Deal or No Deal
Updated: Dec 16, 2019
Brexit Must Not Stop Medicines Reaching the UK
Words by Niall Dickson, Co-Chair, Brexit Health Alliance
The health system – and indeed British industry, business, and services in general – will be in unprecedented territory when the UK leaves the EU next year.
Given the issues arising from a possible no-deal Brexit, such as changing customs and border control policies, many organisations in the health service are asking one question: can patients continue to receive an uninterrupted supply of the medicines and vital medical supplies they need?
The government’s rollout of guidance recently on preparing for a no-deal Brexit scenario was a welcome, positive step – but only a first step. The NHS will now want to see more comprehensive operational advice on issues such as the stockpiling of medicines and equipment, medical research, and public health, in time to take robust action locally well before the UK leaves the EU.
In addition to ensuring the medical supply chain is uninterrupted, there are potential regulatory issues ahead too – for the EU 27 countries as well as for the UK.
When the UK leaves the EU, the European Medicines Agency (EMA) will relocate from London to Amsterdam and expects to lose at least 30% of its staff.
The EMA has historically relied heavily on the UK’s Medicines and Healthcare Products Regulatory Authority (MHRA) to assess new medicines, often handing it the most complex cases. In preparation for Brexit disruption, the EMA has already had to start scaling back operations.
Assuming a Brexit deal is brokered, the UK is likely to remain a part of the EMA during the implementation period, until December 2020. But the UK will lose its ability to lead. Companies applying for marketing authorisation for new drugs in future would have to seek marketing authorisation from both the MHRA as well as the EMA, but they may not choose to go through the MHRA process if they consider the UK market alone may be insufficiently lucrative, for example in the case of new treatments for small patient populations with rare diseases.
Can patients continue to receive an uninterrupted supply of the medicines and vital medical supplies they need?
These are among the many reasons why the Brexit Health Alliance was formed – it brings together the NHS, medical research, industry, patients, and public health organisations to safeguard the interests of patients and the healthcare and research they rely on. We are also seeking assurances around the regulation and supply of medicines as the UK leaves the EU.
There should be no negative impact on patients, either from disruptions in supply or from a reduction in standards or safety. In order to achieve this, as far as possible the UK and EU should continue close regulatory alignment and co-operation. Pragmatic solutions should be reached to allow the mutual benefits of the UK continuing to participate in EU systems such as data sharing networks on pharmacovigilance and clinical trials.
And there needs to be a longer implementation period beyond the 2 years outlined by the Article 50 negotiations to give enough time for industry and the NHS to prepare and to ensure that the relevant customs, trade, and regulatory infrastructure is in place.
Most importantly, it may be acceptable to argue about delays to some consumer products at the border, but it cannot be acceptable if patients’ lives are put at risk.
The alliance and its members will keep working together with the UK government over the next few critical months. With the right planning and support at national level, we should be able to deal with this challenge, at least in the short term.