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Health and Care Bill

Volume 818: debated on Wednesday 26 January 2022

Committee (6th Day) (Continued)

My Lords, the noble Baroness, Lady Brinton, will be speaking remotely in this debate. I should also alert the Committee that, should this amendment be agreed to, I will not be able to call Amendment 163 by reason of pre-emption.

Amendment 162A

Moved by

162A: Clause 26, page 37, leave out lines 23 to 30

Member’s explanatory statement

This amendment, along with another to this Clause, would remove the power of the Secretary of State to set, and from time to time revise, objectives and priorities for the CQC, but would require the CQC to consult the Secretary of State when it revises indicators of quality for the purposes of assessments under subsection (4).

My Lords, the purpose of Clause 26 is to introduce a process by which the Care Quality Commission inspects integrated care systems. The structure of this is the subject of my Amendments 162A and 164A. Those two amendments go together—they are not separate, but entirely linked. The purpose of Amendment 162A is to remove the process by which the Secretary of State sets objectives and priorities for the Care Quality Commission in undertaking such inspections of integrated care systems; Amendment 164A then seeks to insert a process by which the Secretary of State, and indeed others, are consulted by the Care Quality Commission over the quality indicators that it would use to assess the quality and performance of integrated care systems.

A bit of background would be helpful for noble Lords in this respect. Think back to what the Care Quality Commission’s existing statutory arrangements are in relation to reviews and performance assessments of existing bodies in the National Health Service. The structure is very straightforward. The commission is asked to set quality indicators, to consult on those and then to review against them and produce reports. I know from personal experience that the Secretary of State cannot direct the Care Quality Commission to undertake a particular review, but they can certainly make a request, and their role as steward of the whole healthcare system has certainly led Secretaries of State to do that from time to time. But the legislation does not permit the Secretary of State to direct the Care Quality Commission in how it does its job; it is an independent body corporate. There is intrinsic merit in the Care Quality Commission, as an inspectorate, operating independently. The structure of this clause in this Bill is at odds with the way in which the existing legislation is structured in the 2008 NHS Act as amended. The effect of these two amendments would be to restore the independence of the Care Quality Commission in undertaking its activities and in the way in which it goes about its job.

The Government’s drafting of the legislation is wrong anyway. There are references to objectives and priorities. The priorities are referred to in new subsection (3), inserted by Clause 26(2), which says that they

“must include priorities relating to leadership, the integration of services and the quality and safety of services.”

I have to say that this is teaching grandmothers to suck eggs. There is no way in which the Care Quality Commission is not going to incorporate such indicators of quality. We know that from the generic nature of the quality indicators that it uses generally for existing NHS bodies. The reference to setting objectives is not only novel but completely undefined. The Secretary of State can set whatever objectives they wish to; we do not know what they are and there is no indication of what they might be. Taking out references to objectives and priorities seems to me to be a very good thing.

As it happens—I declare my own role in this—in the 2012 legislation there was previously a process by which the Secretary of State set standards for the Care Quality Commission in determining what the quality indicators should look like. We actually took that out of the 2012 legislation, precisely on these grounds: that the Care Quality Commission is, and should be, as independent as possible.

I think this clause proceeds from the mistaken apprehension that the Care Quality Commission is a part of the management process of the NHS. It is not. If the Secretary of State wishes integrated care systems to proceed in any particular way, the Secretary of State has the means to do so available via the mandate; the Government plan to add specific powers of direction; and NHS England has duties that go in exactly the same direction. The Care Quality Commission is not part of the management process for integrated care systems; it is an inspectorate. If—and this is a risk we must avoid—the Secretary of State were directly intervening to set objectives for integrated care systems to be inspected subsequently by the Care Quality Commission, whereas NHS England is itself setting objectives for integrated care systems through its responsibilities and duties, those two may come into conflict.

For all those reasons, the Government would be well advised to accept these two amendments and put the Care Quality Commission into the independent role in relation to ICSs that it, and people working in the National Health Service, would recognise as being its role. I beg to move.

My Lords, the noble Lord, Lord Lansley, has set out the tensions underlying the Bill about returning to the Secretary of State powers over independent, arms-length bodies; specifically, in this amendment, the inspections carried out by the Care Quality Commission in its role as a regulatory body. He rightly reminded us of the current arrangements, which give the CQC the ability to set its indicators and which, frankly, work well. I will not repeat his arguments, except to say in a slightly wider context that almost every piece of legislation brought to Parliament by this Government has given Ministers more powers—including, as in Clause 26, the power to intervene and to change remits.

The noble Lord’s amendments maintain the independence that the CQC—and other regulatory bodies—need to be able to inspect and make rulings without fear of favour or influence from politicians, while ensuring that the CQC must consult the Secretary of State when it revises indicators of quality for the purposes of assessment. That seems to me to provide the requirement for the CQC and the Secretary of State to engage in dialogue, but without the political intervention outlined in Clause 26(2) and (5).

Can the Minister explain why the Government feel the need to remove the independence of the CQC—whether this is an issue of management, as the noble Lord, Lord Lansley, said—and how giving the Secretary of State these powers can maintain the independence of a regulatory body?

My Lords, it is essential that we get the arrangements for the Care Quality Commission right throughout the Bill, and I am grateful to the noble Lord, Lord Lansley, for trying to do that through these amendments. If the health and social care provided is to be of the highest standards, we must ensure, through the powers of scrutiny and review in your Lordships’ House, that we enable the watchdog to have the proper tools and framework to achieve that, so I support the amendments.

As the noble Baroness, Lady Brinton, emphasised, this is about putting the responsibility in the right place to ensure that a key inspectorate can do an independent job and support proper integration and delivery. I hope the Minister will accept the good sense in these amendments.

Can I briefly ask my noble friend whether part of the thinking behind the current wording might be that the remit of the CQC may need extending? For example, when it comes to private operators of social care, the CQC currently does not have the power to look at the financial stability of those operators. Is this provision perhaps based on the thought that the Secretary of State may need to widen the remit and powers of the CQC? If not, we will be returning to this at some point.

My Lords, I thank my noble friend Lord Lansley for bringing this debate before the Committee. He has made some worthwhile points but I hope to be able to explain why I think his amendments should not be pressed.

My noble friend Lady Altmann is not quite right in what she suggested was the intention of Clause 26. Clause 26 will allow the CQC to look across the integrated care system to review how integrated care boards, local authorities and CQC-registered providers of health, public health and adult social care services are working together to deliver safe, high-quality and integrated care to the public. That will include the role of the integrated care partnership. These reviews serve several functions. They will provide valuable information to the public, help drive improvement, and review progress against our aspirations for delivering better, more joined-up care across the system.

These amendments would remove the requirements on the Secretary of State to set and approve the priorities for these reviews. They would also remove the Secretary of State’s ability to direct the CQC to revise the indicators of quality that it will determine for these reviews. Instead, the amendments would add a requirement on the CQC to consult on those indicators with the Secretary of State, prescribed persons and other persons considered appropriate.

I entirely see where my noble friend is coming from as regards the CQC’s independence, but I must tell him that we have thought about this issue very carefully and we think it is right that the Secretary of State, who is accountable to Parliament, should have the flexibility to set the overall strategic direction of these reviews, with priorities and objectives. That is not an open-ended facility. In the other place, we accepted an amendment to develop this further by making it clear that the priorities set by the Secretary of State must relate to leadership, integration, and quality and safety. The amendment would remove that certainty.

As I have already mentioned in previous debates, there will be quite a range of different forms of accountability and oversight within the system, including NHS England’s role in overseeing ICBs. As a result, we think that the Secretary of State should play a strategic role to ensure that the CQC reviews complement the other oversight and accountability mechanisms. This will be achieved, in part, through the Secretary of State’s approval of the quality indicators. To provide my noble friend with an analogy, we believe, as I am sure he does, that there is a proper role for the Secretary of State in setting the strategic direction of NHS England. He does this, of course, through the mandate.

Finally, the drafting of this clause is not an accident. It is drafted deliberately to protect the independence of the CQC in how it operates, while also encouraging consultation and collaboration. It will allow the CQC to develop its approach in collaboration with NHS England and other partners in the system. The CQC is already intending to develop its approach to these reviews co-operatively and is able to consider a wide range of views in doing so. We do not think it is necessary to require it to consult.

I hope this has given my noble friend some reassurance as to why we have taken the approach we have and, for these reasons, I ask him to withdraw his amendment.

I am grateful to my noble friend for that explanation, which, I am sorry to tell him, wholly fails to provide reassurance. First, he was wrong, in the sense that he maybe implied that my amendments would have removed the Secretary of State’s requirement to approve the indicators on which the commission chooses to base its reviews. That is left in at new Clause 46B(4)(b), so the approval of the Secretary of State for the indicators would remain. What is being taken out by my amendments is the requirement for the Secretary of State to set objectives and priorities. I am afraid that everything that my noble friend said went to support my view that there is an erroneous perception on the part of the Government that the CQC must be turned into an integral part of the management of the NHS and the integrated care system. That is simply not the case.

I am grateful to the noble Baroness, Lady Brinton, for her support. I quibble with her slightly in a pedantic way. We should not talk about the CQC as just another regulator; it is the inspectorate. In my experience, inspection should never be regarded as a substitute for management. Quality is integral to the management of the service. The CQC is there to determine and review whether that quality is being achieved, which is why I am perfectly happy for the Secretary of State, and indeed others, to be consulted and for the Secretary of State to approve the indicators of quality that the CQC arrives at. Frankly, however, for the Secretary of State to go further and start to prescribe the way the objectives of the CQC are set in this way is directly at odds with how the CQC reviews and reports on other NHS bodies. I can see the drift of this. If we accept it, we will end up with the CQC being told by the Secretary of State what its indicators of quality are for every NHS body and setting objectives and priorities for the CQC right across the board, which is completely at odds with the independence of the CQC.

I shall make one final point. I am grateful to my noble friend Lady Altmann. Exactly the same argument applies to Clause 137, although I have not tabled amendments to it. It creates the CQC’s additional scrutiny and performance assessment of social care functions. We should therefore come back to precisely the point that she is talking about, as she suggests.

I hope my noble friend the Minister will take my point and that we might have further conversations between now and Report. However, I have to tell him that it is not just me who raises these points; I have been asked by representative bodies within the NHS to do so. We should take them seriously and hope that between now and Report we might see whether there are better ways to structure Clause 26 to secure both the Government’s objectives and what the NHS would expect to happen. I beg leave to withdraw the amendment.

Amendment 162A withdrawn.

Amendment 163 not moved.

We come to the group beginning Amendment 164. The noble Baronesses, Lady Brinton and Lady Masham, will be contributing remotely to this debate.

Amendment 164

Moved by

164: Clause 26, page 37, line 35, at end insert—

“(4A) The indicators of quality set by the Commission under subsection (4) must include—(a) whether national standards in the care of people with rare and less common conditions are being met;(b) whether the views of patients with rare and less common conditions are being represented;(c) whether people with rare and less common conditions have access to a named clinical nurse specialist.”Member’s explanatory statement

This amendment would require integrated care boards to be assessed by the Care Quality Commission on the provision of care for people with rare and less common conditions, in particular.

My Lords, Amendment 164 heads this wide-ranging group and probes how the proposed Care Quality Commission rating system for ICBs’ work in practice, with a particular focus on rare and less common conditions, although this debate is more broadly relevant to all aspects of the CQC’s role.

Amendments 178 and 240 from the noble Lord, Lord Sharkey, to which I have added my name, also relate to people with rare diseases and their access to innovative medicines and medicinal products, and the general need for awareness-raising about those conditions among health and social care staff. I remind the Committee of my role as vice-chair of the Specialised Healthcare Alliance. The noble Lord will speak to those amendments later.

The group also covers amendments on wider care and safety issues that impact on patients, including ensuring that liothyronine T3 is available to patients when it is prescribed by a doctor and the regulation of healthcare and associated professions. This includes safeguards to apply under the Secretary of State’s power to alter the professional regulatory framework; protecting the use of the title “nurse”; hospital food standards for patients and training for staff; reviewing the surgical consultants’ appointment process; and licensing aesthetic non-surgical cosmetic procedures in registering cosmetic surgery practitioners.

The noble Lords who have their names to these amendments will speak to them, so I will leave them to it and concentrate on my rare disease issues and the matters that our Front Bench team have added their names to. Returning to the CQC, and following on from the previous debate on Clause 26, on the amendment tabled by the noble Lord, Lord Lansley, regarding the role of the Secretary of State in setting objectives and priorities, overall, we welcome the extension of the CQC’s remit to ICBs but now need to understand how it will work in practice.

As it stands, the Bill establishes an overarching framework under which the CQC will need to determine for itself the quality indicators against which it will assess ICBs. My amendment raises the issues about the quality indicators relevant to those with rare and less common conditions. If the purpose of the rating system is to protect patients, it must help to ensure that national standards of patient care, where they exist, are being met. Under the NHS’s plans to jointly commission or delegate commissioning responsibility for specialised services to ICBs, set out in NHS England’s Integrating Care paper, an important assurance given is that specialised services will

“continue to be subject to consistent national service specifications and evidence-based policies determining treatment eligibility.”

Will the CQC ensure that services organised by ICBs are organised in line with these national specifications?

Moreover, people with rare diseases are concerned that if services are to be commissioned in some way by ICBs in future, rather than just NHS England, their voices may be lost. NHS England’s specialised commissioning team meets regularly with representatives of the rare disease community, including the SHCA, and it is important that ICBs can hear their views too. How will this happen and how will the CQC rating system act to ensure that this happens?

Finally, one of the key asks of patients with rare diseases to help deliver continuity in their care is that they have access to a named clinical nurse specialist, which is commonplace for patients with more common conditions. That continuity of care is an important marker of quality. Will the CQC rating system help to deliver it?

Beyond these questions are broader ones. If the bulk of the CQCs work will continue to focus on inspecting providers, can the Minister explain how it will ensure that its ICB ratings are not unnecessarily duplicative, given that providers will form part of ICBs? Also, the CQC looks at whether services are safe, effective, caring, responsive and well led. Given that the first three of these should continue to be the primary concern of those providing care, rather than of the ICBs organising it, how will the CQC ensure that the new rating system clarifies rather than dilutes this accountability? How will the CQC’s work align with the wider performance management of ICBs undertaken by NHS England? How specialised services will operate is a complex area and I am happy for the Minister to write to me on some of the specifics of my questions.

As I said, I will speak briefly to other amendments in this group, to which Labour Front-Benchers have added their names. Amendment 243, tabled by my noble friend Lady Merron, covers the important issue of the protection of the title “nurse”, and is supported by three respected medical and healthcare professionals whose contributions I look forward to. The recent Health Service Journal survey found hundreds of roles that do not require Nursing and Midwifery Council registration but use “nurse” in the job title. While “registered nurse” is a title protected by the NMC, “nurse” is not. The term may be used by anyone in the UK to offer professional advice and services, and people with no nursing qualifications or experience, or who have been struck off the professional register, may use it.

Obviously, this is worrying and even dangerous—a dangerous trend which potentially compromises patients’ health. What progress is being made on the Government’s review of healthcare professional regulation following their consultation last year? Surely we must follow the example of other countries, such as France and Australia, in giving the consistently most trusted profession in the UK the recognition and protection that it deserves.

My noble friend Lady Thornton has added her name to Amendment 258, from my noble friend Lord Hunt, to the welcome new Clause 145, on hospital food standards. It underlines the importance of investment in the food served to patients in hospital and other care and treatment settings. It is welcome because it specifies food quality and standards and stresses the importance of recognising staff skills, experience and training, as well as ensuring investment in NHS kitchens and catering equipment to ensure that the highest standards can be maintained.

On Amendment 266 from my noble friend Lady Merron, we seek to give the Secretary of State power to introduce a licensing regime for aesthetic non-surgical cosmetic procedures and to introduce an offence of practising without a licence. This area is crying out for regulation. The Department of Health’s own report has said that non-surgical interventions which can have major and irreversible adverse impacts on health and well-being are almost entirely unregulated. We fully recognise that this is also a highly complex policy area. However, I understand that noble Lords concerned about this issue had constructive and positive discussions yesterday with the Minister, and I look forward to the Minister updating the House on the scope and discussions of the Government’s ambition in this important area.

Finally, I offer my strong support for my noble friend Lord Hunt’s Amendment 176, which seeks to ensure that the general powers of the Secretary of State to direct the functions of NHS England include ensuring that when T3 is prescribed to patients with hyperthyroidism, the drug is made available to them. My noble friend rightly raises this issue at every opportunity, and I hope the Minister will have a bit of good news for him today and tell us that some real progress has been made. It is clear that many thyroid patients would benefit hugely from the declassification of T3 as a high-cost drug, back to a drug that is routinely prescribed in primary care. It is much cheaper now, and the many patients who were taken off the drug and continue to be denied it need to have it restored. The Government must ensure that the now updated NICE guidelines which reflect this new position are implemented consistently across the new NHS structures, rather than repeat the record of the nearly 50% of CCGs which failed to ensure that the drug is properly prescribed.

I will leave it at that, and I look forward to the debate.

I remind the Committee that both the noble Baronesses, Lady Brinton and Lady Masham, will be contributing remotely. I call the noble Baroness, Lady Brinton.

My Lords, I have signed two amendments in this very wide-ranging group. The first, in the name of the noble Lord, Lord Hunt, is Amendment 264 on the appointment of surgical consultants. As the noble Baroness, Lady Finlay of Llandaff, said in your Lordships’ House recently, 48% of advertised consultant posts last year went unfilled. Given our discussions about the workforce earlier this week, we need as many posts filled as possible and to remove any bureaucratic barriers to so doing.

Part of the problem at the moment is that trusts are having difficulties establishing appointment panels which can make these consultant appointments. Currently, the rules are too tightly drawn in the National Health Service (Appointment of Consultants) Regulations 1996 and the subsequent 2005 guidance. The members of all the royal colleges across the UK have a wealth of expertise, but the current legislation says that only members of English royal colleges can help trusts fill their appointment duties. In its helpful briefing, the Royal College of Surgeons says that the Royal College of Emergency Medicine, the Royal College of Physicians and Surgeons of Glasgow and the Royal College of Physicians of Edinburgh are excluded from being eligible to join these panels. This amendment would be a simple remedy and speed up the appointment of much-needed consultants, and I do hope that the Minister can agree to it.

I have also signed Amendment 266 in the name of the noble Baroness, Lady Merron, on the urgent need to ensure that practitioners undertaking non-surgical aesthetic procedures such as lip fillers, injectables, thread lifts, semi-permanent make-up, laser treatments, piercings and tattoos are properly trained and licensed. These treatments are easily available to members of the public, but without the safeguards required when being carried out in the health sector. I am afraid that we see daily in the press and media reports on the many problems when treatments go wrong, which can include infection, disfiguration and burns, among other serious issues. When treatments do go wrong, it is usually the NHS that has to pick up the pieces, so I believe it is very much in the interests of the Department of Health and Social Care to accept this amendment.

The signatories to this amendment have been working with the Chartered Institute of Environmental Health, alongside a coalition of public health organisations and industry representatives, so that we can make sure that a licensing scheme can be introduced for all non-surgical aesthetic procedures. This will enable the setting of appropriate standards, a level playing field for practitioners and, importantly, protect consumers in this sector.

My Lords, I shall speak to Amendments 178, 266 and 293. Amendment 178, which was tabled by the noble Lord, Lord Sharkey, is important for people with rare and less common diseases. The amendments could be a lifeline for people who have rare conditions who use products that may be the only substances that work. There is an enormous selection of rare conditions. It can be a desperate situation when some medicines are developed but take a long time to be given the all-clear by NICE. Some medicines are not available in England on the National Health Service but are available in other countries, sometimes even in Scotland. That is devastating and frustrating.

I support Amendments 266 and 293, on the cosmetic surgery industry, which must be made safer. It is extraordinary that this business is only partially registered. Many people who have such a procedure take for granted that the practitioner will be registered and fully insured. There have been some disastrous results when things go wrong with a beauty procedure. I know of some plastic surgeons who work only in the National Health Service, as they do not want to be tarred with the same brush as uninsured cowboys. Amendments 266 and 293 deal with a wide selection of cosmetic procedures, some of which are psychologically important to many people. There is wide interest in making this trade safe and getting it registered. I hope the Minister realises that this is an important matter that needs putting right.

My Lords, I have Amendment 176, the second amendment in this group, and two other amendments. I shall start with Amendment 176 which is concerned with the treatment of thyroid patients who continue to be denied liothyronine, otherwise known as T3, as the most appropriate treatment for them. For some patients, the standard treatment is not effective. T3 has proven to be a much better treatment, but tragically, a few years ago the manufacturers grossly inflated the cost of T3 by a massive 6,000%. Understandably, NHS England and its associated prescribing advising machinery strongly discouraged the use of the drug and, as a result, many patients had T3 withdrawn and suffered quite considerably or had to fund it privately or source it from abroad. Happily, the price of T3 has come down by 75%, although it could go down further, but I believe it is no longer categorised as a high-cost drug.

The problem is that clinical commissioning groups still treat it as a high-cost drug, so the situation is still very difficult for patients who need it—those for whom the standard treatment is not appropriate. The current guidance states that T3 can be prescribed to patients who have unresolved symptoms on the standard treatment if it is initiated or confirmed following a review by an NHS consultant endocrinologist. A statement in July 2021 restated NHSE guidance, but it has not been followed by clinical commissioning groups. A survey done recently by UK thyroid charities, to which I pay huge tribute, says that 44% of CCGs have not fully adopted the national guidelines or are wrongly interpreting them.

What are we to do? What is the situation here, where we have clear guidance that is not being followed? This goes back to our previous debates about the various mechanisms being brought in to ration treatments, against national guidance or technology appraisal advice from NICE. It is the same issue. I am not expecting the Minister to issue a direction but I am expecting him to tell CCGs and, in future, integrated care boards to get off their backsides, start implementing the guidance properly and realise that this is no longer such a high-cost drug. I appeal to him to do something about that.

I also hope that the Minister will do something about hospital catering. I confess to your Lordships that I am president of the Hospital Caterers Association, where I work very closely with some great professional staff who have to work with their hands tied behind their back. Often they do not have the resources to provide the high-quality food that everyone wants and expects.

During Covid we saw in many local NHS facilities a determination to do everything possible to improve nutrition for both patients and staff. Miraculously, hot food was made available to staff overnight, which, as noble Lords know, seems to have been beyond the capacity of the NHS for many years. I do not know why I am looking at the former Chief Nursing Officer as I say this; I think it is an appeal for support.

This clause is highly welcome as I believe it will lead to higher standards, but my amendments would enable the caterers to deliver on them. The first key point is this: they need the resources to be able to do it. The amount of money spent on hospital food per day at the moment is simply not sufficient. Secondly, we need more training for staff. The training programmes have disappeared, and we need to get them back in to give staff the opportunity to show what they can do. Thirdly, we need to make sure that NHS trusts and foundation trusts are fully on board with bringing forward these regulations. There is no doubt that the efficiency programmes have taken their toll on the budgets for hospital catering and that, equally, the old-style national training schemes fell away and have not been replaced. The pay grade of qualified chefs and cooks needs to be reviewed to reflect the importance of their role. This issue is important in terms of the standards of food and nutrition for our patients and for the well-being of our staff.

My final amendment in this group is Amendment 264. What links all these amendments is that we need more consultants appointed—a small effort to enable us to improve the efficiency of the system. I remind the Committee of my GMC connections in relation to this. The amendment would add the Royal College of Surgeons of Edinburgh and the Royal College of Physicians and Surgeons of Glasgow, and their associated dental faculties, to the colleges that may be involved in the appointment of NHS consultants. My amendment was inspired by the Royal College of Surgeons of Edinburgh, which noble Lords might be surprised to learn has an office in Birmingham because many consultants who work in the English NHS are members of the Scottish colleges.

There seems to be a lacuna in the current regulations. According to the National Health Service (Appointment of Consultants) Regulations 1996 and subsequent guidance issued by the department in 2005, only the Royal College of Surgeons in England is permitted to review surgical consultant job descriptions and send a royal college representative to the advisory appointment committees when it comes to the appointment of consultant surgeons. Other elements of my amendment apply to the appointment of physician clinicians, and the Royal College of Physicians of Edinburgh and the Royal College of Emergency Medicine are also supportive. Although the process and guidance apply only to NHS trusts, foundation trusts are encouraged to follow it.

The Minister has yet to accept any amendment to the Bill. The usual line from the Government is, “We will do this when legislation is available to do so.” Here is a great opportunity for the Minister, as we are here on day 6 of Committee, to get up and say that he is going to accept my amendment.

My Lords, in following the noble Lord, Lord Hunt, I declare an interest as the patron of the National Association of Care Catering, a position that I took over from the noble Baroness, Lady Greengross. I admit that, when I had this great honour thrust upon me, I had little idea what I was getting into—and I have discovered a world of highly dedicated, professional people whose contribution to the health of the nation is very much overlooked. I managed to attend their national conference in Nottingham last October, and I have to say that it was one of the most harrowing afternoons I have spent, as they talked about what they had gone through as the people who supply catering not only in hospitals and acute hospitals but in care homes, as well as doing meals on wheels.

I will pick up one point that the noble Lord, Lord Hunt, made, on training. He is absolutely right that this area has suffered a great deal because of various changes not just to training in the NHS but to the training in higher education. We do not have a recognised qualification in care catering in this country, yet these are people who have to produce food for people who have dysphagia, multiple food intolerances and dementia, people who quite often are suffering from malnutrition when they come into hospital, and people who have allergies and often suffer from dehydration. The people who have worked in this field, and some of them have worked in it for many years, suffer a deep sense of frustration, which is that when young people in school or college show an aptitude for or a willingness to go into the world of catering, they are directed towards restaurant catering, because that is where the teachers and lecturers think the money is to be made. Actually, catering for people with difficult medical conditions is a lot more complicated.

I say to the Minister that I am also really impressed by the specialist companies that work in this field—those that produce specialist menus and enable people to order ingredients for complicated menus in complicated settings, as well as those that manufacture cutlery and crockery and vessels that can be used by people whose interaction with that sort of thing is hampered. These can bring a dignity and focus to something that is much overlooked—but talk to dieticians and you will increasingly understand the importance that food plays in maintenance of health and recovery.

I do not know whether or not this will make it into the Bill, but will the Minister go back to the department and ask whether his officials might meet some of the people who do a remarkable and much overlooked job, day in, day out, and who these last two years, perhaps more than anybody else in the NHS, deserved the clap, if only people knew what they had done?

My Lords, in this rather large group of amendments, I shall take us from catering to my Amendment 242 on professional regulation. I thank the noble Baroness, Lady Finlay, for adding her name. I draw your Lordships’ attention to my registered interests, in particular as chief executive of Cerebral Palsy Scotland. I am involved with the employment of regulated allied health professionals.

Clause 142 gives the Secretary of State far-ranging powers to alter the professional regulatory landscape, with the potential to make significant changes to how certain health and care professions may be regulated, including the power to remove professions from, or bring professions into, statutory regulation.

The UK model of regulation for healthcare is rigid, complex and needs to change to better protect patients, to support our health services and to help the future workforce meet future challenges. The case for reform has been acknowledged.

Whether a health and care profession falls under regulation is a major decision affecting not only the professions themselves but employers, patients and service users who place their trust in those professionals. My Amendment 242 is a probing one. I want to explore some of the issues that will be particularly important for the Government to consider as and when they might seek to use these extended powers.

I want first to thank my noble friend the Minister and the Bill team for the time they have taken so far to discuss the issues around my amendment. We are all agreed on the importance of encouraging greater collaboration between regulators, with the ability to share data and intelligence, but I remain to be convinced that the legislation is being used to reduce regulatory silos, which is crucial to reducing regulatory failures in the future.

I want to be clear that I am not advocating for a single super regulator, which would be a step in the wrong direction, not to mention complicated, disruptive and expensive. I would rather harness the best elements of professional regulation and give the regulators the tools to work more closely together and share best practice more consistently.

I accept that work is being done in the department on various regulatory reform initiatives. These are all important, but it strikes me that they are all focused on individual regulators and amend specific operational issues, rather than looking at the landscape as a whole and what could be achieved.

We have sadly seen all too many reviews and inquiries which have identified regulatory silos as a key factor in why something went terribly wrong. My noble friend Lady Cumberlege’s First Do No Harm report highlights the issue starkly, but the Paterson inquiry, the Sir Robert Francis report on Mid Staffs, the Shipman inquiry and others have all underscored the value of greater collaboration between regulatory bodies, sharing data and intelligence as well as adopting shared professional standards. Reducing and removing silos is also good for professionals and employers, with benefits in terms of intra-professional learning and for professional and patient safety.

I am grateful to the Health and Care Professions Council for its briefing, but I was concerned to note something which regulators have stressed to me: that due to their tightly defined duties, they have often been forced to resort to informal memorandums of understanding to try to make the system work better. That is piecemeal and inefficient— frankly, I would be extremely disappointed if the Minister in his response was to rely on such MoUs to fix the issue.

Do not the powers in this Bill offer a chance to look at things differently: a whole system regulatory approach rather than a set of silos? Amendment 242 identifies some principles and considerations that I believe the Government would find beneficial in developing this more collaborative landscape.

Maintaining regulatory independence is crucial. The Government have rightly recognised this in other legislation recently, but I would welcome confirmation from the Minister that this remains a cornerstone of any future regulatory reform proposals. I would be grateful for reassurance that no regulatory reform would be undertaken by the UK Government without working with the devolved Administrations to ensure that it worked for all parts of the UK.

I particularly want to highlight the benefits of multi-profession regulation, which, as the CEO of an organisation that relies on a range of expert allied health and care professionals registered with the HCPC, I see at first hand, supporting improvements across professions that are increasingly interconnected. As the Minister is aware, the HCPC regulates 15 professions, so is able to utilise common frameworks and outcome-based standards. This approach could, and should, be spread among all the professional regulators.

This is particularly important as the Government, NHS England and NHS Improvement seek to create a more flexible workforce with an ability to move between professions, work as multidisciplinary teams and support career progression. From my own experience, I know that this is positive, but we need our regulatory system to keep up with innovations in delivery. Can my noble friend the Minister therefore tell us about how we can harness the benefits of multi-profession regulation and how he anticipates this will influence the Government’s thinking in terms of reform? Collaboration and the development of a system-wide approach to overcome fragmentation and silos is critical to the future success of regulation. It is an enabler of better care, and a collaborative structure would generate considerably higher and richer levels of data.

Finally, this holistic approach would offer an opportunity to create consistent criteria for making decisions about which professions may be brought into or taken out of regulation. Could the Minister put it on record today that the issues in the amendment are principles that would govern the future use of the powers within Clause 142, that they are all principles that the Government are actively considering and that no decisions on regulatory change would be taken if the criteria set out in this amendment were not met? Once again, I thank him and his team for his engagement so far, and I look forward to his response today. I hope we can continue discussions between now and Report.

My Lords, I rise to speak to Amendment 243 in the name of the noble Baroness, Lady Merron, and Amendment 264 in the name of the noble Lord, Lord Hunt of Kings Heath.

Yesterday I was chastised—wrongly, in my view—for speaking at length. Such boldness requires training in speaking up, confidence in being right and using authority. The comments came from a government Whip, who happens to be a registered nurse. As a doctor, I am used to that. When a nurse speaks up, patient safety improves, health equity improves, collegial relationships are stronger—again, as a doctor I can vouch for that—and healthcare systems improve. This is because of their training. Not recognising legally the status that the title of “nurse” brings to those that are highly trained and qualified and on a nursing council register is wrong.

We all know what a nurse is; a nurse is highly trained, highly competent, can do the job well and is on a nursing register. Anybody else is not a nurse. It is right, therefore, that we recognise this and give it a legal status. Furthermore, the NHS and health providers should not employ anyone as a nurse who does not meet the above criteria. I understand that last year there were 195 advertisements for nurses in the NHS which did not say that the qualification of being registered was necessary. In my view, that is wrong. I strongly back this amendment, and I look forward to the contribution of my noble friend Lady Watkins.

Turning to Amendment 264 on the appointment of consultants in surgery, I am a fellow of the Royal College of Surgeons of England, the Royal College of Surgeons of Edinburgh and the Royal College of Physicians and Surgeons of Glasgow, so I speak on behalf of all surgical colleges. Let me give your Lordships an example: there is a surgical post empty in Birmingham. A highly qualified person, who was well-trained in Scotland and holds a fellowship of the Royal College of Surgeons of Edinburgh, is a key candidate for application but cannot be appointed because the Royal College of Surgeons of England cannot provide an assessor. On the other hand, there is a surgical vacancy in Glasgow, and the top candidate is a fellow of the Royal College of Surgeons of England but can be appointed without a Royal College of Surgeons of England assessor being there. That is a total anomaly.

A person can be appointed who is fully trained in Scotland, is a fellow of the Royal College of Surgeons of Edinburgh, works in Cambridge, applies in Cambridge, but you cannot have an assessor from the Royal College of Surgeons of Edinburgh. In all other specialties—the Royal Colleges of Obstetricians and Gynaecologists, of Ophthalmologists, of Radiologists, of Psychiatrists, of Anaesthetists, and in public health—the assessor can come from any part of the United Kingdom. This anomaly can be stopped very easily. I agree with the noble Lord, Lord Hunt of Kings Heath, that it is not a big deal; just change it in legislation. I do not know who opposes it.

My Lords, it is a pleasure to follow the noble Lord, Lord Patel, on the term “nurse”, which is protected in law at the moment only for those who are a “registered nurse”. This means that anyone can describe themselves as a nurse, as the noble Baroness, Lady Wheeler, outlined. They can even describe themselves as a nurse if they have no qualifications or experience—or, perhaps more seriously, have just been struck off the register. As somebody who was a member of the forerunner to the Nursing and Midwifery Council, I can say that we do not strike people off the register lightly, so the risks of such people being at large and describing themselves as nurses are serious. For this reason, a petition was created calling for the title “nurse” to be protected further in UK law.

In the initial response by the Government to the petition, recognition was given that the protection of professional titles

“provides assurance to the public that someone using that title is competent and safe to practise.”

The response references a consultation by the Department of Health and Social Care on professional regulation, Regulating Healthcare Professionals, Protecting the Public. In the Nursing and Midwifery Council response to this consultation, the nursing regulator recognised issues around the limitations of “nurse” not being a protected title and said it did not think that its current powers are sufficient,

“given that they are primarily based around titles that are not widely understood by the public or used by the professions.”

This amendment is designed to ensure that there are sufficient regulatory levers to be able to protect the public in the future.

Nurses on the NMC register find it difficult to understand why the Government are reluctant to protect the title. As part of the statutory regulations of the Health and Social Care Act 2012, it was mandated that registered nurses would be part of the clinical commissioning group governing body. In Regulation 11 of the National Health Service (Clinical Commissioning Groups) Regulations 2012, the CCG governing body is required to include at least one registered nurse within its membership. This created a statutory commissioning role for nursing leaders in England that will be lost should this not be required within integrated care boards’ executive membership. Please can the Minister explain whether guidance will include a recommendation that there should be a registered nurse as part of the executive team on integrated care boards?

My Lords, I support Amendment 264, in the name of the noble Lord, Lord Hunt of Kings Heath, to which I have added my name. In so doing, I remind noble Lords of my own interests, particularly as a fellow of the Royal College of Surgeons of England, a fellow of the Royal College of Physicians of London and an honorary fellow of the Royal College of Surgeons of Edinburgh.

This is a critical amendment, as the noble Lord, Lord Hunt of Kings Heath, indicated, strongly supported by my noble friend Lord Patel. Currently, the National Health Service (Appointment of Consultants) Regulations 1996, with additional guidance provided by the department in 2005, restricts membership of advisory appointments committees for consultants to certain royal colleges, as we have heard with the appointment of surgeons by the Royal College of Surgeons of England alone—and, indeed, for physicians by the Royal College of Physicians of London. This is an anomaly. The medical royal colleges across the United Kingdom are recognised in terms of the postgraduate training that they are able to supervise, the continuing professional development they are able to provide and, indeed, collaborate with regard to postgraduate examination which is required for provision of the certificate for the completion of specialist training. However, when it comes to the question of consultant appointment, there is this restriction.

Noble Lords might ask why it is important that this matter be dealt with. The provision by a medical royal college of a professional member to serve as part of the appointment process for a new consultant is critical. Those representatives provide expertise and insight with regard to the nature of the job description, the requirements for the individual post, and the assessment of individual candidates as part of the selection process on the day.

The regulations apply only to non-foundation trusts, but guidance provided in 2005 recommends that NHS foundation trusts follow exactly the same process and involve representatives on these advisory appointments committees. In addition, the Academy of Medical Royal Colleges has strongly encouraged that all consultant appointments follow these regulations and guidance. This means that, when it comes to the question of consultant appointment, only representatives nominated by the Royal College of Surgeons of England can serve.

This is creating a bottleneck in terms of appointment of consultants, and this is happening at a critical moment, when the NHS must look to make more and more consultant appointments to meet the increasing demands we are seeing—particularly with regard to long elective waiting lists—that attend surgical specialties and subspecialties in particular.

It is possible that NHS foundation trusts might take the view that this bureaucratic hurdle to finding members for advisory appointments committees from the royal colleges could easily be overcome by ignoring the guidance. Then, we would lose this critical element of expert professional input into the appointment of future consultants. That would really be a very unfortunate situation.

As we have heard from the noble Lords, Lord Hunt of Kings Heath and Lord Patel, this is a very easy issue to address. There is no objection, and it would send a very powerful signal, with regard not only to the importance of professional participation in the appointment of future consultants but to the recognition that, although health is a devolved matter, we recognise the United Kingdom as a single entity in so many questions for the provision of health and, in particular, the training and development of healthcare professionals and their ability to work across our entire country.

My Lords, can I just take us back to Amendment 266, to which I have added my name, before we lose sight of it? It was helpfully introduced by the noble Baroness, Lady Wheeler, and its purposes were explained very well by the noble Baroness, Lady Brinton.

I just want to add a bit of context, which I hope will commend itself in particular to my noble friend Lord Howe on the Front Bench, in that he and I tackled together the PIP breast implant problems that emerged in December 2010 and which led directly, subsequently, to us asking the distinguished first medical director of NHS England, Bruce Keogh, to undertake an inquiry. Since the report of that inquiry, we have made considerable progress. Most recently, noble Lords will recall that the noble Baroness, Lady Wyld, took through the Private Member’s Bill from Laura Trott in the other place to assist in the regulation of Botox treatment for under-18s.

The point is that there is still unfinished business. Amendment 266 relates to giving the Secretary of State the power to set up a licensing process for non-surgical cosmetic procedures—not through the CQC in this case, because the CQC regulates healthcare professionals, but almost certainly through the mechanism of asking local authorities to undertake a licensing process. It gives the Secretary of State all the flexibility that we have grown accustomed to legislation having to give them, but it does so in a way that enables the regulation that would be brought in using this power to be proportionate, being very clear that it should apply only to those activities that present a significant risk. It makes sure that it takes advantage, for example, of the national standards that have been put in place by the Joint Council for Cosmetic Practitioners. It would be very helpful in trying to mitigate the risks associated with non-surgical cosmetic procedures.

Amendment 293 in my name is a follow-up to a Private Member’s Bill that made no progress. It again follows Bruce Keogh’s report and looks to give the General Medical Council the legislative opportunity and requirement to bring forward a scheme to put surgeons who have a specialty relating to cosmetic surgery on to its specialist registers. With Amendment 293, we have the benefit of being able to do this by virtue of the recommendations in recent years from the Cosmetic Surgery Interspecialty Committee of the Royal College of Surgeons. It gives us an opportunity to give those who wish to undertake surgical treatments for cosmetic purposes the opportunity to see who is on the specialist register. All this relates to the safety of those undertaking cosmetic treatments, which is a large number of people; there is a large amount of activity and a significant need for the consumers of these services to have a degree of protection. I think we can make progress on that.

In the rest of this group, we have another opportunity to take action. My noble friend was right when she spoke about a more general approach. She will recall that, in April 2014, the Law Commission produced its recommendations on the regulation of healthcare professionals, so there is an opportunity to do something here. If we do not do it in this Bill, it would not hurt for the Government to tell us more about how they might make progress on the broader regulation, in addition to what is being proposed here.

I want to mention two other things. First, we had an earlier debate about access to innovative medicines. This is another opportunity for my noble friend to tell the Committee that NHS England is proceeding with its consultation on the implementation of the innovative medicines fund. Secondly, we do not need to repeat the short debate we had in Grand Committee not so very long ago under the auspices of my noble and learned friend Lord Mackay of Clashfern, who enabled us to present a lot of arguments about the future of NHS Resolution and clinical negligence within the NHS. We do not need to repeat that, but Amendments 178 and 297E would of course help us in that direction, not least by repealing the redundant NHS Redress Act 2006, which has never been implemented. With that thought, I pass the ball to the noble Lord, Lord Storey.

My Lords, I support Amendment 266 in the name of the noble Baroness, Lady Merron, and Amendment 293 in the name of my noble friend Lord Lansley for all the reasons that my noble friend just articulated. I will not repeat them as he put them so very well. However, I would say to the Minister that, coming from the innovation space, I can see that the technologies for both cosmetic surgery and non-surgical cosmetic interventions are improving all the time. There is an incredibly rapid pace of change. They are set to continue to get better and better, so the marketplace is getting more sophisticated and their popularity is also exploding. We have been briefed on evidence about the role of social media in promoting non-surgical cosmetic interventions in particular. This is exciting, because it is great that people have access to these interesting products, but also extremely worrying, because not all the surgeries and non-surgical interventions are successful. It is the right time for the Government to intervene, so that we have a register of cosmetic surgical practitioners and a much clearer regulatory regime for non-surgical interventions.

I am pro cosmetic surgery. As a young boy, I had an inherited condition of having very big, sticking-out ears, which my father had and my cousins and aunts have, and it was miserable. I had them pinned back and I am very grateful that that happened. It meant that I could be a much more confident person as I grew up. I am pro cosmetic interventions; if people want to use the benefits of medicine to improve their confidence in the way they look, I applaud that. However, standing next to my noble friend Lady Cumberlege, I am also aware of Bruce Keogh’s extremely good report and the very large number of interventions that have not gone well. I know that the Minister’s instincts are not to intervene unless absolutely required and my suggestion to him is that we have hit that moment. The marketplace is exploding and now is the right time to intervene.

My Lords, as I address Amendment 266, I should declare that I am a vice-president of the Chartered Institute of Environmental Health. I stress that this amendment has been supported by the Beauty Industry Group, which represents 10 industry organisations—two voluntary registers for cosmetic practitioners, the Mental Health Foundation and others.

There are currently significant gaps in our regulatory system. Environmental health and licensing professionals work at a local authority level. They inspect, register and license premises for a very limited set of procedures, such as acupuncture, tattoos and piercing. Even for these procedures, however, there are no nationally set training programmes or qualification requirements for somebody to practise. For the riskier beauty procedures, such as the injectables, there are only voluntary registers of accredited practitioners. They have some approved education and training but that is not mandatory.

That means that there are many unaccredited practitioners on the high street providing services to people directly with no checks. A licensing scheme, as outlined in the amendment, would provide appropriate qualification and competency standards for practitioners wishing to practise, which is key to improving safety. The amendment as drafted is an open power for the Secretary of State, so it is easily amended as new procedures come online and on to the marketplace. The weakness of existing legislation in the area is that it fails to cover many of the newer treatments that are now popular.

When things go wrong, it is the NHS that has to pick up the pieces. Infections, injuries, scarring, burns and allergic reactions from a range of procedures often all end up in the NHS, sometimes with people being hospitalised and disfigured. Injection of fillers—or botulinum toxins—into blood vessels can cause dying back of tissues as well as blindness when administered by people who really are not adequately trained and certainly not registered. That means that there is no recompense for people damaged by these practitioners, who have no medical insurance or qualifications. In addition, there are unauthorised advertisements that breach advertising standards. There are strict laws around prescription-only medicines such as botulinum toxin, but these advertisements seem to bypass those.

Among members of the public who have had cosmetic procedures, alarmingly, three-quarters were given no information about the product, volume, brand or batch number of whatever was being used and just under three-quarters were not asked anything at all about their psychosocial or mental health or any body image issues. It is a vast and complex area and there are gaps in regulations. We need a national framework of standards with qualifications that can be recognised, so that there is a clear badge for members of the public.

To briefly address Amendment 297, I suggest that it is not needed because dermatological surgery and plastic surgery are subsections of medical practice and already registered with the General Medical Council. This gets nearer to credentialling than to requiring a separate qualification. These are doctors. They are highly trained, they have gone through a recognised training programme and they have been often examined as part of their exit from their training in whatever procedure they are undertaking.

I remind the Committee that, in a recent letter from the right honourable Michael Gove, he said that he is considering a licensing scheme. I hope the Government will see that this amendment would allow such a scheme without tying the Government down, and I hope that they will accept it, as well as Amendment 264 from the noble Lord, Lord Hunt, for which I should declare that I am an honorary fellow of the of the Royal College of Physicians of Edinburgh and the Royal College of Emergency Medicine. I think the contents of the amendment would go wider than simply surgical procedures. The Royal College of Emergency Medicine was established as a separate medical college in 2008, but the guidance and regulations were written prior to that, so they are completely out of date for what is now emerging as a major specialty across medicine. That amendment would rectify a lacuna.

The last amendment I want to speak to is Amendment 242, so clearly introduced by the noble Baroness, Lady Fraser. We need clear and transparent criteria for deciding which professions are regulated, and how the Government use their powers and the principles behind the criteria. Amendment 242 would provide such criteria. As we have discussed in the context of a previous Bill on domestic abuse, titles such as “therapist”, “psychotherapist” and “counsellor” are not protected. Courses in these subjects are unregulated, their quality varies widely and they are not registered anywhere. Charlatan practitioners can wreak havoc on people’s lives. The public have no idea that these people are not registered or regulated in any way. Even if serious concerns are expressed or complaints raised about them, they remain immune from investigation through the channels by which the health professions are regulated. I urge the Minister to look at that carefully.

Linked to this is the proposal that the title “nurse” should be protected, and I, for one, strongly support that. There is confusion in the mind of the public, and I recall one charitable sector provider that put all nurses and care assistants in the same uniform. That meant that patients and relatives were completely confused as to who was a trained nurse and who was a care assistant. They had no idea about what staff could and could not do and how much information they could give. Fortunately, the uniforms were changed fairly quickly. The public have a right to know that they are being looked after by a highly qualified, very skilled person—and that is a nurse.

Briefly, I support Amendment 176 from the noble Lord, Lord Hunt. I first declare two interests as a patron of thyroid charities, particularly the Thyroid Trust, whose leader, Mrs Lorraine Williams, has done great work on behalf of patients. I should also declare that I once suffered from Graves’ disease, with an unpredictably hyperactive thyroid gland. This may have been one of the few parts of my body that was hyperactive, but it was surgically removed and, ever since, I have taken daily levothyroxine. However, some patients cannot take levothyroxine but need liothyronine instead. It is a shame that some patients have been unable to get that drug when they need it so badly. I know that the NHS must control total drug costs, but the history of its control of that particular drug has perhaps not been perfect. The fault is originally that of the manufacturer, not the NHS, but it is patients who have suffered. The amendment of the noble Lord, Lord Hunt, would solve this problem.

My Lord’s, I shall speak to Amendments 178 and 240, and I remind the Committee of my interest as chair of the Specialised Healthcare Alliance.

Amendment 178 deals with innovative medicines and medicinal products. The debate on this amendment is very timely, given the recent conclusion of NICE’s review of its methods and processes and the current consultation on the innovative medicines fund. Both the review and the IMF consultation are to be welcomed. It is clear that they will result in improvements in the system of assessing medicines and medicinal products, particularly in respect of analysing and addressing uncertainty and incorporating more real-world evidence into decision-making. However, it is also clear that both the IMF proposals and the outcome of NICE’s review are at risk of falling short of the hopes of many patients, clinicians and the life sciences sector more generally in a number of important ways.

First, there is still a lacuna in NICE’s approach to considering treatments for rare disease. For ultra-rare diseases—those affecting fewer than 1,000 people—NICE retains its highly specialised technologies process. For more common conditions—those affecting more than 25,000 people—NICE has its separate technology appraisal process. But for patients with rare diseases—those affecting between 1,000 and 25,000 people—there is no process, and so treatments for these patients have to be considered instead through the unsuitable technology appraisal process. This gap sets us apart from other countries, such as the more generous ASMR system in France and the AMNOG system in Germany for evaluating rare disease treatments.

It was therefore very disappointing to see that the case for the rare disease modifier was again rejected in NICE’s review. It was rejected on the grounds that society does not value treatments for rare disease more highly than those for more common diseases. Those representing rare-disease patients would contend that the fact is that these treatments are inherently costly. The Government accept this in relation to ultra-rare disease, so why do they not do so for rare disease treatments? I would be grateful if the Minister could address that specific question when he replies.

Secondly, NICE’s own consultation looked favourably on reducing the discount rate at which NICE assesses the future costs and benefits offered by a treatment, saying that such a change

“could make a particularly big difference to some treatments, like gene therapies.”

However, NICE has now said that this change would not be possible, due to the views of “system stakeholders”, and this has disappointed many people. When the Minister replies, I would be grateful if he could expand on what “system stakeholders” really means in this context. Who is NICE talking about and why did it assign conclusive weight to their views?

Thirdly, the system in England still fails to formalise the input of patients and clinical experts in the way that, for example, the SMC in Scotland does through its patient and clinical engagement process.

Finally, proposals for the innovative medicines fund now move far beyond the originally planned narrow focus on autoimmune and rare diseases. This causes some SHCA members to worry that rare diseases will get less attention than originally envisaged.

These proposals fall short of the hoped for bridge between the MHRA’s licensing process—which reforms are speeding up in some cases—and NICE’s reimbursement process. Without such a bridge, earlier licensing will not deliver benefits to NHS patients, and ultimately companies will lose interest in making bespoke licensing applications to the MHRA. The Government’s own figures—the life sciences competitiveness indicators, published by the Office for Life Sciences—demonstrate that it is already the case that the per capita uptake of new medicines remains lower and slower in this country than in comparable countries.

Our Amendment 178 suggests that the Government review the situation by the end of the year, when we will have a good half year of experience of the changes to NICE and the operation of the IMF, and when we will be able to see that the hoped for improvements have materialised. I hope that the Minister will consider this suggestion.

I now turn to Amendment 240, which seeks to probe the Government’s actions to improve awareness of rare diseases among healthcare professionals. There are more than 7,000 rare diseases, and it would clearly be impossible for every healthcare professional to receive training on every single one of them. However, as the Government’s rare disease framework notes, healthcare professionals can improve their awareness of rare diseases more generally, be more alert to considering them and be provided with the educational resources that help them recognise rare diseases in patients. Healthcare professionals can also be better supported to help signpost patients with rare disease to information about their condition and to help them understand it.

In a 2016 survey by Rare Disease UK, it was found that 70% of patients were not provided with sufficient information on their condition following diagnosis, and that 35% of patients given information did not understand the information that they were given.

More recent surveys demonstrated that these challenges continue. The Government’s national conversation on rare diseases in 2019 found that almost one in five people living with a rare condition reported that a lack of healthcare professional awareness of their disease was the number one challenge that they faced, and healthcare professionals themselves identified it as the second biggest challenge they faced behind only the well-known difficulties in obtaining an accurate diagnosis. I accept that healthcare professional regulators can do only so much to make improvements, but it would be helpful to understand from the Minister what steps they might be able to take to help better embed rare disease content in training frameworks.

Finally, there is a wider question of how the Government currently track progress in increasing awareness of rare diseases among healthcare professionals. How do the Government do that? I look forward to the Minister’s reply.

My Lords, in speaking to Amendment 266, I shall not speak for long because everything has been said. The noble Baroness, Lady Finlay of Llandaff, explained the problem very clearly as did other speakers.

The only reason I want to speak is that in April last year I spoke in favour of the Private Member’s Bill introduced to this House by my noble friend Lady Wyld which sought to prevent cosmetic procedures being performed in England on people aged under 18 unless under the direction of a medical practitioner. The Bill was passed with cross-party and government support. As a result, children are now better protected. It is high time that we protected the population at large. When one hears of all the side-effects and that people can buy a product online and inject it into themselves or somebody else, it feels like the wild west, and the consequences can be quite dramatic, as we have heard. I very much hope that the Government will be able to support this amendment. This is not complicated and needs to be done quickly.

I want to follow the noble Lord, Lord Sharkey, because I am former chair of the Specialised Healthcare Alliance. I shall speak very briefly in support of Amendments 164 and 178 in his name and that of my noble friend Lady Wheeler.

Every reorganisation of the NHS leaves patients who have a rare or less common condition anxious about how their particular needs will be assessed, how they will be met and even how they will be noted. It is sadly true that the rarer or more specialised a condition, the more it comes down to a postcode lottery whether the patient will be able to access care in spite of established national standards. Not only is it harder to access care, it is also harder for these patients to access the support groups or information networks which are vital when finding out the sometimes rare information about these conditions. The suggestion in Amendment 164 that the CQC assess the provision by ICBs of care for those with rare or less common conditions would provide the assurance that is so badly need.

My Lords, in part because I listened to the lecture with which we started this session but more because it is an old anecdote, I shall forbear from telling my hospital food horror story. However, I will pick up on the points made by the noble Lord, Lord Hunt, and the noble Baroness, Lady Barker, about hospital food and how hard people are trying to improve the situation. This relates to the answer the Minister gave me on Monday in Oral Questions. Of course, it is dependent on the budget that caterers have and the quality of the food that is available to them. I was pleased that the Minister then said that the Government are looking to tackle government procurement to improve the quality of vegetables and fruit. In terms of joining up the dots, that is a useful point to make.

On Amendment 243, I offer the Green group’s support and note that, having been in your Lordships’ House for only a little more than two years, I have debated a very similar amendment at least once before—I think it must have been on the Medicines and Medical Devices Bill. We have all seen briefings that are very much a cry from the heart from the nursing profession for this to happen. Surely we can get this into this Bill.

I mainly want to address Amendments 266 and 293 in the name of the noble Lord, Lord Lansley, to which I have attached my name. While I take the point of the noble Lord, Lord Bethell, that these procedures can be crucial to people’s well-being and enable them to feel more comfortable in their skin, I want to briefly address where these amendments have arrived from. A headline from the Sunday Times two weeks ago said that

“TikTok and Instagram have fuelled demand for nose jobs, butt lifts and boob implants”.

I was a sub-editor on the Times 20 years ago. Quite aside from thinking “What is the world coming to?” when I read that headline, it is important to stress how much pressure there is from social media, particularly on young people, to have these surgical and non-surgical procedures.

It is important to acknowledge that it is not just young people who are affected. We live in an extremely ageist society, and many older people, despite our shortage of labour in many areas, can find it difficult to get jobs, or at least jobs that fit with their qualifications. A survey from the American Aesthetic Surgery Journal found that 30% of people sought surgery after they had suffered discrimination. Ministry of Justice figures show that in 2020 there were 3,668 complaints about age discrimination at employment tribunals, and that was up from 2,112 in 2019. I am aware we are likely to hear from the Minister, “These amendments may be heading in the right direction, but we need more time. There are issues to think about before we do anything.” It is crucial to get action now on surgical and non-surgical issues.

Finally, last July’s report from the APPG on Beauty, Aesthetics and Wellbeing addressed the absence of regulation, and this particularly relates to Amendment 266. Picking up on the point from the noble Baroness, Lady Finlay, the report also called for mandatory psychological screenings to be implemented.

I would love to hear the Minister say “Yes, go ahead”, because there is a demand here for urgent action.

My Lords, I apologise to the Committee for omitting to say that I am a registered nurse on the NMC database. I think this is important in relation to Amendment 243.

My Lords, I will be as brief as I can. I have a few words about some of the amendments in this wide-ranging group.

Amendment 243 would protect the title “nurse”. I know from family members that the qualification of registered nurse is always hard won, the result of very hard work. It involves rigorous basic training, often followed by further training in a specialty such as mental health nursing or surgery. The title provides a high level of trust among patients and the general population, because we know that a nurse must be registered with the Nursing and Midwifery Council, or a different responsible body for dental or veterinary nurses. There should therefore be clarity about who can use the title, and it could be sorted out very simply by the Minister—I hope he will do it.

A further anomaly, which the Minister can easily sort out in his reply, is that of the appointment of surgeons. I hope he will remove that anomaly as well.

I commend the work of my noble friend Lord Sharkey on rare diseases. I will not repeat what he said about what is needed, but I hope the Minister can give him some assurance.

I strongly support Amendment 266 on the need for a register for those who practise aesthetic non-surgical interventions. I will not repeat what my noble friend Lady Brinton and others have said about the reasons for this.

Amendment 293 requires a special register for cosmetic surgery. It is important that we have an up-to-date, comprehensive and rigorous method of assessing and registering the qualifications of surgeons safely to carry out cosmetic surgery. The question is: how is that done? I have received a briefing from the GMC, which tells me that it does not support the creation of a separate register for cosmetic surgery practitioners. Instead, the GMC believes that its proposal to move to a single GMC register that includes all doctors, anaesthesia associates and physician associates, and special annotation with work to develop relevant credentials, will provide additional assurance beyond that which could be provided by a separate additional register.

We are told that something better is coming down the track and that the forthcoming regulatory reform programme is intended to rationalise and streamline registration across all the UK healthcare regulators, and will allow the GMC to deliver an accessible, flexible and discretionary registration framework for all registrant groups. That is why the GMC believes that that will provide greater flexibility to develop and amend registration rules and improve its ability to innovate. Given the rapid development of new spheres of medicine and practices, such flexibility could be advantageous.

I understand that the GMC is now developing credentials with royal colleges and health education bodies, and that the first group of those is led by one on cosmetic surgery, plus four other disciplines. So, while I heartily agree with the intention of Amendment 293, I ask the Minister: when will the regulatory reform mentioned in the GMC briefing be completed? When will Parliament be able to see it and, in the meantime, how can we be assured that the current system gives the assurance on patient safety that is required?

I too support the noble Lord, Lord Hunt, on hospital catering and I too will resist giving my anecdote.

I thank noble Lords for their contributions and for sharing their knowledge and expertise—and, in the case of hospital food, not sharing their tales of inadequate and unhealthy food. I will try to answer as many of the questions as possible but, given the experience of the noble Lord, Lord Patel, of being advised by a nurse Whip, I am keen to make sure that I do not suffer those same warnings, as it were.

On rare diseases, specifying requirements in the way proposed by the amendment would restrict the ability of the CQC to collaboratively develop its assessments of integrated care systems. However, the Government are committed to improving the lives of people living with rare diseases. The noble Lord, Lord Sharkey, rightly talked about the UK Rare Diseases Framework that we published in January 2021, which set out our key priorities for tackling rare diseases. England’s action plan will be published at the end of next month.

I have had conversations with some in the life sciences industry who are keen on the fact that we are focusing on rare diseases and extremely rare diseases, and see that as a positive. One of the things that we are trying to do across government is to make sure that we are seen as a hub for expertise in rare diseases and especially rare diseases. One of my predecessors as a Minister suffered from a rare disease. The momentum is still there in the department to make sure that we tackle the issue.

Also, the CQC, through its ICS assessment methodology, will seek to understand how system leaders are monitoring and meeting the needs of the local population, including those with rare diseases. We expect the CQC, in collaboration with system partners, to use its experience as the independent regulator of health and adult social care in England to develop an approach to those reviews. I know that noble Lords may be tired of hearing this but it is important that the legislation allows the CQC flexibility to do so.

On Amendment 240, while the Government have sympathy with the need to raise awareness, we do not consider it appropriate to put such a requirement into primary legislation. I hope I have reassured the noble Lord about our programmes and our push to raise the profile of rare diseases and extremely rare diseases. We prefer that all healthcare professional regulators require professionals to have the necessary skills and knowledge to practise safely, including awareness of rare conditions. It is the responsibility of the regulators to determine what specific role they should play in raising awareness of rare and less common conditions.

On—and I apologise if I mispronounce this—liothyronine and the power of direction, the NICE guideline on the assessment and management of thyroid disease, as the noble Lord acknowledged, does not recommend liothyronine for primary hypothyroidism. NICE states that there is not yet enough evidence that it offers benefits over levothyroxine monotherapy, and its long-term adverse effects are uncertain. If new evidence was to emerge, I am sure NICE would consider it.

In addition, we must be careful not to override NICE guidelines. But, given the concerns raised by the noble Lord, Lord Hunt, and my noble friend Lord Borwick, I would like a further conversation, if that is okay, to see what can be done in this area, as well as where it is appropriate for me to act and what conversations would be appropriate, given the noble Lord’s experience as a Health Minister.

On Amendment 178, we are committed to further strengthening the innovation metrics and to improving our understanding of how innovative medicines and these products are used in the NHS. Noble Lords will be aware that following the publication of the final report of the Accelerated Access Review, the Government established the Accelerated Access Collaborative—AAC—last year. In fact, last year alone we helped over 300,000 patients access proven innovations, resulting in 17,000 fewer hospital admissions and 140,000 fewer days spent in hospital.

As noble Lords are aware, we published our ambitious Life Sciences Vision, which laid out our priorities. We want to make sure that the NHS is seen as a partner in innovation and that research is embedded into everything the NHS does. I know that this has been raised in relation to other amendments. We are currently developing implementation plans for delivering on these commitments.

As noble Lords acknowledged, NICE is in the final stages of the review of its methods and processes, and is proposing a number of changes that will introduce real benefits to patients, including rare disease patients. The Government are also committed to developing an innovative medicines fund, which my noble friend referred to, and a consultation on detailed proposals for the fund closes on 11 February.

Finally, our rare disease framework outlines the key priorities for rare diseases in the UK over the next five years. One priority area is to improve access to specialist care, treatments and drugs.

On hospital food, although we recognise the expertise and declarations of the noble Lords who spoke, we believe that this amendment is unnecessary because the issues are already covered, either as part of the ongoing work to implement recommendations from the hospital food review or in the NHS food standards document, to be published in spring 2022.

The Government are supporting NHS England to implement the recommendations from the independent review. These recommendations cover a broad range of issues, including nutrition, hydration, healthier eating and sustainable procurement. It is important for me to learn more about this as a Minister, given what the noble Baroness, Lady Barker, said about many people not receiving the recognition they deserve. It would be appropriate, perhaps, for us to meet and follow this up.

In addition, the Government already have sufficient legal powers and obligations to enable them to consult on proposed food standards, and we have engaged with NHS trusts, the food standards and strategy group, and the NHS food review expert group through the NHS food review. We will continue to do all this.

On Amendment 264, the regulations already allow trusts to seek alternative members to contribute to the process. They can be from colleges such as the Royal College of Surgeons of Edinburgh, the Royal College of Physicians and Surgeons of Glasgow and the Royal College of Emergency Medicine. However, the Government agree that the changes proposed by noble Lords in Amendment 264 would potentially be advantageous —to put it that way—and we have undertaken to review the situation with officials.

The National Health Service Act 2006 stipulates that consultation with affected parties must be undertaken before any changes are made. Therefore, before we jump to it and agree, we are required to consult the relevant parties. It does seem a clear-cut case, but we are still under a duty to consult.

Turning to Amendment 266, I thank the noble Baroness, Lady Merron, for the meeting yesterday. Interestingly, we kicked around some of the issues and realised that this is not as simple as it might appear: where do you draw the line? The Government are committed to improving the safety of cosmetic procedures and ensuring that the regulatory framework allows consumers to make informed but safe choices. Patient safety must always come first. A number of noble Lords referred to the Private Member’s Bill from my noble friend Lady Wyld, which we were pleased to support for these reasons. The department wants to work with stakeholders to take this work forward in the most appropriate way, and we commend the work of the All-Party Parliamentary Group on Beauty, Aesthetics and Wellbeing in this area.

However, we must look at where you draw the line. When I have looked at studies from, for example, the United States, on structural racism and getting people from poorer backgrounds into work and them becoming entrepreneurs, an issue often raised is whether occupational licences are a barrier to people. In some states, you require a licence to braid hair. Where do we draw the line? Clearly, where there is a safety concern and where chemicals are used, but that is probably a more straightforward case. We have to make sure that it is not a barrier to people getting to work and is seen as part of structural racism.

On Amendment 293, I thank my noble friend Lord Lansley and others for mentioning the work commissioned from Sir Bruce Keogh. As many noble Lords will know, doctors who practice cosmetic surgery are regulated by the General Medical Council. I take the point made by the noble Baronesses, Lady Walmsley and Lady Finlay. I repeat that, to strengthen assurance, the GMC, in conjunction with the Royal College of Surgeons, is developing a cosmetic surgery credential. GMC-approved credentials formally recognise doctors’ expertise in specific areas of practice. The credential will aim to enhance regulation and patient protection by recognising surgeons who have the appropriate training qualifications. I do not have the exact deadlines here yet, but I can find out and write to noble Lords, probably in my write-around.

On Amendment 242, our proposed reforms will introduce a new duty on regulators to collaborate with one another and key stakeholders when making changes to how they regulate. There are many factors that we need to consider when bringing forward legislation, but the fundamental consideration must always be public protection. The professions protected in law need to be the right ones, and the level of regulatory oversight must be proportionate to the risks to the public.

The noble Baroness, Lady Wheeler, asked about the review of professional regulators. We have commissioned KPMG to carry out an independent review of the regulatory landscape. It submitted its report at the end of last year, and the findings are now being considered. Any use of the powers provided for in Clause 142 will be subject to consultation and the approval of both Houses.

To respond to my noble friend Lady Fraser, we are committed to bringing forward a programme to reform the legislative framework and professional regulators across the UK. There are various strands to the reform programme, and we are making progress. We have received over 500 responses to the consultation and officials are analysing them. We hope to bring forward legislation on the issue this year.

Given all that, and given the public consultation and other issues, I ask noble Lords to withdraw and not press their amendments.

My Lords, the Minister suggested that, to have any changes in the appointment of surgeons, the department would have to consult first. I assume that the only body it would need to consult is the Royal College of Surgeons, which I understand is sympathetic to the change. If that is the case, it is a simple matter, so can it not be consulted before Report?

My Lords, I thank noble Lords for their many expert and very informative contributions. It has been a fascinating debate on a number of issues.

On specialised care services and rare diseases, I note the Minister’s comments and thank him for some of his reassurances, but there were some issues that he did not cover, particularly in relation to my noble friend’s Amendment 178. However, I welcome the dialogue that is taking place on these issues, and the recognition of their complexity, and am very hopeful that that will continue. We will take stock to see if anything else needs to come back on Report. I also thank my noble friend Lady Pitkeathley for her support on this issue.

In the general debate, noble Lords will, I am sure, follow up on the points that they made, as the noble Lord, Lord Patel, just did. I thought the contributions of my noble friend Lord Hunt and the noble Baroness, Lady Barker, on the hospital food situation, really drove home the importance of this issue. We must make progress on it and move forward.

On the title “nurse”, strong support was expected and we certainly got it from across the House. I hope that progress can be made. The issue will not go away, as the Minister knows, and neither will the determination of my noble friend Lord Hunt to pursue the issue of the availability of T3 for thyroid patients. We hope that progress can be made on that, because again it is a situation that a must be addressed.

The noble Baronesses, Lady Masham and Lady Brinton, and other noble Lords made valuable points on the vital need for a licensing regime for non-surgical cosmetic procedures, again underlining the need for urgent, step-by-step progress, and demonstrating in particular why the current situation is unacceptable. Progress can be made. As the noble Lord, Lord Lansley, pointed out, it was seen in the recent Private Members’ Bill on Botox fillers. We need progress to be made, and steadily.

Finally, on the reference to when the review of the regulatory system will be completed—the noble Baroness, Lady Walmsley, also raised this—the issue was about timescales. We know there is a review. We are told that KPMG is on the case and has delivered its report, but we need timescales and action as soon as possible.

With those comments, I beg leave to withdraw my amendment.

Amendment 164 withdrawn.

Amendment 164A not moved.

Clauses 26 and 27 agreed.

Amendment 165

Moved by

165: After Clause 27, insert the following new Clause—

“Place based integrated care and Primary Care Commissioning Boards

(1) Each place based integrated care board is to be established by regulations made by the Secretary of State for an area within an integrated care board.(2) An order establishing a place based integrated care board must provide for the constitution of the board.(3) Before making, varying or revoking an order under this section, the Secretary of State must consult—(a) the integrated care board in which the place based integrated care committee is intended to operate;(b) the relevant local authority or local authorities;(c) the integrated care partnership in which the place based integrated care committee is intended to operate;(d) the local healthwatch organisations whose areas coincide with or fall wholly or partly within the proposed area of the place based integrated care board; and(e) members of the public living within the proposed area of the place based integrated care board.(4) The place based integrated care board may arrange under a scheme of delegation from the integrated care board for the provision of such services or facilities it considers appropriate for the purposes of the health service that relate to securing the improvement—(a) in the physical and mental health of the people for whom it has responsibility, or(b) in the prevention, diagnosis and treatment in these people.(5) In imposing financial requirements on integrated care boards under Section 223GB of the National Health Service Act 2006, NHS England may give additional directions in respect of placed based integrated care committees.(6) Integrated care boards may give place based integrated care board directions as to any of the functions to which it has given delegated functions. (7) The Schedule to the Public Bodies (Admission to Meetings) Act 1960 (bodies to which that Act applies) shall be amended as follows.(8) After paragraph 1(k), there shall be added the following sub-paragraph—“(l) Place Based Integrated Care Boards.””Member’s explanatory statement

It’s likely that ICBs will set up place based entities which may take many of the key commissioning decisions at the local/Constituency level. This amendment puts place based integrated boards on a statutory basis and subject to Parliamentary oversight and meeting in public.

My Lords, my Amendments 165 and 166 are rather more focused than the last group. They are probing amendments, rather than me urging that Ministers take the specific wording of them.

One of the rather surprising characteristics of integrated care systems is that they are not defined in the Bill, although people talk about these entities all the time. The statutory parts are integrated care boards and integrated care partnerships, but much of the real power, decision-making and influence potentially lies with non-statutory groups, whose membership, governance and procedures are not regulated. These are placed-based partnerships, provider collaboratives or networks, primary care networks, or companies accredited to the health system support framework. My two amendments would put the first two of these non-statutory groups on a statutory basis. Place-based partnerships are described and supported by NHSE and the Local Government Association as the foundation of integrated care systems. I am very grateful to the policy research unit in health and social care systems and commissioning at the University of Manchester for its very helpful work on this.

In our debate on primary care, the Minister referred to his hope that integrated care boards would

“exercise functions through place-based committees”.—[Official Report, 20/1/22; col. 1852.]

It is pretty clear that many ICBs will delegate considerable responsibility to them. I can see the potential for that, but given their increased responsibilities, there are legitimate questions to be asked about how place-based committees are to be held to account. What are their governance arrangements? Who will serve on them? What are their leadership arrangements? What functions will they be allowed to carry out? The noble Earl, who I think is responding, may say that that is best left to local decision-making. I see that up to point, but rather like with ICB governance, surely some framework and safeguards need to be built around them.

A similar argument might be made in relation to provider collaboratives. Such collaboratives are essentially partnership arrangements involving two or more trusts or foundation trusts. Participation is mandated for trusts providing acute or mental health services. They are expected to be part of one or more provider collaboratives, with discretionary participation of other providers. Such collaboratives may form at supra-ICS level, may partially cover multiple ICSs and may cover multiple places. Additionally, providers may be members of multiple overlapping collaboratives. The collaboratives may contain acute or mental health members only, or may include wider membership such as community providers and primary care. It is anticipated that they will deliver systems’ strategic priorities. The original White Paper, Integration and Innovation: Working Together to Improve Health and Social Care for All, indicates that “significant” delegation to both place level and provider collaboratives from integrated care systems is expected. It is also suggested that, in time, provider collaboratives may play a role in oversight. At Second Reading, the noble Lord, Lord Lansley, said:

“we have new provider collaboratives which, in fairness, is where the power in the NHS will lie. The Bill makes no provision for them in terms of transparency, openness or accountability”.—[Official Report, 7/12/21; col. 1789.]

This was confirmed on 2 December by the Health Service Journal:

“In the minds of most acute trust chiefs, it is provider collaboratives and groups, and not integrated care boards that will wield the greatest influence (although the former may act through their representation on the latter).”

So I want to put a few questions to the Minister. First, what degree of oversight will be exerted over the formation of these arrangements, and by whom? Secondly, if a lead provider contract is in place, or if providers agree how to spend their respective resources as a provider collaborative, who would oversee that arrangement and where would accountability lie in the delivery of outcomes or in the case of poor performance? How would it be ensured that the work of provider collaboratives took into account the interests, aims and work of the wider health and social care community, including the patient voice?

On the latter, the NHS England design framework made it clear that the involvement of patients, unpaid carers and the public is expected at place and system levels, with requirements for public meetings and published minutes in both the partnership and the NHS board. It is not specified how provider collaboratives, where significant decisions regarding the planning and provision of services may be made, will be publicly accountable.

I believe that the Government are going to discuss with noble Lords the formation and governance of integrated care boards and integrated care partnerships. I suggest that that discussion be extended to look at the position of place-based committees and provider networks, because at the end of the day Parliament is entitled to establish some kind of framework and governance and transparency arrangements without going too much into the minutiae of the detail. On that basis, I hope that the Government might be prepared to take away these amendments as part of that broader discussion. I beg to move.

My Lords, perhaps I may make two quick points. At an earlier stage in the Committee, using the example from the noble Lord, Lord Mawson, in relation to Bromley by Bow and north-east London, I asked why the legislation cannot allow clinical commissioning groups, as they have established themselves over years, to continue as place-based committees or subsidiary elements of an integrated care system. I am sure that many of them would be willing to do so; we should allow them to do exactly that, because there is otherwise a gap in relation to how large ICBs will do their place-based work.

Secondly, the noble Lord, Lord Hunt of Kings Heath, referred to what I said about provider collaboratives. I still think it. Where are we going to end up with this? It will be with NHS England having within it, as each integrated care board has within it, the provider interest and the commissioner interest. The Government purport to be abolishing the purchaser/provider split. Every Secretary of State prior to the former Secretary of State, Matt Hancock, seemed to believe in it, with the exception of Frank Dobson. There was a reason why we did that: because it is a fact. We might legislatively abolish the purchaser/provider split, but, in reality, it will exist. As my noble friend Lord Hunt of Wirral said earlier, if that conflict of interest is not properly recognised and managed, it will emerge with potentially damaging consequences. Transparency about how provider interests are to be properly managed inside the NHS is not something I yet see in the substance of the Bill. I hope that my noble friend on the Front Bench will agree to think hard about this and perhaps talk about how we might give transparency and accountability to that conflict of interest.

My Lords, I have added my name to Amendment 165 in the name of the noble Lord, Lord Hunt. This is a small but important group of amendments.

I have added my name to the amendment because I am interested in what is happening to primary care and particularly the voice of GPs in the new arrangements. Frankly, we are not hearing much about them. As it stands, the legislation will place NHS trusts and foundation trusts in quite a privileged position in deciding how plans are made and resources allocated. I am not quite sure where the voice of GPs comes into the new arrangements. I understand that NHS England has commissioned a review of the role of primary care in the NHS structures, but my understanding is also that it will not report until after the Bill has been passed if we continue with the current timetable. Frankly, by then, it will be a bit late to make sure that we have got the arrangements absolutely right.

It is right that primary care commissioning is undertaken at a local level by people with relevant knowledge and skills, and with the necessary experience of what primary care needs to look like at locality level. That is why it is right that the new place-based partnerships are to be given that commissioning role. However, like the noble Lord, Lord Hunt, I think it is important that these primary care commissioning arrangements are established in statute, because it is only if that happens that Parliament will be clear about the accountability arrangements and the governance and leadership. It is also important that there is real transparency in the system. At the moment, it all feels a bit opaque. I hope that the Minister can give some assurances on this point.

My Lords, I just wanted to respond to the last set of very important questions that have arisen. It is fair to say that the Bill increases the accountability for commissioning primary care services locally, as compared with its predecessor, the 2012 Act. That is because one consequence of having GPs represented on the clinical commissioning groups was that clinical commissioning groups could not, therefore, be the commissioners of local primary care services, at least in statute. One had the paradox that the most local of all the services in the NHS was stripped out from the local commissioning bodies, the CCGs, and instead given nationally to NHS England, as a work-around to deal with the conflict of interest that GPs would otherwise have had in commissioning themselves on the CCGs.

In practice, the CCGs have been given the ability to influence those local commissioning arrangements but, to be clear, that is not the accountability mechanism set through the 2012 Act. What this Bill does is to improve the position, in that it is local integrated care boards that have that local commissioning responsibility for GP and other family health services, as compared with NHS England nationally.

My Lords, we have been reminded many times during the debates in Committee of the aims of the Bill to improve the health and well-being of the population, to improve the quality of care and to use NHS resources sustainably through integration, co-operation and collaboration. Of course, the point at which these resources are used at the coalface, known as “place” in the Bill, is in these place-based organisations. To ensure integration at this level, we are told that the ICB must create an integrated care partnership, otherwise known as a place-based integrated care board, which probably has an acronym as well. There is, however, very little detail about those, despite their crucial importance, and these amendments from the noble Lord, Lord Hunt, are an attempt to put a bit of flesh on those bones.

I put my name to Amendment 166, but I could just as easily have put it to Amendment 165. Amendment 166 says that, within the place-based partnership, there should be mandated a provider network board with duties delegated to it by the ICB. It would be under parliamentary scrutiny and have an obligation to meet in public. These networks already exist and exert considerable influence, but it is essential that they operate in this new integrated care system under a regulated constitution, with obligations to consult and financial provisions. This amendment would ensure the transparency, for which the noble Lord, Lord Lansley, called, over how well integration is operating at this very important level so that there can be proper control and accountability and scrutiny as to where the money is being spent and whether it is achieving the duties placed on all these systems by the Bill.

I thank my noble friend for tabling these amendments; I have added my name to both of them. They are about transparency and legitimacy, raising very important questions which the Minister needs to answer.

I go back to what the noble Lord, Lord Lansley, said at Second Reading, which I think my noble friend referred to. He said that

“we have new provider collaboratives which, in fairness, is where the power in the NHS will lie. The Bill makes no provision for them in terms of transparency, openness or accountability.”—[Official Report, 7/12/21; col. 1789.]

I do not need to say any more than that. The Minister needs to answer that question, because it needs to be resolved before the Bill completes its passage.

My Lords, I am grateful to the noble Lord, Lord Hunt, for bringing us back to the subject of place-based structures and taking us into the issues relating to provider networks. I hope it will be taken as a given that the Government have sympathy with the intentions behind his amendments.

On Amendment 165, we absolutely agree on the importance of place, and I hope I can provide the Committee with reassurances on that score. First, the linchpin to the accountability issue is, I suggest, the ICB constitution, which is required to set out how its functions will be discharged. That may include how functions will be carried out by committees and sub-committees, which will include place-level committees. The best size for an ICB area varies according to local circumstances, and some of the smaller ICB areas are coterminous with the local authority. In those systems, place arrangements will quite rightly look very different from the large ICB areas.

ICBs need to be clear about the expectations and roles of place-based structures, including what they are responsible for commissioning, what powers have been delegated to them, and what resources they are responsible for. The current legislation provides for the ability to establish place-based structures and set them out clearly in ICB constitutions. However, Frimley is not Cumbria, and Essex is not Manchester. We want to give ICBs the flexibility to determine structures that work best for them. To help them do that, NHS England has the power to issue guidance to ICBs on the discharge of their functions, and is working with CCGs and the current non-statutory ICSs to develop model constitutions for the future ICBs. Those constitutions will, of course, also have to be approved by NHS England before the ICB is established. This approach should achieve the right balance, because it allows us to support ICBs to develop, without the danger of putting in place further legislation which could act as a barrier to future evolution. Requiring the establishment of a separate place-based board is simply not necessary and would come at a bureaucratic cost.

I turn to Amendment 166. I appreciate the noble Lord’s concern about transparency and accountability for groups of providers working together where they are exercising functions that an ICB has delegated. I shall come on to the concern expressed by my noble friend Lord Lansley, about the purchaser/provider split. Provider collaboratives are intended to deliver the benefits of scale, with providers working together to implement best practice and reduce variation in access, experiences and outcomes for patients and populations. For example, this could involve sharing workforce and managing capacity on a wider scale. Depending on the local circumstances, such arrangements may include a delegation of ICB functions. ICBs and providers should have the flexibility, in line with guidance that will be issued by NHS England.

Has the Minister actually seen the model constitution that will be imposed by NHS England, and does it do what he is suggesting it does? Maybe the rest of us could see it, too.

Is it not then unsatisfactory that we should complete the passage of the Bill without having sight of the constitution, so that we can be assured that the assurances that the Minister is giving us will in fact work?

I do not think that is a reasonable ask by the noble Baroness, if I may say so. I am trying to describe a structure that should deliver what I am sure she wants to see—safeguards and good pointers for ICBs to make their own decisions, while also ensuring that some of the pitfalls mentioned in the debate are not fallen into. If I can let her see the work in progress, I shall certainly be glad to do so—I do not have a problem with that—but I suggest that it is not necessary for her to do that to accept the proposition that I am trying to put forward.

As I have mentioned, the Bill requires an ICB to set out in its constitution how its functions will be discharged, including any arrangements to delegate functions to provider collaboratives. Furthermore, as an additional safeguard, the Secretary of State may impose conditions on the exercise of the power through regulations.

I wholeheartedly agree with the noble Lord on the need for transparency and accountability, but—he partly forecast my reply here—we are giving the NHS the flexibility to determine the structures that work best for individual areas. That is not something we are foisting upon the NHS; I draw the Committee’s attention to the NHS Confederation’s urging to

“embrace a flexible and permissive approach that considers a range of models that will work in varied geographies and contexts.”

We therefore come to the issue of accountability that the noble Lord rightly raised. Where NHS England or an ICB delegates a function as part of a collaborative arrangement, it will be expected to take appropriate steps to ensure that the function is being effectively carried out on its behalf. That will include the power to set the terms of delegation agreements, which can impose terms as to how the delegation powers can be exercised. The Bill includes a number of safeguards; for example, as I have mentioned, NHS England will have a power to issue statutory guidance in relation to delegated functions and joint working arrangements, and there will be transparency through the constitutions.

My noble friend Lord Lansley understandably raised the issue of the purchaser-provider split. As he knows, the Bill does not abolish that split, but I understand the point of his question. I think I can best answer it by saying that ICBs or NHS England will still bear ultimate responsibility for protecting the interests of patients and taxpayers, and will be able to oversee providers’ exercise of delegated functions through the terms of the delegation agreement and the performance assessment functions. Providers can be given greater flexibility to design services around their understanding of patient needs. That will happen only where ICBs are satisfied that quality standards continue to be met and the function is being effectively carried out.

My noble friend also suggested that we might consider keeping CCGs to enable the local assessment of patient need and the services that are required to be retained in the commissioning arrangements. Instead of that, we need to go back to the functions of the health and well-being boards and the ICPs. The system will enable the kinds of granular insights, described earlier by the noble Lord, Lord Mawson, that will inform strategies for the whole population.

We come to the question that noble Lords asked earlier: why do we have health and well-being boards and ICPs? The best answer is that they perform complementary functions. The ICP will be responsible for developing an integrated care strategy for the whole population within the geographical footprint of its relevant ICB, but that strategy should be informed by local assessments of needs developed by health and well-being boards at the local level so that the system plans reflect the needs of every community within the area. That is how the circle is intended to be squared.

Not all of my reassurances today have landed well, but I hope I have provided reassurance to the Committee that place-based commissioning structures are already an intention and sufficiently catered for in the current provisions, and that the noble Lord, Lord Hunt, will feel able to withdraw his amendment.

Before the Minister sits down, is he in a position to answer the question I asked about the timing of the review regarding the position of GPs within this new set of arrangements?

I shall need to write to the noble Baroness about that timing because I do not have it. I meant to say that I was grateful to the noble Lord, Lord Stevens, for his intervention on the way in which we hope that primary care will be better built into the commissioning arrangements than it has been up to now.

My Lords, I am grateful to the noble Earl and to the noble Baroness, Lady Tyler, for her helpful interventions on primary care, which were very important.

In essence, the noble Earl said that we should be reassured because, either through the constitution of the ICB or through the more general guidance given out by NHS England, appropriate accountability and monitoring arrangements will be put in place. I accept that, but there are questions about the guidance and the constitution which mean that we may well want to come back. I think it would be appropriate for Parliament to give some oversight approval to that.

We are a bit jaundiced about NHS England guidance because we still cannot get hold of the guidance put out 10 or so days ago about the make-up of ICBs and the new timetable, which I mentioned on our previous Committee day. It is on something called but not even our Library can get hold of it because there is a security wall around it, and I do not understand why it has not been put into the public domain. That is why we are a bit wary of any guidance that is going to be put out. I cannot resist saying that I hope the guidance is not going to say that local authority councillors cannot be on the place-based committees, because that would be a mistake. It could be helpful in some places for them to be so appointed.

On the more general issue of purchaser-provider tension, we have had a really interesting debate. The noble Lord, Lord Lansley, said that every Secretary of State apart from Frank Dobson, of blessed memory—my first ministerial job was serving under Frank before he was persuaded, if that is the word, by Tony Blair’s persuasive skills to go and fight Ken Livingstone for the mayorship of London—believed in it.

The point is that, whatever you call it, there is clearly going to be a relationship between the organisations of the NHS that have the dosh handed out by the department and those organisations that provide the services. There is going to be an unnecessary tension and an issue of accountability and monitoring. The puzzle that some of us have is how that is going to work within the integrated care boards when the big providers are sitting around the table. I think the clue was given in the Health Service Journal, which said:

“In the minds of most acute trust chiefs, it is provider collaboratives and groups, and not integrated care boards that will wield the greatest influence”—

an interesting phrase. I suspect the real dynamic is going to be between those collaboratives and the chair and chief executive of the integrated care board, while the board itself, which looks as though it is going to be very large, will be the legitimiser of those discussions and tensions. Still, it is a bit of a strange beast.

The noble Lord, Lord Stevens, raised the issue of CCGs and the fact that, because they were essentially membership organisations of GPs, they could not do the nitty-gritty of managing the contracts, which in the end was kind of half-devolved down to them but with accountability held at the NHS England level. That illustrates the problem of having providers and commissioners around the same table. For very good reasons people want to encourage them to integrate, but that poses its own challenges.

I think it is inevitable that we are going to come back to this issue. This has been a very good debate and I am most grateful. I beg leave to withdraw the amendment.

Amendment 165 withdrawn.

Amendment 166 not moved.

Schedule 4: Integrated care system: minor and consequential amendments

Amendment 167 not moved.

Schedule 4 agreed.

Clause 28 agreed.

Schedule 5 agreed.

Clauses 29 to 34 agreed.

Amendments 168 and 169 not moved.

Clause 35: Report on assessing and meeting workforce needs

Amendments 170 to 172 not moved.

Clause 35 agreed.

Amendments 173 and 174 not moved.

Clauses 36 to 38 agreed.

Clause 39: General power to direct NHS England

Amendment 174A

Moved by

174A: Clause 39, page 47, line 17, at end insert—

“(4A) A direction under subsection (1) may be given only in relation to a particular instance, not generally.(4B) A direction under subsection (1) must provide for the direction to cease to have effect on a date specified in the direction, which must be no later than one year from the date the direction was given.”Member’s explanatory statement

This amendment, along with the other amendments to Clause 39 in the name of Lord Hunt of Kings Heath, would reduce the scope of the Secretary of State powers to direct NHS England by adding safeguards and additional exceptions.

My Lords, we come to Clause 39, which I think is one of the most significant ways in which the Bill will increase the powers of the Secretary of State over the NHS. The clause gives a general power of direction over NHS England in the exercise of its functions. It is a very significant change from the legislation the noble Lord, Lord Lansley, put through in 2011-12. It also is clear that many NHS bodies are, like the Nuffield Trust,

“concerned that these new powers will result in a more politicised NHS, with ministers dragged into micromanaging how local services work.”

I do not think you can consider this clause without considering further clauses in the next group, led by the noble Baroness, Lady Cumberlege, in relation to the power of the Secretary of State to intervene at any time in proposals to change services. In addition, Part 3 of the Bill gives the Secretary of State the power to move responsibilities between several arm’s-length bodies in health and to abolish them. We have already had the CQC debate today, about an increase in the Secretary of State’s capacity for intervention. There is also the question of the regulators, which will be discussed later, which again leads to the individual professional regulators, which, again, the Secretary of State can abolish.

Although I am going to talk about the general direction, I do not think you can do that without thinking about the other accretions of power that the Bill takes. Together, I believe it is a fundamental difference —a change in philosophy—from the 2012 legislation. NHS Providers, with which I have discussed this extensively, is concerned. As it says:

“Clinical and operational independence must be maintained in order to ensure equity for patients within the service; the best use of constrained funding; and clinical leadership with regard to prioritisation and patient care.”

Although I do not want to completely open up this debate, I have to say that the allegations made by Conservative MPs about threats made in the last few days by Government Whips, over the funding of services, are very apposite to how a power direction might be used by Ministers under this Bill.

Let me explain my amendments. Amendment 174A would mean that a direction by the Secretary of State

“may be given only in relation to a particular instance, not generally … A direction … must provide for the direction to cease to have effect on a date specified in the direction, which must be no later than one year from the date the direction was given.”

This really reflects the reality that the public interest is not static and objective circumstances may change. If, after a year, the Secretary of State believes the direction is still necessary, they can renew it, but there has to be an explanation of why it remains in the public interest.

Amendment 174B would mean that a direction must include a statement of

“why the Secretary of State believes the direction will be in the best interests of the public.”

The public interest test is based on the principle of them carrying out their duties. Ministers, civil servants and public authorities must act demonstrably on behalf of the public as a whole, not on behalf of individuals or private interests. This constitutes another check and balance that needs to be put in place.

Amendment 175A would mean:

“The Secretary of State must publish any direction … at the time that the direction is issued and lay it before Parliament.”

Additionally, I would like the Secretary of State to

“publish an impact assessment … at the time the direction is issued or within that financial year.”

Again, transparency is essential to ensure all the required processes and safeguards are being adhered to during the decision-making process.

Amendment 176A would mean that the power could not be used to direct NHS England to make a particular procurement decision or grant of NHS funds to a particular person. This means the power could not be used to undermine the integrity of a fair-share allocation to local systems by unfairly seeking to amend allocations to a particular part of the country, contrary to the allocation formula.

Amendment 176A would remove existing procurement requirements, with the intention to move away from the competitive tending by default in favour of a more collaborative approach to planning and delivering services. For example, ICBs will have the ability to continue with an existing provider while having to go through a competitive procurement process, under the Bill. We discussed this on our last Committee day.

While the Secretary of State sets the overall budget for NHS England, they should not have the power to circumvent and interfere with this new procurement regime. The power of direction conferred on the Secretary of State in Clause 39 should not be used to interfere in NHS England’s operational independence and direct it to make a particular procurement decision.

My Amendment 176A concerns the weighted allocation formula. NHS allocations are underpinned by a weighted capitation formula, which calculates the target fair share of the national budget for local authorities. The ACRA makes recommendations on the optimum geographical distribution of health spending, advising the Secretary of State on public health allocations and the chief executive of NHS England on NHS allocations. The power of direction in the Bill should not be used to undermine the integrity of fair-share allocations to local systems.

The noble Lord may say, “This is all fine and dandy, because the Secretary of State will only ever use this power of direction on very few occasions.” My view, however, is that this is such a significant difference from current legislation that safeguards ought to be set out in legislation. In reality, I have to say that once you have a power of direction, it changes the relationship between the Secretary of State and NHS England in any case, because if NHS England knows that the Secretary of State has a power of direction, it is bound to take note of that in terms of their relationship and the instructions and advice the Secretary of State may give it. I am not naive enough to think that my amendments would necessarily prevent undue involvement by Ministers in the operational activities of NHS England, but I do think they would go some way to providing some reassurance.

Again, I say that you cannot consider this group of amendments without taking account of the noble Baroness’s group of amendments, which are equally important, and the other accretions of power that the Minister is taking. I hope the Minister will give a proper justification—I have not yet heard one—for why the Secretary of State feels the need to take these powers. I beg to move.

My Lords, I shall intervene relatively briefly. The noble Lord, Lord Hunt, quite rightly said that this is a significant departure from the intentions of the 2012 legislation. The 2021 Act, among other things, created the body that is now NHS England and gave it independence. None of that independence was intended to mean, nor has proven to, that it was not responsive to even the day-to-day wishes of a Secretary of State, as I am sure the noble Lord, Lord Stevens, would verify. What it did put in statute was that, if the Secretary of State wants to set something as an objective of NHS England, they put it in the mandate. If the Secretary of State requires a change to those objectives, they publish a revision to the mandate.

Going beyond it is, I think, the product of circumstances where we had a Secretary of State who was encountering an emergency and thought he could press lots of buttons and things would happen, but pressed some and they did not. I think, even in his experience, that was more outside NHS England than inside it— I may be wrong, but that was certainly my impression. The point is that the Secretary of State did not even realise what powers he had in an emergency; they are all there and he was not required to change the mandate, because it was an emergency. In a public health emergency, none of this, strictly speaking, is within the same bounds.

Ministers have quite rightly said that this is the Bill the NHS asked for. But Clause 39 is not the clause that the NHS asked for; it is the opposite of what it is asking for. There are many practical issues. The noble Lord, Lord Hunt, is right; if it appears, including to the senior people and bright youngsters, that power is going to shift from NHS England back to the Department of Health and Social Care, they will go and work in the department. One of the things I was most pleased about was that some of the brightest and best, including civil servants in the department who I knew well, went to work in NHS England, because they thought, “This is a great future.” That is terrific, because one of the problems was that NHS managers were being imported into the Department of Health, rather than bright policymakers going to the NHS. The NHS is too important an institution for it not to have the best possible policymakers under its own purview.

The noble Lord, Lord Hunt, and the noble Baronesses, Lady Thornton and Lady Walmsley, have done a sterling job in trying to mitigate a general power of direction for the Secretary of State. Frankly, I have not heard a case for it, it is contrary to where we are and where we need to go, and the simplest thing is to simply take Clause 39 out of the Bill.

My Lords, it is a delight to follow the noble Lords, Lord Lansley and Lord Hunt, on this set of amendments, with which I totally agree. I want to dilate for a few moments on the realpolitik of being a Minister in the great, august organisation called the Department of Health and Social Care. I can say some things that the noble Lord, Lord Lansley, as a former elected Minister, possibly cannot.

When I ceased to be a Parliamentary Secretary and was promoted to work with the big boys and girls as a Minister of State, and had to deal with issues such as reconfiguration, poor performance and so forth, I became used to regularly meeting elected MPs who wanted to tell me about the errors of their ways in decisions that had been taken in the public interest. There was a steady flow of them, which, if I may say, tended to get bigger the nearer you got to an election. If people wanted to go through the archives, I would refer them to the history of Lewisham Hospital and of Chase Farm Hospital, to name but two.

Very often in these situations, it is not about closing a whole hospital but about re-engineering—we will come to some of this in the next group. I give the example of stroke services in London. It is re-engineering a particular set of services, which the local MP is then put up for trying to ensure that change does not happen. That is where you need to help Ministers do the right thing, when it is in the public interest to make changes. The amendments from the noble Lord, Lord Hunt, help Ministers do the right thing.

The point the noble Lord, Lord Lansley, made is absolutely valid. In many of these circumstances, it becomes very difficult if you are an elected Minister—as distinct from an appointed Minister, who does not have to face the electorate—to resist some of the local pressures to avoid change which would be disadvantageous to a local hospital. For those realpolitik reasons, I think the noble Lord, Lord Hunt, is on the right track and we should support the amendments.

My Lords, I support the noble Lord, Lord Lansley. Clauses 39 and 64 give the widest possible powers of intervention to the Secretary of State and even the power to delegate that power to someone else. The noble Lord, Lord Hunt, and other noble Lords clearly believe that the Government are going too far, hence the large number of amendments in this and the next group.

I believe that the Clause 39 powers could justifiably be used only in the case of some cataclysmic failure of the NHS. There are four questions to ask. Is it possible that the Secretary of State would ever need these powers of intervention at an operational level, given that he already has the mandate? Does the Secretary of State have any other powers which could be used prior to this atomic bomb of a power? Has the NHS survived well enough over the last 10 years without the Secretary of State having such powers? Does Clause 39 upset the balance between the Secretary of State and the autonomy of NHS England? I think the answers are no, yes, yes and yes—your Lordships can work it out.

The Health and Social Care Act 2012 removed the Secretary of State from this sort of meddling. I thought at the time that it might also avoid him or her taking the blame for failure, but that was just me being cynical and there has actually been no failure of political accountability over the last 10 years. The ninth report of the House of Lords Constitution Committee refers to this issue. It notes that, in 2011, it

“raised concerns that that Bill could erode ministerial responsibility due to the proposed duty on the Secretary of State to promote autonomy for persons exercising functions in relation to the health service. What is now section 5 of the Health and Social Care Act 2012 was amended, such that the Secretary of State instead must have regard to the desirability of securing autonomy. This helps ensure a balance between enabling those providing health care services to deliver services in a manner that they consider appropriate, whilst ensuring ministerial responsibility.”

The Constitution Committee believes that, in combination with Clause 64, the powers taken for the Secretary of State by Clause 39 would undermine that autonomy and upset the balance. They also risk

“undermining accountability by making it more difficult to understand which body is responsible for a particular function of the NHS.”

The fact is that the Secretary of State already has the power to change the mandate of NHS England—as the noble Lord, Lord Lansley, pointed out—to adjust its funding or to bring political pressure upon it to behave in certain ways, without the need for the powers in this clause. Indeed, I think it would be very unwise to use these powers, and he or she will certainly get the blame if it all goes pear-shaped. The Bill, as has already been pointed out in some detail by noble Lords, the DPRRC and the Constitution Committee, gives the Government considerable regulatory and guidance powers, about half of which allow no parliamentary scrutiny at all. Does that not give the Secretary of State enough ability to ensure things are done in the way the Government wish? The Secretary of State already wants to be Henry VIII; does he also want to be King Herod?

The Bill lays out in some considerable detail the powers and duties of the new integrated care systems, and the Government tell us they do not want to be prescriptive as to how these duties should be carried out—yet here, we are expected to rubber-stamp an enormous set of powers which could do absolutely the opposite. Clause 39 is not needed. In addition to all the regulatory and guidance powers in the Bill, the Government still hold the overall purse strings and can always provide additional resources after the initial budgets have been set if particular needs arise. The Secretary of State should then leave it to those who have been so carefully chosen and so rigorously regulated to get on with the job. I support removing Clause 39.

My Lords, I am nearly convinced that I should have put my name to the opposition to Clause 39 standing part of the Bill.

We have had a very informed and interesting debate which comes to the heart of the balances of power that the Bill seeks to change. My noble friend Lord Hunt set out concerns over Clause 39, which gives general powers of direction to NHS England. Amendments 174A, 174B, 175A, 176A and 175 seek to mitigate the power and to put in safeguards. This is very much in tune with concerns expressed across the Committee, by the Delegated Powers and Regulatory Reform Committee, and by the Constitution Committee. Our amendments stop short of that from the noble Lord, Lord Lansley, and the noble Baroness, Lady Walmsley, but theirs is a more elegant solution in many ways. However, the Minister will need to explain why some powers of direction are required, and we on these Benches will listen very carefully indeed.

This is all part of the balance between the responsibilities of the Secretary of State, especially to Parliament, and the powers the Secretary of State has to enable them to discharge their duties. If there is a clear and consistent solution to this, we have yet to hear it. In a way, we are repeating debates we have already had in Committee. The Bill has been severely criticised as a clear and disturbing illustration of disguised legislation, and it will need to be changed. We will need to move on to proper talks about how to do that.

On whether Clause 64 should stand part of the Bill, the issue is a different one. The 2012 Act introduced the formal notion of NHS bodies having autonomy, and since 2003, foundation trusts have had some degree of at least theoretical autonomy. But in the years of austerity a lot of that has gone, and all trusts of all kinds are simply struggling to manage day by day. It may have been the noble Lord, Lord Stevens, who observed that the difference between a trust and a foundation trust was a distinction without a difference. For some years, the process of managing foundation trusts has been the same as for trusts.

We have been hearing in our recent deliberations about local flexibilities. Our scepticism about this has been strong, because it appears—and this group of amendments addresses this—that any flexibility will be as great as NHS England permits. Let us not reject autonomy. Why remove the duties to promote autonomy? Why not replace them, for example, as the noble Lord, Lord Mawson, said, with a duty around subsidiarity and localism?

I will not repeat what was said by the Constitution Committee, but it was very critical of the powers that the Secretary of State seeks to take. Indeed, I raise a different issue: the fact that I thought NHS England was undertaking implementation of the Bill before it has finished its passage through Parliament. It is all part of the same pattern. Since we have an undertaking from the Minister to respond to that concern, we will look for an undertaking from him to provide an explanation and perhaps further discussion about why he wants autonomy removed from the Bill.

I thank all noble Lords for their amendments and for challenging the issues around the power of direction. We believe that we must have the right framework for national oversight of our health system. Following the merger of NHS England with Monitor and the Trust Development Authority, NHS England will be one of the largest arm’s-length bodies in government, responsible for over £130 billion of taxpayers’ money. Without this power, we would be expanding the functions and responsibilities of NHS England without ensuring that there are enhanced accountability measures in place.

Accountability must run from NHS England to Ministers, from Ministers to Parliament, and from Parliament to the public. This is what the power of direction supports. Indeed, a number of politicians from different sides agree that if you walked out into Parliament Square and asked people who is responsible, they would expect us to have answers. Therefore, we want to make sure there is the appropriate power of responsibility.

I also want to give reassurances that we expect the situations where the Government issue directions to NHS England to be rare. Where it does happen, Ministers will of course ensure that the direction is clear, appropriate and has suitable timeframes. It is paramount that this power can be deployed quickly when required, and limiting it to specific instances, or prescribing a time limit as to its efficacy, would undermine the intent of these provisions.

That said, we agree it would be inappropriate to use this power to intervene in clinical decisions, and we have specifically exempted this in the Bill. For example, we have made sure that a direction cannot be given in relation to drugs, medicines or—interestingly, given our previous discussions—on treatments that NICE has not recommended or issued guidance on. The noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt, rightly questioned the draft guidance that NHS England has given—we are trying to find a copy of that. However, we recognise the unique role the Secretary of State for Health and Social Care plays in the system. The Secretary of State could use the powers to request to see the guidance developed by NHS England before it is published, to ensure that NHS England is working effectively with other parts of the system, such as local authorities, given the concerns that both the noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt, raised.

On Amendments 176A and 174A, we have already included a number of exemptions to the power of direction in the Bill to ensure the Secretary of State is not able to intervene in day-to-day operational matters. There is also no intention that the power will be used to direct NHS England on procurement matters. Any decision to exercise the power will be subject to and guided by general public law principles and general statutory duties. This means, for example, that Ministers will have to use regulations where they exist, as they do for procurement, and that the Secretary of State cannot direct NHS England to breach procurement regulations, since this would be unlawful.

In relation to allocations to ICBs, NHS England uses a formula to allocate NHS resources to different parts of the country based on long-standing principles of equal opportunity of access for equal needs and informed by the independent Advisory Committee on Resource Allocation. There is no intention to use the power to interfere in this process.

In relation to local organisations, I make the point that the Bill will provide more practical autonomy at a local level by strengthening local leadership and empowering local organisations to make decisions about their population, while also allowing for national accountability. This is the approach we want to take with this power: directing NHS England only on the functions it holds in respect of local bodies, to provide necessary support and assistance to them, especially if they are failing. It is also vital that a power of this nature is accompanied with appropriate safeguards and transparency requirements.

On Amendment 174B, which relates to public interest, the clause already ensures that all directions must be made in the public interest.

On Amendment 175A, the noble Lord, Lord Hunt, has called for directions to be laid in Parliament. It is already the case that any direction issued must be made in writing and will have to be published. This will allow Parliament to hold Ministers to account for use of this power.

On Amendment 175, Ministers already work in partnership with NHS England, and any direction made would come after close working and considered discussion. NHS England will continue to make the vast majority of its decisions without direction, consulting the Government as it needs to. We believe that this power provides additional transparency by ensuring that where Ministers direct NHS England, it is clear, published and available for scrutiny by all. Any direction will come after a considered discussion with NHS England and advice, including on the impact and deliverability of such a direction. Ministers will of course consider, with NHS England and others, that the priorities being set are the right ones and whether they are affordable. However, it is important that we do not put in place too bureaucratic a structure that would bind Ministers’ hands when decisions have to be made quickly.

I end by addressing the questions put forward by my noble friend Lord Lansley and the noble Baroness, Lady Walmsley, about Clauses 39 and 64 being removed from the Bill. Clause 39 is part of our ambition to put increased accountability for the Secretary of State at the heart of these proposals while committing to the NHS’s clinical and day-to-day operational independence. We reiterate that the power will add to the existing ways that the Secretary of State and NHS England work together. The mandate to NHS England, which has been an established means of providing direction since 2013, will continue to be the main place for strategic direction-setting.

Let me give my noble friend one simple example of how this could shift decision-making from NHS bodies to the Secretary of State. We discussed previously, in an earlier group, the availability of in vitro fertilisation services. There will be pressure on the Secretary of State to issue a direction that the NICE recommended availability of in vitro fertilisation services should be provided. By what means is the Secretary of State going to say, “No, I can’t issue such a direction”? It is entirely within his power to do so. The pressures will all be on the Secretary of State to issue directions to do things that the NHS locally may choose or choose not to do. The power will shift. Is he aware of what he is wishing for?

Before the Minister answers that question, could I add another? We have had 10 years’ experience of NHS England under three chief executives and a number of different chairmen. Can the Minister give any examples of where the powers the noble Lord, Lord Lansley, gave the Secretary of State have been inadequate for them to give direction to NHS England?

The Secretary of State cannot issue a direction to CCGs or ICBs on any of this using this power. We have been clear that direction cannot be given in relation to drugs, medicines or on treatments that NICE has recommended or issued guidance on. I gave the example of where we want this guidance—with the draft guidelines published for ICBs. The Secretary of State would be able to intervene and ask to see that guidance—

I am sorry to interrupt my noble friend again but let us be clear: the Secretary of State would be asked to give a direction in line with NHS guidance. There is nothing in the exception in Clause 39 which says that the Secretary of State cannot give such a direction.

If my noble friend will allow me, I will have to consider that and write, and make that available to all noble Lords.

We have included a number of exceptions to the power of direction in the Bill to ensure that the Secretary of State is not able to intervene in day-to-day operational matters. For example, there is no intention to use the power to direct NHS England on procurement matters.

On Clause 64, the rationale for removing these duties is twofold. First, the pandemic has highlighted the importance of different parts of the health and care system working together. The clause removes some barriers in legislation that hinder collaboration between system partners. It facilitates collaboration between NHS England and system partners and enables broader thinking about the interests of the wider health system. Secondly, removing the Secretary of State’s duty to promote autonomy will put increased accountability at the heart of the Bill.

Overall, these clauses encompass flexibility, allowing Ministers to act quickly and set direction, while balanced with safeguards and transparency requirements to ensure that they can be held to account. I understand that there are a number of concerns about this group of amendments and others. I am sure we will have a number of discussions, but in the meantime, I ask noble Lords not to press their amendments.

My Lords, this has been a very significant debate, because when the Minister referred to the fact that Ministers needed to have the answers, I realised that the intention is to go back to command and control from the centre. It was quite clear: that is the intention. I think that is very depressing, because I do not believe that the NHS is going to benefit at all. When he said that this will strengthen local accountability—oh no, it will not. There is no local accountability whatever in this structure. I am sorry to say this again, but the fact that the Government are taking local authority councillors out of ICBs is a visible demonstration that this is a centrally driven health service from the Department of Health.

In this debate and the next, we have two parallel lines of thinking. I have attempted to produce some constructive amendments to try to constrain the powers of the Secretary of State. The noble Lord, Lord Lansley, and the noble Baroness, Lady Walmsley—and I think my noble friend Lady Thornton—think that this is such a wrong route to go down that we should take Clause 39 out. I am absolutely persuaded now that that is the right approach. From what is being said, it is clear that whatever constraint we put in, basically Ministers want to run the NHS again. The same argument relates to Clause 40, because, again, the noble Baroness, Lady Cumberlege, has tabled what I believe are constructive amendments, and then there is a stand part debate.

The moment that the Government take this power, they will be expected to answer for everything that happens. We will expect it here. They will not be able to say, “This is a matter now for NHS England”—oh no, it is not. It is a matter for the Government. The moment the Government have power of direction, they change the whole dynamic and relationship.

We have said enough now, but I urge the Government to think again on this. I think that they do not understand the risk they take by going down this route. Having said that, I beg leave to withdraw my amendment.

Amendment 174A withdrawn.

House resumed. Committee to begin again not before 7.15 pm.