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By Simon Lester in Non-Violation Nullification or Impairment, Trade and Intellectual Property —

The Future of the TRIPS Agreement Non-Violation / Situation Complaint Moratorium

One of the things that didn't get done at MC14 was the adoption of a Ministerial Decision to extend the moratorium on TRIPS Agreement non-violation and situation complaints. As explained by the WTO DG, this issue will now be part of the continued work in Geneva.

As a result of these developments, the moratorium has, for the moment, expired. Does that mean we are about to see a flood of TRIPS non-violation – or the even less well-known situation – complaints? As much fun as that would be in various ways, I doubt it, and I think the following may help explain why.

At the WTO General Council meeting in December, the moratorium was discussed by various governments, including two that appear to have particularly strong views. Colombia put the issue on the meeting agenda, and made its case for continuing the moratorium:

26.4. In our daily conversations with other WTO delegations, the intellectual property moratorium seems somewhat strange and overly technical, but the fact is that it is a recurring WTO decision that has significant effects on our economies and, in particular, on the health of our populations.

26.5. Allow me to explain the matter briefly. In general, disputes in the WTO involve a country's allegations that a country has violated an agreement or broken a commitment. But in some situations, a government can go to the Dispute Settlement Body even when an agreement has not been violated.

26.6. This is called a non-violation complaint. It is allowed if one government can show that it has been deprived of an expected benefit because of another government's action, or because of any other situation that exists. Non-violation complaints are possible for goods and services, but not in the field of intellectual property. At the time of the negotiation of the Marrakesh package, Members decided not to allow these non-violation disputes under the TRIPS Agreement. Why?

26.7. In what situations could non-violation complaints based on the TRIPS Agreement pose a problem? Various scenarios are conceivable and the Secretariat made a list of them 10 years ago, but one stands out: price controls on medicines.

26.8. All our countries have policies to control medicine prices – all of them. For example, as I remarked at a previous General Council meeting, one economically advanced country used price controls to slash the monthly cost of insulin for patients with diabetes from USD 400 to USD 35. We thought this was wonderful, because it clearly improved access and many patients with diabetes surely benefited.

26.9. One could claim that, even if patent protection is observed and even if the intellectual property protection system is in order and working properly, price controls nullify or impair the expected benefits from a patent.

26.10. It is as simple as that – an enormous risk that no-one has wanted to take since 1995. This discussion is taking place in the TRIPS Council and remains unresolved. It is very important for this decision to not allow non-violation complaints to be renewed in Cameroon and to be made permanent once and for all, as the risks to our economies and budgets are the same now as they were in 1995, and as they will be in the future.

For Colombia, allowing non-violation complaints under the TRIPS Agreement risks undermining established and widely used health policies such as price controls for medicines.

In response, the U.S. argued for letting the moratorium lapse and allowing non-violation and situation complaints in the TRIPS context:

26.13. The United States' position on this issue remains unchanged. We reiterate our support for allowing the current moratorium to expire so that Members may bring non-violation and situation complaints in the future, as appropriate.

26.14. The United States has provided detailed and extensive analysis in each of our statements under this item over the past several years. We have explained the legal basis for non-violation and situation complaints in the GATT and TRIPS Agreement texts, the extensive safeguards that exist to protect Members' rights and obligations under the TRIPS Agreement, and concrete descriptions regarding how such disputes would work in practice.

26.15. As we have detailed in past interventions, non-violation and situation claims have a long lineage in the WTO and in international trade. The availability of such claims under the WTO agreements is the rule; their non-application is the exception. The TRIPS Agreement moratorium is the exception.

26.16. We continue to believe that WTO Members are being deprived of an important tool to enforce their rights under the TRIPS Agreement, which is why we support the expiration of the current moratorium so that complaints of this type might be brought under the TRIPS Agreement.

26.17. While we remain of the view that the text of the WTO agreements provide Members with sufficient guidance on the application of non-violation and situation complaints under the TRIPS Agreement, the United States remains open to considering specific proposals from Members wishing to further examine the scope and modalities for complaints of these types.

In reaction to these arguments, I have a couple questions and comments.

First, what are the chances of a complainant winning a non-violation complaint under the TRIPS Agreement? Colombia mentions price controls on medicines as a measure that might be targeted, and if we apply the conventional non-violation elements, it seems to me that a complaint against these price controls might be tough to win. As the Japan - Film panel explained in discussing one of the key elements of a GATT non-violation claim:

10.76 ... in order for expectations of a benefit to be legitimate, the challenged measures must not have been reasonably anticipated at the time the tariff concession was negotiated. If the measures were anticipated, a Member could not have had a legitimate expectation of improved market access to the extent of the impairment caused by these measures.

My sense is that price controls on medicines are widely used, and therefore they shouldn't come as a surprise to other Members. Arguably, then, any price controls should have been anticipated. Could there be a particular type of price control that could not have been reasonably anticipated? It's possible, I guess, but I'm not sure what that would be.

Second, building on the first point to some extent, what purpose do non-violation complaints serve these days, either in the TRIPS Agreement or other contexts? In the early years of trade agreements, these agreements could have been seen as "incomplete," and the non-violation remedy may have been useful for circumstances in which a particular issue was not covered by the agreement. Today, by contrast, aren't the WTO agreements in general, as well as the TRIPS Agreement in particular, fairly "complete" in terms of their scope as a contract? Arguably, these agreements establish a comprehensive regime for what is permitted and what is not, and there is no need to supplement this regime with the non-violation remedy as a gap-filling tool.

In terms of specific examples of circumstances where the governments who support the non-violation remedy would like to see it applied under TRIPS, Colombia pointed to a Secretariat note from 10 years ago. I see this note from 2012, which may be what they meant (although there could be another note that I couldn't track down on WTO docs online). But even with these examples, at this point the scope and implications of such a remedy are fairly speculative, as we just don't have any practical experience with using it. It's very hard to say how a WTO panel would apply it.

As to what's coming next, my best guess is that we will see the moratorium extended at some point, providing a bit more certainty here. But even without the extension, I doubt we are likely to see any complaints. Note that the U.S., which is one of the biggest proponent of the remedy, hasn't filed any WTO complaints at all since 2019. On the other hand, U.S. Trade Rep. Jamieson Greer recently talked up the non-violation remedy, so maybe it could actually happen? I would bet against it though.

Law prof Daniel Gervais also has a post on the failure to extend the moratorium: "The TRIPS non-violation moratorium has expired: What happened in Yaoundé, and what comes next." For those looking for more background on these issues, you can check out the discussion at recent TRIPS Council meetings: November 2025; June 2025; March 2025; November/December 2024; July 2024; April 2024; October 2023/February 2024; June 2023; and March 2023. Other resources for people who want to dive deeper are: