Text: the draft WTO intellectual property waiver for the 2022 Ministerial Conference

Photo of a shirt with a sticker saying "I got my COVID-19 vaccine”

This text accompanies
‘Quad’ raise hopes of a COVID-19 deal and revival for the beleaguered WTO
It updates the earlier versions in
Text: the group-of-4’s compromise WTO intellectual property waiver proposal

The text finally agreed at the Ministerial Conference is in
Text: the agreed WTO intellectual property waiver for the pandemic

See also
The draft (separate) trade and health declaration (The WTO response to the Covid-19 pandemic and preparedness for future pandemics)

and
8 reasons why countries disagree over a WTO intellectual property waiver and more

Posted by Peter Ungphakorn
JUNE 11, 2022 | UPDATED JUNE 18, 2022

This is the draft submitted by the chair of the WTO intellectual property (TRIPS) Council to the June 12–15 Ministerial Conference. It contains a number of unresolved parts, indicated by square brackets [], meaning ministers will have to negotiate further if it is to be issued at the conference.

The reference to paragraphs 1, 3 and 4 of Article 9 of the WTO Agreement confirms that this is officially a “waiver” under WTO rules.

The draft is the result of negotiations based on a compromise text produced from high level consultations between the EU, India, South Africa and US coordinated by WTO Director-General Ngozi Okonjo-Iweala and her deputy Anabel González from late 2021 to mid-March 2022, when the text was leaked and posted on STAT+ (accessed on March 16, 2022, and here in pdf format).

The compromise was then circulated in document IP/C/W/688 on May 3, 2022 with some minor changes and a cover letter from Okonjo-Iweala. (See also this WTO news story.)


TRIPS = Trade-related aspects of intellectual property rights

WTO members first discussed the compromise in the intellectual property (TRIPS) council on May 6, 2022, and then in the General Council on May 10 (see this Twitter thread and this WTO news story. This was enough of a compromise for the membership as a whole to be prepared to start negotiating a text for the first time.

Although the text came from consultations among the four, no one was prepared to own it. Reports said the EU was the only one of the four to have accepted it internally. In the US, a bipartisan group of senators complained that Congress had not been consulted.

The text was then negotiated among a group of key delegations, including coordinators of groups of members active in the talks, right up to the eve of the Ministerial Conference. Various further changes were discussed and proposed. (See also this Twitter thread.)

The WTO’s full membership has the final decision on whether to adopt it. The aim is for the final version to be agreed at the Ministerial Conference. Whether ministers can settle the outstanding issues remains to be seen.

> See earlier analysis: 8 reasons why countries disagree over a WTO intellectual property waiver

Below is the official version for the Ministerial Conference. It is in html, with hyperlinks and notes on the latest changes added. It’s also available in pdf format.


This image has an empty alt attribute; its file name is wto_eng_cmjk.png

(22-4432)

WT/MIN(22)/W/15

10 June 2022

Page: 1/3


Ministerial Conference
Twelfth Session
Geneva, 12-15 June 2022

Original: English

DRAFT MINISTERIAL DECISION

COMMUNICATION FROM THE CHAIR OF THE COUNCIL FOR TRIPS

Following text-based negotiations in the TRIPS Council on the basis of document IP/C/W/688, and without prejudice to the final position of Members, the following draft decision is being forwarded to Ministers for consideration at the 12th Ministerial Conference.

It remains the understanding of all delegations that any overall outcome will have to be agreed by all Members.

MINISTERIAL DECISION ON THE TRIPS AGREEMENT

Adopted on [XX] June 2022

The Ministerial Conference,

Having regard to paragraphs 1, 3 and 4 of Article IX of the Marrakesh Agreement Establishing the World Trade Organization (“the WTO Agreement”);

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 patented subject matter2 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.


1 [For the purposes of this Decision, all developing country Members are eligible Members. Developing country Members with the capacity to export vaccines are encouraged to opt out from this decision.][For the purpose of this Decision, developing country Members who export more than 10 percent of world exports of COVID-19 vaccine doses in 2021 are not eligible Members.]

(NOTE: Square brackets indicate text that has not been agreed, or alternatives proposed.)

(NOTE: this leaves China’s status unresolved. In the May 10 General Council meeting, China — the only developing country to export more than 10% of exported doses in 2021 — said it could not accept the text in the second pair of square brackets but it would voluntarily opt out under the first part of the footnote if the second part was deleted. See also this.)


2 For the purpose of this Decision, it is understood that ‘subject matter of a patent’ [includes][means all finished COVID-19 vaccine products,]ingredients and processes [necessary] for the manufacture of the  COVID- 19 vaccine.

(NOTE: This footnote has been changed essentially adding the text in square brackets or putting the brackets around some words.


2.            For greater clarity, an eligible Member may authorize the use of patented subject matter 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 waivers for eligible Members to authorize the use of patented subject matter in accordance with paragraphs 1 and 2:

(a)          An eligible Member need not require the proposed user of the patented subject matter to make efforts to obtain an authorization from the right holder for the purposes of Article 31(b).

(NOTE: the original sub-paragraph a on“single authorisation” and listing all patents has been deleted.)

(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.

(NOTE: This has been slightly rephrased. See the original.)

(c)          Eligible Members shall undertake all reasonable efforts to prevent the re-exportation of the COVID-19 vaccine that has been imported into their territories under this Decision.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.


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.

(NOTE: Footnote 3 added. The second sentence has been rephrased. See the original.)

(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 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)

(NOTE: WHO-WIPO-WTO study added)


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.

(NOTE: The original “Nothing in Article 39.3 … shall prevent” rephrased as “Recognising the importance …” with additional re-wording)

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.5


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[, if possible before a/any shipment takes place].

(NOTE: the text in square brackets at the end is added)


6.            An eligible Member may apply the provisions of this Decision [so that authorized uses continue no later than][until] [3][5][10] 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.

(NOTE: the text in square brackets and the option of 10 years are added)

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.

(NOTE: at one stage this paragraph on “nullification and impairment” or “non-violation complaints” was removed. It has been restored.)

8.            [No later than six months from the date of this Decision, Members [will][shall] decide [whether to extend this decision] [on its extension] to cover the production and supply of COVID-19 diagnostics and therapeutics.]

(NOTE: This entire paragraph is now in square brackets. The alternatives “shall” and “whether to extend this decision” have been added.)

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.

(NOTE: This is a new paragraph.)


Updates: June 18, 2022 — adding the link to the text agreed at the Ministerial Conference

Image credits:
● Vaccine sticker | Marisol Benitez, Unspalsh licence

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