How can entrepreneurs experience inform responsible health innovation policies? A longitudinal case study in Canada and Brazil

Aim To foster equity and make health systems economically and environmentally more sustainable, Responsible Innovation in Health (RIH) calls for policy changes advocated by mission‐oriented innovation policies. These policies focus, however, on instruments to foster the supply of innovations and neglect health policies that affect their uptake. Our study's aim is to inform policies that can support RIH by gaining insights into RIH‐oriented entrepreneurs' experience with the policies that influence both the supply of, and the demand for their innovations. Methods We recruited 16 for‐profit and not‐for‐profit organisations engaged in the production of RIH in Brazil and Canada in a longitudinal multiple case study. Our dataset includes three rounds of interviews (n = 48), self‐reported data, and fieldnotes. We performed qualitative thematic analyses to identify across‐cases patterns. Findings RIH‐oriented entrepreneurs interact with supply side policies that support technology‐led solutions because of their economic potential but that are misaligned with societal challenge‐led solutions. They navigate demand side policies where market approval and physician incentives largely condition the uptake of technology‐led solutions and where emerging policies bring some support to societal challenge‐led solutions. Academic intermediaries that bridge supply and demand side policies may facilitate RIH, but our findings point to an overall lack of policy directionality that limits RIH. Conclusion As mission‐oriented innovation policies aim to steer innovation towards the tackling of societal challenges, they call for a major shift in the public sector's role. A comprehensive mission‐oriented policy approach to RIH requires policy instruments that can align, orchestrate, and reconcile health priorities with a renewed understanding of innovation‐led economic development.