Legal Protection of Interests Related to Human Biomaterial

The permanently extending scope of human biomaterial application has brought the issue of their legal nature to the forefront. This article analyzes the legal nature of biomaterials intended to restore the health of a citizen (originator or recipient), as well as biomaterials used in the formation of biobanks for conducting, inter alia, scientific and clinical research. The importance of introducing the categories “functional biomaterial” and “donor biomaterial” is underscored; criteria for differentiating their legal regime are developed. It is proposed to classify donor biomaterials into those related to the recipient’s personality and those not related to the recipient's personality. On this basis, the legal regime for each type is distinguished. The possibility of sharing human biomaterial for the purposes of scientific research purposes is considered. The recognition of biomaterial objects as intangible assets excludes the possibility of their joint use; however, under the condition of depersonalization of information and the loss of personalized properties, such objects, representing the results of intellectual activity, can form collections and big data databases. Falling under the legal regime that regulates the results of intellectual activity, the boundaries of the absolute right to use such objects should be defined, assuming free access and openness of information while observing a number of conditions for conducting scientific research.

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