Legal aspects of intestinal microbiome application

Overview

Application of intestinal microbiome (Fecal Microbiota Transplantation) is currently discussed treatment procedure which is the subject of professional interest not only when it comes to its medical aspects, but also its legal regulation. The aim of this article is to introduce a legal perspective on this subject matter and outline possible newly regulated areas. The subject matter is linked not only with the legislation contained in the Czech Civil Code in the section devoted to products having its origin in the human body, but also with other laws in the area of medical law. The position of regulatory authorities in the EU is also mentioned. It is apparent that EU’s regulatory authorities leave this area for the legislation of individual EU member States.

Keywords:

Microbiome – fecal microbiota transplantation – products arising in the human body – pharmacological – metabolic and immunological effects of action – Civil Code – Law on medicines – Law on medical devices – Law on tissues and cells – Transplantation Law – legal regulation de lege ferenda