPS Agreement , including with the 
requirements in Article  31.  
580.  The United States encourages its trading partners to consider ways to address their public 
health challenges while maintaining intellectual property systems that incentivize the investment 
and research necessary to develop innovative new medicines.  
581.  The Un ited States continues to encourage all WTO Members  to promote a stable and 
predictable patent system that can nurture innovation. WTO Members  can and should ensure 
supportive environments for innovators to achieve success and make significant contributions  to 
economic growth in their country.  
582.  Many pharmaceuticals have their origins in countries with strong patent systems.  
583.  Robust and predictable patent systems provide interested parties with incentives necessary to 
encourage them to invest many years and sig nificant financial resources into worthy endeavours  
without a guarantee of success.  
584.  Compulsory licensing diminishes the exclusivity of the patent grant and undermines the 
incentive for innovation and investment that is a critical component of technologica l progress.  
585.  We urge other Members  to exercise caution and careful deliberation on issues related to 
compulsory licensing, as they have significant implications that could negatively affect investment 
in research and development for the treatments of tomorr ow and restrict investment into new 
markets, including investments in new manufacturing facilities.  
14.19   Sri Lanka  
586.  We thank the delegation  of South Africa for bringing this important issue to the attention of 
this Committee through their submission.  
587.  There is a need for a focused discussio n among WTO Members  on the implications of 
intellectual property rights over the technologies and products required for responding to COVID -19 
health issues. In the context of this global pandemic, it will be important for WTO Members  to work 
together to e nsure that IP rights including patents, industrial designs, copyright and trade secrets 
do not create barriers to scaling up R&D, manufacturing and supply of technologies and products 
necessary to combat COVID -19 health challenges. Sri Lanka, therefore, vi ews that the proposal by 
South Africa is extremely relevant in this current global context.  
588.  The discussions in response to the guiding questions raised in the proposal can be useful in 
many ways, particularly to understand:  
a. the extent to which different f orms of IP rights impact the rapid development and 
affordable access to the various kinds of technologies and products required for responding 
to COVID -19; 
b. the flexibilities available under the TRIPS Agreement  to ensure that such IP rights do not 
constrain timely, equitable and affordable access ; 
c. the constraints to the use of such flexibilities ; and  
d. the adequacy of mechanisms that have been put in place to ensure global access.  
589.  In the light of this discussion , WTO Members  can come to an informed view on the kind of 
IP-related measures that could be adopted at the multilateral level to support the need for ensuring 
rapid, equitable and affordable access to the products and technologies required to respond to si milar 
unprecedented health crisis, such as the COVID -19. 
590.  The understanding of Doha Declaration is predominantly in the context of patents, though it 's 
not the only area of IP which should be covered under this. The use of TRIPS flexibilities in other 
areas  of IP beyond patents is less understood. In this context and the relevancy of variety of IP IP/C/M/95/Add.1  
 
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  rights in the fight against COVID -19, we see immense value in proposed discussion and invite 
Members  to constructively engage in this dialogue.  
14.20   Japan  
591.  The delegation  of Japan would like to reiterate the importance of "Access to Medicine and 
medical technology ", which needs to be discussed in a broader context, taking into accoun t not only 
the special compulsory licensing system but also various other relevant measures and factors such 
as manufacturing capacity, distribution networks as well as regulatory framework.  
592.  On countless occasions, humanity has overcome crises throughout h istory by the development 
and promotion of innovation. In this regard, medical technologies used to fight the pandemic have 
been created due to inventions throughout time. This type of development has been made possible 
by robust intellectual property syst ems that incentivize and protect innovation.  
593.  In addition, there are a number of voluntary initiatives to deal with the COVID -19 pandemic. 
We believe that voluntary basis approach is essential for such initiatives, because it provides possible 
options for r ight holders to find solution on the basis of each situation and does not impede the 
incentive for innovation.  
594.  Finally, the delegation  of Japan would like to mention that the Doha Declaration, which 
confirmed the TRIPS flexibilities, its relevant statement s, and the resulting Amendment  to the TRIPS 
Agreement  all rest on an intricate balance between importance of IP protection and protection of 
public health.  
14.21   South Africa  
595.  South Africa thanks all Members  who contributed to this discussion. I am very encouraged by 
the level of engagement that we are seeing on this particular topic it has not seen like this for a long 
time and it is a good precedent going forward. So , from that point of view, we also watch with 
interest as we develop further topics on the intersection between IP and public interest.  
14.22   World Health Organization  
596.  We have seen over the pas t months how countries have mobilised unprecedented investments 
in collaborative, not -for-profit R&D. The COVID -19 pandemic is showing what we can do when we 
come together to face a shared global health threat. That  is the kind of collaboration that can sa ve 
lives and transform the health of billions of people globally. That is what the nations of the world 
agreed on SDGS and SDG 3 "ensure healthy lives and promote wellbeing for all at all ages ". 
597.  WHO would like to thank the initiative of the Government  of South Africa to open the 
discussions on this topic related to the interfaces between access to medicines and medical 
technologies and intellectual property. WHO understands the reference in the communication 
(contained in document IP/C/W /666) to the who rec ently launched "COVID -19 technology access 
pool" (C-TAP) and the South African concern as one of the 40 WHO Members  that launched "the 
solidarity call to action: to realize equitable global access to COVID -19 health technologies through 
pooling of knowledge, intellectual property and data ", one month ago, together with who director 
general and the president of Costa Rica . 
598.  South Africa  mentions that "to date no company has committed to doing so. Instead limited, 
exclusive and often non -transparent voluntary licensing is the preferred approached of 
pharmaceutical companies, which will be insufficient to address the needs of the current COVID -19 
pandemic ". 
599.  WHO Secretariat would like to take this opportunity to inform the TRIPS Council  that this 
knowledge, IP and data sharing platform, C-TAP, is meant to provide equitable access to life -saving 
technologies by promoting through voluntary mea ns open innovation models and technology 
transfer, as well as promoting equitable global access through access -oriented licensing to fast -track 
product development and mobilizing additional manufacturing capacity.  IP/C/M/95/Add.1  
 
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  600.  WHO calls on WTO Members  to join "the soli darity call to action " and support C-TAP initiative, 
which is a complementary tool to the access to COVID treatment Accelerator  (ACT-A) and in line 
with the global strategy and plan of action on public health, innovation and intellectual property, as 
well as in accordance to the most recent WHA resolution on COVID -19 response that, among other 
aspects, "calls on international organizations and other stakeholders: (…)(2) to work collaboratively 
at all levels 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 in order to facilitate timely, equitable and 
affordable access to the m, consistent with the provisions of relevant international treaties, including 
the provisions of the agreement on trade -related aspects of intellectual property rights 
(TRIPS  Agreement ) and the flexibilities within the Doha Declaration on the TRIPS Agreement  and 
Public Health". 
15  INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO  
15.1  Dispute Settlement Developments Relevant to the TRIPS Agreement  
601.  No statements were made under this agenda item.  
15.2  TRIPS Amendment  
602.  No statements were made under this agenda item.  
15.3  IPR-Related Issues in Trade Policy Reviews and the Director -General 's Monitoring 
Reports  
15.3.1   WTO Secretariat  
603.  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.  
604.  Since the last TRIPS Council  Meeting in February, the Trade Policy Reviews of the Eur opean 
Union, Australia and Japan have taken place. These three reviews covered a very wide range of 
intellectual property and related trade policy issues. Developed and developing -country Members  
actively registered their continuing interest in TRIPS -related issues. In particular, they sought details 
on: 
• Composition of IP assets;  
• Reform of the copyright regime;  
• Protection of Indigenous Cultural Intellectual Property;  
• Modernization of the trademark regime and the protection of olfactory or taste marks;  
• Geogr aphical indications and the GI regime for non -agricultural products;  
• Patent regime, supplementary patent certificates and patent extension;  
• Compulsory licenses;  
• Implementation of the Protocol Amending the TRIPS Agreement ; 
• Protection of test data;  
• Regulatio n applicable to genetic resources accessed in Parties of the Nagoya Protocol;  
• Protection of trade secrets;  
• Enforcement, online and at the border;  
• Anticompetitive practices;  
• Technical assistance and cooperation programmes implemented in the framework of 
Article 66.2 of the TRIPS Agreement ;  
• Programmes to support IP management by Small and Medium Enterprises; and  IP/C/M/95/Add.1  
 
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  • Accession and implementation of WIPO instruments.  
605.  The Secretariat has also contributed to the G20 and WTO wide 
Director -General  Roberto  Azevêdo 's Monitoring Reports. The G20 report was circulated on 29 June  
2020 and the WTO -wide report has been available since 24 July  2020. The WTO -wide report covers 
developments on trade -related aspects of intellectual property rights (TRIPS), including t he 
information on developments in domestic legislation and administrative issues submitted for the 
monitoring exercise by Australia, Azerbaijan, Canada, Chile, India, Indonesia, the Kingdom of Saudi 
Arabia, Singapore, Chinese Taipei and Ukraine.  
606.  On this oc casion, the 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 a dministrative IP matters. 
The table containing these measures is regularly updated and available on the WTO website, as was 
discussed under agenda item 3 [when a number of these COVID -related measures were described 
by Members ]. 
15.3.2   Canada  
607.  International cooperation and coordination are essential to facilitate the cross -border 
movement of critical goods, services and personnel by maintaining open and connected supply 
chains.  
608.  Canada has led on, contribu ted to, and supported a number of statements in multilateral fora 
(e.g. G20, WTO, APEC) and in other groups of likeminded countries committing to open supply chains 
and minimizing disruptions to trade during the pandemic.  
609.  Here at the WTO, that includes sta tements that underscore the importance of open and 
predictable agricultural trade, a Friends of the System statement outlining the critical importance of 
the rules -based multilateral trading system during this unprecedented global crisis, and the 
MSME  Working Group statement highlighting the importance of supporting MSMEs in the time of 
COVID -19. 
610.  We have advocated, and will continue to stress, that emergency measures – if necessary,  to 
address COVID -19 – be targeted, proportionate, transparent, temporary, a nd consistent with 
WTO rules.  
611.  Canada continues to work with like -minded partners to turn these bold declarations into 
concrete, collective, and tangible actions.  
612.  As conveners of the Ottawa Group, our objective is to provide leadership, ideas and proposals 
on possible actions the broader WTO Members hip could take to respond to the pandemic. This 
includes developing and promoting trade rules and policies that will contribute to a sustainable, 
inclusive and resilient international economic recovery, as well as  guide our responses to future 
global crises.  
613.  Canada also remains determined to continue achieving progress in longstanding priorities in 
WTO reform, to help ensure a strong WTO that is modernized and relevant to 21st -century trade 
realities.  
16  OBSERVER STAT US FOR INTERNATIONAL INTER GOVERNMENT AL ORGANIZATIONS  
614.  No statements were made under this agenda item.  
17  OTHER BUSINESS  
17.1  Annual Review of the Special Compulsory Licensing System  
615.  No statements were made under this agenda item.  IP/C/M/95/Add.1  
 
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  17.2  18th  Annual Review under Paragraph  2 of the Decision on the "Implementation of 
Article  66.2 of the TRIPS Agreement " 
616.  No statements were made under this agenda item.  
17.3  Other Planned Activities for the Benefit of LDCs  
617.  No statements were made under this agenda item.  
17.4  Date of Next Meeting  
618.  No statements were made under this agenda item.  
__________  