Several times German courts dealt with the matter whether the 'Gesetzliche Krankenversicherung' (GKV), which stands for statutory health insurance, have to pay the costs for the off-label drug use. In a ruling in 2002 the Federal Social Court (BGS) permitted the off-label drug use at first only with very tight constrictions, to the disadvantage of the GVK. In a more recent ruling from 2006 - based on an order of the Federal Constitutional Court from 2005 - the BGS concretised and liberalised the guidelines at the same time. According to this, now 7 criteria in total have to be fulfilled for reimbursable off-label drug use:

1. Life-threatening or constant illness
2. Absence of an approved alternative therapy
3. Other miscellaneous criteria of the obligation to perform are fulfilled
4. No violation of the Pharmaceutical Act
5. Positive risk-benefit analysis
6. Treatment to be performed by a qualified doctor
7. Right of self-determination

To be able to comply with the restrictions the Federal Ministry of Health regulated, via remission, from September 17th 2002 to establish a panel of experts 'Drug application outside of the authorized indication ambit' ('Panel of experts Off-Label'). Their tasks are: 1. Delivery of assessments about the state of scientific findings about authorized permitted medicinal products for indication and indication ambits, which are not authorized according to the Pharmaceutical Act. The assessments are to check within appropriate intervals and possibly require to be adjusted to the enhancement of the state of the scientific findings. 2. Information on request to the Federal Ministry of Health and the Federal Joint Committee on the strength of §91 SGB V (Social Security Statues) concerning questions about the state of the scientific findings how to use permitted medicinal products for indication and indication ambits, which are not authorized according to the Pharmaceutical Act.

The final decision on reimbursability rests with the "Gemeinsamer Bundesausschuss (G-BA)" (Federal Joint Committee).