Explanatory Memorandum to COM(2022)721 - Fees and charges payable to the European Medicines Agency - Main contents
Please note
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. |
|---|---|
| source | COM(2022)721  |
| date | 13-12-2022 |
1. CONTEXT OF THE PROPOSAL
• Reasons for and objectives of the proposal
Article 67(3) of the founding Regulation 1 of the European Medicines Agency (EMA, the Agency) stipulates that fees and charges are part of the revenues of the Agency. Article 86a of that regulation, as amended by Regulation (EU) 2019/5 2 , provides that the Commission is to put forward, as appropriate, legislative proposals with a view to update the regulatory framework for fees payable to the Agency in relation to medicinal products for human use and veterinary medicinal products (VMP).
Over the years, the legal framework governing EMA fees has become rather complex, requiring some legislative simplification. EMA fees are currently laid down in two separate regulations: Council Regulation (EC) No 297/95 and Regulation (EU) No 658/2014. Both regulations convey the will of the co-legislators that revisions of fees levied by the Agency should be based on an evaluation of the costs of the Agency and the costs of the tasks carried out by competent authorities in Member States 3 .
Following changes introduced recently to the EMA Founding Regulation 4 (the EMA Regulation) and to the rules applicable to the authorisation of veterinary medicinal products, the provisions applicable to the fee system need to be adapted. In particular, the current legislation does not envisage fees in support of new or changed activities introduced by Regulation (EU) 2019/6 5 (VMP Regulation), which became applicable in January 2022. In addition, Regulation (EU) 2022/123 introduced new activities for the Agency that require further adjustments of the costs that the EMA fees should take into account 6 . The structure of the EMA’s revenue sources should also be aligned with the provisions in Article 67 of the EMA Regulation. In particular, the EMA is able to levy not only fees, but also charges for services and activities of the Agency for which a fee is not levied.
When establishing a new fee system for veterinary medicinal products, the characteristics and specificities of the veterinary sector should be taken into account 7 .
This revision also aims to address the following problems identified by the recent evaluation of the EMA fee system 8 :
1) complexity of the fee system due to the many different categories and types of fees it currently establishes;
2) misalignment of some fees with underlying costs;
3) lack of any fees or national competent authority remuneration for some procedural activities;
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4) misalignment with the underlying costs of certain remuneration paid to national competent authorities in Member States; and
5) discrepancy between the main EMA Fee Regulation (Council Regulation (EC) No 297/95) and the Pharmacovigilance Fee Regulation (Regulation (EU) No 658/2014), which differ in their approach to determining the amount of national competent authority remuneration and in the approach to national competent authority remuneration in the case of reduced fees 9 .
By addressing these specific problems, the general objective of this proposal is to contribute to providing a sound financial basis to support the EMA’s operations, including remuneration for services to the EMA rendered by national competent authorities, in line with the applicable legislation. This translates into the objective of providing for fee and remuneration amounts that are cost-based, following a thorough evaluation of the costs of the Agency and its various statutory tasks and the cost of the contributions of competent authorities of the Member States to its work.
In addition, the proposal aims to streamline the system by simplifying the fee structure to the extent possible and by addressing the unnecessary complexity of the corresponding legal framework through bringing together in a single legal instrument fee rules that are currently governed by the two EMA Fees Regulations.
Finally, a key objective pursued by this proposal is to make the fee system future-proof by introducing regulatory flexibility in the way it is adjusted, on an objective basis.
This initiative is part of the Regulatory Fitness Programme (REFIT).
• Consistency with existing policy provisions in the policy area
This proposal repeals the two current EMA Fee Regulations, Council Regulation (EC) No 297/95 and Regulation (EU) No 658/2014.
Fees and charges proposed are levied for EMA activities as set out in Regulation (EC) 726/2004, Regulation (EU) 2019/6.
Consistency with fee reductions and exemptions set out in Regulation (EC) No 2049/2005, Regulation (EC) No 1901/2006, Regulation (EC) No 141/2000, and Regulation (EC) No 1394/2007 is ensured through the correlation table in Annex VII.
• Consistency with other Union policies
The proposal is consistent with the SME (small and medium enterprises) strategy 10 and its pillar aimed at reducing regulatory burden and improving market access. This consistency is ensured through specific fee reductions for post-authorisation procedures, in addition to fee reductions provided for in Commission Regulation (EC) No 2049/2005.
The proposal also takes into account the Joint Statement and Common Approach on decentralised agencies 11 . In particular, the proposal includes a requirement for a positive opinion by the Commission before working arrangements for the application of the regulation can by adopted by the Management Board of the Agency or before the Board decides to grant further fee reductions. This is consistent with the role of the Commission to monitor whether the Agency’s Management Board takes decisions that are in compliance with the mandate of the Agency, EU law and EU policy objectives 12 .
By offering fee incentives to certain types of veterinary medicinal products, such as immunological products, which often prevent diseases whose treatment relies on the use of antimicrobials, the proposal is also consistent with the Commission objective under the Farm to Fork Strategy 13 of halving by 2030 EU sales of antimicrobials for farmed animals and aquaculture.
This proposal is presented in the context of the respective evaluation and assessment of impacts relating to the EMA fee legislation, as part of the same process. It is presented ahead of the revision of the EU basic pharmaceutical legislation, in order to allow for a more agile EMA fee system, with quicker adjustments to possible changes stemming from that revision, through the flexibility of Commission delegated acts. The timing of the proposal also takes into account the timeline of the legislative financial statement of the proposal (COM(2020) 725 final) of Regulation (EU) 2022/123. This has a specific objective No 3 ‘Allow timely access and analysis of EU-wide health data to support better decision-making throughout the product lifecycle on medicines (development, authorisation, performance monitoring) with valid and reliable real-world evidence’ (‘node reuse data’). In line with this, funding for the operational phase of EMA activities, making it possible to achieve the above-mentioned objective, should be switched from the EU EMA budget contribution to fee income as of 2024. Thus the proposal is also consistent with the digital health policy.
The proposal also contributes to administrative simplification and reduction of burden by reducing the number of legal instruments setting EMA fees from two to one.
2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
• Legal basis
The proposed regulation has a dual legal basis: Article 114 and Article 168(4)(c) and (b) of the Treaty on the Functioning of the European Union (TFEU).
The proposed regulation is based, firstly, on Article 114 TFEU. Differences between national legislative, regulatory and administrative provisions on medicinal products tend to hinder intra-EU trade and therefore directly affect the operation of the internal market. This regulation will ensure in particular the availability of the necessary financial resources for the application of EU procedures for the assessment of serious safety issues for nationally authorised products, which, among other things, prevent or eliminate obstacles that could result from parallel procedures at national level. Therefore, this regulation will contribute to the smooth functioning of the internal market and the common post-marketing surveillance of medicinal products.
The proposed regulation is based, secondly, on Article 168(4)(c) and (b) TFEU. It aims to support the goal of setting high standards of efficacy, quality and safety of medicinal products and measures in the veterinary fields that have as their direct objective the protection of public health.
In accordance with Articles 168 i and 4(2)(k) TFEU, this EU competence is – like the one under Article 114 TFEU - a shared competence that is exercised through the adoption of the proposed regulation.
The proposed regulation ensures the availability of sufficient financial resources to support the performance and assessment activities that are necessary to guarantee that high standards are not only applied for the authorisation of products but also maintained once the product is authorised.
Article 168(4)(c) and (b) TFEU cannot serve as the sole legal basis. It needs to be complemented by the legal basis of Article 114 TFEU, which, as set out above, pursues equally as objectives the establishment and functioning of the internal market, and the setting of high standards of quality and safety for medicinal products. Both objectives are pursued simultaneously and are inseparably linked, so that one is not secondary to the other.
• Subsidiarity (for non-exclusive competence)
The EMA is a decentralised agency of the EU. Therefore, decisions on its funding and the fees it may charge can only be taken at EU level. Only the EU can act to enable the Agency to charge fees and to define the levels of those fees. EU action is therefore justified and necessary.
This Regulation only regulates fees and charges which that are to be levied by the Agency, for its statutory tasks. The competence to decide on possible fees levied by the national competent authorities remains with the Member States, including in relation to possible adaptation of such fees as the statutory tasks of the Agency evolve.
• Proportionality
The proposal does not go beyond what is necessary to achieve the general objective pursued, i.e. to introduce fees to ensure the necessary funding for the proper implementation of EU pharmaceutical legislation. The proposal addresses the problems that have been identified only in respect of EMA fees, based on costs related to EMA activities. Contributions and respective costs of national competent authorities are taken into account only insofar as they contribute to an EMA activity. Thus, to achieve its aims, the EU only takes those actions that it needs to take and does not go beyond them.
• Choice of the instrument
Since the Treaty on the Functioning of the European Union became applicable, all legislative procedures are normally based on the previous co-decision procedure involving both the Council and the European Parliament. Therefore, for legal certainty, it is proposed to create a new regulation of the Council and the European Parliament, which will be subject to the ordinary legislative procedure (Article 294 of the TFEU).
The adoption of a proposal for a regulation on fees and charges collected by the European Medicines Agency aims to ensure that the Agency has appropriate funding to properly implement the applicable legislation, taking into account the EU budget contribution. Moreover, the EMA fee system should be sufficiently flexible to adapt to changes to the Agency’s mandate, in order to make it future-proof and resilient in times of crisis. In parallel, the EMA fee system should also have the necessary agility to respond to future developments in science and possible changes in the complexity of scientific assessments that are required by existing regulatory procedures.
For the above reasons, it is proposed that the annexes to this regulation should be amendable by delegated acts. The annexes lay down the cases where a fee is charged and where remuneration is paid to national competent authorities, as well as the amounts of those fees and the amounts for national competent authorities’ remuneration and the applicable fee reductions. This proposal is justified by the need for agility of the EMA fee system and the fact that it does not grant discretionary powers. Indeed, all activities of the Agency are either funded by budget contributions or grants, the main budget contribution being the EU budget contribution, or by a fee that includes in its calculation, where relevant, remuneration for national competent authorities for services to the Agency performed by rapporteurs and co-rapporteurs, or by a charge. It is proposed that the Commission may act based on the information in its possession on:
●new costs or significant changes in existing costs due in particular to a change in the legal tasks of the Agency stemming from future amendments to the respective legal frameworks; or
●a significant change in the inflation rate; or
●a significant change in the costs of performing the existing tasks of the Agency, in particular in relation to the outcome of a cost monitoring system, including based on a special report delivered by the Agency or information from the budgetary reporting of the Agency .
3. RESULTS OF EX POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS
• Ex post evaluations/fitness checks of existing legislation
The evaluation 14 of the EMA fee system identified the following problems.
i) The fee system is too complex due to many different categories and types of fees and is therefore difficult to apply and not easily predictable.
ii) There is misalignment of some fees with the underlying costs. Fees for some assessment procedures exceed the total EMA and national competent authority costs of delivering them (e.g. major variations), while fees for some other assessment procedures fall short of costs (e.g. initial marketing authorisation procedures). Furthermore, no fee exists for some assessment procedures that create costs and, consequently, no remuneration is provided to national competent authorities for their participation in such activities (e.g. assessment procedures related to paediatric investigation plans and orphan designation).
iii) There is misalignment with underlying costs of some remunerations paid to national competent authorities. National competent authorities receive more remuneration than their incurred eligible costs for certain assessments (e.g. variations) and less than their incurred eligible costs for others (e.g. assessment of initial marketing authorisation).
iv) The Fee Regulation and Pharmacovigilance Fee Regulation differ in their approach to determining the amount of national competent authorities’ remuneration and in the distribution of the financial burden of fee incentives between the EMA and national competent authorities. This creates a lack of coherence within the fee system.
These problems are addressed by the proposal, as follows.
i) The complexity of the fee system is reduced by including some post-authorisation activities under the annual fee for centrally authorised products.
ii) Fees are better aligned to costs, and some new fees and remuneration amounts are introduced. These fees and remuneration amounts have been calculated using a budget model of the Agency. This relies on an evaluation of cost of assessment procedures and maintenance activities based on data from national competent authorities and the EMA.
iii) Remuneration for national competent authorities is better aligned with costs and is included in the calculation of fees that are determined as an output of the above-mentioned model.
iv) A unified approach is proposed for determining national competent authorities’ remuneration (such that national competent authorities remuneration is not reduced when fee reductions apply).
• Stakeholder consultations
Due to the highly technical nature of the measures under consideration and their limited direct relevance, no public consultation was conducted during the impact assessment process. Instead, the six key stakeholder groups (EMA; national ministries and national competent authorities; EU pharmaceutical industry associations for human and veterinary medicines; research associations; and wider EU stakeholder associations, including healthcare professional and patient and consumer associations) concerned by the EMA fee system were consulted via a targeted survey.
These surveys were followed up by a series of targeted interviews with seven national competent authorities, the EMA and the Heads of Medicines Agencies (HMA). A brief description of the subjects discussed is set out in the paragraphs below.
●Asked about issues relating to governance, good administration and financial stability, consultees’ feedback focused on financial stability. All stakeholders generally underlined the importance of a proper financing of EMA activities and national competent authorities’ contributions, with national competent authorities indicating that an overall decrease in their remuneration relative to the current situation would not be sustainable. This was taken into account by the Commission to the extent that any proposal for a revised fee system should be cost-based, i.e. the way the fees are calculated and set should have as its guiding principle the recovery of the respective costs incurred. The fee amounts presented in this proposal have therefore been recalculated as compared with those presented during the consultation process, using a less granular approach to assessing eligible costs for activities of national competent authorities that are not directly attributable to a specific assessment procedure but represent a service to the EMA. In particular, a revised approach was applied when calculating the annual fee for centrally authorised products and the related annual remuneration to national competent authorities.
●The need for financial predictability and simplification was also raised by those consulted, including in terms of the role of annual versus procedural fees. Following consultations, a new option emerged that sought a middle way with respect to simplification, whereby the costs of some minor post-authorisation procedures are included in the annual fee calculation, but major post-authorisation procedures still attract a fee per procedure. This represents a simplification of the existing system while taking into account a major requirement of the legislation for a cost-based approach. It is this option which forms the basis of the present proposal.
●Certain specificities of the veterinary sector highlighted by stakeholders during the consultations were taken into account by proposing targeted fee reductions for veterinary products.
●With regard to monitoring and adjusting of the amounts for fees and remunerations, the proposal takes into account the views expressed during consultations that the system should be flexible in order to be future-proof. It therefore proposes the delegation of powers to the Commission to amend fee and remuneration amounts based on a monitoring mechanism or a change in the legal tasks of the Agency.
●Applying country coefficients to national competent authorities remuneration, although bringing the remuneration closer to the cost base, was unanimously rejected by stakeholders as unfair and too burdensome. It does not therefore form part of this proposal.
• Impact assessment
The proposal is supported by an impact assessment in the accompanying staff working document. The Regulatory Scrutiny Board issued an opinion on the impact assessment on 13 May 2022. The impact assessment received a positive opinion with reservations. The opinion of the Board and the final impact assessment and its executive summary are published together with this proposal.
Four alternative policy options were assessed against a do-the-minimum baseline option. The do-the-minimum baseline option is the reference scenario, consisting of the current fee system, which remains unchanged, while taking into account the newly introduced provisions for the veterinary sector (to the extent possible without legal change) and the legislative financial statement of the proposal (COM(2020) 725 final) of Regulation (EU) 2022/123. In this way, and given the aim to ensure the specific objective No 3 is achieved (activities related to access and reuse of real-world data), funding for the operational phase of the respective EMA activities would be switched from the EU EMA budget contribution to fee income as from 2024.
●The first option (Option 1) consisted of aligning the fee system with the provisions introduced by the VMP Regulation, including recalculation of fees for the veterinary sector in line with the cost-based principle. For human medicines, the related fees and national competent authorities’ remuneration remain unchanged under this option.
●The second option (Option 2) aligned the fee system with the VMP Regulation and also aligned fees and remuneration amounts for both veterinary and human medicines with the respective costs of the EMA and national competent authorities for carrying out the work. Thus, Option 2 introduced a cost-based fee system for all national competent authorities’ activities, while the overall architecture of the system remained unchanged as compared with the baseline and Option 1.
●The third option (Option 3) built on Option 2, not only introducing a cost-based fee system for human and veterinary activities, but also significantly simplifying the fee system structure for both human and veterinary medicines. A reduced number of procedural fees were applied for post-authorisation non-pharmacovigilance activities for human and veterinary medicines. Procedural fees were levied for pre-authorisation activities (human and veterinary), inspections and only some major post-authorisation activities (e.g. referrals) 15 . The annual fee for centrally authorised products covered a broader set of costs as compared with the current system, including those non-pharmacovigilance post-authorisation procedures for which a procedural fee is no longer levied. National competent authority remuneration for those post-authorisation procedures, which are charged under this option through the centrally authorised product annual fee, was no longer per procedure and was included in the annual remuneration paid to national competent authorities via the annual fee for centrally authorised products.
●The fourth option (Option 3 Light) was a lighter version of the third option, which simplified the fee system structure to a lesser extent. This option was developed in response to feedback received on the inception impact assessment requesting the Commission to consider an option with a more modest level of simplification, as compared with Option 3, in order to remain closer to the cost, as and when it occurs. Under Option 3 Light, fewer procedural activities were covered by annual fees compared with Option 3 (mainly assessment of minor variations and of renewals of authorisations) while procedural fees were maintained for a larger number of activities (mainly major variations).
All options were assessed on the basis of a detailed financial model of the Agency’s budget (cost and revenue), including the cost for remuneration to national competent authorities, and detailed projections. The financial model developed for the assessment of the policy options used as an input estimated costs of activities of the Agency and of contributions of national competent authorities, as well as estimated level of activities (frequencies). Workload data for the Agency and competent authorities of the Member States were collected during a vast data gathering exercise initiated by the Agency’s Management Board, with the full participation of the Agency and competent authorities of the Member States represented at the Management Board. Frequencies and unitary cost were estimated in detail during the evaluation and were further updated for the purpose of the impact assessment. The detailed outputs of the financial model were presented for consultation to stakeholders during the impact assessment. The feedback to those targeted consultations was taken into account in a subsequent update of the model calculations and the final updated output was used for this proposal.
The analysis of the options was based on a range of indicators relating to:
●performance as regards cost coverage (on aggregate, and also for individual activities, analysed both for the EMA and for contributions from national competent authorities);
●capacity of the system to adjust to changes;
●balance between simplicity, i.e. fewer fee levels, and more granular cost-based approach, i.e. more fee levels;
●capacity to finance fee incentives;
●adaptability to exceptional circumstances;
●predictability;
●administrative burden;
●position of small and medium-sized enterprises (SMEs);
●impact on research and innovation; and
●functioning of the internal market.
Indicators related to cost-reflectiveness were given the highest relative weight in the analysis. This is due to the clear requirement in the legislation that any revision of fees should be based on cost estimations. The validity of this approach was clearly confirmed by the feedback to consultations from all types of stakeholders, where the emphasis was on cost-reflectiveness. The next greatest weighting was given to the indicators related to the simplification of the fee system, as the need for simplification had been clearly identified during the evaluation and in the consultations. The minimisation of administrative burden was also important, being a general principle of all EU legislation.
On these criteria, Option 1 performed noticeably worse than the other options. This is the result of Option 1 doing especially poorly on cost-reflectiveness, assessed through several indicators on both an aggregate and granular level.
Comparing Option 3 with Option 3 Light, they differed in terms of alignment to granular costs, predictability, and administrative burden, and on the balance achieved between the two major criteria, i.e. the cost-based approach and simplicity. Option 3 Light scored relatively better overall than Option 3 since cost-reflectiveness is the single most important indicator and it scored higher in terms of achieving the balance with simplicity as well.
The differences between Options 2 and 3 were less pronounced than the differences between Options 3 and 3 Light. Option 2 achieved a higher score than both Options 3 and 3 Light in terms of alignment to individual (granular) costs, but a lower score in terms of predictability, administrative burden, and balance achieved between cost-based approach and simplicity.
The choice between Options 3 and 3 Light was finely balanced. In the final analysis, Option 3 Light was preferred because it had the merit of achieving some improvements in simplicity compared with the current fee system, while at the same time introducing cost-reflective fees for all activities at a sufficiently granular level.
The Regulatory Scrutiny Board of the Commission issued a positive opinion with reservations that were addressed in the Staff Working Document accompanying this initiative. Interlinkages and coherence with the upcoming revision of the EMA founding regulation were mentioned, which is addressed via the flexibility sought with the provisions enabling the Commission to update the annexes of the proposed regulation. In addressing the RSB comments, the trade-offs between cost alignment, simplicity and the flexibility objectives were better explained, with cost-alignment being singled out as the objective carrying the most relative weight, as required by the legislation. Further, the impact assessment report clarifies that internal efficiency improvement measures rather relate to the founding regulation of EMA, whereas the objective of the fee legislation is to cover the relevant costs. The report also clarifies that country coefficients for national competent authorities remuneration would lead to significant administrative burden, outweighing any marginal benefits. It also explains that national competent authorities’ remuneration is calculated based on a weighted average cost as opposed to the highest cost. A clarification is provided that the baseline (no change to the legislation) is not a viable way forward, in particular it as cannot provide full alignment to the changes in the veterinary sector and full alignment to EMA projected costs, in particular for activities related to allowing timely access and analysis of EU-wide health data to support better decision-making throughout the product lifecycle on medicines with valid and reliable real-world evidence. Impacts on fee payers are presented by types of fees. The overall impact of this initiative on the development and availability of medicines is equally clarified by comparison with estimated development costs. It is clarified that there are no significant social, environmental or fundamental rights impacts. It is equally clarified that the impact on the administrative burden is neutral (or possibly positive through the relative simplification of the system achieved under the preferred option).
The initiative is consistent with the climate-neutrality objectives, as does not impact on the EU greenhouse gas emissions, due to the nature and the scope of the initiative.
In line with EU policy to support SMEs, fee reductions are proposed for SMEs within the meaning of Commission Recommendation 2003/361/EC. Reductions include those already provided for in Commission Regulation (EC) No 2049/2005 and, in order to take due account of the ability of SMEs to pay, further reductions to post-authorisation fees.
Consistent with EU policy, microenterprises within the meaning of the above-mentioned Recommendation are exempt from all post-authorisation fees established under this Regulation.
The proposal is consistent with the principles of digital-ready policymaking in several aspects.
●It takes into account the digitalisation of minor variations (changes to the terms of a marketing authorisation, e.g. the processing of variations that do not require assessment in the EU database on veterinary medicinal products (Union Product Database).
●It provides for publication of fee-related information on the website of the Agency.
●The respective definitions of ‘chargeable unit’ for products for human and use and veterinary products are consistent with the IT tools used by the Agency, in the human and veterinary areas, consistent with a user-centric and ready-for-automation process.
●The information flows between the Agency and applicants/marketing authorisation holders and between the Agency and national competent authorities are taken into account.
The proposal also contributes to administrative simplification by bringing together fee rules in a single legal instrument.
• Fundamental rights
The proposal has no impact on the protection of fundamental rights.
4. BUDGETARY IMPLICATIONS
The multiannual financial framework until 2027 is fully respected by the amounts calculated for this proposal. This proposal does not have implications on the EU budget and its contribution to the EMA budget. The proposal will not result in the need for additional resources to effectively manage the fee system.
5. OTHER ELEMENTS
• Implementation plans and monitoring, evaluation and reporting arrangements
The proposal aims to put in place a monitoring framework, whereby the Agency collects and monitors data relating to the cost of activities, including remuneration to national competent authorities, and flags to the Commission significant trends on an objective basis. The Agency will monitor the implementation, application and compliance of these new provisions with a view to assessing their effectiveness.
The experience gathered with the monitoring framework will be used for the next evaluation of the EMA fee legislation and the fee system it governs.
• Detailed explanation of the specific provisions of the proposal
The first two articles provide the subject matter and the definitions relevant to the proposed regulation.
In particular, in order to have a fair system, in Article 2 it was considered necessary to identify a harmonised unit by which relevant pharmacovigilance-related fees would be charged with regard to nationally authorised products, as there are different ways in the EU of assigning authorisation numbers to, and of counting, medicinal products. To facilitate adverse reaction reporting and signal detection 16 , it is necessary to describe with maximum precision medicinal products at unit level in order to take account of differences in strength, pharmaceutical forms, routes of administration, etc.
For medicinal products for human use, the structure of the database described in Article 57(2) of Regulation (EU) 726/2004 neutralises these differences by means of individual entries. These entries have been chosen as a chargeable unit, as it is the case currently under Regulation (EU) No 658/2014.
This proposal introduces a similar approach with regard to veterinary medicinal products, for which the Union Product Database, referred to in Article 55 of Regulation (EU) 2019/6, will be the system that will be used for calculating the chargeable units. That database being more recent, the definition is even more precise and includes the pharmaceutical form, with chargeable units for veterinary products being counted with a level of granularity when setting the fee levels that would ensure they cover the corresponding costs.
Articles 3 and 4 describe the types of fees and charges than can be levied by the EMA and refer to the relevant annexes where the corresponding amounts are laid down with, where relevant, the amounts for remuneration to the national competent authorities in Member States.
Article 5 deals with the conditions of remuneration paid to national competent authorities in relation to fees levied by the Agency.
Article 6 sets out applicable fee reductions and related rules and refers to the relevant annex where the reductions are set out. The Article also empowers the EMA Executive Director to grant further fee reductions in exceptional circumstances, while the Management Board of the Agency is empowered, following a favourable opinion from the Commission, to grant further reductions in non-exceptional circumstances for justified reasons, such as for protection of public and animal health.
Articles 7 deals with conditions and rules pertaining to payment of fees and charges.
Article 8 mandates the Management Board of the Agency to specify detailed technical arrangements to facilitate the application of the proposed regulation, such as payment methods of fees and charges and the precise mechanism under which the remuneration provided for by the proposed regulation is paid to national competent authorities. A positive opinion by the Commission is required to ensure consistency with EU legislation, in line with the Joint Statement and Common Approach on decentralised agencies.
Article 9 deals with due dates and provides for the possibility for the Executive Director to suspend services in the case of non-payment.
Article 10 sets out requirements for transparency of the amounts provided for by the proposed regulation and provides for monitoring of costs and inflation and reporting. It provides for the possibility for the EMA Executive Director to present to the Commission a factual and quantified ad hoc special report based on the above monitoring and to recommend amendment of the fees, charges and remuneration laid down in the annexes.
Article 11 sets out the conditions for a review of the amounts laid down in the Regulation, following a cost-based approach. It enables the Commission to adopt delegated acts to amend the annexes, based on the above-mentioned ad hoc report or the budgetary reporting of the Agency, a monitoring of the inflation rate, a change in EU legislation with respect to tasks of the Agency or new information on practical aspects of implementation of activities that attract a fee or a charge.
Article 12 sets out how the Agency will provide budgetary estimates, including detailed information on income from various types of fees and charges.
Article 13 sets out the conditions for the Commission to adopt delegated acts to amend the annexes.
Article 14 provides the legal basis for fees in accordance with the procedure under Article 106(14) of Regulation (EU) No 2017/745 to be charged by the Agency.
Article 15 repeals the two current EMA Fee Regulations that the present proposal replaces.
Article 16 specifies the conditions for applicability of the proposed regulation in relation to its date of entry application.
Article 17 provides the date of entry into force and application.
Annexes I and II set out fees, charges and remuneration for procedures and services relating to, respectively, medicinal products for human use and veterinary medicinal products.
Annex III sets out annual fees and remuneration for medicinal products for human use and veterinary medicinal products.
Annex IV sets out various other fees and charges for both medicinal products for human use and veterinary medicinal products, as well as consultations on medical devices – for inspections, transfer of authorisations, pre-submission services, re-examination of opinions and other scientific and administrative services.
Annex V sets out fee reductions for specific applicants and products.
Annex VI sets out the performance information provided by the Agency, including information collected from national competent authorities in Member States.