Article 46¹⁰ and its purpose
Article 46¹⁰ of the Code of Administrative Offences of Georgia establishes administrative liability for breaching the appropriate rules, standards and requirements established by Georgian legislation for protecting the quality and safety of human organs, tissues and cells. The norm serves the protection of patients: human organs, tissues and cells used for medical purposes must meet strict quality and safety standards, because the health and life of the recipient depend directly on the quality of this material.
The scope of the article is defined as follows: it concerns human organs, tissues and cells, with the exception of reproductive tissues and cells — material of the reproductive direction therefore remains outside the frame of this norm. The object of the offence is compliance with the appropriate rules, standards and requirements established for the protection of quality and safety.
What counts as a violation
Under the first part of the article, the administrative offence is a breach of the appropriate rules, standards and requirements established by the legislation of Georgia for protecting the quality and safety of human organs, tissues and cells, with the exception of reproductive tissues and cells. The case thus concerns a broad complex of rules, standards and requirements — from the conditions of storage and transportation to the requirements of quality checking — whose concrete content is determined by the relevant legislation. For a patient this means that breaking any link of the safety chain entails administrative liability.
The fine for a first violation: GEL 10,000 with confiscation
The first part provides that this offence entails a fine of GEL 10,000 with the confiscation of the object of the relevant offence. The confiscation is an important detail: the penalty is not exhausted by the fine but also includes the taking away of the object — the material connected with the violation. Through this the legislator immediately stops the circulation of material whose quality and safety are in doubt.
A repeat violation: GEL 20,000 with confiscation
The second part establishes a separate, stricter composition: the act provided for by the first part of this article, committed repeatedly, entails a fine of GEL 20,000, likewise with the confiscation of the object of the relevant offence. The tiers are clearly distinct: a first violation — GEL 10,000, a repeated one — GEL 20,000, and confiscation is provided for in both cases. The method of counting repetition and the time limits for imposing the penalty are determined by other provisions of the Code.