Update: see here for joint donor response to Q&A as of Jan 14, 2025. Additional questions maybe submitted to [email protected],

BACKGROUND  

Depot Medroxyprogesterone Acetate (DMPA) is a highly effective, long-acting form of hormonal contraception which can be administered through either intramuscular (IM) or subcutaneous (SC) methods.  Administered every 12 weeks, DMPA can be provider administered (PA) by a trained healthcare worker or self-injected (SI) subcutaneously by the user.  

 As a self-injectable contraceptive product, DMPA-SC (SI) empowers users by offering greater control over their reproductive health, thereby reducing dependency on healthcare providers and alleviating pressure on health care systems.  DMPA-SC (SI) is packaged in a prefilled, all-in-one injection system and offers a convenient, discreet, and effective method of family planning. Robust research has proven that women can successfully self-inject after training, can accurately recall for subsequent doses, and that self-injection increases continuation rates. Every month, hundreds of thousands of DMPA-SC users opt for self-injection. 

 The Injectables  Access Collaborative (AC) project (led by PATH), has supported over 60 countries in introducing and scaling up DMPA-SC and self-injection through technical assistance and market insights. To date, there are 59 countries with DMPA-SC and self-injection regulatory approval and 20 sub-Saharan African countries have DMPA-SC on their respective national essential medicine lists. There have been 5.3 million DMPA-SC visits recorded over the past year (Q2 2023-Q1 2024) among 14 countries with data reporting (including Benin, Burkina Faso, Côte d’Ivoire, DRC, Ghana, Guinea, Malawi, Mali, Mauritania, Nigeria, Senegal, Togo, Uganda, and Zambia). Among DMPA-SC visits in these countries, 22% were for self-injection. The AC has driven market growth by integrating DMPA-SC into policies, regulatory frameworks, and health information systems, fostering demand generation, and addressing supply chain challenges to expand contraceptive access and choice globally. 

 The global rollout of DMPA-SC and SI remains at a critical phase for coordination and market shaping and we believe this is an opportune time to build on our momentum and to continue to scale DMPA-SC and SI across the entire health system. As the AC project concludes in late 2025, the Gates Foundation (GF) and Children’s Investment Fund Foundation (CIFF) seek to fund the next evolution of this work with a new award to establish and galvanize the Future Injectable Market Steward (FIMS) for injectable contraceptives.  

INTRODUCING: FUTURE INJECTABLE MARKET STEWARD (FIMS)  

With inputs and consensus from the Injectables Strategic Advisory Group (I-SAG; whose membership includes donors, representatives from country ministries, USAID, UNFPA, key partners and other lead market actors), the FIMS was developed.  The primary role of the FIMS will be to lead the global contraceptive injectables market and advance the 2030 strategic vision for DMPA-SC which states:  

Quality assured product is consistently available, affordable and accessible for women via their preferred channels (including in the private sector) and via their preferred method of administration, in the context of informed choice.  

Responding to evolving market needs, FIMS will oversee all DMPA injectable contraceptive products including all administrative methods (subcutaneous, self-injection, provider administered and intramuscular), near-term generic options that are entering the market, and future injectable products in the pipeline. A key goal for FIMS is to catalyze a sustainable market for DMPA-SC (SI) with full independence by 2030, at which point the goal will be to reach a market of over 100 million units annually (up from the current allocation of 34 million units per year in 2024), with self-injection as a routine option.  

The primary functions of the FIMS will include:  

1. Market intelligence, landscaping and strategy development to achieve the vision for a healthy injectables market by 2030 [high priority]. 

2. Establishment and maintenance of a supportive in-country enabling environment for introduction and scale, including advocacy, policy, regulation and service delivery [high priority]. 

3. FP commodity planning, forecasting and quantification to support a robust supply chain [high priority] 

4. Demand generation to increase awareness of and support for new products [medium-low priority] 

5. Research, learning and dissemination of best practices to build evidence and inform action [medium priority] 

OVERVIEW: REQUEST FOR PROPOSAL (RFP)  

This RFP invites concept note submissions for the Future Injectable Market Steward (FIMS). Co-funded by GF and CIFF, this new award will provide funds to monitor, manage and move the contraceptive injectables market towards maturity by 2030. 

Key details for the RFP include:   

• Funding source: Co-funded by CIFF and GF 

• RFP timeline and investment development timeline:  

• RFP concepts: submissions due by January 31, 2025  

• Partner selection: early March 2025 

• Full investment proposal and budget development: March – September 2025 

• Award activated: September 2025 

• Partner criteria: Both public and private/or public-private entities will be considered (with various requirements for each considering foundation obligation to ensure charitable purpose of funds); see below for more details on eligibility and key capabilities/skills required. 

• RFP concept length: No longer than 2500 words in concept note template; please use this provided template. Oral presentations may be requested before final selection. 

• Budget details: Proposals will be judged based on the efficient use of resources and sustainability plans. The proposed budget should include a summary of cost details by FIMS market functions 1-5. Additional consideration will be given to budget proposals that reflect clear value and the engagement of local partners, where possible. Please use the provided template (attached). 

• Appendices: (1) please include CVs for up to 5 key project leadership staff and (2) Organigram depicting the structure of the proposed consortium or partner ecosystem. 

This open-call request for proposals (RFP) will be open through January 31, 2025, and is subject to Gates Foundation policies1 and CIFF’s processes and requirements regarding approvals, due diligence, and contracting. 

PROJECT OUTLINE AND EXPECTATIONS 

The grant to FIMS will be a single, multi-year award that will aim to catalyze the global market for injectable contraceptive  products. Through the RFP process, the donors seek to identify a partner (or consortium of partners) to execute the five core functions detailed below. Each proposal must be able to address the following prompts:   

• Project approach - Describe the approach you will take to achieve the intended results of this project, including the overall scope of work, timing and/or phases, and resource needs to support the budget (e.g., people, technical expertise, experience, specific assets including any in priority countries). 

• Primary outcome(s) or result(s) - How will you know when the result(s) has been achieved? How will the results be measured? Describe the vision of long-term sustainability of this project. Consider the economic/financial, organizational or behavioral factors to sustain outcomes beyond this project’s time frame and funding. 

• Potential risks or challenges - Include any external factors or critical relationships with other partners/projects that may influence the success of this project. 

• Capacity of your selected organization to do the work - Why is the organization qualified to undertake this work and achieve the desired impact? Describe any changes or improvements you plan to make to your organization's capacity to undertake or achieve the outcomes of the proposed investment. 

 Applicants are encouraged to consider a range of potential models, such as a consortium approach, where multiple partners collaborate to bring diverse expertise and resources; or a lead-partner approach, where a single entity assumes overall responsibility while subcontracting specific components to specialized organizations. Proposals should clearly describe the rationale for the chosen model, including how it will maximize impact, ensure effective coordination, and achieve the program's goals (including an illustrative organigram of the proposed partnership model). 

Throughout the proposal, applicants should expect to cover both the what—the high-level goals and objectives of the program—and the how —the proposed approaches and methodologies for achieving them. At the core of the submission for FIMS should be a clear theory of change framework that defines outcomes, the key pathways to achieve them.  This should include  high-level indicators to guide monitoring, evaluation, and reporting, ensuring a balanced focus on both outcomes and processes throughout the program. 

In addition, applicants should consider a strategic market phasing approach when budgeting for resources and level of effort (LOE), tailoring activities to the varying needs of countries in different phases of market maturity. . The vision for FIMS is to work to accelerate countries through market maturation (considering sustainable growth) and through activities that meet the needs of national level actors, key local stakeholders and ultimately women and girls around the world. Figure 1 (attached here) illustrates the current market phasing strategy and the status of each geography within the market (attributed development to the Access Collaborative team). Note: Greater resources and efforts may be required for Phase 2-4 countries to support scale-up, address gaps, and operationalize policies, while Phase 5 mature markets (ie: Malawi) may need sustained support to maintain integration. This phased approach ensures strategic and efficient allocation of resources to maximize impact across priority geographies. Source: PATH (2024)

CORE FUNCTIONS AND ILLUSTRATIVE COMPETENCIES 

The primary objective for FIMS is to advance the  2030 strategic vision for DMPA-SC  and to catalyze a sustainable injectables market  by 2030. This will occur through the following core functions and activities for FIMS:  

1. Market Intelligence, landscaping, and strategy to achieve the vision for a healthy injectables market by 2030. FIMS will act as the overall market steward for injectables, both leading activities directly and supporting stakeholders at the global and country levels.  This role will require solution-oriented approaches, with a heavy reliance on relationships and stakeholder engagement. At the global level, FIMS will develop a comprehensive global product roadmap, toolkit, or playbook that consolidates market strategies and best practices. When entering a new market, FIMS will be responsible for in-country market landscaping, mapping of key stakeholders, and adapting the global playbook to respond to country-specific nuances. FIMS will also be responsible for developing a robust market monitoring plan that leverages advanced analytics to analyze, synthesize, and report aggregate market data across channels and line extensions, using external datasets and near real-time reporting approaches to track demand, supply, service delivery integration, provider trainings, and progress against KPIs. This will require FIMS to obtain and maintain Network Player Membership with the Global Family Planning Visibility & Analytics Network (GFPVAN) and to engage collaboratively with the Consensus Planning Group (CPG) to generate deliverables. Lastly, FIMS should coordinate financing for injectables by mapping and understanding current and future financing scenarios, advocating for sustainable sources of financing, and developing insights and recommendations for financing that lead to a sustainable injectables market. It is expected that FIMS will work towards the goal of a sustainable market and will incorporate mechanisms to gradually transition market stewardship responsibilities to local stakeholders. 

Illustrative competencies: Market research and analysis; stakeholder mapping and engagement; strategic planning and strategy development; advanced analytics and data synthesis with proficiency with AI, data and technology tools; agile problem-solving and critical thinking; product and project management; relationship management of high level stakeholders such as UNFPA, USAID, donors, and ministry of health officials; health financing and advocacy; capacity-building and transition planning; monitoring and evaluation; sustainability planning; change management; effective communication; leadership; and vision alignment. 

2. Establishment and maintenance of a supportive in-country enabling environment for scale, including advocacy, policy, regulation, service delivery and market access. Experience has shown the importance of supporting the development of policy, regulatory guidelines, and service delivery guidelines in order to prime the market for introduction and scaleup. It will also be critical to engage with relevant payers to ensure that key stakeholders understand the various public health and health economic implications of providing market access to DMPA-SC. This will require high levels of engagement with in-country stakeholders, technical working groups, and advocates across a variety of fora to ensure that best practices are followed for adoption and implementation of self-care policies, task-shifting policies, updates to pre-service and in-service training guidelines, updating of regulatory policies, market access coverage, financing, and integration of metrics into existing national HMIS/LMIS/pharmacovigilance systems. Lessons learned across countries should inform new market entry, ensuring that best practices in contraceptive product introduction are followed. Once an enabling environment is primed for introduction and scaleup, FIMS will be responsible for the ongoing monitoring of and trouble-shooting support to that enabling environment.  

Illustrative competencies: Measured, thoughtful and strategic stakeholder engagement; understand policy cycles, policy development and analysis; understand regulatory guideline formulation and service delivery guideline development; facilitation of multi-stakeholder collaboration; data- and evidence-driven; ability to synthesize lessons learned across countries. 

3. Commodity planning, forecasting, and quantification to support a robust supply chain. It is not the intention of FIMS to resolve entrenched supply chain challenges related to family planning commodities. Rather, the goal is to identify, document, and elevate solutions for injectable-specific supply chain challenges, coordinating/working in partnership with key organizations responsible for the quantification, procurement, storage, distribution, and tracking of commodities. FIMS will be responsible for developing a high-level supply chain vision across donors and procurers, supporting global and in-country market forecasting, identifying and proactively resolving supply chain issues across the value chain, and providing targeted regulatory support, where required, by monitoring regulatory pathways and liaising with in-country regulatory bodies, manufacturers, and procurers to expedite responses to challenges.  

Illustrative competencies: Supply chain planning and management; commodity forecasting and quantification; market forecasting expertise; stakeholder engagement and coordination; ability to identify and document supply chain solutions; problem-solving and issue resolution across the value chain; knowledge of procurement, storage, distribution, and tracking systems; regulatory pathway monitoring; liaising with regulatory bodies, manufacturers, and procurers; strategic vision development for supply chains; collaboration with donors and procurers; understanding of injectable-specific supply chain dynamics. 

4. Demand generation to increase awareness of and support for new products. FIMS will identify, coordinate, and curate demand generation needs and activities for injectables, working with implementing partners, donors, ministries of health, private sector / social marketing organizations and other key stakeholders to carry out and monitor the progress of those activities. FIMS will be responsible for mapping demand generation needs at the country level and providing targeted technical assistance to in-country partners to respond to gaps. FIMS will collate, curate, and synthesize information on end-user preferences and behavior to better understand demand-side issues, and to use these insights to inform programmatic activities at the country and global level. FIMS will be responsible for disseminating this information to donors, country stakeholders, and manufacturers (as appropriate) to inform marketing strategies, branding approaches, and programmatic priorities. FIMS will not be responsible for collecting primary data nor will FIMS be responsible for conducting in-country demand generation activities or campaigns.  

Illustrative competencies: Marketing strategy development; stakeholder coordination and engagement; mapping and analysis of demand generation needs; technical assistance provision to address in-country gaps; knowledge of end-user preferences and behavior; ability to synthesize information on demand-side issues; collaboration with implementing partners, donors, ministries of health, private sector, and social marketing organizations; monitoring and evaluation of demand generation activities; application of insights to inform programmatic activities; understanding of country-specific contexts and cultural nuances; strategic thinking to align demand generation efforts with broader market goals. 

5. Research, learning and dissemination of best practices to build evidence and inform action. This work will require close collaboration with key stakeholders whose role is to disseminate best practices and lessons learned in family planning. FIMS will be responsible for coordinating and supporting research on injectables, for example by identifying gaps in understanding and collating insights across countries and regions. FIMS will also be responsible for thought leadership and the dissemination of lessons learned by participation in country, regional, and global working groups. Where possible, subject matter expertise should be led by in-country partners and should be translated into multiple languages to ensure that the voices of in-country experts are represented. 

Illustrative competencies: strong expertise in research synthesis, including identifying knowledge gaps; demonstrated thought leadership and active participation in regional and global working groups; excellent communication skills for disseminating findings, including the ability to translate technical content into accessible formats and multiple languages; organizing, cataloging, and curating knowledge resources for accessibility and usability; expertise in knowledge management systems to ensure efficient storage, retrieval, and dissemination of research outputs; expertise in developing and sharing best practices and lessons learned through innovative dissemination methods; cultural and contextual sensitivity to ensure inclusivity and relevance of research and findings; and programmatic learning capabilities to integrate evidence into future strategies and monitor the impact of shared best practices. 

KEY OUTCOMES AND MEASURES OF SUCCESS 

The vision for the DMPA-SC market and core functions for the market steward will guide the key outcomes and measures of success. The expectations for impact, deliverables, milestones and outputs will be co-developed during the formal investment development process by the grantee, donors, and I-SAG group (including global procurers, country level governments and other entities). Thorough development of key performance indicators (KPI) will lead the development of a results framework and will receive emphasis during both the concept review period and formal proposal development for the selected entity.  

CORE CAPABILITIES  

A sufficient application will showcase an organization and/or partner consortium model where relevant previous experience, deep sector knowledge, a clear and aligned strategic approach, and CVs of team members (where available) are evident and clear.  Beyond the illustrative competencies listed above for each of the core functions for FIMS, the following criteria represent other required core capabilities:  

• Geographic Focus & Market Stewardship: Ability to deliver results in priority geographies and manage multi-country market stewardship for contraceptive products. 

• Data Analysis & Strategic Recommendations: Strong data analysis skills to synthesize complex information and drive actionable recommendations, utilizing advanced data science methodologies. 

• Market Shaping & Product Introduction: Expertise in market stewardship, product introduction, and shaping approaches across the value chain, particularly for SRH or related products. 

• Collaboration & Stakeholder Engagement: Proven ability to convene and collaborate effectively, including with Ministries of Health, procurers, agencies, and other key stakeholders; experience with accessing and utilizing HMIS/commodity data. 

• Supply Chain Management: Significant experience addressing and overcoming supply chain challenges, both within countries and with upstream partners. 

• Private Sector & Sustainability Engagement: Experience working with private sector and social marketing channels to drive long-term sustainability. 

• Adaptability & Problem-Solving: Open-minded, proactive, and solution-oriented approach to quickly adapt and respond to a rapidly changing landscape. 

SELECTION PROCESS AND CRITERIA  

The evaluation committee (comprised of representatives from the donors programmatic and business teams) will review concepts for the FIMS award based on the following criteria:  

Technical Approach (50%) 

• Quality, relevance, and feasibility of proposed metrics of success and KPIs, including alignment with program objectives, specificity, measurability, data feasibility, timelines, adaptability, and demonstrated linkage to program outcomes. 

• Clarity of the proposed strategic approach to achieving the defined measures of success. 

• Quality and use of evidence for each component 

• Proposed country and regional implementation arrangements, including a robust monitoring, evaluation, and learning (MEL) plan. 

Organizational Capacity and Experience (35%) 

• Demonstrated past performance of the applicant or consortium group, including references from former clients in the past 3-5 years. 

• Ability to draw expertise from diverse fields and staff accordingly, integrating global health professionals with experience in policy and health systems alongside private sector experts from pharmaceuticals, technology, supply chain, and strategy consulting, with skills in market strategy and analytics. The ideal team will be multidisciplinary, blending best practices across fields with technical expertise, product management capabilities, leadership, cultural sensitivity, and operational agility, while engaging global and local stakeholders, influencing policy, and fostering sustainable market solutions tailored to priority geographies. 

• Effective coordination within the consortium, showcasing strong collaboration mechanisms. 

• Capacity of the applicant or consortium, including access to relevant health and market data. 

• Expertise in convening stakeholders and demonstrated competency in market stewardship. 

• Quality and expertise of key personnel, ensuring an optimal mix of talent and skills. 

• Balance of global and sub-regional presence to effectively manage implementation. 

Cost Efficiency (15%)  

• Budget submission using the Budget Template provided with a clear breakdown of costs, including disaggregation by partner(s), if applicable. 

DONOR REQUIREMENTS 

• To ensure a positive impact for the intended beneficiaries, the foundation requires that all projects and outputs be managed to ensure Global Access. “Global Access” is a foundation policy requiring that: (a) the knowledge and information gained from the project be promptly and broadly disseminated; and (b) the Funded Developments be made available and accessible at an affordable price (i) to people most in need within developing countries, or (ii) in support of the U.S. educational system and public libraries, as applicable to the project.  For more information and resources on Global Access, see the foundation’s Global Access Statement and Global Access webpage. 

• The Bill & Melinda Gates Foundation is committed to information sharing and transparency. We believe that research resulting from our funding should be promptly and broadly disseminated. We have adopted an Open Access policy that enables the unrestricted access and reuse of research funded, in whole or in part, by the foundation, including any underlying data sets.