Streit Renz
Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, 63225, Langen, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2017 Nov;60(11):1203-1207. doi: 10.1007/s00103-017-2622-x.
Falsified medicines are a raising problem for the German drug market. The complex distribution channels across the European market facilitates the introduction of falsified and stolen medicines into the legal supply chain and may pose a risk for patients. The "Herceptin® case" from 2014 of falsified medicines of Italian origin demonstrates how complex distribution systems have been misused by criminal organizations in order to introduce stolen and thus falsified medicines via the parallel trade into the market, and which measures the authorities and the parallel-traders in the national and European network have taken to ensure patient safety. Falsified medicines will continue to be a problem in the future, so new monitoring systems have to be established and effectively used for prevention. The introduction of the EU-wide serialisation system in February 2019 is therefore intended to identify falsified drugs and to prevent the further trade as well as the expenditure to the patient. Furthermore, the maintenance and intensification of the cooperation between all EU authorities involved remains indispensable to close gateways in the distribution system for falsified medicines and to minimise the risk to the population.
假药问题在德国药品市场日益凸显。欧洲市场复杂的分销渠道使得假药和被盗药品得以流入合法供应链，这可能给患者带来风险。2014年源自意大利的“赫赛汀®案”假药表明，犯罪组织是如何利用复杂的分销系统，通过平行贸易将被盗进而伪造的药品引入市场的，以及国家和欧洲网络中的当局及平行贸易商采取了哪些措施来确保患者安全。假药在未来仍将是个问题，因此必须建立并有效利用新的监测系统进行预防。2019年2月在欧盟范围内引入的序列化系统旨在识别假药，防止其进一步流通以及患者遭受损失。此外，所有相关欧盟当局之间保持并加强合作对于封堵假药分销系统中的漏洞以及将对民众的风险降至最低而言仍不可或缺。
