Beware of these illegal marketing practices
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Omitting or downplaying risks
Marketing of drugs and medical devices to health care providers, including any promotional materials, must present product information in a balanced manner.
Risk information must:
- be clearly presented
- not be downplayed in any manner
- be given the same prominence as the therapeutic benefits of the product
Risk information includes:
- side effects
- warnings and precautions
For example, the product monograph for an amphetamine lists a risk of "varying degrees of abnormal behaviour". The advertiser may downplay this risk with statements indicating that this is not a common occurrence.
Advertisers may seek to promote their products by:
- exaggerating their effectiveness
- making efficacy claims not supported by Health Canada's Terms of Market Authorization
For example, a drug may be marketed as providing relief within 2 days, whereas the product monograph indicates that the drug provides relief after 10 days.
Promoting Unauthorized (Off-Label) Use
Prescription drugs, over the counter drugs, natural health products, as well as Class II, III and IV medical devices are authorized by Health Canada for specific indications. Veterinary health products are notified for specific recommended uses. These products may not be marketed for uses beyond the scope of the Health Canada authorized indications or notified recommended uses.
An advertiser may, for example, make a statement claiming that other health care providers have said that a particular opioid works well for patients with mild pain. This would be prohibited if:
- the product is only indicated for moderate to severe pain
- it gives the misleading impression that the product is intended to be used in this manner
Promoting an unauthorized product
Marketing prescription drugs, over the counter drugs, natural health products, as well as Class II, III and IV medical devices is prohibited unless the product is authorized for sale by Health Canada.
Note: This does not apply to medical devices being advertised in a catalog that includes a clear and visible warning that the device may not have been licensed in accordance with Canadian laws. Veterinary health products (VHPs) are not authorized by Health Canada, but they must be notified to Health Canada at least 30 days prior to being advertised in Canada. Find more information about illegal marketing of VHPs.
For example, an advertiser may promote a product that is being assessed by Health Canada for market authorization before Health Canada's decision on whether to deny or grant the authorization.
Poster to share
Endorsements, seals of recognized organizations, testimonials and quotations are only acceptable if they represent the honest and current opinions of the individuals or organizations. Furthermore, they must be consistent with the Health Canada authorized indications for the product (in the case of veterinary health products, the notified recommended uses).
For example, a vendor of a laser-based medical device may claim that a prominent podiatrist is using their laser to treat onychomycosis. However, such a claim would not be permitted if the device has not been indicated for the treatment of onychomycosis.
Claims of endorsement by government authorities, such as Health Canada, are not permitted. While Health Canada authorizes products for sale for specific indications, we do not "approve" or "endorse" products. Thus, only claims of Health Canada authorization are permitted.
Example of Permitted Statements:
If a product is authorized for sale: "Health Canada has authorized this device for sale."
Example of Prohibited Statements:
Claims implying approval or endorsement: "This device is Health Canada-approved."
Misleading comparative claims
Advertisers may seek to promote their products through comparisons with other products on the market. These comparisons may claim that their product is equivalent, non-inferior or superior to an established product in terms of effectiveness or safety. All comparative claims must follow the Therapeutic Comparative Advertising Directive. Some aspects of the directive may not apply to medical devices and veterinary health products. Additionally, the comparative claims must be based on therapeutic aspects supported in the product monograph for:
- prescription drugs
- over the counter drugs
- natural health products
For example, a marketer may promote a laser-based medical device for the treatment of onychomycosis as superior to topical or oral antifungal drugs. This may be inconsistent with the applicable principles of the Therapeutic Comparative Advertising Directive.
How to confirm product status and verify the information provided to you
To confirm whether the indications of a drug or device that is being marketed has been authorized by Health Canada, check for proof of preclearance by an advertising preclearance agency (APA) recognized by Health Canada (ex. APA logo).
If proof of preclearance is not available, consult the databases for the product lines:
- medical devices, the Medical Devices Active Licence Listing
- therapeutic, biologic and veterinary drugs, the Drug Product Database
- natural health products and homeopathic medicines, the Licensed Natural Health Products Database
- veterinary health products, the List of Notified Products
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