Summary of September 28, 2023 comments to the TRIPS Council On Paragraph 8 Of The Ministerial Decision On The TRIPS Agreement
James Love
Knowledge Ecology International (KEI)
The June 17, 2022 decision on the TRIPS Agreement and COVID-19 vaccines was very narrow. It was a temporary, conditional waiver of Article 31.f of the TRIPS Agreement, which provided additional but limited flexibility on exports under a non-voluntary authorization to use patented inventions. The decision only applied to one virus, only to vaccines, is temporary, and attached conditions.
In the decision, the WTO limited eligibility to developing countries, for both importing and exporting, subject to further opt-outs. This condition limits the ability of vaccine manufacturers to benefit from economies of scale and importers’ ability to engage with many potential suppliers. There were some clarifications issued regarding the decision, but in the nature of restating existing flexibilities in the TRIPS Agreement. The decision did not address IP or investment provisions in bilateral or plurilateral agreements, nor did it deal with access to know-how protected in Article 39.2 of TRIPS. The decision has not been used by WTO members.
Despite its limitations, the decision does have some potential value, particularly for therapeutics, where the regulatory pathway is less challenging than is the case for vaccines, and where there is a robust and promising pipeline, including both new and repurposed drugs. Negotiators should also consider that for example, in HIV, HCV, and other diseases often combination treatments are more effective. There can be patent challenges even for testing combination products given the terms of some voluntary licensing agreements, such as the Pfizer license for Paxlovid.
Negotiators should also reflect on the contrasts between the narrow and limited June 17, 2022 decision and what measures high-income countries enacted in their domestic legislation in 2020 and 2021, and are continuing to do today. In the Spring of 2020, Canada and Germany created very broad exceptions to patent rights for emergencies, exceptions that were not limited to vaccines. The United States issued dozens of contracts with FAR 52.227-1 authorization and consent clauses, giving Merck, Sanofi, Lilly, Moderna, Novavax, Siemens, Philips, Quidel, and others the freedom to use any US government-issued patents, to make and sell a very diverse set of countermeasures.
Today the European Commission has proposed legislation for exceptions to intellectual property rights that include multi-country compulsory licenses, exceptions to rights in test data, a cap on royalties of four percent of the generic price and the ability to compel the sharing of manufacturing know-how or other complementary measures. The EU’s proposed exceptions will be permanent, not limited to particular diseases or viruses, and will apply to all countermeasures.
As an alternative to extending the extremely limited June 17, 2022 decision, WTO members should consider new exceptions and other measures more in line with the ambitions of the current European Commission’s proposal on compulsory licensing.
Links and references:
- COM(2023)224 – Proposal for a regulation of the European Parliament and of the Council on compulsory licensing for crisis management and amending Regulation (EC) 816/2006.
- FAR 52.227-1 Authorization and Consent. https://www.acquisition.gov/far/52.227-1
- German Government Plans Possibilities to Limit Patents In View of Corona Pandemic Thomas Musmann (Rospatt Osten Pross)/March 24, 2020. https://patentblog.kluweriplaw.com/2020/03/24/german-government-plans-possibilities-to-limit-patents-in-view-of-corona-pandemic/
- Governmental Use of Patented Inventions during a Pandemic: A Global Survey, April 16, 2020. Norton Rose Fullbright. https://www.nortonrosefulbright.com/-/media/files/nrf/nrfweb/knowledge-pdfs/governmental-use-of-patented-inventions-during-a-pandemic.pdf
- KEI Briefing Note 2022:3: Selected differences between Article 30, 31 and 44 of the WTO TRIPS Agreement as regards non-voluntary use of patented inventions.
- KEI Research Note 2023:2. Examples of US agency uses of FAR 52.227-1.
- BIO COVID-19 Therapeutic Development Tracker, https://www.bio.org/policy/human-health/vaccines-biodefense/coronavirus/pipeline-tracker
This is the slide deck used on 28 September 2023.