Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) Amendments to the Food and Drugs Act (Bill C-17)

On December 6, 2013, the Government of Canada introduced the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law). On November 6, 2014 it received Royal Assent.

The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) introduces amendments to the Food and Drugs Act that will improve Health Canada's ability to collect post-market safety information, and take appropriate action when a serious risk to health is identified. These amendments will improve better protection of patient health and safety and increase consumer confidence in therapeutic products on the market.

Key amendments to the Food and Drugs Act include:

• Power to require information, tests or studies
• Power to require a label change/package modification
• Power to recall unsafe therapeutic products
• Ability to disclose information in certain circumstances
• Tougher measures for those that do not comply
• Mandatory reporting of serious adverse drug reactions and medical device incidents by healthcare institutions

For more information:

• Consultation on the Protecting Canadians from Unsafe Drugs Act Transparency Needs-based Assessment – What We Heard [2016-07-29]
• Notice of Intent to amend the Food and Drug Regulations and Medical Devices Regulations to implement key authorities under Vanessa’s Law [2016-06-20]
• Amendments to the Food and Drugs Act Guide to New Authorities [2015-07-31]
• Consultation on the Amendments to the Food and Drugs Act: Guide to New Authorities (power to require & disclose information, power to order a label change and power to order a recall) – What We Heard [2015-07-31]
• Overview of Vanessa's Law
• Implementation of Vanessa's Law
• Transparency Measures
• Questions and Answers
• News Releases
  •  2014-11-06 - Harper Government Announces Passage of Vanessa's Law
  •  2014-06-13 - House of Commons adopts government strengthened patient safety legislation
  • 2013-12-06 - Harper Government Introduces New Law to Protect Patients - Delivers on 2013 Throne Speech Commitments on Mandatory Adverse Drug Reaction Reporting, Recalls and Accurate Labels
  • 2013-12-06 -Taking Action on Patient Safety
•  Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)