All APS must be accurate, complete and clear so as to promote credibility and trust. Statements or illustrations must not mislead.
Ensure that the reference (or relevant segment of the reference) is acceptable.
APS must be presented in a manner that accurately interprets valid and representative research findings.
Claims and/or quotations in Advertising/Promotion Systems must be consistent with, and within the limitations of, the Health Canada TMA. Any APS containing direct or indirect product claims and/or quotes from scientific literature must include a complete listing of the scientific references. Labelling must be authorized by Health Canada. See Making Comparisons, Section 5, for claims that are of a comparative nature.
Clinical or therapeutic claims must be based on published, peer-reviewed, controlled, and well-designed studies with clinical and statistical significance clearly indicated. Review articles, pooled data, meta-analysis, post-hoc analysis, are generally regarded as not being acceptable evidence in drug advertising. Data included in the TMA may be acceptable. Additionally, high quality meta-analysis and observational studies may be acceptable. Non-clinical claims must be well supported by relevant evidence.
Clinical and therapeutic APS presentations based on the following types of data are required to meet tailored standards outlined in the listed guidance documents:
- Real-World Evidence (including, but not limited to, observational studies). See the RWE Guidance Document for evidentiary and presentation format considerations.
- Subjective endpoints from unblinded RCTs. See the Attention Icon Guidance Document for presentation format considerations.
- Clinical studies from other jurisdictions where the inactive ingredients differ from the corresponding Canadian version of that product. The therapeutic use evaluated in the study must align with the use approved in Canada for that product. All relevant provisions of the code apply to inclusion of the study within advertising targeted to Canadian health professionals. See the Attention Icon Guidance Document for presentation format considerations.
Unpublished data is regarded as having received independent review when:
i) There is evidence that an editor of a peer-reviewed journal has accepted this data (or study) for future publication.
ii) The data has been reviewed as part of a submission to Health Canada and there is evidence of acceptance indicated by inclusion in the TMA. Citation in the bibliography section of the TMA does not indicate proof of acceptance by Health Canada.
Please note that abstracts presented at conferences and/or in journal supplements (such as study design and results analyses) that have not been subject to independent review are generally regarded as not having sufficient evidence to support claims and may not be used as reference in APS.
Papers published in journal supplements must demonstrate that the supplement has also been subject to a rigorous peer-review process similar to the attached journal.
Non-evidence based statements such as testimonials regarding adverse drug reactions are not acceptable. Testimonial statements consistent with data and supported by evidence may be used.
With respect to advertising of non-prescription drugs without a Product Monograph, a Senior Regulatory Official of the Market Authorization Holder (MAH) may provide confirmation that a claim has been approved by Health Canada, for example: “Name of the Market Authorization Holder hereby attests that the claim (specific expanded claim) has been authorized by Health Canada for (complete product Brand name).” The MAH may be asked to provide further information.
For Drug Identification Number (DIN) products transitioned to Natural Product Numbers (NPNs), the Product License is the preferred evidentiary support for claims. However, the previously accepted Product Monograph will be considered acceptable evidence to support claims made regarding the transitioned Natural Health Product (NHP). This does not apply to products whose ingredients were altered. The previously accepted Product Monograph may not be used to support claims that are inconsistent with the current TMA.
PAAB may allow the use of sub-group analysis with specific conditions.
PAAB may allow the use of observational studies when specific acceptance criteria are met.
References cited in the APS must be available to health professionals on request, in English and/or French, either in their original form or translated.
Data on file must be made available to the Commissioner and may be classified as ‘Confidential’ by the advertiser or the author (pending publication).
A copy of the summary of the Data on File must be provided to health professionals upon request.
Copies of all reference sources cited in an APS must be provided to the PAAB Commissioner for verification of claims and/or quotes.
Statistics must be presented so as to accurately report the findings and to help make reliable and valid conclusions.
Statistical information should include dosage and the level of significance (e.g. confidence interval [CI] and/or p-value), in the presentation. Where confidence intervals and p-values are both available, the manufacturer may decide to report both. The use of 95% CI is encouraged in preference to p-value. Information such as patient numbers, time span, dosage, etc. that are needed to assess the data, may appear in the web link destination containing the Terms of Market Authorization (TMA).
The advertiser must honor market research company agreements and must submit a release of market share claims from the source of the data. Data should be the most current available, at least within the past six months.
Company-generated charts/graphs, etc. from pooled studies may not be acceptable.
The compared drugs/products have an authorized indication for use in common, and the comparison is related to that use; or, in addition to the common indication for use, a second authorized indication is claimed as an added benefit of the advertised drug, and
The comparison is drawn between drugs under the same conditions of use (e.g. equivalent part(s) of their authorized dose ranges (maximum vs. maximum dosage), in a similar population, and
The claim does not conflict with the Terms of Market Authorization of the compared products (Note 1), and
The claim is of clinical relevance in humans, i.e. relevant to treatment selection, and, where this is not readily apparent, its clinical relevance can be justified by the sponsor, and
The evidence generated to substantiate the claim is conclusive and based on:
i) Consideration of all relevant data, and
ii) Scientifically accurate, unbiased, reproducible data obtained from studies conducted and analyzed to current scientific standards using established research methodologies and validated end points, and
iii) Appropriate interpretation of the data (Note 2).
The claim and its presentation should:
i) Identify the compared entities (Note 3), and
ii) The medicinal use related to the claim where this is not readily apparent (Note 4), and
iii) Not obscure the therapeutic use of the advertised product/ingredient (Note 5), and
iv) Not attack the compared drug product(s)/ingredient(s) in an unreasonable manner, and
v) Be expressed in terms, language and graphics that can be understood by the intended audience.
Advertisers are responsible for ensuring that comparative claims that fall within the scope of these Health Canada Principles, meet these requirements. Furthermore, all comparisons must satisfy the requirements of the full PAAB Code, including the following provisions:
Comparative claims of efficacy and safety generally require support of evidence from head-to-head, well-designed, adequately controlled, blinded, randomized clinical studies. Open-label studies are generally not considered to be a high level of evidence and are not acceptable support for marketing benefit claims relating to subjective endpoints. Comparative claims should be consistent with current medical opinion and practice. Canadian guidelines are to be adhered to. In the event that they are not available, see the following document on what constitutes current medical opinion.
For standards pertaining to informational presentation of subjective endpoints in open-label trials see s.3.1.1.i.
Adverse events and clinical efficacy data quoted from two or more TMAs or derived from studies that were not head-to-head, are not acceptable support for comparative claims of clinical safety or efficacy. This is due to the fact that factors such as study methodologies, patient populations, dosing and measurement criteria used in the separate trials can vary widely. Furthermore, a side-by-side presentation of these adverse events and efficacy data, which lack comparability, could leave a misleading impression and does not meet the PAAB Code acceptance standards.
Methodologies, endpoints and independent review. To be considered as evidence, clinical studies must use established research methodologies and validated endpoints. To aid in the assessment of these study parameters, PAAB looks for evidence that the full study results have been subject to independent review, such as that found by achieving the publishing of study results, including statistical analyses, in a peer-reviewed journal. (Note 6)
Alternatively, unpublished data are regarded as having received independent review when:
i) There is evidence that the full study manuscript has been accepted by the editor of a peer-reviewed journal for future publication, or alternatively when
ii) The data have been reviewed as part of a submission to Health Canada and there is evidence of acceptance (such as inclusion in the TMA).
When presented only in the following form, study design and results analyses are not regarded as having been subject to independent review and are not sufficient evidence to be used as reference support for advertising claims:
i) Abstracts presented at conferences and in journal supplements.
ii) Papers published in journal supplements unless the advertiser can demonstrate that the supplement has also been subject to an adequate peer review process.
Analysis of Data: To be considered as evidence, results must achieve an acceptable level of statistical significance. Where confidence intervals (CI) and p-values are both available, the manufacturer may decide to report both. The use of 95% CI is encouraged in preference to p-value. The use of 90% CI is acceptable for presentations of pharmacokinetic data. Failure of study results to demonstrate a statistically significant difference in the measured effect is not sufficient to support a claim of equivalence between the treatments studied.
All direct and indirect comparisons must not mislead and be supported by reliable current data.
i) Comparisons of adverse events or efficacy of a product or drug ingredient may be supported by a peer-reviewed, published meta-analysis of data from studies in which the conditions of use of the compared drugs are consistent with those authorized in Canada.
ii) Pharmacoeconomic and quality of life claims must be supported by high-quality studies. Disclosure of study parameters (See Section 5.11) is important for interpretation of results.
iii) For comparisons of non-clinical data (e.g. pharmacokinetics and pharmacodynamics), no direct or indirect clinical conclusions may be made in advertising unless a strong correlation can be established (e.g. where the rate of absorption is a direct measure of the onset of symptom relief).
The following classes of claims are subject to these requirements noted:
i) Market share and price claims, must be based on and referenced to, current authoritative data and must not state or imply therapeutic equivalence.
ii) Other non-therapeutic product claims, such as taste or packaging, require support from adequate, unbiased and statistically valid Data.
iii) Information from two or more TMA on products’ properties (Note 7) and on instructions for use or use limitations (Note 8) may be acceptable as side-by-side presentations and in text form. While the Code permits products to be accurately differentiated by these parameters, no clinical significance must be stated or implied where none has been proven, as is required under the Code for any statement. To ensure that clinical significance is not implied, a disclaimer may be required:
“Data from separate product monographs; comparative clinical significance has not been proven.”
Any such side-by-side presentation or statement must be complete, in that other data relevant to the presentation also contained in the TMAs must not be omitted. The presentation or statement must not be accompanied by a heading that implies an overall comparison of clinical efficacy or safety.