On 30 December 2025, Regulation (EU) 2025/2645 of the European Parliament and of the Council of 16 December 2025 was published. The Regulation establishes rules on the conditions and procedure for granting compulsory licences for intellectual property rights to manage crises at European Union level, and amends Regulation (EC) No 816/2006.
A compulsory licence is a licence to use an invention protected by intellectual property rights without the consent of the rights holder. It is provided for as a measure of last resort, where voluntary agreements are not feasible or sufficient, in compliance with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
The new Regulation aims to address crises with cross-border dimensions within the European Union that do not fall within the scope of protection of national compulsory licensing regimes, so that measures can be taken at EU level for the granting of such licences.
In order for the procedure for granting a Union compulsory licence for an industrial property right to be activated, the following conditions must be met:
a) a crisis or emergency situation must have previously been declared in the EU (e.g. health crises) by the competent EU bodies,
b) the compulsory licence must be used only in cases where the use of a protected invention is required for the supply of crisis-related products within the Union, and
c) it must be granted as a measure of last resort.
The licence is limited in time to the duration of the declared crisis or emergency. It is issued by the European Commission under specific procedures and conditions and is valid throughout the European Union. It may be granted for patents or utility models, published applications thereof, as well as supplementary protection certificates. Products manufactured under a Union compulsory licence may not be exported outside the EU. In the event of non-compliance with the licence conditions, the European Commission may impose financial penalties and fines on both the licence holder and the patent proprietor.
The text of Regulation (EU) 2025/2645 can be found at the following link: https://eur-lex.europa.eu/legal-content/EL/TXT/PDF/?uri=OJ:L_202502645 .
