Brussels, 16 January 2024 – Doctors Without Borders/Médecins Sans Frontières (MSF) supports the proposed Union compulsory license (CL) that is currently being reviewed by the European Parliament, and soon by the European Council. Compulsory licenses are important public health safeguards that can enable wider production and access to more affordable medical products for everyone who needs them. The Union CL would allow for cross-border collaboration of production and supply in the European Union (EU) so that, for example, multiple EU member states could share the production of medical products regardless of patent barriers.
However, the Union CL draft proposal contains language prohibiting the exportation of products produced under the CL, allowing their supply and use only within EU countries. This is against the flexibilities enshrined under Article 31(f) of the World Trade Organization (WTO) TRIPS Agreement, which allows for a non-predominant part of products produced under a CL to be exported to other countries. Including such a flexibility in the Union CL proposal would promote global access to medical tools and be especially useful during international health emergencies. Although the Union CL proposal includes an exception that does allow for it to be used exclusively for exports, this is through a cumbersome procedure and does not allow for the Union CL to be used to supply both EU countries and countries outside of the EU at the same time, should the need arise. This is problematic, as use of a Union CL would likely be triggered by a situation that would also affect countries outside of the EU, either in the region or globally.
The export prohibition contradicts the EU’s own position at the WTO and the WTO TRIPS COVID-19 declaration that called for due restraint in the imposition of export restrictions on essential medical goods, as well as the European parliament resolution on lessons learned from COVID-19.
Dimitri Eynikel, EU Policy and Advocacy Advisor, MSF Access Campaign:
“MSF calls on the European Parliament and Council to remove the export prohibition from the Union compulsory license proposal and instead align the proposal with the WTO TRIPS Agreement by incorporating the flexibility under Article 31(f), as earlier proposed by the European Parliament Trade Committee.
“Lessons from COVID-19 stress the imperative for a united, equitable response to major health emergencies that transcend borders and ensure access to medical tools for everyone, everywhere, as the EU recognised when exporting COVID-19 vaccines outside of the EU during the pandemic. The export prohibition in the Commission's proposal would hamper the EU’s effective response to global emergencies, potentially prolonging crises and fostering global inequity.
“We therefore strongly urge the European Parliament and Council to lift the language prohibiting exports in the Union compulsory license proposal, as flexibility for export can significantly enhance access to medical products for people in countries that have limited or no manufacturing capacity.
“With this Union compulsory license proposal, the EU will be better prepared to handle future health emergencies. However, if the EU hopes to better handle regional and global health emergencies, it must remove the export prohibition so to ensure that the global disparities witnessed during the COVID-19 pandemic – when certain countries and some of the world’s most vulnerable people were at the back of the queue for accessing vaccines, tests, and treatments – are not repeated."