Academic journal article Health Law Review

Paternalistic or Protective? Freedom of Expression and Direct-to-Consumer Drug Advertising Policy in Canada

Academic journal article Health Law Review

Paternalistic or Protective? Freedom of Expression and Direct-to-Consumer Drug Advertising Policy in Canada

Article excerpt

I. Background: What is Direct-to-Consumer Advertising?

Introduction

Direct-to-consumer advertising (DTCA) of prescription drugs is an increasingly contentious issue in Canada. Under the Food and Drugs Act (1), the pharmaceutical industry is limited to advertising prescription medications to medical intermediaries such as doctors and pharmacists. Straightforward advertising directly to the public is proscribed, with such advertisements limited to describing either the name, quantity, and price of a drug or what it is used for--but not both. Proponents of DTCA contend that Canadians have a right of access to health information that is denied under the current ban. In this paper, I will argue that the prohibition on DTCA could be successfully challenged under the Charter of Rights and Freedoms (2), on the grounds that it represents a violation of the guaranteed right to freedom of expression under s. 2(b). I will further suggest that the relevant jurisprudence indicates that this limitation on expression would likely fail an attempt at justification under s. 1.

What is the status of DTCA under Canadian law?

Direct-to-consumer advertising of prescription drugs involves the promotion of medications by the pharmaceutical industry to the public via the media. Any advertising related to food or drugs is regulated in Canada by the FDA, which was enacted in 1953. In s. 3(1), it is stipulated that "No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A".

The effect of the American stance on DTCA on Canada

Advertising is defined broadly in s. 2 of the FDA as "any representation by any means whatever for the purposes of promoting directly or indirectly the sale or disposal of any food, drug cosmetic, or device". Health Canada, the government body responsible for the enforcement of FDA regulations, therefore restricts any prescription drug advertising to two types of advertisements: "Branded" or "Reminder" advertisements, which mention the name, price, or quantity of the drug but not what it does; and "Help-seeking" advert isements, which describe the condition it treats, but not the name, price, or quantity (3). Such advertisements must be first approved by Health Canada, and are also subject to review by the Advertising Standards Board. (4)

The only countries that currently permit DTCA of prescription drugs are New Zealand and the United States. (5) In the United States, television commercials for prescription medications may name both the product and the disease, so long as viewers are provided with information concerning the major risks of the drug, and directed to other sources of information such as websites or toll-free numbers. (6) Canadians who watch American television, however, frequently see these ads. (7) A recent survey indicates that approximately 53% of Canadians believe that prescription drug advertising is legal, even though it is not--a fact that is likely due to the media spill over from the United States. (8) Moreover, commercials coming from the United States are largely unregulated--the American Food and Drug Administration does not require the pre-clearance of such ads before they are released. (9) Canadian advocate groups such as the Alliance for Access to Medical Information thus argue that a Canadian solution that gives consumers access to "balanced, accurate, and regulated information" is critical. (10)

DTCA: Critics vs. Advocates

There are numerous arguments advanced by both sides of the DTCA debate. Opponents of DTCA maintain that it benefits pharmaceutical companies more than patients by creating demand for particular drugs. (11) They argue that drug advertising may lead people to believe they are suffering from a certain condition when, in fact, they are not. (12) These critics also fear that patients will be prescribed drugs inappropriately because of pressure on the physician. …

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