Ensuring Medicines for Tomorrow’s World
7. Regulation and the role of the courts The role which governments have increasingly assumed of protecting the public interest in the field of medicines in no way obviates the role of the public in defending its own interests by exerting pressure through representative organizations or the media, or more importantly by taking legal action in the civil courts where necessary. Such action may be taken against various parties such as physicians, pharmacists, hospitals or public health authorities. The discussion that follows is primarily concerned with legal action brought against the pharmaceutical trade or industry, on grounds that may range from the publication of misleading advertisements to the sale of dangerous products. In some matters there is also a role for administrative sanctions and for the institution of criminal proceedings by the regulatory agency itself. From the point of view of public policy, civil litigation in this field may at its best be seen as complementing the protective role of the state. As Australian John Braithwaite concluded, surveying the scene in depth as long ago as 1984: In most countries, but especially the United States, product liability law rather than criminal law has provided most of the deterrence against corporate crime in the pharmaceutical industry. Compensation, not deterrence, is the recognized function of product liability law. Yet the conclusion from my interviews was that pharmaceutical executives report fear of product-liability suits as a reason for obeying the Food, Drug and Cosmetic Act of immensely greater importance than fear of criminal...
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