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<\/p>\nThe 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.<\/p>\n
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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.<\/p>\n
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.<\/p>\n
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.<\/p>\n