LEGAL REGULATION OF GENETIC RESEARCH AND GMO CIRCULATION

Abstract

The article examines the legal foundations for the regulation of genetic research and the circulation of genetically modified organisms (GMOs) in Ukraine and at the international level. The provisions of the Law of Ukraine "On the State Biosafety System for the Creation, Testing, Transportation and Use of Genetically Modified Organisms" of May 31, 2007, No. 1103-V, as the basic regulatory act in this area are analyzed, and gaps in legal regulation are identified, in particular regarding CRISPR-Cas9 gene editing technologies, which differ significantly from traditional methods of genetic modification. The Cartagena Protocol on Biosafety to the Convention on Biological Diversity of January 29, 2000, ratified by Ukraine in 2002, is examined and its role in forming international standards for regulating the transboundary movement of GMOs is determined. The approaches of the European Union to the regulation of GMOs are considered, including Directive 2001/18/EC on the deliberate release of genetically modified organisms into the environment and the judgment of the Court of Justice of the EU in Case C-528/16 (2018) on extending GMO legislation requirements to organisms obtained by directed mutagenesis methods. The legal and ethical aspects of human genome editing are analyzed taking into account the provisions of the Oviedo Convention on Human Rights and Biomedicine of April 4, 1997, and the UNESCO Universal Declaration on the Human Genome and Human Rights of November 11, 1997. The necessity of updating domestic legislation taking into account the latest achievements of genetic science is substantiated, in particular the revision of the definition of a genetically modified organism in the Biosafety Law of 2007 to cover organisms obtained by gene editing methods, as well as the formation of a legal framework for regulating the clinical application of human genome editing technologies in accordance with international bioethics standards.