The Paul-Ehrlich-Institut (PEI) has published an overview of reports submitted pursuant to section 8d of the Transplantation Act (Transplantationsgesetz, TPG) for the year 2023. The data provides a comprehensive list of all activities involving the extraction, processing, import, and export of human tissues in Germany. It forms a basis for transparency and clarity in this area of healthcare.
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According to section 4 subsection 30c of the Medicinal Products Act (Arzneimittelgesetz, AMG), tissue establishments are all establishments that conduct activities requiring a permit involving tissues, tissue preparations, or haematopoietic stem cells, or stem cell preparations derived from peripheral blood or from umbilical cord blood. Pursuant to section 8d subsection 3 of the TPG, tissue establishments are obligated to document their activities and to submit an annual report online to the Paul-Ehrlich-Institut. This report contains information on the type and quantity of human tissue removed, prepared, treated, processed, stored, delivered, imported, exported, or otherwise used.
The Paul-Ehrlich-Institut publishes the anonymised data in an annual overview. The types of tissue documented include corneas, femoral heads, and skin tissue. In 2023, for example, 13,757 corneas were removed in Germany, 9,929 of which were made available for transplantation.
The overview of the reports submitted in accordance with section 8d of the TPG contributes to transparency, planning, and quality assurance in the field of tissue supply. The reports support tissue establishments, authorities, and policy makers so that they can better assess the supply situation and avoid supply shortages.
Updated: 03.12.2024
