3D Bioprinting in a 2D Regulatory Landscape: Gaps, Uncertainties, and Problems

Phoebe Li, Alex Faulkner, Nicholas Medcalf (2020) 12 (1) Law, Innovation and Technology

26 Pages Posted: 20 May 2020

See all articles by Phoebe Li

Phoebe Li

University of Sussex Law School

Alex Faulkner

affiliation not provided to SSRN

Date Written: April 23, 2020

Abstract

In this paper we assess both the ex ante and the ex post dimensions 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.

Keywords: Redistributed Manufacturing (RDM), mass customisation, bioprinting, co-regulation, ATMP, medical device

Suggested Citation

Li, Phoebe and Faulkner, Alex, 3D Bioprinting in a 2D Regulatory Landscape: Gaps, Uncertainties, and Problems (April 23, 2020). Phoebe Li, Alex Faulkner, Nicholas Medcalf (2020) 12 (1) Law, Innovation and Technology , Available at SSRN: https://ssrn.com/abstract=3583441

Phoebe Li (Contact Author)

University of Sussex Law School ( email )

Falmer
Brighton BN1 9QN
United Kingdom

HOME PAGE: http://www.sussex.ac.uk/profiles/305243

Alex Faulkner

affiliation not provided to SSRN

No Address Available

Do you have a job opening that you would like to promote on SSRN?

Paper statistics

Downloads
54
Abstract Views
372
Rank
765,318
PlumX Metrics