DRW Monthly
September 2007
Issue No. 10

Review of Pharmaceutical Advertising Regulations in Canada

Health Canada is the national regulatory authority on drug and health product advertising whose primary responsibilities center on developing policies to effectively regulate marketed health products, establishing guidelines to interpret governing regulations and overseeing regulated advertising activities. Although the agency bears the ultimate regulatory responsibility for enforcing the advertising provisions laid down in the Food and Drugs Act (FDA) and the Food and Drug Regulations (FDR) on products approved for sale in Canada, Health Canada has delegated the review and preclearance of advertising materials to two independent agencies, the Pharmaceutical Advisory Board (PAAB) and Advertising Standards Canada (ASC). Drug manufacturers submit advertising materials for preclearance review to PAAB and ASC on a voluntary basis, although submission is strongly recommended by Health Canada.

Both PAAB and ASC are responsible for ensuring that submitted advertising material is consistent with the product's approved labeling before its release. Each of these agencies has developed advertising codes to provide additional guidance on requirements for advertising acceptance: PAAB's standards are delineated in its Code of Advertising Acceptance and ASC requirements are outlined in the Canadian Code of Advertising Standards. PAAB reviews drug advertising directed to healthcare professionals while ASC evaluates advertising for nonprescription drugs directed to consumers. In the case of approved prescription drugs, the product monograph and Notice of Compliance serves as the reference against which all promotional materials are assessed by PAAB. For approved nonprescription drugs, the Notice of Compliance is also used by ASC as the basis for evaluating industry advertising submissions.

Insofar as the specific provisions of the FDA are concerned, the definition of "advertisement" includes "any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device".(1) While the rule in Section C. 01.044 of the FDR stipulates that " [w]here a person advertises to the general public a Schedule F Drug, the person shall not make any representation other than with respect to the brand name, proper name, common name, price and quantity of the drug."(2) The fundamental impact of this definition and rule when applied to prescription drugs is that drug firms are severely restricted in their ability to advertise their products to the public as they are not permitted to combine promotional information on a specific prescription drug and a particular disease or condition in a single advertisement. Consequently, there is very limited direct-to-consumer advertising of prescription drugs in Canada. Although Canada shares this restriction with most countries in the world excluding the US and New Zealand, there has been a growing debate surrounding this topic due to a push by the drug industry to shift the interpretation of the policy governing the direct-to-consumer advertising strategy.

Since 2003-2004, Health Canada has been consulting on proposed changes to Canada's health protection legislation with the goal of replacing outdated statutes resulting in a new Health Protection Act. The Act would replace the existing Food and Drugs Act, the Hazardous Products Act, the Quarantine Act and the Radiation Emitting Devices Act. The direct-to-consumer advertising issue is one of the controversial areas being examined during this process of "legislative renewal." Health Canada has targeted 2007 for the completion of this regulatory framework.(3)

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