The Mud and the Blood and the Beer: Canada’s new Progressive Licensing Framework for drug approval

Ron A. Bouchard

Abstract

Canada is currently undergoing a 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, regulat-ing, 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. 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. 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 global governments seek to integrate the wide range of competing scientific, economic, and public health interests involved in innovative product development. This article reviews developments leading up to the 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 advocates of lifecycle regulation argue it will help solve certain post-market safety problems.