A proteção da dimensão genética do corpo em face do uso terapêutico da edição genética em células somáticas humanas

Abstract

The purpose of this study is to investigate the legality of the clinical use of gene editing in human somatic cells for therapeutic purposes. The intervention therefore focuses on the genes that make up the already differentiated cells that form the human body, constituting tissues and organs, to treat or cure diseases. In this context, the clinical practice of editing genes in this class of human cells is categorized as an advanced therapy, falling under the expanded legal concept of medications, based on what are known as “Gene Therapy Products” (GTP), according to the current classification adopted by the Brazilian Health Regulatory Agency (ANVISA). Parallel to the development of these new precision technologies, there is a growing international movement of home practices known as biohacking. This movement aims to disseminate biotechnological knowledge, promoting the “do-it-yourself biology” in order to make certain technologies, such as genetic editing, accessible to those who cannot afford the high costs of conventional treatments. Thus, the crux of the problem lies in investigating whether the practice, as a direct intervention in the genes that make up human organs and tissues, can be legitimized in accordance with constitutional principles, given the absence of a law in the strict sense that regulates the subject, as well as ascertaining whether home practices of intervention in the genetic integrity of the human body should be prohibited. The results of the research revealed that only genetic editing of a therapeutic nature, after health registration authorized by the competent authority and when performed by a professional qualified to practice medicine, complies with the principle of human dignity. In addition, the right to health is a fundamental social right essential for the incorporation of technology into the public and supplementary health systems. Finally, it was found that the practice, in complying with the general clause of protection of the human person, does not violate the principle of protection of diversity in human genetic heritage. The research was exploratory in nature, using national and international bibliographic reviews, as well as national jurisprudential and documentary research. The analytical-deductive method was adopted as the method of reasoning, and the methodology of constitutional civil law was used as the method of interpretation of norms and rules.