9.2.1 Monitoring performance

Drug information is probably disseminated over just as wide an area as drug products are distributed, if not further. Moreover, the existence of the power to control does not necessarily guarantee that information reaching the providers and the consumers conforms with the provisions set forth in the legal documents. Monitoring, like inspection, is therefore essential in order to ensure that promotion and advertising comply with the legislation.

How is advertising monitored in the survey countries? Where active means are used, the responsible agencies check whether samples of advertising materials and promotion activities conform with legislation. The drug regulatory authorities of Estonia, Venezuela and Zimbabwe take this approach. For example, samples of promotional materials are checked by the officers at the SAM in Estonia, and television drug advertisements are viewed by staff of the MCAZ. Where passive methods are used, the discovery of violations relies on voluntary reporting, generally by competing companies and consumers filing complaints to the responsible bodies. This approach is the main method used in Australia, Cyprus and others.

Which monitoring approach is more effective? Generally speaking, an active approach allows more systematic and thorough monitoring of advertisements and promotion activities. In practice, its effectiveness depends on how it is done, and what happens after a violation has been identified. If active monitoring is carried out only sporadically, with minimal in-depth examination of drug advertisements and promotion, it is unlikely to be effective. If there are no sanctions, or only small fines are imposed when a violation is discovered, then the deterrent effect is minimal. For example, a pharmaceutical company that violates the law may have to pay nothing more than a small fine. In that case, it may be more cost-effective from the company’s point of view, given the large amount it has already spent on advertising, to pay the fine for an extended period of time rather than withdraw the advertisement.

9.2.2 Sanctions

In the survey countries, the types of sanction imposed for a violation range from verbal and written warnings, through fines, prohibition and correction of the advertisement and revocation of registration, to imprisonment. The fines charged for violations in Australia are relatively high. Fines for violations in Estonia (US$4 286 to US$7 143) are much higher than those in either Malaysia (US$780 to US$1 300) or Cyprus (US$900).

The empirical data for assessing the regulation of drug information are highly inadequate. Even records of the number of violations and the percentage of each type of sanction imposed are generally unavailable. So, too, is information on the effectiveness of action to prevent inaccurate and misleading drug information from reaching health care providers and the public. The information obtained through the country reports on the monitoring of promotion and advertising and the sanctions taken against violations is shown in Table 9.2.

Table 9.2 Monitoring mechanisms and sanctions for promotion and advertising

N/A = not applicable