3D bioprinting in a 2D regulatory landscape: gaps, uncertainties, and problems

ABSTRACTIn this paper we assess both the ex anteand the ex postdimensions of the regulatory landscape of 3D bioprinting governance. While the former is mainly concerned with the market approval and safety of 3D bioprinting, the latter is concerned with the matter of liability once bioprinting has been licensed or authorised for use. In this 2D landscape, we highlight three sets of choices: whether regulation should focus on the process, the product or both; whether to rely on existing regimes or create a new bespoke and distinct regulatory framework; and whether to employ top down, bottom up, or co-regulation. We identify a series of interpretative uncertainties as well as gaps in the current legal regimes. We consider an initial provisional ‘process-based’ approach and a co-regulation model for bioprinting governance. We anticipate that the study of the regulatory landscape will offer key insights in relation to other types of biofabrication.