Project
afgesloten

Study on off label use of medicinal products in the European Union

Off-label use refers to any intentional use of an authorised medicinal product for e.g. a different indication or to another target group than for which the medicine is authorised. Off-label prescribing has pros (e.g. unfulfilled medical need can be met) and cons (e.g. lack of knowledge and effects). Off-label use is leading to an increasing number of questions by Member States and stakeholders towards the European Commission. An overview is needed on off-label prescribing to understand the ramification of the issue of off-label use.

What are uses, practices and drivers regarding off-label medicine use in the EU, and what is the position of member state authorities and stakeholders towards off-label use?

Literature review, interviews and brainstorm sessions with stakeholders, analyses of court cases regarding off-label use.

A clear description of existing and foreseen practices of off-label use across EU Member States and a factual analysis of all parties’ positions towards the existing measures and possible envisaged tools to regulate the off-label medicine use.
Funding
DG Santé
CHAFFA (Europese Commissie)
In this project we work together with
RIVM (Marjolein Weda)