   
  
IP/C/W/674  
 
15 January 2021  
(21-0503) Page: 1/3 
Council for Trade -Related Aspects of  
Intellectual Property Rights  Original: English  
 
  
WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR THE PREVENTION, 
CONTAINMENT AND TREATMENT OF COVID -19 - QUESTIONS BY PROPONENTS  
COMMUNICATION FROM INDIA, MOZAMBIQUE, PAKISTAN AND  SOUTH AFRICA  
The following communication, dated 14 January 2021, is circulated at the request of the delegations 
of India, Mozambique, Pakistan and South  Africa .  
 
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This document contains the questions by proponents raised on the waiver proposal IP/C/W/ 669 in 
the TRIPS  Council meetings on 3 and 10 December 2020.  
1  INFORMAL TRIPS COUNCIL MEETING - 3 DECEMBER 2020  
1.1  Question raised by Mozambique  
1.  After years of discouraging WTO Members especially developing countries to take steps to 
improve their patent law so that compulsory licenses may be issued in the interest of public health, 
how does the E uropean Union expect all WTO Members to be ready to use compulsory licenses 
should the need arise?  
1.2  Questions raised by South Africa  
2.  We would like to ask Canada, Germany and Hungary, when they decided to swiftly amend 
national laws to enable quicker use of compulsory license,  what kind of data was relied upon at that 
time - demonstrating the necessity of revising the laws? [We refer to the Secretariat note and 
compilation of COVID -19 measures.]   
3.  The E uropean Union (EU)  and Switzerland both highlight the flexibilities as the key measures for 
Members to use, does it mean the EU and Switzerland will from now on commit not to pressure 
developing countries when t hey improve their laws on compulsory license and other TRIPS 
flexibilities or make use of compulsory license? Would the European Commission from now on 
exclude compulsory license and other TRIPS flexibilities from its IP enforcement report? Would the 
Unite d States  Trade  Representative (USTR)  do the same to its Special 301 report?  
4.  If voluntary licensing (VL) mechanisms work, why do various license agreements concluded by 
companies exclude half of the world 's population from supply and only license to a few very specific 
manufacturers. Why is it that no one knows the full terms of the license?  
5.  If VL works then why are there geographical restrictions in the VL to limit supply to only to low - 
and middle -income countries (LMICs) under the agreements, excluding s upply to other developing 
countries? Taking note that the issue of classification of countries based on singular criteria such as 
per capita GDP ignores the deep and persistent structural deficits between developed and developing 
countries.   IP/C/W/674  
 
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  6.  The E uropean Union IP Action Plan, released on 25 November 2020, reiterates the exigent need 
to deploy COVID -19 technologies, "not only in Europe but also on a global basis. "To this end, the 
EU IP plan calls for "voluntary pooling and licensing of intellectual propert y related to COVID -19 
therapeutics and vaccines, in line with the recent resolution of the World Health Assembly to promote 
equitable global access as well as a fair return on investment. " Can the European Union elucidate 
further on how they intend to tran sform this lofty rhetoric into concrete action?  The EU IP Action 
Plan notes that the Commission is "working on mechanisms that would enable and incentivise the 
rapid pooling of critical IP in times of crisis ". Could the European Union please explicate on 
these mechanisms that would enable the "rapid pooling of critical IP in times of crisis. " 
7.  Following on from President Ursula von der Leyen 's State of the Union call for the establishment 
of an EU BARDA, the EU 's IP action calls for the development of an "effective framework for march -in 
rights that should guarantee that publicly funded IP is available in case of critical shortages ". Could 
the European Union please provide details on the design of these march -in rights?  
8.  We would counter the EU 's assertion, repeated once again today, that compulsory licensing 
should be used as "means of last resort and a safety net when all other efforts to make IP available 
have failed. " Nonetheless, could the European Union pleas e provide further details on the EU 
IP Action Plan 's recommendation that EU Member States "establish fast -track procedures 
to issue compulsory licenses in emergency situations "? 
9.  The Commission will explore with Member States the possibility of creating an emergency 
co-ordination mechanism, to be triggered at short notice when Member States consider issuing a 
compulsory license. What is the rationale behind this policy decision?  
10.  In the European Union, data exclusivity and on certain products market exclusiv ity are granted. 
How does the EC want to make effective use of CL in this pandemic with these non -patent 
barriers in place?  
11.  As the European Union has opted out of Article 31 bis of the TRIPS Agreement, how would EU 
Member States with no or insufficient manu facturing capacities make effective use of the compulsory 
licensing provisions of the TRIPS Agreement, especially in light of the IP Action Plan 's emphasis on 
establishing "fast-track procedures to issue compulsory licenses in emergency situations "? 
1.3  Questi ons raised by India  
12.  Do the opponents have any data regarding how the waiver would demonstrably have negative 
impact on Members ' economies, if any?  
13.  Public funding has been driving COVID -R&D. In addition, billions of dollars are spent on 
purchasing the vacci ne. Given the demand volumes, pharma companies will anyway make profits. 
So why is there a need for IP as an incentive, in a global pandemic situation?  
14.  Can the opponents provide data as to how voluntary licensing approaches and existing global 
cooperation mechanisms, including ACT Accelerator, the COVAX facility and COVAX AMC, would be 
sufficient to address the vaccine requirements of 7.8 billion people in the world?  
15.  If voluntary mechanisms work, why has the pharmaceutical industry collectively rejected 
participation in the World Health Organization (WHO) COVID -19 Technology Access Pool (C -TAP), 
an initiative that encourages voluntary contribution of IP, technology and data to support global 
sharing and scale -up of manufacturing and supply of COVID - 19 medic al and pharmaceutical 
products?  
2  FORMAL TRIPS COUNCIL MEETING - 10 DECEMBER 2020  
2.1  Questions raised by South Africa  
16.  In launching the Pharmaceutical Strategy for Europe, Vice President Schinas underscored the 
importance that the transparency of R&D costs plays in ensuring access to affordable  medicines.1 In 
 
1 https://ec.europa.eu/commission/presscorner/detail/en/speech_20_2212  IP/C/W/674  
 
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  his remarks to the press on 25 November 2020, Vice -president Schinas said,  "Equally important, 
ensuring affordability of medicines will be guaranteed through bolstering transparency on R&D costs 
and expendit ure on medicines in healthcare systems, finding a consensus on costing principles and 
addressing aspects that impede the competi tive functioning of the markets impacting on 
affordability. " Could the European Union provide more details on how it intends to 
ensure  the "affordability of medicines " through the "bolstering of R&D costs "? 
2.2  Questions raised by Pakistan  
17.  How would countries that argue for such licensing arrangements ( voluntary licensing ), address 
companies ' conduct and ensure the availability of non -exclusive, global, open licenses on reasonable 
terms and conditions, where all manufacturers globally may be engaged; and all countries may 
benefit from supply without any restrictions?  
18.  Also, what steps are those  countries taking to ensure full transparency and accountability in the 
cost of R&D and in licensing agreements?  
2.3  Question raised by India  
19.  We would like to know how E uropean Union plans to persuade pharma companies to enter into 
transparent, non -exclusive g lobal open licenses, where all manufacturers can be engaged without 
any restrictions, and what steps EU is taking to ensure full transparency and accountability in the 
cost of R&D and in licensing agreements.  
 
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