The amendment is in my name and that of the noble and learned Lord, Lord Woolf. This group includes four amendments, three of which are mine. I am glad to see in it too Amendment 124, in the name of the noble Lord, Lord Hunt, because it goes to similar issues. I hope that he will find some common ground between us.
Amendments 17 and 79 would add to the considerations to which the Secretary of State should have regard when making medicines regulations and medical devices regulations respectively—Amendment 17 referring to the former and Amendment 79 to the latter. They would bring the same factors into play.
The first factor is the effect of the regulations on the ability of the National Health Service to meet the needs of patients. There could be two interpretations of how this might be seen. The first is that the medicines regulations could give rise to the authorisation of medicines that the NHS was not in a position at that point to fund. I do not think that it is about that. If the NHS has difficulty in paying for such medicines, it has a power under the National Health Service Act to vary the funding mandate that would otherwise be applicable under NICE. The NICE funding mandate for medicines is in that Act and not in the regulations for medicines. What I think this is about is the NHS being increasingly keen to secure the benefits of innovation. We have had a decade or more of reports telling the NHS that while there is a great deal of innovation there is poor diffusion of its benefits through its adoption in the National Health Service. This is about the ability of the medicines regulations to help the NHS to meet unmet medical need, to bring forward innovations and to deploy them. One might say, “Well, the medicines regulator just authorises medicines”, but let me give a couple of examples.
The first is the early access to medicines scheme, which is precisely about giving the NHS the opportunity to bring forward innovative new medicines that meet unmet medical need and to do so more quickly and in ways that often require collaboration between the NHS, MHRA and NICE. The second example is the Accelerated Access Collaborative, which also looks at other schemes such as the small business research
initiative. Its purpose is to bring products through to authorisation and approval, which is quite often in relation to medical devices.
The amendments would require the Secretary of State when making the regulations to have regard to the potential for innovative medicines and medical devices respectively, so that they might be accelerated through processes of authorisation in order to realise their benefits more quickly and hence help the National Health Service to meet its objectives.
The second factor to which the amendments would require the Secretary of State to have regard is consultation. Clause 41 places a requirement on the Secretary of State to consult when making the regulations. A later amendment, Amendment 131, requires the Secretary of State to make a report on any such consultation—I think that my noble friend the Minister referred to it earlier—but there is nothing that links back the consultation to the making of regulations. The amendments say not only must the Secretary of State conduct consultation but he must have regard to the outcome of it—these are specifically “have regard to” factors; they are not factors that should be placed above any other factors in the hierarchy that we are talking about or conflict with them.
Amendment 85 is a bit different. I freely admit, before my noble friend the Minister explains it to me, that trying gently to insert it into Clause 13 is probably quite difficult in terms of the legal structure, because that is a place where requirements are to be laid on those who bring products forward for marketing and supply, whereas the amendment would place a requirement on those who are effectively buying medical devices—that is, the NHS in particular. However, I want to ask my noble friend to consider that we are trying to stimulate innovation in medical devices and bring them through into practice. We know that there are significant potential benefits to the National Health Service in such innovations, which improve outcomes for patients and can reduce costs—it can be a win-win. However, there is no funding mandate for medical devices which mirrors that for medicines, so that when NICE produces a positive evaluation the NHS after a period of delay has an obligation to bring forward the funding for those devices.
In January 2019, the NHS Long Term Plan said that the NHS wanted to accelerate proven affordable innovations into use in the NHS. In November 2019, a consultation was launched to look specifically at what is known as the medtech funding mandate—that is, to give that funding mandate to medical technology devices, not just medicines. By March this year, the Accelerated Access Collaborative was meeting and agreeing—this was one of its objectives—that, in the financial year beginning in April 2020, three such products would be brought forward. Those three products were placental growth factor-based testing, whose title more or less explains what it is; SecurAcath, which, as the title again implies, makes catheters more secure, reducing infection; and HeartFlow, which piloted at the Royal United Hospitals Bath NHS Trust and is a 3D model mechanism for imaging coronary arteries in ways that
reduce intensive testing and enable clinicians to work with a highly developed form of imaging in their practice.
Those three products were to come forward in 2021. The intention, as reported to the board of the Accelerated Access Collaborative, was to do more in future years. As I understand it, NHS England intended to establish this as a medtech funding mandate—perhaps with slightly different characteristics and requirements than that of medicines but, none the less, to give medical device manufacturers the same sense of assurance that, if they bring this forward in the United Kingdom, the NHS, with a positive evaluation, will bring them into practice. However, that has stopped. I have seen nothing since April; it seems to have fallen by the wayside. I seek from my noble friend the Minister an assurance that NHS England wants to do it, that the Accelerated Access Collaborative will help to push it forward and that we will see action on this—if not this day, then this year. I beg to move.