The regulatory challenge.

Abstract

The concepts of drug regulation should ideally be derived from an appropriately defined and broadly agreed national drug and health policy, according to health needs, relevant criteria and the local circumstances. The major long term challenge emerging from these concepts is how to establish a sufficiently comprehensive and functional drug and therapeutic audit as a basis for regulatory and other decisions within the health chain that strike a balance between sociomedical and economic requirements. Such an audit involves three sequential phases: collection and compilation of all relevant facts and premises; data organisation and analyses by competent auditors and decision, implementation, and re-evaluation with subsequent adjustments. Despite extensive international and national efforts during recent years, only fragmentary solutions exist, and only in a few countries. Thus, another major challenge still remains: how to weight and integrate the sometimes quite conflicting interests and scopes of politicians, administrators, the teaching institutions, the health professions, the pharmaceutical manufacturers--and the consumers. All the partners involved have to emphasise that the problems behind the present miseries of global drug use are basically of political and economic nature, although there are considerable limitations imposed by widely varying attitudes and deficient knowledge and criteria. Thus there is a need for joint action and a strengthening of collaboration and communication combined with the best possible elements of professional skills and common sense.