ABSTRACT
INTRODUCTION: The use of unlicensed drugs is an unsettling issue in medical circles. "Dear Doctor Letters", batch recalls and important notifications about them are not provided systematically. Unlicensed use is, however, sometimes the only promising option for further medical treatment. Approaches to improve vigilance of pharmaceutical agents are available in many countries. An outline of legislation on and experiences with unlicensed use in selected industrial countries is reviewed in this article. Research data, documentation and assessment of the legal status of unlicensed drugs in selected industrial countries were obtained and compared to the situation in Germany. Expert interviews with specifically recruited representative samples from academic centers as well as regulatory and industrial sources, health technology assessments and health insurance data were analysed (N = 44, t = 20-120 min, transcribed verbatim). Approaches and limitations of licensing in different countries compared: Granting of a license has been an obligatory condition and there has been a duty of disclosure (sometimes with the right of prohibition) as well as reservations on the granting of permission. Central administration of data has made it possible to quantify and identify required drugs and ensure surveillance of their use. High administrative costs involved in giving notice of approval has caused delays in patient care. Procedures by which a medical doctor has to obtain permission affect physicians' freedom of action. Unlicensed and off-label use is variably regulated across the analysed settings. Legislation and regulation continue to be highly heterogeneous. Most promising approaches include the duty of disclosure, which allows quantification of use and surveillance of safety, including the right of recall while ensuring doctors' freedom to treat with medicinal products.
