3D biop in 2D reg_Final.pdf (643.32 kB)
3D bioprinting in a 2D regulatory landscape: gaps, uncertainties, and problems
journal contribution
posted on 2023-06-09, 14:58 authored by Phoebe LiPhoebe Li, Alex Faulkner, Nicholas MedcalfIn 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 TechnologyISSN
1757-9961Publisher
Taylor & FrancisExternal DOI
Issue
1Volume
12Page range
1-29Department affiliated with
- Law Publications
Research groups affiliated with
- Centre for Global Health Policy Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2018-09-07First Open Access (FOA) Date
2021-08-16First Compliant Deposit (FCD) Date
2019-02-01Usage metrics
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