Updates

Starting in December 2019, regulations came into effect requiring all hospitals in Canada to report serious adverse drug reactions and medical device incidents to the federal Minister of Health in accordance with Vanessa’s Law. Vanessa’s Law, enacted in November 2014, amended the Food and Drugs Act to provide greater authority to the federal Health Minister in the oversight of therapeutic drugs and devices – collectively known as “therapeutic products”. The bill grants greater ability of the Minister to compel the disclosure of information, recall drugs and devices, impose fines, and collect post-market safety information. This reform was designed to improve transparency in the rapidly-developing area of biotechnology and to safeguard the health and safety of patients. The ability of this bill to effect change may be limited by the Health Minister’s ability and willingness to exercise their authority in provincial and territorial health systems.