Publication

A comprehensive assessment of ATMP. Difficulties and approaches

Journal Paper/Review - Jul 1, 2011

Units
PubMed
Doi

Citation
Thanner M, Nagel E. A comprehensive assessment of ATMP. Difficulties and approaches. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2011; 54:843-8.
Type
Journal Paper/Review (Deutsch)
Journal
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2011; 54
Publication Date
Jul 1, 2011
Issn Electronic
1437-1588
Pages
843-8
Brief description/objective

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.