Corruption of the Canadian Drug Regulatory System

Abstract

The thesis of this chapter is that the long-standing relationship between Health Canada and the pharmaceutical industry has corrupted the Canadian regulatory system. Health Canada is much more geared to the philosophy that drug regulation is primarily a commercial activity to help manufacturers get their products to the market as quickly as possible than to the idea that regulation should protect public health by ensuring that medicines that reach the market are efficacious and sufficiently safe to ensure that the benefit–harm balance is favourable. Corruption is a “loaded” term. In this case, it does not mean that bribes have been paid to Health Canada employees or that anything illegal has taken place, rather that the regulatory system has been corrupted from its primary purpose of serving the public interest to serving commercial interests. This thesis will be explored first by reviewing the history of industry–Health Canada relations and how it demonstrates an ongoing cooperative relationship whereby Health Canada has been willing to delegate regulatory responsibilities to the industry and prioritize industry’s views over those of others. The chapter then looks at how clinical trials are regulated and how the desire of industry for trials to be done quickly and as inexpensively as possible means that economic values can outweigh scientific ones. The chapter then turns to the regulatory review process and how the quality of evidence that Health Canada accepts and how quickly it reviews that information impacts on the efficacy and safety of drugs that reach the market. Promotion has a significant effect on how drugs are prescribed by physicians and the chapter critically examines how Health Canada has turned over the regulation to either industry or bodies that are closely aligned with industry. Finally, the chapter looks at the deficiencies in how safety is monitored once drugs are being prescribed, sold and used by patients.