ALGORITHM: Choosing the Appropriate Canadian Healthcare Regulatory Guidelines

As a pharmaceutical marketer, you need to be creative and innovative to achieve your brand’s strategic and financial objectives, but you must do so while staying within the regulatory guidelines.  In Canada, there are several sets of regulatory guidelines and codes that relate to Canadian pharma / healthcare advertising and promotion.  How do you know which ones to follow for which circumstances?

Patrick Massad, the Chief Review Officer at the PAAB, presented an algorithm at the “Social Media Marketing in Pharma: What Works in Canada” workshop, which is meant to help identify which set of guidelines to follow in certain circumstances. A modified version is found below.

When in doubt, contact the various regulatory bodies and explain your specific situation to determine which organization is responsible for clearing your advertising / promotional collaterals and campaigns. Note that the Health Canada Food & Drugs Act is the basis for the policies, guidelines, and regulations on drug advertising. Regulatory bodies enforce these.

	TYPE OF PRODUCT
	Rx and Schedule D product	Non-prescription / Natural health product
Promoting to Healthcare Professionals	Pharmaceutical Advertising Advisory Board (PAAB)	Pharmaceutical Advertising Advisory Board (PAAB)
Promoting to Patients (have a prescription for the product)	Pharmaceutical Advertising Advisory Board (PAAB)	Pharmaceutical Advertising Advisory Board (PAAB)
Promoting to Consumers	Pharmaceutical Advertising Advisory Board (PAAB) OR Advertising Standards Canada (ASC) can provide an opinion on behalf of Health Canada	Advertising Standards Canada (ASC) OR MIJO (Formerly BCA)

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For those who are curious, the following is a list of promotional guidelines for some other countries;

Australia:
Medicines Australia

Medical Technology Association of Australia

Brazil:
Agência Nacional de Vigilância Sanitária (Anvisa) / (Brazilian Health Surveillance Agency). Promotional guidelines in Portuguese only.

Denmark:
Danish Medical Association (LF), Danish Pharmaceutical Association (DA), Danish Association of the Pharmaceutical Industry (Lif), Danish Generic Medicines Industry Association (IGL), Parallel Importers of Pharmaceuticals (PI)

Europe: European Federation of Pharmaceutical Industries and Associations (EFPIA)
EFPIA Code on the promotion of prescription only medicines to, and interactions with, healthcare professionals

EFPIA Code of practice on relationships between the pharmaceutical industry and patient organisations

France:
Les Entreprises du Médicament (LEEM)

United Kingdom:
Association of the British Pharmaceutical Industry (ABPI)

United States of America:
Pharmaceutical Research and Manufacturers of America (PhRMA)

Division of Drug Marketing, Advertising, and Communications (DDMAC)

Advanced Medical Technology Association

Note that I am not a pharmaceutical regulatory expert.  I am providing these resources as a service to my blog’s readers.  If you have specific regulatory questions, please contact the appropriate organization.

Stay in touch,
Natalie

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