Optimal Liability for Off-Label Use of Drugs

在德国和美国，药物在满足特定的安全性和有效性标准后获得批准。批准后，如果制造商的产品信息是完整的，即包括剂量，已知的副作用和相互作用，则制造商不必对患者的损害负责。正确遵守制造商说明的开处方医生也不承担责任。相比之下，在未经批准或标签外使用药物的情况下，无法获得有关该药物特性的信息。开这类药的医生要承担对病人造成损害的责任。因此，标签外规定产生了两种效果。如果一种药物的批准程序无利可图，说明书外使用会产生正利润。这将导致未来的研发投资，并从长远来看增加福利。与此相比，由于缺乏安全测试和责任责任的变化，产生了福利损失。因此，制造商销售过于危险的药物。由于这种权衡，总的福利效应尚不清楚。至少必须怀疑，制造商对其产品安全缺乏责任是低效的。在我的研究项目中，我想确定标签外规定的总福利效应。从经济分析中得出一个有效的监管方案，可以作为改变现行规则的建议。我打算对推导出的理论结果进行实证检验。

Drugs in Germany as well as in the USA are approved upon meeting particular standards of safety and effectiveness. After approval a manufacturer cannot be held liable for the patients damages if his product information is complete, i.e. comprising the dosage, known side-effects and interactions. The prescribing physician who correctly complies with the manufacturer¿s instructions can also not be held liable. By contrast, in case of an unapproved or off-label use of a drug, information about the drug¿s characteristics is not available. Physicians who prescribe such drugs expose themselves to the risk of liability for patients¿ damages. As a result the off-label provision causes two effects. If the approval procedure for a drug is unprofitable, the off-label usage generates a positive profit. This leads to future R&D investments and increases the welfare in the long run. Compared with this a loss of welfare arises due to the lack of safety tests and the changed liability responsibility. Therefore, manufacturers distribute too dangerous drugs. Due to this trade-off the total welfare effect is unclear. At least it has to be suspected that the lack of the manufacturers¿ responsibility for safety of their products is inefficient. In my research project I would like to determine the total welfare effect of the off-label provision. Out of an economic analysis an efficient regulation scheme will follow which may serve as a proposal for a change of the current rules. I plan to test empirically the derived theoretical results.