Side Events

Since the Covid-19 pandemic, unprecedented investments have been made to expand and modernize laboratory infrastructure worldwide. However, global heterogeneity in national regulations for biosafety and biosecurity, diversity in how laboratory facilities are managed and maintained, and laboratory staff training and competencies, continue to create vulnerabilities that can undermine both global health security and One Health preparedness. The adoption of performance-based standards with a continual improvement cycle, such as ISO 35001:2019, offers a pathway to harmonize safe, secure, and responsible laboratory operations, while allowing for local adaptation. Beyond reducing biological risks—whether accidental or deliberate—ISO 35001:2019 strengthens transparency, accountability, and partner confidence,  supporting evidence-based  funding decisions,  return-on-investment tracking, and equitable selection of research partners by clarifying operational and biorisk management expectations.

Despite its potential, ISO 35001:2019 has seen limited uptake globally. Common barriers include the perceived cost and complexity of implementation, lack of accredited certification pathways, restricted access to technical guidance, resistance to change and low visibility of the standard’s added value. However, a growing number of regional and international initiatives—spanning Africa, the Asia-Pacific, and Europe—are now piloting scalable, context-adapted implementation models. These efforts are generating practical tools and lessons that can inform future WHO and WHA-aligned frameworks (e.g., WHA Resolution 77.7) and other performance-based biosafety and biosecurity standards.