Jun 3, 2015
The American Journal of Tropical Medicine and Hygiene
The iatrogenic pandemic of untreated illness related to falsified and substandard medicines is intolerable, but has a logical explanation: in many countries, inadequate laws make it barely illegal to manufacture or distribute poor-quality medicines. The law hardly punishes those who intentionally or recklessly deal in falsified or substandard medicine, when clearly it should criminalize these perpetrators in proportion to the grievous—even fatal—injury they inflict on public health. To solve this omission, this article presents a new Model Law on Medicine Crime, which countries may freely use as a template for strengthening their national laws. The Model Law includes criminal prohibitions against manufacturing, trafficking, or selling poor-quality medicines; principles for appropriately punishing offenders; special provisions for Internet-based medicine crimes; tools for encouraging whistle-blowers to cooperate with law enforcement; incentives for developing governments to strengthen their drug regulatory capacity; and important exceptions to prevent the law being abused, such as to prevent the prosecution of legitimate medical researchers or to prevent good-quality generic medicines being seized while in transit. The Model Law is discussed and explained and is offered free of charge under a Creative Commons license to any governments wanting to implement it.