This text accompanies
‘Quad’ raise hopes of a COVID-19 deal and revival for the beleaguered WTO and
UPDATES: expanding the WTO intellectual property waiver for COVID-19
Two earlier versions are in
Text: the draft WTO intellectual property waiver for the 2022 Ministerial Conference and
Text: the group-of-4’s compromise WTO intellectual property waiver proposal
See also
The 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
July 6 TRIPS Council meeting
The first discussion of expanding the waiver (Par.8) to diagnostics and therapeutics, reported by Geneva Health Files and the WTO website
Posted by Peter Ungphakorn
JUNE 18, 2022 | UPDATED JULY 8, 2022
This is the decision taken by consensus at the rescheduled and extended World Trade Organization (WTO) Ministerial Conference on June 17, 2022. All previously unresolved parts were settled and all square brackets in the final draft that was submitted to ministers were removed.
The decision is the result of negotiations ultimately among the full membership, but also in small groups. One issue (footnote 1 on eligibility) was reportedly settled bilaterally between the US and China in the final hours of the Ministerial Conference.
Continue reading this introduction or jump down the page to the text
There has been some comment about whether this is a “waiver” or not. It’s a rhetorical debate about whether enough intellectual property protection can be suspended under the decision and whether the conditions are reasonable.
TRIPS = Trade-related aspects of intellectual property rights
As far as the WTO is concerned, it is a waiver, legally. This was always about waiving WTO provisions. It was called the “TRIPS waiver”, a reference to the WTO intellectual property agreement. More specifically, the decision refers to paragraphs 1, 3 and 4 of Article 9 of the WTO Agreement confirming that this is officially a “waiver” under WTO rules. Paragraph 3 says:
“In exceptional circumstances, the Ministerial Conference may decide to waive an obligation imposed on a Member by this Agreement or any of the Multilateral Trade Agreements ….”
If “an obligation” is waived for any member under Article 9, then it’s a waiver. And it’s normal for waivers to contain conditions. So the real question is whether the decision does enough. Debating whether or not it is a waiver is pointless.
The waiver originated in a compromise text produced from high level consultations between the “Quad” of the EU, India, South Africa and US, coordinated by WTO Director-General Ngozi Okonjo-Iweala and her deputy Anabel González.
The compromise was an attempt to break the deadlock between countries supporting the original proposal from India and South Africa and those opposing it (details of the debate are here). Without some sort of compromise, consensus — needed for any WTO decision — would not have been possible. It eventually succeeded, although public debate continued as to whether it was good enough.
The Quad talks took place from late 2021 to mid-March 2022. They were confidential but Okonjo-Iweala was upfront from the start that they were taking place. In March, the text was leaked and posted on STAT+ (accessed on March 16, 2022, and here in pdf format).
It was first circulated officially 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.)
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. It 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, and in the lead up to the Ministerial Conference it was the only WTO member to openly advocate accepting the compromise.
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.)
In the end, the WTO’s full membership had the final decision on whether to adopt it. Switzerland and the UK, who had opposed the waiver all along, dropped their opposition during the Ministerial Conference.
> See earlier analysis: 8 reasons why countries disagree over a WTO intellectual property waiver
Two important points:
- No country is obliged to use the waiver, and those opposing it are unlikely to do so. “Developing country” (the criterion for eligibility) is a loose label in the WTO and includes South Korea and Brazil, for example
- Countries using the waiver will have to change their laws or regulations in order to suspend patent protection — assuming their laws comply with the WTO intellectual property agreement, as is required. This may take some time. And when they do that, they have to notify the WTO as is required for any changes to their intellectual property protection regimes.
Below is the final agreed text. It is in html, with hyperlinks and notes on the latest changes added. It’s also available in pdf format. Although it says “draft”, it was gavelled through, with no objections, by Ministerial Conference chair Timur Suleimenov, First Deputy Chief of Staff of the Kazakh President on June 17 (see also this WTO video).
(22-4786)
Ministerial Conference
Twelfth Session
Geneva, 12-15 June 2022
Original: English
DRAFT MINISTERIAL DECISION ON THE TRIPS AGREEMENT
ADOPTED ON 17 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;
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 patent 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 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.
(NOTE: this resolves China’s status. A low share of exported vaccine doses worldwide is removed as a possible criterion for eligibility. Instead, major exporters are “encouraged” to opt out and to make that binding by declaring in the General Council that they will not use the waiver. The May 10 General Council meeting is mentioned specifically. That’s when China — the only developing country to export more than 10% of exported doses in 2021 — said it would voluntarily opt out under the first part of the original footnote if the second part (the export share criterion) was deleted. See the previous draft text and explanation here.)
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.
(NOTE: The broader option of “includes” has been picked over the narrower “means”, with some other tweaking.)
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).
(NOTE: the original sub-paragraph (a), on“single authorisation” and listing all patents, remains 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.
(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. 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.
(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)
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.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: the text in square brackets at the end — “[, if possible before a/any shipment takes place]” — has been deleted)
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.
(NOTE: the middle number, 5 years, is picked. The other options were 3 or 10 years. Also deleted is “[so that authorized uses continue no later than]”, leaving “until”. )
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: This is about “nullification and impairment” or “non-violation complaints”. They cannot be used to challenge measures taken under the waiver.)
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.
(NOTE: Square brackets removed. “Will” has been picked over “shall”, and “on its extension” is preferred to “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.
Updates:
July 8, 2022 — adding the links in the box at the top to the reports of the July 6 debate on expanding the waiver to diagnostics and therapeutics
June 24, 2022 — changing the formatting at the top of the official text to reflect the final decision instead of the draft submitted to ministers
Image credits:
● Ministerial Conference chair Timur Suleimenov, First Deputy Chief of Staff of the Kazakh President, with the gavel in the concluding session of the conference | WTO
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