Question to the Department of Health and Social Care:

To ask Her Majesty’s Government whether they have any plans to replace direct funding of the Medicines and Healthcare products Regulatory Agency by fees paid by industry.

The Medicines and Healthcare products Regulatory Agency (MHRA) operates as a government trading fund and recovers 92% of its total regulatory costs from fees and charges. In addition it receives income from the Department in recognition for the Agency providing both a devices service and a biologicals service from the National Institute for Biological Standards Control.

In 2016/17 the Department is purchasing a devices service of £8.1 million plus capital funding of £1 million which covers the remaining 8% of its regulatory costs.

The MHRA and the Department are considering charging the devices service directly to industry by fees.

The MHRA is also looking at the potential for increasing fees from international work over the coming years.