The Legal Discipline of a Phase II/III Protocol
Phase II and III clinical trials are conducted on broad populations of patients, and it is at this stage that the principal data on a product's efficacy and safety are accumulated. Article 5¹ of the Law of Georgia on Drugs and Pharmaceutical Activities gives this process a clear frame: preclinical and clinical research into pharmacological agents in Georgia is conducted in accordance with the standards and guidelines approved by the relevant Minister. The protocol is the direct expression of these standards — every detail of it is calculated for compliance.
For research conducted on patients the guarantee of participant protection is especially important: the rights of patients and healthy volunteers participating in clinical research are protected by the legislation of Georgia. Before the trial begins, the sponsor — the person, company, institution or organisation responsible for the initiation, management or funding of the research — secures insurance of the trial's risk for the duration of its conduct, reimbursing or compensating the participants' treatment costs.
Protocol Compliance and the Permit Regime
A phase II/III protocol must satisfy the Minister's standards in the design of the research, the collection of data and safety monitoring. The start of the trial is subject to a permit, and conducting it without one is punishable under Article 37² of the law. This means that disregarding even a single detail of the protocol that contradicts a requirement of the standards undermines the entire result of the research.
In practical terms the preparation of a phase II/III protocol proceeds along three lines: first, the scientific design, which contemplates participant groups that are statistically sufficient and ethically justified; second, the completeness of the documentation, so that each stage remains reconstructable; and third, the safety monitoring mechanism, which records in a timely manner every new effect identified among the patients. The harmonious combination of these three components is exactly what the Minister's standards demand.
The Unified Side-Effect Monitoring System
The distinctive feature of phases II/III is their connection with the unified system for monitoring the side effects of medicines, established by the twenty-sixth article of the law. Participating in this system are the treating physicians of the curative-prophylactic network, the specialists of the medical services of curative institutions, and the structures of the Ministry. This means that information about side effects identified among the patients participating in the trial is connected to a broad medical network.
The general coordination of the system and the analysis of the received information are carried out by the Agency. It collects, analyses and generalises information about adverse effects of medicines; exchanges this information with the medical services of other countries and the World Health Organization; organises the expertise of the data found and prepares recommendations on the release of medicines, their withdrawal from circulation and the cancellation of registration certificates; and studies, in stages, the incompatibility and interaction of medicines.
The Duty to Supply Information
The law obliges the subjects of the circulation and use of medicinal products to supply the Agency with information about every case of a side effect of a medicinal product and about other peculiarities of its interaction that are not indicated in the instructions for use. For the organiser of a phase II/III trial this means that the flow of information about new effects identified during the research must be planned in advance.
The rules and sequence for forming the information flow about side effects from the curative network are developed and approved by the Ministry. The monitoring mechanism written into the protocol must therefore fit these rules, so that the research data integrate smoothly into the national system.
Liability for Violation
Article 37² of the law provides that activity of pharmaceutical manufacturing, export or import of a specially controlled pharmaceutical product, an authorised pharmacy, or a clinical trial of a pharmacological agent without a permit entails a fine of 4 000 lari, and the same conduct repeated — a fine of 8 000 lari. The implementation of a phase II/III protocol must be covered by a permit from the very outset.
Frequently Asked Questions
Under what rules is a phase II/III trial conducted in Georgia?
The research is conducted in accordance with the standards and guidelines approved by the Minister and requires a permit. The rights of the participating patients are protected by the legislation of Georgia.
Who participates in the side-effect monitoring system?
The treating physicians of the curative-prophylactic network, the specialists of the medical services of curative institutions and the structures of the Ministry; coordination is carried out by the Agency.
To whom must information about side effects be supplied?
The subjects of the circulation and use of medicinal products must supply the Agency with information about every case of a side effect not indicated in the instructions for use.
What fine is provided for conducting research without a permit?
A fine of 4 000 lari, and in case of repeated commission — a fine of 8 000 lari. This is established by Article 37² of the law.
How We Help on Legal.ge
A phase II/III protocol is simultaneously a medical and a legal document. On Legal.ge we help assess the protocol's compliance, plan the permitting procedure, and examine the obligations connected with side-effect monitoring. Contact us — we will strengthen the legal foundation of your research in every detail.