Some thoughts on this article. theguardian.com/world/2020/mar…
I have to say that I am a bit edgy about linking the current Coronavirus crisis to discussion of Brexit. More heat than light is likely to emerge out of such links.
And the authors actually point out half way through the article that leaving the EU medicines regime won’t delay licensing of (eg) a new Covid 19 vaccine if we simply fast track without further processes any vaccine approved by the EU. Which could always be done.
But the article does reveal a choice facing the UK on medicines regulation post a hard Brexit: a choice where neither option is great.
The problem is that the process for getting approval of a new medicine (a “marketing authorisation” in the EU) is expensive and time-consuming. Rightly so given the risks to patients and the need to ensure that a new medicine actually works.
Even big pharma can’t run many of these processes at once. So they start with the big ones: the US and the EU. Then others.
So (for example) Canada gets new medicines rather later than the US and EU.
Hence the UK hard choice. If you run your own system then you risk delays in getting new medicines or vaccines.
That is so even though the UK regulator - the MHRA - is superb, and has a justifiably high reputation, based on 40+ years of playing a leading part - punching above its weight - in the complex EU system of shared national and EU competence.
(Though I should also disclose that I have represented the MHRA in a number of recent cases.)
The other choice is just to passport any medicine approved by the EU.
The problem with that, though, is that no pharma company would ever bother getting UK approval: they’d just go to the EU. So we would lose our own regulatory capacity.
And when something went wrong (remember thalidomide?) the answer “we just passported this EU approved drug through without looking at it” isn’t a great answer: it’s not exactly “taking back control”.
There’s no right answer to that dilemma. But that dilemma is forced on us by the UK’s policy choice - and it is the UK’s choice - not to seek the involvement in the EU medicines system that ( for example) Switzerland has.
