Vanessa's Law has received Royal Assent and is now Canadian law. This Act applies to prescription medications, over-the-counter medications, vaccines, gene therapies, cells, tissues and organs, and medical devices (see Health Canada Q & A, here).
Alongside Plain-Language Labeling, Vanessa's Law aims to protect Canadians who take both prescription and over-the-counter medications by requiring more comprehensive safety warnings from drug manufacturers, giving Health Canada the power to order unsafe drugs off of the Canadian market when dangers become clear, require mandatory adverse drug reaction reporting, and create a robust warning system for patients. Vanessa's Law gives Health Canada, Canada's federal health products regulatory agency, the ability to collect safety information on products approved to be marketed in Canada and require additional transparency on clinical trial registration, Health Canada's regulatory decisions, and company disclosure of confidential business information.
Vanessa's Law gives Health Canada the power to:
- Initiate mandatory recalls for unsafe products
- Impose new, tougher penalties for companies that market unsafe products (including jail times and fines of up to $5 million per day, rather than the previous $5000 per day)
- Provide Canadian courts with the ability to impose harsher fines if violations were intentional (for example, courts may decide that an appropriate fine is the the total profit earned from the drug or device in question)
- Order, and take a directing role with, drug companies to revise medication labels, including health warnings for children, to ensure that they are labelled clearly and in plain language to accurately reflect the health risk information
- Order drug companies to conduct additional testing on a pharmaceutical product, including when new risks or adverse events are identified in certain at-risks populations
- Enhance surveillance on adverse events by requiring mandatory adverse drug reporting by healthcare institutions
- Require new transparency measures regarding Health Canada's regulatory decisions about granting drug authorizations (i.e. requiring transparency for both approval and rejection of drugs submitted to Health Canada for market approval)
- Require information about authorized clinical trials to be posted on a public clinical trial registry
- Require that "confidential business information" is more clearly defined and that such information about a product is disclosed if it may pose a serious risk to Canadians
- Seek injunctions to ensure that Health Canada's orders are followed.
A well-deserved congratulations to MP Terence Young and his team for their unwavering persistence, determination, and hard work to achieving passing the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law).
Moving forward, all Canadians depend on, and are looking to, Canadian regulatory officials to smartly, appropriately, and effectively enforce this new legislation and in a timely manner. All Canadians of all ages, who take or will ever take medications, depend not only on the presence of Vanessa's Law, but also its enforcement.
Legislation: Protecting Canadians from Unsafe Drugs Act (November 6, 2014)
Health Canada: Protecting Canadians from Unsafe Drugs Act
Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)
Bill C-17: Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)
Overview of Vanessa's Law
Harper Government Announces Passage of Vanessa's Law - Modernized Laws for Drugs and Medical Devices Mark a New Era in Canadian Patient Safety
"How do we face the outside world when they begin criticizing us for suppressing data?" FDA finds that Canadian drug companies have hidden, altered, and destroyed data