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Official Journal EN
of the European Union L series
2025/2645 30.12.2025
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.
(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.
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(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.
(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).
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(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.
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(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.
(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).
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(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.
(19) A Union compulsory licence authorises the use of a protected invention without the consent of the right holder.
Therefore, such a licence should be granted only exceptionally and under conditions that take into account the
interests of the right holder. For that reason, the scope, duration and territorial coverage of the licence should be
clearly determined. In the context of a Union crisis or emergency mechanism, the crisis or emergency mode is
declared for a limited period of time. Where a Union compulsory licence is granted within such a framework, the
duration of the licence should not extend beyond the duration of the declared crisis or emergency mode. In order to
ensure that the Union compulsory licence fulfils its objective as well as the conditions for being granted, the use of
the protected invention should be authorised only to a qualified person or entity that has the capacity to exploit the
protected invention and consequently to manufacture or market the crisis-relevant product and to pay an adequate
remuneration to the right holder. When selecting potential licensees, the Commission should also take into account
criteria such as the price of the crisis-relevant products, the potential licensees’ capacity to supply crisis-relevant
products of the quality required in the relevant field and to supply them in sufficient quantities, in a timely manner
and in accordance with all the industrial and sanitary requirements. To that end, the potential licensees should
provide any information relevant for that purpose in the course of the procedure for granting a Union compulsory
licence, as well as information about any changes to their capacity of supply that occur after the granting of the
licence.
(20) When considering the granting of a Union compulsory licence, the Commission should, in order to be able to take
a well-informed decision, be assisted and advised by an advisory body. Discussions on whether there is a need for
a Union compulsory licence might often already start in the context of the work of an advisory body involved
pursuant to the relevant Union crisis or emergency mechanism. Those early discussions should provide the
Commission with information on the lack of adequate supply of crisis-relevant products and available
manufacturing capacities, as well as, whenever possible, initial information on the intellectual property rights
and the right holders concerned. In the context of the early discussions within the competent advisory body, the
Commission should also assess whether the specific measures taken pursuant to the relevant Union crisis or
emergency mechanism are sufficient to address the lack of adequate supply of crisis-relevant products. If this is not
the case and a Union compulsory licence seems, a priori, necessary, the competent advisory body should provide the
Commission with a clearer idea of how products manufactured or marketed under the Union compulsory licence
could be adequately delivered. The preliminary information gathered by the competent advisory body should help
the Commission in determining whether to initiate the procedure for granting a Union compulsory licence, as well
as in establishing the content of the notice to be published for that purpose.
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(21) The aim of an advisory body participating in the Union compulsory licensing process is to guarantee
a comprehensive, thorough, and concrete assessment of the situation, taking into consideration the individual merits
of each case. It is therefore important that the competent advisory body have the correct composition, expertise, and
procedures to support the Commission when deciding on whether to grant a Union compulsory licence and on the
content of that licence. Union crisis or emergency mechanisms usually include the setting-up of an advisory body
ensuring coordination of action of the Commission and relevant Union bodies and agencies, the Council and the
Member States. In that respect, Regulations (EU) 2022/2371 and (EU) 2022/2372 provide for a Health Security
Committee and a Health Crisis Board, respectively, while an Internal Market Emergency and Resilience Board is set
up under Regulation (EU) 2024/2747. Those advisory bodies have the correct composition, expertise, and
procedures to address the crises and emergencies for which they have been set up. Where compulsory licensing is
being discussed in the context of a Union crisis or emergency mechanism, relying on the advisory body set up under
the relevant mechanism allows the Commission to be adequately advised and avoids duplication of advisory bodies
that would lead to inconsistencies between processes. However, considering its specific role, it should be ensured
that the competent advisory body draws on additional expertise in intellectual property rights, in particular patents,
and in the granting of compulsory licences. The competent advisory bodies should be listed, together with the
corresponding Union crisis or emergency mechanisms, in the Annex to this Regulation. Where the Union crisis or
emergency mechanism does not provide for an advisory body, the Commission should set up an ad hoc advisory
body for the granting of the Union compulsory licence (the ‘ad hoc advisory body’). The ad hoc advisory body set up
by the Commission should be composed of one representative of each Member State and should include
a representative of the European Parliament as an observer. The rules of procedure of that ad hoc advisory body
should include provisions relating to the avoidance of potential conflicts of interest in order to ensure accountability
and transparency.
(22) The role of the competent advisory body is to assist and advise the Commission where discussions arise on the need
to grant a Union compulsory licence and on its content. To that end, the competent advisory body should support
the Commission in taking the necessary steps to identify the intellectual property rights and the right holders
concerned. To allow for the widest dissemination of information on the initiation of the procedure for granting
a Union compulsory licence, the competent advisory body should contact the national intellectual property offices
and the relevant business and industry associations, as well as relevant international organisations. The competent
advisory body should draw the attention of such entities to the notice published by the Commission on the initiation
of the procedure for granting a Union compulsory licence, containing the relevant information, and should
encourage the further dissemination of that notice by any appropriate means. Given that a Union compulsory
licence should be granted only to a person or entity having the capacity, including the facilities, expertise and supply
chains, to manufacture or market crisis-relevant products adequately and swiftly, the competent advisory body
should assist the Commission in identifying potential licensees and establishing whether they meet that requirement.
The right holders and potential licensees should have the opportunity to make their views known to the competent
advisory body, which should analyse their written comments and invite them to participate in the relevant meetings.
Those meetings should also serve as a forum to explore the possibility of reaching a voluntary agreement within
a reasonable timeframe. The Commission and the competent advisory body should serve as facilitators in that
respect. It might also be useful to invite other actors to provide contributions, in particular economic operators in
the sectors concerned, and other relevant entities, such as representatives of academia and of civil society, social
partners, and representatives of international bodies such as the European Patent Office or the World Health
Organization. Given the importance of expediency in managing a crisis or emergency, consultations and exchanges
with the various actors should be carried out quickly and by the means most appropriate to the situation. In order to
consider properly all relevant aspects of intellectual property law and, more specifically, compulsory licensing, it is
necessary to fully involve in the relevant discussions within the competent advisory body the national intellectual
property offices and other national authorities responsible for granting compulsory licences. Each Member State
should designate the most suitable representatives to that end. Given its expertise, the advisory body set up under the
relevant Union crisis or emergency mechanism is the most competent entity to gather and analyse the available
crisis-related information from the Member States and from other relevant bodies at Union and international level.
The analysis of that information should provide the Commission with a clearer view of the situation, its
characteristics and the way in which it could evolve, in order to tailor the potential Union compulsory licence to
current and future needs. As crises and emergencies rarely remain confined within borders, the competent advisory
body should engage in cross-border collaboration and cooperation with other crisis-relevant bodies at Union,
national and international level. Finally, the competent advisory body should assist the Commission in deciding
whether to modify or terminate a granted Union compulsory licence for reasons set out in this Regulation.
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(23) A Union compulsory licence should be granted only in the context of a Union crisis or emergency mode. In such
a context, the discussions within the advisory body set up under the relevant Union crisis or emergency mechanism
could reveal that the lack of adequate supply of crisis-relevant products results from intellectual property rights or
the exercise thereof. In such cases, the Commission should have the possibility to initiate the procedure for granting
a Union compulsory licence. For reasons of expediency, the Commission should initiate the procedure by publishing
a notice on its website. It should also publish that notice in the Official Journal of the European Union without undue
delay.
(24) The publication of the notice on the initiation of the procedure should serve to inform the public that discussions
are ongoing as regards the possible granting of a Union compulsory licence. To that end, the notice should include
information on the crisis-relevant products for which a lack of adequate supply is considered to exist, as well as on
the relevant intellectual property rights and the right holders, where available. The competent advisory body should
assist the Commission in gathering that information. The notice should also include an invitation to the right
holders, potential licensees and other interested persons to submit their comments to the Commission and the
competent advisory body, including on whether voluntary licensing agreements could be concluded within
a reasonable timeframe. That notice should also include information on the competent advisory body and the
contact details for submitting the comments. Those rules should ensure that the procedure is inclusive and that all
relevant information reaches the competent advisory body.
(25) After publishing the notice on the initiation of the procedure, the Commission should request the competent
advisory body to disseminate it further through appropriate channels and to provide an opinion on the need for
a Union compulsory licence and on its content. The Commission should set a time limit for the submission of the
opinion. That time limit should be reasonable and appropriate in view of the circumstances of the case and of the
urgency of the situation.
(26) The work performed under this Regulation by the competent advisory body for the purposes of advising and
assisting the Commission should result in an opinion, including an assessment of the need for a Union compulsory
licence and its content. That opinion should not be binding. The assessment set out in the opinion of the competent
advisory body should enable the Commission to consider the individual merits of the case and determine, on that
basis, the conditions of the Union compulsory licence, including what would be adequate remuneration to be paid
by the licensee to the right holder. That opinion should also include an annex containing explanations, arguments,
factual elements and the results of the analysis conducted, which have been taken into account to carry out the
assessment submitted in the opinion. The confidentiality of information is of paramount importance and should be
preserved throughout the procedure, including when deciding whether and how information should be included in
the opinion and the annex thereto.
(27) After receiving the opinion of the competent advisory body, the Commission should assess whether to continue the
procedure for granting a Union compulsory licence. Where the Commission, having taken into account the opinion
of the competent advisory body, considers that continuing the procedure is justified, it should inform, as soon as
reasonably practicable, any right holder whose interests could be affected by the Union compulsory licence, and the
potential licensees. The Commission should inform the right holder and the potential licensees of the envisaged
content of the Union compulsory licence and provide a summary of the opinion of the competent advisory body. In
addition, the Commission should invite the right holder and the potential licensees to submit comments within a set
time limit, including on whether voluntary licensing agreements have been concluded.
(28) The right holder concerned should be able to submit comments throughout the procedure for granting a Union
compulsory licence. The involvement of the right holder should be ensured at every relevant step of the procedure,
from the start, with the publication of the notice, until the final stages of the procedure, including after the
competent advisory body has issued its opinion. In addition, it should be possible to conclude voluntary licensing
agreements at any time during the procedure or after the granting of a Union compulsory licence. Those elements
should ensure that the right holder’s rights and interests are protected and make it possible to explore ways of
reaching voluntary solutions that would adequately and swiftly remedy the lack of adequate supply of crisis-relevant
products in the Union. The right holder should be involved in the procedure in such a manner that the right holder
can exercise the right to be heard before the granting of the Union compulsory licence and that a voluntary solution
can be reached at any time throughout the procedure, thereby rendering the granting of a Union compulsory licence
unnecessary. The Commission should also end the procedure without granting a Union compulsory licence where
a Union compulsory licence appears no longer to be necessary. For the sake of transparency, a notice indicating the
end of the procedure should be published in the Official Journal of the European Union.
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(29) The Commission should ensure that there is a secure environment for the sharing of confidential information and
should take measures to preserve the confidentiality of the documents provided by the right holders and other
relevant actors in the context of the procedure for granting a Union compulsory licence.
(30) In the implementing act by which it grants a Union compulsory licence, the Commission should identify the patents
and, where applicable, published patent applications, as well as utility models and, where applicable, published
applications for utility models, and supplementary protection certificates related to the crisis-relevant products. The
Commission should also identify the right holders of those intellectual property rights. It cannot be fully excluded
that, despite the efforts undertaken by the Commission and the competent advisory body, further intellectual
property rights covering the crisis-relevant product referred to in a Union compulsory licence by its non-proprietary
name or Combined Nomenclature (CN) code are identified only after the licence has been granted and therefore are
not listed therein. As the Union compulsory licence should ensure the adequate and swift supply of crisis-relevant
products, in such a situation, the Commission should modify the Union compulsory licence by means of an
implementing act, so as to update the list of intellectual property rights and right holders. To ensure a balance
between the safeguarding of the public interest and the rights and interests of right holders, that modification
should, where appropriate, have retroactive effect. That retroactive effect should not prevent the right holders from
submitting comments on the possibility of reaching a voluntary licensing agreement with the licensees and on the
amount of adequate remuneration. It should prevent situations such as recalls from the market or the destruction of
crisis-relevant products due to an incomplete list of intellectual property rights and right holders, where such
measures would threaten the supply of crisis-relevant products in the Union. The modified Union compulsory
licence should also identify any necessary safeguards and adequate remuneration to be paid to each newly identified
right holder. In accordance with Article 297 of the Treaty on the Functioning of the European Union (TFEU), the
Commission should notify the addressees of the implementing act granting the Union compulsory licence, as well as
of the implementing act modifying or terminating the Union compulsory licence.
(31) The Union compulsory licence should include information enabling the crisis-relevant product in respect of which it
is granted to be identified, including details about the description, name or brand of the crisis-relevant product,
where appropriate, the non-proprietary name of the crisis-relevant product or the CN code under which the
crisis-relevant product is classified, as set out in Annex I to Council Regulation (EEC) No 2658/87(13), and details on
the licensee and, where applicable, the manufacturer, to whom the Union compulsory licence is granted, including
their name or trade name, their contact details, their unique identification number in the Member State or third
country where they are established and, where available, their Economic Operators Registration and Identification
(EORI) number. Where required under Union law, other information enabling the crisis-relevant product to be
identified should be included, such as its type, reference, model, batch or serial number, or unique identifier of its
product passport.
(32) The licensee should pay adequate remuneration to the right holder. The amount of the adequate remuneration
should be determined by the Commission having regard to the circumstances of each case, considering the economic
value of the exploitation authorised under the Union compulsory licence. To assess that economic value, the
Commission should take into account the expected total gross revenue generated by the licensee through the
relevant activities under the Union compulsory licence, the hypothetical amount that a reasonable right holder
would request and that a reasonable licensee would pay under a voluntary agreement, as well as any public support
received by the right holder to develop the invention. The amount of the adequate remuneration should be
determined also taking into account the extent to which research and development costs have been amortised by the
right holder. That amount should ensure proper remuneration in cases where the development costs have not been
appropriately amortised. Depending on the circumstances of the case and where relevant, the Commission should
also be able to take into account humanitarian grounds relating to the granting of the Union compulsory licence. In
addition, the Commission should consider the comments submitted by the right holder and the assessment made by
the competent advisory body with regard to the amount of the adequate remuneration, taking into consideration
general practices and any existing precedents in the relevant field. In the case of a Union compulsory licence granted
with regard to a published patent application that ultimately does not lead to the granting of a patent, the grounds
for the patent applicant to be remunerated in respect of the subject matter of the application will not have come into
being. In such circumstances, the right holder should be required to refund the remuneration received under the
Union compulsory licence. The same rule should apply mutatis mutandis in the case of published applications for
utility models.
(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).
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(33) It is imperative that the crisis-relevant products manufactured or marketed under a Union compulsory licence are
supplied only within the internal market. The Union compulsory licence should therefore impose upon the licensee
clear conditions as regards the activities authorised under the licence, including the territorial scope of those
activities. In accordance with Directive 2004/48/EC, the right holder should be able to challenge as infringements of
its intellectual property rights actions of the licensee and uses of the intellectual property rights covered by the
Union compulsory licence that do not comply with the conditions of the licence. In order to facilitate monitoring of
the distribution of crisis-relevant products manufactured or marketed under a Union compulsory licence, including
controls by customs authorities, the licensee under a Union compulsory licence should ensure that such products
have special characteristics that make them easily identifiable and distinguishable from the products manufactured
or marketed by the right holder or other licensees. In addition, the licensee under a Union compulsory licence should
regularly record the quantities of crisis-relevant products manufactured or marketed under the Union compulsory
licence. Those records should make it possible to establish the quantities of crisis-relevant products so manufactured
or marketed during a given period.
(34) The Commission should be able to consider, as a matter of its internal organisation, entrusting actions relating to
cooperation on enforcement as provided for in this Regulation to the European Anti-Fraud Office (OLAF), which has
relevant expertise in that regard. Such internal decisions should not affect the continued exercise of the powers
conferred upon the Commission or OLAF by other Union legal acts, including Council Regulation (EC)
No 515/97(14).
(35) A Union compulsory licence in the context of a Union crisis or emergency mechanism should be granted to supply
only the internal market with crisis-relevant products. Therefore, without prejudice to Regulation (EC) No 816/2006
of the European Parliament and of the Council(15), it should be prohibited to export products manufactured or
marketed under a Union compulsory licence.
(36) Customs authorities should ensure, by applying a risk analysis approach, that crisis-relevant products manufactured
or marketed under a Union compulsory licence are not exported. To identify such products, the main source of
information for such customs risk-analysis should be the Union compulsory licence itself. Information on each
implementing act granting or modifying a Union compulsory licence should thus be entered by the Commission
into the electronic customs risk management system referred to in Commission Implementing Regulation (EU)
2015/2447(16). When customs authorities identify a product that is suspected of not complying with the export
prohibition, they should suspend the export of that product and notify the Commission immediately. The
Commission should inform the right holder and, where appropriate, the licensee, accordingly. The Commission
should reach a conclusion on the compliance with the export prohibition within 10 working days, but should have
the possibility of requiring the customs authorities to maintain the suspension where necessary. To help it in its
assessment, the Commission should be able to consult the relevant right holder. Where the Commission concludes
that a product does not comply with the export prohibition, customs authorities should refuse its export.
(37) Pursuant to the TFEU, and in particular Article 263 thereof, the validity of implementing acts granting a Union
compulsory licence and the adequate remuneration provided for therein, as well as the validity of any other
implementing acts pertaining to the Union compulsory licence, are subject to judicial review by the Court of Justice
of the European Union (the ‘Court’).
(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).
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(38) During the procedure for granting a Union compulsory licence, and after such a licence has been granted, the right
holder and the licensee should refrain from actions and omissions that could jeopardise the efficiency of the Union
compulsory licensing process. Where applicable, the right holder and the licensee should also provide the
Commission and the competent advisory body with information about the known intellectual property rights,
including rights of third parties, covering the crisis-relevant products. Information to be provided in relation to the
Union compulsory licence and the process for its granting should include, in particular, information on the changes
to the status of the relevant intellectual property rights, any pending infringement or invalidity actions in relation to
them, as well as the associated voluntary licensing agreements. On request from the right holder or the licensee, or
on its own initiative, the Commission should have the possibility of arranging meetings or other exchanges between
the right holder and the licensee on matters relevant for the fulfilment of the objective of the Union compulsory
licence. The Commission should also have the possibility of sharing crisis-relevant information with the right holder
and the licensee, including new information on available manufacturing capacities of crisis-relevant products in the
Union. Information shared during such meetings or exchanges should be treated confidentially.
(39) In order to respond appropriately to crisis or emergency situations, the Commission should be empowered to review
the conditions of the Union compulsory licence and adapt them to new circumstances. Where necessary, the list of
the rights and right holders covered by the Union compulsory licence should be updated, with retroactive effect
where appropriate. Where a published patent application or a published application for a utility model is included in
the content of the Union compulsory licence but such application does not result in a patent or a utility model or
where the scope of protection of the patent or the utility model granted based on such application no longer covers
the crisis-relevant product, the list of the rights and right holders should be updated accordingly, without retroactive
effect. In addition, that list should be modified without retroactive effect in the case of a transfer or revocation of
a right covered by the Union compulsory licence. If the circumstances which led to the Union compulsory licence
being granted cease to exist and are unlikely to recur, the Union compulsory licence should be terminated. The
Commission should notify the right holder and the licensee of the termination of the Union compulsory licence, as
well as of its expiry in the event that the relevant crisis or emergency mode has ended. The right holder and the
licensee should be notified sufficiently in advance to enable the orderly completion of the activities relating to
crisis-relevant products covered by a Union compulsory licence. However, such advance notification should not be
required in certain cases, for instance where the licence is terminated due to non-compliance with a licensee’s
obligation laid down in this Regulation. When deciding on the modification of the Union compulsory licence, the
Commission should consult the competent advisory body and duly consider the rights and interests of the right
holder and the licensee.
(40) In addition to the possibility of terminating the Union compulsory licence, the Commission should be authorised to
impose fines and periodic penalty payments on the licensee in order to enforce the licensee’s obligations laid down
in this Regulation. It should be possible to apply fines and periodic penalty payments cumulatively. The aim of fines
and periodic penalty payments is to safeguard the rights and interests of the right holder and to guarantee the
efficient implementation of the Union compulsory licence. The fines and periodic penalty payments imposed should
be effective and dissuasive. They should also be subject to the overarching principles of proportionality and ne bis in
idem.
(41) Appropriate levels of fines for non-compliance with the obligations laid down in this Regulation, and of periodic
penalty payments to put an end to the non-compliance with such obligations should be set, taking into account any
aggravating or mitigating factors. Limitation periods should apply for the imposition of fines and periodic penalty
payments, as well as for their enforcement. In accordance with Article 297 TFEU, the Commission should notify the
addressees of its decision on fines or periodic penalty payments. In accordance with Article 261 TFEU, the Court
should have unlimited jurisdiction in respect of all Commission decisions imposing fines or periodic penalty
payments.
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(42) Where a national compulsory licence has been granted for the purposes of addressing a crisis or emergency at
national level, which in nature corresponds to a crisis or emergency falling within the scope of a Union crisis or
emergency mechanism, the Member State concerned should inform the Commission of the granting of the licence,
and of the conditions attached to it. That information would allow the Commission to form an overview of national
compulsory licences granted by the Member States and to take them into account when considering the need to
grant a Union compulsory licence, and in particular when setting the conditions attached to a Union compulsory
licence. Considering that there are differences between the Member States in terms of the authorities responsible for
granting compulsory licences at national level, it should remain for the Member States to establish appropriate
procedures under their national laws to ensure that the relevant information is provided to the Commission without
undue delay. To ensure efficient cooperation, Member States should inform the Commission of the national
authority that is responsible for providing information on national compulsory licences granted for the purposes of
addressing a crisis or emergency. The Commission should establish a list of those national authorities and publish it
on its website.
(43) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be
conferred on the Commission as regards the granting, modification or termination of a Union compulsory license,
establishing the rules of procedure of the ad hoc advisory body and establishing the characteristics enabling
crisis-relevant products manufactured or marketed under a Union compulsory licence to be identified. Those powers
should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the
Council(17). The examination procedure should be used for the adoption of implementing acts granting, modifying
or terminating a Union compulsory licence and establishing the rules of procedure of the ad hoc advisory body, and
of implementing acts establishing the characteristics enabling crisis-relevant products manufactured or marketed
under a Union compulsory licence to be identified. The choice of the examination procedure for the adoption of
such implementing acts is justified by the fact that decisions on a Union compulsory licence have a potentially
significant impact on the fundamental right to intellectual property.
(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.
(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).
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(45) The possibility of granting a compulsory licence at Union level should not be available only with regard to the
internal market. It should also be possible, under certain conditions, to grant a Union compulsory licence for the
purposes of export to countries with public health problems, which is a matter already regulated by Regulation (EC)
No 816/2006. Under Regulation (EC) No 816/2006, the granting of such compulsory licences is decided upon and
carried out at national level by the competent authorities of the Member States acting on a corresponding
application from a person that intends to manufacture and sell pharmaceutical products covered by a patent or
a supplementary protection certificate for export to eligible third countries. Regulation (EC) No 816/2006 allows
only compulsory licensing covering the manufacturing of products across several Member States through national
procedures. In the context of a cross-border manufacturing process, national compulsory licences granted in more
than one Member State would be needed. That could lead to a burdensome and lengthy process as it would require
initiating a number of national procedures with potentially a different scope and different conditions. In order to
achieve the same synergies and efficient process as provided for by this Regulation for the Union crisis or emergency
mechanisms, a Union compulsory licence should also be available in the context of Regulation (EC) No 816/2006.
That possibility would facilitate the manufacturing of the relevant product across several Member States, and provide
a Union-level solution, thus avoiding a situation where compulsory licences in more than one Member State would
be required in order for a licensee to be able to manufacture and sell for export the relevant product as planned. Any
person intending to apply for a compulsory licence under Regulation (EC) No 816/2006 should have the possibility
of requesting, with a single application, a compulsory licence under that Regulation that is valid throughout the
Union, where that person, if relying on the national compulsory licensing systems of the Member States, would need
to apply for several compulsory licences for the same product in more than one Member State in order to carry out
its intended activities of manufacture and sale for export. To that end, the applicant should specify the Member States
in which the intended activities of manufacture and sale for export of the product to be covered by the Union
compulsory licence are to be carried out. Regulation (EC) No 816/2006 should therefore be amended accordingly.
(46) On 1 February 2020, the United Kingdom of Great Britain and Northern Ireland (the ‘United Kingdom’) withdrew
from the Union. 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(18) (the ‘Withdrawal Agreement’) was
concluded between the Union and the European Atomic Energy Community, of the one part, and the United
Kingdom, of the other part. It was approved by Council Decision (EU) 2020/135(19) on 30 January 2020, and
entered into force on 1 February 2020. The Withdrawal Agreement provided for a transition period which ended on
31 December 2020. At the end of the transition period, Union law ceased to apply to the United Kingdom, whilst
the Protocol on Ireland / Northern Ireland (the ‘Windsor Framework’), which forms an integral part of the
Withdrawal Agreement, became applicable. In accordance with Article 5(4) of the Windsor Framework and point 7
of Annex 2 to the Windsor Framework, Regulation (EC) No 816/2006, as well as legal acts of the Union
implementing, amending or replacing that legal act, apply to and in the United Kingdom in respect of Northern
Ireland. Considering that the amendments to Regulation (EC) No 816/2006 would be applicable to and in the United
Kingdom in respect of Northern Ireland in accordance with the Windsor Framework and that the competent
authorities of the United Kingdom should continue to exercise their responsibility for issuing compulsory licences in
respect of Northern Ireland, it is appropriate to stipulate that the procedure for granting a Union compulsory licence,
and a Union compulsory licence granted under that Regulation, should not apply to or in the United Kingdom in
respect of Northern Ireland. However, the United Kingdom in respect of Northern Ireland should ensure that the
products manufactured under such a licence are not reimported into the territory of the Union or Northern Ireland,
in accordance with Article 13 of Regulation (EC) No 816/2006, and should take necessary actions to that end in
accordance with Article 14 of that Regulation.
(47) This Regulation provides for a tool of last resort that is to be used only in exceptional circumstances. The application
of this Regulation should be evaluated by the Commission. However, such an evaluation should be carried out only
if one or more Union compulsory licences have been granted by the Commission. The Commission should submit
its evaluation report to the European Parliament, the Council and the European Economic and Social Committee by
the last day of the third year following the granting of the first Union compulsory licence, to allow for an adequate
and substantiated analysis.
(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).
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(48) In line with the Union’s efforts to enhance its preparedness for and resilience against crises, the list of Union crisis or
emergency mechanisms capable of triggering a Union compulsory licence should be kept up to date. To that end, the
Commission should assess that list on a regular basis, in particular by taking into consideration new legislative acts
or proposals, as well as the general objective of enhancing the Union’s preparedness for and resilience against crises.
The assessments should be carried out having particular regard to semiconductors for medical equipment. Where
appropriate, the Commission should be able to propose amendments to the Annex, in order to adapt the list of
Union crisis or emergency mechanisms. The Commission should report on its assessments to the European
Parliament and to the Council, including on any legislative proposals for amending the Annex.
(49) Since the objective of this Regulation, namely to facilitate access to crisis-relevant products needed to address crises
or emergencies in the Union, cannot be sufficiently achieved by the Member States because of the fragmented nature
of the existing compulsory licensing framework in the Union and the limited territorial scope of national
compulsory licences, but can rather, by reason of the scale and effects of the necessary solution, be better achieved at
Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of
the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this
Regulation does not go beyond what is necessary in order to achieve that objective,
HAVE ADOPTED THIS REGULATION:
Article 1
Objective and subject matter
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.
Article 2
Scope
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.
(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).
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Article 3
Definitions
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).
Article 4
General conditions for granting a Union compulsory licence
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.
Article 5
General requirements concerning a Union compulsory licence
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;
(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).
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(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.
Article 6
Competent advisory body
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;
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(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).
Article 7
Procedure for granting a Union compulsory licence
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;
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(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.
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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.
Article 8
Content of the Union compulsory licence
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.
Article 9
Remuneration
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.
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Article 10
Obligations of the licensee
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.
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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).
Article 11
Prohibition of export
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.
Article 12
Customs control
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.
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Article 13
Conduct of the right holder and the licensee
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.
Article 14
Review and termination of the Union compulsory licence
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.
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Article 15
Fines
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.
Article 16
Periodic penalty payments
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.
Article 17
Limitation period for the imposition of fines and periodic penalty payments
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’).
(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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Article 18
Limitation period for the enforcement of fines and periodic penalty payments
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.
Article 19
Right to be heard and access to the file in the procedure for imposing fines or periodic penalty payments
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.
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Article 20
Publication of decisions on fines and periodic penalty payments
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.
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
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.
Article 23
Committee procedure
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.
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Article 24
Amendments to Regulation (EC) No 816/2006
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.’;
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(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 For the Council
The President The President
R. METSOLA M. BJERRE
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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 Public health emergency at Union Health Security Committee
Parliament and of the Council of 23 November level formally recognised by means of
(Article 4 of Regulation (EU)
2022 on serious cross-border threats to health a Commission implementing act
2022/2371)
and repealing Decision No 1082/2013/EU
(Article 23 of Regulation (EU)
2022/2371)
2. Council Regulation (EU) 2022/2372 of Emergency framework activated by Health Crisis Board
24 October 2022 on a framework of measures means of a Council Regulation
(Article 5 of Regulation (EU)
for ensuring the supply of crisis-relevant medical
(Article 3 of Regulation (EU) 2022/2372)
countermeasures in the event of a public health
2022/2372)
emergency at Union level
3. Regulation (EU) 2024/2747 of the European Internal Market emergency mode Internal Market Emergency and
Parliament and of the Council of 9 October activated by means of a Council Resilience Board
2024 establishing a framework of measures implementing act
(Article 4 of Regulation (EU)
related to an internal market emergency and to
(Article 18 of Regulation (EU) 2024/2747)
the resilience of the internal market and
2024/2747)
amending Council Regulation (EC) No 2679/98
(Internal Market Emergency and Resilience Act)
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