The Austrian «Atypical model» of criminal protection of the circulation of medical devices

Abstract

The Austrian model of criminal protection of the circulation of medical devices is considered. The authors note that atypicality of the Austrian “model” of criminal law protection of circulation of medical devices is due to several factors.

It is analyzed that the main ones are those related to: a) the legislative definition of the concept of pharmaceutical products, since the content of this concept “legislatively outlines” the limits of criminal protection and affects the mechanism of ensuring this protection; b) determination of the limits of criminal protection of medical devices depending on the requirements of the Austrian Federal Law on Medical Devices.

The authors note that the atypicality of the Austrian “model” of criminal protection of medical devices is influenced primarily by the absence of a legislative definition of the concept of “medical devices”, as well as the “negative sign” of the corresponding types of administrative offenses, indicated in the sanction of part 1 § 80 of the Austrian Federal Law on Medical Devices (2021).

The authors also focus their attention on the fact that the atypicality of the Austrian “model” of criminal protection of medical devices is also due to the fact that the aforementioned Federal Law on Medical Devices in its § 80 contains provisions on “administrative punishment (Verwaltungsstrafe)” for violations of the established procedure for the circulation of medical devices, which affect the provision criminal law protection of medical devices and its limits.

It is proven that the specified “negative sign” directly affects the definition of offenses of those specific types, which are provided for in the Austrian Code of Criminal Procedure and encroach on the circulation of medical devices. The peculiarities of such limits under Austrian criminal law should be connected primarily with the fact that the specified “negative feature” is fixed in the sanction of part 1 § 80 of the Austrian Federal Law on Medical Devices (2021), “does not eliminate” the formation of relevant signs of acts and illegality as mandatory structural elements of criminal offenses of certain types.