New Legislation Increases Health Canada's Oversight Of Medical Devices

By Chuck Seegert, Ph.D.

A newly implemented Canadian law has given Health Canada greater powers over the medical device market. The new legislation is designed to better align Canadian patient safety requirements with international standards.

The Canadian government has introduced new legislation designed to protect consumers from unsafe medications and medical devices. The intent of the law is to reduce adverse events, and it has implemented stiffer fines and measures to deter manufacturers from taking risks that may harm Canadians.

The law, commonly referred to as “Vanessa’s law,” has its roots in an unfortunate event that took place 13 years ago, according to a story from the Huffington Post. The law was named in honor of the daughter of Terence Young, a conservative member of Parliament. Young’s daughter died at the age of 15 years. At the time, the young girl was taking medication for a stomach ailment, which induced a heart attack. Later, the drug was yanked from the market.

The new law is officially titled The Protecting Canadians from Unsafe Drugs Act. While the law was instigated by controversy in the pharmaceutical space, there are significant changes that affect medical devices. Some of the most impactful changes include:

• Device Recalls: Medical devices can be removed from the Canadian market if the Minister of Health finds that they pose an imminent and/or serious health risk.
• Product Labeling: The Minister of Health can require labeling and packaging of a medical device or drug to be altered or removed if health risks are not accurately or adequately conveyed.
• Post Market Surveillance: As information becomes available after the release of a product, device makers may have to perform additional tests and studies to assess the benefits and risks of their devices.
• Confidential Information: To increase transparency, companies may be required to disclose confidential or proprietary information to determine if a product poses a serious risk of injury to users and patients. This information may also be shared with advisors, governments, and public health personnel if deemed necessary by the Minister of Health.
• Clinical Trial Data: Clinical trial data will now be archived in a clinical trial registry, and clinical data must be made publicly available.

In addition to the more stringent measures placed on medical device manufacturers, the lawmakers have made penalties stiffer for those violating the law. Maximum fines and penalties now include up to $5 million and 2 years in prison. In the case of individuals who knowingly mislead or make false statements to Health Canada or the Ministry of Health, the fines are even higher, and prison sentences can be as long as 5 years.