So it appears that the UK Prime Minister and the European Commission do agree on one thing. Brexit means Brexit; particularly for the pharmaceutical industry.

The first day of June saw the European Medicines Agency release a regulatory update in response to some frequently asked questions about the impact of the UK invoking Article 50 to leave the European Union. You can read the update here. It is worth 10 minutes of your time. It brings into sharp focus the reality of the UK leaving the European Union and how it has the potential to turn the UK pharmaceutical industry on its head.

Do you have an EU QPPV based on the UK? They better get ready to move or you need to find another based in the EU. Do you export products into European countries? If so you better get ready for tariffs and the need to have a site of batch release based somewhere other than in the UK. You better get ready for headaches caused by issues you have already thought about and issues that have not yet crossed your mind.

So what happens next? Two things are a certainty.

One – lawyers are going to have a field day. Corporate advisors will be up all hours cooking up all manner of ways of relieving the pain that will be felt by the clients. When they are not inventing new business models, they will be charging clients millions for advice that is based on nothing more than conjecture and gut instinct. Why the cynicism? No amount of experience can prepare you for what happens next. The UK and EU members are about to start unpicking 40 years of legislation.

Two – Entrepreneurs with a modicum of understanding of EU legislation and the pharmaceutical industry will be pondering the potential that this sea change will present to those with the guile to see opportunity in anything. Get ready for new, weird and wonderful ways of navigating the EU pharmaceutical market.

What do we make of all this at Quality Context? Candidly, a combination of resignation and intrigue. Resignation, as it is apparent that no one appears to have a detailed plan for Brexit. Intrigue, as no one with anything sensible to say can predict precisely what happens next.

What we do know is that navigating through Brexit will be about sticking to what our industry knows best. Risk management and quality management.

Risk management begins with assessing the risks and then having a plan to mitigate the risks. Quality management begins and ends with the requirement for rigour and clear thinking. That’s why the phone keeps ringing as clients look to us for some clear thinking as they start to plan for the future.

If you are interested in exploring how we can help you through this maelstrom, then do get in touch. In the meantime, we offer you one prediction. The EU and UK will not drive the UK pharmaceutical industry off a cliff. UK products are too valuable to the EU and the industry is too valuable to the UK. All that the EMA statement has done has focussed the industry and the UK government on the reality that the cliff edge is getting closer…..quickly.