Attaran Amir
Am J Trop Med Hyg. 2015 Jun;92(6 Suppl):127-132. doi: 10.4269/ajtmh.15-0154. Epub 2015 Apr 20.
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.
由假药和劣质药品导致的未得到治疗的疾病所引发的医源性大流行令人无法容忍,但这却有其合理的解释:在许多国家,法律不完善,使得生产或销售劣质药品几乎不被视为违法。法律几乎不惩处那些故意或鲁莽地经营假药或劣质药品的人,而显然应该根据他们对公众健康造成的严重甚至致命伤害,将这些违法者定罪。为解决这一疏漏,本文提出了一项新的《药品犯罪示范法》,各国可自由将其用作加强本国法律的模板。该示范法包括对生产、贩运或销售劣质药品的刑事禁令;适当惩处违法者的原则;针对基于互联网的药品犯罪的特别规定;鼓励举报人配合执法的手段;激励发展中国家政府加强其药品监管能力的措施;以及防止法律被滥用的重要例外情况,例如防止起诉合法的医学研究人员或防止在运输途中扣押优质仿制药。本文对该示范法进行了讨论和解释,并根据知识共享许可免费提供给任何想要实施它的政府。