19 Amendments of Henna VIRKKUNEN related to 2023/0132(COD)
Amendment 27 #
Proposal for a directive
Recital 4 a (new)
Recital 4 a (new)
(4 a) The pharmaceutical framework should be consistent with overarching EU industrial policy, including the Council Conclusions from 23 March 2023 which stressed the importance of strengthening incentives for investment in innovation and the 2016 Council Conclusions which stress any revision, including to the incentive framework, should not discourage the development of medicinal products needed for the treatment of rare diseases; increased innovation will further support patient outcomes and public health.
Amendment 72 #
Proposal for a directive
Recital 50
Recital 50
(50) The establishment of a criteria- based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, ‘relevant patient population’, ‘quality of life’, ‘burden of administration’ following scientific assessment by the Agency. The Agency will seek input from a broad range of authorities orand bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development. The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest.
Amendment 113 #
Proposal for a directive
Recital 63
Recital 63
(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and it is considered necessary, in order to facilitate the market entry of generic, biosimilar, hybrid and bio-hybrid medicinal products that rely on a reference medicinal product, to clarify its scope and limitations in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conduct studies and trials and other activities needed for the regulatory approval process, health technology assessment and pricing reimbursement request, even though this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval process. Any (excess) patented products that were manufactured for the purpose of Art 85 (a) or (b) shall not be commercially exploited, including after the approval of said marketing authorization application. These should be dealt with in accordance with TRIPS Article 46.
Amendment 121 #
Proposal for a directive
Recital 64
Recital 64
(64) It will allow, inter alia, to conduct studies to support pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that period, contributing to the market entry of generics and biosimilars on day one of loss of the patent or SPC protection.
Amendment 128 #
Proposal for a directive
Recital 69
Recital 69
(69) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem, and there is scientific evidence that the presenclevels of some of thoese substances inmay pose a risk to the environment from their manufacturing, use and disposal poses a risk to the environment and public health. The evaluation of the legislation showed that strengthening of existing measures to reduce the impact of medicinal products' lifecycle on the environment and public health is required. Measures under this Regulation complement the main environmental legislation, in particular the Water Framework Directive (2000/60/EC50 ), the Environmental Quality Standard Directive (2008/105/EC51 ) the Groundwater Directive (2006/118/EC52 ), the Urban Wastewater Treatment Directive (91/271/EEC53 ), the Drinking Water Directive (2020/218454 ) and the Industrial Emissions Directive (2010/75/EU55 ). _________________ 50 Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). 51 Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84). 52 Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration (OJ L 372, 27.12.2006, p. 19). 53 Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40). 54 Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast) (OJ L 435, 23.12.2020, p. 1). 55 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (recast) (OJ L 334, 17.12.2010, p. 17).
Amendment 133 #
Proposal for a directive
Recital 70
Recital 70
(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures where medicinal products are demonstrated to pose a risk to the environment according to the ERA. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation should be refused. The ERA should be updated when new data or knowledgand fails to address short- comings indicated by the Agency or competent authority, the marketing authorisation shall be provisional while not prohibiting or delaying patient access to medicines. The ERA should be updated when new data that changes the ERA conclusions or evidence about relevant risks become available.
Amendment 138 #
Proposal for a directive
Recital 71
Recital 71
(71) Marketing authorisation applicants should take into accountconsider the relevance of environmental risk assessment procedures of other EU legal frameworks that may apply to chemicals dependent on their use. Further to this Regulation, there are four main other frameworks: (i) Industrial chemicals (REACH, (Regulation (EC) No 1907/2006); (ii) Biocides (Regulation (EC) No 528/2012); (iii) Pesticides (Regulation (EC) No 1107/2009); and (iv) Veterinary medicines (Regulation (EU) 2019/6)). As a part of the Green Deal, the Commission has proposed a ‘one-substance one- assessment’ (OS-OA) approach for chemicals56 , in order to increase the efficiency of the registration system, reduce costs and unnecessary animal testing. while not prohibiting or delaying patient access to medicinal products. _________________ 56 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, Brussels (2019), COM(2019) 640 final.
Amendment 142 #
Proposal for a directive
Recital 72
Recital 72
(72) The emissions and discharges of antimicrobialbiotics to the environment from manufacturing sites may lead to antimicrobialbiotic resistance (“AMBR”), which is a global concern regardless where the emissions and discharges take place. Therefore, the ERA scope should be extended to cover the risk of AMR selection during the entire life cycle of antimicrobials, including manufacturingantibiotic resistance selection during manufacturing of the antibiotics.
Amendment 143 #
Proposal for a directive
Recital 74
Recital 74
(74) For medicinal products authorised prior to October 2005, without any ERA, specific provisions should be introduced to set up a risk based prioritisation programme for the ERA submission or update by the current market authorisation holders for those medicinal products that present a serious risk to the environment.
Amendment 151 #
Proposal for a directive
Recital 96
Recital 96
(96) Scientific and technological progresses in data analytics and data infrastructure provide valuable support to the development, authorisation and supervision of medicinal products. The digital transformation has affected regulatory decision-making, making it more data-driven and multiplying the possibilities for regulatory authorities to access evidence, across the lifecycle of a medicinal product. This Directive recognises the competent authorities of the Member States’ capacity to access and analyse data submitted independently from the marketing authorisation applicant or marketing authorisation holder. On thise basis, competent authorities of the Member States should take initiative to of the totality of evidence made available to the Agency, the Agency should be able to propose updates to the summary of product characteristics in case new efficacy or safety datavidence has an impacts on the benefit- risk balance of a medicinal product. In such case, the Agency and the marketing authorisation holder should collaborate to determine the particulars of any such update.
Amendment 401 #
Proposal for a directive
Article 57 – paragraph 1
Article 57 – paragraph 1
1. The marketing authorisation holder shall declare to the public any direct financial support received from any public authority or publicly funded body based in the European Union, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity based in the European Union that received that support.
Amendment 401 #
Proposal for a directive
Article 57 – paragraph 1
Article 57 – paragraph 1
1. The marketing authorisation holder shall declare to the public any direct financial support received from any public authority or publicly funded body based in the European Union, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity based in the European Union that received that support.
Amendment 407 #
Proposal for a directive
Article 57 – paragraph 2 – point a – point ii
Article 57 – paragraph 2 – point a – point ii
(ii) the public authority or publicly funded body based in the European Union that provided the financial support referred to in point (i);
Amendment 407 #
Proposal for a directive
Article 57 – paragraph 2 – point a – point ii
Article 57 – paragraph 2 – point a – point ii
(ii) the public authority or publicly funded body based in the European Union that provided the financial support referred to in point (i);
Amendment 410 #
Proposal for a directive
Article 57 – paragraph 2 – point a – point iii
Article 57 – paragraph 2 – point a – point iii
(iii) the legal entity based in the European Union that received the support referred to in point (i).
Amendment 410 #
Proposal for a directive
Article 57 – paragraph 2 – point a – point iii
Article 57 – paragraph 2 – point a – point iii
(iii) the legal entity based in the European Union that received the support referred to in point (i).
Amendment 423 #
Proposal for a directive
Article 58 a (new)
Article 58 a (new)
Article58a Obligation to submit an application for pricing and reimbursement in all Member States 1. The marketing authorisation holder shall, upon request by a Member State in which the marketing authorisation is valid, submit in good faith and within the limits of its responsibility an application for pricing and reimbursement for the medicinal product no later than two years from the date when the Member State made its request, or within four years from that date for any of the following entities: (i) SMEs; (ii) entities not engaged in an economic activity (‘not-for-profit entity’); and (iii) undertakings that, by the time of granting the marketing authorisation, have received not more than seven centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest. For the purposes of this Directive and [revised Regulation (EC) No 726/2004], the Commission shall by ... [18 months after the date of entry into force of this Directive] adopt delegated acts in accordance with Article 215 to supplement this Directive by laying down the criteria to qualify as a micro, small and medium-sized enterprise, taking into account the specificities of enterprises of this sector within the Union. The marketing authorisation holder shall notify that it fulfilled the obligations set out in the first subparagraph through the EU Access to Medicines Notification System provided for in Article 58b. 2. For the purposes of paragraph 1of this Article, Member States shall make their request within two years of the granting of a marketing authorisation. Following the filing for pricing and reimbursement by the marketing authorisation holder, Directive89/105/EEC shall apply. Where a Member State has not complied with the timelines laid down in Directive 89/105/EEC, the obligation on the marketing authorisation holder set out in this Article shall be considered to be fulfilled in that Member State. 3. By way of derogation from paragraph 1, the marketing authorisation holder for a designated orphan medicinal product or for an advanced therapy medicinal product may choose instead: (a) to make a medicinal product directly available to patients and the prescribing doctors who requested it; or (b) to submit an application for pricing and reimbursement within the limits of its responsibility only in the Member States where the relevant patient population has been identified and/ or where there is appropriate infrastructure to diagnose and administer the medicinal product. 4. Following agreement between a Member State and a marketing authorisation holder, timelines that are different from those set out in paragraphs 1 and 2 may apply. Following consultation with the Marketing Authorisation Holder a Member State may choose, after making a request in accordance with paragraph 1, to issue a product-specific waiver after which the obligation to submit an application shall cease. 5. The Commission shall, after consultation of the Agency and other relevant stakeholders, adopt by means of implementing acts a list of products to be exempted from the obligations set out in this Article. Inclusion of a medicinal product in that list may be based on criteria such as the administration of a medicinal product in most Member States being impracticable. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). 6. Where a marketing authorization is transferred to a different legal entity before the end of the period referred to in paragraph 1, the obligations shall be transferred to the new marketing authorisation holder. 7. The Commission shall by means of implementing acts establish a conciliation mechanism to facilitate discussions between applicants and Member States to resolve potential process-related disputes with regards to the submitted applications for pricing and reimbursement and with respect to the timelines set out in Directive 89/105/EEC. The conciliation mechanism expressively excludes any other matters such as relating to the value assessment of medicinal products and the allocation of resources assigned to medical care or price levels. In the event of continued disagreement between an applicant and a Member State regarding the fulfilment of the obligations set out in this Article, the Commission shall be empowered to issue a legally binding Commission decision following an opinion of the Agency. 8. Member States and the Marketing Authorization Holders may request the Commission to discuss issues related to the practical implementation of this Article and to align with any other relevant stakeholders on any further guidance required to ensure the appropriate implementation thereof based on clear and predictable criteria. These guidelines shall be reviewed and updated regularly in consultation with all relevant parties to account for new technologies and any relevant changes in the access ecosystem.
Amendment 423 #
Proposal for a directive
Article 58 a (new)
Article 58 a (new)
Article58a Obligation to submit an application for pricing and reimbursement in all Member States 1. The marketing authorisation holder shall, upon request by a Member State in which the marketing authorisation is valid, submit in good faith and within the limits of its responsibility an application for pricing and reimbursement for the medicinal product no later than two years from the date when the Member State made its request, or within four years from that date for any of the following entities: (i) SMEs; (ii) entities not engaged in an economic activity (‘not-for-profit entity’); and (iii) undertakings that, by the time of granting the marketing authorisation, have received not more than seven centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest. For the purposes of this Directive and [revised Regulation (EC) No 726/2004], the Commission shall by ... [18 months after the date of entry into force of this Directive] adopt delegated acts in accordance with Article 215 to supplement this Directive by laying down the criteria to qualify as a micro, small and medium-sized enterprise, taking into account the specificities of enterprises of this sector within the Union. The marketing authorisation holder shall notify that it fulfilled the obligations set out in the first subparagraph through the EU Access to Medicines Notification System provided for in Article 58b. 2. For the purposes of paragraph 1of this Article, Member States shall make their request within two years of the granting of a marketing authorisation. Following the filing for pricing and reimbursement by the marketing authorisation holder, Directive89/105/EEC shall apply. Where a Member State has not complied with the timelines laid down in Directive 89/105/EEC, the obligation on the marketing authorisation holder set out in this Article shall be considered to be fulfilled in that Member State. 3. By way of derogation from paragraph 1, the marketing authorisation holder for a designated orphan medicinal product or for an advanced therapy medicinal product may choose instead: (a) to make a medicinal product directly available to patients and the prescribing doctors who requested it; or (b) to submit an application for pricing and reimbursement within the limits of its responsibility only in the Member States where the relevant patient population has been identified and/ or where there is appropriate infrastructure to diagnose and administer the medicinal product. 4. Following agreement between a Member State and a marketing authorisation holder, timelines that are different from those set out in paragraphs 1 and 2 may apply. Following consultation with the Marketing Authorisation Holder a Member State may choose, after making a request in accordance with paragraph 1, to issue a product-specific waiver after which the obligation to submit an application shall cease. 5. The Commission shall, after consultation of the Agency and other relevant stakeholders, adopt by means of implementing acts a list of products to be exempted from the obligations set out in this Article. Inclusion of a medicinal product in that list may be based on criteria such as the administration of a medicinal product in most Member States being impracticable. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). 6. Where a marketing authorization is transferred to a different legal entity before the end of the period referred to in paragraph 1, the obligations shall be transferred to the new marketing authorisation holder. 7. The Commission shall by means of implementing acts establish a conciliation mechanism to facilitate discussions between applicants and Member States to resolve potential process-related disputes with regards to the submitted applications for pricing and reimbursement and with respect to the timelines set out in Directive 89/105/EEC. The conciliation mechanism expressively excludes any other matters such as relating to the value assessment of medicinal products and the allocation of resources assigned to medical care or price levels. In the event of continued disagreement between an applicant and a Member State regarding the fulfilment of the obligations set out in this Article, the Commission shall be empowered to issue a legally binding Commission decision following an opinion of the Agency. 8. Member States and the Marketing Authorization Holders may request the Commission to discuss issues related to the practical implementation of this Article and to align with any other relevant stakeholders on any further guidance required to ensure the appropriate implementation thereof based on clear and predictable criteria. These guidelines shall be reviewed and updated regularly in consultation with all relevant parties to account for new technologies and any relevant changes in the access ecosystem.
Amendment 643 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii