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制药企业诚信监管策略中的寻租行为及政府奖惩机制考量

Pharmaceutical enterprises integrity supervision strategy when considering rent-seeking behavior and government reward and punishment mechanism.

作者信息

Chen Yanhua, Zhu Lilong

机构信息

School of Business, Shandong Normal University, Ji'nan, China.

Quality Research Center, Shandong Normal University, Ji'nan, China.

出版信息

PLoS One. 2025 May 19;20(5):e0320964. doi: 10.1371/journal.pone.0320964. eCollection 2025.

DOI:10.1371/journal.pone.0320964
PMID:40388539
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12088600/
Abstract

The integrity of pharmaceutical enterprises is crucial to public health, social stability, and national security, consistently garnering attention from both the government and society. The efficiency of pharmaceutical integrity supervision is closely linked to government oversight mechanisms and the behaviors of third-party testing agencies. This study constructs an evolutionary game model that incorporates rent-seeking dynamics and introduces a reward-punishment mechanism, integrating drug production enterprises, third-party testing agencies, government regulators, and drug wholesale enterprises. By solving for the stable equilibrium points of each participant's strategic choices and analyzing the stability of strategy combinations using Lyapunov's first method, the study employs Matlab 2022b for simulation analysis to verify the impact of various decision variables on the strategic choices of different entities. The findings reveal that: 1) The rejection of rent-seeking by third-party testing agencies enhances the incentives for drug production enterprises to operate with integrity, indicating that the government should increase penalties for accepting rent-seeking behavior. 2) Drug wholesale enterprises' reporting likelihood increases production enterprises' integrity and third-party testing agencies' rejection of rent-seeking, inversely tied to reporting costs. 3) Reducing the costs of stringent government supervision and increasing the speculative costs of rent-seeking for third-party testing agencies help prevent dishonest practices among drug production enterprises. 4) A well-designed reward and punishment mechanism facilitates a synergistic environment of government supervision, self-discipline among pharmaceutical enterprises, and social harmony. This paper enriches the theoretical foundation of pharmaceutical integrity supervision and offers pertinent countermeasures and recommendations.

摘要

制药企业的诚信对公众健康、社会稳定和国家安全至关重要,一直受到政府和社会的关注。药品诚信监管的效率与政府监管机制和第三方检测机构的行为密切相关。本研究构建了一个包含寻租动态的演化博弈模型,并引入奖惩机制,涉及药品生产企业、第三方检测机构、政府监管部门和药品批发企业。通过求解各参与者战略选择的稳定均衡点,并运用李雅普诺夫第一方法分析战略组合的稳定性,本研究采用Matlab 2022b进行仿真分析,以验证各种决策变量对不同实体战略选择的影响。研究结果表明:1)第三方检测机构拒绝寻租增强了药品生产企业诚信经营的激励,表明政府应加大对接受寻租行为的处罚力度。2)药品批发企业的举报可能性提高了生产企业的诚信度和第三方检测机构拒绝寻租的程度,与举报成本成反比。3)降低政府严格监管的成本,增加第三方检测机构寻租的投机成本,有助于防止药品生产企业的不诚信行为。4)设计完善的奖惩机制有助于营造政府监管、制药企业自律和社会和谐的协同环境。本文丰富了药品诚信监管的理论基础,并提供了相关的对策和建议。

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本文引用的文献

1
Question-based review for pharmaceutical development: An enhanced quality approach.基于问题的药物研发综述:一种增强的质量方法。
Eur J Pharm Biopharm. 2024 Feb;195:114174. doi: 10.1016/j.ejpb.2023.114174. Epub 2023 Dec 29.
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Quality by Design in Pharmaceuticals: A Review of its Impact on Regulatory Compliance and Product Quality.药品质量源于设计:对其对法规合规性和产品质量影响的综述
Drug Res (Stuttg). 2024 Jan;74(1):18-23. doi: 10.1055/a-2185-4916. Epub 2023 Dec 22.
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The quality of drugs and drug products - Always guaranteed?
药品和药物产品的质量 - 始终有保证吗?
J Pharm Biomed Anal. 2024 Feb 15;239:115880. doi: 10.1016/j.jpba.2023.115880. Epub 2023 Dec 10.
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Drug Saf. 2024 Mar;47(3):217-225. doi: 10.1007/s40264-023-01385-2. Epub 2023 Dec 11.
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Tackling Counterfeit Drugs: The Challenges and Possibilities.打击假药:挑战与可能性。
Pharmaceut Med. 2023 Jul;37(4):281-290. doi: 10.1007/s40290-023-00468-w. Epub 2023 May 15.
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Pharmaceutical enterprises drug quality strategy analysis considering government supervision and new media participation.考虑政府监管和新媒体参与的制药企业药品质量策略分析。
Front Public Health. 2023 Jan 17;10:1079232. doi: 10.3389/fpubh.2022.1079232. eCollection 2022.
7
The capacity of young national medicine regulatory authorities to ensure the quality of medicines: case of Rwanda.年轻的国家药品监管当局确保药品质量的能力:卢旺达的情况
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Combatting Substandard and Falsified Medicines: Public Awareness and Identification of Counterfeit Medications.打击劣药假药:公众对假药的认知与识别。
Front Public Health. 2021 Oct 26;9:754279. doi: 10.3389/fpubh.2021.754279. eCollection 2021.
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Digitalization in pharmaceutical industry: What to focus on under the digital implementation process?制药行业的数字化:在数字化实施过程中应关注什么?
Int J Pharm X. 2021 Oct 6;3:100095. doi: 10.1016/j.ijpx.2021.100095. eCollection 2021 Dec.