The consultation launched by the European Commission on the Inception impact assessment on the evaluation of the fee system of the European Medicines Agency (EMA) closed on 16 October. The Impact assessment is part of the Staff Working Document released by the Commission on its site. EMA’s fee system has been generally considered efficient and effective, but there are opportunities to make it more flexible and sustainable in order to adapt to future regulatory developments, says the Commission.
Open issues call for a review of fees
The entry into force of regulation EU 2019/5 on the financing system used by EMA and of regulation EU 2019/6 on veterinary medicines are the two main causes that pushed the Commission to re-evaluate the current framework for regulatory fees.
The veterinary sector, in particular, needs urgent intervention in view of the entry into force – in January 2022 – of the new EU 2019/6 regulation, which include activities currently not covered by EMA’s fees. Possible fluctuations of the financial incomes of the European Medicines Agency and the complexity of the current remuneration system are among other reasons to review it. According to the report published by the Commission, many fees might be not aligned with real costs, both in excess (i.e. for variations) and in defect (i.e. for the initial submission of the request of a new marketing authorisation). Fees specific to some kind of activities are also lacking, for example in relation to paediatric investigation plans or orphan designations. The same applies also to activities run at the national level by local competent authorities.
According to the Commission, a more coherent approach would thus be needed at the level of the two regulations governing fees and pharmacovigilance fees, both at a central and national level. Many are the possible options envisaged in the Staff Working Document to reach a better financial sustainability for EMA’s and local regulatory activities, paying also attention to the provision of services of different complexity or to particular categories of products, markets or applicants which may be subjects to special fees (i.e. SMEs or veterinary medicines).
The options on the table
The Inception Impact Assessment presents three different levels of options to simplify and better align EMA’s fees system, each of one characterised by many secondary alternatives.
The easier choice would simply actualise costs and re-align fees requirements to the two above mentioned regulations. Under this entry, fees for the renewal of the authorisation of veterinary medicines would be due just in some specific cases, as the authorisation itself will assume undefined duration. The same kind of fees as today will apply, with a very limited revision just in some specific cases.
New fees or charges in the veterinary field should also include costs for the reporting of adverse effects and for the process of signal management, as well as costs to maintain authorisations, for pharmacovigilance, to manage the European databases for products, pharmacovigilance and production, import and distribution. Under this option, fees and charges should also reflect costs to collect data on content of antimicrobials.
National competent authorities (NCAs) remuneration would remain the same as today (full fees), without any modification for human medicines. This choice assumes that veterinary fees calculated on costs are lower than those for human products. The Commission also proposed different options for the possible modification of reductions and incentives.
The other options impact also on human medicines
The second option would act on both human and veterinary medicines, without changes of the general framework. Each single fee would be recalculated based on a weighted media taking into account the actualisation of both costs and time. NCAs remuneration would also be recalculated on the basis of the different procedures and costs. The same as above would apply to the veterinary sector.
A new structure for fees and charges would be created to include specific items related to EMA’s committees for orphan and paediatric medicines. Incentives would be linked to the specific legislation that applies to each case, while financing would result from a redistribution of costs on other sources of economic return for EMA. This would also include redefining the distribution of incentives between the central European Agency and national competent authorities. The document details several possible alternatives to reach this goal.
Under the third option – again relative to both human and veterinary medicines – an overall simplification and a better efficiency of the fees system is foreseen. Many are the Commission’s proposals, for example fees specific for not-pharmacovigilance procedures of centrally authorised medicines (CAPs) might be included within a single annual fee due for each CAP. Complex procedures (i.e. line extensions) would be excluded from this possibility. Pre-authorisation and inspection fees may also be simplified, and a flat fee may be created to include the great part of activities in the field of pharmacovigilance, both at a central and national level. A full recalculation for veterinary fees and NCAs remuneration would be also run.
The possible impact
According to the Commission, no macro-economic impacts are expected from the review of the fees system, but some effects on regulatory costs to be afforded by the pharmaceutical industry may be possible. EMA and NCAs may benefit from a more fair fees framework and a more predictable financial impact, leading to lower fluctuations of EMA’s budget and a lower administrative burden. The higher remuneration of NCAs may also result in the possibility for national authorities to better support companies, thanks to a better efficiency of regulatory activities at the European level. The Commission also expects an indirect social impact, due to the faster access of patients to new treatments consequent to the increased regulatory efficiency.