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Current Regulations

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:

http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/actv_promo_vs_info-eng.php

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.

Food and Drugs Act and Regulations applying to DTC messages

  • No person shall ... advertise a new drug unless…the Minister has issued a Notice of Compliance to the manufacturer of the new drug… (FDR c.08.002)
  • No person shall ... advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. (section 9.(1))
  • No person shall, in advertising a Schedule F drug to the general public, make any representation other than with respect to the name, price and quantity. (c.01.044)

Schedule A diseases


Acute alcoholism Acute anxiety state Acute infectious respiratory syndromes
Acute psychotic conditions Acute, inflammatory and debilitating arthritis Addiction, except nicotine addiction
Appendicitis Arteriosclerosis Asthma
Cancer Congestive heart failure Convulsions
Dementia Depression Diabetes
Gangrene Glaucoma Haematologic bleeding disorders
Hepatitis Hypertension Nausea and vomiting of pregnancy
Obesity Rheumatic fever Septicaemia
Sexually transmitted diseases Strangulated hernia Thrombotic and embolic disorders
Thyroid disease Ulcer of the gastro-intestinal tract

Here are some useful/ common definitions and types of DTC messages

(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

What is health product advertising?

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.)

Are all messages which refer to health products considered to be advertising?

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".

Unsolicited Requests for Information

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.

Why do advertising preclearance agencies review health product advertisements?

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.

Categories



Reminder Branded Messages

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.

Consumer Brochures

  1. 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:

    • the content is disease related rather than product related,
    • the various treatment options (drug and non-drug) and their respective risks and benefits are discussed in an objective manner,
    • no emphasis is placed on one drug product, e.g., excessive use of a brand name or description of a product as a "breakthrough", and no emphasis is accorded to the merits of one drug product,
    • no reference is made to an unauthorized drug beyond the mention that research is underway in a particular area, in which case, the regulatory status should be indicated (i.e., market authorization not yet obtained), and
    • no reference is made to the availability of unauthorized drugs through the Special Access Programme.

    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.

  2. 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

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:

  • no specific drug is identified,
  • there is no implication that a drug is the sole treatment available for the disease or condition, and
  • no drug manufacturer's name is included.
  • Such an activity 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 or disposal of a drug.

1-800 Telephone Numbers / Web-sites

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:

  • the content is disease related rather than product related
  • the various treatment options (drug and nondrug) and their respective risks and benefits are discussed in an objective manner,
  • no emphasis is placed on one drug product, e.g., excessive use of a brand name or description as a " breakthrough", and no emphasis is accorded to the merits of one drug product,
  • no reference is made to an unauthorized drug beyond the mention that research is underway in a particular area, in which case, the regulatory status should be indicated (i.e., market authorization not yet obtained), and
  • no reference is made to the availability of unauthorized drugs through the Special Access Programme.

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.

Institutional Messages

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:

  • the purpose of the communication is clearly to provide information about the institution rather than about the drugs being marketed, developed or researched,
  • information about the drugs being marketed, developed or researched is limited to the name and therapeutic use of the drug, and
  • no emphasis is given to any one or more products, or their benefits.

Clinical Trial Recruitment

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:
  • the intent of the announcement is clearly identified as being for recruitment of clinical trial participants,
  • the announcement indicates the patient profile required (the disease/symptoms to be treated, age, etc.),
  • the announcement includes a telephone number for obtaining further information that is related only to the clinical trial, and
  • in the case of patient recruitment, no reference is made to the drug manufacturer's name, or to the name of the drug under investigation.

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:

  • the announcement makes claims respecting the safety and efficacy of the drug, or
  • the announcement draws a comparison with other treatments.
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