Legal provisions of COM(2022)721 - Fees and charges payable to the European Medicines Agency

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dossier COM(2022)721 - Fees and charges payable to the European Medicines Agency.
document COM(2022)721 EN
date February  7, 2024


Article 1

Subject matter

This Regulation lays down the following:

(a)the amounts of the fees and charges established on cost-based evaluation and 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) 726/2004 and (EU) 2019/6;

(b)the corresponding amounts of remuneration established on cost-based evaluation and 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 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 costs of activities and services provided by the Agency and of costs for remuneration referred to in point (b). 

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1) ‘chargeable unit in relation to medicinal products for human use’ (‘chargeable unit - human’) 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:

(a)name of the medicinal product, as defined in Article 1, point (20), of Directive 2001/83/EC;

(b)marketing authorisation holder;

(c)the Member State in which the marketing authorisation is valid;

(d)active substance or a combination of active substances, except in the case of homeopathic medicinal products or herbal medicinal products, as defined in Article 1, points 5 and 30, respectively, of Directive 2001/83/EC;

(e)pharmaceutical form;

(2) ‘chargeable unit in relation to veterinary medicinal products’ (‘chargeable unit - veterinary’) 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:

(a)the Permanent Identifier referred to under Data Field ID 3.1 in Annex III to Implementing Regulation (EU) 2021/16;

(b)the Product Identifier referred to under Data Field ID 3.2 in Annex III to Implementing Regulation (EU) 2021/16;

(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 12(1) of Decision No 1082/2013/EU of the European Parliament and of the Council 40 .

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, set out in Annex I;

(b)fees for and charges for assessment procedures and services relating to veterinary medicinal products, set out in Annex II;

(c)annual fees for authorised medicinal products for human use and for authorised veterinary medicinal products, set out in Annex III;

(d)other fees and charges for medicinal products for human use, veterinary medicinal products and consultations on medical devices, 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 these services are not covered by another fee or charge provided for in this Regulation. The amount of the scientific service fee shall take into account the workload involved. Its minimum and maximum amount 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 it provides, at the request of a third party, if these services are not covered by another fee or charge provided for in this Regulation. The amount of the charge for administrative services shall take into account the workload involved. Its minimum and maximum amount 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 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 remuneration referred to in Article 1(b) in accordance with the amounts of remuneration provided for in this Regulation.

2. Unless otherwise provided for in this Regulation, where fee reductions apply, the remuneration to competent authorities of the Member States payable in accordance with this Regulation shall not be reduced.

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 shall be established by the Management Board of the Agency, in accordance with Article 8 of this Regulation.

Article 6

Reductions of fees and charges

1. The Agency shall apply the reductions set out in Annex V.

2. Where an assessment, an opinion or a service of the Agency is requested either by a Member State or by a Union institution, the Agency shall waive the respective fee or charge, as applicable, in full.

3. Where the applicant or marketing authorisation holder may also benefit from another reduction provided for in Union legislation, only the reduction that is the most favourable to the applicant or marketing authorisation holder shall apply.

4. On a duly justified proposal from the Executive Director of the Agency, in particular for the protection of public or animal health or for the support of specific types of products or applicants, selected for duly justified reasons, the Management Board of the Agency may grant, following a favourable opinion from the Commission, a total or partial reduction of the applicable amount, in accordance with Article 8.

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 for the fees set out in Annexes I, II, III and IV, with the exception of the fees set out in points 6, 15 and 16 of Annex I, points 7 and 10 of Annex II and point 3 of Annex III. Any decision taken pursuant to this Article shall state the reasons on which it is based.

Article 7

Payment of fees and charges

1. Fees and charges due under this Regulation shall be paid in euro.

2. Payment of the fees and charges shall be made after the payer has received a request for payment issued by the Agency specifying the deadline for payment.

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 deadline for payment shall be considered to have been complied with only if the full amount has been paid in due time. 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

The Management Board of the Agency shall, on a justified 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 and the mechanism for payment of remuneration to competent authorities of the Member States under this Regulation.

Those arrangements shall be made publicly available on the Agency’s website.

Article 9

Due date and measures in case of non-payment

1. 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 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 amounts set out in the annexes shall be published on the website of the Agency.

2. The Agency shall monitor its costs and the Executive Director of the Agency shall provide, 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 a cost breakdown related to the previous calendar year and to a forecast for the following calendar year. The Agency shall also publish an overview of that information in its annual report.

3. 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, may be provided by competent authorities of the Member States responsible for medicinal products or by experts contracted for the procedures of the expert panels on medical devices 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 official financial information on the nature and the extent of the financial impact on costs for services to the Agency. To that end, the Agency may provide a common format facilitating comparison and consolidation. The competent authorities of the Member States and the experts contracted for the procedures of the expert panels on medical devices to the Agency shall provide such information in the format provided by the Agency, together with any supporting information allowing to verify the correctness of the amounts submitted. 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.

4. 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.

5. The Commission shall monitor the inflation rate, measured by means of the Harmonised Index of Consumer Prices published by Eurostat pursuant to Regulation (EU) No 2016/792, in relation to the amounts of fees, charges and remuneration set out in the Annexes to this Regulation. The monitoring exercise shall take place no earlier than [OP: please insert date one year after the date of application of this Regulation], and thereafter 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.

6. At the earliest on [OP: please insert date 3 years after the date of application] and at three-year intervals thereafter, the Executive Director of the Agency may, where considered relevant in view of Article 11(2), and after consultation of the Management Board of the Agency, provide the Commission with a special report outlining, in an objective, fact-based and sufficiently detailed manner, justified recommendations:

(a)to increase or decrease the amount of any fee, charge or remuneration, following a significant change in the respective costs as identified, documented and justified in the report;

(b)to amend any other element of the Annexes pertaining to the levying of fees and charges, including additional fees and charges referred to in Article 4.

7. The special report referred to in paragraph 6 and the recommendations it contains shall be based on the following:

(a)continuous 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;

(b)objective and verifiable information and quantification that directly supports the relevance of the recommended adjustments.

8. The Commission may request any clarification or further substantiation of the report and its recommendations, if considered necessary. Following such a request, the Agency shall without undue delay provide the Commission with an updated version of the report which addresses any comments made and questions raised by the Commission.

9. The reporting time interval referred to in paragraph 6 may be shortened in any of the following situations:

(a)in the case of a public health emergency;

(b)in the case of a change of the legal mandate of the Agency;

(c)in the case there is clear and compelling evidence of significant changes in the costs or the cost-revenue balance of the Agency, including 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 it deems it justified in view of any of the following:

(a)a special report received by the Commission in accordance with Article 10(6);

(b)the findings from the monitoring of the inflation rate referred to in Article 10(5);

(c)a change in the statutory tasks of the Agency leading to a significant change in its costs;

(d)the budgetary reporting of the Agency;

(e)other relevant information, in particular on practical aspects for the execution of activities for which the Agency collects fees or charges.

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 relevant costs of the services provided to the Agency by the competent authorities of the Member States.

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 fees and charges and respective remuneration. In accordance with the typology of fees and charges set out in Article 3 of this Regulation, that information shall distinguish, respectively, 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.

A breakdown by type of procedure may be provided by the Agency 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 5 years from [tbc] 20[xx]. The Commission shall draw up a report in respect of the delegation of power not later than 6 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period.

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 2 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 2 months at the initiative of the European Parliament or of the Council.

Article 14

Amendment to Regulation (EU) No 2017/745

Article 106 of Regulation (EU) No 2017/745, paragraph 14 is replaced by the following:

‘14.The fees payable to EMA in accordance with the procedure under paragraph 13 of this Article related to the advice provided by expert panels for which EMA provides the secretariat in accordance with Article 30 of Regulation (EU) 2022/123 of the European Parliament and of the Council 41  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 to this Regulation involving a manufacturer who is a micro, small or medium-sized enterprise within the meaning of Recommendation 2003/361/EC.’.

Article 15

Repeal

Regulations (EC) No 297/95 and (EU) No 658/2014 are repealed.

References to Regulation (EC) No 297/95 shall be construed as references to this Regulation and read in accordance with the correlation table in Annex VII to this Regulation.

Article 16

Transitional provisions

1. This Regulation shall not apply to procedures and services for which the payable amount became due before [OP: please insert date of application]. 

2. With regard to annual fees set out in Annex III, this Regulation shall not apply to products for which an annual fee has become due pursuant to Regulation (EC) No 297/95 or Regulation (EU) No 658/2014 in the year [OP: please insert calendar year of application]. 

Article 17

Entry into force and date of application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from [OP: please insert date of first day of the month following expiration of 6 months after entry into force].

This Regulation shall be binding in its entirety and directly applicable in all Member States.