This text accompanies
‘Quad’ raise hopes of a COVID-19 deal and revival for the beleaguered WTO
The final agreed decision is here
(with notes and links to earlier versions)
See also
8 reasons why countries disagree over a WTO intellectual property waiver and more
Posted by Peter Ungphakorn
MARCH 16, 2022 | UPDATED JUNE 17, 2022
This is the 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 March 2022. It was circulated in document IP/C/W/688 on May 3, 2022 (See this WTO news story.)
An earlier version was leaked in mid-March and posted on STAT+ (accessed on March 16, 2022). Here it is in pdf format. The official version has some very minor changes from that version.
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.
Since then, members have been working on further revisions with the aim of agreeing on a final version at the June 12–15 Ministerial Conference, although whether that can be achieved is touch-and-go. For now, the main presented text below is the May 3 version with subsequent revisions noted.
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. Various further changes were discussed and proposed. (See this Twitter thread.)
The WTO’s full membership will have the final decision on whether to adopt it. They are bound to make some changes.
> See earlier analysis: 8 reasons why countries disagree over a WTO intellectual property waiver
Below is the official version circulated to WTO members in May 2022. It is in html, with hyperlinks added. It’s also available in pdf format.
The changes from the earlier leaked version are minor, including square brackets around paragraph 3(a), a new footnote 1, and a new footnote 3. Changes from mid-May are reflected in notes in blue.
In the May document, WTO Director-General Ngozi Okonjo-Iweala attached a cover letter explaining how the compromise was set up. The letter is reproduced at the end of the text below.
May 3 version title:
TRIPS COVID-19
03 MAY 2022
Title of leaked March version:
TRIPS COVID-19 solution (the outcome of the quadrilateral discussions at the end of last week, to be presented to WTO Members)
From mid-May: the drafts that members worked on took the simple title of an “Outcome text”. Some of the further changes were linguistic or correcting typographical error. In particular “patented subject matter” became “the subject matter of a patent”.
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: 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.
In the version leaked in March, footnote 1 was:
1 For the purpose of this Decision, an “eligible Member” means any developing country Member that exported less than 10 percent of world exports of COVID-19 vaccine doses in 2021.)
2 For the purpose of this Decision, it is understood that “patented subject matter” includes ingredients and processes necessary for the manufacture of the COVID-19 vaccine.
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) With respect to Article 31(a), an eligible Member may issue a single authorization to use the subject matter of multiple patents necessary for the production or supply of a COVID-19 vaccine. The authorization shall list all patents covered. In the determination of the relevant patents, an eligible Member may be assisted by WIPO’s patent landscaping work, including on underlying technologies on COVID-19 vaccines, and by other relevant sources. An eligible Member may update the authorization to include other patents.]3
3 This paragraph is under consideration as to whether to keep or delete.
(Note: the March version did not have square brackets
around sub-paragraph (a), and it had no footnote.)
From mid-May: this was deleted in the drafts members worked on.
(b) 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).
(c) 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 authorized use to be exported to eligible Members and to supply international or regional joint initiatives that aim to ensure the equitable access of eligible Members to the COVID-19 vaccine covered by the authorization.
(d) 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. All Members shall ensure the availability of effective legal remedies to prevent the importation into their territories of COVID-19 vaccines produced under, and diverted to their markets inconsistently with, this Decision.
From mid-May, second sentence: “All Members shall ensure the availability of effective legal means to prevent the importation into, and sale in, their territories of COVID-19 vaccines produced under this Decision, and diverted to their markets inconsistently with its provisions, using the means already required to be available under the TRIPS Agreement.”
(e) 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 Guidelines for Non-Voluntary Use of a Patent on Medical Technologies published by the WHO (WHO/TCM/2005.1)
(Note this is footnote 3 in the March leaked text)
4. Nothing in Article 39.3 of the Agreement shall prevent a Member from taking measures necessary to enable the effectiveness of any authorization issued as per 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.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
(Note this is footnote 4 in the March leaked text)
6. An eligible Member may apply the provisions of this Decision until [3][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.
From mid-May: paragraph 7 is deleted.
8. No later than six months from the date of this Decision, Members will decide on its extension to cover the production and distribution of COVID-19 diagnostics and therapeutics.
Cover letter from the WTO director-general
(Page 2 of this document)
3rd May 2022
Excellency,
I am writing to inform you about progress regarding the informal TRIPS Waiver discussions. You may recall that at the Informal Heads of Delegation meeting on 3 December 2021, the Chairs of the General Council and the TRIPS Council reported on their efforts with Members regarding the WTO Response to the Pandemic and the TRIPS Waiver. What was evident was the need for additional Impetus to the TRIPS Waiver discussions given the impasse in the TRIPS Council. I therefore Informed Members that I would be reaching out to various Ministers for needed input. In this regard, working with DDG Gonzalez [Deputy Director-General Anabel Gonzalez], we have tried to support an informal group of Ministers to come together around what could be a meaningful proposal, without prejudice to their respective positions, that could provide a platform to be built upon by the membership.
As I have Informed Members on several occasions during TNC [Trade Negotiations Committee] and General Council meetings — the most recent briefing being at the 28 March Informal General Council, I assured Members that whatever outcome emerged from this Informal process would be put forward transparently to the full Membership for discussion in the TRIPS Council. Please now find attached the outcome of this process for your information. For transparency purposes, Ambassador, I request you as TRIPS Council Chair to bring the contents of this letter to the attention of the TRIPS Council.
I am grateful to all Members for their understanding and patience during this informal process.
Please accept, Ambassador, the assurance of my highest consideration.
Yours sincerely,
[Signature]
Dr Ngozi Okonjo-Iweala
H.E. Ambassador Lansana Gberie
Chair of the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS)
Permanent Representative of Sierra Leone to the UN and the WTO
Route de Ferney 194, Grand-Saconnex
Geneva, 1218
Switzerland
Updates:
June 18, 2022 — Link to final agreed version added to the box at the top
June 6, 2022 — changes in revised drafts from mid-May added in notes in blue
May 26, 2022 — adding a reference and link to further negotiations and proposed changes in the introduction before the draft text.
May 10, 2022 — the officially circulated (May 3) version is now the main text, with differences from the March leaked text as notes. Links added to Twitter threads on the TRIPS Council and General Council meetings and to the US senators’ letter complaining they had not been informed.
May 3–4, 2022 — adding links the officially-circulated text and the notes on where the two versions differ, and the cover letter
Image credits:
● Vaccination centre | “Hello I’m Nik”, Unspalsh licence
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