AMC Governance and Institutional Support

Objectives Build on existing capacity Ensure appropriate independence and credibility through transparency, efficiency and accountability Define roles and procedures in advance as part of the legal agreement.

Stakeholders GAVI – host AMC Secretariat and provide programmatic functions World Bank – provide administrative and financial services Donors – credible funding and technical input on appropriate policies and procedures ex ante, monitor implementation. Vaccine, pharma and biotech firms – technical input on policies and procedures ex ante. Developing and producing pneumococcal vaccines. Developing countries – evidence-based decision to introduce the vaccine, co-payment for vaccine Technical agencies (e.g. WHO and UNICEF) – specific technical support such as WHO support to the IAC to set Target Product Profile (TPP) and prequalify vaccines against it Independent Assessment Committee (IAC) - body tasked to establish TPP and ascertain when they are met.

AMC stages Establishment Product Development Activation Implementation

Establishment AMC AMC Stages - Timeline for Pneumococcal AMC 2020 Product Development 1st 2nd3rd Implementation/vaccine delivery Ongoing Monitoring Activation

Establishment AMC AMC Stages - Establishment 2020 Product Development 1st 2nd3rd Implementation/vaccine delivery Ongoing Monitoring Activation Signed Framework Agreement

Establishment Activities Secure financial commitments - Donors and World Bank structure national financial commitments and means to bundle them into single credible commitment Establish AMC Secretariat – GAVI hire two staff and establish program Establish IAC and set TPP – WB and GAVI implement transparent process to identify IAC members. IAC establish the Target Product Profile for pneumococcal vaccines Establish financial management – World Bank and donors agree on procedures to efficiently manage donor payments and flows and AMC payments Determine all AMC terms – Stakeholders agree on consistency of TPP, price, total envelop Negotiate framework agreement – World Bank and GAVI work with all stakeholders to draft Framework Agreement.

Establishment AMC AMC Stages – Product Development 2020 Product Development 1st 2nd3rd Implementation/vaccine delivery Ongoing Monitoring Activation Signed Framework Agreement

Product Development Activities Industry investments – industry invests in the incremental studies and production capacity to serve the developing world Tracking and reporting on AMC progress –Secretariat reports on progress toward AMC objectives (firms engaged, level of investment, status of product development and installed capacity, country demand Parallel work to ensure country demand - GAVI and immunization partners ensure governments have data for timely decision Ensure systems in place for activation – –WHO capacity for timely prequalification of AMC pneumococcal vaccines –GAVI preparation for timely receipt of country applications for AMC support for pneumo introduction…

Establishment AMC AMC Stages - Activation 2020 Product Development 1st 2nd3rd Implementation/vaccine delivery Ongoing Monitoring Activation

Activation phase When a vaccine submitted to AMC IAC determines if meets TPP-- IAC initiates process with WHO for recommendation on whether vaccine meets TPP (pre-qualification) Finalize Supply and Guarantee Agreement – include additional specifics (e.g. post-AMC price) for signature by manufacturer Country demand forecast - GAVI and immunization partners work with donors to assure accurate demand forecasts and national product orders with country co- payments Trigger donor payments - If IAC find vaccine eligible and GAVI receives country demand and authorizes procurement, then World Bank calls donor commitments to make payments

Establishment AMC AMC Stages – Implementation / vaccine delivery 2020 Product Development 1st 2nd3rd Implementation/vaccine delivery Ongoing Monitoring Activation

Implementation Activities Once the Guarantee and Supply Agreement is signed --- Commission a procurement agent – GAVI determine procurement agent to issue supply contracts in line with AMC terms Disburse payments – World Bank ensure efficient and timely payments to firms or procurement agent Collecting co-payments – Country co-payments collected through existing GAVI processes. GAVI may further reduce co-payment of $1/dose Manage donor commitments and payments to match disbursements – World Bank be responsible for efficient timing and management.

Establishment AMC AMC Stages – On-going monitoring 2020 Product Development 1st 2nd3rd Implementation/vaccine delivery Ongoing Monitoring Activation Signed Framework Agreement

Monitoring activities Financial management, disbursements, status of funds: World Bank report on financial status of AMC, collective management of donors funds and disbursements Efficiency of implementation: GAVI report on programmatic implementation of pneumococcal vaccine introduction –Vaccine introduction –Demand –Procurement –Country co-financing –Vaccine delivery Technical progress: Reports of public information on progress by firms to develop, scale-up capacity and deliver pneumo vaccines Public Health impact: GAVI and partners will report on the estimated public impact by coverage and deaths prevented

Oversight Donor Committee to facilitate donor engagement –Establishment of AMC – refine and agree on procedures, responsibilities and review mechanisms –Oversee progress once AMC launched GAVI Alliance Board – comprised of many donor, country and technical partners responsible for implementation and reporting of programmatic functions World Bank oversight of financial administration and financial reporting

Establishment AMC AMC Legal Agreements 2020 Product Development 1st 2nd3rd Implementation/vaccine delivery Ongoing Monitoring Activation Framework Agreement Guarantee and Supply Agreements

Framework Agreement Terms, policies and processes governing AMC over its life AMC terms: size, price per dose, TPP, post-AMC pricing and supply Obligation to enter into Guarantee and Supply Agreement for qualified sales to eligible countries IAC terms: governance, operating procedures, decision powers, terms of AMC review Donor financial commitments Processes to translate country demand into vaccine procurement Post-AMC requirements Industry obligations GAVI and World Bank responsibilities Reporting Requirements

Guarantee and Supply Agreements Terms of agreement with specific suppliers Industry obligations (remain licensed and continue to supply vaccine that meets requirements) Post-AMC terms: price, quantity, duration Procurement, shipment, payment terms Dispute resolution Reporting requirements