December 6, 2013
OTTAWA – Health Minister Rona Ambrose today tabled legislation in Parliament that gives the federal government more power to remove unsafe medication and prescription drugs from the marketplace, and impose hefty fines on organizations that leave dangerous medicines on store shelves.
The Protecting Canadians from Unsafe Drugs Act is dubbed “Vanessa’s Law” after the daughter of Conservative Member of Parliament Terence Young’s daughter who died in 2000 from complications of medication she was prescribed. The new legislation, if passed into law, would allow Ottawa to impose fines of up to $5 million a day for leaving unsafe prescription drugs and medications in the marketplace. The current maximum daily fine that can be levied on companies for leaving unsafe products on the market is $5,000.00.
The bill would also:
- Require mandatory adverse drug reaction reporting by health-care institutions.
- Allow the federal government to recall unsafe products.
- Impose new penalties for unsafe products, including jail time.
- Provide the courts with discretion to impose even stronger fines if violations were caused internationally.
- Compel drug companies to revise labels to clearly reflect potential health risks.
- Force drug companies to do further testing on a product, including when issues are identified.
The legislation represents the most significant changes to Canada’s Food and Drugs Act in more than 50 years. In a statement, Minister Ambrose said that Canadians deserve to have confidence that the medicines they use are safe.
“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,” said Minister Ambrose.
The new legislation comes after consultations with manufacturers, patients, healthcare professionals, and consumer groups. The pharmaceutical industry is likely to embrace the changes as it brings Canada’s regulatory regime in-line with other OECD countries. The modernization of the Food and Drugs Act as it relates to prescription and non-prescription medications is a significant milestone in updating Canada’s regulatory regime.
Bill C-17, An Act to amend the Food and Drugs Act, was introduced in the House of Commons today and has had first reading. From here, the legislation will travel through the parliamentary process, including second reading and referral to committee, likely the Standing Committee on Health, and finally consideration by the Senate before receiving Royal Assent. With the ruling Conservative Government holding a majority in both the House of Commons and Senate, Bill C-17 is anticipated to pass and could become law in 2014.
However, while some of the new powers in Vanessa’s Law, such as increased fines and penalties, will become law immediately once the legislation is given Royal Assent, other changes to Canada’s Food and Drugs Act cannot come into force until supporting regulations are published. There will be an opportunity for Canadians to comment on the supporting regulations as part of the regulatory development process.