[Off-label use of drugs - the legal framework].

The off-label use is the therapeutic use of a drug for indications, dose form, dose regimen, population or other use parameter that is not mentioned in the approved labeling of the drug. The most common off-label use is the use for an indication that is not mentioned in the drug's labeling. The relevance of the off-label use for the practical drug therapy is enormous. Under German law, the doctor is entitled to use a drug for therapeutic purposes off-label. Such off-label use per se is not qualified as malpractice. But the doctor needs to observe the medical state of the art and has to review carefully the benefits and risks of an off-label use. If the off-label use is the standard treatment for a disease, he may be obliged to such use. Before an off-label use, doctors have an increased duty to inform patients about the therapy. During such therapy doctors have an intensified duty to monitor the therapy. Violations of these duties may lead to liability under civil and criminal law. Under German statutory health insurance laws, the off-label use is not qualified as an insurance service. Only in exceptional situations, the statutory health insurance covers the costs of off-label therapies. Such exceptions apply in case of at least serious diseases, very rare diseases, unexplored diseases and if the statutory health insurance steering committee has approved the off-label use as a therapy that is covered by the health insurance. More healthcare services research is necessary to obtain more systematic data about the off-label use in practice and the underlying needs of the patients.