The World Health Organization (WHO) suggests a broader and internationally accepted definition of “counterfeit medicine”:
“A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. This applies to the product, its packaging or any other information on the packaging or labeling. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.”
Counterfeit drugs must thus be differentiated from:
- Defective drugs: produced legally but with manufacturing defects.
- Sub-standard drugs: while genuine and produced by authorized manufacturers, they do not fulfill the associated specifications and quality standards required by the registration specifications.
Generic drugs are authorized copies of brand name drugs whose patent has reverted to the public domain. Generics have the same qualitative and quantitative composition in terms of the active principle, the same pharmaceutical form and the same bioavailability as their brand name counterparts. They are regulated, monitored, and require authorization before entering the market. They therefore represent no difficulties in terms of public health. However, they too can be counterfeited!
These semantic difficulties have caused and still cause complications in terms of information about and the identification of falsified medicines, as well as posing legal problems. This confusion is exploited by counterfeiters who benefit from legislative loopholes to develop their traffic, risking little more than derisory sentences and inadequate law enforcement processes.
In order to put an end to these problems, the WHO now uses the term “falsified drugs” in all its releases and reports as well as terms such as “spuriously / falsely-labeled / falsified / counterfeit(SFFC) medicines. The ambiguous term “counterfeit” must no longer be used.