Europe’s main pharma industry bodies — EFPIA, EGA, EuropaBio, AESGP and EUCOPE — have issued a joint statement to express concern about “the increasing financial burden of regulatory costs incurred since the adoption of the pharmacovigilance package in 2010″.
The EU’s procedural fees, such as for pharmacovigilance referrals, the industry argues, have been significantly increased in the last five years without open and transparent communication of calculations supporting this increase. The cost of pharmacovigilance activities should have been partly covered by community funding, their statement adds, as they are “part of the general mission of the EMA and of the National Competent Authorities to ensure public health.”
An overall legislative revision of the EMA fees regimes in the medicinal products sector is expected in the coming year. The industry is now calling for annual cost breakdowns and detailed information on performance indicators for the activities covered by the fees regime.
The statement concludes that industry “looks forward to establishing a 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.”