Understanding the New MHRA Fees Update: What You Need to Know

The UK government, through the Medicines and Healthcare products Regulatory Agency (MHRA), has introduced an updated fee structure for the regulation of medicinal products for human use. These changes, set to take effect in April 2025, are part of a routine revision to ensure the MHRA can sustainably cover its operational costs. Here’s a breakdown of what this means for stakeholders and the wider public.

Why the Change?

The MHRA is responsible for overseeing medicines, medical devices, and blood components for transfusion across the UK. To fund these regulatory activities, the agency charges fees that are periodically reviewed and adjusted. The most recent adjustment aims to align with rising service costs, ensuring the MHRA remains financially viable without government subsidies, thereby adhering to HM Treasury's "Managing Public Money" principles.

Key Changes to the Fees

1. General Increase: The new fees reflect an increase to match inflation and additional operational costs. Most fees have risen between 8.85% and 22%, with some specific services experiencing higher hikes.

2. Service-Specific Adjustments: Certain services, like scientific advice meetings and inspections, have seen significant fee increases due to historical under-recovery and benchmarking against industry standards.

3. Elimination of Redundant Fees: The update also removes 51 fees, simplifying the structure by eliminating charges for services that have become obsolete post-Brexit.

4. Homeopathic Products Clarification: The definition of a "standard variation” for homeopathic products has been updated, although the fee itself remains unchanged. This aims to clarify the scope of variations covered under this category.

5. Impact on Stakeholders: The overall impact of these fee changes on businesses is estimated at £14.5 million annually. While this may affect small and micro businesses, existing easements and waivers for smaller companies will continue to apply.

Consultation and Feedback

The fee amendment process involved a public consultation conducted by the MHRA and the Department of Health in Northern Ireland. Feedback from this consultation led to a reconsideration of certain proposals, particularly concerning fees for medical devices, which will be addressed in a separate legislative instrument.

Monitoring and Future Adjustments

The MHRA commits to reviewing its fees every two years, providing predictability for businesses and ensuring fees remain aligned with service costs. This regular review process is critical for maintaining a balance where the agency neither profits at the expense of stakeholders nor incurs losses that taxpayers must cover.

Conclusion

These updates are crucial for maintaining the MHRA's capacity to regulate effectively while adapting to economic changes. By ensuring cost recovery through these adjusted fees, the agency aims to continue delivering high-quality regulatory services that safeguard public health in the UK. For further details, stakeholders can access guidance and information on the MHRA website.