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才被批准。批准后，如果制造商的产品信息完整，即包括剂量、已知副作用和相互作用，则制造商不对患者的损害负责。正确遵守制造商说明的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，无法获得有关药物特性的信息。开这类药物的医生将自己暴露在对患者损害负责的风险中。因此，标签外规定造成两个影响。如果一种药物的批准程序是无利可图的，那么标签外使用就会产生正利润。这导致了未来的研发投资，并从长远来看增加了福利。与此相比，由于缺乏安全测试和责任的改变，福利损失也随之产生。因此，制造商分发太危险的药物。由于这种权衡，总的福利效果是不清楚的。至少人们不得不怀疑，制造商对其产品安全缺乏责任是效率低下的。在我的研究项目中，我想确定标签外规定的总福利效应。在经济分析的基础上，一个有效的监管计划将随之而来，这可能会成为改变现行规则的建议。我计划用经验来检验所得出的理论结果。

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.