Amendments to Patient Safety Legislation (“Vanessa’s Law”) Receive Third Reading in the Senate

On October 23, 2014, Bill C- 17, An Act to Amend the Food and Drugs Act (known as the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)) (the Bill) received its Third Reading in the Senate. The Bill deals with post-market regulation of medical devices and pharmaceutical products (both prescription and over-the-counter drugs). Once enacted, it will implement the most significant amendments to the Food and Drugs Act in 50 years. The amendments will substantially increase the power that Health Canada has over industry stakeholders, including new powers to:

• require information, tests or studies from the holder of a therapeutic product authorization;
• require a label or packaging change to “prevent injury to health”;
• recall a therapeutic product if the Minister of Health believes that the therapeutic product presents “a serious or imminent risk of injury to health”;
• impose tougher penalties for those that do not comply, including a maximum penalty up to $5 million and/or 2 years in prison on conviction by indictment;
• impose mandatory reporting of serious adverse drug reactions and medical device incidents by prescribed health care institutions; and
• disclose confidential business information in specified circumstances without notifying or obtaining consent from the person to whose business or affairs the information relates.

Some amendments (eg fines and penalties) will become law on royal assent. Other amendments (eg therapeutic product assessments and health care institution reporting) will not come into force until supporting regulations are in place. Summary by: Junyi Chen