Baroness Merron (Lab)

I am grateful to the noble Lord for his interest in this important subject and for expressing his concerns, which I will address. I know that he is more than supportive of patient safety and taking a risk-proportionate and pro-innovation approach —I hope that is not putting words into his mouth, but that is my experience of him—and that is what this is about. I have heard his request to defer consideration of these regulations. I would not want to agree to that, not least because of the timetable we have set out. In running the consultation and responding very directly to the concerns raised, which were very real and appreciated, as well as by working with industry and being transparent and prepared, we feel that it is time for these regulations. The noble Lord, Lord Kamall, referred to substantial additional costs on businesses. The impact on business is estimated at £4.3 million a year in total. Of course, de minimis assessments are not usually published. However, we have included that figure in the Explanatory Memorandum and committed—I hope that this will be helpful—to a full impact assessment for the fully cost-recovering fee in 2027-28. I hope that that will go some way to assist the noble Lord.