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Illegal Marketing of Drugs and Medical Devices in Canada

Health Canada is not only the national regulatory authority for issuing health product marketing authorizations, but it also oversees and enforces the regulatory requirements related to health product advertising. While smart marketing strategies are important for driving sales, it is also crucial to ensure those strategies comply with Canadian legislative and regulatory requirements.  

The Canadian Food and Drugs Act prohibits health product advertising which is false, misleading or deceptive, or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. BEWARE of these common illegal marketing practices!

  • Promoting an Unauthorized Product:

Marketing of prescription drugs, non-prescription 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. All medical devices (with the exception of Class I devices) must obtain marketing authorization from Health Canada in the form of a Medical Device Licence before it can be marketed in Canada. All natural health products must obtain marketing authorization from Health Canada in the form of a Product Licence, and be assigned a NPN number. Similarly, all drugs (prescription and non-prescription drugs) must obtain approval from Health Canada and be assigned a DIN number.  

  • 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. These products may not be marketed for uses beyond the scope of the Health Canada authorized indications or notified recommended uses. For example, if a particular opioid product is authorized by Health Canada to “treat moderate to severe pain”, you would be prohibited to claim that the product can be used to treat “mild pain”, or give misleading impression that the product is intended to be used in this manner.

  • 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 including side effects, contraindications, warnings and precautions must be clearly presented and given the same prominence as the therapeutic benefits of the product. In addition, since all health products, including those derived from nature, carry some degree of risk, it is unacceptable to suggest that a product is “safe”, is “side effect free”, or has “no known side effects”.

  • Overstating Effectiveness:

Some companies may be tempted to promote their products by exaggerating their effectiveness. However, this is strictly prohibited. Promotional claims must not be directly or indirectly inconsistent with the scope of the Marketing Authorization, including the approved product licence, the product monograph, or the product label. For example, a drug may not be marketed as “providing relief within 2 days” when the approved product monograph indicates that the drug provides relief after 10 days.

  • Misleading Endorsements:

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. Claims of endorsement by government authorities, such as Health Canada itself, are not permitted. While Health Canada authorizes products for sale for specific indications, you cannot advertise the product as “approved” or “endorsed” by Health Canada. Thus, only claims of Health Canada authorization are permitted, meaning you may claim the product is “authorized for sale by Health Canada”.

  • Misleading Comparative Claims:

A common advertising strategy is to promote 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 based on scientific evidence or data. You cannot make any untrue or exaggerated comparative claims. The comparative claims must also be within the terms of the authorized indications of the compared products. In addition, all comparative claims must follow additional requirements outlined in the Therapeutic Comparative Advertising Directive.

  • Direct-to-Consumer Marketing of Prescription Drugs:

Direct-to-consumer marketing of prescription drugs is restricted. Any drug product listed in the Prescription Drug List is subject to Section C.01.044 of the Food and Drug Regulations. This prohibits consumer-directed prescription drug advertising beyond the drug’s name, price and quantity. This means, for example, that when a prescription drug is advertised by name to consumers, no reference can be made to its therapeutic use and/or benefits.

Illegal marketing of health products may potentially harm patients and adversely influence prescribing practices by health care providers. Therefore, Health Canada is always proactively monitoring drug and device marketing to enforce the existing rules around illegal advertising, and take action where necessary, including recommending criminal charges where appropriate. More information on Health Canada’s compliance and enforcement approach is available in the Inspectorate’s Compliance and Enforcement Policy (POL-0001).

If you want to be sure your health products are marketed in compliance with Canadian legislations and requirements, Quality Smart Solutions has a team of specialists who can assist with preparing and obtaining marketing authorization for your product or reviewing your promotional materials. Get prepared now and contact us today to discuss how we can be your solution!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 11 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Cannabis, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

References

Canadian Food and Drugs Act, 2019-06-21, https://laws-lois.justice.gc.ca/eng/acts/f-27/

Inspectorate’s Compliance and Enforcement Policy (POL-0001), 2018-12-21, https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/policies-standards/compliance-enforcement-policy-0001.html

Stop illegal marketing of drugs and devices, Health Canada, 2019-08-29, https://www.canada.ca/en/health-canada/services/drugs-health-products/marketing-drugs-devices/illegal-marketing/stop.html