Regulation of Pharmaceuticals in Canada

Abstract:     
The established role of pharmaceutical products in the current health care landscape combined with increasing reports of serious and often fatal toxicity associated with these products have led to growing calls for reform of drug regulation. The growing public-private partnerships in research and drug development and their impact on the regulatory control of pharmaceuticals are in this context the target of much criticism. Ensuring the safety and efficacy of pharmaceuticals in continuously changing health care, research and economic environments has been an increasingly significant challenge for public health. In this chapter, we seek to give a critical overview of various components of this important public health topic. We review the general regulatory framework in which drugs are approved in Canada. As part of this discussion, we outline the steps required to be taken by pharmaceutical manufacturers to obtain regulatory approval and trace the changing roles of public and private actors in the drug development cycle, using several recent controversies related to pharmaceutical products to illustrate this point. We also describe how drug regulation in Canada is connected to other domestic and international regulatory regimes that relate to various aspects of pharmaceutical product development, medical research and health care. Finally, we review several important new developments involving federal policies that underpin pharmaceutical regulation in Canada, with particular emphasis on the increasing partnership between Canadian policy-makers and corporate interests. Indeed, the larger regulatory landscape surrounding pharmaceuticals is undergoing significant change at this time and it is important to situate this development in the context of the current regulatory regime. In order to appreciate the nature of these policy changes, and to facilitate a critical assessment of their potential impact, we will first give a brief overview of the history of drug regulation. Indeed, the historical context helps to understand the rationale behind drug regulation and to appreciate the important role for regulatory oversight in the context of drug regulation.

Number of Pages in PDF File: 56

Keywords: regulation, pharmaceuticals, drugs, policy, health law

JEL Classification: K32, K23, I18

Accepted Paper Series