Legal regulation of genetic safety: international and national aspects

Abstract

Genetic safety is a special state of security of human and environment, in which: a) any unnatural impact on the human genome is absent; b) any unnatural impact on genome of biosphere objects is absent; c) uncontrolled impacts on genome of agricultural plants, animals and industrial microorganisms, which leads to their negative and /or undesirable properties are absent.

The object of genetic safety is genome — the entire set of hereditary genetic information of an organism. These objects are human genome and genome of any biosphere objects, including agricultural plants, animals and industrial microorganisms.
Legal regulation of genetic safety is ensured primarily at the international level by: a) prohibition of interference in the human genome, aimed at its modifi cation, except when such interference with preventive, therapeutic or diagnostic purposes and only on condition that such intervention is not aimed at changing genome of heirs of the person; b) prohibition of any form of discrimination against a person on grounds of genetic heritage; c) guaranteeing the human right to privacy of genetic data; d) securing the right to fair compensation of any damage caused as a result of the direct and determining infl uence on his genome; f) prohibition of human cloning for the purpose of reproduction of the human person, and the cultivation of human embryos for research
purposes; e) guaranteeing the preservation of biological diversity, particularly in the process of obtaining, handling, transport, use, transfer of living modifi ed organisms; g) implementation of the precautionary principle in the study, diagnosis and treatment connected with the genome of any person and the principle of threats avoidance when implementing projects that could signifi cantly adversely affect the biological and landscape diversity.

Ukrainian legislation has specifi c provisions, aimed at guaranteeing genetic safety by: a) prohibition of reproductive human cloning; b) preventing unnatural impact on genome of biosphere objects as a result of genetically modifi ed organisms discharge into environment; c) regulation of genetic engineering activities aimed at modifying genome of agricultural plants, animals and industrial microorganisms. However, provisions of special laws of Ukraine «On the prohibition of human reproductive cloning» and «On state biosafety system for creating, testing, transportation and use of genetically modifi ed organisms» are mainly declarative. The above mentioned determines the necessity of signifi cant improvement of Ukrainian legislation in the fi eld of genetic safety with regard to international legal requirements.