On the 10th of July, the European Brain Council (EBC) hosted an extremely insightful roundtable on “Ensuring the safe prescription of medicines off-label in Europe: what role for the European Union?”.

Over 30 leading healthcare and policy stakeholders shared insights on how to best address the existing challenges with off-label use. The event provided an opportunity to debate the European Commission’s study on off-label use released last February and a number of key questions about the path forward for off-label use regulation.

Speakers at the event included:

  • Frédéric Destrebecq, Executive Director of the European Brain Council
  • Aude L’hirondel, Unit B5 – Medicines: policy, authorisation and monitoring, DG Sante, European Commission
  • MEP Lieve Wierinck (BE, ALDE)
  • MEP José Inácio Faria (PT, EPP)
  • Marc Dooms, Senior orphan drug pharmacist, University Hospitals Leuven, and main author of the GOLUP Declaration
  • James Killick, Lawyer and regulatory expert, White & Case LLP
  • Lucia Ruggieri, TEDDY Network Scientific Secretariat

A call to the European Commission and the European Medicines Agency for the adoption of EU guidelines came out strongly from participants, including Members of the European Parliament.

As a way to progress the discussion on this important issue, an improved version of the Good Off-Label Use Practice Declaration (GOLUP) was also presented and found wide support among stakeholders in the room.