Scope:

Evaluation of the fee system of the European Medicines Agency.

The effectiveness and the efficiency of the system were examined notably with respect to the sustainability and the fairness of the financial model of the fees charged by EMA to industry at large, including the remuneration paid by EMA to rapporteurs and experts from national competent authorities.

Evaluation findings:

The outcome of the evaluation indicated that the fee system of the EMA is generally efficient and effective. However, the acquired experience indicates that it may need to be revised in order to be more flexible to adapt to future developments, including the implementation of the new veterinary legislation, and also to be more sustainable in the long term. The evaluation also concluded that the fee system is complex and would benefit from streamlining.

² https://ec.europa.eu/transparency/documents-register/detail?ref=SWD(2019)336&lang=en

Which objective(s) does the Commission pursue?

The general objective pursued is to provide the EMA with a sound financial basis for the future. The specific objectives of the revision of the EMA fee system are to:

● align revenue from fees with estimated costs;

● align the EMA fee system with the VMP regulation;

● ensure a fair distribution of cost-based fees and cost-based NCA remuneration, while respecting applicable fee incentives; and achieve a balance between simplification of the system and a cost-based approach

In addition, the proposal addresses the unnecessary complexity of the corresponding legal framework, by streamlining the EMA fee legislation and bringing together in a single legal instrument fee rules that are currently governed by the two EMA Fee 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.

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 definitions of ‘chargeable unit’ for products for human use and for 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.

Estimated savings and benefits:

The quantification of the administrative costs in the impact assessment demonstrates that no significant administrative costs will be added by the initiative (i.e. the estimated effect is a limited saving in administrative net cost in the range of €55,000 to €112,000 which is limited in the context of the entire EMA fees system)