Consultation on MHRA Fee Structure Changes
- Date
- September 12, 2024
- Category
UK Regulations
- Description
The Medicines and Healthcare products Regulatory Agency (MHRA) has recently launched a consultation aimed at revising its statutory fee structure. Whilst fees were last updated in April 2023, the consultation marks the first significant update since 2016 for medicines and 2017 for medical devices. The consultation, open until October 2024, is part of MHRA's broader goal to ensure financial sustainability and continued recovery of costs in line with HM Treasury guidance on managing public funds. The proposed changes are set to be implemented by April 2025 with a plan thereafter to update fees every two years.
The MHRA’s primary motivation behind this fee restructuring is the need for full cost-recovery, as the agency has faced rising operational costs over the years without corresponding adjustments to its fee schedules. This review aims to address this gap by increasing fees across various regulatory services to ensure that the agency can continue to deliver its critical functions. As part of the update, the MHRA is introducing new fee categories and modifying existing ones to reflect the changing landscape of healthcare regulation in the UK.
For example, a notable change includes the introduction of 22 new fees related to emerging services, particularly those linked to innovative technologies and advanced therapeutic products. Additionally, the agency plans to update fees for established services like medicine licensing and medical device registration. These updates will include more granular, banded fees based on company size and scope of registration. Smaller organizations, such as those with single Global Medical Device Nomenclature (GMDN) registrations, would pay lower fees, whereas larger firms with more extensive portfolios could face significantly higher costs.
One of the key features of the new fee structure is its aim for fairness, ensuring that fees are proportional to the scale of the service provided. For instance, companies with high GMDN registrations might be charged up to £280,000 annually, while smaller firms with minimal registrations could pay as little as £210. This scaling helps balance the financial burden, ensuring that larger organizations contribute more to cost recovery while smaller players maintain accessibility to MHRA services without facing prohibitive costs.
The MHRA also emphasized that the fee restructuring is crucial for its long-term viability and ability to maintain high standards in regulatory oversight. With the changes, the agency aims to provide better predictability for companies, allowing them to plan for their regulatory expenditures over the coming years. The updated fees will also contribute to MHRA's modernization efforts, including its digital infrastructure and improved service delivery, which are essential for handling the increasing complexity of medical products entering the market.
As the consultation progresses, stakeholders are encouraged to provide input on the proposed changes, ensuring the revised fee structure balances the need for cost recovery with maintaining accessibility and fairness across the industry. The final decision on the new fees will be made after the consultation closes, with implementation slated for April 2025.
The online survey can be found using the following link: https://www.surveys.mhra.gov.uk/66c5b1cac08298bd15040d1b