Activities of Susana SOLÍS PÉREZ related to 2022/0417(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council of the Council on fees and charges payable to the European Medicines Agency, amending Regulation (EU) 2017/745 of the European Parliament and of the Council and repealing Council Regulation (EC) No 297/95 and Regulation (EU) 658/2014 of the European Parliament and of the Council
Amendments (7)
Amendment 22 #
Proposal for a regulation
Recital 1
Recital 1
(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 a high level of expertise and protection of human and animal health. It is therefore necessary to ensure sufficient resources are available to the Agency to maintain its attractiveness as an employer in a very competitive sector and to finance its activities, including resources emanating from fees.
Amendment 23 #
Proposal for a regulation
Recital 3
Recital 3
(3) The fees payable to the Agency should be proportionate to the work carried out in relation to obtaining and maintaining a Union authorisation, and should be based on an evaluation of the Agency’s estimations and forecasts as regards the workload and related costs for that work, as well as on an evaluation of the costs of the services provided to the Agency by the competent authorities of Member States that are responsible for regulating medicinal products, which act as rapporteurs and, where applicable, co- rapporteurs appointas co-rapporteurs, and where applicable as multinational teams, appointed by the scientific committees of the Agency. The fees should take into account the increased requirements for marketing authorisation as proposed by [the scientific committees of the Agencyproposal for a Directive on the Union code related to medicinal products for human use (2023/0132 (COD))] and [the proposal for a Regulation laying down procedures for the authorisation and supervision of medicinal products for human use (2023/0131(COD))] and, respectively, the expected increase in workload and demand for expertise by both the Agency and the national competent authorities. Adequate financing should be ensured for this critical public infrastructure to boost its expertise and ensure its sustainability through appropriate financing.
Amendment 33 #
Proposal for a regulation
Recital 16 a (new)
Recital 16 a (new)
(16a) The rules governing the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of veterinary medicinal products have been reviewed and updated as part of Regulation (EU) 2019/6. Pursuant to recital 5 of this Regulation, a key objective is to reduce the regulatory administrative burden for veterinary medicinal products. Regulation (EU) 2019/6 entered into force on 28 January 2022, and the transition to new systems and procedures will not be completed before 2024. Progress towards the objective of reducing the administrative costs for veterinary medicines should be evaluated by the European Commission after 2024, and corrective measures proposed if necessary, and a new cost analysis of the new systems and procedures should be carried out in 2025. Subsequently, the fees for veterinary medicinal products should be revised accordingly.
Amendment 80 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
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. Any other factors that may have a substantive impact on the Agency’s budget, including but not limited to its workload and potential risks related to fluctuations in its fee revenues, should be taken into account. The level of fees shall be set at a level which ensures that the revenue derived from them, when combined with other sources of revenue of the Agency, is sufficient to cover the costs of the services delivered in accordance with the key performance indicators and transparency principles set out in this Regulation.
Amendment 86 #
Proposal for a regulation
Article 16 – paragraph 2 a (new)
Article 16 – paragraph 2 a (new)
2a. Following the entry into force of Regulation 2019/6 on veterinary medicinal products, Annex II shall be amended in 2025 following an evaluation of the costs of the activities carried out by the Agency in the field of veterinary medicinal products.
Amendment 87 #
Proposal for a regulation
Article 16 – paragraph 2 b (new)
Article 16 – paragraph 2 b (new)
2b. By way of derogation from Article 15, the provisions of Regulation (EC) No 297/95 and (EU) No 658/2014 shall apply to fees, charges and remuneration for the assessment procedures and services referred to in Annex II and until Annex II is revised, based on the cost analysis of paragraph 2a (new).
Amendment 111 #
Proposal for a regulation
Annex VI – paragraph 1 – point 6 a (new)
Annex VI – paragraph 1 – point 6 a (new)