Modernized Laws for Drugs and Medical Devices Mark a New Era in Canadian Patient Safety
OTTAWA, Nov. 6, 2014 /CNW/ - The Honourable Rona Ambrose, Minister of Health, joined by Member of Parliament for Oakville Terence Young, today 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). 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.
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.
"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."
Minister of Health
"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."
Minister of Health
"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."
Member of Parliament
SOURCE: Health Canada
For further information: Contacts: 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; Health Canada news releases are available on the Internet at: www.healthcanada.gc.ca/media