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

Proposal for a Regulation of the European Parliament and of the Council

Introduction

Within the European Union (EU), all medicinal products for human and veterinary use must be authorised either at EU (central) or Member State (national) level. At EU level, the Commission authorises these products based on the scientific assessment of their quality, safety and efficacy, as delivered by the European Medicines Agency (EMA), with the contribution of national competent authorities (NCAs) in Member States. The EMA charges fees to marketing authorisation holders and applicants for obtaining and maintaining EU-wide marketing authorisations for medicinal products for human and veterinary use. The EMA remunerates NCAs for their scientific assessment work. The services for which EMA charges fees include scientific advice, assessment of applications for a marketing authorisation, changes to existing marketing authorisations (variations and extensions), and other pre- and post-authorisation procedures, and annual fees for the maintenance of already authorised medicines. Pharmacovigilance activities conducted at EU level for nationally authorised medicines for human use are also financed by fees paid by marketing authorisation holders to the EMA.

The legislation requires that EMA fees be based on an evaluation of the Agency’s costs and of the related costs of services provided by Member States (national competent authorities).

The main problems facing the EMA fee system

The main problems, identified in the 2019 evaluation of the EMA fee system , are as follows:

·misalignment of some fees with the underlying costs of the activities estimated by the evaluation;

·misalignment of some NCA remuneration with the underlying costs estimated by the evaluation;

·the fee system may not be flexible enough to keep pace with innovations, meaning that, in the future, some assessment processes for new medicinal products will likely be more complex than in the past; and

·the fee system is rather complex and not fully coherent both externally with the underlying pharmaceutical legislation and internally between the two EMA Fee Regulations, thus creating unnecessary administrative burden and difficulties for some stakeholders when predicting the fees that will be charged.

These problems are driven by:

·new and amended procedures for veterinary medicines introduced as a result of revisions to the Veterinary Medicinal Products (VMP) Regulation; and a new EMA activity included in Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices, which requires additional funds as of 2024;

·levels of fees and remuneration that are not fully cost-based on the granular level (i.e. unitary fees and unitary remunerations);

·lack of a clear approach to the distribution of the financial burden of fee incentives between the EMA and NCAs;

·lack of a monitoring system to track and detect significant trends having an impact on the cost base of fee and remuneration amounts, e.g. changes in complexity of scientific assessments;

·the wide variety of EMA activities and the complexity of the underlying pharmaceutical legislation; and

·lack of an appropriate mechanism to easily adjust the fee system to changes in EMA responsibilities (the full ordinary legislative procedure is required to amend the fee amounts set in the legislation beyond inflation adjustments).

These problems are a challenge to the financial sustainability of the EMA going forward, including the capacity of the Agency to remunerate NCAs for their contributions to EMA activities in line with the pharmaceutical legislation.

The case for and objectives of EU action

The general objective pursued is to provide the EMA with a sound financial basis for the future. The EMA is a decentralised Agency of the EU. The terms of its funding, including fees as a source of revenue, are determined exclusively by EU legislation. Any amendment of the two EMA Fee Regulations requires an ordinary legislative procedure . Hence, only the EU can act to enable the Agency to charge fees.