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Does Brexit Spell Bad Medicine For Drug Naming?

Drug naming in the EU

The Brexit “leave” vote was stunning, and no doubt causes a great deal of uncertainty for Britain. The former 28-country European Union (EU) will be 27, when Europe’s second-largest economy (and the world’s fifth largest) exits.

And how is the biopharma industry feeling about Brexit? A bit nauseous:

  • For the UK-based companies, AstraZeneca and GlaxoSmithKline, greater regulatory uncertainty is expected for new drug development

  • Given the millions of healthcare professionals and hundreds of millions of patients in the EU, UK companies will now have to “compete” (against EU companies) for access to these key audiences

  • EU funded research will no longer be readily available to the UK

  • The regulatory body for the EU, the European Medicines Agency (EMA) based in London, will have to relocate out of the UK

  • The UK will need to re-establish it’s own regulatory framework

Another sequela of Brexit: drug name development in Europe will be more costly and more time-consuming.

Why? Because it is expected that additional regulatory evaluations and legal filings will need to be done for drug names in the UK, apart from those in the EU.

It’s hard to say when this will happen, but experts predict secession could take at least two years or more. We’ll keep you posted ––check back here for updates.

Do you think the impact of Brexit is bad medicine? Let us know.

On a lighter note, if Brexit (short for “British exit”) was submitted for a drug name review in the EU, would the Name Review Group (NRG) reject the name due to its potential to "create a public-health concern or potential safety risk"?

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