Paul-Ehrlich-Institut Publishes 2024 Report on Tissue Supply in Germany Pursuant to Section 8d of the Transplantation Act
The Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines, has published its report on tissue supply in Germany for the year 2024. The report contains data submitted to the Paul-Ehrlich-Institut by tissue establishments pursuant to section 8d of the Transplantation Act (Transplantationsgesetz, TPG). It provides a comprehensive list of all activities concerning the extraction, processing, import, and export of human tissues in Germany and forms a basis for transparency and traceability in medical treatments using human tissues.
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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 overall report.
In 2024, 764 clinics, treatment centres and specialised medical practices reported data on human tissues to the Paul-Ehrlich-Institut. The types of tissue documented include corneas, heart valves, and skin tissue. As an example, in 2024 15,668 corneas were removed and 11,431 were transplanted in Germany. A cornea transplant can restore vision to people whose vision is impaired or completely lost due to opacification or injury to the cornea.
The Paul-Ehrlich-Institut's report on the data submitted in accordance with section 8d of the TPG makes an important contribution to transparency, planning, and quality assurance in the field of tissue supply in Germany.
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