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