In December, Dr Virginia Acha, ABPI Executive Director – Research, Medical & Innovation gave evidence to the Exiting the EU Committee stating that a primary objective for Government in Brexit negotiations should be to secure alignment and cooperation with EU medicines regulation.

The UK is currently part of the European Medicines Agency (EMA), a network that facilitates the harmonisation of medicines regulation for more than 25% of global pharmaceutical market and over 500m patients. This includes EU member states, and non-EU members of the European Economic Area (EEA), Iceland, Liechtenstein and Norway.

Robust and internationally aligned medicines regulation, has been essential for protecting and improving the health of patients, has ensured effectiveness and safety, and has brought forward advances in medical innovation to large patient populations in a way that minimises delays and cost.

The UK having an aligned framework in place for medicines regulation ‘from day one’ of leaving the EU would be important for maintaining drugs availability and supply.

Upon reviewing the Committee’s report published on January 14th, the ABPI welcomes their explicit focus on the importance of transitional arrangements and the UK’s future relationships with regulatory agencies and bodies.

Mike Thompson, ABPI, Chief Executive commented:“We welcome the Committee’s focus on the importance of getting medicine regulation right from day one of the UK leaving the European Union.

Securing continued regulatory cooperation and alignment with the EU for medicines will be in the best interests of the UK Government, EU member states and patients.

We are confident that Government understands that any transitional arrangements should not put patient access to medicines under threat. We will continue to work with Government to make sure this happens as smoothly as possible.”