Analysis of the main provisions of Federal law No. 180-FZ «On biomedical cell products»
DOI: 10.22138/2500-0918-2017-14-1-104-110
L.A. Solonitsyna, S.V. Sazonov, S.L. Leontiev
Institute of Medical Cell Technologies, Yekaterinburg, Russian Federation;
Ural State Medical University, Yekaterinburg, Russian Federation
Abstract. The purpose of this work is to review the main provisions of the Federal Law No. 180-FZ «On Biomedical Cell Products», which entered into force on January 1, 2017. Methods and materials. The main object of study were the norms of the Federal Law No. 180-FZ «On Biomedical Cell Products». Methods used: formal legal, system-structural, formal-logical (description, comparison, analysis), grammatical-linguistic. Results. In this paper, we analyze the goals of the adoption of the law, the fundamental principles of the legal regulation of the circulation of biomedical cellular products, the stages of creating and introducing a biomedical cellular product into circulation. Conclusions and prospects. Federal Law No. 180-FZ «On Biomedical Cell Products» can be attributed to acts of a complex nature, since the subject of its regulation are relations relating to several branches of activity: science, medicine, health, production of biomedical cellular products. The law is aimed at regulating relations arising in connection with the development, preclinical research, expertise, state registration, clinical research, production, sale, storage, transportation, use, destruction, importation into the Russian Federation, export of biomedical cellular products for prevention, Diagnosis and treatment of the patient's diseases (conditions), maintaining pregnancy and medical rehabilitation of the patient, as well as with the donation of biological material rial for the production of biomedical cell products. At the same time, the treatment of medicines and medical products, the transplantation of human organs and tissues and cells, the donation of blood and its components, and also the relationships in the circulation of cellular products for the purposes of science and education are not included in the subject of its regulation. Thus, the legislator laid the conflict of norms, which will have to resolve in practice. The prospect of implementing the norms of the law in question depends on the speed of adoption of by-laws, as well as sufficient funding for the creation and registration of biomedical cellular products. To date, ten secondary legislation needed for the real entry into force of provisions of the law, passed two. Feasibility study in connection with the adoption of the Act does not provide for an increase in the expenditure part of the health care budget.
Keywords: Federal Law, biomedical cellular product, new medical technology, treatment of cellular products, the production of biomedical cell products, clinical trials, Biobank
Received 28.02.2017
For citation:
Solonitsyna L.A., Sazonov S.V., Leontiev S.L. Analysis of the main provisions of Federal Law no. 180-FZ «On biomedical cell products». Vestn. Ural. Med. Akad. Nauki. – Journal of Ural Medical Academic Science. 2017, Vol. 14, no. 1, pp. 104–110. DOI: 10.22138/2500-0918-2017-14-1-104-110 [In Russ.]
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Authors
Lyubov A. Solonitsina
Institute for Medical Cell Technologies
M.S, Head of Department
K. Marksa str., 22a, Yekaterinburg, Russian Federation, 629916
solla@bk.ru
Sergey V. Sazonov
Institute for Medical Cell Technologies
Ural State Medical University
Dr. Sci. (Med.), Professor
K. Marksa str., 22a, Yekaterinburg, Russian Federation, 629916
Prof-SSazonov@yandex.ru
Sergey L. Leontiev
Dr. Sci. (Med.), Professor
Institute for Medical Cell Technologies
K. Marksa str., 22a, Yekaterinburg, Russian Federation, 629916
imct@celltechnologies.ru
