EFPIA unhappy about proposed pharmacovigilance fees
Overall the proposed fees are excessive, says organisation
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has attacked proposed fees charged to pharma manufacturers for pharmacovigilance work undertaken by the European Medicines Agency (EMA) and associated bodies.
In September, the European Commission tabled a series of fees – some high, with some pharmacovigilance referrals, for example, incurring fees ranging from €80,300 to €267,400.
The EFPIA opposed Brussels’ suggestion that the pharma sector should cover all pharmacovigilance costs.
‘We consider that pharmacovigilance activities should receive at least some Community [EU] funding…[because] these activities serve public health and cannot be considered a unique service to industry,’ the organisation said.
Furthermore, EFPIA voiced ‘significant concerns about the level of fees proposed’ as some were ‘significantly higher [more than 10 times greater] than proposed in the Commission’s original 2008 proposals for updating EU pharmacovigilance legislation’.
‘Overall the proposed fees appear excessive and the justification provided is based on an analogy with existing tasks rather than time recording,’ the EFPIA added. It argued these work assessments were faulty and ‘do not seem to be supported by an analysis of the actual tasks’.
The EFPIA called for more information. A statement from the Association of the British Pharmaceutical Industry (ABPI) backed the EFPIA’s complaints.
