Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023

Lord Jones Excerpts

Monday 20th March 2023 Grand Committee

[Lord Jones (Lab)]

My Lords, I thank the Minister for his concern and his introduction on the very important matter of blood. Much detail is given by the department in the papers that we have, particularly in the Explanatory Memorandum. Clearly, a lot of work has gone into producing what we have before us.

Currently, a lengthy inquiry by a learned judge and his board is drawing to a close. It regards how, a generation ago, contaminated blood was given to unsuspecting patients, resulting in great distress—and worse—for not only the patients affected but their families. I think the learned chair will report soon; the Minister might confirm that.

My basic question is: can the Minister say what sort of people are involved in the receipt of these fees? One presumes that they are medical professionals or ancillaries who perhaps deal with the details of making available what is required. Can he give examples of the status, titles and work of those who receive the fees? He might agree that, on the face of it, the fee rise is steep.

Clearly, time has gone by, so I intend my interjection to be very brief, but I think I have raised a pertinent question. I rise in this Committee fairly often because I believe that many important regulations come to us, but debates are thinly attended. In many cases, what we consider in our debates here would be better taken on the Floor of your Lordships’ House. That is an opinion, but what we are debating now is very important, and I look forward to the Minister’s reply.

[Lord Allan of Hallam (LD)]

My Lords, we echo the Minister’s comments in praise of the agency for the valuable work that it does in the United Kingdom. Of course, we also want to make sure that it is effectively funded for that work, but we have a few questions on the instrument before us.

First, if we look through the Explanatory Memorandum, the Minister has already explained the item referred to in Paragraph 7.6, that

“the Office for National Statistics reclassified the MHRA from a Trading Fund to a Market Regulatory Agency”,

and said that this affected the way in which it can use cash reserves. In exchanges with the Minister prior to the Committee we talked about the fact that we do nerdy regulation in here. I am curious to know whether any more detail might be made available in writing or otherwise about the way in which that classification or reclassification can take place and the effect that it has, as clearly it may be relevant to other agencies in this space. Understanding what it means to move from being a trading fund to a market regulatory agency is quite important for our work more generally.

Specifically on the cost increases, paragraph 10.2 tells us that there was “a general acceptance” of the need for increased fees in the responses, noting that people said that there was an understanding of the need for an increase in the fees but that they expected to see corresponding consistency in the service that they were given. Again, I hope that the Minister can come back to that later and talk about the assurances that the industry is looking for with regard to the service. However, if we look in detail at the consultation responses, we see that they were not uniformly positive. If we look at the category 1 increases, which was the simple 10% indexation, it was 61% for and 39% against. However, if we look at category 2, where there are some cost-based increases—they are significant and we will touch on those—it was 56% against to 44% for, so clearly, people were more uncomfortable with that. When we come to the third category of new fees, opinion was just in favour but was more balanced: 55% for and 45% against. Importantly, the consultees were then asked whether they thought there would be some impact of the new fees structure on particular kinds of businesses, and 89% said yes and only 11% said no, so a significant number of the consultees felt that in particular small and medium-sized enterprises might be disproportionately affected. We should not gloss over that. I know that officials are trying to summarise things when they produce an Explanatory Memorandum but if you summarise, sometimes you lose these important nuances where there was a much more mixed picture in the response to the proposals.

Paragraph 12.1 of the Explanatory Memorandum tells us that the anticipated costs that will fall on businesses, charities and voluntary bodies will be £1.9 million per year, which is echoed in paragraph 25 of the impact assessment, where it says that these costs will fall on businesses. Of course, the direct costs do, but those businesses will in turn have to pass those costs on to someone, and in most cases the eventual purchasers will be NHS bodies. Therefore again, at one level, it will fall on the business; I do not think that the businesses will simply absorb that cost, and there will be an impact on the taxpayer which does not necessarily come out. I hope that the Government will look at that and at whether, perhaps by increasing the regulatory costs, perhaps for good reasons, we end up increasing the cost base of the equipment. The noble Baroness, Lady Merron, and I were just in the Chamber talking to a Question about the cost pressures on medical equipment and devices and the need to replace significant amounts of outdated equipment with more modern equipment. In many cases, that more modern equipment will go through this approvals process, which will add on cost, so we need to be mindful of that cost base impact.

That brings me to my last point, which was about the impact of the new costs—again, we should not lose sight of them. We get the detailed figures in the annex to the instrument, which is extremely helpful. However, certainly for medical devices, if we look at the status quo ante and the status quo post the adoption of the regulations—these are my rough calculations and I am sure that the people who advise the Minister will be able to do it in more detail—there are costs potentially of £40,000 or of that order under the current regime for somebody to get a new medical device through the designation process, the audit process, and so on. In many cases, those costs are increasing three or fourfold, so you are talking about somebody potentially having to find £150,000 and numbers north of that now to get a medical device through the process.

Care Workers: Professional Register

Lord Jones Excerpts

Monday 10th January 2022 Lords Chamber

[Lord Kamall (Con)]

As my noble friend will appreciate and probably anticipate, there will be debate on the Health and Care Bill for the next few weeks. I am sure that that is one of the issues that will come up.

[Lord Jones (Lab)]

My Lords, can the Minister tell us how many care workers there are at work on a given day? Does he agree that it would be a good idea to have a considered, perpetual publicity campaign persuading those in the care service of the importance of gaining qualifications?

[Lord Kamall (Con)]

To ensure that the profession is attractive, we want to focus not only on making sure that social care staff are paid a decent wage but that they are recognised. The idea behind the skills passport is, first, that we want to understand all the different qualifications that there are with regard to the social care sector; and, secondly, we want to make sure that they can transport that when they move from one employer to another. That is the important thing that we want to look at.

NHS: Staff Numbers after Covid-19

Lord Jones Excerpts

Thursday 4th March 2021 Grand Committee

[Lord Jones (Lab) [V]]

I offer tribute to our local NHS staff, those hard-pressed, weary, dedicated, resourceful, very local nurses and GPs and ever-courteous volunteers aplenty. They, the nurses, have injected tens of thousands so very professionally. Daily, we queued in our hundreds at the Deeside Leisure Centre. We sought immunity and we got it—the heroic nurses gave it. The nurse and the gatekeeper GP are the backbone of the NHS. We need more of them, urgently, and let us reward the heroic nurses better.

NHS Counter Fraud Authority (Establishment, Constitution, and Staff and Other Transfer Provisions) (Amendment) Order 2020

Lord Jones Excerpts

Monday 7th September 2020 Grand Committee

[Lord Jones (Lab)]

My Lords, I thank the Minister for his introductory remarks, his comprehensive review and his brevity. I support the order. The NHS has been magnificent at tackling Covid-19. Perhaps we should consider striking medals for that army of devoted NHS servants. I was a Health Minister in three Administrations. There was fraud in those far-off days; there is fraud now. Ministerial intervention was not effective then; my colleagues and I did not stamp out fraud. The Minister now is finding fraud to be resilient if he seeks a renewed continuation of the NHS Counter Fraud Authority. Surely he is engaged in a positive, considered and professional reactive policy.

I could say that a distinguished Chief Medical Officer said in my hearing that in this respect, the NHS is a monster and it has got a brain. The Minister has a more positive attitude than that exasperated senior official, the Chief Medical Officer. The noble Lord, Lord Lawson, got it right when he ventured to say most positively that the NHS is the nation’s religion. Certainly, it is a great NHS: that is absolutely certain.

I have some brief questions for the Minister. How many prosecutions for fraud were there in each of the years 2018 and 2019? How many successful prosecutions were there in those years? By what process are prosecutions initiated? With reference to paragraph 7.2 in our helpful notes, does his department have an estimate in money terms of the amount of fraud currently under way? How does his department gather and seek such information? Given the large sums of fraudulent moneys that have been discovered to be involved, will he consider enlarging the budget of the authority for better and ever more effective working? How many staff are engaged in the authority? Perhaps the Minister will give the name of the current chair or director of the authority and indicate the salary paid annually to that person. In conclusion, congratulations must go to the authority on saving the sums of money already indicated.

Health: Dementia

Lord Jones Excerpts

Wednesday 22nd January 2014 Lords Chamber

[Lord Jones (Lab)]

My Lords, I most sincerely thank the noble Baroness, Lady Gardner of Parkes, for this debate and acknowledge the importance of the subject and the skilfully drafted Question that frames our debate.

I have no doubt that the Government are determined to address the issues of dementia. When I was a Health Minister in the 1970s, serving Prime Ministers Wilson and Callaghan, one scarcely heard the word “dementia”. The NHS then was a battleground between administrators, unions and consultants. A royal commission was hopefully deployed; the International Monetary Fund moved in, and there was competitive recruitment between unions. Ministers were moved out or sacked, and there were endless resource-allocation working parties. London was accused of gaining too much of the available moneys.

The question of the noble Baroness, Lady Gardner, is as strategic as any that faces administrators and politicians who now give leadership to the nation. The scale of the challenge of dementia socially and financially in the future is truly massive. The amount of money available is inevitably insufficient. The amount of research needs to be expanded, if not the quality. Already, our social services and NHS are stretched almost to breaking point. We have on our hands, in effect, an emergency. Longevity guarantees that this massive national challenge will not go away.

In all of this, there is a shining light: the Alzheimer’s Society, one of Britain’s greatest and most relevant charities. It stands ready to assist and advise countless families whose happiness is blighted by the emergence of dementia in a loved family member. I have the privilege of being a dementia champion in Wales and, at the grass roots of community, I have seen the good done by ordinary people for those who are at their wits’ end struggling to cope with the challenges of domestic change. As president of the society in north Wales for some 20 years, I have seen the enthusiasm of volunteers and their assistance, encouragement, organisation and fund-raising—all of these positives are constant and most effective. These activities generate friendship, teamwork, humour and even expertise though training as a friend. I am sure that the Alzheimer’s Society and its headquarters will continue to harness this great reservoir of energy and goodwill at the grass roots.

The society has a deeply committed communicator as chief executive, and a wise, experienced chair in Dame Jill Morgan. My hope is that the Minister will listen carefully to the demands and advice of the Alzheimer’s Society’s leadership. The Minister is, after all, accessible and open-minded in his dedication to the health service. However, the national response to the dementia emergency will be at its most positive at the grass roots, by mobilising the volunteer and by appealing to the generosity, practicality and familial loyalty at local level. Facing up to the national challenge of dementia will require more than the findings and promulgations of the Westminster and Whitehall village.

There are exemplary approaches being made in my own country of Wales. The director for Wales, Mrs Sue Phelps, called a conference in Wrexham, north Wales, recently. It was packed out by an army of youthful volunteers, family members, and dementia sufferers. The society’s Flintshire office, led by Mrs Baldini, organised this hearteningly successful gathering in the principal town of north Wales. We heard of best practice. We had professorial insights and examples of families coping. It was an inspirational gathering, and pointed to—as the noble Baroness, Lady Gardner, seeks—the support available.

Two central questions emerged. First, what are the Government doing to increase the numbers of those receiving formal diagnosis? I hope there may be a reply from the Front Bench tonight. Secondly, what support is on offer for people following a diagnosis? If the Alzheimer’s Society is a shining light, the great European aerospace company, Airbus, is a white knight extraordinaire. It has made the Alzheimer’s Society its preferred national charity and it is on course to raise, in this calendar year, £220,000 or more for responses to dementia. The able charity organiser is Mr Phil McGraa, based in north-east Wales at the giant, world-class aerospace factory at Broughton, which is where I live. More than 6,000 women and men work at that plant; they are big-hearted, supportive and imaginative in their financial and organisational support. They are great people; they are skilled and caring citizens.

Airbus and the north-east Wales office of the Alzheimer’s Society joined forces to organise a giant memory walk for the purpose of fundraising for dementia sufferers. The walk took place in perfect, warm, sunny weather on an immaculately curated racecourse, Bangor-on-Dee, with superb views of our Welsh mountains. There were no horses, but many hundreds of Airbus workers, volunteers and families in the walk. This mass memory walk was a thundering success, with the Airbus sponsor, the Alzheimer’s Society, volunteers and countless families all co-operating at the grassroots. I should say that this racecourse does not have an all-weather surface.

Quite simply, Airbus is magnificent. It exports billions of pounds of product, outperforms its great competitor, Boeing, and raises tens of thousands of pounds for dementia suffers. It has encouraged families with dementia sufferers in their midst in the most practical way, by being alongside them. I was fortunate to be on the memory walk, and it was heartening to meet a family of 17, and all of them were working for who they knew as their granddad. The support services on the walk were partly provided by high school pupils from Castell Alun High School, who showed great promise on that day.

My message to the Minister and to the Alzheimer’s Society is to invest in the localities and to use the great reservoir of experience, good will and practicality of all the volunteers. After all, they—the ordinary families—experience the distress and bewilderment when this dreadful condition enters the family. Every high school with involvement in that community could begin what might become a lifelong commitment to helping dementia sufferers. After all, the future years will see much more domiciliary care for dementia sufferers, and perhaps our youth will be able to tackle this emergency.

Health and Social Care Act 2012 (Consequential Amendments) Order 2013

Lord Jones Excerpts

Wednesday 27th February 2013 Grand Committee

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

My Lords, we had many debates in the House and in this Committee on the Health and Social Care Act, and the noble Lord will remember the lengthy debates on the Bill itself. In this Session debates have taken place on secondary legislation that puts in place key elements of the new system. Most recently, we debated the NHS Bodies and Local Authorities (Partnership Arrangements, Care Trusts, Public Health and Local Healthwatch) Regulations on 5 February and the draft Local Authorities (Public Health Functions and Entry to Premises by Local Healthwatch Representatives) Regulations on 7 February.

This draft order, however, is very different from those sets of regulations. It is short, and it raises no new issues of substance. Since it seeks to amend primary legislation, it is right and proper that it is subject to affirmative resolution. But it is made under a narrow power to,

“make provision in consequence of the Act”.

I cannot claim that the amendments it makes are of significant interest. They are minor adjustments, needed as a direct consequence of the Health and Social Care Act 2012. They help to keep the statute book up to date and coherent, but they involve no new policies. Consistently with this, neither the Joint Committee on Statutory Instruments nor the Secondary Legislation Scrutiny Committee has seen a need to draw special attention to the draft order. That confirms that the amendments in the order are indeed consequential on the Act.

Because the order is brief and amends only a few pieces of legislation, it may be helpful if I explain the reason for the amendments to each Act in turn. I will start with the simplest. Section 403 of the Education Act 1996 refers to an NHS body within the meaning of Section 28(6) of the National Health Service Act 2006. Following the amendments to the 2006 Act made by the Health and Social Care Act, this is now Section 275(1). The draft order amends the cross-reference in the Education Act accordingly.

The order amends two other Acts by removing references to primary care trusts. These bodies are being abolished by the Health and Social Care Act 2012 on 1 April 2013, so it makes no sense to keep references to them on the statute book.

The first of the Acts in question is the Vehicle Excise and Registration Act 1994. Schedule 2 to this Act identifies the vehicles that are exempt from vehicle excise duty. Currently a vehicle is exempt when it is being used or kept on the road by, among others, a primary care trust or by,

“a health service body, as defined in section 60(7) of the NHS and Community Care Act 1990”.

The definition of “health service body” in Section 60(7) currently includes strategic health authority.

Schedule 5 to the Health and Social Care Act already removes the reference to “strategic health authority” from the definition of “health service body” in Section 60(7) of the NHS and Community Care Act 1990. Consistently with that, the draft order now removes the reference to primary care trust from the Vehicle Excise and Registration Act.

The second Act is the Welfare Reform Act 2012. Section 130 of this Act identifies circumstances in which local authorities may use or disclose information about certain benefit claimants, including when the claimant is in hospital accommodation provided by an NHS trust, a foundation trust or a primary care trust. Again, the draft order removes the reference to “a primary care trust” without replacement. The Health and Social Care Act creates no new provider bodies, so it is not necessary to replace this reference to a primary care trust.

I turn next to the Audit Commission Act 1998. The amendments to this Act look more complex because they amend a number of provisions, but their purpose is very simple. The Audit Commission Act is best known for setting out the audit framework for local authorities, which also applies, with some differences, to health service bodies. As matters currently stand, however, the Health and Social Care Act provides for clinical commissioning groups’ accounts to be audited by the Audit Commission in accordance with the Audit Commission Act, but the Audit Commission Act itself does not apply to clinical commissioning groups. These are the new bodies that are being established under the Health and Social Care Act to commission the majority of secondary healthcare. The draft order therefore amends the Audit Commission Act to ensure that its requirements for health service bodies apply to clinical commissioning groups. The amendments also recognise the role of the NHS Commissioning Board in relation to clinical commissioning groups. For example, if an auditor of a clinical commissioning group thinks that there has been unlawful expenditure, the auditor must notify the Commissioning Board in addition to the Secretary of State.

[Lord Jones]

Will the noble Earl give way? I shall be brief.

[Earl Howe]

My Lords, if the Committee will allow me, I think it is probably helpful if I complete my remarks. Our normal procedure is that the noble Lord, Lord Hunt, as opposition spokesman, will speak first, followed by other noble Lords. I will answer all questions at the end, if that is acceptable.

I turn now to the amendments to the Local Government Act 2000 and to the Local Government and Public Involvement in Health Act 2007, which I shall refer to as the 2000 Act and the 2007 Act. In both cases, the draft order removes references to primary care trusts and replaces them with references to the NHS Commissioning Board and to the relevant clinical commissioning group. The context here is one of commissioning services rather than providing them, so it is appropriate to make this substitution. To explain this in more detail, Section 104 of the 2007 Act sets out persons who are “partner authorities” of certain local authorities. The list currently includes primary care trusts. The definition of “partner authority” is relevant for a number of provisions in both the 2000 Act and the 2007 Act. For example, Section 9FF of the 2000 Act applies, with some exceptions, where an overview and scrutiny committee or its sub-committee makes a report or recommendation to the local authority or its executive on certain functions of a “relevant partner authority” that are exercised in relation to the committee’s area or residents of that area. In such a case, Section 9FF(2) enables the committee to require the relevant partner authority,

“to have regard to the report or recommendation in question in exercising its functions”,

and Section 9FF(4) requires the relevant partner authority to comply.

--- Later in debate ---

[Lord Jones]

My Lords, I am grateful to the noble Earl for his patient and detailed explanation of what the order entails. I had intended an early intervention so that he might be able to give the answer to my query during the debate. Does this order, which refers to social care, presage a better deal for those this with Alzheimer’s disease? In the context of my question, is the noble Earl able to give the briefest definition of social care?

[Earl Howe]

I am grateful to both noble Lords for their comments and questions. I turn first to the question posed by the noble Lord, Lord Hunt, around the Audit Commission and its role. The noble Lord is right: the Government’s intention is to bring forward legislation, as soon as parliamentary time allows, to replace the Audit Commission. The legislation will abolish the Audit Commission and establish a new framework for the audit of local public bodies in England. The Commons committee that undertook pre-legislative scrutiny of the Draft Local Audit Bill published its report on 17 January. The Government are considering the report very carefully and we will publish a response in due course. I think that that is all I can say in the context of the noble Lord’s question about fees, but if I have any further points to add I will, of course, write to him.

The noble Lord also asked me about the procurement regulations, and I congratulate him on taking the opportunity to do so. We remain absolutely committed to the undertakings given during the passage of the 2012 Act, and we are clear that the regulations we have laid adhere to both the letter and the spirit of those undertakings. However, we understand the concerns that have been raised by noble Lords and stakeholders, and we are making a public commitment to engage intensively with Members of Parliament and Peers to understand their concerns. We will look again at the regulations to see how we can explain them better, clarify our position and address the concerns that have been raised.

The noble Lord asked me about the definition of social care in the context of this order. I am perhaps not the best person for making up definitions on my feet. However, in terms of care of the elderly, social care is that activity which is characterised by the service provided by local authorities and their contractors to look after elderly people, both in residential accommodation and in their own homes by way of domiciliary care. The noble Lord mentioned patients with Alzheimer’s disease. I would perhaps sound a slight caveat because people with Alzheimer’s disease can, of course, be looked after in a variety of settings, including a healthcare setting. However, there are very many individuals who are looked after in their own homes and in residential care as well. Social care tends to be characterised as care that does not involve a specific health input, but rather the care of an individual for their day-to-day living needs.

[Lord Jones]

The noble Earl has been very courteous and helpful. Since I held, many years ago, a position like his in three Administrations, I know that to ask a question early enough enables the Minister to have the answer prepared by officials. I thus rise again to my feet simply to say that my original intervention was well intended because I knew that, notwithstanding the elegance and brilliance of the noble Earl’s ministerial reputation, it would have been more helpful if I had spoken earlier than I did.

[Earl Howe]

I thoroughly regret my earlier answer to the noble Lord, and I should have allowed him to intervene. I hope he will forgive me.

Health: Funding

Lord Jones Excerpts

Tuesday 1st November 2011 Lords Chamber

[Earl Howe]

Yes, I agree with the noble Lord. It is important that officials from both Wales and England have a dialogue to ensure that problems do not arise of the kind that the noble Lord refers to. Having said which, I repeat that the protocol that currently exists, and the funding that we in England give to the Welsh Government to compensate for differences in prices between either side of the border, serve to ensure that patients are treated promptly and as they should be.

[Lord Jones]

Does the Minister fully comprehend that the border between England and Wales is over 200 miles long; that the bulk of the population of Wales is in the east; and that historically there has always been access—for example, from north-east Wales—to the great hospitals of Christie in Manchester, Broadgreen in Liverpool and Alder Hey in Wirral? Does he fully comprehend the current anxiety? It is the wish of the mass of the population that they should have access to these hospitals—hospitals of access and excellence—and that Ministers in England should take a generous and understanding attitude to the wishes of a population who have always had access to the excellence of these great hospitals, of which the people of north-east Wales are very fond.

[Earl Howe]

My Lords, I appreciate everything that the noble Lord has said. He may like to know that the protocol to which I have referred states as follows:

“The patient’s safety and well-being must be paramount at all times. No treatment must be refused or delayed due to uncertainty or ambiguity as to which”—

local health board or PCT—

“is responsible for funding the healthcare provision”.

I think that that should give patients in Wales every reassurance.