title: [A comprehensive assessment of ATMP. Difficulties and approaches].
abstract: Advanced therapy medicinal products (ATMP) are associated with high expectations because they offer new opportunities for the treatment of diseases, e.g., the possibility of regenerating damaged or lost tissue. What the products (gene therapy, somatic cell therapy, and tissue engineered products) have in common is an innovative and complex development process that combines science and engineering. At the same time, this field of research is becoming increasingly interdisciplinary and requires international cooperation. A comprehensive assessment of ATMP has to take these issues into account. The application of Beauchamp and Childress' Four Principles (Principle-Based Ethics) as well as Discourse Ethics as a framework may lead to a broader consideration of medical ethics issues.
authors.affiliation: Institut für Medizinmanagement und Gesundheitswissenschaften, Universität Bayreuth, 95440, Bayreuth, Deutschland. mirjam.thanner@uni-bayreuth.de
authors.forename: M
authors.initials: M
authors.lastname: Thanner
authors.forename: E
authors.initials: E
authors.lastname: Nagel
mesh_terms: D001688:Biological Products / Q000627:therapeutic use*; D003257:Consumer Product Safety; D015316:Genetic Therapy / Q000941:ethics*; D005858:Germany; D006801:Humans; D007391:International Cooperation; D028662:Principle-Based Ethics; D044968:Regenerative Medicine / Q000941:ethics*; D033581:Stem Cell Transplantation / Q000941:ethics*; D035703:Therapies, Investigational / Q000941:ethics*; D023822:Tissue Engineering / Q000941:ethics*
chemical_list: D001688:Biological Products