Ad Standards is now reviewing and pre-clearing medical device advertising and has updated its Guidelines for Consumer Advertising of Health Products - for Nonprescription Drugs, Natural Health Products, Vaccines and Medical Devices ("Guidelines") accordingly. Formerly Advertising Standards Canada, Ad Standards is Canada's advertising self-regulatory body, including for regulated products like health products, food, alcohol and cosmetics and children's advertising. Medical devices and vaccines were not addressed in the previous version of the Guidelines. The industry can now use the Guidelines to help develop compliant medical device or vaccine advertising. As of July 1, 2018, Telecaster Services will require an Ad Standards pre-clearance approval number for any new medical device broadcast commercials.
In general, the Guidelines require consumer health products to be promoted responsibly, keeping consumer health and safety paramount. Further, any advertising of intended product use must be consistent with the product licence, as well as applicable requirements under the Food and Drugs Act.
Although Ad Standards was already offering pre-clearance for vaccines, the Guidelines now set out specific requirements that apply to consumer-facing vaccine advertising. Under the Guidelines, vaccine advertising must comply with the product monograph (as submitted to Health Canada) and provide fair and balanced information about the benefits and risks of the vaccine. For example, these ads must provide information about use, the most serious side effects, booster doses, duration of protection and any limitation of strains, as well as advise the consumer to consult his/her healthcare professional. This section of the Guidelines should be read in conjunction with Health Canada's Interim Guidance Fair Balance in Direct-to-Consumer Advertising of Vaccines.
As for medical devices, Ad Standards will now pre-clear these ads for compliance with the Guidelines, product licence and applicable legislation and self-regulatory guidance. Medical devices are health and medical instruments that are used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition, and include products as diverse as contact lenses, power toothbrushes, dermal fillers, blood glucose meters and breast implants. Devices are regulated by risk, Class I (low) to Class IV (high). Upon request, and for a fee, Ad Standards will now review advertisements featuring consumer-used medical devices in Class II - IV.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
