Feature Briefing

How “Brexit” might affect the pharmaceutical industry

BMJ 2016; 353 doi: https://doi.org/10.1136/bmj.i2615 (Published 10 May 2016) Cite this as: BMJ 2016;353:i2615
  1. Anne Gulland, journalist, London, UK
  1. agulland{at}bmj.com

Big UK based drug companies have said they want Britain to remain in the EU, but would exit affect access to medicines? Anne Gulland examines the key questions

Will new drugs take longer to reach the British market?

This depends how the UK negotiates its exit from the EU. The UK could become part of the European Economic Area, like Norway, Liechtenstein, and Iceland. These countries are covered by the European Medicines Agency and still have access to the single marketing authorisation, meaning that companies only have to go through one approval process before launching their drugs throughout Europe. However, they have no influence over the operations of the EMA, unlike EU member states.

If the relationship became more distant the UK may lose access to the single authorisation, meaning an extra regulatory hurdle for drug companies. The BioIndustry Association (BIA), which represents UK biotechnology companies, told the House of Commons inquiry into EU regulation of life sciences that new drugs would probably be launched first in the EU and then in the UK.1 The UK …

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