The results of a research study conducted at Caucasus University, titled “Balancing Object-Based and Process-Based Regulation of Genome Editing in the European Union,” have been published in the international peer-reviewed journal Samartlis Matsne.

The author of the article is Tengiz Verulava, Professor at Caucasus University, Doctor of Medicine, and Director of the Health Policy Institute.

Article reference:

Verulava, Tengiz (2025). Balancing Object-Based and Process-Based Regulation of Genome Editing in the European Union. Samartlis Matsne, Vol. 12, pp. 94–112.

Abstract

Modern genome-editing technologies have fundamentally transformed the trajectory of biomedical development and necessitated a reassessment of existing ethical, legal, and safety paradigms.

Across the European Union, somatic genome editing is widely regarded as a legitimate therapeutic approach, while germline interventions remain largely restricted, primarily due to ethical considerations.

The article introduces a two-pillar governance model for genome editing: Object-based regulation, which focuses on evaluating technological products and instruments; Process-based regulation, which concentrates on clinical applications and therapeutic procedures.

The study demonstrates that the current EU regulatory framework contains structural inconsistencies. Moratoriums based on knowledge gaps may hinder scientific progress, while morality-based patent restrictions fail to ensure effective risk control and may encourage technological development outside the EU. In this context, the research argues for a transition from precaution-driven restrictions to a knowledge-and risk-assessment-based governance model, prioritizing safety, effectiveness, and responsible innovation.

The article recommends the implementation of a regulatory model in which the European Union continues to regulate technological instruments, while member states retain the authority to determine the ethical framework of clinical applications and ensure process-based oversight.

Such a regulatory distribution requires coordinated research efforts, unified evaluation standards, and sustained interdisciplinary dialogue.

A knowledge-based regulatory transition would not only improve policy coherence and transparency but also strengthen public trust and support the realization of future therapeutic breakthroughs.

Health Policy Institute