Abstract
The pervasive nature of infections causing major outbreaks have elevated biosafety and biosecurity as a fundamental component for resilient national laboratory systems. In response to international health security demands, the Global Health Security Agenda emphasizes biosafety as one of the prerequisites to respond effectively to infectious disease threats. However, biosafety management systems (BMS) in low-medium income countries (LMIC) remain weak due to fragmented implementation strategies. In addition, inefficiencies in implementation have been due to limited resources, inadequate technical expertise, high equipment costs, and insufficient political will. Here we propose an approach to developing a strong, self-sustaining BMS based on extensive experience in LMICs. A conceptual framework incorporating 15 key components to guide implementers, national laboratory leaders, global health security experts in building a BMS is presented. This conceptual framework provides a holistic and logical approach to the development of a BMS with all critical elements. It includes a flexible planning matrix with timelines easily adaptable to different country contexts as examples, as well as resources that are critical for developing sustainable technical expertise.
Highlights
Before the recognition of the importance of biosafety at the World Health Organization’s 58th World Health Assembly in 2005, biosafety has received increased attention in global health capacity building projects
Composed of 11 “action packages,” including biosafety and biosecurity, Global Health Security Agenda (GHSA) aims to reduce the ability of dangerous pathogens spreading rapidly within and across borders [2]
In the biosafety-biosecurity action package of the GHSA, the overarching goals are the: “Implementation of a comprehensive, sustainable and legally embedded national oversight program for biosafety and biosecurity, including the safe and secure use, storage, disposal, and containment of pathogens found in laboratories and a minimal number of holdings across the Laboratory Biosafety Management Approach country, including research, diagnostic and biotechnology facilities
Summary
Before the recognition of the importance of biosafety at the World Health Organization’s 58th World Health Assembly in 2005, biosafety has received increased attention in global health capacity building projects. BMS is based on a management system approach, which enables an organization to effectively identify, assess, control, and evaluate the biosafety and biosecurity risks inherent in its activity [7]. They typically have focused only on few key elements of a national BMS, usually due to various constraints, such as budgetary limitations, time, or a limited understanding of what is a BMS [4,5,6, 8]. 16.2 Issue an official classification of pathogen by risk group (for human, animal and environment)
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