Paternalistic or protective? Freedom of expression and direct-to-consumer drug advertising policy in Canada.

• Author: Gold, Jennifer L.

1. 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. (13) Finally, they express concern that this increased self-diagnosis of disease and demand for particular medications will inevitably lead to increased physician visits and drug expenditure--both of which would burden the Canadian health care system. (14)

Proponents of DTCA, however, contend that promoting drugs to the public will empower patients; that it will help them identify their conditions and play a more active role in their own health care. (15) Further, they assert that DTCA can provide people with medication alternatives to current treatment regimes that may be insufficiently effective or have unpleasant side effects. It is also suggested that individuals who would otherwise be unlikely to seek medical care might be persuaded to do so by such ads. (16) These enthusiasts dismiss the arguments of DTCA critics, underscoring the fact that physicians are the ultimate gatekeepers with respect to prescription medication, and are not required to prescribe any drug they feel to be unwarranted. (17)

II Charter of Rights and Freedoms: Analysis

Establishing a violation of freedom of expression under s. 2(b)

The Charter guarantees the right to freedom of expression under s. 2(b). Expression has been defined broadly by the Supreme Court of Canada to include any activity that attempts to convey meaning. (18) All forms of expression receive Charter protection, with the exception of those communicated through violence. Advertising, which is a form of commercial expression--expression that is intended to promote the sale of a product or service--is also protected under s. 2(b). Direct-to-consumer drug advertising would therefore qualify as a form of commercial expression, as it is intended to communicate information to the public for the purpose of profit.

The Supreme Court has deemed commercial expression to be protected under s. 2(b). In Ford v. Quebec (A.G.) (19), a law permitting signs in Quebec to be in French only was held to be unconstitutional. It was decided that by forbidding signs in English, the law violated the right to freedom of expression. This decision was followed in Irwin Toy, wherein the Supreme Court of Canada determined that a "broad, inclusive approach" should be used when deciding whether the right to freedom of expression as guaranteed under s. 2(b) has been violated. (20) Accordingly, it determined that advertising is constitutionally protected under the Charter. Since the decision in Ford in 1988, the Supreme Court has granted protection to commercial speech concerning numerous issues, including public opinion polls in Thomson Newspapers v. Canada (A.G.) (21), dental advertising in Rocket v. Royal College of Dental Surgeons (22), and tobacco advertising in RJR-MacDonald Inc. v. Canada (A. G.) (23). It is therefore clear that the relev ant jurisprudence, as well as the Court's broad interpretation of freedom of expression, indicate that DTCA would be considered to be a form of commercial expression. As such, it would easily be found to be covered by the guarantee to freedom of expression under s. 2(b) of the Charter.

Analysis under s. 1

Is the limitation justifiable?

Once the Court has determined that a challenged law is indeed in violation of a guaranteed right, it must then decide whether the limit is justifiable according to s. 1, which stipulates that the rights and freedoms in the Charter are guaranteed "subject only to such reasonable limits prescribed by law as can be demonstrably justified in a free and democratic society". (24) In R.. v. Oakes (25), the Supreme Court described the requirements that must be met in order to establish that a limitation is justified under s. 1. The "Oakes Test", as it is referred to, is two-pronged. The government, as the party invoking s. 1, must first demonstrate that the objective of the legislation must he sufficiently "pressing and substantial" to warrant the override of a constitutional right. Second, the means used to override the right must satisfy three proportionality criteria. First, there must be a rational connection between the reason for the Charter override and the objective of the legislation. Second, the means must minimally impair the right in proportional to their objective; the more deleterious the effects, the more important the objective must be.

Applying the Oakes Test

i) Objective of Restrictions

There are three objectives that would likely be acknowledged in legislation banning DTCA, or advanced by the government should the case go to court. The first objective is that the ban is in the...