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Regulating innovative health technologies: dialectics, dialogics, and the case of faecal microbiota transplants


Kaldor, J and Eckstein, L and Nicol, D and Stewart, C, Regulating innovative health technologies: dialectics, dialogics, and the case of faecal microbiota transplants, Law, Innovation and Technology, 12, (2) pp. 284-296. ISSN 1757-9961 (2020) [Refereed Article]


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Copyright 2020 Routledge

DOI: doi:10.1080/17579961.2020.1815403


This paper interrogates the common characterisation of innovative health technologies ‘leading’, while law and regulation ‘lag’ behind. We analysed the case of faecal microbiota transplants (FMT), an innovative procedure whose regulatory status remains in flux worldwide. We searched the literature for papers that described the regulation of FMT, and coded these according to a simple analytic framework. We identified 21 relevant papers. To date, no jurisdiction has implemented FMT-specific regulation. Instead, FMT is dealt with under a range of approaches, which include fitting it within existing regulation, and the use of ‘soft’ law. We found that metaphor, or argument by analogy, played a central role in delineating the potential regulatory options. We also found the relationship between innovation and regulation to be more ‘dialogic’ than oppositional, dialectical, or akin to a race. These findings underscore the importance of case-by-case investigation to determine the applicability of general narratives about law and regulation to specific instances of innovative technologies.

Item Details

Item Type:Refereed Article
Keywords:regulation, innovation, health technology, faecal microbiota transplant
Research Division:Law and Legal Studies
Research Group:Law in context
Research Field:Medical and health law
Objective Division:Law, Politics and Community Services
Objective Group:Justice and the law
Objective Field:Law reform
UTAS Author:Kaldor, J (Ms Jenny Kaldor)
UTAS Author:Eckstein, L (Dr Lisa Eckstein)
UTAS Author:Nicol, D (Professor Dianne Nicol)
ID Code:142083
Year Published:2020
Funding Support:Australian Research Council (DP180101262)
Deposited By:Law
Deposited On:2020-12-10
Last Modified:2021-04-29
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