About this service
Clinical trials law is the body of norms that determines how the state protects the person participating in a trial — and who answers when that protection fails. The Law of Georgia on Drugs and Pharmaceutical Activities builds this field on three pillars: the guarantees of the rights of participating patients and healthy volunteers together with the sponsor's insurance obligation, the system for monitoring the side effects of medicines, and the sanctions for unlawful pharmaceutical activity. This page reads those norms from the standpoint of participant protection and liability, and emphasises where an injured party looks for legal redress.
Participant rights and the sponsor's insurance
Under Article 5¹ of the law, the rights of patients and healthy volunteers participating in a clinical trial are protected by Georgian legislation. The formulation is brief, but its content is defined by the context of the entire body of legislation, and the framework of the trial itself is set by the law: trials are conducted in accordance with the standards and guidelines for preclinical and clinical trials approved by the minister, and only certain types of trials may be conducted on healthy volunteers — bioequivalence studies, pharmacokinetic studies, and studies permitted on a market under the control of another regulator.
The most concrete instrument of participant protection is insurance. Before a trial begins, the sponsor — the person, company, institution or organisation responsible for initiating, managing or funding the trial — must arrange insurance of the trial's risk and liability for the period of the trial's conduct. The insurance must provide for reimbursement or compensation of a participating person's treatment costs, to the extent they were needed for participation in the trial. This means that in the event of harm the participant has a concrete insurance source that the sponsor was obliged to create even before the trial started.
Side-effect monitoring: who must supply the information
Article 26 of the law constructs a unified system for monitoring the side effects of medicines. The system involves the attending physicians of the curative-prophylactic network, the specialists of the medical services of treatment institutions and the structures of the ministry. Overall coordination of the system and analysis of the information received are carried out by the agency, which collects, analyses and generalises information about undesirable effects of medicines, exchanges it with the medical services of other countries and the World Health Organization, organises the expert examination of the data obtained and prepares recommendations on the release of a medicine, its withdrawal from circulation and the cancellation of a registration certificate.
What is decisive is that subjects involved in the circulation and use of medicinal products are obliged to supply the agency with information about every case of a side effect, and about peculiarities of a product's interaction not indicated in its instructions for use. In the context of a clinical trial this means that the medical side of the trial — physicians and institutions — is embedded in the chain of collecting and transmitting information about undesirable effects. The procedure and sequence for forming the information flow are developed and approved by the ministry.
Sanctions and liability
Article 37² of the law establishes an administrative sanction: conducting a clinical trial without a permit triggers a fine of GEL 4 000, and the same act committed repeatedly — a fine of GEL 8 000. The same article also punishes the manufacture, export or import of a pharmaceutical product subject to special control and activity without an authorised pharmacy. The sanction carries a preventive function — it does not replace civil liability towards the participant and does not release the sponsor from the obligation of reimbursement provided by the insurance.
Conducting the dispute: where a party seeks protection
The law does not prescribe a special procedural regime for trial-related disputes — they are conducted under the general procedure established by other norms of Georgian legislation. The material foundations, however, lie precisely in these articles: the participant relies on the guarantee of protection of his or her rights and on the insurance arranged by the sponsor, which must cover reimbursement or compensation of treatment costs. Conversely, the obligation to supply information about side effects, likewise protected by the same legislation, may prove to carry evidentiary weight in a dispute. The application of the sanction itself proceeds by the administrative route.
Frequently asked questions
Who insures a trial participant?
The sponsor. Under Article 5¹ of the law, before the trial begins it arranges insurance of the trial's risk and liability for the duration of the trial, providing for reimbursement or compensation of a participant's treatment costs.
Who is involved in side-effect monitoring?
Under Article 26, the unified system involves attending physicians, specialists of the medical services of treatment institutions and the ministry's structures; coordination is carried out by the agency.
What fine is provided for conducting a trial without a permit?
Under Article 37² — GEL 4 000, and on repeated commission — GEL 8 000. The sanction is uniform for other forms of pharmaceutical activity carried out without a permit as well.
Is there a special procedural regime for trial disputes?
No — the law sets no special regime; the dispute proceeds under the general procedure established by other norms of legislation, while the material foundations arise from the guarantees of these articles.
How We Help on Legal.ge
We analyse the legal position of a clinical trial participant: we determine what guarantees flow from Article 5¹ of the law and how the sponsor's insurance should operate; we assess the obligations of the parties embedded in the side-effect monitoring system and their significance for the evidentiary base of a dispute; and we prepare claims for reimbursement from the insurance. Contact us as a participant, a sponsor or a medical institution — and receive a concrete legal plan.