The Effects of Regulation on the Discovery, Supply and Cost of New Drugs

Abstract

Regulation of the manufacture of medicinal products in the UK was formalised by the Therapeutic Substances Act of 1925 which applied to sera and vaccines and other specified, usually biological, products. After the thalidomide tragedy a voluntary system of regulating the introduction of new drugs was introduced in 1963, under the aegis of the Committee on Safety of Drugs, often referred to as the Dunlop Committee (Cahal, 1968). This committee worked well, and provided a basis for the more elaborate legal control introduced by the Medicines Act of 1968. The working and consequences of this more elaborate process have recently been reviewed by Griffin and Diggle (1981) and Binns (1981). In other European countries the methods of regulation differ. In all countries the practical consequence has always been a growth, sometimes a rank growth, of detailed regulations about the assessment of the safety of potential new drugs. The UK has differed from most other countries in requiring extensive pharmacological and toxicological data before clinical trials are permitted, and a particularly lengthy procedure for approving applications. The position has been modified recently because the authority has conceded to pharmaceutical firms the facility, already open to doctors and dentists, to conduct studies on their own responsibility without undue bureaucratic interference (Griffin and Diggle, 1981). This concession appears to allow substantial administrative savings, although it is too early to know how it will work in practice.