A landmark development in Canadian drug regulation is the new C-17 Bill, or commonly known as Vanessa’s Law. This bill amends the Food and Drugs Act established over 50 years ago. This amendment strengthens the regulation of therapeutic products and improve the reporting of adverse reactions by healthcare institutions.
Specifically, Health Canada now requires strict surveillance within healthcare institutions and would require health professionals to report all adverse drug reactions. This bill also strengthens Health Canada’s ability to recall unsafe therapeutic products as well as impose fines of up to $5 million per day. Currently, unsafe products are given a fine to a maximum of $5,000 per day, but with the new law, jail time could be an additional penalty to unsafe product marketers. The fines may also be raised by the courts under Health Canada’s discretion if violations were made knowingly. This bill also gives power to Health Canada to compel drug companies to make revisions to their labels to reflect health risks and to improve the labels when health warnings for children are updated. The bill will also press drug companies to perform additional testing on a product, including when issues with at-risk populations are identified.