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

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Arabella Ferguson
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1 Pandemic Influenza Preparedness Framework Sharing influenza viruses & access to vaccines and other benefits

pandemic influenza Focus is on increasing equity of access to life saving measures Member

2 What is PIP? Landmark, innovative public health arrangement to increase global preparedness to respond to pandemic influenza Focus is on increasing equity of access to life saving measures Member States Civil society organizations WHO Brings together Member States, industry, other key stakeholders, and WHO Industry Other key stakeholders World Health Organization

Objectives of PIP Framework Two objectives to be pursued on an equal footing: Improve sharing of influenza viruses with the potential to cause a pandemic among humans

3 Objectives of PIP Framework Two objectives to be pursued on an equal footing: Improve sharing of influenza viruses with the potential to cause a pandemic among humans Achieve more predictable, efficient, and equitable access to benefits arising from the sharing of viruses, notably vaccines and antiviral medicines World Health Organization

4 Limited framework scope Applies to H5N1 and other influenza viruses with human pandemic potential Does not apply to seasonal influenza viruses World Health Organization

5 Main elements of Framework Virus sharing Benefit sharing: SMTA 2* & Partnership contribution Governance & review * The PIP Framework has two Standard Material Transfer Agreements or SMTA. They are found in Annex 1 and Annex 2, respectively, of the PIP Framework. SMTA type 1 Applies solely to transfers of PIP Biological Materials (also known as PIPBM ) among laboratories within the GISRS network SMTA type 2 Applies to transfers of PIPBM to entities outside the GISRS network World Health Organization

Virus sharing Member States share influenza viruses with potential to cause human pandemic through the Global Influenza Surveillance and Response System (GISRS), a

6 Virus sharing Member States share influenza viruses with potential to cause human pandemic through the Global Influenza Surveillance and Response System (GISRS), a WHO-coordinated network of Public Health labs GISRS labs use these viruses to assess the risk of pandemic influenza & to develop candidate vaccine viruses World Health Organization

Benefit sharing PIP Framework benefit-sharing system provides: Equitable access to vaccines Surveillance & risk

benefit-sharing mechanisms: SMTA 2: Contracts between WHO and non-gisrs recipients of PIP biological materials.

vaccines, antivirals, diagnostics) Partnership Contribution: Annual payments from manufacturers to WHO, used to

7 Benefit sharing PIP Framework benefit-sharing system provides: Equitable access to vaccines Surveillance & risk assessment information Technical assistance Support to strengthen national pandemic influenza response capacities Two benefit-sharing mechanisms: SMTA 2: Contracts between WHO and non-gisrs recipients of PIP biological materials. Recipients commit to provide real-time access to pandemic supplies needed for pandemic response (e.g. vaccines, antivirals, diagnostics) Partnership Contribution: Annual payments from manufacturers to WHO, used to strengthen preparedness & response capacities in countries in need (e.g. Lab & Surveillance, Risk communications, Regulatory capacities) World Health Organization

8 SMTA 2 Research & academic institutions GISRS PIP biological materials 1 (PIPBM) Biotech firms Non-GISRS recipient of PIPBM Influenza vaccine manufacturers Diagnostic manufacturers Pharmaceutical manufacturers Preparedness Technical support to strengthen influenza laboratory and surveillance capacities in developing countries Licenses to technology relevant to the production of pandemic related products Response Donations and/or reserve for purchase by WHO at affordable prices, of pandemic influenza vaccine, antiviral medicines, or other pandemic related products SMTA 2 Agreement negotiated and signed Recipients assess benefits to be shared through WHO according to their nature & capacity 1 Definition of PIP Biological Materials, PIP Framework, section 4.1 World Health Organization

9 Partnership Contribution Data Vaccine virus GISRS Reagents Manufacturers use GISRS Antiviral susceptibility assays Other Sequence information Benefit sharing Preparedness Lab & surveillance capacity building Burden of disease studies Regulatory capacity building Risk communications Planning for deployment Response Pandemic response products and services including: antiviral medicines; pandemic vaccines; diagnostic products; and other pandemic related products 70% 30% Partnership Contribution (US$ 28 million / year to WHO) 1 Definition of PIP Biological Materials, PIP Framework, section 4.1 World Health Organization

10 Annual PC vs. One-time SMTA 2 Annual PC payments by manufacturers to WHO Time Year Year Year Year Year Year Year Partnership Contribution SMTA 2 Licenses, tech transfer, training, etc. SUPPLY COMMITMENTS Equity & solidarity in pandemic response SMTA 2 signed once between WHO and non-gisrs recipient of PIPBM. Activated upon the declaration of a pandemic. Once signed, signatory has access to any and all PIPBM needed without need to sign another SMTA 2. Pandemic declared. Vaccines, antivirals, diagnostics and other pandemic response products committed under SMTA2 become due. World Health Organization

Director-General on the use of the Partnership Contribution Monitors & assesses implementation

11 Governance & review 3-pillared oversight mechanism World Health Assembly: oversees implementation Director-General: promotes implementation Advisory Group: Advises Director-General on the use of the Partnership Contribution Monitors & assesses implementation of Framework Interacts with Industry & other stakeholders Full Framework review by 2016 World Health Organization

Key implementation milestones to date Virus sharing H5N1 and other viruses Governance

stakeholders Review Group - 2016 Benefit sharing Partnership Contribution processes

(e.g. questionnaire for contributor identification; distribution formula; SoPs) High Level

12 Key implementation milestones to date Virus sharing H5N1 and other viruses Governance Advisory Group established Regular interaction with Member States, Industry & other stakeholders Review Group Benefit sharing Partnership Contribution processes established & operating (e.g. questionnaire for contributor identification; distribution formula; SoPs) High Level Partnership Contribution Implementation Plan & Gap Analyses approved SMTA signed Communications Website, brochure, Q&A doc, bi-monthly newsletter World Health Organization

13 PC Preparedness Implementation Area of Work Laboratory & Surveillance Burden of Disease Regulatory Capacity-Building Planning for Deployment Risk Communications Goals Improve national ability to detect, monitor and share novel influenza viruses Training and support for burden of influenza estimates to contribute to development of global burden of influenza estimate Build national regulatory capacity so that vaccines, diagnostic tests and antiviral medicines for influenza can be deployed quickly Plan for efficient and equitable deployment of vital supplies for pandemic influenza Build national capacity to provide accurate public health information during emergencies World Health Organization

14 Bringing it all together: Detection to protection World Health Organization

15 Next steps Ramp up implementation: Virus sharing, Partnership Contribution and SMTA2 negotiations Improve & increase communications Prepare for full Framework review in 2016 World Health Organization

16 World Health Organization 20 Avenue Appia 1211 Geneva 27 Switzerland PIP Framework Secretariat Pandemic and Epidemic Diseases Health Security Thank you 谢谢 Merci Cпасибо شكرا Gracias

PIP Framework Information Session 10 April 2018

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: