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Advertising of Nonprescription Medicines

In contrast to labeling, advertising, as a lower involvement, less targeted communication medium, is ill-suited to carry detailed information. Recognizing these limitations, it must be focused on what it can do: attract the viewer, listener, or reader’s attention and communicate the availability of a product. Rather than relying on advertising, labeling is the place to effectively convey fuller information to consumers.

With this background in mind, WSMI believes that government policies which regulate advertising should, first of all, rest on two basic standards:

  1. Claims must be truthful: Another way of saying this is that objective claims made by advertisements should be supported by adequate substantiation.
  2. Advertising should not be misleading: This may seem the same as saying an advertisement must be truthful, but in fact the focus is different. The US Federal Trade Commission approaches this aspect from the deception perspective: material representations, omissions, or practices likely to mislead consumers acting reasonably under the circumstances. Japanese authorities approach the concept through a prohibition on implicit exaggerated statements regarding indications or effects of drugs.

There are a variety of mechanisms – both governmental and self-regulatory – governments can use to ensure that nonprescription drug advertisements are truthful and nonmisleading. Where they can be applied effectively, WSMI strongly favors self-regulatory or co-regulatory methods and government post-publication enforcement (i.e., taking action against violations rather than government pre-clearing or pre-vetting advertisements). Where adequate mechanisms to enforce such systems are not present, WSMI encourages their adoption and is available to advise on their creation.

The United Kingdom, the Netherlands, Australia, and Canada are examples of self-regulatory or co-regulatory systems (i.e, a system where an industry or self-regulatory body acts on behalf of the government in preclearing, enforcing or controlling advertising standards). Japan, Germany, and the US are examples of post-publication control, including both governmental and self-regulatory components. In the latter three countries, their governments and other parties have ample enforcement tools against violative advertisements.

In contrast to self-regulatory approaches – either including preclearance or based on post-publication measures – and post-publication measures by government, preclearance by government can be more costly and more prone to delays. Experiences in Australia and Canada with increased reliance on co-regulatory mechanisms serve as an example of a shift away from government preclearance.

Regardless of the system or systems chosen, WSMI requires its member associations to either introduce their own Codes of Advertising Practice or, where such codes already exist, to periodically re-examine them when necessary. WSMI has prepared Guidelines for the Production of Voluntary Codes of Advertising Practice to aid member associations in this area. WSMI does not believe, however, that a single code applicable to all parts of the world would be appropriate, given the wide variety of advertising control systems in place, and the need to ensure that national codes reflect cultural diversity in relation to healthcare generally and the use of medicines specifically.

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