Production of Biomedical Cell Products in the Russian Federation

Author Name(s): Alsu M. Khurmatullina, Evgeniya A. Sharkovskaya
Author Email: akm551@mail.ru

Abstract

The donation of biological material in the era of the scientific and technological revolution becomes the essential problem for legal regulation due to the need to ensure the biogenetic safety of man. Current Russian legislation lacks a clear mechanism for protecting the rights of the donor and the recipient, in connection with which it seems necessary to strike a balance between the donor’s constitutional right to privacy and his right to information, on the one hand, and the recipient’s right to health, on the another hand. The special legal significance of the issue is related to the problems of the application of laws such as the Federal Law of June 23, 2016 No. 180 “On Biomedical Cell Products”, the Federal Law of 20.07.2012 N 125 “On Donation of Blood and Its Components”. The article analyzes the legal regime for the provision of biological material for the production of a biomedical cell product (BMCP). The need for legal regulation of the protection of the rights of the parties when using BMCP is noted. The research results are based on the use of comparative legal, system-structural and formal-legal methods.

Introduction

The progress of science and technology inevitably affected the methods and methods of treating and preventing human diseases. One hundred years have not passed since the discovery of penicillin, and today’s medicine has reached previously unimaginable heights. The most striking example is the use in medicine of cell and genomic technologies that allow medical intervention using human cells with a certain degree of modification – biomedical cell products (hereinafter – BMCP). However, the rapid development of research in this area and the application of the results of such research in practice is fraught with many dangers, primarily in the field of protecting human rights. This is due to the fact that now the cells can be torn away from their carrier for subsequent processing, storage and use, become the object of influence and themselves act as active substances. In other words, there is a paradigm shift in the interaction of man and technology, a philosophical rethinking of the biological essence of man and a social revolution in the healthcare system. Against the background of these processes, it is necessary to ensure the maximum level of protection of human rights and freedoms, if necessary, revise existing approaches to legal regulation, always focusing on one of the main tenets of modern law – a person, his rights and freedoms are the highest value. The most vulnerable subjects in the application of cell technologies are the donor – the person who provides his biological material for research and the creation of cell products, and the recipient – the person for whom the created product is ultimately intended.

Conclusion

The development of cell products, their widespread production and effective use are objectively possible only if there is a basis – cell lines isolated from the biological material of the donor. It is important to develop legal standards that will reflect the balance of private and public interests, public requests for personalized treatment and the interests of an individual patient or donor. The collection of biological material – one of the first procedures in a long and difficult way for BMCP to enter the medical market, should be carried out in full accordance with the law. In turn, the system of normative legal acts regulating donation should be streamlined, which is currently not observed in Russia. “Russian law currently underestimates the importance of genetic information which can be extracted from human biological material and constitutes human biometric data

500 total views, no views today

Download PDF File

About the author: admin