How to shorten the market entry innovation in a highly regulated market. The case of Early access programs in the pharmaceutical industry

Government regulation impacts deeply on the innovation process. Regulatory frameworks influence firms’ innovativeness. This study aims to provide an exploratory investigation of Early Access programs as a tool to shorten the time to place innovation in highly regulated markets. Thus, our research question is: How do institutional actors push the entry of innovation in highly regulated markets? To address the research question, a qualitative analysis was conducted using the multiple case study method among different countries. The analysis practised an inductive approach. The results provide an inductive conceptual framework to identify different configurations of Early Access programs based on three characterizing dimensions: (1) authorities involved, (2) eligibility criteria and (3) applicant. This study provides implications for both theory and practice. Future research will be needed to investigate the emerging aspects further and make the model generalisable.