Health Canada has recently announced the initiation of the Stop Illegal Marketing of Drugs and Devices (SIM-DD) program. Health Canada’s introduction of this particular program is part of its contribution to assist in the proactive monitoring and awareness of the health product marketing environment.
As a background, product advertising must be compliant with the applicable Canadian laws, which for drug and device products falls (see list below) under the Food and Drugs Act, and/or the Controlled Drugs and Substances Act. Only products that have been authorized for sale by Health Canada are permitted to be advertised in Canada. Product advertising is illegal if the statements made for the product are:
- Misleading, false or deceptive
- Communicate an unbalanced representation of the benefits and risks of the product
- Are inconsistent with the market authorization of that product (e.g. NPN for a Natural Health Product)
In the SIM-DD announcement, health experts are encouraged to help report any illegal marketing practices for drugs and device products in Canada for these categories (1) as follows:
- Prescription drugs
- Biologics and biosimilars
- Opioids and other controlled substances
- Medical devices
- Veterinary health products
- Natural health products
This program is an online platform, to help educate Canadians about the manner in which drug and health products are marketed to consumers and to healthcare providers. The SID-DD lists information on illegal marketing practices or techniques that could be considered misleading and deceptive.
The platform has an online tool for reporting of illegal marketing practices via the following email address: firstname.lastname@example.org, which makes it quicker and easier for Canadians to file complaints or concerns about non-compliant marketing practices (e.g. advertising and/or promotional materials). An overview of the details for the complaint process are provided as well, which involves an acknowNaturalledgment letter being sent to the complainee, the complaint being assessed as per applicable laws, prioritization and appropriate action taken for non-compliant findings (pending degree of risk posed), and complaint being added to the table of advertising incidents by Health Canada (2).
The site also displays the complaints received by Health Canada, with both active complaints and closed complaints listed, along with details on each complaint case (3). The summary table for the active complaints has easy to access information including the date complaint first received, the company to which the complaint was addressed, the product/product line, the product type, the complaint detail, and the action. The table for health product advertising incidents is part of Health Canada’s Regulatory Transparency and Openness Framework (4).
In the recent launch of the SIM-DD, Health Canada also communicates the impact of illegal marketing indicating that this may potentially harm patients and may adversely influence prescribing practices by health care professionals, which often rely on information sources including marketing materials provided by a company for the specific product. In particular, Health Canada also provides a background for how opioid marketing contributes to the opioid crisis (5). Opioid-related advertising materials must be reviewed and precleared by a Health Canada recognized advertising preclearance agency prior to being distributed to health care professionals in Canada (whereas, other product categories listed above, may voluntarily have their advertising pre-cleared). Health Canada is additionally taking other steps in order to further restrict the marketing and advertising of opioids, with more information on this particular substance found here. Meetings and letters of communications by Health Canada and Stakeholders relating to the marketing of opioids are listed publically in a table, with the option of ordering copies of letters, and this list is updated on a monthly basis (6).
The take-home message is that Health Canada is proactively monitoring the marketing of drugs and devices and enforcing necessary action for illegal advertising, which may include recommendation of criminal charges where appropriate. Overall, this program is aimed at a) communicating that Health Canada will not tolerate illegal advertising of these products, and b) bringing awareness of this issue to consumers and health care professionals with full transparency.
For more assistance in assessing regulatory compliance of your marketing and/or advertising materials for marketed health products (i.e. Natural Health Products, Medical Devices or Veterinary Health Products), please fill out the form below for more information on how we can help you.
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dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. We can also assist you with your classification determinations for delivery systems or combination drug-device products.