Countries at all levels of wealth are struggling to ensure access to innovative medicines, challenged by increasing drug prices and pressure on budgets from growing population health needs. Recently, policy attention has increased towards the question of whether restructuring the financing, laws and incentives driving the current R&D system could deliver both innovation and affordable prices for medicines – an approach we call “new business models” of R&D. Some small-scale efforts at non-traditional approaches to organizing and conducting R&D have been implemented and have achieved important successes, but there has been relatively little scholarly research on these phenomena.
The overall objective of this project is to deepen understanding of the political, economic, scientific and organizational factors required to implement new business models of medicines R&D that will deliver both innovation and globally affordable medicines. The project will investigate competing conceptualizations of R&D, the history and scope of “new business models” for medicines innovation, and identify what led to their creation as alternatives to the status quo. Through an in-depth examination of six case studies of new business models, we will also assess the feasibility and effectiveness of such models, exploring impact, structural strengths and weaknesses, and implications regarding who does or does not benefit. Finally, we will examine medicines innovation as a challenge for global governance, and illuminate which actors do and do not engage in new business models and why, the power dynamics at play, and the implications of these new approaches for broader questions of international relations.