The following appears to be the “Draft Ministerial Decision on the TRIPS Agreement.” Will COVID-19 vaccines become more available based on the waiver? I am sure this will be carefully tracked.
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 Member[Footnote 1] 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
patent [Footnote 2] 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 paragraphs 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, emergency 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 legislative 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 eligible 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 holder 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 efforts to prevent the re-exportation of the products manufactured
under the authorization in accordance with this Decision that have been
imported into their territories under this Decision. [Footnote 3]
Members shall ensure the availability of effective legal means to 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 available 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. [Footnote 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 from 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 related to the implementation of this Decision,
including the granting of an authorization. [Footnote 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 consideration 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.
Footnote 1: For the purpose of this Decision, all
developing country Members are eligible Members. Developing country Members
with existing capacity to manufacture COVID-19 vaccines are encouraged to make
a binding commitment not to avail themselves of this Decision. Such binding
commitments include statements made by eligible Members to the General Council,
such as those made at the General Council meeting on 10 May 2022, and will be recorded
by the Council for TRIPS and will be compiled and published publicly on the WTO
website.
Footnote 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.
Footnote 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.
Footnote 4: This includes the remuneration 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).
Footnote 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
[Hat tip to Professor Justin Hughes]
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