The UK government has warned the European Commission of the danger of "spiralling" pharmacovigilance costs across the European Union (EU), which, it says, “could potentially affect the overall costs of bringing products to market."
Responding to the Commission's consultation on proposals to introduce industry fees for new tasks to be undertaken by the European Medicines Agency (EMA) under the recently-introduced EU pharmacovigilance legislation, the UK points out that this work is currently done on a non-remunerated basis by the EU member states' national competent authorities (NCAs).
The new fee regime for pharmacovigilance activities operated by the EMA and NCAs must be transparent, cost-effective and should, at all times, avoid dual charging, says the UK."We need to consider how the overall governance of the…fee structures can ensure that the pharmacovigilance fees in the EU remain cost-effective and do not deter companies from marketing their products in the Union," it emphasises.
Given that the new pharmacovigilance legislation took effect in July, the levels of fees which the EMA should charge industry for its new tasks need to be established urgently, says the Commission consultation. It also points out that, as the Agency's new work will cover both nationally and centrally-authorised products (CAPs), "it is justified that EMA will charge fees also where nationally-authorised products (non-CAPs) are involved.""It should also be borne in mind that while the new pharmacovigilance legislation lays down certain obligations on the industry, the activity of the regulatory authorities in the area of pharmacovigilance (notably the detection of safety signals, assessment of these signals and regulatory follow-up) constitutes a service to the industry," the Commission adds.
The consultation proposes the following different types of fees for the various assessment procedures involving EMA's Pharmacovigilance Risk Assessment Committee (PRAC):
- a single, EU-wide assessment of Periodic Safety Update Reports (PSURs), with a maximum fee of 80,300 euros for each assessment for products which have been authorised for two years or more, dropping to 40,150 euros for those authorised for less;
- a new fee, of 80,300 euros, for assessment of Post-Authorisation Safety Studies (PASS); and- a fee for assessment of pharmacovigilance referrals, varying from a minimum of 80,3000 euros up to 267,400 euros, which would apply when the workload was equivalent to a full benefit-risk assessment.
For all these fees, there would be the possibility of "grouping" of products where the marketing authorisation holder (MAH) is not the same for the same product in different member states, and of fee reductions for small and medium-sized enterprises (SMEs).
In addition, the Commission is proposing to charge each MHA a pharmacovigilance service fee of up to 1,000 euros per product per year. This would cover EMA's new services and activities, such as literature monitoring, that benefit the industry but for which it is not possible, or very difficult, to identify individual addressees, it says.
In its response, the UK says it is difficult to give an informed view on the proposed size of the fees because the Commission's consultation document does not give enough information on how they have been calculated. It also points out that NCAs remain responsible for ensuring the safety of medicines on their markets, and they must retain the right to undertake relevant pharmacovigilance activities and charge fees for them. "We must ensure that in such cases industry is not double-charged by EMA," says the UK.On the proposal to charge SMEs lower fees, the UK says it could only agree to this if NCAs would be fully reimbursed for the work they do and receive the amount which would have been paid if no reduction had been applied.
While the UK says it recognises the urgency of getting a fee regime in place, it adds that it would value "a more developed discussion about how to ensure that the new system is implemented in a way that brings greatest public health gain in the most cost-effective and efficient manner."
Moreover, it says, the new legislation and supporting fee structure provide "a robust basis for the broader consideration of issues such as adaptive licensing that may lead to changes in how and when new medicines are made available on the EU market."