Commission welcomes political agreement on compulsory licensing to enhance EU crisis resilience

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The European Commission welcomes the political agreement between the European Parliament and the EU Member States on new rules for compulsory licensing, an important intellectual property tool to the existing EU crisis response toolkit.

The new Regulation establishes an EU-level framework to efficiently grant a compulsory licence in clearly defined cross-border crisis or emergency situations. Under the new Regulation, the Commission may grant an EU-wide compulsory licence for the use of a protected invention concerning crisis-relevant products, where a crisis or emergency has been declared or activated under the relevant EU crisis instruments.

Currently, compulsory licensing is governed solely at national level, resulting in 27 distinct regimes. This fragmentation creates uncertainty and procedural delays in EU-wide crises requiring rapid and coordinated action. By establishing an EU-level mechanism for issuing compulsory licences in defined crisis situations, the new Regulation closes this gap. The proposal would also make it possible to grant a Union compulsory licence for export purposes, in addition to the already existing possibility at national level.

The compulsory licensing mechanism is strictly designed as a measure of last resort. It is subject to clearly defined conditions to ensure that its use remains targeted, proportionate, and limited in time. The framework includes robust safeguards, such as clear limitations on the scope and duration of licences, and the requirement to provide fair and adequate remuneration to rights holders, in compliance with the Agreement on Trade-Related Aspects of Intellectual Property Rights. While national compulsory licensing regimes remain fully in place, this Regulation offers a coordinated solution for situations that require cross-border action. It also reinforces the integrity of the Single Market by ensuring the free movement and availability of crisis-relevant goods in emergencies.

Next Steps

The provisional agreement reached in the trilogue must now be formally approved by both the European Parliament and the Council. Once adopted by the co-legislators, the Regulation will be published in the Official Journal of the European Union and will enter into force on the day of its publication.

Background

Compulsory licensing is a legal mechanism that enables public authorities to exceptionally allow the use of a patented invention without the consent of the right holder – the person or organisation that legally owns the patent – under defined conditions. In crises, such as pandemics or natural disasters, a compulsory licence can serve as a last-resort solution to enable access to patented products when voluntary agreements to share the patent – for example, a company refusing to license a medicine or charging unaffordable prices – are not available or don’t meet the requirement of urgency.

The Union compulsory licensing Regulation is a key element 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 Union instruments, including Regulation (EU) 2022/2371, which allows the Commission to recognise a public health emergency at Union level, Regulation (EU) 2022/2372, establishing rules to secure the availability of crisis-relevant medical countermeasures, and the Regulation (EU) 2024/2747 establishing a framework of measures related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98. It also complements the Unitary Patent system, operational since 1 June 2023, helping to build a more integrated and effective EU patent landscape in the Single Market.