European Commission Publishes Study on Off-Label Use

The European Commission has published its report “Study on off-label use of medicinal products in the European Union“. The report aims to provide a description of off-label usage across EU Member States, listing several drivers for off-label usage such as:

  • increasing the treatment options and the presence of health care professional guidelines;
  • limited incentives to extend a marketing authorisation, especially for products out of patent;
  • financial considerations, i.e. off-label prescribing, in case there is an “off-label” product that is cheaper than the authorised product

The report also outlines policy options on the regulatory, healthcare system and healthcare professional – patient levels, including

  • incentives for pharmaceutical companies to register new indications and modalities,
  • providing EU guidance for national guidelines on off-label use,
  • temporary recommendation for use, and
  • reimbursement measures

The report acknowledges that stakeholders agree that medical need should be leading rather than financial considerations.

Tagged with

Published 2. March 2017 in News EU