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.
Who is liable
The article does not directly list a circle of subjects — it describes the act and the penalty, while the responsible person is determined under the general norms of the Code and the circumstances of the case. In practice this field concerns specialised medical activity, so cases are, as a rule, connected with persons involved in that activity; this assessment, however, always depends on the concrete facts.
Procedural questions
The drawing up of the protocol, the time limits for examining the case, the procedure for adopting the decision and the appeal procedure are not regulated directly by this article — they are determined by other provisions of the Code. The procedure for applying confiscation is likewise resolved by the general norms. Where a case exists, it is important to prepare documents on the questions of quality and safety: test records, documentation of storage conditions, relevant certificates.
Practical recommendations
For organisations operating in this field, a documented quality-control system is decisive: a record of every stage — from receipt to use — a definition of the responsible persons and regular checks of compliance with the standards. Such a system provides the means to defend a position when the case is examined and reveals risks at an early stage. Monitoring changes in the regulations is also important — the requirements are refined over time.
To summarise: Article 46¹⁰ punishes the breach of the rules, standards and requirements established for protecting the quality and safety of human organs, tissues and cells, with the exception of reproductive tissues and cells: a first violation — a fine of GEL 10,000 with confiscation of the object, a repeated violation — a fine of GEL 20,000 with confiscation. The concrete content of the rules is determined by the relevant legislation.
The system of quality and safety requirements is built on all three levels — rules, standards and requirements — precisely because even a single doubtful part of human biological material may pose a serious threat to several patients. That is why including confiscation in the penalty alongside the fine is logical: it not only punishes the past breach but also interrupts a future risk.
For organisations operating in this field it is also important to take decisions promptly with regard to doubtful material: if the quality of material raises doubt, continuing its further use creates additional risk both for the patient's health and from the point of view of administrative liability. Stopping, checking and documenting are in this case the only reasonable algorithm.