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Global Health Security Agenda Introducing an Analytical Approach to Strengthen Global Capacity for Pathogen Biosafety and Biosecurity
Global Health Security Agenda
Introducing an Analytical Approach to Strengthen Global Capacity for Pathogen Biosafety and Biosecurity
Overview • Global Health Security Agenda (GHSA) was launched in February 2014
and is a growing partnership of more than 50 nations, plus international organizations and non-governmental stakeholders
• Purpose of GHSA is to build and strengthen country capacities to create a world safe and secure from infectious disease threats, and to elevate global health security as a national and global priority
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Purpose of the GHSA • Focus political attention and technical action
to accelerate health security capacity building in 11 areas
• Highlight measurable approaches countries can adopt
• Provide a mechanism for collaboration and sharing of best practices
• Stimulate collaborative action between leading and contributing countries
Outline • Each Action Package has a five-year national
target to focus efforts, with specific measures and desired impacts to guide implementation over time
• A member country agrees to support Action Package implementation
• Support could include financial resources, providing subject matter expertise, sharing lessons learned and best practices, or developing replicable models that can be implemented elsewhere
Biosafety and Biosecurity Action Package
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Leading Countries: Canada, Denmark, Kenya, Peru, Portugal, and Spain Contributing Countries: Azerbaijan, Finland, Germany, Ghana, India, Indonesia, Jordan, Republic of
Korea, Saudi Arabia, Singapore, Tanzania, Uganda, United Kingdom, and United States Contributing International Organizations: FAO, IAEA, INTERPOL, OIE, and WHO
• The Action Package aims to promote national biosafety and biosecurity by providing tools and training for the development, implementation, and maintenance of national biosafety and biosecurity frameworks and oversight systems.
• Both biosafety and biosecurity aim to ensure that pathogens are identified, secured, and monitored appropriately.
o Biosafety – Focuses on preventing the accidental release of pathogens by promoting national standards of practice for their safe handling and secure laboratory containment.
o Biosecurity – Focuses on preventing the intentional release of pathogens by having adequate controls in place at the institutional level to mitigate biosecurity risks, including up-to-date inventories of pathogens and plans for physical and personnel security.
Five-Year National Target A whole-of-government national biosafety and biosecurity system is in place, ensuring that:
1. Especially dangerous pathogens are identified, held, secured and monitored in a minimal number of facilities according to best practices
2. Biological risk management training and educational outreach are conducted to:
a. Promote a shared culture of responsibility b. Reduce dual-use risks c. Mitigate biological proliferation and deliberate use threats d. Ensure safe transfer of biological agents
3. Country-specific biosafety and biosecurity legislation, laboratory licensing, and pathogen control measures are in place, as appropriate
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Biosafety and Biosecurity Analytical Approach • In 2014, Canada made a commitment to help build capacity in the area of
national program development for pathogen biosafety and biosecurity
• To support this commitment, Centre for Biosecurity at the Public Health Agency of Canada (PHAC) developed an analytical approach that could assist countries with the development of their national policies and oversight systems for pathogen biosafety and biosecurity
– Scalable step-by-step process that can be used by regional, national or local authorities
– Provides a structure for critical thinking that will assist with clarifying and defining country-specific issues, and identifying feasible solutions
– Supports risk management for both moderate and high risk pathogens and toxins using safety and security lenses
– Includes practical guidance, overview of common policy instruments, and options for combining them into a national program
– Assists officials to identify and prepare a sound recommendations to decision-makers
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Benefits of the Analytical Approach • Part of a suite of integrated products to help build global biosafety and biosecurity
capacity (e.g., International Health Regulations capacity assessment tools, Global Partnership Program biological security education resources, Denmark’s Biosecurity Handbook)
• Provides a country or region with an approach that could be used, in whole or in part, to ask and answer their own questions in an effort to identify local solutions that respond to identified issues and risks
• Stresses the importance of outreach and engagement in an effort to get to know the various people and populations that are implicated in the issue and including them to be part of a solution
• Includes identification of the root causes of a biosafety and biosecurity-related issue
• Encourages the development of solutions that are practical and sustainable
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Analytical Approach
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Benefits of Piloting the Analytical Approach • Through piloting of the analytical approach, pilot countries would:
– Benefit from international support to advance GHSA road maps, or address
gaps identified during capacity assessment (e.g., Joint External Evaluation, International Health Regulations);
– Increase understanding of local biosafety and biosecurity challenges and identify possible solutions; and
– Contribute to the improvement of the analytical approach and international efforts to develop, implement, and maintain national biosafety and biosecurity frameworks and oversight systems for pathogen biosafety and biosecurity.
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Commitments Prior to initiation of the pilot, Canada and the pilot country will develop and agree on the Terms of Reference for the engagement, which may include the following elements. • Canada is committed to:
– Engaging in a meaningful and appropriate manner for the context of the pilot country; – Documenting lessons learned and using them to validate the usefulness and
relevance of the analytical approach to the target audience; and – Integrating the feedback and experiences gained through the pilot to inform the
second edition of the analytical approach.
• The pilot country must commit to: – Designating a resource to support the planning and delivery of the pilot; – Participating in the pilot; – Documenting and sharing lessons learned; and – Setting a concrete plan for moving towards development and/or strengthening of
national oversight frameworks for the safe use and secure containment of pathogens and toxins.
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Current Status and Timelines Canada is presently finalizing the first edition of the analytical approach, and is soliciting priority countries or regions to pilot the approach.
Timelines
November 2016: First edition of the analytical approach finalized
December 2016 to December 2017: First edition of the analytical approach piloted in up to five priority countries and lessons learned documented and used to inform future revisions
January 2018: Second edition of the analytical approach finalized
Spring 2018: Second edition of the analytical approach endorsed by GHSA APP3 members
Activities beyond set commitment will be informed by the future of the GHSA initiative
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Overview of the Pilot
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1. Review background information 2. Agree to participate in the pilot and identify the country lead
3. Identify the core team and designate resources for the duration of the pilot 4. Virtually/In-person meet with the representatives from Canada to discuss and agree on the
logistics/scope of the pilot by developing and agreeing on a Terms of Reference
5. Research and provide preliminary background on the countries' current state of biosafety and biosecurity efforts
6. Participate in an in-depth (approximately half a day) virtual meeting with Canadian officials to go through the analytical approach, discuss current status of biosafety and biosecurity efforts, and agree on the details of future engagements
7. Define and complete preliminary analysis of the issue
8. Pilot country to lead the logistics of organising the pilot workshop and identify local participants 9. Canada, with input from the pilot country, to lead the technical planning of the face-to-face pilot
workshop
10. Canada to facilitate the pilot workshop 11. Canada and the pilot country to capture the lessons learned 12. Pilot country to develop an approach to address the identified issue
13. Canada to facilitate pilot country sharing lessons learned to improve approach 14. Pilot country to report on the progress (approximately 3-6 months following the workshop)
Agree to participate
Agree on the logistics
Research the issue
Plan the workshop
Deliver the workshop
Report on and share lessons learned
Confirmation of Participation
Readiness Check-in
Readiness Check-in
Enquiries
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Anastasia Rogaeva Centre for Biosecurity, Public Health Agency of Canada
Copies of this presentation are available in English and French by e-mail request.
• Develop an issue statement that defines the public health, safety and/or security challenge that is being targeted through the analysis. For example:
– Safe response to outbreaks – Ability to track work with dangerous pathogens – Accidental or deliberate release – Pathogens with dual-use capabilities, emerging technology
• Identify and assess what is contributing to the issue. For example:
– Gaps in or dated legal authorities for government oversight – Proliferation threats and the stockpiling of bioweapons – Risk of equipment failure, dangerous pathogens, lack of biosafety training,
infrastructure
• Identify and assess who is contributing to the issue by looking at pathogen and toxin users in various sectors and their attitudes, knowledge, and behaviors. For example:
– Academia, industry, government, human and animal health, distributors, healthcare – Limited knowledge of biosafety and biosecurity risks, history of non-compliance
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Step 1 Understand the Issue
Step 2 Set Objectives
• Establish guiding principles and criteria that are important for the country or region – A national oversight program should be measured, risk-based, scalable, and
sustainable
• Identify and understand key stakeholders and their needs and wants – Groups or organizations likely to be affected by proposed changes
• Other government departments • Laboratory managers, researchers and workers • Healthcare professionals • Business owners • General public
• Identify and assess critical intervention points or opportunities for strengthening
oversight – Handling and storage of pathogens, transportation and transfers, recruitment of
researchers, import and export of pathogens and toxins
• Clarify policy objectives and expected outcomes – Review the issue statement and reword into positive public policy objectives and sub-
objectives
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Step 3 Move Towards Solutions • Identify and assess various policy instruments that could help reduce identified risks
– National standard that sets out requirements for laboratory containment and operational practices, training, licensing, security clearances, legislation
– Work through additional considerations (e.g., strategies on how to deliver policy instruments such as, compliance and enforcement, training, stakeholder outreach and engagement efforts)
• Select and combine policy instruments into national program options – Determine which approach (e.g., a new/revised legislation, a licensing scheme,
inspections) is ideal and feasible to change behavior and mitigate risks posed by pathogens and toxins
• Test options – Characterize positive and negative impacts of the proposed approach – Assess receptiveness of the stakeholders (e.g., pathogen and toxin user community,
management, other government departments) towards the new/revised national program options
• Make a recommendation – Assess program options (including the cost, time and resources required to support) – Help prepare for the proposing of the recommended option
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Step 4 Build the Program
• Plan for implementation – Transition into program development by using sound project planning and
management approaches
• Set performance indicators – Measure and report on the success of the program by identifying performance
measurement strategy
• Implement the plan for program development – Utilize sound program monitoring and evaluation practices – Anticipate and respond to the need for course corrections
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Overview: Face-to-Face Workshop • An interactive face-to-face workshop, in English or French, will be held at the
pilot country for the duration of three (3) days – Resources are available to the pilot country to support the planning, delivery, and
participation at the workshop
• The workshop will be open to the identified participants by the country lead and may include government policy analysts, program managers, and biosafety and biosecurity subject matter experts
• Canadian biosafety and biosecurity government official and a trained facilitator will be present in-person
• At the workshop, participants will benefit from: – Facilitated discussion – Knowledge transfer through guided instructions – Case studies – Group work and discussion – Self-guided work sheets
• Feedback and input will be solicited at the end of the workshop
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