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More than 100 pharmacies in Germany are being investigated for importing drugs not registered in Germany for use in the preparation of intravenous chemotherapy. Two companies in Denmark and the Isle of Man that import and export drugs are also being investigated.
The district attorney in Mannheim said in a press release that the main charge being considered was one of fraud, because the chemotherapy drugs were bought at low prices abroad but had been illegally sold at the high price of registered drugs in Germany.
The chief financial victims of the alleged fraud seem to be the insurance companies, because they were charged inflated prices. The problem came to light when a health insurance company noticed irregularities in the billing for courses of chemotherapy.
It is not yet known whether patients were harmed. The district attorney said it was possible that fake drugs were used, as well as drugs that were ineffective or did not contain enough of the active ingredient.
Insurance companies have probably lost several million euros, because one course of chemotherapy costs between €15000 (£10000; $21000) and €25000. The German Society of Haematology and Oncology says that about €900m is spent every year on intravenous chemotherapy in Germany. The profit margin for the individual pharmacy preparing the infusion is normally between 10% and 50%.
Of the 21000 independent pharmacies (that is, not belonging to a hospital) in Germany, only 300 have a licence to prepare intravenous chemotherapy. They mainly get the drug from pharmaceutical dealers that buy them from the drug firms.
The president of the German Society of Pharmacists, Magdalene Linz, said that suspicions that patients had been harmed had yet to be confirmed, but she demanded severe punishments for convicted pharmacists and for pharmaceutical dealers, including the withdrawal of their licences.
The health insurance companies are insisting that prepared infusions be labelled with all their components. German oncologists have also asked for detailed documentation of drug preparations, as they are ultimately responsible for the treatment. They also want to limit who can prescribe chemotherapy infusions to qualified oncologists.