Draft Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations
(Limited Text - Ministerial Extracts only)
Read Full debate
The Minister for Secondary Care (Karin Smyth)
I beg to move,
That the Committee has considered the draft Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025.
It is a pleasure to serve under your chairmanship, Sir Desmond. Before I turn to the detail of the statutory instrument, I would like to highlight the important role that the Medicines and Healthcare products Regulatory Agency plays in safeguarding public health, and the importance of the agency’s continuing to be properly funded to deliver its role.
The MHRA is a world-leading regulator of medicines, medical devices and blood components for transfusion in the UK. It charges fees for its services; the fees are set to recover the cost of delivering a service, in line with His Majesty’s Treasury’s guidance, “Managing Public Money”. To ensure that it continues to recover its costs, it aims to update its fees every two years, which is standard practice for Government bodies that operate on a cost recovery basis, and for other regulators, here and abroad.
All fees are set by taking into account various factors to reflect the cost of the activities involved in delivering a service, such as the time taken and the number and grade of staff involved; this is also informed by staff activity recording. In addition, in line with “Managing Public Money”, the MHRA includes the cost of services, of necessary corporate overheads and of system investments. Regular fee uplifts are necessary to ensure the MHRA’s long-term financial sustainability and enable it to deliver the responsive, innovative and efficient regulatory service that its customers expect, and one which protects and improves patient and public health.
The draft instrument will do three main things. First, it will update the fees that the MHRA charges for its activities regulating medical devices and blood components for transfusion. These fees were last updated in April 2023. The implementation date for the proposed changes is June, and they will ensure cost recovery until 2027.
Secondly, the draft instrument will introduce a fee for a new optional service: a regulatory advice meeting for medical devices. This new service will support manufacturers in interpreting regulations and requirements, particularly for complex, innovative products.
Finally, the draft instrument will introduce a new payment easement for small and medium-sized enterprises for clinical investigation fees. The easements will not reduce the overall fee, which would require cross-subsidisation, but will enable the fee to be paid in two instalments, providing some flexibilities for SMEs.
I should note that the draft instrument will not change the MHRA’s fees for activities relating to medicines regulation. Given the different legal positions in relation to the powers to make regulations about fees relating to medicines, medical devices and blood components for transfusion, the MHRA has used two instruments for this fees uplift. A second instrument for human medicines fees has already been laid before the UK Parliament and the Northern Ireland Assembly and has already come into force.
Karin Smyth
I thank the hon. Members for Sleaford and North Hykeham and for Chichester for their comments, which I will try to address.
As I think everyone agrees, the MHRA provides essential services that play a crucial public health role, and it is important that it recovers its costs, which is what these fee increases are set to do. The main benefit of the draft regulations will be that patients and innovators have the faster and better-delivered service that has been committed to. I meet the MHRA regularly, and I will be meeting with the new chief executive and chair later this week to make sure that the improvement that we have seen recently continues. I know that the whole House is interested in that, because, like all regulators, the MHRA is a huge contributor to the growth that we want to see as part of our growth agenda. I expect patients and the industry to see the impact.
Recovering the fees is crucial. It is also right that the regulated bear the cost of regulation, rather than it falling to UK taxpayers to subsidise it. By supporting the draft regulations, we will ensure that the MHRA continues to contribute to the Government’s health mission, balancing the responsibilities to maintain product safety and to champion innovation. It has made progress in responding to the recommendations set out in Baroness Cumberlege’s independent medicines and medical devices safety review. It has listened carefully to the people who gave evidence and to the findings of the independent review team, which are a matter of concern to many Members and constituents across the country, as the Liberal Democrat spokesperson, the hon. Member for Chichester, quite rightly highlighted.
The MHRA is committed to bringing about the changes that have been identified and to achieving ambition to be a regulator that absolutely delivers for UK patients, as well as delivering at speed to give confidence to the industry. We absolutely do not want to deter innovation; that is why in the draft regulations we are making some changes to support SMEs, which may find regulation more burdensome. We will keep that under review.
We expect the organisation to look closely at staff costs and make sure, like all organisations, that it produces the efficiencies needed to deliver a good service.
Dr Johnson
Before the Minister concludes, could she answer my questions on national insurance and on below-inflation pay rises? If not, will she commit to answering my remaining questions by letter?
Karin Smyth
I am happy to answer any questions, but as far as I am aware, they are NHS-employed staff, so they will be dealt with in the usual way. I am happy to write to the shadow Minister with any specifics if that is helpful.
In conclusion, the draft regulations are important to ensure that the MHRA has the resources that it needs to continue delivering reliable services and its public health role. I commend them to the Committee.
Question put and agreed to.