Law, medicines and the doctor: a critical look at drug regulation

Abstract

The current status of medicines regulation and legislation throughout the world is reviewed. The basic task of drug regulatory agencies is to ensure that the medicines available to the physician are sufficiently safe and effective, and that the information supplied on these medicines is adequate and reliable; the final choice of drug remains the physician's task. By examining the way in which regulatory agencies have dealt with different problems it is possible to identify many of the norms which are emerging. By and large these would seem to be reasonable, and it appears unlikely that drug regulation has, in fact, impeded the development of valuable new medicines. Such problems as do arise are due in part to marked differences in national control systems. It is suggested that these problems may be more readily resolved by informal international co-operation than by formalized international control of medicines.