Lobbying on Adjustment of EMA Pharmacovigilance fees for inflation (Regulation (EU) No 658/2014)

Adjustment of EMA Pharmacovigilance fees for inflation (Regulation (EU) No 658/2014)

Public health

Technical update of the EMA fees for pharmacovigilance and the corresponding remuneration of rapporteurs from the National Competent Authorities to take into account the inflation rate for 2020 and 2021 in the EU, as published by the Statistical Office of the European Union.

Links

Public consultation

ID: 13374

Lobbying Activity

1 response

Medicines for Europe opposes inflation-linked fee increases for generics

MEDICINES FOR EUROPE, 28 Apr 2022

The organization opposes adjusting monitoring fees in line with inflation, arguing that off-patent medicine prices cannot be raised accordingly due to strict price regulations and price-driven tendering.

This would prevent additional cost burdens while their product prices remain fixed.

EMA and national authorities lose funding needed to maintain pharmacovigilance capacity.