Abstract

Canada is currently undergoing a substantial transition in its system of public health, including major redefinition of the duties, accountabilities and risks assumed by public and private actors responsible for developing, regulating and consuming innovative therapeutic products. This has been accompanied by increasing political rhetoric to the effect that many distinct elements of Canada's health care system are functioning poorly or not at all, with great economic and quality of life costs for all Canadians. In particular, the nation's proposed new drug regime, termed the "Progressive Licensing Framework", has received considerable attention since the announcement of Bill C-51 in early 2008. One the one hand, critics claim that expedited review, or so-called flexible departure, may lead to a lower standard for drug approval and a further increase in unsafe products directed to the market. On the other, supporters claim that more emphasis on post-market safety will effectively recalibrate the risks, benefits, costs and uncertainties of therapeutic product development. Ironically, the focus of both groups is on the balancing function of drug regulation, as governments, including Canada, seek to integrate and dynamically balance the wide range of competing scientific, economic and public health interests of public and private actors responsible for innovative product development and regulation. This article focuses on the historical developments leading up to the current focus on the "lifecycle" or "real world" approach to drug regulation, including shifts in the speed and mechanism of drug approval, the growth in intellectual property and regulatory rights attached to drug products, the effects of these developments on post-market safety, and the manner in which proponents of the lifecycle approach argue that it will mitigate, if not ameliorate, pre-marketing and post-marketing safety and efficacy problems that have become so prevalent over the last decade.