Toelichting bij COM(2023)224 - Verlening van dwanglicenties voor crisisbeheersing

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dossier COM(2023)224 - Verlening van dwanglicenties voor crisisbeheersing.
bron COM(2023)224 EN
datum 27-04-2023
1.CONTEXT OF THE PROPOSAL

•Reasons for and objectives of the proposal

Intangible assets such as inventions, trade secrets and know-how are the cornerstone of the EU economy and competitiveness. Patent rights, in particular, play a key role in supporting EU innovation and creating the right environment for investment. For European innovation to flourish, a solid, predictable, and flexible legal framework for intellectual property rights, including patents, needs to be created. The Unitary Patent system helps further improve and harmonise the EU legal framework on patents. Beyond this, the Commission action plan on intellectual property rights has identified several areas of patent law that need to be further improved and harmonised. One of these areas is compulsory licensing. The COVID-19 crisis highlighted that an appropriate balance between patent rights and other rights and interests is a staple of the patent system. During the COVID-19 crisis, the conflicting interests were access to health products and preserving innovation incentives that are key to developing new health products, such as vaccines and therapeutics. The pandemic added another element to the discussion: the role intellectual property rights could and should play in a crisis. In other words, the question became: how we can preserve the balance and incentives for innovation while ensuring swift access to critical products and technologies in crises, even in the absence of voluntary agreements. Patent law already provides a solution: compulsory licensing.

A compulsory licence is the possibility for a government to allow a third party to use a patent without the authorisation of the rights-holder, subject to certain conditions. Compulsory licensing can therefore complement current EU efforts to improve its resilience to crises. In the aftermath of the COVID-19 crisis, the EU has tabled several EU crises instruments, such as the Proposal for a Regulation establishing a Single Market Emergency Instrument (SMEI) or 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. These instruments provide the EU with a means of ensuring access to products needed to tackle a crisis in the Internal Market. The instruments focus on voluntary approaches. As evidenced by the COVID-19 crisis, voluntary agreements remain the most efficient tool to enable rapid manufacturing of patent-protected products, including in crises. However, there may be cases where such voluntary agreements are not available or appropriate. In such circumstances, compulsory licensing can provide a solution to allow the rapid manufacturing of products needed to tackle a crisis. However, to guarantee that such products can freely circulate within the Internal Market and reach all those in need, the compulsory licensing shall be granted at EU level.

Compulsory licensing has a dual role, as it can incentivise the conclusion of voluntary agreements and also enable the manufacturing of products needed to tackle a crisis in the absence of (appropriate) voluntary agreements. However, for compulsory licensing to fulfil this role, an efficient compulsory licensing scheme needs to be built in the EU, able to rely on the Single Market, complementing EU crisis instruments and in line with the EU’s international obligations.

The Agreement on Trade-Related Aspects of Intellectual Property Rights (‘TRIPS Agreement’) sets the international legal framework on compulsory licensing. Article 31 of the TRIPS Agreement provides the framework for compulsory licensing in relation to the domestic market, while Article 31bis of the TRIPS Agreement provides the rules for compulsory licensing for the manufacturing and export of pharmaceutical products to countries with public health problems.

There is currently no EU-wide harmonisation of compulsory licensing for the domestic market, including as regards European patents with a unitary effect. Instead, there is a patchwork of different national rules and procedures on compulsory licensing. National rules have insufficient territorial reach, since products manufactured under a compulsory licence in one Member State either cannot be supplied to another Member State, or can only be supplied in limited quantities. National procedures are also different from each other, and decision-making is not coordinated at EU level. This limits the ability to rely on the Internal Market to guarantee supplies across all the Union territory.

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

•Consistency with existing policy provisions in the policy area

In its intellectual property action plan, the Commission underlined ‘the need to ensure that effective systems for issuing compulsory licences are in place’. The 2023 Commission work programme announced the establishment of clear rules for the compulsory licensing of patents. In the Council conclusions of 18 June 2021, the Council confirmed that the EU stood ready to discuss the flexibilities of compulsory licensing for the domestic market and for export purposes to third countries. It also confirmed the need to explore possible intellectual property tools and options to better coordinate the management of cross-border crises. In its resolution of November 2021, the European Parliament called on the Commission ‘to analyse and explore possible options for ensuring effectiveness and better coordination of compulsory licensing in the EU’.

The TRIPS Agreement provides the international legal framework for compulsory licensing. This initiative is strictly in line with the boundaries of the TRIPS Agreement. Although the Unitary Patent system aims to further harmonise EU law on patents, it leaves the issue of compulsory licensing to national legislation. There are currently three other pieces of EU legislation that contain provisions on compulsory licensing:

·Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights: Article 29 of this Regulation provides for the possibility for the Community Plant Variety Office to grant a compulsory licence on a community plant variety right, on application by a Member State, by the Commission or by an organisation set up at EU level;

·Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions: Article 12 of this Directive provides for the possibility to apply for a compulsory licence, where a plant breeder cannot use a plant variety without infringing a patent or where the holder of a patent concerning a biotechnological invention cannot exploit it without infringing a prior plant variety right;

·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: This Regulation sets out a procedure to grant compulsory licences in relation to patents and supplementary protection certificates concerning the manufacture and sale of pharmaceutical products, when such products are intended for export to eligible importing countries that need these products to address public health problems.

The first two EU acts cited above are not impacted by this proposal. The proposal would amend Regulation (EC) No 816/2006 in order to add the possibility, in the context of a cross-border manufacturing process, to rely on a compulsory licence granted by the Commission and applicable in the territory of the Union.

Member States have implemented different compulsory licensing schemes in national legislation, only applicable to their national territory. The proposal leaves these national compulsory licensing systems untouched. The Union compulsory licensing system introduced by this proposal does not aim at addressing purely national crises. The proposal instead aims to address crises that have a cross-border dimension within the EU, which do not fall within the scope of national compulsory licensing schemes.

This proposal is part of the EU patent package, which also provides for the introduction of a system for Unitary Supplementary Protection Certificates and an initiative on standard essential patents. The proposal complements the Unitary Patent system, which is a major step towards the completion of the Single Market for patents. Against this backdrop of increasing completion of the Single Market for patents, the initiative on compulsory licensing is therefore at the crossroads between the different EU crisis instruments and the international obligations and discussions on IP rights and compulsory licensing.

•Consistency with other Union policies

The Commission has recently tabled proposals to improve the EU’s resilience to crises and better guarantee well-functioning supply chains in the Single Market. In that respect, reference can be made to the following key EU legislations:

·Proposal for a Regulation establishing a Single Market emergency instrument (‘SMEI’);

·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 (‘SCBTH’);

·Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level (‘Emergency Framework Regulation’);

·Proposal for a Regulation of the European Parliament and of the Council establishing a framework of measures for strengthening Europe's semiconductor ecosystem (‘Chips Act’).

These pieces of legislations can either qualify as crisis instruments or as containing a crisis mechanism, setting up emergency mechanisms to ensure the supply of and access to critical products in the Single Market. None of these EU crisis instruments explicitly includes the use of compulsory licensing to address a crisis. This proposal makes compulsory licencing one of the tools available to respond to a crisis within the respective emergency frameworks, by closely linking compulsory licencing to EU crisis instruments.

The reform of the pharmaceutical legislation also provides for the suspension of regulatory data and market protection where a compulsory licence has been granted for a patent relating to a medicinal product in order to address a public health emergency (see Article 80 para. 4 of Directive (EU) XXX/XX [COM(2023)192]). This increases the effectiveness of a compulsory licence, as rules on regulatory data and market protection can impede the authorisation of generic medicinal products.

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2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY


•Legal basis

The proposal is based on Articles 114 and 207 of the Treaty on the Functioning of the EU (‘TFEU’). Article 114 TFEU empowers the European Parliament and the Council to adopt measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States, which have as their object the establishment and functioning of the internal market. Article 207 TFEU confers on the EU competence in the field of common commercial policy, including as regards IP rights which is relevant, since the proposal has an impact on Regulation (EC) No 816/2006, relating to the compulsory licensing of medicines for export purposes to third countries.

•Subsidiarity (for non-exclusive competence)

Action at EU level is justified to ensure the smooth functioning of the Single Market in crises. Currently, Member States can only act nationally, meaning that they can grant a compulsory licence for their own territory only. This can be sufficient for purely national crises, where both the crisis and the manufacturing capacities are in the same Member State. However, this will not be sufficient when a crisis has a cross-border dimension – this is considered highly probable due to the prevalence of cross-border supply chains. The inability of Member States to properly address a crisis with a cross-border dimension originates in the territoriality of national compulsory licensing schemes and the divergent, sometimes sub-optimal, compulsory licensing schemes in place to tackle a crisis. The proposed EU action will act on these specific points by creating a Union compulsory licence with a streamlined procedure. Without action at EU level, Member States would remain vulnerable to crises that have a cross-border dimension. Introducing an EU compulsory licensing scheme will help build a more resilient EU by providing an additional collective tool that supports other crisis instruments such as SMEI or the Emergency Framework Regulation.

•Proportionality

The adoption of a Regulation establishing a Union compulsory licensing scheme for crisis management does not go beyond what is necessary to achieve the identified objectives. It is limited to the aspects that Member States cannot achieve satisfactory on their own and where the EU can act more effectively, efficiently and with greater added value. The initiative’s objective is to build a Union compulsory licensing scheme able to tackle crises with a cross-border dimension, in addition to the existing compulsory licensing national schemes for grounds other than crises. The proposal is therefore limited to what is necessary to tackle crisis with a cross-border dimension, only when such action cannot be implemented at national level or when such implementation would be inefficient.

•Choice of the instrument

The chosen instrument is a Regulation establishing a compulsory licencing system for crisis management at EU level with its own triggers, procedure and conditions. It leaves national compulsory licencing schemes in the Member States untouched but ensures coherence with other crisis and emergency instruments at EU level and is fully compliant with the international requirements for compulsory licencing laid down in the TRIPS Agreement.

Alternative regulatory methods such as a Directive harmonising national compulsory licencing schemes of the Member States are not considered appropriate.

First, a Directive would only create a certain degree of harmonisation. While the harmonisation of key aspects of compulsory licencing could help improve and clarify the features of national schemes, Member States’ competent authorities would remain in charge of determining whether a crisis exists and whether to grant a compulsory licence. Hence, there would be a risk that the Directive would not be implemented and applied in a uniform manner due to existing differences in national law proceedings and judicial traditions.

Second, a Directive would only improve the situation of cross-border supply of products to a limited extent, as both the compulsory licence granted in the manufacturing country and those granted in the importing country would be based on harmonised rules. However, the lack of exhaustion of the patent right would still require several compulsory licences in all manufacturing and importing Member States.

Other measures like the adoption of recommendations aiming to bring about more uniformity of national laws would neither satisfactorily address the fragmentation of compulsory licensing in the EU nor the insufficient territorial reach of a national compulsory licence and coherence with existing and upcoming EU crisis instruments at EU level.

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3.RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS


•Stakeholder consultations

The Commission conducted a call for evidence between 1 April and 29 April 2022, to gather views, opinions and evidence from public and private sector stakeholders. 57 stakeholders submitted feedback.

The European Commission also held an open public consultation between 7 July 2022 and 29 September 2022. This public consultation aimed to collect views from all stakeholders on how to build the most efficient compulsory licensing scheme in the EU and to ensure that it is fit to tackle EU-wide and global crises. This consultation was available on the Commission’s better regulation portal and open to everybody. The public consultation received 74 replies. The results of the public consultation show that a large majority of respondents consider that public authorities should be entitled to allow production of critical products through a compulsory licence. Respondents are usually more in favour of a coordinating role for European institutions than a decision-making role. This can be explained by the fact that businesses and industry representatives expressed low levels of support for a decision-making role, and they were the dominant group of respondents to the consultation. Stakeholders generally consider the option of granting a compulsory licence at EU level, as proposed in this initiative, more positively in relation to the EU’s ability to tackle crises than the granting of a compulsory licence at national level. There is a clear difference between among stakeholder views on this, with low support from industry representatives: a majority of companies and business associations consider that the impact would be negative. In contrast, no respondent in any other category considers the impact to be negative. A large majority considers it positive.

•Collection and use of expertise

In March 2022, the Commission launched the ‘Compulsory licensing of intellectual property rights’ study [CEIPI(2023)]. The study’s objective was to assist the Commission in identifying potential problems as regards compulsory licensing in the EU and identifying and assessing policy options to improve coherence and effectiveness in the field. To this end, the study aimed to collect data through desk research, case studies, interviews with stakeholders as well as organising two workshops. The study was conducted by the Centre for International Intellectual Property Studies (CEIPI), the Université de Strasbourg (UNISTRA), the Impact Licensing Initiative (ILI) and Ecorys Nederland BV (ECORYS).

During the study, Member State experts were asked to complete a questionnaire. The questions focused on the national experiences with compulsory licensing, the scope of application of compulsory licences and procedural aspects. In addition, a series of 25 semi-structured interviews of national experts, academia, policy representatives and industry experts were conducted. These interviews focused on gathering ‘non-published’ data on national procedures and legal requirements of compulsory licensing.

Two workshops were held:

·A first workshop on ‘information collection on specific compulsory licence cases with exchange of views and experiences in the field of IPRs’ was held in Brussels on 28/29 April 2022;

·A second workshop on ‘policy options for compulsory licensing in Europe in case of a crisis’ was held in Brussels on 9/10 June 2022.

A total of 24 participants attended both workshops, representing patent attorneys from multiple Member States, policy officials and representatives from different industries.

•Impact assessment

An impact assessment was carried out for the initiative, which received a positive opinion with reservations from the Regulatory Scrutiny Board on 3 February 2023. The impact assessment considered four policy options, in addition to the policy option consisting of no policy change:

·Option 1: Recommendation on compulsory licensing for crisis management. This would identify good national practices on compulsory licensing for crisis management and good coordination practices, with a view to increasing their uptake in Member States. This option was deemed insufficient, as it would not have a sufficient harmonising effect nor an appropriate territorial reach. In addition, it would not fully embed compulsory licensing in the EU crisis instruments.

·Option 2: Harmonisation of national laws on compulsory licensing for crisis management. The legislative initiative would harmonise national laws on the grounds, scope, procedure, and conditions for granting a compulsory licence for crisis management. The compulsory licence would remain within the remit of Member States and have predominantly a national effect. Although this option would further harmonise national compulsory licensing schemes, the territorial reach and coherence with EU crisis instruments of this option were still considered suboptimal.

·Option 3: Harmonisation and EU level binding measure to grant a compulsory licence for crisis management. The compulsory licence could be triggered: (i) by an EU-level decision activating a crisis mode or declaring an emergency under an existing EU crisis instrument (e.g. activation of the emergency mode under SMEI); or (ii) upon a request made to the Commission by more than one Member State in case of a cross-border crisis. The Commission, assisted by the relevant advisory body, would adopt an activation measure requiring one or several Member States to issue a compulsory licence. Option 3 would lead to several national compulsory licences, each applying to the territory of several EU countries or the whole EU. This option provided an appropriate territorial reach and ensured good coherence with EU crisis instruments. In addition, it would provide increased harmonisation compared to Option 2. However, this harmonisation, and resulting coherence and efficiency of the Union compulsory licence, was limited compared to the optimal solution provided under Option 4.

·Option 4: Union compulsory licence to complement existing EU crisis instruments. The triggers would be the same as under Option 3. However, the Commission, assisted by the relevant advisory body, would adopt an activation measure granting a compulsory licence. This option would lead to the issuance, by the Commission, of one compulsory licence, with its own procedure and conditions and applicable to the territory of several EU countries or the whole EU.

According to the impact assessment, Option 4 would be the most effective and efficient to achieve the initiative’s objectives. This preferred option would create a single procedure to grant a Union compulsory licence with the necessary features to tackle a crisis. The Commission activation measure would ensure that conditions are the same across the EU and would avoid national discrepancies that are likely to slow down or prevent an efficient compulsory licensing scheme to tackle cross-border crises. This single compulsory licence would apply in all relevant territories, covering cross-border situations. This would be the case for both the EU market and for export purposes. Coherence with EU crisis instruments would be ensured by the possibility to use their trigger and by reference to the (advisory) bodies set-up by the EU crisis instruments to discuss a Union compulsory licence. The proposed procedure would also cover crises with a cross-border dimension in the EU but which do not reach the activation threshold for an EU crisis instrument (e.g. a crisis spreading across several Member States). In the option described in the impact assessment, the procedure could be also initiated by the Member State(s) affected. However, following internal discussions within the Commission, the Member State right to initiate the procedure was not included in the legislative proposal. (as a result, the proposal partially deviates from Option 4 discussed in the impact assessment). Maintaining only the EU crisis instrument route was judged to be more coherent with the remaining EU crisis preparedness policy tools and more appropriate in terms of the exceptional nature of the proposed tool. The likely impacts of this change would be an even simpler procedure of initiation and more confidence among patent holders that the instrument would only be activated in case of major EU-wide crises. The latter would also limit potential detrimental effects of the proposal on competitiveness. No additional costs would be created by the change.

Under the preferred option, patent owners would see a reduction in costs and legal uncertainty, as negotiations would be limited to participation in one EU-level procedure. Potential licensees would benefit from the centralised procedure and the wide territorial scope of the licence that can bring economies of scale. Better sharing of information would also allow a reduction of costs for Member States as it could help identify best practices. On enforcement costs, Member States would benefit from the centralised procedure, as costs linked to the negotiations with the patent owners and the manufacturers would be incurred solely at EU level. EU residents would greatly benefit from this option as it would improve the EU’s ability to issue an effective and efficient compulsory licence for the whole EU, including where there are cross-border supply chain disruptions. Third countries would also benefit from this option as this would provide the possibility of a compulsory licence covering a cross-border supply chain.

Improved EU readiness to tackle a major crisis would bring positive social impacts, as it would help limit various disruptions to everyday societal processes by curbing the crisis or eliminating it altogether. Although societal disruption can be caused by a crisis in any area (e.g. threats to the environment, national security, etc.), the recent COVID-19 pandemic provided multiple examples of disruptions that could have been avoided with a more effective resilience tool. With regard to the environmental impact, the initiative’s positive impacts could be decisive in increasing access to products and technologies that can tackle environmental crises. Since no environmental legislation is affected by this proposal and its principal objective is to streamline and harmonise compulsory licensing procedures in cross-border crises, no significant harm to the environment is expected under any of the options analysed.

•Regulatory fitness and simplification

The proposal creates a compulsory licencing system centralised at EU level. In crises a compulsory licence covering the whole EU can be granted by filing a single application and using a single procedure under unitary procedural rules and conditions. This means that one procedure can achieve what would otherwise only be achievable with the help of several national compulsory licencing procedures before different competent authorities of the Member States. If an unforeseen future crisis occurs, the compulsory licencing system established by the proposal would lower the costs of participation in compulsory licencing negotiations incurred by patent holders, manufacturers and Member States.

•Fundamental rights

The initiative would provide an additional tool to face crises. Through the improved supply of critical products and services, the most fundamental needs and rights of people in the EU (such as safety and health) would be more swiftly and efficiently catered for in a crisis setting.

This initiative impacts the right to intellectual property of patent and utility models owners (Article 17 i of the EU Charter of fundamental rights – the ‘Charter’), as compulsory licensing partially deprives patent owners of control over their rights. Intellectual property rights are not absolute rights, and limitations on the exercise of these rights are allowed under the Charter, provided that the proportionality principle is respected. In that respect, the proposal provides that compulsory licensing would remain an exceptional mechanism, with a scope limited to cross-border crises. In addition, compulsory licences would always be granted on a non-exclusive basis and subject to a definite duration. Finally, patent owners would be able to share their views on granting a compulsory licence and the conditions surrounding it. An important aspect of the conditions relates to patent owners being able to receive fair compensation for the limitation of their right. The proposal provides that patent owners would always be entitled to receive appropriate remuneration in respect of each compulsory licence granted under this initiative. This initiative may have a positive impact on other fundamental rights, as it would provide an additional tool to face crises, including health-related (right to health care – Article 35 of the Charter) or environmental crises (right to environmental protection – Article 37 of the Charter).

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4.BUDGETARY IMPLICATIONS


If an unforeseen future crisis occurs, the proposed initiative would lower the costs incurred by patent holders, manufacturers and Member States of participating in compulsory licensing negotiations. These costs could be lower by roughly 75% to 80% for firms, compared to the status quo scenario (see impact assessment). For Member States, if national compulsory licensing negotiations were replaced by EU-level negotiations, the administrative costs are expected to stay unchanged or fall, as the same effort would be shared among several countries. The exact monetary value of cost savings for stakeholders is not possible to provide due to the rarity of such events and because the type and scale of any such future crisis are unknown. As the new instrument would only be used during major crisis affecting the EU, as a measure of last resort, its expected frequency of use is very low.

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5.OTHER ELEMENTS


•Implementation plans and monitoring, evaluation and reporting arrangements

The proposed legislation includes a provision requiring an evaluation report no later than 3 years after the activation of a Union compulsory licence procedure. The preferred option requires Member States to inform the European Commission when they are considering granting and when they have granted a compulsory licence for crisis management, as well as providing information on the compulsory licence (i.e. transparency over the subject matter of the compulsory licence, the manufacturer, the conditions, etc.). Since recourse to compulsory licensing is expected to be rare, the overall number of compulsory licences issued on the basis of the proposed instrument is expected to be low. This means that monitoring of the basic descriptive indicators is not expected to require additional systems for data collection and monitoring (the collection and processing of information can be done manually).

•Detailed explanation of the specific provisions of the proposal

Article 1 specifies the subject matter of the proposal. It specifies that this proposal lays down the procedure and conditions for granting a Union compulsory licence to address a crisis in the EU.

Article 2 provides for the scope of the Union compulsory licence. To ensure the Union compulsory licence functions effectively during crises, the scope of the compulsory licence covers patents, published patent applications, supplementary protection certificates and utility models.

Article 3 provides definitions of key elements of this proposal. The definitions are based on existing definitions.

Article 4 provides the legal basis for the Commission to grant a Union compulsory licence for the whole EU. Under this provision, the Commission is entitled to grant a Union compulsory licence when a crisis mode or emergency mode is activated or declared at EU level. This aims to complement EU crisis mechanisms by allowing compulsory licensing to be used as part of such mechanisms.

Article 5 lays down the general conditions to be taken into account by the Commission when granting a Union compulsory licence.

Article 6 sets out rules for the consultation of an advisory body that is meant to provide the Commission with a non-binding opinion when considering a Union compulsory licence.

Article 7 sets out the procedure for granting a Union compulsory licence. The article states that the Union compulsory licence is granted by means of an implementing act. It also provides for sufficient participation by the rights-holder in order to guarantee their right to be informed and to provide comments. Further, it sets out the Commission’s obligation to identify relevant rights-holders with regards to the compulsory licence.

Article 8 lays down rules on the specifications of the Union compulsory licence. The article further specifies the aspects the Commission should consider in its decision and the details that need to be specified.

Article 9 obliges the licensee to pay appropriate remuneration to the rights-holder and lays down criteria for the Commission to determine such remuneration.

Article 10 provides for specific conditions of the Union compulsory licence, to be fulfilled by the licensee. The article includes conditions limiting the use of the invention covered by the Union compulsory licence.

Article 11 provides for an export ban on products manufactured under a Union compulsory licence. These products cannot be exported outside the European Union.

Article 12 details the control measures undertaken by custom services, including as regards the export ban.

Article 13 establishes the principle of good faith in the relationship between rights-holder and licensee.

Article 14 entitles the Commission to modify, complement with additional measures or terminate the compulsory licence under certain conditions.

Article 15 entitles the Commission to issue fines if any of the parties to the compulsory licence do not comply with their obligations under this Regulation.

Article 16 entitles the Commission to issue periodic penalty payments if any of the parties to the compulsory licence do not comply with their obligations under this Regulation.

Article 17 provides for the rules as regards the limitation period for the imposition of fines and periodic penalty payments.

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Article 18 provides for the rules as regards limitation period for the enforcement of fines and periodic penalty payments


Article 19 provides for the rules as regards the right for the rights-holder and the licensee to be heard and to access to the file in relation with the imposition of fines and periodic penalty payments.

Article 20 requires that the Commission publish the decisions on the imposition of fines and periodic penalty payments.

Article 21 provides that the Court of Justice of the European Union is entitled to review decisions by which the Commission has imposed fines or periodic penalty payments.

Article 22 requires Member States to notify the Commission if a national compulsory licence has been granted in order to address a crisis situation.

Article 23 amends existing Regulation (EC) No 816/2006 by Article 18a and Article 18b. Article 18a lays down rules on the grant of a Union compulsory licence for purposes of exporting medical products to third countries with public health problems. The article states that the Union compulsory licence is granted by means of an implementing act.
Article 18b establishes a reference to the comitology committee as well as the reference to Regulation (EU) No 182/2011.

Article 24 establishes a committee for comitology procedure as well as the reference to the respective provisions in Regulation (EU) No 182/2011.

Article 25 requires the Commission to carry out a review where a Union compulsory licence has been granted due to a cross-border crisis in the EU.

Article 26 sets out the date when the regulation enters into force.