The proposals
Updated 31 January 2023
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This publication is available at https://www.gov.uk/government/consultations/consultation-on-proposals-for-changes-to-the-medicines-and-healthcare-products-regulatory-agencys-statutory-fees/the-proposals
The MHRA is proposing to prepare secondary legislation to implement the following proposals, which would apply from 1 April 2023.
Proposal 1
The first proposal is to apply a 10% indexation uplift across Agency statutory fees. The indexation is linked to staff costs which, in line with the Civil Service pay award, have risen by 10% since the last fees review in 2016. Staff costs account for over half of the MHRA’s total expenditure and the Agency has no control over the pay award.
The remaining expenditure include items such as IT, laboratories and accommodation. These costs should have risen in line with inflation, CPI is 21% since 2016, however Agency cost reduction programmes mean the MHRA is able to cover any increases within the 10% price rise.
The proposed list of fees reflecting the 10% indexation uplift can be found in Annex B – MHRA statutory fee proposals (Table 1).
Proposal 2
The second proposal is to apply a further, cost-based uplift, for 61 significantly under recovering fees, on top of the indexation uplift, to achieve full cost recovery.
Through a review of its fees, the MHRA has identified 61 fees which are under-recovering so significantly that the 10% indexation uplift would mean they still do not achieve cost recovery. The MHRA is therefore proposing to uplift these 61 fees on top of the indexation increase in order to achieve full cost recovery. Each specific fee uplift varies as it reflects the cost of the activity, tasks and workload involved in delivering the service and is set solely to achieve cost recovery.
For example, in recent years there has been substantial technological progress in the field of medical devices and increased rigour is required in order to accommodate the growing complexity of modern devices. This requires the MHRA to extend scrutiny of these devices, which is more resource intensive and time consuming.
In addition, as the MHRA changes its approach to be a more responsive, enabling and supportive regulator, it requires additional time to help applicants to prepare more effectively for assessment. The MHRA’s new approach to clinical investigations is an example, where the MHRA spends more time supporting applicants, and as a result carrying out these activities is more resource intensive but better prepares applicants for successful applications. The cost of the additional time invested into supporting applicants has to be recovered, and this is reflected in the additional increase to some of these fees.
Finally, the MHRA now has improved operational experience and a greater understanding of resources required to carry out the activities related to these fees, meaning the Agency can more accurately understand the real costs and more appropriately match these to fees.
The proposed list of fees reflecting this cost-based uplift can be found in Annex B – MHRA statutory fee proposals (Table 2).
Proposal 3
The MHRA’s statutory fees have not been changed since 2016/17 for medicines and 2017/18 for medical devices. The third proposal is to introduce 22 new fees, to ensure that the Agency appropriately recovers the cost of the regulatory activity across its services, in line with HM Treasury’s principles on Managing Public Money.
For example, the introduction of a fee for a clinical trial complex amendment reflects modern innovative investigational medicinal products and the use of innovative trial designs, where amendments may require significant assessment activity not covered by the existing standard amendment fee. For instance, an example of this could be adding a new unlicensed medicine into an arm of the clinical trial or substantial changes to the manufacture of a biological product.
The MHRA has also introduced new services for which statutory fees are required. For example, in 2021 the MHRA introduced the Innovative Licensing and Access Pathway (ILAP), a new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access. The MHRA is proposing to include new fees for the ILAP, specifically for the scientific advice.
The fees proposed have been set according to estimates of the cost of the activity, workload and tasks involved in delivering the service. The fees for these services will be kept under review over the next 12-month period and will be adjusted in April 2024, if required, to ensure they are as close to cost recovery as possible.
The list of the proposed 22 new fees can be found in Annex B – MHRA statutory fee proposals (Table 3).