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)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 207 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1) Crises require the carrying out of exceptional, swift, adequate and proportionate measures capable of providing means to address them or their impact. To do so, the use of patented products or processes could prove indispensable. Voluntary licensing agreements usually suffice to licence the patent rights on those products or processes and to allow their supply in the Union. Voluntary agreements are the most appropriate, quickest, and most efficient solution to allow the use of patented products and processes and to scale up production in crises. Nevertheless, it might not be possible to reach voluntary agreements or such agreements might involve inadequate conditions such as lengthy delivery times. A compulsory licence, which is an authorisation to use an invention protected by intellectual property rights without the consent of the right holder, can provide a solution of last resort, where voluntary agreements would not be achievable or where they would prove inadequate, to allow access to patented products or processes, in particular in respect of products necessary to tackle the impact of a crisis.

(2) In the context of a Union crisis or emergency mode under a crisis or emergency mechanism provided for in a Union legal act listed in the Annex to this Regulation (a ‘Union crisis or emergency mechanism’), the Union should have the possibility to rely on compulsory licensing, in conformity with the framework of the Agreement on Trade-Related Aspects of Intellectual Property Rights (3) (the ‘TRIPS Agreement’). The declaration of a crisis or emergency mode addresses obstacles to free movement of goods, services, and persons in crises and the lack of adequate supply of crisis-relevant products and services. As a last resort, where adequate and swift access to crisis-relevant products and processes required to manufacture crisis-relevant products, which are covered by intellectual property rights, cannot be achieved through other means, including through the increase of own manufacturing capacities by the right holder or through voluntary cooperation, compulsory licensing can allow the use, in the public interest, of a protected invention for the manufacturing and supply of crisis-relevant products needed to address an ongoing crisis or emergency. It is therefore important, in the context of such crisis or emergency mechanisms, that the Union can rely on an efficient and effective compulsory licensing system at Union level, which is uniformly applicable within the Union. Such a system would guarantee a functioning internal market, ensuring the supply and the free movement of crisis-relevant products subject to compulsory licensing in the internal market.

(3) The possibility of using compulsory licences in situations of national emergency or other circumstances of extreme urgency is explicitly provided for under the TRIPS Agreement. In that context, this Regulation should establish a system for granting a compulsory licence for crisis management at Union level (the ‘Union compulsory licence’). In accordance with the international obligations laid down in the TRIPS Agreement, as a condition for making use of compulsory licensing, efforts should have been made to obtain prior authorisation from the right holder on reasonable commercial terms and conditions, and such efforts should prove to have been unsuccessful within a reasonable period of time. However, that requirement could be waived in the case of a national emergency or other circumstances of extreme urgency, or in cases of public non-commercial use. The process for granting a Union compulsory licence should be designed in such a way that it ensures the participation of the right holder throughout the procedure, with a view to enabling and encouraging the conclusion of voluntary agreements.

(4) All Member States have implemented compulsory licensing frameworks for patents in their national laws. National laws usually allow compulsory licensing on the ground of public interest or in the event of a crisis or emergency. However, divergences exist between Member States as regards the grounds, conditions, and procedures under which a compulsory licence can be granted. Those divergences result in a fragmented, suboptimal, and uncoordinated system preventing the Union from effectively relying on compulsory licensing in cases where it is needed to address a cross-border crisis or emergency.

(5) National compulsory licensing systems operate only within the national territory. They are designed to meet the needs of the population of the issuing Member State and to satisfy the public interest of that Member State. That limited territorial scope of the national compulsory licensing systems is accompanied by the fact that there is no exhaustion of the patent right regarding products manufactured under a compulsory licence. Consequently, those compulsory licensing systems do not provide an adequate solution for cross-border manufacturing processes, and therefore there is no functioning internal market for products manufactured under such compulsory licences. Apart from the fact that the issuance of multiple national compulsory licences is a significant obstacle to cross-border supply within the internal market, it also entails the risk of contradictory and incoherent decisions among Member States. As a result, the current compulsory licensing framework appears inadequate to address the realities of the internal market and its inherent cross-border supply chains. That suboptimal compulsory licensing framework prevents the Union from relying on an additional instrument when facing a crisis or emergency, where means other than a Union compulsory licence, including voluntary agreements, could not be achieved within a reasonable timeframe and could not adequately and swiftly ensure access to crisis-relevant products or to processes required to manufacture those products, which are covered by intellectual property rights. The Union and its Member States are striving to improve their resilience with regard to crises. It is therefore necessary to provide for an optimal compulsory licensing system for crisis management that takes the full advantage of the internal market and allows Member States to support one another in crises.

(6) Therefore, it is necessary to establish a compulsory licensing system for crisis management at Union level, in addition to the national compulsory licensing systems. Under the Union compulsory licensing system, the Commission, after considering the opinion of the competent advisory body as defined in this Regulation, should be empowered to grant, in the public interest and as an exceptional measure, a temporary and non-exclusive compulsory licence that is valid throughout the Union and that allows the use of a protected invention in order to supply products necessary to address a crisis or emergency in the Union.

(7) In recent years, the Union has adopted several Union crisis or emergency mechanisms to improve its resilience with regard to crises or emergencies affecting the Union. The recent mechanisms include Regulation (EU) 2022/2371 of the European Parliament and of the Council (4), under which the Commission can recognise a public health emergency at Union level, Council Regulation (EU) 2022/2372 (5), which, in the event of a public health emergency at Union level, provides a framework of measures for ensuring the supply of crisis-relevant medical countermeasures, and Regulation (EU) 2024/2747 of the European Parliament and of the Council (6) establishing a framework of measures related to an internal market emergency.

(8) Those Union crisis or emergency mechanisms provide for the declaration of a crisis or emergency mode and aim at providing the means to address Union crises or emergencies. By allowing the Commission to grant a Union compulsory licence when a crisis or emergency mode has been declared under a Union legal act, the necessary synergy between the relevant Union crisis or emergency mechanisms and a Union-wide compulsory licensing system can be achieved. In such a case, the determination of the existence of a crisis or emergency will depend solely on the underlying Union legal act and the relevant definition of ‘crisis’ or ‘emergency’ included therein. For the sake of legal certainty, the Union crisis or emergency mechanisms that provide for measures that qualify as emergency or extreme urgency measures at Union level and that can trigger a Union compulsory licence should be listed in the Annex to this Regulation.

(9) To ensure optimal efficiency of the Union compulsory licence as a tool for addressing crises or emergencies, it should be available in respect of a patent or utility model or a supplementary protection certificate. It should also be available in respect of a published patent application or a published application for a utility model. The Union compulsory licence should apply to the same extent to national patents, European patents and European patents with unitary effect.

(10) Utility model systems offer protection for technical inventions based on criteria that are, as a general rule, less stringent than those for patents. The owner of a utility model is granted an exclusive right to prevent third parties, for a limited period, from commercially exploiting the protected invention without the consent of the right holder. The concept of ‘utility model’ varies from one Member State to another, and not all Member States have a utility model system. In general, utility models are suitable for protecting inventions that make small improvements to, or adaptations of, existing products, or that have a short commercial life. However, similarly to patents, utility models can protect inventions that could prove necessary to address a crisis or emergency, and should therefore be included in the scope of the Union compulsory licence.

(11) A Union compulsory licence concerning a patent should extend to the supplementary protection certificate where such certificate takes effect after the expiry of the patent, during the duration of that compulsory licence, and where the supplementary protection certificate covers the crisis-relevant product. The Union compulsory licence should specify, where relevant, that it extends to the supplementary protection certificate. That extension would allow a Union compulsory licence concerning a patent to produce its effects where the invention is no longer protected by a patent but is protected by a supplementary protection certificate after the expiry of the patent. It should also apply to a supplementary protection certificate on its own where a Union compulsory licence is granted after the expiry of the patent.

(12) The Union compulsory licence should also apply to published patent applications for national patents and for European patents, as well as to published applications for utility models. As the process for granting a patent after the publishing of the patent application can take years, targeting only inventions protected by a granted patent could prevent an effective and timely crisis response. In crises, solutions can derive from the latest state-of-the-art technology. Moreover, certain national patent legislation, as well as the European Patent Convention of 5 October 1973, provide for provisional protection of patent applicants with regard to unauthorised use of their inventions and the corresponding possibility for such applicants to license the use of their rights protected by a patent application. For similar reasons, it should be ensured that a Union compulsory licence also applies to published applications for utility models. This Regulation does not harmonise national legislation governing the provisional protection of published patent applications and published applications for utility models. In order to ensure that a Union compulsory licence concerning a published patent application or a published application for a utility model maintains its effects once the patent or utility model is granted, the Union compulsory licence concerning a published patent application or a published application for a utility model should also extend to the patent or utility model once it has been granted, to the extent that the crisis-relevant product still falls within the final scope of protection of those intellectual property rights.

(13) It should be clarified that this Regulation is without prejudice to Union law on copyright and related rights, including Directives 96/9/EC (7), 2001/29/EC (8), 2004/48/EC (9), 2009/24/EC (10) and (EU) 2019/790 (11) of the European Parliament and of the Council, which establish specific rules and procedures that should remain unaffected. It should also be clarified that this Regulation is without prejudice to Directive (EU) 2016/943 of the European Parliament and of the Council (12). In addition, nothing in this Regulation should be interpreted as imposing any obligation to disclose undisclosed know-how, business information or technological information protected by trade secrets as defined by Directive (EU) 2016/943, or as precluding the voluntary conclusion of agreements on trade secrets.

(14) The Union crisis or emergency mechanisms provide for dedicated measures aimed at ensuring the supply in the Union of products that are critical for tackling a crisis or emergency or their impact. Such measures include, for instance, priority-rated orders for crisis-relevant products, a joint procurement procedure, as well as the possibility for the Commission to act as a central purchasing body. Considering that the Union compulsory licensing system is intended to complement the relevant Union crisis or emergency mechanism, the supply and distribution of the crisis-relevant products manufactured or marketed under a Union compulsory licence should be carried out within the framework of the specific measures provided for in that Union crisis or emergency mechanism. Those measures should set out the details relating to the supply and distribution of crisis-relevant products. In addition, a Union compulsory licence should not permit the manufacturing or marketing of products that are excluded from the scope of the relevant Union crisis or emergency mechanism.

(15) When a compulsory licence has been granted, regulatory data protection could prevent the effective use of the compulsory licence as it impedes the authorisation of generic medicinal products. That situation would have serious negative consequences for Union compulsory licences granted to tackle a crisis, as it could affect access to medicinal products needed to address the crisis or emergency. For that reason, it is important that the relevant Union law on pharmaceuticals provide for the suspension of data exclusivity and market protection, in particular where a compulsory licence has been granted to tackle a public health emergency. Such suspension should be allowed only in relation to the granted compulsory licence and its beneficiary and should be consistent with the objectives, the territorial scope, the duration, and the subject matter of that compulsory licence. That suspension means that the data exclusivity and market protection have no effect in relation to the licensee under the compulsory licence while that licence is valid. When the compulsory licence expires or is terminated, the data exclusivity and market protection should resume. That suspension should not result in an extension of the original duration of the regulatory data protection.

(16) Matters relating to product liability in relation to crisis-relevant products manufactured or marketed under a Union compulsory licence should be governed by the relevant Union or national law, as applicable.

(17) In order to ensure as much coherence as possible with regard to the existing crisis or emergency mechanisms, the definition of ‘crisis-relevant product’ laid down in this Regulation should be sufficiently general to cover products related to various types of crisis or emergency modes under the relevant Union crisis or emergency mechanism.

(18) A Union compulsory licence should be granted only where specific conditions are fulfilled. In particular, given the fact that the Union compulsory licensing system complements the Union crisis or emergency mechanisms, a Union compulsory licence should be granted only where a crisis or emergency mode listed in the Annex to this Regulation has been declared. Secondly, a Union compulsory licence should be relied upon only in situations in which the use of a protected invention is required to supply crisis-relevant products in the Union. As a third condition, a Union compulsory licence should be granted only as a measure of last resort, in the sense that it should be granted only where means other than a Union compulsory licence, including voluntary agreements to use a protected invention concerning crisis-relevant products, could not be achieved within a reasonable timeframe and could not ensure access to those products. The Commission should, with the assistance and advice of the competent advisory body, evaluate and assess whether the second and third conditions have been fulfilled, in accordance with the procedure laid down in this Regulation. Finally, it is of utmost importance that the right holder be given the opportunity to submit comments during the procedure for granting a Union compulsory licence in order to safeguard the right holder’s rights, as well as to enable the competent advisory body to obtain all the necessary information.