The use of medicines off-label is often a necessity in areas of unmet medical need. As shown by a study commissioned by the European Commission on the off-label use of medicinal products in the European Union (EU), the prevalence of off-label use in the EU in both the paediatric and adult population is high in a broad range of therapeutic areas (especially oncology, psychiatry, neurology and rheumatology) in both hospitals and outpatient settings.

The Good Off-Label Use Practice (GOLUP) initiative aims to provide a clear framework on when and how the off-label use of medicinal products could safely take place. A clear approach on the issue is important, due to the current trend of promoting the prescription of medicines off-label for reasons other than the medical need of patients. In fact, some European Union Member States are imposing prescribing guidelines that effectively promote off-label use for the sole purpose of reducing healthcare spending.

The Declaration for Good Off-Label Use Practice is supported by a coalition of European organisations that are dedicated to ensuring that high standards of patient care are upheld and that progress in medical research and innovation is achieved. Support is still welcome and activities continue till this day, with the latest GOLUP event taking place in June 2021.