Bill _ Melinda Gates Foundation

Bill & Melinda Gates Foundation In support of Vaccine Preventable Diseases Open Request for Proposals #SOL1001047 “Constraints to New Vaccine Adoption in Lower Middle Income Countries” Proposals due by: May 18, 2009 Table of Contents Summary Background Objectives and Scope Capabilities and Skills Budget and Timeline Eligibility Criteria Proposal Format How to Apply and Review Process Evaluation Inquiries Application Checklist Annexes: Annex 1. World Bank list of economies by Income Classification (Lower Middle and Upper Middle Income) as of 1 July 2008, GAVI eligibility, population, and GNI per capita Annex 2. WHO plan of action for new and under-utilized vaccines implementation: 2008-2011, version December, 2008 2 3 5 7 8 9 9 10 10 11 12 ` 1 SUMMARY The Bill & Melinda Gates Foundation (the “Foundation”) invites proposals from qualified organizations interested in receiving support to enhance global knowledge and understanding of the challenges that Lower Middle Income Countries (LMICs) face as they explore the potential of new vaccines. Among key areas for consideration are: Which challenges limit the rate at which new vaccines are adopted by these countries? What are the potential options to address the rate limiting constraints? And what are the likely costs, benefits and implications of various options for supporting countries to address identified rate limiting constraints? Based upon these analyses the grantee will be asked to develop prioritized strategies and suggest practical measures at the global and national level to support LMICs that choose to adopt new vaccines. The Foundation believes that there may well be substantial benefits to enhancing new vaccine introduction in LMICs including contributing to improvements in global health by preventing priority diseases; paving the way for other more risk averse countries to introduce new vaccines (providing information on licensing, vaccine presentation issues, adverse events following immunization (AEFI), impact of vaccine use on disease burden); and, as a potentially large and attractive market for manufacturers, LMICs rate of vaccine adoption will affect vaccine supply, pricing, and demand forecasting, and encourage a broader market strategy rather than one that focuses mainly on high-end markets. The grant may be allocated up to U.S. $750,000 over nine (9) months. 2 BACKGROUND Recent years have seen a dramatic increase in the number of new vaccines that will have a direct impact on diseases responsible for high mortality, particularly among children. As more vaccines become available, interest is mounting among donors and partners to assist countries that are most affected with these diseases and that are likely to benefit from the use of new vaccines. With support from the international partners and the GAVI Alliance (GAVI), many vaccine initiatives have been launched to expedite the potential benefits from promising immunization technologies. The Expanded Program on Immunization (EPI), launched in 1974 was designed to develop vaccine delivery systems in countries. Traditionally the vaccines delivered through EPI have been against disseminated forms of tuberculosis, diphtheria, tetanus, pertussis, poliomyelitis, and measles, although in some countries additional vaccines have been added. With the launch of GAVI in 2000, financing became available to help the poorest countries (GNI<$1000 per capita) introduce vaccines against hepatitis B, Haemophilus influenzae type b, and yellow fever (in areas at high risk of the disease) to their programs. To date, most of the global resources available to support the adoption of new vaccines have been focused on the poorest countries of the world, those with a GNI per capita <$1000. This is largely due to the recognized limited national resources available in these countries and establishment of GAVI as a financing mechanism to support new vaccine introduction and immunization program improvement. Countries that are relatively poor – though not poor enough to be eligible for support from GAVI – have received limited technical and financial support. Recent analyses have shown that LMICs, with the exception of some located in the Americas, are beginning to lag behind even the world’s poorest countries eligible for GAVI support in terms of introducing the newer vaccines. The potential benefits of greater attention to LMIC needs include the following:    Contribute to improvements in global health by preventing priority diseases and progressing towards attainment of the Millenium Development Goals; As frequent early adopters of new vaccines, these countries can pave the way for other more risk averse countries, providing information on licensing, vaccine presentation issues, adverse events following immunization (AEFI), impact of vaccine use on disease burden; As a potentially large and attractive market for manufacturers, LMICs affect vaccine supply, pricing, and demand forecasts, and require a broader market strategy rather than one that focuses mainly on the high-end market. Background: Characteristics of Middle Income Countries Countries that are above the income eligibility threshold for GAVI support represent a large population whose health could be dramatically be improved by the timely adoption of new vaccines. Based on 2007 fiscal data, the World Bank classifies 93 countries as MI countries (Annex 1). Removing those 23 countries that are GAVI eligible leaves 70 countries of potential focus. However this is a very diverse group of countries having a per capita income ranging between US $936 and US $11,455. The members of this group, most of which are eligible for International Bank for Reconstruction and Development (IBRD) loans, include a number of populous countries, such as Brazil, China, the Russian Federation, the Philippines, Thailand, and Turkey, with a total population of almost 2.6 billion. The World Bank Middle Income classification is further divided into two categories, “upper” and “lower” 3 MI countries, with the upper limit of GNI for lower MI countries (LMICs) as US$ 3705. There are 32 LMICs that are not GAVI-eligible. These 32 countries have a total population of 1.86 billion. Historically, MI countries have been early adopters of new health interventions demonstrating impact and addressing programmatic challenges and thereby paving the way for lower income countries. These countries have traditionally financed their own vaccines, often paying higher prices than low income countries. In some instances new health interventions were initially adopted by the private sector in MI countries, which in turn spurred adoption of these interventions by the public sector. Importantly, MI countries are more likely to have the infrastructure needed to quantify disease burden and measure vaccine impact, thereby building the evidence base for decision-makers in the countries with less sophisticated infrastructure. Finally, this group accounts for six of the nine regulatory authorities included in the Developing Country Vaccine Regulators Network (DCVRN) and five of the 12 emerging manufacturers producing WHO-prequalified products. Background: NUVI Strategy and Plan of Action After meetings in 2007 and 2008 on their New and Under-Utilized Vaccines Introduction (NUVI) Strategy, and a resolution of the World Health Assembly stating that the needs of Middle Income countries not be neglected, WHO and its partners developed a “Plan of action for new and under-utilized vaccines implementation” one of the core areas of which relates to meeting MI country needs in new vaccine introduction. This Plan proposes strategies and activities including milestones for seven key vaccines up to 2011 (Annex 2). The NUVI meeting held in June 2008 recommended that work in nonGAVI eligible LMICs should focus on the following six areas: 1. 2. 3. 4. 5. 6. Developing support to strengthen the national decision making process Including the private health sector in vaccine delivery issues Developing potential vaccine supply strategies Addressing the challenge of vaccine procurement systems Strengthening regulatory systems Identifying financing opportunities. Understanding rate limiting constraints and potential impact Beyond the general acknowledgement that LMICs are lagging behind in new vaccine introduction, the impact of the limited support and focus that LMICs receive is not fully understood or documented. Further, the potential impact of making additional targeted investments to support national efforts to adopt new vaccines on rates of adoption both in MI countries and GAVI eligible countries has not been explored systematically nor the impact on the global vaccine market itself. Any concerted activities or interventions targeted at this group of countries to accelerate new vaccine introduction will have an effect on vaccine supply, pricing, total vaccine demand, vaccine presentations etc., and these effects need to be well understood before a program of work to support these countries is developed. The high price of many new vaccines is one obstacle facing LMICs. However, vaccine price is not believed to be the only major rate limiting step to new vaccine introduction. Other needs identified to date include the need for: strengthening national advisory groups so that countries and their partners can make more informed decisions, enhancing capacity to assess disease burden, estimate, and demonstrate vaccine impact, building capacity to conduct cost effectiveness analyses, improving procurement systems to 4 address challenges of new vaccines purchase including mechanisms to facilitate better pricing agreements with manufacturers; and extending planning tools such as the comprehensive Multi-Year Plan (cMYP) to guide the vaccine introduction process and facilitate long term vaccine program planning as a critical element of comprehensive national health planning. The current understanding is that LMICs want inputs into their national processes based on knowledge services and access to technologies, rather than through traditional development assistance. OBJECTIVES AND SCOPE OF RFP The purpose of the work requested through this RFP is to gain greater knowledge and understanding of the challenges that LMICs face as they explore the potential of new vaccines, which of these challenges limits the rate at which new vaccines are adopted by these countries, and what are the implications of options for supporting countries to address rate limiting constraints. Based upon these analyses the respondents will be asked to develop prioritized strategies and suggest practical measures at the global, regional, and national level to support lower middle income countries that choose to adopt new vaccines. The three key objectives of this RFP are:  Diagnostic: Understand the needs of LMICs and the challenges of vaccine introduction and potential methods for supporting countries to address the identified challenges. (All MI countries should be considered in data collection to gain insights into how all countries have addressed adoption challenges. Particular consideration should be given to LMICs which have successfully introduced new vaccines.) Analysis: Develop options to address the rate limiting constraints to vaccine adoption by LMICs. Analyze the impact of these options. Pay particular attention to the potential impact of accelerated vaccine adoption by LMICs on the vaccine supply situation, with emphasis on the impact on the global demand forecast for priority vaccines, on the impact of different procurement options, and on the potential impact of different pricing strategies for this group of countries. Strategy: Prioritize possible strategic interventions, such as those included in the NUVI plan, in accord with maximal positive global impact, consistency with national priorities and needs, feasibility, partner support, and timeframes.   Some preliminary data collection has already started through WHO and other partners. The results of this work will be made available to the selected and awarded applicant from this RFP process. The purpose of this work is to gain greater knowledge and understanding of the current situation of LMICs in new vaccine introduction so as to inform future partners’ activities and support. The study will determine:   Priority needs and constraints faced by LMICs in introducing new vaccines Options and strategies for interventions with estimates of potential impact 5 The scope of work covered by this RFP is structured into three major modules described below, corresponding to the three key strategic objectives. 1. Diagnostic work. The diagnostic work is designed to provide a better picture of the challenges and most important issues facing all MI countries, including those that are GAVI eligible for new vaccine introduction. The general considerations for data collection and priority areas are provided in Annex 2. This work is already underway by the partners and those results will be shared with the selected awarded applicant to this RFP. The Applicant may suggest additional areas for study to provide the clearest pictures of the challenges and issues. For example, a recent study by McKinsey1 suggested that in addition to the traditional areas of work, three activities were important in the uptake of new vaccines: involving international experts, involving finance ministers, and fostering cross-border cooperation. Based on a review of the data assembled by the partners, the selected Applicant will develop hypotheses about characteristics that constrain or enhance new vaccine uptake, and propose carefully planned in-depth country assessments to support or refute these hypotheses. Implementation of some six to ten in-depth studies is suggested. Country visits should enlist the participation of relevant partners, and be carefully prepared with an in-depth and justifiable data collection instrument. Applicants should propose a methodology for these visits as a critical part of the submission. 2. Analytical work. The analytical work will include two major areas of work. The first area of work is an analysis of the findings of the diagnostic work described above, identifying the key constraints to vaccine adoption by MI and LMICs. Based upon the finding of these analyses the applicant will develop criteria to select options to address the key rate limiting constraints. Each of the options will be assessed based upon criteria developed by the team and described in their proposal. The second area of work is an assessment of procurement strategies, promoting the use of global demand forecasts, and exploring the implications of various pricing, procurement and financing strategies that could benefit LMICs. From the data and analyses provided by partners and with the needed adjustments and updates, impact on global demand and supply to include MICs and in particular LMICs could be explored. It is proposed that this work would include, in addition to those “new” vaccines already being introduced in developing countries (hepatitis B, Hib, pneumococcal conjugate, and rotavirus), vaccines against the following diseases: Japanese encephalitis, typhoid, meningitis A, HPV, and rubella. Applicants may wish to add or subtract from this list as they feel warranted, however any modifications should be justified in the proposal. 3. Prioritization of strategies. Based on the results of the data collection, the in-depth country studies, a synthesis of the overall findings, and an in-depth assessment of a comprehensive set of options, the selected Applicant will develop a list of prioritized strategies for supporting LMICs in their efforts to adopt new vaccines. These strategies should be based upon maximal positive 1 Michael D. Conway, Carlo D. Rizzuto, and Leigh M. Weiss: A better way to speed the adoption of vaccines: Mapping the way decision makers interact could hasten the introduction of vaccines. The McKinsey Quarterly, September2008. 6 global impact, consistency with national priorities and needs, feasibility, partner support, resources available, likely costs and timeframes. The criteria on which the strategies were prioritized should be clearly described. These strategies are likely to need to include activities at country, regional, and global level. Deliverables: The grantee will be expected to provide an inception report (workplan), a mid-term report, draft final report, and a final report at the conclusion of the grant. Timing of mid-term and final reports will be determined as part of the review of the inception report. Oversight: The day-to-day oversight of this grant will be undertaken jointly by the Foundation and the World Health Organization. It is further anticipated that a 7-10 member Advisory Group comprised of representatives from key partner agencies and organizations will be established to inform the grant work plan and next steps, if identified. It is envisaged that the Advisory Group will have two face-toface meetings and one video/telecom during the course of the grant, specifically at the beginning of the grant to review the work plan and advise on the study process, at the mid-term to understand progress, challenges, and preliminary findings, and at the end of the study to review the findings and provide advice to the Foundation, WHO and other stakeholders on the results, recommendations, and ways forward. CAPABILITIES AND SKILLS REQUIRED The selected Applicant will need to demonstrate the following capabilities: Technical Expertise  An understanding of immunization/health programs and their financing at the country level.  A knowledge of the policy making process for immunization/health-related institutions at global and regional levels.  In-depth knowledge of vaccine production and procurement economics, including vaccine pricing.  An understanding of country decision making processes especially for the social sectors and health  Ability to model outcomes based on data input.  Experience organizing and executing country visits to solicit information from governments and local stakeholders.  Experience in developing and using data collection forms.  Experience in synthesizing information to develop a strategic approach. Strategic Vision  Documented history of providing innovative approaches to developing country health/immunization problems.  Demonstrated ability to take inputs from stakeholders operating from different perspectives and synthesize these inputs into coherent, integrated strategies that can be endorsed by the partners.  Ability to project the implications of proposed pathways for the short, medium, and long term. Managerial Capacity 7   Demonstrated ability to enlist the required experts, consultants, support staff, and provide the technical and logistics support (travel arrangements, meetings, etc) required by the scope of work. Experience in providing oral (power point slide decks) and written presentations which are informative, evidence-based, and clear. Other  Ability to work within a budget and established time frames.  Experience in working in the global public health environment  Multilingual skills and capacities BUDGET AND TIMELINE The size of the grant award will be determined according to the approach, scope, and budget identified in successful proposals up to a maximum of US$ 750,000. Applicants may plan up to nine (9) months duration. Budget Applicants are required to fill out a budget spreadsheet and budget narrative provided by the Foundation to illustrate the costs of the project. Together, the budget narrative and budget spreadsheets should provide a complete financial and qualitative description that supports the proposed project plan. The budget spreadsheet will illustrate the costs of the project. The budget narrative supplements the information provided in the budget spreadsheet by justifying how the budget cost elements are necessary to accomplish the project objectives. The budget narrative is a tool to help the foundation staff fully understand the budgetary needs of the applicant and is an opportunity to provide descriptive information about the costs beyond the constraints of the budget template. Applicants are also responsible for ensuring that sub-contractors and sub-grantees are aware of the foundation’s indirect cost policy.  Direct costs: Grant funds may be used for the following costs: personnel, necessary travel, equipment, supplies, contracted services, sub-grants, and consultants.  Indirect costs: Government agencies are not eligible for indirect cost reimbursement. A non-government agency grantee will be eligible to receive indirect cost reimbursement up to 10% of modified direct cost (defined as total direct cost less sub-contracts, sub-grants, and equipment) for U.S. universities and up to 15% of modified direct cost for NGOs and non-U.S. universities. Additionally, the grantee will be eligible to receive indirect cost reimbursement up to 10% or up to 15% (in accordance with institutional definitions above) on the first $100,000 per annum for each distinct sub-contractor or sub-grantee. Timeline 8 1 April 2009 RFP posted on Foundation website 18 May 2009 Deadline for receipt of proposals 27 May 2009 Proposals reviewed 28 May 2009 Internal Foundation approvals and compliance review 10 July 2009 Formal notification of contract awards Applicants should anticipate a start date no earlier than mid-July 2009. ELIGIBILITY CRITERIA This grant award will be made to a single primary grantee on behalf of itself or a consortium of organizations. Applicant organizations may either be governmental entities or publicly supported non-profit organizations that are tax exempt under section 501(c)3 of the U.S. Internal Revenue Code. Relevant nonU.S. governmental agencies, multinational organizations, and non-government organizations (with documented equivalency to a U.S. publicly supported non-profit organization) with the requisite expertise and capabilities are also eligible. PROPOSAL FORMAT Organizations interested in responding to the RFP are asked to submit a 15 to a maximum 20 page document outlining their approach to the grant. With the exception of the budget, budget narrative, and attached examples of recent work (Power Point or written document) from the proposed team, no appendices will be accepted or reviewed. Proposals will be evaluated according to the applicant’s experience, approach and organizational capacity. The proposal must be submitted electronically through the external portal. I. Executive Summary – This section should present a high-level synopsis of responses to the RFP as a brief overview of the work to be accomplished, the approach proposed, and the main features of the project. It should identify the benefits of the proposed approach, as well as major challenges and risks to success. Context, Goals and Objectives – Describe the overall context, goals and measurable objectives of the project. Project Framework – This section should provide a detailed description of the proposed means for collecting the necessary information including examples of data collection instruments, conducting the necessary analyses and developing the priority options for investments and recommendations for their implementation. Key assumptions should be noted. Include methods and approach for monitoring the project. Organizational Capacity and Management Plan: Include the overall organizational capacity and management and staffing plan for the project. List the personnel who would work on the project along with their biographies, qualifications and relevant experience and their budgeted level of effort for the project. Please identify any sub-contractors here. Describe and submit 1 to 2 related pieces of work that demonstrate the capacity of the team to II. IV. V. 9 VI. conduct the proposed analyses. (These examples will not be included in the 20 page limit.) Please note that the day-to-day oversight of the grant will be undertaken jointly by the Foundation and World Health Organization. Budget - The budget should be provided as a separate document, and in the attached format. HOW TO APPLY AND REVIEW PROCESS This RFP will be a one-step application process. One applicant will be awarded this grant. Please submit the proposal by midnight Pacific Standard Time on 18 May, 2009.  Applicant organizations MUST fully meet the Foundation’s eligibility criteria.  Proposals must be submitted electronically using the web site. No applications will be accepted if they are not sent through this medium.  Applications that are not properly submitted will be returned to the applicant.  With the exception of the budget, budget narrative, and examples of prior work, no appendices will be accepted or reviewed.  Incomplete or late proposals will not be considered for review. Note that:  Prior to submitting proposals, applicants may wish to submit questions or areas for clarification to Foundation and WHO Staff. These questions should be sent via the web site through the “Ask a Question” on the main page.  Questions will be compiled, answered, and posted on the website weekly.  The Bill & Melinda Gates Foundation do not provide individual critiques of proposals.  A panel of external reviewers convened jointly by WHO and the Foundation will make recommendations on the proposals; however final decisions will be made by the Foundation.  The day-to-day management of this grant will be undertaken by the Foundation and the World Health Organization. EVALUATION CRITERIA The proposals will be reviewed according to the following criteria: Vision and Knowledge (Approach)  Does the Applicant demonstrate an understanding of the situation of national immunization in a wide range of developing countries?  Is the Applicant familiar with GAVI policies and practices?  Is the applicant familiar with the issues facing MI countries?  Is the approach described by the Applicant responsive to the RFP and likely to help WHO, BMGF, and the other partners determine how to meet the priority needs of LMICs?  How does the Applicant propose to implement the country visits?  How does the Applicant propose to conduct the required analyses? 10  How does the Applicant propose to identify the prioritized strategies? Innovation  Does the Applicant propose novel ways of carrying out the modules defined in the RFP?  Is the approach to the modeling analyses of the impacts of various strategies on the global vaccine access situation appropriate and likely to yield the required information with sufficient accuracy to inform recommendations? Technical Expertise  Does the Applicant demonstrate access to appropriate technical expertise (both direct project personnel and any sub-contractors) to respond to the RFP and to carry out the approaches defined? Cost-efficiency  Does the Applicant’s budget include sufficient resources to accomplish the objectives?  Are the costs in line with the average costs of similar activities?  Are the activities of the partners leveraged? Experience in similar projects  Can the Applicant show documented success in accomplishment of similar projects? INQUIRIES Please direct all questions about this RFx through the Ask a Question facility on the main page. 11 APPLICATION CHECKLIST - PROPOSAL □ □ □ □ Your organization meets the eligibility requirements. You have included “RFP ID: SOL1001047”in the header of the narrative pages of the text. You have provided budget estimates for allowable costs. You have submitted your proposal online through external portal. 12