Extension of EU penalties for paediatric medicine rule breaches wins support
EFPIA backs the idea
Conditional support has been secured for the European Commission’s plans to extend the European Union (EU) pharmaceutical industry financial penalties system to the EU’s paediatric regulation controlling child medicines.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) backed the idea, but stressed that fines should only be levied on medicine manufacturers for major breaches of paediatric medicine rules ‘where the infringements concerned may have significant public health implications in the EU, or where it has a EU dimension or where interests of the EU are involved’.
The Czech government fully backed the idea, saying that the paediatric law is designed to protect the ‘public health of the youngest part of population’ and so it is ‘most appropriate that the obligations imposed to fulfil this goal are subject to enforcement’.
Brussels-based corporate law firm Covington & Burling welcomed the harmonisation of EU medicine law, noting it would ensure the ‘same principles and rules apply to all obligations the infringement of which may be sanctioned by financial penalties, regardless of the nature or origin of the obligation infringed’.
In another issue raised by the Commission’s review of the EU’s pharmaceutical development penalties system, the EFPIA said penalties should not be levied where ‘post-marketing studies are made a condition for granting marketing authorisation at a late stage’, and ‘detailed information’ is not ‘readily available at that time to determine whether a study is feasible or appropriate’.
The EFPIA said it is ‘not necessary or proportionate’ to impose financial penalties in such situations.