Direct-to-consumer advertising for prescription drugs in Canada: beyond good or evil.

• Author: Regis, Catherine

Canadians have always had a hard time reconciling health and mercantilism. The publicly-funded system is, in part, responsible for nourishing this collective position, as Canadians rarely have to pay physicians and hospitals directly for the health care and services they receive. Direct-to-Consumer-Advertising (DTCA) is a particularly controversial issue for Canadians, as it not only involves commercial interests in health, but also allows for the appealing possibility of greater involvement for patients in decisions related to their health. (1)

DTCA for prescription drugs is, in principle, forbidden in Canada. Pharmaceutical companies are limited to aiming their advertisement solely to health professionals. However, discussion surrounding the DTCA issue remains relevant, as the federal government has indicated its interest in revising the Food and Drug Act. Key changes with respect to the advertising of health care products are being seriously considered, notably regarding the introduction of DTCA for prescription drugs. (2)

Even though the legislation restricts most DTCA, the truth is that Canadians, whether they want to be or not, are aware of it. The current loopholes in Canadian legislation and policies, combined with the fact that advertising from the United States reaches Canada via magazines, television and the Internet, make DTCA an already-existing reality for Canadians (3). Therefore, in this article I propose stepping away from the traditional binary debate about whether DTCA is good or not in order to focus on some practical issues and solutions. I will first discuss the legislation and policies surrounding DTCA in Canada. Secondly, I will underline the lack of involvement by certain key actors in the debate. Finally, I will propose some potential solutions (should DTCA be further implemented in Canada) that would notably provide for greater involvement of these actors.

The Status of DTCA Under Canadian Law

The responsibility for interpreting and enforcing drug-advertising regulations lies with Health Canada. It seems that Canada, through current Canadian law on the subject, has put its foot in the door with respect to DTCA, but now doesn't know if it should step in or slam the door shut again. While DTCA is allowed for non-prescription drugs, it is, in principle, restricted for prescription drugs. (4) The Canadian Food and Drugs Act mentions that, "No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventive or cure for any of the diseases, disorders or abnormal physical states [...]". (5) The Act defines advertisement as including any representation by any means whatsoever for the purpose of directly or indirectly promoting the sale or disposal of any food, drug, cosmetic or device. (6)

Whereas the applicable regulation seems quite broad on the definition of advertisement, a policy statement made by Health Canada in 1996 indicated a distinction between advertising and "information dissemination". (7) This statement had the impact of allowing "help-seeking" advertisement, which describes the condition the drug treats, but not the name, price, or quantity. (8) As well, "reminder" advertisement, which provides the name, price, or quantity of the drug without stating its use, is permitted in Canada. (9) The type of advertisement that is presently not allowed in Canada is that which links both categories of information; that is, the products' names and their specific therapeutic claims. This last type is called "product claim" and is permitted in the United States.

However, the current capacity of Health Canada to effectively restrict "real advertising" remains uncertain. Various actors have expressed serious doubts about the ability of Health Canada to deal with the "offenders". (10) As an illustration, it took Health Canada six months to inform Wyeth-Ayerst Canada of its contravention of the Food and Drug Regulations. Wyeth-Ayerst astutely aired branded television advertisements (ads) for a birth control pill and, a few weeks later, aired unbranded ads with the same actors. Although this tactic could appear prima facie to be in accord with Health Canada's policy statement, a notice of violation was sent to the drug company. (11) In another case involving Glaxo Wellcome (now GlaxoSmith-Kline), it took seven weeks after its first ad was aired for Health Canada to intervene. (12) One explanation to the lack of efficiency might be that, since "official" advertisement is not permitted, Health Canada remains relatively ineffectively equipped to deal with DTCA issues. This is particularly obvious when considered in light of the means available to the U.S. Food and Drug Administration (FDA). (13)

Is the Pharmaceutical Industry the Only Party Involved?

The pros and cons of DTCA have been extensively discussed by various actors. Most notably, opponents to DTCA argue that it can mislead patients, stimulate inappropriate and unnecessary prescriptions of drugs, and promote new drugs for which certain adverse effects remain unknown. On the other hand, its proponents claim that DTCA can educate and empower patients, improve compliance with treatment, and encourage earlier diagnosis of medical conditions. Beyond this binary debate, for which convincing arguments and supporting data can be found on both sides, one astonishing fact...