513 - Section 3(1) of the Food/Drugs Act implies DTC-A is prohibited for products treating Schedule A diseases. Yet, there seems to be many approved DTC-A campaigns for STDs, Arthritis, etc. How is Section 3(1) being implemented in PAAB practice?

  • PAAB DTCA reviews are based on the Food & Drugs Act, the Food & Drug Regulations and the applicable Health Canada guidance documents. The PAAB would therefore question healthcare product advertising open to the general public which indicates that the product is for the treatment of a schedule A disease. Note that there are some nuances here which may explain what you’ve seen. For example:Not everything generated by pharma is advertising (i.e. don’t assume that all pharma generated DTC is necessarily DTCA). For example, pharma tools meeting the provisions for “Consumer Brochures” and “Help-seeking announcements” in the Health Canada policy document “The Distinction Between Advertising and Other Activities” are not subject to the advertising regulations. Such tools would be DTCI (i.e. direct to consumer information). Those tools may be about schedule A diseases. The policy document can be found at the following link: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/actv_promo_vs_info-eng.php Non-prescription products can be advertised to the public (DTCA) for the prevention of schedule A diseases (assuming this is consistent with their Terms of Market Authorization). Some DTC materials have not been reviewed by any of the preclearance bodies and may contravene the regulations (e.g. treatment of Schedule A diseases promoted to consumers). When coming across such advertising, it may be appropriate to launch a complaint. Per the Health Canada guidance document “Health Canada and Advertising Preclearance Agencies’ Roles Related to Health Product Advertising”, you can forward complaints related to DTCA of prescription drugs and Schedule D drugs (biologics, including vaccines) to the Regulatory Advertising and Risk Communications Section of MHPD. You can forward complaints related to DTCA of other healthcare products to Ad Standards or Extreme Reach.511 What is the status of advertising of Schedule II drugs (non-Pr but behind the counter) to the general public? Beyond name, price, quantity? It is the Federal Schedules (not the provincial schedules) that determine the advertising regulations. The restriction you referred to (i.e. name price quantity) applies specifically to products on the Federal schedule “Prescription”. But please note that, as stated in several Q&A responses, even non-prescription products may not be promoted to consumers as treatments for schedule A diseases.