Protecting the Rights of Persons in Case of Injury Due to the Use of Gene Therapy

Abstract

The article is devoted to the consideration of legal mechanisms aimed at protecting the life and health of persons participating in gene therapy clinical trials. It is noted that gene therapy carries the risk of adverse consequences for the life and health of the patient due to the inability of a person to exercise full control over the process and results of its application. The rights of participants in clinical trials of gene therapy are protected through the mechanism of compulsory insurance of their life and health. Particular attention is paid to the fact that proving the causal link between participation in a clinical trial and causing harm to life and health, which is necessary to receive insurance benefits, presents significant difficulties for persons applying for insurance benefits and who are the weak side of the emerging relationship. In this regard, it is proposed to consolidate a rebuttable presumption, according to which harm caused to the life or health of a participant in clinical trials, during such or within one year from the date of their completion, would be recognized as being in a causal link with participation in the clinical trial. A separate place is given to the justification that the organizer of gene therapy clinical trials is obliged to compensate for the injuryto the participant, regardless of fault.