EUROPEAN COMMISSION

Brussels, 29.10.2025

COM(2025) 661 final

2023/0129(COD)

COMMUNICATION FROM THE COMMISSION
TO THE EUROPEAN PARLIAMENT

pursuant to Article 294(6) of the Treaty on the Functioning of the European Union

concerning the

position of the Council on the adoption of a Regulation of the European Parliament and of the Council on compulsory licensing for crisis management and amending Regulation (EC) 816/2006

2023/0129 (COD)

COMMUNICATION FROM THE COMMISSION
TO THE EUROPEAN PARLIAMENT

pursuant to Article 294(6) of the Treaty on the Functioning of the European Union

concerning the

position of the Council on the adoption of a Regulation of the European Parliament and of the Council on compulsory licensing for crisis management and amending Regulation (EC) 816/2006

1.Background

2.Objective of the proposal from the Commission

The aim of this proposal is to provide the Internal Market with an efficient compulsory licensing scheme for crisis management. The initiative therefore has two main objectives. First, it aims to enable the EU to rely on compulsory licensing during crises under certain EU crisis instruments. Second, it introduces an efficient compulsory licensing scheme, with appropriate features and safeguards, to allow a swift and appropriate response to crises, with a functioning Internal Market, guaranteeing the supply and the free movement of crisis-critical products subject to compulsory licencing in the internal market.

3.Comments on the position of the Council

The position of the Council as adopted at first reading fully reflects the political agreement reached between the European Parliament and the Council on 21 May 2025. The Commission supports this agreement. The main points of this agreement, which is reflected in the position of the Council, are the following:

On the disclosure of trade secrets: It is clarified that the proposal does not impose any obligation to disclose trade secrets, while acknowledging the possibility of voluntary conclusion of agreements on trade secrets.

On the scope: The list of crisis instruments triggering the compulsory licensing scheme no longer includes the Chips Act and the Gas Supply Security Regulation. Defence-related products 1  are now explicitly excluded from the scope of the proposal. An evaluation clause was included for the list of relevant crisis instruments, with the possibility of assessing new and existing instruments and with a specific reference to semiconductors for medical equipment.

Addition of conditions to grant a compulsory licence: The granting of a Union compulsory licence is now subject to four cumulative conditions, namely (i) a crisis or emergency mode has been declared, (ii) the use of a protected invention which concerns crisis-relevant products is required to secure the supply of those products in the Union, (iii) means other than a Union compulsory licence, including voluntary agreements, could not be achieved within a reasonable timeframe and could not ensure access to the products, (iv) the rightsholder concerned was given the opportunity to provide comments to the Commission and the competent advisory body.

Changes to the procedure for granting a compulsory licence: The role of the advisory body to assist and advise the Commission largely remains the same, although the tasks have been restructured and further specified. In particular, experts from intellectual property offices and national authorities responsible for granting compulsory licences must now be involved in advisory body discussions on intellectual property. In addition, the EP can also participate, as an observer, in the relevant meetings of the competent advisory body, including the ad hoc advisory body. Changes made to Article 7 include a reference to preliminary information gathered under the relevant Union crisis or emergency mechanism, which the Commission should consider when deciding whether to initiate the procedure for granting a Union compulsory licence. In addition, the procedure is to be formally initiated by publishing a notice on the Commission’s website. It is now stated that where the Commission’s decision to grant a Union compulsory licence departs from the opinion of the advisory body, it must indicate the reasons for this. Furthermore, where the Commission decides not to grant a Union compulsory licence, a notice must be published in the Official Journal of the European Union to provide information about the end of the procedure. Finally, the possibility of concluding voluntary licensing agreements at any time during or after the procedure for granting a Union compulsory licence is explicitly set out in the text.

On comitology: the advisory procedure was replaced by the examination procedure for implementing acts adopting, modifying and terminating a Union compulsory licence. A no-opinion clause was included for the adoption of the implementing act. A recital justifying the use of the examination procedure in light of the spirit of the Comitology Regulation was added.

4.Conclusion

The Commission supports the outcome of the interinstitutional negotiations and can therefore accept the Council’s position at first reading.

5.Statement from the Commission

The Commission has made one unilateral statement, which can be found in the appendix.

APPENDIX

Statement from the Commission

Commission statement on Regulation 816/2006:

The Commission commits to present a report to the European Parliament, the Council, and the European Economic and Social Committee on Regulation 816/2006, in line with Article 19 of this Regulation.

(1)    As defined in Article 3(1) of Directive 2009/43/EC simplifying terms and conditions of transfers of defence-related products within the Community.