Notice to Stakeholders: Further Restrictions to the Marketing and Advertising of Opioids
Health Canada is seeking input from Market Authorization Holders (MAHs) on proposed additional Terms and Conditions (Ts and Cs) for Class B opioid products. Building on the Ts and Cs imposed in October 2018 by the Minister of Health, which included mandatory preclearance of advertising materials, the proposed additions would serve to further restrict the marketing and advertising of opioids under the authority of section C.01.014.21 of the Food and Drug Regulations.
Prescriptions written by health care professionals are a common source of opioids in Canada. Health care 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 may be contributing to increased sales and availability of prescription opioids. It is also noteworthy that Canada has one of the highest prescription rates of opioids in the world.
In May 2018, regulations were introduced which gave the Minister of Health the authority to impose Ts and Cs on opioid products. In October 2018, through these Ts and Cs, Health Canada advised MAHs that they must provide Health Canada with Canadian Specific Opioid targeted Risk Management Plans (CSO-tRMP) for their Class B opioid products. As part of this requirement, MAHs must submit all materials regarding opioid products they intend to provide to health care professionals for preclearance to an external advertising preclearance agency (APA) recognized by Health Canada. The APA assesses whether the materials are consistent with the terms of the product’s market authorization and determine whether any statements are false or misleading.
In June 2018, Health Canada published a Notice of Intent to restrict the marketing and advertising of opioids whereby it consulted on whether and how to proceed with the restriction on opioid marketing and advertising. A summary of the feedback received from health care professionals and associations, patients, academics, and pharmaceutical industry representatives was published in December 2018. Respondents were generally supportive of restrictions on marketing and advertising of opioids, and noted the importance of having access to unbiased educational information to support appropriate opioid prescribing.
Proposed Further Restrictions
Recognizing the current ongoing opioid crisis, Health Canada is considering further restricting the marketing and advertising of opioids by proposing additional Ts and Cs for prescription opioid-containing products. The proposed additional Ts and Cs would restrict all advertising materials of Class B opioids provided to health care professionals to only 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.
Importantly, the mandatory preclearance imposed through the October 2018 Ts and Cs would continue to apply. This proposed approach allows the pharmaceutical industry to convey educational and scientific information about a health product, while ensuring that information is evidence-based, unbiased, and accurate, and the benefits and risks of opioid products are conveyed in a balanced way.
Advertising of controlled substances, including Class B opioids, must be consistent with the Food and Drugs Act, the Controlled Drugs and Substances Act, and associated regulations.
MAHs have until April 1, 2019 to submit comments in writing. Health Canada plans to notify individual MAHs of the additional Ts and Cs by end of April 2019 with the expectation that all advertising materials developed as of June 2019 would be required to comply with the new Ts and Cs.
Questions concerning the proposed additional restriction should be directed to MHPD_DPSC-Advertising_Reg_Publicite@hc-sc.gc.ca.
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