Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will make an assessment of the potential impact of the proposed reform of Medicines and Healthcare products Regulatory Agency statutory fees on investment in the UK market by medical technology companies in the (a) short and (b) long term.

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the United Kingdom.

Most of the MHRA’s income comes from charging fees for its services. Its fees are set to recover the full cost of delivering the respective services. This is in compliance with the HM Treasury guidance, Managing Public Money.

The MHRA aims to update its fees every two years, so that it can continue to recover its costs. This ensures the agency’s continued financial sustainability, and the ongoing delivery of its services.

The MHRA has recently consulted on its current fee uplift. The consultation has now closed, and they are analysing the responses. The Government response to the consultation should be published in the new year.

By ensuring that the MHRA is fully recovering costs, it is in a better position to deliver the level of service that industry, patients, and the public want and expect. The fees uplift is not expected to adversely impact the UK favourability in the short- or the long-term. Regular fee increases are standard practice across all regulators.