Covid-19: Vaccinations for School Pupils

Earl Howe Excerpts

Monday 17th January 2022 Lords Chamber

[Lord Kamall (Con)]

I think the noble Lord is being slightly unfair in the sentiment of his question. We have to remember that, when it came to vaccinating children, there was a huge debate around, first, whether it was ethical to do so and, secondly, whether the vaccines used for adults were effective in children. We could not really do any of that until we had sufficient data. It would have been irresponsible just to have pushed ahead without the data. Once we got the data, we started the vaccination programme for 16 and 17 year-olds and then for 12 to 15 year-olds, and we are pushing through as much as possible. Parents can book for their children on a national booking service. We expect many more parents to do so.

[Earl Howe (Con)]

My Lords, the noble Baroness, Lady Brinton, has indicated her wish to speak virtually, and I think this is a convenient point for me to call her.

[Baroness Brinton (LD) [V]]

My Lords, many parents are still saying that they have not heard when their clinically extremely vulnerable five to 11 year-olds will get their vaccinations, despite the JCVI saying that they should. Last week’s update to the GP green book now includes severely CEV children as eligible for the third primary dose, which is progress. However, there is no news for CEV young children not classed as severe, so can the Minister please say what he will do to ensure that GPs will call all these children for their vaccinations as soon as possible?

Health and Care Bill

Earl Howe Excerpts

Lords Hansard - Part 2 & Committee stage
Thursday 13th January 2022 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, I am very grateful to the noble Baroness, Lady Walmsley, because she has helped me to clarify my thinking about this group of amendments. Basically, they have good intentions and they make good points about the things that need to happen, but I am not absolutely certain they need to be in the Bill. I am also particularly grateful to the noble Baroness, Lady Finlay, for her very well-informed contribution about what actually goes on. There are of course problems in relationships between the devolved nations and NHS England, some of which are down to not being very well organised, some of which are down to arrogance on the part of the bigger ones, and some of which are down to the funding not actually being available—and some of them might be politically motivated too.

Amendment 17 opens some new thinking on the subject of integration, and accepts that devolution has given us different systems for care in Wales, Northern Ireland and Scotland, but seeks to ensure that what is done in one part of the UK—that is, England—does not adversely impact on other parts. The intention to bring collaboration between the nations is, of course, commendable.

I note that Amendment 205 places some requirements such that

“Welsh Ministers, Scottish Ministers and a Northern Ireland department must make regulations providing that the choices available to patients in England by virtue of regulations under section 6E(1A) or (1B) of the National Health Service Act 2006 (inserted by section 69 of this Act) are available to patients for whom they have responsibility.”


Again, we can understand the need for consistency, but I am unclear about how that will play out against the devolved nature of healthcare—so I think the case will have to be made out for that and, indeed, why that would be included in the legislation.

In a similar fashion, Amendment 301 looks to establish interoperability around the use of data across the whole UK. Again, that is a wholly worthwhile intention, and one that I would hope that the various authorities could collectively work on and agree. Once more, what the role is for primary legislation to address this point is not entirely clear, and I welcome the discussion. I look forward to hearing what the Minister has to say.

[Earl Howe (Con)]

My Lords, I begin by thanking my noble friend Lady Morgan for raising these important matters both via this Committee and by engaging—as I understand she has recently—with my honourable friend the Minister of State for Health. I am also grateful to all other noble Lords who have spoken so powerfully and knowledgably on these issues.

There is no escaping one overarching reality in this policy area, to which the noble Baroness, Lady Thornton, has just alluded. As a Government of the whole United Kingdom, Ministers are responsible for all people of the UK; that is a given. However, while the core principles of the NHS are shared across all parts of the United Kingdom, it is the devolved Governments in Scotland, Wales and Northern Ireland who are responsible for developing their own health policies. Health is largely a devolved matter in the UK, and the commissioning and provision of health services for people in Scotland, Wales or Northern Ireland will continue to be a matter for the devolved Governments.

It will not surprise my noble friend to know that the UK Government continue to respect existing devolution settlements, so our aim is close collaboration with the devolved Administrations to deliver the best outcomes for the people across the four nations. This means that, while we are sympathetic to the spirit of these amendments, I am afraid that we cannot accept them.

I shall address the detailed issues. On Amendment 17, I agree with my noble friend that there is more we can do to align our healthcare for the good of patients across the United Kingdom. We are already exploring several projects to support the NHS to work more closely across the UK, and this includes refreshing the current memoranda of understanding between all four Governments and working with the Office for National Statistics to establish a number of UK-wide datasets. Steps like that will improve transparency and collaboration for the good of all patients across the UK. We do not believe that these steps require primary legislation, but we will keep that question under review. We will also continue to work with NHS England to ensure that a number of groups that it currently hosts, such as the rare diseases advisory group, and their specialised commissioning processes, also meet the relevant needs of the devolved Administrations.

Turning to Amendment 205, we know that choice of healthcare is an important right for patients across the UK. The NHS Constitution for England, for example, enshrines the patient’s right to informed choice. We will be preserving the important right for patients in England to choose their first elective outpatient appointment, GP and GP practice through regulations made under powers provided by the Bill. NHS England works closely with the devolved Governments, including on commissioning and ensuring access to specialised services. Requests for patients to have treatment in other nations are generally to secure continuity of care, to provide care close to patients’ support mechanisms, or because of specialist expertise.

The health services in Scotland, Wales, and Northern Ireland already have the power to contract with any NHS provider in England. As my noble friend Lord Lansley rightly pointed out, they already have in place arrangements for commissioning specialised services from English providers, including cross-border agreements, referral schemes and service-level agreements. Taking further steps, as suggested in this amendment, would place a significant burden on a smaller number of providers, particularly those along borders, with consequences for the smooth running of those health systems. From a legal perspective, such a change would be a significant impingement on a devolved competence and would require the consent of the devolved legislatures. Of course, patients matter most, but such a change would also be unlikely to greatly benefit them, since they are already served by existing arrangements.

Amendment 301 deals with data interoperability. The UK Government are committed to working with officials across the devolved Administrations to explore the benefits that healthcare data can provide while working collaboratively to respect the devolved nature of this work. As in other areas, we are looking at ways to improve collaboration on data matters and address issues with data sharing. There are commitments within the data strategy for health and social care to work across central government and the devolved Administrations to improve appropriate data linkage, thus supporting people’s health care outcomes. This builds on the work of units such as the Joint Biosecurity Centre, and the newly established UK Health Security Agency.

That work will help us to collaborate to solve public health issues, improve disease surveillance and overcome any behavioural or structural obstacles to appropriate data sharing across our respective health and social care systems. In addition, we are speaking to the Office for National Statistics about collecting data on performance and outcomes across the UK. We are pursuing this with it, working in concert with the devolved Administrations. The ONS has assured us that it does not need additional powers to gather such data.

The problems encountered by the daughter of my noble friend Lady Fraser in proving her vaccination status are being actively addressed on both sides of the border. I must concede that the problems are not fully resolved yet, but understand that a Covid status pass from Wales, Scotland or Northern Ireland will be recognised in England and vice versa.

[Lord Bradley (Lab)]

My Lords, I am sorry to interrupt, but I have been meaning to ask this question for a while. Will that also apply to students who currently study abroad and had their first vaccinations abroad, and who then come back to work in their home country? Will that be connected to the NHS app as well?

[Earl Howe (Con)]

Rather than give a wrong answer to the Committee, I had better take advice on that and write to the noble Lord, if he will allow it.

I say to the noble Baroness, Lady Walmsley, that if we look at this area in general, we are clear that we must and will continue to work closely with the devolved Administrations to ensure a fully interoperable, UK-wide approach to healthcare, including in relation to the provisions in this Bill.

It is worth adding that the devolved Administrations already have powers in legislation under Section 255 of the Health and Social Care Act 2012 to request NHS Digital to collect and analyse data, so they have that ability if they wish to exercise it. I am very grateful for my noble friend’s interest in this important area. I assure her that we will continue to keep listening to ways in which we can make the NHS work for all four nations of our union. It is vital that we do so and implicit in the collaborative processes we are engaged in. However, for the reasons I have set out, I ask my noble friend to understand why I am unable to accept this amendment.

[Baroness Morgan of Cotes (Con)]

I thank my noble friend very much for his response. Although this has been a short debate, it has been a very good one. It has certainly been very helpful in noble Lords on all sides sharing their experiences and thoughts. It has raised some important issues and some comments on drafting. I am grateful to noble Lords for them. It has also enabled your Lordships to share some practical experiences, not least about the NHS Covid app. It sounds as if it is moving towards a resolution.

I was slightly amused that some of those who said that these issues do not need to be addressed in the Bill are often those who say that other issues need to be addressed in primary legislation so, when we are talking about consistency, we all need to think about that.

I am very grateful to my noble friend for saying that he agrees that more needs to be done and is being done to align healthcare across the United Kingdom and for stressing the importance of collaboration. I will, of course, withdraw this amendment, but the amendments in this group raise important issues and I hope that discussions can continue. As the noble Baroness, Lady Walmsley, I think, said, this is about practical, positive treatment and outcomes for patients, which is what we all want to see regardless of where they live.

Health and Care Bill

Earl Howe Excerpts

Committee stage & Lords Hansard - Part 1
Tuesday 11th January 2022 Lords Chamber

[The Lord Bishop of London]

My Lords, I declare my background as a former government Chief Nursing Officer and non-executive director of a number of healthcare trusts. I was not going to speak, but I have listened to noble Lords’ comments today and I come down with the noble Baroness, Lady Harding, in saying that we should not stipulate what skills are required of a board too tightly. What is in front of organisations changes over time, so the chair needs to be empowered to change. However, one caveat is that it would be wise to consider having somebody on the board with a background in patients. I speak from experience as a clinical professional: we can too easily forget the patient and to see things through their eyes. Far too often, we see things through the eyes of the clinician, which is not always in the best interest of patients.

[Earl Howe (Con)]

My Lords, I am grateful to all noble Lords who took part in this short debate, and particularly the noble Baronesses, Lady Merron and Lady Walmsley, and the noble Lords, Lord Patel and Lord Howarth, for bringing these important issues before the Committee. As they made clear, these amendments seek to make changes to the membership and composition of the board of NHS England. Amendment 2 also outlines the conditions that should be met for the appointment process.

Like my noble friend Lady Harding, I am in sympathy with the spirit of these amendments. It is imperative that the membership of the board of NHS England is able to represent the diverse needs of patients and the populations they serve, as well as their twin functions of commissioning and holding commissioners and providers to account.

I was very much in sympathy with the principles and sentiments expressed by the noble Lord, Lord Howarth, in speaking to his Amendment 3. Executive members of the board are selected based on their expertise and ability to manage the delivery of NHS England’s functions. It is also important that non-executive members have the right skills and backgrounds to effectively support and challenge, and hold the executive to account.

I hope I can reassure noble Lords on the existing and planned board membership arrangements. We absolutely aim to ensure that the most suitably skilled and experienced candidates are appointed to the fully merged NHS England board. The legal provisions therefore need to be flexible, and I can tell the Committee that they already are. Existing provisions setting out the membership of the NHS England board in the NHS Act 2006 already provide the flexibility required for the fully merged NHS England to lead our more integrated health and care system.

I agree that robust governance arrangements are absolutely necessary to oversee public appointments, particularly to NHS England. Unlike appointments to integrated care boards, the appointments of the chair and non-executive members of NHS England are public appointments made by the Secretary of State. As your Lordships are undoubtedly aware, as public appointments, they are managed in line with the Governance Code on Public Appointments and regulated by the Commissioner for Public Appointments. These appointments are made on merit in a fair, open and transparent manner. In line with the governance code, they require due regard to be given to ensuring that they properly reflect the populations they serve, including a balance of skills, expertise and backgrounds—exactly as sought by this amendment, as I understand it. We are fully committed to the importance and value of both candidate diversity and equality of opportunity.

The commissioner works with government to encourage candidates from a diverse range of backgrounds to consider applying for public appointments. All public appointees are expected to uphold the standards of conduct set out in the Committee on Standards in Public Life’s Seven Principles of Public Life, as included in the Code of Conduct for Board Members of Public Bodies. The code sets out, clearly and openly, the standards expected from those who serve on the boards of UK public bodies and includes a clear process for managing any conflicts of interest.

--- Later in debate ---

[Baroness Walmsley (LD)]

My Lords, I am certainly with the noble Baroness, Lady Finlay, on the issue of outcomes. Like her, I am a member of the All-Party Group on Cancer, and I was right behind our former chairman John Baron’s attempt to get a clear focus on outcomes. I am delighted to see how successful that has been.

My Amendment 8 is very simple. It would prevent the Secretary of State tinkering too often with the mandate. As others have said, the mandate is the primary instrument through which the Secretary of State provides the Government’s direction to the NHS. He is right to do so, since the NHS uses the most enormous amount of our money and is of vital concern to every voter and taxpayer—those whom the Government represent.

However, the NHS is a little like the “QE2” in that it is absolutely enormous and takes quite a while to change direction. Indeed, a great many levers have to be pulled for it to do so. Chief executives, boards and professional staff need time to set new plans, targets and employment policies—to say nothing of moving the money around—to comply, as they must, with changes to these mandatory directions from on high. It is therefore highly undesirable for a Secretary of State to change the mandate too frequently. As the noble Baroness, Lady Thornton, said, even when it happens, adequate notice and reasons must be given.

Other amendments in this group deal with other aspects of the mandate, but I want to be fully assured that, given the difficult tasks we set our NHS, its outline instructions and targets are not unfairly changed too often. I feel justified in having this concern, because the evidence of clauses later in the Bill indicates to me a tendency by the Government to want to meddle where meddling is inappropriate and could have negative effects. I refer, of course, to the Secretary of State’s attempted power grab, which we will discuss later in Committee.

Can the Minister assure me that there is already some effective measure that would prevent the mandate being changed more than once in any financial year, which would make it very difficult for the NHS to comply?

[Earl Howe (Con)]

My Lords, I am glad to be able to respond to these amendments relating, in their several ways, to the NHS England mandate. I will cover each in turn.

I begin with my noble friend Lord Lansley’s Amendment 4. I confess that I am not in the least surprised that he, of all noble Lords, should have reminded us of the key importance of the NHS outcomes framework. Amendment 4 would require the Secretary of State to specify objectives that will help NHS England achieve improvements in the outcomes provided for in the NHS outcomes framework. As he and I remember clearly, the NHS outcomes framework is a set of indicators that provide for national-level accountability for the health outcomes that the NHS delivers. The first version was published in 2010 to inform the first mandate to what was then still known as the NHS Commissioning Board. In essence, it looks at long-term health trends across various domains, including quality of care and patient experience. It is a valuable resource and, as my noble friend knows, remains an important tool for measuring the NHS’s contribution to improving outcomes over the long term.

I quite agree with my noble friend that progress against outcomes is vital. That is why we have included Clause 3 in the Bill. One of the main advantages of a longer-term mandate is that it will allow us to take a longer-term view of progress against outcomes that can be measured meaningfully only across a number of years.

The noble Lord, Lord Patel, asked who will be responsible for improving outcomes. The answer is that NHS England and ICBs have duties in relation to improving the quality of services. I can assure him that we will hold them to account for doing so. Having said that, we are moving now to a system-wide approach. That entails the need to measure shared outcomes across health and the wider social care and public health system. Some of these outcomes are led by the NHS but many are system-wide, so the business of measuring patient and service-user outcomes will inevitably become more sophisticated.

We want to ensure that our system is flexible and able to adapt as those system approaches develop and mature. I hope my noble friend therefore appreciates why we would not want to enshrine the NHS outcomes framework in the mandate in statute, in a way that might limit or compromise our ability to explore broader system approaches as we go forward. However, I seek to reassure him that the NHS outcomes framework will continue to be a vital tool to look at long-term trends in health outcomes and the NHS’s role in supporting health outcomes. That basic role for the NHS outcomes framework will not change.

I fully understand the concern of the noble Baroness, Lady Thornton, in her Amendment 7 that the mandate should not be revised unnecessarily and without good reason. I completely agree with that sentiment; again, it lies behind our desire to look at the mandate over a longer timeframe than has hitherto been possible. My concern is that her amendment goes much further than, I suspect, she intended, because it would prevent the mandate being revised at all in anything other than an urgent or unforeseen situation. That would be unhelpful, because it would wholly prevent planned changes to reflect, for example, evolving strategic priorities, emerging evidence of need or even a planned general election.

The purpose of Clause 3 is to strengthen the role of the mandate by enabling the Government, where appropriate, to set a mandate that can endure, rather than having an annual use-by date. Looking back to our debates on the Health and Social Care Bill in 2011, the noble Baroness will remember that it was always the intention that the Government should set a multiyear mandate, and Parliament agreed. In practice, that intention has been hampered by the inevitability of an annual review of the mandate to a fixed deadline—a deadline that does not neatly align to a number of events and strategic processes, including the Budget, spending reviews and general elections. Clause 3 addresses this. I seek to reassure the noble Baroness that there is no intention to revise mandates unnecessarily at the drop of a hat, as it makes no sense to do so.

I am grateful to the noble Baroness, Lady Walmsley, for highlighting a similar set of issues to those raised by the noble Baroness, Lady Thornton. Her Amendment 8 would prevent the Government revising our mandate for NHS England more than once in the same financial year, for any reason. As I said to the noble Baroness, Lady Thornton, I completely understand her concern that the mandate should not be revised so frequently that NHS England is unable to plan for or deliver government priorities effectively. This is why I reassure her that this will not happen, except in the most exceptional of circumstances. I hope she accepts that reassurance, because it cannot be in the interests of any Government, or of patients and service users, to set a mandate that changes NHS priorities too frequently. I expect any such revisions to be very rare. As I have indicated, though, one can imagine that they may be necessary to respond to unforeseen events, to reflect the result of a general election or to signal future shifts in priorities at a point when the NHS is planning ahead. The Government need the necessary mechanism to deal with these and other similar eventualities.

The noble Baroness will see that Clause 3 already contains an explicit safeguard in respect of reasonableness: NHS England will not be obliged to revisit a business plan that it has already published, should the Government revise the mandate within a year of its issue. The Government will also have a continuing duty to consult NHS England before making any revision. I believe that, in combination, these two safeguards work together to fully answer the point that the noble Baroness made.

Health and Care Bill

Earl Howe Excerpts

2nd reading
Tuesday 7th December 2021 Lords Chamber

[Baroness Uddin (Non-Afl)]

My Lords, I spent some decades of my personal and professional life trying to improve health and social care through the statutory and voluntary sector. I welcome the prospect of refining the Bill in the interest of service users and staff alike, to whom I pay my deepest respects in the light of what has been an impossible and worsening situation for the health of our nation.

I recently witnessed two contrasting events: a patient in an acute ward for mental health, and another progressing though intensive care and then a surgical ward. The staff shortage and lack of adequate care support is indeed grave at every level, and I know my family will not be the first or last to share these harrowing experiences. Therefore, my principal reaction to the many aspects of this ambitious legislation and the report on adult social care is that they ring hollow as wishful prayers.

The Government have said that the Bill is driven by NHS demand. I fear that most frontline staff across the service do not agree; nor have they asked for the inevitable fragmentation and the huge structural upheaval which may result, given the existing shortage of staff and funding within the NHS and care sector as it struggles with Covid.

Of course, I hope that the panacea on the written papers will improve service users’ actual experience. Given the glaring lack of any meaningful references to workforce development and, ominously, of any indication that the long-standing consequences of inequalities and discrimination are being addressed, my confidence is rather low at this point.

We are asked to respond to a 10-year plan fit enough to address a massive, long-standing crisis where people are waiting to receive the urgent care to which they are entitled: 1.5 million hours of commissioned care is not being delivered and at least 400,000 adults and families are waiting for formal assessment. This gravely undermines the human rights of those who may already be experiencing a great deal of indignity, pain and desperation. Does the Minister accept that the new proposed boards and commissioning structures may create an even greater backlog of unmet needs?

How do the Government propose to address these anomalies while introducing the new challenges of means-tested personal care and private care companies into an already frail NHS, which struggles to manage current demands? According to the Royal College of Nursing, the Bill as it stands does not address nursing staff concerns, ensure patient safety or give adequate weight to staffing shortfalls in the NHS and the social care sector.

According to other leading experts, including ADASS, £1 billion for the social care sector, while extremely welcome, is not aligned to the reality of the £7 billion investment required to meet urgent needs, and is unlikely to remedy the current crisis in social care. The fear is that the prolonged and chronic historical underfunding—the insufficient resources allocated for social care in the community, which is a disjointed system at local level—will exert even more pressure and cause untold misery and suffering for individuals and families who are among the most vulnerable: the elderly, the disabled with learning disabilities and autism, and people needing mental health support. Integrated care will therefore remain dysfunctional locally, regardless of the fact that half the available social care budget is spent on working-age adults with learning and physical disabilities and the elderly to empower care in the community.

We know that supported housing is seen as a critical linchpin of independent living and is projected to increase by 2030. With only £300 million for these options, does the Minister accept that the Government will have to broaden their reach to widen the network of providers, including specialist and BAME providers, to provide comprehensive and equal care across all communities?

How will these proposals affect the lives of black and Muslim men experiencing mental health crisis who are festering in hospital wards without adequate support, counselling and rehabilitative programmes, and with next to nothing on prevention? I am pleased to hear the new announcement for funding for drug and alcohol treatment. As an experienced leader in the field of dealing with substance misuse at local and national level, I can assure the House that adequate funding for resources and social work support is indeed effective in preventing revolving doors, which can save the NHS and the justice system millions. As the distinguished noble Lord, Lord Ramsbotham, clearly and eloquently said, the Bill should be the right place to consider this service.

Caring institutions and organisations are often run by poorly paid and undertrained staff, including social workers, who are once again in our sight for scrutiny. I declare my interest as one. I have worked in child protection and with domestic violence victims and survivors, as well as those with disabilities and substance misuse problems. I understand the horrendous pressures at the front line.

I have two final points. The APPG on Children, alongside many leading NGOs, is anxious that the Bill does not do enough to bring the benefits of integrated working to children and families. I support its asking the Government to commit to assess the Bill’s impact on children within two years of its implementation. Lack of investment in social work, police and education has once again led us to a tragic death, that of Arthur Labinjo-Hughes. As a social worker, I have witnessed the demeaning and catastrophic effect of child abuse. Heartbreakingly, it is a fact that lessons learned from what happened to diminish the hope, the smiles and Arthur’s last breath may not prevent the last cry of a child unless we empower staff at the front line of managing complex violence and abuse in our midst.

Finally, I draw the House’s attention to the points raised by the Inter-Collegiate and Agency Domestic Violence Abuse coalition. It views the Bill as an opportunity to deliver the health needs of survivors of domestic abuse. It rightly asks that the guidance for integrated care systems and partnership boards be placed on a statutory footing to ensure that it is adhered to across the health service. I agree with the noble Lord, Lord Shinkwin, that this guidance should also apply to those with learning disabilities and communication needs.

I welcome and congratulate noble Lords—

[Earl Howe (Con)]

My Lords, contrary to the clock, the noble Baroness has been speaking for nearly eight minutes. Perhaps she could bring her remarks to a conclusion.

[Baroness Uddin (Non-Afl)]

I welcome and congratulate the noble Lord, Lord Stevens of Birmingham. I hope that we will all work together to enhance this Government’s efforts for better regulation. I hope that we can safeguard the needs of the most vulnerable in our society.

Medicines and Medical Devices Bill

Earl Howe Excerpts

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

Relevant documents: 19th Report from the Delegated Powers Committee, 10th Report from the Constitution Committee

[Earl Howe (Con)]

My Lords, it may be for the assistance of noble Lords if I make a short statement before we recommence proceedings. As noble Lords will be aware from my noble friend Lord Bethell’s letter to Peers of 13 October, the Government have tabled a number of amendments for consideration in Grand Committee. Many of these amendments are designed to address criticisms of the Bill expressed by noble Lords at Second Reading, and in particular by your Lordships’ Delegated Powers and Regulatory Reform Committee and Constitution Committee, in an endeavour to provide reassurance to this Committee at an early moment.

Unfortunately, it has since come to light that the Government’s intention to move these amendments in Grand Committee, which we had believed was implicit in my noble friend’s letter and understood from subsequent discussions, had not in fact been clearly and properly communicated. I further understand that there was a two or three-day delay in noble Lords on the Labour Front Bench, and perhaps others, receiving the letter. I apologise to the Official Opposition, Liberal Democrat Peers, noble Lords on the Government Benches and those on the Cross Benches for the shortcomings in our communications, which, I need hardly add, we shall use our utmost endeavours not to see repeated.

There is a substantive reason why the Government wished to move their amendments in Grand Committee. It is that, according to the clear advice we have received, a legislative consent Motion by the Northern Ireland Assembly cannot be put in motion until such time as the government amendments to which I have referred become part of the Bill. Were we to delay approval of the amendments until Report, our clear advice was that this would put back the Northern Ireland legislative consent process by up to three months. Such a delay would in turn have serious consequences for the completion of this Bill, whose importance in the context of the United Kingdom’s exit from the European Union cannot be overemphasised. It is very important for the health of the public that we achieve a timely completion which does not leave us without a means of passing necessary regulations at the start of 2021.

These were the reasons why, in the short adjournment that took place during last Monday’s Grand Committee proceedings, we asked noble Lords to allow two government amendments to go through on that day. We did so particularly bearing in mind that the alternative to moving the amendments was to withdraw them, which might in turn have signalled to the Northern Ireland Executive that the amendments no longer represented government policy. We are sincerely grateful to noble Lords for their understanding and for the agreement reached on that occasion. As I have indicated, we made that request to noble Lords in good faith, driven by clear legal advice relating to the process around Northern Ireland consent Motions. Since then, some doubts have been cast on whether that advice was in all respects accurate. It is still our belief that it was, but we are seeking urgent confirmation of this, which we shall convey to noble Lords at the earliest opportunity.

More importantly, however, for this Committee, we have received unequivocal legal advice from the Public Bill Office that, notwithstanding any amendments approved in Grand Committee by unanimity, it is open to the House, and indeed to individual noble Lords, to return to the issues covered by such amendments on Report and to debate and vote on any further amendments that noble Lords wish to table. That means that by allowing government amendments to go through in Grand Committee, noble Lords would not be precluded from returning to those issues, in any way they chose, on Report. On behalf of the Government, I undertake that the Government will raise no objection to this if it is the wish of noble Lords that such further debates take place. If, notwithstanding the assurances I have given, any noble Lord wishes to object to a government amendment spoken to in Grand Committee, the Government will withdraw that amendment. In the meantime, it is the Government’s wish to enable all noble Lords to engage with Ministers and officials as fully and as regularly as they may require in an effort to achieve what we all desire for this important Bill, which is understanding and, if possible, consensus across the House.

[Baroness Thornton (Lab)]

I thank the noble Earl for that statement, which is extremely helpful. I am alarmed, or surprised, that we are at this stage looking at a grey area about whether or not it is necessary for these amendments to be moved and accepted. It is very important that that is clarified, and I would just like to make one or two other points.

Grand Committee is for probing; it is for consensus, and then it is up to the House to take the decisions on Report about that. These amendments, which we are being asked to nod through, really are not consistent with what the Companion says Grand Committee is there for, so the clarification that we will have to return to these at a later stage is, of course, absolutely necessary.

However, that also means that on Report we will have a Bill before us that is not the same Bill as we have now. It will have been significantly amended in some very significant areas of policy. So I am writing to the Constitution Committee and the Delegated Powers Committee today to ask them to look again at the Bill. When the amendments have been accepted, it will not be the same Bill as we have now.

We will not negative the amendments today, because I accept the noble Earl’s statement and, on the balance of risks, the Opposition would not wish to delay the Bill for three months, into next year. We can see the dangers that that would represent. However, I ask the Government to examine the proposal made by my noble friend Lord Hunt to the Minister and the Bill team in a meeting to discuss the issue. That was that they should look at paragraph 8.127 of the Companion and consider removing from the Bill all the government amendments concerned with this issue. We could then take those in a group at the end, on the Floor of the House. That would give us time to do the stuff we have not yet done and discuss the substance of the amendments.

If the Minister and the Bill team had come to us a month ago and said, “We’ve got this problem with the Northern Ireland consent process, and this is what it means,” we would not be having this discussion now, because we would have worked out how to resolve that problem. I regret that that is not what happened and I hope that we will now move forward in a more positive way. Finally, we will look carefully at what is added in Grand Committee as a result of these very particular circumstances and we may seek to delete or amend some of the government amendments at the next stage of the Bill.

[Baroness Jolly (LD) [V]]

With the Northern Ireland component, a time constraint was imposed on the Committee, and people have been looking at ways of solving the problem since our previous meeting. Since 8.30 am I have been in various meetings with various people looking for ways forward. The one described by the noble Earl, Lord Howe, is on the table and has been agreed by all party spokespersons. It was finally agreed at a meeting with the Minister and others at 1.30 pm. Like the noble Baroness, Lady Thornton, I am grateful to the noble Earl for his help in resolving this issue.

[Earl Howe (Con)]

I am grateful to both noble Baronesses for their responses. I think that this provides a basis on which to proceed with our Grand Committee debate today, pending further clarification on the matters that I referred to earlier between now and Wednesday, our next Grand Committee day. I can assure noble Lords that my colleagues and I will endeavour to achieve that clarity, which we will disseminate at the earliest opportunity.

[Baroness Thornton (Lab)]

I thank the noble Earl. I think that we probably need to continue this discussion, to make sure that we end up in the right place, with a Bill that we can take forward to Report.

Penrose Inquiry

Earl Howe Excerpts

Thursday 26th March 2015 Lords Chamber

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

My Lords, with the leave of the House, I shall now repeat, in the form of a Statement, an Answer given in another place by my honourable friend the Minister for Public Health on the Penrose inquiry. The Statement is as follows:

“Yesterday, the Prime Minister issued an apology on behalf of the Government for these tragic events, and my right honourable friend the Secretary of State for Health laid a Written Ministerial Statement as an interim response to the Penrose inquiry. I would, however, like to remind the honourable Member for Hull North that this is a Scottish public inquiry, and I understand that Scottish Ministers will not be making a Statement to their Parliament until this afternoon. It would therefore be inappropriate for me to comment about the report in detail at this stage.

However, I can say that Lord Penrose reviewed more than 118,000 documents and more than 150 statements from patients and relatives and also took oral evidence from many of the officials involved in decision-making at that time. It would therefore seem to be an extremely thorough job, which for the first time provides an authoritative narrative of events.

I said in this House during a Back-Bench debate on 15 January that this Government would be making an interim response to Lord Penrose’s report, which we did yesterday in a Written Ministerial Statement, and that it would be for the next Government to consider a more substantive response, once they have had time to consider what the inquiry says.

Yesterday, we announced that we will be allocating up to an additional one-off £25 million from the Department of Health’s 2015-16 budget to support any transitional arrangements to a different system of financial assistance. We intend this to provide assurances to those affected by these devastating events that we have heard their concerns and are making provision to reform the system.

We had hoped to consult during this Parliament on reforming the ex-gratia financial assistance schemes. I very much regret that our considerations on the design of a future system of financial assistance for those affected have been subject to postponement while we awaited publication of Lord Penrose’s final report. The Prime Minister also said yesterday that if he were to remain Prime Minister after the election in May, we will respond to the findings of the report as a matter of priority”.

My Lords, that concludes the Statement.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I thank the noble Earl for repeating that Answer. Clearly the Penrose report is a detailed factual account of what happened, and I pay tribute to Lord Penrose for the work that he and his team have completed.

I noted the noble Earl’s comments this afternoon that we have the initial response, but that the full response is to be left to the next Government. It is clear that the report needs very careful reading in order to come to a substantive view. Certainly, as a Minister, I dealt with this issue in my time at the Department of Health—I see the noble Lord, Lord Fowler, and other former Ministers here—and Dr David Owen has on a number of occasions drawn attention to some issues about the way this was handled by the Department of Health. On the face of it, does the noble Earl think that at the very least this warrants some discussion about whether his own department needs to establish some kind of view on the Penrose report?

Lord Penrose made a single recommendation: that all people in Scotland who had a blood transfusion before 1991 should be tested for hepatitis C. Again, is that to be left to the substantive response after the election, or can he give an initial view on the implications of that recommendation for people affected in England?

The noble Earl referred to relief. Can he say anything about the Skipton Fund payments and progress made on that fund since its establishment in 2004, and about decisions that I believe were made by the Government in January 2011 with regard to payments to the estates of people who died prior to the announcement of the scheme in August 2003?

One of the stark conclusions from reading the report is about what could be described as the paternalistic view taken by doctors on information to be given to patients. He says that the expert evidence available to the inquiry indicated the withholding of information from patients on the absence of treatment for the condition, which from a contemporary ethical perspective was not acceptable. Does the noble Earl agree with that, and does he consider that circumstances have moved on such that today such information would not be withheld?

[Earl Howe]

My Lords, I am grateful to the noble Lord, Lord Hunt, for his comments and questions. There is no doubt that Lord Penrose has done a very thorough job in examining the facts. It is worth understanding that he has considered the evidence from England as well as Scotland.

I pay tribute to those who showed tremendous courage in telling the inquiry about the impact of infection on their lives and the lives of their families. The report has systematically examined the facts and set them out. As well as other inquires, such as the Archer inquiry, with which the noble Lord is familiar, this report has now given us a detailed account of what happened, which is extremely valuable. I agree that there will be a need to reach a formal view on Penrose’s conclusions once my department and the next Government have had an opportunity properly to consider the conclusions that he reached.

As for Lord Penrose’s recommendation to offer a hepatitis C test to everyone who had a blood transfusion before 1991, the department conducted a look-back exercise in 1995 to try to identify everyone who might have received infected blood prior to 1991. We will consider whether anything more can be done on this in England, although obviously Lord Penrose’s recommendation relates specifically to the Scottish Government taking steps along these lines. We have already done an exercise to identify anyone who could have been affected, and we will consider whether anything more should be done on this.

The noble Lord asked about the Skipton Fund, which, as noble Lords will remember, is there to make non-discretionary payments to patients infected with hepatitis C. To date, over 5,100 individuals in the UK have received the stage one payment and around 1,500 have received a stage two lump sum in the UK, with around 700 receiving annual payments in the UK.

[Lord Fowler (Con)]

My Lords, I am very glad to hear the Government’s pledge to give all possible help to those who have been harmed through no fault of their own. However, with respect that pledge has been given before. It is very important this time that it is properly, and above all generously, followed through.

Does my noble friend agree that we should take note of Lord Penrose’s statement, following his very detailed and long inquiry, when he said yesterday:

“Much of the comment made over the years on the topics discussed in the Final Report has reflected strongly-held beliefs. Some commentators believe that more could have been done to prevent infection in particular groups of patients. Careful consideration of the evidence has, however, revealed few respects in which matters could or”—

more importantly—

“should have been handled differently”.

Will my noble friend endorse that conclusion?

[Earl Howe]

My Lords, if my noble friend will forgive me, I do not want to be drawn too closely on Lord Penrose’s comments, as we should reflect on them carefully. However, it is clear that, as knowledge of these viruses began to emerge in the 1970s and early 1980s, no tests were available to screen blood donations and no means existed to inactivate the virus in blood or blood products. By 1985, a screening test for HIV was available, and heat-treated plasma products that inactivated the virus had been developed. It was not until 1990 that an effective screening test for hepatitis C was available. It is important to put that into context, because Lord Penrose found that clinicians acted in accordance with the technical facilities that they had available to them and in accordance with the ethical frameworks that were in place during the 1970s and 1980s. The ethical frameworks in which clinicians operate today are of course very different from those that were in place then.

[Baroness Masham of Ilton (CB)]

My Lords, looking ahead to the future with the new Government, would the noble Earl agree with me that there are new drugs coming along for hepatitis C? For those poor, unfortunate patients who had haemophilia and who got HIV and hepatitis C, it really was a disaster. Would he consider, if he is still a Minister, that the very best treatment with these new hepatitis C drugs will be given to these patients? That would prevent liver disease, which is a huge problem.

[Earl Howe]

The noble Baroness makes a very important point. NICE guidance on the first of the new hepatitis C drugs is expected in June this year. Pending that, in April last year NHS England introduced an early access scheme for the new hepatitis C therapies. Over 700 patients have now been treated as a result of that policy, including some of those who were infected by blood or blood products in the 1970s and 1980s. NHS England is considering a further early access policy to include patients with cirrhosis, which it is aiming to have in place in the first half of this year. I think that should be of comfort to many patients.

[Lord Hope of Craighead (CB)]

I am very grateful to the noble Earl for repeating the Statement. He may be aware that the report was very badly received by the public in Edinburgh, which is a source of concern. One of the people, no doubt someone affected by the disaster, was shown on television burning the report. Against that background, and appreciating of course that this is primarily a Scottish matter, will the noble Earl take steps to ensure that the Statement itself and some of the reassuring remarks that he and indeed the noble Lord opposite have made are drawn to the attention of the media in Scotland, as the more it can be put across that this is a valuable report that has done a great deal of work and sets a basis for further study, the more the public will be reassured? I would be grateful if the noble Earl would do that.

[Earl Howe]

I am happy to undertake to use my best endeavours in that regard.

Care Act 2014 and Children and Families Act 2014 (Consequential Amendments) Order 2015

Earl Howe Excerpts

Wednesday 25th March 2015 Lords Chamber

Moved by

[Earl Howe]

That the draft order and regulations laid before the House on 5, 11 and 25 February be approved.

Relevant documents: 24th and 25th Reports from the Joint Committee on Statutory Instruments (Special attention drawn to an instrument). Considered in Grand Committee on 19 March.

Motions agreed.

Public Contracts Regulations 2015

Earl Howe Excerpts

Wednesday 25th March 2015 Lords Chamber

[The Lord Bishop of Peterborough]

My Lords, I am grateful to the noble Lord, Lord Hunt, for bringing this Motion. I will speak only very briefly because he has given most of the detail and said most of what I want to say, particularly about the confusion in the tendering and commissioning process. Integrating health and social care is obviously right—I very strongly support it—but why the rush? Why not do it slowly and carefully? If I understand aright, Scotland has entered a lengthy, considered stakeholder consultation and will finalise its regulations on health and social care at the same time, by April 2016, along with the majority of EU member states. So why do we have to go so quickly? I do not understand the rush in one-half of the equation, which unbalances the whole thing.

Experience tells us—we have had examples from the noble Lord, Lord Hunt—that changes on this scale are highly complex, deeply disruptive to those involved and often much harder to implement than initially imagined. Is not proper consultation, careful decision-making and measured implementation the right way forward in such matters? I, too, urge the Government to take this more slowly and get it right, because it really is important and we want to support it.

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

My Lords, I am grateful to the noble Lord, Lord Hunt, for initiating this debate on what is a very important subject. Let me begin by emphasising one key point. The main purpose of the Public Contracts Regulations 2015 is to implement the new EU procurement directive. There is no choice over whether the UK transposes that directive: it is mandatory to do so. It contains the new rules regime by which all European public authorities have to abide. The Government implemented this directive early to realise as soon as possible the economic benefits from the modernised rules regime. Both the noble Lord and the right reverend Prelate have expressed criticism to us for doing so, but the reason is that this should lead to more than £4 billion-worth of benefits to the economy each and every year. That could not be overlooked.

Since 2010, the Government have embarked on a radical programme of commercial reform as a lever to stimulating economic growth and reducing the deficit. In 2013-14 alone, this approach saved taxpayers £5.4 billion. As part of our ongoing commercial reform programme, the UK negotiated hard in the European negotiations on the new EU procurement directives in 2012-13, and we were successful in securing a number of key improvements to the European public procurement rules regime. The new rules support UK government priorities of economic growth and deficit reduction by making the public procurement process faster, less costly and more effective for business and procurers alike. The European Commission estimates that SMEs across the EU could save up to 60% of bidding process costs.

Aside from transposing the new public procurement directive, the regulations include a number of domestic reforms, instigated by my noble friend Lord Young of Graffham, to make it simpler for small businesses when bidding for public sector contracts. The Minister for the Cabinet Office, my right honourable colleague Francis Maude, and my noble friend Lord Young of Graffham have driven these reforms from concept through to implementation in these regulations. The changes include ensuring that all advertisements for public sector contracting opportunities appear in one place on a national website, the abolition of time-consuming and costly pre-qualification questionnaires for low-value contracts, and improving payment terms down the supply chain.

The statutory instrument was laid in Parliament on 5 February 2015. The regulations came into force, for most purposes, on 26 February 2015. I stress the words “for most purposes” because, although most public procurement activities will be subject to these rules from that date, there are special provisions in some areas. One such special area is the healthcare sector. The Government have delayed the coming-into-force date for procurements by NHS clinical commissioning bodies to the latest possible date allowed by the EU—18 April 2016—to give clinical commissioners more time to prepare for the rule change in recognition of the interplay between the new EU procurement rules and the UK’s existing healthcare procurement legislation.

I make it clear that the Public Contracts Regulations themselves were not foisted upon Parliament at the last minute or hidden until the regulations were laid but have been, in line with good practice, subject to formal public consultation over a period of time, over and above what had already taken place for the EU procurement directive.

The Government received more than 200 stakeholder responses to the public consultation on the draft regulations. Most respondents were supportive of the overall approach to early transposition, and the delayed transposition for NHS clinical commissioning services was welcomed by stakeholders in that sector. The government response to the consultation was published and publicly available from 30 January 2015.

I should now like to reflect on the concerns about potential confusion as to which procurement rules regime applies for integrated health and care contracts. To consider this, it is helpful to reflect not only on the regulations and the directive that they implement but on the pre-existing set of UK healthcare procurement rules. Those rules have existed in the UK since 2013, following the Health and Social Care Act 2012; the noble Lord, Lord Hunt, alluded to them in tabling this Motion. The new EU procurement directive includes a mandatory new provision for member states to put in place a new light-touch regime of procurement rules for health, social, education and certain other service contracts. In transposing that requirement, the UK has taken careful account of stakeholders’ concerns and has designed its national provisions to be as genuinely light touch as possible, within the parameters set by the EU. In the UK health sector, a set of healthcare-specific procurement rules has been in place for some time, covering arrangements for the purchasing of clinical services. The NHS Procurement, Patient Choice and Competition Regulations 2013 were put in place to drive improved quality and best value, which effectively put in place a light-touch regime for clinical services.

During the Government’s recent public consultation on the Public Contracts Regulations 2015, it became apparent that stakeholders in the field of clinical services procurement were concerned about the interplay between the new light-touch procurement rules regime and the existing healthcare procurement rules. The Government acted upon this feedback and agreed to allow more time for clinical service commissioners to adapt. Consequently, the Government decided to take the sensible and pragmatic decision to delay the application of the new regulations on clinical services procurement by clinical commissioning groups and NHS England until the transposition deadline of April 2016. Such procurements will continue to be governed by the pre-existing procurement regulations—that is, the Public Contracts Regulations 2006—until that time.

The delayed implementation in respect of clinical procurement is clearly defined, and rests on the identity of the commissioning body. Commissioners of healthcare services are exempt until 18 April 2016. Local authorities are not. Integrated commissioning plans, joint commissioning or arrangements for a CCG or local authority to commission on behalf of the other will all remain available. The decision about which rules regime applies will depend on which commissioner leads the procurement and the service in question. The Government’s response to the public consultation on the draft regulations acknowledged the potential for short-term complexity.

The Government have since published guidance on the new light-touch regime, in addition to providing a wide variety of training and guidance materials on the new procurement rules overall. In the health sector, work is also under way to bring greater clarity in the system about how health commissioners, both from NHS bodies and local authorities, can work together under the respective legal regimes. NHS England and Monitor have, and continue to, run a successful series of joint workshops for commissioners and continue to provide advice and support to clinical commissioners in individual cases, where appropriate.

Turning to the concerns about the freedom of NHS commissioners to commission services in the best interests of patients, I would like to reassure noble Lords that these regulations respect those freedoms. As I have already set out, these regulations do not apply to the procurement of clinical services procured by NHS England or clinical commissioning groups yet. But even when they do apply in April 2016, they will not force commissioners to tender NHS services automatically.

Advertisements for competitively procured contracts will have to be placed in the official journal of the EU where the contract is worth more than €750,000, unless an exemption applies. Commissioners can consider whether there is, in the circumstances, an obligation to go to the market or not under the terms of the directive and implementing regulations. The requirement to advertise if no exemption exists is a mandatory feature of the new EU procurement directive. The Government have no option but to implement it in national legislation but, as I have already said, we are delaying implementation of that requirement to the latest date possible.

The Public Contracts Regulations 2015 and the Procurement, Patient Choice and Competition Regulations 2013 are consistent in requiring contracts to be procured fairly and transparently. They also both contain appropriate exemptions that apply to contracts that need not be advertised—for example, where there is only one possible provider.

It is perhaps helpful at this stage to delve deeper into the issue of when to tender, in particular to address some of the incorrect commentary that is often perpetuated suggesting that all services have to be put out to tender. The Public Contracts Regulations, when implemented for health, contain a number of flexibilities that can, where justified, be utilised by commissioners to dispense with the need for an open competition. Importantly, the Public Contracts Regulations require a fair and transparent process once the commissioner has decided to go out to competition. The major change introduced by the directive relates to the need ordinarily to advertise in the Official Journal of the European Union—or OJEU, as it is generally known—rather than to the decision on which procurement process to follow.

False or Misleading Information (Specified Care Providers and Specified Information) Regulations 2015

Earl Howe Excerpts

Thursday 19th March 2015 Grand Committee

Moved by

[Earl Howe]

That the Grand Committee do consider the False or Misleading Information (Specified Care Providers and Specified Information) Regulations 2015.

Relevant document: 24th Report from the Joint Committee on Statutory Instruments

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

My Lords, before I go into the detail of the regulations, I will briefly set out the background for why this offence was set in statute and why the regulations are required.

The report of the Francis inquiry into the events at Mid Staffordshire NHS Foundation Trust made clear the need for clear and reliable information about the quality of care and organisational performance. The inquiry found that inaccurate statistics about mortality rates obscure the true picture of care and can allow poor care to continue unchecked. The creation of a culture of openness and honesty is vital in improving care in the NHS and in empowering staff to challenge poor care where and when it occurs, and this Government have taken great strides to ensure that this is the case.

The provision of accurate information is central to the safe functioning of the NHS. It provides the intelligence on which commissioners and regulators form judgments about the quality of care. Where that information is wrong, it can result in delays in taking action to protect patients and service users. Deliberately falsifying such information is a serious matter that can frustrate attempts to provide safe care for patients and service users.

Care providers, which are directly responsible for the standard of services, have a clear responsibility to ensure that the information they supply is accurate and gives a true picture of the standards of care that they provide. The Care Act 2014 put in place a new criminal offence that will apply to care providers that supply, publish or otherwise make available false or misleading information. The offence will apply to the misreporting of information that is required to comply with a legal obligation. I wish to emphasise that last point: this offence applies only to providers of care, not regulators or commissioners of care.

Where a provider is found to have committed the offence, which could be as a result of deliberately supplying false or misleading information or as a result of neglect, the provider can be fined by the courts. In addition, the courts can require the provider to take action to address the failings which led to the offence occurring and make publicly known the action it is taking.

The FOMI offence can also apply to senior individuals within a care provider but only when the care provider has been found guilty of the offence. Senior individuals can also be found guilty of the offence where they have consented or connived in the publication or submission of false or misleading information, or have been sufficiently neglectful in their duties to allow false or misleading information to be published. An individual found guilty of the offence could face imprisonment of up to two years, a fine or both.

Of course, misreporting of information can be the result of genuine error and it is essential that such mistakes do not result in a criminal conviction. The Care Act 2014 therefore allows for a defence against the offence where a care provider is able to demonstrate that it took all reasonable steps and exercised due diligence to avoid the misreporting of information.

The primary legislation contains a regulation-making power that allows the types of care providers and the types of information to which the offence applies to be specified in regulations. The regulations before the Committee specify that the offence will apply to NHS trusts in England, NHS foundation trusts and other persons who provide health services from a non-NHS hospital,

“pursuant to arrangements made with a public body”.

For clarification, this means that the offence can apply to independent providers delivering services under an NHS contract, but only if they are also required to submit or publish the information included in the regulations.

The information to which the FOMI offence applies is focused on the issues raised by Robert Francis, such as mortality figures, and is supplied by providers of NHS secondary care. This is a short list, but one that represents a significant quantity of data provided by the NHS and forms the foundation of the information used to assess NHS performance.

The regulations include other key information supplied by providers of NHS secondary care, including cancer waiting times, maternity data sets, many of the core commissioning data sets and NHS quality accounts. The latter is an important inclusion, as Sir Robert Francis specifically recommended that:

“It should be a criminal offence for a director to sign a declaration of belief that the contents of a quality account are true if it contains a misstatement of fact concerning an item of prescribed information which he/she does not have reason to believe is true at the time of making the declaration”.

All the information listed in the regulations is that which providers are or will be required to publish or submit because of a statutory or other legal obligation. This is a requirement of the primary legislation of the Care Act 2014 and an important part of the legislation for a few reasons.

First, it means that a provider cannot opt out of submitting or publishing information just because it wants to circumvent the false or misleading information offence. Secondly, as this is information that is already required to be published or submitted, we are not requiring providers of NHS secondary care services to undertake any additional work—only that they should ensure the information they provide is accurate and not misleading. Finally, providers of NHS secondary care services publish or submit on a voluntary basis a great deal of information which is incredibly valuable to improving the delivery of services and developing a greater understanding of the nation’s health. We do not want to dissuade providers from submitting or publishing such information, which is why the offence cannot be applied to information of that type.

In summary, the offence will apply only to the providers listed in the regulations and only where the offence occurs in relation to the provision or publication of the information listed. When the Department of Health consulted on the regulations in 2014, it was noted that the application of the offence was quite complicated. We have addressed this concern through guidance on the application of the FOMI offence which sets out how this law works.

The FOMI offence puts in place an important new sanction against providers of NHS-funded secondary care that mislead others about the performance of their services. As this offence is new, the regulations have been developed to focus the application of the offence so that it covers important data sets and data that can be robustly interrogated to determine if a provider has committed the offence. Designing the regulations this way will enable us to better understand how the offence operates in practice and allow us to make changes to the regulations in a targeted way in the future. I hope that noble Lords will support this rationale and will therefore agree to these regulations being commended to the House. I beg to move.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am very grateful to the noble Earl for introducing these important regulations, which the Opposition are very happy to support. It is clearly unacceptable for anyone or any organisation in the NHS to knowingly publish false or misleading information. We are fully behind the Government on this. The noble Earl will probably remember that during the passage of the Care Act we tried to strengthen the clause that the regulations emanate from by tabling an amendment which would have made it an offence to withhold information with the intention to mislead or misdirect. That was not accepted by the Government.

I come back to the point that the Minister ended with. He emphasised that this applies only to NHS trusts, foundation trusts and those providing services. He will know from our discussions on the Bill that we wanted to expand this to cover other organisations, including local authorities and clinical commissioning groups. I would be grateful if he could respond on why the Government still think this should be confined to those who provide services.

I put to him that the Francis report into Mid Staffordshire, and indeed the more recent report by Bill Kirkup looking at the very worrying incidents that happened in Morecambe Bay, do not just put responsibility for what happened at the door of the providers, though I fully accept that in the end the board of the Mid Staffordshire NHS Foundation Trust and the board of the trust that ran Morecambe Bay must take primary responsibility. However, a number of other organisations were listed—organisations that would not be defined as providers. There are circumstances in which clinical commissioning groups, or part of NHS England, ought to be covered by the same rules and law because one depends on honesty and openness throughout the system. I would be interested in the Minister’s comments on that.

This is part of wishing to develop a culture of openness and transparency. People in the health service are very cynical about these proposals because they do not see the same transparency and openness and, to be frank, honesty emanating from the Minister’s own department. If my noble friend Lord Brooke were here, he would remind the Minister about the lack of publication of the interim risk register. I point to the report by the noble Lord, Lord Rose, on management capacity. It is one thing to have a legal provision, but it is another to ensure that everyone in the system actually operates according to the spirit of what the Government intend. I myself believe that that should apply as much to the Minister’s department and NHS England as it does to the providers in the health service.

[Earl Howe]

My Lords, I am grateful to the noble Lord for his support for these regulations. He returned us to an issue that we debated during the passage of the Care Act: the question of why this offence is restricted to providers and does not extend further to either NHS or local authority commissioners. We took the view that, in determining the scope of the offence, the focus should be on information that is closest to patient care, where inaccurate statements can allow poor and dangerous care to continue. This type of information is required by law from providers of NHS secondary care, such as hospital trusts, and to be frank we have not yet identified information that would warrant extending this offence to commissioners or other providers of information. The scope of the offence is therefore determined by the information to which it applies.

The noble Lord referred to the need for openness throughout and across the system. I agree with him, of course, and I contend that over the past five years this Government have done more than any other to promote transparency in the health service and indeed from the department itself. The particular case of the risk register is one that we have debated on a number of occasions. He may recall that while the decision was taken by the Cabinet not to publish the transition risk register, nevertheless I laid before the House the essential elements contained within the register to enable noble Lords to understand the broad content of the risks that the transition addressed. The approach to risk registers in general is one that was taken under the previous Administration in a number of departments.

The report prepared by the noble Lord, Lord Rose, on NHS leadership is being looked at in the light of NHS England’s five-year review. The five-year review was published during the time that the noble Lord, Lord Rose, was preparing his report and the possibility of extending the report to take account of the review is being considered. We look forward to seeing the conclusions of the report once it is ready.

Motion agreed.

Nicotine Inhaling Products (Age of Sale and Proxy Purchasing) Regulations 2015

Earl Howe Excerpts

Thursday 19th March 2015 Grand Committee

Moved by

[Earl Howe]

That the Grand Committee do consider the Nicotine Inhaling Products (Age of Sale and Proxy Purchasing) Regulations 2015.

Relevant document: 25th Report from the Joint Committee on Statutory Instruments

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

My Lords, these regulations restrict children’s access to electronic cigarettes. I am glad that we have the opportunity to debate these regulations, as they are the final element of the package of measures the Government introduced in the Children and Families Act aimed at protecting young people from tobacco and nicotine addiction and the serious health harms of smoked tobacco.

The provisions in the Act give Ministers regulation-making powers to introduce an age of sale requirement for electronic cigarettes and we have taken the decision to do so. The market for electronic cigarettes—which are also known as e-cigarettes—has developed rapidly in recent years. There are many different types and brands now available. Some of them are designed to look and feel like conventional cigarettes; others have a tank or reservoir which is filled and refilled with liquid nicotine. E-cigarettes can be disposable or rechargeable.

Most of the e-cigarettes on the market are flavoured and some of these flavours, such as cherry cola, bubble gum and gummy bear, may be appealing to children. The use of e-cigarettes is also increasing. Action on Smoking and Health estimates that 2.1 million adults in Britain currently use them. This is an increase on the estimated 700,000 users in 2012. Use of e-cigarettes by people under the age of 18 is not currently widespread in this country; however, international evidence suggests that this may increase. The emerging evidence suggests that awareness of e-cigarettes by British children is high. A Public Health England report found that two-thirds—66%—of 11 to 18-year olds had heard of e-cigarettes. Some 7% had tried e-cigarettes at least once and 2% reported using them sometimes or often. E-cigarettes are widely promoted through social media. They are sold in a wide range of retail outlets, including supermarkets, newsagents, specialist shops and pharmacies, and are often prominently displayed and promoted in store.

It is clear that more research is needed before we can determine whether e-cigarettes are acting as a gateway into tobacco use. While e-cigarette use by children is currently associated with existing tobacco smoking, research published by the Welsh Government provides tentative evidence that e-cigarette use may represent a new form of childhood experimentation with nicotine. The Chief Medical Officer has raised concern about e-cigarette use by children and the World Health Organization has recommended that they should not be sold to minors.

Nicotine is highly addictive; it is five to 10 times more potent than cocaine or morphine, and young people can rapidly develop nicotine addiction. Research shows that adolescents are more sensitive to the rewarding effects of nicotine and this may be a reason why many people start to smoke during adolescence. We are aware that responsible e-cigarette manufacturers and retailers do not sell e-cigarettes to children at the moment. However, we have decided to introduce an age-of-sale requirement; we consider that concerns about the increased awareness and use of these products by children make this an appropriate step to take. The age of sale requirement will also provide clarity and consistency for retailers and enforcement officers.

Proxy purchasing occurs when a person over 18 buys an age-restricted product on behalf of someone underage. Young people are known to approach strangers outside shops or ask friends, neighbours or, in some cases, parents to buy tobacco for them. That is why we introduced a new offence of proxy purchasing of tobacco in the Children and Families Act. The regulations extend this offence to cover e-cigarettes.

I shall briefly set out what the regulations will do. The first set of regulations defines a “nicotine inhaling product” as any device which is intended to enable nicotine to be inhaled through a mouthpiece. The definition encompasses e-cigarettes, including disposable and rechargeable types, and certain component parts such as nicotine refill cartridges and nicotine refill substances, often called “e-liquids”. It does not cover component parts such as batteries or charging devices. The regulations do not apply to tobacco products, because we already have age of sale laws for tobacco. The regulations include exemptions for products that are licensed as medicines and so are subject to separate regulatory rules. There are exemptions for nicotine inhaling products that are a medicine or medical device made available in accordance with a valid prescription by a pharmacist. The regulations also exempt the sale of any nicotine inhaling product licensed as a non-prescription medicine—that is to say, available for general sale—and which the licensing authority has determined is indicated for use by children under 18. In such cases, the seller need not be a pharmacist, as such medicines can be sold in other types of shops including newsagents. This means that those under 18 years trying to quit smoking would still be able to access e-cigarettes as well as products such as nicotine patches or gum.

The regulations also extend the proxy purchasing provision in the Act to make it an offence for an adult to buy, or attempt to buy, a nicotine inhaling product on behalf of a child aged under 18 years. The penalties for these offences are set out in the Act: a person making a proxy purchase may be issued with a fixed penalty notice or could be referred to court; and the adult making the purchase would be committing the offence, not the retailer. A retailer guilty of selling nicotine inhaling products to someone under the age of 18 could be fined up to £2,500 on conviction. Local authority trading standards officers would be responsible for enforcing the regulations, as they enforce much of the tobacco control laws.

The regulations bring the age of sale offence for nicotine inhaling products within the scope of primary authority. This arrangement allows businesses to form a statutory partnership with one local authority, which then provides advice for other local regulators to take into account when carrying out inspections or addressing non-compliance.

We are also debating a second set of regulations, which set the amount of the fixed penalty notice for the proxy purchase provisions at £90; this is reduced to £60 if it is paid within 15 days. This provides consistency for retailers and enforcement officers as it will bring the proxy purchase of tobacco and nicotine inhaling products in line with the equivalent offence for alcohol.

The regulations will apply to England and Wales and have been agreed by the Welsh Government. They would come into force on 1 October 2015. We have decided to use the October—rather than April—common commencement date to allow time for the training of enforcement officers and to raise retailer and public awareness.

There will also be further negative statutory instruments to complete the enforcement regime. One will set out the fixed penalty notice form for the proxy purchase of tobacco and nicotine inhaling products in England, and one will add age of sale and proxy purchasing to the list of offences for which enforcement officers can carry out directed surveillance, subject to existing safeguards; for example, to allow test purchasing operations.

The Department of Health held a six-week public consultation on the draft regulations and received 81 responses. The consultation responses confirmed that many responsible manufacturers recommend that their products are for use by adults only and responsible retailers already voluntarily restrict children from accessing e-cigarettes. Almost all respondents supported the policy aims and the specific proposals set out in the regulations. Retailers, e-cigarette manufacturers, local authorities, enforcement officers and the public health community have all been absolutely clear that they want these regulations in place.

The regulations are business-friendly and a number of retail organisations have told us that putting the age of sale in law will help those responsible retailers that already refuse to sell e-cigarettes to children, by ensuring that they are not at a competitive disadvantage by doing so. The cost of the regulations is estimated to be very small indeed and will be mainly on businesses that currently profit from selling e-cigarettes to children and young people.

Many consultation respondents emphasised that this is a fast-moving market in terms of product development as well as patterns of consumer use, and that research evidence into the effectiveness of e-cigarettes in smoking cessation and potential long-term health harms is still emerging. I agree that these are all important aspects of this policy area and we have therefore included a duty to review the regulations within five years of them coming into force.

As I said earlier, I am very pleased to be able to present these regulations to the Committee. They represent the final stage in the implementation of the important public health measures in the Children and Families Act. In recent weeks, we have also introduced legislation to end smoking in private cars carrying children, and earlier this week noble Lords debated the regulations that will introduce standardised packaging for tobacco products. They are all part of our comprehensive approach to tobacco control and make an important contribution to our vision of a tobacco-free generation in the future. I commend the regulations to the Committee.

[Baroness Finlay of Llandaff (CB)]

My Lords, I thank the noble Earl for introducing these regulations and welcome the way in which they have been drafted. Clearly, a great deal of care was taken in the drafting, and they seem eminently sensible.

It is most reassuring to know that the Association of Convenience Stores welcomes these regulations and the clarity that they provide. It says:

“We support strong enforcement against proxy purchasing of tobacco. We need to see these properly enforced, something that is lacking with the same powers that are in place for alcohol proxy purchasing”,

and that the penalty for proxy purchasing on e-cigarettes puts everything consistently in line. Indeed, it has welcomed the age restriction.

I was glad, too, to hear the reference to the Welsh study because it was the data from Wales that really began to make me personally concerned about these products. There is evidence of increased use among under-18s. I know some people will say that data from ASH are biased, but ASH has been fairly neutral in its view on electronic cigarettes because of the way that they have helped people quit ordinary tobacco cigarettes. It has found that the number of 11 to 18 year-olds who have tried an electronic cigarette increased from 5% in 2013 to 8% in 2014, although it did put the caveat around those figures that the use is closely linked with smoking behaviour.

One piece of research which is really important to have on the record is the work from Counotte and colleagues, published in Developmental Cognitive Neuroscience in 2011, which found that,

“nicotine exposure during adolescence can disrupt brain development bearing long-term consequences on executive cognitive function in adulthood”.

These are new products, with high levels of nicotine in them. We know that the propensity for the developing brain in the age group up until 25 years to develop addictions of all sorts, right across the board, and addictive behaviour is greater than in the older brain. There is a concern that exposure in the young leads to a much greater propensity to develop nicotine addiction.

I have been concerned at the way that these products are marketed, especially to the young, and about their appeal almost as a fashion accessory. When I have looked at those shops which specialise in selling these products, they have made me feel as if I was probably a bit too old to go and buy one. They seem to be marketed very much to a young, vibrant population, which I find alarming. If they are shown to be as addictive as they might be, this will create a long-term market for them in the future.

I have been to several meetings about electronic cigarettes, including one held here in your Lordships’ House at which I was concerned at the almost aggressive way in which vaping was being pursued by some people present, which set alarm bells ringing a bit in my head over the process. These regulations are proportionate, timely and welcomed by those who have the responsibility for selling these products. I am glad that they appear to have universal support.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I welcome both sets of regulations. The Opposition fully support them. Like the noble Baroness, Lady Finlay, I was very impressed by the evidence from the Association of Convenience Stores and its support for the regulations. It is very persuasive in relation to the introduction of a minimum age of sale and I commend the ACS for the responsible briefing that we were sent ahead of these regulations.

The noble Earl referred to the research, such as the Welsh data and the evidence we have received from ASH, and mentioned the CMO’s concerns. Essentially, although one can certainly see that these products can have a beneficial health impact for many adult smokers, there is this issue about whether children go to smoking through these e-products. Is the noble Earl satisfied that enough research is being undertaken at the moment, either through the traditional research areas such as the MRC and Wellcome or perhaps through Public Health England? I do not know if he has information about this, but clearly it would be good to know that his department is keeping a continuing watchful eye to ensure that enough research is being done. Particularly relating to children, there is enough uncertainty around to make us want to ensure that there is ongoing research on this.

I have another question for the Minister, raised by the evidence that ASH submitted to his department when it was consulting on the regulations. ASH says that there is real confusion about the relative risks of electronic cigarettes compared to smoking, not just among the general public but among health professionals. It quotes from newspaper articles saying that smokers have been given advice by medical people and have had the impression that it is nicotine rather than tobacco smoke that is harmful. ASH quotes a study presented at the UK National Smoking Cessation Conference; it was some years ago so the profession may be more up to date now, but in one study presented at the conference a substantial proportion of GPs incorrectly asserted that nicotine in cigarettes caused CVD, strokes and lung cancer.

The point that ASH makes is that at the same time as regulations are introduced, the Department of Health should promote better understanding of the relative harm of electronic cigarettes and other nicotine products, including those authorised as medicine and their potential benefit to smokers. I understand that with regard to children there are areas where we are uncertain, but there are areas where we are more certain as well. I would be interested to know whether any advice or guidance accompanying the regulations is to be given to medical practitioners in particular.

I welcome the proxy purchasing offence, which is something that we very much support. The Minister quoted cases of young smokers having their cigarettes bought for them by another person, and outlawing this will help to crack down on it and send a wider public message that this is wrong. The other point comes back to the issue raised by the ACS regarding the e-cigarette issue: introducing the offence will give greater power to responsible shopkeepers not to serve people who they know, or strongly suspect, are going to pass cigarettes on to children. Overall, we are glad to see these regulations and to support them.

[Earl Howe]

My Lords, I welcome the support that the noble Baroness, Lady Finlay, and the noble Lord, Lord Hunt, have given to these regulations. I shall respond to the questions and points that they have raised. The study mentioned by the noble Baroness, Lady Finlay, was referenced in our consultation document. It was an important study, showing the impact of nicotine on the adolescent brain, and it influenced us considerably in informing the policy.

E-cigarettes are not risk-free. We do not know enough about the long-term health effects of adults using them, let alone children. There have as yet been no long-term studies to examine whether e-cigarettes serve as a gateway to tobacco use. Therefore, we cannot be certain at this stage whether there is a gateway effect from the use of e-cigarettes into tobacco smoking. Further research is needed to answer the question definitively. However, we know that nicotine is highly addictive, and we wish to protect children from the risk of nicotine addiction and the impact that nicotine can have on the developing adolescent brain.

The noble Baroness expressed a fear, which I share, about the aggressive marketing of these products. It is worth noting that the revised European tobacco products directive, which will apply from 20 May next year, includes a ban on advertising e-cigarettes, with a cross-border dimension—that is, advertising through television, radio, newspapers, magazines and sponsorship of sports events.

On the point made by the noble Lord, Lord Hunt, about what are sometimes seen as mixed messages around e-cigarettes, there is no doubt that, looked at in a certain context, e-cigarettes could be seen to have a role in enabling smokers to quit where they have tried other methods and not succeeded. We recognise that e-cigarettes are used by some smokers in that way. That is why the Government are working towards a regulatory framework that ensures that these devices meet basic standards of safety, quality and efficacy. We are clear that e-cigarettes must be accompanied by sufficient information to enable users to make informed choices.

The noble Lord asked about research. I agree that these matters must be kept under the policy spotlight going forward. The National Institute for Health Research recently commissioned a large, randomised control trial to examine the efficacy of e-cigarettes compared with conventional nicotine replacement therapy when used within UK stop smoking services. That research study is inevitably quite long-term. It is envisaged that the project will end in 2018, but the NIHR is confident that it will improve our current understanding considerably.

Motion agreed.