AMC Governance and Institutional Support

1. AMC Governance and Institutional Support

2. 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.

3. 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.

4. AMC stages • Establishment • Product Development • Activation • Implementation

5. 2nd 3rd 1st AMC Stages - Timeline for Pneumococcal AMC 2007 2008 2010 2011 2016 2020 Establishment AMC Product Development Activation Implementation/vaccine delivery Ongoing Monitoring

6. 2nd 3rd 1st AMC Stages - Establishment 2007 2008 2010 2011 2016 2020 Establishment AMC Product Development Activation Signed Framework Agreement Implementation/vaccine delivery Ongoing Monitoring

7. 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.

8. 2nd 3rd 1st AMC Stages – Product Development 2007 2008 2010 2011 2016 2020 Establishment AMC Product Development Activation Signed Framework Agreement Implementation/vaccine delivery Ongoing Monitoring

9. 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…

10. 2nd 3rd 1st AMC Stages - Activation 2007 2008 2010 2011 2016 2020 Establishment AMC Product Development Activation Implementation/vaccine delivery Ongoing Monitoring

11. 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

12. 2nd 3rd 1st AMC Stages – Implementation / vaccine delivery 2007 2008 2010 2011 2016 2020 Establishment AMC Product Development Activation Implementation/vaccine delivery Ongoing Monitoring

13. 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.

14. 2nd 3rd 1st AMC Stages – On-going monitoring 2007 2008 2010 2011 2016 2020 Establishment AMC Product Development Activation Signed Framework Agreement Implementation/vaccine delivery Ongoing Monitoring

15. 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

16. 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

17. 2nd 3rd 1st AMC Legal Agreements 2007 2008 2010 2011 2016 2020 Establishment AMC Product Development Activation Framework Agreement Implementation/vaccine delivery Guarantee and Supply Agreements Ongoing Monitoring

18. 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

19. 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