Health Canada Takes on Opioid Transparency – Notice of Intent to Restrict Marketing and Advertising of Opioids

In the United States, the need for transparency when it comes to prescribing opioids has been a topic of discussion for months now. Just recently, however, our neighbor to the north, Canada, has issued a “Notice of Intent to Restrict the Marketing and Advertising of Opioids.”

According to the notice, Canadians are the second highest users per capita of prescription opioids in the world and rates of opioid-related hospital visits and deaths have been increasing rapidly. In Canada, the pharmaceutical industry can market in many different ways, including direct and indirect activities and incentives, including 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/or texts.

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.

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-centered way, and increase transparency in the marketing and promotion of therapies.”

The Proposal

Health Canada proposes to restrict drug manufacturers’ advertising of opioids. To that end, 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.

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.

Pending feedback, Health Canada anticipates introducing proposed regulations in early 2019.

All interested parties are invited to provide their comments on the Notice of Intent in writing by July 18, 2018 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 via email to hc.ppiad.dppai.sc@canada.ca.