Insight into the off-label use of medicinal products in the European Union, 2015-2016

Duration: May 2015 - Jun 2016

Background
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.

Research question
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?

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

Result
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.