Government–donor–academia collaboration model in the pharmaceutical regulatory system and considerations for sustainability in low- and middle-income countries

PURPOSE: This study assesses how collaboration between Lebanon's Ministry of Public Health (MoPH), Agence Française de Développement (AFD) and ESA Business School (ESA) strengthened the pharmaceutical regulatory framework during severe crises. It reviews the design and outcomes of reforms in governance, pharmacovigilance and quality assurance; identifies key enabling and limiting factors and draws lessons for other low- and middle-income countries (LMICs). DESIGN/METHODOLOGY/APPROACH: A descriptive-qualitative approach combined a desk review of technical documents, reports, and outputs with triangulated semi-structured interviews involving key institutional actors. Data were thematically analyzed and compared with international literature to generate evidence-based insights. FINDINGS: Results show that well-governed partnerships can sustain reform momentum during instability. Sustainability requires costed financial roadmaps, domestic co-financing and value-for-money disciplines to reduce dependence on fluctuating external funding. Long-term capacity building, institutional ownership and adaptive policy design are vital to safeguard regulatory and supply-chain quality. The MoPH-AFD-ESA case demonstrates a triple-helix model aligning government, donor support and academic expertise to deliver durable institutional capacity and effective regulatory institutionalization. ORIGINALITY/VALUE: The study provides rare empirical evidence from a fragile context, contributing to limited literature on government-donor-academia cooperation and offering a transferable model for resilient, locally led and financially integrated regulatory reform.