B

Baroness Merron (Lab)

Speaking in the House of Lords on 17 June 2025

Debate

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

Contribution

That is understood. I am going to come on to that, because I think it is important. Of course, with any uplift in fee, I would expect that to be the case, but I have a particular response as I continue. The uplifts we are speaking about today ensure ongoing, reliable delivery. They are necessary for the continued delivery of initiatives that promote growth and innovation. We are not just standing still; we are looking to the future. To the noble Lord’s point, industry has been clear that it supports these fee uplifts as long as they are accompanied by reliable performance. Although noble Lords have not specifically raised this, I add that the MHRA recognises that there have been some delays in some of its regulatory services of late and these delays were felt by those who pay fees. I am pleased to say that, from 31 March this year, all backlogs were cleared that relate to its statutory functions. Throughout its work to eliminate these backlogs, the MHRA put patients first and prioritised licence applications according to public health need, including those needed to avoid medicine shortages. Importantly, the MHRA is working to ensure that this continues, so that we have predictable, optimised and sustainable services across all the functions. I can assure the noble Lord, Lord Scriven, that the MHRA is taking steps to improve its performance and efficiency, not least because it does not wish to get into the situation of a backlog again. This includes a modernised RegulatoryConnect IT system and improved agency structures and processes. On accountability, it will also publish performance targets and report against them online and in its annual report and accounts. There are also mechanisms in place for monitoring the impact of these changes. Ministers, including me, meet the MHRA regularly and the MHRA and the department monitor the impact via stakeholder feedback and ongoing performance and finance reporting. I assure the noble Lord, because I know it is a particular interest, that we have key performance indicators in place to monitor the delivery of these services. I return to the point about small and medium-sized enterprises that the noble Lord, Lord Kamall, raised. In most cases, SMEs are dependent on grants from the NIHR and others, so there is no cost to them as a company when they submit an application to the MHRA. The noble Lord also asked about the assessment of increased fees on SMEs. Benchmarking fees compared to those of other regulators is somewhat difficult, to be quite honest, because of the difference in the way that the regulators operate and their different funding models. For example, a different model is where the regulator is subsidised, which is not the case here. With regard to employer national insurance contributions, the noble Lord is correct that the MHRA is subject to the increases in employer national insurance contributions. The agency believes that these fees will cover the costs of the increase in NI contributions. If there are any shortfalls, efficiency savings will have to be used to manage them appropriately.

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