Canada Proposes Much Higher Fines for Unsafe Drugs

Rona Ambrose, the country's minister of health, introduced the government's new patient safety legislation on Dec. 6.

Mandatory reporting of adverse drug reactions and much tougher penalties – jail time and fines as high as $5 million per day for distributing unsafe medicines – are included in patient safety legislation proposed Dec. 6 by Canada's government. Rona Ambrose, the minister of health, announced the new Protecting Canadians from Unsafe Drugs Act. "Canadians deserve to have confidence that the medicines they use are safe," she said. "Today, we have introduced … a law that would protect Canadians and help ensure that no drug that is unsafe is left on store shelves."

It is called Vanessa's Law after Vanessa Young, who died of a heart attack while taking a prescription drug that later was deemed unsafe and was removed from the market. The proposed law would allow 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 as high as $5 million per day instead of the current $5,000
  • Provide the courts with discretion to impose even larger 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
  • Compel drug companies to do further testing on a product, including when issues are identified with certain at-risk populations, such as children

"This new legislation is a welcome arrival for our health care system," said Gail Attara, who chairs 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."

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