Lord Kamall:

Moved by Lord Kamall

4: After Clause 4, insert the following new Clause—“Duties in respect of research: business plan and annual report etc(1) The National Health Service Act 2006 is amended as follows.(2) In section 13L (duty in respect of research), after “functions,” insert “facilitate or otherwise”.(3) In section 13T (business plan), in subsection (2)(a), after “13G” insert “, 13L”.(4) In section 13U (annual report), in subsection (2)(c) (as amended by section 69(4) of this Act), at the appropriate place insert—“section 13L;”.”Member’s explanatory statementThis Clause provides that NHS England’s duty to promote research etc includes doing so by facilitating research. NHS England is also required to explain in its business plan and annual report how it proposes to discharge or has discharged its duty to facilitate or otherwise promote research etc.

My Lords, in moving Amendments 4, I shall also speak to Amendments 23, 58 and 79 in my name. Before I start, I really should acknowledge the contribution and engagement of a few noble Lords, in particular the noble Lords, Lord Sharkey and Lord Patel, and my noble friends Lady McIntosh and Lady Blackwood for their constructive engagement with me and my officials.

We have seen the power of research as we have made our way through the pandemic, and research will continue to be essential. I agree that research needs to be embedded in the very DNA of the NHS. Earlier this week, I chaired a round table with a number of research charities and other stakeholders, and we all talked about the importance of embedding research into the NHS. A bit like the challenge I had when I was in academia, when you wanted more time for research but at the same time were told to get on with your day job of teaching students, likewise many clinicians are under the same pressures in terms of the day-to-day delivery of healthcare while wanting time for research.

We know that informed research helps to improve healthcare and health outcomes. It brings benefits to patients, staff, the NHS and the wider economy. We believe that integrated care boards will play a leading role facilitating and enabling research and fostering a culture and environment for research to flourish. To this end, the Bill currently places a duty on each ICB that it

“must, in the exercise of its functions, promote … research on matters relevant to the health service, and … the use in the health service of evidence obtained from research.”

I have, however, heard clearly from noble Lords that they want to see a step change in research. That is a request, or a plea, that I agree with, so rather than directly funding or conducting research, ICBs will primarily facilitate and enable it. However, ICBs will also have the power to conduct, commission or assist the conduct of research. This could include hosting or being a collaborating partner in research infrastructure.

I also heard from noble Lords, particularly the noble Lord, Lord Sharkey, that it is not clear what a duty to promote research should involve. To that end, I have tabled Amendments 4, 23 and 79 to clarify that the meaning of “promote” includes “facilitate”. I once again thank the noble Lord, Lord Sharkey, for his engagement. This highlights that facilitation is a subset of the range of activities meant by promoting research while retaining the breadth of a duty to promote research.

The duty is broad and could be met in a number of ways. For example, when exercising its commissioning functions, an ICB may select providers which have a proven track record of being research-active or can demonstrate the intention and capability to participate in research. The provision is also flexible so that bodies can develop the processes and structures that work most effectively, but we anticipate that ICBs would have dedicated research offices or teams to support their role in research and to encourage the conduct of research.

To ensure that research is fully embedded in local systems, we expect ICBs to consider research when preparing, with the responsible local authority, a joint strategic needs assessment articulating local research needs where they identify them. We would also expect ICBs to ensure that the joint local health and well-being strategy sets out how research needs can be met by the ICB. We have tabled Amendment 35, which is to be debated in the next group, to ensure that the research duty, along with other duties, is given particular consideration during ICBs’ planning of their strategies. We have also tabled a package of amendments to provide increased transparency, accountability and oversight of the research duties.

During the debate in Committee, my noble friend Lady Harding remarked that

“what gets measured gets done”.—[Official Report, 24/1/22; col. 47.]

We agree. Amendment 4 requires NHS England’s business plan to explain how it proposes to discharge its research duty and requires its annual report to contain an assessment of how effectively it discharged this duty. We have tabled similar amendments for ICBs. Amendment 55, also to be debated in the next group, would require that ICB annual reports must explain how the ICB has discharged its research duty. Amendment 58 would require that the NHS England’s performance assessment of each ICB includes an assessment of how well it discharged its research duty. I beg to move.

My Lords, I take this opportunity to thank my noble friend for listening and acting in the terms set out in the amendments in this group, which I support on research as far as they go. I have to express my disappointment that my noble friend has not seen fit to extend his bonhomie to NICE. I have therefore tabled Amendment 29, and I am delighted to have the support of the noble Lords, Lord Hunt of Kings Heath and Lord Patel. As set out by the noble Lord, Lord Kakkar, our thoughts are with the noble Lord, Lord Patel, who is unable to be with us today, and we wish him the speediest possible recovery. It is a great shame that he cannot be here today because we would all wish to pay tribute to his work historically as the forerunner of NICE. We are grateful to him for it. It is a great disappointment to me that he is not able to be here in person.

I also support Amendments 171 and 178 in the name of the noble Lord, Lord Hunt, but I shall leave the noble Lord to set them out.

My noble friend has set out that the government amendments set a responsibility on integrated care boards to respond annually and to measure the research work that they have done. Quite frankly, I am a little concerned and gobsmacked as to why my noble friend is not insisting that integrated care boards do the same as regards NICE. The key provision of my Amendment 29 is:

“Within 28 days of any medicine or device receiving market authorisation from NICE, an integrated care board must update its formulary to include that medicine or device.”

I have set out other provisions, but the other one to which I draw attention is in proposed new subsection (3), which says that every year an individual ICB must report

“in a publicly accessible format”— to me that would mean it being accessible on its website—

“all medicines and devices that have been added and removed from their formulary over the previous year and maintain an active list of all medicines and devices available on their formulary.”

I would like to get away from what is an effective postcode lottery, meaning that where you live determines the medicine or device from which you can benefit. In this day and age, in the 21st century, it is unacceptable that, for all the good work that NICE does, we are still living in that capacity, whereby not everyone will be able to benefit, as pharmacists, physicians or patients, from the advice that NICE has given.

I am delighted to say that I am supported in this by a number of bodies, including the JDRF, which makes particular reference to the importance of NICE’s work on type 1 diabetes—and we know how invasive and extensive type 1 diabetes is. I pay tribute to our Right Honourable Friend, the former Prime Minister Theresa May, who went public with the fact that she was a type 1 diabetes sufferer. For a woman in that position to go public about her condition captured the public imagination and made it more acceptable to say that people suffer from type 1 diabetes. EMIG, the ethical medicines association, also supports this provision, as does Vertex Pharmaceuticals.

I have only recently become aware of a project called the Orbis scheme, which aims to deliver faster regulatory approval of innovative cancer treatments. I think that all noble Lords would wish to support the speediest possible diagnosis and delivery of treatment that is in play through this project and scheme.

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.

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.

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.

My Lords, I remind noble Lords of my own declarations of interests made in Committee: I am chairman of the Office for Strategic Coordination of Health Research, chairman of the King’s Fund and chairman of King’s Health Partners. In so doing, I make particular reference to the King’s Fund, since the Minister, in closing the last group of amendments, indicated the contribution to discussion which the fund has made with regard to the questions of inequalities.

I strongly support the amendments on the question of research that have been put by Her Majesty’s Government, and so ably and thoughtfully presented and introduced to your Lordships’ House by the Minister. The noble Lord, Lord Sharkey, has summarised why this is so very important. Ultimately, a research culture needs to be promoted at the heart of the NHS, and these amendments go a long way to achieving that clear objective.

There is so much by way of other initiatives that Her Majesty’s Government promote on the funding of research and support to bring together different parties to drive the broader life sciences agenda. However, ultimately, this all depends upon an NHS which is strongly supportive of, and facilitated to deliver, that research. Without this commitment, there was a very real risk that, with the other priorities that the NHS is inevitably required to pay attention to, the need to promote and facilitate research would be lost.

In facilitating research, NHS organisations, the Secretary of State, the NHS board and integrated care boards will have to pay attention to not only the facilities provided but the attendant workforce questions, ensuring that a workforce is properly prepared and able to engage in the research agenda, that progress in that regard is properly reported and that the full benefits of a research culture and the output of research are available to patients throughout our country.

My Lords, very briefly, I support Amendments 171 and 178 in this group, spoken to so ably by the noble Baroness, Lady McIntosh, and the noble Lord, Lord Hunt. I do so as a former pharmaceuticals Minister and a former NICE Minister. The rather boring thing about all this is that the postcode lottery issue was alive and well when I stopped being a Minister, 15 years ago. It has continued to flourish throughout that time. The noble Lord, Lord Hunt, does not exaggerate in any way how the NHS is quite creative at finding ways around implementing speedily some of the drugs and medicines recommended by NICE.

For a long time, part of the problem has been—Amendment 178 starts to make a move in the direction that I think has been lacking—that we simply do not monitor enough what has happened to NICE recommendations and the take-up of new medicines. It is not really built into the regulatory system. If we are serious about inequalities—I have listened to many of the debates on inequalities today and previously—and levelling up, access to new medicines is pretty important. I have a terrible suspicion that, if we looked around very carefully, we would find that the same parts of the country, year in and year out, are not taking up the medicines as speedily as others. The reason I say this is that we know from the regulator’s evidence that the financial and clinical underperformers are, much of the time, the same places, year after year. I suspect that these are many of the places we need to look at if we want to tackle the postcode lottery of NICE recommendations.

My Lords, I join the debate briefly to add my thanks to the Government for the amendments on research that they have brought forward in this group. It is extremely helpful, as the noble Lord, Lord Kakkar, said, to entrench the concept of a research culture inside the NHS. In our various ways and guises, we have all encountered some of the difficulties of diffusing innovation and the take-up of new medicines in the NHS.

The point was made very well by the noble Lord, Lord Hunt of Kings Heath, but he did not say why the NHS does not adopt new medicines as rapidly as some other European systems have. I do not think we have more conservative clinicians than other countries, but we do not have a third-party payments system. We do not have a system whereby the patient can ask “What about this?”—these days, increasingly, they do—and the clinician can say yes, and pass the bill to somebody else. Instead, our system centrally determines the extent to which new medicines will be available. We have a particular requirement in the National Health Service for a system which looks for areas where there is value in innovation, disseminates it, takes it up and makes it available to patients.

I make two other points. One is to say thank you, as I am not sure I will get another opportunity to do so. We had substantive discussions about rare diseases; the noble Lord, Lord Sharkey, in particular spoke very well and fully about the needs involved, and the Government published their England Rare Diseases Action Plan yesterday. On orphan drugs, that will give significant additional impetus to the availability of treatments for those with rare diseases. I very much welcome that.

Secondly, Amendment 178 in particular is interesting. I do not necessarily advocate that we adopt it, but it asks the Government do something that they generally have not done and ought to do, which is to come back to the issue of access to medicines and treatments—and, I would add, to medical devices—and ask how well we are doing at the process of bringing that into effect and how well our Accelerated Access Collaborative, which is supposed to look at all these things and make them work together, is making that happen.

The beauty of Amendment 178, on which I will add just a little, is that we ought to have a very clear timetable for how we move the system forward. I hope the Government will adopt this. In January 2024, we will have the next voluntary pharmaceutical pricing and access scheme. The industry will be looking, rightly, to arrive at a position where all the initiatives mentioned give patients access to medicines in this country as soon as in any other healthcare system. On that basis, the industry will be prepared to understand that not just the NHS but the Government will look to get some pretty cost-effective prices out of it.

Now I do not happen to think that it is NICE’s job to make that relationship happen. I happen to think that NHS England is increasingly equipped to be a central player in this process. It should sit alongside NICE when it carries out health technology assessments in what is effectively a trialogue with the industry and say, “Well, how can we ensure that the patient has access to this medicine, and at what price? Can NICE act as the referee to establish whether the price and the incremental benefit are reconciled to be cost effective for the NHS?”

We should build that into the system over the next 18 months so that, when we start the new scheme in January 2024, the system is understood to work. It should not depend on large-scale transfers of money, with overpriced new branded medicines on the one hand being recycled back to the NHS to go into the innovative medicines fund on the other. This tracking of money around the system is not the best way to make it happen. We should aim for the industry to be paid what the health technology assessments and the NHS budget requirements mean is a fair price for the medicines it is providing—and that is what the industry should expect.

Everybody should be working to arrive at a position where, when a medicine obtains authorisation—in other words, when it is deemed safe, clinically effective and of good quality—and a clinician recommends it for a patient, the patient should have access to that medicine through the NHS. That is what we are aiming for. It has not always been true, but it ought to be in the future. We need a system that people, including clinicians in the NHS, understand and that supports their ability to prescribe medicines in that way.

My Lords, I do not intend to speak about this for very long, because I feel that I am the least well-equipped person in the whole Chamber to do so—possibly with the exception of the Minister, which is often the way and is how I felt when I was a Minister; I would stand up to speak about research and other huge subjects and everybody else in the Chamber who had spoken certainly knew a lot more than I did, and that is the case here.

Noble Lords may recall that the starting point at Second Reading and in Committee was that there was no place for research in the Bill at all—so I congratulate noble Lords who picked this up and ran with it, and, indeed, the Minister and the Bill team on taking it on board and producing these amendments. That is helpful; as the noble Lord, Lord Kakkar, said, it is about the future and it is exactly the right thing to do.

I also agree with the noble Baroness, Lady McIntosh, and my noble friend Lord Hunt in their disappointment on the issue of NICE. They are quite right about the access and availability of medicine and devices to healthcare practitioners and that the system is still uneven; also, of course, nobody is asking how we are doing and whether it is working. It is a shame that these aspects have not been included in the Bill, but I suspect that the noble Baroness and my noble friend will probably live to fight another day.

My Lords, I am grateful to all noble Lords who have spoken thus far in this debate. I also thank the noble Baroness, Lady Thornton, for expressing her confidence in my ability to understand these issues; I fear that she may be right.

Turning first to Amendment 29, it is firstly important to note that it is the MHRA, not NICE, that licenses these medicines in the UK. NICE makes recommendations on whether the price that the NHS pays for treatments represents value for money. Access to effective new treatments for NHS patients is a priority for the Government. That is why we have committed to maintain the funding requirement for NICE appraisal of recommended treatments.

The standard contract also stipulates that providers must ensure that formularies include all NICE appraisal-recommended treatments. NICE’s guidance on developing and updating local formularies also clearly states:

“When a NICE technology appraisal recommends a medicine, adopt the medicine into the local formulary automatically, if clinically appropriate and relevant to the services provided by the organisation. This process should take place within 3 months.”

I believe that this represents a robust legal framework for ensuring compliance with NICE’s appraisal decisions. A stronger legislative requirement to include all NICE-recommended treatments on formularies within 28 days of a NICE decision would remove any flexibility both to vary the timescale where there are barriers to implementation, or where a product was not relevant to a particular organisation.

Turning to Amendment 171, NICE rightly operates independently from the Government, and key to this is setting its own procedures for developing guidance and recommendations. This includes setting its own discount rate, taking into account the wider policy and fiscal implications. NICE recently carried out a comprehensive review of its methods and processes for making appraisal recommendations, and the changes that NICE is introducing will ensure that its processes are fairer, faster and more consistent. I assure noble Lords that NICE already aims, wherever possible, to make timely recommendations on new medicines with draft guidance around the time of licensing, and final guidance within three months of licensing. However, NICE’s ability to issue guidance depends on an evidence submission from the manufacturer. It would not therefore be appropriate to place a requirement in legislation for a specified timeframe when that is dependent on other organisations.

This amendment would also require NICE to take account of a company’s membership of the Voluntary Scheme for Branded Medicines Pricing and Access, or the statutory scheme, in making its recommendations on medicines. These schemes have a very different purpose from NICE appraisals, which ensure that new medicines are clinically and cost effective, and they are time-limited, so would create significant disparities between medicines launched at different times.

I turn now to Amendment 178. I hope I can assure the noble Lord that arrangements are already in place to regularly review and monitor delivery against priorities and objectives, including through accountability meetings, engagement with external partners and public board meetings. The Government believe that regular monitoring through existing arrangements is the right approach and do not consider that a requirement to carry out a review is necessary. I assure the noble Lord that the changes recently introduced by NICE will make its methods and processes fairer, faster and more consistent, will ensure that they are suited to new and emerging types of technology, and will provide more equitable access for those with severe diseases. The vast Majority of cancer medicines covered by the previous end of life flexibilities would also be covered by the severity modifier.

Placing requirements on NICE through primary legislation to use specified processes would fetter its independence to determine its own methods and processes, and it would be unfair to operate two different approaches at the same time. The amendment proposed by the noble Lord could also impact negatively on cancer medicines that were not eligible for the end-of-life flexibilities in their first appraisal but may be eligible for the severity modifier.

I will now turn to a couple of specific questions, one of which was about the uptake of medicines in the UK. The NHS is legally required to fund NICE-recommended treatments, normally within three months, and this requirement will apply to ICBs once established. Differences in healthcare systems between different countries—in commissioning, disease prevalence and population demographics—make any direct comparison of uptake difficult, and the speed at which innovation is taken up is not the only effective measure of quality of care.

However, we are committed to making the UK one of the most pro-innovation healthcare systems in the world, and we have made some real progress in recent years. Noble Lords have mentioned the Accelerated Access Collaborative, which was established to support the appropriate uptake of NICE-recommended medicines and devices, as my noble friend Lord Lansley said. In 2019-20 alone, the AAC helped more than 2,500 innovators to develop their cutting-edge products and launch them in the NHS. Nearly 750,000 patients have benefited from access to these products, and they spent around 125,000 fewer days in hospital as a result.

I should add that NICE is the independent body responsible for methods and processes. NICE’s consultation stated that there is an evidence-based case for changing the discount rate to 1.5%, but it acknowledged the wider policy and fiscal implications and proposed to maintain the existing reference case discount rate while further data is collected on the likely effects of a change to the discount rate. NICE’s changes are in line with the department’s expectations for the review as set out in the VPAS agreed with industry. It is important to recognise that any changes to NICE’s methods could have financial impacts beyond the duration of the current VPAS.

On the postcode lottery, we have reporting tools at our disposal to monitor the use of innovative medicines and products. NHS Digital publishes a biannual report on the use of innovative medicines by the NHS in England, known as the innovation scorecard. The latest publication, from June 2021, shows that uptake of more than 70% of NICE-approved medicines reported in the scorecard has increased over the past 12 months. We are committed to further strengthening these innovation metrics and to improving our understanding of the use of innovative medicines and medicinal products within the NHS.

It is for these reasons that I ask noble Lords not to press their amendments when they are reached.

Amendment 4 agreed.

Clause 5: NHS England: wider effect of decisions