The weird debate about drug approval and Brexit that is currently going is interesting for several regulatory aspects (thread)
1) The headlines "first in the race" show the enormous pressure on a regulatory regime set up to be independent and evaluate thoroughly.
If this were a race in which being first is the most important thing, Russia would have won. A reminder: this is not the point of approval.
If this were a race in which being first is the most important thing, Russia would have won. A reminder: this is not the point of approval.
Fortunately I have faith in the MHRA. I believe they work well. The best way to destroy them, though, is to start regarding drug approval as a race in which the first one wins.
2) From an EU - federalist regulatory point of view the discussion is interesting because it makes us look up the powers of national drug authorities under the current EU system.
Curiously under EU law national Marketing Authorization Applications (MAAs) still exist. And as @GeorgePeretzQC has looked this up, I do not have to: national regulators can approve the corona vaccines under EU law as it currently stands.
https://twitter.com/GeorgePeretzQC/status/1334106288549203969?s=20
This shows the curious nature of EU federalism as opposed to a federal state: Länder/states/cantons would not replicate a federal infrastructure. But in a supranational entity states are reluctant to let go of things regarding national security or emergencies.
3) So what does all of this mean for the debate:
Resist easy attempts at dramatization. Look at content and detail.
Resist easy attempts at dramatization. Look at content and detail.
(I apologise that this is neither a pro- nor an anti-Brexit thread. I don't tend to do those, but you will see no lack of them on the internet, so feel free to look elsewhere)
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