UPDATES: expanding the WTO intellectual property waiver for COVID-19

Latest developments with links to some key documents and news

Collage of COVID-19 test kit and Paxlovid triple pills

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By Peter Ungphakorn

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. It includes 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 will be added here for the latest developments, with links to new documents and news items.

(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)

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.

Photo of Lansana Gberie, chair of the WTO TRIPS Council
Gberie | WTO

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

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


Author: Peter Ungphakorn

I used to work at the WTO Secretariat (1996–2015), and am now an occasional freelance journalist, focusing mainly on international trade rules, agreements and institutions. (Previously, analysis for AgraEurope.) Trade β Blog is for trialling ideas on trade and any other subject, hence “β”. You can respond by using the contact form on the blog or tweeting @CoppetainPU

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