Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what estimate his Department has made of the cost to the taxpayer of the Medicines & Healthcare products Regulatory Agency taking on regulatory functions carried out by EU regulatory bodies when the UK leaves the EU.

As a Government trading fund, the Medicines and Healthcare products Regulatory Agency (MHRA) is funded mostly by income from fee-charging activities. In 2018/19 income from fee-generating activities was £124.0 million and income from the sponsoring the Department was £34.6 million. The Agency’s income from trading activities has reduced compared to previous years as a result of the United Kingdom preparations to exit the European Union, which has led to a reduction in revenue from centralised (European Medical Agency-managed) as well as decentralised (EU-member states led) licence applications.

In addition, the MHRA is incurring costs to prepare for ‘no deal’ and transition to a stand-alone regulator. The Department has provided support via transitional funding (£6 million in 2018/19 and a further commitment of £11 million in 2019/20) and £1.6 million targeted ‘no deal’ funding towards decoupling the MHRA IT Customer Portal.