Affiliations: School of Health Policy and Management, York University, Toronto, ON, Canada | Emergency Department, University Health Network, Toronto, ON, Canada | Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada
Note: [] Joel Lexchin, MD, School of Health Policy and Management, York University, 4700 Keele St., Toronto, ON M3J 1P3, Canada. Tel.: +1 416 736 2100x22119; Fax: +1 416 736 5227; E-mail: [email protected]
Abstract: The Food and Drugs Act theoretically gives Health Canada considerable authority in dealing with safety issues but there are also significant limitations in the legislation. Furthermore, the priorities of Health Canada are skewed in favour of rapid approval of new drugs at the expense of the postmarketing pharmacosurveillance system as judged by how much money and many personnel are allocated to each activity. Health Canada has explicitly rejected developing quantitative standards for evaluating its postmarketing pharmacosurveillance system. In addition to lacking standards in this area, it does not monitor whether or not its communications to professionals and the public have had the desired effect in terms of changing the way that drugs are prescribed and used. Health Canada continues to treat safety information that companies submit as confidential business information. What safety information it does release is insufficient to allow an adequate independent assessment of a drug’s safety. Progressive licensing is a new regulatory model that would allow Health Canada to retain control over a drug throughout the product's entire lifecycle. In its initial incarnation progressive licensing would have actually further strengthened Health Canada’s reliance on the industry for information and would have worked to enhance regulatory secrecy.
Keywords: Adverse drug reactions, drug regulation, drug safety, pharmaceutical industry, user fees
