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Report to the Board 22-23 June 2016 SUBJECT: Report of: Authored by: HEALTH SYSTEM AND IMMUNISATION STRENGTHENING SUPPORT Hind Khatib-Othman, Managing Director, Country Programmes Aurélia Nguyen, Director, Policy and Market Shaping Emma Clarke, Judith Kallenberg, Alan Brooks, Marya Getchell Agenda item: 12 Appendices 1-3 Category: For Decision Strategic goal: SG1 - Vaccines, SG2 - Health systems, SG3 - Financing Board-2016-Mtg-1-Doc 12 - Appendices 1-3 1

Report to the Programme and Policy Committee 12-13 May 2016 SUBJECT: Report of: Authored by: Health System and Immunisation Strengthening Support Hind Khatib-Othman, Managing Director, Country Programmes Aurélia Nguyen, Director, Policy and Market Shaping Emma Clarke, Judith Kallenberg, Alan Brooks, Marya Getchell Agenda item: 04 Category: For Decision Strategic goal: SG1 - Vaccines, SG2 - Health systems, SG3 - Financing Section A: Overview Purpose: The purpose of this report is to share the findings and recommendations from the review of Gavi s Health System Strengthening (HSS) grants, Vaccine Introduction Grants (VIGs), operational support for campaigns (Ops), and other grants supporting immunisation programmes, collectively referred to as Health System and Immunisation Strengthening (HSIS) support. Executive Summary 2.1 Despite tremendous progress in increasing access to vaccines since Gavi was launched in 2000, one in five children in Gavi-eligible countries still miss out on their basic EPI vaccinations. This leaves them exposed to preventable disease and often unable to take full advantage of the new vaccines Gavi is helping to roll out. To address this inequity, Gavi s 2016-2020 strategy places a stronger emphasis than ever before on reaching the fifth child. This is in line with the central aspiration of the Sustainable Development Goals (SDGs) to leave no one behind. 2.2 Health System and Immunisation Strengthening (HSIS) support is a key instrument for delivering on these ambitious goals. A review of this funding modality was initiated in 2015, with a view to optimising HSIS for sustainable coverage and equity improvements. 2.3 A Steering Committee (SC) was convened to assess the evidence, lessons learned, and best practices related to Gavi s HSIS support and to develop recommendations to the PPC for changes to the model. The SC s deliberations from September 2015 through March 2016 were informed by evaluations and analyses of past and current Gavi support; recommendations from Gavi s technical advisory bodies such as the Independent Review Committee (IRC); and consultations with PPC-2016-Mtg-3-Doc 04 1

Report to the Programme and Policy Committee representatives from governments in Gavi-eligible countries, Alliance partners, and independent experts. 2.4 While the Alliance has made considerable efforts to strengthen Gavi s HSIS support to date, evidence and experience indicate that: Funding has not been sufficiently targeted to the populations and areas with the greatest need or to evidence-based interventions with the highest potential for impact; The effectiveness and efficiency of support have been hindered by a complex grant architecture that does not promote holistic planning or responsiveness to new evidence and findings from reviews; and Resource allocation has not sufficiently aligned with countries needs and Gavi s strategic goals for 2016-2020. 2.5 To address these challenges, and following guidance from the PPC in October 2015, this report reflects the SC s final recommendations for improvements to Gavi s HSIS, in three areas: (a) Programming: To focus Gavi s relatively limited resources on supporting countries to deliver measurable impact, the SC recommends: Strengthening the focus on equity in coverage, targeting investments that contribute to sustainable improvements in coverage in low performing areas and among neglected populations across all countries. Leveraging Gavi s new Programme Capacity Assessments (PCAs) to inform the programming of grants; Tailoring support by transition stage to promote long-term programmatic and financial sustainability of HSIS investments. Leveraging funding for the operational costs of vaccine introductions, product switches, and campaigns to support sustainable improvements in routine coverage. (b) Grant architecture: To facilitate more efficient use of HSIS support, the SC recommends: Integrating planning and budgeting for all HSIS support to improve visibility across different grants, identify opportunities for synergies across investments, and promote holistic planning and management of HSIS support, in alignment with national health plans and strategies. Increasing responsiveness to new evidence and implementation experience during the grant cycle, aligning long-term priorities for support with countries national health and immunisation strategies, and ensuring operational budgets and work plans are regularly updated to reflect new data and evidence (including implementation progress and other Joint Appraisal findings). (c) Allocating resources: To allocate Gavi s limited resources in a transparent, predictable and equitable manner across countries that is consistent with Gavi s strategic goals and targets for 2016-2020, and to PPC-2016-Mtg-1-Doc 04 2

Report to the Programme and Policy Committee protect Gavi s overall resource envelope for HSS grants, 1 the SC recommends: Modifying the HSS resource allocation formula to include indicators that reflect the population in need of immunisation and the strength of the immunisation system. Setting a minimum amount for HSS disbursements (including performance payments) for grant programme years in the 2016-2020 strategic period to strengthen predictability for countries of available Gavi funds and prevent reductions if vaccine expenditures go down. 2 The Board would have the possibility to allocate additional funding to HSS should resources be available. 2.6 To better reflect the purpose of this funding modality, previously referred to as Direct Financial Support during discussions with the Steering Committee and the PPC for this policy review, the term Health System and Immunisation Strengthening (HSIS) support is proposed and used throughout this report. 2.7 The proposed changes will require strengthened Secretariat and partner capacity for engaging in countries planning processes and for engaging throughout the grant cycle to support implementation. Ongoing changes in the Secretariat to strengthen grant management capacities and skillsets, and increased focus across the Alliance on accountability for country-level results through the PEF, will be critical for the success of the new approach. This will be a key area for continuing consideration and assessment as the Alliance begins to implement the HSIS Support Framework. 2.8 Gavi s Measles and Rubella Strategy (approved by the Board in December 2015) indicated the importance of country co-financing of measles and measles-rubella (MR) follow-up campaigns. It also recommended that the HSIS (DFS) review process consider incentive structures to promote quality Supplementary Immunisation Activities (SIAs) when these are needed and, ultimately, to incentivise improvements in routine measles coverage and reduced reliance on SIAs. Responding to this request, a modification to Gavi s co-financing policy is proposed, to introduce co-financing requirements for these SIAs and incentives for improved measles routine coverage and high coverage SIAs. The PPC is asked to recommend that the Board approve this proposal. 2.9 This paper describes the rationale and context for proposed changes to Gavi s HSIS support, reflecting the SC s recommendations. The Health System and Immunisation Strengthening (HSIS) Support Framework, attached as Annex A, sets out the proposed approach and, if approved, would serve as the basis for the development of implementation guidelines 1 Other HSIS grants such as VIGs are not allocated upfront but committed in response to country demand for vaccine introductions, campaigns and other relevant immunisation events. 2 The HSS Resource Allocation Formula is used to allocate a pre-determined amount of HSS funding across eligible countries. The total amount of funding for other HSIS grants (e.g. VIGs, Ops) is not pre-determined because it is driven by country demand (e.g. for new vaccine introductions and campaigns). PPC-2016-Mtg-1-Doc 04 3

Report to the Programme and Policy Committee for countries, Alliance partners, and the Secretariat. Implications for previous Board decisions and Board-approved policies, and proposed implementation plans for phasing in the proposed changes are set out in Annex B. An amended Co-Financing Policy, reflecting the proposed requirements for co-financing measles and measles-rubella campaigns, is attached as Annex C. Recommendations 3.1 The PPC is requested to recommend to the Gavi Board that it: (a) Approve the Framework guiding implementation of Gavi s Health System and Immunisation Strengthening support attached as Annex A to Doc 05; (b) Approve the Implications for previous Board decisions and Boardapproved policies, as well as the implementation plans as set out in Annex B attached to Doc 05; (c) Approve the modifications to Gavi s Co-Financing Policy regarding cofinancing for measles and measles-rubella follow-up campaigns as set out in Annex C to Doc 05; (d) Agree that an amount of at least US$ 1.3 billion is available for HSS disbursements (including performance payments) for grant programme years in the 2016-2020 strategic period, with additional funding being subject to future Board decisions. Section B: Content Introduction 4.1 Gavi complements its in-kind vaccine support (81% of its programmatic support to countries from 2011-2015) with cash grants of different kinds (the remaining 19% together is referred to as HSIS support in this paper) to strengthen systems and support operations to introduce and deliver vaccines. In the 2011-2015 strategic period, Gavi disbursed US$ 1.1 billion in HSIS grants, including: US$ 531 million (9% of Gavi s overall programmatic expenditure) in HSS grants; US$ 364 million (6%) in operational support for campaigns (Ops); US$ 121 million (2%) in vaccine introduction grants (VIGs); US$ 0.4 million (<1%) in product switch grants; and The remaining US$ 133 million (2%) through other HSIS windows. 3 3 This includes several funding windows that are no longer open to new applications: CSO support, Injection Safety Support (INS) and Immunisation Services Support (ISS). It also includes support for Human Papillomavirus (HPV) vaccine demonstration projects and Ebola recovery, as well as support for operational costs of outbreak response campaigns. PPC-2016-Mtg-1-Doc 04 4

Report to the Programme and Policy Committee 4.2 As of the end of 2014, DTP3 coverage in Gavi-eligible countries had reached its highest point ever at 81%. Despite this progress, across the vast majority of Gavi-eligible countries, significant numbers of children continue to miss the opportunity to receive life-saving vaccines as a result of inequities due to geographic, socioeconomic, and/or gender-related barriers. (a) Out of the 68 countries eligible to receive some Gavi support in the 2016-2020 strategic period, in 2014 27 (39%) had DTP3 coverage over 90%, 30 (44%) had DTP3 coverage between 70 and 90%, and 11 (16%) had DTP3 coverage below 70%. As routine immunisation coverage in Gavi eligible countries increases, it is increasingly important to focus on addressing inequities. 4.3 The Gavi Alliance is uniquely positioned to support countries in increasing equitable access to immunisation. This will require innovative approaches by countries and in Gavi s support model. 4.4 This focus on equity and sustainability is strongly aligned with the post-2015 development agenda, as articulated in the Sustainable Development Goals (SDGs) adopted by world leaders in September 2015. Recommendations for Gavi s HSIS support are put forward in the spirit of the SDGs and of the Alliance s aspiration to reach every child. Lessons learned: 5.1 Based on recent evidence and lessons learned from experience to date, there are several components of Gavi s current model that should be maintained: Providing support through governments in a country-led process that aligns with national plans and strategies; The emphasis in guidelines on addressing health system bottlenecks that affect the efficient and effective delivery of immunisation services, and on strengthening integrated service delivery at the country level; The provision of technical assistance to support planning and implementation of HSIS support; The provision of support to cover a portion of the operational costs of the introduction of new vaccines and of campaigns (e.g. Vaccine Introduction Grants). 5.2 While the Alliance has made considerable efforts to increase the effectiveness and efficiency of Gavi s HSIS support since it was first introduced, evidence and experience point to a number of challenges: 5.3 An insufficient focus on coverage, equity, and sustainability: Gavi s HSIS support has had a broad focus on addressing bottlenecks to immunisation outcomes, and has not insisted on strategic prioritisation in the use of funds; HSIS grants have not been sufficiently informed by assessments of programme capacity necessary for successful implementation; PPC-2016-Mtg-1-Doc 04 5

Report to the Programme and Policy Committee Long-term programmatic and financial sustainability considerations have not been sufficiently taken into account in country investment decisions; Support for SIAs has not sufficiently promoted country ownership and campaign quality. 5.4 A complex grant architecture that: Provides insufficient visibility across Gavi grants, leading to fragmentation, creating risks of duplication and missed opportunity for synergies; Has not been supported with clear and consistent communication and tools for effective planning and reporting across Gavi grants, with relatively limited budget oversight; Burdens countries with high transaction costs, leading to an overreliance on consultants in the proposal development process, long delays in reprogramming HSS when situations demand a change, and inconsistency with national health and immunisation work plans, budget cycles, and priorities; Places a strong emphasis on the proposal development stage (e.g. for 5- year HSS proposals) and insufficient focus on adapting operational plans and budgets in response to findings from program reviews or changing country needs during the grant lifecycle. 5.5 Allocative challenges: The current formula to allocate HSS across countries, based on country population and Gross National Income per capita (GNI p.c.), does not sufficiently speak to the magnitude of the challenge at hand for different countries or to Gavi s strategic priorities for 2016-2020; and The envelope for Gavi s cash programmes is recalculated annually to stay within 15-25% of Gavi s overall programmatic expenditure on a 3- year rolling average basis. 4 This envelope can change year to year, as vaccine expenditures change. Therefore, Gavi calculates HSS ceilings for countries that are expected to submit new proposals in the upcoming 1-2 years to stay within the 15-25% boundaries. This makes the allocation to an individual country dependent on timing of a country s application, which arbitrarily gives certain countries an advantage over others. In addition, as operational support for campaigns become a larger portion of Gavi s HSIS support with the implementation of the Measles and Rubella Strategy, there is a risk that the funding available for HSS would have to decrease significantly to stay within this boundary. 5 Programming 6.1 Strengthening the focus on equity in coverage: The SC recommends focusing HSIS grants more explicitly on the achievement of the Boardapproved 2016-2020 strategic goals for equitable uptake and coverage of 4 As agreed by the Gavi Board in November 2010. 5 The November 2010 Board decision did not include operational support for campaigns within the 15-25% envelope for cash programmes but under the proposed Framework it would be included as part of HSIS. PPC-2016-Mtg-1-Doc 04 6

Report to the Programme and Policy Committee vaccines; effectiveness and efficiency of immunisation delivery as an integrated part of strengthened health systems; and sustainability of national immunisation programmes. For individual countries, investments to achieve those Goals should be tailored to context-specific needs and priorities. Country progress towards the Board-approved Goal-level Targets should inform dialogue to prioritise support across different potential investment areas. 6 6.2 To support the achievement of these strategic goals, the SC recommends deliberately and pro-actively targeting HSS investments to interventions that improve coverage in underimmunised groups and areas, through investing primarily in four strategic focus areas (SFAs), where these align with country needs and priorities. These are: data availability, quality, and use; supply chain; demand generation; and in-country leadership, management, and coordination Under the proposed Framework Gavi would also consider investments outside these areas when a clear justification is provided, linking investments to coverage and equity improvements, or when investments are critical for addressing needs identified by Programme Capacity Assessments (as discussed in section 6.5). 6.3 To reach unreached children, countries need supply chains that extend to the most remote geographic areas (e.g. through the use of innovative technologies such as solar direct drive refrigerators); data systems with the granularity to identify target populations in low performing areas (e.g. building upon experience from polio to use satellite imagery and geospatial mapping), and capacity to use this data to inform planning and targeting of resources; strong awareness of and demand for immunisation services (e.g. through SMS reminders to mothers and social mobilisation campaigns among socioeconomically disadvantaged communities); and strong leadership and management to ensure resources are deployed effectively and efficiently to reach the unreached. Through the development of potentially transformational approaches within the strategic focus areas (SFAs), the Alliance is working to strengthen its engagement in these critical areas to better support countries in addressing equity-related barriers to immunisation. Guidance on evidence-based investments within the SFAs with high potential for impact on equity in coverage, including innovative approaches for reaching the unreached, are included in the 2016 application guidelines and will be expanded upon in the future. 6.4 Future guidelines will also provide a greater degree of clarity on the types of investments that Gavi funds and does not fund including in the area of 6 These targets focus Alliance-wide efforts on measurable outcomes (or, in some cases, processes). The Board has approved, or will be asked to approve in future meetings, indicators and targets for the four goals in Gavi s 2016-2020 Strategy. All of these are included as mandatory indicators in all countries Performance Frameworks. Approved indicators that would be relevant for the programming of HSIS grants include: routine coverage (penta3 and measles first dose); equity of coverage and barriers (distribution by geography, wealth quintiles, education status of mothers/female caregivers); supply chain (Effective Vaccine Management benchmarks); data quality (the difference between administrative coverage data and survey data); and access, demand, and service delivery (penta1 coverage and drop-out). Indicators are currently under development for programmatic sustainability, institutional capacity, and CSO engagement. PPC-2016-Mtg-1-Doc 04 7

Report to the Programme and Policy Committee Human Resources for Health (HRH), with a focus on avoiding perverse incentives and promoting financial sustainability. Gavi will promote the use of innovative methods for training such as the use of e-learning models rather than traditional model of cascading training.. In addition, Gavi will support training focused on strengthening core capacities in the SFAs such as in the analysis and use of data, in supply chain management, and in leadership and management of EPI programmes. 6.5 Leveraging Gavi s new Programme Capacity Assessments to inform grant programming: HSIS support should be leveraged to address capacity gaps identified by Gavi s PCAs. To enable this, it is critical that output from PCAs is available in time to inform countries planning of HSIS investments and associated Performance Frameworks. 6.6 Tailoring support by transition stage: The SC emphasized the importance of sustainability planning from the outset of Gavi support, not only as countries approach transition. Therefore, under the proposed framework, Gavi would tailor HSIS support to countries in the different stages of transition, as part of a broader effort to strengthen the sustainability of Gavi s investments (including New Vaccine Support and support provided through the Partners Engagement Framework). HSIS support for countries still far away from transition would focus on issues requiring long-term systemic change, such as strengthening immunisation registries or optimising the design of supply chain systems. As countries approach transition, support would increasingly focus on addressing findings from Transition Assessments and preparing for the responsible phasing out of Gavi support. 7 For example, Gavi would reduce support for the recurring costs of immunisation programmes in Phase 1 and Phase 2 transition countries. For further detail, including a discussion of the development of sustainability tracers to track how HSIS investments contribute to financial and programmatic sustainability, see Document 09 on the New Approach to Sustainability. 6.7 Promoting more targeted and efficient use of support for vaccine introductions, product switches, and campaigns: The SC recommends that Gavi seek further synergies and efficiencies in how these one-time grants are used. Under the proposed HSIS Support Framework, Gavi would encourage countries to leverage this funding for activities that strengthen routine immunisation and to identify synergies across activities, including through concurrent vaccine introductions where relevant and feasible. (a) For example, a training activity that is supported by a VIG could provide an opportunity for refresher training on data collection. 7 Through the end of 2020, Gavi is providing Transition Grants to countries transitioning from Gavi support to ensure critical bottlenecks are addressed. Going forward, sustainability will be a critical consideration in all HSIS investments from the low-income phase onwards, and findings from Transition Assessments will be addressed through HSIS grants. PPC-2016-Mtg-1-Doc 04 8

Report to the Programme and Policy Committee (b) Countries introducing multiple new vaccines concurrently would be encouraged to identify synergies in activities (e.g. in demand promotion, health worker training, and launch activities). Grant architecture 7.1 Integrating planning and budgeting: To promote holistic planning and management, the SC recommends moving towards integrated planning and budgeting processes for all HSIS support (including HSS grants and associated performance payments, VIGs, product or presentation switch grants, and Ops). Disbursements would also be consolidated wherever possible on the condition that this does not delay the disbursement of timesensitive components of HSIS support (e.g. Ops) and that there is sufficient assurance that funds will be well accounted for and used for intended purposes. (a) Integrated planning processes would foster identification of synergies across grants and opportunities for savings from VIGs, product switch grants, or Ops. Any residual funding from a country s VIGs, product switch grants, or Ops would become available for additional HSS investments in that country. 8 To ensure a strong focus on system strengthening, funding could not be reallocated from HSS grants to other grants such as Ops. 9 (b) The SC stressed the importance of aligning HSIS support with national health and immunisation plans and strategies, and of ensuring coherence and complementarity with funding from other donors (see Section 14.4 for further information on donor harmonisation). (c) Today, different grants may be planned and budgeted for in different Departments of a country s health ministry. The SC recommended that Gavi continue to use government-led management and coordination mechanisms where possible; and that oversight for all HSIS support typically reside at a level in the health ministry with the authority to link to the broader national health planning and financing system, and authority relative to immunisation. The SC highlighted the need to improve the effectiveness of country coordination mechanisms (such as the Interagency Coordination Committees [ICCs] and Health Sector Coordination Committees [HSCCs]) to enable this approach. 10 (d) The SC recommended that Gavi seek to further engage civil society organisations (CSOs) at the country level, as CSOs can play an important role in some countries in planning, advocacy for domestic resources, service delivery and oversight. 8 This would represent an improvement on the current system, in which residual funds from these grants can in some cases remain idle after introductions and campaigns are completed. 9 Gavi will develop detailed procedures for unspent HSS funds, clarifying the amount that may be rolled over into future years and the amount that must be returned to Gavi if it is not used. 10 The SFA on Leadership, Management, and Coordination (LMC) is currently exploring ways to strengthen these mechanisms. PPC-2016-Mtg-1-Doc 04 9

Report to the Programme and Policy Committee 7.2 Increasing responsiveness to new evidence and implementation experience during the grant cycle: Under the proposed Framework, longterm priorities for Gavi s contribution through HSIS support would be agreed in alignment with countries national health and immunisation strategies, and targets for support would be captured in Performance Frameworks. Detailed operational budget and work plans would be updated regularly (e.g. every 1-2 years) to proactively respond to new evidence (e.g. from program reviews and assessments), new risks identified through Gavi s risk management tools, implementation to date, and progress towards the agreed targets. (a) Compared with the current approach (whereby countries are required to submit up to 5-year budgets and work plans at the HSS proposal stage) this change would bring a greater focus on near-term implementation planning. (b) This approach would leverage the existing Joint Appraisal process to track progress and results, consider how new data could inform revisions to operational plans and budgets, identify best practices and joint learning, and identify potential synergies across Gavi investments. Intermediate indicators would be monitored to ensure that grant support is on track to have the intended results and to inform modifications to operational budgets and work plans as needed. New risks identified through the country risk matrix could inform modifications to planned investments for mitigation. The updating of operational budgets and plans would leverage countries existing operational planning processes (typically occurring on an annual basis). 7.3 In implementing the new HSIS Support Framework, the Alliance will endeavour to promote forward planning so that, even as countries approach the end of a national plan or strategy, there is visibility on planned investments in an upcoming period (e.g. 3 years). Such forward planning would increase the predictability of support, promote better preparation for introductions and campaigns, and reduce gaps between HSS grants and disbursement delays. Allocation of resources 8.1 HSS resource allocation formula: Relevant factors to take into account when distributing Gavi s global resources for HSS across eligible countries include the size of the population in need, the strength of the immunisation system, and countries ability to pay. The first two factors are not currently reflected in Gavi s HSS resource allocation formula, which is based on Gross National Income per capita (GNI p.c.) and overall population size. Thus, to allocate HSS resources across countries in a manner that is better aligned with Gavi s strategic goals for 2016-2020, while maintaining the benefits of a transparent allocation formula, the SC recommends adapting the formula to include three parameters with equal weighting: Live births ( population in need ); PPC-2016-Mtg-1-Doc 04 10

Report to the Programme and Policy Committee Number of under-immunised children ( strength of the immunisation system ), reflecting the focus on equity in line with Gavi s 2016-2020 strategy; and Gross National Income per capita ( ability to pay ). 8.2 VIGs, Ops and product switch grants: The SC recommends that the current funding levels for these grants be maintained, apart from the modifications proposed to introduce financial sustainability considerations. (a) Under the proposed HSIS Support Framework, Gavi discourages the use of HSIS support for human resource remuneration in countries approaching transition to promote financial sustainability (discussed above in Section 6.6). In line with this, VIGs and Ops funding levels would be reduced for countries entering the final stages of transition. (b) Modifications to Gavi s switch grant provisions are proposed to ensure that countries have access to support to safely and effectively switch products or presentations, for programmatic or financial reasons. 8.3 Performance-based funding (PBF): Performance payments provided through Gavi s PBF approach would be supplementary to HSS grants. (a) This is a change from the current approach, whereby performance payments are calculated as part of the country s HSS ceiling, which is set at a fixed annual amount. In changing to a supplementary approach countries would have more flexibility to vary annual budgets within an overall five year ceiling amount; performance payments would be additional to this. This does not change the overall amounts of HSS and performance payments that may be provided to countries compared with the current approach, but simplifies communication about performance payments and clarifies that these are reward payments (as opposed to the current approach under which Gavi withholds a portion of a country s ceiling). (b) Given that Gavi s PBF approach to HSS is relatively new, the SC recommended that the current model be maintained until there is sufficient experience to conduct a rigorous evaluation. At that time, Gavi could consider the use of intermediate indicators to trigger performance payments. 8.4 Overall resource envelope: Currently, in line with the November 2010 Board decision, the cash programmes envelope is limited to 15-25% of Gavi s overall programmatic expenditures on a 3-year rolling average basis. The envelope includes HSS grants as well as other forms of HSIS support (e.g. VIGs, product switch grants). While the Board approved cash programmes envelope did not include operational support for campaigns, this type of support will be considered part of HSIS going forward. 8.5 In December 2015 the Board reviewed the financial forecast for the HSS envelope for the 2016-2020 strategic period, which was US$ 1.3 billion (16% of total programmatic expenditure). Under the current policy, this PPC-2016-Mtg-1-Doc 04 11

Report to the Programme and Policy Committee amount could decrease if vaccine expenditures go down (e.g. as a result of market shaping success, changes in forecasted vaccine introductions, or if countries transition out of Gavi faster than expected). Additionally, as operational support for campaigns is brought into the category of HSIS support, there is a need to ensure that funding available for HSS grants in the future does not decrease as Gavi increasingly allocates resources to the operational costs of campaigns in line with the Measles and Rubella Strategy. 8.6 Therefore, to prevent a fall in available resources for HSS grants and increase predictability for countries, it is proposed to set the December 2015 amount of US$ 1.3 billion as a minimum for HSS disbursements (including performance payments) for grant programme years in the 2016-2020 strategic period, with additional resources subject to Board decision without a proportional ceiling. (a) The amount of funding that Gavi disburses through VIGs, operational support for campaigns, and product and presentation switch grants is driven by country demand and is forecasted to be US$ 620 million in the 2016-2020 strategic period. Promoting country ownership of measles immunisation to reduce reliance on follow-up measles and MR SIAs 9.1 Countries with low routine measles coverage rely on periodic follow-up or recurrent measles or measles-rubella (MR) supplementary immunisation activities (SIAs, or campaigns) to avoid measles outbreaks. Though necessary to ensure sufficient coverage is achieved, these are costly and unsustainable. In addition, in some countries, follow-up SIAs have not achieved the necessary coverage levels for outbreak prevention, as measured by post-campaign coverage surveys or demonstrated by the occurrence of outbreaks soon after campaigns. 9.2 Through Gavi s Measles and Rubella Strategy 11 (approved by the Board in December 2015), Gavi now supports measles and MR follow-up SIAs in all Gavi eligible countries as needed based on measles epidemiology. The Strategy states, While catch-up campaigns would be fully funded, the Technical Working Group considered it important to require co-financing measles or MR vaccines for follow-up campaigns to avoid perverse incentives for countries to do campaigns rather than strengthening routine, and to encourage country ownership. The amount and mechanism need to be further determined during the preparatory year (2016). It also states that, in order to ensure good quality, high and equitable coverage campaigns are conducted, potential incentives based on performance could be explored, as part of the policy review on direct financial support, to be submitted to the Board in June 2016. It is equally important to minimise perverse incentives that may exist from frequently conducting campaigns, and this should be looked into in the policy review." At its meeting in 11 Gavi s Measles and Rubella Strategy, 2015. PPC-2016-Mtg-1-Doc 04 12

Report to the Programme and Policy Committee December the Board was informed that work over the next few months would be focused on the design of the programme and in particular on the definition of the appropriate incentives and monitoring steps for campaigns. 9.3 This review considered ways of strengthening country ownership of measles immunisation to promote quality SIAs where these are needed and, ultimately, to promote improvements in routine coverage and reduced reliance on SIAs. The SC supported the introduction of a co-financing requirement and a reward for SIA performance, provided that the cofinancing requirement does not place an undue fiscal burden on countries. The SC requested that the Secretariat model the impact that this would have on countries overall co-financing requirements. 9.4 Based on this analysis, the following modifications to Gavi s co-financing policy are proposed: (a) Low-income countries are not required to co-finance periodic measles or MR follow-up campaigns, unless the agreed target for routine measles coverage and/or the agreed target for the preceding Gavisupported campaign is not achieved. In this case, the country is required to co-finance 5% of the follow-up campaign. (b) Phase 1 and Phase 2 countries are required to co-finance 5% of the vaccines for measles or MR periodic follow-up campaigns. If a country has not achieved the agreed routine measles coverage target and/or the agreed target for the preceding Gavi-supported campaign, then the co-financing requirement increases to 10%. (c) Countries would be expected to make co-financing contributions in time for the campaign to occur as planned. Gavi s contribution to procurement of vaccines for the campaign would be conditional on countries fulfilling the co-financing requirement. (d) Countries in fragile or emergency contexts may be exempted from cofinancing requirements for campaign vaccines. 9.5 Analyses indicate that co-financing requirements of up to 5% for low-income countries (representing, on average, a projected one-time increase of 6% in co-financing obligations relative to the year preceding an SIA) and up to 10% for Phase 1 and Phase 2 countries (representing on average projected one-time average increases of 5% and 4%, respectively) would be appropriate. These requirements strike a balance between avoiding unintended consequences for other (routine) co-financing obligations or other critical health priorities, while not being so low as to be meaningless. 9.6 This change would come into effect for new proposals for campaigns to be implemented from 1 January 2018. For the first Gavi-supported campaign from this date, the co-financing requirement is the lower level indicated in section 9.4 (0% for low-income countries; 5% for Phase 1 and Phase 2 countries). PPC-2016-Mtg-1-Doc 04 13

Report to the Programme and Policy Committee 9.7 The projected financial impact of these modifications to the Co-Financing Policy is modelled in Annex D. 9.8 Processes for assessing the achievement of measles coverage targets on the basis of available data, e.g. from independent post-campaign coverage surveys and WHO/UNICEF estimates, will be developed and included in Gavi s guidelines for countries. Targets will be agreed in dialogue with countries and partners. Section D: Risk implication and mitigation and Financial implications Risks and mitigation (co-financing of measles and MR follow-up SIAs): 10.1 There is a risk that campaigns get delayed because countries do not fulfil the co-financing requirement for measles and MR follow-up SIAs on time. To strengthen country ownership, it is important to require countries to procure vaccines in a timely fashion. 10.2 There is a risk that this co-financing requirement does not create a strong incentive for higher quality SIAs or improvements in routine coverage, either because the requirement is insufficient or because the incentive does not target the root cause of reliance on recurrent SIAs. To mitigate this risk, the Measles and Rubella Strategy also introduces other measures to promote high quality measles immunisation. To strengthen country ownership of routine, the Measles and Rubella Strategy introduces a requirement that Gavi-eligible countries domestically finance routine measles vaccination. To strengthen Alliance accountability for high quality SIAs, a Key Performance Indicator (KPI) for the 2016-2020 strategic period will track the % of countries where Gavi-funded measles and MR SIAs achieve 95% coverage as measured by a post-sia coverage survey. 10.3 There is a risk that an additional co-financing requirement could undermine the ambitious agenda of increasing countries commitment to routine immunisation financing. However, the proposed co-financing levels are considered low enough not to pose a significant financial burden and threat to routine vaccine co-financing. Moreover, reducing potential perverse incentive through co-financing is even more critical for campaigns as they are ultimately unsustainable and as the long-term solution to measles outbreaks lies in improving routine coverage. 10.4 There is a risk that the use of routine measles coverage targets as part of the co-financing incentive structure could influence countries selection of targets, biasing them downwards. This will be an important consideration in agreeing on country-specific targets. Including a link to routine coverage improvements is important for signalling the need to reduce reliance on SIAs through improved routine coverage. Risks and mitigation (HSIS Framework): 11.1 The proposed approach will require strengthened Secretariat and partner capacity for engaging in countries planning processes and for engaging PPC-2016-Mtg-1-Doc 04 14

Report to the Programme and Policy Committee throughout the grant cycle to support implementation. Ongoing changes in the Secretariat to strengthen grant management capacities and skillsets, and increased focus across the Alliance on accountability for country-level results through the PEF, will be critical for the success of the new approach. This will be a key area for continuing consideration and assessment as the Alliance begins to implement the HSIS Support Framework. 11.2 There is a risk that, in practice, implementation of the proposed changes is challenging due to insufficient planning or poor communication. The Secretariat is proactively engaging country representatives and Alliance partners in the implementation planning process to ensure alignment among key stakeholders on how to most effectively and efficiently implement the proposed changes. Any changes will need to be communicated clearly and will require an investment of time and resources to support countries in transitioning to the new approach. 11.3 The proposed approach will require strengthened country capacity for robust planning and coordination processes. Strengthening country capacity is a key focus of Gavi s work on the Leadership, Management, and Coordination (LMC) SFA. 11.4 An increased focus on investments to address coverage and equity bottlenecks primarily through the SFAs may reduce resources available for other investment areas that have in the past been funded through Gavi HSS. There is a risk that such areas are not adequately funded. However, strategic prioritisation of HSS is necessary not only because Gavi s resources are limited but also to create strong incentives for domestic investment in areas not primarily targeted with Gavi resources. Ultimately, Gavi s investments are premised upon being complementary to investments by the government and other development partners. This is particularly important for countries approaching transition where Gavi would progressively limit support for recurrent costs. The Alliance s work under SG3 to strengthen political will for domestic financing of immunisation will be critical in this regard. 11.5 There is a risk that some Phase 2 countries will not be able to access needed support to promote sustainability and equity in coverage in line with the key principles of the Programming proposals. Under Gavi s current Eligibility and Transition Policy, a country receives HSS support during Phase 2 if its existing HSS grant (which began in Phase 1) extends into Phase 2, if its existing grant ends in time for it to apply for a new grant during the grace year (the first year after passing the eligibility threshold) and/or if DTP3 coverage is below 90%. Thus, for a country with DTP3 coverage above 90%, continued HSS support in Phase 2 is dependent on where it is in its HSS cycle when crossing the eligibility threshold, rather than on relative need. Extra attention will be paid to those countries that will not be eligible for ongoing HSS support through the end of Phase 2 to address inequities before the end of support. 11.6 Decreased funding for VIGs and Ops for countries approaching transition, in alignment with Gavi s overall financial sustainability approach, could lead PPC-2016-Mtg-1-Doc 04 15

Report to the Programme and Policy Committee to insufficient funding for vaccine introductions and campaigns. However, it is important to ensure countries approaching transition increase domestic commitments for immunisation, in particular (in the case of campaigns) for the recurrent costs associated with human resources. Gavi will closely monitor the potential effect of this change on introductions and campaigns. 11.7 Timely disbursements: While the proposed grant architecture changes are intended to improve efficiency over time, there is a risk that some delays could persist and that some changes could contribute to disbursement delays, particularly during early implementation. The Alliance is working to incorporate lessons learned from past experience in its approach to grant management in order to reduce delays. (a) In the shift towards an integrated approach, delays in disbursement of the annual HSIS allocation (e.g. due to underutilisation of the previous year s grant) which may include VIG or Ops allocations as relevant, could delay time-sensitive vaccine launch preparations or campaign activities. This risk reinforces the need for robust planning and effective management of funds, and for timely reporting. In all cases, Gavi will commit to disbursing VIGs and operational support for campaigns six months in advance of the planned launch or campaign date. (b) For HSS, the shift towards an emphasis on near-term operational planning (as opposed to the current approach of requiring detailed long term plans at the proposal stage) could lead to disbursement delays if annual plans are not submitted to Gavi in a timely fashion. The Alliance will explore ways to leverage countries existing annual operational planning processes while also committing to timely disbursements. (c) Financial Management Assessments (FMAs) (now expanded as Program Capacity Assessments) and similar reviews have contributed to delays in the past. It is anticipated that, to the extent possible, such assessments will be conducted prior to the start of support. 11.8 Complex planning: The proposed grant architecture changes the way that countries engage in processes around implementing Gavi support. This could increase complexity in the short term especially where country capacity for robust planning is weak. (a) For example, the integration of planning and budgeting for HSS and other HSIS support (e.g. VIGs) will require broader coordination than has been required in the past for immunisation-specific grants. However, in the long run, such coordination is considered critical for the achievement of Gavi s second strategic goal, increasing the effectiveness and efficiency of immunisation delivery as an integrated part of strengthened health systems. PPC-2016-Mtg-1-Doc 04 16

Report to the Programme and Policy Committee (b) Furthermore, the proposed grant architecture changes are aligned with ongoing work to improve Gavi s country engagement strategy. A shift in focus away from detailed planning and budgeting for a long time period, towards near-term implementation planning, is ultimately intended to contribute to more efficient implementation. (c) Finally, in implementation, the Alliance will focus on aligning with national planning and budgeting cycles, leveraging multi-year planning cycles for the setting of long-term priorities and (typically annual) operational planning and budgeting cycles for near-term implementation planning. This alignment is intended to reduce complexity for countries. 11.9 The integration of budgets and work plans for all HSIS support could increase the risk that funding is not used for the intended purposes. Gavi is developing a more rigorous approach to budget review, financial reporting, and audits for HSIS grants as part of its strengthened emphasis on risk management. The Secretariat s new Programme Finance (PF) team together with the Country Support (CS) team will be focused on ensuring a high degree of compliance with Gavi requirements and scrutiny on financial reporting. 11.10 There is a general risk that the proposed changes are not bold and ambitious enough to lead to measurable improvements in immunisation outcomes. As the HSIS Support Framework is introduced it will be important to closely monitor implementation. The Alliance could consider an active learning agenda to capture lessons and best practices, such as through further full country evaluations and/or future thematic evaluations. Even well-targeted investments may take time to translate into improved outcomes, so it will be important to systematically document intermediate results through strengthened performance frameworks in the interim. Financial implications: 12.1 The proposal to set a minimum of US$ 1.3 billion for HSS disbursements for grant programme years in the 2016-2020 strategic period means that, depending on Gavi s vaccine expenditure, the total percentage of cash programmes investments could increase above the 25% ceiling set by the Board in 2010. The proposed approach would not change the value of existing commitments made to countries within the 2016-2020 period. 12 However, the proposal moves Gavi away from a proportion-based envelope for cash programmes and towards an approach of setting an absolute envelope for HSS grants. 12 As of March 2016, approximately US$ 870 million has been recommended for approval by the IRC for HSS grants over the 2016-2020 strategic period, leaving approximately US$ 430 million in HSS commitments to be made through new proposals (including to India). Countries that apply for grants beginning in 2017-2020 will receive indicative commitments for the years of their proposed grant that extend beyond the 2016-2020 strategic period. PPC-2016-Mtg-1-Doc 04 17

Report to the Programme and Policy Committee 12.2 The proposed changes to VIG and Ops funding levels for Phase 1 and Phase 2 countries will result in a modest reduction of spending in this area relative to the amount forecasted for the upcoming strategic period. Section E: Other Implications Transition to the proposed HSIS Support Framework 13.1 Annex B describes proposed implementation plans for the HSIS Support Framework. The proposed changes to HSIS Programming and Resource Allocation (as set out in section VII of the proposed HSIS Support Framework) would come into effect for new proposals from 2017 onwards. The timing of introduction of the proposed grant architecture changes (as set out in section V of the proposed HSIS Support Framework) would be dependent on individual country contexts (e.g. countries with HSS grants that are coming to an end, and countries that are planning to reprogram existing HSS grants would be prioritised to introduce the new approach). The provisions for Product and Presentation Switch Grants would be effective immediately following the Board decision in June 2016. Cofinancing for measles and MR follow-up SIAs would be effective for SIAs implemented from 2018 onwards. Implications for Alliance partners and stakeholders 14.1 Implementing the proposed changes will require greater responsibility and accountability for implementation and results at the country level through the Partners Engagement Framework (PEF). 14.2 The Alliance will continue to promote civil society engagement and community partnership, in alignment with the principles articulated in Gavi s 2016-2020 strategy. 14.3 Implementation of the proposed HSIS Support Framework will require increased engagement of the Secretariat in country planning processes, requiring augmented capacity (e.g. skillsets) and increased travel and time spent in Gavi countries. This builds on ongoing changes in the Secretariat, such as the introduction of a country team approach and the increased number of Senior Country Managers (SCMS) to strengthen grant management. 14.4 Donor harmonisation: A key principle in the proposed HSIS Support Framework is that Gavi support must complement and be coherent with support from other development partners, such as the Global Fund to Fight AIDS, Tuberculosis, and Malaria (GF), the World Bank, and the Measles & Rubella Initiative. PPC-2016-Mtg-1-Doc 04 18