Designing fit-for-purpose regulation for evolving healthcare systems (360G-Wellcome-210291_Z_18_Z)

Healthcare markets in low- and middle-income countries (LMICS) are undergoing dramatic change, with private sector expansion, emergence of new organisational forms and business models, and growing foreign investment. The regulation systems in these countries are inadequate and ill-suited to manage these challenges and future market evolution, and rarely incorporate modern perspectives on regulation which highlight the need for "responsive", "smart" and risk-based regulation, drawing on an expanded range of regulatory strategies, tools and actors. We aim to understand the challenges that recent developments in LMIC healthcare markets pose for effective regulation. We will review recent trends in private sector development and regulation systems in 3 LMICs with rapidly changing healthcare markets. We will assemble a group of scholars and policymakers with expertise in regulatory theory and implementation in a set of middle- and high income countries. We will debate appropriate theoretical frameworks and methods for studying regulatory developments, and consider what concepts and lessons might be relevant to LMICs (taking into account differences in resources, institutions, health systems, and history) and identify critical research questions. Outputs will be a network of scholars, an agenda setting paper, and a proposal for a larger scale project to take these ideas forward.