A comparative legal analysis of the regulation of advertising of medicinal products: a malaysian perspective

Abstract

Advertisements of medicinal products can empower consumers with information. Ideally, this information might enable them to make informed decisions, or lead to an early diagnosis or treatment of illnesses, or assist discussions with physicians regarding embarrassing conditions such as erectile dysfunction, weight loss and baldness. However, the content of advertisements is not always true and accurate. On many occasions, consumers have been misled by exaggerated claims or false claims of miracle cures. The increasing deceptive health claims in advertisements has resulted in an environment of confusion and mistrust amongst consumers and patients. Medicinal products and these include prescription drugs and non-prescription drugs as well as products such as food, dietary supplements and cosmetics which are classified as medicinal products (the latter referred to as health-related products in the thesis), are at times promoted through the use of deceptive claims. In some instances, important information regarding the side effects of products and contraindications, where it is inadvisable to use the products, is omitted as this may have a negative impact on the purchase of the products. The consequence is that consumers are harmed by false and misleading advertising. Countries adopt a variety of measures to address the problems posed by deceptive advertising. These include use of different types of rules and regulatory controls. In some instances varied advertising standards are used so as not to unduly restrict information. There are also differing levels of participation from industry in the regulation. This thesis compares and assesses the regulation of the advertising of medicinal products in three jurisdictions, namely Malaysia, Australia and the United States. The study analyses significant reforms to the regulation of two types of advertising: (1) advertising of prescription drugs and (2) advertising of non prescription drugs and health related products. The issues therein analysed include: the classification of products as medicinal products in the respective regulatory regimes; the modes of regulation adopted in the regulation of advertising and the respective systems of regulatory controls, including pre-approvals of advertisements, monitoring of infringement and the respective enforcements. The thesis argues that DTCA (direct-to-consumer advertising) of prescription drugs should not be allowed in Malaysia. It presents analysis that demonstrates why DTCA of prescription drugs may be appropriately regulated through its prohibition. With regard to advertising of non prescription drugs and health-related products, it argues that collaboration between regulatory agencies and industry associations would be beneficial in their regulation. The thesis considers the use of modes of regulation such as co-regulation and enforced self-regulation in the regulation of advertising of medicinal products, and uses economic analyses to gauge their effectiveness. The thesis makes an original contribution to knowledge by exploring this under studied topic through the means of a comparative and economic analysis. It is hoped that the analysis drawn in this thesis will be of use to the regulator in Malaysia when considering an improvement to the regulation of advertising of medicinal products.