amc governance and institutional support. objectives build on existing capacity ensure appropriate...
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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
EstablishmentAMC
2007 2010 2011 20162008
AMC Stages - Timeline for Pneumococcal AMC
2020
Product Development
1st2nd 3rd
Implementation/vaccine delivery
Ongoing Monitoring
Activation
EstablishmentAMC
2007 2010 2011 20162008
AMC Stages - Establishment
2020
Product Development
1st2nd 3rd
Implementation/vaccine delivery
Ongoing Monitoring
ActivationSigned 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.
EstablishmentAMC
2007 2010 2011 20162008
AMC Stages – Product Development
2020
Product Development
1st2nd 3rd
Implementation/vaccine delivery
Ongoing Monitoring
ActivationSigned 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…
EstablishmentAMC
2007 2010 2011 20162008
AMC Stages - Activation
2020
Product Development
1st2nd 3rd
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
EstablishmentAMC
2007 2010 2011 20162008
AMC Stages – Implementation / vaccine delivery
2020
Product Development
1st2nd 3rd
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.
EstablishmentAMC
2007 2010 2011 20162008
AMC Stages – On-going monitoring
2020
Product Development
1st2nd 3rd
Implementation/vaccine delivery
Ongoing Monitoring
ActivationSigned 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
EstablishmentAMC
2007 2010 2011 20162008
AMC Legal Agreements
2020
Product Development
1st2nd 3rd
Implementation/vaccine delivery
Ongoing Monitoring
ActivationFrameworkAgreement
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