Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025

Lord Kamall Excerpts

Tuesday 17th June 2025 Grand Committee

[Lord Scriven (LD)]

My Lords, I thank the Minister for outlining the purpose of these regulations so eloquently and succinctly. It is clear that the change to the fee structure for regulating medical devices and medical products is part of a realm of profound importance both to public health and to the future of healthcare in the UK. As Liberal Democrats, we unequivocally support a robust, efficient and well-resourced Medicines and Healthcare products Regulatory Agency, but it is important that our regulatory bodies possess the financial stability to ensure the safety, quality and efficacy of medical products and blood safety, which touch the lives of millions throughout the year.

I am not going to speak on these regulations at great length; I just want to tease out a couple of issues about which I would like a little more information from the Minister. First, increasing the fees will mean that costs will be covered automatically. What mechanisms are in place to ensure that efficiency and effectiveness are in place, rather than just ballooning costs that it would be assumed the industry would absorb? I am not clear from reading the impact assessment or the regulations exactly how the Government will ensure that the cost really is the cost and is not excessive cost.

Secondly, it is clear in the impact assessment that most of those who gave feedback to the consultation question were against these fees. How have the Government taken into consideration the reservations, not just of the “no” element but in particular that the fees were seen in some cases to be disproportionately high and to exceed inflation? How has that developed? Why are these costs disproportionately high and why do they exceed inflation?

Finally, it is important to increase the fees to ensure the agency’s work can continue but, critically, the impact assessment demonstrates a lack of concrete detail on how these increased fees will translate into tangible improvements in these MHRA services. Although the rationale for increased fees is often framed around enhancing regulatory efficiency and speed, the document provides insufficient assurances of the measurable commitments as to how the additional revenue will be specifically utilised. There is no clear framework for accountability that demonstrates how these funds will lead to faster approvals or increased safety. How will the department measure such improvements? In particular, what improvements are expected on the back of this fee increase?

These regulations are a serious matter. They impact on the health of our nation and, to some degree, the vibrancy of our life sciences industry, but we must ensure that our regulatory framework is not only robust but forward thinking and truly serves the best interests of every patient in the UK by ensuring that the increased cost will both increase efficiency and, we hope, improve the services that the MHRA provides.

[Lord Kamall (Con)]

My Lords, I also thank the Minister for introducing these regulations succinctly, as the noble Lord, Lord Scriven, said. Perhaps in common with the Liberal Democrats, we on these Benches—the numerous people on these Benches—do not seek to oppose this statutory instrument. Rather, we just wish to reflect on its purpose and practical implications, and ask a few questions for clarification that I hope the Minister will be able to answer.

As noble Lords have said, this instrument amends three pieces of legislation. We understand that these changes are intended to enable the MHRA to increase the fees to manufacturers, suppliers and other regulated entities involved in the approval of medical devices and blood components. Noble Lords understand that the current model relies primarily on contributions from industry and that the MHRA’s fees were last comprehensively reviewed in April 2023, as the Minister said. Of course, we have seen a rise in operational costs, particularly relating to staff and overheads, so we completely understand that the intention behind these regulations is to bring the MHRA’s income more closely in line with the cost of delivering its services. It is also to place the agency on a more sustainable financial footing, thereby reducing its reliance on central government funding, which I think is something on which we all agree.

As the noble Lord, Lord Scriven, said, the impact assessment accompanying this instrument identified the primary benefit of this additional income—to enable the MHRA to continue fulfilling its responsibilities —but, as was raised by some in the industry and in the other place, it is less clear how these changes will directly benefit patients, healthcare providers or, indeed, medical innovators, in particular those operating in the small and medium-sized business sector. We understand that the Government decided to pause their proposed reforms to the medical device registration fee following concerns raised by stakeholders. That decision is welcome, and I thank the Minister and the Government for that. The paused proposals would have had a disproportionate impact on companies registering a large number of products, particularly due to the proposed fee model linked to the global medical device nomenclature codes. However, the broad uplift in the other fees will still go ahead, and it is in this wider context that we seek some reassurance about these changes.

I shall look at some of the areas on which some clarity would be welcome. First, we recognise the MHRA’s need for stable funding, but we want to make sure it does not create barriers to innovation, in particular for start-ups and SMEs, which, as we know, often operate on much narrower margins and already navigate a complex regulatory environment. What assessment has been made of the cumulative impact of these fee increases on smaller firms? Do we know how these changes compare with the regulatory costs faced by manufacturers in other major markets, such as the EU, the US or Asia? Is the Minister able to give some international context here?

Secondly, the impact assessment confirms that the staffing costs remain the largest cost driver for the MHRA and assumes a 2.2% annual pay increase through to 2027—below the current rate of inflation. Has any thought been given to whether that is a realistic assumption and basis for planning? If the actual costs prove higher than forecast, how will that impact the MHRA’s progress towards the full cost of recovery? Would the agency be forced to scale back its services, or would the taxpayer be expected to cover any shortfall?