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.

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.

Barts Health NHS Trust

Earl Howe Excerpts

Thursday 19th March 2015 Lords Chamber

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

My Lords, I will now repeat in the form of a Statement an Answer to an Urgent Question tabled in another place and given by my honourable friend the Minister for Public Health on the subject of Barts Health NHS Trust. The Statement is as follows:

“The NHS Trust Development Authority announced on Tuesday 17 March that Barts Health would be placed into special measures. This followed a report by the Care Quality Commission that rated services at the Barts Health site at Whipps Cross as ‘inadequate’. As a result of this decision, the trust will receive a package of tailored support to help it to rapidly make the necessary improvements for patients. This will include the appointment of an improvement director and the opportunity to partner with a high-performing trust.

The Chief Inspector of Hospitals has highlighted the scale of the challenge ahead and this is an opportunity to ensure that the trust has the extra support it needs to meet this challenge. Barts Health has already announced that it has begun to strengthen management arrangements at Whipps Cross, in response to concerns raised by the CQC.

We make no apology that, under the new rigorous inspection regime led by the Chief Inspector of Hospitals, if a hospital is not performing as it should, the public will be told. If a hospital is providing inadequate care and we do not have confidence in the ability of its leadership to make the required improvements without intensive support, it will be put into special measures. It will remain in special measures until it is able it to reach the quality standards that patients rightly expect.

While the trust is in special measures, it will receive increased support and intensive oversight to help it address its specific failings. This process is publicly transparent so that patients and the public can see and track for themselves, online through the NHS Choices website, the progress that their trusts are making. Any changes or additional support required for the trust leadership are put in place early on in the improvement process, as has already taken place at Barts Health.

The expectation is that an NHS trust or foundation trust will be reinspected by the CQC within 12 months of being placed in special measures. It is the job of the Chief Inspector of Hospitals to recommend when a trust is ready to exit special measures. The NHS Trust Development Authority or Monitor will then formally decide to take the trust out of special measures when they consider that the trust is able to sustain the quality of care at the level that patients expect.

A total of 21 trusts have been put into special measures over the past 20 months as a result of this new approach to poor care. Six trusts have exited the regime and there has been progress at nearly all the others. The willingness to recognise poor care has been critical in starting a journey to improvement and we make no apology for upholding the high standards of care that are rightly expected of the NHS”.

My Lords, that concludes the Statement.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am sure that the House is grateful to the noble Earl, Lord Howe, for repeating that. It is a worrying report about the largest trust in England, which is directly managed by his department through the NHS Trust Development Authority. Why have these problems been allowed to get worse over the past two years? Does he agree that the report has identified that the root cause of the problem was the reorganisation of the trust in 2013? Can he say why Ministers overruled the Co-operation and Competition Panel, which advised against the proposed merger and warned of the adverse consequences for patients?

[Earl Howe]

The decision to create Barts Health was taken following a report that analysed the options open to the department at that time. As the noble Lord knows, there was, effectively, a merger of several trusts to create Barts Health. The advice received by the Secretary of State at the time was that none of the three trusts subject to the merger with Barts was sustainable as a stand-alone organisation. The appraisal of the options identified the three-way merger as the most beneficial and strategic solution for the system as a whole, taking into account a wide range of clinical, financial and government issues.

[Baroness Finlay of Llandaff (CB)]

My Lords, in looking at the non-viability, I have been concerned that the PFI deals that Barts Health is saddled with amount to £115 million a year. I wonder whether the other trusts that went into special measures have also had this albatross of PFI deals around their necks that has pulled them down over the years. Why have the Government been unable to address the problem of the burden of previous PFI deals?

[Earl Howe]

Early on in the Government’s term of office, we analysed all the trusts that were subject to PFI liabilities. The worst affected trusts were singled out to be given ongoing financial support by the Department of Health. Barts has a very large PFI debt of about £1 billion, and I have asked whether it is considered that this in itself has proved to be a deciding factor in the trust’s financial stresses. The advice I have been given is that it is not seen as a particular cause of the difficulties now being experienced.

[Baroness Donaghy (Lab)]

My Lords, I want to ask a question about a trade union representative who was dismissed from the authority two years ago for raising some of these very issues. She was a member of UNISON, and I declare an interest as a former member. I wonder whether, in working closely with trade unions, a better step would be to look after the interests of all the staff and to be not afraid to listen to some of the difficulties. The authority fought that case tooth and nail. She won at an employment tribunal but did not get reinstatement. Can the Minister give us a reassurance that in future there will be a more constructive relationship with the trade unions?

[Earl Howe]

My Lords, I cannot disagree with the philosophy expounded by the noble Baroness. It is very important that not just the trade unions but members of staff generally feel involved and have a sense of ownership of the organisation for which they work. I hope it is of some reassurance to the noble Baroness that staff and health partners will be fully involved in the development and implementation of the improvement programme and that a staff representative will be a member of a new improvement board at Whipps Cross.

[Baroness Masham of Ilton (CB)]

My Lords, it was stated in the press that there had been bullying at Whipps Cross and that people had been denied food and fluid for far too long. What is being done about those people who bullied patients?

[Earl Howe]

The noble Baroness is right. The CQC found that there was a culture of bullying at Whipps Cross. They had concerns about whether enough was being done to encourage a culture of openness and transparency—something on which, as she knows, we place great emphasis in the light of the report on Mid Staffordshire NHS Foundation Trust. I can only say to the noble Baroness that this is one of the issues that will be top of the list for the new improvement director at Whipps Cross.

[Baroness Manzoor (LD)]

My Lords, the culture within the NHS appears to be changing, and not for the better. Is the Department of Health looking at that, as well as at the issue of PFI across the NHS, and is it doing so not in a piecemeal fashion whereby things are identified only when they go wrong?

[Earl Howe]

It is precisely because we have wanted to confront the issue across the NHS that so much has been done following the report of Sir Robert Francis into Mid Staffordshire NHS Foundation Trust. All the recommendations flowing from that report should resonate with every part of the NHS. The recent work done by Sir Robert on whistleblowing can be put into the same category. There are lessons and messages for the NHS as a whole, and I believe that progress is being made, as it needs to be in particular quarters.

[Lord Campbell-Savours (Lab)]

My Lords, I declare an interest as a financial sponsor of research into cancer at St Bartholomew’s Hospital in central London. Can we be given an assurance that the work done at St Bartholomew’s is in no way under criticism in the Statement made by the Minister?

[Earl Howe]

The Statement related to Whipps Cross specifically, but the Trust Development Authority took the decision to place the entire trust into special measures. That was a slightly unusual step to take but I think that it reflected the concern that it felt about the management of the trust generally. However, the TDA also singled out some areas at Barts for particular praise. It is important to stress that patients will receive the good care that they have known about at Barts in the future.

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

Earl Howe Excerpts

Thursday 19th March 2015 Grand Committee

Moved by

[Earl Howe]

That the Grand Committee do consider the Care Act 2014 and Children and Families Act 2014 (Consequential Amendments) Order 2015.

Relevant document: 25th Report from the Joint Committee on Statutory Instruments (Special attention drawn to the instrument)

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

My Lords, this order, while detailed, has a simple overarching purpose: to make amendments to primary legislation in relation to England consequent to new laws already passed by Parliament, primarily the Care Act 2014, but also to a small extent the Children and Families Act 2014, as I shall explain.

Part 1 of the Care Act 2014 is a crucial step in delivering the commitments in the Government’s White Paper Caring for Our Future: Reforming Care and Support. It takes forward the recommendations of the Law Commission to consolidate 60 years of fragmented law into a single statute, refocusing the law around the person, not the service.

The order before us today is part of the final step in this process, disapplying current legislation for England which is to be replaced by the Care Act, and changing references to that legislation in other Acts to reflect the Care Act. For example, many of the core entitlements to social care services included in the National Assistance Act 1948 are disapplied for England by this order because they are to be replaced by the overarching duty and power to meet care and support needs included in Sections 18 and 19 of the Care Act 2014.

The Department of Health and the Department for Education have worked together to ensure that carer provisions have been extended in key areas. Part 1 of the Care Act introduces improved rights for adult carers caring for adults, including to assessment and support. Sections 96 and 97 of the Children and Families Act 2014 amend the Children Act 1989 to introduce significant new rights for young carers and parent carers respectively. These new provisions will work alongside those in the Care Act 2014 for assessing adults to enable services to co-ordinate their approaches to assessment and support for young carers and the people they care for.

This consequential order therefore makes some amendments which are in consequence of the new provisions introduced by the Children and Families Act 2014. Because the previous legislation relating to carers is being replaced by a combination of provisions in these two Acts, it makes sense to deal with the necessary consequential amendments in a single order.

The order also includes some savings provisions which are necessary for the purposes of transition from the old system to the new one. Essentially the amendments in the Schedule to the primary order “turn off” the old law in England but, in respect of those currently in receipt of services, the order enables services to continue under the old law until those people move over to the new system. These savings provisions will work with separate transitional provisions, to be made by another instrument, and will ensure a smooth transition for those currently in receipt of services under the present law.

Lastly, I briefly outline how this order fits into the broader context of statutory instruments under the Care Act. Subject to parliamentary approval of this order, we will, as I have mentioned, be making a further transitional order that will complete the temporary legislative framework for local authorities and partners to move from old legislation to the Care Act. Also subject to approval of this order, we will make a commencement order to formally commence the relevant provisions in the Care Act from 1 April 2015.

We have also laid before Parliament the Care Act 2014 (Consequential Amendments) (Secondary Legislation) Order, which makes similar amendments to secondary legislation as the order before us makes to primary legislation. This is subject to the negative procedure.

I hope that this standard exercise of ensuring legislative coherence will not prove controversial, so I commend this statutory instrument to the Committee.

[Baroness Wheeler (Lab)]

My Lords, I thank the Minister for his comprehensive introduction to the order. As we have heard, it is part of the final steps of implementing the Care Act and related aspects of the Children and Families Act in respect of transition for disabled children into adulthood and on parent and young carers. Contrary to previous form on such Care Act SIs, I do not intend to raise many issues. The SI is very much a technical instrument, potentially complex and involved. However, read in connection with the 2014 statutory guidance to local authorities on implementation and transition to ensure that current services can continue under the old law until the new legal framework applies, it becomes clearer and more intelligible, even to non-lawyers such as myself.

The key imperative, which we strongly support, is for local authorities to be able to manage the transition for existing people receiving care and support services and carers before 1 April 2015 in a practical, case-by-case way. Assessments, care plans and funding arrangements and services agreed under the previous legislation continue unless circumstances have changed, and in accordance with the established review procedures to ensure that arrangements comply with the new Acts.

The Minister knows that we share local authorities’ continuing concerns over capacity and resource issues to ensure effective implementation, and I would be grateful if he could update the House on the latest stock-take survey of local authorities’ readiness and their continuing areas of concern. I understand that the joint LGA/Department of Health/ADASS programme office will continue to monitor and evaluate implementation, as well as co-ordinating the consultation on phase 2 of the Care Act implementation on the care costs cap. I hope that regular updates and information on implementation can be provided over the critical April/May period, and I would be grateful for the Minister’s reassurance on that—even if only up until 7 May.

As the Minister said, the separate transitional order setting out the detail of the circumstances in which the new order is to apply is to follow shortly, so this is especially important. The Department of Health has undertaken to circulate the draft next week via its local authority and other networks before it is formally issued, to confirm the approach for both phase 1 and phase 2 of the Care Act implementation so that it can address some of the recent detailed queries and concerns from local authorities. That is to be welcomed, as I am sure that we all agree that the local authorities need all the help and support that they can get on what is a huge and complex implementation programme.

The department has also undertaken to share the draft with us, and I am grateful for that. However, publishing the final transitional order so close to the date on which the Care Act comes into force will cause considerable difficulties to local authorities. The Minister will know that the order cannot be published until after this SI has been passed in the other place, which will take place next Wednesday. Even if it is published immediately after Commons agreement, that is exactly a week before the changes begin to be implemented and there will be no real opportunity for parliamentary comeback on such a detailed and important implementation document. I recognise that much of the order content will have already been discussed with and communicated to local authorities, but receiving the final authorisation so late in the day presents even greater implementation challenges than already faced. What steps are the Government taking to mitigate that very difficult position?

Two other key issues arise from the statutory instrument. The first is that it formally sets out the position in respect of Wales concerning the Social Services and Well-being (Wales) Act 2014 in relation to adult social care law and to children. The enforcement date of that is currently intended to be 1 April 2016, but that is rightly up to Welsh Ministers. The SI provisions underline that any provisions disapplied in England to make way for the Care Act and the Children and Families Act continue to apply in Wales until such time as Wales brings in the Welsh Act. The Explanatory Note has reassured us that full consultation has taken place with the devolved Administrations in both Wales and Scotland. It also underlines that the order does not contain any provision which changes the current law as it applies to Scotland or Wales, and we welcome those assurances.

The second issue in the SI is in the detail of the Schedule setting out the consequential amendments to existing legislation on the provision of care and support to carers in England resulting from the implementation of the Care Act and the Children and Families Act. That has obviously been a major exercise in cross-government departmental working, and we fully recognise the scale and extent of the task that the department has had to undertake. It is to be congratulated on this work. It is also timely to remind ourselves of the pioneering work described in the Law Commission’s 2008 report, which set out the agenda for the reform of social care law. We have always strongly supported the need to update, consolidate and modernise social care legislation and the key principles of the Care Act, and have been committed to working closely with Members from across the House to ensure improvements and amendments to the Act.

Can the Minister update the Committee on the issue arising from the recent report from the Joint Committee on Statutory Instruments in respect of the drafting of paragraph 95 of the Schedule? The committee has said that the amendments to the Personal Care at Home Act 2010 made by this paragraph are not comprehensive and that consequential amendments are needed. This is an important issue and the department has undertaken to remedy this omission, so will the Minister ensure that the amendments are communicated to all interested parties and organisations as soon as possible?

[Earl Howe]

I am grateful to the noble Baroness. She asked about the local authority stock take. The results of the recent stock take in relation to implementation of the Care Act for January and February reported a positive picture overall regarding local authority preparedness. Specifically, the stock take’s headline findings reported that 99% of councils say that they are very or fairly confident that they will be able to deliver the Care Act reforms from April 2015, compared to 97% of councils in stock take 2 and 90% in stock take 1. Of the four authorities which reported low confidence in stock take 2, three are now fairly confident and one is very confident; one authority has gone from fairly to not very confident.

Seventy-five per cent of councils say that they are on track in 2015-16 in their preparations for the Care Act, the remainder being slightly behind. Confidence has increased on six out of 10 proxy measures from stock take 2 to stock take 3. The exceptions are self-funders, carers’ assessment costs and information, advice and advocacy.

We have already invested more than £5 million in developing a suite of support materials, learning modules and other tools to help councils implement the Act. This is in addition to £23 million of investment in regional and local support that we have provided this year.

The noble Baroness referred to the transition order and regretted the fact that, in her view, it had been published rather late in the day. We set out the approach to transition in the statutory guidance published last October. The joint implementation programme of the Department of Health, the Local Government Association and ADASS has supported transition conversations with local authorities since that time. We do not think that anything in the transition order will have come as a surprise to local authorities.

The noble Baroness referred to the JCSI report, which pointed out that a particular consequential amendment had been omitted from the order. We accept that paragraph 95 of the Schedule to the 2015 order should have amended Section 1(2) to (5) of the Personal Care at Home Act 2010. Failure to do so was an oversight. Those subsections make some prospective amendments to Section 15 of the Community Care (Delayed Discharges etc.) Act 2003. The issue here, however, is that the 2010 Act is not yet in force and there are currently no plans to commence it. The department will ensure that if the provisions of the 2010 Act are commenced, the necessary consequential amendments to Section 1(2) to (5) will be made in the same order using the consequential amendment powers in the Care Act 2014. In summary, while we regret the missed amendment, the omission has no practical effect, and we will have ample opportunity to correct it if the relevant legislation is ever commenced.

Motion agreed.

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.

Proxy Purchasing of Tobacco, Nicotine Products etc. (Fixed Penalty Amount) Regulations 2015

Earl Howe Excerpts

Thursday 19th March 2015 Grand Committee

Moved by

[Earl Howe]

That the Grand Committee do consider the Proxy Purchasing of Tobacco, Nicotine Products etc. (Fixed Penalty Amount) Regulations 2015.

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

Motion agreed.

Health and Social Care (Safety and Quality) Bill

Earl Howe Excerpts

Wednesday 18th March 2015 Lords Chamber

[Lord Turnberg (Lab)]

My Lords, I hope your Lordships will allow me just one minute. I do not intend to oppose this Bill, but in Committee I expressed some concerns about the possible unintended consequences of Clause 1. In fact, I have withdrawn an amendment I had intended to move that would have tried to mitigate some of these consequences by pointing to a rather better way of avoiding harm to patients by proper education, training and supervision within hospitals and care homes which would lead to a continuing, progressive reduction in harm but without stifling innovation. I withdrew my amendment because I was told that I would cause the Bill to fall and I have no intention of doing that. But I do hope, at least, that the noble Earl will be able to offer some reassurances on the points that I have raised.

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

My Lords, I understand concerns that noble Lords have raised about the Bill potentially stifling innovation and openness. I assure noble Lords that this is in no way the intention of the Bill. Indeed, the Bill does not place any requirements on providers of healthcare and adult social care registered with the Care Quality Commission. This is achieved through regulations and the associated guidance issued by the CQC. My officials have been in contact with the Chief Inspector of Hospitals, who would be very happy to meet noble Lords to discuss the content of the guidance to ensure that the CQC’s approach to inspection supports continuing reductions in avoidable harm, innovation and supervision and training of staff.

Report received.