Off-Label-Use

Under admission border application, Eng. off-label use, refers to the regulation of approved finished product outside of the requested in the approval and approved by the national or European regulatory authorities regarding the use uses ( indications) and types, dosages or patient groups.

The applications for authorization of pharmaceutical companies in drug authorities for new drugs are often very narrow, for various reasons and requests for extension of existing approvals are rare. One important reason is the high cost of the necessary clinical trials. Legislators in Germany and Europe currently trying this development through simplified licensing regulations or economic incentives, such as an extended retention period for admission of children to counteract.

Areas of application

In many areas of medicine, especially pediatrics and oncology, much of the drug off-label is applied. Also in the induction of labor is often resorted to misoprostol, but is authorized only for the treatment of gastric and duodenal ulcers. For many orphan indications no approved drug is available at all, and in areas with rapidly progressing research lags the approval status of the preparations the treatment standards enormously afterwards.

Liability

The doctors are liable for off- label use for the medical correctness or for any side effects. Recommend The medical associations to conduct off-label regulations only on the basis of valid guidelines, recommendations or recognized scientific literature. Also additional demands are placed on the patient education.

Even in the case of the off- label use, however, a liability to the pharmaceutical company may be. According to § 84 Section 1 No. 1 AMG, the pharmaceutical company is liable if there is an injury to the " intended use ". The "intended use " is not restricted solely to the use for the purposes of admission. 3a may be required pursuant to § 28 para example, by using observations of the drug manufacturer after approval, for market monitoring. Thus, if the company from the regular use outside of the authorization would know and take appropriate risk mitigation measures, then the pharmaceutical company shall also be liable.

Reimbursement by health insurance

The eligibility of such prescribed medication by the statutory health insurance ( SHI ) was frequently the subject of litigation. In a landmark judgment, the Federal Social Court (BSG ) of 19 March 2002 ( B 1 KR 37/00 R), therefore, the criteria for reimbursement of medicines outside the approved indication ( off- label use ) by the statutory health insurance funds have been set: it must itself

By judgment of 4 April 2006 ( B 1 KR 7/05 R), the Federal Social Court has further refined the criteria for the off- label use.

The Bavarian State Social Court differed with the judgment of 13 June 2006 also between off- label use and a claim to constitutional power expansion in terms of a Beyond -label use. It noted that a claim for performance enhancement for the re-use of a drug for the same patient to justify the same drug and the same treatment, in special cases, concrete evidence of a severe form of a disease could be sufficient. In the specific case of further treatment of ADHD patients after reaching the age of 18, however, the Social Court considered the requirements for a claim for reimbursement as not given.