Manufacturing Assessment for Maternal Health Supplies in Africa Poster Presentation

Publication date: 2024

Manufacturing Assessment for Maternal Health Supplies in Africa Perrer Tosso, Ignatia Stephens, Juliet Konje, Freda Kissi, Nanavi Dansou, Allie Phillips and Aubrey Clark Introduction Purpose and Objectives of the Study Methodology Results Recommendations Results Conclusion Conclusion Strengthening the manufacturing capacity is crucial for enhancing maternal health outcomes. There is need for targeted policy interventions, investment in manufacturing infrastructure, and collaborative efforts to build a more self-sufficient and resilient health supply chain in the region. Enhancing local production capabilities can contribute to the availability of essential MH products, ultimately reducing maternal mortality in SSA. Sub-Saharan Africa (SSA) faces critical challenges in ensuring the availability of maternal health (MH) supplies, a situation exacerbated by the COVID-19 pandemic. This landscape assessment addresses the urgent need for a resilient health supply chain that ensures the continuous availability of essential MH products, specifically focusing on heat-stable carbetocin (HSC), magnesium sulfate, misoprostol, oxytocin, and tranexamic acid (TXA). The reliance on imports and limited local manufacturing capabilities underline the vulnerability of MH supplies in SSA, impacting maternal mortality rates. Overall, the analysis provides a comprehensive understanding of the MH product landscape in SSA, highlighting potential vulnerabilities and opportunities for intervention to strengthen regional manufacturing capacities and ensure a more resilient and diversified supply chain. Additionally, the report highlights the challenges associated with estimating the demand of these MH products in SSA. The purpose of this study was to conduct a landscape assessment of RMH products to: ▪ Determine the current demand for RMH products ▪ Assess resources, capacity, and needs of manufacturers of RMH products in SSA ▪ Identifying and assessing current and future manufacturers and their capability to meet market demands. The assessment included the following products: ▪ Oxytocin ▪ Misoprostol ▪ Magnesium sulfate ▪ Tranexamic acid ▪ Heat-stable carbetocin Employing a mixed-methods approach, the assessment involved an extensive review of regulatory databases, interviews with manufacturers, and analysis of procurement data across eight selected SSA countries. The study focused on understanding the production capacity, regulatory compliance, market authorization, and the challenges and opportunities faced by manufacturers in the region. Supply assessment: • Countries with a diverse range of pharmaceutical companies producing a wide array of products. • Countries whose national regulatory agencies are listed by the World Health Organization (WHO) as Maturity Level 3 (ML3). • Countries where there is at least one manufacturer with at least one product prequalified by the WHO. Demand assessment: • Desktop reviews on medicine stockouts and quantification and demand forecasting challenges in public health systems in SSA. • A search for tender award information from 2017/2018 to 2022/2023 from procurement portals and websites of ministries of health (MoHs), public procurement authorities, and central procuring entities. Data were assessed and captured into excel spreadsheets. Current manufacturing of MH products in Africa • Main buyers: Public health systems (50% to 100%), pharmacies, and private hospitals; No NGO/Donors • Low utilization rates: 10% to 60% (median 40%) • Most batches are produced based on customer order (60% to 100%) and stock inventory • 2 magnesium sulfate manufacturers are currently pursuing WHO- PQ Planned manufacturing of MH products in Africa • Prospective MH manufacturers plan to rely on technology transfer to produce ~85% of their MH products and develop 15% in-house. • Most prospective MH manufacturers plan to begin production of one or more products in 1-2 years. Perrer Tosso, Ph.D. Director, Pharmaceutical Manufacturing Programs United States Pharmacopeia (USP) perrer.tosso@usp.org Juliet Konje (Presenter) Senior Program Manager United States Pharmacopeia (USP) juliet.konje@usp.org . Report: https://www.usp.org/global-public- health/publications/manufacturing-maternal-health-supplies mailto:perrer.tosso@usp.org mailto:juliet.konje@usp.org https://www.usp.org/global-public-health/publications/manufacturing-maternal-health-supplies https://www.usp.org/global-public-health/publications/manufacturing-maternal-health-supplies Slide 1

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