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As the votes were being tallied, the entire world had its eye on the UK. The implications of “Brexit” reverberated around the world as it waited with baited breath. In a 52-48 majority, the UK decided to exit the European Union (EU) after close to 50 years.

The actual implementation of Brexit will not be smooth. As previously mentioned, the UK was home to the European Medicines Agency, a major research hub, and was going to be a division of the Universal Patent Court (UPC). Companies and government officials alike are unsure of what’s to come. The British Pound hit a 30-year low and caused stocks to fall across all the markets.

How Will Brexit Affect Pharma?

The UK is now charting unsure waters. After utilizing the European Medicines Agency (EMA) for so long, the UK must revisit its own policies and procedures for launches of new drugs. This includes obtaining authorizations and setting up new standard test procedures, amongst other things. This will certainly slow researchers and manufacturers down.

The EMA headquarters will leave London after 20 years. Its 800 staff members will have to be relocated. Researchers and scientists are not far behind. There’s no more benefit of border mobility.

European Union research grants will dry up; the UK will have to seek outside investment after heavily benefitting from the grants. The one pro of leaving the EU is that the UK no longer has to abide by regulations regarding incentives to lure businesses.

Companies enjoyed using London as a headquarters for European operations, but now they will lose access to the borderless countries and the coveted EU passport that allowed them to move freely. J.P. Morgan responded by announcing job relocations after the announcement of Brexit. The UK enjoyed being the “market entry” for companies and has lost a lot of influence in the region. The EU has not announced who will succeed the UK as head of the EMA, it’s been widely reported that Denmark and Sweden are the top contenders to fill that role.

The biggest consequence of Brexit is that the UK loses seats on councils and commissions. The UK’s input on EU legislation is analogous to a lobby group.

The Divorce Terms

The UK and EU will enter in to a series of talks about what will be given up and retained following Brexit. Per EU policy, the UK has two years to disentangle from the EU and must address pension liabilities, outstanding budgetary questions, and the rights of EU citizens remaining in the UK. It’s believed that the UK will try to negotiate some sort of trade strategy, otherwise they will be treated as any other country in the World Trade Organization (WTO) and must compete with Russia and China.

Many members of the EU are not pleased with the UK’s declaration of isolationism, causing officials to declare that the divorce will not be amicable and negotiations will be tough.

Revisited Regulation

While the UK disentangles itself from the EU, it must consider updating its own standards for Pharmaceutical & Biotech manufacturing.

Fortunately, the Food & Drug Administration (FDA) and UK Medicines and Healthcare Products Regulatory Agency (MHRA) have many similarities when it comes to compliance in manufacturing pharmaceuticals. Our InstantGMP™ PRO software is utilized by companies worldwide to manufacture with compliance to Good Manufacturing Practices (GMPs). Be sure to watch our online demo or sign up for an individualized demonstration. We’ll show how InstantGMP™ PRO can integrate with your current process and more.

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