The Pharmaceutical Advertising Advisory Board can provide an opinion on your Direct-to-Consumer (DTC) projects. The opinion is provided within the context of the applicable provisions of the Food and Drugs Act, Regulations made pursuant to the Act, and the Health Canada policy document "The Distinction Between Advertising and Other Activities" which can be found at the following link:
Please note that Health Canada has requested to be kept informed of Direct-to-Consumer communications reviewed by the PAAB and we will be forwarding the final copy to them once we have completed the review.
For a complete list, see http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/advert-publicit/actv_promo_vs_info-eng.pdf
Health product advertising is considered to be any representation, by any means (e.g. television, radio, Internet, print, etc.), for the purpose of promoting directly or indirectly the sale or distribution of any health product (drugs, natural health products, medical devices, vaccines and biological products, etc.)
No. Some messages, depending upon the content and the context in which they are disseminated may be considered non-promotional. These could include press releases, consumer brochures, help-seeking announcements, scientific exhibits and journal articles, if they meet the criteria that are outlined in the Health Canada policy "The Distinction Between Advertising and Other Activities".
Information provided to an individual about a drug treatment(s) by a pharmaceutical manufacturer in response to a request for information that has not been solicited in any way (by the manufacturer of the drug) is not considered to be advertising for the sale of a drug.
Advertising preclearance agencies review and preclear advertising material in order to help industry ensure compliance with the regulatory provisions of the Food & Drugs Act and Regulations (FDR), the Natural Health Products Regulations and the various Health Canada guidance documents and codes of advertising. The regulatory framework is intended to protect the health of Canadians. The agencies also offer independent mechanisms to resolve complaints on advertising for authorized health products.
These types of messages which include the name of the brand are restricted to the name, price and quantity as per FDR c.01.044.
i. Consumer brochures include leaflets/brochures that may make reference to but do not accompany a drug product, and are made available directly or indirectly to the consumer by a drug manufacturer, or other organization, by various means, e.g., by mail, in retail outlets, in health professionals waiting rooms, etc.
Declaration of sponsorship of such a brochure by a drug manufacturer does not in itself render the information promotional. Consumer brochures may be nonpromotional information in the following circumstances:
Consumer brochures may be advertising where any of the aforementioned conditions are not met, or where other factors indicate that the primary purpose of the publication is to promote the sale of a drug.
ii. Consumer brochures also include leaflets/brochures that are not product-specific but expound on the pharmacological properties/actions of an ingredient, e.g., herb, vitamin, mineral, etc., and are made available in retail outlets selling products containing the same ingredients.
Such information packages may be considered to be advertising for a drug product when displayed in close proximity to or distributed with products containing the same ingredient, in the same retail outlet.
Help seeking announcements are defined as announcements that ask patients among the general public having a particular medical disorder, or that experience a given set of symptoms, to consult a physician for discussion of treatment, or to call a 1-800 telephone number for further information.
Such an announcement may be a nonpromotional activity in the following circumstances:
Information provided by the sponsor to a member of the general public in response to a call placed on a 1-800 line or web-site url address set out in a help-seeking announcement may be a nonpromotional activity, in the following circumstances:
Information supplied pursuant to a call placed on the 1-800 telephone line or web-site may be advertising where any of the aforementioned conditions are not met or where other factors indicate that the primary purpose is to promote the sale of a drug.
An institutional message is defined as a communication (e.g., brochure, published article, prospectus, annual report, etc.), which provides information about a pharmaceutical manufacturer, or other institution, concerning its philosophy, activities, product range (by name), financial details, area of future development or research, etc. Such a message may be a nonpromotional activity in the following circumstances:
An announcement that is intended to assist in the recruitment of patients or clinical investigators for a clinical trial, including an Open-label or Treatment IND, may be a nonpromotional activity in the following circumstances:
In contrast, an announcement used in the recruitment of clinical trial participants (patient and investigator) may be advertising where any of the aforementioned conditions are not met, or where other factors indicate that the primary intent of the announcement is to promote the sale of a drug, for example:
For the complete Health Canada policy document "The Distinction Between Advertising and Other Activities" , please consult the following link: