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.
| Original language | English |
|---|---|
| Pages (from-to) | 411-434 |
| Number of pages | 24 |
| Journal | Law, Innovation and Technology |
| Volume | 15 |
| Issue number | 2 |
| Early online date | 22 Aug 2023 |
| DOIs | |
| Publication status | Published - Oct 2023 |
Bibliographical note
Funding Information:This study has been carried out with funding from the UK Engineering & Physical Sciences Research Council (EPSRC), under the grant reference EP/P006485/1, for the Future Targeted Healthcare Manufacturing Hub based at University College London (UCL). We would like to thank our colleagues within the Hub and all our interviewees for sharing their time and expertise with great generosity.
© 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/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The terms on which this article has been published allow the posting of the Accepted Manuscript in a repository by the author(s) or with their consent.
Keywords
- Advanced Therapy Medicinal Products (ATMPS)
- Brexit
- legal geography