Question to the Department of Health and Social Care:

To ask Her Majesty's Government, further to the Written Answer by Lord O'Shaughnessy on 5 June (HL8120), whether they will publish details of the changes to Marketing Authorisation Holder fee models they are calling for at a (1) national, and (2) European level to take account of the specific situation of small companies; and whether they are calling for fee waivers for a wider number of Marketing Authorisation Holders than in SecurMed’s new fee waiver scheme.

In their supervisory capacity, the Department and the Medicines and Healthcare products Regulatory Agency’s aim is to ensure that SecurMed is complying with the regulation in a fair and proportionate way and this includes consideration of their fee structure. We are not seeking changes to SecurMed’s fee model at this time, including wider fee waivers. We have no current plans to publish details of our supervisory role, but to date this has included scrutiny over the European Medicines Verification Organisation’s blue print resulting from their assessment of different cost-allocation models; aligning the United Kingdom’s approach with other European Union National Medicines Verification Organisations; and seeking to ensure that the fee model is fit for purpose for the UK.