In the public interest? Changes to the rules for advertising non-prescription drugs in Canada.

[ILLUSTRATION OMITTED]

Canadians are exposed to a barrage of drug advertising everyday on television and in the print media. Recent changes to federal legislation have expanded the claims allowed to be made in advertising by manufacturers of natural health products and over-the-counter drugs. Legal and ethical issues are raised by this relaxation of permitted advertising.

The new federal regulations allow manufacturers of natural health products and many over-the-counter drugs to advertise that their products will prevent disease in relation to a list of serious diseases contained in the Food and Drugs Act. In order to understand the impact of this change, it is necessary to understand the regulatory regime with respect to drug advertising in Canada.

In brief, Canada restricts advertising with respect to food, drugs, cosmetics, and medical devices under s. 3 of the Food and Drugs Act for a list of conditions found in Schedule A. Until the present changes, manufacturers were not allowed to claim that their products could prevent, treat, or cure any disease on the list. For diseases or disorders not on the list, manufacturers of non-prescription drugs or natural health products have always been able to advertise their products as preventatives, treatments or cures, providing they comply with other safeguards.

Schedule A includes, for example, diseases which pose a serious health risk or limit a person's ability to make health care decisions. Other illnesses are included because they pose a public health risk or because they are recently recognized disorders where it is unclear whether self-treatment is appropriate. In all cases, diseases in Schedule A require treatment by a health care professional. The list of disorders in Schedule A includes, most notably: cancer, heart disease, sexually transmitted diseases, obesity, hypertension, acute infectious respiratory disorders, acute psychotic conditions, and diabetes. Historically, the rationale behind the advertising restrictions has been to prevent fraud and protect consumers.

The new regulations partially lift this ban by allowing preventative claims for natural health products and many over-the-counter drugs. Health Canada has justified the change in terms of the current health care environment in which consumers increasingly wish to take control of their own health and actively participate in health care decisions. As well, Canadians are demonstrating a greater interest in alternative health care. Thus, the theory is that allowing the advertising of preventative claims will increase the amount of self-help information available to Canadians.

Health Canada maintains that other safeguards currently in place will ensure that Canadians are not presented with misleading or false preventative advertising claims. To advertise a preventative claim, manufacturers will required submit scientific evidence and have the wording used in labelling and advertising approved by Health Canada. With respect to natural health products, when advertising preventative claims, manufacturers will be required to supply evidence beyond traditional use with supporting human clinical evidence of efficacy and safety. Further, any preventative advertising claims will continue to be subject to ss. 5, 9 and 20 of the Food and Drugs Act which prohibit false, deceptive or misleading labelling and advertising.

Allowing advertising of preventative claims for Schedule A diseases represents a major policy shift away from the historical emphasis on protecting vulnerable consumers in advertising directed at serious diseases. The prohibition on advertising preventative claims, which included claims of risk reduction, has been in place since 1953.

Undoubtedly, the expansion of allowable advertising for natural health products and over-the-counter drugs will be good for business. Bayer Canada has publicly applauded the regulatory change. In the U.S., heavily advertised prescription drugs result in significantly increased sales. Studies in the U.S. have shown that patient demand for advertised drugs has resulted in increased prescriptions by physicians.

Allowing advertising of preventative claims raises a number of issues, such as concerns that the advertising will not be educational, may not be effectively monitored by Health Canada, and may lead to delays in treatment for serious illnesses.

There is a danger that the preventative claim advertising will not educate the public and, even worse, may be false and misleading. Drug advertising can lead consumers to believe that the drugs are safe. A California survey found that 43% of respondents believed that only drugs that were completely safe were allowed to be advertised. This belief is at odds with the fact that in the U.S. about half of prescription drugs are found to have serious health risks after being marketed to the public.

A study in the U.S. of magazine advertising for prescription drugs found that, overall, the educational value of the advertising was minimal. The majority of the ads made no mention of risk factors, other possible treatments, or other helpful activities, such as diet or exercise. In Canada, a recent study of articles in Canadian newspapers and magazines discussing alternative treatments for cancer found similar results. The majority of the articles did not contain information on the benefits or risks of the alternative treatments and few articles recommended that a patient talk with a health care professional before using the therapy. The authors concluded that the purpose of the articles appeared to be entertainment rather than the provision of accurate information.

Advertising of preventative claims may mislead consumers into believing that the product will not only prevent serious disease, but may also treat or cure such a disease. This may result in delays in seeking treatment. Allowing natural health products to be advertised as preventatives for serious diseases such as cancer may also lead consumers to believe that the products are conventional medical treatments or leave the impression that the manufacturers are mainstream health professionals.

Furthermore, monitoring of advertising by Health Canada may not be adequate. Health Canada has stated that there will be additional staff to ensure compliance with advertising standards. However, evidence suggests that rigorous enforcement has not taken place in the past. As of 2004, no penalties have been imposed on any pharmaceutical company for illegal advertising since 1978.

Health Canada has been under pressure from industry and the public to expand the categories of allowable advertising of drugs for some time, and to relax the restrictions on advertising of prescription drugs. In 2005, the Health Quality Council of Canada examined this idea and concluded that lifting the restrictions would not be in the public interest. This was mainly due to the U.S. experience with direct-to-consumer advertising of prescription drugs, which has been criticized as resulting in the overuse of prescription drugs and increased spending on expensive drugs. In addition, the Food and Drug Administration has been criticized for failing to enforce the regulations governing such advertisements.

It is suggested here that the recent changes allowing advertising of preventative claims for natural health products and many over-the-counter drugs are also not in the public interest. The educational value of such advertising is likely to be minimal and may also be misleading. Is this expansion the first step in a further relaxation of advertising restrictions, which may ultimately extend to prescription drugs, to allow the advertising of claims to treat or cure serious diseases? Indeed, Bill C-51: An Act to amend the Food and Drugs Act introduced in the spring of 2008 would have removed s. 3 of the Food and Drugs Act which contains the advertising restrictions for Schedule A diseases. This Bill died on the Order Paper when the general election was called on September 7, 2008. It is interesting to note that in the U.S., undoubtedly as a result of the withdrawal of the arthritis drug Vioxx from world markets in 2005, there have been recent calls for limits on drug advertising, particularly for new drugs. In the interest of protecting consumers, the remaining restrictions on advertising for non-prescription drugs and natural health products should remain in place.

Elizabeth Robertson is Project Manager/Research Associate, Health Law Institute, Faculty of Law, University of Alberta, Edmonton, Alberta.