This backgrounder explores the use of ‘off label’ (unlicensed) medicines. Physicians in Europe can prescribe medications ‘off-label’. In the UK, according to the British General Medical Council, off-label prescriptions must better serve patient needs than alternatives and must be supported by evidence or experience to demonstrate safety and efficacy. However, it isn’t always so. On occasion, decisions can and have been made that exploit loopholes and subjectivities in the above system.