My Lords, I welcome the Bill. As my noble friend rightly said in a very positive opening speech, it is not only a necessary Bill but one which presents us with opportunities. I hope that, during the passage of the Bill, we will look to realise those opportunities, and I want to refer to one or two.
My noble friend talked about the Delegated Powers Committee’s remarks, which made the very compelling point that, in reproducing the regulation-making powers, we are moving from the power to make regulations to meet EU legal requirements to the ability of Ministers to set down their own legal requirements; these are very different things. What we need to do in the latter case is not to move from where we are now, as my noble friend might have suggested, to something that sets out in primary legislation the detail of these regulations—nobody is intending that—but to something that moves us from a skeleton Bill to a framework Bill. What is the difference? The difference, in my mind, is a very straightforward one. The framework Bill is purposive. It sets out why regulations are being made and gives an ability to look at the primary legislation and ask, “Do these secondary instruments fulfil the purposes of the primary legislation?” During the passage of the Bill, we must look very carefully to meet that test.
I want to make three quick points. First, I think we are already among the best places in the world for medicines innovation. We may be 3% of the pharmaceuticals market but we are 10% of medicines innovation. I want to continue that. One thing the industry has told us, including me, over past years is that it wants to see our NHS take up new medicines and make them available to patients—a point that my noble friend reiterated. There is a commitment in our manifesto that says:
“We will extend the successful Cancer Drugs Fund into an Innovative Medicines Fund”.
I think the time has come for that and I hope that the Bill will make provision for that to happen.
Secondly, the MHRA is a world leader—for example, in the assessment of medical devices—but we have a problem, as the noble Lord, Lord Hunt of Kings Heath, said. We will be accepting CE markings through to 2023. I am pretty sure, unless somebody tells me otherwise, that the EU is not going to accept UK conformity assessments any time soon. So we are in an asymmetric relationship, and we have to think very hard about how we can sustain the MHRA. In the course of that, what the noble Baroness, Lady Barker, said is absolutely right: we must not be pulled between American FDA standards and EMA standards. We should be trying to move everybody to international standards, and that is something we will have to look at hard.
As we put more registries in place, I hope that they will include patient-reported outcomes: that is important. For medical devices, I hope that we will show how we are going to take them up in the NHS as well. On the consultation that ended last year on the medtech funding mandate, the time has come to do it. Ministers have not said that it will be brought into place this year or next. I think that the Bill should bring forward the medtech funding mandate, as the medicines mandate is in place. Finally, on clinical trials, the EU has not implemented its clinical trials information system and is not at present expected to do so until the end of 2021. We need to be in it. The legislation says “corresponding or similar to” but I do not know what “or similar to” means. We are either in it or not in it, and I hope we will be in it.
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