With a tip of the cap to our old friend, Peter Pliszka, north of border: Earlier this month, the so-called Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) received royal assent and became law in Canada. This new legislation on paper was intended to protect Canadians from the potential risks related to drugs and medical devices by substantially increasing Health Canada’s pre- and post-market powers over industry stakeholders, and changing the consequences for violating the Food and Drugs Act and its regulations.
Peter suggests that Vanessa’s Law introduces the most significant amendments to the Food and Drugs Act in 50 years, and represents in some ways a new chapter in Canadian drug and medical device regulatory enforcement.
Peter notes that the new powers granted to Health Canada include:
•The power to order any person to provide information related to a drug or medical device where Health Canada believes that the product may present a serious risk of injury to human health;
•The power to order a manufacturer to conduct an assessment of a drug or medical device and to provide Health Canada with the results;
•The power to order a manufacturer to conduct additional tests or studies, or monitor experience, in relation to a drug or medical device for the purpose of obtaining additional information about the product’s effects on health or safety, and to provide Health Canada with the results;
•The power to order a manufacturer to modify the label of a drug or medical device or to replace its packaging, where Health Canada believes that doing so is necessary to prevent injury to health; and
•The power to order any person who sells a drug or medical device to recall the product where Health Canada believes that a drug presents a serious risk of injury to health.
It appears that new regulations may be coming down the pike as well, on issues such as clinical trials information and product label issues outside of Canada.