No-deal Brexit: access to epilepsy medicines

Published: August 24 2018
Last updated: September 29 2022

What’s happened?

The government has released more information about the possible impact of a no-deal Brexit on the UK healthcare sector. This includes the steps being taken to ensure that patients are able to access the medical supplies they need in the event of a no-deal Brexit.

Epilepsy Action are pleased that the government has stepped up preparations for a possible no-deal Brexit and provided more practical details. A major focus of today’s announcements is ensuring that medicines remain available to those who need them, whatever the outcome of Brexit.

While the information below is focussed on a potential no-deal situation, the government remains committed to securing a deal with the European Union (EU) before we leave. As part of this deal, the government has committed to negotiating continued membership of the European Medicines Agency (EMA).

Epilepsy Action believe that the best outcome for the UK healthcare sector and for people with epilepsy is for the UK to remain a member of the EMA. This would limit the potential negative impact of Brexit on healthcare and access to medicines.

The Health Minister, Matt Hancock, has reassured patients that they will not need to store additional supplies of medicines at home. The government is confident that the plans set out below will ensure that medicines including antiepileptic drugs continue to be available from the moment we leave the EU, deal or no-deal.

The government’s advice is largely aimed at pharmaceutical companies but it should also provide some reassurance to people with epilepsy.

 What has the government said?

There are two main strands to today’s announcements. These are planning for the continued supply of medicines and batch testing regulations.

Planning for the continued supply of medicines [source]

The government recognises that a no-deal Brexit could affect the availability of medicines and other medical products in the UK.

The Department for Health and Social Care (DHSC) is working with pharmaceutical companies to ensure the UK has an additional 6-week supply of medicines. This will make sure medicines are available immediately after Brexit even if imports of medicines from the EU are affected by a no-deal situation.

This 6-week supply will be in addition to the normal levels of surplus medicines held by pharmaceutical companies.

The DHSC has also launched the Medicines Supply Contingency Planning Programme. This programme will work with suppliers of UK medicines that come from or through the EU to ensure suitable contingency plans are in place for a no-deal Brexit. The government will provide practical support to suppliers where necessary.

Batch testing regulations [source]

There were concerns that a no-deal Brexit could mean that the UK would have to change how it tested and regulated licensed medicines. This is because at present the UK is a member of the European Medicines Agency (EMA). This EU wide regulatory agency oversees the testing and authorising of licensed medicines for use in EU countries.

In the event of a no-deal Brexit, the UK would no longer be part of the EMA. This could affect the availability of medicines in the UK.

The government has announced that the UK will not require licensed medicines that have been tested by the EMA to be retested before being made available in the UK after Brexit. This should ensure that medicines manufactured in or imported through the EU would continue to be available in the UK in the event of a no-deal situation.

Moving forward

Epilepsy Action welcomes the reassurances from the government about the continued availability of medicines in the UK, deal or no deal.

The Secretary of State for Health and Social Care, Matt Hancock, has said that;

‘The Government has plans in place to ensure a continued supply of medicines to patients from the moment we leave the EU. Patients will not need to and should not seek to store additional medicines at home’ [SoS letter to health and care sector]

We will continue to monitor this issue closely as the Brexit deadline approaches. This will include ensuring the voice of the epilepsy community is heard and providing information for people with epilepsy as more details are made available.

Epilepsy Action believe that the best outcome for the UK healthcare sector and for people with epilepsy is for the UK to remain a member of the EMA. This would limit the potential negative impact of Brexit on healthcare and access to medicines.