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[关于基于草药和大麻素的产品的“药品”概念解读]

[Interpretation of the concept of 'medicinal product' in relation to herb- and cannabinoid-based products].

作者信息

Zsigmond Ferge

出版信息

Orv Hetil. 2014 Nov 30;155(48):1902-7. doi: 10.1556/OH.2014.30029.

Abstract

On 10th of July 2014 the European Court of Justice made in his decisions in relation to the cases D. (C-358/13) and G. (C-181/14) an interpretation, that the concept of 'medicinal product' according to the law of the European Union does not include the materials, which are - as not covering substances, such as those at issue in the main proceedings, which produce effects that merely modify physiological functions but which are not such as to have any beneficial effects, either immediately or in the long term, on human health, are consumed solely to induce a state of intoxication and are, as such, harmful to human health. The Court made his interpretation after the request for preliminary ruling from the Bundesgerichtshof (the High Court of Justice in Germany). The Court had to decide in two criminal procedures, whether for the retail of mixtures including syntetic canabinoids, such as complements of marihuana, due the fact that they are "unsafe medicinal products", a criminal proceeding can be initiated or not. The Ordinary Courts had two persons (D. and G.) for selling the unsafe medicinal products sentenced to one year and nine months imprisonment, and suspension (D.), and sentenced (G.) to four years and six months imprisonment and fined with a charge of two hundred thousand Euro. The retail of herb mixtures containing, inter alia, synthetic cannabinoids, did not fall under the German law on narcotic drugs at the material time, resulting that the German Authorities could not initiate a criminal procedure.

摘要

2014年7月10日,欧洲法院就D.(C-358/13)和G.(C-181/14)案作出裁决并进行了解释,即根据欧盟法律,“药品”概念不包括某些物质,这些物质——如主程序中所涉物质,仅改变生理功能但对人体健康无直接或长期有益影响,仅为诱导中毒状态而使用且对人体健康有害。该法院是在德国联邦最高法院(德国高等法院)提出初步裁决请求后作出这一解释的。法院必须在两项刑事诉讼中裁定,对于销售含合成大麻素的混合物(如大麻替代品),鉴于其为“不安全药品”,是否可启动刑事诉讼程序。普通法院判定两人(D.和G.)因销售不安全药品分别被判处一年零九个月监禁及缓刑(D.),以及四年零六个月监禁并处以20万欧元罚款(G.)。当时,零售含合成大麻素等的草药混合物不属于德国麻醉药品法范畴,这导致德国当局无法启动刑事诉讼程序。

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