The European Union Commission ( EU )will start examining the pharmaceutical company fee system that allows fund the European Medicines Agency (EMA).
“The efficiency and the effectiveness of the system will be analyzed especially with regard to the sustainability and the fairness of the financial model of the fees charged by EMA to industry at large, which includes the compensation paid by EMA to rapporteurs and experts from national competent authorities,” the commission mentioned in an evaluation roadmap published online recently.
The EMA can approve new drugs within the centralized process for all of the EU member states, and offer scientific support to member state competent regulators if there’s disagreement authorizing new drugs under the decentralized process (authorization of a new drugs in various member states in parallel) or the mutual identification procedure (a medicine is approved in various member states centered on an existing authorization in a member state). EMA also offers technical and administrative assistance to a coordination group composed of the member states’ regulators.
To be able to meet these responsibilities, EMA charges pharmaceutical organizations fees to evaluate their applications for a marketing authorization within the centralized procedure, and for changes made to marketing authorizations, along with yearly fees for approved drugs. Pharmacovigilance activities are also financed via fees.
This assessment, set to start in Q3 of 2016 and end in Q4 of 2017, is linked to the common fee regulation of EMA, which initially called for the evaluation to happen by 24 November 2010.
But the commission states that the report “has not been provided to date, due to adopting of the pharmacovigilance fee rules of EMA, which setup new fees particularly for the pharmacovigilance activities of EMA,” and also specified that any future modifications of the fees charged by the agency must be part of a “transparent and independent assessment of the expenses of the agency and the expenses of the tasks performed by the national competent authorities.”
EMA and national competent authority consultations will be carried out in the first quarter of 2017 in order to recognize more about the agencies’ cost structures.
And then an open public discussion with industry groups, patient and provider companies, member states and EMA will be performed in the second half of 2017 dependent on the initial conclusions following the preliminary evaluation.
“Sustainability is recognized primarily as to what level the system is centered on a cost-related model. The assessment will concentrate on unitary costs / fees per kind of process. In inclusion, some fees, especially annual fees, which cover some cross-cutting activities of the authority, like as IT activities, will also comes under the scope of the assessment,” the commission says. “Prospective for simplification and burden decrease will be explored.”
As part of the assessment, the commission will search to “close possible data spaces of the result of the EMA Management Board data collecting initiative,” which puts together proof on workload and resources, such as a reflection on time used and by whom on EU level procedures at EMA and the national qualified authorities.
In addition, costing models will be proposed, reviewed and applied to the time data stemming from the EMA Management Board data. These costing designs will use data on cost of labour and overheads which are to be collected from both the EMA and the national competent regulators
The assessment will also contain an analysis of the requirement for a dispute settlement process in relation to the payment of fees.