Overview

• The Oberlandesgericht Frankfurt am Main ruled that a Hessian pharmacist can continue manufacturing and selling his self-produced, unapproved cancer medication.
• The medication targets rare and fatal pediatric cancers, offering potential stabilization or cure where no alternative treatments exist.
• The court determined that the urgent medical needs of affected patients outweigh strict adherence to drug approval regulations.
• A US pharmaceutical company is conducting clinical trials in Germany for a similar drug, but the pharmacist's actions are not deemed to interfere with these studies.
• The decision, made through an expedited and non-appealable process, highlights the tension between innovation in personalized medicine and traditional regulatory frameworks.