DOI: https://doi.org/10.25040/medicallaw2019.02.035
Med. pravo., 2019; 2(24): 35-46
UDС: 347.121.2.022
KVIT NATALIIA MYKHAILIVNA
PhD in Law, Associate Professor at the Department of Civil Law and Procedure of Ivan Franko National University of Lviv
Legal regulation of the biological materials concept as an integral part
of a biobank, and their relation with anatomical materials
This article is devoted to the problem of defining the concept of biological
material, the object of legal relations regarding the creation and use of
biological banks. Components of this concept, such as tissues, cells, embryofetal 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 regulation
of relations regarding the creation and use of biobanks with the scope
of transplantation legislation in Ukraine, the characteristic features of biological
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 embryo-fetal origin, the legal regulation of which has its own peculiarities and excludes the possibility of using living in vitro embryo; biological 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.
Key words: biological materials, anatomical materials, tissues, cells,
biobanks.
Reference list:
1. Pro zastosuvannya transplantaciyi anatomichnyh materialiv lyudyni: Zakon Ukrayiny vid 17.05.2018 r. 2427-VIII. Retrieved from https://zakon.rada.gov.ua/laws/show/2427-19
2. Dyrektyva 2004/23/YeS Yevropejskogo Parlamentu i Rady shchodo pevnyh tehnichnyh vymog do nadannya, otrymannya i testuvannya tkanyn i klityn lyudyny. Retrieved from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex
3. Gesetz über die Spende, Entnahme und Ubertragung von Organen und Geweben (Transplantationsgesetz - TPG). Retrieved from: https://www.gesetze-im-internet.de/tpg/TPG.pdf
4. Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG). - Retrieved from https://www.gesetze-im-internet.de/amg_1976/AMG.pdf 5. Gesetz über Qualität und Sicherheit von menschlichen Geweben und Zellen (Gewebegesetz). Retrieved from http://www.gesetze-im-internet.de/gewebeg/GewebeG.pdf
5. Gesetz über Qualität und Sicherheit von menschlichen Geweben und Zellen (Gewebegesetz). Retrieved from http://www.gesetze-im-internet.de/gewebeg/GewebeG.pdf
6. Pro zatverdzhennya Pereliku tkanyn i klityn lyudyny, z yakymy dozvolena diyalnist bankiv pupovynnoyi krovi, inshyh tkanyn i klityn lyudyny: Nakaz Ministerstva ohorony zdorovya Ukrayiny vid 20.04.2012 r. 267. Retrieved from https://zakon.rada.gov.ua/laws/show/z1124-12
7. Pro zatverdzhennya Poryadku provedennya klinichnyh vyprobuvan tkanynnyh i klitynnyh transplantativ ta ekspertyzy materialiv klinichnyh vyprobuvan: Nakaz Ministerstva ohorony zdorovya Ukrayiny vid 10.10.2007 r. 630. Retrieved from https://zakon.rada.gov.ua/laws/show/z1206-07
8. Pro zatverdzhennya Licenzijnyh umov provadzhennya gospodarskoyi diyalnosti bankiv pupovynnoyi krovi, inshyh tkanyn i klityn lyudyny zgidno z perelikom, zatverdzhenym Ministerstvom ohorony zdorovya: Postanova Kabinetu Ministriv Ukrayiny vid 02 bereznya 2016 r. 286. Retrieved from https://zakon.rada.gov.ua/laws/show/286-2016-
9. Pro zatverdzhennya Pereliku anatomichnyh utvoren, tkanyn, yih komponentiv ta fragmentiv i fetalnyh materialiv, dozvolenyh dlya vyluchennya u donora-trupa i mertvogo plodu lyudyny: Nakaz Ministerstva ohorony zdorovya Ukrayiny vid 25.09.2000 r. 226.Retrieved from zakon.rada.gov.ua/laws/show/z0701-00
