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

Li, Phoebe, Faulkner, Alex and Medcalf, Nicholas (2020) 3D bioprinting in a 2D regulatory landscape: gaps, uncertainties, and problems. Law, Innovation and Technology, 12 (1). pp. 1-29. ISSN 1757-9961

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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.

Item Type: Article
Keywords: Redistributed Manufacturing, mass customisation, bioprinting, co-regulation, ATMP, medical device
Schools and Departments: School of Law, Politics and Sociology > Law
School of Law, Politics and Sociology > Sociology
Research Centres and Groups: Centre for Global Health Policy
Subjects: K Law
K Law > K Law in General. Comparative and uniform Law. Jurisprudence
Depositing User: Phoebe Li
Date Deposited: 07 Sep 2018 16:10
Last Modified: 16 Aug 2021 01:00
URI: http://sro.sussex.ac.uk/id/eprint/78577

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Project NameSussex Project NumberFunderFunder Ref
Biomodifying technologies and experimental space: organisational and regulatory implications for the translation and valuation of health researchG2291ESRCES/P002943/1