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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.

DOI:10.1007/s10198-025-01826-y
PMID:40892190
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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Tough versus soft regulations to promote generic medications in Italy.意大利促进仿制药发展的严格监管与宽松监管
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本文引用的文献

1
Herding-like behaviour in medical decision making: An experimental study investigating general practitioners' prescription behaviour.羊群效应在医疗决策中的作用:一项关于全科医生处方行为的实验研究
PLoS One. 2024 Jul 8;19(7):e0297019. doi: 10.1371/journal.pone.0297019. eCollection 2024.
2
Methodological considerations for estimating policy effects in the context of co-occurring policies.在同时存在多项政策的背景下评估政策效果的方法学考量。
Health Serv Outcomes Res Methodol. 2023;23(2):149-165. doi: 10.1007/s10742-022-00284-w. Epub 2022 Jul 9.
3
Multimorbidity prevalence and patterns in chronic kidney disease: findings from an observational multicentre UK cohort study.
慢性肾脏病的多种合并症患病率和模式:来自英国多中心观察队列研究的结果。
Int Urol Nephrol. 2023 Aug;55(8):2047-2057. doi: 10.1007/s11255-023-03516-1. Epub 2023 Feb 21.
4
State Laws and Generic Substitution in the Year After New Generic Competition.新仿制药竞争一年后各州法律与仿制药替代情况
Value Health. 2022 Oct;25(10):1736-1742. doi: 10.1016/j.jval.2022.03.012. Epub 2022 Apr 26.
5
Attitude and Purchase Intention to Generic Drugs.对仿制药的态度和购买意愿。
Int J Environ Res Public Health. 2021 Apr 26;18(9):4579. doi: 10.3390/ijerph18094579.
6
Generic versus brand-name over-the-counter analgesics: knowledge and attitudes among Swedish pharmacy customers.非专利药与品牌名非处方镇痛药:瑞典药房顾客的认知与态度
J Pharm Policy Pract. 2020 Oct 1;13:60. doi: 10.1186/s40545-020-00269-5. eCollection 2020.
7
Polypharmacy in older people: time to take action.老年人的多重用药问题:是时候采取行动了。
Eur Geriatr Med. 2019 Feb;10(1):1-3. doi: 10.1007/s41999-018-0140-5. Epub 2018 Nov 30.
8
Ultra-low price of generic agents in China may weaken patients' drug recognition and compliance.中国仿制药的超低价格可能会削弱患者对药物的认知度和依从性。
Drug Discov Ther. 2020 May 6;14(2):103-104. doi: 10.5582/ddt.2020.01011. Epub 2020 Apr 15.
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Financial incentives and physician prescription behavior: Evidence from dispensing regulations.经济激励与医生处方行为:来自配药规定的证据。
Health Econ. 2019 Sep;28(9):1114-1129. doi: 10.1002/hec.3893. Epub 2019 Jul 1.
10
Physician altruism and moral hazard: (no) Evidence from Finnish national prescriptions data.医生利他主义与道德风险:(无)来自芬兰全国处方数据的证据。
J Health Econ. 2019 May;65:153-169. doi: 10.1016/j.jhealeco.2019.03.006. Epub 2019 Mar 19.