PIP Framework Information Session 10 April 2018

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1 Pandemic Influenza Preparedness Framework Sharing of influenza viruses & access to vaccines and other benefits PIP Framework Information Session 10 April 2018

PIP Framework Information Session Purpose: Deepen understanding of topics related to the PIP Framework and implementation of WHA70(10) Topics to be addressed: 1. Overview of the PIP Framework 2.

2 PIP Framework Information Session Purpose: Deepen understanding of topics related to the PIP Framework and implementation of WHA70(10) Topics to be addressed: 1. Overview of the PIP Framework 2. Overview of the Global Influenza Surveillance and Response System by GISRS representatives 3. Preview of the Director-General s report on progress to implement WHA decision 70(10) - Relevant documentation and webcast can be found at - Director General s Report WHA 71/24 is found at: World Health Organization

3 Influenza Unique, seasonal, highly contagious, infectious disease Among few known pandemic-prone pathogens Pandemic is question of when not if Member States share viruses with WHO's Global Influenza Surveillance and Response System (GISRS) World Health Organization

5 Origins of PIP Framework Bird Flu - Re-emergence of A(H5N1) in SE Asia ~ 2003 Viruses sent into GISRS (GISN) for characterization, risk assessment and vaccine virus development Candidate vaccines developed BUT limited availability & high price World Health Organization

6 Global Discussions on Equitable Access to Vaccines : WHO Member States negotiate an innovative approach to increasing public health security: Share influenza viruses with pandemic potential (IVPP) with WHO/GISRS Ensure all countries are prepared for pandemic response Establish mechanisms to ensure greater equity of access to pandemic vaccines and other response products Member States Industry CSOs Member States WHO Other key stakeholders PIP Framework brings together Member States, GISRS, industry, CSOs, NGOs, philanthropic organizations, databases, initiatives, other stakeholders and WHO Civil society organizations Key Guiding Principles: Equity Transparency Partnership WHO World Health Organization

PIP Framework The best-documented success story is the Pandemic Influenza Preparedness, or PIP, Framework. Many of you invested long hours of negotiation to make this a success.

7 PIP Framework The best-documented success story is the Pandemic Influenza Preparedness, or PIP, Framework. Many of you invested long hours of negotiation to make this a success. The Framework was set up in 2011 as a bold and innovative preparedness tool that puts virus sharing and benefit sharing on an equal footing. This is a ground-breaking model for partnership with the private and nongovernmental sectors to ensure greater fairness in global public health. It is also a model for global solidarity that addresses critical policy, operational, and capacity barriers ahead of an emergency. - Dr Margaret Chan, Former WHO Director-General Address to the WHO Executive Board at its 140 th session World Health Organization

9 Scope of the Framework Applies to H5N1 and other influenza viruses with human pandemic potential Does not apply to seasonal influenza viruses World Health Organization July

Benefit Sharing: Two key mechanisms Standard Material Transfer Agreement (SMTA 2): Contracts to provide to WHO, real-time access to pandemic products needed at the time of a pandemic Negotiated with

10 Benefit Sharing: Two key mechanisms Standard Material Transfer Agreement (SMTA 2): Contracts to provide to WHO, real-time access to pandemic products needed at the time of a pandemic Negotiated with all recipients of PIP Biological Materials Vaccines, antivirals and diagnostics manufacturers Approximately 45 producers Multinationals to small start ups Located mainly in Europe, N America and Asia Academic, research and biotech institutions Approximately 150 research institutions Contribute to pandemic preparedness activities such as training To date: 77 agreements signed Partnership Contribution (PC): Annual payments to WHO from manufacturers that use GISRS Funds support activities to increase preparedness & response capacities. 3 operational guiding principles: Aligned with other initiatives Leverage other resources for greater impact Sustainability To date, nearly USD 142 million has been contributed World Health Organization

11 Key achievements SMTA 2 >400M doses of vaccines 10 million treatment courses of antivirals 250,000 diagnostic kits 13 agreements signed, including with all multinational vaccine manufacturers (as of 9 April 2018) World Health Organization

12 SMTA2 Pandemic Vaccine Commitments 2.5% 8 World Health Organization

13 Benefit Sharing: Two key mechanisms Standard Material Transfer Agreement (SMTA 2): Contracts to provide to WHO, real-time access to pandemic products needed at the time of a pandemic Negotiated with all recipients of PIP Biological Materials Vaccines, antivirals and diagnostics manufacturers Approximately 45 producers Multinationals to small start ups Located mainly in Europe, N America and Asia Academic, research and biotech institutions Approximately 150 research institutions Contribute to pandemic preparedness activities such as training To date: 77 agreements signed Partnership Contribution (PC): Annual payments to WHO from manufacturers that use GISRS Funds support activities to increase preparedness & response capacities in countries where they are weak WHO guided by 3 principles: Aligned with other initiatives Leverage other resources for greater impact Sustainability To date, nearly USD 142 million has been contributed World Health Organization

Objectives for Strengthening Pandemic Preparedness In a decade s time Laboratory & Surveillance: Improve capacities to detect, monitor & share influenza viruses with pandemic potential Burden of

14 Objectives for Strengthening Pandemic Preparedness In a decade s time Laboratory & Surveillance: Improve capacities to detect, monitor & share influenza viruses with pandemic potential Burden of Disease: Support development of influenza disease estimates to inform evidence-based policies Regulatory Capacity Building: Strengthen national regulatory authority capacities to facilitate rapid approval of pandemic influenza products Planning for Deployment: Strengthen global & national systems for vaccine deployment Risk Communications: Support countries to provide effective public health information during a pandemic

16 High Level Results L&S BOD REG DEP RC 42 additional countries routinely share influenza viruses with GISRS. 36 additional countries share influenza epidemiological data through FluID. 22 additional countries share influenza virological data through FluNET. New global influenza mortality estimate was published in additional countries completed BOD and 6 countries published All 48 targeted countries have an approach to facilitate timely approval of pandemic influenza products during an emergency World s first global simulation portal for pandemic influenza vaccine deployment PIPDeploy was launched in 2017 Online knowledge-transfer platform OpenWHO launched in 2017, with 8 influenza-related courses. Over 7,500 registered users from 191 countries. 16

19 Governance & review 3-pillared oversight mechanism World Health Assembly: oversees implementation Director-General: promotes implementation 18 member Advisory Group: Advises Director-General on the use of the Partnership Contribution Monitors & assesses implementation of Framework Interacts with Industry & other stakeholders Full PIP Framework review in 2016 Comprehensive Review 8 independent Experts Robust Report submitted to WHA 70 World Health Organization

Pandemic Influenza Preparedness Framework. Sharing influenza viruses & access to vaccines and other benefits

Pandemic Influenza Preparedness Framework Sharing influenza viruses & access to vaccines and other benefits What is PIP? Landmark, innovative public health arrangement to increase global preparedness to