GAVI s Financing for Pneumococcal Vaccines, including the Advance Market Commitment Tania Cernuschi Third Regional Pneumococcal Symposium, Istanbul, 13th - 14th February 2008 1
The GAVI Alliance Public-private partnership bringing together all the major stakeholders in immunization GAVI s mission is to save children s lives and protect people s health by increasing access to immunization in poor countries. Our work is positioned within the broader context of Child Survival and Millennium Development Goal 4 for which Target 5 is to Reduce by two thirds the mortality rate among children under five by 2015.
GAVI Partners 3
Strategic Goals 1. Strengthening the capacity of the health system to deliver immunisation and other health services in a sustainable manner 2. Accelerate the uptake and use of underused and new vaccines and associated technologies and improve vaccine supply security 3. Increase the predictability and sustainability of long-term financing for national immunisation programmes 4. Increase the added value of GAVI as a public-private global health partnership through efficiency, advocacy and innovation
Support for Vaccine Introduction Support to countries Support to partners and global initiatives Special projects GAVI Work plan New Vaccine Support (NVS) Immunisation Services Support (ISS) Injection Safety (INS) Health Systems Strengthening (HSS) Civil Society Organizations (CSO) ADIPs / Hib Initiative
Innovative Funding The International Finance Facility for Immunization - IFFIm Co-financing (Poorest, Intermediate, Least Poor, Fragile) Advance Market Commitment - AMC 6
GAVI s Co-financing Groupings Category Definition Mutually exclusive groupings Poorest Intermediate Least poor Post conflict / fragile 2005 GNI under $1000/capita & Classified by the UN as least developed country (LDCs) 2005 GNI under $1000/capita & Not classified by the UN as least developed country 2005 GNI over $1000/Capita* GAVI eligible country meeting post conflict / countries in crisis criteria (independent of GNI/capita) * Eligible GAVI countries which had a GNI under $1000 in 2003, and have gone above in 2005
GAVI s Co-financing Levels Poorest Group Intermediate Group Least Poor (starting level) ** Fragile Group First Vaccine $0.20 $0.30 $0.30 $0.10 Second Vaccine $0.15 $0.15 $0.15 $0.15 Third vaccine $0.15 $0.15 $0.15 $0.15 These policies will be evaluated in 2009 and revised in 2010 ** The «group of the least poor» will be requested to increase payment 15% annually
AMC Concept A financial commitment by donors, to subsidize vaccine purchase at a set price, if it meets specified criteria (TPP) and is in demand by GAVI-eligible countries. Vaccines not yet developed. Additional to current package of solutions pull mechanism. 9
Challenges to introduction of vaccines in developing countries Vaccine formulations for developing countries - O1: development Vaccine supply may not be available at the time of demand - O2: availability Sustainable, affordable pricing - O3: uptake Disease burden, vaccine efficacy data Systems constraints for delivery 10
Two-Stage AMC Price Curve Price 14 Guaranteed first stage price (AMC price) In return, firms obliged to sell at lower long run price (tail price) AMC Funds 1 2 3 4 5 6 7 8 9 10 11 12 13 Quantity (& time) 11
How does an AMC Help? Source: GAVI Assurances of a future price (purchasing power) as incentive for more timely investment by industry. Predictability for countries: predictability of long term price; guarantee future financing before funds are needed to purchase doses. Only use funds if there are results: vaccine developed. 12
AMC Timeline Publication of Making Market for Vaccines 2005 G7: launch of consultation process on pilot AMC 2005 Launch of the Pilot AMC: 1.5 billion US$ Feb 2007 Econ Expert Final Report March 2008 IAC First Meeting 25 March 2008 Signature of Final T&C, Donors, Stakeholders' & Offer Agreements May/June 2008 Disease Expert Committee: recommendation on pilot Feb 2006 GAVI and World Bank preparing AMC Pilot implementation, with support from different expert committees Economic Expert Group defines AMC structure Refininement of Legal Agreements 2005-2008 Consultations with different stakeholders TPP approved by DG of WHO - Dec 2007 IAC members selected by panel of public health leaders M&E Study UNICEF agrees to act as procurement agent Nov 2007 13
PneumoADIP 2003: Accellerated Development and Introduction Plan: Addressed demand uncertainty Addressed supply issues Addressed funding issues Virtuous circle November 2006: Approved funding of investment cases for accellerating pneumococcal vaccine introduction Background work crucial for AMC design 14
Financing for Prevnar Available now to all GAVI eligible countries Guyana, Nicaragua and Honduras have applied and been approved introduce Prevnar in 2008 Yemen and Kenya received conditional approval The vaccines will be funded through the NVS window and will require country co-financing The 2008 deadlines for country applications are Feb 8, May 2, and Sept 25
Source: PneumoADIP Back
The AMC Structure Back
Target Product Profile Attribute Vaccines sereotypes Immunogenicity Minimally Acceptable Profile Must cover at least 60% of invasive disease isolates in target region Must include 1,5,14 In accordance with WHO criteria: non inferiority to a licensed pneumo vaccine Target population Prevent disease among children < 5, in particular < 2 Safety, reactogenicity Dosage and schedule Interference Routes of administration Product presentation Product Formulation Storage and cold chain Packaging and labelling Product registration and prequalification Post marketing surveillance Similar to currently licensed vaccine Compatible with national infant immunization programmes and no more than 3 doses in first year of life No significant interaction or interference with currently administered vaccines Intramuscolar or subcutaneous Mono-dose or low multi-dose Liquid formulation Stable at 2-8 C with shelf life of at least 24 months In accordance with WHO recommendations WHO pre-qualified In accordance with national regulatory authorities and WHO prequalification requirements Back
25 February 2008 GAVI Provide Operational & Programmatic functions Permanent bodies Temporary bodies AMC Key bodies AMC SECRETARIAT Supports IAC; manages pilot AMC; reports to stakeholder committee IAC AMC decision making body: oversees establishment of TPPs; recommends vaccines for AMC funding; establishes changes to AMC terms and conditions STAKEHOLDER COMMITTEE ToR to be determined. No governance structure; only advisory powers DONOR COMMITTEE (DC) Decision Making Body: defines objectives, scope, procedures etc. of pilot AMC Timeline: Will cease to exist after signature of legal agreements COMMUNICATION SUB-GROUP AMC Communication & outreach WHO Defines TPPs and prequalifies AMC vaccines WB Provides financial and fiduciary support. Manages donor commitments UNICEF Proposed procurement agent LEGAL SUB-GROUP Aim: Defines legal agreements governing AMC Timeline: Will phase out after signature of agreements : Advise Sub-groups: Composed of donors & external experts Groups and Committees: Composed of only external experts ECONOMIC EXPERT GROUP Aim: Defines financial terms of AMC (e.g. price, tail price, demand variables etc.) Timeline: Final recommendations to DC MONITORING & EVALUATION SUB- GROUP Aim: Develops indicators and plan for AMC M&E Timeline: Recommendations to DC and then phase out DISEASE EXPERT COMMITTEE Aim: Advises on disease to be chosen for AMC Timeline: Phased out. Will be reconvened for 2 nd AMC ADVISORY GROUP Informed work of disease expert Committee Convened in 2006. Phased out back
Terms & Conditions Self-standing attachment to AMC agreements, describes the AMC mechanism: e.g. size of envelope; price for vaccines; TPP; procedures and monitoring for AMC implementation (e.g. functions of IAC); supply arrangements. Feeds into Offer Agreement Between GAVI and WB: Commitment to subsidize the future purchase of targeted vaccines according to the AMC Terms &Conditions. Legal Structure AMC-Eligible Vaccine IAC Charter Defines IAC s functions. Supply Agreement Anticipated to be signed by procurement entity (e.g., GAVI and UNICEF), and vaccine manufacturer. Conditions for supply and procurement of vaccines during the AMC and the post-amc period. IAC Stakeholder Agreement Between GAVI, WB and grantors: Sets out AMC mechanics for matters relevant to all grantors: e.g. use and application of AMC funds; undertakings of GAVI and WB; payment arrangements; decisionmaking, monitoring and supervision. Donor Grant Agreements Between each AMC donor and WB, sets out grantor obligation, payment schedule and details. IAC Bylaws Define IAC s operational procedures. Licensed by stringent regulatory authority/who PQ Vaccine SUPPLIERS GAVI- WHO Memorandum of Understanding Anticipated to be signed by WHO and GAVI for review of AMC vaccines through the WHO pre-qualification process. 20 back
AMC-FIRM Model Overview ANALYSIS COMPONENTS Determine Vaccine Need f {population cohort, doses/fully compliant person} f {# of suppliers, vaccine availability, supplier capacity plan} Determine Potential Vaccine Capacity Determine Potential Vaccine Market f {vaccine need, vaccine coverage rate} AMC Investment AMC Price Post-AMC Price Define AMC Terms Determine Potential Vaccine Demand f {vaccine availability, country adoption timing, time to peak coverage} Determine Supply/Demand f {vaccine price, country co-pay, country willingness to pay, country financial sustainability, AMC investment} Determine Supplier, Funder & Country Financials f {supplier costs, capacity utilized, supplier discount rate, funder/country discount rate} 25-Feb-08 iterate 21