The MHRA is the regulatory body in the UK which licences medicines and medical devices, either just for the UK or using the EU centralised procedure which allows companies to sell products throughout the EU.
The UK Parliament’s briefing paper on Brexit and medicines regulation published on 20 November 2017 provides an overview of current medicines regulation in the UK and the relationship with the EMA. The EMA’s departure for Amsterdam will have a significant impact on the work of the MHRA which will also be impacted upon by the change to the regulatory framework given that the UK will no longer be in the EU.
Leaving the EU will mean the regulatory process in the UK will change not least since there will no longer be automatic access to the EMA. The EMA already has recognition agreements with countries such as Canada and Switzerland, so something similar could be mirrored for the UK. Without that, the UK will not be able to participate in EU wide marketing authorisation procedures.
The Chairman of the MHRA has said that he is concerned that Brexit will mean that the UK is at the “back of the queue” when it comes to new medicines as companies look to have their products licensed in larger markets. In terms of future regulation, two broad options have been mooted: the UK benefits from the EU system through a mutual recognition agreement or the MHRA stands alone as a regulator, possibly relying on the approvals of other medicines regulators such as the Food and Drug Administration (FDA) in the United States.
Another key role played by the MHRA is in respect of the work it does with the EMA including testing products; the Financial Times has said that EMA work carried out by the MHRA makes up about a third of the MHRA income; it is unclear whether that work will now be carried out by the MHRA equivalent in Amsterdam.
The MHRA has said that it will continue to play a full and active role in European regulatory arrangements and that this remains a priority for them.
These issues will all form part of the complex negotiations which are ongoing between the UK and the EU.