Notice of Intent to restrict the marketing and advertising of opioids
Project InformationDue Date:
Health Canada published Regulations on May 2, 2018 that allow the Minister of Health to require companies to develop and implement risk management plans. This includes preclearance of opioid-related materials provided to health care professionals to ensure advertising materials comply with the terms of market authorization.
For the purposes of this proposal, the Food and Drugs Act defines advertisement as any representation by any means for the purpose of promoting, directly or indirectly, the sale of any drug or device.
Recognizing the urgency of the opioid crisis and the role that the marketing and advertising of opioids may be playing, Health Canada proposes to further restrict drug manufacturers’ advertising of opioids. On June 19, 2018, the Minister of Health announced a series of measures to address industry’s opioid marketing practices, including a notice of intent to restrict opioid marketing and advertising in Canada.
Health Canada is requesting information and comments on the following:
- the scope of opioid marketing and advertising, including:
- the format, frequency, volume and cost (in dollars);
- the purpose of opioid-related information and materials conveyed (e.g. promotional, educational, training or scientific purposes).
- the potential risks, benefits and impacts of opioid marketing and advertising on patients, provinces and territories, health professionals, opioid manufacturers and distributers, health and patient organizations, and others, including:
- the risks and benefits of advertising that are specific to different opioid products.
- the potential risks, benefits and impacts of restricting and/or disclosing opioid marketing and advertising on patients, provinces and territories, health professionals, opioid manufacturers and distributors, health and patient organizations, and others.
- the potential risks, benefits and impacts of regular mandatory reporting by opioid manufacturers, to Health Canada and the public, of their marketing and advertising activities, objectives and budgets.
Health Canada will consider all of the comments received during the consultation period in determining how to most appropriately further restrict the advertising of opioids by drug manufacturers. This may include the introduction of proposed regulations in early 2019.