Notice of Intent to Restrict the Marketing and Advertising of Opioids

Prescription opioids can help Canadians who need them to manage pain. However, over-prescription of opioids has contributed to Canada’s current opioid crisis. To help address this issue, Health Canada intends to restrict the marketing and advertising of opioids.

Background

Canadians are the second highest users per capita of prescription opioids in the world, and rates of opioid prescribing and opioid-related hospital visits and deaths have been increasing rapidly. Prescriptions written by health professionals are a common source of opioids in Canada. Health professionals receive information from a variety of sources to inform their prescribing decisions and advice to patients, including from the pharmaceutical industry. While there is value in the pharmaceutical industry conveying educational and scientific information about a health product, evidence suggests that the marketing and advertising of opioids has contributed to increased prescription sales and availability of opioids.

The pharmaceutical industry’s marketing practices can take many forms of direct and indirect activities and incentives, including, for example, manufacturer-sponsored presentations at conferences, continuing education programs, advertisements in medical journals, and personal visits from sales representatives. It can also include use of promotional brochures, fees for research, consulting or speaking, reimbursement for travel and hospitality expenses to attend industry-sponsored events, and gifts of meals, equipment, and medical journals and texts.

Through administration of the Food and Drugs Act and related Regulations, Health Canada regulates drugs for safety, quality and efficacy, which includes oversight of advertising undertaken by market authorization holders (manufacturers and distributors). Further, the Controlled Drugs and Substances Act and related Regulations allow legitimate activities with controlled substances and precursors, while minimizing the risk of their diversion to illicit markets or uses.

The Food and Drugs Act defines advertising as any representation by any means for the purpose of promoting, directly or indirectly, the sale of any drug or device. Specific requirements exist for advertisements of prescription drugs to consumers. The advertising of opioids to the public is strictly prohibited. However, advertising of opioids to health care professionals is currently permitted if the claims are consistent with the terms of market authorization. 

Health Canada published Regulations on May 2, 2018, in Canada Gazette, Part II, 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.

Oversight of this issue is a shared responsibility between federal, provincial, and territorial governments. Provincial and territorial governments have primary responsibility for design and delivery of health care and physician services, which includes oversight of health professionals, and identifying and addressing conflicts of interest that might have an influence on prescribing practices of health professionals in their jurisdiction. 

As part of the Government of Canada’s comprehensive approach to the opioid crisis, the Minister of Health’s 2017 mandate letter committed to “consult with provinces, territories, and professional regulatory bodies to introduce appropriate prescribing guidelines to curb opioid misuse, ensure prescriptions are appropriately tracked in a consistent and patient-centred way, and increase transparency in the marketing and promotion of therapies.”

Proposal

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. The Department is consulting on the scope and intent of the restrictions. 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. 

Health Canada calls on all interested stakeholders, including opioid manufacturers and distributors, health professionals, health and patient organizations, provinces and territories, professional regulatory bodies and other members of the public, to submit information and comments pertaining to this Notice of Intent.

Health Canada is requesting information and comments on:

• 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.

Next steps

The Government of Canada will take into consideration all comments received during the public comment period in determining whether and how to proceed with a restriction on opioid marketing and advertising. Pending the feedback received, Health Canada plans to introduce proposed regulations in early 2019.

Comments

Interested parties may by July 18, 2018, provide their comments on this Notice of Intent, in writing, to the Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Address Locator: 2005A, Ottawa, Ontario, K1A 0K9, Department of Health. Comments can also be sent by email to hc.ppiad-dppai.sc@canada.ca.

For more information about how your information may be collected, used, and disclosed please see the Information and Privacy Notice for Specific Health Products and Food Branch Initiatives.