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

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.