BAKGRUNN (fra europaparlaments- og rådsforordning)

(1) The European Medicines Agency (the ‘Agency’) plays a key role in ensuring that only safe, high-quality and efficacious medicinal products are placed on the Union market, thus contributing to the smooth functioning of the internal market and ensuring high standards of quality and safety for medicinal products for human use and for veterinary medicinal products, and a high level of protection of public and animal health. Adequate financing should therefore be provided to ensure the sustainability of the operations of the Agency. For that purpose, it is necessary to ensure that sufficient resources, in particular from fees, are available to the Agency to attract and maintain the expertise required to fulfil its tasks and to finance its activities, and to remunerate, in a sustainable manner, the fundamental contribution of competent authorities of the Member States to the scientific assessments performed by the Agency.

(2) The general objective of this Regulation is to contribute to providing a sound financial basis for the operations of the Agency, thus contributing to ensuring a high level of protection of public and animal health. It should establish 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. There should be a single Union remuneration amount per type of fee, where relevant, regardless of the Member State of origin of the competent authority. 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 for the Agency and to introduce regulatory flexibility for adjustment to that fee system in the future.

(3) Whereas this Regulation should regulate the fees and charges to be levied by the Agency, competence regarding fees levied by the competent authorities remains with the Member States. Applicants and marketing authorisation holders should, however, not be charged twice for the same activity.

(4) The fees payable to the Agency should be proportionate to the work carried out in relation to obtaining and maintaining a Union marketing authorisation. The fees should be based on a 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 the 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. The fees, charges and fee structure should take into account any objective information on costs or on changes to the regulatory framework.

(5) Pursuant to Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council (3), 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 (4), 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.

(6) Following the COVID-19 pandemic and a rise in the number of initiatives in the field of health at Union level, the Agency is faced with a constantly increasing workload, which can entail additional budgetary needs in terms of staff and financial resources. The additional workload should be accompanied by appropriate funding as provided for in Regulation (EC) No 726/2004, to ensure, among other things, that the Agency can fulfil its obligations and transparency commitments.

(7) Although the majority of its funding comes from fees, the Agency is a public authority. It is of utmost importance to safeguard its integrity and independence in order to maintain public trust in the Union regulatory framework.

(8) The fees paid to the Agency reflect the complex evaluations which it carries out and that are necessary in order for Union marketing authorisations to be obtained and maintained. It is appropriate to recognise the contributions from competent authorities of the Member States, as well as the expenses incurred by them. It is particularly appropriate to recognise the synergies achieved through multinational assessment teams and support the collaborative efforts of those teams. The Commission and the Agency therefore monitor developments and determine the changes that would be necessary to the structure of remuneration of Member States.

(9) 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 Regulations (EC) No 141/2000 (5), (EC) No 726/2004, (EC) No 1901/2006 (6), (EC) No 1394/2007 (7), (EC) No 470/2009 (8), (EU) 2017/745 (9), (EU) 2017/746 (10), (EU) 2019/6 (11) and (EU) 2022/123 of the European Parliament and of the Council (12), Directive 2001/83/EC, Commission Regulations (EC) No 2141/96 (13), (EC) No 2049/2005 (14), (EC) No 1234/2008 (15) and (EU) 2018/782 (16), and Commission Implementing Regulation (EU) 2021/1281 (17).

(10) 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.

(11) 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 whose 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 that is not the case. Therefore, a transparent cost monitoring system should be put in place. The purpose of such a monitoring system should be to detect significant changes in the costs of the Agency which, taking into account the Union contribution and other non-fee revenue, could necessitate a change in fees, charges or remuneration established under this Regulation. That monitoring system should also be able to detect, based on objective and verifiable information, significant changes in the costs of remuneration for services provided to the Agency by competent authorities of the Member States, which act as rapporteurs and, where applicable, co-rapporteurs, and by experts contracted by the Agency to carry out the work of the expert panels on medical devices. Cost information relating to services for which the Agency provides remuneration should be auditable in accordance with Article 257 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (18).

(12) 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 medicinal 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 medicinal product has been authorised, namely under Regulation (EC) No 726/2004, Regulation (EU) 2019/6 or Directive 2001/83/EC, but also of the way in which marketing authorisation numbers are assigned by Member States or the Commission. However, medicinal products for human use, authorised to be placed on the market under Article 126a of Directive 2001/83/EC, should not be taken into account for the purposes of establishing a chargeable unit. For medicinal products for human use, the objectives of fairness and proportionality should be met by establishing the chargeable unit on the basis of the active substances and the pharmaceutical form of the medicinal 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 relation to homeopathic medicinal products or herbal medicinal products.

(13) For veterinary medicinal products, the same objectives 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 (19), as well as the Permanent Identifier referred to under Data Field ID 3.1 in Annex III to that Implementing Regulation.

(14) In order to take into account all the marketing authorisations for 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 each marketing authorisation is valid.

(15) In order to take account of the variety of the statutory tasks of the Agency and of the rapporteurs and, where applicable, co-rapporteurs, for costs relating to the assessment of medicinal products for human use and for veterinary medicinal products, fees should be levied per procedure. For costs incurred by the Agency for other ongoing activities that it carries out under its mandate that benefit marketing authorisation holders overall, fees should be levied on an annual basis. For the purpose of simplification, the costs related to minor variations of Type I and to renewals should be included in the annual fee on the basis of an average estimation.

(16) The Agency should levy 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 to cover the costs connected with the overall post-authorisation supervision and maintenance activities for those medicinal 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, minor variations of Type I and renewals and activities contributing to a continuous follow-up of the benefit-risk balance of authorised medicinal products. Those activities also comprise access to and analysis of Union-wide health data to support better decision-making throughout the product lifecycle of medicines with valid and reliable real-world evidence. The revenue from that annual fee should be used to fund the 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.

(17) The Agency should levy an annual pharmacovigilance fee 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.

(18) The Agency should levy fees where the fee corresponds to services of a scientific nature provided by the Agency under its mandate and which contribute to the assessment relating to medicinal products and the maintenance of authorised medicinal products, including the continuous monitoring of the benefit-risk balance. Fees for inspections should be set per distinct inspection. Each distinct inspection should trigger a separate fee. The Agency should levy charges for activities and services of an administrative nature, such as issuing certificates, that are not covered by a fee provided for in this Regulation or another Union legal act.

(19) Where a fee is waived in full, this Regulation should still provide for the theoretical full amount of that fee, for reasons of transparency and cost recovery.

(20) 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). In addition to commercial entities, not-for-profit organisations and the academic sector can play an important role in the development of medicines. However, fees can present a significant obstacle for those entities that are not engaged in an economic activity. For that reason, they should equally benefit from fee reductions, provided that they are not owned or controlled by a commercial undertaking and that they have not concluded agreements with any commercial undertaking concerning sponsorship or participation in the development of the medicinal product which would give the commercial undertaking any rights to the final medicinal product. It is also appropriate to provide for fee reductions to respond to specific circumstances, such as medicinal 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.

(21) The market for veterinary medicinal products is smaller and more fragmented than 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. It is also appropriate to closely monitor associated costs for competent authorities of the Member States and the Agency, in order to support the objectives of Regulation (EU) 2019/6. Therefore, the adjustment to inflation applied to the amounts in Annex II takes into account only 50 per cent of the annual inflation rates for the calendar years 2021 and 2022 and of the forecast of the inflation for 2023.

(22) The Management Board of the Agency should be empowered to grant further fee or charge reductions for duly justified reasons of protection of public and animal health or for justified reasons for the support of specific types of products or applicants. 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 an examination of the situation specific to each case.

(23) It is recognised that improved access to information contributes to public awareness, gives the public the opportunity to express its observations and enables authorities to take due account of those observations. The general public should therefore have access to information on the granting by the Agency of reductions or waivers of fees and charges and on the amounts of remuneration paid to competent authorities of the Member States, broken down by Member State and by activity. That information should not include, however, any commercially confidential information. The Agency should therefore remove such information in advance, where relevant. Regulation (EC) No 1049/2001 of the European Parliament and of the Council (20) gives the fullest possible effect to the right of public access to documents and lays down the general principles and limits on such access. Nonetheless, certain public and private interests, such as personal data and commercially confidential information, should be protected by way of exceptions in accordance with Regulation (EC) No 1049/2001.

(24) In order to provide flexibility, in particular to adapt to developments in science and to address 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 of the Agency should be able to establish, first, due dates and deadlines for payment, payment methods, timetables, detailed classifications, lists of additional fee reductions, detailed amounts within the limits of an established range; second, a sufficiently flexible common format for financial information to be provided by competent authorities of the Member States or experts contracted for the work of the expert panels on medical devices to the Agency; and third, for each type of inspection, what constitutes a distinct inspection. A favourable opinion from the Commission on the proposal of the Executive Director should be mandatory before the proposal is put to the Management Board of the Agency for adoption, in order to ensure alignment with Union law and with relevant policies of the Union.

(25) Rapporteurs, co-rapporteurs and persons performing other roles considered as equivalent for the purposes of this Regulation rely on the scientific evaluations and resources of the competent authorities of the Member States for their assessments. 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.

(26) In light of that, and to ensure that Member States have sufficient resources for the scientific assessments relating to the procedures carried out at Union level, the Agency should remunerate the rapporteurs and co-rapporteurs appointed by the Member States as members of the scientific committees of the Agency, or, where relevant, the rapporteurs and co-rapporteurs in the coordination group referred to in Article 27 of Directive 2001/83/EC, for the scientific assessment services which they provide. The amount of remuneration for those services should be based on estimations of the workload involved and should be taken into account in setting the level of the fees levied by the Agency.

(27) In line with the policy of the Union to support SMEs as defined in Commission Recommendation 2003/361/EC (21), fee reductions should apply to them. Such reductions are to be established on a basis that takes due account of the ability of SMEs to pay. In order to ensure consistency of such reductions for SMEs with Regulation (EC) No 2049/2005, current post-authorisation fee reduction rates should be granted to SMEs. Furthermore, microenterprises should be exempted from all post-authorisation fees.

(28) 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 the subject of pharmacovigilance procedures at Union level, the full fee should be levied by the Agency in view of the additional work involved.

(29) 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 incorrect information has been submitted.

(30) For reasons of predictability and clarity, the amounts of the fees, charges and remuneration are set in euro.

(31) The amounts of the fees and charges of the Agency and of 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) 2016/792 of the European Parliament and of the Council (22) should be used. The first adjustment of fees, charges and remuneration due to inflation should take into account the annual inflation rates for each calendar year following the inflation adjustment already applied to the amounts in the Annexes, up to and including 2024. The inflation rate already applied to the amounts in the Annexes for 2023 is 5,9 %, which corresponds to the projected annual inflation for 2023, and 1,2 % for 2024. The first adjustment due to inflation should therefore also take into account the correction needed in view of the final annual inflation rate for 2023 and 2024.

(32) In order to ensure the swift adjustment of the structure and amounts of fees and charges of the Agency and of 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 specifying the activities of the Agency subject to fees or charges, as well as determining the amounts of such fees and charges and, where relevant, the amount of remuneration of competent authorities of the Member States. That determination should be carried out on the basis of objective information on costs or on changes to the regulatory framework. That information is provided mainly via a special report adopted by the Management Board of the Agency, which contains justified recommendations to increase or decrease the amount of any fee, charge or remuneration, amend the Annexes, including on the basis of changes in the statutory tasks of the Agency, add fees and adapt the specification of activities for which the Agency collects fees or charges to changing conditions and requirements. 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 (23). 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. If a change in the fees were to result in an increased share of such fees on the part of the Agency, special consideration should be given to the aim of maintaining a cost-based, balanced, objective and fair distribution of fees between the Agency and the competent authorities of the Member States.

(33) In order to ensure cost recovery, the Agency should provide services falling within the scope of the tasks entrusted to it only once 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 (24), in exceptional circumstances, it is possible for a service to be provided without prior payment of the corresponding fee or charge.

(34) In accordance with Article 30 of Regulation (EU) 2022/123, the Agency provides, on behalf of the Commission, the secretariat for the expert panels designated in accordance with Regulation (EU) 2017/745. Article 106 of Regulation (EU) 2017/745 and Article 30, point (f), of Regulation (EU) 2022/123 concerning the payment of fees for advice provided by expert panels should therefore be amended in order to allow the Agency to levy fees for the provision of that service, once such fees are established by the Commission in accordance with Regulation (EU) 2017/745.

(35) Since the objectives of this Regulation, namely to ensure appropriate financing for Agency activities and tasks carried out at Union level through the establishment of cost-based fees and charges levied by the Agency, and to ensure cost-based remuneration to competent authorities of the Member States for their contributions to the achievement of those tasks, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale or effects of the action, 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 those objectives.

(36) In order to allow for the prompt application of the measures provided for in this Regulation, it should enter into force on the day following that of its publication in the Official Journal of the European Union,