Compulsory licensing

Compulsory licensing for crisis management

The regulation on compulsory licensing for crisis management establishes an EU-level framework to grant compulsory licences in clearly defined cross-border crisis or emergency situations. It allows the Commission to act quickly and consistently across the EU when access to crisis-relevant products is at risk.

Under the regulation, the Commission may grant an EU-wide compulsory licence for the use of a protected invention related to crisis-relevant products. This can only happen once a crisis or emergency has been declared or activated under the relevant EU crisis instruments.

The regulation was published in the Official Journal of the European Union on 30 December 2025.

Why an EU-level framework was needed

Until now, compulsory licensing has been governed exclusively at national level, resulting in 27 different systems across the EU. This fragmentation can create legal uncertainty and procedural delays, especially in EU-wide crises that require rapid and coordinated action.

The new regulation addresses this gap by introducing a single EU mechanism for issuing compulsory licences in defined crisis situations. It also makes it possible to grant a Union compulsory licence for export purposes, complementing existing national arrangements.

Safeguards and limits

Compulsory licensing under the regulation is designed as a measure of last resort. It can only be used under clearly defined conditions and for a limited period of time.

The framework includes strong safeguards, such as

clear limits on the scope and duration of licences
the requirement to provide fair and adequate remuneration to rights holders
full compliance with the agreement on trade-related aspects of intellectual property rights (TRIPS)

National compulsory licensing regimes remain fully in place. The regulation provides a coordinated EU solution only where cross-border action is necessary. It also supports the integrity of the single market by helping to ensure the free movement and availability of crisis-relevant goods in emergencies.

Background

Compulsory licensing is a legal mechanism that allows public authorities, in exceptional circumstances, to authorise the use of a patented invention without the consent of the rights holder, under specific conditions.

In crises such as pandemics, compulsory licensing can help ensure access to essential patented products. This may be necessary when voluntary licensing agreements are unavailable or cannot meet urgent needs.

The Union compulsory licensing regulation is part of the EU’s broader crisis preparedness and response framework and is listed in the action plan of the preparedness union strategy. It complements existing EU instruments on public health emergencies, medical countermeasures and internal market resilience, as well as the unitary patent system, operational since 1 June 2023.

Compulsory licensing