Question to the Department of Health and Social Care:

To ask Her Majesty's Government whether they conducted a cost analysis before the implementation of the Coronavirus Test Device Approvals process; and how the desktop review fee amount for test applications was decided.

The Department’s online only impact assessment included a cost analysis and calculations on the implementation of the Coronavirus Test Device Approvals process. It is intended that this regulation should be cost neutral for taxpayers and as such, the Government recovers the costs from applicants, while ensuring fees are as low as possible. However, through engagement in a public consultation and with industry, we recognised concerns on ensuring smaller businesses can access the market. Therefore a discounted rate of 55% is offered, in line with taxation benefits for research and development spending offered to small to medium-sized enterprises. We have committed to review the policy at the end of 2022.