title: [Legal Framework of Autologous Fat Usage in Point-of-Care Treatments in Plastic and Aesthetic Surgery - Risks of Criminal Prosecution and Infringement of Medical Law Due to Pharmaceutical Regulations].
abstract: The use of autologous fat, especially for (stem) cell-assisted lipotransfer in plastic and aesthetic surgery, has regularly been regarded as the manufacture and application of so called Advanced Therapy Medicinal Products (ATMP). However, the in-house production of such pharmaceuticals at the point-of-care (PoC) in the surgeon's practice is not permitted without an official manufacturing license. Therefore, before beginning such treatments, a pharmaceutical manufacturing license has to be granted to the surgeon to avoid criminal prosecution and negative consequences due to infringement of professional regulations. Because such a license is linked to compliance with GMP standard, in-house manufacturing of such pharmaceuticals also implies extra technical and personnel expenses. The surgeon is obliged to check that the available autologous fat based applications are in compliance with pharmaceutical legislation. Repeated infringements of pharmaceutical regulations are incompatible with medical reliability - a prerequisite for the license to practice medicine.
authors.affiliation: Martin-Luther-Universitat Halle-Wittenberg Juristische und Wirtschaftswissenschaftliche Fakultät, Halle.
authors.forename: T
authors.initials: T
authors.lastname: Faltus
mesh_terms: D006801:Humans; D007603:Jurisprudence; D016365:Liability, Legal; D019095:Point-of-Care Systems; D015203:Reproducibility of Results; D013518:Surgery, Plastic / Q000331:legislation & jurisprudence*