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意大利促进仿制药发展的严格监管与宽松监管

Tough versus soft regulations to promote generic medications in Italy.

作者信息

Dhingra Aarushi, Fiorentini Gianluca, Fouda Ayman, Moy Naomi

机构信息

Department of Economics, University of Bologna, Bologna, Italy.

MCI Management Center Innsbruck, Innsbruck, Austria.

出版信息

Eur J Health Econ. 2025 Sep 2. doi: 10.1007/s10198-025-01826-y.

Abstract

This paper investigates the effects of regulations aiming to optimise the multi-agency relationships, with a focus on the prescription choice between generic versus branded medications. In 2012, Italian legislators introduced two laws targeting general practitioners prescription behaviour, a soft (recommendations) law followed by a hard (mandatory) law to promote generic medication. We implement a regression discontinuity in time framework and an event study to quarterly administrative data for individuals with chronic kidney disease linked to data from their general practitioners in Emilia-Romagna, Italy. The results indicate that the policies were effective, but had modest effects on increasing the prescription of generic medications. Hard laws seem to have played a key role in driving this change. Heterogeneity checks provide evidence that less competition among GPs and interaction with specialists increased generic medication prescriptions.

摘要

本文研究旨在优化多机构关系的法规的影响,重点关注通用药物与品牌药物之间的处方选择。2012年,意大利立法者出台了两项针对全科医生处方行为的法律,先是一项软性(建议性)法律,随后是一项硬性(强制性)法律,以推广通用药物。我们对意大利艾米利亚 - 罗马涅地区慢性肾病患者的季度行政数据实施了时间框架内的回归断点设计和一项事件研究,并将这些数据与他们全科医生的数据相联系。结果表明,这些政策是有效的,但在增加通用药物处方方面效果有限。硬性法律似乎在推动这一变化中发挥了关键作用。异质性检验提供的证据表明,全科医生之间竞争较少以及与专科医生的互动增加了通用药物的处方量。

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