   
  
IP/C/W/68 1 
 
18 June 2021 
(21-5034) Page: 1/3 
Council for Trade -Related Aspects of  
Intellectual Property Rights  Original: English  
 
  
DRAFT GENERAL COUNCIL DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC 
HEALTH IN THE CIRCUMSTANCES OF A PANDEMIC  
COMMUNICATION FROM THE EUROPEAN UNION TO THE COUNCIL FOR TRIPS  
1.  On 4 June 2021 the European Union submitted to the Council for TRIPS a communication on 
"Urgent trade policy responses to the COVID -19 crisis: intellectual property" 
(document  IP/C/W/680).  
2.  Following that communication, the European Union requests that the Council for TRIPS 
recommend to the General Council the adoptio n of the annexed declaration text.  
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  IP/C/W/68 1 
 
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  ANNEX  
DRAFT DECLARATION TEXT  
DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH IN THE CIRCUMSTANCES OF A 
PANDEMIC  
The General Council,  
Reaffirming  the content of the General Council Declaration 'A Trade Policy Response to the COVID -
19 Pandemic and to Enhance Resilience Against Future Pandemics', which this Declaration aims to 
complement,  
Recognizing  that the COVID -19 pandemic continues to be a globa l health and economic crisis that 
affects all WTO Members and that urgent multilateral action is key to respond to this crisis swiftly,  
Recognizing that pandemics affect all countries and therefore require concerted global efforts to 
ensure that all peopl e in all countries have access to safe and effective vaccines and medicines as 
soon as possible,  
Recognizing  that our main objective is to ensure fair and equitable distribution of vaccines and 
medicines to fight against COVID -19 and that this objective re quires concerted efforts to increase 
manufacturing capacity and investment, as well as supplies at an affordable cost,  
Recognizing  that the WTO must step up its efforts to ensure that the rules -based global trading 
system plays its role in response to the COVID -19 crisis,  
Recognizing  the need to provide and preserve appropriate incentives for investments in research 
and development of COVID -19 vaccines and medicines, particularly in view of the continuing 
emergence of new variants of the virus,  
Recognizing  that the response to the COVID -19 crisis needs to be comprehensive and include , but 
not be limited to , ensuring that the intellectual property system supports efforts to enhance 
production and supply of vaccines and medicines,  
Recognizing  that pandemics pose specific challenges for developing and least -developed countries,  
Recognizing  that, in the circumst ances of a pandemic, an urgent multilateral response requires 
accelerating the production of vaccines and medicines and their equitable global distribution,  
Emphasizing  that, where Members need to use compulsory licensing for those purposes, legal 
certain ty on the flexibilities provided for in the Agreement on Trade -Related Aspects of Intellectual 
Property Rights ('the TRIPS Agreement') is essential,  
Recognizing  that, in the circumstances of a pandemic, it is also essential to support the production 
and su pply of vaccines and medicines at affordable prices to low - and middle -income country 
Members, including through international joint initiatives that aim to ensure equitable access of 
vaccines or medicines, such as the COVAX Facility for the COVID -19 pande mic, and through 
concerted efforts of voluntary technology transfer,  
Stressing  the need to ensure that the established procedures to use compulsory licences for those 
purposes be as efficient and streamlined as possible,  
Desiring to clarify that a pandemi c constitutes a national emergency or a circumstance of extreme 
urgency for the purposes of issuing a compulsory licence, including for export, under the TRIPS 
Agreement, to support a swift use of the compulsory licensing system in the times of a pandemic,   
Desiring to facilitate the determination of the remuneration to be paid under a compulsory licence 
in the circumstances of a pandemic, in order to support manufacturers ready to produce IP/C/W/68 1 
 
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  pharmaceutical products, including vaccines or medicines, at afforda ble prices for low - and middle -
income countries,  
Desiring  to facilitate the use of the WTO notification procedures on compulsory licensing for exporting 
or importing purposes, including in the context of international joint initiatives that aim to ensure 
equitable access of the vaccines or medicines covered by a compulsory licence.  
Declares that:  
We, the WTO Members, reaffirm the content of the Doha Declaration on the TRIPS Agreement and 
Public Health.  
We agree that the TRIPS Agreement does not and should  not prevent Members from taking measures 
to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we 
affirm that the Agreement can and should be interpreted and implemented in a manner supportive 
of WTO Members' righ t to protect public health and, in particular, to promote access to vaccines and 
medicines for all.  
In this connection, we reaffirm the right of WTO Members to use the provisions in the TRIPS 
Agreement, which provide flexibility for this purpose, including  those relating to compulsory licensing 
in Articles 31 and 31 bis. 
We agree that:  
a. A pandemic is 'a national emergency or other circumstances of extreme urgency' within the 
meaning of Article 31(b) of the TRIPS Agreement. For the purposes of issuing a compul sory 
licence pursuant to Articles 31 and 31bis of the TRIPS Agreement, a Member may waive the 
requirement of making efforts to obtain authorization from the right holder, provided for in 
Article 31(b).  
b. In the circumstances of a pandemic and to support man ufacturers ready to produce vaccines 
or medicines addressing the pandemic at affordable prices for low - and middle -income 
countries, a Member may provide, for the purposes of determining the remuneration to be 
paid to the right holder pursuant to Article 3 1(h) and paragraph 2 of Article 31bis of the 
TRIPS Agreement, that the remuneration reflects the price charged by the manufacturer of 
the vaccine or medicine produced under the compulsory licence.  
c. In the circumstances of a pandemic, for the purposes of Ar ticle 31bis and paragraph 2.c) of 
the Annex to the TRIPS Agreement, the exporting Member may provide in one single 
notification a list of all countries to which vaccines and medicines are to be supplied by the 
exporting Member directly or through indirect means, including international joint initiatives 
that aim to ensure equitable access to the vaccines or medicines 1 covered by the compulsory 
licence. It shall be presumed that such joint initiatives supply those vaccines and medicines 
to eligible importin g Members within the meaning of paragraph 1.b) of the Annex to the 
TRIPS Agreement.  
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1 It is understood that, in the circumstances of the COVID -19 pandemic, COVAX is an international joint 
initiative within the meaning of this paragraph.  