“生物退出”：在后脱欧时代的背景下，为生物技术产业规划政策和监管途径。

'Bioexit': navigating the policy and regulatory pathways for the biotechnology industry in a post-Brexit landscape.

机构信息

Department of Anesthesiology, University of California, San Diego School of Medicine, San Diego, CA, USA; Division of Infectious Diseases and Global Public Health, University of California, San Diego School of Medicine, Department of Medicine, San Diego, CA, USA; Global Health Policy Institute, San Diego, CA, USA.

School of Law, University of San Diego, San Diego, CA, USA.

出版信息

Drug Discov Today. 2018 Jul;23(7):1324-1327. doi: 10.1016/j.drudis.2018.02.013. Epub 2018 Mar 1.

DOI:10.1016/j.drudis.2018.02.013

PMID:29501912

Abstract

The withdrawal of the UK from the European Union (EU) is a complicated event. Although implications vary by industry, the biotechnology sector is especially vulnerable to the consequences of Brexit. Accordingly, here we evaluate potential repercussions under four post-Brexit political pathways: European Economic Area (EEA) affiliation (Norwegian Model); negotiated bilateral access (Swiss Model); limited participation in EU Customs Union (Turkish Model); or independence under the World Trade Organization (WTO) designation. We conclude that all four pathways fail to protect the mutually beneficial UK-EU biotechnology relationship and that alternative pathways need to be explored. Accordingly, we outline a suite of policy mechanisms aimed at ensuring continued EU-UK regulatory synergy, with the central aim of ensuring access to biomedical innovations and ensuring patient safety.

摘要

英国退出欧盟（EU）是一件复杂的事件。尽管各行业的影响不尽相同，但生物技术行业尤其容易受到英国脱欧后果的影响。因此，在这里我们根据英国脱欧后的四种政治途径评估了潜在影响：欧洲经济区（EEA）成员资格（挪威模式）；双边谈判准入（瑞士模式）；有限参与欧盟关税同盟（土耳其模式）；或在世界贸易组织（WTO）的指定下独立（WTO 模式）。我们的结论是，这四种途径都不能保护英欧之间互利的生物技术关系，需要探索替代途径。因此，我们概述了一系列政策机制，旨在确保欧盟和英国继续保持监管协同，核心目标是确保获得生物医学创新和保障患者安全。