A licence to cure

Almost 800 years ago the Ordinances of the Guild of Pepperers of Soper Lane (1316) prohibited mixing products of different quality and price, adulteration, and wetting to falsify.1 UK medicines regulation has seen the establishment of the Committee on Safety of Drugs,2 the Medicines and Healthcare Products Regulatory Agency (MHRA), and the Commission on Human Medicines.

Under the 1968 Medicines Act, an important landmark, applicants are granted licences (properly called marketing authorisations) permitting them to market medicinal products, a process now covered by the 2012 Human Medicines Regulations.3 The terms of a product’s licence, known as the label, are described in the Summary of the Product Characteristics (also known as the product information), the format of which is regulated.4 The summary specifies, for example, indications, dose regimens, routes of administration, contraindications, and cautions. If a licensed product is used in any other way than described—for example, for an unspecified indication or in an unspecified dose or patient population—it is said to be used off-label. The term “unlicensed” refers to a product that does not have a licence at all. These terms can be confusing and are often …