Abstract
The paper substantiates the necessity of the introduction into Ukrainian legislation the concept of «biobank» and the derivation of the relevant legal category and the relevant legislative term. Many countries have long experience in the functioning of biobanks. Ukraine is currently only at the beginning of the path to creating a system of biobanks and ensuring their proper functioning. In Ukraine there is no comprehensive legal regulation of the biobank activity, and the term «biobank» is not used in the Ukrainian legislation. The theoretical and practical biobank functional aspects are left behind attention. The paper analyzes the definition of the term of «bank of umbilical cord blood, other tissues and human cells», which are enshrined in the current Ukrainian normative legal acts. There are two definitions of the term of «bank of umbilical cord blood, other tissues and human cells»: in the Resolution of the Cabinet of Ministers of Ukraine dated March 03, 2016 No. 286 About Approval of Licensing Conditions for the Economic Activity of Cord Blood Bank, Other Human Tissues and Cells in accordance with the List approved by the Ministry of Health and in Order of the Ministry of Health of Ukraine dated April 10, 2012 No. 251 About Approval of Licensing Conditions for the Economic Activity of Cord Blood Bank, Other Human Tissues and Cells. The above definitions do not duplicate each other, but are characterized by a certain inconsistency and do not provide a complete and comprehensive description of the term «bank of the umbilical cord blood, other tissues and human cells». For indications of repositories that store biological samples use the terms: biorepositories, biobanks and biological resource centers. The differences among biobank, biorepository and biological resource centre are emphasized. The paper studies the definition of the term «biobank», formulated by international legal science. The conclusions about the expedience of using the concept of «biobank» in the Ukrainian legislation, formation of the corresponding legal category and its proposal to the national legal doctrine of medical law are formed.
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