Considerations on COM(2022)721 - Fees and charges payable to the European Medicines Agency - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2022)721 - Fees and charges payable to the European Medicines Agency. |
|---|---|
| document | COM(2022)721  |
| date | February 7, 2024 |
(2) The general objective of this Regulation is to contribute to providing a sound financial basis for the operations of the Agency by establishing cost-based fees and charges to be levied by the Agency, as well as cost-based remuneration to competent authorities of the Member States for the services they provide for the completion of the Agency’s statutory tasks. Cost-based fees should take into account an evaluation of costs of the Agency’s activities and of the contributions of competent authorities of the Member States to its work. In addition, this Regulation aims to establish a single framework for a streamlined fee system of the Agency and to introduce regulatory flexibility for adjustment to that fee system in the future.
(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 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.
(4) Pursuant to Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council 19 , the revenue of the Agency consists of a contribution from the Union, a contribution from third countries participating in the work of the Agency with which the Union has concluded international agreements for this purpose, fees paid by undertakings for obtaining and maintaining Union marketing authorisations and for services provided by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC of the European Parliament and of the Council 20 , charges for other services provided by the Agency, and Union funding in the form of grants for participation in research and assistance projects, in accordance with the Agency’s financial rules and with the provisions of the relevant instruments supporting the policies of the Union.
(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 Council 21 , Directive 2001/83/EC, Regulation (EC) No 1901/2006 of the European Parliament and of the Council 22 , Regulation (EC) No 141/2000 of the European Parliament and of the Council 23 , Regulation (EC) No 1394/2007 of the European Parliament and of the Council 24 , Commission Regulation (EC) No 2049/2005 25 , Commission Regulation (EC) No 1234/2008 26 , Regulation (EU) 2017/745 of the European Parliament and of the Council 27 , Regulation (EC) No 470/2009 of the European Parliament and of the Council 28 , Commission Regulation (EU) 2018/782 29 , Commission Implementing Regulation (EU) 2021/1281 30 and Commission Regulation (EC) No 2141/96 31 .
(6) Pursuant to Article 6(1) of Regulation (EC) No 726/2004, each application for the authorisation of a medicinal product for human use is to be accompanied by the fee payable to the Agency for the examination of that application. Pursuant to Article 43(1) of Regulation (EU) 2019/6, an application for a centralised marketing authorisation for a veterinary medicinal product is to be accompanied by the fee payable to the Agency for the examination of the application.
(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 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 Council 32 .
(8) Fees should be levied on marketing authorisation applicants and holders on a fair basis whereby the fee charged is proportionate to the assessment work. Therefore, for the purpose of charging some post-authorisation fees where products authorised by the Member States are included in the assessment performed by the Agency, a chargeable unit should be established, irrespective not only of the procedure under which the product has been authorised, namely under Regulation (EC) No 726/2004 or Regulation (EU) 2019/6 or Directive 2001/83/EC, but also of the way in which authorisation numbers are assigned by Member States or the Commission. For medicinal products for human use, that objective should be met by establishing the chargeable unit on the basis of the active substances and the pharmaceutical form of the products that are subject to the obligation to be registered in the database referred to in Article 57(1), second subparagraph , point (l), of Regulation (EC) No 726/2004, based on information from the list of all medicinal products for human use authorised in the Union referred to in Article 57(2), second subparagraph, of that Regulation. The active substances should not be taken into account when establishing the chargeable unit in respect of homeopathic medicinal products or herbal medicinal products. For veterinary medicinal products, the same objective of fairness and proportionality should be met by establishing the chargeable unit based on information contained in the Union product database referred to in Article 55(1) of Regulation (EU) 2019/6, such as the active substances, the pharmaceutical form and the strength of veterinary medicinal products, which are taken into account in the Product Identifier referred to under Data Field ID 3.2 in Annex III to Commission Implementing Regulation (EU) 2021/16 33 , as well as the Permanent Identifier referred to under Data Field ID 3.1 in Annex III to that Implementing Regulation.
(9) In order to take into account all the marketing authorisations of medicinal products granted to marketing authorisation holders, the number of chargeable units corresponding to those authorisations should take into account the number of Member States in which the marketing authorisation is valid.
(10) In order to take account of the variety of the statutory tasks of the Agency and of the rapporteurs and, where applicable, co-rapporteurs, fees should be levied per procedure, for costs relating to the assessment of medicinal products for human use and for veterinary medicinal products, and on an annual basis for costs incurred by the Agency for other ongoing activities that it carries out under its mandate that benefit marketing authorisation holders overall. For the purpose of simplification, the costs related to minor variations of Type I should equally be included in the annual fee on the basis of an average estimation.
(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 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.
(12) A specific annual fee should be charged for medicinal products authorised in accordance with Directive 2001/83/EC and for veterinary medicinal products authorised by the Member States in accordance with Regulation (EU) 2019/6 specifically for the pharmacovigilance activities carried out by the Agency that benefit marketing authorisation holders overall. Those activities relate to information technology, in particular maintenance of the EudraVigilance database referred to in Article 24(1) of Regulation (EC) No 726/2004, the Union product database referred to in Article 55(1) of Regulation (EU) 2019/6 and the Union pharmacovigilance database referred to in Article 74(1) of that Regulation, the monitoring of selected medical literature and the timely access to and analysis of Union-wide health data to support decision-making throughout the product lifecycle on medicines with valid and reliable real-world evidence.
(13) Charges should be levied for activities and services of an administrative nature, such as issuing certificates, that are not covered by a fee provided for in this Regulation, whereas fees levied by the Agency should correspond to services of a scientific nature provided by the Agency under its mandate, which contribute to the assessment relating to medicinal products and the maintenance of authorised products, including a continuous monitoring of the risk-benefit balance.
(14) Where a fee is reduced by 100 %, the theoretical full amount of that fee should still be provided for, for reasons of transparency and cost recovery.
(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), 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.
(16) The market for veterinary medicinal products is smaller and more fragmented compared to the market for medicinal products for human use. Therefore, it is appropriate to provide for a reduction of the annual fee and of some specific fees for veterinary medicinal products.
(17) The Management Board of the Agency should be empowered to provide further fee reductions for 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 certain types of fees on the basis of a critical examination of the situation specific to each case.
(18) In order to provide flexibility, in particular to adapt to developments in science, 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.
(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.
(20) In line with the policy of the Union to support SMEs within the meaning of Commission Recommendation 2003/361/EC 34 , fee reductions should apply to them. Such reductions should be established on a basis that takes due account of the ability of SMEs to pay. In order to ensure that the current framework for support to SMEs remains unchanged until a possible revision of Commission Regulation (EC) No 2049/2005 35 , current post-authorisation fee reduction rates should be granted to SMEs. Furthermore, microenterprises should be exempted from all post-authorisation fees.
(21) Generic medicinal products for human use and generic veterinary medicinal products, medicinal products for human use and veterinary medicinal products authorised under the provisions relating to well-established medicinal use, homeopathic medicinal products for human use and homeopathic veterinary medicinal products, as well as herbal medicinal products for human use should be subject to a reduced annual pharmacovigilance fee, as those medicinal products generally have a well-established safety profile. However, in cases where such medicinal products are subject of any of the pharmacovigilance procedures carried out at Union level, the full fee should be charged in view of the work involved.
(22) In order to avoid a disproportionate administrative workload for the Agency, fee reductions and fee exemptions should be applied on the basis of a declaration of the marketing authorisation holder or applicant claiming to be entitled to such a measure. The submission of incorrect information in that respect should be discouraged by means of the application of a specific charge if the Agency establishes that such incorrect information has been submitted.
(23) For reasons of predictability and clarity, the amounts of the fees, charges and remuneration should be set in euro.
(24) The amounts of the fees and charges and the remuneration to competent authorities of the Member States should be adjusted, where appropriate, to take account of significant changes in costs, detected through cost monitoring, and to take account of inflation. For the purpose of taking into account the impact of inflation, the Harmonised Index of Consumer Prices published by Eurostat pursuant to Regulation (EU) No 2016/792 of the European Parliament and of the Council 36 should be used.
(25) In order to ensure swift adjustment of the structure and amounts of fees, charges and remuneration to competent authorities of the Member States to significant changes of costs or processes, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the relevant amounts and the activities subject to fees and charges and remuneration, on the basis of objective information related to costs or changes to the regulatory framework. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making 37 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
(26) In order to ensure cost recovery, the Agency should provide services by virtue of the tasks entrusted to it only after the corresponding fee or charge has been paid in its entirety. However, in accordance with Article 71, fourth subparagraph, of Commission Delegated Regulation (EU) 2019/715 38 , in exceptional circumstances, a service may be provided without prior payment of the corresponding fee or charge.
(27) In accordance with Article 30 of Regulation (EU) 2022/123 39 , the Agency provides, on behalf of the Commission, the secretariat for the expert panels designated in accordance with Regulation (EU) 2017/745. The provision in Article 106 of Regulation (EU) 2017/745 concerning the payment of fees for advice provided by expert panels should therefore be amended in order to allow the Agency to receive those fees, once such fees are established by the Commission in accordance with that Regulation.
(28) Since the objective of this Regulation, namely to ensure appropriate funding of Agency activities carried out at Union level, cannot sufficiently be achieved by the Member States but can rather, by reason of the scale of the measure, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.