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.