(Not 100% sure about this being the right place to ask)

According to here, orphan drugs have a market exclusivity of 10 years in Europe.

UK is now (...sooner or later) getting out of Europe, so will this affect the market exclusivity of orphan drugs?

The whole point of orphan drugs was that the diseases they treat are so rare that it's not commercially worth it to produce the drugs, so they get exclusivity to compensate for it.

(Yes, companies have also been abusing this for quite some time, but that's another discussion)

I'm probably a bit naive here, but what I see is the chance that someone in the UK might start producing and selling high-cost drugs for a fraction of the price and make them available for export, especially in the (relatively) not-so-far Europe.

I've seen this, but my question is different: it's not really about trade, it's about regulations.

(Maybe worth nothing: the European Medicines Agency's offices are located in the UK)

  • 1
    You mean currently located in the UK. They're on course to move to Amsterdam. ema.europa.eu/en/about-us/uks-withdrawal-eu/…
    – origimbo
    Jan 14, 2019 at 14:18
  • @origimbo True, I missed that. Not surprising though, considering how many companies/institutions have decided to move to the Netherlands because of brexit.
    – ChatterOne
    Jan 14, 2019 at 14:24
  • Regarding producing them cheaply in the UK and selling them to the EU, why would manufacturers in the UK suddenly be able to produce them cheaper? What would be stopping those manufacturers now? The whole point of orphan medicine, as I understand it, is that it's more expensive to make the medicine than you can earn from selling it, i.e. if there was a viable method to make it profitable, it could be done regardless of Brexit. If I'm missing something, please comment.
    – JJJ
    Mar 31, 2019 at 17:44

1 Answer 1


Like almost everything else Brexit-related, there is no settled answer because the UK is still debating the withdrawal agreement and any future arrangements. The EMA have their own continuity planning under way.

But none of that changes what the directive says: only one company can market drugs in the EU which have market exclusivity. So it doesn't matter if e.g. Bayer is the market authorized producer of GeneriDrug and a post-Brexit UK company is outside the remit of the directive; they're still not allowed to market it in Europe.

  • Where presumably Europe should be interpreted as the EEA?
    – origimbo
    Jan 14, 2019 at 18:01

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