EuropaBio, EFPIA, EGA, AESGP and EUCOPE (the industry), 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 (EMA) for these Pharmacovigilance activities[1]. 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 € 145 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 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 (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.

1. Following the adoption of the pharmacovigilance legislation in 2010, the Pharmacovigilance Regulation outlines the fee system, which aims at providing the necessary funding to the EMA and the National Competent Authorities in the implementation of certain pharmacovigilance activities

ENDS

For media enquiries, please contact:

• EuropaBio -  Marie Blanchard, Healthcare officer, m.blanchard@europabio.org  or Rosalind Travers, Communications manager r.travers@europabio.org   
• EFPIA - Gabriella Almberg, gabriella.almberg@efpia.eu
• EGA - Maarten Van Baelen, mvanbaelen@egagenerics.com
• AESGP -  Miranda Moussa, m.moussa@aesgp.eu
• EUCOPE - Oliver Sude, sude@eucope.org

About EuropaBio

EuropaBio is the European Association for Bioindustries, bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 56 corporate members, 14 associate members and Bio Regions and 19 National Biotechnology Associations- representing some 1800 small and medium sized enterprises across Europe.