7 th Bi-regional NIC Meeting 12-15 November 2013 ● Beijing

1. Pandemic Preparedness and PIP Framework Wenqing Zhang 7th Bi-regional NIC Meeting12-15 November 2013 ● Beijing

2. Updated WHO guidance on pandemic preparedness: PIRM Pandemic Influenza Risk Management

3. Background • WHO Guidance on pandemic preparedness 1999, 2005, 2009 • Review Committee on the Functioning of the International Health Regulations (2005) in relation to Pandemic (H1N1) 2009 recommended: (WHA64.1) • WHO should revise pandemic preparedness guidance by: • Drawing on country, regional and global level lessons learnt • Emphasizing risk-based approach to enable flexibility • Including guidance on risk assessment • Simplifying the phase structure • Developing measures for severity • Relying on multi-sectoral participation

4. Drivers for revision • From past: lessons learned A(H1N1) 2009 pandemic • National actions linked to phases proved unworkable • In many Member States the MoH was not the lead agency in pandemic response • Communication was one of the major issues • Planned responses were inflexible, or based on a severe pandemic with little room to maneuver for a less severe event • Current needs • Countries asking for direction in reviewing their guidance • Flexible plans to manage the emergence of new respiratory pathogens • Promoting all-hazards, multi-sectoral approach to emergency risk management

5. Revision process • PIRM updates and replaces the 2009 WHO Pandemic Influenza Preparedness and Response: a WHO guidance document • PIRM guidance • Peer review group meeting 11-12 April 2013 • Interim PIRM posted on WHO website for MS comments 10 June 2013 • Comments collected and are being addressed • Plan – to produce a version 2 Interim PIRM guidance shortly

6. Revision process • A living document: for constant review with newly gained knowledge and experience • Key technical elements are being developed/strengthened in parallel: • Severity assessment tool • Implementation of PIP Framework and its components • IHR core capacity building

7. Main differences 2009 guidance 2013 guidance Recommended actions based on risk assessment, resources and needs Recognition that phases represent a ‘global average’ Based on principles of all-hazard emergency risk management Flexible approach – decisions made at national level commensurate with risk • Recommended actions based on global phases • Assumption phases applicable to every country at the same time • Influenza specific • Rigid approach

8. Highlights of 2013 guidance PIRM • Promote all-hazards approach to Emergency Risk Management for Health (ERMH) • Emphasize a risk-based approach and provide high-level guidance on risk assessment • Strengthen whole of government and whole of society approach to risk management • Uncouple global phases from national actions • Introducing flexibility in countries for planning and response • Incorporate new developments e.g. PIP Framework

9. Global Phases

10. WHO Declarations Declarations are based upon specific assessments. • Determination of a PHEIC: The responsibility of determining a PHEIC lies with the WHO Director-General using the algorithm in Annex 2 of the IHR(2005). • The determination leads to the communication of temporary recommendations. • Declaration of a pandemic: During the period of spread of human influenza caused by a new subtype, based on risk assessment, and appropriate to the situation, the WHO Director-General may make a formal declaration of a pandemic.

11. Implications related to non-declaration of a pandemic • Communication challenges • Operational challenges • Regulatory response to be trigged by the declaration of a pandemic • Trigger of release of some SMTA 2 benefits for pandemic response • Execution of possible national/local agreements with vaccine/other entities

12. PIP Framework

13. PIP Framework May 2011 WHA 64.5 adopted PIP Framework Objective: To improve pandemic influenza preparedness and response, and strengthen the protections against the pandemic influenza by improving and strengthening the WHO Global Influenza Surveillance and Response System (GISRIS), with the objective of a fair, transparent, equitable, efficient, effective systems for, on an equal footing: (i) the sharing of H5N1 and other influenza viruses with human pandemic potential; and (ii) access to vaccines and sharing of other benefits.

14. PIP Framework Scope: Sharing of H5N1 and influenza viruses with human pandemic potential and sharing benefits derived from them Does not apply to seasonal influenza viruses or other non-influenza pathogens or biological substances that may be contained in clinical specimens shared under Framework

15. Main elementsof PIP Framework Virus sharing Benefit sharing Governance and review

16. Virus sharing • Member States urged to share PIP biological materials from all H5N1 & other influenza viruses with human pandemic potential • With WHO CC or H5 Reference Laboratories of GISRS of their choice • PIP biological materials: • Human clinical specimens • Wild type viruses • Modified viruses: candidate vaccine reassortants • RNA from wild type viruses* • cDNA encompassing the entire coding region of one or more viral genes* * Operational exemption

17. Implementation tools Influenza Virus Traceability Mechanism (IVTM) Internet-based tool to track movements of PIPBM In operation since 2008; upgraded in 2010; being under further development Publicly accessible https://extranet.who.int/ivtm/ Guiding principles for GISRS Terms of Reference: High level principles applicable to all of GISRS labs, current & future Terms of reference for GISRS labs Bring uniformity to TORs for all GISRS labs – current & future Effective since May 2011 (WHA 64.5) SMTA1 and SMTA2 Partnership Contribution

18. Standard Material Transfer Agreement 1 (SMTA1) • Incorporated into GISRSTORs & applicable 'as is' • Establishes rights/obligations of GISRS labs when transferring PIPBM • SMTA1 covers: • Use of IVTM to record transfers of PIPBM • Participation of originating labs in research • Acknowledgments in publications • Intellectual Property Rights (IPR) • Dispute resolution

19. Standard Material Transfer Agreement 2 (SMTA2) • Applies to allrecipients of PIPBM outside GISRS • Requires agreement between WHO & recipient • Recipients • Include influenza vaccine, diagnostic & pharmaceutical manufacturers, biotech firms, research & academic institutions (defined in Article 1 Footnote 1) • Must assess benefits they can contribute based on their nature and capacity • Must sign an agreement with WHO to receive PIPBM • 3 SMTA2s have been signed to date (6 in the pipeline)

20. Partnership Contribution (PC) Provides predictable, annual cash contribution to WHO by influenza vaccine, diagnostic and pharmaceutical manufacturers using GISRS Combined contributions are equivalent to 50% of GISRS running costs Commenced in 2012 Contribution resources are to be used to strengthen pandemic preparedness & response Director-General decides on use Based on advice of the Advisory Group and interaction with industry and other stakeholders Two main uses: preparedness & response EB Jan 2013 decided 70%/30% split through 2016 based on PIP AG advice

21. PC allocations 2013-2016

22. PC to date • 2012: US $18,101 M received • 2013 and beyond: US$ 28M expected • Use of funds: Implementation Plan based on a gap analysis being finalized. • Following approval by the DG, it is anticipated that funds will be disbursed for a phased start-up of activities in a limited number of countries in January 2014.

23. PC implementation plan 2013-2016(draft outline) • Laboratory and surveillance capacity building • Outcome: global capacity to detect and monitor influenza epidemics is strengthened in countries that have weak or no capacity • Output1: National capacity to detect respiratory disease outbreaks, due to a novel virus, is strengthened • Output2: National capacities to monitor trends of circulating influenza viruses is strengthened • Output3: Global collaboration, through the sharing of information and viruses, is strengthened and PCR detection quality assurance is improved

24. PC implementation plan 2013-2016(draft outline) • Burden of disease assessment • Outcome: National policy makers will have influenza disease burden data needed for informed decision-making and prioritization • Output1: Derive regionally representative influenza disease burden estimates from selected countries • Output2: Develop a global estimate of influenza disease burden derived from national estimates

25. PC implementation plan 2013-2016(draft outline) • Regulatory capacity building • Risk communications • Planning for deployment

26. Governance & Review of PIP Framework • Oversight mechanism (Article 7.1) • WHA: oversees implementation • Director-General: promotes implementation • Advisory Group: monitors; provides guidance to strengthen functioning of GISRS; and assesses implementation (next meeting April 2014) • Monitoring and review (Article 7.4) • Director-General to report on biennial basis to WHA through EB • Framework to be reviewed by 2016 • Any proposed revisions to WHA in 2017

27. Governance & Review of PIP Framework • PIP AG • AG meetings: 2 face-to-face meetings each year; March/April and October/November. Includes 1 day meeting with Industry and Other Stakeholders • AG reports: • Annual: Report from the PIP AG to DG on its evaluation of implementation of the PIP Framework • Biennial: Report from the DG to the WHA through the EB PIP Framework website: http://www.who.int/influenza/pip/en/

28. Acknowledgement • Global Influenza Programme and PIP Framework, WHO HQ • PIP Team • EPI Team • GISRS Team • Ex– Pandemic Preparedness group, ADGO, HSE, WHO HQ