Gene Therapy Legal Framework: In Search of Balance of Interests

The paper deals with the problem of finding a balance of interests in the light of the use of gene therapy. The rapid development of new medical technologies determines the need to solve bioethical problems related to ensuring respect for human dignity. Gene therapy refers to specialized, including high-tech, medical care and is a set of genetic engineering (biotechnological) and medical methods aimed at making changes in the genetic apparatus of human somatic cells for the treatment of diseases. At the same time, the main directions of modern gene therapy can be attributed not only to untraceable genome modifications, namely genome editing in situ (in vivo) and genome editing of somatic cells in vitro with subsequent transplantation, but also inherited genome modifications, i.e. editing of the embryo genome.

Editing of the embryo genome gives rise to a serious discussion, due to the legislative ban on interference in the human embryonic line. Despite this ban, the use of CRISPR/Cas9 has contributed to the creation of the world’s first people with artificially altered genes, resulting in the scientific community called for a moratorium on the editing of the human genome in clinical practice. The current situation is due to the need to find a fair balance of private and public interests in the field of gene therapy. According to the author, in the context of the embryo genome editing public interest is manifested in the development of scientific research. This allows the state not only to create the conditions for ensuring the protection of the population health, improve the level of their life, but also to establish control over the person, to obtain certain advantages in international relations with other sovereign states. In view of this, ensuring a fair balance between private and public interests in the application of gene therapy should be based on the principle of priority protection of the rights and interests of the individual.

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