In recent years, a policy shift toward increased transparency and openness has taken place at Health Canada. The most evident manifestation of this policy shift is Bill C-17, Protecting Canadians from Unsafe Drugs Act, also known as “Vanessa’s Law.” The law honors former MP Terence Young’s late daughter, who died after suffering a heart attack while on medication for a stomach ailment.
Vanessa’s Law was enacted in 2014 to provide Health Canada with increased powers to protect Canadians from unsafe medications and adverse reactions. The law introduces new changes to the Food and Drugs Act (FDA), representing the most substantial FDA amendments in over 50 years. The amendments seek to achieve three goals: (1) strengthen safety oversight of therapeutic products throughout their life cycle, (2) improve reporting by certain health-care institutions of serious adverse drug reactions and medical device incidents that involve therapeutic products, and (3) promote greater confidence in the oversight of therapeutic products by increasing transparency.
The legislation and general policy shift have important public policy objectives, but the changes at Health Canada mean that pharmaceutical manufacturers need to be acutely aware of additional disclosure obligations that may be imposed on them.