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

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posted on 2023-06-09, 14:58 authored by Phoebe LiPhoebe Li, Alex Faulkner, Nicholas Medcalf
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.

Funding

Biomodifying technologies and experimental space: organisational and regulatory implications for the translation and valuation of health research; G2291; ESRC; ES/P002943/1

History

Publication status

  • Published

File Version

  • Accepted version

Journal

Law, Innovation and Technology

ISSN

1757-9961

Publisher

Taylor & Francis

Issue

1

Volume

12

Page range

1-29

Department affiliated with

  • Law Publications

Research groups affiliated with

  • Centre for Global Health Policy Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2018-09-07

First Open Access (FOA) Date

2021-08-16

First Compliant Deposit (FCD) Date

2019-02-01

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