Anaesthesia Associates and Physician Associates Order 2024

Debate between Lord Patel and Lord Hunt of Kings Heath

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 Patel and Lord Hunt of Kings Heath

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 Patel and Lord Hunt of Kings Heath

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 Patel and Lord Hunt of Kings Heath

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 Patel and Lord Hunt of Kings Heath

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 Patel and Lord Hunt of Kings Heath

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 Patel and Lord Hunt of Kings Heath

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 Patel and Lord Hunt of Kings Heath

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.