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'Bioexit': navigating the policy and regulatory pathways for the biotechnology industry in a post-Brexit landscape
1Department 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.
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.