Health Canada

Health Canada

December 06, 2013 13:16 ET

Harper Government Introduces New Law to Protect Patients

Delivers on 2013 Throne Speech Commitments on Mandatory Adverse Drug Reaction Reporting, Recalls and Accurate Labels

OTTAWA, ONTARIO--(Marketwired - Dec. 6, 2013) - The Honourable Rona Ambrose, Minister of Health, joined by MP Terence Young, today announced from the Children's Hospital of Eastern Ontario (CHEO) that the government is introducing new patient safety legislation, known as the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) as pledged in the 2013 Speech from the Throne.

"Canadians deserve to have confidence that the medicines they use are safe," said Minister Ambrose. "Today, we have introduced Vanessa's Law, a law that would protect Canadians and help ensure that no drug that is unsafe is left on store shelves."

This marks an important milestone in our government's commitment to patient safety, as announced in the 2013 Speech from the Throne.

The Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) is named after Vanessa Young, who tragically died of a heart attack while on a prescription drug that later was deemed not safe and removed from the market. The Law would protect Canadian families and children from unsafe medicine by enabling the Government to:

  • Require strong surveillance including mandatory adverse drug reaction reporting;
  • 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 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 Government of Canada consulted extensively with patients, healthcare providers and industry on the issues addressed by this new legislation. These changes will build on our existing efforts to ensure that drug labels and safety information are easier to read and understand.

"This new legislation is a welcome arrival for our healthcare system," said Gail Attara, the Chair of the Best Medicines Coalition, a patient advocacy group. "It would give providers and hospitals better information to make the best choices when prescribing medications - which is good news for patients."

"It is difficult to overstate the impact this bill will have for Canadians who take prescription and over the counter drugs," said MP Terence Young. "It represents a quantum leap forward in protecting vulnerable patients and reducing serious adverse drug reactions. It is absolutely necessary to reduce deaths and injuries caused by adverse drug reactions, seventy percent of which are preventable, and will serve Canadians extremely well."

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Health Canada news releases are available on the Internet at: www.healthcanada.gc.ca/media

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.

Taking Action on Patient Safety

December 2013

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.

Contact Information

  • Media Inquiries:
    Michael Bolkenius
    Office of the Honourable Rona Ambrose
    Federal Minister of Health
    (613) 957-0200

    Health Canada
    Media Relations
    (613) 957-2983

    Public Inquiries:
    (613) 957-2991
    1-866 225-0709