NHS: Cancer Drugs Fund

Earl Howe Excerpts

Monday 16th March 2015 Lords Chamber

[Lord Hunt of Kings Heath]

To ask Her Majesty’s Government why the public are not allowed to appeal against a decision to remove certain drugs from the Cancer Drugs Fund list of approved drugs.

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

My Lords, NHS England’s appeal process for the national cancer drugs fund list centres on whether due process is followed with regard to decisions to add or remove drugs from that list. NHS England considers that third parties not involved in the application process, including patients, would not be in a position to make a judgment about whether due process had been followed.

[Lord Hunt of Kings Heath (Lab)]

My Lords, the cancer drugs fund was set up as a way of getting round NICE’s refusal to approve the use of a number of drugs by NHS patients. Would the noble Earl concede that NHS England has, essentially, set up a new rationing tool to exclude patients from drugs which had originally been agreed through the cancer drugs fund? Last Thursday, NHS England listed 19 drugs no longer available. Although the noble Earl said that the process is around the procedure used, does he not agree that in the end this impacts directly on patients who can no longer get those 19 drugs? Why should not patients be involved in an appeal process? How does the mantra “No decision about me without me”, which the Government have set for the NHS, fit the lack of patient involvement in these decisions?

[Earl Howe]

The noble Lord is right that NHS England has just gone through a reprioritisation process. There are three important things to observe in that process. NHS England has assured the department that no patient whose treatment is currently being funded through the fund will have funding withdrawn, as long as it is clinically appropriate that they continue to receive that treatment. In addition, no drug will be removed from the fund where it is the only therapy for that condition. Clinicians will still be able to apply for individual patients to receive a drug not on the national list on an exceptional basis. We have seen through experience that many of those applications succeed.

[Lord Walton of Detchant (CB)]

Would the Minister accept that NICE is faced with an extremely difficult problem in continually having to consider the efficacy and affordability of new cancer drugs as they emerge in a National Health Service under financial constraint? Would he also accept that another major problem is emerging in relation to the orphan and ultra-orphan drugs now coming on stream for the treatment of rare diseases, which are equally deserving in many respects? How does he feel that the next Government—however they are constituted—will be able to consider this increasingly serious problem?

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[Earl Howe]

My Lords, the noble Lord is right that there is a particular issue around the appraisal of new cancer drugs. That is why NHS England, the Department of Health, cancer charities, NICE and the Ethical Medicines Industry Group, as well as the ABPI, are working together currently as part of a new working party tasked with finding the best way to get new cancer drugs appraised and commissioned for patients. A number of proposals have been looked at to reach an integrated process between NHS England and NICE which results in clear and final decisions on baseline commissioning of chemotherapy drugs.

[Baroness Brinton (LD)]

My Lords, given the good news that the Minister just gave us about the working group looking at the future of some of these complex drugs, and the whole policy about “No decision about me without me”, would it not be sensible to have patients’ advocates, such as Prostate Cancer UK, able both to present and to appeal the case for a drug? It seems bizarre that this is the one area where there is no input of anybody other than the committee making the decision.

[Earl Howe]

I differ slightly from my noble friend on this point. I think that the key determinant for the reprioritisation process has to be clinical input, and that is indeed what happened. It is necessary to have as objective a process as possible when looking at how to reprioritise a cash-limited fund of this kind.

[Lord Hunt of Kings Heath]

My Lords, if I could come back to the noble Earl, the NICE processes make sure that patients are involved in every stage of the process. I do not understand why there is a difference between the NICE process, which is incredibly thorough and well regarded internationally, and this hurried rationing tool used by NHS England, which is more about its own budgetary problems than an effective solution to these issues.

[Earl Howe]

My Lords, I do not agree about the hurried rationing tool, as the noble Lord puts it. The tool used by NHS England is one that has been tried and tested, and accepted and shared with the pharmaceutical industry. The point here, as I said in my original reply, is that there is due process here. NHS England believes that any patient group or third party not involved intimately with that due process would not be in a position to make a judgment about whether the process had been followed correctly.

NHS: Health and Social Care Act 2012

Earl Howe Excerpts

Monday 16th March 2015 Lords Chamber

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

My Lords, the Act created the architecture within which NHS England’s innovation, health and wealth strategy is being implemented. As part of this, the innovation scorecard shows a real improvement in the uptake of certain NICE-approved innovations. The NICE implementation collaborative has also resulted in increased national spend on key technologies. The department and NHS England have commissioned an independent evaluation of innovation, health and wealth, which is expected to be completed by winter 2017.

[Lord Wills (Lab)]

I am grateful to the noble Earl for that Answer, but does he recognise that there is a significant gap between those fine words and what is actually happening on the ground? To take the case of giant cell arteritis, for example, 2,000 to 3,000 people go blind needlessly as a result of it. I hope the House will indulge me for a few seconds if I set out this important example. The condition is easily treatable. Professor Dasgupta, in Southend, has pioneered a fast-track pathway for diagnosis and treatment which has reduced the numbers of people going blind by two-thirds. Rolled out nationally, that would save thousands of people every year from going blind. It would save them and their families needless misery and suffering and would save the taxpayer hundreds of millions of pounds every year.

In January, Sir Bruce Keogh, the medical director of NHS England, wrote to me and said that this “represents a new way of doing things which is better and costs no more. We must learn from such innovative examples”. Is the Minister aware of what has happened since he wrote to me? Thousands of people have gone blind—

[Lord Wills]

Noble Lords opposite ought to listen to this; the people who suffer most from this are elderly and it is very much in their own interests to listen. Nothing has been done to roll out this innovative pathway. Can the Minister not accept that having a few guidelines is simply not good enough? Can he not accept that since the Health and Social Care Act came in, there has been no good example of good practice in this area?

[Earl Howe]

My Lords, I recognise the noble Lord’s close interest in this important topic. We recognise that early diagnosis and treatment of giant cell arteritis is extremely important to preventing sight loss. I am aware of the interest in the Southend GCA pathway developed by Professor Dasgupta. I recently raised the issue of the pathway with NHS England and understand Sir Bruce Keogh will be writing to the noble Lord very shortly about this. As he may be aware, the Royal College of Physicians has produced a best practice guideline on the diagnosis and management of GCA, which Professor Dasgupta has helped to develop. That is good progress and provides a very good framework for disease assessment, immediate treatment and urgent referral.

[Lord Hunt of Kings Heath (Lab)]

My Lords, the noble Earl has been answering health Questions for nearly five years now with courtesy and skill. How does he feel, as possibly the sole apologist, other than Mr Andrew Lansley, for the Health and Social Care Act 2012? What is his response to the independent King’s Fund, which described the Act, which the noble Earl piloted through this House with great skill, as having an impact that was both “damaging and distracting”? Is that not the real answer to my noble friend? The reason he has identified a problem and a shambolic decision by NHS England is that we have a shambolic organisation, which this Government are responsible for.

[Earl Howe]

If I had to single out two or three things from that Act which have been of enormous and incomparable benefit, one would be the enhancement and promotion of clinical leadership within the system, which has happened as a result of the creation of clinical commissioning groups. The second is the creation of Public Health England and the transformation of public health delivery in this country. The third is the separation of elected politicians from the running of the health service, which has enabled the NHS to free itself up to look at innovation in a more creative way

[Baroness Greengross (CB)]

My Lords, does the noble Earl not agree that if specialist secondary clinicians worked a more significant part of their time in primary settings in the community, this would be a welcome innovation across the country?

[Earl Howe]

I do agree. That idea is being taken up by a number of the vanguard sites, which are looking at the new models of care that were foreshadowed by the five-year forward view. It is, I think, the shape of things to come.

[Lord Brooke of Alverthorpe (Lab)]

My Lords, it would be churlish not to accept the noble Earl’s remarks that there have been some changes which have been beneficial. But does he not agree that the public at large recognise that overall there have been many downsides? Many of those downsides have been hidden and continue to be hidden by politicians, who refuse to release the risk register that was drawn up prior to that Act going through.

[Earl Howe]

My Lords, we are back to that one. As the noble Lord knows, the strategic risk register for the department is something that we are entitled to keep confidential, as all Governments have done. The Cabinet took the decision that the transition risk register should remain confidential because of the principle of the need to preserve private space for civil servants when advising Ministers.

[The Countess of Mar (CB)]

My Lords, some months ago I led a debate on the lack of clinical governance between health and social care. I was promised a meeting with the noble Earl by the noble Baroness, Lady Jolly. One of the big problems is the fact that there is no governance framework between health and social care, and as a result a lot of people are falling into a black hole. Can the noble Earl say when that meeting will take place?

[Earl Howe]

My Lords, I should be more than happy, as I always am, to meet the noble Countess. I am sorry if there has been a delay in that respect. I would be happy to talk to her one to one on that matter.

[Baroness Corston (Lab)]

My Lords, does the Minister accept that one of the—I hope unintended—consequences of the Health and Social Care Act has been the disastrous effect on the recruitment of GPs, the number of people going into the GP profession and the number of people leaving the profession or who have said that they will be retiring early? It was described to me recently as an impending car crash.

[Earl Howe]

My Lords, I think we all recognise that general practice is under unprecedented pressure but I would not attribute that to the 2012 Act; I would attribute it to the unprecedented rise in demand from patients. The NHS across the piece is busier than ever before and naturally that has an effect on morale. We are, however, taking steps to promote recruitment into general practice and to reduce the day-to-day burdens that are imposed on general practitioners.

Local Audit and Accountability Act 2014 (Special Trustees) Amendment Regulations 2015

Earl Howe Excerpts

Monday 16th March 2015 Lords Chamber

Moved by

[Earl Howe]

That the draft regulations laid before the House on 29 January and 3 February be approved.

Relevant documents: 22nd and 23rd Reports from the Joint Committee on Statutory Instruments. Considered in Grand Committee on 10 March.

Motions agreed.

Standardised Packaging of Tobacco Products Regulations 2015

Earl Howe Excerpts

Monday 16th March 2015 Lords Chamber

Moved by

[Earl Howe]

That the draft regulations laid before the House on 23 February be approved.

Relevant documents: 24th Report from the Joint Committee on Statutory Instruments, 29th Report from the Secondary Legislation Scrutiny Committee

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

My Lords, these regulations propose to introduce standardised packaging for tobacco products, which I believe to be an important public health measure. I pay tribute to all the noble Lords who campaigned for the introduction of these regulations—in particular the noble Baroness, Lady Finlay, the noble Lord, Lord Faulkner, and my noble friends Lady Tyler and Lord McColl, who all pressed for it during the passage of the Children and Families Bill in 2014.

Tobacco use remains one of our most significant public health challenges. Smoking places an enormous strain on the NHS, and is a significant driver of health inequalities. More people die from lung cancer in the UK than any other form of cancer and almost nine in 10 of all lung cancers are caused by smoking. For this reason, the Government have prioritised action to reduce smoking rates, which is why we published the tobacco control plan for England in early 2011.

We have looked carefully at the evidence and it shows that introducing standardised packaging is highly likely to bring important public health benefits, primarily by reducing the appeal and attractiveness of tobacco packs, especially to children and young people, and improving the salience of health warnings on packets. Packaging and branding are promotional tools used to attract consumers. Since the ban on advertising tobacco products in the UK, packaging has become a key avenue for the promotion of tobacco, and it is notable that one tobacco company referred to tobacco packaging as its “mobile billboard”. Opponents of standardised packaging claim that there is no evidence that it will bring about a reduction in smoking prevalence or the resulting health benefits. In fact, Sir Cyril Chantler, who reviewed the evidence, concludes that,

“it points in a single direction”,

and that there is no,

“convincing evidence pointing the other way”.

Let me first outline what the regulations propose, before discussing the wider issues. The Children and Families Act 2014 gives the Secretary of State powers to regulate the retail packaging of tobacco products. In November 2013, Health Ministers commissioned Sir Cyril Chantler, the eminent paediatrician and medical researcher, to undertake an independent review into whether standardised packaging would be likely to have an effect on public health, in particular in relation to children. Sir Cyril’s thorough and well considered report, published in April 2014, concluded that standardised packaging would be highly likely to have a positive impact on public health.

On the publication of the review, my honourable friend Jane Ellison, Public Health Minister, announced that the Government were minded to proceed with standardised packaging, subject to a final consultation. There has been extensive engagement and consultation with the public and stakeholders on this proposal, including two public consultations—one in 2012 and a further consultation in 2014. The Department of Health has carefully considered all responses to both these public consultations and the wider points that they raise.

These regulations propose to standardise the retail packaging of all cigarettes and hand-rolling tobacco. Cigars and pipe tobacco are not currently covered by the regulations. The regulations specify mandatory colours for those parts of the packaging that are not taken up by health warnings or duty marks. The outside of packs will have to be a uniform dull brown and the insides plain white. The brand name of the product may appear but must be in grey with a fixed size and typeface. This means, in effect, that no branding will be allowed except for the brand name. The regulations also specify that individual cigarettes must be plain white with a cork effect or white tip, but will allow the brand name to be printed in small text. An illustration of what a standardised cigarette packet could look like has been published, which noble Lords may wish to see.

The draft regulations will also implement certain packaging-related requirements from the European tobacco products directive that was agreed last year, such as the shape, material and minimum content of packs. The remainder of the tobacco products directive will then be implemented through separate regulations, which the Department of Health will be consulting on shortly. Standardised packaging would be a UK-wide measure. Public health is a devolved matter but Scotland, Wales and Northern Ireland have provided the necessary consent for the regulations to extend to their Administrations.

Looking wider than the UK, there is international momentum towards introducing standardised packaging. Although the only country to have implemented standardised packaging is Australia, many other countries are taking positive steps towards legislating, including Ireland, France, Norway, New Zealand and Turkey. The Australian Government were clear when introducing the measure that they expected the benefits of standardised packaging to be “generational” and come in the longer term. The Cancer Council Victoria has recently reviewed the available Australian evidence and data so far, and concluded:

“Prevalence of smoking in Australia fell dramatically between 2010 and 2013”,

and that,

“plain packaging is likely to continue to contribute along with Australia’s other tobacco control policies to further reducing the prevalence of smoking in Australia”.

There have been some suggestions that standardised packaging may lead to growth in the illicit tobacco market. I want to reassure noble Lords that this issue has been considered carefully across government. HMRC leads on reducing the size of the illicit tobacco market and has undertaken a detailed assessment of the potential impact of standardised packaging on the illicit trade of tobacco, which was published and put into the Library in February. The HMRC report concluded:

“We have seen no evidence to suggest the introduction of standardised packaging will have a significant impact on the overall size of the illicit market”.

Some also have concerns that this will be the start of a slippery slope towards standardised packaging for other products, such as unhealthy foods or alcohol. I want to be absolutely clear that the Government have no intention to extend standardised packaging to any product other than tobacco. Tobacco has been treated uniquely in regulatory terms before, as it is a uniquely harmful consumer good. All smoking is addictive and harmful to health, and half of all regular smokers are eventually killed by smoking-related illness. This is not true for other consumer products.

I understand that some noble Lords will, rightly, have concerns with regard to the potential legal implications of introducing standardised packaging. Let me be clear that thorough consideration has been given to such concerns. We know that the tobacco industry is likely to challenge this measure should the regulations be made, as it has with other tobacco control legislation. Threats of legal action have already been made by tobacco companies. However, we believe that these regulations are a proportionate and justified response to a major public health challenge, and will be defensible in the courts. We cannot let the vested interests of the tobacco industry control the public health agenda, and we will defend public health legislation from legal action.

Smoking remains a critical public health concern. Smoking is an addiction, largely taken up in childhood and adolescence. The choice to smoke is not like other choices and is often not made as an adult decision. Research included in the Chantler review shows that around 600 children between the ages of 11 and 15 start smoking every day in the UK. It is crucial that we do all we can to reduce that number. We also need to do all that we can to assist those already addicted to quit; and I believe that standardised packaging will contribute to doing so. The introduction of standardised packaging is likely to deliver important public health benefits and, as part of a comprehensive tobacco control strategy, will bring us a step closer to a smoke-free generation. I beg to move.

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[Lord Hunt of Kings Heath]

My Lords, I sense that the House is ready to come to a view on this very interesting matter, and I am looking forward to the response of the noble Earl, Lord Howe. I should start by declaring my interest as president of the Royal Society for Public Health.

Not surprisingly, noble Lords will know that I support the regulations, for which the Labour Party campaigned vigorously. The noble Lord, Lord Stoddart, is right that they come on the back of a successful amendment in your Lordships’ House to ban smoking in cars when children are present. Like the noble Earl, I pay tribute to the noble Lord, Lord Faulkner, the noble Baronesses, Lady Tyler and Lady Finlay, and the noble Lord, Lord McColl, for their outstanding work on this issue in your Lordships’ House.

I have some questions to put to the noble Earl, Lord Howe, in relation to the effectiveness of the measure, following the debate. That is the fair test that we need when reaching a decision. First, can the noble Earl confirm that opinion polls have shown very strong support among the public for this policy? Does he agree with me that, if we look back at the measure we passed in relation to smoking in cars with children present, again the public showed enormous support for the action that was being taken? It is not as if we have an authoritarian measure, imposing a sort of public-health view on the public; what we have here is a sensible measure that the great majority of people in this country support.

I turn now to the evidence. I listened with care to the comments of the noble Lord, Lord Naseby. Does the noble Earl stand by the evidence contained in the impact assessment published with the Explanatory Memorandum? Is it his view that, far from what the noble Lord, Lord Naseby, said, the evidence is clear about the Australian experience so far? Industry leaders have talked about market decline in Australia. On a point made by the noble Lord, Lord Walton, I refer to Sir Cyril Chantler. He may not be a marketing expert, but, goodness me, he is a man of enormous reputation in his ability to sift evidence, so can the noble Earl confirm that Sir Cyril Chantler took a highly dispassionate view on this issue? He made himself available to people on all issues. It is not an emotional report; it is a dispassionate, weighing up of the evidence.

On the issue of illicit trade, can the noble Earl confirm that the HMRC concluded that standardised packaging is not likely to have a significant effect on that? In answer to the point raised about the paragraph in the assessment, is his reading of it that, on balance, it is “very unlikely” to have an impact on illicit trade? The words, “very unlikely” mean that obviously there is a small percentage chance that it might not. That is my reading of that paragraph. Will he confirm that I am right about that?

As for the view of the noble Viscount, Lord Falkland, that because it is legal we should therefore not place any controls around it, I fail to understand the argument. Driving is legal, but we do not recoil from setting speed limits. There is general support for seat belts. Is that not the same issue? It is a legal activity, but we are right to place constraints on it to safeguard people from its worst effects.

On whether the packaging industry will be hit by the change to plain packaging, can the Minister confirm that cigarette packaging accounts for less than 5% of all packaging cartons manufactured in the UK—and, of course, packs will still be required in future? Perhaps he can then address points made about questions asked in the other place that were not answered. There is a question about the process and timetable to be followed once the regulations, if accepted by your Lordships’ House, are put in place.

The question of enforcement was raised today. I understand that several local authorities have advocated the need to ensure that trading standards officers are equipped and trained to implement the measure. That is clearly important, and perhaps the Minister can say something about the programme by which the Government intend to help local authorities once the regulations come into law.

My view is that the noble Earl, Lord Howe, in his speech today, in the regulations, in the Explanatory Memorandum and in the impact assessment has made a very powerful case for why the regulations should be passed. I sincerely hope that the House will listen to that and pass the regulations.

[Earl Howe]

My Lords, this has been a very powerfully argued debate. I am grateful to those noble Lords who have welcomed the regulations for the many supportive points that they have made. I also thank my noble friend Lord Naseby for setting out his objections and concerns with his customary clarity and courtesy. Several noble Lords have already done part of my job for me in responding to my noble friend’s critique, but I believe it to be incumbent on me to address directly all the matters that he raised, as well as the questions posed by other speakers.

I turn to the issue of the illicit trade and the evidence from Australia. Contrary to what the tobacco industry would have people believe, the evidence from Australia does not show an increase in the illicit market in that country following the introduction of plain packaging. There have been a number of criticisms of the tobacco-funded reports on that issue. It is therefore useful to consider the data provided from official Australian government sources. Official data from Australia on the use of illicit tobacco show a drop in those aged 14 years and over currently smoking illicit tobacco following the introduction of plain packaging. From 6% using illicit tobacco in 2007, the figure dropped to 5% in 2010 and then to under 4% in 2013—after plain packaging had been introduced.

A study published in BMJ Open analysed data from smokers before, during and one year after the introduction of plain packaging in Australia. The proportion of smokers reporting current use of illicit tobacco did not change significantly after plain packaging was introduced. I assure the House that the Government have looked very carefully at the potential impact on the illicit market. Tackling tobacco smuggling is a government priority. I can tell the noble Lord, Lord McFall, in particular, that, due to the fantastic work of HMRC and others, there has been a long-term decline in the tax gap for tobacco products over the past decade. The potential impact of standardised packaging on the illicit trade was considered extensively by HMRC, Sir Cyril Chantler, the Select Committee’s inquiry on smuggling, the Trading Standards Institute and RUSI. They all concluded that standardised packaging will not have a significant impact on the illicit market. HMRC has undertaken a detailed assessment of the potential impact of standardised packaging on the illicit market, which is the most comprehensive and reliable information available. Its assessment is that:

“We have seen no evidence to suggest the introduction of standardised packaging will have a significant impact on the overall size of the illicit market or prompt a step-change in the activity of organised crime groups.”

The Trading Standards Institute, which has extensive experience of tackling illicit tobacco at retail level, said in its consultation response that it,

“is aware that the tobacco industry regularly argues against standardised packaging for the reason that it will inevitably lead to an increase in the illicit tobacco trade. The Institute does not regard this as a valid argument”.

My noble friend referred to the system known as Codentify. That system is a voluntary security feature developed and controlled by the tobacco industry. We know that HMRC is starting to make use of the system to assist in identifying illicit tobacco. We are working across government to ensure that anti-counterfeit systems that are useful to HMRC and other enforcement agencies now and in the future can continue to feature on standardised packs. That will require such anti-counterfeit systems to be put on to a statutory footing.

My noble friend suggested that the prevalence of smoking had increased in Australia and that standardised packaging had not helped. Australian government figures show that smoking prevalence is in fact at an all-time low since the implementation of standardised packaging, with a 15% drop between 2010 and 2013. This change is likely to be attributable to the cumulative effects of a range of policies, including standardised packaging.

My noble friend also referred to the study by Kaul and Wolf apparently showing that smoking had increased among teenagers. The Kaul and Wolf report was funded and its release was closely directed by Philip Morris International, part of the tobacco industry. It was based on a specific survey of population smoking that is not intended to provide reliable estimates of smoking among teenagers, and the sample size was very small. It also compared figures immediately before and after implementation, and the effects of standardised packaging are more likely to be gradual. It is not a reliable study, we suggest, from which to draw any conclusions.

My noble friend Lord Blencathra urged the Government to wait for more evidence from Australia. He may like to know that studies in Australia have found that smokers buying standardised packets reported being more likely to prioritise quitting than smokers using fully branded packs. Calls to quit lines have increased. Smoking has decreased in outdoor cafes and fewer packs are being displayed on tables.

What has happened to tobacco sales in Australia? There have been suggestions that sales have gone up. Sales of tobacco can be measured in many different ways—sales by manufacturers to wholesalers, wholesalers to retailers or by retailers to consumers. Different pictures of sales emerge depending on the source of the data and the timeframe. In fact, official government data from Australia suggest that a continuing decline in per capita consumption of tobacco products has taken place. Commonwealth Treasury figures show that excise and customs clearances of tobacco declined by 3.4% in 2012-13, and that is generally regarded as the most reliable indicator of population sales.

I turn now to the print industry and my noble friend’s complaint that more time should be given to the print industry to enable a proper lead-in period. Standardised packaging is not a policy that has been sprung on the print industry. It has been under discussion since 2008 and two public consultations have been held on the subject, as I mentioned earlier. The regulations would come into force in May 2016, which provides the print industry with a lead time of over a year. I confirm to my noble friend Lady Tyler that the regulations will be implemented at the same time as the European directive is transposed in May 2016, so the industry does not have to undergo two changes to its manufacturing process.

The previous changes to tobacco packaging, such as the requirement for picture warnings in 2008, showed that a 12-month period in which to sell through old stock is appropriate and that stock sells through more quickly than one year. In answer to my noble friends Lord Naseby and Lord Blencathra, it is not true to say that standardised packaging will make it easier to copy packs and therefore make things easier for counterfeiters. Standardised packaging would remain complex to counterfeit. The packs will continue to feature large and complicated to reproduce picture health warnings and will retain all the security features currently on packs, including covert anti-counterfeit marks. The European Union directive includes provisions on the printing of labels. As I said, we have given very careful and measured consideration to that. We believe that the synchronised introduction of the provisions in the directive with the coming into force of these regulations is a sensible course.

Mention was made of intellectual property issues. As I said earlier, we have given very careful and measured consideration to all legal aspects of the policy, and this includes intellectual property aspects. These regulations regulate the use of tobacco branding, which includes trade marks. I emphasise that we regard tobacco as a unique consumer product in this context because it is a uniquely harmful consumer product. For the record, we do not consider that these regulations breach intellectual property laws or our international obligations in relation to trade marks.

I listened with care to my noble friend Lord Geddes, who argued from experience of his National Service that plain packs would not deter smoking. He referred to “Blue Liner” cigarettes, which I was interested to hear about. However, there are several key differences with regard to our proposals. First, the regulations we are considering mandate health warnings, which did not appear on “Blue Liner” cigarettes. Secondly, there is the colour of the packaging. Our regulations take into consideration the extensive market research the Australian Government undertook to determine the most effective designs for standardised packaging. Of the eight different colours tested during the research, dark brown packaging was the least appealing and thought to contain cigarettes most harmful to health. After carefully considering the research, our regulations adopt the same dull brown colour as the packs required in Australia.

The noble Viscount, Lord Falkland, referred to the possibility of unintended consequences. We believe very firmly that the benefits of these regulations far outweigh any of the unintended consequences that might come from introducing standardised packaging. In some cases, we are not convinced that certain predicted unintended consequences are anything more than scare stories. The department has run two consultations on standardised packaging, which contributed to our understanding of all the relevant factors in making our decision.

My noble friend Lord Blencathra queried the Explanatory Memorandum. I think he might have been referring to the impact assessment, which was rated green by the Regulatory Policy Committee, meaning that it is fit for purpose.

The noble Lord, Lord Hunt, asked about public support for standardised packaging. Multiple surveys have shown that the public support it. A YouGov poll in spring last year, with a representative sample of 10,000 people, found that 64% of adults in England supported standardised packaging while 11% opposed it. Even among smokers, more people were in support of or neutral towards standardised packaging than opposed it. After the implementation of standardised packs in Australia, support for the policy increased from 28% to 49% among smokers. Survey data from Australia show that more smokers approve of the policy than oppose it.

The noble Lord, Lord Stoddart, made a point that I have heard him make powerfully before—that alcohol is, in fact, the most addictive and harmful drug, not tobacco. I just say to him, as mentioned in my speech, that all smoking is addictive and harmful to health, and half of regular smokers are eventually killed by smoking-related illness. That is simply not true of other consumer products such as alcohol. Tobacco is being treated uniquely in regulatory terms because it is a uniquely harmful consumer good. All smoking is addictive and harmful to health. Therefore, to be absolutely clear, we see the introduction of standardised packaging as a unique approach to tackling smoking and its appalling effect on public health. It fits within a comprehensive tobacco control policy.

We are proud that smoking rates are the lowest ever recorded in this country, and my noble friend Lord Naseby was right to point that out. However, we cannot rest on our laurels. In other parts of the world we have seen that if Governments take their foot off the pedal with tobacco control, smoking rates can go up. For the good of public health, we want to continue our policy action to see smoking rates continue to fall, which is why I once again commend these regulations to the House.

[Lord Naseby]

My Lords, I should like, first, to thank my noble friend on the Front Bench for addressing the four points that I raised and were vital to be addressed. I shall comment on only two short matters because I sense that the House wants to move on.

My first comment is on youth smoking, which a number of Members raised. One may dispute this or not, but the facts are that the Australian Institute of Health and Welfare has stated that youth smoking rates have not declined as a result of standard packaging; in fact, they are at a seven-year high. Secondly, there is the matter of illicit tobacco consumption, which is the issue that worries me most. One has only to go round a building site in the United Kingdom today. I recently did so and checked a bit. Illicit tobacco is being offered on many building sites in this country; it is costing the Revenue and genuine companies a great deal. Not only that, when we look at Australia specifically, which we have done this evening, we see that by mid-2014 in that country illicit tobacco consumption stood at an unprecedented 14.7% of the market—25% higher than it had been in 2012. Whatever anyone says, as far as the industry is concerned—after all, it knows exactly how many cigarettes are produced and sold—that is a crucial area, and a crucial area of public health. Unless someone does something about that, we may well find increasing numbers of counterfeit cigarettes imported into this country. That will have an effect on public health because they kill even quicker than the genuine ones do.

I am grateful to all those who have taken part. I particularly thank my noble friends who have supported me this evening. Some home truths have been spelt out by the noble Lord, Lord Stoddart, the noble Viscount, Lord Falkland, the noble Earl, Lord Erroll, and a number of other colleagues who have supported me. The key issue, however, is a little wider than the tobacco industry, because what this Motion does, if it goes through—I imagine that it may well do so—is totally to undermine intellectual property rights, which are the very foundation of our modern capitalism. Intellectual property rights are fundamental to every business and defend a company from rogue competition—wherever it may come from—and, in my view, from totally misguided Governments on occasion.

I have to decide whether to divide the House. I take note of the fact that in another place nearly 25% of that Chamber voted against the Motion. I sense this evening that about 25% are against this Motion and I thank that 25% for the support they have given me. Nevertheless, it does not seem to me to be terribly productive for us all to march through the Lobbies and for me to get only 25% of the vote, or thereabouts, so with the leave of the House I will withdraw my amendment.

Health: Deprivation of Liberty Safeguards

Earl Howe Excerpts

Monday 16th March 2015 Lords Chamber

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

My Lords, I am very grateful to the noble Baroness, Lady Finlay, for raising this important issue for debate and for her authoritative speech, alongside those of the noble and learned Lord, Lord Hope, and the noble Lord, Lord Bradley. I also very much appreciated the contributions from the noble Baroness, Lady Hollins, and my noble friend Lord Howard of Lympne.

Since the Supreme Court judgment in the case of Cheshire West on 19 March 2014, social care and NHS providers have been working hard to understand the implications for their service users and to plan a response that prioritises the well-being of all the individuals for whom they care. I pay tribute to their efforts and the efforts of the local authority teams responsible for assessing and authorising any deprivation of liberty.

The phrase “deprivation of liberty” arouses a lot of emotion, some of it unhelpful. It can feel intimidating, perhaps even stigmatising. The phrase derives from the European Convention on Human Rights, which stipulates that, when an individual is subject to a deprivation of liberty, they must be provided with legal safeguards and a legal route of appeal. In England, for those who lack capacity in hospitals and care homes, this is provided by the system known as the deprivation of liberty safeguards, or DoLS. Despite the negative connotations of the phrase, a deprivation of liberty can be entirely appropriate, if it is in the best interests of the individual concerned and an appropriate and proportionate approach to providing necessary care and treatment. An example would be a dementia sufferer who requires 24-hour care and who would be prevented from leaving a care home because he does not know where he is going, does not know how to safely cross a busy road and who has a history of endangering himself when he does leave. This could be an entirely appropriate deprivation of liberty.

The noble Baroness referred to the Supreme Court judgment, as did noble Lords. The judgment clarified the test for a deprivation of liberty. There are three parts: first, that the individual lacks capacity to consent to the arrangements for their care; secondly, that they are under continuous control and supervision; and, thirdly, that they are not free to leave. Many have welcomed the Supreme Court judgment for emphasising the universal nature of human rights. As for the scope of the judgment, about which the noble Baroness asked me, I hope that she will excuse me for not attempting to interpret case law here and now. However, she may be interested to know that, by the end of this month, the Law Society, commissioned by the department, will publish extensive guidance on the matter.

How we regard those who lack capacity is a cultural challenge. A Select Committee of this House recognised that the health and care system, and society at large, have a way to go to implement the Mental Capacity Act, of which DoLS are part. It noted the tendency of the health system to act in a paternalistic fashion—that of “doctor knows best”. Of course, all health and care professionals want what is best for the service user, but this does not mean that health and care settings can be exempted from the legal safeguards that all of us are entitled to and which ensure that our human rights are protected.

Let us be clear on another point as well: DoLS do not cause a deprivation of liberty. The deprivation of liberty results from the nature of the care and treatment package. As I indicated, the restrictions on freedom of movement and choice that constitute a “deprivation of liberty” may be entirely justifiable and necessary. DoLS exist to ensure that this is the case—in other words, to assess the individual’s situation and ensure that the deprivation of liberty really is necessary—and, if not, to instigate the steps to ensure the person is provided with more freedom. Therefore, DoLS, despite the sometimes negative attention, are positive things that promote the equal human rights of the individual.

The key question, then, is this: are the current deprivation of liberty safeguards the best they can be? Do they allow the individual’s human rights to be protected, but, at the same time, can they be implemented at a population level so that all individuals have their rights protected? As has been mentioned, following the Supreme Court judgment there has been a great surge in DoLS applications: 90,000 in the nine months following the judgment. This represents a tenfold increase. Many local authorities are struggling to process these; there is a significant backlog of applications. It seems clear to the Government that the current DoLS system was designed when deprivation of liberty was seen to be a fairly rare occurrence. The law—perhaps even society—has now moved on.

The Government believe that the DoLS system may not be the best way to provide safeguards at a population level. That is why we have secured the services of the Law Commission to fundamentally review the legislation and propose a new system that covers care homes, hospitals and community settings. This summer, the Law Commission will produce a detailed public consultation paper on future options.

Meanwhile, the Government have been taking steps to assist providers. We have instigated more frequent data collection to monitor better the impact of the Supreme Court judgment. We have issued guidance notes to reassure and to inform. We have significantly cut the number of standard forms associated with making a DoLS application from 32 to 13. We have commissioned extensive guidance as to what now constitutes a deprivation of liberty, which will be published within the next two weeks.

The noble and learned Lord, Lord Hope, and the noble Lord, Lord Bradley, referred at some length to the backlog of applications. We are aware of this. ADASS has produced some helpful guidance that assists local authorities to prioritise the applications for those most at risk. The reduction in the number of forms will also reduce the administrative burden, allowing applications to be processed more quickly. However, the backlog is concerning as it indicates that some people may not be benefiting from the safeguards. We are working more closely with local government and are closely monitoring the situation.

There is a positive element here: because of a clarification by the Supreme Court, tens of thousands of vulnerable individuals are having their care scrutinised. There is work to be done in responding to the judgment, but as I have said, we will work closely with local authorities to get the safeguards provided to as many as possible. I can tell the noble Lord, Lord Bradley, and the noble Baroness, Lady Finlay, that the Department of Health has provided local authorities with £35 million in 2014-15 for their MCA/DoLS responsibilities.

The Government, together with the Care Quality Commission and the Association of Directors of Adult Social Services, have stressed over the last year the importance of a proportionate response to the Supreme Court judgment that puts the individual’s best interests first. DoLS will become a paperwork exercise only if it is applied as a blanket measure—for example, assessing all individuals in a ward together and not considering each patient’s individual circumstances. If providers can demonstrate that they have an understanding of the Supreme Court judgment, that they have policies and procedures in place to ensure that restrictive care practices are minimised, and that they are doing their very best to make DoLS applications where appropriate, then we do not expect that they will be unfairly penalised.

The noble Baroness, Lady Finlay, asks whether decisions are properly scrutinised and whether advocates or relatives are asked to feed in to those decisions. Government officials are in regular contact with those working on the front line. So far, it seems that assessors are keeping to the ethos of the Mental Capacity Act—namely, they are not treating this simply as paperwork. The DoLS forms were subject to consultation with a range of practitioners. We are still taking on board comments on the forms and we welcome suggestions for improvement.

The noble Baroness, together with the noble Baroness, Lady Hollins, referred to the difficulty posed by delayed discharges. The Government have recently done a lot of work to speed up appropriate discharges from hospital settings. It is hard to be conclusive about the impact of DoLS here, but it is reasonable to assert that in some cases a DoLS application could help discharges, identifying, as it may, a least restrictive option outside of hospital.

The noble Baroness, Lady Finlay, asked about consent—whether it had to be in writing and the timeliness of the consent. It is important that any wishes that the person made known when they had capacity are considered when decisions are made at a later date when they may lack capacity. This would apply, however those wishes were expressed. However, having something in writing means that the wishes are clear and not second or third hand, and therefore that form of consent may hold more weight. In terms of timeliness, any medical professional should always give consideration to whether a statement of wishes or an advance decision reflects the person’s current wishes or feelings. As these may have changed over time and/or in the light of a change of circumstances, it is important that family members and carers are consulted on the current validity of such decisions.

The noble and learned Lord, Lord Hope, referred to long-term placements as compared to restrictions imposed on a temporary basis. It is an important principle that any deprivation of liberty authorisation must be for the shortest time needed to achieve the desired outcome. Currently, we have essentially a one-size-fits-all model for DoLS. However, the Law Commission will be considering whether a more flexible model might be better.

The noble and learned Lord, Lord Hope, and my noble friend Lord Howard questioned whether there might be changes to the law that we could make more quickly to help alleviate the pressure on the system pending the Law Commission report. I know that some partners have called for rapid legal changes. One example is increasing the time for which hospitals can authorise a deprivation of liberty—that is, instead of the current seven days, perhaps 14 or 21 days. Another suggestion that I have heard is to change the requirement for local authorities to process applications within 21 days by extending that period. Although I sympathise with local authorities and hospitals because of the pressures they are under, the counterargument that I know many others make is that, with something as important as fundamental human rights, government should not weaken the safeguards. My own belief is that the changes proposed should be considered in the round with the wider changes that the Law Commission is currently considering so that we do not inadvertently cause negative or unhelpful side-effects.

The noble Baroness, Lady Finlay, questioned whether there should be a test case—and, if so, who should do it and where the funding should come from. In terms of a test case to take to the Supreme Court, the Government are not yet minded to force this issue. The majority of partners that officials have spoken to support the Cheshire West judgment. We understand that the implications are many and that they vary by settings. As such, the Government have provided, where possible, guidance on specific settings, such as those that the noble Baroness, Lady Finlay, referred to relating to hospices. That guidance has, I think, been very well received.

I understand the noble Baroness’s concern about the implications of the judgment for different settings, particularly those where the fewest number of DoLS applications have traditionally come from. She has, as we all acknowledge, considerable expertise in this area and I would be grateful and pleased to facilitate a meeting with the officials leading this work if she would find that useful—and, indeed, with the Law Commission team looking at future legislation. It is vital to have the support of medical professionals for any future system to replace the current DoLS system.

I have not addressed all the points made by noble Lords this evening. If I am able to add to the comments that I have made, I would be happy to do so in writing. Suffice it to say, for now, that the Supreme Court judgment has challenged us to think about how we regard the most vulnerable members of society. The ultimate test is for those of us fortunate to have full capacity to put ourselves in the place of those who do not. If we were prevented from leaving a hospital ward—if we could exercise no choice over our day-to-day activities, over whom we met and when we met them—I wonder how we would feel. I suspect that we would expect at the very least to have a legal route of redress. Those who lack capacity deserve and are entitled to exactly the same. The challenge now is to deliver these rights in a busy and pressurised health and care system upon which demand continues to rise.

House adjourned at 8.03 pm.

Health and Social Care (Safety and Quality) Bill

Earl Howe Excerpts

Friday 13th March 2015 Lords Chamber

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

My Lords, I shall first address a concern that several noble Lords have flagged up most prominently: that the regulations are not sufficiently clear that the duties that we are talking about here are duties on providers rather than individuals. The regulations apply to registered persons. Schedule 1 to the Interpretation Act 1978 makes it clear that in legislation “person” includes not only natural persons but legal persons, such as companies. Under the Health and Social Care Act 2008, the registered persons are providers, not individual members of staff.

The noble Lord, Lord Hunt, asked why the clause does not list the bodies covered by the Bill. The clause amends Section 20 of the Health and Social Care Act 2008. It is the 2008 Act which sets out who the regulations apply to. They apply to registered persons who, under the Act, are the providers, not individual staff, as I said. He also asked whether almost all providers would be likely to be in breach of the regulations for one reason or another. The clause amends the Secretary of State’s regulation-making powers. It would not by itself impose requirements on providers. Those requirements will be as laid down in the fundamental standards regulations, to which I shall come in a moment. On the specific example that the noble Lord gave, where a surgeon did not engage meaningfully with the WHO checklist prior to an operation, my answer is that that would be a disciplinary issue for the employer and/or the professional regulator, if it became known.

[Lord Hunt of Kings Heath]

That is an extremely helpful answer, but will it be made absolutely clear to employers in the guidelines to be issued alongside the regulations that they have not only a right to take disciplinary action but a duty to do so? If that is set from the centre, that will give a lot of authority to boards, which they sometimes feel that they do not have at the moment.

[Earl Howe]

That is a very important point, which I shall be happy to take away.

Amendment 1, tabled by the noble Lords, Lord Turnberg and Lord Warner, would replace the reference to “no avoidable harm” with “take steps to reduce” avoidable harm. I accept that in some settings regulated by the CQC, including the NHS, that phrase may better reflect the scale of what can be achieved. However, regulation by the CQC is not just about the NHS. In the case of some health and adult social care services, I believe that it is reasonable to strive to eradicate all avoidable harm. It is for that reason that I prefer the current wording. Yes, it is more ambitious, but its ambition contains an incentive to strive towards a continuous reduction of avoidable harm across all settings regulated by the CQC.

The amendment would also result in requirements on providers to monitor the steps they take to reduce avoidable harm and to train staff in the reduction of avoidable harm. That is clearly desirable, but I must question whether it needs to be a duty set out in primary legislation. The training of staff in reducing avoidable harm is important, and Section 20(3)(d) of the Health and Social Care Act 2008 already expressly provides for regulations to include requirements on the training of staff.

The fundamental standards regulations, to which I referred a minute ago, which were passed by this House in November and come into force in April, already meet the test of the Bill, and no change to regulations is required. The fundamental standards require that care and treatment is provided in a safe way for service users. They give the CQC power to take action against providers where a failure to take steps to provide care in a safe way results in avoidable harm.

The regulations are breached not whenever avoidable harm occurs, but where there has been a significant failure effectively to manage the risks of harm. They are clear that that involves assessing the risks and taking steps to mitigate them. They ensure that staff have the right skills and qualifications, that premises and equipment are safe and that medicines are properly managed. They also require providers to have systems in place to assess, monitor and improve the quality and safety of services.

Noble Lords have cautioned that the clause might lead to staff taking a risk-averse approach. The noble Lord, Lord Hunt, expressed the concern that it could encourage staff to lose sight of the patient and instead focus on covering up mistakes. I firmly believe that the reverse is the case. What it does is to underpin our efforts to strive for the very thing so strongly advocated by the noble Lord, Lord Turnberg: an open reporting culture where identifying errors helps organisations to improve the safety of care. Where providers take the steps to manage the risk to safety, front-line staff can focus on the needs of patients and service users, content in the knowledge that the environment in which they work promotes safety and quality.

Our debate up to now has perhaps given the erroneous impression that the fundamental standards are just about the systems and processes. They are not. They focus on the outcomes of care and treatment. The new regulations, which come into force in less than three weeks, place patients and service users at the heart of service provision. They require that treatment and care meet the needs of service users and reflect their preferences. They prohibit providers from providing care without consent. They also put in place a new duty of candour that requires providers to inform service users where there have been failings in their care.

In those ways, patients and service users are central to the fundamental standards. Clause 1 rightly ensures that safety and the reduction of avoidable harm will always be the foundation of the regulatory system operated by the CQC.

I turn to Amendment 4, in the name of the noble Baroness, Lady Finlay. I am confident that all noble Lords share the same objective as that of Clause 1, which is to place patient safety at the heart of the delivery of services. The Committee will be aware of the importance that the Government place on improving safety. The recent report of the Morecambe Bay investigation has re-emphasised that that is the right approach. Moving towards the reduction of avoidable harm requires action across the health and social care system.

I agree with those who say that the main way to reduce avoidable harm is through changes in culture. None the less, there is also a role for legislation. The role of the law in this area is straightforward: it can define minimum acceptable standards and introduce ways to protect patients who are put at risk when those standards are not met. It provides a safety net that protects people from harm.

I stress that the regulations issued under Section 20 of the Health and Social Care Act 2008, which Clause 1 amends, apply to registered providers of health and adult social care in England. There are two important points here. First, the regulations do not apply to individual members of staff but to the providers of care. In that respect, they offer protection to staff as well as to patients and service users. Secondly, the scope of the regulations is not restricted to the health service but applies also to adult social care. In that respect, the scope of the clause is broader than that of the noble Baroness’s amendment. For that reason, I prefer the current wording, which offers the same protection to patients and service users wherever they receive care, not just in the NHS.

The noble Baroness asked whether the clause applies to all care organisations, including those in the voluntary sector. All providers of regulated activities must register with the CQC and meet the registration requirements, including voluntary sector and independent sector providers. She also asked whether the regulations will be consulted on and subject to affirmative resolution. The answer to both questions is yes, but having said that, the fundamental standards regulations are consistent with the objective of Clause 1. Those regulations were consulted on and were subject to affirmative resolution. Any future regulations amending or replacing those regulations would also be consulted on and, unless the changes are minor, would be subject to affirmative resolution.

[Lord Warner]

Can the Minister clarify something for me, because I am increasingly puzzled? He keeps talking about the fundamental regulations which are coming into force in three weeks’ time being consistent with Clause 1. If they are consistent with Clause 1 as they are framed, why do we need Clause 1?

[Earl Howe]

What Clause 1 does is to amend the provision whereby the Secretary of State may require the CQC to have safety as its prime objective to one where it must have that requirement as its prime objective. That is what Clause 1 essentially does, so there is a good reason for having the Bill alongside the regulations.

[Lord Warner]

I am sorry but this is quite a key point. If the Minister is right and those regulations were drafted in accordance with the law as it stood before this Bill, they presumably make the same requirement. The Minister is saying that they meet the requirements of the Bill. I still cannot reconcile why you need to change the law, particularly if we are now into “may” and “must” territory, which always delights your Lordships’ House. I am obviously being very dim but I still cannot understand why you need to change the law—the primary legislation—but do not then need to revisit the regulations which were made under other primary legislation. I thought I saw the Minister proceeding, uncharacteristically, with a degree of caution on this. There is an issue here on which, so far, the Government have not given me a particularly convincing explanation.

[Earl Howe]

I am very sorry that I have not given that explanation clearly enough. The point was well drawn out at Second Reading by my noble friend Lord Ribeiro that what Clause 1 essentially does is to bring patient safety absolutely to the fore in the context of the CQC’s work. That is entirely consistent with the approach that we took in the fundamental standards regulations which, as the noble Lord knows, flowed out of the work done by Sir Robert Francis QC in his report on Mid Staffordshire. If I can be clearer to the noble Lord before the conclusion of this debate, I will be glad to do so but I find it difficult to say more than I already have on this.

The noble Lord, Lord Turnberg, asked about the CQC’s guidance. Its guidance on the new fundamental standards has been consulted on. The CQC has a range of actions that it can take when a provider does not meet the fundamental standards, ranging from a warning notice to cancelling registration. The CQC’s enforcement policy is clear that any action that it takes will be proportionate to the risks to patients and that its most serious sanctions will be used only in response to the most serious service failings.

[Lord Elton (Con)]

My Lords, would another way of addressing the concerns of the noble Lord, Lord Warner, be to say that Clause 1 removes from the Secretary of State a discretion to produce regulations which are not as satisfactory as the current ones are?

[Earl Howe]

Not for the first time, my noble friend Lord Elton comes to my aid. That is exactly right.

[Lord Turnberg]

My Lords, I listened extremely carefully to what the noble Earl has just said and I am grateful to him for clarifying what a registered person is—I think that it is the word “person” that gets very personal here. I remain somewhat concerned about whether legislation to stop avoidable harm is a feasible proposition.

--- Later in debate ---

[Lord Ribeiro]

No. The heading “harm-free care” will be changed to “reducing harm in care”.

[Earl Howe]

My Lords, before the noble Lord, Lord Turnberg, decides what to do with his amendment, I shall reinforce the explanation I gave earlier in answer to the noble Lord, Lord Warner. This clause removes the Secretary of State’s discretion around whether the requirements for registration with the Care Quality Commission should cover the safety of care. That is the approach at the moment, but the impact of the change we are making is to embed current policy and practice. As my noble friend Lord Ribeiro has helpfully explained, without this change a future Secretary of State could in theory decide not to include patient safety requirements in future regulations. The Bill ties the hands of future Secretaries of State on this important matter. It would require a change to primary legislation to alter that. That has substantive significance as well as presentational significance.

--- Later in debate ---

[Lord Hunt of Kings Heath]

My Lords, this has been an interesting debate. I thought that the noble Baroness, Lady Finlay, raised some important points in relation to the definition of “best interests”. Because she referred to a number of identification streams within the health service, I ought to declare my interest as president of GS1 UK, the barcode association. Barcoding is, of course, another indicator that can be used.

I recently had an interesting discussion in Solihull with people who are helping the integration board that is aiming to bring health and social care together to provide integrated services. It was interesting to get an insight from a company that is helping the statutory providers to do this by confronting situations in which individuals are provided with services from a number of different statutory agencies but where there is, seemingly, no co-ordination at all between them. One often gets professionals arriving at the same time but not communicating with each other. This is partly due to the problem over information systems.

I should like to ask whether the noble Earl considers that the passage of the Bill will help the integration of that information, provided that the public have confidence in the process under which information is shared. There is clearly a balance to be drawn between the benefit of information sharing between statutory bodies in terms of integrating provision, alongside the safeguards necessary to the public. One should be in no doubt that this is quite a tension. Yesterday, the parliamentary Intelligence and Security Committee published a report on the holding of information by the security services. Reading it gives some cause for concern, in many cases, about the amount of information available about individuals. Although, as I understand it, the committee report says that that information is often never referred to or used, it none the less could be. The whole issue regarding the integrity of confidential information is important. On the other hand, we know that we have considerable failures in service because there is no sharing of information. The point that the noble Baroness raised about what we mean by “best interests” and the issue of how we can ensure public confidence is extremely important.

I support the amendment in the name of the noble Baroness, Lady Hollins, which offers an opportunity to debate the importance of including people’s communication needs in the information shared between health and care professionals. I have received helpful briefing from Mencap, the RNIB, the National Autistic Society and Sense. It has become abundantly clear that failure to understand the best way in which to talk to individuals can result in misunderstandings, misdiagnosis and, ultimately, poor care. Accessible and easy-to-read information, perhaps with pictures, to which the noble Baroness, Lady Hollins, referred, and the presence of family, advocates or interpreters, can make the difference between diagnosis and misdiagnosis.

It would be very helpful if the noble Earl could clarify that the communication needs of disabled people and the reasonable adjustments that they might need will be an important part of the health information that should be shared between professionals. I certainly hope that he is willing to place on record that guidance associated with the Bill will reflect this and that it will reach the relevant professionals.

[Earl Howe]

My Lords, let me turn first to Amendment 5. I understand the noble Baroness’s concern that there should be no confusion over the “best interests” wording in the Bill and the more technical and prescribed “best interests” checklist test in the Mental Capacity Act 2005. The key point for me to emphasise straightaway is that in this Bill the phrase “best interests” is ascribed its ordinary meaning: the consideration of a range of factors, including the wishes of the individual. Nothing in the Bill detracts from patient autonomy or the importance of supportive partnership working between clinicians and patients. This is in marked contrast to the “best interests” test checklist found in the Mental Capacity Act, which the noble Baroness was instrumental in shaping. In that Act, which concerns individuals who lack capacity, the term is not defined. A checklist of considerations helps professionals to determine what a patient’s best interests are.

The information-sharing provisions of the Bill respond to concerns expressed by the National Data Guardian. Dame Fiona Caldicott, in her 2013 review of information sharing, identified a risk-averse culture and concluded that the duty to share information for a person’s own direct care should be considered as equally important as the duty of confidentiality. I quote from her review:

“Health and social care professionals should have the confidence to share information in the best interests of their patients”.

These provisions seek to establish that sentiment in law.

The presence of the phrase “best interests” in this Bill ensures that it complies with the central principle of the Data Protection Act and the Caldicott review: to share information only where necessary and relevant. The term “best interests” is used elsewhere in primary legislation, including in the Human Fertilisation and Embryology Act 1990 and Section 38 of the Medical Act 1983. It was also used more recently in the Charities Act 2011, the Legal Services Act 2007, and in the Pensions Schemes Act 2015, which received Royal Assent last week—all are without reference to the checklist in Section 4 of the Mental Capacity Act. It is a term used across a wide-ranging legislative landscape with its ordinary meaning.

The “best interests” test in this Bill is no different from that in the pensions Act or the Legal Services Act. It requires a professional to apply a common-sense approach. I appreciate the noble Baroness’s concern that the use of the word “best” could herald a return to a “doctor knows best” kind of paternalism and to disempowering patients in the process. I sincerely hope that I can convince her that this is neither the intent nor the effect of this Bill. I am sure that the whole House will agree that the focus of information sharing should be on the needs of the individual, rather than defensive, risk-adverse behaviour of the type we have sometimes seen in the past.

I can confirm that the Department of Health will provide guidance to support the interpretation of these new duties. This will include a clarification that the term “best interests” is ascribed its ordinary meaning. The Government will also amend the Explanatory Notes to that effect.

[Lord Hunt of Kings Heath]

My Lords, that was a very helpful response. May I just ask the noble Earl whether explicit examples will be given in the guidance? The issue of professional defensiveness is very important. He will know that, out in the field, people often have a different view about data protection. Sometimes it gets in the way of sensible, professional working together. I urge that the guidance should be as practical as possible and that it should be aimed at field workers, rather than just the organisations they work for. Let us take as examples care workers, health service workers, health visitors and nurses, in regard to whom it is clearly in an individual’s best interests that information is shared about visits, and that sometimes responsibilities are shared, and that they are not inhibited because of some myth about their inability to share information.

[Earl Howe]

The noble Lord makes some very good points. The duty to share information will, we trust, ensure consistency in the sense that it will make it clear when the duty to share applies. It is clear that there is a real commitment throughout health and adult social care to overcome the cultural barriers that Dame Fiona referred to. For example, the sharing of information for the purposes of an individual’s direct care is already required as part of the professional duties of health and care professionals, and sharing for direct care purposes can be undertaken in accordance with the common-law duty of care.

The department is already working with its national partners to offer practical support to local provider and commissioner organisations on information governance and sharing. For example, the department is partner to the Information Governance Alliance, a group of national health and care organisations which has been established to provide a single authoritative source of guidance and support on information sharing. I confirm to the noble Lord that the guidance will include specific examples and will be prepared in consultation with our key stakeholders.

Turning to Amendment 6, the NHS number helps to ensure that an individual’s health and adult social care history is readily accessible when they move along their care pathway. This will improve safety and the experience of care. The adoption of the use of the NHS number as a consistent identifier has been a long-standing government objective.

It may help if I explain a little about the purpose and use of the NHS number. An individual does not need to know their NHS number to get treatment. Conversely, having an NHS number does not imply entitlement to the free use of all NHS services. The NHS number helps to confirm the identity of patients and link health records. There are some electronically based services for which an NHS number is essential and from which a patient who objects to the number being shared may not be able to benefit—for example, as the noble Baroness said, screening programmes, choose and book referrals, and electronic prescriptions in primary care. In these instances, the implications of objecting may be serious, which underlines why the decision to opt out should always be considered carefully and discussed with professionals.

That said, there is an important principle at stake here. The Government are committed to empowering the individual. In the future, it will increasingly be the citizen who determines who has access to their data, with care professionals respecting their preferences. For that reason, the Bill provides that if an individual objects, or is considered likely to object, then no duty to share information will arise under these new provisions. I hope that that is a useful explanation for the noble Baroness.

I am pleased to reassure her also that the Bill will not have any effect on the existing systems to protect victims of abuse. The Care Act 2014 sets out clear duties on adult safeguarding. Under the Act, local authorities must make inquiries, or cause others to do so, if they reasonably suspect that an adult who has needs for care and support is, or is at risk of, being abused or neglected.

Statutory guidance will provide that the early sharing of information is key to providing an effective response where there are emerging concerns. Where an adult has refused to consent to information being disclosed, practitioners must consider whether there is an overriding public interest that would justify information sharing.

There are equally robust mechanisms in place to protect children. The Department for Education has produced statutory guidance entitled Working Together to Safeguard Children, which clearly sets out that professionals should share information with local authority children’s social care where they believe that a child is at risk of abuse or neglect. It states:

“Fears about sharing information cannot be allowed to stand in the way of the need to promote the welfare and protect the safety of children”.

Existing guidance on information sharing for practitioners and managers states that if a child is suffering or is likely to suffer significant harm, professionals should share information even if consent is refused or withdrawn. The interests of the child are paramount.

I agree wholeheartedly with the sentiment behind the amendment in the name of the noble Baroness, Lady Hollins. It is critical that an individual’s communication needs are identified and shared appropriately with those responsible for providing and commissioning care and services. This Bill requires the sharing of information where this information is,

“likely to facilitate the provision to the individual of health services or adult social care in England, and … in the individual’s best interests”.

An individual’s particular communication needs would be a good example of such information. This will be made clear in guidance.

The concerns that the amendment seeks to address reflect those Mencap has recently raised with the Department of Health. I am pleased to say that my officials have had constructive discussions with Mencap and we welcome its offer to help shape the guidance. Mencap welcomes the Bill as it has the potential not only to improve information sharing between health and social care, especially for people with a learning disability, but also has, in its words, the potential to “save lives”. I would add that, provided the patient or his or her attorney have consented to its inclusion, any information from a GP record that can be coded can be included on a summary care record. Work is already under way to expand the summary care record inclusion data set to include specific communication needs items.

[Lord Ribeiro]

My Lords, I thank the Minister for clarifying the issues around the consistent identifier. It is interesting that the use of the consistent identifier and the sharing of information was welcomed at Second Reading by the noble Lords, Lord Turnberg, Lord Willis of Knaresborough and Lord Hunt of Kings Heath. The noble Lord, Lord Hunt, confirmed that the Opposition were very supportive of sharing a patient’s information, which, as he said, was,

“clearly in the best interests of their patients”.—[Official Report, 6/2/15; col. 961.]

That slides me very easily and comfortably into Amendment 5 and the question of best interests, which, again, has been addressed. I must confess that I have always used, and continue to use, the term “best interest” without assuming that this can be used only about those without mental capacity, as defined by the Mental Capacity Act 2005. It is my understanding that in these clauses the phrase “best interests” assumes its general meaning and provides a relevant person with a duty to act in the individual’s best interest when providing information for direct patient care. That is my understanding of the term.

As regards Amendment 6, patient control and choice about how their information is used is the subject of wider government policy. I believe that what needs to be done in that respect has already been illustrated. It is about empowerment of the individual and giving them control over their own information. I also welcome the intervention of the noble Baroness, Lady Hollins, in highlighting a key piece of information in patient care. Her description of a patient who died after surgery for want of the right word when asked a question—the patient answered incorrectly, which led to a fatal outcome—was truly revealing. In my experience, it is critical that if an individual has particular communication needs, those who provide care or treatment should know about them beforehand.

I am confident that the requirements to share information in support of direct care in the Bill already encompass communication needs. The Minister commented that Mencap has sought reassurances that health professionals should become more aware of the ways in which people can communicate their health and care needs. I am sure that, from his statement earlier, work on this will take place to ensure that those concerns are met. With those comments, I hope the noble Baroness will be happy to withdraw her amendment.

--- Later in debate ---

[Lord Hunt of Kings Heath]

My Lords, I am not sure about the noble Lord’s latter point. I think my noble friend has done us a great service in raising this issue. Since we are talking about unique personal identifiers again, perhaps I may first remind the House of my presidency of the bar-coding association, GS1.

As a resident of Birmingham, I thank my noble friend for his work as the Children’s Commissioner, which has been invaluable. Your Lordships will have a great opportunity to discuss these matters further on Monday night after we debate standardised packaging of cigarettes, because I have a Motion to Take Note on the Birmingham electoral order, which changes the electoral cycle in Birmingham following the work of the three commissions and the Permanent Secretary at the DCLG.

On the substantive point, my noble friend raised the case of Victoria Climbié, on which I well remember making the Statement to this House a long time ago now. What was so striking in that report was that she went through, I think, at least eight or nine public agencies. If any one of them had talked to another, it is likely that she would still be alive today. It was a shocking report, because there were so many failures by so many different organisations. Although, inevitably, the local authority always tends to be the focus of concern, neither the health service nor the police covered themselves in glory. I am not really in a position to commit the Opposition in exactly the way that my noble friend wants, but if the noble Earl would like to institute some urgent cross-party discussions with my noble friend, we would certainly be very happy to take part.

[Earl Howe]

My Lords, to start with a given, I am sure I speak for the whole Committee when I say that we are all committed to taking whatever steps are necessary to protect children from abuse and neglect. Clauses 2 and 3 are, as they stand, based on long-standing policy intentions. They have real buy-in and support from those who will need to deliver them.

As regards children’s social care and wider children’s services, the difficulty with proceeding without delay in the direction that the noble Lord, Lord Warner, is advocating is that we do not yet have robust evidence on the impact of the potential burdens and risks of an extension of these duties. Moving to the use of a common identifier for the education and children’s social care sector would represent a substantial change. In the discussions that I have had on this, I have been persuaded that it is only right that we fully understand and assess the impact before considering legislation.

However, I can give the noble Lord, Lord Warner, some hopeful news. I am pleased to inform him that the Department for Education has committed to undertake an evidence-gathering exercise to understand fully the impact of adopting a consistent identifier for these types of provision. That exercise is expected to report before the end of the year. I hope the noble Lord will understand that we would not want to pre-empt the outcome of that or make decisions now on behalf of Ministers in the next Government, who will wish to consider the evidence once it is available.

The amendment would also have the effect of creating a power to extend Clauses 2 and 3 to other public bodies where there was evidence that this would benefit the health and well-being or protection of children. I recognise and welcome the sentiment and reasoning behind the desire to extend the information-sharing duty under this Bill to encompass child protection issues. As I have already assured the noble Baroness, Lady Finlay, there are clear requirements on professionals to share information to protect children. I hope that reassurance is helpful.

[Lord Elton]

In fact, Reg Wells-Pestell, not Goronwy Roberts, was the Minister. I want to get that right for anyone who is old enough to remember and reads Hansard.

--- Later in debate ---

[Lord Hunt of Kings Heath]

My Lords, some very important points have been raised by the noble Baroness, Lady Finlay, and my noble friend Lady Pitkeathley. My regret is that we are dealing with these regulatory matters in this Bill. A number of statutory instruments will also come through your Lordships’ House, one from the GMC, in the next few days.

We had a Law Commission draft Bill which should have been a fifth Session Bill and would have enabled your Lordships to look at the statutory regulation provisions in the round. However, because of the Government’s decision not to proceed with that Bill, not even in pre-legislative scrutiny, we now have to look at this matter in a piecemeal way. It is wholly unsatisfactory. I am very sorry that we are having to deal with these issues in this way without enough time to focus on them properly. I am worried about Clause 5; I think that we are going to let it through without understanding its implications. We would be very grateful for anything that the noble Earl can do to clear this up.

[Earl Howe]

My Lords, I very much hope that I can allay the concerns of both noble Baronesses and the noble Lord. In its report, the Law Commission recommended a consistent main objective for professional regulators and the PSA around patient safety. It also recommended two subsidiary objectives: maintaining confidence in the profession and proper professional standards and conduct. The Law Commission’s report describes this proposal as restating the existing legislative position that public protection is the regulators’ main objective. The Government’s view is that public protection is sufficiently important that it should be expressly adopted in the legislation.

The noble Baroness, Lady Pitkeathley, asked whether public confidence might conflict with public health, safety and well-being. In the example of the Professional Standards Authority identifying a poorly performing regulator, it is clear that the interests of public protection and public health, safety and well-being would require the PSA to take action. In this example, any argument that the objective of promoting and maintaining public confidence in the professions would require the PSA to conceal poor performance would clearly run counter to public protection. The objective of promoting and maintaining public confidence in the professions does not mean that the PSA or the regulatory bodies should be promoting the reputation of the professions generally. Rather, it is about taking action where there is a risk that confidence in the profession as a whole is undermined to the extent that it may deter people from seeking the treatment or care that they need and impact on public protection. This example highlights the fact that while the objectives are all linked to public protection, in practice they may not always necessarily be relevant, or relevant to the same extent in particular cases. It is not a case of one objective overriding another or preventing it being considered but ensuring that they are pursued only where they are relevant to public protection.

The Bill does not prioritise or weight one element of public protection over another. It is for the PSA to determine how it applies those elements in carrying out its functions in relation to the regulators and considering the issues of the case. My view is that health, safety and well-being will always be relevant to public protection when the PSA is carrying out its functions in relation to the regulators. It will be for the PSA to determine how to apply the objectives appropriately.

The noble Baroness asked whether the objective to promote and maintain public confidence might inadvertently lead the regulators to be less transparent in highlighting bad practice. Equally, that might lead to regulatory committees and panels punishing professionals who do not pose any threat to the public. If the actions of a doctor appear likely to reduce confidence in the medical profession and influence the decision of individuals as to whether to seek medical help at all, it may be right to take action. However, panels and committees will be asked to reach their own objective judgment as to whether particular acts or omissions would affect public confidence if no action were taken. A subjective view, uncritically influenced by public opinion or the media, would be an unacceptable basis for a decision.

Turning to the term “well-being”, the BMA has raised concerns with my ministerial colleague Dr Dan Poulter about how it would be interpreted by fitness to practise panels and committees. Well-being has been a long-standing and established feature of the legislation for three of the regulators. It encompasses those aspects of a professional’s role that may have an impact on individual patients but not directly impact on their health or safety. Dignity, compassion and respect are all important in delivering care, and it would not be right to disregard them.

It will be for the regulators to formulate and issue guidance for fitness to practise panels on interpreting and applying the objectives in practice, including the term well-being. The legislation makes clear that those objectives are considered only under the umbrella of public protection.

My officials will draw the regulators’ attention to those concerns should the overarching objective become law. That is in order to inform any guidance that will be needed to implement both this Bill and the secondary legislation for the GMC.

The noble Baroness, Lady Finlay, also asked about how we view the definition of “public” in the Bill. It of course includes patients and service users, as well as other parts of the collective public. I hope that that reassures the noble Baroness that the objectives in relation to well-being and public confidence will not be pursued outside the regulators’ objective to protect the public.

[Lord Ribeiro]

In following the Minister, perhaps I may deal, first, with “well-being”. At paragraph 3.20, the Law Commission’s report states:

“We disagree with the criticism of ‘well-being’. This term has already been incorporated without difficulty into the main duties or objectives of many of the regulators”.

Within that context, it feels strongly that that term cannot be misinterpreted.

The Bill introduces consistent objectives for the PSA and the regulators based on the proposals of the Law Commission’s review last year. Most of the professional regulators have some form of main objective. Although they are not consistently expressed they are generally to protect, promote and maintain the health and safety of the public. It is the health aspect with which the noble Baroness, Lady Pitkeathley, was particularly concerned at Second Reading. I think that that concern has been allayed today.

It is clear that public protection—by “public” I of course include patients—is sufficiently important that it should be adopted expressly in legislation. Defining public protection in terms of these three elements to be pursued by the regulators and the PSA as their overarching objective enables public protection to be considered in its fullest sense. That should give comfort and reassurance to the noble Baronesses who have spoken. With that, I hope that the noble Baroness will agree to withdraw the amendment.

Health Service Commissioner for England (Complaint Handling) Bill

Earl Howe Excerpts

Friday 13th March 2015 Lords Chamber

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

My Lords, I very much welcome the debate on this important Bill. I thank my right honourable friend in another place, David Davis, and the noble Baroness, Lady Finlay, for their stewardship of the Bill, which makes the health service ombudsman more accountable to people taking their complaints to her and, more generally, to Parliament. A productive debate was had in the other place, with support for the Bill from all sides. Speaking for the Government, I hope that we can get the Bill on to the statute book as soon as possible, although I understand that parliamentary time is limited.

The Government very much support the principles that lie behind the Bill. It is a good Bill, and an important one. We are committed to continuing to improve the way in which complaints are handled across the health and social care systems and are actively encouraging the NHS to be more open and receptive to complaints. We remain committed to putting patients first.

Rightly, our focus on giving patients a stronger voice, coupled with reviews such as those by Sir Robert Francis QC and Ann Clwyd MP with Professor Tricia Hart, have raised people’s awareness of their right to complain. If someone is dissatisfied with the NHS services that they have received, it must be right for them to expect that their complaint will be investigated efficiently and effectively. The health service ombudsman investigates, and makes final adjudications on, complaints that individuals have been treated unfairly or have received poor service from the NHS in England. She is the second, independent stage of the NHS complaints arrangements, being independent of both government and the NHS, accountable directly to Parliament. An efficient ombudsman service is therefore vital if we are to deliver the effective complaints service to which NHS patients are entitled.

In response to the noble Baroness, Lady Hayter, and the noble Lord, Lord Hunt, who asked about the prospects for having a more unified and integrated ombudsman service, I would add that the Cabinet Office is reviewing the way in which the public services ombudsmen currently operate. We take complaints about the public services, including the NHS, very seriously. We consider that there is a continuing need to improve the handling of these complaints—in particular, to use information obtained from them to improve service delivery. As part of that work, we have been looking at reform of the public services ombudsmen. Noble Lords will be aware that Robert Gordon, a former director-general in the Scottish Government, has been asked to undertake this review, and the Cabinet Office is hoping to go out to consultation on reform before the end of this Parliament.

Dame Julie Mellor, the Parliamentary and Health Service Ombudsman, has transformed the way her office works. The noble Baroness, Lady Finlay, was absolutely right about that. The circumstances have been challenging, but she has done a good job. There is more openness and transparency in how the office works. The number of complaints investigated by her office has recently greatly increased, and we expect a further rise to be recorded in her 2014-15 annual report. Complaints are generally efficiently reviewed and assessed in a timely manner.

However, certain cases suggest that the ombudsman might benefit from legislative reinforcement in the difficult task of working towards further improvement. The noble Baroness has made reference to the Sam Morrish case. I shall not repeat what she has said; suffice it to say that the family’s experience of the NHS fell well below, and tragically below, an acceptable standard and, unfortunately, so, too, did their experience of taking their complaint to the health service ombudsman. Dame Julie rightly apologised to Mr and Mrs Morrish. In answer to the noble Lord, Lord Hunt, I think lessons have been learnt from that case. At the very least, I hope that the health service ombudsman would consider carefully and learn from the Morecambe Bay report where appropriate. It is not possible for me to say more than that; as noble Lords are aware, the ombudsman is independent of government, and it would not be proper for me to do so.

It is still true to say that any unnecessary delay in investigating cases adds to the distress of those involved. NHS complaints often raise personal or sensitive issues. It is important to respond to the person making the complaint as quickly as possible. Reducing unnecessary delay in completing the investigation of a case will reduce the distress of those involved. However, where there are considerable delays of more than 12 months, even if seemingly unavoidable, it is surely right for individual complainants to be told why an investigation has taken so long to conclude. We also think it right for Parliament to be informed, in the ombudsman’s annual report, of how many complainants are kept waiting longer than 12 months for their case to be concluded and, equally importantly, the action being taken to reduce that number.

In summary, this Bill will improve the accountability of the Health Service Commissioner for England to people making a complaint, and to Parliament. The Government fully support these aims, and we fully support the Bill.

Local Audit and Accountability Act 2014 (Special Trustees) Amendment Regulations 2015

Earl Howe Excerpts

Tuesday 10th March 2015 Grand Committee

Moved by

[Earl Howe]

That the Grand Committee do consider the Local Audit and Accountability Act 2014 (Special Trustees) Amendment Regulations 2015.

Relevant document: 22nd Report from the Joint Committee on Statutory Instruments

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

My Lords, these regulations are among a number of statutory instruments relating to the audit of the accounts of relevant authorities in the new regime introduced by the Local Audit and Accountability Act 2014. The Act also abolishes the Audit Commission, passing responsibility for auditor appointments to the local public bodies.

I will not take up the Committee’s valuable time by repeating the arguments put forward during the passage of the 2014 Act in this debate. There was broad support across the House during the debates on the Act for creating a more efficient audit system, giving greater responsibility to local bodies while providing greater opportunities for local people to hold those bodies to account.

These regulations introduced today make a minor but important change to the application of the Act, relating to one particular type of local public body—special trustees appointed by the Secretary of State for NHS charities. Special trustees are established by the Secretary of State to administer property or funds held on trust at particular teaching hospitals. There are currently special trustees at only three hospitals— Great Ormond Street Hospital, Moorfields Eye Hospital and Royal National Orthopaedic Hospital. All the special trustees were established to manage charitable funds and they represent some of the largest NHS charities.

The Local Audit and Accountability Act 2014 makes provisions for audit appointment, conduct and regulation for a range of local bodies which are defined as “relevant authorities”. The relevant authorities include local government, parish councils, NHS trusts, clinical commissioning groups and special trustees. The special trustees’ charitable accounts fall outside the account definition in the Local Audit and Accountability Act. These accounts are covered by the Charities Act 2011, which sets the audit and reporting arrangements for all English NHS charities. However, the Local Audit and Accountability Act 2014 applies generally to matters which do not relate to the accounts of trustees. For example, there is a requirement in the Act for relevant authorities, which include special trustees, to have auditor panels. The intention, however, was that the Act should apply to special trustees only if they held non-charitable funds.

These regulations therefore amend the definition of relevant authorities as far as it relates to special trustees so as to restrict its application to instances where the trustees are dealing with non-charitable funds. The amendment would also remove any overlap which exists in relation to matters which are already covered by the Charities Act 2011, and so it will restore the current position, making special trustee arrangements consistent with those for other NHS charities. This amendment will also make the application of the Local Audit and Accountability Act to special trustees clearer. The fact that the Act does not apply to special trustees’ charitable accounts is currently not directly stated. To establish this, readers have to follow two cross-references to other Acts. In preparing these regulations, we discussed the implications with the Charity Commission and the Association of NHS Charities, which agreed that the overlap between the Acts should be removed.

In conclusion, these regulations will amend the Act so that it does not apply to the charitable trust funds of special trustees and applies only where the trustees are dealing with non-charitable funds. I commend these regulations to the Committee.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am sure that we all are grateful to the noble Earl. As he will understand, I laboured long and hard over these regulations. Rather like the previous RIA, they are quite remarkable in that there has been no consultation, guidance or impact assessment, no charities are affected apart from the charitable trustees—I do not think that the special trustees count as charities in that sense—and they do not impact on small and medium-sized enterprises. No doubt if there had been an RIA, it would have been another “Nul points” return.

I think the noble Earl said that as of today the regulations will have no impact because the three special trustees who still exist do not engage in non- charitable activities. I have a genuine question for the noble Earl with regard to the Government having adopted a deregulatory or better regulatory approach. I wonder whether this SI was really necessary and whether a letter from his department to the three special trustees telling them not to engage in non-charitable activities might not have been a better option. I was going to ask him which three special trustees still existed, but he very kindly gave their names. I wonder why they are still special trustees. He may not know why, but it struck me that, with the options that are now available for these trustee arrangements, other NHS trusts and foundation trusts have decided on different options.

Finally, it is worth noting that in some cases we are talking about quite considerable sums of money that, in one way or another, have been left or that special trustees operate. They can therefore have a major impact on the activities of those hospitals, particularly on research but also on contributions to patient comfort. I do not know whether the noble Earl really thinks that these funds are generally in good hands and whether there are any trends in giving at the moment; clearly the NHS finds them to be extremely useful.

[Earl Howe]

My Lords, I am grateful to the noble Lord for his questions and comments. Essentially, these regulations are about creating legal certainty when the 2014 Act commences. The policy intention has always been that the Act should apply only where special trustees are dealing with non-charitable matters. That policy is already reflected in the Act, albeit in an indirect way, through cross-reference to other legislation in respect of the accounts of special trustees. However, the background legislation to this amendment is complex, and by not limiting the relevant authority reference to special trustees to when they deal with non-charitable matters, a number of provisions apply generally to special trustees. We considered that to be unsatisfactory and it is why the amendment we are making is necessary as a point of clarification. In other words, there is an overlap between the Local Audit and Accountability Act and the Charities Act. The noble Lord knows as well as I do that lawyers find that sort of thing extremely untidy.

Lest the noble Lord think that this is purely an academic matter, I am advised that it is perfectly possible for special trustees to hold non-charitable property. The DH guidance in 2011 says that NHS trustees have the power to accept and hold trust funds other than charitable funds and asks the NHS trustees to consult the department if they are considering accepting donations under terms not regarded as charitable. That could occur where funds are donated for the support of an independent patient, or for such a small and specific group of patients that it does not qualify as a charitable purpose under the Charities Act 2011. In other words, the special trustees would just be custodians of those funds in those circumstances.

As regards the noble Lord’s final question on whether I consider the charitable funds to be safeguarded and in good hands, I have no reason to doubt that that is the case. I do not have any background on the charitable funds themselves, but if I can comment on that matter, I would be happy to write to him.

Motion agreed.

Local Authorities (Public Health Functions and Entry to Premises by Local Healthwatch Representatives) and Local Authority (Public Health, Health and Wellbeing Boards and Health Scrutiny) (Amendment) Regulations 2015

Earl Howe Excerpts

Tuesday 10th March 2015 Grand Committee

Moved by

[Earl Howe]

That the Grand Committee do consider the Local Authorities (Public Health Functions and Entry to Premises by Local Healthwatch Representatives) and Local Authority (Public Health, Health and Wellbeing Boards and Health Scrutiny) (Amendment) Regulations 2015.

Relevant document: 23rd Report from the Joint Committee on Statutory Instruments

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

My Lords, these regulations mandate the provision of five health and development assessments and reviews as set out in the healthy child programme. The healthy child programme for the early life stages focuses on a universal preventive service, providing families with a programme of screening, immunisation, health and development assessments and reviews, supplemented by advice around health, well-being and parenting. The assessments and reviews are to be offered to pregnant women and children from birth to age five.

These regulations also adjust the 12-month exemption period from the community right to challenge for health visiting, the Family Nurse Partnership and other child health services for reviewing the development and promoting the health and welfare of children under five years of age.

The Local Authorities (Public Health Functions and Entry to Premises by Local Healthwatch Representatives) Regulations 2013 set out steps that local authorities are obliged to take in carrying out their health improvement functions and describe what they must do in the exercise of certain of the Secretary of State’s public health functions. This instrument amends those regulations by prescribing what local authorities must do to provide or secure the provision of universal health visitor reviews, thereby ensuring that certain elements of the healthy child programme are provided by all local authorities in England.

I am pleased to report that according to the most recent management information—from January 2015—published by NHS England, the number of health visitors has increased by 3,736, which is an increase of 46% since May 2010. We will know in due course exactly when the coalition’s commitment of 4,200 has been achieved, but I can say now that an enormous amount of effort, both locally and nationally, has gone into delivering the additional numbers, and those efforts continue as we speak.

It should also be noted that the latest indications show that the Government’s commitment to increase the number of Family Nurse Partnership places to 16,000 will be met. This is crucial, as family nurses deliver the five reviews these regulations aim to mandate to those families under the care of the FNP programme.

The policy document Healthy Lives, Healthy People: Update and Way Forward, published in 2011, sets out the Government’s intention to transfer responsibility and power to local government, allowing local public health services to be shaped to meet local needs. The document set out the progress made to date in developing that vision and identified those issues where further development was needed.

Subsequently, public health services for children and young people aged five to 19 and other mandated functions were transferred in April 2013. The transfer of public health services for children age nought to five was delayed until 2015 to provide NHS England with sufficient time to deliver the Government’s commitment to increase the number of health visitors and transform the service, allowing the transfer of a much improved public health service.

This Government are committed to improving the health outcomes of our children and young people so that those become among the best in the world. What happens in pregnancy and the early years of life impacts throughout the life-course. Therefore, a healthy start for all children is vital for individuals, families, local communities and, ultimately, the whole nation. Health visitors provide valuable advice and support to families and are trained to identify health and well-being concerns. We have supported the profession more than ever before to transform the service.

By introducing these regulations we intend to provide a degree of consistency within local government for the delivery of these services. I am confident that that sends a clear signal to health visitors, family nurses, local authorities and the public of the Government’s ongoing commitment to universal public health support for pregnant women, children and their families.

We have been clear that we need to avoid creating new unfunded burdens. I can confirm that the requirement on local government in this instance to make arrangements for the reviews will be no greater than at the point of transfer. The funding for local authorities will reflect that for services at the point of transfer. However, the regulations require local authorities to act with a view to continuous improvement in participation in the five mandated reviews.

Back in 2010, at the time of the publication of the White Paper Healthy Lives, Healthy People: Our Strategy for Public Health in England, the Government consulted on the funding and commissioning routes for public health services and proposed how the department might create a public health outcomes framework. Over 2,000 responses to the consultation were received from a wide spectrum of individuals and organisations.

Respondents were generally supportive of the proposal that local authorities should commission public health services for five to 19 year-olds. However, a number of respondents commented that having different commissioning routes for children’s public health services from pregnancy to the age of five, and five to 19, could lead to fragmentation. The transfer of commissioning to local authorities from 1 October 2015 and these regulations will address this, and will allow for joined-up commissioning from nought to 19 years, improving continuity for children and their families.

In the period since the formal consultation took place we have continued to work alongside our stakeholders to develop plans for the nought-to-five transfer and to draw up these regulations. We are grateful for their continued input and would like to express our gratitude in supporting us to get to where we are today.

The Government have committed to fund local authorities for their new commissioning responsibilities that will transfer to them. The exact costs of delivering the mandated reviews will vary across the country. However, the funds being transferred—£428 million for the half year from 1 October 2015—are more than sufficient to enable local authorities to deliver the mandated elements as set out in the impact analysis. However, the mandated elements are only part of the nought-to-five service transferring.

Subject to parliamentary approval, the amendments in these regulations provide that a review may be carried out of the performance of local authorities around the five mandated universal reviews. The provisions in the draft regulations confirm that these regulations will cease to have effect on 31 March 2017. However, if a future Government conclude, after considering the results of any review, that the new provisions in these regulations should continue to have effect, the regulations amended by these regulations may need to be further amended accordingly.

The second area covered by these regulations concerns the community right to challenge. The Localism Act 2011 makes provision for a community right to challenge, under which a local authority has a duty to consider expressions of interest made by voluntary and community bodies, and certain other persons, in providing or assisting in the provision of its services. In line with the original government intention to exempt health visiting and other similar child health services for children under five years for one year from the point of transfer, these regulations amend provisions in legislation for the exemption period from the community right to challenge so that it would begin from the revised date of transfer—namely, 1 October 2015—and end on 30 September 2016.

I commend these regulations to the Committee. I beg to move.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I thank the noble Earl for his very detailed explanation of these regulations. I want to ask just a couple of questions.

First, the original plan for transferring the commissioning of services to local government from the NHS was due to start on 1 April and has now been changed to 1 October. I may have missed it in the noble Earl’s introduction, but could he explain the reason for that delay?

--- Later in debate ---

[Earl Howe]

My Lords, I am grateful to the noble Lord for his questions and comments.

The noble Lord asked me why we decided to delay the coming into force of these regulations until October, when the original intention was that it should be in April. We decided, after discussion with partners, that stability would be best served by transferring in October rather than April—the point at which the target of 4,200 health visitors was only just due to be met. It was felt that a six-month period when local authorities could reasonably prepare was prudent.

As regards the services we are mandating, as I think the noble Lord recognises, we are mandating the five universal health visitor assessments, and we will review that after 12 months if we are re-elected. This mandation is designed to support a smooth transfer to require local authorities to provide vital services that give parents and their baby the best start in life. However, it is true that a balance had to be struck. When we consulted on this, responses ranged from suggestions that all services should be mandated in all areas to respondents suggesting that none should be. In between, almost the full range of health improvement and health protection services were proposed for mandation. A number of respondents agreed with the department’s intention for the list of mandatory functions to be as short as possible to give local authorities the maximum possible freedom. We hope that we have got the balance right.

The noble Lord, Lord Hunt, asked me about monitoring. We will work with Public Health England to monitor how delivery has progressed. However, it is worth noting that the new service model has been tested in early implementer sites, and case-study material has been published. Those sites saw increases in the number of children receiving the two to two and a half year review almost double. We have launched six priorities for demonstrating success and building sustainable services, including: transition to parenthood and the early weeks; maternal mental health; breast-feeding; healthy weight, including healthy nutrition; and other measures. So there are a number of measures by which we will be able to assess the extent to which the arrangements are gaining traction in the way that we would like.

On funding, the proposed allocations for local authorities in 2015-16 are, as I mentioned, £428 million for a half year. The department is investing £36 million in a full year to pay for additional health visitors and Family Nurse Partnership places we have created, and £2 million to ensure that £15,000 per half year is available to every local authority for commissioning costs.

As with other elements of the public health grant, local authorities will be asked to report on spend in 2015. Reporting on spend will be split into two categories: spend related to mandated functions, set out in the regulations, and non-mandated spend. Local authorities are required to report spend against the sub-categories on a quarterly basis to the DCLG, which Public Health England will review on behalf of the Department of Health. Those data will be used as a means of monitoring usage, and local authorities will be required to ensure that the figures are verified and in line with the purpose set out in the grant conditions. Local authority chief executives and the director of public health will be required to return a statement confirming that.

Local authority allocations have been determined on the basis of “lift and shift”, supported by funding adjustments, including a minimum floor. That is, we have identified the scope of NHS England’s existing obligations under service specification 27 of the Section 7A agreement between the department and NHS England, and funding relating to that will provide the main basis for local authority allocations.

The noble Lord asked me about the possibility of a ring-fence. Yes, that money will form part of the public health ring-fence which we committed to for 2015-16, but of course decisions beyond that are for the next Government to make.

I think that has answered most of the noble Lord’s questions. If I have failed to do so, I will be happy to write to him.

Motion agreed.

Gender-based Violence: Screening

Earl Howe Excerpts

Monday 9th March 2015 Lords Chamber

[Baroness Gould of Potternewton]

To ask Her Majesty’s Government what steps they are taking to improve screenings at healthcare settings, including HIV clinics, to screen for gender-based violence and to provide the necessary support for affected women.

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

Routine inquiry of domestic abuse is in place in maternity and mental health services. It will be introduced in maternity services for FGM from April 2015 and for child sexual abuse in some targeted services next year. Accident and emergency departments in England have been sharing data on attendances involving body injuries with their local police forces to help prevent violent crime.

[Baroness Gould of Potternewton (Lab)]

I thank the Minister for his reply. Currently, there is professional guidance on screening, particularly for domestic violence, for health visitors, school nursing programmes and antenatal clinics. Does he not agree that such guidance should be expanded to HIV clinics, because we know that there is a correlation between women who have HIV and domestic violence, so that they can get the help and support that they need, because they have two problems to sort out for themselves?

[Earl Howe]

I do agree. Sexual health and HIV services are already sensitive to the risk of domestic violence, including gender-based violence, in their routine consultations. One of the most important elements in that is to have an environment and atmosphere that is welcoming, comfortable and calm, so that it engenders a sense of trust. Most sexual health clinics have developed local templates to identify those at risk of domestic violence, with signposting and referral to police and other support services if needed.

[Baroness Knight of Collingtree (Con)]

My Lords, could there be a greater example of gender violence than the acceptance that it is perfectly legal to abort an unborn child who is a girl? There is so much disagreement about that—I know my noble friend agrees that it is a wrong policy and ought to be illegal—but the fact is that abortion nursing homes do it every day, and there is great uncertainty about whether this is illegal or not. Ought it not to be quite clear that it is an illegal practice?

[Earl Howe]

My noble friend has emphasised an issue which I am sure all noble Lords feel equally strongly about. The Department of Health has been quite clear that abortion on grounds of gender alone is illegal. We reissued that guidance last year in no uncertain terms. It is a pity if there is any misconception about that.

[Baroness Barker (LD)]

My Lords, health and well-being boards have a responsibility under the Health and Social Care Act to commission sexual and reproductive health services and HIV services. Are they being asked to include gender-based violence in the commissioning formats that they put forward to the NHS?

[Earl Howe]

Most certainly. Gender-based violence is one of the issues which sexual health clinics, and indeed all parts of the NHS, are now alert to. New guidance from NICE was issued in February last year on domestic abuse and how health and social care services and the organisations with which they work can spot and respond to abuse earlier in a more joined-up and preventive way.

[Baroness McIntosh of Hudnall (Lab)]

My Lords, does the noble Earl agree that not all domestic abuse results in physical symptoms? In his Answer, he mentioned mental health services. What is being done to deal with emotional abuse and to discover and refer people who suffer from it?

--- Later in debate ---

[Earl Howe]

My Lords, the provision in the Serious Crime Act on controlling behaviour is one of the ways in which we have addressed that. The noble Baroness is absolutely right: abuse can take many forms. It can be physical, sexual, emotional or psychological. Thirty per cent of this abuse starts in pregnancy, and existing abuse may get worse during pregnancy or after giving birth. In the context of health and care services, the challenge is to alert staff to all those possibilities in a way that avoids them stereotyping the person sitting in front of them.

[Baroness Wheeler (Lab)]

My Lords, more than 26,000 women in the UK received HIV care in 2013. What are the Government doing to assess the relationship between women with HIV and domestic violence, so that effective counselling, advice and support can be given to the women at greatest risk?

[Earl Howe]

My Lords, NHS England is working with the Department of Health to identify the right pathways, access to and availability of psychotherapeutic support for victims of sexual abuse and, in that context, the risk factors at play for women who have HIV. It is vital that the support services that we have and the alerts in the system are sensitive to the issue which the noble Baroness raises.

[Baroness Farrington of Ribbleton (Lab)]

My Lords, would the Minister care to reassure the House on the progress towards parity between mental health services and the rest? It is no good identifying people who need mental health service support and psychological support if those services are not there, and in many parts of the country they have been decimated.

[Earl Howe]

My Lords, we are concerned about the sometimes patchy provision of mental health services in certain parts of the country, and we have channelled additional money to address that in recent months. One of the main ways in which we have demonstrated our commitment to parity of esteem is by introducing, for the first time, waiting-time standards for mental health treatment. That it is a landmark.

[Baroness Manzoor (LD)]

My Lords, can the Minister please give an assurance that FGM is given a high priority in the health commissioning groups’ plans?

[Earl Howe]

Yes, my Lords. The Government hosted the first ever Girl Summit last year on ending female genital mutilation as well as forced marriage and other issues. We set up a specialist female genital mutilation unit following that summit. We provided money last year for the FGM prevention programme, and as part of this we introduced the first ever data collection in the NHS for all acute trusts, which are now required to record in a patient’s healthcare record whenever FGM is identified. We have also said that front-line professionals will in future have a mandatory duty to report cases of FGM in those under 18.

[The Earl of Listowel (CB)]

My Lords, following on from my noble friend Lord Laming’s question on children in these circumstances, is the Minister ensuring that where gender-based violence is at play, any children in those circumstances are being identified and getting the help and support that they need?

[Earl Howe]

The noble Earl makes an extremely important point. I can reassure him that children and young people are very much the focus of the work that we have been doing, and that a guidance document was issued recently to that effect.