Advanced therapies and the Brexit process: emerging geographies of legal responsibilities and market opportunities

Q1 Social Sciences

Law, Innovation and Technology Pub Date : 2023-07-03 DOI:10.1080/17579961.2023.2245674

E. Bicudo, I. Brass

{"title":"Advanced therapies and the Brexit process: emerging geographies of legal responsibilities and market opportunities","authors":"E. Bicudo, I. Brass","doi":"10.1080/17579961.2023.2245674","DOIUrl":null,"url":null,"abstract":"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.","PeriodicalId":37639,"journal":{"name":"Law, Innovation and Technology","volume":"15 1","pages":"411 - 434"},"PeriodicalIF":0.0000,"publicationDate":"2023-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Law, Innovation and Technology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1080/17579961.2023.2245674","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"Social Sciences","Score":null,"Total":0}

引用次数: 0

Abstract

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.

查看原文本刊更多论文

先进疗法与英国脱欧进程：法律责任和市场机会的新兴地域

摘要:本文分析了英国脱欧对先进治疗药物(atmp)区域地理的影响。后者是源自细胞操作、基因编辑、组织工程或这些技术的组合的疗法。它们的开发和交付是通过国际范围的研究合作和商业关系实现的。在欧盟，这是通过商业活动和法律责任的复杂分配来实现的。随着英国脱欧，发生了三种主要的重新配置:研究和制造活动的转移;重组质量控制测试，以管理临床风险;以及法律责任和代表的重新分配。这种技术和法律上的重新配置是通过法律地理学新兴领域的理论见解来捕捉的。通过对参与ATMP开发的欧盟和英国专业人士的采访，本文揭示了英国脱欧给欧盟和英国当前和未来的ATMP格局带来的主要挑战。此外，它还展示了法律安排的变化如何影响科学密集型领域。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

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.