Falsifikovanje lekova i medicinskih sredstava – opravdanost i karakteristike krivično-pravne reakcije

Snežana Soković
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Abstract

In the activities of suppression of counterfeit medical products, the interests and interventions of various branches of private and public law, intellectual property law, medical law of the public health protection and criminal law, overlap. Considering that actions of suppression of counterfeit medicines are often reduced to protection of commercial interests and court procedure of determining the right to compensation, and less to protection of public health interests and procedure of criminal intervention, the paper discusses the legitimacy of criminal law measures in suppression of counterfeiting of medical products. The aim of the paper is to point to the role and mechanisms of criminal law in the global system of suppression of medical products counterfeiting, bearing in mind that last year the Republic of Serbia signed the CoE Convention on the counterfeiting of medical products and similar crimes involving threats to public health (MediCrime Convention). After analyzing the scope and consequences of counterfeiting of medical products and problems in suppression of this phenomenon, it is concluded that the legitimacy of criminal law intervention justifies the evident "pandemic" expansion of the market of counterfeit medicines and the almost complete lack of incrimination of counterfeiting of medicines in national legislation. The paper presents the system of criminal law measures established by the Convention and analyzes the relationship of substandard, unregistered and generic medicines in relation to the category of counterfeit medicines defined by the Convention.
在打击假冒医疗产品的活动中,私法和公法、知识产权法、医疗法的公共卫生保护和刑法各部门的利益和干预存在重叠。鉴于打击假冒药品的行动往往被简化为保护商业利益和确定赔偿权利的法院程序,而不是保护公共健康利益和刑事干预程序,本文讨论了刑事法律措施在打击假冒医疗产品中的合法性。该文件的目的是指出刑法在打击假冒医疗产品的全球体系中的作用和机制,同时铭记去年塞尔维亚共和国签署了关于假冒医疗产品和涉及威胁公共健康的类似犯罪的《欧洲共同体公约》(《医疗公约》)。在分析了假冒医疗产品的范围和后果以及在打击这一现象方面存在的问题之后,得出的结论是,刑法干预的合法性证明了假冒药品市场明显“大流行”扩张以及国家立法中几乎完全没有将假冒药品定罪的理由。本文介绍了《公约》确立的刑法措施体系,分析了不合格药品、未注册药品和非专利药品与《公约》界定的假药类别的关系。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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