On 30 December 2025, the regulation on compulsory licensing for crisis management, amending Regulation (EC) No 816/2006, was published in the Official Journal of the European Union.
The new regulation establishes an EU-level framework to grant compulsory licences in clearly defined cross-border crisis or emergency situations. It allows the Commission to issue an EU-wide compulsory licence for the use of a protected invention related to crisis-relevant products, once a crisis or emergency has been declared or activated under the relevant EU crisis instruments.
Compulsory licensing under the regulation is designed as a measure of last resort. Its use is subject to strict conditions and safeguards, including clear limits on the scope and duration of licences and the obligation to provide fair and adequate remuneration to rights holders, in line with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
The Union compulsory licensing regulation is a key element of the EU’s crisis preparedness and response framework, supporting co=ordinated action across the single market in times of emergency.
