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) support the implementation of an effective pharmacovigilance system to ensure patient safety and recognize 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 EMA for these pharmacovigilance activities. Notably the industry welcomes the improvements regarding the annual fee to be paid by the Marketing Authorization Holders to the EMA.
However 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 $199.5 million 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.
Furthermore, as pharmacovigilance activities are part of the general mission of the EMA 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.
An overall legislative revision of the EMA fees regimes in the medicinal products sector is expected in the coming year. The healthcare industry therefore calls on E.U. 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 (including national annual fees and safety related variations), in order to come to a European-wide picture.
The 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.