Legal provisions of COM(2022)721 - Fees and charges payable to the European Medicines Agency - Main contents
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| dossier | COM(2022)721 - Fees and charges payable to the European Medicines Agency. |
|---|---|
| document | COM(2022)721  |
| date | February 7, 2024 |
Article 1
Subject matter and scope
1. This Regulation lays down rules concerning:
| (a) | the fees and charges levied by the European Medicines Agency (the ‘Agency’) for assessment activities relating to obtaining and maintaining a Union authorisation to market medicinal products for human use and veterinary medicinal products, and for other services provided or tasks carried out by the Agency, as provided for in Regulations (EC) No 726/2004 and (EU) 2019/6; |
| (b) | the corresponding remuneration payable by the Agency to the competent authorities of the Member States for the services provided by rapporteurs and, where applicable, co-rapporteurs from competent authorities of the Member States, or by persons performing other roles considered as equivalent for the purposes of this Regulation, as referred to in the Annexes to this Regulation; and |
| (c) | the monitoring of the costs of activities and services provided by the Agency and the monitoring of the costs of the remuneration referred to in point (b). |
2. This Regulation also lays down the following:
| (a) | the amounts of the fees and charges referred to in paragraph 1, point (a), established on a cost-based evaluation; and |
| (b) | the corresponding amounts of remuneration referred to in paragraph 1, point (b), established on a cost-based evaluation. |
3. Medicinal products for human use which are authorised to be placed on the market in accordance with Article 126a of Directive 2001/83/EC shall not be subject to the fees for pharmacovigilance activities set out in the Annexes to this Regulation.
Article 2
Definitions
For the purposes of this Regulation, the following definitions apply:
| (1) | ‘chargeable unit in relation to medicinal products for human use’ means a unit defined by a unique combination of the following dataset derived from information on all medicinal products authorised in the Union, held by the Agency, and consistent with the obligation of marketing authorisation holders referred to in Article 57(2), points (b) and (c), of Regulation (EC) No 726/2004 to submit such information to the database referred to in Article 57(1), second subparagraph, point (l), of that Regulation:
|
| (2) | ‘chargeable unit in relation to veterinary medicinal products’ means a unit defined by the unique combination of the following data fields contained in the Union product database established pursuant to Article 55(1) of Regulation (EU) 2019/6:
|
| (3) | ‘medium-sized enterprise’ means a medium-sized enterprise within the meaning of Recommendation 2003/361/EC; |
| (4) | ‘small enterprise’ means a small enterprise within the meaning of Recommendation 2003/361/EC; |
| (5) | ‘microenterprise’ means a microenterprise within the meaning of Recommendation 2003/361/EC; |
| (6) | ‘public health emergency’ means a situation of public health emergency recognised by the Commission in accordance with Article 23(1) of Regulation (EU) 2022/2371 of the European Parliament and of the Council (25). |
Article 3
Types of fees and charges
The Agency may levy the following types of fees or charges:
| (a) | fees and charges for assessment procedures and services relating to medicinal products for human use, as set out in Annex I; |
| (b) | fees and charges for assessment procedures and services relating to veterinary medicinal products, as set out in Annex II; |
| (c) | annual fees for authorised medicinal products for human use and for authorised veterinary medicinal products, as set out in Annex III; |
| (d) | other fees and charges for medicinal products for human use, veterinary medicinal products and consultations on medical devices, as set out in Annex IV. |
Article 4
Additional fees and charges
1. The Agency may levy a scientific service fee for scientific services it provides if those services are not covered by another fee or charge provided for in this Regulation or in another Union legal act. The amount of the scientific service fee shall take into account the workload involved. The minimum and maximum amount of such scientific service fees and, where relevant, the corresponding remuneration to the rapporteurs and, where relevant, co-rapporteurs, are set out in point 5 of Annex IV.
2. The Agency may levy a charge for administrative services that it provides at the request of a third party, if those services are not covered by another fee or charge provided for in this Regulation or in another Union legal act. The amount of the charge for administrative services shall take into account the workload involved. The minimum and maximum amount of such charges are set out in point 6.4 of Annex IV.
3. Fees and charges levied pursuant to paragraphs 1 and 2 shall be set by the Management Board of the Agency following a favourable opinion by the Commission, in accordance with the procedure established under Article 8. The applicable amounts shall be published on the website of the Agency.
4. The Commission shall take into account any fees and charges levied by the Agency in accordance with this Article in any revision of this Regulation.
Article 5
Payment of remuneration to competent authorities of the Member States for the provision of services to the Agency
1. The Agency shall pay the competent authorities of the Member States the remuneration referred to in Article 1(1), point (b), in accordance with the amounts of remuneration provided for in this Regulation.
2. Where reductions or waivers apply to fees or charges, the corresponding remuneration payable to competent authorities of the Member States in accordance with this Regulation shall not be reduced, unless otherwise provided for in this Regulation.
3. The remuneration to competent authorities of the Member States shall be paid in accordance with the written contract referred to in Article 62(3), first subparagraph, of Regulation (EC) No 726/2004. The remuneration shall be paid in euro. Any bank charges related to the payment of such remuneration shall be borne by the Agency. Detailed rules concerning the payment of remuneration to competent authorities of the Member States shall be established by the Management Board of the Agency, in accordance with Article 8 of this Regulation.
Article 6
Reductions and deferrals of fees and charges
1. The Agency shall apply the reductions and deferrals set out in Annex V.
2. Member States or Union institutions that have requested an assessment, opinion or a service from the Agency shall not be subject to fees or charges under this Regulation.
3. Without prejudice to Article 5(2), where the applicant or marketing authorisation holder may also benefit from a reduction provided for in another Union legal act, only that reduction which is the most favourable to the applicant or marketing authorisation holder shall apply.
4. On a reasoned 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 types of 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 fee or charge, in accordance with Article 8. The Agency shall make information on such reductions publicly available on its website, after deletion of all information of a commercially confidential nature.
5. In exceptional circumstances and for imperative reasons of public or animal health, the Executive Director of the Agency may grant, on a case-by-case basis, total or partial reductions of the fees set out in Annexes I, II, III and IV, with the exception of the fees set out in Sections 6, 14 and 15 of Annex I, Sections 7 and 10 of Annex II and Section 3 of Annex III. Any decision taken pursuant to this Article shall state the reasons on which it is based. The Agency shall make information on such reductions, including the reasons for the reductions, publicly available on its website, after deletion of all information of a commercially confidential nature.
Article 7
Payment of fees and charges
1. Fees and charges due to the Agency under this Regulation shall be paid in euro.
2. Where fees and charges are due under this Regulation, the Agency shall issue a request for payment to the payer, stating the amount due and specifying the deadline for payment.
Where the payer receives a request for payment under the first subparagraph, the payer shall make payment by the deadline for payment specified in the request.
3. Payment of the fees and charges shall be made by means of a transfer to the bank account of the Agency specified in the request for payment. Any bank charges related to that payment shall be borne by the payer.
4. The payer shall be deemed to have made the payment by the deadline for payment set by the Agency only if the full amount has been paid by that deadline. The date on which the full amount of the payment is received in the bank account held by the Agency shall constitute the date on which the payment has been made.
Article 8
Working arrangements
1. The Management Board of the Agency shall, on a reasoned proposal from the Executive Director and following a favourable opinion from the Commission, establish working arrangements to facilitate the application of this Regulation, including payment methods of the fees and charges levied by the Agency, the mechanism for payment of remuneration to competent authorities of the Member States under this Regulation, a total or partial reduction of applicable fees or charges in accordance with Article 6(4), and the establishment of a common format, based on a transparent methodology, to be used by competent authorities of the Member States or experts contracted for the work of the expert panels on medical devices when providing the financial information to the Agency in accordance with Article 10(4).
2. As part of the working arrangements referred to in paragraph 1, the Management Board of the Agency shall also establish the scope of a distinct inspection, for each type of inspection. This shall include, where relevant, the medicinal product concerned, the site concerned, the activity concerned and the inspection team concerned.
3. The Agency shall make the working arrangements publicly available on its website.
Article 9
Due date and measures in case of non-payment
1. By 1 January 2025, the due dates of the fees or charges levied in accordance with this Regulation shall be specified in the working arrangements set out in accordance with Article 8 of this Regulation. Due account shall be taken of the deadlines of the assessment procedures provided for in Regulations (EC) No 726/2004 and (EU) 2019/6 and in Directive 2001/83/EC.
2. Where the payment of any fee or charge levied by the Agency in accordance with this Regulation is overdue, and without prejudice to the Agency’s capacity to institute legal proceedings to ensure payment pursuant to Article 71 of Regulation (EC) No 726/2004, the Executive Director of the Agency may decide that the Agency will not provide the services or will not carry out the procedures to which the respective fee or charge relates, or that the Agency will suspend any ongoing or future services and procedures until the respective fee or charge has been paid, including relevant interest as provided for in Article 99 of Regulation (EU, Euratom) 2018/1046.
Article 10
Transparency and monitoring
1. The Agency shall publish on its website the amounts of fees, charges and remuneration set out in the Annexes.
2. The Agency shall monitor its costs and the Executive Director of the Agency shall provide, in a timely manner as part of the annual activity report delivered to the European Parliament, the Council, the Commission and the Court of Auditors, detailed and substantiated information on the costs to be covered by fees and charges that are within the scope of this Regulation. That information shall include the performance information set out in Annex VI and may include other relevant information, such as information related to the practical aspects of carrying out the activities of the Agency, and a cost breakdown related to the previous calendar year and to a forecast for the following calendar year. The Agency shall also publish, in a timely manner, an overview of that information in its annual activity report.
3. In its annual activity report, the Agency shall publish the annual revenue received per type of fee and charge, including where reductions and waivers have been granted, and including fees and charges that are due but have not yet been received by the Agency.
The Agency shall also include in its annual activity report a detailed breakdown of all remunerated amounts paid to competent authorities of the Member States for their work.
4. Competent authorities of the Member States responsible for medicinal products or experts contracted for the work of the expert panels on medical devices may provide the Agency with evidence of significant changes in the costs of services provided to the Agency, excluding any effect of inflationary adjustments and any costs for activities that do not constitute a service to the Agency.
Such information may be provided once per calendar year or less frequently, as a complement to the information provided in accordance with Annex VI. Such evidence shall be based on duly justified and specific financial information on the nature and the extent of the financial impact on costs for services to the Agency. To that end, the competent authorities of the Member States or experts contracted for the work of the expert panels on medical devices shall use the common format facilitating comparison and consolidation, established in accordance with Article 8. The competent authorities of the Member States and the experts contracted to the Agency for the procedures of the expert panels on medical devices shall provide such information in the format provided by the Agency, together with any supporting information allowing the correctness of the amounts submitted to be verified. The Agency shall review and aggregate that information and shall use it, in accordance with paragraph 6, as a source for the special report provided for in that paragraph.
5. Article 257 of Regulation (EU, Euratom) 2018/1046 shall apply to the information provided to the Agency in accordance with paragraph 3 of this Article and Annex VI to this Regulation.
6. From 1 January 2025, the Commission shall monitor the inflation rate, measured by means of the Harmonised Index of Consumer Prices published by Eurostat pursuant to Regulation (EU) 2016/792, in relation to the amounts of fees, charges and remuneration set out in the Annexes to this Regulation. Such monitoring shall cover the period since the last inflation adjustment and shall thereafter take place on an annual basis. Any adjustment, in line with inflation, to fees, charges and remuneration established in accordance with this Regulation shall become applicable, at the earliest, on 1 January of the calendar year following the calendar year in which the monitoring exercise took place.
7. At the earliest in January 2026 and at three-year intervals thereafter, the Executive Director of the Agency shall provide the Commission with a special report adopted by the Management Board of the Agency outlining, in an objective, fact-based and sufficiently detailed manner, reasoned recommendations to:
| (a) | increase or decrease the amount of any fee, charge or remuneration, following a significant change in the respective costs as identified, documented and substantiated in the report; |
| (b) | amend any other element of the Annexes pertaining to the levying of fees and charges by the Agency, including additional fees and charges referred to in Article 4; |
| (c) | adapt the specification of activities for which the Agency collects fees or charges to changing conditions and requirements; |
| (d) | increase, decrease or introduce any fee, charge or remuneration following a change in the statutory tasks of the Agency leading to a significant change in its costs. |
8. The special report referred to in paragraph 7 and the recommendations it contains shall be based on the following:
| (a) | monitoring of the information referred to in paragraphs 2 and 3 and of the cost of the activities necessary for the fulfilment of the statutory tasks of the Agency, aimed at identifying significant changes to the cost base of services and activities of the Agency; and |
| (b) | objective and verifiable information, including quantification that directly supports the relevance of the recommended adjustments. |
9. The Agency shall make publicly available, in a timely manner, on its website the special report referred to in paragraph 7.
10. The Commission may request any clarification or further substantiation of the special report and its recommendations, if considered necessary. Following such a request, the Executive Director of the Agency shall without undue delay prepare an updated special report which addresses the matters raised in the Commission’s request. That updated special report shall be adopted in accordance with paragraph 7 and submitted forthwith to the Commission.
11. The time interval for the first special report as well as the reporting time interval referred to in paragraph 7 may be shortened in any of the following situations:
| (a) | a public health emergency; |
| (b) | a change in the statutory tasks of the Agency; |
| (c) | there is evidence of significant changes in the costs or the cost-revenue balance of the Agency; |
| (d) | there is evidence of significant changes in the costs for cost-based remuneration to competent authorities of the Member States. |
Article 11
Revision
1. The Commission is empowered to adopt delegated acts in accordance with Article 13 to amend the Annexes where justified in view of any of the following:
| (a) | a special report received by the Commission in accordance with Article 10(7); |
| (b) | the findings from the monitoring of the inflation rate referred to in Article 10(6); or |
| (c) | the budgetary reporting of the Agency. |
2. Any revision of the fees and charges and of the remuneration paid to competent authorities of the Member States provided for in this Regulation shall be based on the Commission’s evaluation of the Agency’s costs and revenues and of the full costs of the services provided to the Agency within the scope of this Regulation by the competent authorities of the Member States, taking into account also the impact of such services on the sustainability of the operations of the Agency, including the services provided to the Agency by the competent authorities of the Member States, and a fair and objective allocation of fees, charges and remuneration.
The Commission may take into account any factors that could have a substantive impact on the Agency’s costs, including but not limited to the workload associated with its activities, and potential risks related to fluctuations in its fee revenue. The fees and charges shall be set at a level which ensures that the Agency has sufficient revenue to cover the costs of the services delivered.
3. In any revision of the Annexes, the amounts of remuneration paid to competent authorities of the Member States provided for in this Regulation shall be maintained as a single amount of remuneration irrespective of the Member State of the competent authority concerned.
Article 12
Estimate of the Agency’s budget
The Agency shall, when producing an estimate of revenue and expenditure for the following financial year in accordance with Article 67(6) of Regulation (EC) No 726/2004, include detailed information on income from each type of fee and charge and on the corresponding remuneration. In accordance with the typology of fees and charges set out in Article 3 of this Regulation, that information shall distinguish between the following:
| (a) | medicinal products for human use and consultations on medical devices; |
| (b) | veterinary medicinal products; |
| (c) | annual fees, by type; |
| (d) | other fees and charges, by type. |
The Agency may provide a breakdown by type of procedure in an annex to the single programming document produced in accordance with Article 32(1) of Delegated Regulation (EU) 2019/715.
Article 13
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 11(1) shall be conferred on the Commission for a period of five years from 15 February 2024. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-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 three months before the end of each period.
3. The delegation of power referred to in Article 11(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6. A delegated act adopted pursuant to Article 11(1) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 14
Amendment to Regulation (EU) 2017/745
In Article 106 of Regulation (EU) 2017/745, paragraph 14 is replaced by the following:
‘14. The fees established in accordance with the procedure under paragraph 13 of this Article shall be set in a transparent manner and on the basis of the costs for the services provided. The fees payable shall be reduced in the case of a clinical evaluation consultation procedure initiated in accordance with Section 5.1, point (c), of Annex IX involving a manufacturer who is a micro, small or medium-sized enterprise within the meaning of Recommendation 2003/361/EC.
The fees related to the advice provided by expert panels are payable to EMA pursuant to Article 30, point (f), of Regulation (EU) 2022/123 of the European Parliament and of the Council (*1).
The fees related to the advice provided by expert laboratories are payable to the Commission.
Article 15
Amendment to Regulation (EU) 2022/123
Article 30, point (f), of Regulation (EU) 2022/123 is replaced by the following:
| ‘(f) | levy fees in accordance with Article 106(14) of Regulation (EU) 2017/745 and ensure that remuneration and expenses are provided to experts in accordance with implementing acts adopted by the Commission pursuant to Article 106(1) of Regulation (EU) 2017/745;’. |
Article 16
Repeal
Regulation (EU) No 658/2014 of the European Parliament and of the Council (26) and Council Regulation (EC) No 297/95 (27) are repealed with effect from 1 January 2025.
References to Regulation (EC) No 297/95 shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VII to this Regulation.
Article 17
Transitional provisions
This Regulation shall not apply to annual fees, procedures or services for which the amount became due pursuant to Regulation (EC) No 297/95 or Regulation (EU) No 658/2014 before 1 January 2025.
Article 18
Entry into force and date of application
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 January 2025.
This Regulation shall be binding in its entirety and directly applicable in all Member States.