  
  
WT/MIN(22)/W/15/Rev.1  
17 June 2022  
(22-4708 ) Page: 1/2 
Ministerial Conference  
Twelfth Session  
Geneva, 12-15 June  2022 Original: English  
 
DRAFT MINISTERIAL DECISION ON THE TRIPS AGREEMENT  
Revision  
The Ministerial Conference , 
 
Having regard  to paragraphs 1, 3 and 4 of Article IX of the Marrakesh Agreement Establishing the 
World Trade Organization .  
 
Noting the exceptional circumstances of the COVID -19 pandemic;  
 
Decides as follows:  
 
1.   Notwithstanding the provision of patent rights under its domestic legislation, an eligible 
Member1 may limit the rights provided for under Article 28.1 of the TRIPS Agreement 
(hereinafter "the Agreement ") by authorizing the use of the subject matter of a patent2 
required for the production and supply of COVID -19 vaccines without the consent of the right 
holder to the extent necessary to address the COVID -19 pandemic, in accordance with the 
provisions of Article 31 of the Agreement, as clarified and waived in para graphs 2 to 6 below.  
2.   For greater clarity, an eligible  Member may authorize the use of the subject matter of a patent 
under Article 31 without the right holder's consent through any instrument available in the 
law of the Member such as executive orders, em ergency decrees, government use 
authorizations, and judicial or administrative orders, whether or not a Member has a 
compulsory license regime in place. For the purpose of this Decision, the "law of a Member" 
referred to in Article 31 is not limited to leg islative acts such as those laying down rules on 
compulsory licensing, but it also includes other acts, such as executive orders, emergency 
decrees, and judicial or administrative orders.  
3.   Members agree  on the following clarifications and waiver for eligib le Members to authorize the 
use of the subject matter of a patent in accordance with paragraphs 1 and 2:  
(a) An eligible Member need not require the proposed user of the subject matter of a patent 
to make efforts to obtain an authorization from the right holde r as set out in 
Article  31(b).  
(b) An eligible  Member may waive the requirement of Article 31(f) that authorized use under 
Article 31 be predominantly to supply its domestic market and may allow any proportion 
of the products manufactured under the authorization in accordance with this Decision 
to be exported to eligible Members, including through international or regional joint 
initiatives that aim to ensure the equitable access of eligible Members to the COVID -19 
vaccine covered by the authorization.  
(c) Eligible  Members shall undertake all reasonable ef forts to prevent the re -exportation of 
the products  manufactured under the authorization in accordance with this Decision that 
 
1 [pending ] 
2 For the purpose of this Decision, it is understood that 'subject matter  of a patent ' includes ingredients 
and processes necessary for the manufacture of the COVID -19 vaccine.  WT/MIN(22)/W/15/Rev.1  
 
- 2 - 
 
  have been imported into their territories under this Decision.3 Members shall ensure the 
availability of effective legal means t o prevent the importation into, and sale in, their 
territories of products manufactured under the authorization in accordance with this 
Decision, and diverted to their markets inconsistently with its provisions, using the 
means already required to be avail able under the TRIPS Agreement.  
(d) Determination of adequate remuneration under Article 31(h) may take account of the 
humanitarian  and not -for-profit purpose of specific vaccine distribution programs aimed 
at providing equitable  access to COVID -19 vaccines in  order to support manufacturers 
in eligible Members to produce and supply these vaccines at affordable prices for eligible 
Members. In setting the adequate remuneration in these cases, eligible Members may 
take into consideration existing good practices in  instances of national emergencies, 
pandemics, or similar circumstances.4 
4.   Recognizing  the importance of the timely availability of and access to COVID -19 vaccines, it 
is understood that Article 39.3 of the Agreement does not prevent an eligible Member fr om 
enabling the rapid approval for use of a COVID -19 vaccine produced under this Decision.  
5.   For purposes of transparency, as soon as possible after the adoption of the measure, an 
eligible Member shall communicate to the Council for TRIPS any measure relat ed to the 
implementation of this Decision, including the granting of an authorization.5 
6.   An eligible Member may apply the provisions of this Decision  until 5 years from the date of 
this Decision. The General Council may extend such a period taking into co nsideration the 
exceptional circumstances of the COVID -19 pandemic. The General Council will review 
annually the operation of this Decision.  
7.   Members shall not challenge any measures taken in conformity with this Decision under 
subparagraphs 1(b) and 1(c) of Article XXIII of the GATT 1994.  
8.   No later than six months from the date of this Decision, Members will decide on its extension  
to cover the production and supply of COVID -19 diagnostics and therapeutics.  
9.   This Decision  is without  prejudice to the flexibilities that Members have under the TRIPS 
Agreement, including flexibilities affirmed in the Doha Declaration on the TRIPS Agreement 
and Public Health , and without prejudice to their rights and obligations under the TRIPS 
Agreement,  except as otherwise provided for in paragraph 3(b). For greater certainty, this 
Decision is without prejudice to the interpretation of the above -mentioned flexibilities, rights 
and obligations outside the scope of this Decision.  
__________  
 
3 In exceptional circumstances, an eligible Member may re -export COVID -19 vaccines to another eligible 
Member for humanitarian and not -for-profit purposes, as long as the eligible Member communicates in 
accordance with paragraph 5.  
4 This includes the remun eration aspects of the WHO -WIPO -WTO Study on Promoting Access to Medical 
Technologies and Innovation (2020), and the Remuneration Guidelines for Non -Voluntary Use of a Patent on 
Medical Technologies published by the WHO (WHO/TCM/2005.1).  
5 The information provided shall include the name and address of the authorized entity, the product(s) for 
which the authorization has been granted and the duration of the authorization. The quantity(ies) for which the 
authorization has been granted and the country(ies) to which the product(s) is(are) to be supplied shall be 
notified as soon as possible after the information is available . 