MHRA publishes the consultation outcome on statutory fees

By Annette van Raamsdonk and Karen Hill

From August 29, 2024, to October 24, 2024, the Medicines & Healthcare products Regulatory Agency (MHRA) held a public consultation on its proposed amendments to the statutory fees. The consultation reflected fees for services related to medicines, medical devices and blood components for transfusion in the UK.

The statutory fees for services are intended to recover the costs involved with the work that comes with these services. Statutory fees need to be aligned with the UK treasury guidance. The height of the fees will reflect the costs of necessary overheads, system investments, costs and complexity of the service the MHRA provides.

The consultation covered 5 proposals

1. Increase the statutory fees.
2. Amend the Medical Device Registration fee to include the medical device post-market work.
3. Create a new service providing regulatory advice meetings or medical devices.
4. Amend and increase the fee model for scientific advice meetings, control testing and unlicensed medicines importation.
5. Update and clarify the legal definition of a “standard variation” application for homeopathic products.

The first proposal, to increase statutory fees led to a flood of objections from respondents, pointing out that an increase would “exacerbate existing financial pressure on manufacturers, particularly small and medium-sized enterprises (SMEs), and discourage investment in the UK”. Therefore, the consultation outcome led to a new SME payment easement, allowing SMEs to spread their costs over two installments. This is available for certain services only, mainly services related to Human Medicines market access in the UK. Fees for clinical investigations will significantly increase (see Annex I of the government response).

The second proposal would have had a significant impact on medical device manufacturers, as the MHRA initially proposed replacing the current one-off medical devices registration fee, with a new annual fee of £210 per GMDN code registration. The majority of respondents (72%) made objections and the MHRA has decided not to proceed with the proposal. Fees will increase, but the one-off medical device registration fee will stay in place. After indexation, the fee will rise from £240 to £261.

The MHRA realized that proceeding with this proposal would potentially lead to shortages of medical devices in the UK.

The third proposal was welcomed by respondents, as it would enable expert regulatory advice to medical device manufacturers by the MHRA. The MHRA aims to facilitate an earlier and better understanding of the relevant regulatory requirements to get market access to the UK. This service will be charged at £987 per hour per meeting. Concerns have been raised, related to conflicts between the MHRA advice versus the Approved Body advice. The MHRA will publish guidance on this.

Lastly proposals 4 and 5, MHRA proposal to change the current model for scientific advice meetings for medicine, control testing and unlicensed medicine importation as well as clarification on the legal definition of “standard variation” application for homeopathic products.

Summarizing, proposal 4 received few responses. Almost half of the respondents did not have an opinion on the proposal, except for welcoming the fee simplification. More detail would be needed for this proposal, of increasing fees for the 3 services listed above and removing 51 outdated fees. The model will be simplified, and certain fees will be removed, the MHRA will publish further guidance on the model and clarification where needed.

Regarding proposal 5, the MHRA will proceed with updating the definition of “standard variation”. It will be further clarified what a “standard variation” application covers. The “standard variation” application fee will remain unchanged.

Concluding, the MHRA announced that going forward, they intend to update their fees every two years “as regularity provides more certainty to customers and enables financial planning”. However, the MHRA has realized that increasing certain fees would discourage investment in the UK, resulting in less medical device availability for UK patients.