The Next Capacity-Building Project: The IEGBBR Model of Standardized Regulatory Practices for Biosafety and Biosecurity Incidents

The IEGBBR’s next international capacity-building reference tool will aim to serve as a basis for national regulatory authorities to develop or strengthen their regulatory oversight of biosafety and biosecurity incidents. To undertake this project, we will collect, collate and analyze current practices around biosafety and biosecurity incident reporting and the associated regulatory response from the established oversight systems of the IEGBBR members. The most well-known type of incident that would fall within the scope of this project would be laboratory accidents. However, the scope of the project includes both biosafety and biosecurity incidents, and both exposure and non-exposure events.

National governments will be able to use the IEGBBR model to develop their oversight systems to prevent and manage the risks of biosafety and biosecurity incidents and to strengthen the associated regulatory response. If the model was implemented by multiple countries, an international analysis of incidents would be possible and would provide meaningful data that could be leveraged to contribute to international biosafety and biosecurity capacity-building. A global alignment of incident reporting would set the base for international comparisons and enhance data sharing, which would in turn contribute to global health security.

IEGBBR capacity-building tools and information can be used regardless of the level of development or resources in a beneficiary country, and can reduce the need for extensive legwork or environmental scanning of international oversight systems.

8th Biennial Meeting Report of the IEGBBR

Due to pandemic impacts, the IEGBBR hosted its 8th biennial meeting virtually on March 3rd and 11th, 2021, to discuss challenges encountered with regulatory biosafety and biosecurity oversight during the COVID-19 pandemic. The pandemic provided a situation that tested the national biosafety and biosecurity oversight systems of the IEGBBR member countries. Despite all the pandemic planning and preparations undertaken well in advance of the COVID-19 pandemic and the established oversight systems of IEGBBR member countries, an event of this scale and duration presented numerous challenges.

The goal of the meeting was therefore to develop reference materials that could assist other countries in their pandemic response, based on the knowledge and expertise of IEGBBR member countries. The IEGBBR meeting report is intended to serve as capacity-building information to benefit biosafety and biosecurity oversight systems in the broader global community, towards increased global health security with respect to SARS-CoV-2 and other biological agents posing a public health risk.

The IEGBBR meeting report indicates that regulators largely relied upon available national regulatory tools to respond to the COVID-19 pandemic. The existing legislative biosafety and/or biosecurity frameworks in IEGBBR member countries were generally structured to allow effective public health response to any pandemic, including the COVID-19 pandemic. There was a consensus that regulatory oversight should not impede efforts necessary for public health service or response during the COVID-19 pandemic, but at the same time would provide appropriate biosafety and biosecurity guidance and recommendations to allow the necessary work to proceed safely. Areas where regulators experienced significant challenges included adapting the regulatory oversight programs to allow for pandemic response, handling of human clinical COVID-19 diagnostics, risk assessment and dual-use issues, risk group categorization, transport of specimens, the interface of human and animal pathogen oversight, identifying occupational exposure, and emerging technology. The meeting report expands on each of these areas and describes lessons learned and challenges experienced during the COVID-19 pandemic by IEGBBR member countries. The meeting concluded on the premise that the biosafety and biosecurity oversight systems will have to be adapted according to the future path of the COVID-19 pandemic, which remains unknown.

The eight-page meeting report is available for download.

Additional IEGBBR Work

The IEGBBR shares knowledge and experience and provides lessons learned from the perspectives of their established regulatory systems, in order to coordinate and lead concurrent projects related to the international alignment, strengthening, and advancement of biosafety and biosecurity oversight. Through the Secretariat, the IEGBBR is in a position to influence and help advance key priority areas, including the following initiatives:

  • Poliovirus containment – World Health Organization and Global Polio Eradication Initiative Global Action Plan (GAPIII) biorisk management
  • Multi-regional, multi-economy perspectives provided in feedback to World Health Organization on the draft of the fourth edition of the Laboratory Biosafety Manual
  • Global Health Security Agenda Action Package Prevent 3 (APP3)

International Biosafety and Biosecurity Capacity-Building

Each of the 11 IEGBBR member countries has their own well-established regulatory regime in place, governing the federal or national biosafety and biosecurity of human and animal pathogens as well as oversight for dual-use issues in the life sciences. This makes the IEGBBR uniquely suited as a source of assistance and expertise for countries wishing to develop their own biosafety and biosecurity regulatory oversights.

The IEGBBR can serve as a focal point for the promotion of effective biosafety and biosecurity regulation internationally, including the building of capacity in fields such as inspections, risk assessment, and safety and security measures, and as a source of technical assistance for other countries that aim to develop or strengthen their national biosafety and biosecurity capacities.

IEGBBR member countries undertake bilateral work to develop or strengthen regulatory biosafety and biosecurity capacity, such as the Danish-Kenyan Biosecurity Partnership Program or the projects undertaken in Uganda by the Netherlands, in keeping with their commitments to international biosafety and biosecurity initiatives and agreements.

International Biosafety and Biosecurity Initiatives for which IEGBBR expertise can be leveraged

International Biosafety and Biosecurity Initiatives for which IEGBBR expertise can be leveraged.

IEGBBR Capacity-Building Reference Materials

The composition of the IEGBBR makes it uniquely suited to identify possible approaches for interoperability, enhanced compatibility, and regulatory convergence in the day-to-day implementation of biosafety and biosecurity operational activities. Associated capacity-building reference materials would represent practical information that could be used by international stakeholders towards the establishment or strengthening of day-to-day biosafety and biosecurity activities that form a part of the system of regulatory oversight. These reference materials can guide countries in the implementation of their oversight frameworks and will therefore further strengthen global health security.

Reference materials under development include a standardized core incident reporting model and a generic laboratory inspection checklist.

Unlike in traditional capacity building, the IEGBBR develops reference tools and materials that are relevant to all countries, including developing countries and countries such as the IEGBBR members that already have established biosafety and biosecurity oversight frameworks. This is due to the universal nature of the IEGBBR’s reference materials that can benefit the international community, regardless of level of development or resources.