This Regulation has the objective of ensuring that a Union compulsory licence may be granted in the context of a crisis or emergency affecting the Union. To that end, this Regulation lays down rules on the conditions and the procedure for granting a Union compulsory licence for intellectual property rights that are necessary for the supply of crisis-relevant products to the Member States in the context of a crisis or emergency mode which has been declared pursuant to a crisis or emergency mechanism provided for in a Union legal act listed in the Annex (a ‘Union crisis or emergency mechanism’). This Regulation provides that a Union compulsory licence is granted in the public interest and as a measure of last resort where other means, including voluntary agreements to use a protected invention that concerns crisis-relevant products, could not ensure access to those products.
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Regulation (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)
1. This Regulation establishes Union compulsory licensing of the following intellectual property rights in force in one or more Member States:
(a)
patents and published patent applications;
(b)
utility models and published applications for utility models; or
(c)
supplementary protection certificates.
2. This Regulation is without prejudice to the rules laid down by other Union legal acts regulating copyright and related rights, including Directives 2001/29/EC and 2009/24/EC. This Regulation is also without prejudice to the sui generis rights granted by Directive 96/9/EC and to Directive (EU) 2016/943.
3. This Regulation does not impose any obligation to disclose trade secrets.
4. This Regulation does not apply to defence-related products as defined in Article 3, point 1, of Directive 2009/43/EC of the European Parliament and of the Council ( 20 ) , or as defined by national law of Member States, in compliance with Union law.
5. The Union compulsory licence shall be granted in accordance with the conditions and the procedure established in this Regulation. The Union compulsory licence shall be granted only for the purpose of carrying out the specific measures related to crisis-relevant products provided for in the relevant Union crisis or emergency mechanism and in the context of a declared crisis or emergency mode.
For the purposes of this Regulation, the following definitions apply:
(1)
‘Union compulsory licence’ means a compulsory licence granted by the Commission to exploit a protected invention in order to carry out in the Union relevant activities concerning crisis-relevant products or processes required to manufacture those products;
(2)
‘crisis or emergency mode’ means a crisis or emergency mode listed in the Annex, which has been declared pursuant to a Union crisis or emergency mechanism;
(3)
‘crisis-relevant product’ means a product that is indispensable for responding to a crisis or emergency in the Union, or for addressing the impact of a crisis or emergency in the Union;
(4)
‘relevant activities’ means the act of manufacturing, namely making, or the act of marketing, namely using, offering for sale, selling or importing;
(5)
‘right holder’ means the holder or holders of any of the intellectual property rights referred to in Article 2(1);
(6)
‘protected invention’ means any invention protected by any of the intellectual property rights referred to in Article 2(1);
(7)
‘competent advisory body’ means the advisory body competent under a Union crisis or emergency mechanism as listed in the Annex or, where applicable, the ad hoc advisory body referred to in Article 6(5);
(8)
‘customs authorities’ means customs authorities as defined in Article 5, point (1), of Regulation (EU) No 952/2013 of the European Parliament and of the Council ( 21 ) .
The Commission may grant a Union compulsory licence only if all of the following conditions are fulfilled:
(a)
a crisis or emergency mode has been declared pursuant to the relevant Union crisis or emergency mechanism;
(b)
the Commission has concluded, in accordance with Article 7, that the use of a protected invention which concerns crisis-relevant products is required in order to supply those products in the Union;
(c)
the Commission has concluded, in accordance with Article 7, that means other than a Union compulsory licence, including voluntary agreements to use a protected invention which concerns crisis-relevant products, could not be achieved within a reasonable timeframe and could not ensure access to those products (‘measure of last resort’);
(d)
the right holder concerned was given the opportunity to submit comments to the Commission and the competent advisory body in accordance with Articles 6 and 7.
1. The Union compulsory licence shall:
(a)
be non-exclusive and non-assignable, except with that part of the enterprise or goodwill which enjoys the Union compulsory licence;
(b)
have a scope and duration that are strictly limited to the purpose for which the Union compulsory licence is granted and to the scope and duration of the crisis or emergency mode in the framework of which it is granted;
(c)
be strictly limited to the relevant activities that are necessary to ensure the adequate supply of crisis-relevant products in the Union;
(d)
be granted only against payment of an adequate remuneration to the right holder, as determined in accordance with Article 9;
(e)
be strictly limited to the Union;
(f)
be granted only to a person or an entity that has the capacity to exploit swiftly the protected invention in a manner that permits the proper carrying out of relevant activities concerning the crisis-relevant products; and
(g)
automatically expire if the crisis or emergency mode ends.
2. A Union compulsory licence for an invention protected by a published patent application shall also cover a patent granted based on that application, provided that the patent is granted while the Union compulsory licence is valid. This paragraph shall apply mutatis mutandis to published applications for utility models.
3. A Union compulsory licence for an invention protected by a patent shall cover a supplementary protection certificate issued with reference to that patent, where that certificate continues to cover the crisis-relevant product, provided that:
(a)
the transition from patent protection to protection conferred by a supplementary protection certificate takes place while the Union compulsory licence is valid, and
(b)
the Union compulsory licence specifies that it applies to such supplementary protection certificate.
1. For the purposes of this Regulation, the competent advisory body shall assist and advise the Commission in the following tasks:
(a)
identifying the intellectual property rights covering the crisis-relevant product, and identifying the corresponding right holder;
(b)
disseminating the notice published in accordance with Article 7(1) through appropriate channels;
(c)
identifying potential licensees and assessing whether they have the capacity to exploit swiftly the protected invention in a manner that permits the proper carrying-out of relevant activities concerning the crisis-relevant product, in accordance with the obligations referred to in Article 10;
(d)
gathering the views of the right holder and potential licensees, including on whether voluntary licensing agreements can be concluded within a reasonable timeframe and, where relevant, by ensuring the participation of the right holder and potential licensees in the discussions within the competent advisory body, as well as analysing comments received, in accordance with Article 7(2), point (c);
(e)
gathering the views, where relevant, of economic operators in the sectors concerned, and of other relevant entities;
(f)
gathering the views of experts from national intellectual property offices and the views of national authorities responsible for granting national compulsory licences, including by ensuring their participation in the discussions within the competent advisory body where those discussions concern intellectual property rights;
(g)
gathering and analysing crisis-relevant information, including on the existing national compulsory licences reported to the Commission in accordance with Article 22, and the market intelligence available, in particular in order to take account of:
(i)
the characteristics of the crisis or emergency and how it is expected to evolve;
(ii)
the lack of adequate supply of crisis-relevant products in the Union;
(iii)
the existence of means other than a Union compulsory licence to remedy the lack of adequate supply of crisis-relevant products in the Union;
(h)
facilitating the exchange and sharing of information with other relevant bodies and other crisis-relevant bodies at Union and national level, as well as with relevant bodies at international level, where appropriate.
2. The chair of the competent advisory body shall invite a representative of the European Parliament to the relevant meetings of the competent advisory body as an observer, where possible under the applicable Union crisis or emergency mechanism.
3. The competent advisory body shall provide an opinion on the need for a Union compulsory licence and on the content of the licence, in accordance with Article 7(4).
4. The competent advisory body shall provide views on whether the Union compulsory licence should be modified or terminated, in accordance with Article 14.
5. Where there is no advisory body referred to in the Annex, the competent advisory body shall be an ad hoc advisory body set up by the Commission (the ‘ad hoc advisory body’). The Commission shall chair the ad hoc advisory body and provide its secretariat. Each Member State shall have the right to be represented in the ad hoc advisory body. The chair of the ad hoc advisory body shall invite a representative of the European Parliament as an observer to the relevant meetings of the ad hoc advisory body.
6. The Commission shall, by means of an implementing act, lay down the rules of procedure of the ad hoc advisory body referred to in paragraph 5 of this Article. The rules of procedure shall specify that the ad hoc advisory body is to be set up for a period not exceeding the duration of the crisis or emergency. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 23(2).
1. Where the Commission, in the context of a declared crisis or emergency mode and on the basis of preliminary information gathered under the relevant Union crisis or emergency mechanism, considers that the use of a protected invention which concerns crisis-relevant products is required to ensure the adequate supply of those products in the Union, it may initiate the procedure for granting a Union compulsory licence by publishing a notice on its website.
The preliminary information referred to in the first subparagraph shall include information on the following:
(a)
the lack of adequate supply of crisis-relevant products;
(b)
the available manufacturing capacities;
(c)
the intellectual property rights and the right holder concerned.
The Commission shall publish the notice referred to in the first subparagraph in the Official Journal of the European Union without undue delay.
2. The notice referred to in paragraph 1 shall include:
(a)
information about the crisis-relevant products in respect of which the Commission considers that there is lack of adequate supply;
(b)
information about the intellectual property rights and right holder concerned gathered at the time of the publication of the notice;
(c)
an invitation to the right holder, to potential licensees and to other persons with an interest to submit comments to the Commission and the competent advisory body on the envisaged Union compulsory licence, in particular on the following:
(i)
whether voluntary licensing agreements can be concluded with potential licensees, within a reasonable timeframe, on intellectual property rights for the purpose of carrying out relevant activities concerning the crisis-relevant products;
(ii)
the need to grant a Union compulsory licence;
(iii)
the envisaged content of the Union compulsory licence, including on the amount of the remuneration;
(d)
information about the competent advisory body.
3. Upon the publication of the notice on its website, the Commission shall request the competent advisory body to disseminate the notice further through appropriate channels and to provide an opinion containing an assessment of the need for a Union compulsory licence and of the envisaged content of such licence.
The Commission shall set a time limit for the submission of that opinion. That time limit shall be reasonable and appropriate to the circumstances of the case, taking particular account of the urgency of the situation.
Where justified, the Commission may set a new time limit for the submission of the opinion referred to in the first subparagraph.
4. The competent advisory body shall provide the opinion referred to in paragraph 3 of this Article in accordance with its rules of procedure. The opinion shall contain an assessment of the need for a Union compulsory licence and of the envisaged content of such licence. The information on the outcome of the tasks performed in accordance with Article 6 shall be annexed to the opinion.
5. The opinion of the competent advisory body shall not be binding on the Commission.
6. After receiving the opinion of the competent advisory body, the Commission shall assess whether continuing the procedure for granting a Union compulsory licence is justified. If continuing the procedure is justified, the Commission shall inform the right holder and potential licensees concerned individually, as soon as reasonably practicable, of the fact that it is considering granting a Union compulsory licence. The Commission shall provide them with:
(a)
the envisaged content of the Union compulsory licence;
(b)
a summary of the opinion of the competent advisory body;
(c)
an invitation to submit their comments and a time limit for doing so, including comments on whether a voluntary licensing agreement has been concluded.
7. Where, after considering the opinion of the competent advisory body and any comments received in accordance with paragraph 6, point (c), of this Article, as well as taking into account the public interest and the rights and interests of the right holder and the potential licensees, the Commission concludes that the conditions referred to in Article 4 are met, it shall grant the Union compulsory licence by means of an implementing act. Where the Commission’s decision to grant the Union compulsory licence departs from the opinion of the competent advisory body, that implementing act shall indicate the Commission’s reasons for departing from that opinion.
8. The implementing act referred to in paragraph 7 of this Article shall be adopted in accordance with the examination procedure referred to in Article 23(2).
On duly justified imperative grounds of urgency relating to the impact of the crisis or emergency, the Commission shall adopt an immediately applicable implementing act in accordance with the procedure referred to in Article 23(3).
9. Where, based on the opinion of the competent advisory body and taking into account the rights and interests of the right holder and the potential licensees, the Commission comes to the conclusion that the conditions referred to in Article 4 are not met, the Commission shall publish in the Official Journal of the European Union a notice informing the public that the procedure initiated under paragraph 1 of this Article has ended.
10. Throughout the procedure for granting a Union compulsory licence, the Commission and the competent advisory body shall ensure that confidential information is protected.
While respecting the confidentiality of the information, the Commission and the competent advisory body shall ensure that any information relied on for the purposes of the Commission’s implementing act referred to in paragraph 7 is disclosed to an extent that allows an understanding of the facts and considerations that led to the adoption of that implementing act.
11. Without prejudice to paragraph 7, voluntary licensing agreements may be concluded at any time during or after the procedure for granting a Union compulsory licence set out in this Article.
The Commission shall specify in the Union compulsory licence the following:
(a)
the intellectual property rights, namely the patent, published patent application, supplementary protection certificate, utility model or published application for a utility model in respect of which the Union compulsory licence is granted;
(b)
the right holder;
(c)
the licensee, in particular the following information:
(i)
name and trade name;
(ii)
contact details;
(iii)
unique identification number in the country where the licensee is established;
(iv)
where available, the Economic Operators Registration and Identification (EORI) number;
(d)
the duration for which the Union compulsory licence is granted;
(e)
the remuneration to be paid to the right holder and the timeframe within which it is to be paid, as determined in accordance with Article 9;
(f)
where appropriate, the non-proprietary name of the crisis-relevant product which is to be manufactured or marketed under the Union compulsory licence or the Combined Nomenclature (CN) code under which the crisis-relevant product is classified, as set out in Annex I to Regulation (EEC) No 2658/87;
(g)
the details referred to in Article 10(1), points (c), (e) and (f), which make it possible to identify the crisis-relevant product manufactured or marketed under the Union compulsory licence and, where applicable, any other specific requirement under the Union legislation applicable to the crisis-relevant product and making its identification possible; and
(h)
the maximum quantity of the crisis-relevant products to be manufactured or marketed under the Union compulsory licence.
1. The licensee shall pay an adequate remuneration to the right holder. The Commission shall determine the amount of that remuneration and the timeframe within which it is to be paid.
2. When determining the amount of the adequate remuneration, the Commission shall take into account the economic value of the relevant activities authorised under the Union compulsory licence, as well as the circumstances of each case, such as any public support received to develop the protected invention. The Commission shall also take into account the opinion of the competent advisory body and any comments received under Article 7(6), point (c).
3. If a published patent application in respect of which a Union compulsory licence has been granted does not lead to the granting of a patent, the right holder shall refund to the licensee the remuneration paid under this Article.
This paragraph shall apply mutatis mutandis to published applications for utility models.
1. The licensee shall be authorised to exploit the protected invention covered by the Union compulsory licence only where the licensee complies with the following obligations:
(a)
the licensee shall ensure that the quantity of the crisis-relevant products manufactured or marketed under the Union compulsory licence does not exceed the maximum quantity determined in accordance with Article 8, point (h);
(b)
the licensee shall carry out relevant activities concerning the crisis-relevant products solely for ensuring the adequate supply of the crisis-relevant products in the Union;
(c)
the licensee shall ensure that the crisis-relevant products manufactured or marketed under the Union compulsory licence are clearly identified, through specific labelling or marking, as being manufactured or marketed pursuant to a Union compulsory licence granted under this Regulation;
(d)
the licensee shall keep regular records of the quantities of crisis-relevant products manufactured or marketed under the Union compulsory licence;
(e)
the licensee shall ensure that the crisis-relevant products manufactured or marketed under the Union compulsory licence can be distinguished from products manufactured or marketed by the right holder or under a voluntary licence granted by the right holder by means of special packaging, colouring or shaping, unless such distinction is not feasible or has a significant impact on the price of the crisis-relevant products;
(f)
the licensee shall ensure that the packaging of the crisis-relevant products manufactured or marketed under the Union compulsory licence and any associated marking or leaflet indicate that those products are subject to a Union compulsory licence granted under this Regulation and specify clearly that they are exclusively for distribution in the Union and are not to be exported;
(g)
before marketing the crisis-relevant products covered by the Union compulsory licence, the licensee shall make available on a website the following information:
(i)
the quantities of the crisis-relevant products manufactured under the Union compulsory licence per Member State of manufacturing;
(ii)
the quantities of the crisis-relevant products to be supplied under the Union compulsory licence per Member State of destination;
(iii)
the distinguishing features of the crisis-relevant products covered by the Union compulsory licence.
The licensee shall communicate the address of the website referred to in point (g) to the Commission. The Commission shall communicate the address of the website to the Member States.
2. In the event of a failure by the licensee to fulfil any of the obligations laid down in paragraph 1 of this Article, the Commission may:
(a)
terminate the Union compulsory licence in accordance with Article 14(3);
(b)
impose fines or periodic penalty payments on the licensee in accordance with Article 15 or 16.
3. Where there are sufficient grounds to suspect that the licensee has failed to fulfil the obligations laid down in paragraph 1, the Commission, in cooperation with the relevant national authorities of the Member States, may, based on information from those authorities or from the right holder, request access to books and records kept by the licensee as necessary for the purpose of checking compliance with the licensee’s obligations laid down in paragraph 1.
4. The Commission shall, by means of implementing acts, establish rules for the specific labelling or marking referred to in paragraph 1, point (c), of this Article, and for the packaging, colouring and shaping referred to in paragraph 1, point (e), of this Article, as well as rules for their use and, where relevant, their positioning on the crisis-relevant products. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 23(2).
The export of products manufactured or marketed under a Union compulsory licence shall be prohibited.
This Article is without prejudice to Regulation (EC) No 816/2006.
1. This Article is without prejudice to other Union legal acts governing the export of products, in particular Articles 46, 47 and 267 of Regulation (EU) No 952/2013.
2. Customs authorities shall rely on the Union compulsory licence and on any modifications thereto to identify products that could fall under the prohibition laid down in Article 11 of this Regulation. For that purpose, the Commission shall enter risk information, as regards each Union compulsory licence and any modification thereto, into the Union electronic customs risk management system, referred to in Article 36 of Implementing Regulation (EU) 2015/2447. Customs authorities shall take such risk information into consideration when they carry out controls on products placed under the customs procedure ‘export’ in accordance with Articles 46 and 47 of Regulation (EU) No 952/2013.
3. Where customs authorities identify a product that could fall under the prohibition laid down in Article 11, they shall suspend its export. Customs authorities shall immediately notify the Commission of the suspension, and provide it with all relevant information to enable it to establish whether the product was manufactured or marketed under a Union compulsory licence. The Commission shall inform the right holder and, where appropriate, the licensee. The Commission may consult the right holder to assess whether the product is covered by a Union compulsory licence.
4. Where the export of a product has been suspended in accordance with paragraph 3, that product shall be released for export provided that all the other requirements and formalities under Union or national law relating to such export have been fulfilled, and where either of the following conditions is fulfilled:
(a)
the Commission has not requested the customs authorities to maintain the suspension within 10 working days of it being notified thereof;
(b)
the Commission has informed the customs authorities that the product is not manufactured or marketed under a Union compulsory licence.
5. Where the Commission concludes that the export of a product manufactured or marketed under a Union compulsory licence does not comply with the prohibition laid down in Article 11, the customs authorities shall not authorise the release for export of that product. The Commission shall inform the customs authorities and the right holder concerned of such non-compliance.
6. Where the release for export of a product has not been authorised, the Commission may, where appropriate in view of the declared crisis or emergency mode, require, through the customs authorities, the exporter to take specific actions at its own expense, including supplying the product to designated Member States, if need be, after rendering it compliant with Union law.
In all other cases, the product concerned may be disposed of in accordance with national law, in compliance with Union law. In such cases, Articles 197 and 198 of Regulation (EU) No 952/2013 shall apply accordingly.
When exercising the rights or performing the obligations laid down in this Regulation, the right holder and the licensee shall refrain from any actions or omissions that could undermine the Union compulsory licensing process.
1. The Commission shall review the Union compulsory licence upon a reasoned request by the right holder or the licensee, or on its own initiative, and shall, where necessary, modify the content of the licence as referred to in Article 8 by means of an implementing act.
Without prejudice to the Commission’s obligation laid down in Article 8, points (a) and (b), to identify the intellectual property rights and the right holders before granting the Union compulsory license, the Commission shall modify the Union compulsory licence, where necessary, to update the list of intellectual property rights and right holders covered by the Union compulsory licence. That modification shall, where appropriate, have a retroactive effect.
2. Where the Commission is considering updating the list of rights and right holders covered by the Union compulsory licence, it shall inform the right holders concerned and invite them to submit comments on the possibility of reaching, within a reasonable timeframe, a voluntary licensing agreement with the licensee, as well as comments on the amount of the adequate remuneration.
3. The Commission shall terminate a Union compulsory licence by means of an implementing act where the circumstances which led to it being granted cease to exist and are unlikely to recur.
The Commission may terminate a Union compulsory licence by means of an implementing act where the licensee fails to comply with the obligations laid down in this Regulation.
4. Where a Union compulsory licence is terminated in accordance with paragraph 3 of this Article or where it expires in accordance with Article 5(1), point (g), the Commission shall notify the right holder and the licensee accordingly. Where appropriate, advance notification shall be provided to enable the orderly completion by the licensee of the activities relating to the crisis-relevant products covered by the Union compulsory licence.
5. Where the Commission is considering modifying or terminating a Union compulsory licence, it shall consult the competent advisory body.
6. Where a Union compulsory licence is terminated in accordance with paragraph 3 of this Article or where it expires in accordance with Article 5(1), point (g), the Commission may require that the licensee, within a reasonable period of time, arrange for any crisis-relevant products in its possession, custody, power or control to be redirected or otherwise disposed of, at the expense of the licensee and in the manner determined by the Commission in consultation with the right holder and the licensee.
7. The implementing acts referred to in paragraphs 1 and 3 of this Article shall be adopted in accordance with the examination procedure referred to in Article 23(2).
On duly justified imperative grounds of urgency relating to the impact of the crisis or emergency, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 23(3).
When adopting the implementing acts referred to in paragraphs 1 and 3 of this Article, the Commission shall ensure that confidential information is protected and shall duly consider the rights and interests of the right holder and the licensee.
1. The Commission may, by means of a decision, impose fines where the licensee, intentionally or negligently, fails to comply with its obligations laid down in Article 9(1), Article 10(1) or Article 11.
2. The fine imposed in accordance with paragraph 1 shall not exceed EUR 300 000. Where the licensee is a micro, small or medium-sized enterprise (SME) as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC ( 22 ) , the fine shall not exceed EUR 50 000.
3. In fixing the amount of the fine, regard shall be had to the nature, gravity, duration and any recurrence of the infringement, as well as to any other aggravating or mitigating factor applicable to the circumstances of the case, such as actions taken to mitigate the harm, and the financial benefits gained from, or losses avoided through, the infringement, directly or indirectly.
1. The Commission may, by means of a decision, impose on the licensee a periodic penalty payment for each working day calculated from the date determined in that decision, in order to compel the licensee to put an end to the non-compliance with the obligations laid down in Article 9(1), Article 10(1) or Article 11.
2. The periodic penalty payment imposed in accordance with paragraph 1 shall not exceed 1,5 % of the average daily turnover of the licensee in the preceding financial year. Where the licensee is an SME, the periodic penalty payment shall not exceed 0,5 % of its average daily turnover in the preceding financial year.
3. Article 15(3) shall apply mutatis mutandis .
4. Where the licensee has satisfied the obligation which the periodic penalty payment was intended to enforce, the Commission may fix the definitive amount of the periodic penalty payment at a figure lower than that which would arise under the original decision.
1. The powers conferred on the Commission by Articles 15 and 16 shall be subject to a limitation period of five years.
2. 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.
3. 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.
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’).
1. 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.
2. The limitation period referred to in paragraph 1 shall begin to run on the day on which the decision becomes final.
3. 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.
4. 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.
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
1. 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.
2. 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.
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.
1. 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 .
2. 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.
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.
4. 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.
Regulation (EC) No 816/2006 is amended as follows:
(1)
the following article is inserted:
‘Article 18a
Union compulsory licence
1. By way of derogation from Article 1, second subparagraph, from Article 2, point (4), and from Article 3, the Commission may grant a compulsory licence applicable to the whole of the Union where the activities of manufacture and sale for export are spread across different Member States and would therefore require compulsory licences for the same product in more than one Member State.
2. Any person may submit an application for a Union compulsory licence referred to in paragraph 1 of this Article. By way of derogation from Article 6(1) and (2), that application shall be submitted to the Commission. The application shall fulfil the requirements laid down in Article 6(3), points (a) to (f), and shall specify the Member States in which the activities of manufacture and sale for export of the product to be covered by the Union compulsory licence are to be carried out.
Articles 7, 8, 9 and 12 shall apply mutatis mutandis .
3. The Union compulsory licence referred to in paragraph 1 of this Article shall be subject to the conditions set out in Article 10 and shall specify that it is applicable to the whole of the Union.
4. The Commission shall, by means of an implementing act:
(a)
grant a Union compulsory licence referred to in paragraph 1;
(b)
reject an application for a Union compulsory licence submitted pursuant to paragraph 2;
(c)
modify or terminate the Union compulsory licence granted pursuant to point (a).
In cases referred to in the first subparagraph, point (b), of this paragraph, Article 11 shall apply mutatis mutandis .
In cases referred to in the first subparagraph, point (c), of this paragraph, Article 5, point (c), and Article 16 shall apply mutatis mutandis .
The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 18b(2).
On duly justified imperative grounds of urgency relating to the impact of the public health problems to be addressed, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 18b(3).’
;
(2)
the following article is inserted:
‘Article 18b
Committee procedure
1. The Commission shall be assisted by a committee (the “Compulsory Licensing Committee”). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.
4. 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.’
;
(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.’.
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.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Schedules & Appendices
ANNEX
List of Union crisis or emergency mechanisms, crisis or emergency modes and advisory bodies
Union crisis or emergency mechanism
Crisis or emergency mode
Advisory body
1.
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
Public health emergency at Union level formally recognised by means of a Commission implementing act
(Article 23 of Regulation (EU) 2022/2371)
Health Security Committee
(Article 4 of Regulation (EU) 2022/2371)
2.
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
Emergency framework activated by means of a Council Regulation
(Article 3 of Regulation (EU) 2022/2372)
Health Crisis Board
(Article 5 of Regulation (EU) 2022/2372)
3.
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)
Internal Market emergency mode activated by means of a Council implementing act
(Article 18 of Regulation (EU) 2024/2747)
Internal Market Emergency and Resilience Board
(Article 4 of Regulation (EU) 2024/2747)
Cite this act
Regulation (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) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32025R2645
© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.
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