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Taking Action on Patient Safety

December 2013

Harper Government Introduces New Law to Protect Patients - Delivers on 2013 Throne Speech Commitments on Mandatory Adverse Drug Reaction Reporting, Recalls and Accurate Labels

On December 6, 2013, the Government of Canada introduced the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) to help better identify potentially dangerous drugs and ensure the quick recall of unsafe drugs.

The new legislation will update the law that apply to drugs and medical devices to increase patient safety in key areas of concern and will enable the Government to:

  • Require strong surveillance, including mandatory adverse drug reaction reporting by healthcare institutions;
  • 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, including potential updates for health warnings for children; and
  • Compel drug companies to do further testing on a product, including when issues are identified with certain at-risk populations such as children.

The patient safety legislation builds on our existing efforts to ensure that drug labels and safety information are easier to read and understand.

The Act would apply to prescription and over-the-counter drugs, vaccines, gene therapies and medical devices.

Families, patients, healthcare providers and industry were consulted in the development of the new patient safety legislation to ensure that it provides safety improvements in the areas of greatest concern.  At these consultations, there was a general agreement that we need a stronger safety regime for drugs and medical devices, including mandatory adverse reaction reporting, recalls, and increased fines and penalties that better reflect the serious nature of the offences. 

Delivering on this latest key safety commitment will ensure that Canadian families have confidence in the medicine they and their children use.

For more information on the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) Amendments to the Food and Drugs Act (Bill C-17), please visit the Health Canada information web page and questions and answers web page.