Reforming the Regulatory Environment for Innovative Health Technologies: Identifying Congestion and Filling Gaps (#3)
The pace of innovation in health technologies has increased dramatically over the last decade. Previously unforeseeable advances in health innovation are testing the capacity of regulators to ensure patient safety. Those at the research coalface are faced with myriad regulatory hurdles that may exert significant influence over the process of conducting research. Current regulatory frameworks assume a linear model of innovation which is far removed from current practice. This paper will outline an ARC-funded Discovery project that aims to map this regulatory environment and to identify gaps, and areas of regulatory congestion, or over-regulation. The project focuses on three technologies: genome editing, biologics and 3D bioprinting. These technologies have been selected because taken together, they encounter the gamut of regulatory issues that might face health innovators and regulators. This paper will highlight some of these challenges and begin to consider how they might be overcome.