European politicians and industry have disagreed on new plans to ask pharmaceutical firms to pay fees for drug safety assessments.
The draft plan – which was approved by the Council of the European Union last week – would introduce two new pharmacovigilance fees for firms that hold marketing authorisations.
The first levy is designed to cover the cost of drug safety assessments at EU level, with the fees set to very per procedure.
For example, under the plan periodic safety update reports - the scope of which was expanded last year - will cost €19,500 ($26,760), while post authorisation studies and assessments triggered by routine monitoring will cost €43,000 and €17,900, respectively.
In addition a flat fee of €67 per dosage form will be charged for all products authorised at a national level to cover the cost of the European Medicines Agency (EMA) data management and IT activities, including the EudraVigilance database .
Council president Adonis Georgiadis said the plan – which will need to be approved by the European Parliament – “is a great step towards the enhancement of public health, it secures the sustainability of the system while it is based on the principles of fairness and transparency."
The pharmaceutical industry has been less positive.
In a joint statement industry groups EFPIA, EGA, EuropaBio, AESGP and EUCOPE said while they back the idea of a stronger pharmacovigilance system they have some misgivings about the level of the proposed fees.
“The industry is concerned about the increasing financial burden of regulatory costs incurred since the adoption of the pharmacovigilance package in 2010 especially in light of the annual saving for pharmaceutical industry of €145m that was anticipated in the 2008 Commission Impact Assessment.
“Procedural fees, such as for pharmacovigilance referrals, have been significantly increased compared to the 2008 Commission initial impact assessment calculations accompanying the new pharmacovigilance legislation, without open and transparent communication of calculations supporting this increase.”
Instead, the industry groups want the EU to make a bigger contribution toward pharmacovigilance costs.
EGA spokesman Maarten Van Baelen told in-Pharmatechnologist.com most of the EMA's funding comes from industry fees rather than the EU - payments are expected to make up 86% of the agency's €290m budget in 2014 - and that "the industry had therefore expected that part of the cost of the new EMA activities for pharmacovigilance would also be covered, in part, by community contribution.
He added that: "In addition, the calculation of these new referral fees has not been done with open and transparent communication."
News of the draft plan comes just a few days after the EMA announced that it plans to hold a monthly pharmcovigilance teleconference with counterparts from the US Food and Drug Amdinistration (FDA ).