Frolova O. Implementation of EU legislation into the criminal legislation of Ukraine to ensure criminal legal protection of pharmaceutical activity

https://doi.org/10.33098/2078-6670.2023.16.28.176-183

The purpose of the article is to determine the specifics of the implementation of EU legislation into the criminal law of Ukraine to ensure the criminal protection of pharmaceutical activity. The methodology includes the author’s emphasis on basic international legal guidelines. Directive No. 2001/83/EC of the European Parliament and the Council of the EU on the Community Code on Medicinal Products for Human Use of November 6, 2001 serves as one of the main guidelines here. In the author’s opinion, this is important based on the fact that the adopted Law of Ukraine “On Medicinal Products” of July 28, 2022 implemented many provisions of the said Directive, including those that are important for the criminal protection of pharmaceutical activity. The article pays special attention to the issue of determining the “limits” of criminal protection of the circulation of medicinal products, which depend on the specific requirements of Directive 2001/83/EC, which define the concept of “medicinal product” and provide for the limited use of medicinal products, as well as mandatory components circulation of medicinal products (as defined in Article 2 of Directive 2001/83/EC), each of which is related to the state registration procedure and obtaining the necessary permission. The results. Attention is focused on other international legal documents, such as EU Council Directive 85/374/EEC “On the approximation of laws, regulations and administrative provisions of the member states regarding liability for low-quality products” dated July 25, 1985, which contains an independent general declaratory prescription that the “special liability system” created by this Directive is an effective legal means of protecting consumers of pharmaceutical products. Scientific novelty. The author notes that the construction of a “national model” of criminal law protection of pharmaceutical activity must in any case take into account the main international legal standards regarding the “subjects” of pharmaceutical activity and their separate varieties, “accompanying” subjects that ensure the “handling” of pharmaceutical activity products (in particular, accessories, documents), integral components of pharmaceutical products (active substances and excipients, parts and materials), types and varieties of pharmaceutical activity, as well as state regulation of pharmaceutical activity. Practical significance. The results of the research can be used in law-making and law-enforcement activities during the investigation of crimes related to the field of pharmaceutical activity.

Key words: implementation, harmonization, criminal legislation, circulation of medicinal products, EU Directive, criminal protection of pharmaceutical activity.

References

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