Brexit May Affect Drug Approvals in the UK

Regardless of how the UK decides to move forward, it could take several years before the implications of the vote to leave the EU are fully realized.

The European Medicines Agency (EMA) is currently responsible for reviewing and approving new drugs in the European Union (EU), including the United Kingdom (UK). New drugs can be further reviewed and appropriately priced by each country’s national regulatory body. For the UK, that body is the Medicines & Healthcare Products Regulatory Agency (MHRA).

Pharmaceutical companies wanting to sell new drugs or devices in the UK have to get them licensed by the MHRA, but an alternative route is to obtain centralized authorization from the EMA. The EMA is run by regulators from member states who staff its committees, amassing input from across the EU (including the UK for now) on each drug approval. This removes the need for a separate national process because once the EMA grants centralized authorization, it’s valid in both member states and countries in the European Economic Area (EEA), which includes all EU member countries as well as Iceland, Liechtenstein, and Norway.

Since the UK just voted to leave the EU, the EMA (which is currently located in London) will most likely be moved to a member country. Several have signaled interest, including Sweden, Denmark, and Italy. However, the move isn’t expected to occur any time soon, as it will require more than 600 regulatory and scientific experts to relocate.

If the UK decides to negotiate to stay in the EEA, there likely won’t be much difference in regulations because it’s possible that the MHRA could function like other regulatory agencies located in non-EU EEA countries, which work with the EMA even though they’re outside the EU. But, if the UK stays out of the EEA, drug companies would need to go through a separate process with British regulators for new products, as the EMA route wouldn’t be applicable to the UK.

On the other hand, the UK might follow the footsteps of Switzerland, a non-EU country that isn’t included in the EEA. Switzerland’s regulatory agency, Swissmedic, independently authorizes medical products but works with the EMA under mutual recognition and sharing agreements.

Regardless of how the UK decides to move forward, it could take several years before the implications of the vote to leave the EU are fully realized.