The main trade associations that represent Europe's healthcare industry have called for "balanced and transparent funding" of the continent's pharmacovigilance system.
The European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Generic medicines Association (EGA), the European biotech industry (EuropaBio), the Association of the European Self-Medication Industry (AESGP) and the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) have issued a joint statement about their concerns for “the increasing financial burden of regulatory costs incurred since the adoption of the pharmacovigilance package in 2010″.
The trade bodies say they support the implementation of an effective pharmacovigilance system to ensure patient safety "and recognise recent efforts which have been made to ensure greater fairness, proportionality and transparency" in some aspects of the proposals for the mechanism of fees to be paid to the European Medicines Agency for these activities. Notably the industry welcomes the improvements regarding the annual fee to be paid by the marketing authorisation holders to the EMA.
However, the industry is concerned about rising costs "especially in light of the annual saving for the pharmaceutical industry of 145 million euros that was anticipated in the 2008 European Commission "impact assessment". Procedural fees, such as for pharmacovigilance referrals, have been significantly increased compared to the aforementioned impact assessment calculations accompanying the new pharmacovigilance legislation, "without open and transparent communication of calculations supporting this increase".
The healthcare industry has therefore called on EU decision-makers to present "annual cost breakdowns and detailed information on performance indicators for the activities covered by the fees regime". The financial overview should include the pharmacovigilance costs at the European and national levels and the associations add that that the cost "should have been partly covered by community funding as established in the pharmaceutical legislation".
A revision of the EMA fees regimes in the medicinal products sector is expected in the coming year and the statement concludes with a call for dialogue with regulators and payers "in order to ensure that the future system is firmly based on the principles of cost-effectiveness, fairness, proportionality and transparency".