8 reasons why countries disagree over a WTO intellectual property waiver

What the countries are saying — and it’s more than just ‘yes’ or ‘no’ to the waiver

What they are saying: the deadlock is about more than just whether to ‘waive’ or ‘not’

UPDATES

In February it was “no sign of a breakthrough”. By mid-March there were signs
More in: ‘Quad’ raise hopes of a COVID-19 deal and revival for the beleaguered WTO

The waiver was agreed at the Ministerial Conference on June 17, 2022. The final text is here.

By Peter Ungphakorn
POSTED FEBRUARY 22, 2022 | UPDATED JUNE 18, 2022

The deadlock in the World Trade Organization (WTO) over a proposal to waive intellectual property protection related to COVID-19 is now well into its second year with no sign of a breakthrough.

India and South Africa first made the proposal in October 2020. They produced a revised draft the following May, saying it was based on discussions in the months in between, but the revision produced little change in positions.

The proposal would temporarily waive countries’ obligations under WTO rules to protect some types of intellectual property, for products used to deal with COVID-19.

That’s the general idea. Every part of it is debated.

NEW: WHO’s African ‘hub-and-spokes’ vaccine technology set-up

The proposal is sometimes called the “TRIPS waiver” after the WTO’s intellectual property agreement — trade-related aspects of intellectual property rights.


The proposed waiver is one of three tracks of WTO work on responding to the pandemic.

Two are on intellectual property: the “TRIPS waiver”, and an EU-proposed clarification of WTO rules so countries can use flexibilities in the TRIPS agreement without a waiver.

The third is about trade more broadly, such as removing blocks in supply and in supply chains, improving equitable access to medicines, food and other goods and services, and building resilience.

All WTO material on COVID-19 and trade (but not minutes of meetings) can be found here.

In the WTO, a waiver is a particular type of decision, governed by specific rules (see “jargon buster” below).

As with all WTO decisions, agreement to adopt a waiver requires consensus among the WTO’s whole membership.

This article is an attempt to identify what countries’ positions are and why consensus is elusive, so far at least.

It is largely based on the discussions from May 2021 — when the revision was circulated and the US said it was in favour of a waiver — until the end of the year. (See sources below.)

In that period, WTO members started to dig deeper into the specifics. As a result, some of their positions on the issues became clearer.

(Details of the original basic arguments and the options for dealing with the pandemic are here.)

Continue reading or jump down the page to:

Basic positions | Jargon buster

1. Would a waiver would be counterproductive? | 2. Would waiving patents help vaccinate the world? | 3. Should the waiver only cover patents? | 4. Should the waiver only cover vaccines? | 5. How should the waiver end? | 6. What is missing from the draft? | 7. Is it time to negotiate the text? | 8. Are there alternatives to a waiver?

PS, a ninth reason? | Sources | Meeting dates

Basic positions
The basic positions Back to top

What are countries’ positions in the debate on the waiver? Some are clear. Some are open-minded or ambivalent. To identify some countries’ positions requires interpretation. And not all WTO members have spoken in meetings. (See sources below.)

The latest list of sponsors is clear:

India and South Africa, with the African and least-developed countries groups, plus individually Argentina, Bolivia, Egypt, Eswatini, Fiji, Indonesia, Jordan, Kenya, Malaysia, the Maldives, Mozambique, Mongolia, Namibia, Pakistan, Vanuatu, Venezuela and Zimbabwe.

Individually they are 65 of the WTO’s 164 members:

Afghanistan, Angola, Argentina, Bangladesh, Benin, Bolivia, Botswana, Burkina Faso, Burundi, Cabo Verde, Cambodia, Cameroon, Central African Republic, Chad, Congo, Democratic Republic of the Congo, Côte d’Ivoire, Djibouti, Egypt, Eswatini, Fiji, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Haiti, Indonesia, Jordan, Kenya, Kenya, Laos, Lesotho, Liberia, Madagascar, Malawi, Malaysia, Maldives, Mali, Mauritania, Mauritius, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nepal, Niger, Nigeria, Pakistan, Rwanda, Senegal, Seychelles, Sierra Leone, Solomon Islands, South Africa, Tanzania, Togo, Tunisia, Uganda, Vanuatu, Venezuela, Yemen, Zambia, Zimbabwe.

The current coordinators of the African and least-developed countries groups usually speak in meetings, with individual group members often joining in.

Those that have supported the India-South Africa proposal in the meetings, without becoming sponsors, include:

Cuba, Peru, Jamaica, the Philippines, Taiwan, and Vietnam.

The African-Caribbean-Pacific group supported the original proposal without sponsoring it. But in the July 20, 2021 formal TRIPS (intellectual property) Council meeting, the group was non-committal on the waiver.

Countries opposing the waiver include:

The EU (28 WTO members), Japan, Mexico, Switzerland and the UK.

Somewhere in between are ambivalent countries. Some support the idea of a waiver, but not specifically the India-South Africa version. Some are open-minded or non-committal. Some say they are still studying the proposal. Some are asking for more information.

There’s a big difference between Canada — “Canada can support any consensus-based way ahead in this process, including text-based negotiations” — and Norway, which does not exactly oppose a waiver but has specifically objected to the “broad coverage” of the draft and how the duration is left open-ended.

This group includes:

Australia, Brazil, Canada, Chile, China, Colombia, El Salvador, Hong Kong, Rep. Korea, New Zealand, Norway, Russia, Singapore, Taiwan, Turkey, Ukraine and the US.

The nuances mean that some arguments overlap. For example various members — including those that are open to a waiver — argue that equitable access to vaccines and therapeutics can be achieved while using intellectual property protection as an incentive to innovate and to license technology transfer. They include: Brazil, Chile, Colombia, the EU, Japan, Mexico, Switzerland, the UK and the US.


JARGON BUSTER

TRIPS — trade-related aspects of intellectual property rights.

TRIPS flexibilities — leeway given to governments under the TRIPS Agreement to override some intellectual property rights, usually for patents. Includes research, “government use” and …

compulsory licensing — when a government allows someone else to produce a patented product or process without the consent of the patent owner. For patents in any field, not just pharmaceuticals. Conditions apply.

Waiver — in the WTO, a decision to waive some obligations temporarily under WTO agreements. The TRIPS waiver would allow countries to suspend protection of some intellectual property rights. They would not be obliged to do so — it’s their choice. See Articles 9.3 and 9.4 on waivers in the WTO Agreement.

Consensus — “no one says no.” Decision-making principle in the WTO, where an agreement is reached when there are no more objections. Although voting is allowed it’s never used. Explained here.

In other words, the deadlock is not just about whether to waive the rules or not. If only it were that simple.

Crucially, it is also about what the waiver should cover (its “scope”). It’s about the actual text that India and South Africa put on the table.

The deadlock remains, with no sign of movement, but towards the end of 2021 delegations said the tone of their private discussions was more positive.

This is partly because countries were more willing to discuss the waiver in parallel with the two other tracks, ending months of bickering over whether the waiver should be the priority.

In December 2021, WTO Director-General Ngozi Okonjo-Iweala tried to broker a breakthrough by arranging an online meeting of four key ministers, from the EU, India, South Africa and the US. This and what appear to be subsequent meetings (no dates have been given) produced no visible movement either.

Several delegations (such as Australia, Japan, Switzerland and the UK) said in formal and informal meetings of the WTO intellectual property (TRIPS) and General councils that they supported the move so long as the process was transparent and involved the whole membership.


This summary takes countries’ statements at face value because these are serious arguments. We can always challenge their sincerity, but that cuts both ways

In the General Council on February 24, Switzerland, the UK, Japan, Russia and Indonesia objected to the lack of information coming from the the meetings of the four, WTO spokesman Keith Rockwell said.

That concern was repeated by the African Group, Switzerland and the UK in the TRIPS Council on March 9, 2022. (The role of small groups in “concentric circles” is discussed here.)

In January 2022, India proposed a different tack, an online meeting of ministers from the whole of the WTO. The proposal fell well short of consensus support.

Interestingly and away from the WTO, the Biden administration has set up a “Quad Vaccine Partnership” (see also the dashboard) with four countries spanning the full spectrum of opinions on the waiver — Australia, India, Japan and the US — perhaps to rival China’s vaccine push in east Asia.

This summary takes countries’ statements at face value because these are serious arguments. We can always challenge countries’ sincerity, but that cuts both ways.

If one side can be accused of simply yielding to the power of money and the big pharmaceutical companies, the other side can be questioned for proposing a text that clearly stands little chance of being agreed (for example on how the waiver would end). Ulterior motives are not discussed here.

1. Would a waiver be counterproductive?
1. Would a waiver would be counterproductive? Back to top

This is where countries disagree about any form of waiver — whether it’s a good idea at all. Pro-waiver countries say it would unblock an obstacle that manufacturers around the world face, particularly when the owners of intellectual property are unwilling to share their technology, either at an affordable price or for free.


The share of the population that has received at least one vaccine dose is almost 7 times higher in high-income countries than in low …

Anabel González
WTO deputy director-general

Waive protection for intellectual property and it will be easier to reproduce COVID-19 products and reduce global inequalities in tackling the pandemic, the argument goes.

Opposing countries counter that protecting intellectual property helps to encourage invention and produce new vaccines and medicines. Without it, fewer new products would be available. They say present intellectual property rules do not hinder access to vaccines and other medicines. They also argue that the waiver would make technology transfer more difficult because companies would be reluctant to share unprotected trade secrets.

The debate is complex. It includes how protecting intellectual property compares with other incentives, whether the protection makes drug companies earn unjustifiably large profits, and how protection for private companies can be justified when inventions are developed from publicly-funded research in academic laboratories.

In the past, when countries have negotiated on intellectual property and health in the WTO, they have aimed to strike a balance between different objectives. On the proposed waiver, they are nowhere near agreeing where the balance lies.

Which countries take which view on this? See the basic positions above.

2. Would waiving patents help vaccinate the world?
2. Would waiving patents help vaccinate the world? Back to top

The main point here is that COVID-19 vaccines are complex involving multiple ingredients and complicated biological processes.

The recipe: to make a vaccine, but it still needs know-how | Chad Bown and Thomas Bollyky, details below
The recipe: to make a vaccine needs know-how | Chad Bown and Thomas Bollyky

That complexity is reflected in the multiple patents that apply to each vaccine.

Chart 4 on vaccine patent families from the Chiang and Wu paper
Multiple patent families: complex products and processes mean complex patents | Ting-Wei (Alex) Chiang and Xiaoping Wu

Ten of the main COVID-19 vaccines involve between one and 23 “patent families”, according to a new WTO staff working paper.


On February 3, 2022, Nature reported that South African scientists had successfully copied Moderna’s mRNA COVID-19 vaccine. This was achieved without a WTO waiver because the scientists used publicly available information and Moderna said it would not enforce its patents — in effect Moderna voluntarily waived its own patents.

Still in early stages, the breakthrough would take some time to turn into industrial scale production, and before completing the trials needed for the vaccine to be approved medically and marketed.

See: WHO “hub-and-spokes” programme
Also: analysis by Priti Patnaik (Geneva Health Files), Alan Beattie (Financial Times.)

(“Patent families” is a phrase used to group several patents or patent applications for the same or similar technical content. For example, for various reasons, a single invention can be patented in slightly different ways in different countries. That would count as one patent family.)

The sceptics say that even without patent protection, companies in most developing countries would struggle to reproduce the vaccines.

This is partly because of the complexity and partly because the drug companies are reluctant to hand over their technology secrets without proper licensing arrangements.

For many countries, the quicker and more effective solutions lie in other ways to expand production globally.

Examples include: pressure on the pharmaceutical companies to share their technology, donations from richer countries, international-scale purchasing such as by COVAX, and other arrangements such as pooling patents.

Which countries take which view on this? Again, see the basic positions above.

3. Should the waiver only cover patents?
3. Should the waiver only cover patents? Back to top

Proposed intellectual property coverage: Patents are not the only type under discussion. The proposal would waive the obligation to protect copyright, industrial designs, patents and trade secrets and to enforce protection, where related to the pandemic.

For example, protecting industrial designs has implications for equipment such as respirators.

(In case there’s any doubt, movies and music played to help people in lockdown or for COVID-19 patients would still be protected by copyright.)

The US’s support for a waiver covers “intellectual property protections” for vaccines, apparently without identifying which protections.

Some other countries have said the proposal is too broad, without going into details. They include Hong Kong and Norway.

The proposal’s sponsors have defended their position on this and other subjects in a 9-page document circulated on September 30, 2021.

Trade secrets (“undisclosed information”): This type of intellectual property is linked to technology transfer. The WTO agreement requires trade secrets to be protected against anyone acquiring, disclosing or using them without their owners’ permission.

Test data and other information submitted to governments in order to obtain marketing approval for new medicines (or agricultural chemicals) must also be protected against unfair commercial use and disclosure.

India, South Africa and their supporters argue that protection for trade secrets must be waived in order to allow others to use the technology.

Switzerland says removing protection for trade secrets would be counterproductive because it would discourage companies from sharing their technology. It advocates voluntary arrangements that include confidentiality agreements.

The EU argues that a waiver on trade secrets would only remove minimal penalties (“remedies”) against misappropriation and would not necessarily lead to companies disclosing their confidential information. Nor would the waiver itself allow a government to force companies to hand over the information — that is outside the scope of intellectual property law, the EU says.

It adds that WTO rules already allow some flexibility on “regulatory data” (used to authorise putting a product on the market) “where necessary to protect the public”, which the EU itself has used.

The proposal’s sponsors have defended their position on this and other subjects in their September 30,2021 document (see paragraph 35).

> More: the draft on coverage, with assessment

4. Should the waiver only cover vaccines?
4. Should the waiver only cover vaccines? Back to top

Australia, China, Colombia, New Zealand, Taiwan and the US say any waiver should only apply to vaccines.

That would rule out other products related to COVID-19 such as antivirals and other therapies, protective clothing and masks, diagnostic and testing kits, ventilators, and other equipment.

The proposal’s sponsors say those other products should also have intellectual property protection waived. They have defended their position on this and other subjects in the September 30,2021 document.

> More: the draft on coverage, with assessment

5. How should the waiver end?
5. How should the waiver end? Back to top

On the waiver’s duration, India and South Africa have drafted a text that few observers believe will be accepted. The draft proposes an initial period of three years, which would be extended unless the membership agreed to terminate it.

Since decisions are by consensus, it would take only one country to prevent termination — one country out of 164 wanting to continue with the waiver would be enough to keep it going because there would be no agreement to terminate it.

Some delegations described this as a blank cheque to waive forever the various provisions in the WTO’s intellectual property agreement.

Countries questioning this provision include: Hong Kong, Norway and the US as well as those opposing the waiver. They want the sponsors to explain how the proposed wording on duration complies with WTO rules that require a waiver to have a precise end date (“shall state … the date on which the waiver shall terminate”, says Article 9.4 of the WTO Agreement).

The proponents argue that they are not trying to create a permanent waiver. They have not clarified how this could be prevented.

In their September 30,2021 document, the sponsors say in section 5 that the drafted duration is justified because it is not possible to know in advance when the conditions that require the waiver will cease to exist. The paper does not address the question of needing a consensus to terminate the waiver.

> More: the draft on duration, with assessment

6. What is missing from the draft?
6. What is missing from the draft? Back to top

These are sometimes grouped under “implementation” — how the waiver would be implemented. Several of the topics are related:

Transparency: This is one of the WTO’s fundamental principles. Countries wanting to use the waiver would currently have laws and regulations that comply with the WTO obligation to protect intellectual property. To use it they would have to change their laws and regulations. WTO rules already require them to notify each other through the WTO when new or amended laws are introduced. The discussion on the proposed waiver has included questions about identifying the steps to be taken domestically.

A previous waiver has additional transparency conditions: countries using the waiver have to notify the WTO membership each time a product benefits from the waiver. Sponsors of the latest proposal say the requirement is “onerous”, a claim that some other countries reject.

In the present discussions, some countries have started talking about notifications when the proposed waiver is applied, wholly or partially.

Legal certainty: This is about owners of patents and other rights knowing with some certainty what happens to their intellectual property when the waiver is implemented and after it is terminated, not least because legal systems vary among WTO members. Some countries such as Chile, Mexico, Norway, Singapore, and the United Kingdom say questions on the subject are still unanswered.

Transparency also plays a part here. Brazil has linked transparency to “a sufficient level of legal certainty for stakeholders, so that we do not unreasonably disrupt collaboration efforts.”

One of the questions is whether new inventions made while the waiver applies could be protected after the waiver expires. Dealing with this could involve complex drafting.

Products ending up where they’re not supposed to. The question arises if a product benefiting from the waiver, from a country that applies it, is exported to one that has chosen not to, or only applies the waiver partially.

A previous waiver required countries to use distinctive packaging for products supplied under the wavier, so that they could be spotted if they ended up on the wrong markets. The discussion about this has only just started.

> More: the draft on transparency and other conditions, with assessments

7. Is it time to negotiate the text?
7. Is it time to negotiate the text? Back to top

Moving to “text-based” discussions is a rite of passage in WTO negotiations. It takes the talks away from generalities and principles, and towards a more mature phase with a possible outcome in sight.

This is no guarantee that agreement will be reached; many text-based negotiations still end in deadlock. But countries opposing the waiver may not want to be seen to endorse it as an objective by agreeing to negotiate a text.

Those calling for talks based on the text include the present draft’s sponsors and allies such as Sri Lanka. Those prepared to work on the text (some of them ambivalent about the present draft, others about any form of waiver) include: Australia, Brazil, Canada, China, New Zealand, Norway, Taiwan, Ukraine and the US.

The US’s line all along has been to call for a pragmatic text that is likely to be agreed by all members. In mid-2021 it also said members should clarify the objectives and the envisaged timeline before looking at details such as what the waiver should cover.

Those saying issues need to be sorted out before going through the text — such as how a waiver would improve access — include the EU, Rep. Korea, Switzerland and the UK.

Back in June and July 2021, Chile, El Salvador, Hong Kong, Mexico, Russia, Singapore and Turkey said they were willing to proceed but wanted to know more about the scope and duration envisaged in the draft. They also wanted more time to analyse the proposal. It’s unclear if their positions have changed since then.

8. Are there alternatives to a waiver?
8. Are there alternatives to a waiver? Back to top

The EU is spearheading the argument that the current flexibilities in the WTO agreement offer enough leeway for governments to tackle the problem. It proposes various means to streamline their use. (See press release and linked material, paper, and draft declaration.)

The flexibilities allow governments to bypass some patent rights including through compulsory licensing — so that others can reproduce an invention under licence even if the patent-owner does not agree, but with some conditions.

Brazil has said it is willing to discuss reforming the WTO intellectual property agreement so that flexibilities can be used more easily, as proposed by the EU.

Switzerland and the UK argue that voluntary collaboration in research and development and to expand production of vaccines and medicines is the best way to meet the challenge of the pandemic under WTO rules. They point to innovative ways of sharing technology voluntarily that is being developed globally through hubs of mRNA technology used in vaccines.

The waiver’s sponsors say this is not enough: the flexibilities are too difficult to use, and voluntary collaboration has not removed inequalities in access to vaccines and other products.

Note that these flexibilities only apply to patents. They do not apply to copyright, industrial designs and trade secrets.


PS, a ninth reason? On February 4, 2021, Priti Patnaik of Geneva Health Files reported that the US had proposed excluding India and China from the waiver because they are major manufacturers, or to limit the its use only to Africa. She said India would not accept the idea, which would make this a ninth reason why there is no consensus on the waiver.

So far the report has not been confirmed.


See also: all blog posts on the WTO waiver | suggested reading

9. SOURCES
Sources and meetingsBack to top

The positions described above are based on what the delegations said in 2021, from May (when the revised draft was circulated) to December (the latest available information at the time of writing). Their statements in formal intellectual property (TRIPS) council meetings is recorded in the minutes (some are still restricted). Accounts of their positions in informal meetings of the full membership, and formal meetings whose minutes are still restricted, are according to officials in Geneva. The information may be incomplete, but the main positions are on the record.

The formal meetings’ minutes are in two parts. A main document (such as IP/C/M/100), contains the essential information, particularly statements from the chair. It typically includes lists of the delegations that spoke without recording what they said. For most meetings, an additional document (“addendum” ending with something like “Add.1”, such as IP/C/M/100/Add.1) contains the delegations’ statements in full. All TRIPS Council minutes are here. All minutes are derestricted after a few months. (IP = intellectual property. C = council. M = minutes. 100 = running number).

Part of the debate has been in the General Council. Its minutes are documents in the WT/GC/M/* series. On the TRIPS waiver, what members said is similar to their statements in the TRIPS Council. The relationship between the two councils can be seen in this organigram.

Meanwhile, the WTO’s website has news of the formal meetings, covering the chair’s statements and the main points of the debate among members. The website’s gateway page on COVID-19 and trade contains links to a large amount of information on the subject, including papers members have circulated. It does not have links to the minutes of meetings.


Meeting dates Back to top
2021
  • December 16, 2021 (formal) from October 13–14, November 5, 18, 29. Minutes (IP/C/M/103) still restricted | Statements (IP/C/M/103/Add.1) not circulated yet | WTO website news
  • December 2021 (bilateral meetings and small group consultations, including ministers from South Africa, India, US and EU with the WTO Director-General. See December 16
  • November 29, 2021 (formal) from October 13–14, November 5, 18, continued December 16, WTO website news
  • November 18, 2021 (informal/formal) from October 13–14, continued November 29 and December 16, WTO website news
  • November 5, 2021 (informal) (WTO website news on a formal decision, not the waiver)
  • October 13–14, 2021 (formal) continued on November 5, 18, 29 and December 16 | WTO website news
  • October 4, 2021 (informal/formal) minutes | no separate statements
  • September 23 and 29, 2021 (small group meetings)
  • September 14, 2021 (informal)
  • September 2021 (“contacts” between members in first two weeks)
  • July 20, 2021 (formal) minutes | statements (IP/C/M/101/Add.1) still restricted | WTO website news
  • July 14, 2021 (informal)
  • July 6, 2021 (informal)
  • July 5, 2021 (small group consultation)
  • June 29-30, 2021 (informal)
  • June 29, 2021 (formal) minutes | statements | WTO website news
  • June 24, 2021 (informal)

June 18, 2021 EU draft declaration circulated (IP/C/W/681)

  • June 17. 2021 (informal)
  • June 8-9, 2021 (formal) continued on June 29 | WTO website news
  • June 4, 2021 (informal)

June 4, 2021 EU proposal on existing flexibilities circulated (IP/C/W/680) (also WT/GC/231 for the General Council)

  • May 31, 2021 (informal)

May 29, 2021 Revised draft waiver text circulated (IP/C/W/669.Rev1)
May 5, 2021 US announces supportfor waiving intellectual property protections for COVID-19 vaccines

2020

October 2, 2020 Draft waiver text circulated (IP/C/W/669)


Updates:
June 18, 2022 — adding a link to the final agreed waiver in the updates box
February 26 and March 10, 2022 — adding comments in the February 24 General Council and March 9 TRIPS Council on the meeting of four delegations

Image credits:
● Hypodermic | Diana Polekhina, Unspalsh licence
● Vaccine production chart | Chad Bown and Thomas Bollyky: Here’s how to get billions of COVID-19 vaccine doses to the world, Peterson Institute for International Economics (PIIE). Reproduced with permission
● Vaccine patents chart | Ting-Wei (Alex) Chiang and Xiaoping Wu: Innovation and patenting activities of covid-19 vaccines in WTO members, WTO Staff Working Paper

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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