Vanessa's Law: Strengthening Drug and Device Safety in Canada

Author: Government of Canada
Published: 2014/11/10 - Updated: 2025/04/28
Publication Type: Announcement
Category Topic: Pharmaceuticals - Academic Publications

Page Content: Synopsis - Introduction - Main - Insights, Updates

Synopsis: This article, authored by the Government of Canada, details the passage and significance of Vanessa's Law-the Protecting Canadians from Unsafe Drugs Act-which marks a major advancement in patient safety and regulatory transparency. The law empowers the government to recall unsafe drugs and medical devices, impose much tougher penalties (including fines up to $5 million per day and possible jail time), and require drug companies to update labels and conduct further testing, especially for at-risk groups like children. It also mandates that healthcare institutions report adverse drug reactions, increases transparency by making regulatory decisions and clinical trial information public, and allows disclosure of confidential business information if a product poses a serious risk.

This information is authoritative and highly relevant for people with disabilities, seniors, and anyone reliant on medications or medical devices, as it ensures stronger protections, clearer information, and quicker responses to safety concerns-addressing longstanding gaps in Canada's health product oversight and providing reassurance to vulnerable populations - Disabled World (DW).

Introduction

The Honorable Rona Ambrose, Minister of Health, joined by Member of Parliament for Oakville Terence Young, celebrated a major milestone for patient safety in Canada - the passage of new legislation known as Vanessa's Law (the Protecting Canadians from Unsafe Drugs Act).

Main Content

"Today is an historic day for patient safety in Canada. As Minister of Health, nothing is more important to me than the safety of Canadians and their families. Through Vanessa's Law, Canadians will be better informed about medications they are prescribed, and our Government will be empowered to recall unsafe products from the market. I am confident that Canadians will be better protected and lives will be saved as a result of these changes." - Rona Ambrose - Minister of Health.

Delivering on a promise in the 2013 Speech from the Throne, the Act will protect Canadians from unsafe medicine by enabling the Government to:

• Recall unsafe products.
• Impose tough new penalties for unsafe products, including jail time and new fines of up to $5 million per day instead of the current $5,000.
• Provide the courts with discretion to impose even stronger fines if violations were caused intentionally.
• Compel drug companies to revise labels to clearly reflect health risk information in plain language, including updates for health warnings for children.
• Compel drug companies to do further testing on a product, including when issues are identified with certain at-risk populations such as children.
• Enhance surveillance by requiring mandatory adverse drug reaction reporting by healthcare institutions.
• Require new transparency for Health Canada's regulatory decisions about drug authorizations, both positive and negative.
• Require information about authorized Canadian clinical trials to be posted on a public registry.
• Better define confidential business information and disclose such information about a product if it may pose a serious risk to Canadians.

"I am honoured today to stand with my colleague Terence Young and his family to announce the passage of Vanessa's Law. Terence has devoted fourteen years of hard work to ensure that Canadians are safer and better informed about their health. Nothing will ever make up for the loss of their beloved Vanessa, but I hope they can find consolation in this accomplishment." - Rona Ambrose - Minister of Health.

These new transparency measures build on the progress Health Canada has already achieved through its Regulatory Transparency and Openness Framework. The Framework commits Health Canada to a set of concrete initiatives that will make easy-to-understand regulatory health and safety information more available to Canadians.

Vanessa's Law is named after Member of Parliament Terence Young's daughter Vanessa, who died of a heart attack while on a prescription drug that later was deemed not safe and removed from the market.

The Bill received all-party support in the House of Commons in light of its important new safety provisions that will benefit Canadians.

The Protecting Canadians from Unsafe Drugs Act introduces the most profound and important changes to the Food and Drugs Act that have been made since it was introduced more than 50 years ago.

"I am extremely grateful for the overwhelming support that Vanessa's Law has received. These stronger drug and medical device safety tools are absolutely necessary to protect all Canadians." - Terence Young - Member of Parliament.

Insights, Analysis, and Developments

Attribution/Source(s): This quality-reviewed publication was selected for publishing by the editors of Disabled World (DW) due to its relevance to the disability community. Originally authored by Government of Canada and published on 2014/11/10, this content may have been edited for style, clarity, or brevity.