Interagency collaboration to implement the International Health Regulations

1. Interagency collaboration to implement the International Health Regulations A Presentation for the 2009 USPHS Scientific & Training Symposium LCDR Maria Benke, MPH, CHES 1 June 2009

2. 1 Presentation Overiew Provide an overview of the International Health Regulations (IHR) Describe US government (USG) efforts to develop an IHR implementation plan Describe the USG assessment and implementation process Describe the role of the HHS Secretary’s Operation Center as the USG IHR National Focal Point

3. International Health Regulations: Overview Origins: 1851 International Sanitary Conference, Paris. International law agreed upon by Member States of the World Health Organization (WHO). Revised in 2005; 194 signatories. IHR (2005) Overarching Goals: Prevent, protect against, control, and respond to the international spread of disease. Avoid unnecessary interference with international traffic and trade. Reduce the risk of disease spread at international airports, seaports, and ground crossings. Adopted by the World Health Assembly in May 2005 – referred to as IHR(2005) HISTORY 1851: International Sanitary Conference in Paris 1951: WHO Member States adopted the International Sanitary Regulations (ISR) 1969: ISR replaced and renamed - International Health Regulations 1973 & 1981: minor modifications to 1969 Regulations May 23, 2005: WHA adopted revised International Health Regulations (2005) July 18, 2007: IHR enter into force in United StatesAdopted by the World Health Assembly in May 2005 – referred to as IHR(2005) HISTORY 1851: International Sanitary Conference in Paris 1951: WHO Member States adopted the International Sanitary Regulations (ISR) 1969: ISR replaced and renamed - International Health Regulations 1973 & 1981: minor modifications to 1969 Regulations May 23, 2005: WHA adopted revised International Health Regulations (2005) July 18, 2007: IHR enter into force in United States

4. 3 Major Changes from IHR(1969): Overview

5. 4 IHR Overview:Key Actions for IHR Compliance Establish a National IHR Focal Point (NFP) Strengthen the following core capacities for public health events: Disease surveillance and reporting Assessment and notification Response Assess and report potential public health emergencies of international concern (PHEIC) Provide routine inspection and control activities to prevent international disease spread at designated airports, ports and ground crossings Collaborate with other Member States and WHO concerning IHR implementation

6. 5 Public Health Emergency of International Concern (PHEIC) An extraordinary public health event that is determined: to constitute a public health risk to other States through the international spread of disease; and to potentially require a coordinated international response. PHEIC decision criteria (IHR Annex 2): Is the public health impact of the event serious? Is the event unusual or unexpected ? Is there a significant risk of international disease spread? Is there a significant risk of international travel or trade restrictions? The IHR defines a PHEIC as an extraordinary event which is determined to: (1) constitute a public health risk to other countries through international spread of disease and (2) to potentially need a coordinated international response. This slide lists the criteria in Annex 2 of the IHR. If any two of these four questions are “YES” then a determination should be made that a potential PHEIC exists. The potential PHEIC must be reported to WHO. WHO then makes the official determination of whether a PHEIC exists or not. ONLY WHO CAN DECLARE A PHEIC. Time requirements for DOMESTIC assessment and notification: 48 hours to assess an event once the national government becomes aware of it 24 hours to report a potential PHEIC if assessment indicates 24 hours to report a potential PHEIC outside of a Member State’s territory The IHR defines a PHEIC as an extraordinary event which is determined to: (1) constitute a public health risk to other countries through international spread of disease and (2) to potentially need a coordinated international response. This slide lists the criteria in Annex 2 of the IHR. If any two of these four questions are “YES” then a determination should be made that a potential PHEIC exists. The potential PHEIC must be reported to WHO. WHO then makes the official determination of whether a PHEIC exists or not. ONLY WHO CAN DECLARE A PHEIC. Time requirements for DOMESTIC assessment and notification: 48 hours to assess an event once the national government becomes aware of it 24 hours to report a potential PHEIC if assessment indicates 24 hours to report a potential PHEIC outside of a Member State’s territory

7. 6 PHEIC Determination This is Annex 2 of the IHR, of the decision instrument for the Assessment and Notification of Events that may constitute a PHEIC. It includes the list of conditions that are always notifiable to WHO – smallpox, polio, SARS, human influenza caused by a new subtype. It includes a list of conditions that are notifiable if the decision criteria are met, such as such as cholera, pneumonic plague, yellow fever, West Nile fever, and meningococcal disease. It includes the provision for any other event of potential international concern, including those of unknown causes or sources, to be notifiable, if the decision criteria are met. The criteria for assessment include the 4 major questions mentioned previously. If any 2 criteria are met, the condition is notifiable. In the US, assessment using this instrument is intended to take place at the national level. WHO officially classifies an event as a PHEIC after consultation with the Member State and other technical specialists, such as the WHO Emergency Committee. WALK THROUGH THE PHEIC REPORT FORM HEREThis is Annex 2 of the IHR, of the decision instrument for the Assessment and Notification of Events that may constitute a PHEIC. It includes the list of conditions that are always notifiable to WHO – smallpox, polio, SARS, human influenza caused by a new subtype. It includes a list of conditions that are notifiable if the decision criteria are met, such as such as cholera, pneumonic plague, yellow fever, West Nile fever, and meningococcal disease. It includes the provision for any other event of potential international concern, including those of unknown causes or sources, to be notifiable, if the decision criteria are met. The criteria for assessment include the 4 major questions mentioned previously. If any 2 criteria are met, the condition is notifiable. In the US, assessment using this instrument is intended to take place at the national level. WHO officially classifies an event as a PHEIC after consultation with the Member State and other technical specialists, such as the WHO Emergency Committee. WALK THROUGH THE PHEIC REPORT FORM HERE

8. 7 IHR Assessment and Implementation Timeline Entry into force 191 WHO Member States: June 15, 2007 U.S.: July 18, 2007 India: August 7, 2007 Montenegro: February 5, 2008 Assessment Phase 2007–2009: Assess the ability of existing national structures and resources to meet the minimum requirements described in Annex 1. Implementation Phase 2009-2012: Develop, strengthen, and maintain the minimum requirements described in Annex 1. The key date on this slide is July 18, 2007. This is the date the revised IHR entered into force for the United States. The IHRs entered into force for most member states on June 15, 2007 – two years after the revised were accepted by the World Health Assembly. Recall the reservation and understandings the USG submitted. The deadline for another member states to register an objection to the reservation was July 17th, 2007. This is why the IHR entered into force at a later date. The Assessment and Implementation Phases allow time for member states to assess their existing systems and work toward building the core capacities outlined in the IHR. The USG completed these actions and was fully compliant with the revised IHR by July 18, 2007. The key date on this slide is July 18, 2007. This is the date the revised IHR entered into force for the United States. The IHRs entered into force for most member states on June 15, 2007 – two years after the revised were accepted by the World Health Assembly. Recall the reservation and understandings the USG submitted. The deadline for another member states to register an objection to the reservation was July 17th, 2007. This is why the IHR entered into force at a later date. The Assessment and Implementation Phases allow time for member states to assess their existing systems and work toward building the core capacities outlined in the IHR. The USG completed these actions and was fully compliant with the revised IHR by July 18, 2007.

9. 8 U.S. IHR Assessment and Implementation: Overview Process: Collaboratively focused: 20 USG departments/agencies involved. Coordinated by the Department of Health and Human Services. ASPR Office of Medicine, Science and Public Health Oversight provided by the White House. Homeland Security Council and National Security Council Requirements: Identify IHR requirements and specific actions. Ensure USG partners have identified roles and responsibilities. Identify relevant non-USG stakeholders Develop outreach and education strategies. Assess and build upon (when possible) existing systems, policies, and procedures.

10. 9 USG Departments and Agencies Involved in IHR Implementation Partners in implementation this slide lists the 20 federal agencies in the U.S. that worked with DHHS to develop and approve the IHR implementation plan, all federal agencies relevant to an specific event would be expected to respond, regardless of whether they are listed on this slide or not, IAW the NRPthis slide lists the 20 federal agencies in the U.S. that worked with DHHS to develop and approve the IHR implementation plan, all federal agencies relevant to an specific event would be expected to respond, regardless of whether they are listed on this slide or not, IAW the NRP

11. 10 Interagency Assessment and Implementation Tool: The Matrix Table of all specific actions that address the requirements identified in the IHRs. Each action was assigned the following: Measure of performance Completion timeframe Working group Lead and support departments or agencies Legal authorities 97 individual actions were identified to address 66 Articles of the IHR. The Office of Medicine, Science and Public Health (OMSPH) within ASPR took the lead in coordinating the USG’s efforts to implement the revised IHR. The first step was to develop a specific action to address each requirement identified in each IHR article, to ensure full compliance with all of the requirements indicated in the IHR. Each action item was assigned: measure of performance summary of the associated article status and timeframe for tracking progress working group assignment lead and support departments/agencies with points of contact and relevant legal authorities. In all, there were # number of action items identified to meet the # articles specified in the IHR. In addition, there were # measures of performance needed to be met, against which compliance was assessed.The Office of Medicine, Science and Public Health (OMSPH) within ASPR took the lead in coordinating the USG’s efforts to implement the revised IHR. The first step was to develop a specific action to address each requirement identified in each IHR article, to ensure full compliance with all of the requirements indicated in the IHR. Each action item was assigned: measure of performance summary of the associated article status and timeframe for tracking progress working group assignment lead and support departments/agencies with points of contact and relevant legal authorities. In all, there were # number of action items identified to meet the # articles specified in the IHR. In addition, there were # measures of performance needed to be met, against which compliance was assessed.

12. 11 IHR Implementation Matrix

13. 12 IHR Work Groups National IHR Focal Point Lead Department: Health & Human Services Focus: Messaging to/from WHO and the U.S. National IHR Focal Point regarding potential PHEICs. U.S. Points of Entry Lead Department: Homeland Security Focus: Surveillance and health measures for people at points of entry (airports, seaports, and land border crossings). Health Measures for Conveyances Lead Department: Transportation Focus: Surveillance and health measures for baggage, cargo, containers, goods, and parcels. Education and Outreach Lead Department: Health & Human Services Focus: Creation of educational tools; stakeholder awareness-raising. Four working groups, or clusters, were established to ensure a coordinated approach to implementation National IHR Focal Point Cluster (HHS/ASPR – Keith Holtermann) Mission: Ensure communication flow regarding potential PHEICs Collaborate with partner dapartments and agencies to establish the process for communicating messages to/from WHO from the National Focal Point (HHS-SOC) about potential PHEICs. U.S. Points of Entry Cluster (DHS/OHA – Bill Lyerly) Mission: PHIEC prevention by ensuring persons do not facilitate the spread of disease Coordinate human surveillance and implementation of health measures (such as vaccination, health screenings and possibly quarantine) for persons at key points of entry, such as international airports, to recognize and contain transmission of a potential PHEICs Health Measures for Conveyances Cluster (DOT – Arnie Konheim) Mission: PHIEC prevention by ensuring conveyances do not facilitate the spread of disease Coordinate surveillance and implementation of health measures (such as issuing a ship sanitation certificate) for vessels, baggage, cargo, containers, goods and parcels that may be a source of infection or contamination, to prevent transmission of diseases that may lead to a potential PHEIC Education and Outreach Cluster (HHS/ASPA – Bill Hall) Mission: Ensure key stakeholders are aware of the revised IHR (no small task, given the extent the IHR covers) developed a comprehensive roll-out strategy for outreach to and education of both U.S. Government (USG) and non-USG IHR-relevant stakeholders: state, local, tribal, and territorial government entities, the public and private healthcare sector, professional organizations, international partners, NGOs, and the general public. Four working groups, or clusters, were established to ensure a coordinated approach to implementation National IHR Focal Point Cluster (HHS/ASPR – Keith Holtermann) Mission: Ensure communication flow regarding potential PHEICs Collaborate with partner dapartments and agencies to establish the process for communicating messages to/from WHO from the National Focal Point (HHS-SOC) about potential PHEICs. U.S. Points of Entry Cluster (DHS/OHA – Bill Lyerly) Mission: PHIEC prevention by ensuring persons do not facilitate the spread of disease Coordinate human surveillance and implementation of health measures (such as vaccination, health screenings and possibly quarantine) for persons at key points of entry, such as international airports, to recognize and contain transmission of a potential PHEICs Health Measures for Conveyances Cluster (DOT – Arnie Konheim) Mission: PHIEC prevention by ensuring conveyances do not facilitate the spread of disease Coordinate surveillance and implementation of health measures (such as issuing a ship sanitation certificate) for vessels, baggage, cargo, containers, goods and parcels that may be a source of infection or contamination, to prevent transmission of diseases that may lead to a potential PHEIC Education and Outreach Cluster (HHS/ASPA – Bill Hall) Mission: Ensure key stakeholders are aware of the revised IHR (no small task, given the extent the IHR covers) developed a comprehensive roll-out strategy for outreach to and education of both U.S. Government (USG) and non-USG IHR-relevant stakeholders: state, local, tribal, and territorial government entities, the public and private healthcare sector, professional organizations, international partners, NGOs, and the general public.

14. 13 National IHR Focal PointWorking Group Active interagency participation. Established the HHS Secretary’s Operations Center as the U.S. National IHR Focal Point. New policies, procedures, and programs: National Focal Point Policy USG roles and responsibilities; overall IHR message flow Interagency Communications Group Standard Operating Procedure International Health Regulations Program Established within ASPR/Office of Medicine, Science and Public Health 24/7 Action Officers to monitor, assess and report potential PHEICs PHEIC Report Form USG National IHR Focal Point is the HHS Secretary’s Operation Center (NFP/SOC) HHS lead an interagency group to Establish how the USG will manage the Identification and determination of a PHEIC within the US Communications to/from WHO through the National Focal Point (NFP) as identified in the revised IHRs. Ensure transparency and coordination of IHR messages across USG department and agencies. USG National IHR Focal Point is the HHS Secretary’s Operation Center (NFP/SOC) HHS lead an interagency group to Establish how the USG will manage the Identification and determination of a PHEIC within the US Communications to/from WHO through the National Focal Point (NFP) as identified in the revised IHRs. Ensure transparency and coordination of IHR messages across USG department and agencies.

15. 14 IHR Message Flow: Role of the National Focal Point As the focal point, the HHS SOC coordinates the United State Government communications process for reporting the PHEIC to WHO. The HHS SOC is also responsible for communicating verification requests from WHO, communicating to WHO reports of evidence for events taking place elsewhere in the world, and dissemination of information from WHO including any temporary and standing recommendations. As the focal point, the HHS SOC coordinates the United State Government communications process for reporting the PHEIC to WHO. The HHS SOC is also responsible for communicating verification requests from WHO, communicating to WHO reports of evidence for events taking place elsewhere in the world, and dissemination of information from WHO including any temporary and standing recommendations.

16. 15 USG PHEIC Report Form

17. U.S. IHR Notifications toWHO of Potential PHEICs

18. Continued USG (Domestic) Collaboration 17

19. International Collaboration ASPR IHR Program: Technical assistance on implementation to Canada, France, Japan, and Mexico. Shared U.S. implementation plan with 43 countries in all six WHO regions. ASPR: Global Health Security Initiative (GHSI) project to develop a single, web-based platform for GHSI partners to receive early warnings of credible CBRN threats and avian influenza outbreaks. Security and Prosperity Partnership of North America (SPP) work to integrate U.S, Canadian, and Mexican epidemiological information systems, allowing simultaneous access.

20. Points of Contact HHS Secretary’s Operation Center (24/7) Phone: (202) Email: hhs.soc@hhs.gov IHRP Action Officer on-call (24/7) Phone: (202) 360-3066 Email: hhs.ihrp@hhs.gov Dr. Jose Fernandez (IHR Program Manager) Phone: (202) 205-9320 Email: Jose.Fernandez@hhs.gov LCDR Maria Benke Phone: (202) 205-0957 Email: MariaLourdes.Benke@hhs.gov

21. Thank you for your attention.