Activities of Michèle RIVASI related to 2022/0417(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council of the Council on fees and charges payable to the European Medicines Agency, amending Regulation (EU) 2017/745 of the European Parliament and of the Council and repealing Council Regulation (EC) No 297/95 and Regulation (EU) 658/2014 of the European Parliament and of the Council
Amendments (39)
Amendment 24 #
Proposal for a regulation
Recital 3
Recital 3
(3) The fees payable to the Agency should be proportionate to the work carried out in relation to obtaining and maintaining a Union authorisation, and should be based on an transparent evaluation of the Agency’s estimations and forecasts as regards the workload and related costs for that work, as well as on an evaluation of the costs of the services provided to the Agency by the competent authorities of Member States that are responsible for regulating medicinal products, which act as rapporteurs and, where applicable, co- rapporteurs appointed by the scientific committees of the Agency.
Amendment 25 #
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4a) Following the COVID-19 pandemic and increased initiatives in the field of health at the EU level, the Agency is continuously faced with an additional workload, which entails additional budgetary needs in terms of staff and financial resources. Such additional work, including following the extended EMA mandate in health emergencies and the creation of the European Health Data Space, must come with an appropriate funding from the Multiannual Financial Framework. Additional funding from the EU budget should also include resources for an effective implementation of the Agency’s transparency policy, including timely publication of scientific data, minutes of meetings and timely replies to requests for access to documents.
Amendment 26 #
Proposal for a regulation
Recital 4 b (new)
Recital 4 b (new)
(4b) The EMA final programming 2023-2025 document1astresses that transparency is key to reinforcing trust in regulatory decisions, and exceptional measures to maximise the transparency of its regulatory activities on treatments and vaccines for COVID-19 should hence be maintained. Nevertheless, the document expresses concern that due to a lack of resources EMA’s commitment to complying with Article 15 of the Treaty on the Functioning of the European Union (TFEU) with regard to the right of access to EU documents within the time limits laid down in Articles 7 and 8 of Regulation (EC) No 1049/2001, as well as the implementation of EMA Policy 0070 on publication of clinical data submitted by pharmaceutical companies to support their regulatory applications for human medicines under the centralised procedure, have been downscaled or deprioritised. _________________ 1a European Medicines Agency, Final Programming Document 2023-2025, EMA/36710/2023, https://www.ema.europa.eu/en/documents /report/final-programming-document- 2023-2025_en.pdf.
Amendment 27 #
Proposal for a regulation
Recital 4 c (new)
Recital 4 c (new)
(4c) Although the majority of its funding comes from private sources, the EMA is a public authority and it is of the utmost importance to safeguard its integrity and independence in order to ensure public trust in the legislative and regulatory framework for pharmaceuticals in the EU. Therefore, sufficient funding should be allocated to EMA’s transparency commitments and obligations and a high degree of transparency needs to be ensured through all its activities, including on the amounts covered by fees payable to the agency and waivers granted, as well as ensuring stringent conflict of interest rules for EMA staff, staff of national competent authorities involved in EMA’s work, members of working groups, and other experts and stakeholders.
Amendment 28 #
Proposal for a regulation
Recital 5
Recital 5
(5) Fees and charges should cover the cost of statutory services and activities of the Agency that is not already covered by the contributions to its revenue from other sources. All relevant Union legislation governing the Agency’s activities and fees should be taken into account when establishing the fees and charges, including Regulation (EC) No 726/2004, Regulation (EU) 2019/6 of the European Parliament and of the Council21, Directive 2001/83/EC, Regulation (EC) No 1901/2006 of the European Parliament and of the Council22, Regulation (EC) No 141/2000 of the European Parliament and of the Council23, Regulation (EC) No 1394/2007 of the European Parliament and of the Council24, Commission Regulation (EC) No 2049/200525, Commission Regulation (EC) No 1234/200826, Regulation (EU) 2017/745 of the European Parliament and of the Council27, Regulation (EC) No 470/2009 of the European Parliament and of the Council28, Regulation (EU) 2022/123 of the European Parliament and of the Council2a,Commission Regulation (EU) 2018/78229, Commission Implementing Regulation (EU) 2021/128130and Commission Regulation (EC) No 2141/9631. _________________ 2a Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1). 21 Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43). 22 Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1). 23 Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1). 24 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121). 25 Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises (OJ L 329, 16.12.2005, p. 4). 26 Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 334, 12.12.2008, p. 7). 27 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1). 28 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11). 29 Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (OJ L 132, 30.5.2018, p. 5). 30 Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021 laying down rules for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products (OJ L 279, 3.8.2021, p. 15). 31 Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorization for a medicinal product falling within the scope of Council Regulation (EC) No 2309/93 (OJ L 286, 8.11.1996, p. 6).
Amendment 29 #
Proposal for a regulation
Recital 7
Recital 7
(7) In line with the Joint Statement of the European Parliament, the Council of the EU and the Commission of 19 July 2012 on decentralised agencies, for bodies for which the revenue is constituted by fees and charges in addition to the Union contribution, fees should be set at a level that avoids a deficit or a significant accumulation of surplus, and should be revised when this is not the case. Therefore, a transparent cost monitoring system should be put in place. The purpose of such monitoring system should be to detect significant changes of costs of the Agency that, taking into account the Union contribution and other non-fee revenue, could require a change in fees, charges or remuneration established under this regulation. That monitoring system should equally be able to detect, based on objective and verifiable information, significant changes of costs of remuneration of services provided to the Agency by the competent authorities of Member States, which act as rapporteurs and, where applicable, co-rapporteurs and by experts contracted by the Agency for the procedures of the expert panels on medical devices. Cost information relating to services remunerated by the Agency should be auditable in accordance with Article 257 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council32. _________________ 32 Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
Amendment 30 #
Proposal for a regulation
Recital 11
Recital 11
(11) An annual fee for medicinal products authorised in accordance with the centralised procedure set out in Regulation (EC) No 726/2004 or the centralised procedure set out in Regulation (EU) 2019/6 should be levied to ensure coverage of the costs connected with the overall post-authorisation supervision and maintenance activities for those products. Those activities include the recording of the actual marketing of medicinal products authorised in accordance with Union procedures, the maintenance of marketing authorisation dossiers and of the various databases managed by the Agency, and activities contributing to a continuous follow-up of the risk-benefit balance and transparency requirements related to the publishing of scientific data of authorised medicinal products. They also comprise access to and analysis of Union- wide health data to support better decision- making throughout the product lifecycle on medicines with valid and reliable real- world evidence. The revenue from that annual fee should be used to fund an annual remuneration of the services of rapporteurs and co-rapporteurs from competent authorities of the Member States for their respective contributions to the supervision and maintenance activities of the Agency.
Amendment 32 #
Proposal for a regulation
Recital 15
Recital 15
(15) In line with union policies, it is appropriate to provide for reductions of the fees to support specific sectors and applicants or marketing authorisation holders, such as micro-, small- and medium-sized enterprises (SMEs) and academia, or to respond to specific circumstances, such as products responding to recognised public health or animal health priorities or veterinary medicinal products intended for a limited market authorised in accordance with Article 23 of Regulation (EU) 2019/6.
Amendment 35 #
Proposal for a regulation
Recital 17
Recital 17
(17) The Management Board of the Agency should be empowered to provide further fee reductions forin exceptional circumstances for duly justified reasons of protection of public and animal health. A favourable opinion from the Commission should be mandatory before granting further fee reductions, in order to ensure alignment with Union law and with overall policies of the Union. In addition, in duly justified exceptional cases, for imperative reasons of public or animal health, it should also be possible for the Executive Director of the Agency to reduce within a specific time frame certain types of fees on the basis of a critical examination of the situation specific to each case. All executive decisions of the Executive Director and the Management Board related to fee reductions and waivers should be made publicly available on the EMA web portal and listed in the Agency’s annual report.
Amendment 38 #
Proposal for a regulation
Recital 18
Recital 18
(18) In order to provide flexibility, in particular to adapt to developments in scienceaddress unforeseen circumstances and medical needs, the Management Board of the Agency should be enabled to specify working arrangements to facilitate the application of this Regulation, on a duly justified proposal from the Executive Director. In particular, the Management Board should be able to establish due dates and deadlines for payment, payment methods, timetables, detailed classifications, lists of additional fee reductions, and detailed amounts within the limits of an established range. A favourable opinion from the Commission should be mandatory before the proposal is put to the Management Board for adoption, in order to ensure alignment with Union law and with overall policies of the Union.
Amendment 39 #
Proposal for a regulation
Recital 19
Recital 19
(19) For their assessments, rapporteurs and co-rapporteurs and the other roles considered as equivalent for the purposes of this regulation in scientific advice and inspections rely on the scientific evaluations and resources of the competent authorities of Member States, while it is the responsibility of the Agency to coordinate the existing scientific resources put at its disposal by the Member States, in accordance with Article 55 of Regulation (EC) No 726/2004. In light of that, and to ensure appropriate resources for the scientific assessments relating to the procedures carried out at Union level, the Agency should remunerate the scientific assessment services provided by the rapporteurs and co-rapporteurs appointed by the Member States as members of the scientific committees of the Agency, or, where relevant, provided by rapporteurs and co-rapporteurs in the coordination group referred to in Article 27 of Directive 2001/83/EC. The amount of remuneration for the services provided by those rapporteurs and co-rapporteurs should be based on estimations of the workload involved and should be taken into account in setting the level of the fees charged by the Agency. Based on a specific public interest benefitting both the Union and the Member States, where the Agency grants a complete waiver of fees, the remuneration of rapporteurs and co- rapporteurs should be reduced by 50% or 100%, as specified in the Annexes.
Amendment 40 #
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(20a) The academic and non-profit research sector plays an increasingly important role in the development and evaluation of medicines. It often develops treatments in the area of unmet medical need or supporting studies in marginal populations and post-market monitoring of efficacy and safety. Therefore, fee waivers should apply to the non-profit research sector, in particular for protocol assistance and scientific advice.
Amendment 42 #
Proposal for a regulation
Article 2 – paragraph 1 – point 5 a (new)
Article 2 – paragraph 1 – point 5 a (new)
(5a) ‘Academia’ or ‘academic sector’ should be understood as consisting of public or private higher education establishments awarding academic degrees, public or private non-profit research organisations whose primary mission is to pursue research, and international European interest organisations;
Amendment 43 #
Proposal for a regulation
Article 2 – paragraph 1 – point 5 b (new)
Article 2 – paragraph 1 – point 5 b (new)
(5b) ‘Non-profit organisation’ or ‘non- profit legal entity’ should be understood as a legal entity which by its legal form is non-profit-making or which has a legal or statutory obligation not to distribute profits to its shareholders or individual members;
Amendment 44 #
Proposal for a regulation
Article 2 – paragraph 1 – point 5 c (new)
Article 2 – paragraph 1 – point 5 c (new)
(5c) ‘International European interest organisation’ should be understood as an international organisation, the majority of whose members are Member States or associated countries, and whose principal objective is to promote scientific and technological cooperation in the Union;
Amendment 45 #
Proposal for a regulation
Article 2 – paragraph 1 – point 6
Article 2 – paragraph 1 – point 6
(6) ‘public health emergency’ means a situation of public health emergency recognised by the Commission in accordance with Article 12(1) of Decision No 1082/2013/EU23 of Regulation (EU) 2022/2371 of the European Parliament and of the Council40. _________________ 40 Decision No 1082/2013/EURegulation (EU) 2022/2371 of the European Parliament and of the Council of 22 Octo3 November 201322 on serious cross-border threats to health and repealing Decision No 2119/981082/2013/ECU (OJ L 293314, 56.112.201322, p. 156).
Amendment 47 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Unless otherwise provided for in this Regulation, where fee waivers are granted, the remuneration to competent authorities shall be reduced by 50% or 100%, as laid down in the Annexes to this Regulation. Unless otherwise provided for in this Regulation, where less than 100% fee reductions apply, the remuneration to competent authorities of the Member States payable in accordance with this Regulation shall not be reduced.
Amendment 50 #
Proposal for a regulation
Article 6 – paragraph 4
Article 6 – paragraph 4
4. OIn exceptional circumstances, on a duly justified proposal from the Executive Director of the Agency, in particular for the protection of public or animal health or for the support of specific types of products or applicants, selected for duly justified reasons, the Management Board of the Agency may grant, following a favourable opinion from the Commission, a total or partial reduction of the applicable amount, in accordance with Article 8.
Amendment 53 #
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. In exceptional circumstances and for duly justified imperative reasons of public or animal health, the Executive Director of the Agency may grant, on a case-by-case basis, a time-limited total or partial reductions for the fees set out in Annexes I, II, III and IV, with the exception of the fees set out in points 6, 15 and 16 of Annex I, points 7 and 10 of Annex II and point 3 of Annex III. Any decision taken pursuant to this Article shall state the reasons on which it is based.
Amendment 55 #
Proposal for a regulation
Article 6 – paragraph 5 a (new)
Article 6 – paragraph 5 a (new)
5a. All waivers granted pursuant to this Article shall be transparent and published on the EMA web portal and listed in the Agency’s annual report.
Amendment 72 #
Proposal for a regulation
Article 10 – paragraph 8
Article 10 – paragraph 8
8. The Commission or the European Parliament may request any clarification or further substantiation of the report and its recommendations, if considered necessary. Following such a request, the Agency shall without undue delay provide the Commission or the European Parliament with an updated version of the report which addresses any comments made and questions raised by the Commissrespective institution.
Amendment 77 #
Proposal for a regulation
Article 10 a (new)
Article 10 a (new)
Article10a Fee and remuneration transparency and conflict of interest 1. All fees received by the Agency, including where redactions and waivers were granted and where payments are pending past set timelines, shall be published on the Agency’s web portal and listed in its annual report; 2. The Agency’s annual report shall also list a detailed breakdown of all remunerated amounts paid to national authorities for their work; 3. All staff members of the EMA and remunerated experts of national competent authorities shall have no direct or indirect economic, financial or personal conflicts of interest that may be considered prejudicial to their independence and that may, directly or indirectly, affect the impartiality of their professional conduct. Their annual declarations of interest shall be made available upon request.
Amendment 82 #
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. The power to adopt delegated acts referred to in Article 11(1) shall be conferred on the Commission for a period of 54 years from [tbc] 20[xx]. The Commission shall draw up a report in respect of the delegation of power not later than 6 months before the end of the 54-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period.
Amendment 91 #
Proposal for a regulation
Annex I – point 6 – point 6.1
Annex I – point 6 – point 6.1
6.1. A fee of EUR 136 700 shall apply to the assessment carried out in the context of a procedure initiated under Article 5(3) of Regulation (EC) No 726/2004. Such fee shall be waived in full. The remuneration shall be EUR 12 46 200 for the rapporteur and EUR 12 46 200 for the co-rapporteur.
Amendment 92 #
Proposal for a regulation
Annex I – point 6 – point 6.2
Annex I – point 6 – point 6.2
6.2. A fee of EUR 262 400 shall apply to the assessment carried out in the context of a procedure initiated under Article 13 of Regulation (EC) No 1234/2008. Such fee shall be waived in full. The remuneration shall be EUR 15 307 650 for the rapporteur and EUR 15 307 650 for the co-rapporteur.
Amendment 93 #
6.3. A fee of EUR 83 000 shall apply to the assessment carried out in the context of a procedure initiated under Article 29(4) of Directive 2001/83/EC. Such fee shall be waived in full. The remuneration shall be EUR 2 81 400 for the rapporteur and EUR 2 81 400 for the co-rapporteur.
Amendment 95 #
Proposal for a regulation
Annex I – point 10 – point 10.1
Annex I – point 10 – point 10.1
10.1. A fee of EUR 143 200 shall apply to an application for evaluating and certifying the quality and non-clinical data pursuant to Article 18 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council43. Such fee shall be waived in full. The remuneration shall be EUR 47 423 700for the rapporteur. _________________ 43 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
Amendment 96 #
Proposal for a regulation
Annex I – point 10 – point 10.2
Annex I – point 10 – point 10.2
10.2. A fee of EUR 95 200 shall apply to an application for evaluating and certifying only the quality data pursuant to Article 18 of Regulation (EC) No 1394/2007. Such fee shall be waived in full. The remuneration shall be EUR 31 5015 750 for the rapporteur.
Amendment 97 #
Proposal for a regulation
Annex I – point 11 – point 11.1
Annex I – point 11 – point 11.1
11.1. A fee of EUR 31 700 shall apply to an application for agreement of a paediatric investigation plan requested pursuant to Article 15 of Regulation (EC) No 1901/2006. Such fee shall be waived in full. The remuneration shall be EUR 6 703 350 for the rapporteur.
Amendment 98 #
Proposal for a regulation
Annex I – point 11 – point 11.2
Annex I – point 11 – point 11.2
11.2. A fee of EUR 17 600 shall apply to an application for a modification of an agreed paediatric investigation plan pursuant to Article 22 of Regulation (EC) No 1901/2006. Such fee shall be waived in full. The remuneration shall be EUR 6 43 200 for the rapporteur.
Amendment 99 #
Proposal for a regulation
Annex I – point 11 – point 11.3
Annex I – point 11 – point 11.3
11.3. A fee of EUR 12 000 shall apply to an application for a product-specific waiver pursuant to Article 13 of Regulation (EC) No 1901/2006. Such fee shall be waived in full. The remuneration shall be EUR 1 8900 for the rapporteur.
Amendment 100 #
Proposal for a regulation
Annex I – point 11 – point 11.4
Annex I – point 11 – point 11.4
11.4. A fee of EUR 8 000 shall apply to a request for compliance check with the paediatric investigation plan pursuant to Article 23 of Regulation (EC) No 1901/2006. Such fee shall be waived in full. The remuneration shall be EUR 1 0500 for the rapporteur.
Amendment 102 #
Proposal for a regulation
Annex I – point 12 – paragraph 2
Annex I – point 12 – paragraph 2
A fee of EUR 16 800 shall apply to an application for the designation of an orphan medicinal product pursuant to Regulation (EC) No 141/2000. Such fee shall be waived in full. The remuneration shall be EUR 1 50750 for the rapporteur.
Amendment 103 #
Proposal for a regulation
Annex II – point 7 – point 7.1
Annex II – point 7 – point 7.1
7.1. A fee of EUR 152 700 shall apply to an assessment carried out in the context of a procedure initiated under Article 54(8) of Regulation (EU) 2019/6. Such fee shall be waived in full. The remuneration shall be EUR 21 1010 550 for the rapporteur and EUR 9 64 800 for the co-rapporteur.
Amendment 104 #
Proposal for a regulation
Annex II – point 7 – point 7.2
Annex II – point 7 – point 7.2
7.2. A fee of EUR 209 300 shall apply to the assessment carried out in the context of a procedure initiated under Article 70(11) of Regulation (EU) 2019/6. Such fee shall be waived in full. The remuneration shall be EUR 29 214 600 for the rapporteur and EUR 12 906 450 for the co- rapporteur.
Amendment 105 #
Proposal for a regulation
Annex II – point 7 – point 7.3
Annex II – point 7 – point 7.3
7.3. A fee of EUR 147 200 shall apply to the assessment carried out pursuant to Article 141(1), points (c) and (e), of Regulation (EU) 2019/6. Such fee shall be waived in full. The remuneration shall be EUR 17 508 750 for the rapporteur and EUR 7 703 850 for the co-rapporteur.
Amendment 107 #
Proposal for a regulation
Annex V – point 1 a (new)
Annex V – point 1 a (new)
Amendment 109 #
Proposal for a regulation
Annex VI – paragraph 1 – introductory part
Annex VI – paragraph 1 – introductory part
The following information shall relate to each calendar year and shall be made publicly available on the Agency’s web portal:
Amendment 110 #
Proposal for a regulation
Annex VI – paragraph 1 – point 4 a (new)
Annex VI – paragraph 1 – point 4 a (new)
(4a) number of fee reductions granted as per executive decisions set out in Article 6;