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Regulating vaccine trials is a combination of three interconnected questions: under what rules a vaccine's clinical trial is conducted, how the product needed for the trial — one not yet registered — may be manufactured, and what follows from acting without a permit. The Law of Georgia on Drugs and Pharmaceutical Activities answers these three questions respectively with trial standards, the licensing regime for manufacture, and an administrative fine. This page assembles that framework from the standpoint of the organisers of vaccine trials — sponsors, manufacturers and investigating centres.
The trial framework: standards and volunteers
Under Article 5¹ of the law, preclinical and clinical trials of a pharmacological product in Georgia are conducted in accordance with the standards and guidelines approved by the minister — which means that the documentation and procedures of a vaccine trial must obey precisely this approved framework. The rights of patients and healthy volunteers participating in a trial are protected by Georgian legislation. As for healthy volunteers, the law is strikingly specific: they may undergo a bioequivalence study of a medicinal product, a pharmacokinetic study of a pharmacological product developed in Georgia, and a study permitted on a market subordinate to the control of a foreign or international regulatory state authority for pharmaceutical products, conducted on healthy volunteers.
For biological medicinal products — and a vaccine belongs to exactly this circle — the law adds a further condition: a clinical trial of a pharmacological product intended as a progressive-therapy medicinal product is admissible if the product is manufactured under a standard of good manufacturing practice recognised by the Government of Georgia, at an enterprise holding the authority to manufacture biological medicinal products. At the same time, conducting clinical trials using the specific products and means defined by law is impermissible.
The sponsor's insurance and participant protection
The central mechanism protecting a vaccine trial participant is insurance. Before a clinical 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. Given the specificity of vaccine trials — where the volunteer is a healthy person — the configuration of the insurance deserves particular attention: the policy should also cover the costs that may befall the volunteer in connection with possible complications after the trial.