Abstract

Advanced therapy medicinal products (ATMP) offer hope for health benefits in all situations where traditional methods of therapy fail or cannot be used for various reasons. The main purpose of this article is to analyze the concept of innovation as applied to the biotechnologies employed in ATMP. In the analysis of the concept, five main contexts of meaning that contribute to its understanding will be distinguished: a change in the way of thinking about the available spectrum of medical procedures, the short time of recognition of technologies in the experimental and theoretical models, lack of clinical data in advance of used technologies, increase of technologies’ complexity and diversity of substrates used in them. The conducted analysis indicates the need to adopt an attitude of far-reaching caution in the evaluation of the safety of ATMP therapies in which innovative biotechnologies are used.