Fees and charges payable to the European Medicines Agency

AnimalhealthEurope supports the appropriate funding of regulatory agencies essential to the efficient regulatory control of veterinary medicinal products (VMPs). However, the proposed cost-based system for EMA fees will be too expensive for the VMP sector. The EMA is being asked to expand its role, but this cannot and should not be funded by the VMP sector.

At Teva pharmaceuticals, our mission is to improve the lives of patients across the globe. In Europe, Teva is a strategic partner of healthcare systems, producing 96% of its European generic, biosimilar and innovative portfolio in plants across 15 European countries (53% of our APIs are manufactured in-house, 40% of which are in Europe), and 2020 saving healthcare systems more than 8.4.

Please see below the AESGP comments on the European Commission proposal on updating the rules on fees payable to the European Medicines Agency. The detailed comments are provided in the attached document. The EMA is currently funded at 86% by fees, 13% by EU contribution and 1% by other sources.

Medicines for Europes comments of the EMA fees regulation. Medicines for Europe supports a cost-based EMA fee system with a simpler fee structure. For generic medicines with very low margins, regulatory costs can be critical to maintain older products (with low to zero profitability) or supply products to small markets.

Fondazione Telethon (Italy) is an Italian non-profit organization that has been supporting bio-medical research on rare and genetic diseases for more than 30 years. Fondazione Telethon welcomes the opportunity to comment on the EU Commissions proposal on the revision of EMA fees.

EFPIA welcomes the opportunity to comment on the EU Commissions EMA fees proposal. EFPIAs comments reflect those of its members in the innovative industry which extensively remit EMA fees. Exacerbated by the COVID crisis and the impact of Brexit, the EU regulatory system is experiencing significant resourcing challenges that hinder its ability to achieve optimal efficiency and sustainability.

Lif Sweden is the trade association for the research-based pharmaceutical industry in Sweden. Lif welcomes the opportunity to comment on the EU Commissions EMA fees proposal. The up-coming revision of the EU regulatory system is an opportunity to make the system faster, more efficient and flexible and thereby strengthen EU global competitiveness.

Proposal for a REGULATION amending Regulation (EU) 2017/745 and repealing Council Regulation (EC) No 297/95 and Regulation (EU) 658/2014 on fees and charges payable to the EMA To date, EMA has applied a 50 % reduction in the rate for the evaluation of marketing authorisations, variation notifications, etc. for veterinary medicinal products compared to the fees charged for medicinal products for human use.

Filed in German · English published by the European Commission

Medicines for Europe welcomes an opportunity to comment on the concept of the EMA fees revision. Despite the fact that the current EMA fee system is complex due to many different categories and types of fees, the feedback from the Medicines for Europe’s membership is that EMA fees system is not that difficult to apply it and it is quite predictable.

Since this field for feedback offers a small number of characters for the entire text, please find the entire text of Czech national competent authority feedback in the attached word document. Part of the provided reaction is presented for your information: "As regards the veterinary medicinal products, there may be significant difficulties to set-up correct fees based on data gathered in 2016 as the new rules which…

ECHAMP welcomes this consultation and we are pleased that possible misalignment of some fees with the underlying costs will be addressed. We fully support the objective of ensuring a fair distribution of fees. We ask for your specific attention for the category of homeopathic medicinal products.

Specific feedfack in the suboptions is included in the attached document The IIA does not address some important and pressing issues that are important to keep in mind, and we would like to bring them to the attention of the Commission: • The data gathering and cost exercise performed jointly by the network was performed in 2016, and costs have since increased.