Problems and prospects of the circulation of biomedical cell products in the Eurasian Economic Union

Abstract

Biomedicine has a great integration potential according to regulatory acts in the Eurasian Economic Union (EAEU). Moreover, one of the most relevant areas in modern biomedicine is regenerative personalized medicine using biomedical cell products. The article discusses various approaches to the legal regulation of the circulation of biomedical cellular products in the EAEU — a national and integration approach. As part of the study of the national approach, the author compares the current legislation of Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia, while also identifying similar and different features. There is a common licensing procedure for conducting activities on the circulation of biomedical cell products, an increased degree of quality control, efficiency and safety, taking into account the ethical side of the issue, and emphasis on respect for human rights. The differences lie in the formal legal aspects, a heterogeneous understanding of the nature and content of biomedical cell products. The integration approach is illustrated by regulatory acts adopted at the EAEU level; their shortcomings are highlighted. Only import and export issues are adequately resolved from the entire life cycle of biomedical cell products at the EAEU level. However, there are no standards for a single market for cell products. For comparison, the author refers to the experience of the European Union in regulating the circulation of cell-based products and focuses on free movement, a centralized registration procedure, ethical requirements, and good clinical practice. According to the results of the article, the author identifies such basic problems of legal regulation as the lack of unification of the conceptual items, registration procedures, and procedures for applying to patients. Solving these problems will allow the market for biomedical cell products to grow rapidly and provide a qualitative breakthrough in the treatment and prevention of diseases. It is proposed to establish either a mechanism for verifying biomedical cellular products in the territory of the EAEU member countries in order to simplify registration procedures or create a unified registration procedure. The global goal is to develop a single standard for the
legal regulation of the circulation of not only cellular products, but also all advanced medical devices in general.

Keywords:

biomedical cell product, biological material, biomedicine, regenerative medicine, unification, harmonization, registration procedure, common market