All 9 Lord Sharkey contributions to the Health and Care Act 2022

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Tue 7th Dec 2021
Health and Care Bill
Lords Chamber

2nd reading & 2nd reading & 2nd reading
Tue 11th Jan 2022
Health and Care Bill
Lords Chamber

Lords Hansard - Part 2 & Lords Hansard - Part 2 & Committee stage: Part 2
Mon 24th Jan 2022
Health and Care Bill
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Lords Hansard - Part 1 & Committee stage: Part 1
Mon 24th Jan 2022
Health and Care Bill
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Lords Hansard - Part 2 & Committee stage: Part 2
Wed 26th Jan 2022
Health and Care Bill
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Lords Hansard - Part 1 & Committee stage: Part 1
Wed 26th Jan 2022
Health and Care Bill
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Lords Hansard - Part 2 & Committee stage: Part 2
Mon 31st Jan 2022
Health and Care Bill
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Lords Hansard - Part 2 & Committee stage: Part 2
Tue 1st Mar 2022
Health and Care Bill
Lords Chamber

Lords Hansard - Part 1 & Report stage: Part 1
Mon 7th Mar 2022
Health and Care Bill
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Lords Hansard - Part 1 & Report stage: Part 1

Health and Care Bill

Lord Sharkey Excerpts
Lord Sharkey Portrait Lord Sharkey (LD)
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Like other noble Lords, I welcome the noble Lord, Lord Stevens of Birmingham, and congratulate him on his frank and witty maiden speech. I declare an interest as chair of both the Association of Medical Research Charities and the Specialised Healthcare Alliance.

Last year, members of the Association of Medical Research Charities contributed £1.7 billion to medical research in the United Kingdom—more than either the NIHR or the MRC. The Specialised Healthcare Alliance’s 120-plus members campaign for those with less common and rare diseases, which affect some 3.5 million people in the United Kingdom. Both organisations bring the patient’s voice and interests to medical research in the UK. I will focus my remarks on medical research and rare diseases.

The Bill before us does not offer any significant differences in these areas from its predecessor, the 2012 Act. In Clause 20 on page 17, the Bill sets out a duty in respect of research for each ICB. As the noble Baroness, Lady Blackwood, explained, it says only that ICBs will have a duty to “promote” research. This is equivalent to the duties already existing in the 2012 Act. In the Commons, there were significant attempts to strengthen this and upgrade the duty to promote to a duty to conduct. We believe that the amendments proposed to achieve this—notably from Chris Skidmore, a former research and innovation Minister, and my colleague, Wera Hobhouse—had real merit. We will want to return to them in Committee.

We will also want to make sure that, to make a duty to conduct research effective, this duty will also extend to eligible organisations for which ICBs are responsible. The benefits of making it a duty to conduct, rather than just promote, research are well evidenced and wide-ranging. They include improved patient outcomes, improved job satisfaction among health workers and significant gross value added being generated. It is well evidenced that patients treated in research-active settings have lower mortality rates and increased confidence in the care they receive. There is an equally strong body of evidence that shows that engaging in research improves job satisfaction, boosts staff morale and can reduce burn-out. Research also presents the ideal opportunity for patient involvement.

I now turn to rare diseases and patients with complex conditions. The proposed structural changes in dealing with these areas would benefit from some additional safeguards and reassurances. The plan to delegate or transfer the commissioning of certain specialised services from NHS England to ICBs makes it vital that minimum national standards are strictly observed. I know from conversations with NHS England that that is its clear intention. However, we need more detail on how this is to be done, how it is to be monitored and how any corrective actions may take place. Also, what mechanisms will be in place to take advantage of learnings across ICBs and generate continuous improvement? It is especially important that we know what measures will be in place to prevent the fragmentation of the care for people with complex comorbidities. We shall want to ask how the interests of this group can be embedded in the ICB decision-making process.

Finally, I turn to the question of approvals. We want to see provision made in this Bill for establishing a new assessment route for medicines for people with rare and less common conditions, with better engagement with these patients and faster timescales—perhaps something analogous to the approach taken to the creation of the highly specialised technologies appraisal programme of 2012. We will want to discuss this issue in Committee.

The UK is already a medical research superpower, as recent events have demonstrated. If we are to maintain and profit from that position, as the Government wish, investment in research is absolutely critical. That investment does not only require proper funding; it requires collaboration between funders, especially between medical research charities, the NHS, our research universities and industry. It also requires recognition of the importance of listening to patients and patient groups and involving them in every step. I look forward to raising all these matters, as well as the Government’s bizarre and overenthusiastic use of delegated powers, in more detail as the Bill makes progress.

Health and Care Bill Debate

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Health and Care Bill

Lord Sharkey Excerpts
Lords Hansard - Part 2 & Committee stage
Tuesday 11th January 2022

(2 years, 2 months ago)

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Baroness Wheeler Portrait Baroness Wheeler (Lab)
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My Lords, with 6 million people in England waiting for operations and routine procedures, many of whom are in pain, I make no apology for moving my amendment at the start of this grouping, which seeks to ensure that the 18-week waiting time target is maintained as a key part of the NHS mandate. This group also covers key amendments on the commissioning role of integrated care boards in relation to specialised healthcare services, and on the duty of ICBs to share best practice on innovation and the quality of services.

On waiting lists, the pandemic has resulted in a huge backlog of care and treatment, compounding pre-existing challenges. The 18-week waiting time standard has not been met by the NHS since 2016. Instead, we have a situation where the NHS’s latest planning guidance sets out plans to eliminate only waits of 104 weeks, to reduce waits of 78 weeks and to support an overall reduction in 52-week waits. Even as a temporary measure this should be unacceptable, and at best we should have a commitment and a plan to restore performance.

Last week’s report from the Health and Social Care Select Committee described the unquantifiable challenge faced by the NHS in addressing the backlog, with 300,000 people now waiting for more than a year for treatment for surgery, such as hip or knee replacements. We know the devastating suffering that the long delays in diagnosing cancer and other diseases such as heart conditions or stroke are causing. The Secretary of State himself said that the waiting list might grow to 13 million, and that was before the current omicron wave, which has only exacerbated this challenge. His promise in November to publish the Government’s plans to meet the workforce requirements needed to address staff shortages and the record waiting lists has yet to materialise.

Of course, this is not just about elective care. In emergency departments, waiting lines in October 2021 were the worst since records began, with one in four patients waiting longer than four hours to be admitted, transferred or discharged, and with trolley waits at a record high. October last year saw the highest number of 999 calls on record. There is a serious risk that the ongoing crisis in emergency care could derail the elective recovery programme.

Although the problems are manifold, prioritisation of the elective backlog is understandable. However, a focus on those areas most amenable to numerical task risk effectively deprioritises other equally important areas such as primary care, community services and mental health services, which all play a crucial role in keeping people healthy and out of hospital. It would be helpful if the plans around recovery in other aspects of care, with some sort of target or at least objective spelled out, were also made known—access to GPs being a primary example.

We know that workforce shortages are the key limiting factor on success in tackling the backlog. Without better short and long-term workforce planning, the 9 million additional checks, tests and treatments will not be deliverable. NHS England’s chief executive, Amanda Pritchard, told the Select Committee that the NHS currently has 93,000 vacancies for NHS positions and shortages in nearly every speciality. The social care workforce has, at present, 105,000 vacancies and a turnover rate of 28.5%, rising to 38.2% for nurses working in social care. Changing the way the cap is calculated will not help this, and of course discussions on both the cap and the need for a credible and systematic workforce plan in the light of the current chronic staff shortages will follow later in the Bill.

The waiting times focus of my amendment, which seeks to insert a new paragraph into Clause 3(2), is tangible and measurable, as are the constitutional targets. In the context of the huge challenges the NHS faces, the 18-week waiting time target remains vital. The discipline it imposes helps focus the entire system on the needs of patients. It drives behaviour and focuses funding, and it facilitates the organisation of seamless care for the patient, from the GP practice through diagnostic tests, out-patient care and, ultimately, if needed, to in-patient treatment. It gives leaders at local level in particular the leverage they need to unblock barriers to speedy care, such as delayed discharges from the hospital—another key issue on which we will focus later in the Bill.

The second part of my amendment reinforces the importance of the target for care for people with rare conditions and mental health conditions, which can all too often be Cinderella areas—overlooked in favour of more common conditions. I have a personal interest, which I declare, as vice-chair of the Specialised Healthcare Alliance, a coalition of more than 100 patient-related charities, groups and corporate supporters campaigning for improvements to care for patients with rare and specialised conditions, and for greater awareness of their needs, treatment and support.

The amendment also underlines the need for speedy diagnosis for this key group of patients. The SHCA chair, the noble Lord, Lord Sharkey, has added his name to my amendment and will speak on the importance of this in his contribution. He will also speak to Amendment 19 in this group, to which I have also added my name, which would ensure that ICBs

“commission specialised services in line with national standards”,

that their performance in this regard is published and monitored, and that there are safeguards that will operate if this commissioning role is removed from an ICB.

On treatment standards, can the Minister reaffirm that despite the current situation, every patient legally retains the right to treatment within 18 weeks? If so, what steps can patients take if the NHS does not deliver in line with this requirement? Can he assure the House that the Government have no plans to weaken this legal right and are fully committed to returning the NHS to an 18-week standard?

I am also speaking to Amendment 60 from my noble friend Lady Thornton, which would insert a new subsection, within the proposed new sections in Clause 20 on ICBs, to ensure that innovation and best practice on the quality of services

“is shared … openly and prevents individual trusts and foundation trusts from refusing to share beneficial developments or improvements through any issues around competition between organisations.”

This is crucial in helping to overcome any obstacles linked to the autonomy or independence of the organisations evolved.

We also support Amendment 215 from my noble friend Lady Merron, which would insert an important new clause after Clause 80, requiring the Secretary of State to publish an annual report to Parliament

“on waiting times for treatment in England, including disparities”

across the country. It is vital that this report also details the steps taken to ensure that patients, in line with their rights under the NHS constitution, are able to access services within minimum waiting times.

We also note Amendment 21 from my noble friend Lord Davies. He will be fully aware of Labour’s support in commissioning from the NHS as the preferred provider. His amendment is borne out of the right motivations but, I am afraid, misses the point that there are many social enterprises, charities and community organisations whose delivery of healthcare is vital to the functioning of the NHS and social care—for example, in end-of-life care—and we fully support the key role that they play.

The situation facing the NHS as it struggles to address waiting times and lists is dire, yet the recent NAO report on waiting times recovery pointed to some reasonable projections indicating that, far from improving on the current trajectory, the position will be even worse in March 2025 and beyond. That takes into account all the Government’s promised funding. The situation has echoes of the 1990s; Labour was able to address the challenges then, under different circumstances, but the current challenges are even harder. By 2010, the situation had improved to such an extent that demand for private healthcare had dropped. Now we see the opposite, with people having to pay to jump the queues.

Targets were an important part of how improvement was achieved through Labour’s three terms, backed by greater investment and a genuine commitment to public service solutions. The NHS responded to the confidence placed in it but today, there is no plan and no commitment, and totally inadequate funding to address the waiting times issue—the issue that patients are usually most concerned about. The NHS Mandate and the NHS constitution contain crucial rights and standards of care for patients and stakeholders, ensuring that the NHS has basic stability, knows what is expected of it and can be judged on its performance. We must keep the 18-week target and make sure that it is not fudged away. I beg to move.

Lord Sharkey Portrait Lord Sharkey (LD)
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My Lords, I declare an interest as chair of the Specialised Healthcare Alliance. I will speak to Amendment 6 and 19. I added my name to Amendment 6 and I wholeheartedly support the points made by the noble Baroness, Lady Wheeler, in her eloquent opening remarks. I will make a few brief supplementary points on rare and less common diseases.

Proposed new subsection (2A)(b) in Amendment 6 refers to waiting times for a rare disease diagnosis and is intended to probe the Government’s ambitions in this area. The Government’s rare disease framework noted that it can take years to receive a final and definitive diagnosis of a rare disease and that some people living with a rare condition may never receive one at all.

In 2019, the Government’s national conversation on rare diseases found, perhaps not entirely surprisingly, that getting the diagnosis right was the number one challenge in rare disease care. But the process of getting this diagnosis has been called, entirely understandably, an odyssey—many journeys, many ports of call, and many difficulties. This odyssey frequently involves multiple referrals, inconclusive tests and even incorrect diagnoses before a final definitive diagnosis is arrived at.

The rare disease framework makes a very welcome commitment to making improvements in this journey. I would be grateful if the Minister could say what concrete steps are being taken to bring about the desired improvements to arrive at Ithaca much earlier and in better shape. For example, the rare disease framework talks of a need to improve diagnosis rates. How is this to be measured and what is the baseline to be? Is there a target that the Government are working towards? If there is, when is it expected to be reached? The framework also commits to making use of advanced diagnostics to improve the speed of diagnosis. Can the Minister say what new technologies are being deployed and which are under active consideration? Finally, the spending review announced funds for a new newborn genetic screening programme. What might we expect in terms of a timeline for the piloting of this programme and its wider implementation if the benefits are proven?

I turn to Amendment 19, in my name and that of the noble Baroness, Lady Wheeler, for whose support I am grateful. We have around 3.5 million people with rare or less common diseases or complex conditions. This number grows as our population ages. Many of these people require specialised treatment of one kind or another. Currently, these treatments are provided by the specialised commissioning team of NHS England. In total, there are 149 specialised services directly commissioned by NHS England, and in 2018-19 £18 billion or so was spent on these services.

There are some problematical aspects to the large-scale direct national commissioning of this very large range of specialised services. The NHS points to these in its paper of last January, Integrating Care: Next Steps to Building Strong and Effective Integrated Care Systems across England. It said that

“these national commissioning arrangements can sometimes mean fragmented care pathways, misaligned incentives and missed opportunities for upstream investment and preventative intervention.”

The paper goes on to propose a new model whereby the provision of some specialised services can be delegated to be more responsive to place-based needs and local collaborations.

The NHS proposes that there will be four principles underlying this new approach to the delivery of specialised services. The first is that all specialised services will continue to be subject to consistent national service specifications and evidence-based policies determining treatment eligibility. The second is that strategic commissioning, decision-making and accountability for specialised services will be led and integrated at the appropriate population level. The third is that clinical networks and provider collaborations will drive improvement, service change and transformation across specialised and non-specialised services. The fourth is that funding of specialised services will shift from provider-based allocations to population-based budgets, supporting the connection of services back to base.

Amendment 19 is a probing amendment to allow us to ask a few detailed questions about how these principles will operate in practice. The first is to do with the ability of ICBs to commission specialised services in line with ongoing national standards. How will this ability be assessed, and by whom? Can the Minister confirm that being judged to have the appropriate ability will be a transparent decision and an absolute condition of delegation? Following this, can the Minister also confirm that there will be at least an annual published review of ICBs’ performance in the commissioning of these specialised services? Can the Minister tell us what the circumstances are in which such a delegation of specialised commissioning may be withdrawn? What is the legal mechanism for doing that? Finally, there is the question of money. How can we be sure that the appropriate funds are spent by ICBs on specialised commissioning? Is a ring-fencing of funds being considered, for example?

I close by noting the many successes of the NHS specialised commissioning group and its frequent and very welcome engagement with patient groups and the Specialised Healthcare Alliance.

Health and Care Bill

Lord Sharkey Excerpts
Lords Hansard - Part 1 & Committee stage
Monday 24th January 2022

(2 years, 2 months ago)

Lords Chamber
Read Full debate Health and Care Act 2022 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 71-VI Sixth marshalled list for Committee - (24 Jan 2022)
With these few remarks, I beg to move.
Lord Sharkey Portrait Lord Sharkey (LD)
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My Lords, it is a pleasure to follow and to agree with the noble Baroness, Lady McIntosh. I will cover some of the same ground in my remarks.

I start by declaring my interests as chair of the Association of Medical Research Charities and of the Specialised Healthcare Alliance. The alliance campaigns on behalf of those 3.5 million of us who have rare or complex conditions. The members of the AMRC spend around £1.7 billion a year on medical research, mostly through universities in the United Kingdom. That is more than is spent by the Government via either the Medical Research Council or the National Institute for Health Research.

I will speak to Amendments 79 and 196 in my name and the names of the noble Lords, Lord Kakkar and Lord Patel, and the noble Baroness, Lady Blackwood. It is a privilege to have the support of such extremely distinguished and expert Members, and I am very grateful to them. The amendments also have the support of much of the medical research sector. Both amendments concern research within the NHS. This subject is a long-standing preoccupation of the medical research community, the NHS and the Government.

As long ago as 2011, the Academy of Medical Sciences published an influential paper setting out some key findings, prominent among which was the difficulty in attaining NHS permissions for research. In fact, this was identified as the single greatest barrier to health research. In 2017, the NHS and NIHR published a joint paper called 12 Actions to Support and Apply Research in the NHS. The NHS Long Term Plan, published in 2019, was generally received positively but actually had little to say about research. As your Lordships would expect, the NIHR did have something to say about research in its work of March last year, “Embedding a Research Culture”, which rehearsed the benefits of a research-intensive NHS. Three of the main actions called for were:

“Improving visibility and making research matter to the NHS … Making research more diverse and more relevant to the whole UK … Strengthening public, patient and service user involvement in research.”


These are obviously very important goals, but setting them out as clearly as the NIHR does makes it clear that the NHS’s performance in this vital area really does need improvement.

Also in March last year, the Government published a ministerial paper focused entirely on the delivery of UK clinical research. The paper set out the value of clinical research and our world-leading position. It made the assertion that

“research is the single most important way in which we improve our healthcare—by identifying new means to prevent, diagnose and treat disease.”

It concluded that that meant

“embedding clinical research at the heart of patient care and the NHS, making participation as easy as possible and ensuring all health and care staff feel empowered to support research.”

I strongly agree with both these assessments, and I am very glad to see them as firm policy goals. I welcome the clear and directive language and the signals of intent, which is why I was extremely disappointed to see such a very weak obligation as regards research in the Bill.

New Section 14Z40, inserted by Clause 20 on page 17, sets out what it describes as a duty in respect of research for ICBs. It simply says:

“Each integrated care board must, in the exercise of its functions, promote— (a) research on matters relevant to the health service, and (b) the use in the health service of evidence obtained from research.”


This is essentially the same kind of duty as imposed by the 2012 Act, and it is extraordinarily weak. The word “promote” is not really meaningful. What would satisfy this condition? Mere exhortation would probably qualify. Imposing a duty to actually do research would be much clearer, much simpler and more likely to have an effect. This would also be consistent with the Government’s view of the critical importance set out in the ministerial paper. That is what our Amendment 79 seeks to do. It is a “must actually do something” obligation rather than a “promote the doing of something” obligation. It requires that ICBs must ensure that those eligible organisations for which the ICB is responsible conduct research on matters relevant to improving patient outcomes and healthcare delivery and promote the use in health and care of evidence obtained by research.

The amendment has two additional parts. The first is to impose a requirement for ICBs to co-produce research aims with local place-based partnerships and to ensure diversity of participation. This acknowledges both the benefits and the necessity of place-centred research and close partnership in the production of research aims. The second additional part of our amendment is simply a requirement that the ICB publishes via its annual reports and joint forward plans the steps it has taken or plans to take to deliver clinical research.

Our Amendment 196 is also in this group. It deals with research directly in trusts and foundation trusts. As things stand, Schedule 4(16) of the 2006 Act says only that

“An NHS trust may undertake and commission research and make available staff and provide facilities for research by other persons.”


This is clearly permissive and not directive. Our Amendment 196 would remove this paragraph and replace it with a requirement for both trusts and foundation trusts to actually carry out research, as in Amendment 79. The amendment would also preserve, from the 2006 Act, making available staff and providing facilities for research by other persons.

I strongly believe that both amendments—all parts of them—are in keeping with the ministerial paper, Saving and Improving Lives: The Future of UK Clinical Research Delivery. I hope that the Minister will recognise the cross-party and not adversarial character of our proposals. We really agree with the Government about the paramount importance of research in the NHS—we just need to make it happen. I look forward to the Minister’s reply and to further discussions between now and Report.

Earl of Kinnoull Portrait The Principal Deputy Chairman of Committees (The Earl of Kinnoull) (CB)
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The noble Lord, Lord Howarth of Newport, is participating remotely. I invite him to speak now.

Health and Care Bill

Lord Sharkey Excerpts
Lords Hansard - Part 2 & Committee stage
Monday 24th January 2022

(2 years, 2 months ago)

Lords Chamber
Read Full debate Health and Care Act 2022 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 71-VI Sixth marshalled list for Committee - (24 Jan 2022)
Lord Lansley Portrait Lord Lansley (Con)
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My Lords, I am pleased to follow the noble Lord and I endorse the points he makes about the diversity of provision, which is certainly something that we should aim for; I am not sure how we will make sure it is in the Bill, but we will get to that later on. I will not dwell on the other amendments; I will simply explain why I oppose Clause 70 standing part. I was pleased to see that the noble Baroness, Lady Thornton, shares that view, although she may do so for different reasons.

This gives me an opportunity to explain something that I have been saying to Ministers—not necessarily these Ministers but their predecessors—for the last two or three years: if the NHS took the view that the structure of the procurement regime that was applied to it was a constraint, cumbersome and the various other words that it used, Ministers could do something about it very quickly because, in the legislation, they have the power to change the regulations. So why do they not do so? I also want to explain that the existing regulations do not impose some of the constraints that it is argued they do. That begs the question behind my opposition to the clause standing part: why are we legislating in this way in this clause, when the effect is to remove a power to make regulations relating to the procurement regime in order to then put into the Bill a power to do just that? It really does nothing much more than that.

Of course, in truth, we do not know what these new regulations will look like because they have not been published, as the noble Lord, Lord Hunt of Kings Heath, rightly said. The issue lies in the regulations because, as I will demonstrate, what mattered to the service, as it turned out, was not what was in Section 75 of the 2012 Act but what was in the subsequent 2013 procurement, choice and competition regulations. I am sorry, but this is going to take a few minutes.

Clause 70 does nothing much more than refer to the fact that there should be transparent and fair processes, that “managing conflicts of interest” should take place and that compliance should be verified—I do not know quite what that means but it is probably a good thing. It also makes reference to general procurement objectives. You might ask what those are, since they are not specified in Clause 70 itself.

If one goes back to the previous legislation, one gets to the point in the NHS (Procurement, Patient Choice and Competition) (No. 2) Regulations 2013, which are also revoked later in Clause 70. In the regulations, there is a paragraph that says what the procurement objectives are:

“for the purposes of the NHS … a relevant body must act with a view to … securing the needs of the people who use the services … improving the quality of the services, and … improving efficiency in the provision of the services”.

I rather hope that we are not yet encountering anything to which people would object. It then goes on to say:

“including through the services being provided in an integrated way (including with other health care services, health-related services, or social care services).”

Frankly, we have had years now of people explaining that the legislation did not allow them to do things in an integrated way. But when one looks back to 2013 and the regulations brought in, they say that the objective is to do things in an integrated way. I slightly wonder why the NHS did not do that, rather than complain that it could not.

Let me go on. When looking at the general requirements of procurement subsequently in that regulation, it includes the provision to

“act in a transparent and proportionate way, and … treat providers equally and in a non-discriminatory way”,

and wants projects delivered with “best value”. So far, again, there is nothing to which people object.

In Regulation 3(4) we hit something that people might object to. In defining what quality and efficiency look like, the regulations go on to say that the services should be

“provided in a more integrated way”—

which we have already heard about, and it repeats exactly that point—

“enabling providers to compete to provide the services”.

This may be where the objection came from, in which case my argument to Ministers is this: if that is what you do not like in the regulations, omit it from them. Ministers could have done it literally in a matter of weeks.

What is the other objection to the existing structure of the legislation? Section 75 of the Health and Social Care Act 2012, about the power and what it should be used to do, talked about good practice in procurement and the right to patient choice. I mentioned in a previous group the importance of, in my view, putting the right to patient choice into the provider selection regime, but we will come on to that again at a later stage.

Here is a third point, and something to which I think some people objected to, and have objected to subsequently; that providers

“do not engage in anti-competitive behaviour which is against the interests of people who use such services.”

I might say that if the anti-competitive behaviour is in the interests of the people who use those services, it is not necessarily objectionable. However, when one looks further, Regulation 10 of the subsequent regulations describes the circumstances in which anti-competitive behaviour might be justified:

“unless to do so is in the interests of people who use health care services … which may include … the services being provided in an integrated way”.

We keep coming back to this.

The other point I would make—she is not here, but the noble Baroness, Lady Blackwood, said it at Second Reading—is that the NHS objected to the fact that it was required to engage in compulsory competitive tendering. Section 75 of the 2012 legislation says that the regulations may

“impose requirements relating to … competitive tendering”,

as well as to the management of conflicts of interest, but it does not require the regulations to be made at all, and it certainly does not require the regulations to include compulsory competitive tendering, and nor do the subsequent regulations published in 2013 require that.

All of that leads me to the conclusion that Section 75 of the 2012 Act simply creates a power; it does not need to be changed for new regulations to have been made. Section 75 says that subsequent 2013 regulations may be objectionable to people in so far as they refer to qualified providers and to competitive tendering. If that was the problem, you should revise the regulations, publish them, take out the bits you object to and give the NHS a provider selection regime that fits their anticipated needs. The objectives are all there: quality, efficiency, best value, fairness, proportionality and an integrated service—and an integration, if that is what this Bill is all about, was already there in the 2012 legislation.

My question to my noble friend for before Report, and the question asked by the stand part debate, is: why are we doing what we are doing in Clause 70? Cannot we do it perhaps more simply and effectively by amending the existing legislation, rather than by trying to do wholesale repeals, introducing something that we will not know what it looks like until after this Bill has passed through this House?

Lord Sharkey Portrait Lord Sharkey (LD)
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My Lords, Amendment 213 is in my name and that of the noble Baroness, Lady Thornton, and I am very grateful for her support. I can be briefer than I was expecting to be, given what the noble Lords, Lord Lansley and Lord Hunt, have said in the last few minutes.

My amendment addresses another instance of an attempt by the Government to bypass parliamentary scrutiny, and it proposes in response an enhanced form of parliamentary scrutiny. As the noble Lord, Lord Hunt, remarked, the DPRRC report on the Bill notes that the delegated powers memorandum says that, although initial consultation has been carried out by NHS England on the content of the procurement regime, full analysis has not been completed and there has not been time to produce a more developed proposal. Clause 70 gives the Minister the power to impose a new procurement regime, without giving any details of what it might be. This is the clearest possible example of the Government taking powers to make policy without specifying at all what that policy may be.

The DPRRC rejects the inclusion of regulation-making powers as a cover for inadequately developed, or undeveloped, policy. What is worse, the delegated powers memorandum says that a Cabinet Office procurement Bill will most likely follow this Bill, and it may require some amendments to the regulation-making powers that we are discussing in this Bill. The regulatory powers in question are to be subject to the negative procedure. I think we all, except for the Government Front Bench, would recognise that the negative procedure is emphatically not effective parliamentary scrutiny.

What we have here is a skeleton clause, with regulation-making powers of very broad scope. There is nothing in this clause, or in the Bill more generally, which would in practice constrain how broadly these powers could be used in constructing a procurement regime. It would probably be better, from the point of view of parliamentary scrutiny, to leave out Clause 70 entirely, as the noble Lord, Lord Lansley, my noble friend Lady Walmsley and the noble Baroness, Lady Thornton, propose, and wait for the full policy to be set out in the Bill, as promised to follow soon from the Cabinet Office.

If the Minister can advance compelling reasons why this Bill should be the vehicle for setting up the procurement regime by regulations, there is one route we could take, as set out in my amendment. This amendment imposes the super-affirmative procedure on the delegated powers proposal. The super-affirmative procedure is designed and used to deliver a measure of real scrutiny in circumstances that require it. In proceedings on the recent Medicines and Medical Devices Bill, the Minister very helpfully summarised the super-affirmative procedure as follows, saying that the

“procedure would require an initial draft of the regulations to be laid before Parliament alongside an explanatory statement and that a committee must be convened to report on those draft regulations within 30 days of publication. Only after a minimum of 30 days following the publication of the initial draft regulations may the Secretary of State lay regulations, accompanied by a further published statement on any changes to the regulations. They must then be debated as normal in both Houses and approved by resolution.”—[Official Report, 19/10/20; col. GC 376.]

According to the Library, the last recorded insertion in a Bill of a super-affirmative procedure was by the Government themselves, in October 2017, in what became the Financial Guidance and Claims Act.

I repeat that, if the Minister really can convince us that he has a compelling reason to have this new procurement regime set up by regulations in the Bill, my amendment would provide the opportunity for detailed parliamentary scrutiny. If he cannot accept that, then we would be wise to take out Clause 70 in its entirety.

--- Later in debate ---
Lord Kamall Portrait Lord Kamall (Con)
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May I explain about the point made by the noble Lord, Lord Lansley, on Clause 70—

Lord Sharkey Portrait Lord Sharkey (LD)
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Before the Minister abandons Amendment 93 entirely, could he explain why it is necessary to have, in this Bill—when there is another one coming along—regulation-making powers that are unconstrained and non-specific?

Lord Kamall Portrait Lord Kamall (Con)
- Hansard - - - Excerpts

We do not believe that they are, but clearly there is a difference of opinion about it.

I would like to turn, however, to the point made by my noble friend Lord Lansley on Clause 70. The regulations that we create under Clause 70 will have a broader scope than those currently created under Section 75. The provider selection regime will include public health services commissioned by local authorities, thereby recognising their role as part of joined-up health services delivered for the public. While we always want to act in the interests of people who use our services, our regime recognises the reality that in some cases integration, rather than competition, is the best way to achieve this for the health service. Finally, removing the section and creating a new bespoke regime, is—despite the scepticism of the noble Lord, Lord Warner—what the NHS has asked for. There is strong public and NHS support for scrapping Section 75 of the 2012 Act—

Health and Care Bill

Lord Sharkey Excerpts
Lords Hansard - Part 1 & Committee stage
Wednesday 26th January 2022

(2 years, 2 months ago)

Lords Chamber
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Moved by
106: Clause 20, page 20, leave out lines 20 to 43
Lord Sharkey Portrait Lord Sharkey (LD)
- Hansard - -

My Lords, Amendment 106 is in my name and those of my noble friend Lady Walmsley and the noble Baroness, Lady Thornton. I am very grateful for their support.

Two months ago, two of our Select Committees, the DPRRC and the SLSC, published simultaneous and collaborative reports. The DPRRC report is entitled Democracy Denied? The urgent need to rebalance power between Parliament and the Executive, and the SLSC report is called Government by Diktat: A call to return power to Parliament. It would be very hard to exaggerate the importance of these reports, and I congratulate both committees on a very timely and disturbing reminder of the Government’s habit of trying to bypass Parliament and avoid effective scrutiny, as they do again in this Bill.

Both the reports focused on the long-standing abuse of the use of delegated powers legislation, and the DPRRC concluded:

“The abuse of delegated powers is in effect an abuse of Parliament and an abuse of democracy, and this report will, we hope, be a prompt to strengthen Parliament in the coming years.”


We can make a start on that hope with this Bill.

The DPRRC noted in its report of 15 December that the Bill contains 155 substantive provisions and 156 delegated powers. It concluded:

“The Health and Care Bill is a clear and disturbing illustration of how much disguised legislation a Bill can contain and offends against the democratic principles of parliamentary scrutiny.”


The report examines some of the Bill’s clauses in some detail, including the insertion via Clause 20 of a new Section 14Z48 into the National Health Service Act 2006. Essentially, the new section gives a Minister the power to make law by simply publishing “a document”. The department tries to justify the lack of any parliamentary procedure associated with the publication of a document on the grounds that the power is concerned with operational and administrative matters. However, the DPRRC goes on to say:

“Such a power is very unusual. If used in a context other than one involving public sector health bodies, it might give grave cause for concern and set an extraordinary precedent. Statutory liabilities should be imposed transparently, subject to clear legal conditions and parliamentary scrutiny.”


I should point out here the force of the word “unusual” in the committee’s comments. This is the highest form of disapprobation used by committees, and for good reason. This proposed new section is a blatant, transparent and disgraceful attempt to avoid any parliamentary scrutiny whatever.

The DPRRC’s conclusion is damning. It says:

“The power to impose a legal liability by merely publishing a document, without any parliamentary scrutiny, is a striking example of disguised legislation. We regard it as an inappropriate delegation of power, which should be removed from the Bill.”


In its report on the Bill of 7 January, the Constitution Committee agreed with the DPRRC’s recommendation to remove the new section from the Bill. I agree strongly, and that is what our amendment would do. I suggest to the Minister that if he wants to retain the powers set out in proposed new Section 14Z48, he rework them between now and Report so that they at least involve scrutiny by the affirmative procedure. If not, he can certainly expect us to return to this serious abuse of delegated powers on Report. I beg to move.

Lord McFall of Alcluith Portrait The Lord Speaker (Lord McFall of Alcluith)
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My Lords, the noble Baroness, Lady Brinton, is taking part remotely and I invite her to speak.

--- Later in debate ---
Lord Kamall Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Kamall) (Con)
- Hansard - - - Excerpts

My Lords, I thank the noble Lord, Lord Sharkey, and the noble Baronesses, Lady Finlay and Lady Greengross, for bringing this group of amendments.

I understand the intention behind Amendment 106, on payment to providers, which is to remove new Section 14Z48 in its entirety, but the section will allow NHS England to specify the circumstances in which an ICB is liable to make payments to a provider for services commissioned by another ICB.

The Government are committed to ensuring that delegated powers in the Bill use the most appropriate procedure, so that Parliament has due oversight of their use. We recognise that the Bill contains a significant number of guidance-making powers and powers to publish documents. However, we believe that they are appropriate because, as the noble Baroness, Lady Walmsley, said, they reflect the often complex operational details and the importance of ensuring that the guidance keeps up with best practice, especially as the system flexes and evolves. I understand the noble Baroness’s point about Parliament, but the issue here is whether, every time the system flexes, Parliament has to have another debate. The ICBs will be reading the guidance, not Hansard, and the guidance should reflect that.

Nor is it our intention to interfere unduly in the financial affairs of ICBs. Instead, the intention is to resolve specific circumstances, such as emergency services. The legislation makes it clear that each ICB has to arrange for urgent care services to be available for all people physically present in the area, not just for the people who are its core responsibility by virtue of their GP registration. I am sure noble Lords will agree that it would be neither fair nor in the best interests of promoting an efficient health service for the ICB to both arrange and cover the cost of all additional emergency treatment brought by visitors to the area, particularly in areas with high visitor numbers. A number of noble Lords referred to that principle in debates last week.

Instead, this provision allows NHS England to mandate a different payment rule for those services, ensuring that, where necessary, the ICB where a patient is registered will pay, rather than the ICB where they receive treatment. This ensures that the financial impact is felt in the right commissioning organisation and eliminates the risk of some ICBs having unreasonable financial demands placed on them—for example, during the holiday season.

The wording of this provision replicates almost exactly the National Health Service Act 2006 as amended in 2012, but it is updated to reflect the new ICB structure. As my noble friend Lord Howe mentioned to me, we had a massive debate about this 10 years ago, but the provision seems to have worked effectively in the CCGs, and we wish to continue that with the ICBs.

Amendments 143 and 144, in the name of the noble Baroness, Lady Finlay, are about NHS England directing ICBs. I understand the interest in ensuring that NHS England has the necessary tools to intervene in ICBs where necessary. However, we believe that NHS England already has sufficient powers to direct ICBs. NHS England already has certain powers to direct an ICB under Section 14Z59(2), and powers to intervene over ICBs in order to prevent failure and to ensure that the lines of accountability from ICBs through NHS England to Parliament are strong.

However, this power has a threshold in that it can be used only if NHS England deems an ICB to be failing to discharge a function or at risk of failing to do so. The threshold removes the possibility of NHS England overdirecting the system while retaining the power for use if necessary. This balances the need to prevent failure and to support accountability with allowing ICBs the autonomy they need to operate effectively.

Amendments 133, 139 and 161 expressly require that ICB annual reports and NHS England performance assessments of ICBs include specific consideration of commissioned services, including NHS Continuing Healthcare, which noble Lords have spoken about, and that the CQC reviews of ICSs include specific consideration of that. We agree with the principle, but we believe that it is already covered in the Bill. NHS England already has a key role in overseeing ICBs. For example, the Bill requires NHS England to assess the performance of each ICB every year, and ICBs are required to provide NHS England with their annual report. These reports will include an assessment of ICB commissioning duties, which would encompass any arrangements for NHS Continuing Healthcare.

In addition, as noble Lords are aware, Clause 26 gives the CQC a duty to assess integrated care systems, including the provision of relevant healthcare and adult social care within the area of each ICB. This would include the provision of NHS Continuing Healthcare. We intend the CQC to pilot and develop its approach to these reviews in collaboration with NHS England, but also with other partners in the system. This should ensure that the methodology does not duplicate or conflict with any existing system oversight roles.

With this in mind, we believe that these amendments are not necessary, because commissioned services, which we would expect to encompass NHS Continuing Healthcare, are already included in these clauses. I hope that I have been able to somewhat reassure your Lordships. For these reasons, I ask noble Lords not to press their amendments.

Lord Sharkey Portrait Lord Sharkey (LD)
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My Lords, it is clear that new Section 14Z48 is an unambiguous abuse of delegated powers. It provides for a law to be created by the simple issuing of a paper. There is no real possibility of a coherent defence of this procedure and the Minister did not provide one, relying as he did on special pleading and the extraordinary notion that Parliament cannot handle complexity.

As the Bill stands, Parliament is bypassed and scrutiny is avoided. I remind the Committee that the DPRRC and the Constitution Committee have recommended the removal of this section. I again suggest to the Minister that if he wants to retain the powers set out in Section 14Z48, he should rework them between now and Report at least to involve scrutiny by Parliament via the affirmative procedure. If he does not, we will return to this issue on Report. In the meantime, I beg leave to withdraw the amendment.

Amendment 106 withdrawn.

Health and Care Bill Debate

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Department: Leader of the House

Health and Care Bill

Lord Sharkey Excerpts
Lords Hansard - Part 2 & Committee stage
Wednesday 26th January 2022

(2 years, 2 months ago)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Baroness Meyer Portrait Baroness Meyer (Con)
- Hansard - - - Excerpts

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

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

Health and Care Bill

Lord Sharkey Excerpts
Lords Hansard - Part 2 & Committee stage
Monday 31st January 2022

(2 years, 1 month ago)

Lords Chamber
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Baroness Brinton Portrait Baroness Brinton (LD) [V]
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My Lords, along with the noble Baroness, Lady Thornton, and other noble Lords, I was involved in the passage of the Bill that started off life as the Healthcare (International Arrangements) Bill, and which, by the time it was passed, had been renamed the Healthcare (European Economic Area and Switzerland Arrangements) Bill—a name almost as long as the Bill itself, and after some of the worst Henry VIII powers had been removed, including the power of Ministers to sign international trade agreements that could include preferential access to NHS contracts without the formal scrutiny and decision-making powers in Parliament.

The frustration with the remote arrangements is that I am speaking before my noble friend Lord Sharkey. I know that he will speak about the delegated powers in Clause 136. I wish I could hear his contribution before I speak, but I want to say that it seems the Government have forgotten, in nearly three years, the roasting that they got from your Lordships’ House during the passage of the Healthcare (International Arrangements) Bill. The noble Lord, Lord Wilson of Dinton, said:

“The sweeping nature of the powers proposed in the Bill are in many ways offensive to the proper conduct of legislation. I accept that they are needed in the current situation in relation to the EU and Switzerland, but to go wider than that is wrong, I think. We have to insist on legislation being properly prepared, properly debated, properly scrutinised and properly consulted on.”—[Official Report, 12/3/19; col. 926.]


The then Health Minister, the noble Baroness, Lady Blackwood, when conceding on those Henry VIII powers later that day on Report, said:

“I want to be clear that the consequential Henry VIII powers were initially included as a future-proofing mechanism. They were never free-standing and we had envisaged using them in only a limited set of circumstances … we want to alleviate any fears that we are taking powers which are not absolutely necessary in this Bill. As such we are prepared to take the significant step of removing the entire Henry VIII consequential powers in Clauses 5(3) and (4).”—[Official Report, 12/3/19; col. 963.]


One of the reasons that your Lordships’ House is so concerned is that it looks as if the provisions in that Bill are being resurrected in Clause 136 of this Bill. I will give two brief examples: “2 Healthcare agreements and payments” on page 110 of the Bill, among other clauses, gives the Secretary of State the powers to make a healthcare agreement with another country and for Parliament to only comment on it by the negative resolution. For those of us who worked on a previous Bill, that sounds horribly familiar. It also gives the Secretary of State the power to give directions to a person about the exercise of any function, which is familiar not only from that Bill but from other parts of this one.

In “2B, regulations under Section 2A: consent requirements” on page 112, it says at (5) that the consent of the Secretary of State is required for a

“healthcare agreement”

which means

“an agreement or other commitment between the UK and either a country or territory outside the UK or an international organisation, concerning health provided anywhere in the world”.

Any type of “agreement” or “commitment” brings us full circle back to the Healthcare (International Arrangements) Bill as first drafted. This would include international treaties, as was planned back in 2019, to include that access to providing major parts of healthcare in the NHS, but without the consent or knowledge of Parliament, because the detail of the agreement would not need be seen before it was signed, including by the NHS, its stakeholders and the staff who work in the sector.

Lest we think that this is just words, the Chancellor of the Exchequer and the Secretary of State for Health and Social Care have both talked extensively in America to healthcare providers in recent months. What is different about this clause is the breadth of definition of a healthcare agreement, the powers that are held only by the Secretary of State, and the total lack or paucity of consultation or scrutiny by Parliament and other stakeholders before the Bill came to your Lordships’ House.

Why has Clause 136 reinstated some of the key elements of the Healthcare (International Arrangements) Bill that were removed because Ministers recognised that the scope was too wide, the Henry VIII powers were egregious, and Parliament, the NHS and other stakeholders were being totally disregarded?

Should my noble friend Lord Sharkey wish to propose on Report that the clause do not stand part, I will support him.

Lord Sharkey Portrait Lord Sharkey (LD)
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My Lords, as the noble Baroness, Lady Brinton, said, I have given notice of my intention to oppose the Motion that Clause 136 stand part. This clause is yet another example of the Government’s abuse of delegated legislation and the avoidance of any meaningful parliamentary scrutiny. It is also a clear and obvious breach of an important constitutional convention.

Clause 136 amends the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019, which started off life as the Healthcare (International Arrangements) Bill, as we just heard. It would enable the Government to implement healthcare agreements with countries outside the European Economic Area and Switzerland. The exercise of the powers in this clause is through regulations subject only to the negative procedure. The department points to the 2019 Act as for seeking these powers, despite what we just heard from the noble Baroness, Lady Brinton.

During the passage of the then Bill in 2018-19, the Government justified or tried to justify taking the relevant powers as the need for speed and flexibility in the extraordinary circumstances of the EU withdrawal process. Parliament did not accept the provisions in the original Bill that the powers should be geographically and temporarily unlimited. After interventions by Parliament, the powers ended up being confined to the EEA and Switzerland and being sunsetted.

The department may be correct to state that the Secretary of State currently lacks the necessary powers to implement reciprocal healthcare agreements with countries outside the European Economic Area and Switzerland. However, this does not mean that there is currently no way to implement such agreements. They could and should be implemented by primary legislation. This would be in keeping with a long-standing constitutional convention that, outside the exceptional case of making provision for EU law, international legal agreements that make changes to UK law are given domestic force by an Act of Parliament. This ensures proper parliamentary scrutiny.

Our committees have pointed out breaches of this convention to the Government on several recent occasions. The last occasion was the proceedings of what was originally the Healthcare (International Arrangements) Bill, as I have just mentioned. Before that, the DPRRC commented on the breaches of this convention in the Professional Qualifications Bill in May 2021 and the Private International Law (Implementation of Agreements) Bill in March 2020. The Constitution Committee commented on the same Bill in its May 2020 report and concluded that:

“It is inappropriate for a whole category of international agreements to be made purely by delegated legislation.”


This is exactly what the Government are proposing in Clause 136.

The department does not address why such international healthcare agreements could not be implemented by primary legislation. We could try to remedy this abuse of delegated powers and breach of convention, as we did with the 2019 Act, by limiting their application and by sunsetting provisions. But, without a clearer understanding—or indeed any understanding—of exactly what agreements the department intends to use these powers for, it is not really possible to limit the power as we did then. The powers could also be sunsetted, as per that Act, but it is clear this would be inappropriate, given there is no longer a pressing time constraint on their use, unlike the then imminent departure from the EU. A better solution would be for the Government to abide by the constitutional convention and bring forward the appropriate primary legislation. That is the only way in which to enable any meaningful parliamentary scrutiny of these important reciprocal arrangements.

I look forward to the Minister’s explanation of why it is necessary to bypass Parliament and breach the constitutional convention in the manner proposed. I understand why it may be convenient, but cannot see why it is necessary or proper. We will certainly return to this issue as the Bill progresses.

Baroness Finlay of Llandaff Portrait Baroness Finlay of Llandaff (CB)
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My Lords, I am most grateful to the noble Lord, Lord Sharkey, for that completely comprehensive overview of the problem with this clause. I simply have some questions relating to it. We have devolved powers in the devolved nations of the United Kingdom and, to my understanding, this clause does not oblige the Government to have undertaken a comprehensive consultation with them before entering into such an agreement. It does not seem to require legislative competence before such legislation is proposed, and that legislation certainly would not come before this Parliament anyway.

Health and Care Bill

Lord Sharkey Excerpts
Lords Hansard - Part 1 & Report stage
Tuesday 1st March 2022

(2 years ago)

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Lord Hunt of Kings Heath Portrait Lord Hunt of Kings Heath (Lab)
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My Lords, as this is my first contribution on Report, I declare my interests as a member of the GMC board and president of GS1, the British Fluoridation Society, the HCA and HCSA.

I welcome what the Minister said about research and its importance, and some of the tensions between practical work as a clinician and the crucial importance of clinicians engaged in research. The amendments that he introduced are very welcome, but like the noble Baroness, Lady McIntosh, I am disappointed that he has not brought similar amendments forward in relation to NICE. One suspects that it is something to do with money; he thinks that giving away amendments on research is cost-free, whereas there might be a resource implication when it comes to NICE. That is a pity.

The noble Baroness has talked about a postcode lottery in this country on the outcome of NICE judgments, but we also have a European postcode lottery. The fact is that NHS patients have much less access to modern new medicines and devices than those in many other countries. Stats that I have seen on medicines suggest that, for every hundred European patients who can access new medicines in the first year they are available, just 15 UK patients have the same access. We know that even when NICE has given its blessing to new medicines and treatments, take-up in the NHS still lags behind that in other countries.

I think that the noble Baroness, Lady McIntosh, and I were somewhat puzzled by the ministerial response in Committee in this area. We know that the NHS uses all sorts of rationing devices to prevent those new medicines and devices being allocated generally throughout the NHS, notwithstanding what NICE has to say—that is why I support the noble Baroness’s amendments. Essentially, my two amendments seek to build on the principles that she has referred to.

Amendment 171 relates to three issues which I think remain from Committee. The first relates to the links between licensing and reimbursement processes. Happily, the MHRA has established two new licensing pathways, ILAP— the Innovative Licensing and Access Pathway—and Project Orbis, for cancer medicines. This is very welcome; it is designed to speed up access.

However, the challenge with faster licensing decisions is that NHS reimbursement decisions need to speed up too, otherwise medicines can be placed on the market but cannot be made available to patients on the NHS. To its credit, the MHRA has designed this into ILAP, because NICE is directly involved in ILAP, and licensing and reimbursement decisions can be joined up. However, in respect of Project Orbis, there has been no such effort. Late last year, breast cancer patients faced the worrying situation where a drug, Trodelvy, which offered them hope, was licensed through Orbis but was not then available on the NHS. My amendment would therefore ensure that NICE acted to issue guidance on Project Orbis medicines as close to licensing as possible, as it does for ILAP.

Secondly, the amendment would clarify that NICE alone is responsible for determining its methods, as an independent body should be. In its recent methods and processes review, it concluded that

“there is an evidence-based case for changing the reference-case discount rate to 1.5% for costs and health effects. However, because of the wider policy and fiscal implications and interdependencies that are beyond the reach of this review, no change to the reference-case discount rate”

could be made. It further stated:

“Reducing the discount rate will make most technologies appear to be more cost effective.”


We are therefore in a situation where NICE wants to make a change to its methods, which would result in more medicines being made available to patients but is being stopped from doing so. That is not acceptable. NICE should be free to determine its methods, including the discount rate.

The final effect of the amendment would be to clarify the role that the current voluntary scheme, VPAS, and the statutory scheme play in reimbursement decisions. These schemes essentially cap the NHS’s expenditure on drugs, meaning the exposure of the taxpayer to spending on drugs is limited. The problem is that the health service then adds a whole host of other mechanisms to restrict access to medicines as well. My own view is that once we have VPAS and the statutory scheme in place, we do not need those other mechanisms.

Amendment 178 builds on this. I have already referred to the Project Orbis scheme. It has great potential, but unfortunately, as Gilead has pointed out, there is a lack of alignment across the system between government, the MHRA, NICE and NHS England, which has an impact on timelines for approval. This is particularly concerning in light of moves by other countries such as France to legislate to enable early access to innovative therapies prior to a cost-effectiveness assessment, with any difference in the final agreed price rebated by the company. We need an integrated access and funding pathway for medicines licensed by Orbis, prior to NICE approval, modelled on the French system, whereby companies rebate any difference in price following the decision by NICE.

The final point I will make is that we also need to deal with NICE capacity issues. In January 2022, NICE highlighted in its board papers that approximately 20 evaluations were paused in 2021-22 due to capacity constraints because of vacancies. This is despite increased industry fees paid for health technology assessments. While NICE’s vacancy rate has reduced, the same board papers note that:

“Organisational capacity continues to be the key risk for NICE ... strategy, and gaps in hard to fill specialist roles in a competitive global market.”


I would like the Minister to respond to this.

More generally, I hope that the Minister can give us some assurance that he and other Ministers recognise that all these initiatives to speed up access, excellent though they are, will come to very little unless they can sort out the NHS side of things and get rid of some of these rationing mechanisms which have been put in place.

Lord Sharkey Portrait Lord Sharkey (LD)
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My Lords, like the noble Lords, Lord Patel and Lord Kakkar, I have added my name to the government amendments in this group. These amendments directly address the criticisms which we made in Committee that, as things stood, a duty to promote research lacked any real force. Since we made these criticisms, we have met with the Minister and his officials to try to strengthen this research duty and make it more meaningful and concrete. These amendments, and the others in the next group, are the result of our discussions.

The Minister has explained, and given some examples, how they would help. The importance lies on what new things the amendments put in place. They require the NHS to explain, in its business plans and annual report, how it proposes to discharge, or has discharged, its research obligations. They also require a performance assessment of ICBs, which includes how well they have discharged their research duty and their duty to facilitate and promote the use of evidence in research. I thank the Minister and his team for their extensive engagement on the question of research in the NHS. I am pleased that we have strengthened the research duties of the Secretary of State and the ICBs. I am particularly pleased that progress will now be formally reported and assessed.

I should also mention that, in his letter of yesterday, the Minister listed a number of non-legislative measures either being taken or developed for facilitating or fostering a culture of research within the NHS, and for holding to account the people responsible for delivering this.

Finally, the noble Lord, Lord Patel, has asked me to say how sorry he is that he cannot be here today. He wanted the House to know that he supports the Government’s research amendments and is grateful for their co-operation in generating more research in the NHS. As the noble Lord, Lord Kakkar, has said, he is at home recovering from Covid, and I am sure that the House wishes him a speedy recovery.

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

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

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

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

Health and Care Bill

Lord Sharkey Excerpts
Moved by
126A: Clause 151, page 117, line 40, leave out subsection (3) and insert—
“(3) In section 1, omit “an EEA state or Switzerland” and insert “a relevant state or territory”.(4) In subsection 2(1)(b) omit “an EEA state or Switzerland” and insert “a relevant state or territory”.(5) In subsection 2(2) after (i) insert—“(j) make provision to make payment (otherwise than under a healthcare agreement) in respect of healthcare provided in a relevant country or territory, but only when the Secretary of State considers that exceptional circumstances justify the payment and has laid before Parliament the reasons for such consideration and the details of the payments;”.(5) Omit subsection 2(7).(6) After section 2 insert—“(2ZA) Regulations under section 2 may—(a) confer functions on a relevant public authority or a Scottish or Welsh health board (including discretions);(b) provide for the delegation of functions to a relevant public authority or a Scottish or Welsh health board.(2ZB) The Secretary of State may give directions to a person about the exercise of any functions exercisable by the person under regulations made by virtue of section 1 (and may vary or revoke any such directions).””
Lord Sharkey Portrait Lord Sharkey (LD)
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I shall speak to all the amendments in this group. I am very grateful to the noble Baronesses, Lady Brinton and Lady Thornton, for their support. All the amendments in this group address Clause 151. The purpose of this clause is to enable the Secretary of State to implement reciprocal healthcare agreements with countries other than the EEA states and Switzerland, where we already have such agreements. These agreements were provided for by the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019. This Act was the subject of intense debate as it passed through this House. Noble Lords approved the inclusion in the Act of explicit constraints on the powers of the Secretary of State to make such agreements. This ensured that wider and different purposes, such as privatisation, could not be included. I make it clear at this point that we strongly support the intention to extend the geographical range of reciprocal healthcare agreements.

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Lord Sharkey Portrait Lord Sharkey (LD)
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My Lords, I am very grateful to the Minister for the comprehensive way she addressed the various anxieties about Clause 151. I am reassured by her clear statement that the purpose of the 2019 Act, as amended in this Bill, is not to implement trade deals, and by her equally clear statement that reciprocal healthcare agreements do not relate to the commissioning and provision of services for the NHS. I heard the Minister say that Clause 151 actually narrows the power given under the 2019 Act and explained how this was so. I am grateful for that explanation too. I am even more grateful that all the regulations produced by Clause 151 will now made under the affirmative procedure. On that note, I beg leave to withdraw the amendment.

Amendment 126A withdrawn.