European Parliament Proposes Changes to Pharmacovigilance User Fee Collection System

A new legislative draft report posted by the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) on 18 October 2013 calls for changes to be made to the way in which user fees are payable to the European Medicines Agency (EMA) for some application filings.

EMA, like the US Food and Drug Administration (FDA), partially funds its review work through user fees payable to the agency for many routine activities, such as the registration of facilities and acceptance of applications.

Now ENVI is proposing to increase the list of activities on which a fee can be demanded by regulators, including several activities called for under last year's pharmacovigilance legislation.

In one area, legislators clarified that the size of a drug unit should not be taken into consideration for the purposes of assessing a user fee. "Whether the pack contains 10 or 20 tablets is not relevant for Pharmacovigilance," ENVI legislators wrote. "It would be more appropriate to charge according to the number of authorizations per active ingredient, and per pharmaceutical form (i.e. whether the product is a spray, a tablet or an injectable solution)."

Importantly, the user fees will now fully cover generic medicinal products for the purposes of pharmacovigilance, which will no longer be eligible for a "reduced annual flat fee."

The EU Commission has been pushing for a reduction in fees because "those products generally have a well-established safety profile." ENVI gave no reason for the change.

Elsewhere in the draft amendments text, ENVI has called for a variable fee assessment, noting that procedures can be simple or complex. "Instead of charging the same average fee whatever the workload involved, a more cost-based approach would be to move to a tiered system."

"As discussions are still ongoing about how many hours work are involved per active substance, the exact amounts are not yet included in this draft report," ENVI added.

Another area set to see changes will be signal detection fees. ENVI has proposed charging a yearly flat fee on pharmacovigilance activities and monitoring of medical literature. However, signal detection activities-unless they occur at the EU-wide level-will fall to member states, which may still charge fees.

ENVI Draft Report