Activities of Heidi HAUTALA related to 2023/0129(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on compulsory licensing for crisis management and amending Regulation (EC) 816/2006
Shadow opinions (1)
OPINION on the Proposal for a Regulation of the European Parliament and of the Council on Compulsory licensing for crisis management and amending Regulation (EC) 816/2006
Legal basis opinions (0)
Amendments (102)
Amendment 25 #
Proposal for a Regulation
Recital 3
Recital 3
(3) The possibility of using compulsory licences in situations of national emergency or other circumstances of extreme urgencyand determining the grounds upon which such licences can be granted is explicitly envisaged under the Agreement on Trade-Related Aspects of Intellectual Property Rights (‘TRIPS Agreement’)3 . __________________ 3 OJ L 336, 23.12.1994, p. 214
Amendment 31 #
Proposal for a Regulation
Recital 28
Recital 28
(28) It is imperative that products manufactured under a Union compulsory licence areach only the internal marke predominantly destined for the internal market, in line with Article 31f of the TRIPS Agreement. 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 Council9 . 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. __________________ 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).
Amendment 33 #
Proposal for a Regulation
Recital 29
Recital 29
(29) A Union compulsory licence in the context of a Union crisis or emergency mechanismunder this Regulation should only be granted to predominantly supply the internal market with crisis- relevant products. Therefore, it should be prohibited to export products manufactured under a Union compulsory licence.
Amendment 39 #
Proposal for a Regulation
Recital 37
Recital 37
(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 Council11 . 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. In order to ensure the efficient processing of applications for compulsory licences under Regulation (EC) No 816/2006, Member States should have the ability to put in place adequate purely formal or administrative requirements, such as rules on the language of the application, the form to be used, and rules on applications made in electronic form. Such requirements should not add unnecessary costs or burdens on the applicant and, in any event, should not render the procedure for granting compulsory licences under this Regulation more burdensome than the procedure for the granting of other compulsory licences under the TRIPS Agreement. 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. Furthermore, empirical evidence demonstrates that certain conditions are difficult to meet. 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 facilitatshould be further facilitated by reviewing the conditions for issuing compulsory licences for export, in line with the TRIPS Agreement. A Union compulsory licence will facilitate the use of this mechanism and all the 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. __________________ 11 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).
Amendment 42 #
Proposal for a Regulation
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) ‘crisis-relevant products’ means products or processes that are indispensable for responding to a crisis or emergency or for, addressing the impacts of a crisis or emergency in the Union, such as by guaranteeing the continued availability of a product in the Single Market in specific cases where an urgent public interest supersedes the monopoly rights of the patent-holder;
Amendment 44 #
Proposal for a Regulation
Article 6 – paragraph 2 – point b
Article 6 – paragraph 2 – point b
(b) the analysis of the crisis-all relevant information gathered by Member States or the Commission and aggregated data received by other crisis-relevant bodies at Union and international level;
Amendment 46 #
Proposal for a Regulation
Article 6 – paragraph 2 – point c
Article 6 – paragraph 2 – point c
(c) the facilitation of exchanges and sharing of information with other relevant bodies and other crisis-relevant bodies at Union and national level, as well as at international level, where appropriate;
Amendment 52 #
Proposal for a regulation
Citation 1
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114, 168 and 207 thereof,
Amendment 53 #
Proposal for a Regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
The export of products manufactured under a Union compulsory licence is prohibitedproducts manufactured under a Union compulsory licence shall be authorised predominantly destined for the supply of the EU internal market, except for products manufactured under a Union compulsory licence destined for export to countries facing public health problems.
Amendment 54 #
Proposal for a regulation
Recital 1
Recital 1
(1) CThe public interest, notably in the context of crises require the setting-up of exceptional, swift, and adequate measures able to provide means to address the consequences of the crisisa fair response to the needs at hand. In this context, the use of patented products or processes could prove indispensable to address the consequences of a crisis. Voluntary licensing agreements usually suffice to licence the patent rights on these products and allow their supply in the Union territory. Voluntary agreements are the most adequate, quick, and efficient solution to allow the use of patented products, and to scale up production, including in crises. Nevertheless, voluntary agreements may not always be available or only under inadequate conditions such as lengthy delivery times. In such cases, compulsory licensing can provide a solution to allow access to patented products, in particular products necessary to tackle the consequences of a crisis.
Amendment 55 #
Proposal for a regulation
Recital 2
Recital 2
(2) In the context of the Union crisis or emergency mechanisms having a cross- border effect in the Union and involving two or more Member States, the Union should therefore have the possibility to rely on compulsory licensing to adequately respond to the needs commanded by the public interest. 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.
Amendment 57 #
Proposal for a regulation
Recital 3
Recital 3
(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 . WTO Agreement on Trade Related Aspects of Intellectual Property Rights (‘TRIPS Agreement’)3 provides for a possibility, under conditions, to issue compulsory licences. This provides governments the authority to grant the use of a patented invention without the consent of the patent owner. The Doha Declaration on the TRIPS Agreement and Public Health makes it clear that each WTO Member has not only the right to grant a compulsory licence, but also the freedom to determine the grounds upon which such licence are granted, including the possibility of using such licence in situations of national emergency or other circumstances of extreme urgency, as provided by the TRIPS Agreement. _________________ 3 OJ L 336, 23.12.1994, p. 214.
Amendment 60 #
Proposal for a Regulation
Article 12 – paragraph 3
Article 12 – paragraph 3
3. Where customs authorities identify a product that may 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 ithe Commission to establish whether the product was manufactured under a Union compulsory license. To assess whether the suspended products correspond to the Union compulsory licenseBefore taking a decision, the Commission may consult the relevant rights-holder.
Amendment 61 #
Proposal for a regulation
Recital 7
Recital 7
(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. Moreover, Regulation (EU) 2022/123, which strengthens the European Medicines Agency's role in crisis preparedness and management, creates a framework aimed at mitigating shortages of medicinal products during major events. 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].
Amendment 62 #
Proposal for a regulation
Recital 8
Recital 8
(8) These mechanisms provide for the grant of compulsory licences to protect the public interest, including in the context of cross-border crisis or emergency situations in the Union, in one or more Member States or at international level activation of an emergency or crisis mode and aim at providing the means to address Union emergencies. By allowing tThe Commission tomay grant a Union compulsory licence when a crisis or emergency mode has been activated by a Union legal acin the public interest, including but not limited to national emergency or other circumstances of extreme need, including a health crisis or major events in the meaning of Regulation(EU) 2022/123, situations of shortages, or involving excessive or abnormally high prices of a medical product, or where there is a need to build up a strategic stock, or in other situations where the grant of a compulsory licence should be deemed lawful. By allowing the Commission to grant a compulsory licence when a crisis or emergency mode, including in the event of a major event, 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 incluon the assessment requirements provided undedr thereiis regulation. 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 Regulationnot contravene the spirit and provisions of the TRIPS Agreement, especially their Article 31, which should remain the reference on the matter.
Amendment 63 #
Proposal for a Regulation
Article 12 – paragraph 4 – point b
Article 12 – paragraph 4 – point b
Amendment 65 #
Proposal for a Regulation
Article 12 – paragraph 5
Article 12 – paragraph 5
5. Where the Commission concludes that a product manufactured under a Union compulsory licence does not comply with the prohibition laid down in Article 11, customs authorities shall not authorise its release for export. Tthe Commission shall inform the concerned rights-holder of such non-compliance.
Amendment 65 #
Proposal for a regulation
Recital 9
Recital 9
(9) To ensure optimal efficiency of the Union compulsory licence as a tool to address public interest needs and 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.
Amendment 70 #
Proposal for a Regulation
Article 12 – paragraph 6 – introductory part
Article 12 – paragraph 6 – introductory part
6. Where the release for export of a product has not been authorisedCommission concludes that a product manufactured under a Union compulsory licence does not comply with the prohibition laid down in Article 11:
Amendment 71 #
Proposal for a Regulation
Article 12 – paragraph 6 – point a
Article 12 – paragraph 6 – point a
(a) where appropriate in view of the crisis or emergency context, the Commission may require customs authorities to obligeest the exporter to take specific actions at their own costs, including supplying them to designated Member States, if need be, after rendering them compliant with Union law.
Amendment 72 #
Proposal for a Regulation
Article 12 – paragraph 6 – point b
Article 12 – paragraph 6 – point b
(b) in all other cases, customs authoritiesthe Commission may take any necessary measure to ensure that the product concerned is disposed of in accordance with national law consistent with Union law. Articles 197 and 198 of Regulation (EU) No 952/2013 shall apply accordingly.
Amendment 72 #
Proposal for a regulation
Recital 15
Recital 15
(15) In order to ensure as much coherence as possible with requirements pertaining to the public interest, 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 emergencisituations calling for the grant of Union compulsory licenses.
Amendment 76 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a a (new)
Article 23 – paragraph 1 – point –a a (new)
Regulation (EC) No 816/2006
Article 6 – paragraph 2
Article 6 – paragraph 2
(-a a) Paragraph (2) of Article 6 is amended as follows: 2. If the person applying for a compulsory licence is submitting multiple applications to authorities in more than one country for the same product, he shall indicate that fact in each application, together with details of the quantities and importing countries concerned.
Amendment 77 #
Proposal for a regulation
Recital 16
Recital 16
(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 persons able to manufacture the crisis-relevant product and to pay, when relevant, a reasonable remuneration to the rights-holder.
Amendment 78 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a b (new)
Article 23 – paragraph 1 – point –a b (new)
Regulation (EC) No 816/2006
Article 6 – paragraph 3 – point c
Article 6 – paragraph 3 – point c
(c) the-a b) Point (c) Article 6(3) is amended as follows : (c) the expected amount of pharmaceutical product which the applicationt seeks to produce under the compulsory licence;
Amendment 79 #
Proposal for a regulation
Recital 17
Recital 17
(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.
Amendment 81 #
Proposal for a Regulation
Article 23 – paragraph 1- point –a c (new)
Article 23 – paragraph 1- point –a c (new)
Regulation (EC) No 816/2006
Article 6 – paragraph 3 – point e
Article 6 – paragraph 3 – point e
(-a c) Point (e) of Article 6(3) is amended as follows: (e) where applicable, evidence of efforts for prior negotiation with the rights-holder pursuant to Article 9;
Amendment 81 #
Proposal for a regulation
Recital 18
Recital 18
(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, andindependence, expertise, and can rely on the adequate 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, independence, 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’).
Amendment 86 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a e (new)
Article 23 – paragraph 1 – point –a e (new)
Regulation (EC) No 816/2006
Article 7
Article 7
Amendment 87 #
Proposal for a regulation
Recital 20
Recital 20
(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, should it be granted. To avoid overproduction of products manufactured under a Union compulsory licence, the Commission should also consider any existing compulsory licences at national level.
Amendment 89 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a g (new)
Article 23 – paragraph 1 – point –a g (new)
Regulation (EC) No 816/2006
Article 10 – paragraph 1
Article 10 – paragraph 1
(-a g) Paragraph (1) of Article 10 is amended as follows : 1. The licence granted shall be non- assignable, except with that part of the enterprise or goodwill which enjoysnon-profit organisation that makes use of the licence, and non- exclusive. It shall contain the specific conditions set out in paragraphs 2 to 9 to be fulfilled by the licensee. (AM aims at amending paragraph 1 and deleting paragraphs 2, 3, 4, 5, 6, 7 & 8 of Article 10 of Regulation 816/2023. This implies a renumbering (not change of wording) of existing paragraphs 9 (should become new paragraph 2) and paragraphs 10 (should become new, as laid down by the relevant Articles of the TRIPS Agreement. Or. en paragraph 3).)
Amendment 90 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a h (new)
Article 23 – paragraph 1 – point –a h (new)
Regulation (EC) No 816/2006
Article 10 – paragraph 2
Article 10 – paragraph 2
(-a h) Paragraph (2) of Article 10 is deleted.
Amendment 90 #
Proposal for a regulation
Recital 22
Recital 22
(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 balance to be made between the public interest on the one hand, and the situation of the rights-holder andon the other, and considering the urgency of the situation. The comments of the rights-holder should, where relevant, be transmitted by the Commission to the competent advisory body on a timely basis. 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.
Amendment 93 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a i (new)
Article 23 – paragraph 1 – point –a i (new)
Regulation (EC) No 816/2006
Article 10 – paragraph 3
Article 10 – paragraph 3
(-a i) Paragraph (3) of Article 10 is deleted.
Amendment 95 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a j (new)
Article 23 – paragraph 1 – point –a j (new)
Regulation (EC) No 816/2006
Article 10 – paragraph 4
Article 10 – paragraph 4
(-a j) Paragraph (4) of Article 10 is deleted.
Amendment 95 #
Proposal for a regulation
Recital 24
Recital 24
(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, when relevant, to each identified rights-holder.
Amendment 97 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a k (new)
Article 23 – paragraph 1 – point –a k (new)
Regulation (EC) No 816/2006
Article 10 – paragraph 5
Article 10 – paragraph 5
(-a k) Paragraph (5) of Article 10 is deleted.
Amendment 99 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a l (new)
Article 23 – paragraph 1 – point –a l (new)
Regulation (EC) No 816/2006
Article 10 – paragraph 6
Article 10 – paragraph 6
(-a l) Paragraph (6) of Article 10 is deleted.
Amendment 100 #
Proposal for a regulation
Recital 27
Recital 27
(27) The licensee shouldmay have to pay an adequate remuneration to the rights-holder as determined by the Commission. The amount of the remuneration, should it be granted, 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.
Amendment 101 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a m (new)
Article 23 – paragraph 1 – point –a m (new)
Regulation (EC) No 816/2006
Article 10 – paragraph 7
Article 10 – paragraph 7
(-a m) Paragraph (7) of Article 10 is deleted.
Amendment 101 #
Proposal for a regulation
Recital 28
Recital 28
(28) It is imperative that products manufactured under a Union compulsory licence reach onpredominantly 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 Council9 . 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. _________________ 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).
Amendment 102 #
Proposal for a regulation
Recital 29
Recital 29
(29) A Union compulsory licence in the context of a Union crisis or emergency mechanism should only be granted to predominantly supply the internal market with crisis- relevant products. TWherefore, it should be prohibin a Union compulsory licence has been granted tofor export products manufactured under a Union compulsory licenceto countries with public health problems, the full production should be exported to them.
Amendment 103 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a n (new)
Article 23 – paragraph 1 – point –a n (new)
Regulation (EC) No 816/2006
Article 10 – paragraph 8
Article 10 – paragraph 8
(-a n) Paragraph (8) of Article 10 is deleted.
Amendment 106 #
Proposal for a regulation
Recital 32 a (new)
Recital 32 a (new)
(32a) Where appropriate, the Commission should oblige the rights- holder to disclose the trade secrets which are strictly necessary in order to achieve the purpose of the Union compulsory licence. Indeed, it is possible that the detailed description of how to carry out the invention might not be sufficient and complete enough to enable the licensee to efficiently use that invention. This may include but may not be limited to the full transfer of needed technology, knowhow, test data, samples and reference products needed for production and market authorization, taking into account the public interest. In cases where that additional information and know-how is necessary, some of which is an undisclosed trade secret, the disclosure of that necessary trade secret, with a view to achieving the purpose of exercising the Union compulsory licence pursuant to this Regulation, should be considered to be lawful within the meaning of Article 3(2) and Article 5 of Directive (EU) 2016/943 of the European Parliament and the Council. The Commission should require the rights-holders to put in place all appropriate measures, including technical and organisational measures, to ensure the confidentiality of trade secrets, in particular vis-à-vis third parties and the protection of the legitimate interests of all parties.
Amendment 107 #
Proposal for a Regulation
Article 23 – paragraph 1 – point a
Article 23 – paragraph 1 – point a
2. Any person may submit an application for a compulsory licence under paragraph 1. The application shall fulfil the requirements laid down in Article 6 (3) and shall specify the Member States to be covered by the compulsory licence.
Amendment 107 #
Proposal for a regulation
Recital 32 b (new)
Recital 32 b (new)
(32b) This Regulation should guarantee that the Commission has the authority to compel rights-holders to provide all necessary information to facilitate the rapid and efficient production of critical products, such as pharmaceuticals and other health-related items. This information should encompass details about know-how, test data, samples and reference products, particularly when it is essential for the effective implementation of compulsory licensing.
Amendment 109 #
Proposal for a regulation
Recital 33
Recital 33
(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 potential remuneration or if the change itself could be the subject of a separate compulsory licence, it should be required to consult the advisory body.
Amendment 111 #
Proposal for a regulation
Recital 34
Recital 34
(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, and should not contravene the usual enforcement measures of Intellectual Property rights as provided by Directive 2004/48/EC.
Amendment 113 #
Proposal for a regulation
Recital 36
Recital 36
(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.
Amendment 114 #
Proposal for a regulation
Recital 37
Recital 37
(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 Council11 . 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. _________________ 11 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).
Amendment 117 #
Proposal for a regulation
Recital 38
Recital 38
(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 tohat may 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 Council12 . 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, should it be granted. 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. _________________ 12 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 the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 118 #
Proposal for a regulation
Recital 39
Recital 39
(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 potential remuneration, imperative grounds of urgency so require.
Amendment 119 #
Proposal for a regulation
Recital 40
Recital 40
(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. It should focus on the efficiency of the procedures set up by this regulation, notably with respect to the promptness in which all stakeholders, including rights- holders, participate in them. 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.
Amendment 122 #
Proposal for a regulation
Recital 41
Recital 41
Amendment 123 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation has the objective to ensure that in crises the Union has access to crisis-relevant productsa temporary and non-exclusive Union compulsory license may be granted for the exploitation of the patent or the patent application, to protect the public interest, including in the context of cross-border crisis or emergency situations in the Union or at international level. To this end, this Regulation lays down rules on the procedure and conditions for the granting of a Union compulsory licence of intellectual property rights that are necessary for the manufacture and supply of crisis-such relevant products to the Member States in the context of a Union crisis or emergency mechanismand their components to the Member States when needed.
Amendment 131 #
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
2. This Regulation is without prejudice to the rules laid down by other Union legal acts regulating copyright and related rights, including Directive 2001/29, Directive 2009/24, Directive 2004/48/EC and the sui generis rights granted by Directive 96/9/EC on the legal protection of databases.
Amendment 134 #
Proposal for a regulation
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) ‘crisis-relevant products’ means products or processes that are indispensable for responding tostrumental for safeguarding the public interest, o for responding to exceptional public health needs, such as in a crisis or emergency, or for addressing the impacts of a crisis or emergency in the Union, as determined by the Commission through the guidance of the advisory body in accordance with Article 6;
Amendment 139 #
Proposal for a regulation
Article 3 – paragraph 1 – point e
Article 3 – paragraph 1 – point e
(e) ‘Union compulsory licence’ means a compulsory licence granted by the Commission or a relevant authority to exploit a protected invention of crisis-relevant products for any of the relevant activities in the Union;
Amendment 145 #
Proposal for a regulation
Article 4 – paragraph 1 a (new)
Article 4 – paragraph 1 a (new)
The Commission may grant a Union compulsory licence in the public interest, including in but not limited to the following situations: (a) a national emergency or other circumstances of extreme need, including a health crisis; (b) a situation involving problems of supply or availability in insufficient quantity or quality; (c) a situation involving excessive or abnormally high prices of a medical product, building up a strategic stock; (d) in case of lawful uses of the Intellectual Property rights, such as public non-commercial uses; (e) any other situations where considered needed by the applicant of the request for a compulsory licence, following proper examination by the Supervisory Board according to the provisions of this Regulation.
Amendment 147 #
Proposal for a regulation
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) be non-exclusive and non- assignable, except with that part of the enterprise or goodwillnon-profit which enjoys such compulsory licence;
Amendment 151 #
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
(b) have a scope and duration that isare limited to the purpose for which the compulsory licence is granted and limited to the scope and duration of the crisis or emergency mode in the framework offramework and conditions under which it is granted;
Amendment 153 #
Proposal for a regulation
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
(c) be strictly limited to the relevantnecessary activities of crisis-relevant products in the Union;
Amendment 155 #
Proposal for a regulation
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) only be granted against payment of an adequate remuneration to the rights- holder, when relevant ;
Amendment 160 #
Proposal for a regulation
Article 5 – paragraph 1 – point f
Article 5 – paragraph 1 – point f
(f) only be granted to athe persons deemed to be in a position to exploit the protected invention in a manner that permits the proper carry out of the relevant activities of the crisis-relevant products and in accordance with the obligations referred to in Article 10.
Amendment 166 #
Proposal for a regulation
Article 6 – paragraph 2 – introductory part
Article 6 – paragraph 2 – introductory part
2. The advisory body referred to in paragraph 1 shall be the advisory body competent for the Union crisis or emergency mechanism as listed in Annex I to thisFor the purposes of the present Regulation, (the ‘competent advisory body’). For the purposes of the present Regulation, referred to in paragraph 1 (‘the competent advisory body’) shall assist and advise the Commission as regards the following tasks:
Amendment 169 #
Proposal for a regulation
Article 6 – paragraph 2 – point a
Article 6 – paragraph 2 – point a
(a) the gathering of crisisontext-relevant information, market intelligence and the analysis of those data;
Amendment 171 #
Proposal for a regulation
Article 6 – paragraph 2 – point c
Article 6 – paragraph 2 – point c
(c) the facilitation of exchanges and sharing of information with other relevant institutional bodies and other crisis-relevant bodentities at Union and national level, as well as at international level, where appropriate;
Amendment 172 #
Proposal for a regulation
Article 6 – paragraph 2 – point d
Article 6 – paragraph 2 – point d
(d) the identification of the rights protecting the crisis-relevant product;
Amendment 173 #
Proposal for a regulation
Article 6 – paragraph 2 – point f
Article 6 – paragraph 2 – point f
(f) the identification and consultation of the representatives of right holders or their representatives as well as potential licensees and consulting other stakeholders and economic operators, and the industrincluding industry, academia and civil society;
Amendment 178 #
Proposal for a regulation
Article 6 – paragraph 4 – point a
Article 6 – paragraph 4 – point a
(a) shall ensure participation and invite representatives of other crisis-relevant institutional bodies at Union level as observers to the relevant meetings of the advisory body in order to ensure coherence with the measures implemented through other Union mechanisms; and
Amendment 181 #
Proposal for a regulation
Article 6 – paragraph 4 – point b
Article 6 – paragraph 4 – point b
(b) may invite representatives of the European Parliament, rto contribute to the meetings of the advisory body. Representatives of economic operators, right holders, potential licensees, stakeholder organisations, social partners and experts to attend meetings of the advisory bodymay be invited as observers.
Amendment 188 #
Proposal for a regulation
Article 6 – paragraph 6
Article 6 – paragraph 6
6. The Commission shall adopt an implementing act laying down the rules of procedure for the ad hoc advisory body referred to in paragraph 5. The rules of procedure shall specify that the ad hoc advisory body shall not be set up for a period exceeding the duration of the crisis or emergenforce stringent safeguards to avoid any potential conflicts of interest, and to ensure accountability and transparency. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 24 (3).
Amendment 189 #
Proposal for a regulation
Article 7 – paragraph 1 – point a
Article 7 – paragraph 1 – point a
(a) the nature of the public interest, crisis or emergency;
Amendment 190 #
Proposal for a regulation
Article 7 – paragraph 1 – point b
Article 7 – paragraph 1 – point b
(b) the scope of the public interest, crisis or emergency and how it is expected to evolve;
Amendment 191 #
Proposal for a regulation
Article 7 – paragraph 1 – point c
Article 7 – paragraph 1 – point c
(c) the shortage of crisis-or lack of access to relevant products and the existence of other means than a Union compulsory licence that could adequately and swiftly remedy such shortage.
Amendment 196 #
Proposal for a regulation
Article 7 – paragraph 3 – introductory part
Article 7 – paragraph 3 – introductory part
3. Before the granting of a Union compulsory licence, the Commission shall give the rights-holder and the licensee an opportunity to comment in a reasonable delay on the following:
Amendment 201 #
Proposal for a regulation
Article 7 – paragraph 3 – point a
Article 7 – paragraph 3 – point a
(a) the possibility to promptly reach a voluntary licensing agreement with manufacturers on intellectual property rights for the purpose of manufacturing, using and distributing the crisis-relevant products;
Amendment 212 #
Proposal for a regulation
Article 7 – paragraph 6 – point b
Article 7 – paragraph 6 – point b
(b) the rights and interests of the rights-holder and the licensee;
Amendment 214 #
Proposal for a regulation
Article 7 – paragraph 6 – point c
Article 7 – paragraph 6 – point c
(c) existing national compulsory licences and relevant procedures reported to the Commission in accordance with Article 22.
Amendment 215 #
Proposal for a regulation
Article 7 – paragraph 6 – point c a (new)
Article 7 – paragraph 6 – point c a (new)
(ca) the public interest identified.
Amendment 223 #
Proposal for a regulation
Article 8 – paragraph 1 – point a
Article 8 – paragraph 1 – point a
(a) the patent, patent application, supplementary protection certificate or utility model for which the licence is granted or, where the identification of those rights would significantly delay the granting of the licence, the non- proprietary name of the products which are to be manufactured under the licence;
Amendment 236 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. The licensee shallmay pay an adequate remuneration to the rights-holder. The amount of the remuneration shall be determined by the Commission and specified in the Union compulsory licence.
Amendment 244 #
Proposal for a regulation
Article 9 – paragraph 3 – point d a (new)
Article 9 – paragraph 3 – point d a (new)
(da) the possible disclosure of trade secrets for the purpose of exercising the Union compulsory licence pursuant to Article 13a(1), and the relevant limitations to the protection of trade secrets according to Directive (EU) 2016/943.
Amendment 248 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point a
Article 10 – paragraph 1 – subparagraph 1 – point a
(a) the number of crisis-relevant products manufactured under the Union compulsory licence does not exceed what is necessary to meet the needs of the Union;
Amendment 250 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point b
Article 10 – paragraph 1 – subparagraph 1 – point b
(b) the relevant activities are carried out solepredominantly for the supply of the crisis- relevant products in the Union market, unless intended for export for countries facing public health challenges regulated under Regulation 816/2006;
Amendment 252 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point c
Article 10 – paragraph 1 – subparagraph 1 – point c
Amendment 253 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point d
Article 10 – paragraph 1 – subparagraph 1 – point d
Amendment 254 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point e
Article 10 – paragraph 1 – subparagraph 1 – point e
Amendment 258 #
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. The European Anti-Fraud Office (OLAF) in cooperation with the relevant national authorities of the Member States may, at the request of the rights-holder or on its own initiative, and on the basis of sufficient elements of proof of misuse, request access to books and records kept by the licensee, for the purpose of checking whether the content and the conditions of the Union compulsory licence, and in general the provisions of this Regulation, have been complied with.
Amendment 259 #
Proposal for a regulation
Article 10 – paragraph 4
Article 10 – paragraph 4
4. The Commission is empowered to adopt implementing acts establishing rules for the specific labelling or mregarkding referred to in paragraph 1, point (c), and for the packaging, colourthe conditions applicable under this Regulation, ing and shaping referred to in point (d) as well as rules for their use and, where relevant, their positioning on the producccordance with the requirements enshrined in the TRIPS Agreement. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24(2).
Amendment 260 #
Proposal for a regulation
Article 11 – title
Article 11 – title
Amendment 262 #
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
The export ofproducts manufactured under a Union compulsory licence shall be authorised predominantly for the supply of the internal market, except for products manufactured under a Union compulsory licencse is prohibitedfor export under Regulation (EC) No 816/2006.
Amendment 264 #
Proposal for a regulation
Article 12 – paragraph 3
Article 12 – paragraph 3
3. Where customs authorities identify a product that may 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 under a Union compulsory license. To assess whether the suspended products correspond to the Union compulsory license, the Commission may consult the relevant rights-holder and refer to the requirements provided under Directive 2004/48/EC.
Amendment 266 #
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. In compliance with the good faith obligation, the rights-holder and the licensee shall make their best efforts to fulfil the objective of the Union compulsory licence. This may include but may not be limited to the full transfer of needed technology, knowhow, test data, samples and reference products needed for production and market authorisation, taking into account each other'sthe public interests.
Amendment 268 #
Proposal for a regulation
Article 13 a (new)
Article 13 a (new)
Article 13a Additional measures complementing the Union compulsory licence 1. Where necessary , the Commission shall decide, upon a reasoned request by the rights-holder or the licensee, or on its own initiative, on additional measures complementing the Union compulsory licence to ensure it achieves its objective as well as to facilitate and ensure the good collaboration between the rights-holder and the licensee. 2. Where necessary, the Commission shall request from the rights-holders the disclosure of trade secrets to the licensee in order to provide them with the necessary know-how, test data, samples and reference products to strictly achieve the objective of the Union compulsory licence as provided for in this Regulation. In such cases, the Commission shall order all appropriate measures necessary to preserve the confidentiality of trade secrets, in particular in relation to third parties. 3. Where the Commission considers modifying or adopting additional measures as referred to in paragraphs 1 and 2, it shall consult the advisory body referred to in Article 6. 4. Appropriate remuneration to the rights-holders in compensation for the disclosure of their trade secrets may be granted in accordance with Directive (EU) 2016/943.
Amendment 272 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The Commission shall review the Union compulsory licence upon reasoned request by the rights-holder or the licensee or on its own initiative and shall, where needed, modify the specifications referred to in Article 8 by means of an implementing act. Where necessary and feasible, the Union compulsory licence shall be modified to indicate the complete list of rights and rights-holders covered by the compulsory licence.
Amendment 292 #
Proposal for a regulation
Article 22 – paragraph 1 – introductory part
Article 22 – paragraph 1 – introductory part
When a national compulsory licence has been granted for the public interest or for the purpose of addressing a national crisis or emergency, the Member State shall notify the Commission of the granting of the licence and of the specific conditions attached to it. The information provided shall include the following:
Amendment 293 #
Proposal for a regulation
Article 22 – paragraph 1 – point d
Article 22 – paragraph 1 – point d
(d) the remuneration to be paid to the rights-holder, when relevant;
Amendment 294 #
Proposal for a regulation
Article 23 – paragraph 1 – point a
Article 23 – paragraph 1 – point a
Regulation (EC) No 816/2006
Article 18a
Article 18a
2. Any person may submit an application for a compulsory licence under paragraph 1. The application shall fulfil the requirements laid down in Article 6 (3) and shall specify the Member States to be covered by the compulsory licence.
Amendment 295 #
Proposal for a regulation
Article 26 – title
Article 26 – title
Entry into force and application
Amendment 296 #
Proposal for a regulation
Article 26 – paragraph 1 a (new)
Article 26 – paragraph 1 a (new)
It shall apply from [the first day of the month following the period of twelve months after the date of entry into force].
Amendment 300 #
Proposal for a regulation
Annex I
Annex I