This morning, 17 June at 5 AM the 12th World Trade Organization (WTO) Ministerial Conference (MC12) approved a package of decisions and declarations. The Ministerial Conference took place in Geneva, Switzerland 12-16 June; negotiations were extended a day to allow more time to come to an agreement. The agreed package includes a Ministerial decision on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement aka the “TRIPS Waiver”. It took a year and a half of intense discussions to reach this result on the TRIPS issues.
This Decision is no longer a TRIPS waiver in the sense it was proposed by South Africa and India in October 2020, which was a more comprehensive waiver of TRIPS obligations to be able to produce and access Covid-19 countermeasures. The broad waiver characteristics were lost when the EU’s counter-proposal from October 2021, which was centred around using the existing TRIPS flexibility of compulsory licensing, became the core of the draft that was put in front of the ministers to work with this week. We commented on that draft here.
The Decision that is now adopted allows an eligible Member of the WTO to use a patent related to vaccine technology without the consent of the right holder (compulsory licence), using any national legal mechanism such as an executive order, emergency decree, government use authorisation or judicial or administrative orders. This may make the issuing of a compulsory licence easy and swift and will help the few countries that currently do not have workable compulsory licensing mechanisms, but it does not substantively expand the legal space countries already have under TRIPS.
The following issues were still up in the air at the start of the MC12 and are now resolved:
Footnote 1 clarifies that developing country Members of the WTO are eligible to use the Decision, but strangely enough, also aims at excluding countries with “existing” production capacity by encouraging them to make “a binding commitment not to avail themselves of this Decision”. Those are the countries that are most likely to be able to put the decision to work, including those working with the World Health Organization (WHO) mRNA vaccine technology transfer hub. The consequences of this limitation could even be more serious if and when the decision is expanded to include therapeutics and diagnostics. This raises the question: Will the extension to treatments and diagnostics be subject to “binding commitments” of countries with existing capacity to manufacture not to avail themselves of the Decision? The consequence of that could be far-reaching. From a public health point of view, the ideal is that the countries with production capacity would make full use of the new mechanism (and any other TRIPS flexibility) and be able to swiftly manufacture and export pandemic countermeasures.
Subject matter of a patent
Footnote 2 offers a useful improvement because it specifies that the subject matter of a patent for the purpose of this decision includes ingredients and processes.
Waiving TRIPS Art. 31(f)
Paragraph 3 (b) is the tiny bright light of the Decision, waiving the requirement that production under the Decision has to be predominantly for the domestic market. It is important that this export restriction is dropped without having to use the unworkable Article 31(bis).
Par 3(c) discourages the re-exportation of products that have been supplied under this decision. This is not helpful in efforts to combat a pandemic and where regularly vaccines are sent from one place to another.
In contrast, the remuneration paragraph 3(d) does refer to the humanitarian and not-for-profit nature of vaccine supply and leaves flexibility to determine the level of royalties payable. It is useful that footnote 4 directs Members to the WHO/United Nations Development Programme (UNDP) remuneration guidelines for that purpose.
Paragraph 4 states the obvious, namely that TRIPS Article 39.3 does not contain an obligation on Members to instate a data exclusivity regime whereby the originator company is granted monopoly use of registration data for a certain period of time. While it does not change anything in the status quo it is helpful to remind Members of it.
Paragraph 6 specifies that the duration of the mechanism may be applied for the next 5 years. For mounting vaccine production facilities, this is still a relatively short period. This term will be reviewed and may be reviewed by the General Council annually.
The Decision as it stands only concerns vaccines, while it would have been most useful for therapeutics and other health technologies. Waiving IP rights on vaccines is unlikely to be all that is needed to facilitate their development and production; know-how transfer is also necessary. Other health technologies are still excluded from this Decision, but Members made a commitment in Paragraph 8 to decide within the next six months whether to extend its scope to include the production and supply of therapeutics and diagnostics. Therefore, it will be important for eligible countries with production capacity to avoid committing to not avail themselves of the Decision as they are encouraged to do in footnote 1.
Let’s not forget that the waiver discussions at the WTO have their origins in the refusal of companies such as Pfizer and Moderna to share their Covid-19 vaccine manufacturing IP, technology, and know-how, including with technology sharing platforms such as the WHO Covid-19 Technology Access Pool and the Vaccine Technology Transfer Hub.
DG Ngozi Okonjo-Iweala said at the closing press conference when commenting on the TRIPS Decision: “Now we have something in hand. Exciting to now be able to go to those factories that are being set up all over the developing world and to work with them and to see how this can actually be made real.”
If the TRIPS Decision contributes to nudging the companies to share the IP and manufacturing know-how in the future necessary to produce important medicines and vaccines it may not all have been in vain. But we are scraping the barrel now.