Stop illegal marketing of drugs and devices

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Illegal marketing

Advertising must be compliant with Canadian laws.

Specific laws apply to drug and device advertisements. The legislation consists of the:

• Food and Drugs Act
• Controlled Drugs and Substances Act

Health Canada is responsible for ensuring compliance with the legislation and regulations. Only drugs and devices that have been authorized for sale by Health Canada may be advertised in Canada.

Advertising of drugs and devices to health care providers is prohibited if the claims:

• are false, deceptive or misleading
• do not provide a balanced representation of benefits and risks
• are not consistent with the terms of market authorization of the product

Health product advertising is the direct or indirect promotion for the sale or use of any drug or device. This can be done by any means including:

• print
• Internet
• broadcast

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The impact of illegal marketing

Illegal marketing may:

• potentially harm patients
• adversely influence prescribing practices

When making decisions about treatments for patients, health care providers use many different information sources. These include marketing materials provided by the pharmaceutical industry. It is important that these industry materials accurately convey the benefits and risks of their health products.

How opioid marketing contributes to the opioid crisis

In Canada, opioids are commonly obtained through prescriptions written by health care providers. Prescription opioids can help Canadians who need them to manage pain. However, the opioid crisis has shown the devastating effects that problematic use of opioids can have on families and communities across Canada.

There is value in the pharmaceutical industry conveying educational and scientific information about opioids to health care providers. However, marketing of opioids can unduly influence health care providers. We are taking action to address industry's marketing practices that are false, deceptive or misleading. For more information, visit our Restricting the Marketing and Advertising of Opioids page.

What we are doing to stop illegal marketing

We are working to support health care providers in identifying:

• the illegal marketing of:
  • medical devices
  • natural health products
  • veterinary health products
  • other prescription drugs
  • biologics and biosimilars
  • opioids and other controlled substances
• the potential consequences of illegal marketing
• marketing techniques that may be used to influence decisions in daily practice

To help protect Canadians from the impact of illegal marketing, we:

• encourage and support health care providers to report illegal marketing
• provide a process through which health care providers can report in a confidential manner

Proactive monitoring of health product advertising

Health Canada has developed a proactive monitoring program for advertising drugs and devices. The initial focus is on opioid promotion.

The Health Canada team will:

• proactively monitor drug and device marketing to enforce the existing rules around illegal advertising
• take action where necessary, including recommending criminal charges where appropriate

We are sending a clear signal that illegal advertising of drugs and devices will not be tolerated.

The goal of the program is to prevent and address non-compliant advertising. The program will:

• identify illegal advertising
  • monitor new and previous promotional materials and activities
• respond with compliance and enforcement tools
  • request immediate cessation of illegal marketing activity
  • seek voluntary compliance
  • use existing regulatory sanctions
  • use regulatory and non-regulatory tools
• prevent non-compliant activities from occurring
  • educate parties found to engage in illegal marketing
  • require preclearance for all opioid advertising
  • accredit and audit advertising preclearance agencies (APAs)
  • conduct outreach and training activities with stakeholders (such as industry and health care provider organisations), and build on strategic partnerships
• monitor progress over time
  • develop an evaluation plan with associated indicators
  • report on data and trends

Raising awareness

To raise awareness of compliant versus non-compliant advertising, information on non-compliance will be shared with:

• health care providers
• various industry stakeholders
• health care professional accreditation bodies such as the Royal College of Physicians and Surgeons of Canada

We are also considering introducing further restrictions on the advertising of opioids.

The advertising preclearance system

Health Canada encourages pharmaceutical manufacturers and advertisers to take advantage of the independent Canadian advertising preclearance system, except for opioids where it is mandatory.

This system helps advertisers develop promotional material that complies with the advertising provisions of:

• the Food and Drugs Act
• the Controlled Drugs and Substances Act
• associated Regulations

The preclearance system is:

• mandatory for
  • opioids (mandated by the Food and Drug Regulations)
• voluntary for:
  • medical devices
  • natural health products
  • other prescription drugs
  • biologics and biosimilars
  • other controlled substances

The Pharmaceutical Advertising Advisory Board (PAAB) provides review and preclearance services for all drugs advertised to health care providers that are submitted to them.

Extreme Reach and Ad Standards provide review and preclearance services for advertising related to consumer-directed products that are submitted to them, including:

• natural health products
• non-prescription drugs

Ad Standards also provides these services for:

• Vaccines
• Medical devices (class II, III and IV)

The goal of preclearance is for promotional materials to be:

• balanced
• evidence-based
• compliant with our regulatory framework for advertising

Both PAAB and Ad Standards provide advisory opinions on:

• educational material discussing a medical condition/disease
• messages directed to consumers on prescription drugs and vaccines

They do this with the goal that the advertising meets regulatory requirements.

How you can report illegal marketing

Report a marketing complaint

You report. You protect.