Health Canada’s powers over medical device market increased due to new legislation

A new legislation has been introduced by the Canadian government to protect consumers from unsafe medications and medical devices by reducing adverse events. This law has implemented stricter measures to restrict the manufacturers from taking risks which may be harmful to Canadians.

The law is called as “Vanessa’s law,” named after the daughter of a conservative member of Parliament, Terence Young. Young’s daughter died at the age of 15 years due to a heart attack by the medication which she was taking for her stomach ailment. This law is now officially titled as “The Protecting Canadians from Unsafe Drugs Act” and is designed to align the Canadian patient safety requirements with international standards.

The lawmakers have also made penalties upto $5 million and 2 years of imprisonment to be given in case of violation of the law. For those individuals intentionally making false statements to Health Canada the penalty price is higher and imprisonment can be as long as 5 years.

The changes as per the new legislation are as mentioned below:

  • Device Recalls-If a medical device is found to pose significant or serious health risk by the minister of health then it can be removed from the market
  • Product Labeling-If the health risks are not correctly and accurately conveyed to the consumers then the health minister can ask for the removal or alteration of labeling and packaging of a medical device or drug
  • Post Marketing Surveillance-The device manufacturers may require to perform additional tests to measure the benefits and risks of their devices depending on the availability of any new information after the release of the product into the market
  • Confidential Information-Companies may be required to disclose the confidential or proprietary information which may also be shared with the advisors, governments, and public health personnel if found necessary by the Minister of Health to assess the serious risk of injury to users and patients by a product
  • Clinical Trial Data-Archival of clinical trial data with the clinical trial registry is required and should be made publicly available