Raising the ante in anti-counterfeit drug legislation.

The definition of a counterfeit drug would at firsthand seem relatively simple: “a medicinal product that is produced and sold to deceptively represent its origin, authenticity or effectiveness”.1 However, when we actually consider the differences in terminology used among international providers of health care, it would seem that a legal definition of counterfeit as described in a legal text such as Black’s Law Dictionary remains inadequate. The escalation of “Pharma Fraud” has reached globally staggering levels, and is presently estimated to be about US$200 billion per year. It is therefore important that a universal definition of drug counterfeiting be developed; only then can we even start to police counterfeit drugs.2 Consequently, the World Health Organization has attempted to redefine a counterfeit drug and now specifically includes the concepts of correct and incorrect ingredients, insufficient or no active ingredients, and also fake packaging and mislabelling. It may be applied to both branded and generic products, and it is with this definition that most leading health care providers have reached a consensus.3