Inception Impact Assessment (IIA) and feedback

Based on the outcomes of the evaluation study, Inception Impact Assessment (IIA) was developed presenting three policy options to address, in a step-by-step manner, the findings of the evaluation.

The IIA was published on 18 September 2019 and provided for a feedback period of one month, ending 16 October 2019. The responses received from stakeholders are published and have been summarised.

The feedback received has been taken into account, and the options have consequently been refined. The refined options are those which are currently being used to inform the methodology of this IA study. Additional clarifications have been made to the options since the start of the current study, to take into account changes that have occurred since the IIA was completed.

Additional details regarding how the options have been implemented can be found here

Eligibility of declared additional costs for NCAs

Beyond NCAs’ procedural activities,the EMA Management Board data gathering exercise also considered time spent on two other groups of NCA activities: (1) attending EMA’s committees and working groups, outside procedures, and (2) additional activities declared by NCAs as potential EMA activities, beyond the assessment procedures and the committee and working groups non-procedural time. These two groups of NCAs activities were considered in the evaluation study and their cost was estimated, but their relevance was not analysed with regard to the remuneration that EMA pays to NCAs.

The analysis for such assessment was later carried out by DG SANTE services. For the analysis of eligibility for remuneration by EMA of the additional activities declared by NCAs an ad-hoc survey of NCAs was conducted, to quantify the relative allocation of each of these activity groups within the overall costs of all activity.

Input provided by NCAs, was then analysed to determine their eligibility for remuneration from EMA, based on three cumulative conditions stemming from the analysis of the relevant provisions in the respective legislation:

1. The activity must be of a scientific nature;
2. The activity must be related to EMA’s mandated tasks;
3. The activity must represent a service provided to the EMA (i.e. not a national activity).

The overall amount eligible for remuneration from EMA fee income (and therefore used in the calculation of the fee levels presented for the consultation) was estimated at roughly €12 mil.

Regarding NCA time spent participating in EMA committees and working parties when the NCAs are not in charge of a procedure, this activity is considered to be part of the overall contribution to the EU regulatory system. In this context, all Member States share a collective responsibility for the authorisation and monitoring of centrally authorised medicines and enjoy the collective benefit of having medicines registered and monitored in all Member States through a single procedure. Therefore, being part of these EU-level structures is not consistent with the remuneration paid by EMA, as an EU decentralised agency, specifically for the work carried out by the national competent authorities of the Member States which act as rapporteurs and, where applicable, co-rapporteurs. Moreover, calculating a monetary equivalent of benefits associated with the EU centralised system is also not considered appropriate for the purpose of this exercise. This rationale is applied as an overarching matter of principle.

The full analysis of the NCA cost and remuneration calculations can be found here.

 

Impact Assessment of the EMA fee system

Recent changes to the legal framework affect the EMA fee system, specifically:

• Changes to the regulatory framework for veterinary medicines following the entry into force of the Veterinary Medicinal Product (VMP) Regulation, which becomes applicable in January 2022; and
• Changes to the EMA Founding Regulation that provide for the possibility of introducing a new potential source of revenue for the EMA (i.e. charges) and place an obligation on the Commission to pay attention to potential risks related to fluctuation in the fee revenue of the Agency when it reviews the fee system (Art.86a).

The Commission has also issued recently a legal proposal for an extension of the EMA mandate, including EMA activities to access and analyse EU-wide health data in support of decision-making on medicines. Since the EU budget contribution for these activities is available only until 2023, they are projected to affect the fee system as of 2024 and are therefore taken into account in the impact assessment study.

In light of these changes, and the results of the evaluation of the EMA Fee System, as well as feedback received to the Inception Impact Assessment described above, the European Commission is conducting an impact assessment of potential revisions to the EMA fee system. The objectives of the impact assessment are to analyse a set of options aimed at:

• Aligning the main categories of fees and charges with the EMA Founding Regulation,
• Allowing for adequate financing of veterinary procedures,
• Achieving a simplification of the system, and
• Ensuring a fair level of fees and NCA remuneration, while respecting fee incentives established in existing policies.

The present study is being undertaken to support the impact assessment. The study team led by ICF and RAND Europe has modelled impacts over a five-year period from the time when the VMP Regulation becomes applicable (2022).The results of the modelling exercise presented in the survey that you have been asked to complete are based on the evaluation and on further information provided by DG SANTE, EMA and NCAs.

A methodology note explaining the data sources, adjustments and assumptions underlying the modelling results is available. It should be noted that the budgetary projections are indicative and are based on a certain number of assumptions, e.g. the frequency of procedures. The results presented in the survey are preliminary outputs for comments from the first run of the model. They are presented in the framework of the study report and do not represent an official position of the Commission services.

The figures may change as the model is refined over the course of the study, for example, as a result of the consultations.

Your input, along with other information gathered through desk research, interviews and analysis, will inform the European Commission’s assessment of the impacts of potential revisions to the EMA fee system. This consultation is strictly limited to the EMA fee system. The underlying legislation governing the activities and incentives of the EMA is not within the scope of this consultation.