Global Health Security Agenda: GHSA Biosafety and Biosecurity Action Package (GHSA Action Package Prevent-3)

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Global Health Security Agenda: GHSA Biosafety and Biosecurity Action Package (GHSA Action Package Prevent-3)

Five-Year Target: A whole-of-government national biosafety and biosecurity1 system is in place, ensuring that especially dangerous pathogens2 are identified, held, secured and monitored in a minimal number of facilities according to best practices; biological risk management training and educational outreach are conducted to promote a shared culture of responsibility, reduce dual use risks, mitigate biological proliferation and deliberate use threats, and ensure safe transfer of biological agents; and country-specific biosafety and biosecurity legislation, laboratory licensing, and pathogen control measures are in place as appropriate.

As Measured by: Number of countries who have completed/Completion of a national framework and comprehensive oversight system for pathogen biosafety and biosecurity, strain collections, containment laboratories and monitoring systems that includes identification and storage of national strain collections in a minimal number of facilities.

Desired National Impact: 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 country, including research, diagnostic and biotechnology facilities. A cadre of biological risk management experts possesses the skillset to train others within their respective institutions. Strengthened, sustainable biological risk management best practices are in place using common educational materials. Rapid and culture-free diagnostics are promoted as a facet of biological risk management. The transport of infectious substances will also be taken into account.

Country Commitments to Action Package:

  • Leading countries: Canada, Denmark, Kenya, Peru, Portugal, Spain
  • Contributing countries: Azerbaijan, Germany, India (to be confirmed), Jordan, Republic of Korea, United Kingdom, United States
  • Contributing international organizations: FAO, IAEA, INTERPOL, OIE, WHO

Five-Year Action Items:

  1. Develop and implement a strategic plan for biosafety and biosecurity.
  2. Develop, modernize, enact, and sustain country-specific legislation to support a national program.
  3. Develop, implement, and sustain a national oversight program for pathogen biosafety and biosecurity that will incorporate biological risk evaluations of the nation’s biological entities; the creation of a legal framework and legal authorities; a multi-sectoral approach; the design and construction of the oversight program; the assessment and establishment of best practices to be put in place in laboratories and facilities; the training of national officials on biological risk evaluation; and existing security arrangements.
  4. Establish a new (or mandate an existing) government agency to administer and enforce biosafety and biosecurity oversight systems; creation of the country’s list of agents of concern; and development of best practices, information material and tools for government and other entities. Activities should be conducted to ensure that agents are identified, licensed, transported, secured, monitored, and disposed of in a minimum number of facilities with biosafety and biosecurity best practices in place.
  5. Integrate field investigation and emergency response capability as an important part of the national program.
Baseline Assessment and Planning Activities
  1. Develop a strategic plan—informed by a policy framework and including best practices and model national programs—to guide the development and implementation of a national whole-of-government oversight program for pathogen biosafety and biosecurity.
  2. Identify common educational training materials and personnel to be trained as trainers. Implement biological risk management training and educational outreach to promote a shared culture of responsibility, awareness and reduction of dual use biological risks. Develop tools and identify opportunities to assist trainees in implementing new skills at their institutions—or more broadly within their country or region—to train cadres of biological risk management professionals. Conduct national and/or regional training events.
  3. Promote sustainable, rapid and culture-free diagnostic methods for biosurveillance as part of biological risk management and support development and training in such methods.
  4. Work with other countries to develop a policy development protocol to be used to initiate the development and/or refinement of a national biosafety and biosecurity framework. This protocol will begin with an in-depth issues analysis to explore the following policy considerations: outstanding risks to public health and safety and national security (gap analysis); environmental scan of stakeholder groups and behavior profiling; international comparison; national and state challenges or limitations; social and economic considerations; required controls and authorities; options considered; recommended option for moving forward; and expected impact to stakeholders.
  5. Share models, approaches and regional best practices to assist in developing and implementing legally embedded national programs for pathogen biosafety and biosecurity that would address risks posed by a range of activities involving pathogens: possessing, handling, using, producing, storing, permitting access to, transferring, importing, exporting, and releasing or otherwise abandoning. Assistance should include a nationwide assessment of risks in laboratories and facilities by trained biosafety and biosecurity evaluation officials, and where appropriate, biosafety and biosecurity enhancements. Legal authority must be provided to conduct these assessments, to develop elements of the biological risk management oversight program, to train officials in conducting biological risk assessments and identifying mitigating solutions to biological risks, and to implement sustainable programs of bio-risk assessment and oversight.
  6. Strengthen and sustain biological risk management best practices with partner countries by training a qualified group of staff members at priority institutions using common educational materials, including biosafety and biosecurity components. Trainings can utilize existing curricula and training models. Newly trained personnel will maintain biological risk management training and training of other trainers with global partners. In-kind contributions will include the provision of expert trainers, materials, and common educational materials.
Monitoring and Evaluation Activities
  1. Monitor and evaluate the impact of the national program and provide recommendations for future enhancements.

1 Biological Risk Management: The analysis of ways and development of strategies to minimize the likelihood of the occurrence of biorisks (i.e. the probability or chance that a particular adverse event, including accidental infection or unauthorized access, loss, theft, misuse, diversion or intentional release, possibly leading to harm, will occur).
2 In this context, especially dangerous pathogens include biological agents and toxins capable of producing significant adverse health and economic effects due to an uncontrolled or intentional release within or outside the laboratory.