Health and Care Bill

Lord Hunt of Kings Heath Excerpts

Lords Hansard - Part 1 & Report stage
Tuesday 1st March 2022 Lords Chamber

I end with a plea to my noble friend that the Government, MHRA, NICE and NHSE all work closely together, not just among themselves but with the industry and with all patient organisations and clinicians, to make swifter regulatory approval a reality, in keeping with the ambitious government life sciences vision, which I support.

[Lord Hunt of Kings Heath (Lab)]

My Lords, as this is my first contribution on Report, I declare my interests as a member of the GMC board and president of GS1, the British Fluoridation Society, the HCA and HCSA.

I welcome what the Minister said about research and its importance, and some of the tensions between practical work as a clinician and the crucial importance of clinicians engaged in research. The amendments that he introduced are very welcome, but like the noble Baroness, Lady McIntosh, I am disappointed that he has not brought similar amendments forward in relation to NICE. One suspects that it is something to do with money; he thinks that giving away amendments on research is cost-free, whereas there might be a resource implication when it comes to NICE. That is a pity.

The noble Baroness has talked about a postcode lottery in this country on the outcome of NICE judgments, but we also have a European postcode lottery. The fact is that NHS patients have much less access to modern new medicines and devices than those in many other countries. Stats that I have seen on medicines suggest that, for every hundred European patients who can access new medicines in the first year they are available, just 15 UK patients have the same access. We know that even when NICE has given its blessing to new medicines and treatments, take-up in the NHS still lags behind that in other countries.

I think that the noble Baroness, Lady McIntosh, and I were somewhat puzzled by the ministerial response in Committee in this area. We know that the NHS uses all sorts of rationing devices to prevent those new medicines and devices being allocated generally throughout the NHS, notwithstanding what NICE has to say—that is why I support the noble Baroness’s amendments. Essentially, my two amendments seek to build on the principles that she has referred to.

Amendment 171 relates to three issues which I think remain from Committee. The first relates to the links between licensing and reimbursement processes. Happily, the MHRA has established two new licensing pathways, ILAP— the Innovative Licensing and Access Pathway—and Project Orbis, for cancer medicines. This is very welcome; it is designed to speed up access.

However, the challenge with faster licensing decisions is that NHS reimbursement decisions need to speed up too, otherwise medicines can be placed on the market but cannot be made available to patients on the NHS. To its credit, the MHRA has designed this into ILAP, because NICE is directly involved in ILAP, and licensing and reimbursement decisions can be joined up. However, in respect of Project Orbis, there has been no such effort. Late last year, breast cancer patients faced the worrying situation where a drug, Trodelvy, which offered them hope, was licensed through Orbis but was not then available on the NHS. My amendment would therefore ensure that NICE acted to issue guidance on Project Orbis medicines as close to licensing as possible, as it does for ILAP.

Secondly, the amendment would clarify that NICE alone is responsible for determining its methods, as an independent body should be. In its recent methods and processes review, it concluded that

“there is an evidence-based case for changing the reference-case discount rate to 1.5% for costs and health effects. However, because of the wider policy and fiscal implications and interdependencies that are beyond the reach of this review, no change to the reference-case discount rate”

could be made. It further stated:

“Reducing the discount rate will make most technologies appear to be more cost effective.”


We are therefore in a situation where NICE wants to make a change to its methods, which would result in more medicines being made available to patients but is being stopped from doing so. That is not acceptable. NICE should be free to determine its methods, including the discount rate.

The final effect of the amendment would be to clarify the role that the current voluntary scheme, VPAS, and the statutory scheme play in reimbursement decisions. These schemes essentially cap the NHS’s expenditure on drugs, meaning the exposure of the taxpayer to spending on drugs is limited. The problem is that the health service then adds a whole host of other mechanisms to restrict access to medicines as well. My own view is that once we have VPAS and the statutory scheme in place, we do not need those other mechanisms.

Amendment 178 builds on this. I have already referred to the Project Orbis scheme. It has great potential, but unfortunately, as Gilead has pointed out, there is a lack of alignment across the system between government, the MHRA, NICE and NHS England, which has an impact on timelines for approval. This is particularly concerning in light of moves by other countries such as France to legislate to enable early access to innovative therapies prior to a cost-effectiveness assessment, with any difference in the final agreed price rebated by the company. We need an integrated access and funding pathway for medicines licensed by Orbis, prior to NICE approval, modelled on the French system, whereby companies rebate any difference in price following the decision by NICE.

The final point I will make is that we also need to deal with NICE capacity issues. In January 2022, NICE highlighted in its board papers that approximately 20 evaluations were paused in 2021-22 due to capacity constraints because of vacancies. This is despite increased industry fees paid for health technology assessments. While NICE’s vacancy rate has reduced, the same board papers note that:

“Organisational capacity continues to be the key risk for NICE ... strategy, and gaps in hard to fill specialist roles in a competitive global market.”


I would like the Minister to respond to this.

More generally, I hope that the Minister can give us some assurance that he and other Ministers recognise that all these initiatives to speed up access, excellent though they are, will come to very little unless they can sort out the NHS side of things and get rid of some of these rationing mechanisms which have been put in place.

[Lord Sharkey (LD)]

My Lords, like the noble Lords, Lord Patel and Lord Kakkar, I have added my name to the government amendments in this group. These amendments directly address the criticisms which we made in Committee that, as things stood, a duty to promote research lacked any real force. Since we made these criticisms, we have met with the Minister and his officials to try to strengthen this research duty and make it more meaningful and concrete. These amendments, and the others in the next group, are the result of our discussions.

The Minister has explained, and given some examples, how they would help. The importance lies on what new things the amendments put in place. They require the NHS to explain, in its business plans and annual report, how it proposes to discharge, or has discharged, its research obligations. They also require a performance assessment of ICBs, which includes how well they have discharged their research duty and their duty to facilitate and promote the use of evidence in research. I thank the Minister and his team for their extensive engagement on the question of research in the NHS. I am pleased that we have strengthened the research duties of the Secretary of State and the ICBs. I am particularly pleased that progress will now be formally reported and assessed.

I should also mention that, in his letter of yesterday, the Minister listed a number of non-legislative measures either being taken or developed for facilitating or fostering a culture of research within the NHS, and for holding to account the people responsible for delivering this.

Finally, the noble Lord, Lord Patel, has asked me to say how sorry he is that he cannot be here today. He wanted the House to know that he supports the Government’s research amendments and is grateful for their co-operation in generating more research in the NHS. As the noble Lord, Lord Kakkar, has said, he is at home recovering from Covid, and I am sure that the House wishes him a speedy recovery.

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[Baroness Whitaker (Lab)]

My Lords, as well as supporting Amendments 9 and 12 and the rest of the group, I would like briefly to add my support for Amendment 31 in my capacity as patron of the British Stammering Association. This amendment is very much welcomed by the Royal College of Speech and Language Therapists, for all the reasons that we set out in Committee. It would do much to improve the expertise available for these damaging difficulties with the basic human need to communicate and the capacity to swallow, so I hope the Government adopt it—I am sure they will, because it is a government amendment. I am very grateful.

[Lord Hunt of Kings Heath (Lab)]

My Lords, before the noble Baroness, Lady Walmsley, speaks, I congratulate her and the Minister on Amendment 31. I also want to ask a question. It very much looks as if the integrated care board is marking its own homework, because the duty to keep the experience of members under review is placed on an integrated care board. It is then for the integrated care board itself to make a judgment as to whether it

“lacks the necessary skills, knowledge and experience”.

Quite clearly, any board that has already appointed a group of members is almost certain, in undertaking its review, to come to the conclusion that it was altogether wise in appointing the members with the balance it did. Who is going to monitor this? Who is going to check?

What if you are a local nursing body concerned that nursing issues are not being debated and reflected enough within an integrated care board? What do you do? Who do you go to? As far as I can see, apart from judicial review proceedings there is absolutely no way you can get any change. That is why—and I pay tribute to the noble Baroness, Lady Walmsley, for her work on this—you need amendments like my noble friend Lord Bradley’s to make some specification in relation to those critical areas where it is essential that the board has members with the relevant experience.

My second point for the Minister is this. In introducing her Amendment 9, my noble friend Lady Thornton essentially said that the Bill already lays out constraints on integrated care boards in relation to potential conflicts of interest. All she seeks to do is to extend that to sub-committees of the integrated care board, including place-based committees, which will commission a huge amount of health service provision in future. For the life of me, I cannot see how those sub-committees can be constituted under any different principle from that of the integrated care board itself. Unless the Minister really comes up with a convincing answer on this, I think the House should make its views clear.

[Baroness Harding of Winscombe (Con)]

My Lords, as this is my first contribution on Report, I begin by declaring my interest as the recently stepped-down chair of NHS Improvement and NHS Test and Trace.

I commend the noble Baroness, Lady Walmsley, and my noble friend the Minister and support Amendment 31. In Committee, we debated in considerable detail the constituent elements of the ICBs. I think it hugely important that integrated care boards have a loud, strong, forceful voice for mental health, public health and prevention in all its forms, but I also think it really important that we enable a board to be a proper board.

The noble Lord, Lord Hunt, questions whether a board would ever assess its own competence and members. Any really good, functioning board in the public and private sector views that as one of its primary obligations. The first line of defence to ensure that a board is performing well is whether it is actually doing an assessment every year of whether it has the appropriate skills. Yes, you should have second and third-line assessments through the CQC and NHS England, but it is the role of a board, and we should let them do that. I believe that Amendment 31 holds these boards to account to do that.

The amendments we have already debated today, enshrining the obligations around public health, health inequalities and mental health, ensure that that is the clear objective of those integrated care boards. I encourage my noble friend the Minister to hold firm and support his amendments and not the others.

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[Lord Kamall (Con)]

My Lords, despite what the noble Baroness, Lady Thornton, said at the beginning about this perhaps being the end of the harmonious start to our debates so far, I feel that this has been a helpful and constructive debate. I am grateful to noble Lords for bringing these issues before the House.

Let me start with Amendment 9, as I understand the wide interest in the membership of the committees of the board and potential conflicts of interest. We firmly agree that conflicts of interest must be handled carefully, and have included multiple references to that in the Bill. We also recognise the concern that ICBs should not allow private providers to control commissioning decisions, which is why we added the amendment relating to private providers in the other place, in paragraph 4 of Schedule 2.

Furthermore, in the helpful discussions we have had with noble Lords since then, there has been mutual recognition that we need to balance the importance of protecting the core values and public nature of the NHS while not overly restricting the membership of ICBs. I am pleased that the amendment to Schedule 2 balances on that tightrope and gives appropriate reassurance. We think that it is reasonable to allow private providers and social enterprises to sit on some committees and sub-committees of the ICB, as barring them risks blocking sensible integration and joint working.

I am also aware of the mixed reactions to this amendment from stakeholders. Many noble Lords will have seen the NHS Providers Report stage briefing, which states that

“there could be circumstances where a local private or voluntary sector provider would be well placed to join a joint committee with a focus on integrated service delivery whereby the usual arrangements to identify and manage conflicts of interest would, and should, apply.”

It goes on to say:

“It does not seem reasonable … therefore to further restrict the membership of those committees in a way which is prescriptive in law.”


Further, the NHS Confederation stated in its Report stage briefing that this amendment

“risks critically undermining integration by reinforcing a rigid, out-dated purchaser-provider split and derailing the fundamental purpose of these reforms.”

As it so eloquently put it:

“The current reforms aim to facilitate collaborative working by bringing all partners in local areas around the table to plan the most effective and the most efficient way to deliver care. This, by its nature, involves bringing providers of services, alongside commissioners, into committees and sub-committees of the ICB to plan how care is delivered”.


Potential conflicts of interest are inevitable in commissioning, especially when we are looking to increase integration and bring multiple bodies together. The ICBs will be required to manage conflicts of interest as part of their day-to-day activities. That is set out in the Bill and will be part of their constitution as well.

For all committees, the board of the ICB will have to determine what functions they exercise, their membership, and the level of oversight of their decisions. The board of the ICB cannot delegate a function and claim to be no longer responsible for how it is discharged, and will be held to account for this by NHS England.

Also, ICBs will be clear and transparent about interests, and how they are being managed. We think that transparency will prevent poor decision-making. New Section 14Z30 makes it clear that an ICB must maintain and give public access to a register of interests for members of its committees or sub-committees. There must be arrangements in place to ensure that conflicts are managed not just for ICB members but within committees. The constitution of the ICB must also include the arrangements to be made to discharge the functions under new Section 14Z30 and a statement of principles to be followed by the board in this regard. This will all be supported by guidance from NHS England. We are quite determined to tackle conflicts head on and not shy away from this issue.

[Lord Hunt of Kings Heath (Lab)]

My Lords, if NHS England is determined to tackle conflicts of interest head on, why is it building them into the whole structure of integrated care boards? Let us think about an integrated care board discussing future strategy: it would inevitably discuss where the priorities will be. That inevitably means that money will follow the priorities. At what point in those discussions do the major providers, who will be sitting round the table, have to withdraw from because of a conflict of interest? At heart, this ambiguity is built in, so it is not surprising that my noble friend wants to see consistency right through the system, including the sub-committees.

[Lord Kamall (Con)]

I thank the noble Lord for that intervention because I was just about to come to it. I should add that new Section 14Z30 very clearly requires ICBs to manage conflicts of interest at sub-committee level.

We think that the approach we have outlined will be more appropriate and possibly more effective than simply barring individuals with a conflict of interest—which, I encourage noble Lords to note, would also include NHS Providers and local authorities— from all committees with a commissioning function. First, this approach is broader than what the noble Baronesses might have intended. Secondly, many committees will have a range of functions, and commissioning may be only a small part of their activity. This approach risks creating a series of duplicated committees with similar interests to enable commissioning decisions to be taken in line with the amendment. This risks undermining one of the very purposes of this reform: to reduce bureaucracy and increase integration.

On Amendment 10A, we are clear that chief executive pay should be value for money. The pay framework is based on our ability to attract the highest-quality candidates. ICB roles, such as the chief executive, are some of the more complex in the health system. Experienced chief executives of trusts already exceed the suggested £150,000 per annum remuneration. Therefore, we do not believe it would be realistic to expect them to take a pay cut to take up a role with such a portfolio.

I remind noble Lords that putting the salary of an ICB chief executive into the Bill would be inappropriate. Such a lack of flexibility would be extremely unusual for a senior position and risks salaries declining in value over time, precisely as ICBs take on more responsibility as they become more established. This would fundamentally weaken ICBs’ ability to recruit and retain senior management. I also warn that directly tying pay to performance is likely to make it significantly harder to recruit chief executives to more challenging ICBs—precisely the organisations that we would want to recruit the very best leaders.

I hope I can reassure noble Lords that the recruitment process will ensure that only the most qualified people can take up these roles. All ICB chief executive appointees across England need to demonstrate how they meet—