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Review
. 2023 Jan;89(1):80-92.
doi: 10.1111/bcp.15497. Epub 2022 Sep 23.

Medicines legislation and regulation in the United Kingdom 1500-2020

Robin E Ferner  1   2 , Jeffrey K Aronson  3
Affiliations
Review

Medicines legislation and regulation in the United Kingdom 1500-2020

Robin E Ferner et al. Br J Clin Pharmacol. 2023 Jan.

Abstract

The initial purposes of regulation of medicines in England, and latterly in the United Kingdom, were principally to raise government revenue, to discourage murder by poisoning and to regulate the activities of pharmacists. It was only much later that regulators sought to ensure that medicines were of good quality, reasonably safe, and at least somewhat effective, and to curtail misuse of drugs. Here we survey the history of the regulation of medicines and poisons in England from the perspective of clinicians with an interest in therapeutics.

Keywords: England; United Kingdom; drug industry; drug legislation; illicit drugs; prescription drugs.

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Conflict of interest statement

Neither author has a direct conflict of interest in relation to this work. J.K.A. is a past vice‐chairman of the Medicines Commission and a President Emeritus of the British Pharmacological Society. He is chairman of the British Pharmacopoeia Commission's Joint Expert Advisory Groups on Pharmacy and Nomenclature and a member of the WHO's Expert Advisory Panel on International Pharmacopoeia and Pharmaceutical Preparations. He has written articles on the history of drug regulation and legislation. R.E.F. is retired Director of the West Midlands Centre for Adverse Drug Reactions and Yellow Card Centre West Midlands, which received funding from the Medicines and Healthcare products Regulatory Agency (MHRA), and a retired Member of the MHRA's Pharmacovigilance Expert Advisory Committee. J.K.A. and R.E.F. have both written articles and edited textbooks on adverse drug reactions and have acted as an expert witnesses in civil and coroners' cases involving such reactions. They have written articles on drug advertising, medicines regulation and the Prevent Future Deaths report of English coroners.

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