Legal Status of the Biobank (Bank of Biological HumanMaterial)

Abstract

The article defines a biobank as a commercial or non-profit organization professionallyengaged in the collection, testing, processing, storage of human biomaterials and itsfixation in the database, as well as in some cases addition-ally — scientific research and(or) the provision of biomaterial to individuals and institutions under certain conditions for afee or free of charge. The legal capacity of the bank of biological samples is special, since itis associated with the specifics of the field of activity — biomedicine, specifics of methodsused — biotechnologies, including genomic technologies, and the specifics of the storagefacility containing human genomic information. Activities of biobank is implemented bymeans of conclusion and execution of civil contracts of donation for scientific, therapeuticactivities, agreements on the fence and long-term storage of biological material, etc. Theprinciples of biobank activity are substantiated: 1) observance of confidentiality of donorsand their informing on the purposes of use of bio-materials, 2) ensuring the safety of thebank’s employees in contact with bio-logical materials, 3) availability of biomaterial forscientific research on condition of anonymity of donors and clients and (or) their consent tosuch use, 4) providing profit to the founders and sponsors of biobank, including through thealienation of donor biomaterials, simplifying the procedure for obtaining donor consent. It isproposed to preserve state and non-state banks of human biological samples. The biobankproperty (property supporting the biobank activity, and the biomaterials stored) is groupedin order to secure a special legal regime for each group. Human biological materials arecharacterized as things limited in circulation. The basic rights of the organizations —founders, recipients of biomaterial, grantees are revealed: 1) the right to profit, 2) the rightto trade secrets, 3) the right to freedom of conclusion and content of contracts with humanbiomaterial. The proposed method of termination of activities of the Biobank is taking intoaccount the interests of its customers.
For citation: Maleina M.N. (2020) Legal Status of a Biobank (Bank of Biological Human Materials). Pravo. Zhurnal Vysshey shkoly ekonomiki, no 1, pp. 98–117 (in Russian) DOI: 10.17323/2072-8166.2020.1.98.117