How Are Drugs Made Available in Australia?

Abstract

The release of prescription drugs in Australia for use by the medical profession is complicated because in practice there is a two-tier system determining availability. The first tier, for new drugs, involves evaluation for safety and efficacy prior to marketing. The final decision is made by the Australian Drug Evaluation Committee (ADEC) serviced by the Department of Health. In the second, much more unusual step, a decision is made by a different committee on whether the now-approved drug is to be included on the government-subsidized drug list (Pharmaceutical Benefits Scheme—PBS). Because the PBS list is unusually extensive for a country without a nationalized health service (1,184 items, including all forms and strengths of over 600 drugs) and because a large proportion of prescriptions are written for drugs on the PBS, the PBS Committee making the listing decisions has a major influence on prescribing patterns. In addition, the government is able to exert considerable pressure on drug prices.