Bicudo, E;
Brass, I;
(2023)
Advanced therapies and the Brexit process: emerging geographies of legal responsibilities and market opportunities.
Law, Innovation and Technology
10.1080/17579961.2023.2245674.
(In press).
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Abstract
This paper analyses how so-called Brexit, that is the United Kingdom’s departure from the European Union (EU), has modified the regional geography of Advanced Therapy Medicinal Products (ATMPs). The latter are therapies deriving from cell manipulation, gene editing, tissue engineering, or a combination of these techniques. Their development and delivery have been realised through research collaborations and commercial relations of international scope. In the EU, this has happened by means of a complex distribution of commercial activities and legal responsibilities. With Brexit, three main kinds of reconfigurations have occurred: the relocation of research and manufacturing activities; the reorganisation of quality control tests aimed to manage clinical risks; and the redistribution of legal responsibilities and representatives. This technical and legal reconfiguration is captured here by means of theoretical insights from the emerging domain of legal geography. Drawing on interviews conducted with both EU and UK professionals involved in ATMP development, this paper reveals the main challenges brought by Brexit to the current and future configuration of the ATMP landscape in the EU and the UK. Furthermore, it demonstrates how shifts in legal arrangements impact on science-intensive domains.
| Type: | Article |
|---|---|
| Title: | Advanced therapies and the Brexit process: emerging geographies of legal responsibilities and market opportunities |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1080/17579961.2023.2245674 |
| Publisher version: | https://doi.org/10.1080/17579961.2023.2245674 |
| Language: | English |
| Additional information: | © 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http:// creativecommons.org/licenses/by/4.0/). |
| Keywords: | Brexit, Advanced Therapy Medicinal Products (ATMPS), legal geography |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > UCL BEAMS UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > STEaPP |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10176259 |
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