32025R2645#rec_44Regulation (EU) 2025/2645 of the European Parliament and of the Council

Recital (44)

The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the granting, modification or termination of a Union compulsory licence, imperative grounds of urgency so require. As regards the granting of a Union compulsory licence, those grounds should relate to the nature and the gravity of the crisis or emergency and to the well-substantiated finding that it is not possible to reach a voluntary agreement to ensure the adequate supply of the crisis-relevant products in the Union. That should include cases where the right holder expressly indicates that it cannot ensure such supply and is unwilling to negotiate voluntary agreements. The same rules should apply in the case of a modification of a Union compulsory licence for the purpose of adding further right holders. In the event of the termination of a Union compulsory licence, those grounds should relate to the well-substantiated finding that the licensee is unable to exploit the protected invention in a manner that permits the licensee to carry out relevant activities concerning the crisis-relevant products, inter alia, where the licensee expressly indicates that to be the case. When deciding whether to adopt immediately applicable implementing acts, the Commission should take into account the preliminary information gathered by the competent advisory body and the preliminary exchanges within that body.

Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.