By Stewart Eisenhart, Emergo Group
A new law implemented in Canada, the Protecting Canadians from Unsafe Drugs Act, has expanded Health Canada’s oversight of the country’s medical device market in an effort to bring Canadian patient safety requirements more in line with international standards.
Under the new law, also known as “Vanessa’s Law,” Health Canada’s enforcement powers have broadened across several areas:
- Device recalls: ordering the removal of a medical device from the Canadian market if that product is found to pose imminent and/or serious health risks
- Product labeling: requiring license holders to change or replace device labeling and/or packaging to include new risk or branding information if such changes are deemed necessary to prevent health risks
- Post market surveillance: requiring license holders to collect and provide information as well as undertake new tests studies to assess benefits and/or risks posed by their devices to public health
- Confidential information: disclosing confidential proprietary information pertaining to device safety when necessary to determine whether a device poses serious risk of injury to users or patients; Health Canada may also disclose such information to governments, advisors and public health personnel
- Clinical trial data: requiring license holders to make their clinical data publically available via clinical trial registries
Canadian lawmakers have put some real teeth behind these new measures, as well: Maximum fines and penalties for noncompliance have been raised to either $5 million or two-year prison sentences. Any individuals found to make knowingly false or misleading statements to Health Canada or the Ministry of Health could face even higher fines or up to five years in prison.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
