在“专利保护—市场定价”的知识产权逻辑下,公立医院产出的临床指南、诊疗方案与管理工具等成果因缺乏适配的估值框架而难以确权,陷入“高社会价值、低经济回报”的困境。这类“不可专利、难定价”的临床知识成果,不仅抑制了医院的创新激励,更因缺乏可被支付方识别的证据形态与标准化载体,难以融入医保支付与监管体系,致使本可提升疗效、规范行为、优化成本的临床知识无法转化为基金使用效能的提升,制约了“价值医疗”的实现。为此,本文基于公共物品与公共价值理论,提出“临床公共物品”这一核心概念,并构建临床知识成果的分层分类体系：将药物等可申请专利成果归入传统知识产权资产轨道;而将临床指南、路径、管理模式与量化工具等划归为临床公共物品范畴。进而,本文建构了“知识产权资产—临床公共物品”双轨治理框架,将后者细分为证据类、标准类、管理类与工具类,并指出其价值需通过制度采纳与规模实施方能转化为健康收益。为破解价值转化难题,本文设计出“政策准入—数据资产化—权益许可”三位一体的实现路径。该路径以政策准入打开制度接口,以合规数据治理夯实证据基础,以权益许可与服务输出促进规范传播与可持续供给,从而为研究型医院非专利临床成果的识别、治理与激励提供了一套清晰、可行的操作方案。
Abstract
Under the prevailing intellectual property logic of “patent protection-market pricing”, outputs from public hospitals—such as clinical guidelines, diagnostic and therapeutic protocols, and management tools—cannot secure patent rights due to the lack of a suitable valuation framework. This situation traps these outputs in a dilemma of high social value but low economic return. These “non-patentable, difficult-to-price” clinical knowledge products not only undermine hospitals' incentives for innovation but also, more critically, due to the absence of payer-recognizable evidentiary forms and standardized vehicles, struggle to enter the healthcare payment and regulatory systems. Consequently, clinical knowledge that could enhance efficacy, standardize practices, and optimize costs fails to translate into fund utilization efficiency, thereby hindering the realization of “value-based healthcare”. To address this, this paper, grounded in public goods and public value theory, introduces the concept of “clinical public goods” and constructs a hierarchical classification system for clinical knowledge outputs. Patentable outputs like pharmaceuticals continue to follow the traditional intellectual property asset logic, while items such as clinical guidelines, pathways, management models, and quantitative tools fall under the category of clinical public goods. Building on this, the paper proposes a dual-track governance framework of “intellectual property assets-clinical public goods”. Clinical public goods are further classified into evidence-based, standard-setting, management, and tool-oriented types, with their value realized through institutional adoption and scaled implementation leading to health gains. To promote value translation, the paper designs a three-pronged pathway: “policy access-data assetization-rights licensing”. Policy access opens institutional entry points, compliant data governance provides a sound evidence base, and rights licensing coupled with service delivery facilitates standardized dissemination and sustainable supply. This pathway provides a clear and actionable operational solution for identifying, governing, and incentivizing non-patent clinical outputs in research-oriented hospitals.
关键词
临床公共物品 /
非专利临床成果 /
双轨制治理 /
价值转化 /
医保支付
Key words
clinical public goods /
non-patent clinical outputs /
dual-track governance /
value conversion /
healthcare payment
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参考文献
[1] 彭东阁,陈晓静,万子叶,等.本地化部署DeepSeek R1模型在肿瘤科多任务临床场景中的应用与真实世界评估[J/OL].健康发展与政策研究, (2025-1-12) [2026-01-02].https://link.cnki.net/urlid/31.2200.R.20250917.1710.002.
[2] Frumkin L.Protocol development for investigator‐sponsored clinical studies[J]. Clinical and Translational Science, 2025, 18.
[3] Boaz A, Baeza J, Fraser A, et al.‘It depends': what 86 systematic reviews tell us about what strategies to use to support the use of research in clinical practice[J]. Implementation Science, 2024,19.
[4] 王畅,王蒲生.多主体共建转化医学创新生态系统的演化研究[J].中国软科学,2025(06):75-87.
[5] Latyntsev A.Proposals for the introduction of certificates of authorship instead of patents for methods of diagnosis and treatment[J]. Actual Problems of Russian Law, 2022, 142(9): 102-111.
[6] Prainsack B.Logged out: ownership, exclusion and public value in the digital data and information commons[J]. Big Data & Society, 2019, 6.
[7] 谢小勇. 数字赋能与制度革新:中国式现代化语境下知识产权治理现代化的理论解构与实践突破[J].知识产权,2025(09):27-51.
[8] 郭海玲,马红雨,吴利明,等.基于数据价值链的我国跨境健康医疗可信数据空间建设研究——以 《欧洲健康数据空间条例》为参照[J/OL].(2025-1-11) [2026-01-02]. https://link.cnki.net/urlid/11.1762.G3.20251225.1627.002.
[9] Mandelblatt J, Ramsey S, Lieu T, et al.Evaluating frameworks that provide value measures for health care interventions[J]. Value in Health, 2017, 20(2): 185-192.
[10] Bican P, Guderian C, Ringbeck A.Managing knowledge in open innovation processes: an intellectual property perspective[J]. Journal of Knowledge Management, 2017, 21: 1384-1405.
[11] Damschroder L, Aron D, Keith R, et al.Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science[J]. Implementation Science, 2009, 4: 50.
[12] Theobald S, Brandes N, Gyapong M, et al.Implementation research: new imperatives and opportunities in global health[J]. The Lancet, 2018, 392: 2214-2228.
[13] Arondekar B, Duh M, Bhak R, et al.Real-world evidence in support of oncology product registration: a systematic review of new drug application and biologics license application approvals from 2015-2020[J]. Clinical Cancer Research, 2021, 28: 27-35.
[14] Dopp A, Kerns S, Panattoni L, et al.Translating economic evaluations into financing strategies for implementing evidence-based practices[J]. Implementation Science, 2021, 16.
[15] Reeves P, Edmunds K, Searles A, et al.Economic evaluations of public health implementation-interventions: a systematic review and guideline for practice[J]. Public Health, 2019, 169: 101-113.
[16] Flight L, Brennan A, Chick S, et al.Value-adaptive clinical trial designs for efficient delivery of publicly funded trials - a discussion of methods, case studies, opportunities and challenges[J]. BMC Medical Research Methodology, 2025, 25.
[17] Naci H, Murphy P, Woods B, et al.Population-health impact of new drugs recommended by the National Institute for Health and Care Excellence in England during 2000-20: a retrospective analysis[J]. The Lancet, 2024, 405: 50-60.
[18] Maurer M, Lavelle M, Hilliard-Boone T, et al.Researcher and partner perspectives on the relationship between engagement in research and three uses of patient-centered comparative clinical effectiveness research study findings[J]. Research Involvement and Engagement, 2024, 10.
[19] Ippolito A, Sorrentino M, Capalbo F, et al.How technological innovations in performance measurement systems overcome management challenges in healthcare[J]. International Journal of Productivity and Performance Management, 2022.
[20] Endalamaw A, Khatri R, Mengistu T, et al.A scoping review of continuous quality improvement in healthcare system: conceptualization, models and tools, barriers and facilitators, and impact[J]. BMC Health Services Research, 2024, 24.
基金
首都卫生发展科研专项公共卫生重点项目“基于‘情景—任务—能力'视域下北京市公立医院重大传染病疫情卫生应急应对能力提升研究”（2024-1G-2013）
