It could well take even longer to get new drugs to patients if we get the medicines regime wrong after Brexit. #r4today
The Chequers White Paper proposed that the UK would seek participation in the European Medicines Agency (EMA) “as an active participant, albeit without voting rights, which would involve making an appropriate financial contribution”
So the Government thinks that the best result that can be obtained after Brexit is to remain subject to, and to carry on paying for, EU regulation in this area even while no longer having any say in that regulation.
But even that modest objective has not been achieved: the political declaration contains only a vague promise that the EU and UK “will also explore the possibility of cooperation of UK authorities with EU agencies such as the EMA”.
That is far short of the promise of “active” UK participation in the EMA’s work sought by the Government (and as sought by the House of Commons when it passed an amendment to the Trade Bill mandating the Govt to seek such a result.)
The reason why the Government is in this position is that there is nothing to be said for the UK setting up its own parallel system of regulation to that of the EU.
Such a parallel regime would be very costly in terms of the additional resources needed to staff the UK regulator. Since the costs of seeking and maintaining regulatory approval are very high, it’d also mean large additional costs for pharmaceutical companies operating in the UK.
At best, there’d be delays in getting medicines onto the UK market, as pharma companies concentrated their efforts on the EU & US, dealing with the UK later (that’s a significant problem in Canada, which runs a separate regulatory system to that of its much larger neighbour).
At worst, pharmaceutical companies will just decide that the additional costs are not worth paying and refuse to market their new products in the UK at all.
In theory, the UK could automatically allow in any product licensed by the EMA or EU27.
But that is hardly “taking back control”: the UK would be delegating responsibility for ensuring the continued safety of all its medicines to a foreign regime in which it played no part (and from which it could not even access relevant data).
That would be an extraordinary position for the UK to be in, given the size and importance of its pharmaceutical sector.
And it would be hard to see it surviving a case where the UK had rubber-stamped a licence for what turned out to be a harmful medicine (thalidomide, for example) just because the EU had decided to license it.
So it’s hard to see any good outcome for medicines regulation after leaving the single market.
