Health Canada Getting Tougher on Opioid and Illegal Advertising
Posted: Monday April 29th, 2019
Author: John Wong, Director, Regulatory Drug Advertising & Promotion, TPIReg/Inomar Strategies
In light of the on-going and escalating opioid crisis, the Federal Health Minister, The Honourable Ginette Petitpas Taylor, issued a request to pharmaceutical companies in June 2018 seeking a voluntary moratorium on opioid marketing and advertising to healthcare professionals (HCPs). Health Canada believes that advertising and promotion of opioids is one of many factors that may be contributing to the increase in opioid prescriptions and sales. Since then, there has been little to no advertising of opioids. The request was sent to over 100 opioid drug manufacturers and distributors and, so far, 47 responded to the Minister’s request to cease advertising activities of opioids.
Later in June 2018, Health Canada released a Notice of Intent to restrict the marketing and advertising of opioids to HCPs. The Notice was open for a 30 day consultation period ending July 18, 2018. Forty-two responses were received from various stakeholders including HCPs, patient groups, industry, provincial governments and academia. In summary, respondents were supportive of federal action to address Canada’s opioid crisis while maintaining access to treatments for those in need. With regards to the advertising of opioids, they were generally supportive of restrictions and noted the importance of unbiased educational information to encourage appropriate prescribing. Suggestions included better regulatory oversight of marketing and advertising of opioids, such as mandatory transparency and disclosure requirements. There was also recognition that the factors contributing to the opioid crisis are complex, and therefore, actions are required beyond addressing the marketing and advertising of prescription opioids.
On March 11, 2019, Health Canada issued a Notice to Stakeholders regarding, “Further Restrictions to the Marketing and Advertising of Opioids”. These proposed restrictions will apply to Class B opioids products, which include opioids that are equal to or stronger than morphine, such as fentanyl, oxycodone and tramadol. These proposals will limit advertising materials for Class B opioids provided to HCPs to statements that have been authorized by Health Canada in the Product Monograph (PM). Specifically, only information contained in the PM would be permitted in such advertising materials and would have to be presented verbatim while meeting fair balance requirements of benefits and risks. The advertising materials would also be required to undergo mandatory preclearance by a Health Canada-recognized advertising preclearance agency (APA). These new restrictions are expected to take effect as of June 2019.
Health Canada is also cracking down on illegal advertising and marketing of drugs and devices. A new campaign called Stop Illegal Marketing of Drugs and Devices (SIMDD) is self-explanatory and has several components including proactive monitoring of health product advertising, raising awareness and encouraging preclearance of advertising. There is also a communication poster to be shared with HCPs aimed at identifying and reporting illegal marketing via a web-based platform (see image).
As a reminder, all advertising and promotion must comply with specific sections related to advertising of the Food and Drugs Act and the Controlled Drugs and Substances Act. Only drugs and devices that have been authorized for sale by Health Canada may be advertised in Canada. The three main areas Health Canada will be monitoring:
· Advertising of drugs and devices that are false, deceptive or misleading
· Advertising that does not provide a balanced presentation of risks and benefits
· Advertising that is not consistent with the terms of market authorization (e.g., product monograph)
About the author:
John Wong is pharmacist graduate from Université Laval. He started his career at the Toronto General Hospital as an Oncology Pharmacist. In 1998, he joined the Pharmaceutical Advertising Advisory Board (PAAB) and later became the Deputy Commissioner. After 10 years at PAAB, John decided to cross over to the ‘other side' and landed at Ogilvy CommonHealth as an Account Director where he helped launch specialty products in Oncology, Hematology and HIV. John has a unique background from both the Canadian regulatory and marketing sides of drug advertising and understands the various advertising Codes and regulations. John is currently the Director, Regulatory Drug Advertising and Promotion at TPIreg/Innomar Strategies.