• Tim K Mackey and John Annaloro.
• 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. Electronic address: tmackey@ucsd.edu.
• Drug Discov. Today. 2018 Jul 1; 23 (7): 1324-1327.

AbstractThe 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.Copyright © 2018 Elsevier Ltd. All rights reserved.

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