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Pharmaceuticals / Quality / Postmarket Safety

EFPIA: EU Pharmacovigilance Fee Structure Flouts Intent of 2010 Law

Feb. 24, 2014

The EU’s proposed new industry fees intended to cover postmarket assessments of drug safety threaten to nullify annual savings for drugmakers promised in the 2010 pharmacovigilance law, the European Federation of Pharmaceutical Industries and Associations (EFPIA) said Friday.

The fees, which could cost drugmakers as much as $330,000 for each drug they make, come as other user fees have gone up, the trade group added. EFPIA also says drugmakers’ financial burdens have blossomed “without open and transparent communication” with EU regulators.

“Furthermore, as pharmacovigilance activities are part of the general mission of the [European Medicines Agency] and of the National Competent Authorities to ensure public health, the industry believes that their cost should have been partly covered by community funding as established in the pharmaceutical legislation,” the group said.

EFPIA calls on EU officials to present annual cost breakdowns and detailed information on performance indicators for the activities covered by the various EU user fees. “The financial overview should include the pharmacovigilance costs at the European and national levels (including national annual fees and safety related variations),” the group said.

The pharmacovigilance fees must still be approved by the European Parliament and then by the Council of the European Union.

The EU’s pharmacovigilance law provides for enhanced monitoring of the benefits and risks of drugs marketed in the EU and gives the European Medicines Agency authority to require post-authorization safety and efficacy studies. — Johnathan Rickman

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