Health laboratory licensing: a policy and best-practice analysis.

IF 8.4 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
Bulletin of the World Health Organization Pub Date : 2025-06-01 Epub Date: 2025-05-03 DOI:10.2471/BLT.24.292760
Markus Huber, Madina Andreyeva, Lance D Presser, Joanna Salvi Le Garrec Zwetyenga
{"title":"Health laboratory licensing: a policy and best-practice analysis.","authors":"Markus Huber, Madina Andreyeva, Lance D Presser, Joanna Salvi Le Garrec Zwetyenga","doi":"10.2471/BLT.24.292760","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To gain insight into how governments regulate their health laboratory sector, by reviewing health laboratory licensing legislation across different health-care systems in a diverse range of 18 countries worldwide.</p><p><strong>Method: </strong>We selected countries for a diverse range of health-care systems, geography, income level, licensing legislation and standards adhered to. We selected aspects of health laboratory licensing that were consistently present in different countries and suitable for meaningful comparison, focusing on legislative approaches, certification and accreditation models, regulation, quality assurance, and biosafety and biosecurity requirements.</p><p><strong>Findings: </strong>Our analysis revealed that the licensing legislation for health laboratories typically encompasses two principal components: administrative procedural law and substantive law. We observed that the different ways in which countries regulate their health laboratories could be categorized within three distinct legislative approaches, namely: standalone licensing act, general licensing act and one based on a health insurance contract. Most countries used a two-step application process, comprising registration and licensing steps. License validity periods ranged over 1-5 years, with some countries opting for permanent licenses. Countries adopted diverse standards and requirements, with some mandating accreditation.</p><p><strong>Conclusion: </strong>Our findings highlight the diverse legislative approaches to health laboratory licensing, reflecting varying national capacities and regulatory priorities. Integrating robust quality standards, especially those aligned with International Organization for Standardization standard no. 15189, is essential for strengthening laboratory oversight and public health response. Effective licensing frameworks not only enhance domestic laboratory systems but also contribute to global health security through alignment with international obligations.</p>","PeriodicalId":9465,"journal":{"name":"Bulletin of the World Health Organization","volume":"103 6","pages":"383-391"},"PeriodicalIF":8.4000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12161156/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Bulletin of the World Health Organization","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2471/BLT.24.292760","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/5/3 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
引用次数: 0

Abstract

Objective: To gain insight into how governments regulate their health laboratory sector, by reviewing health laboratory licensing legislation across different health-care systems in a diverse range of 18 countries worldwide.

Method: We selected countries for a diverse range of health-care systems, geography, income level, licensing legislation and standards adhered to. We selected aspects of health laboratory licensing that were consistently present in different countries and suitable for meaningful comparison, focusing on legislative approaches, certification and accreditation models, regulation, quality assurance, and biosafety and biosecurity requirements.

Findings: Our analysis revealed that the licensing legislation for health laboratories typically encompasses two principal components: administrative procedural law and substantive law. We observed that the different ways in which countries regulate their health laboratories could be categorized within three distinct legislative approaches, namely: standalone licensing act, general licensing act and one based on a health insurance contract. Most countries used a two-step application process, comprising registration and licensing steps. License validity periods ranged over 1-5 years, with some countries opting for permanent licenses. Countries adopted diverse standards and requirements, with some mandating accreditation.

Conclusion: Our findings highlight the diverse legislative approaches to health laboratory licensing, reflecting varying national capacities and regulatory priorities. Integrating robust quality standards, especially those aligned with International Organization for Standardization standard no. 15189, is essential for strengthening laboratory oversight and public health response. Effective licensing frameworks not only enhance domestic laboratory systems but also contribute to global health security through alignment with international obligations.

卫生实验室许可:政策和最佳做法分析。
目的:通过审查全球18个国家不同卫生保健系统的卫生实验室许可立法,深入了解政府如何规范其卫生实验室部门。方法:我们根据不同的卫生保健系统、地理位置、收入水平、许可立法和遵守的标准选择国家。我们选择了卫生实验室许可的各个方面,这些方面在不同国家一直存在,适合进行有意义的比较,重点是立法方法、认证和认可模式、监管、质量保证以及生物安全和生物安全要求。结果:我们的分析表明,卫生实验室许可立法通常包括两个主要组成部分:行政程序法和实体法。我们注意到,各国管理其卫生实验室的不同方式可分为三种不同的立法方法,即:独立许可法、一般许可法和基于健康保险合同的立法方法。大多数国家采用两步申请程序,包括注册和许可步骤。许可证有效期超过1-5年,有些国家选择永久许可证。各国采用了不同的标准和要求,其中一些是强制性的认证。结论:我们的研究结果突出了卫生实验室许可的不同立法方法,反映了不同的国家能力和监管重点。整合强大的质量标准,特别是那些与国际标准化组织标准编号一致的标准。15189对加强实验室监督和公共卫生应对至关重要。有效的许可框架不仅加强了国内实验室系统,而且通过与国际义务保持一致,促进了全球卫生安全。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Bulletin of the World Health Organization
Bulletin of the World Health Organization 医学-公共卫生、环境卫生与职业卫生
CiteScore
11.50
自引率
0.90%
发文量
317
审稿时长
3 months
期刊介绍: The Bulletin of the World Health Organization Journal Overview: Leading public health journal Peer-reviewed monthly journal Special focus on developing countries Global scope and authority Top public and environmental health journal Impact factor of 6.818 (2018), according to Web of Science ranking Audience: Essential reading for public health decision-makers and researchers Provides blend of research, well-informed opinion, and news
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信