Canada Issues New Limits on Marketing of Prescription Opioids

Health Canada is proposing additional restrictions on the marketing and advertising of Class B opioid products, which are equal to or stronger than morphine, provided to health care professionals.

With the opioids crisis continuing in Canada, Ginette Petitpas Taylor, the country's minister of Health, announced new actions by Health Canada on March 11 to further restrict the marketing and advertising of prescription opioids. Health Canada is proposing additional restrictions on the marketing and advertising of Class B opioid products, which are equal to or stronger than morphine, provided to health care professionals.

Under the proposal, all promotional materials about Class B opioids provided to health care professionals, including print and electronic ads and pamphlets, must be limited only to statements that have been authorized by Health Canada in the Product Monograph, which drug manufacturers are required to provide. It is a factual, non-promotional, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug and contains any other information that may be required for optimal, safe, and effective use of the drug.

The proposal says statements would have to be presented verbatim and convey the benefits and risks of opioids in a balanced way.

Affected companies have the opportunity to comment on the proposed restrictions before they are finalized in April 2019. The new requirements would take effect by June 2019.

"I am deeply concerned by the ongoing opioid crisis, which is affecting Canadians from all walks of life," Taylor said. "I recognize that advertising can influence the prescribing practices of health care professionals. Today's announcement will help us to ensure that health professionals are getting only factual information about these products, so that they can provide the best possible support to their patients."

Taylor also announced the launch of the Stop Illegal Marketing of Drugs and Devices online platform, which aims to educate Canadians on the rules governing the advertising of Canadian health products. It offers a tool to file a complaint with Health Canada about promotional activities that may not be compliant with advertising rules.

The new measures build on already announced initiatives to address the pharmaceutical industry's marketing and advertising of opioids. As of October 2018, a warning sticker and a patient information handout must be provided with prescription opioids dispensed to Canadians at pharmacies or in doctors' offices, and an external advertising agency has to pre-clear all materials regarding opioid products that industry intends to provide to health care professionals.

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