dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
The trade in illegitimate drugs is, however, a problem of public health consequence and the topic of this report. In order to discuss this problem more precisely, the report distinguishes two main categories of poor-quality drugs. First, there are substandard drugs, those that do not meet the specifications given in the accepted pharmacopeia or in the manufacturer’s dossier. The other main category of illegitimate products is falsified drugs, those that carry a false representation of identity or source or both. Many countries also have problems with unregistered medicines, those not granted market authorization in a country. Unregistered drugs may be of good quality, though some research indicates they often are not. Unregistered medicines usually circulate outside the controlled distribution chain and are therefore suspect.
The drug failures of public health concern can be divided into two main categories: falsified and substandard. Admittedly, the distinction between the two categories is not always clear. Falsified drugs are usually also substandard; national specifications referenced in the definition of a substandard drug can vary.3 However, these terms cover the two main divisions of interest with sufficient precision. International endorsement of these two categories could advance public discourse on the topic.
Recommendation 1-1: The World Health Assembly should adopt definitions consistent with the following principles. Substandard drugs do not meet national specifications.4 Falsified products have a false representation of identity or source or both. Products unregistered with the regulatory authority are also illegal.
The spirit of these definitions and the exclusion of the term counterfeit are central to this recommendation. The exact wording suggested is not.
THE HEALTH EFFECTS OF FALSIFIED
AND SUBSTANDARD DRUGS
Falsified and substandard drugs may contain toxic ingredients; some of the most compelling stories of pharmaceutical crime are of frank poisoning. By far the more common problem, however, is medicine that simply does
3 Some regulatory authorities may accept standards below those in international pharmacopeias. In such cases, a drug that would be generally regarded as substandard might be technically acceptable in a given country.
4 An emphasis on quality system failures is not essential to the idea of a substandard drug and was removed from the recommendation after the report release. The supporting text describes the committee’s understanding of a substandard drug.