Providing leadership for the life sciences industry

Brexit’s Uncertainty Principle

For many people working in the pharma industry over the period since the UK’s referendum on EU membership, Brexit must feel like being caught up in Heisenberg’s famous work of quantum mechanics. As far as their employment is concerned, they can never simultaneously know their exact position and the exact speed with which it is changing. If they know their position today, they can’t be sure how fast it will have changed by tomorrow and if they can see how fast it is changing, they can no longer be sure of their position. As people don’t experience life at the quantum level, this constant uncertainty is making many lives and careers really difficult. Similarly, for pharmaceutical employers observing the position and speed of change of government policy, we hear every day their understandable complaints about the discomfort that this brings and their very proper demands for information.

Qualified Persons on the move?

I spend quite a lot of my time working in Quality and one of the roles most affected by Brexit is that of the QP (Qualified Persons). A QP is legally responsible for certifying that each batch of a medicinal product is suitable for release for sale or for use in a clinical trial and is named on the manufacturer’s authorisation. QPs are essential in the quality assurance of medicines and are responsible for ensuring that good manufacturing practice is in place.

To sign off medicines in the EU, a QP has to be located in the EU and, after March 2019, that will exclude the UK. At present, the majority EU QPs live and work in the UK.

While the minutiae of the possible upcoming permutations for drug supply depending on various Brexit outcomes have been written about elsewhere (here and here), less thought has been given to the people involved. For QPs, as with so many other roles, Brexit will bring a unique set of changes. For me, the position of QPs, their roles, work and careers is a microcosm of Brexit writ large and an illustration of the scale of change that must be happening everywhere.

People and patients are in the middle of this

It’s the human angle that I’m interested in. If most of the people working as QPs choose to stay in the UK (and many of them  with families are perhaps less likely to move), then will there be enough QPs in the EU, given the length of time it takes to qualify for the role? If they move to the EU, the UK’s pool of QPs will shrink with potentially serious effects.

Of those who would be willing to move, should they go now or wait until there is more certainty over the outcome of Brexit? If they move now, might they find that they didn’t need to once the dust has settled? If they stay put, will their jobs be at risk later? The Heisenberg effect makes this so difficult to be sure about.

And what will all of this mean for patients? For example, people needing drugs for the treatment of rare diseases may find that supply is slowed down owing to a lack of QPs or because of the need to duplicate the work in both the UK and in the EU. Either way, they could lose out and suffer as a result.

Frankly, it’s time to fix this, but then that’s one thing we do know for certain already. What are your views?

Paul Foster, Senior Consultant | paul.foster@theRSAgroup.com

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