Advertising/Promotion Systems must be truthful, consistent with the Terms of Market Authorization, offer a balanced view of risks and be supported by relevant evidence.
All APS must be accurate, complete and clear so as to promote credibility and trust. Statements or illustrations must not mislead.
The product information and/or link must be clearly presented within the main message, as described in Section 7.
In the advertising message portion, the advertiser must present a fair balance of risk to benefit.
In all APS for pharmaceutical products, the brand or trade name, the non-proprietary or generic name and the Federal drug schedule of the product must appear in juxtaposition at least once within advertising copy and must be in good contrast and be legible. For example PRARBACE™ (Arbasartin Sodium). The Federal drug schedule is not required to be disclosed for non-prescription products.
The non-proprietary name must be the same as that cited in the Health Canada Terms of Market Authorization.
APS must be presented in a manner that accurately interprets valid and representative research findings.
Statements that are out of context or distort the conclusions of the author(s) are not acceptable.
APS must reflect an attitude of caution with respect to drug usage, with emphasis on rational drug therapy and proper patient selection for the advertised product. The advertising copy should provide sufficient information to permit assessment of risk/benefit in a prominent manner, whereby the prominence of risk information must be comparable to the prominence of benefit in the main body copy.
The advertising message should include reference to the safety profile that is consistent with the Health Canada Terms of Market Authorization.
Special warnings, precautions, clinically significant serious adverse events, Notice of Compliance with Conditions (NOC/c) or use limitations cited in the TMA should be included in the body copy. Boxed messages in Product Monographs for products with NOC/c should be included in the advertising message. Examples include abuse potential for narcotics or CNS agents, or specific directions for use in special patient groups such as the elderly, pediatric, pregnant women, nursing mothers, women of childbearing age, etc.
With respect to self-care products, the fair balance requirement can be met by inserting the following statements into the APS:
i) For Products with a Product Monograph or Health Canada approved Prescribing Information: “Please consult the Product Monograph [or Prescribing Information] available at websitepage.ca for information to assist in benefit-risk assessment. Always direct the patient to read the label”. This should be followed proximally by a statement that the Terms of Market Authorization is also available upon request through a stated phone number. The indication must appear within the APS.
Note that for electronic APS, the phone number is not required if an electronic link is provided to the Product Monograph. In those cases, the linkage statement should be “Please click here for the Product Monograph available at www.websitepage.ca for information to assist in benefit-risk assessment. Always direct the patient to read the label”. The indication must appear within the APS. See Section 7.
ii) For Licensed Products Without a Product Monograph or Health Canada approved Prescribing Information: “See Warnings, Cautions, and Directions of Use at websitepage.ca for information to assist in benefit-risk assessment. Always direct the patient to read the label”. This should be followed proximally by a statement that the TMA is also available upon request through a stated phone number. The indication must appear within the APS. See Section 7.
A link to a website for information on warnings, cautions and directions of use is not required if all relevant text from the Health Canada labeling and product license is included in the APS. See Section 7.2.1.
Note that for electronic APS, the phone number is not required if an electronic link is provided to this risk information. In those cases, the linkage statement should be “Please click here for Warnings, Cautions, and Directions of Use to assist in benefit-risk assessment. Always direct the patient to read the label”. The indication must appear within the APS.
The Code does not accept APS that are prejudicial to any gender, race, occupation or patient group, or contravene the ethical values of the health professions.
For additional guidance, the Reviewer has access to supplemental codes and guidelines.
The advertiser must reconsider statements or visual presentations that are potentially offensive, or that may have a "negative effect" upon company or patient images.
In company-generated copy or quote(s) from referenced material, no APS may state or imply in absolute terms that any product is ‘safe’, ‘ideal’, ‘non-toxic’, has ‘guaranteed efficacy’, is ‘uniformly well tolerated’, or has "totally predictable action or clinical effect".
The Code does not accept statements that claim directly, or indirectly, 100 percent clinical efficacy or safety.
The advertiser may make properly supported absolute statements when describing product properties (e.g. pharmacology, actions, kinetics, etc.) if these are presented or grouped separately from the clinical claims section; this avoids any extrapolation of laboratory superiority to imply clinical efficacy or advantage.
The following are other examples of terms, which may not be used, in an absolute or categorical sense or in an unqualified manner: "avoids", "eradicates", "cures", and "eliminates".
APS must not imitate the general layout, text or visual presentation of other pharmaceutical company advertisements in a way likely to mislead or confuse the reader.
Promotional items offered in advertisements must be related directly to the product or its use(s), or be of practical value to the health professional. Such items must withstand professional and public scrutiny. Items intended for distribution to patients via a health professional must be useful as aids to patients’ understanding of, or adaptation to, their condition(s) or for encouraging compliance with recommended therapy.
Such presentations must also conform to individual association codes of marketing practices such as the Innovative Medicines Canada, BIOTECanada, CGPA and by health professional organizations such as CMA or CPhA.
For purposes of this Code "practical value" shall be limited to compliance with recommended therapy, items useful to the healthcare professionals in their practice, and/or as teaching aids for patients Innovative Medicines Canada, “Code of Ethical Practices” at www.innovativemedicines.ca.
Advertisements that are displayed in multiple portions over contiguous pages (such as, over pages 3, 5, and 7) may be deemed to be a single advertisement and reviewed as such provided each part can be easily identified as part of the complete ad.
Portions of advertisements that will not be displayed on contiguous pages will be reviewed as discrete advertisements. The advertiser must inform the PAAB if ad portions will not appear contiguously.
Authorized Use: An advertisement is misleading if it suggests that a drug is useful in a broader range of conditions or patients than that which have been approved by Health Canada. The segment of patients for whom the product is authorized should set the context for the corresponding benefits. Also, the indication(s) should be stated in a manner that clearly reflects the Terms of Market Authorization.
Any content setting the boundaries for patient selection from the Indications and Clinical Use section of the Product Monograph (or equivalent section of other TMA types) must be presented prominently among, or prior to, the first set of marketing benefit claims in the APS. This is only required for the indication(s) promoted within the piece. The same applies to the recommended use for products with a product license.
The TMA content “Drug X is indicated for” (or equivalent) must be presented verbatim at least once within the advertising message of the APS.