DefinitionThis section has been translated automatically.
- Compassionate use" refers to the use of (not yet) approved drugs on patients. In German usage, the immediate equivalent is called "individueller Heilversuch". In medical law, compassionate use in individual cases means the use of a possibly effective, but not yet approved drug in patients in life-threatening situations or with serious illnesses that cannot or can no longer be treated in any other way within the framework of the duty of doctors to treat and the freedom to treat.
- With the 14th Amendment to the German Medicines Act (AMG), the "Compassionate Use" was incorporated into German pharmaceutical law and modified by the Act on the Amendment of Drug Law and other Regulations of 17 July 2009. § Section 21 (2) AMG provides under No. 6: A marketing authorisation is not required for medicinal products which are made available free of charge for use in patients suffering from a disease leading to a serious disability or whose disease is life-threatening and which cannot be treated satisfactorily with an authorised medicinal product under the conditions specified in Article 83 of Regulation (EC) No. 726/2004.
Prof. Dr. med. Peter Altmeyer