Canada

Advertising regulation in Canada

Regulator: Health Canada / PAAB ／ Basis: Food and Drugs Act

Claims of efficacyNo person may label, package, treat, process, sell or advertise a drug in a manner that is false, misleading or deceptive as to its character, value, quantity, composition, merit or safety.
Comparative advertisingA therapeutic comparative claim must involve drugs sharing an authorized indication, compare them under the same conditions of use, not conflict with the compared products' terms of market authorization, be clinically relevant, rest on conclusive evidence, and identify the compared entities.
Safety informationRisk information must be given prominence comparable to benefit in the main body copy, the advertising message must reference a safety profile consistent with the Terms of Market Authorization, and special warnings, precautions, clinically significant serious adverse events and use limitations must appear in the body copy.
Direct-to-consumerIf a person advertises a prescription drug to the general public, the person may not make any representation other than the brand name, proper name, common name, price and quantity of the drug.
Materials for HCPsIn materials directed to health professionals the product information or a link to it must be presented within the main message, the brand name, non-proprietary name and federal drug schedule must appear in juxtaposition at least once, and the proposed layout must be submitted to PAAB for preclearance.
Pre-clearancePreclearance of advertising for marketed health products is administered through an independent, self-regulatory and voluntary system, with PAAB reviewing material directed to health professionals and Advertising Standards Canada and MIJO reviewing non-prescription drug and natural health product material directed to consumers.
Digital and socialThe PAAB Code applies to all digital formats and media, including internet, electronic and social media advertising systems, and applies equally to websites and other online activities within the sponsor's control or influence where the intended audience is Canadians.
EnforcementThe general $500/$5,000 scheme in section 31 applies only 'subject to sections 31.1, 31.2 and 31.4', so for medicines those special provisions govern. Under the section 2 definitions, a 'therapeutic product' means a drug or device or any combination of them, and 'drug' includes any substance manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of disease. Section 31.2(1) provides that, subject to section 31.4, every person who contravenes any provision of the Act or the regulations as it relates to a therapeutic product is guilty of an offence and liable on conviction by indictment to a fine not exceeding $5,000,000 or imprisonment not exceeding two years or both, and on summary conviction to a fine not exceeding $250,000 or six months' imprisonment or both for a first offence and $500,000 or 18 months for a subsequent offence. Section 31.4(1) provides that a person who contravenes section 21.6, or who knowingly or recklessly causes a serious risk of injury to human health in contravening another provision as it relates to a therapeutic product, is liable on indictment to a fine in the discretion of the court or to imprisonment not exceeding five years or both, and on summary conviction to $500,000 or 18 months for a first offence and $1,000,000 or two years for a subsequent offence. Section 31.3 makes due diligence a defence except for a section 31.4 offence, and section 31.5 requires a court sentencing under section 31.2 or 31.4 to take into account the harm or risk of harm caused and the vulnerability of consumers of the therapeutic product.

Every cell carries a summary, a source and a date checked. Topics whose source has not been verified are left marked “not researched” rather than filled with plausible text. Directives and statutes bind as to the result; what applies in practice is national implementing law. This is a research aid, not legal advice.