LegalizeRegulation (EU) 2025/2645 of the European Parliament and of the Council of 16 December 2025 on compulsory licensing for crisis management and amending Regulation (EC) No 816/2006 (Text with EEA relevance)
The limitation period referred to in paragraph 1 shall begin to run on the day on which the infringement is committed. However, in the case of continuing or repeated infringements, the limitation period shall begin to run on the day on which the infringement ceases.
Any action taken by the Commission or by a competent authority of a Member State for the purpose of an investigation or of proceedings in respect of an infringement shall interrupt the limitation period for the imposition of fines or periodic penalty payments.
Each interruption shall start time running afresh. However, the limitation period for the imposition of fines or periodic penalty payments shall expire at the latest on the day on which a period equal to twice the limitation period has elapsed without the Commission having imposed a fine or a periodic penalty payment. That period shall be extended by the time during which the limitation period has been suspended pursuant to paragraph 4.
The limitation period for the imposition of fines or periodic penalty payments shall be suspended for as long as the decision of the Commission is the subject of proceedings pending before the Court of Justice of the European Union (the ‘Court’).
Article 18
Limitation period for the enforcement of fines and periodic penalty payments
The power of the Commission to enforce decisions taken pursuant to Article 15 or 16 shall be subject to a limitation period of five years.
The limitation period referred to in paragraph 1 shall begin to run on the day on which the decision becomes final.
The limitation period for the enforcement of fines and periodic penalty payments shall be interrupted:
(a) by notification of a decision modifying the original amount of the fine or periodic penalty payment or refusing an application for the modification of that amount;
(b) by any action of the Commission, or of a Member State, acting at the request of the Commission, intended to enforce payment of the fine or periodic penalty payment.
Each interruption shall start time running afresh.
The limitation period for the enforcement of fines and periodic penalty payments shall be suspended for so long as:
(a) time to pay is allowed;
(b) the enforcement of the payment is suspended pursuant to a decision of the Court or pursuant to a decision of a national court.
Article 19
Right to be heard and access to the file in the procedure for imposing fines or periodic penalty payments
Before adopting a decision pursuant to Article 15 or 16, the Commission shall give the licensee the opportunity to be heard on the alleged infringement.
The licensee may submit observations on the alleged infringement within a reasonable period set by the Commission. That period shall not be less than 14 days from the notification of the invitation to submit observations.
The Commission shall base its decision pursuant to Article 15 or 16 only on arguments on which the parties concerned have been given an opportunity to comment.
The rights of defence of the parties shall be fully respected in the proceedings. They shall be entitled to have access to the Commission’s file under the terms of a negotiated disclosure, subject to the legitimate interests of the right holder or of the licensee, or of any other person concerned in the protection of their commercially sensitive information and trade secrets. The Commission shall have the power to adopt decisions setting out such terms of a negotiated disclosure in the event of disagreement between the parties.
The right of access to the Commission’s file referred to in the first subparagraph shall not extend to confidential information and internal documents of the Commission, of other competent authorities or of public authorities of the Member States. In particular, the right of access shall not extend to correspondence between the Commission and those authorities.
Nothing in this paragraph shall prevent the Commission from disclosing and using information necessary to prove an infringement.
If the Commission considers it necessary, it may also hear natural or legal persons other than the licensee. Applications to be heard on the part of such persons shall be granted, where those persons show a sufficient interest.
Article 20
Publication of decisions on fines and periodic penalty payments
The Commission shall publish in the Official Journal of the European Union the decisions it adopts pursuant to Article 15 or 16. Such publication shall state the main content of the decision, including any fine or periodic penalty payment imposed and, when duly justified, the names of the parties.
The publication referred to in paragraph 1 shall have regard to the rights and legitimate interests of the right holder, of the licensee or of any third parties in the protection of their confidential information, and shall comply with Union law on the protection of personal data.
Article 21
Review of fines or periodic penalty payments by the Court
In accordance with Article 261 TFEU, the Court has unlimited jurisdiction to review Commission decisions imposing fines or periodic penalty payments. The Court may cancel, reduce or increase the fine or periodic penalty payment imposed.
Article 22
Reporting on national compulsory licences
Where a national compulsory licence has been granted for the purpose of addressing a national crisis or emergency corresponding in nature to a crisis or emergency falling within the scope of a Union crisis or emergency mechanism, the Member State concerned shall inform the Commission of the granting of the licence without undue delay. The information to be provided shall include the following:
(a) the purpose of the national compulsory licence and its legal basis in national law;
(b) the name and address of the licensee;
(c) the products concerned and, to the extent possible, the intellectual property rights and the right holder concerned;
(d) the remuneration to be paid to the right holder;
(e) the quantity of products to be supplied under the licence;
(f) the duration of the licence.
Article 2 (4) shall apply mutatis mutandis.
Member States shall inform the Commission of the national authority tasked with providing the information under paragraph 1. The Commission shall publish the list of those national authorities on its website.
Article 23
Committee procedure
The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.
Article 24
Amendments to Regulation (EC) No 816/2006
Regulation (EC) No 816/2006 is amended as follows:
(2) the following article is inserted: ‘Article 18b Committee procedure
(3) the following article is inserted: ‘Article 18c Applicability to and in the United Kingdom in respect of Northern Ireland The procedure for granting a Union compulsory licence under Article 18a, and a Union compulsory licence granted under that Article, shall not apply to and in the United Kingdom in respect of Northern Ireland. The United Kingdom in respect of Northern Ireland shall ensure that the products manufactured under such a licence are not imported into the Union or Northern Ireland in accordance with Article 13, and shall take the necessary actions to that end in accordance with Article 14.’.
Article 25
Evaluation
The Commission shall, by the last day of the third year following the granting of the first Union compulsory licence in accordance with Article 7, present to the European Parliament, the Council and the European Economic and Social Committee an evaluation report on the application of this Regulation.
The Commission shall regularly, and for the first time by 31 December 2027, assess whether the list in the Annex is up to date, including, in particular, in relation to semiconductors for medical equipment. It may, where appropriate, submit proposals to amend the Annex.
Every five years from 19 January 2026, the Commission shall report on the assessments carried out pursuant to the second paragraph to the European Parliament and the Council.
Article 26
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 16 December 2025.
For the European Parliament The President R. METSOLA
For the Council The President M. BJERRE
(1) OJ C, C/2023/865, 8.12.2023, ELI: http://data.europa.eu/eli/C/2023/865/oj.
(2) Position of the European Parliament of 13 March 2024 (not yet published in the Official Journal) and position of the Council at first reading of 27 October 2025 (not yet published in the Official Journal). Position of the European Parliament of 16 December 2025 (not yet published in the Official Journal).
(3) OJ L 336, 23.12.1994, p. 214.
(4) Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022, p. 26, ELI: http://data.europa.eu/eli/reg/2022/2371/oj).
(5) Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level (OJ L 314, 6.12.2022, p. 64, ELI: http://data.europa.eu/eli/reg/2022/2372/oj).
(6) Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 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 (Internal Market Emergency and Resilience Act) (OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj).
(7) Directive 96/9/EC of the European Parliament and of the Council of 11 March 1996 on the legal protection of databases (OJ L 77, 27.3.1996, p. 20, ELI: http://data.europa.eu/eli/dir/1996/9/oj).
(8) Directive 2001/29/EC of the European Parliament and of the Council of 22 May 2001 on the harmonisation of certain aspects of copyright and related rights in the information society (OJ L 167, 22.6.2001, p. 10, ELI: http://data.europa.eu/eli/dir/2001/29/oj).
(9) Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ L 157, 30.4.2004, p. 45, ELI: http://data.europa.eu/eli/dir/2004/48/oj).
(10) Directive 2009/24/EC of the European Parliament and of the Council of 23 April 2009 on the legal protection of computer programs (OJ L 111, 5.5.2009, p. 16, ELI: http://data.europa.eu/eli/dir/2009/24/oj).
(11) Directive (EU) 2019/790 of the European Parliament and of the Council of 17 April 2019 on copyright and related rights in the Digital Single Market and amending Directives 96/9/EC and 2001/29/EC (OJ L 130, 17.5.2019, p. 92, ELI: http://data.europa.eu/eli/dir/2019/790/oj).
(12) Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1, ELI: http://data.europa.eu/eli/dir/2016/943/oj).
(13) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1, ELI: http://data.europa.eu/eli/reg/1987/2658/oj).
(14) Council Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs and agricultural matters (OJ L 82, 22.3.1997, p. 1, ELI: http://data.europa.eu/eli/reg/1997/515/oj).
(15) Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems (OJ L 157, 9.6.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/816/oj).
(16) Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code (OJ L 343, 29.12.2015, p. 558, ELI: http://data.europa.eu/eli/reg_impl/2015/2447/oj).
(17) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13, ELI: http://data.europa.eu/eli/reg/2011/182/oj).
(18) OJ L 29, 31.1.2020, p. 7, ELI: http://data.europa.eu/eli/treaty/withd_2020/sign.
(19) Council Decision (EU) 2020/135 of 30 January 2020 on the conclusion of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (OJ L 29, 31.1.2020, p. 1, ELI: http://data.europa.eu/eli/dec/2020/135/oj).
(20) Directive 2009/43/EC of the European Parliament and of the Council of 6 May 2009 simplifying terms and conditions of transfers of defence-related products within the Community (OJ L 146, 10.6.2009, p. 1, ELI: http://data.europa.eu/eli/dir/2009/43/oj).
(21) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1, ELI: http://data.europa.eu/eli/reg/2013/952/oj).
(22) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).
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