In the last year, several institutions—the

Medicine—have turned their attention, with varying degrees of effectiveness, to the problem of dangerously poor quality medicines [1]. While substandard medi-cines are found everywhere in the world, it is the poorest countries with the weakest capacity for drug regulation and quality control that suffer the most. Everyone agrees that poor quality medicines are undesirable, but not every-one agrees on how to define them. It is clear that iatrogenic harm arises from at least two distinct, concurrent problems: (i) medicines that are accidentally or negli-gently ‘‘substandard’ ’ as a result of various failures in manufacturing, handling, regu-lation, or some combination of these, and (ii) medicines that are deliberately ‘‘falsi-fied,’’—neither being of the correct stan-dard nor being properly registered through a country’s regulatory authori-ty—and that call out for criminal law measures to suppress. In all cases, the result is a potentially dangerous medicine, whether occasioned by criminal activity, accident, or negligence [2]. A sound drug regulatory system is essential to overcome these problems. Yet while WHO estimates that nearly a third of its member states have very limited or no capacity for medicine regulation [3], it has yet to propose a concrete action plan to help ensure th