What Article 46⁹ regulates
Article 46⁹ of the Code of Georgia on Administrative Offences establishes administrative liability for breaching the rules on the characterisation of a human organ, the characterisation of a human organ donor, donor selection and the assessment of compatibility, to the extent those rules are laid down in accordance with the Law of Georgia on the Transplantation of Human Organs and/or the Law of Georgia on the Use of Human Tissues and Cells. The provision serves the medical safety of the transplantation process: the correct characterisation of the organ and the donor and a correct assessment of compatibility form the foundation on which the outcome for the patient directly depends.
On this page we explain which rules are protected by the article, what fines are fixed by its first and second parts, who is regarded as the liable person, and what the article deliberately leaves to other provisions of the Code and to the special laws. Every explanation below is anchored in the text of the article itself, and no figure on this page goes beyond the content of the article.
Which rules are protected
The first part of the article treats as an administrative offence the breach by the appropriate person of the following rules:
- the rules on the characterisation of a human organ;
- the rules on the characterisation of a human organ donor;
- the rules on the selection of a human organ donor;
- the rules on the assessment of compatibility.
It is important to understand the division of tasks between the Code and the special laws. The detailed content of these rules is not set out in the Code at all: it is determined by the Law of Georgia on the Transplantation of Human Organs and the Law of Georgia on the Use of Human Tissues and Cells. The role of the Code is to attach liability: where a rule established by those laws is breached, the offender faces the fine fixed by Article 46⁹.
The assessment of a concrete case therefore always proceeds on two levels: first it must be established which rule and which detail was breached, and only then — under which part of the article and with which sanction the breach is punished. This two-step analysis is also the basis for a successful appeal against a fine or for having a case closed at an early stage.
In practical terms, the protected rules cover consecutive stages of the medical path: the characterisation of the organ, the characterisation of the donor, the selection of the donor and the assessment of compatibility. A defect at any of these stages is assessed through the same article, which is why institutions benefit from mapping their internal procedures onto these four groups of rules and checking each of them separately. Such a mapping takes little time, but it exposes weak points before they become the subject of proceedings.
Who is the liable person
The article attaches the fine to a breach committed by the appropriate person. This wording means that the subject of liability is the person on whom the relevant obligation is imposed by the rules that were breached. Identifying that person in a concrete case requires an analysis of the special legislation and depends on the facts of the case, which is why this question should be resolved through a legal assessment rather than by assumption.
Fine amounts
The article contains two sanctions, each fixed by a separate part:
- breach of the rules covered by the first part — a fine of 5,000 GEL;
- the same act committed repeatedly — a fine of 10,000 GEL.
When the case is examined, it must be established whether the act was committed for the first time or repeatedly, and the corresponding amount follows from that conclusion. The criteria of repeat commission are determined by other provisions of the Code and require separate analysis in every case.
What the article does not regulate
Article 46⁹ contains no rules on who draws up the administrative offence report, which body examines the case, and how and within what time limits a fine may be appealed — these matters are governed by other provisions of the Code. Nor does the article describe the substantive content of the protected rules; that content is defined by the special laws. If a fine has already been imposed, the practical first steps are to study the case materials, verify the qualification of the act under the correct part of the article and prepare a reasoned position for appeal.
History of the provision and how Legal.ge can help
The text of the article refers to the Law of Georgia No. 3622 of 1 November 2023 and the Law of Georgia No. 130 of 13 December 2024, so participants of this field are advised to monitor the current wording of the norm. The Legal.ge team assists medical institutions and professionals in matters connected with Article 46⁹: we assess the qualification of an alleged breach, explain the interplay between administrative liability and the special laws on the transplantation of organs and the use of tissues and cells, and prepare positions for the examination of a case and for appeal. Early legal assessment costs far less than the fine.