Department of Psychiatry, Amsterdam UMC, Location Academic Medical Center, Amsterdam Neuroscience, Research Program Compulsivity, Impulsivity & Attention, Amsterdam, The Netherlands.
School of Law, College of Social Sciences, University of Glasgow, Glasgow, UK.
Eur Addict Res. 2023;29(5):363-372. doi: 10.1159/000531503. Epub 2023 Aug 9.
Generic drug legislation, i.e., simultaneously banning groups of drugs, has been introduced worldwide to counteract the trade and use of emerging "new psychoactive substances" (NPSs) more effectively.
The potential and de facto positive and negative effects of generic drug legislation have been described using an analysis based on documented evaluations of the experiences in the UK and Germany, supplemented with data from other publicly available sources. In particular, the effects of generic drug legislation on availability, use, sales, and overall health harms of NPS, and switches from NPS to traditional (classical) drugs are addressed. The results show that the introduction of generic drug legislation in the UK and Germany has enabled stricter regulation of NPS but has also led to some major harms within the domain of public health. Depending on the population considered, the rate of NPS use remained stable, slightly declined, or increased following the banning of NPS. Once banned, NPSs were more often purchased on the black market, often together with other (more harmful) drugs. Moreover, NPS-related harms did not reduce following the ban, and in some cases even increased. Finally, when harmful NPS, like potent synthetic opioids and cannabinoids, become substantially used and endanger public health, legislators already have the legal means to ban the problem drug, thus overruling the need for a generic ban.
Generic drug legislation may facilitate drug law enforcement, but it is not (very) effective in counteracting NPS use and it may increase NPS-related public health problems. It is concluded that, overall, the advantages of generic drug legislation are overshadowed by its serious disadvantages.
全球范围内已出台仿制药立法，即同时禁止多组药品，以更有效地打击新兴“新型精神活性物质”（NPS）的贸易和使用。
本文基于英国和德国经验的评估文献，并结合其他公开来源的数据，分析了仿制药立法的潜在及实际的积极和消极影响。特别是，本文探讨了仿制药立法对 NPS 的可获得性、使用、销售以及总体健康危害的影响，以及从 NPS 向传统（经典）药物的转变。结果表明，英国和德国引入仿制药立法后，虽然加强了对 NPS 的监管，但也在公共卫生领域造成了一些重大危害。根据所考虑的人群，在 NPS 被禁后，NPS 的使用率保持稳定、略有下降或上升。NPS 被禁后，人们更倾向于在黑市购买 NPS，通常还会购买其他（更有害）药物。此外，NPS 相关危害并没有在禁令后减少，在某些情况下甚至增加。最后，当有害 NPS，如强效合成阿片类药物和大麻素，被大量使用并危害公共健康时，立法者已经拥有禁止该问题药物的法律手段，从而无需进行仿制药禁令。
仿制药立法可能有助于加强禁毒执法，但在打击 NPS 使用方面效果并不显著，反而可能增加 NPS 相关的公共卫生问题。总体而言，仿制药立法的优势被其严重的缺点所掩盖。
