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

Q1 Social Sciences

Law, Innovation and Technology Pub Date : 2020-07-02 DOI:10.1080/17579961.2020.1815403

J. Kaldor, Lisa Eckstein, D. Nicol, C. Stewart

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Abstract

ABSTRACT 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.

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监管创新健康技术：辩证法、对话法和粪便微生物群移植案例

摘要本文探讨了创新卫生技术“领先”而法律法规“滞后”的共同特征。我们分析了粪便微生物群移植（FMT）的案例，这是一种创新的程序，其监管地位在全球范围内仍在变化。我们在文献中搜索了描述FMT调节的论文，并根据一个简单的分析框架对其进行了编码。我们鉴定了21篇相关论文。迄今为止，没有任何司法管辖区实施FMT的具体规定。相反，FMT是根据一系列方法处理的，包括将其纳入现有法规，以及使用“软”法律。我们发现，隐喻或类比论证在描述潜在的监管选择方面发挥了核心作用。我们还发现，创新和监管之间的关系更具“对话性”，而不是对立的、辩证的或类似于种族的关系。这些发现强调了逐案调查的重要性，以确定有关法律和法规的一般叙述是否适用于创新技术的具体实例。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Law, Innovation and Technology Social Sciences-Law

CiteScore

4.50

自引率

0.00%

发文量

期刊介绍： Stem cell research, cloning, GMOs ... How do regulations affect such emerging technologies? What impact do new technologies have on law? And can we rely on technology itself as a regulatory tool? The meeting of law and technology is rapidly becoming an increasingly significant (and controversial) topic. Law, Innovation and Technology is, however, the only journal to engage fully with it, setting an innovative and distinctive agenda for lawyers, ethicists and policy makers. Spanning ICTs, biotechnologies, nanotechnologies, neurotechnologies, robotics and AI, it offers a unique forum for the highest level of reflection on this essential area.