Legal regulation of the biological materials concept as an integral part of a biobank, and their relation with anatomical materials

Abstract

This article is devoted to the problem of defining the concept of biologi cal material, the object of legal relations regarding the creation and use of biological banks. Components of this concept, such as tissues, cells, embryo­ fetal anatomical materials, are analyzed. On the basis of a comparative analysis with the concept of anatomical materials, which made it possible to differentiate the sphere of legal regula tion of relations regarding the creation and use of biobanks with the scope of transplantation legislation in Ukraine, the characteristic features of bio logical material were distinguished. In particular, biological materials are always materials of human origin, which is obtained during the life of a person and on the basis of informed consent (except for the eyeball, which is obtained posmortal by the rules of transplantation legislation); the main components of this concept are tissues and cells, when the organs and their parts are excluded from the content of this concept; a special component of the concept of "biological material" is material of embryo­fetal origin, the legal regulation of which has its own pecu liarities and excludes the possibility of using living in vitro embryo; biologi cal fluids, secrets, vital products, physiological excretions, smears, scrapes, washes, biopsy material are special components of this concept, however, because of the imperfection of the current legislation, they cannot be used in the activity of biobank managers; the majority of biological material after its including to the biobank and as a result of its processing (for example, the selection of stem cells) becomes a "product and / or preparation of cord blood, other human tissues and cells". The result of this study are the formulated proposals for the defining the concept of biological materials and its components in the current legislation of Ukraine to unify the legal terminology according to the world standards.