By Peter Ungphakorn
POSTED OCTOBER 4, 2022 | UPDATED AS INDICATED
The waiver on patent protection for COVID-19 vaccines was agreed at the WTO Ministerial Conference on June 17, 2022. The text with brief explanations is here. The waiver is not an obligation. Countries can choose to suspend certain patent rights if they want.
Much of the work after the Ministerial Conference results from a provision for WTO members to decide within six months (by December 17, 2022) whether or not to expand the waiver to include COVID-19 tests and treatments:
“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”
Background: The original (revised) proposal; the debate; the proposed compromise and analysis.
Updates on the latest developments will be added here, with links to new documents and news items. That will include any notifications from countries changing their laws to apply the waiver. So far there are none.
Key events
- December 20, 2022 — The General Council agrees on postponing the deadline with no date set, but to be reconsidered in the Spring
- December 19, 2022 — The General Council postpones a decision on postponing the deadline
- December 17, 2022 — deadline for expansion decision missed, so far no country has moved to use the vaccine patent waiver agreed in June
- December 16, 2022 — formal meeting: chair’s draft binned, replaced by short paragraph postponing the deadline
- December 7, 2022 — chair’s draft factual report circulated
- December 6, 2022 — informal meeting discusses proponents’ draft and postponing deadline
- December 5–6, 2022 — US announces it will need time to consult stakeholders
- November 2, 2022 — informal meeting, with members’ positions on expanding the waiver to tests and treatments crystallised into three groups
- July 6, 2022 — first meeting after the vaccine patent waiver decision, followed by stock-taking and informal meetings
(TRIPS = trade-related aspects of intellectual property rights, the official description of intellectual property issues that are discussed in the WTO — they should be “trade-related” issues)
December 20, 2022 — The General Council eventually agreed to postpone the deadline with no new date, but to revert to the question at its next meeting, tentatively scheduled for March 2–3, 2023, the WTO website reported.
December 19, 2022 — On the first day of a two-day meeting, the General Council postponed a decision on whether to extend the deadline (see December 17 and December 16). An update was due on December 20.
Quoting WTO spokesman Dan Pruzin, Inside US Trade reported (paywalled) that most members who spoke in the General Council were flexible about how long the extension should be. India, South Africa and others proposed a new deadline of the first General Council meeting in 2023, or by the end of March. The US said this was too soon since it needed until October 2023 to complete its consultations (see December 5–6).
December 17, 2022 — Six months after the Ministerial Conference decision, the deadline passes with no agreement on expanding the waiver on COVID-19 vaccine patents to COVID-19 diagnostics and therapeutics.
The General Council on December 19–20 is expected to extend the deadline indefinitely, under proposed agenda item 2.A.iii (see December 16).
Meanwhile, has anything happened on the waiver for patents on COVID-19 vaccines? Short answer: no.
Countries that want to use the waiver should have patent laws that comply with the WTO intellectual property (TRIPS) agreement. In order to suspend patent protection under the waiver, they would have to amend their laws and regulations. And they would then have to notify fellow-WTO members that those changes have been made.
By December 17, the WTO had received no such notification.
(This does not apply to least developed countries, since they do not have to provide intellectual property rights protection under the TRIPS agreement.)
December 16, 2022 — WTO members agreed to postpone indefinitely their December 17 deadline for a decision on whether to expand to tests and treatments, the waiver on patents for COVID-19 vaccines (explained above).
The agreement was reached in a formal intellectual property (TRIPS) council meeting and will be submitted to the General Council for an official decision on December 19–20.
Both councils comprise the full WTO membership but with different functions. The December 17 deadline came from a decision by ministers; the General Council has the power to act on behalf of the ministers.
The TRIPS Council chair, Sierra Leone Ambassador Lansana Gberie, will submit to the General Council a brief report consisting of one short paragraph, said to have been proposed by US Ambassador Maria Pagán:
“In view of paragraph 8 of the Ministerial Decision on the TRIPS Agreement adopted on 17 June 2022 (the ‘Decision’) providing that no later than 6 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, the TRIPS Council recommends that the General Council extend the deadline.”
Following deadlock on the wording the previous day, the rest of Gberie’s factual report has been discarded.
December 15, 2022 — WTO intellectual property negotiators continued to be divided, not only on expanding the wavier, but also on the draft factual report prepared by their chair, Sierra Leone Ambassador Lansana Gberie for the General Council on December 19–20.
The deadlock emerged in an informal four-hour meeting of the intellectual property (TRIPS) council just two days before December 17.
That date is the six-month deadline that members set for themselves to decide whether the waiver on COVID-19 vaccine patents should be expanded to cover tests and treatments for the pandemic.
The US has already announced it needs several months to consult its stakeholders and therefore a consensus will not be possible by December 17.
The waiver was agreed by WTO ministers in June. It allows governments to suspend some patent rights if they wish to do so.
Gberie’s report outlined the meetings over the past few months (see below) and summarised members’ positions. It observed the continuing lack of consensus.
Sources say his report was welcomed by the EU, Switzerland, UK and US.
Proponents of the waiver and its expansion — including Egypt, India, South Africa, Sri Lanka and the African Group —wanted amendments, including words that would acknowledge efforts to abide by the mandate in the June ministerial decision, and a proposal that the debate in the WTO should listen to expertise and advice of the World Health Organization (WHO).
Developed countries opposed the reference to the WHO on the grounds that the WTO talks are about intellectual property, which is not in the WHO’s remit.
Gberie said that if by Friday morning (December 16) agreement is reached on the text, he will submit it to the General Council on behalf of the intellectual property council. If that fails, he will submit his text under his own responsibility, he said.
December 7, 2022 — The deadline for expanding the vaccine patent waiver should be postponed, Ambassador Lansana Gberie of Sierra Leone, who chairs the WTO intellectual property (TRIPS) council, proposed in a draft report to the General Council.
Gberie suggested June 30, 2023 as a deadline for intellectual property negotiators to “report to” the General Council, rather than to decide — but this might simply reflect arcane procedure where the TRIPS Council reports and the General Council decides.
If agreed in the TRIPS Council, Gberie’s text would be submitted to the General Council’s December 19–20 meeting. The final two paragraphs, as currently drafted, say (hyperlinks modified or added):
“On 6 December 2022 a group of Members tabled a proposal for the General Council to extend the Decision mutatis mutandis to COVID-19 therapeutics and diagnostics2 [footnote: 2 Document IP/C/W/694, Annex]. Other Members preferred to continue fact- and evidence-based discussions on whether there are IP- and TRIPS-related barriers to accessing COVID-19 therapeutics and diagnostics, and on the exact scope of a potential extension of the Decision.
“This means that there is currently no consensus among Members to take a decision under paragraph 8 of the Decision.
“In light of the above, Members agree to continue discussions in the TRIPS Council and to report to the General Council no later than 30 June 2023.”
Paragraph 8 of the decision says members will decide by December 17, 2022 whether or not to expand the waiver for COVID-19 vaccines to diagnostics and therapeutics.
On December 15, members were deadlocked over the report, and the following day, they agreed on a much shorter text that would simply postpone the deadline indefinitely.
December 6, 2022 — Members still showed no sign of a consensus on expanding the waiver to cover patents on therapeutic and diagnostic products, when they met in yet another informal session of the WTO intellectual property (TRIPS) council.
Two new developments:
- the proponents (represented by South Africa) finally supplied a draft text
- the US confirmed it cannot join consensus on expanding the waiver this year, requiring the December 17, 2022 deadline to be extended.
1. The proponents’ draft text, in response to repeated calls from the chair. The key part is just 64 words (Note: MC12 = 12th WTO Ministerial Conference, in June 2022):
“General Council Decision on Extension of the 17 June 2022 Ministerial Decision to COVID-19 Therapeutics and Diagnostics (hereafter referred to as ‘Therapeutics and Diagnostics Decision’)
“The General Council
“Having regard to the 17 June 2022 Ministerial Decision on the TRIPS Agreement, document WT/MIN(22)/30
“Decides as follows:
“The MC12 Decision on the TRIPS agreement is extended mutatis mutandis for the production and supply of COVID-19 therapeutics and diagnostics.
“An eligible Member may apply the provisions of this Therapeutics and Diagnostics Decision until 5 years from the date of this Decision. Any extension of the MC12 Decision on the TRIPS Agreement pursuant to paragraph 6 shall apply to this Decision as well.”
The countries that spoke largely repeated their previous positions.
2. Missing the December 17, 2022 deadline. The US confirmed it still needed time to consult domestically and that it supported a delay. The statement by US Ambassador Maria Pagán echoed the US press release issued a few hours earlier, with a bit more detail.
Several of the waiver’s proponents insisted their draft should be adopted. Countries willing to accept moving the deadline to allow more discussion included China, Singapore and Sri Lanka.
Also:
Taiwan circulated a discussion paper on the implications of adding diagnostics and therapeutics (RD/IP/51, a “room document” not available publicly). It said that the issues involved with diagnostics and therapeutics are more complicated than for vaccines. Several countries that had been seeking more information and discussion welcomed the paper.
WTO Director-General Ngozi Okonjo-Iweala met a group of key delegations before the meeting to take stock. What she heard largely echoed existing positions, said the chair, Ambassador Lansana Gberie of Sierra Leone.
Gberie is drafting a report to the General Council, which is due to meet on December 19–20. If the General Council is to extend the December 17 deadline, or to adopt the text drafted by proponents, it will have to meet to do so on or before December 17. Normally 10 days advance notice is needed.
The next informal meeting is on December 15.
December 5–6, 2022 — The US said on December 6 it would not be able to join a WTO consensus this year on expanding the waiver to cover patents on therapeutic and diagnostic products. It supported delaying the December 17, 2022 deadline, a press release from the Office of the US Trade Representative (USTR) said.
USTR confirmed it has asked the US International Trade Commission (USITC) to investigate “COVID-19 diagnostics and therapeutics and provide information on market dynamics to help inform the discussion around supply and demand, price points, the relationship between testing and treating, and production and access.”
US Trade Representative Katherine Tai said:
“Over the past five months, USTR officials held robust and constructive consultations with Congress, government experts, a wide range of stakeholders, multilateral institutions, and WTO Members. Real questions remain on a range of issues, and the additional time, coupled with information from the USITC, will help the world make a more informed decision on whether extending the Ministerial Decision to COVID-19 therapeutics and diagnostics would result in increased access to those products. Transparency is critical and USTR will continue to consult with Congress, stakeholders, and others as we continue working to end the pandemic and support the global economic recovery.”
Bloomberg broke the news a few hours earlier, citing an anonymous Biden administration source. The USITC investigation could take take nine months to a year, Bloomberg said.
Without the US (and the other sceptical countries — see November 2, 2022 below) consensus on expansion cannot be achieved by the December 17, 2022 deadline.
November 22, 2022 — Little change was reported when the intellectual property (TRIPS) council met informally again. The chair, Ambassador Lansana Gberie of Sierra Leone, said he had held consultations on November 8 and 9, 2022.
South Africa, India, Sri Lanka, Nepal, Nigeria and Indonesia were among those repeating their argument that draft texts are not needed since the mandate is simply to add therapeutic and diagnostic products. The differences described below continue.
The council will meet again informally on December 6 and 15 before the December 17, 2o22 deadline.
November 2, 2022 — With only six weeks to go, an informal meeting of the intellectual property (TRIPS) council saw no change in positions, and no response to the chair’s call for proposals as texts, according to trade sources.
The chair, Ambassador Lansana Gberie of Sierra Leone, repeated that texts are now needed for the negotiations to progress. He said lack of any text was very concerning, according to the the sources. The chair said he would approach individual delegations in the search for areas of possible agreement. South Africa, one of the original authors of the waiver, said it too was talking to other delegations.
Members continued to be split into three broad positions, sources say:
- just extend the waiver to tests and treatments with no additional language or definition — African-Caribbean-Pacific (ACP) Group (Tanzania speaking), Argentina, Bolivia, Egypt, India, Indonesia, Kenya, Pakistan, South Africa, Venezuela, and Zimbabwe
- extend to tests and treatments, but with definitions or lists of covered products — China, Colombia, Costa Rica, Mexico, Uruguay and Taiwan.
- provide evidence that intellectual property protection really does prevent access to tests and therapeutics before agreeing to extending the waiver — Canada, EU, Japan, Korea, Switzerland, Singapore and UK. (See also US, December 5–6, 2022, above.)
The only new document came from Switzerland and Mexico. It looks at supply and demand for diagnostics and therapeutics, including the use of licensing provided voluntarily by patent owners, and how affordable and accessible the products are.
The paper suggests there is little evidence that intellectual property really is an obstacle, and that action is needed to deal with it. Extending the waiver to test and treatments without proper evidence might actually undermine their development, it says.
Switzerland and Mexico asked a number of questions, including why proponents considered extending the waiver to these products is needed when the market is already saturated and shrinking. They noted that no country has used the waiver for COVID-19 vaccines.
The next meeting is scheduled for November 22 followed by December 6 and 15. The deadline is December 17. The chair warned that there would be no point in meeting if members simply repeated their statements.
October 12–13, 2022 — And again, the discussion on this agenda item in the WTO intellectual property (TRIPS) council followed much the same pattern. Details in this WTO website news story. The chair, Ambassador Lansana Gberie of Sierra Leone, urged members to put their proposals in texts.
So far, no member has notified its intention to use the waiver — required under paragraph 5 of the waiver for any country that does intend to use it. Nor has any country notified any changes to its laws or regulations that would allow it to bypass patent rights under the waiver.
The meeting also heard that 28 members still have not ratified the 2005 amendment to the intellectual property agreement allowing compulsory licenses to be used to export pharmaceuticals (the implications are explained here).
October 5–6, 2022 — In the WTO General Council the waiver was one of the items on the agenda. By all accounts the discussion seems to have largely echoed the one earlier in the week in the intellectual property council.
October 3, 2022 — WTO members plan to hold three rounds of informal meetings to discuss expanding the waiver to diagnostics and therapeutics: November 2 and 16, and December 6. A fourth round is also possible on December 15. This was announced by Ambassador Lansana Gberie of Sierra Leone, who chairs the WTO intellectual property (TRIPS) council, at an informal meeting on October 3. The next regular formal council meeting is on October 12–13.
In this meeting, the arguments followed familiar lines. Proponents (South Africa, India, Indonesia, Egypt, etc) again pointed to the large number of patents on diagnostics and therapeutics, the small number of voluntary licences and the limits on access to tests and treatments due to patent monopolies, limited supply and high prices.
Some developed countries (EU, Japan, Switzerland and UK) again called for analysis based on factual evidence to assess any barriers to access created by intellectual property protection.
Rep. Korea, Mexico and Taiwan raised questions such as how to define therapeutics and diagnostics or whether simply to list products, and how to deal with products that have multiple uses such as tests for COVID-19 that are also used for influenza.
September 19, 2022 — WTO members took stock, proponents calling for the talks to accelerate, others calling for more time to analyse the implications and to consult with domestic interests.
The discussion continued along familiar lines. Proponents stressed the difficulty of access to therapeutics and diagnostics, and the strict conditions applying to the two voluntary licences for experimental antiretroviral treatments under the Medicines Patent Pool (Paxlovid and Molnupiravir).
The US, EU and China said they were consulting domestically. Switzerland had a list of questions seeking facts such as on where exactly supply has not been able to meet demand, which companies cannot meet the strict conditions.
July 6, 2022 — The first formal meeting of the intellectual property (TRIPS) council after the waiver was agreed. Some countries argued that the expansion to therapeutics and diagnostics was needed urgently. Others asked for more time to consult domestically. Some called for an analysis based on factual evidence.
For this meeting, a group of proponents — South Africa, India, Pakistan, Indonesia, Egypt and Tanzania — circulated a confidential unofficial “room document”, which has no schedule to be made public, RD/IP/49. See this WTO website news story.
All blog posts tagged intellectual property and WTO waiver
WTO website news archive: intellectual property and COVID-19 and world trade
Main photo collage:
• Test kit | Annie Sprat, Unspalsh licence
• Paxlovid | James Heilman, MD, Wikimedia CC BY-SA 4.0
Other photos:
Lansana Gberie | WTO
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