Muckenfuß Heide
Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Paul-Ehrlich-Straße 51-59, 63225, Langen, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2017 Nov;60(11):1208-1213. doi: 10.1007/s00103-017-2620-z.
The number of falsified medicines on the German market has distinctly increased over the past few years. In particular, stolen pharmaceutical products, a form of falsified medicines, have increasingly been introduced into the legal supply chain via parallel trading. The reasons why parallel trading serves as a gateway for falsified medicines are most likely the complex supply chains and routes of transport. It is hardly possible for national authorities to trace the history of a medicinal product that was bought and sold by several intermediaries in different EU member states. In addition, the heterogeneous outward appearance of imported and relabelled pharmaceutical products facilitates the introduction of illegal products onto the market. Official batch release at the Paul-Ehrlich-Institut offers the possibility of checking some aspects that might provide an indication of a falsified medicine. In some circumstances, this may allow the identification of falsified medicines before they come onto the German market. However, this control is only possible for biomedicinal products that have not received a waiver regarding official batch release. For improved control of parallel trade, better networking among the EU member states would be beneficial. European-wide regulations, e. g., for disclosure of the complete supply chain, would help to minimise the risks of parallel trading and hinder the marketing of falsified medicines.
在过去几年中,德国市场上假药的数量显著增加。特别是被盗药品这种假药形式,越来越多地通过平行贸易进入合法供应链。平行贸易成为假药进入渠道的原因很可能是供应链和运输路线复杂。国家当局几乎不可能追踪在不同欧盟成员国由多个中间商买卖的药品的历史。此外,进口和重新贴标签药品外观各异,便于非法产品进入市场。保罗·埃利希研究所的官方批签发提供了检查一些可能表明药品造假的方面的可能性。在某些情况下,这可能使假药在进入德国市场之前就被识别出来。然而,这种控制仅适用于未获得官方批签发豁免的生物药品。为了加强对平行贸易的监管,欧盟成员国之间更好地联网将是有益的。全欧洲范围的法规,例如关于披露完整供应链的法规,将有助于降低平行贸易风险,阻碍假药的销售。