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
AMC Stages - Timeline for Pneumococcal AMC
2007
2008
2010 2011
Establishment
Product Development
AMC
1st
2nd
2016
3rd
Activation
Implementation/vaccine delivery
Ongoing Monitoring
2020
AMC Stages - Establishment
2007
2008
2010 2011
Establishment
Product Development
AMC
2nd
3rd
1st
Signed
Framework
Agreement
2016
Activation
Implementation/vaccine delivery
Ongoing Monitoring
2020
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.
AMC Stages – Product Development
2007
2008
2010 2011
Establishment
Product Development
AMC
2nd
1st
Signed
Framework
Agreement
2016
3rd
Activation
Implementation/vaccine delivery
Ongoing Monitoring
2020
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…
AMC Stages - Activation
2007
2008
2010 2011
Establishment
Product Development
AMC
2nd
2016
3rd
1st
Activation
Implementation/vaccine delivery
Ongoing Monitoring
2020
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 copayments
• 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
AMC Stages – Implementation / vaccine delivery
2007
2008
2010 2011
Establishment
Product Development
AMC
2nd
2016
3rd
1st
Activation
Implementation/vaccine delivery
Ongoing Monitoring
2020
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.
AMC Stages – On-going monitoring
2007
2008
2010 2011
Establishment
Product Development
AMC
2nd
3rd
1st
Signed
Framework
Agreement
2016
Activation
Implementation/vaccine delivery
Ongoing Monitoring
2020
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
AMC Legal Agreements
2007
2008
2010 2011
Establishment
Product Development
AMC
1st
Framework
Agreement
2nd
2016
3rd
Activation
Implementation/vaccine delivery
Guarantee and
Supply Agreements
Ongoing Monitoring
2020
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