Guidance for Advertising/Promotional Systems (APS) Which Are Openly Visible in Healthcare Professional (HCP) – Patient Interaction Areas:

Based on consultation with Health Canada officials, we are informing you of a policy revision with respect to how the PAAB Code section 6 is applied to APS which are openly visible within HCP - patient interaction areas (e.g. clinic exam rooms, pharmacy counselling rooms, dental treatment rooms). APS openly visible in such areas include (but are not limited to) posters, anatomical models, brochure holders and brochures.

These APS have been and will continue to be subject to PAAB review. The HCP is involved in the decision to place these materials in the examination room and they use these items in patient counselling; hence, they are part of the audience for these materials. These APS will be reviewed to approval and a PAAB acceptance number will be issued.

What’s new is that, based on consultation with Health Canada officials, these materials are regarded as having, in addition to the primary audiences of the HCP and the patient, a secondary audience—the healthcare consumer. Consequently, these APS are subject to the applicable sections of the Food and Drugs Act and Regulations, policy and guidance documents pertaining to advertising, and the PAAB Code.

Please keep the following in mind for materials openly visible to healthcare consumers within HCP – patient interaction areas:

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• Product-branded APS for a prescription drug (Schedule F) must be limited to name, price and quantity as per Section C.01.044 of the Regulations. This limitation does not apply to nonprescription drugs and natural health products (NHPs); however, the schedule A prohibitions discussed below must be considered.
• Product-branded APS for a prescription or nonprescription product may not discuss the treatment or cure of any Schedule A disease (Section 3 of the Act). Note that section A.01.067 added to the regulations on June 1, 2008 permits nonprescription products and NHPs indicated for the prevention of diseases listed on schedule A to make preventative claims.
• Help-seeking announcements must follow the guidance within the Health Canada policy document “The Distinction Between Advertising and Other activities” (e.g. may not disclose the product name or manufacturer’s name).
• Non-product branded examination room posters describing the disease area and therapeutic landscape must follow the guidance for consumer brochures within the policy document “The Distinction Between Advertising and Other activities”.

Please note that there are no changes to the review of APS that will only be visible during HCP-patient counselling; such APS do not have a secondary consumer audience and will be reviewed according to PAAB Code requirements on patient material (e.g. s. 6.4).