Moved by
Lord Kamall Portrait Lord Kamall
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That the House do now resolve itself into Committee.

Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, before we formally move into Committee on the Health and Care Bill, I will raise a matter of general importance about the parliamentary process upon which we are embarked and seek guidance from the Government about a serious matter which is of immediate concern in the parliamentary process we are currently undertaking. I have no wish to delay proceedings so I will get to the point.

In August, the Government and NHS England issued a Readiness to Operate Statement guidance and checklist to all the relevant parts of the NHS concerning planning for the forthcoming legislation. On 19 January this was updated concerning the ICB establishment timeline, regarding the implementation date for the legislation moving from April to July. The words “subject to parliamentary process” may have been included in the guidance but the actions which flow from the NHS England guidance are contrary to those words. For example, it seems that the latest advice from the Government and NHS England confirms deadlines for appointments of leaders, chairs and boards, many of whom have been appointed, possibly involving the spending of public funds, long before the Bill has completed its passage through Parliament. Indeed, there are many other matters which are still subject to parliamentary process. This is pre-emption of parliamentary process.

The issues in the guidance are at the forefront of the Committee’s deliberations and it is possible that much may have changed before the Bill receives Royal Assent. Our scrutiny in your Lordships’ House is important, not least because both the Constitution Committee and the DPRRC have been highly critical of the Bill and the department. They have stressed the importance of the Bill receiving sufficient scrutiny, since it did not have pre-legislative scrutiny and is significant “disguised legislation”, including more than 60 delegated powers and directions which have no parliamentary process at all.

Noble Lords will be familiar with the rules governing preparation for the enactment of legislation. After Second Reading of a Bill, some work may be undertaken, but guidance from Her Majesty’s Treasury in May 2021 is very clear what actions can and cannot be taken. Box A2, point 4C, refers to:

“Expenditure which may not normally be incurred before royal assent.”


First, there is,

“significant work associated with preparing for or implementing the new task enabled by a Bill, eg renting offices, hiring expert consultants or designing or purchasing significant IT equipment”.

Secondly, there is,

“recruitment of chief executives and board members of a new public sector organisation”.

Thirdly, there is,

“recruitment of staff for a new public sector organisation”.

We understand that NHS England was advised by others not to issue this guidance. Will the Government confirm that: first, the legitimate role of this House in the scrutiny of legislation should be made clear to NHS England; secondly, the current guidance will be withdrawn and it will be made clear to NHS England that further action must await the completion of the Bill and Royal Assent; thirdly, it will be made clear that aspects of the changes within scope of the Bill can and may well be amended; fourthly, that adequate time will be allowed for proper scrutiny of the Bill? I shall be referring the guidance to the two said committees. If the Minister is unable to provide a response today, please can he confirm that he will respond in writing by the end of the week; otherwise, we will need to raise this again in your Lordships’ House?

Lord Kamall Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Kamall) (Con)
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I start by thanking the noble Baroness for giving me advance notice of her intervention today. It clearly reflects the mood and concerns of the House that we heard last week. We recognise the strength of the House’s feeling on this matter. I have spoken to my department, and it told me that it is meeting NHS England this week to discuss this matter, and I will update the House accordingly. On the request that the noble Baroness made, I commit to write to her.

Motion agreed.
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None Portrait Noble Lords
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Oh!

Lord Kamall Portrait Lord Kamall (Con)
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The noble Lord has recovered.

Baroness Harding of Winscombe Portrait Baroness Harding of Winscombe (Con)
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I am sorry—the noble Lord, Lord Patel, is here. I meant to say the noble Lord, Lord Bethell. I apologise for my senior moment.

I will begin again. I rise to speak on behalf of my noble friends Lady Blackwood and Lord Bethell, neither of whom is in their place. I should, out of an abundance of caution—particularly given how well I have spoken so far—declare the interests of both my noble friend Lady Blackwood and me, as the present and past chairs of Genomics England.

In speaking to Amendments 79 and 196, we wish to support the noble Lords, Lord Sharkey, Lord Kakkar and Lord Patel, in calling for trusts and integrated care boards to have a duty to conduct research and to report on the steps they have taken to deliver it. We know that there are excellent research-active NHS organisations in the UK, ranging from our acute tertiary university hospitals, such as Oxford, to our district general hospitals, such as Portsmouth.

There are many initiatives to promote research, such as Saving and Improving Lives: The Future of UK Clinical Research Delivery, which sets out a bold and exciting vision. In particular, my noble friends and I await with interest the Find, Recruit and Follow-up service, which plans to use digital tools to identify patients who may be suitable subjects for research. When speaking to patients, one of the refrains that we all hear most often is that they find it hard to find suitable clinical trials, and we welcome any initiative that can make it easier for patients to take part in clinical research.

As well as supporting patients in finding trials, we need to make it as easy as possible for them to participate. In some cases, the pandemic has accelerated a move towards remote monitoring tools—wearables and other devices that allow individuals to participate in trials while reducing the number of visits they have to make to hospitals. We welcome the NIHR remote trial delivery toolkit, which makes recommendations on how some of these positive practices can be continued and so broaden participation and promote patient retention in a beneficial way.

My noble friend Lady Blackwood, as a rare disease patient herself, knows that clinical research is often the only way for patients to get access to innovative treatment. Yet we are saddened to see, in the annual NIHR publication on initiating and delivering clinical research, that some trusts are still not delivering trials every quarter. We continue to see a large disparity in the number of trials being offered in each trust, which leads to a postcode lottery. Those individuals fortunate enough to be under the care of a research-active hospital have an increased chance of being recruited on to a trial, and therefore have better outcomes than patients under the care of less research-active hospitals.

Patients admitted to more research-active hospitals also have more confidence in staff and are better informed about their condition and medication. And as the noble Lord, Lord Davies of Brixton, has said, there is very clear evidence that research-active trusts deliver better outcomes—in part, I am sure, because of their ability to retain and energise staff, as the noble Lord, Lord Kakkar, has mentioned.

The last couple of years, however, have been challenging for the health research community. In 2020, the Association of Medical Research Charities predicted a £320 million shortfall in research spending, forcing many medical research charities to make tough choices about which projects to prioritise. Data also suggests that the UK has been slower to return to pre-pandemic levels of commercial clinical research compared with other European countries.

The Life Sciences Vision sets out the Government’s objective to be a science superpower, but this requires research to be embedded in every part of the NHS, including primary, community and mental health services. That will happen only if NHS organisations, including the new integrated care boards, have a duty to conduct research, as these amendments propose.

In addition, we all know that what gets measured gets done, which is why these amendments place a duty on trusts and ICBs to report the steps that they are taking to deliver clinical research in their annual reports or forward plans. This not only enables progress to be tracked but helps patients understand what research is being done in their area and will encourage NHS organisations to invest in research that meets the needs of their local communities and—

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Baroness Merron Portrait Baroness Merron (Lab)
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My Lords, I am grateful to noble Lords for putting forward these amendments, all of which seek to strengthen the Bill and build on what the noble Baroness, Lady McIntosh, opened with: the need for clear lines of responsibility and for a joined-up strategy—in other words, for us to get to the point that we are looking for.

My noble friend Lord Hunt spoke of the embodiment, perhaps, of that through a chief innovation officer, who could be a reminder—not on their own—of the need to build in research and innovation as core throughout commissioning. I am sure that the Minister has heard that this debate is a cry for us to embed in the Bill and in our NHS not just a requirement for but a delivery of research and innovation to the appropriate standard to serve the country. It will not just happen on its own.

We have seen significant variation of opportunity for patients to engage in research and disparities in participation reported on geographic and socioeconomic lines, by ethnic origin and across different disease areas. This is due to the fact that the NHS has been unable to prioritise resourcing and delivery of research, which has been a particular feature over the past decade.

In the Bill, we have a major opportunity to embed a research-active culture—words used by the noble Baroness, Lady Harding—within the NHS which could build on the response to Covid-19, which the noble Lord, Lord Patel, emphasised. That response saw more NHS sites, staff and patients engage in research than ever before. Let us not waste this opportunity.

The Bill offers little different to the Health and Social Care Act 2012, which also did not and does not mandate clinical research activity, stating just a duty for clinical commissioning groups “to promote” research. Your Lordships will notice the similarity in wording in the current Bill. The noble Lord, Lord Sharkey, is quite right, as are other noble Lords, to speak of the weakness of just using the words “to promote”. This set of amendments is about how we make it actually happen. The amendments are about mandating integrated care boards to conduct research and to monitor and assess innovation, because without that, it will just not happen.

Legislation is indeed a critical element, but it is important to stress that it must be accompanied by the necessary infrastructure: for example, through staffing levels—to which we will return in our next debate—research capability, digital resources and tools and access to services, as well as efficient trial approval processes, the ability reliably to recruit patients, the offering of guidance and, of course, dedicated staff time for research. All of those will make the legislation actually mean something.

As well as a strengthened legislative mandate which moves beyond the current duty simply to promote research, it would support patients, clinicians and NHS organisations across the country to have equal access to the benefits brought about by research participation. This will be better for patients, give greater staff satisfaction and deliver economic benefits not just for the NHS but for the broader economy. The noble Lord, Lord Kakkar, talked about the life sciences being a major player as a contributor to our economic well-being and prosperity in this country—something also emphasised by my noble friend Lord Davies.

Such a mandate would also ensure support for levelling up and make it possible to address health inequalities. This in turn would support the ambition set out in the Government’s clinical research vision: to make access and participation in research as easy as possible for everyone across the UK, including those in rural, diverse and underserved populations. I hope the Minister will take the opportunity to reflect on the points made in this debate, because this group of amendments provides an opportunity to strengthen the Bill to actually deliver.

Lord Kamall Portrait Lord Kamall (Con)
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Like many of the debates on this Bill in Committee, this has been a fascinating one. It has been really interesting to hear from experts who themselves have engaged in clinical research. I start by thanking my noble friends Lady McIntosh of Pickering and Lady Blackwood and the noble Lords, Lord Sharkey and Lord Kakkar, for bringing this debate before the Committee today. I also thank the noble Lord, Lord Howarth, for his points about the arts and social prescribing.

Before I turn to the amendments, perhaps I could make two personal reflections. One is from my early academic career as a postdoctoral research fellow. I saw the benefit of taking the results of my research directly into my teaching. It made the courses more dynamic—it was not just a repeat of last year’s slides for this year’s students—and it showed what progress we were making in that field of research.