“Bioexit”: Navigating the Policy and Regulatory Pathways for the Biotechnology Industry in a Post-Brexit Landscape

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here we examine four post-Brexit political options and highlight the need to explore alternative approaches, with a focus on ensuring continued investment in biomedical research and development, while also safeguarding patients’ access to medicines

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.

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