Baroness Merron (Lab)

I am most grateful to both noble Lords for their constructive contributions and their support for these measures. I welcome their questions and will do my best to respond to them. I will first make a few general points that may assist. Noble Lords acknowledged the role of the MHRA, the essential services it offers and the crucial role it plays. It is also understood that it needs financial backing to do that. Therefore, in supporting these regulations, we will enable the MHRA to continue to contribute to the Government’s health mission and to balance its responsibilities to maintain product safety and champion innovation. As the noble Lord, Lord Kamall, said, that is so important to us as a country and an economy, as well as to the National Health Service. The MHRA is not alone in how it is funded. Most regulators levy charges for their work, and—in response to the question about international comparisons—it is also accepted international practice for healthcare product regulation to follow this trajectory; for example, the European Medicines Agency and the US FDA also charge fees. I certainly feel that the cost recovery approach, which neither noble Lord questioned as a fundamental, ensures that services are paid for by those who use them rather than by the taxpayer—namely, patients. The noble Lord, Lord Kamall, raised some questions about small and medium-sized enterprises. While I understand that increases in costs can place more relative strain on SMEs compared with larger companies, the MHRA has existing SME payment waivers and easements, and the instrument creates a new SME payment easement for some fees for the medical device clinical investigation service. We have sought to be responsive in this regard. On supporting innovation and maintaining the UK’s attractiveness as a place to develop and launch medical products, I certainly want to see the UK as the go-to country for that. It does this in several ways— for example, by providing scientific advice and stream- lining regulatory processes to help reduce costs and the time to market. This is a high priority within our Government. The noble Lord, Lord Scriven, raised questions relating to where costs have exceeded inflation, why this is and what the Government are doing about it. All fees are set to recover costs and it is the case that some services were found to be underrecovering more than others, so this is putting it back in the right place. It is not related directly to inflation but to the real costs and, in some areas, there are concerns about that.