Anaesthesia Associates and Physician Associates Order 2024

Debate between Lord Hunt of Kings Heath and Lord Patel

Monday 26th February 2024 Lords Chamber

[Lord Patel (CB)]

My Lords, I begin with a slight disagreement with the noble Lord, Lord Harris. I take his point about how dental professionals, not just dentists, are regulated by the GDC, but I agree with the comment from the noble Lord, Lord Lansley, about the impression it would give if other professions apart from doctors were regulated by the General Medical Council. Hitherto, the GMC has regulated only doctors, so it would have to be clear in the register how these people were differentiated. I am afraid that the solution of having a prefix on a register would not mean anything to patients.

In the past, if you walked around a hospital, it was easy to know who was a doctor, as they mostly wore white coats; who were the nurses, because they wore different uniforms, including the matron’s uniform, which was a different colour; and who was a trainee nurse, because they wore a pink uniform, which is why junior doctors referred to them as “pinkies”. Physiotherapists wore yet another colour of uniform. However, nowadays everyone wears suits or jackets or jerseys, so you cannot distinguish from that which profession is looking after you.

I take the point that the noble Lord, Lord Winston, made, that for all of us who have done surgery, a qualified, competent anaesthetist is our friend. But sometimes—as he and I have no doubt done—we operate on pretty vulnerable patients for whom the surgery is necessary but they are not a safe bet for anaesthesia, unless by an extremely competent anaesthetist. But I interpret the anaesthesia associate as someone who does not induce anaesthesia but only maintains anaesthetic under strict supervision by a qualified anaesthetist. And that is quite distinct from what a physician associate might do, because they might be involved in different ways in assisting the physician. The point made by the noble Lord, Lord Winston, is important because it is an example that shows up the importance of the scope of the practice of physician associates and anaesthesia associates.

It does not help—and this debate is an example of why so much concern has been expressed—when the NHS health careers website says, in relation to physician associates, that they will be trained in

“taking medical histories … performing physical examinations … diagnosing illnesses … seeing patients with long-term chronic conditions … performing diagnostic and therapeutic procedures … analysing test results … developing management plans”—

which I presume means patient management plans. If you see that, you can see why there are concerns and confusion over what their responsibilities will be and the limitation of the scope of their practice.

I absolutely appreciate the need for physician associates —I keep calling them assistants—and anaesthesia associates and the need for regulation, but I think this crosses the Rubicon since it is the General Medical Council that will regulate this. It is important that what it defines as the scope of the practice is understandable to patients and professionals clearly.

The noble Lord, Lord Hunt of Kings Heath, commented that he took the legislation through this House in 1999, and that Act will subsequently be the vehicle for SIs to be used for future regulation. I am sorry that some of us were not here at the time because some of us might have opposed it. An Act from nearly 25 years ago cannot be the one that continues to be used. If we are going to have further reforms of the regulation of doctors and nurses—where we are talking about 1.5 million health professionals, not 3,000 physician associates or anaesthesia associates—I hope we are not going to have an SI to do that, because there are lots of issues of regulation.

[Lord Hunt of Kings Heath (Lab)]

My Lords, to be fair, I said that that Act had been subsequently amended by the Health and Care Act 2022. If you do not have flexibility through regulation, you will never get anything done in relation to modernising health regulation. Governments simply do not find time in primary legislation to update regulation.

[Lord Patel (CB)]

I hope they do find time, because that allows for better scrutiny and better ability to amend, which we always claim to be our key role—to scrutinise and amend. It is a major piece of legislation to go through using SIs, and it is inappropriate to do so. Maybe we must consider how else we could do it in a way that maintains flexibility.

Moving on from that, as the noble Lord, Lord Harris, already mentioned, if this legislation is going to be the template for future legislation to regulate all health professionals, some issues will need to be discussed. This order does not require that health is considered as a category in the regulation of physician and anaesthesia associates. The statistics show that, when the GMC or, I presume, any other regulator investigates, it is a very stressful situation for the person involved. Some statistics suggest that one in three considers suicide; they are depressed by it. If the category of health is removed as a consideration when a person is investigated, as this order does, it is a backwards step. I need to ask the Minister why health has been removed as a consideration. If this is the template, I presume that this will also apply to other regulations in the future.

Health and Care Bill

Debate between Lord Hunt of Kings Heath and Lord Patel

Lords Hansard - Part 1 & Report stage
Monday 7th March 2022 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, I have put my name to the amendments tabled by the noble and learned Lord and have tabled amendments of my own. As the noble and learned Lord said, his amendments simply take out the HSSIB provisions from the Bill, whereas mine take out the reference to senior coroners.

I think we are all united in supporting the concept of HSSIB improving safety in the health service. A stand-alone Bill in 2019 had a Second Reading in which we were beginning to get to grips with some of the issues around the construct of HSSIB and, particularly, the safe spaces concept. This is very important in the health service because of the traditional reluctance of staff to come forward with information about where things have gone wrong because experience has shown that whistleblowers have often been treated very poorly indeed.

I fully support the concept of HSSIB and safe spaces and believe that if it is implemented properly it will lead to improved safety. However, as the noble and learned Lord has so eloquently pointed out, the problem is that the inclusion in the Bill of the coroner’s ability to access this information would render the whole safe space concept unworkable. Staff will simply not trust it if these provisions are left in the Bill.

We are faced with two options. One is to take out the whole of the HSSIB provisions. Ideally, I would support that because it would benefit from a stand-alone Bill, where we could give it the scrutiny it clearly deserves. On the other hand, our job here is to be constructive as a revising Chamber. On that basis, we would be much safer removing the coroner elements and giving the Government a little more time to discuss this further before the Bill goes on to Third Reading and back to the other place.

I think there are ways through. I have been attracted, for instance, to one solution put forward by the noble Baroness, Lady Brinton, in relation to a memorandum of understanding between the noble Earl’s department and the MoJ. We need to discuss that; in order to do so now, I believe we should remove the coroner provisions from the Bill.

[Lord Patel (CB)]

My Lords, I apologise for rising because I know we need to move on but before I speak to this amendment perhaps I may take the opportunity, as I was not here on the first day of Report, to thank the Ministers for listening—and taking action after doing so on many aspects. I thank them all for that. I also thank all those who sent me good wishes. It helped, and I did not realise I had so many friends.

I shall not speak at length on this group. I have my name on both sets of amendments. The reason I supported removing the whole clause was that there are a lot of issues arising, not just the invasion of the safe space. However, I agree with the noble Lord, Lord Hunt of Kings Heath, that it gives the Government another chance if it is confined to removing the coroner provisions. I agree with what has been said: the medical profession particularly, but even other health professionals, will find it difficult if the safe space of what they say confidentially can be invaded, so I support that proposal.

Health and Care Bill

Debate between Lord Hunt of Kings Heath and Lord Patel

Lords Hansard - Part 1 & Committee stage
Monday 24th January 2022 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, I agree with the thrust of all these amendments. Most of the discussion has been about research—encouraging research in clinical trials within NHS trusts and foundation trusts—but I want to speak in support of Amendment 78, in the name of the noble Baroness, Lady McIntosh, which looks at the issue of commissioning and the role of integrated care boards, because I believe that it is just as important to ensure that integrated care boards have in mind the need, through their commissioning policies, to encourage innovation. In our last debate on NICE, last week, we discussed the same issue, which is the fact that the reason NICE exists is that there are many innovative new medicines and treatments coming on stream, many of them developed in the UK, which the health service has found difficulty in adopting more generally.

The noble Baroness’s Amendment 78, about ICBs, is designed to encourage the ICB boards to consider that they have a responsibility in relation to innovations. It also proposes that integrated care boards must appoint a dedicated innovation officer to the board. I do not want to open up the issue raised by my noble friend Lady Thornton as we went into Committee, but we come back to the issue of the composition of ICB boards. She referred to guidance issued by NHS England a few days ago, which is not obtainable in the public domain. It is obtainable through something called “NHS Net”, but the Library has not been able to get hold of it. It is a bit much that advice on the contents of the Bill has been given out which we cannot even see. I hope that, as part of his response to my noble friend Lady Thornton, the Minister will look into that.

On the question, “Why add another postholder to the board of an ICB?”, I point to the Nuffield Trust report, which says that no organisation in the health service at the moment—or very few places—has someone with a direct responsibility for encouraging innovation. The Nuffield Trust thinks that having chief innovation officers with broad oversight could make what it calls a fundamental difference. I refer the noble Lord to research by the ABHI, which is essentially the trade association for medical devices. It showed that fewer than 20 NHS trusts across the UK have a member of their board with explicit responsibility for the uptake of innovative technologies.

Sometimes one must be wary of having a board appointment that may seem to be a token appointment. However, when it comes to commissioning, having someone around the table who is constantly reminding the board that through commissioning we must encourage and invest in innovation, would be very helpful. The slew of amendments tabled by the noble Baroness, Lady McIntosh, is valuable in getting that message across.

[Lord Patel (CB)]

My Lords, I am seriously concerned, for my sake, that I am invisible to the noble Baroness, Lady Harding—which I regret, but I will tease her about it.

Professional Qualifications Bill [HL]

Debate between Lord Hunt of Kings Heath and Lord Patel

Committee stage
Tuesday 22nd June 2021 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, in introducing this debate, I would like to apologise to my noble friend. I do not think that I was a member of the Better Regulation Task Force. I was the deregulation Minister in the Department of Health for a glorious period of four years, during which time we got rid of a few regulations—but I put through four major Bills to make up for that. Having done that, I was promoted, and I became a Better Regulation Minister in the DWP, the MoJ, Defra and finally DECC, where we were regularly hauled across to Downing Street to be given an absolute bollocking by the Prime Minister for why we were not doing enough to deregulate. Of course, for the other three months, we were called across and asked why we were not doing more to legislate to deal with a specific concern of Downing Street. Life does not change much. This Government talk a lot about deregulation but, my goodness me, they do not half like regulations when it comes to giving Ministers powers. That is really what I would like to explore in this stand part debate.

Clearly, we have had a very illuminating debate this afternoon. Despite the best intentions of the Minister, there is a sense of unease about the Bill, its rationale, the professions to be covered and its drafting. I say to the Minister that I would particularly note the comments from the noble and learned Lord, Lord Hope, when he talked about the unsatisfactory nature of the Bill. Coming from him, those were very telling comments indeed.

My own concern, as I have said, is about the extensive powers being given to Ministers throughout this Bill, and Clause 13 is an example. Clause 13(1)(a), taken together with the definition of legislation in Clause 16(1), means that the powers to which the Delegated Powers Committee has drawn the attention of the House in its report are Henry VIII powers. The powers conferred by Clause 5(2), Clause 6(1) and Clause 10(4) are also Henry VIII powers.

This is just one example of the increasing trend for Ministers to take powers unto themselves without adequate justification or explanation. I know that the Minister has sent a supplementary memorandum to the Delegated Powers Committee, and that we have had amendments to Clause 1, which have been very welcome. But it is noticeable that the Delegated Powers Committee, having considered that, says in its follow-up report that it none the less wishes to continue

“to press the Minister to provide … a much fuller explanation about the provision that could be made in regulations under clause 1; and”—

here it seems to me is the nub—

“full justification for all such provision—including that which amends primary legislation—being made by statutory instrument instead of by primary legislation with its attendant scrutiny.”

I do not want to repeat what I said at Second Reading or in our earlier debates, but the report of the Secondary Legislation Scrutiny Committee must be seen in parallel with the reports of the Delegated Powers Committee. It complains about the number of pieces of legislation that have been introduced, partly in response to the pandemic but partly because of our withdrawal from the EU, which are extraordinary in the powers they give to Ministers. In this Bill so far, the Minister has very courteously defended the use of these Henry VIII powers on what I would call technocratic grounds—in other words, “We need the powers because they are demand-led, and demand will change over time.”

As we have heard today, it is not possible at this moment for the Government to state explicitly where these powers will be used or what organisations or qualifications they will apply to. The Minister has explained the process he is still going through, but you could make the same arguments for any piece of legislation. The question I put to him is this: are we not seeing a general trend towards continuously bringing skeletal Bills in which extensive powers are given to Ministers and of which Parliament has very little opportunity to really go into the details?

The Minister has relied on the need for this Bill in relation to the specific needs of the different regulators, but he has not responded to the constitutional issues raised by it. I have instituted this debate to allow him to do so.

[Lord Patel (CB) [V]]

My Lords, to add to what my friend, the noble Lord, Lord Hunt of Kings Heath, has said, I will concentrate mainly on Henry VIII powers, which apply to other clauses in the Bill, not just Clause 13.

Henry VIII clauses allow Ministers to amend or repeal provisions in an Act of Parliament using secondary legislation. I tried to look up what the laws might say about Henry VIII powers being adopted. For those not familiar with them, Halsbury’s Laws of England provides the following description:

“As a general rule, primary legislation amends other primary legislation but leaves subordinate legislation to amend itself; subordinate legislation frequently amends other subordinate legislation, but mostly does not amend primary legislation.


Powers conferred by statute cannot be assigned without statutory authority, and whether they can be delegated depends on the construction of the statute. It will be assumed by the courts that Parliament does not delegate legislative or other power unless it does so by express provision or unavoidable implication; and provisions conferring power will be construed strictly against the person on whom the power is conferred.


An Act of Parliament may contain a power to make subordinate legislation which in turn can amend the enabling Act or another piece of primary legislation. The clause of the Bill containing such a provision allowing primary legislation to be amended by secondary legislation is commonly termed a ‘Henry VIII clause’ and the power itself is likewise called a ‘Henry VIII power’”—


terms familiar to us all. It goes on:

“The normal principles of statutory construction apply to Henry VIII powers but the courts will apply a restrictive interpretation if there is any doubt as to the scope of the power.”


The noble and learned Lord, Lord Thomas, who is speaking on this group, may wish to comment on that.

--- Later in debate ---

[Lord Hunt of Kings Heath (Lab)]

My Lords, I will carry on with the theme of the previous debate, which was very interesting in relation to statutory instruments and how far they afford us an opportunity to scrutinise provisions in the Bill.

I believe one solution to the challenges facing the Bill is to sunset the whole Bill. I am putting this forward as a proposition for discussion now between Committee and Report. It is not the only solution. The noble Lord, Lord Lansley, also had an interesting amendment earlier which seeks to deal with the issue in a slightly different way, but nonetheless is worthy of consideration.

The Government’s defence, if you like, of parliamentary scrutiny is that the orders that come as a result of the use of the Act, when enacted, will come before Parliament in the form of statutory instruments, and most of them will be affirmative. The noble Baroness, Lady Randerson, asked what that means in practice. Since the Second World War, five statutory instruments have been defeated in your Lordships’ House. We also had the debate on tax credits in 2015 where we agreed two amendments to the Motion to approve the tax credit regulations. They sought essentially to delay consideration of the regulations until certain conditions were met. The Government were very cross about that, but the fact is that they decided not to proceed and one can say that the Lords defeated that statutory instrument, so six since the Second World War.

The Minister says, “Ah, but Parliament can debate them and scrutinise them in relation to an affirmative instrument”, and I accept that most will be affirmative, it means nothing. All we get is an hour’s debate, at most. We can put a regret Motion down, but what does that mean? Ministers take no account of regret Motions. It makes us feel better because we have a vote and defeat the Government, but it is meaningless.

This is the whole problem with the parliamentary appraisal of secondary legislation. It was not really considered when the Parliament Act was first introduced. We have an absolute veto, but because it is an absolute veto we feel very reluctant to use it. In effect we have no leverage whatsoever. As the noble Baroness said, apart from the imaginative use of the 2015 regulations, we cannot amend statutory instruments either. My suggestion is that the only way to deal with this, if the whole of the Bill needs to go forward, is a sunset clause.

Sunset clauses, as the noble Lord, Lord Purvis, reminded us on the second day in Committee, are not unknown to the Minister, who has just taken through the Trade Act, which has sunset provisions. The power there, I gather, is for five years, with an option for another five years through regulation. It simply ensures that if changes are made in that period, Parliament has the opportunity to scrutinise them again through debating further primary legislation. The noble Lord, Lord Purvis, asked for some form of comparable treatment in this Bill, and the Minister said that there is a difference, in that the trade agreements in the Trade Act are rollover agreements, many of which will be replaced in due course by other agreements. He argued that what we are talking about in this Bill are mutual recognition agreements rather than rollover agreements, and that there is a distinct difference. Up to a point, Minister, up to a point. It strikes me that there are some parallels. We currently have a status quo in relation to the existing regulation of professional qualifications. In time, we can expect more mutual recognition agreements to come forward and, as with the Trade Act, surely it is not unreasonable for Parliament to be able to scrutinise them properly and in primary legislation after a period of years.

Sunset clauses provide an expiry date for legislation and are used in circumstances where it is felt that Parliament should be given time to decide on its merits —again, after a fixed period. This is certainly one avenue we need to explore if the Bill is to be taken any further. I beg to move.

[Lord Patel (CB) [V]]

My Lords, I support the amendment of the noble Lord, Lord Hunt of Kings Heath, which would insert a sunset clause into the Bill. Why do I say that? Because many of its clauses, as we have already discussed, take Henry VIII powers and the intent of those clauses is not quite clear. The sunset clause overview states that a such a clause provides an expiry date for legislation:

“Sunset clauses are included in legislation when it is felt that Parliament should have the chance to decide on its merits again after a fixed period.”


Sunset clauses let Parliament reassess the legislation at a later date, once it is clear how it has been used in practice and how suitable it is to the policy challenge at hand.

The introduction of a sunset clause is also a useful method of reaching political compromise. It is clear from our discussions that we do not quite agree with a lot of the clauses. Reaching political compromise in the case of a controversial or sensitive provision allows the Government to make the provision they need for the time being, while building in a statutory guarantee of review of and parliamentary control over the Bill. In that respect, it is also good for the Government: they get their Bill through but it includes a sunset clause to allow Parliament greater scrutiny.

I was interested to see the guidance on the use of sunset clauses. The Government published guidance, through BEIS, on the better regulation framework in March 2020. This was written for government departments and explains how the better regulation system should operate. Section 1.5 of the guidance provides the following information on the use of review and sunset clauses:

“At an early stage in policy development,


government departments

“will need to consider whether either a statutory review clause is required or a sunset clause is appropriate … Sunset clauses are not a requirement, but a tool for policy makers to use where they are deemed appropriate and impose an automatic expiry of the measure on a specified date … and ensure scrutiny of the decision on whether or not to renew the regulation.”

On that basis, a sunset clause is the ideal way to deal with this Bill and the powers it takes through its different clauses, and I therefore support it.

Professional Qualifications Bill [HL]

Debate between Lord Hunt of Kings Heath and Lord Patel

Committee stage
Wednesday 9th June 2021 Lords Chamber

[Lord Patel (CB) [V]]

My Lords, I am grateful to the Minister for these amendments, as I have spoken at length about the problems that would have been created for the General Medical Council otherwise. I am also grateful that he had extensive consultation with his officials and the General Medical Council. As he said, the General Medical Council is grateful to him for bringing forward these amendments.

Having said that, I would like the Minister to confirm on the record that any determination made by a regulator on whether a professional is able to join a register can be based on an assessment of the individual’s knowledge, skills and experience rather than solely on qualifications. Can he further confirm that the regulator would be able to make such an assessment using whichever method they found appropriate, including existing tests of competence and any other test they might develop in the future when it is found necessary?

I also support the probing amendment from the noble Lord, Lord Lansley. When the General Medical Council considers qualifications and experience, it takes into account the experience that the individual may have gained in his or her own country, but it also has the power to look at the experience that the individual may have gained subsequently outside their country. The amendment sought by the noble Lord, Lord Lansley, seems appropriate and I would be interested in the Minister’s response, but, at this juncture, I thank him for his amendments, and I support them.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I refer to my interest as a member of the GMC board for the sake of this group of amendments. Like the noble Lord, Lord Patel, I welcome the government amendments and thank the Minister for his discussions with the regulator. I listened with great interest to the comments and queries of the noble Baroness, Lady McIntosh, about the amendments. In a sense, they reflect the generic and skeletal nature of this Bill, which means that each clause has to relate to many different professions. Frankly, I think it argues for a more detailed Bill, which would meet her issues as well as mine.

The argument that the GMC and others have put is very simple. Clause 1 currently gives power to the appropriate national authority—in the case of health regulators, the Secretary of State for Health and Social Care—to draft regulations to introduce a process that will require them to assess whether someone has a particular overseas qualification that is substantially the same as a UK qualification. In the case of the GMC, a person so deemed would then be eligible to practise as a doctor in the UK. That is because the GMC does not require those with UK qualifications to do anything further to demonstrate that they have the necessary knowledge and skills for registration. This could give an automatic entitlement to practise, under the current provision of Clause 1, for international medical graduates on the same basis as UK graduates. Currently, GMC has a very rigorous process for assessing whether the international medical graduate is safe and fit to practise. Without these amendments, it would be almost impossible for the GMC to manage operationally, with 10,000 international medical graduates applying for registration each year. It would be virtually impossible to assess this number of qualifications from countries as diverse as India, Pakistan, Nigeria, UAE and many others, with hundreds of different medical schools. The concern was that the Bill as drafted could force health profession regulators to accept professionals into UK practice in a way that compromised patient safety.

The Minister was sympathetic, and I am very grateful to him. However, there remains the issue of the relationship of Clause 3 to Clause 1, which we will come on to debate. In relation to the amendment from the noble Lord, Lord Lansley, he clearly has a point. I hope the Minister might take this away and give it further thought.

Medicines and Medical Devices Bill

Debate between Lord Hunt of Kings Heath and Lord Patel

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I hesitate to disagree with my noble friend, but I think it is on page 34—but then, of course, I might have an old edition of the Bill as well, just to confuse things.

The reason for supporting this is the unease about provisions in Clause 27 and Schedule 1. The Delegated Powers Committee concluded that

“in the absence of a full justification … allowing the ingredients of criminal offences … and … the penalties for existing offences to be set by delegated legislation”

amounts to “inappropriate delegations of power”. The Constitution Committee said:

“We have concluded previously that ‘the creation of criminal offences through delegated powers is constitutionally unacceptable’, save for exceptional circumstances. The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”


The Minister has made certain modifications, but I think the general principle still holds good.

The guidance to be issued under paragraph 13 of the schedule is likely to be extensive, including: the imposition of a monetary penalty; the notices to the person it is proposed to fine and the grounds for so doing; the representations that have been made; the appeals process; and the consequences of non-payment. As my noble friend said, lines 9 and 10 on page 34 provides that

“The Secretary of State must have regard to the guidance or revised guidance published under this paragraph”.


Given that the Secretary of State is the person publishing the guidance, it is puzzling that he or she is required only to “have regard to” the very guidance that he or she has published—hence my noble friend’s amendment to require the Secretary of State to “act in accordance with” the guidance. I look forward to hearing from the Minister as to why the Bill is drafted to give the Secretary of State wider discretion on that.

[Lord Patel (CB) [V]]

My Lords, I speak very briefly to support this amendment. The noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt of Kings Heath, have covered the argument extremely well. As the noble Lord said just now, the guidance is produced by the Secretary of State but, when you look at it in practice, it says that the Secretary of State “must have regard to” the guidance—that is, can take note of it but does not have to follow it.

I am a doctor and am used to following guidelines. If I do not follow the guidelines, I am liable to be reported; if I do not follow them for any reason in the management of a patient, I am expected to write down as to why I did not follow them. I am not expected to take note of it or have regard to it—I am expected to follow it. The amendment proposed by the noble Baroness, Lady Thornton, addresses exactly that point: why is the Secretary of State not asked to follow the guidelines which he or she drafted?

Medicines and Medical Devices Bill

Debate between Lord Hunt of Kings Heath and Lord Patel

Committee stage & Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wednesday 4th November 2020 Grand Committee

[Lord Patel (CB) [V]]

My Lords, this amendment was tabled by the noble Lord, Lord Lansley, who unfortunately is not able to attend today. My name is on the amendment and I am very pleased to move it in his name.

This is an amendment that normally one would have thought the Government would have no difficulty in accepting, because it was in the Conservative manifesto at the time of the election. So if you are going to choose an amendment, choose the one that they cannot turn down. I am in the good position of making two speeches, one in the name of the noble Lord, Lord Lansley, and one in my own name. It will be interesting to see which one the Minister accepts, because I am not going to tell her which one is which—I may as well enjoy this while I can.

Patients in the UK often face delays in accessing breakthrough innovations due to the NICE technology appraisal process. This is particularly true of treatments for smaller patient populations, such as patients with rare diseases, where there is greater uncertainty around effectiveness due to the challenges of collecting sufficient data to satisfy NICE’s requirements. To overcome similar challenges and enable access to the latest cancer treatments, in 2016 changes were made to the Cancer Drugs Fund, to increase NICE’s flexibility in decision-making. Between July 2016 and November 2019, approximately 41,000 patients were registered to access 79 drugs, used to treat 160 different cancer conditions. Despite the clear benefits to patients, similar flexibilities have not been extended to other areas such as gene therapy and gene silencing—treatments for rare diseases where there is not much treatment available.

Amendment 28, in the name of the noble Lord, Lord Lansley, would add a clause to the Bill that would require the Secretary of State to establish the innovative medicines fund. This fund was promised in the 2019 Conservative manifesto. Like the Cancer Drugs Fund, its purpose would be to bring innovative medicines into use in the NHS. It would give NHS patients in England access to the latest new medicines, as advised by clinicians, and would give the NHS and NICE valuable data on their effectiveness, often adding information about drugs being used in clinical practice which is not normally available through clinical trials alone. There is an increasing need to extend these access schemes to disease groups beyond cancer, including neurodegenerative conditions such as motor neurone disease and Parkinson’s, as well as haemophilia, cystic fibrosis and sickle cell disease. These are diseases with a high unmet need for treatment, but also with real hopes for new treatment options, including gene therapy and gene silencing, as I have already mentioned.

This amendment would amend Section 261 of the NHS Act, which provides powers for the pharmaceutical voluntary price and access schemes, often known as VPAS, as amended by the Health Service Medical Supplies (Costs) Act 2017. An essential part of VPAS is to improve access to innovative medicines. The new fund would help to deliver this, alongside the MHRA Early Access to Medicines Scheme that we have already heard about. The predecessor to VPAS was the Pharmaceutical Pricing Regulation System. However, over the years, lack of access to innovative medicines has been a source of angst in the industry about the scheme and, for many of us, is part of a system that fails patients. It was not only industry that did not like the scheme; it was denying treatments to patients. We should not have a stand-off between the NHS and drugs companies, with patients losing out in the process. We should have a scheme that adequately rewards the value that is inherent in medicines and also ensures that the NHS is able to provide the treatments that patients need.

The current VPAS sets a budget limit on the NHS drugs bill. If it is exceeded, the industry will provide a rebate. In the past, the NHS has seen rising drug costs but has not seen the rebate—so the NHS took the rebate but did not reinvest it in other innovative medicines. By way of the Innovative Medicines Fund, the NHS, the life sciences sector and patients would all see the benefit of the rebate. The proposed new clause would require the rebate to be made available to the fund, and it is that rebate which will provide the money for the fund. I hope—and I hope that the noble Lord, Lord Lansley, will agree—that it will be open to Ministers to take advantage of these powers to provide additional resources to the fund, according to its needs. The clause will provide the means by which the Government can deliver on their manifesto pledge and, in doing so, deliver to patients, some of whom are in great need.

I do not see how the Government can resist Amendment 28; they can only improve on it. I beg to move.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I am glad to support the noble Lord, Lord Patel, and I have a great deal of sympathy with this amendment. Of course, I speak as one of a long line of former Ministers who have wrestled with the tension between a cash-restrained NHS and the imperative to invest in new medicines and devices. I have come to the conclusion that we are not going to see the investment we want to see in these new medicines without a radical change of approach.

When we debated access in Grand Committee a couple of meetings ago, the Minister used words to the effect that he would not go anywhere near reimbursement. That is at one with the way the NHS regards drug costs: as a price and a cost to be pared down rather than as an investment in patient care. The unwillingness of Ministers to tackle the issue of reimbursement to the industry in a way that incentivises the use of new medicines is, I think, very disappointing. I do not think that there is any way around this, unless we top-slice some of the resource for the NHS and distribute it separately for investment in new medicines.

The noble Lord, Lord Patel, referred to current and previous agreements with the industry. I want to go back to the 2014 PPRS agreement, which does I think provide a model for us. It provided assurance on almost all of the branded medicines bill for the NHS, so the bill stayed flat for the first two years of the scheme and grew slowly after that. The industry made quarterly payments to the Department of Health when NHS spending on branded medicines exceeded the allowed growth rate. The quarterly payments that the industry made could have been used to fund new medicines—but, as the noble Lord, Lord O’Shaughnessy, mentioned last week, it is very hard to explain what exactly happened. With a cap in place and with reimbursements being made by the industry, the NHS proceeded to try to ration drug costs at local level. So, instead of having a virtuous circle where essentially the industry guaranteed the cap on drug costs in order to allow for investment in new medicines, we had a double whammy. The industry price was pared down and the NHS continued in its bad old ways of trying to prevent new medicines being accessed by patients.

Medicines and Medical Devices Bill

Debate between Lord Hunt of Kings Heath and Lord Patel

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

[Lord Hunt of Kings Heath (Lab)]

I have added my name to Amendments 4, 52 and 69, which would remove the provision for criminal offences to be created by delegated legislation.

The Government are developing a reputation for riding roughshod over the law, personal liberties and the role of lawyers. Indeed, the Internal Market Bill, debate on which is taking place in the Chamber today, is a reflection of that.

I am afraid that this Bill continues that trend, as indicated by the Delegated Powers and Regulatory Reform Committee in its very direct criticism of the criminal offence provisions. The committee drew attention to provisions in the Bill which give Ministers powers to create and modify imprisonable offences by statutory instrument. Thus regulations under Clauses 1 and 8 may create a criminal offence of failing to comply with provision made in such regulations that is punishable by imprisonment up to two years. Regulations under Clauses 1 and 8 may also amend the dozens of offence-creating provisions in the existing regulations. Regulations under Clause 12 may create new criminal offences relating to medical devices that are punishable by imprisonment for up to one year. Schedule 2 inserts a new regulation 60A and a new schedule into the 2002 regulations which make it a criminal offence, punishable by imprisonment for up to one year, to breach any of the provisions in the 2002 regulations that are listed in the new schedule. It goes on: Clause 14(1)(d) provides that regulations under Clause 12 may amend the new Schedule 30.

The powers conferred in all these provisions give rise to two concerns. As the Select Committee reported, it has previously expressed the view that it expects a compelling justification for the ingredients of a criminal offence to be set by delegated legislation. The powers in Clauses 1, 8 and 12 would allow Ministers to create completely new criminal offences and make changes to the ingredients of existing offences, yet the memorandum does not appear to contain any justification at all for this. The committee also points out that it has also said that where the penalty for a criminal offence may be set by delegated legislation, it would expect the maximum penalty to be included in the Bill, save in exceptional circumstances.

While the Bill limits the maximum penalty for offences created by regulations under Clauses 1 and 8, it is unclear whether this limit also applies to the many existing medicines offences which could be modified by regulations under Clause 1 or Clause 8. Again, the memorandum does not appear to shed any light on this. The Minister in his Amendments 43, 44, 64 and 65 has attempted to soften the pill by ensuring that regulations under Clause 1 (1) and Clause 8 (1) may not provide for an offence to be punishable with a sentence of more than two years. That is obviously welcome, but I do not think it goes far enough. From my reading of the amendments—no doubt we will hear about them later—they do not deal with the other substantial concern of the committee that the powers in Clauses 1, 8 and 12 would allow Ministers to create completely new criminal offences and make changes to the ingredients of existing offences. Given that, I do not think we can allow these delegated powers to be retained in the Bill. I beg to move.

[Lord Patel (CB) [V]]

My Lords, I shall speak to Amendments 42 and 63, in the name of the noble Baroness, Lady Thornton, to which I added my name and to which the noble Lord, Lord Hunt of Kings Heath, has just alluded. I also have my name to Amendment 92 in the name of the noble Lord, Lord Pannick, and the noble and learned Lords, Lord Mackay of Clashfern and Lord Judge. Noble Lords can immediately tell that I must be the tenth reserve speaking on this important amendment, but the noble Lord, Lord Hunt of Kings Heath, has laid out very clearly the problems with the government amendments that were brought in and the powers they seek.

I shall be brief on this as the Constitution Committee report spelled it out in its last line:

“The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”


It was making a constitutional point.

As the noble Lord, Lord Pannick, who is a member of the Constitution Committee, cannot be here, I shall speak on his behalf. Paragraph 21 of the Constitution Committee’s report states:

“We have concluded previously that ‘the creation of criminal offences through delegated powers is constitutionally unacceptable’, save for exceptional circumstances. The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”


The noble Lord, Lord Pannick, went on to say that the response of the Minister, the noble Lord, Lord Bethel, that regulations cannot be used to provide for an offence to be punishable with a sentence of imprisonment of more than two years is not satisfactory. A sentence of imprisonment of up to two years is a very serious matter. Parliament, not Ministers, should decide when such a potential sentence should be available to the courts.

Access to Medical Treatments (Innovation) Bill

Debate between Lord Hunt of Kings Heath and Lord Patel

Friday 26th February 2016 Lords Chamber

[Lord Patel (CB)]

My Lords, I am delighted to support this Bill and hope that it will have a swift passage through this House and become legislation. I congratulate the noble Lord, Lord Saatchi, on presenting it in great detail and in his usual style, and—given the difficulties his predecessor Bill had—on his tenacity in listening to people in and outside this House and getting to the position whereby the Bill is now acceptable to all the professionals I have spoken to.

Perhaps I may briefly go off the Bill and come on to some comments that have been made. Before I do that, I will declare my interests. I am, as everybody knows, a doctor by background. I am the chancellor of the University of Dundee, which is one of the key UK universities for life sciences. I chaired until recently the UK cancer research centre in Dundee. I now chair, as a board member, another research group in Dundee that is looking at the scientific evidence as to why cancer outcomes can be worse among people from a poorer background, where they are disastrously worse. I was also responsible in this House for chairing a report on genomic medicine. That led, thankfully, to the developments in genomic medicine in the United Kingdom and the research centre which the Government support through the research councils.

It is true that as we learn more and more about genomics and genetics, we will need to have a huge database from which we can learn. What the noble Lord, Lord Ryder, said is correct: there will be patients who would be appropriate for stratifications of medicines that we know now and which are found to be effective because they are used more generically. If we learn from genomic medicine that stratification makes them more suitable for that treatment, because of their genetic make-up, such drugs will be very beneficial.

It is also true that innovations occur in the United States at a faster rate—the noble Lord, Lord Ryder, referred to this—because the processes of the different trial phases there are much more efficient. Some say they are too quick; I do not subscribe to that view. Let me give one example. The noble Lord referred to this concept briefly. Some of the breast cancer treatments do not work in all women. We know that the drug that is given will work but that it cannot be given in the quantities required because most drugs, as we know, are poison. You can use it in a dosage that will treat the disease but if you exceed that dose, you are likely to do more harm than good. But if you can limit that treatment to only the cancer cells, those drugs will be effective. We now have innovations whereby this can be done by identifying the molecular make-up of the cancer and then loading the drug with that molecular marker, so that it will attack only the cancer cells and leave the normal cells alone.

We need a different way of innovating. My own university also has a drug discovery unit. We have contributed to the development of several drugs, two of which would be regarded as blockbuster drugs, through understanding the science of disease processes—the biology of disease. Such understanding is crucial before you develop a treatment.

However, we need to move away from that to other ways of developing drugs. We try to do this by using 70,000 compounds that were previously identified by pharmaceutical companies but not used because they were not found to be effective in treatment. We are seeing if any could be used for the treatment of so-called tropical diseases that are not infectious, which a huge number of people are affected by. We do this in collaboration with other countries by supplying them with these compounds. I agree that we need to look at different ways of innovating drugs and treatments, particularly as the science develops. There will be other ways of dealing with diseases, such as gene-editing, which was how Layla, a young girl in Great Ormond St, was treated. That may also require the development of other drugs to make sure that side-effects are suppressed.

The point I am trying to make is that the Bill may well act as a catalyst. The noble Lord, Lord Saatchi, should be pleased that people are thinking more widely and outside the box. We have an opportunity to develop good databases, as the noble Lord indicated, and to use them for innovative development of treatments. I hope this will happen. I hope that the Government will bring in wider legislation on the issues that the noble Lord, Lord Ryder, referred to, such as better ways of conducting clinical trials. We need transparency and openness. I do not think the medical profession is averse to that, and it is what the public need. We have to be honest: not all the treatments we try will work, but if we try harder, we will find treatments that work which we have been ignoring.

I have to admit to something here, which I hope the GMC does not hear me say—although it might, and if it does, I do not care. I have used off-licensed drugs on several occasions, with the full consent of the patients I was treating, when no other treatment was working. Lots of my colleagues do this. If any doctor stands up and says they never do it, I would not suggest that they might not be telling the truth, but I would be surprised if they were innovators in the true sense.

Then, there is research. I have done research that I am not very happy about and that I wish I had not done, but at the time I did it with a clear conscience. In retrospect, I now know that it probably did not work as well as expected and was probably not all that good for the patient—I hope it did not do any harm—but if I had not tried it, I would never have known. It is important that we stop arguing at length and trying to regulate and control in the minutest detail innovations in medicine that we can drive forward. We do this more easily with innovations in surgical and other procedures. We are much freer about that and clearly understand that, as doctors, you work with people in other countries to introduce the same procedures and use a common database to learn.

[Lord Hunt of Kings Heath (Lab)]

Would many current surgical procedures have been authorised if they had had to go through the kind of clinical trial process that medicines do?

[Lord Patel]

We would not have had stents put in hearts, bypasses, ablations—

National Health Service: Sustainability

Debate between Lord Hunt of Kings Heath and Lord Patel

Thursday 9th July 2015 Lords Chamber

[Lord Patel]

I thank the Minister for his response, and I am encouraged by his last comments. A 10% gain is still a gain—I would not have expected him to agree. By the way, I did not use the words, “royal commission”. I asked for an independent commission. I understand why political parties may not like the idea of a royal commission, but I am encouraged by what the Minister said.

I am grateful to all noble Lords who have taken part. It has been an excellent debate and the stature of those who have spoken indicates the interest in the subject. I do not think that the matter will be left today, just for another debate. I have to say to the noble Lord, Lord Hunt, that I get the feeling that political parties want to keep the health service in some trouble all the time, so they can use that for the next election.

[Lord Hunt of Kings Heath]

My Lords, the noble Lord is far too cynical.

[Lord Patel]

I wonder what makes me cynical.

General Medical Council (Fitness to Practise and Over-arching Objective) and the Professional Standards Authority for Health and Social Care (References to Court) Order 2015

Debate between Lord Hunt of Kings Heath and Lord Patel

Tuesday 17th March 2015 Grand Committee

[Lord Patel (CB)]

My Lords, I rise briefly to support the order. I declare an interest that, maybe for a short while only, I am a licensed practitioner and a registered practitioner, and the rules of the GMC may not be sufficient for me to revalidate.

However, the issue to which I want to refer is the separation of the functions, of which I approve—we have discussed that many times—but for the fact that the GMC can appeal against the decision made by the MPTS. Its role becomes that of an adjudicator as well. I would like the noble Earl to clarify that. I know that in the consultation process there were the same number of responses—39, as mentioned by the noble Earl.

Another issue that we have discussed before is that these changes are welcome, but there are other changes that the Law Commission identified in its report, published in April 2014, on the regulation of health and social care professionals Bill. The Government indicated that they would bring in legislation to deal with all the issues. This is obviously a piecemeal measure taken out of that Bill, so the noble Earl may want to comment on that.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I, too, thank the noble Earl for introducing the order. I shall say at once that the Opposition support it. Like the noble Lord, Lord Patel, we are disappointed that it is yet another Section 60 order being considered in Committee. We should have had the Law Commission Bill, either in pre-legislative scrutiny or in its substantive form. It is disappointing that we are having to deal with these various professional regulation bodies in such a piecemeal fashion.

That said, on the question of the overarching objective, we very much support that and the three pursuits set out in Article 21(1B),

“to protect, promote and maintain the health, safety and well-being of the public … to promote and maintain public confidence in the medical profession, and … to promote and maintain proper professional standards and conduct for members of that profession”.

I want to pick up the point raised by the noble Baroness, Lady Finlay, and the British Medical Association. I suppose it is an issue of proportionality. In its report, the Law Commission expressed concern about examples given, suggesting that regulators were inappropriately imposing moral judgments in essentially private matters under the guise of maintaining confidence. The BMA has raised the issue of whether the order might end up punishing doctors who pose no threat to the health and safety of the public, on the basis that failure to do so might incur the public’s disapproval. The Law Commission has urged regulators to look carefully at regulatory interventions that do not take some colour from the need to protect the public.

This is a very important point. I have been very impressed with the GMC and the way in which it has improved its procedures and processes—and certainly with its current leadership. However, there are other regulators, perhaps not so much in the health sector, which clearly lack confidence and which are very much influenced by the flow and ebb of media comment and potential political interventions. I think that we have to be very careful about regulators which, in a sense, lose confidence in their own ability to make common sense judgments, and then have knee-jerk reactions in the face of media storms. I hope that the noble Earl will agree that that is not the intention in the case of the health regulators, and like me, he will express confidence, particularly in the GMC to apply common sense judgments in response to the points raised by the noble Baroness, Lady Finlay.

I now come to the question of the Medical Practitioners Tribunal Service. The Minister referred to the fact that the consultation demonstrated strong support for enhancing the GMC’s investigative and adjudication roles, but that 52% of respondents took the view that creating an entirely independent body would be preferable, with only 27% supporting the proposal to put the MPTS on a statutory footing.

We must refer in particular to the evidence of the Professional Standards Authority. It,

“did not agree that the proposals to establish the MPTS as a statutory committee of the GMC would achieve the aim”,

of appropriate separation of function. It commented that,

“former and current members of GMC staff should be excluded from sitting on medical practitioner tribunals or interim orders tribunals … The PSA also asked about the ability of the GMC to make rules delegating functions from the MPTS committee to ‘officers of the Council’”,

and it,

“referred to the fact that case managers will be paid by the GMC, but case managers will be performing a statutory office”.

The PSA was obviously concerned that because those managers were paid by the GMC, they might come under undue influence. As the Explanatory Memorandum points out, the PSA,

“conducts annual performance reviews of each of the health and care professional regulatory bodies”.

I would like the noble Earl to explain why the views of the PSA, above all others, were ignored in relation to this issue.

To pick up the point raised by the noble Baroness, Lady Finlay, about guidance, again, the Explanatory Memorandum says that:

“The Department does not intend to publish any guidance in respect of”,

this statutory instrument but that the GMC,

“will publish guidance as appropriate”.

Is the Minister in a position to respond to the noble Baroness about what kind of guidance will actually be produced?

However, overall I believe that the GMC has made great strides in recent years. It deserves to be supported for what it is doing. I accept that this will speed up processes to protect the public and provide more and better information about doctors on the register. It will improve doctors’ education and training and increase efficiency, and on that basis we are very glad to support the order.

Care Bill [HL]

Debate between Lord Hunt of Kings Heath and Lord Patel

Wednesday 7th May 2014 Lords Chamber

[Lord Hunt of Kings Heath]

My Lords, I will speak to my Amendment 45D, although I may speak to the other two amendments, in the names of the noble Lords, Lord Owen and Lord Turnberg, as well, because they are relevant to the whole debate.

There is no question that the NHS has a rich reservoir of patient information. If we can exploit it to the full, its use could enhance care, aid early diagnosis and be a rich source of data for the development of new medicines and treatments. There is no argument at all here between the Opposition and the Government on this. The noble Earl reminded me that I took through legislation in 2002 that set the foundations for what we are now debating. He will recall that I was then arguing for us to use the potential of NHS information to the full. The noble Earl then, supported memorably by the noble Baroness, Lady Cumberlege, was a mite worried, I recall, about patient confidentiality. I think, however, that we reached a broad consensus that this is information to be brought together and used, but alongside safeguards that have public confidence. This is simply the issue that is before us at the moment.

Under the extension of the scheme, the Health and Social Care Information Centre can require GPs to upload patient data in an identifiable form from every GP practice in England. This will be linked to the Hospital Episode Statistics and other data sets. The information centre is a body corporate that can require a health and social care body to provide information—including confidential information. That is all well and good. The problem is that the centre and NHS England have botched its implementation, so much so that the scheme had to be withdrawn, originally for six months until the autumn, but my understanding is that the chief executive of the NHS, in evidence to the Health Select Committee, said that that date no longer applied. Perhaps the noble Earl could, when he winds up, comment on that.

My own view is that this is a dead duck. The Government will not be in a position to enable the scheme to go ahead any time before the election because so much public confidence has been lost. This is not surprising. Clearly, the information centre and NHS England took an inadequate approach in their public communications effort and there was a lack of effectiveness and accountability. It is clear that there are concerns about whether such information can be kept confidential in practice, and there is a worry that pseudonymised data could, in certain circumstances, be manipulated to identify a particular patient. There have also been concerns, referred to by my noble friend, about inappropriate use for commercial reasons, such as by insurance companies. I make a big distinction here: I would want the pharmaceutical industry to be able to use that information in research and development. That is absolutely legitimate.

There is also concern about general practitioners and their approach. Before the decision was made to suspend the scheme, there were worrying signs that a number of GP practices would not co-operate or would advise their patients to opt out of the system. It is important to recognise that we will automatically be part of the system as patients unless we opt out. Again, I agree with that principle. It is the only way to operate it. However, I am not convinced about having to go to my GP, if I can get an appointment, which is quite arguable at the moment, and having to talk to my GP—or, even worse, the receptionist—to say that I want to opt out of the scheme. There are real concerns about this system. Unless the GP body as a whole is confident that it is going to run with this, it will be destroyed because so many people will be encouraged to opt out that it will not achieve what it is meant to achieve.

I agree with the Royal Statistical Society which argues that we need a robust response to restore public confidence. Of course, I welcome the changes that the Government have made as a result of debates in the other place and in your Lordships’ House. The question, however, is: do they go far enough to restore public confidence? In my view, they do not. The Government have to make the bold statement that the system cannot be allowed to run under the people who are running it at the moment. They have lost people’s confidence. I cannot put this across strongly enough to the Minister: if you talk to organisations that know about the subject, you find that they are clear that they now do not have confidence in the people who are running the system.

That is why the Motion of the noble Lord, Lord Owen, is so important. He is basically saying that we need an external body that is independent and can give total oversight to the scheme. I support my noble friend’s amendment as well. I agree that it would be better in primary legislation than secondary, but there is no harm in having some secondary legislation to back up what we may agree in your Lordships’ House today.

In the Commons, the Government introduced amendments regarding the use of the term “promotion of health” for the purposes of the dissemination of information. Of course, “the promotion of health” could be a very open-ended definition. There was some fear in the other place that commercial companies—say, food and drink companies—could argue that they needed information for a public health campaign. My Amendment 45D seeks to provide reassurance by asking for regulations to be laid that are explicit about the circumstances in which information concerning the promotion of health can be used.

In supporting my own amendment, I say again to the Minister that there is no disagreement whatever about the importance of care.data, about the need for it to be successful or about the huge benefit to our country if it becomes successful. Success, though, is not guaranteed, and at the moment I believe it is unlikely unless the Government make changes. I hope that the House and the Minister will be sympathetic to these amendments.

[Lord Patel (CB)]

My Lords, I will speak very briefly. I will not repeat everything that has been said but I support what was said by the noble Lord, Lord Turnberg, particularly about the use of data for biomedical and other medical research. I have been involved on several occasions with perinatal epidemiological research, and such data are vital for that. There is no doubt that we need to be certain that core data will be available for research purposes.

I had not thought that “the promotion of health” might be construed as applying to the food industry; I had interpreted the phrase to mean epidemiological and public health research. However, if the interpretation includes the promotion of health by the food industry, then of course I support it absolutely.

I would be content to have this in secondary legislation at this stage, as the noble Lord, Lord Hunt, mentioned. However, there is no doubt that the way in which the issue has been handled by Public Health England has lost confidence. It could have been handled better, and I hope that Public Health England has learnt lessons from it.

Health: Cardiology

Debate between Lord Hunt of Kings Heath and Lord Patel

Wednesday 6th March 2013 Lords Chamber

[Lord Hunt of Kings Heath]

My Lords—

[Lord Patel]

My Lords, will the Minister explain a little bit more about the proposed public consultation on screening? The evidence for the screening of families where a cardiac death has occurred, particularly in a young person—which is linked to a gene—is conclusive, so what is the public consultation about?

Health and Social Care Bill

Debate between Lord Hunt of Kings Heath and Lord Patel

Wednesday 8th February 2012 Lords Chamber

[Lord Patel]

My Lords, I pay tribute to the noble Earl for how he has met our concerns in the Committee debate on education and training. The noble Lord, Lord Walton, mentioned Amendments 13 and 16. To me, Amendment 13 is crucial. The reason I degrouped them is because Clause 6 addresses the Secretary of State's responsibility for education and training. I hope that we will have the debate about the issues that he raises when we debate Amendment 13. I agree with the amendment of the noble Lord, Lord Turnberg—Amendment 16—which provides that universities need to take a greater part in education and training than they have hitherto.

[Lord Hunt of Kings Heath]

My Lords, as this is a new stage of the Bill, I should declare a number of interests which are also listed in the register; I am chairman of the Heart of England NHS Foundation Trust, a consultant and trainer with Cumberlege Connections, president of the British Fluoridation Society and of the Royal Society for Public Health.

I put my name to Amendment 2, tabled by the noble Baroness, Lady Finlay, which has perhaps not received as much enthusiasm as I would have wished from noble Lords, who have pointed to Clause 6. Behind her amendment is real concern to ensure that we will train enough health professionals in the years ahead and that they will be of sufficiently high quality. There is some history here. I very much support devolving as much as possible decisions about the commissioning of training places to local NHS organisations. I warmly welcome the work of Dame Julie Moore and her team, who have produced the report. She is chief executive of the UHB Foundation Trust in Birmingham and brings a lot of expertise to that position. Some noble Lords will have been to a seminar where the report was debated. I have no argument with its general thrust, but we know from experience that when money is tight, the NHS reduces the number of people that it trains and its training budget. That always happens and, a number of years later, the NHS then pays the consequences. If we are to have a highly effective National Health Service in future, we need to recognise that the quality of our professional staff goes to the core of what we seek to do. Therefore, it is right that the Secretary of State should be seen to have major responsibilities enshrined in legislation. That is the essential point of Amendment 2, whatever the technical deficiencies to which noble Lords have kindly drawn our attention.

In that regard, let me say that I welcome the government amendments in this area and the work of the noble Earl, Lord Howe. Of course, he is also responsible for research in the department, and I think that he well understands how the education and training of our professionals very much ties in to the research agenda. I know that we will come to research later tonight.

In relation to the other amendments in this group, I have already welcomed the government amendments, but perhaps I may pick on Amendment 63. It is right that the national Commissioning Board should have regard to the promotion of training of clinical staff in any provider from which it commissions services. There is essentially a parallel amendment—Amendment 104—which applies to clinical commissioning groups. The whole point here is to ensure that there is a level playing field. If, regrettably, the Government persist with this lunatic idea of a competitive approach within the health service, it is essential that when it comes to commissioning decisions all qualified providers contribute to education and training. It would be an absolute disgrace if clinical commissioning groups and the national Commissioning Board started to commission services from organisations that did not play their full part in education and indeed research. I hope that the noble Earl, Lord Howe, will make it clear that that is what his Amendment 104 means when it says, in parliamentary counsel terminology, that clinical commissioning groups must,

“have regard to the need to promote education and training”.

I take that to mean that the amendment does not permit CCGs to place contracts with qualified providers who do not make a contribution to education and training.

Overall, I echo the words of the noble Lord, Lord Walton, regarding the work of postgraduate deans and his question about their future. Where are postgraduate deans going to lie in the future? Are they going to lie in the local branch offices of the national Commissioning Board; are they going to be aligned with the clinical senates; or are they going to float free? I think we should be told.

I also echo the words of the noble Lord, Lord Willis, regarding the role of universities. It should not be an option; they need to be round the table. It needs to be what I would describe as a “hard partnership”. I think we are all well aware of the issues and concerns surrounding the quality and outcome of nurse training. The noble Earl, Lord Howe, himself has often commented on issues such as dignity, nutrition and so on, where matters have been raised by patients and there is concern about whether today’s nurses are getting the kind of training that is required. It is very important that those who commission from universities do so in as vigorous a way as possible and hold those universities to account. However, equally there has to be a partnership. The noble Earl, Lord Howe, will know about the intention to expand academic clinical science networks. That is a very good example of universities and the health service coming together, and we need to encourage that in the future.

Finally, the noble Lord, Lord Walton, raised a point about the duty on any willing provider regarding training or research. I think that I have covered that, but he also mentioned NHS foundation trusts. I am not aware of any situation in which NHS foundation trusts are ignoring their responsibilities but I certainly agree with him that, as they are more independent of the Secretary of State than other parts of the NHS, some assurances from the noble Earl in that regard would be welcome.

Health and Social Care Bill

Debate between Lord Hunt of Kings Heath and Lord Patel

Tuesday 22nd November 2011 Lords Chamber

[Lord Hunt of Kings Heath]

My Lords, this is one of the most important groups of amendments that we are going to discuss, because, in a sense, it sets the whole relationship between the Secretary of State and the NHS Commissioning Board.

I have considerable sympathy with my noble friend Lord Warner’s Amendment 96, which seeks to avoid the Secretary of State essentially putting in a huge shopping list of demands by limiting the mandate to a maximum of five obligatory and five desirable functions.

I come back to the recent interventions by the Government in the affairs of the National Health Service. The most recent have been around waiting times, both in terms of what happens to patients who have passed the 18-week target and of the activities of some primary care trusts, which, in order to contain their expenditure, have set arbitrary waits for patients even though they are ultimately treated within the 18-week limit. I have said to the Minister that I have no complaint about the intervention of Secretary of State, which I thought was quite proper, but it is very difficult to see how this will happen under the new system. We have yet to receive a satisfactory answer to it. What in the new system will suddenly obviate the need for the Secretary of State to make such interventions?

The question then comes to the mandate. Is it, as my noble friend Lord Warner hopes, a high-level document which will focus on a very limited number of objectives, or will it be a shopping list? The noble Baroness, Lady Murphy, expressed it very well as in a sense legitimising “recent ministerial enthusiasms”. We were rather given the lie to this when we debated this matter last week, because the Minister suggested that if there was an issue such as primary care trusts lengthening waiting in order to meet the budget, the mandate could be used to prevent it. Indeed, that is the risk—that the Secretary of State will, quite properly, come under pressure to intervene in the health service. The Bill weakens the legal powers of the Secretary of State to do so. The risk is clearly that the mandate will be used instead, and it would be used retrospectively if it does not satisfy the intervention power. I believe that there is great reservation among noble Lords as to whether the intervention power is sufficient, because there has basically to be a failure by the NHS Commissioning Board to carry out the objective. If it is not sufficient for an intervention to take place during the year, my goodness me the shopping list will grow when the new mandate is written. So, there are some very important issues on which we have yet to receive any answer from the Minister.

There are, however, a number of other important amendments in this group. Perhaps I may ask the Minister to clarify three points. The first point is how long the mandate will last. My assumption, from what Ministers have said and what is in the Bill, is that it will last for a year. The Minister will be aware that the chairman of the NHS Commissioning Board expressed a wish to the Health Select Committee, which was vetting his appointment, that the mandate should last for three years. I wonder if the Minister could clear up that matter for your Lordships.

Will the Minister also clarify the intention behind the provision in proposed new Section 223D(7)(b), on page 27, which allows changes to total capital and revenue resource use after parliamentary general election takes place? I take it that this is simply to allow for a change of Government but I would be grateful if he could spell that out.

However, my substantive amendment, Amendment 100A, is concerned with parliamentary scrutiny. In Clause 20, proposed new Section 13A states:

“Before the start of each financial year, the Secretary of State must publish and lay before Parliament a document to be known as ‘the mandate’”.

Surely Parliament is entitled to a little more involvement than merely receiving the mandate as a fait accompli. My noble friend Lord Warner has already pushed the Government in their amendment to give Parliament information about any reservations the board may have expressed about meeting the mandate. I would certainly support that in the interests of transparency. There is also, in Amendment 100, reference to the requirement on the Secretary of State to consult the board, HealthWatch England and other persons, with the results of any consultation on the mandate to be published. That too seems reasonable.

However, I wonder if we ought not to go further in terms of parliamentary scrutiny. If we take Ministers at face value—and the Secretary of State has expressed a wish to step back from day-to-day involvement in the National Health Service—it is clear that the mandate assumes special importance. Why is Parliament not being given a proper opportunity to scrutinise the mandate before the Secretary of State finally sets it for the NHS Commissioning Board? If the Secretary of State is really going to tell Members of Parliament in particular that he is not going to intervene in a particular question because he considers that now to be the responsibility of the NHS Commissioning Board, in accordance with the mandate that the Secretary of State has set, then I think that Parliament should be entitled to some involvement in scrutiny of that mandate. My Amendment 100A suggests how that might be done. It is built on the system of scrutiny for national policy statements.

The House will be aware that the Planning Act 2008 introduced a new planning system for applications to build nationally significant infrastructure projects. They cover applications for major energy generation, railways, ports, roads, airports, water and hazardous waste infrastructure. Under this system, national policy on national infrastructure is set out in a series of national policy statements. Under Section 92 of the Planning Act 2008, each proposal for a national policy statement must be laid before Parliament. In so doing, the Secretary of State specifies a relevant period for parliamentary scrutiny.

If during that scrutiny period either House passes a resolution with regard to the proposal, or if a committee of either House makes recommendations regarding the proposal, the Secretary of State must lay before Parliament a Statement setting out his response to the resolution or recommendations. Following completion of parliamentary scrutiny, the Secretary of State may formally designate the proposal as a national policy statement. The final national policy statement is also laid before Parliament.

In the House of Lords, national policy statements are normally debated in Grand Committee, but that does not restrict the freedom of committees of the House or individual Members to make use of the statutory procedures. In the event of a Motion for resolution being tabled, the usual channels have undertaken to provide time for a debate in the Chamber within the scrutiny period.

When I was energy Minister, I had to bring through four energy policy statements. We had three four-hour debates in Grand Committee. They were very thorough. The Government took note of what took place in those debates. In the end, it is up to the Government to make the statement because it is a matter for the Executive. I do not challenge that the mandate, which I regard as important as a national policy statement, is ultimately for Ministers to make. It is rightfully an Executive responsibility. However, the process that I am suggesting in my Amendment 100A would allow Parliament to have much more involvement in the scrutiny. It would allow Ministers to take account of that and then make their minds up in relation to the mandate.

If the Government are determined to hand over such responsibility to a quango—and I remind the House that in this Bill the National Health Service Commissioning Board is given concurrent powers with the Secretary of State in relation to the crucial responsibility in Clause 1—there has to be a great parliamentary scrutiny of that mandate.

[Lord Patel]

My Lords, I added my name to the amendments tabled by the noble Lord, Lord Warner. They were prompted by the lack of clarity in the nature of the mandate that the Secretary of State will issue to the Commissioning Board. There is also a lack of clarity in how he will consult the public, although the provision does say that the Secretary of State will consult HealthWatch England prior to issuing a mandate. Who else will be able to scrutinise the mandate?

On the basis that the Secretary of State will use the mandate to performance-manage the Commissioning Board, what will be the nature of the mandate that will allow him to do that? Will it have measurable outcomes against which the Secretary of State can performance-manage the Commissioning Board? What happens if the Commissioning Board does not agree with the mandate? How is that dispute settled? Will the financial aspects be a major part of it or will it be better outcomes for patients?

Health and Social Care Bill

Debate between Lord Hunt of Kings Heath and Lord Patel

Monday 14th November 2011 Lords Chamber

[Lord Patel]

My Lords, in the absence of the noble Lord, Lord Walton of Detchant, I am very pleased to move the amendment on his behalf. I wish I had a better idea of what his purpose might have been in tabling the amendment. None the less, it is a good opportunity to explore the Government’s thinking in establishing the clinical senate.

It is easier to understand the purpose of the professional networks, which I have spoken about before. I think they are a good idea, and there should be more clinical and professional networks embedded in the health system. The cancer and cardiac networks are two good examples. However, when it comes to the senate, I am less clear about the Government’s intentions. I know that the NHS Future Forum: Clinical Advice and Leadership report said that commissioning consortia—now called commissioning groups—and the NHS Commissioning Board,

“should establish multi-specialty clinical senates to provide ongoing advice and support for their respective commissioning functions”.

It also said that independent advice from public health professionals should be available at every level of the system, but that is by the way.

Therefore, we have a situation where the Future Forum suggested that clinical senates should be a way of getting advice to all the different new structures. In response to the Future Forum, the Government said that clinical senates will give advice to CCGs which they must follow in each area of the country. At the same time, Dr Kathy McLean, who led on the project, is leading another project and has issued a consultation letter to develop the role of clinical senates and clinical networks. Obviously the Government do not have a clear idea of what the clinical senates are for, otherwise why is Dr Kathy McLean leading the project and issuing a consultation letter?

It is proposed that 15 senates will be housed by the NHS Commissioning Board. They will feed their advice back to the NHS Commissioning Board, although about what is not clear. In his two amendments my noble friend Lord Walton of Detchant wonders whether they might be useful in feeding the Commissioning Board and the commissioners advice about specialist commissioning. The senates will have a major say in advising CCGs on their commissioning plans, but their advice will be exactly that—advisory. Membership will consist of doctors, nurses and other health professionals, so it will be a large group. The senates are to be involved in quality aspects of clinical commissioning and an annual assessment of CCGs, and they will report on their annual reports and performance. They have serious work to do in monitoring CCGs, yet they are only advisory for CCGs.

Future Forum suggested that clinical senates should provide advice and support for a range of bodies, including CCGs, the NHS Commissioning Board, health and well-being boards and others. Are senates not likely to end up as just another layer of bureaucracy? Therefore, what is the real role of all 15 clinical senates? Will they be involved in advising the NHS Commissioning Board in its commissioning role? Are they to be advisory for CCGs and check on the quality of their commissioning? Why are the professionals on the senate going to be from outside the commissioning groups’ area of commissioning? The amendments are tabled to explore whether they will really have a role in commissioning specialist services.

[Lord Hunt of Kings Heath]

My Lords, I also have an amendment in this group. I say to the noble Lord, Lord Patel, that he anticipated the remarks of his noble friend Lord Walton remarkably well.

Having argued against bureaucracy in the previous group of amendments, I am now about to argue in favour of putting senates on a statutory basis. I shall explain why. First, this was a very good outcome of the listening exercise. I think that because I am concerned at the Government’s decision to abolish the strategic health authorities. It is what I call the Hagley Road issue. In 1948, the Birmingham Regional Hospital Board was established; its offices were in Hagley Road and throughout 60 years there has always been something there. It may have been a regional health authority, a regional hospital board, a strategic health authority—call it what you will—but there has always been a regional outpost of the department acting essentially as a leader, with a positive role in looking at the region as a whole, ensuring that its services were cohesive and had proper direction and that, by and large, it was self-sufficient. That is to be removed and we are going to get large SHA clusters which will cover a much larger part of the country. Although we do not know the size of the clinical commissioning groups, they will clearly cover much smaller population areas.

I believe that there is still a need for a mechanism whereby strategic leadership can be given over a region, and I see the clinical senates as being the best approach to that. Noble Lords have spent at least two days debating reconfiguration and are concerned that these difficult decisions often have intervention from the centre. Clinical commissioning groups will be too small to take on the kind of strategic leadership that is required. When you are trying to establish in a region where the super specialty and tertiary services should be and trying to come to a view about how many A&E and emergency departments you need, you require a body that can take a strategic overview. The clinical commissioning groups are too small to do that. They could, of course, possibly come together in a kind of federated meeting to try to resolve those kinds of issues, but that could prove to be very difficult. Therefore, the senates could have an important role in setting some of the parameters and giving strategic leadership to a region.

However, as the Government intend them at the moment, these will be informal groups of people who could easily be ignored by the clinical commissioning groups, by the health and well-being boards, by the deaneries and by all the organisations that have an influence on the way in which the health service is going. My amendment is designed to set out a more structured approach to ensure that clinical senates are created as bodies corporate, that they are properly accountable to the national Commissioning Board and that they have the ability to give strategic leadership and have some oversight of the work of clinical commissioning groups.

I suspect that my amendment will not find favour with the noble Earl but the point about the need for strategic leadership in a region is important. I fear that the super SHA clusters will be too large to do that and the clinical commissioning groups will be too small.

--- Later in debate ---

[Lord Hunt of Kings Heath]

My Lords, clinical commissioning groups are, of course, one of the main building blocks of the Government’s proposed changes to the National Health Service and I support my noble friend Lord Whitty when he argues for the need for population-based bodies at that essential local level. However, I will follow the noble Lord, Lord Kakkar, in looking at issues to do with corporate governance in clinical commissioning groups. I am concerned whether the corporate governance structure will be sufficiently robust. Will clinical commissioning groups be sufficiently accountable to the public? What safeguards will be put in place to ensure that clinical commissioning groups operate in the public interest?

Schedule 2 sets out the details of the governance structure. Clinical commissioning groups will be bodies corporate with a constitution and a procedure for decision-making; an accountable officer and audit and remuneration committees are to be appointed. That is fine as far as it goes but I hope the noble Earl will use this opportunity to clarify what effective corporate governance structure is to operate. My Amendments 175CA and 175CB seek to do just that.

On Amendment 175CB, I seek guidance and reassurance about the composition of the boards of clinical commissioning groups. On every other board in the NHS the non-executives are in a majority. Will the noble Earl confirm that that will be the case with clinical commissioning groups? If not, why not? I follow what the noble Lord, Lord Kakkar said: surely, by any definition, GPs are the least experienced in any form of corporate governance in the health service? Therefore, given that they are the least experienced, is it right that they should be subject to so much less scrutiny and challenge than those other organisations in the National Health Service which are hugely well versed in corporate governance? At the very least the chair and vice-chair of the clinical commissioning groups should surely be lay people to ensure that the public interest is represented.

There would be considerable merit in ensuring an external appointments process. I have suggested here the NHS Commissioning Board but there may be other suggestions. All experience with public bodies shows that if boards are responsible for deciding on their membership you will often run into trouble. We have seen this in the education sector, with corporations of colleges simply deciding themselves who should be appointed and who should replace those who retire. Simply leaving clinical commissioning groups to decide on their membership is a recipe for deep trouble, particularly when the temptation for CCGs will be to spend resources on themselves, on their constituent GPs. The issue around public interest and conflict of interest will become a keen problem and, without strong, effective corporate governance, we may well run into great difficulty in the future.

There are probing amendments around membership but, in relation to Amendment 175CA, I would like to know whether the noble Earl feels it is appropriate that local authorities should have some kind of representation on the boards of clinical commissioning groups. Amendment 175CA in particular draws attention to the role of district councils in two-tier areas. That is because clearly the principal local authority will be the host of the health and well-being boards. There will be concern, particularly in rural areas, if the non-metropolitan district councils do not have some involvement. I at least pose the question as to whether they may have some involvement at the clinical commissioning group level.

My principal amendment is Amendment 175D which concerns the accountability of clinical commissioning groups. I do not understand how those groups will account to their patients. As a patient, what do I do if I do not agree with the decisions of the clinical commissioning group? What if I think the decisions made by my clinical commissioning group put me at a disadvantage compared to the decisions made by a clinical commissioning group in a nearby area? What if I think my clinical commissioning group, by its decisions, might affect the viability of my local general hospital? What if I think it is putting too many contracts with itself, bringing up this issue of conflict of interest? There is real concern about the conflict of interest issues around placing contracts with the GPs who form the constituent members of the clinical commissioning groups.

How do members of the public hold the clinical commissioning groups to account? As far as I can see, the Bill is completely silent on that. The noble Earl may say that it is contained in the doctor-patient relationship, but I do not think that is true at all. My relationship with the GP is not about commissioning: it is about essential care. Frankly, there is already a risk that, because GPs are collectively going to commission, the doctor-patient relationship might be undermined in any case. That is because the moment we place commissioning decisions with GPs, there will always be a suspicion among patients that decisions they are making clinically will be governed by the needs of the clinical commissioning group and the need to ration resources. Clearly, the Secretary of State has said, and has been saying consistently, that the reason the budget has been put with GPs is to give control over the budget overall.

I have put forward a model essentially based on the foundation trust model, which says that the members of clinical commissioning groups should be the patients who are on the lists of the GPs within that group. The membership should then vote for a governing body and the governing body should then appoint the non-executives on a clinical commissioning group. I am not completely wedded to that model: I just lifted a model that is currently in operation in the health service. My main point is that I do not believe that it is right and proper that a public body should simply be composed of one profession that is given enormous power—if you are lucky, there may be one or two non-execs on the board as well—accountable to nobody at all at the local level. There is no mechanism at all whereby I as an individual patient have any way of challenging the commissioning decisions of those clinical commissioning groups. This is a very important issue to which I am sure we will return. We have to make CCGs properly accountable.

[Lord Patel]

My Lords, I will be brief in supporting the amendment of my noble friend Lord Kakkar. I also support the comments just made by the noble Lord, Lord Hunt. I think it vital that local commissioning groups are accountable and conduct themselves according to the highest principles of public life. CCGs are legally responsible for the quality of their decision-making processes. Therefore, they need to be able to stand up to judicial review. The individuals making those decisions should be required to adhere to the highest standards of conduct for public officials.

I know that, to a degree, the Government recognise this by raising the structures of CCGs—namely, the inclusion of lay and other professional members on governing bodies, the requirement for compliance, the principles of good governance and the pledges about public access to documents and meetings. While this work is being carried out, however, we need clarification about the methods of identifying and selecting lay and professional members of governing boards.

The Bill also states that CCGs may pay members of the governing body such remuneration and allowances as it considers appropriate. Full autonomy may not be appropriate as it might undermine public confidence in the ability of members of CCG governing bodies to act in the public interest. Some degree of national guidance about fee scales might also be valuable.

Health and Social Care Bill

Debate between Lord Hunt of Kings Heath and Lord Patel

Monday 7th November 2011 Lords Chamber

[Lord Patel]

My Lords, there is no conflict when I use the word “clinical” in recognising that it would encompass the totality of clinical and social care. The problem will arise that while the evidence exists to be able to write clinical quality standards, the evidence to write social standards is lacking, and we may have to develop those. That is why a distinction is made between the two. In terms of immediate outcomes for patients that are seen for medical care, the clinical quality standards will make the difference. That does not mean that I do not recognise clinical and well-being together—and I think that all doctors would recognise that. It is not medicalisation that I am after by using the term “clinically”.

[Lord Hunt of Kings Heath]

My Lords, this has been an interesting series of amendments. The noble Lord, Lord Patel, made a very important point about the influence that legislators can have in drafting legislation on the culture of the NHS. He speaks with great experience because of his work in Scotland on the development of clinical standards, and I am sure he is right to emphasise the words “health” and “clinical” in adding to our understanding of what we seek from the National Health Service.

The point raised by the noble Baroness, Lady Barker, is very interesting. This is meant to be a health and social care Bill, although there is very little about social care in it. Indeed, the only provisions ranging around social care are bad provisions. Remarkably, we are proposing to abolish the General Social Care Council, which ought to be an uplifter of standards among social workers. I give notice that I intend to thoroughly oppose these provisions and place the regulation of social workers into a health body. I look forward to the support of the noble Baroness, Lady Barker, on that when we come to it. I would have thought that the way through is either to add well-being to this part of the Bill or to say “health, clinical and other outcomes” to meet the valid point raised by noble Baroness.

My noble friend Lady Bakewell is very keen in her Amendment 18B to ensure that in securing the outcomes set out in the Bill, we,

“should not exclude sections of the population”,

on grounds of age. We look to the Minister to give us some reassurance on my noble friend’s point about the overarching indicators used extensively in the department and the health service, which go up to only the age of 75. It is not good enough to say that the data are still under development and therefore we will not worry about statistics on the over-75s. One would like to think that those indicators will be revised to embrace people over 75.

Amendment 16A, which is my own amendment, relates to the efficiency of the service. It seeks to add “efficiency” to the criteria that need to be considered. I would be interested to know from the noble Earl why efficiency is not mentioned in line 23 on page 2 of the Bill. My argument would be that a measurement of a service’s effectiveness may be of only limited value. One example might be the fraught question of new drugs and treatment being developed by industry and marketed indirectly to patients, for example through the sponsorship of charities that promote the case for the provision of new treatments in the NHS, and there is a strong case to make those treatments improve the effectiveness, safety and quality of experience. However, if you do not also have to consider efficiency, is there not a risk that you will not look at value for money or productivity and, in the end, not give a rounded analysis of a particular new treatment or technology?

Amendment 19, in the name of the noble Lord, Lord Patel, deals with the standards prepared by NICE under Clause 231. I hope that the noble Earl can clarify the status of NICE standards and guidelines. I have a later amendment on this matter, as do my noble friend Lord Warner and the noble Lord, Lord Patel. We have been concerned by suggestions that the Government are seeking to downplay the role of NICE and the statutory nature of its guidance on technology appraisals. I would be very grateful if the noble Earl could reassure me on that.

I remind the noble Earl that NICE was established because of the traditional delay in the health service when a treatment has been proven to be cost-efficient and effective. There was always reckoned to be a long delay from the time when it was proven to be cost-effective, efficient and clinically effective to the time when it generally available in the National Health Service. NICE guidance was designed to speed up the adoption of such proven new treatments, technologies and drugs. I am concerned about any suggestion of returning to the bad old ways when it was up to each clinical commissioning group simply to decide on a new technology and the group not having to follow the guidance set out in the NICE technology appraisals—if that is what they are called; I think we have probably moved on from that terminology. We will of course return to that later on in the Bill, but some assurance would be welcome.

I turn to my noble friend Lord Warner’s Amendment 109. I never understood the Opposition’s opposition to waiting time targets in the NHS. I remind the Minister that when his Government last left office they had the patients’ charter, which had a waiting time target of 18 months that they did not achieve. We got it down to 18 weeks, which had a hugely beneficial impact on patients. There is no doubt, if you look at regular polling, that the NHS was in very good condition in 2010 because to all intents and purposes the dreadful waiting that had been such a product of the NHS over many decades had been radically reduced.

We know that there is a sense in the health service that the Government are no longer worried about waiting times. I have no doubt whatever that if the pressure is taken off, waiting times will start to rise again. That might suit the Government because of the funding issues that they are confronting the NHS with, and it would certainly suit the private sector, which we know does well out of long NHS waiting times, but it will do patients no good at all. I do not know how far my noble friend Lord Warner intends to take this, either now or at a later stage, but it is important that we say in the Bill that we are concerned about the speed of access to services.