My Lords, I thank the noble Lord, Lord Hunt of Kings Heath, for giving us the opportunity to ask the Minister some questions. As I expected, it was really interesting, starting with NICE from its inception. Those of us who have been involved with the NHS for some while know the standing that NICE has within the NHS community and how it is changing and adapting to changing circumstances, new technologies and the importance of really exciting new pharma, including pharma for specialised conditions. It also gives us the opportunity to better understand the motivations and reasons behind some of the changes.
As I see it, this SI does two things. It enables NICE to recruit experts from across the UK to its appeal panel, as opposed to individuals only in England. This aspect of the SI appears to represent a sensible change. Secondly, it will allow NICE to charge industry for the cost of making technology appraisals—TAs—and highly specialised technology, or HST, recommendations. I see this aspect of the SI as potentially contentious. How will the anticipated savings from the SI be used? To whom will they be allocated? Will they be used to support growth of the life sciences sector in the UK, or will they just become part of the income stream and then go some way towards the possible privatisation of NICE? Is not the reason for this SI that NICE’s government-funded budget is decreasing? The documents with this SI note that in 2013-14 NICE received £66.4 million in government funding, and that by 2018-19 this had dropped to £51.2 million. I wonder how many other NHS-funded organisations have faced cuts of 23% over five years and quite considerable growth in their business.
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The Government argue:
“NICE needs to identify other sources of funding to enable it to continue with its full programme of work”.
The thought of NICE not continuing its full programme of work should, if not send shivers, be an area of concern. Clearly, we need NICE to continue. The department confirmed that charging for TAs and HSTs will enable NICE to continue the full breadth of its
important work, while at the same time reducing its reliance on central government funding. Is this justified? I wonder whether it is the thin end of the wedge. What other cuts do we anticipate to other bodies, such as the CQC or Health Education England? Already, organisations being inspected by the CQC, for example, are expected to pay for the privilege. For health settings, this will come out of their annual funding, while for care organisations their funding is part-private and part-public. How much of their funding will be eroded by potential fee uplifts, and will the Chancellor factor this into his annual grant to local authorities? I think not.
The department found insufficient evidence to conclude that medicines for rare conditions and medical devices would be disproportionately impacted by the introduction of this statutory instrument. Can the Minister tell the House what sort of evidence was gathered to come to this view? What plans are being made to review the impact of this change over the coming years? Will it be reviewed annually or every five years? Will Parliament have a role or will it just be a relationship between the department and NICE? Who is checking whether this impacts on British SMEs? The noble Lord, Lord Hunt, spoke about British SMEs, which are important. The pharmaceutical industry includes a lot of relatively small organisations that are working hard to pull together new drugs, particularly for specialised conditions. What if they decide to market and sell overseas, or even move the business to where the regulation and manufacturing landscape is cheaper and more supportive? Could the Minister tell the House what efforts were made to reach out to equivalent organisations in, say, Australia or Canada, as well as the Medicines and Healthcare products Regulatory Agency, to learn about the problems they have faced in charging for regulation, and to learn from best practice?
Sub-Committee B of the Secondary Legislation Scrutiny Committee asked the department why the Government decided to continue with the proposals considering the consultation outcome. The department explained—I think that all noble Lords will have seen this quote:
“The Government is satisfied that the introduction of charging for NICE TA and HST recommendations will create a sustainable model for NICE, and that the proposed changes to the charging model will mitigate the risk of any unintended and undesirable consequences”.
Efforts to protect small companies are important. However, does allowing small companies to pay by instalments create a potential conflict of interest for teams undertaking appraisals? Can the Minister explain in more detail how this would work?
I find it concerning that the Government have proceeded with this SI, despite 62% of respondents to the consultation disagreeing with the proposals. The rationale for continuing with the SI appears weak. Does it not undermine the intention of consultations to gather and respect the views of industry and experts if, at a stroke, you ignore them? I recognise that the Government have tried. I also recognise that I have asked a lot of questions, and if the Minister is pushed for time or detail, I would be grateful if she would respond by letter.