Overwegingen bij COM(2023)224 - Verlening van dwanglicenties voor crisisbeheersing - Hoofdinhoud
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| dossier | COM(2023)224 - Verlening van dwanglicenties voor crisisbeheersing. |
|---|---|
| document | COM(2023)224  |
| datum | 27 april 2023 |
(2)In the context of the Union crisis or emergency mechanisms, the Union should therefore have the possibility to rely on compulsory licensing. The activation of a crisis or an emergency mode or the declaration of a crisis or a state of emergency addresses obstacles to free movement of goods, services, and persons in crises and shortages of crisis-relevant goods and services. In cases where access to crisis-relevant products and processes protected by a patent cannot be achieved through voluntary cooperation, compulsory licensing can help in lifting any patent-related barriers and thus ensure the supply of products or services needed to confront an ongoing crisis or emergency. It is therefore important that, in the context of said crisis mechanisms, the Union can rely on an efficient and effective compulsory licensing scheme at Union level, which is uniformly applicable within the Union. This would guarantee a functioning internal market, ensuring the supply and the free movement of crisis-critical products subject to compulsory licencing in the internal market.
(3)The possibility of using compulsory licences in situations of national emergency or other circumstances of extreme urgency is explicitly envisaged under the Agreement on Trade-Related Aspects of Intellectual Property Rights (‘TRIPS Agreement’) 3 .
(4)All Member States have implemented compulsory licensing frameworks for patents in their national law. National laws usually allow compulsory licensing on the ground of public interest or in the event of an emergency. However, divergences exist across Member States, as regards the grounds, conditions, and procedures under which a compulsory licence can be granted. This results in a fragmented, suboptimal, and uncoordinated system preventing the Union from effectively relying on compulsory licensing when addressing a cross-border crisis.
(5)National compulsory licensing systems only operate 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. This limited territorial reach of a national compulsory licensing system is reinforced by the fact that there is no exhaustion of the patent right regarding products manufactured under a compulsory licence. Consequently, compulsory licensing schemes do not provide an adequate solution for cross-border manufacturing processes, and therefore there is no functioning internal market for product manufactured under a compulsory licence. Apart from the fact that the issuance of multiple national compulsory licences is a high hurdle for cross-border supply within the single market, it also bears the risk of contradicting and incoherent decisions among Member States. Consequently, the current compulsory licensing framework appears inadequate to address the realities of the internal market and its inherent cross-border supply chains. This suboptimal compulsory licensing framework prevents the Union from relying on an additional instrument when facing crises, in particular when voluntary agreements are unavailable or inadequate. At a time where the Union and its Member States are striving to improve their resilience to crises, it is 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 licence for crisis or emergency management at Union level. Under this system, the Commission should be empowered to grant a compulsory licence that is valid throughout the Union and that allows the manufacturing and distribution of products necessary to address a crisis or emergency in the Union (‘Union compulsory licence’).
(7)In recent years, the European Union has adopted several crisis mechanisms to improve its resilience to crises or emergencies affecting the Union. The recent mechanisms include the Single Market Emergency Instrument (SMEI) established under Regulation (EU) No XXX/XX [COM(2022) 459] and Regulation (EU) No 2022/2371 under which the Commission may recognise a public health emergency at Union level. In the event of a public health emergency at Union level a framework of measures for ensuring the supply of crisis-relevant medical countermeasures might be activated under Regulation (EU) No 2022/2372. Furthermore, in case of a significant shortage of semiconductors due to serious disruptions in their supply, the Commission may activate a crisis stage by means of implementing acts under Regulation (EU) No XXX/XX (Chips Act) [COM(2022) 46].
(8)These mechanisms provide for the activation of an emergency or crisis mode and aim at providing the means to address Union emergencies. By allowing the Commission to grant a compulsory licence when a crisis or emergency mode has been activated by a Union legal act, the necessary synergy between the existing crisis mechanisms and a Union wide compulsory licencing scheme is achieved. In such a case, the determination of the existence of a crisis or emergency depends solely on the Union legal act underlying the crisis mechanism and the crisis definition included therein. For the sake of legal certainty, the crisis mechanisms that qualify as Union emergency or extreme urgency measures and that can trigger a Union compulsory licence should be listed in an Annex to this Regulation.
(9)To ensure optimal efficiency of the Union compulsory licence as a tool to address crises, it should be made available in respect of a granted patent or utility model, of a published patent application or a supplementary protection certificate. The Union compulsory licence should equally apply to a national patents, European patents and European patents with unitary effect.
(10)Utility model systems protect new technical inventions that do not fulfil the patentability requirements through the granting of an exclusive right to prevent others, for a limited period of time, from commercially exploiting the protected inventions without consent of the right holders. The definition of utility models varies from one country to another, and not all Member States provide for utility model systems. In general, utility models are suited 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 and should therefore be included in the scope of the Union compulsory licence.
(11)A Union compulsory licence for a patent should extend to the supplementary protection certificate where such protection is granted when the patent expires during the duration period of that compulsory licence. This would allow a compulsory licence on a patent to produce its effect should the crisis-relevant products no longer be protected by a patent while being protected through a supplementary protection certificate after the expiration of the patent. It should also apply to a supplementary protection certificate in isolation where the 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 the grant of 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 legislations, as well as the European Patent Convention, provide for protection of patent applicants with regard to unconsented use of their inventions and the corresponding possibility for such applicants to licence the use of their patent application rights. In order to ensure that a Union compulsory licence on a published patent application continues to keep its effects once the patent is granted, the Union compulsory licence for published patent applications should extend to the patent once granted to the extent that the crisis-relevant product still falls within the scope of the patent claims.
(13)It should be clarified that this Regulation is without prejudice to Union law on copyright and related rights, including Directives 96/9 4 , 2009/24 5 Directives 2001/29/EC 6 , 2004/48/EC 7 and (EU) 2019/790 8 of the European Parliament and of the Council, which establish specific rules and procedures that should remain unaffected.
(14)When a compulsory licence has been granted, regulatory data protection may, if still in force, prevent the effective use of the compulsory licence as it impedes the authorisation of generic medicinal products. This would result in serious negative consequences for Union compulsory licences granted to tackle a crisis, as this could hamper access to the medicinal products needed to address the crisis. For this reason, Union pharmaceutical legislation (cf. Art. 80 para. 4 of Directive (EU) No XXX/XX [COM(2023)192]) provides for the suspension of data exclusivity and market protection when a compulsory licence has been issued to tackle a public health emergency. Such suspension is allowed only in relation to the compulsory licence granted and its beneficiary and must comply with the objectives, the territorial scope, the duration, and the subject-matter of the granted compulsory licence. The suspension means that the data exclusivity and market protection produce no effect in relation to the licensee of the compulsory licence while that licence is in effect. When the compulsory licence ends, the data exclusivity and market protection resume their effect. The suspension should not result in an extension of the original duration of the regulatory data protection.
(15)In order to ensure as much coherence as possible with existing crisis mechanisms and with other Union legislation, the definition of a ‘crisis-relevant product’ should be based on the definition adopted in the Single Market Emergency Instrument (SMEI) but should be more general in order to cover products related to different kinds of crises or emergencies.
(16)A Union compulsory licence authorises the use of a protected invention without the consent of the rights-holder. Therefore, it must only be granted exceptionally and under conditions that take into account the interests of the rights-holder. This includes a clear determination of the scope, duration and territorial coverage of the licence. In the context of a Union level crisis mechanism, the crisis mode or emergency mode is activated or declared for a limited period of time. Where a Union compulsory licence is granted within such framework, the duration of the licence shall not extend beyond the duration of the activated or declared crisis or emergency mode. In order to ensure that the compulsory licence fulfils its objective as well as its conditions, the use of the invention should only be authorised to a qualified person able to manufacture the crisis-relevant product and to pay a reasonable remuneration to the rights-holder.
(17)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 by an advisory body. The consultation of the advisory body should arise early in the discussions on the need to issue a compulsory licence under the relevant instrument. Discussions on whether there is a need for a Union compulsory licence will often start already in the context of the work of the advisory body involved in the context of the relevant Union crisis or emergency mechanisms. In such case, there is no need for the Commission to convene the advisory body but rather to swiftly indicate that that body also has the competence to assess the need for compulsory licensing at Union level, and the conditions thereof. Clarification as regards the competence of the advisory body should be given early in the process, as soon as concrete consideration of using compulsory licensing at Union level is expressed by the Commission.
(18)The participation of an advisory body aims at guaranteeing a comprehensive, thorough, and concrete assessment of the situation, taking into consideration the individual merits of each situation. It is therefore important that the advisory body has the right composition, expertise, and procedures to support the Commission when deciding on whether to grant a Union compulsory licence and under what conditions. Union crisis mechanisms usually include the setting-up of an advisory body ensuring coordination of action of the Commission and relevant bodies and agencies, the Council and the Member States. In this respect, an advisory group is set up under SMEI. Regulation (EU) No 2022/2371 provides for a Health Crisis Board and under Regulation (EU) No XXX/XX (Chips Act) [COM/2022) 46], the Commission relies on the Semiconductor Board. Those advisory bodies have the right composition, expertise, and procedures to address the crises and emergencies for which they have been set-up. When compulsory licensing is being discussed in the context of such crisis instrument, relying on the advisory body set-up for the specific instrument allows the Commission to be adequately advised and avoid duplication of advisory bodies, leading to incoherences between processes. The competent advisory bodies shall be listed, together with the corresponding crisis mechanisms, in an Annex to this Regulation. In case the Union crisis mechanism does not provide for an advisory body, the Commission should set up an ad hoc advisory body for the granting of the Union (the ‘ad hoc advisory body’).
(19)The role of the advisory body is to advise the Commission when discussions arise on the need to rely on compulsory licensing at Union level. It should provide the Commission with a non-binding opinion. Its main tasks include assisting of the Commission in the determination of the necessity to rely on compulsory licensing at Union level, and in the determination of the conditions for such licensing. When the advisory body is already set up, its existing rules of procedure should apply. As regards ad hoc advisory bodies, they should be composed of one representative of each Member State in order to provide the Commission with information and input concerning the situation on the national level, including information on manufacturing capacities, potential licensees and, if applicable, proposals for voluntary solutions. In addition, the advisory body should have the function of collecting and analysing relevant data, as well as ensuring coherence and cooperation with other crisis relevant bodies at Union and national level in order to ensure an adequate, coordinated and coherent crisis reply at Union level.
(20)The Commission should grant the Union compulsory licence in the light of the non-binding opinion of the advisory body. Persons, in particular the licensee and the rights-holder, whose interests may be affected by the Union compulsory licence should be given the opportunity to submit their comments. These elements should enable the Commission to consider the individual merits of the situation and determine, on that basis, the adequate conditions of the licence, including an adequate remuneration to be paid by the licensee to the rights-holder. To avoid overproduction of products manufactured under a Union compulsory licence, the Commission should also consider any existing compulsory licences at national level.
(21)The Commission should guarantee that the rights-holder has the right to be heard before the adoption of the Union compulsory licence. Therefore, the Commission should inform the concerned rights-holder, where possible individually, without undue delay that a Union compulsory licence might be granted. The involvement of the rights-holder should be possible once there are ongoing advanced discussions in the relevant advisory body as regards the granting of a Union compulsory licence.
(22)When informed of advanced discussions as regards the granting of a Union compulsory licence, the rights-holder should have the possibility to propose a voluntary agreement, should the circumstances of the Union crisis or emergency, including the urgency of the situation, allow it. The rights-holder should also be given the opportunity to comment on the need for a Union compulsory licence and on the conditions of the licence, including remuneration, should it be granted. To this end, the rights-holder should be allowed to provide the Commission with written or oral comments and any information the rights-holder considers useful to allow the Commission to make a fair, comprehensive, and thorough assessment of the situation. The Commission should allow the rights-holder a reasonable period of time to provide comments and information, considering the situation of the rights-holder and the urgency of the situation. The comments of the rights-holder should, where relevant, be transmitted by the Commission to the competent advisory body. In order for confidential information to be shared with the Commission, the Commission shall ensure a safe environment for the sharing of this information and should take measures to preserve the confidentiality of the documents provided by the rights-holder in the context of that procedure. Once a Union compulsory licence has been granted, the Commission should notify the rights-holder as soon as reasonably practicable.
(23)The initiation of the compulsory licensing procedure should be publicised, by means of a notice published in the Official Journal of the European Union. This notice should include information on the discussions about the granting of a Union compulsory licence in the context of a Union crisis or emergency mechanism. This notice should also help the Commission in identifying the intellectual property rights concerned, the rights-holders concerned as well as potential licensees.
(24)The Commission should, assisted by the advisory body, make its best efforts to identify in its decision the patent, patent application, supplementary protection certificate and utility model related to the crisis-relevant products, and the rights-holders of those intellectual property rights. In certain circumstances, the identification of intellectual property rights and of their respective rights-holders may require lengthy and complex investigations. In such cases, a complete identification of all intellectual property rights and of their rights-holders may seriously undermine the efficient use of the Union compulsory licence to swiftly tackle the crisis or the emergency. Therefore, where the identification of all those intellectual property rights or rights-holders would significantly delay the granting of the Union compulsory licence, the Commission should be able to initially only indicate in the licence the non-proprietary name of the product for which it is sought. The Commission should nevertheless identify all applicable and relevant intellectual property rights and their rights-holder as soon as possible and amend the implementing act accordingly. The amended implementing act should also identify any necessary safeguards and remuneration to be paid to each identified rights-holder.
(25)Where the rights-holder or not all the rights-holders could be identified in a reasonable period of time, the Commission should exceptionally be entitled to grant the Union compulsory licence by referring only to the non-proprietary name of the crisis-relevant product where it is absolutely necessary considering the urgency of the situation. Nevertheless, after the granting of the Union compulsory licence, the Commission should identify, notify and consult the concerned rights-holders as quickly as possible, including by relying on publication measures and on national Intellectual Property Offices.
(26)The Union compulsory licence should also include information allowing the identification of the crisis-relevant product for which it is granted, as well as details on the licensee to whom the Union compulsory licence is granted, including details about the description, name or brand of the product; the commodity codes under which the crisis-relevant products are classified, as defined in Council Regulation (EEC) No 2658/87; details on the licensees (and, where applicable, the manufacturers) to whom the compulsory licence is granted, including their name, trade name or registered trade mark, their contact details, their unique identification number in the country where they are established and, where available, their Economic Operators Registration and Identification (EORI) number. Where required under Union legislation, other information should be included, such as a type, reference, model, batch or serial number, or unique identifier of a product passport.
(27)The licensee should pay an adequate remuneration to the rights-holder as determined by the Commission. The amount of the remuneration should be determined considering the economic value of the exploitation authorised under the licence to the licensee and to the Member States concerned by the crisis, any public support received by the rights-holder to develop the invention, the degree to which development costs have been amortized as well as humanitarian circumstances relating to the granting of the Union compulsory licence. In addition, the Commission should consider the comments made by the rights-holder and the assessment made by the advisory body with regard to the amount of the remuneration. In any case, the remuneration should not exceed 4 % of the total gross revenue generated by the licensee through the acts under the Union compulsory licence. This percentage is the same as the one provided for under Regulation 816/2006. In the event of a compulsory licence granted on the basis of a published patent application that ultimately does not lead to the granting of a patent, the rights-holder would have no ground to receive remuneration under the compulsory licence, as the subject matter for the receipt of the remuneration has not materialised. In such circumstances, the rights-holder should refund the remuneration it received under the compulsory licence.
(28)It is imperative that products manufactured under a Union compulsory licence reach only the internal market. The Union compulsory licence should therefore impose clear conditions upon the licensee as regards the activities authorised under the licence, including the territorial reach of those activities. The rights-holder should be able to challenge actions and uses of the rights concerned by the Union compulsory licence that do not comply with the conditions of the licence, as infringement of its intellectual property rights in accordance with Directive 2004/48/EC of the European Parliament and of the Council 9 . In order to facilitate monitoring of the distribution of products manufactured under a Union compulsory licence, including controls by customs authorities, the licensee should ensure that such products have special characteristics that make them easily identifiable and distinguishable from the products marketed by the rights-holder.
(29)A Union compulsory licence in the context of a Union crisis or emergency mechanism should only be granted to supply the internal market with crisis-relevant products. Therefore, it should be prohibited to export products manufactured under a Union compulsory licence.
(30)Customs authorities should ensure, through a risk analysis approach, that products manufactured under a Union compulsory license are not exported. To identify such products, the main source of information to feed such customs risk-analysis should be the Union compulsory license itself. Information on each implementing act granting or modifying a Union compulsory license should thus be entered in the Electronic Customs Risk Management System (CRMS) referred to in Article 36 of Commission Implementing Regulation (EU) 2015/2447 10 . When customs authorities identify a product that is suspected not to comply with the export prohibition, they should suspend the export of that product and notify the Commission immediately. 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 its assessment the Commission may consult the relevant rights-holder. Where the Commission concludes that a product does not comply with the export prohibition, customs authorities should refuse its export.
(31)The legal validity of the implementing act granting the Union compulsory license, or any subsequent implementing act, should be subject to judicial review.
(32)The relation between the rights-holder and the licensee should be governed by the principle of good faith. The rights-holder and licensee should work towards the success of the Union compulsory licence and collaborate, where necessary, to ensure that the Union compulsory licence effectively and efficiently fulfils its objective. The Commission may act as an enabler in achieving the good-faith cooperation between the rights-holder and the licensee, taking into account interests of all parties. In that respect, the Commission should also be entitled to take additional measures in line with Union law to ensure that the compulsory licence meets its objective and ensure that necessary crisis-relevant goods can be made available in the Union. Such additional measures may include requesting further information which is deemed indispensable to achieve the objective of the compulsory licence. These measures should always include adequate safeguards to ensure the protection of the legitimate interests of all parties.
(33)In order to respond appropriately to the crisis situations, the Commission should be authorised to review the conditions of the Union compulsory licence and adapt them to changed circumstances. This should include the modification of the compulsory licence to indicate the complete list of rights and rights-holders covered by the compulsory licence, where this complete identification had not be done initially. This should also include the termination of the licence if the circumstances which led to it cease to exist and are unlikely to recur. When deciding on the revision of the Union compulsory licence, the Commission may decide to consult the competent advisory body for that purpose. If the Commission intends to change essential components of the Union compulsory licence, such as its duration or remuneration or if the change itself could be the subject of a separate compulsory licence, it should be required to consult the advisory body.
(34)To prevent and stop any misuse of the Union compulsory licence, specific safeguards should be in place to allow the Commission to take action. In addition to the possibility to terminate the Union compulsory licence, the Commission should be authorised to impose fines and periodic penalty payments on the rights-holder and the licensee in order to enforce the obligations under this Regulation. The penalties should be effective, proportionate and dissuasive.
(35)Compliance with the relevant obligations imposed under this Regulation should be enforceable by means of fines and periodic penalty payments. To that end, appropriate levels of fines and periodic penalty payments should be laid down and the imposition of fines and periodic penalty payments should be subject to appropriate limitation periods in accordance with the principles of proportionality and ne bis in idem. All decisions taken by the Commission under this Regulation are subject to review by the Court of Justice of the European Union in accordance with the TFEU. The Court of Justice of the European Union should have unlimited jurisdiction in respect of fines and penalty payments in accordance with Article 261 TFEU.
(36)When a national compulsory licence has been granted for the purpose of addressing a crisis, the Member State or its competent authority should be required to notify the Commission of the granting of the licence, and of the specific conditions attached to it, since it allows the Commission to get an overview of national compulsory licences in the Member States and to take those compulsory licences into account when considering a Union compulsory licence, and in particular when setting the conditions for such licence.
(37)The possibility of a compulsory licence at Union level should not only be available for the supply of the Union market but also under certain conditions for export purposes concerning countries with public health problems, already regulated by Regulation (EC) No 816/2006 of the European Parliament and of the Council 11 . Under that Regulation, the granting of such compulsory licences is decided and performed nationally by the competent authorities of the Member States that have received a corresponding application from a person that intends to manufacture and sell pharmaceutical products covered by a patent or a supplementary protection for export to eligible third countries. Regulation (EC) No 816/2006 only allows compulsory licensing covering the manufacturing of products across several Member States through national procedures. In the context of a cross-border manufacturing process different national compulsory licences would be needed. This can lead to a burdensome and lengthy process as this would require the launch of different national procedures with possibly different scope and conditions. In order to achieve the synergies and efficient process as for the Union crisis mechanisms, a Union compulsory licence should also be available, in the context of Regulation (EC) No 816/2006. This will facilitate manufacturing of the relevant products across several Member States and provide Union-level solution in order to avoid a situation where several compulsory licences for the same product in more than one Member States would be required for licensees to manufacture and export the products as planned. Any person considering to apply for a compulsory licence under, for the purposes and within the scope of Regulation (EC) No 816/2006 should have the possibility to request, with a single application, a compulsory licence under that Regulation that is valid throughout the Union, if that person, when relying on national compulsory licencing schemes of the Member States, would otherwise need to apply for multiple compulsory licences for the same crisis-relevant product in more than one Member State in order to realise its intended activities of manufacture and sale for export under Regulation (EC) No 816/2006. Therefore, Regulation (EC) No 816/2006 should be amended accordingly.
(38)In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the granting, complementing, modification or termination of a Union compulsory license, the determination of the remuneration to be paid to the rights-holder, the procedural rules for the ad hoc advisory body and the characteristics allowing the identification of products produced under a Union compulsory licence. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council 12 . The advisory procedure should be used for the adoption of implementing acts granting, complementing, modifying or terminating a Union compulsory licence, and implementing acts determining the remuneration. The choice of the advisory procedure is justified given that those implementing acts would be adopted in the context of a procedure with considerable participation of the Member States through the consultation of the advisory body. The examination procedure should be used for the adoption of implementing acts establishing procedural rules for the ad hoc advisory body and implementing acts establishing the characteristics allowing the identification of products produced under a Union compulsory licence.
(39)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 or the determination of the remuneration, imperative grounds of urgency so require.
(40)Union compulsory licensing for crisis management is a tool that is only used in exceptional circumstances. The evaluation should therefore be conducted only where a Union compulsory licence has been granted by the Commission. The evaluation report should be submitted by the last day of the third year following the granting of the Union compulsory licence, to allow an adequate and substantiated assessment of this Regulation.
(41)Since a period of time is required to ensure that the framework for the proper functioning of the system for Union compulsory licencing is in place, the application of this Regulation should be deferred.