Canada passes Vanessa's Law on unsafe medicines

11 November 2014

New legislation known as Vanessa’s Law (Bill C 17; the Protecting Canadians from Unsafe Drugs Act) has received Royal Assent and is now law, Canadian Minister of Health Rona Ambrose has announced.

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 C$5 million ($4.4 billion) per day instead of the current C$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 health care 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.

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