Smoke-free (Private Vehicles) Regulations 2015
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, these regulations aim to protect children from the harms of second-hand smoke in private vehicles. In 2007, smoke-free legislation was introduced in England and Wales to protect employees and the public from the harmful effects of second-hand smoke in public places, work premises and vehicles. At that time, the legislation was not intended to extend to private vehicles.
The Children and Families Act 2014 amended the Health Act 2006 to give the Secretary of State regulation-making powers to make private vehicles smoke-free places when carrying children under the age of 18. Second-hand smoke is a serious health hazard, and there is no safe level of exposure. Every time someone breathes in second-hand smoke, they breathe in more than 4,000 chemicals. Many are highly toxic, and more than 50 are known to cause cancer. Second-hand smoke is a real and substantial threat to child health, causing a variety of adverse health effects, including increased susceptibility to lower respiratory tract infections such as pneumonia and bronchitis, the worsening of asthma, middle ear disease, decreased lung function and sudden infant death syndrome. We also know that children are more vulnerable to second-hand smoke exposure in vehicles as they breathe more rapidly and inhale more pollutants than adults.
A significant number of children say that they are exposed to second-hand smoke in private vehicles. In 2012, 26% of 11 to 15 year-olds reported being exposed to second-hand smoke in their family’s car and 30% in someone else’s car. We estimate that approximately 3 million children in England are exposed to second-hand smoke in their family car.
Research shows that smoking in vehicles can result in the build-up of high levels of second-hand smoke, which can persist even when windows are open or the ventilation system is in use. Many children feel unable to ask someone to stop smoking when travelling in a car. Research shows that 34% of children who are exposed to second-hand smoke in vehicles do not feel able to ask the person smoking to stop, because they are frightened or embarrassed.
The Government are committed to protecting children from the harms associated with smoking. Much support has been expressed in this House for ending smoking in vehicles carrying children. I commend all the noble Lords who have campaigned for the introduction of these provisions, particularly my noble friend Lord Ribeiro, who sought to introduce similar measures in his Private Member’s Bill.
The regulations extend the existing smoke-free legislation by setting out the circumstances when private vehicles are smoke-free. Specifically, they amend the current regulations that make public vehicles and work vehicles smoke-free so that all road vehicles that are not already smoke-free will be smoke-free places when they are enclosed and a person under 18 is present in the vehicle. As with the existing smoke-free legislation, the regulations do not apply to ships, hovercraft and aircraft, as they are covered under different legislation, and they do not apply to motor homes, camper vans and caravans when they are being used as a home. This is because the policy aim is for the regulations to apply to vehicles, not homes.
Lord Hunt of Kings Heath (Lab)
My Lords, I, too, welcome the regulations. They follow on from my amendment at Report to the Children and Families Bill, which was agreed by 222 votes to 197, to ban smoking in cars when children are present. I am very proud of that amendment and I express my thanks to organisations such as ASH, the British Lung Foundation, the BMA and others who lent their support to it. I echo the tributes to the noble Lord, Lord Ribeiro, and to other noble Lords who have been campaigning on this matter for some years, including the noble Baroness, Lady Finlay, my noble friend Lord Faulkner, and the noble Baroness, Lady Tyler. My noble friend Lord Simon persuasively and eloquently illustrated the issues that we are dealing with. I am confident that these regulations, if they come to be successfully implemented, will do a lot on those issues.
My noble friend Lord Foulkes was very brave, a long time ago, to pioneer the proposal. What he had to say about the tactics and activities of the tobacco companies was a point very well taken. I welcome the Government’s decision to go ahead with standardised packaging regulations but we know that many of those companies will do their best, through representative bodies, to sabotage them—as I think they have attempted to do in Australia. We must be ever watchful about that.
I agree with the noble Baroness, Lady Tyler, that it is interesting how much public support there is for this measure. She may well have seen the work by the British Lung Foundation which has shown, in survey after survey, that a huge majority of children wanted action to be taken. We have also had the ASH poll conducted last March by YouGov, which showed that 77% of all adults—including 64% of smokers—agreed that action should be taken. Does the noble Earl agree that that shows that there is public support for measures such as this, particularly when it comes to the protection of children? I wonder whether he shares our ambition on this side of the Committee to reduce smoking prevalence to 10% by 2025 and, over the longer term, our goal that all children born in 2015 and beyond will become the first smoke-free generation in hundreds of years.
I noted that the regulations come into force on 1 October 2015. The noble Earl explained why 1 April is not appropriate but I wonder whether 1 July could not have been chosen instead. The noble Baroness, Lady Finlay, raised the experience in Wales. Is the noble Earl confident that the provisions for Wales will come in at the same time as those for England? Could he say a little more about the public marketing plan being developed by Public Health England? That very much relates to the questions asked by my noble friend Lord Foulkes about enforceability, which is so important. I am confident that a great majority of the members of the public will in fact respect the change in the law. The evidence is pretty strong on that. None the less, we need an effective public health campaign and the support of the police in being prepared to take action against those who transgress the law.
Earl Howe
My Lords, I am very grateful to all noble Lords who have spoken and I am grateful for their universal welcome for these regulations. I begin by referring to the remarks of my noble friends Lady Tyler and Lord Ribeiro and the noble Viscount, Lord Simon, all of whom reminded us why we are doing this—the noble Viscount from a very personal perspective. Three million children are exposed to second-hand smoke every year and we want to protect them. Existing smoke-free legislation is popular, as has been said, and has a very high rate of compliance. Personally, I credit the public with more willingness to follow the law and therefore protect their children from second-hand smoke, rather than thinking of elaborate ways to break the law.
The noble Lord, Lord Hunt, asked about public attitudes in relation to these regulations. We know from the responses to the consultation that there is widespread support for protecting children from the harms of second-hand smoke. I do not expect people to go to great lengths to carry on smoking in cars when they know that it is an offence to do so. As has been said, legislation can be instrumental in driving behavioural and cultural change. That has certainly been true in other areas of regulation in the past. Of course, we have to inform the public in a reasonable way before these regulations come into force.
More generally, we agree that education is essential in informing people of the harms of second-hand smoke, particularly to children, and we recognise the importance of social marketing campaigns. The department and Public Health England will continue to protect children from the harms of exposure to second-hand smoke by encouraging voluntary action through social marketing. Previous campaign results illustrate that such campaigns have been effective both in changing behaviour and in driving quit attempts. Of course, I agree with the noble Lord, Lord Hunt, that our ambition as a nation should be to drive down the prevalence of smoking to the maximum extent that we can. We are going to monitor progress in respect of these regulations by assessing the reduction in the number of children who are exposed to second-hand smoke in cars from the current level of 26%, and it is possible to do that.
As I said, I agree with my noble friend Lord Ribeiro about the importance of building public awareness of these health harms. Once again, I pay tribute to all his efforts in this sphere of activity. I also add my thanks to the noble Lord, Lord Foulkes, for his welcome for these regulations, and I acknowledge his far-sightedness in this context, even if he felt like a voice in the wilderness for a number of years. He expressed concern about the enforcement of the regulations—in particular, in view of his perception that the police do not go to great lengths to enforce the mobile phone laws. In fact, my advice is that the police assure us that they endeavour to enforce mobile phone legislation, as they would any law. In fact, in 2012 more than 90,000 fixed penalty notices were issued for mobile phone offences. We estimate that considerably fewer fixed penalty notices will be issued for smoking in private vehicles—possibly around or slightly above 2,000 each year.
The noble Lord, Lord Foulkes, also questioned whether the £50 figure was sufficient. The regulations were drafted following discussions with the police and others to provide for effective enforcement. As I said, the police have confirmed that they will enforce these regulations in the same way as they enforce other laws, such as those relating to seat belts and the use of mobile phones. It is for individual police forces to decide how enforcement will be carried out locally. They have advised that this can be taken forward by local police officers in conjunction with their wider functions on road safety. For example, when running an operation to check compliance with the laws on seat belts or child car seats, the police would also check for anyone smoking or discuss the offences with the driver if there was tobacco in the car. A fine of £50 is consistent with the existing smoke-free legislation, but that level of fine could certainly be subject to review when the regulations as a whole are reviewed.
Lord Foulkes of Cumnock
Was any consideration given to putting points on licences? That would be a much greater deterrent. My understanding is that people feel very worried about having any points added to their licence because of the effect: once it tots up, they could lose their licence. I understand that this is being dealt with as a public health matter but in my view smoking while driving creates a bit of a danger, just as mobile phone use while driving does. I wondered whether that was considered as likely to be a more effective deterrent.
Earl Howe
I am grateful to both noble Lords. In answer to the noble Lord, Lord Foulkes, on the question of points on the driving licence, this avenue was considered but rejected because it would be inconsistent with current legislation. However, I take the point about road safety. As he will be aware, if police judge that a driver is driving unsafely, they have powers to take action under different legislation.
With regard to the position in Wales, smoke-free legislation is a devolved matter, as the noble Lord, Lord Hunt, is aware. I am advised that the Welsh Government have consulted on similar provisions, and we are working with them to co-ordinate our approach where possible.
Lord Foulkes of Cumnock
I am sorry to come in again. Will the Minister confirm whether that is also the case in Scotland?
Earl Howe
My Lords, I am aware that there is legislation before the Scottish Parliament that seems to seek to introduce similar provisions, but I am not aware of the proposed timing that the Scottish Government envisage.
I was asked about the implementation date by the noble Lord, Lord Hunt. He put forward the suggestion that 1 July might have been a better date than October. We chose the common commencement date of 1 October because we judged that we would need that length of time to achieve a sufficient level of public awareness, and indeed for the police to be adequately prepared for their enforcement role.
Care and Support (Market Oversight Criteria) Regulations 2014
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Smoking: E-Cigarettes
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Viscount Ridley
To ask Her Majesty’s Government whether they will consider encouraging rather than discouraging the spread of vaping, in the light of the Cochrane review of e-cigarettes published on 17 December 2014 which found that e-cigarettes were more effective as an aid to quitting smoking than any other method.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, we recognise that e-cigarettes are being used by some smokers to help them cut down, or quit, tobacco. That is why the Government are already working towards a regulatory framework that ensures that they meet basic quality standards and are accompanied by sufficient information to enable informed choices. However, we would not wish to see children taking up vaping, as nicotine is a highly addictive substance. That is why we are also introducing a minimum age of sale for these products.
Viscount Ridley (Con)
I thank my noble friend for that encouraging Answer, but I hope that I can lure him into going just a little bit further. Given that 2 million people are vaping in this country, including a number of Members of your Lordships’ House, that 99% of them are smokers or ex-smokers and that the NHS says that vaping is 1,000 times safer than smoking and probably no more dangerous or addictive than coffee, does he therefore agree with me that it might be worth asking the Chief Medical Officer to look into how we can encourage this technology, given that it has a chance to do what patches, bans, health warnings and taxes have failed to do over decades, which is at last to consign the cigarette to the ashtray of history?
Earl Howe
My Lords, e-cigarettes are undoubtedly helpful to some people in enabling them to cut down on, or quit, smoking. The evidence is encouraging and we would not want to stop smokers trying out e-cigarettes as an alternative, particularly if other remedies have failed. Equally, we need to be cautious as regards the long-term health effects of using e-cigarettes. That is why the Chief Medical Officer is currently not able to recommend their use.
Lord Hunt of Kings Heath (Lab)
My Lords, does the noble Earl agree that the noble Viscount is perhaps guilty of a little bit of journalistic licence on this issue? The Cochrane review undoubtedly produces encouraging results, but its research contains a big “but”, in that it cautions that only two studies, covering just over 600 smokers, were reflected in the review. The Cochrane review says that we should await the outcome of further studies. Does the noble Earl agree, and can he inform the House when we are likely to see the outcome of those further studies?
Earl Howe
My Lords, the noble Lord is correct. The Cochrane review concluded that the quality of the evidence overall is low because it is based on only a small number of studies. The National Institute for Health Research has recently commissioned a large randomised control trial to examine the efficacy of e-cigarettes compared with nicotine replacement therapy when used within the UK’s stop smoking services. That project is due to end in 2018 and will certainly improve our current understanding.
Lord Rennard (LD)
My Lords, does my noble friend agree that we need a public health education campaign to persuade people that there are absolutely no health benefits whatever, or indeed any merit, in becoming addicted to nicotine, and that the promotion of devices such as e-cigarettes should be purely for the purposes of encouraging people to be weaned off their addiction to tobacco with nicotine, as tobacco is still killing nearly 300 people every day in this country?
Earl Howe
My noble friend is absolutely right. I hope that message will come through loud and clear from the measures the Government are taking to ban smoking in private cars when children are present, to introduce standardised tobacco packaging and to prohibit proxy purchasing of tobacco.
Lord Cunningham of Felling (Lab)
My Lords, is the noble Earl satisfied that e-cigarettes are tamper-proof and that what they contain cannot be substituted for other more dangerous substances?
Earl Howe
The noble Lord makes an extremely important point. It is one that is addressed in the tobacco products directive, which is due to come into force next year. The EU Commission is clear that any e-cigarettes sold need to be tamper-proof, particularly as regards children interfering with the contents.
Lord Patel (CB)
My Lords, it is good to know that the National Institute for Health Research would support a larger randomised study, but what the noble Viscount, Lord Ridley, said is true. The current evidence from the Cochrane analysis—the most robust method we know of analysing whether a product, device or a drug is effective against the desired outcome—is that, although the studies were small, 14 observational studies and two randomised trials show that e-cigarettes are more effective than nicotine patches or a placebo. Would the Minister agree that the industry should now also address a standard dosage of nicotine and ensure that the quality of the nicotine used in e-cigarettes is standardised across the industry to avoid subsequent risks?
Earl Howe
The noble Lord makes some important points. He has highlighted the fact that many products on sale are of, shall we say, variable quality. There are risks around the extent to which the dose of nicotine delivered varies; the quality of the ingredients can be suspect; and there is a question mark over the electrical safety of some products. We cannot make a general statement about products that are currently on sale. Nevertheless, it is right that the European Union has taken this matter in hand. From May 2016, only licensed e-cigarettes will be able to contain nicotine in strengths greater than 20 milligrams per millilitre. That will introduce some standardisation.
Earl Cathcart (Con)
My Lords, I started smoking before I was a teenager and in recent years smoked up to 50 cigarettes a day—not good for me. I started vaping in July and I have not had or wanted a puff of tobacco since. In spite of trying to give up on countless occasions, only these vaping e-cigarettes have actually helped me kick the habit. Surely that has to be a good thing. Should we not encourage it to help not just me, but the hundreds of thousands or millions of people who want to give up smoking?
Earl Howe
May I congratulate my noble friend on his achievement? As I have indicated, the advice given by the NHS is that, particularly where other remedies have failed, e-cigarettes may have a place where the person wants to quit. It is true that, while levels of toxicants are present in electronic cigarette liquids and vapour, they are very much lower than those found in conventional cigarette smoke. They are not considered to pose any significant passive inhalation risk.
Care and Support (Business Failure) Regulations 2014
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I come before the Committee today to introduce the draft affirmative regulations under Part 1 of the Care Act 2014. The regulations before us relate to some of the most important elements of the Care Act, which consolidated 60 years of fragmented legislation into a single modern statute built around the needs and outcomes of a person.
Following Royal Assent for the Care Act in May 2014, the Government published final statutory guidance and laid those regulations subject to the negative procedure before Parliament in October and November, as well as laying these regulations in draft. In keeping with the collaborative approach that we have sought to maintain through the development of these reforms, over the summer the Government conducted an extensive public consultation on the guidance and regulations, including draft versions of the regulations that we will consider today.
The consultation engaged the full spectrum of stakeholders including: people receiving care and support and their carers; social workers and other front-line practitioners; local authority commissioners; social care providers; national representative groups; and NHS bodies. In total, the consultation drew more than 4,000 responses from many different sources. Responses were carefully analysed and, where appropriate, changes were made to regulations.
I will briefly introduce each of the four statutory instruments. I turn first to the Care and Support (Business Failure) Regulations 2014 and the Care and Support (Market Oversight Criteria) Regulations 2014. I will address these together as they form the two pillars of our broader strategy to protect people from provider failure. There is a diverse provider market in adult social care where entry and exit is a regular occurrence. Local authorities are currently able to intervene to meet needs in relatively rare cases where services are closed at short notice and individuals are put at risk—and historically they have done so effectively.
The Care Act places specific duties on local authorities in Wales and England, and their broad equivalents in Northern Ireland, to temporarily step in and meet needs where a provider is no longer able to carry on because of business failure. The business failure regulations set out the meaning of “business failure” generally by reference to different types of insolvency, for example administration and winding up. This approach ensures that people receiving services are protected in the event that their provider enters insolvency, without diluting the core responsibility of providers to deliver care services under normal circumstances.
The social care market includes large care providers, operating across much of England, whose financial failure, were it to happen, would cause local authorities considerable difficulty in carrying out their business failure duties without early warning. One such recent example was in 2011 when Southern Cross, then the largest provider of residential services in England, was threatened with insolvency. Local authorities had no prior warning of its financial position. While few people eventually had to change care home, the Government recognised that the degree of worry for people receiving care and their families was unacceptable.
The Care Act accordingly places new duties on the Care Quality Commission to assess the financial sustainability of certain registered care providers. The CQC will do this by collecting and analysing financial information. The CQC may respond to significant risks identified to the financial sustainability of a provider by requiring it to develop a plan to mitigate any risks identified, or ordering an independent review of the business. Should the CQC be satisfied that a provider is likely to fail, it will provide relevant local authorities with an early warning and the information that they need to prepare adequately to protect the continuity of care for individuals. Where the CQC is not satisfied that the provider is taking all the necessary steps to return to financial health, or it feels that it has not been given the necessary information to assess financial sustainability, it is able to take a range of regulatory actions, up to and including the deregistration of the provider in question.
The Care and Support (Market Oversight Criteria) Regulations set the entry criteria for the CQC’s financial oversight regime. Any provider meeting those criteria will be subject to the CQC’s regulatory activities that I have described. They have been designed to capture those providers that—because they are particularly large, geographically concentrated or operate in a large number of local authority areas—would be “difficult to replace” were they to fail financially. It is important to note that inclusion in the regime is a comment not on the likelihood of failure but rather on the risks that would be posed should the provider get into difficulties.
The Care and Support (Children’s Carers) Regulations 2014 relate to the power in the Act for local authorities to support carers of children in a similar way to that in which they support carers of adults, setting out how the rest of Part 1 of the Act applies in this situation. It is important to note that this power applies only in the limited circumstances where carers of children have received a transition assessment in preparation for beginning to receive support under the adult statute, but the transition has not yet actually taken place.
The broad principle at work will be that adult carers of children are supported under children’s legislation, while adults caring for adults will be supported under the Care Act. This instrument is merely an acknowledgement that some flexibility in this regard may be desirable around the time of transition. The instrument has been carefully drafted to ensure that it does not replicate the support for carers of children under other legislation, so ensuring that there remains a clear division of responsibility. These regulations allow for flexible and personalised approaches to support, without forcing local authorities into unnecessary changes to different, broader policies for carers of children and of adults, which exist for good reasons.
Lastly, the Care and Support (Eligibility Criteria) Regulations 2014 set out the national eligibility criteria for adult care and support and carer support. All local authorities will at a minimum have to meet this threshold and cannot tighten their criteria beyond it, although they will have a power to meet needs that were not considered eligible. The national eligibility threshold has been set at a level where the person’s care and support needs, and their inability to achieve certain outcomes as a result, have or are likely to have a “significant impact on their well-being”. This is intended to have a similar effect to the eligibility level that the vast majority of local authorities operate at present. Together with funding announced in the 2013 spending round, this will allow local authorities to maintain the level of access to care and support when the new system is introduced in April 2015.
Given the critical importance of the eligibility criteria, the Government have been especially careful to ensure that they have taken account of the full views of all relevant stakeholders. The Department of Health carried out an extensive engagement to gather views on an initial version of the regulations from June to December 2013, and engaged the Personal Social Services Research Unit at the London School of Economics to evaluate the draft regulations against current practice. These findings informed the second version of the eligibility regulations that were consulted upon in summer 2014.
Alongside the consultation, the department asked PSSRU to evaluate the second draft of the regulations, working with 27 local authorities to compare the draft regulations with recent cases. We made a number of changes to refine the criteria on the basis of feedback and independent research. We have also worked closely with stakeholders to test the approach. I am confident that the final version before us fulfils the Government’s commitment to replicate the current access to care and support in setting the national criteria.
These regulations are required to meet fully some of the central aims of the Care Act: protecting people from the reality of provider failure and the extreme worry caused by its spectre; providing flexible and appropriate support for carers; and ensuring more consistency in people’s rights to care and support. I commend these statutory instruments to the Committee.
Baroness Wheeler (Lab)
I thank the Minister for his comprehensive introduction to these four important affirmative regulations. As he knows, I also have a take note Motion tabled for next week on the negative regulations on implementing the Care Act. Inevitably, there will be overlaps between today’s debate and next week’s but I hope that we can clear off some of the major issues today. The four SIs cover a number of important issues so, while we were happy to have them taken together to expedite the business of the Committee, I hope that the Committee will bear with me since there are a number of areas to cover in relation to implementation of the Care Act and the individual SIs. I also thank the Minister for the very helpful briefing meetings that he has had with Opposition Front Bench health team members on the regulations. He will know that both the Opposition’s health and local government teams are keeping a close watch on how the Care Act is being implemented, so we were grateful for the time that he took on this.
We believe strongly that this first phase of implementation has to be viewed across both the local government and health departments, and considered in the context of the huge funding pressures on local authorities, with a 40% cut in their funding since this Government took office. The Minister, of course, disputes this figure and others from independent bodies on the scale of local government cuts cross the piece and their devastating knock-on impact on social care. Whether the figures are from the King’s Fund, the Nuffield Trust or Age UK, they all put the scale of cuts to social care budgets in terms of billions of pounds.
Recent figures from the Association of Directors of Adult Social Services, with which the Department of Health has worked closely on the Care Act’s implementation, point to this year being the third year of continuing cash reductions and the fifth of real-terms reductions in spending on social care. It points out that, since 2010, social care spending has fallen by 12% while the number of those looking for support has increased by 14%. Social services departments have been forced to make savings of 26% in their budgets—the equivalent of £3.53 billion over the last four years. Compared to 2009-10, almost 300,000 fewer people over the age of 65 are receiving state-funded care.
On many previous occasions, the Minister has set out the additional funding being made available for Care Act implementation—and, despite the challenges, the recent DH stock-take shows encouraging overall progress in local authorities’ readiness for the phase 1 implementation from April 2015. Like the department, we commend the role of the joint LGA/ADASS/Department of Health programme management office. We fully recognise the scale and extent of the work that has gone into consultation exercises with stakeholders, the drafting of the regulations and guidance and the joint working on implementation with local authorities.
However, the same stock-take also makes clear councils’ continuing concerns about the adequacy of funding in the face of modelling which shows increasing support needs for local authorities around IT, workforce, information advice, carers and market shaping. Workforce capacity is a particular concern. The LGA view is that these aspects of implementation of the 2015-16 reforms may be underfunded by as much as £50 million.
Before moving on to the regulations, perhaps I may refer quickly to the Government’s plans to close down the Independent Living Fund in June 2015. We seek reassurances from the Minister that the funds transferred to local authorities from that fund will continue to be used to provide vital support for the disabled people who currently depend on it to be able to live independently in the community and have the same rights, choices and chances as any other citizen. My understanding is that it will be for individual authorities to make decisions on how the resources from the fund will be applied. Will the Government issue guidance to help protect the thousands of disabled people currently receiving ILF support who are affected by this decision? How will they ensure that the money is not just diverted into helping to fund the Care Act implementation or into general funding support for social care services?
The care and support regulations on the market oversight criteria, the interlinking negative regulation on market oversight information—covered by my take note Motion next week—and the business failure regulations are about trying to prevent the sort of problems witnessed in 2011 with the collapse of Southern Cross Healthcare, as set out by the Minister, by empowering the Care Quality Commission to monitor and obtain financial information from providers to check their financial stability and spot the early warning signs of potential difficulties and failure. The aim is to protect vulnerable people and their families if there is provider failure, to ensure that local councils have both early warning and support to be able to maintain vital continuity of support and to ensure that no one depending on the service will suffer.
Baroness Pitkeathley (Lab)
My Lords, I will speak briefly on two of these regulations: those relating to the eligibility criteria, following on from my noble friend Lord Lipsey, and, first, the children’s carers regulations.
Some noble Lords in the Room will remember, when the Children and Families Bill went through this House, the struggle that we had to get parent carers recognised at all in the legislation. All credit to the Minister for finally recognising that parent carers had rights. However, there is now a serious problem because the regulations that we were promised would be issued along with the regulations under the Care Act have not in fact been issued. We have therefore left local authorities without clarity or direction about how to implement these new rights for parent carers—rights which we won with such difficulty but with eventual recognition from the Minister.
I ask the Minister, as did my noble friend, when the Government intend to publish statutory guidance on the new rights for parent carers under the Children and Families Act, why the statutory guidance was not issued at the same time as the guidance under the Care Act, and what plans they have to support local authorities in implementing the new rights for parent carers and young carers. I also support what my noble friend Lady Wheeler said about those carers who are left high and dry—the carers of disabled children who do not have parental responsibility. They are not covered by either piece of legislation and are left with a rump of rights under the long-outdated Carers (Recognition and Services) Act 1995. We really do need to clear that up.
I turn to the issue of eligibility criteria. As everybody knows, the Care Act creates an equivalent duty on local authorities to meet the care and support needs of adults and carers alike. In doing so, it puts carers of adults on the same legal footing as adults with care needs. This was a hugely significant legal development, giving carers the clearest rights ever to support in their caring role, and it is greatly welcomed. However, the Government’s decision to set the minimum threshold at the level at which local authorities are already providing support is a cause for huge concern. As we heard from my noble friend, the historic underfunding of social care has left thousands of older and disabled people without access to the care that they need, and has heaped pressure on to family carers, who are increasingly stepping in to provide care at great personal, societal and economic cost.
ADASS reports that spending on social care has been reduced by some 26% in the past four years. It is absolutely vital that a sustainable level of funding is put in place for social care, setting the funding mechanisms which will deliver the amount of money that we need to tackle the existing gap between need and supply and to keep pace with growing demand—and the demand is growing. The number of carers who care for 50 hours or more per week is rising faster than the number of the general carer population—Carers UK estimates that there has been an increase of 25% over the past 10 years. Despite the ongoing rise in the number of carers in the UK, the number receiving carers’ assessments and carer services from their local authorities is falling. I fear that that situation will only get worse. Carers are going without food and cutting back on essentials. Those who care for 35 hours or more a week are twice as likely to be in bad health as non-carers, with the knock-on effect that that will have on their own health in the future. Therefore, I believe that we have to look very carefully at the levels of funding and at what the eligibility criteria mean.
So far as carers are concerned, the Care Act is all that I could wish for—and have been working for for almost the last 30 years. It is ironic that it is being implemented at a time when budgets are so tight that the rights of carers may be threatened, not enhanced.
Earl Howe
My Lords, I am grateful to all noble Lords who have spoken for their questions and comments on these regulations. I turn first to the regulations relating to business failure duties and market oversight criteria, and in particular to the question posed by the noble Lord, Lord Lipsey, about why we have chosen the CQC as the regulator in this regard. I say openly to him that it was a finely balanced decision. We were confident that we had a choice between the CQC and Monitor. Either could have performed the role. Last year, the Health Select Committee recommended that the Government should reconsider their decision to choose the CQC rather than Monitor to undertake this regulatory function.
However, as set out in the committee’s report, there is a close correlation between poor quality and poor financial performance. It recognised that for this reason the CQC is well placed to perform the function. The CQC is gearing up to do that. It recognises that it needs additional skills to assess the financial sustainability of providers. It does not yet have these core skills in-house. The CQC has procured external consultants to assist in designing its new regime and the resources needed to operate it, which will comprise a mix of internal and external expertise. That will ensure value for money. It is recruiting a number of highly experienced specialists in accounting and insolvency who will be responsible for undertaking the financial sustainability assessments of providers in the regime on an ongoing basis.
The department will support the CQC to carry out this function by providing additional funding. I hope that that provides the noble Lord with some confidence that the CQC is well capable of undertaking this task. The CQC has published draft proposals on how the market oversight regime should operate. A four-week public consultation began on 29 January. Revised final guidance will be published in early April.
As regards the process of gathering financial information, which was referred to by the noble Baroness, Lady Wheeler, the CQC has the power to require a provider to supply the information specified. The provider cannot refuse without risking enforcement action by CQC. The CQC’s aim is that the information it requests from providers will be the same as the provider’s own board would use to assess how the business is faring. It will be light touch in the sense of not onerous. The CQC has a duty to minimise burdens on businesses. However, its overriding duty is to protect vulnerable people by understanding providers’ finances and sustainability, and giving early warning of any likely failure to local authorities to help them intervene. It will require information in a proportionate way to deliver this duty.
The noble Baroness also referred to the need to support local authorities to carry out their temporary duties when a care provider fails. We recently published statutory guidance outlining local authorities’ roles and responsibilities in the event of business failure to support them in this area. In addition, the department plans to work with the Association of Directors of Adult Social Services to develop further guidance on contingency planning for provider failure, which should be available by the summer of 2015. The department has also commissioned guidance which will help local authorities to assess the financial sustainability of their local care market and individual providers within it that are not subject to the market oversight regime.
As regards the Care and Support (Children’s Carers) Regulations, concerns were raised by the noble Baronesses, Lady Wheeler and Lady Pitkeathley, around children’s carers, and in particular the new right to assessment for carers in the Children and Families Act which covers adults caring for disabled children only when they have parental responsibility. The Government will address this issue through the Care Act 2014 and the Children and Families Act 2014 (Consequential Amendments) Order 2015, which will be laid in draft before Parliament very shortly. The order will effectively save Section 1 of the Carers (Recognition of Services) Act 1995 in so far as it applies to adults caring for disabled children who do not have parental responsibility. This means that such adults will continue to have a specific right to ask for an assessment under the 1995 Act if they are caring for a child being assessed under the Children Act 1989 or the Chronically Sick and Disabled Persons Act 1970. I hope that that is helpful.
As to the specific right of adults caring for children to support to meet eligible needs, care and support for children and their carers takes place in a different context to that covered by the adult statute. Children’s legislation rightly gives primacy to the welfare of the child and this is reflected in the way the legislation works. With that said, of course the Government recognise the enormous contribution of carers of disabled children and the sacrifices they often make in taking on these caring roles. That is why the Children and Families Act includes a specific right to assessment for parent carers of such children and a requirement that in carrying out these assessments local authorities must now have regard to the well-being of a parent carer. This mirrors the definition of well-being in the Care Act, which is of course also the basis for considering the impact on well-being through the eligibility criteria.
Lord Foulkes of Cumnock (Lab)
My Lords, if the Minister is going to correct my noble friend, could he say what the combined effect will be in percentage terms?
Earl Howe
I shall have to take advice before answering, but I will be happy to answer the question as soon as I receive inspiration.
Implementing the Care Act will be a challenge for local government, and takes place in the context of competing policy and financial pressures. However, we have already announced £470 million in total for the cost of the new duties in the Care Act which come into effect in April 2015. We have made substantial revisions to our impact assessment, following work with local authorities, to reflect changed assumptions on costs. This will mean acknowledging greater costs for carers in 2015-16 and beyond. We have recognised that.
In the first year, we will create a new carers grant to target this funding where it is most needed. As a result of this work, we believe that implementation of the Care Act will be affordable to local authorities in 2015-16. We will take further steps with the LGA and ADASS to agree a process for monitoring the costs in-year during 2015-16, to check on our assumptions and to provide evidence for the next spending review. Affordability is not just about the overall funding. We are also investing in a large suite of materials to help councils implement the Act effectively.
As regards the question posed by the noble Lord, Lord Foulkes, I am advised that the calculation that he seeks is not a simple one. I will need to write him a letter. I hope that he will allow me to do that. I shall try to be as explicit as I can in that letter.
Lord Foulkes of Cumnock
It is certainly not a simple calculation, and I think my noble friend was near the mark. Would the Minister send a copy of the letter to all the Members present?
Earl Howe
I will be very happy to do so.
The noble Baroness, Lady Wheeler, referred to the closure of the Independent Living Fund, and asked for the Government to provide guidance in the light of that. In response to the views of stakeholders during the consultation, we have provided guidance on how local authorities should manage the transition to social care for people previously receiving ILF funding. The guidance is included in the Care Act guidance that has now been published.
Both the noble Baroness, Lady Wheeler, and the noble Lord, Lord Lipsey, questioned the words “significant impact on well-being”. In particular, they expressed concern that there might be a variation of interpretation of that phrase. One of the core principles of the Care Act is that the person is central to the new care and support system, and that support is built around their needs and the outcomes they want to achieve. Considering the impact on the person’s well-being in deciding on their eligibility will make the determination personal to them. This recognises that people with similar needs and inabilities to achieve certain outcomes may have different eligibility determinations because the impact on their well-being is different.
It is important that there is consistency in approach in how the eligibility criteria are used. We have commissioned Skills for Care to develop training material and the Social Care Institute for Excellence to develop practice materials to support implementation of the eligibility criteria across authorities. Professional judgment will remain key to decision-making—this should not become a tick-box approach which does not focus on the person. We have never claimed that this will remove disparity. The system is person-focused, so it is inevitable and right that individual decisions will be made.
As regards the concern of the noble Baroness about requiring people to be unable to carry out two or more outcomes, and whether that would restrict access to care, this was an issue that was raised with the consultation version of the regulations, where there was concern that it would be impossible for people with mental health problems to become eligible due to how we described the outcomes that had to be considered. We addressed this in the regulations we are discussing today by converting the two lists of outcomes which were described in the consultation version of the regulations into one list which would capture all groups. We checked this approach with our stakeholder working group, which included members from the Care and Support Alliance and ADASS. The group concluded that it could not identify any groups that would be unintentionally excluded from eligibility due to this approach.
I turn next to the issue of informing the public, so that they have a clear understanding of their rights and the system overall. The noble Baroness will remember that we discussed this extensively during the passage of what is now the Care Act. We are putting in place a full communications campaign to ensure that people receiving services, their carers and families—and the broader population—understand the impact of the Care Act and what it means for them. The campaign will feature a partnership between the local and the national, building on the successful approaches pioneered by previous campaigns such as Change4Life. Local authorities, working with other local partners including the NHS and the voluntary sector, will get messages out directly to their own populations. We have developed a range of campaign materials and guidance to help councils communicate the changes in their local area. That will be supported by wider-reaching national activity—
The Deputy Chairman of Committees
With great respect to the noble Earl, I am afraid that a Division has been called in the Chamber. The Grand Committee stands adjourned until 4.35 pm.
Earl Howe
My Lords, I have only a few more remarks to make. I was explaining the measures that we would take centrally and nationally to inform the public, including door drops to 2.5 million households and articles in the national media, as well as local radio and digital activity. The first phase, which focuses on people already receiving services, began late last year and is planned to continue through to April 2016. Scoping is also under way for a behaviour change campaign to encourage people to prepare for care and support needs as part of their wider financial planning.
The noble Lord, Lord Lipsey, questioned whether the final version of the regulations described the current level of access to care and support in an adequate way. We have commissioned the PSSRU to evaluate the final version of the eligibility regulations so that we can further our understanding of their impact. It will carry out its evaluation during the summer, when the regulations have been in use for six to eight weeks, and will report in August. However, there is no reason why people currently receiving care and support have to lose their access to this because of the introduction of the national eligibility threshold. The Care Act provides people with the assurance that local authorities must meet needs that meet the national threshold and, as I mentioned earlier, authorities can also decide to meet needs that are not eligible—in other words, they can meet needs that are considered moderate. Therefore, there is flexibility for local authorities in that sense.
To the extent that I have not been able to answer questions, I shall of course write to noble Lords. However, I hope that with those comments the Committee will be sufficiently reassured to approve these sets of regulations.
Mental Health Services: Sign Language Users
Earl Howe Excerpts(9 years, 9 months ago)
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I thank the noble Lord, Lord Ponsonby, for securing this short debate on the mental health of deaf people who use British Sign Language. Over 10 million adults in England live with some degree of hearing loss and, while some will be among the one in 700 babies born with hearing loss, many of us will develop hearing loss over our lifetime. With an ageing population, this figure is only going to increase, with the World Health Organization predicting that by 2030 there will be an estimated 14.5 million people in the UK with hearing loss, with adult-onset hearing loss predicted to be among the UK’s top 10 disease burdens.
We know from research that deaf people are at a much higher risk of mental ill health than the general population, with 40% of the hearing-impaired population and 50% of the profoundly deaf expected to experience mental health problems during a lifetime, compared with around 25% within the general population. It is therefore vital that we provide deaf people with appropriate services that support their mental health needs.
The Government are committed to improving mental health services and ensuring that those services have equal priority with those for physical health. Our mandate to NHS England makes it clear that everyone—I emphasise “everyone”—who needs them should have timely access to evidence-based services. Over £400 million is being invested over the spending review period to make a choice of psychological therapies available for all those who need them in all parts of England. We have put in place for the very first time waiting-time standards for mental health, a significant milestone on the road to parity.
The NHS is a universal service. I listened with care to the remarks from the noble Lord, Lord Hunt, about equality. NHS England is under a specific legal requirement in relation to tackling health inequalities and advancing equality. The Government will hold NHS England to account for how well it discharges this duty. We recognise the importance of deaf people being supported and enabled to communicate through British Sign Language where they wish to do so. Section 20 of the Equality Act 2010 requires CCGs to make “reasonable adjustments” so that disabled people are not placed at a substantial disadvantage compared with non-disabled people. The reasonable adjustment duty is an anticipatory duty, meaning that service providers are expected to anticipate the requirements of disabled people, and the reasonable adjustments that may have to be made for them, before any disabled person attempts to access the service in question. Simply put, it is not acceptable for health services not to be equipped to provide communication support to those who need it.
Equality legislation means that service providers and public bodies must provide a reasonable adjustment to their services to meet the needs of clients when it is reasonable to do so. This may be the provision of interpreters or services delivered in BSL. In September 2013 the Prescribed Specialised Services Advisory Group, PSSAG, considered a proposal from SignHealth for NHS England to commission psychological therapies for deaf sign language users. The PSSAG felt that although the provision of IAPT services using BSL was clearly complex, it did not meet the requirements for a specialised service commissioned directly by NHS England, and therefore responsibility for commissioning psychological therapies for deaf sign language users should remain with clinical commissioning groups. The PSSAG recommended that CCGs be signposted to the relevant organisations and informed about the services and support that they can provide to deaf patients.
From his remarks, the noble Lord, Lord Ponsonby, was clearly in favour of community and secondary deaf mental health services being commissioned as a specialised service. I am sure he will understand that any proposal of that kind would need to be considered by the PSSAG. However, with regard to NHS England retaining responsibility for existing specialised deaf mental health services, even if co-commissioning were introduced I can assure him that NHS England will retain the responsibility as set out in the mandate and the Manual for Prescribed Specialist Services for the specialised deaf services. Future collaborative commissioning arrangements have not been confirmed as yet, but that will not alter NHS England’s responsibilities as the responsible commissioner. However, we know that more needs to be done.
As the noble Lord, Lord Ponsonby, mentioned, my right honourable friend the Minister for Care Services, Norman Lamb, recently met SignHealth. At this point, I pay tribute to the exceptional work of SignHealth in promoting the same sort of access to healthcare and health information for deaf people as hearing people receive. I have visited SignHealth on more than one occasion. SignHealth impressed upon my right honourable friend the importance of psychological therapies for deaf people through the Improving Access to Psychological Therapies service. Since the meeting, officials have been working to develop proposals in support of the commissioning and provision of psychological therapies for deaf people in England. The noble Lord, Lord Ponsonby, asked whether a working group could be established to look at this issue further. I believe that is a sensible suggestion, and I am happy to commit to it. In the mean time, we will remind clinical commissioning groups of the importance of commissioning IAPT services that are accessible to British Sign Language users.
We are committed to delivering health outcomes that are among the best in the world for people with hearing loss. We have made considerable improvements over recent years, including the rollout of a national screening programme for newborn children, significantly reducing waiting times for assessment and treatment and greater choice of hearing aid services—for example, through independent high-street providers.
NHS England is developing a new accessible information standard which will provide clear guidance to health and social care organisations on the steps they need to take to ensure that disabled patients, carers and service users receive information in appropriate formats, and communication support if they need it. This will include the provision of interpreters or BSL users for deaf people. NHS England has worked closely with SignHealth in the development of the standard, and SignHealth has offered advice about aspects of the standard which relate to deaf people. It is anticipated that the standard will be published in the spring and that organisations would then have 12 months to implement it. Alongside the statutory information standard, NHS England will publish guidance on making reasonable adjustments to meet the communication needs of service users with disabilities.
As well as an information standard, NHS England, alongside the Department of Health, is developing an action plan on hearing loss which will identify the key actions that will make a real difference to improve the lives of all those with hearing loss. The action plan is in its final stages of development with a view to being published soon. I hope that goes some way to address the question asked by the noble Lord, Lord Hunt, about a national service framework or the equivalent thereof.
I shall, of course, write to noble Lords whose questions I am unable to answer in the debate. My noble friend Lady Tyler asked me several questions. One was about the 2005 document Mental Health and Deafness—Towards Equity and Access. There are no plans to update that document. She also asked me, as did my noble friend Lord Borwick, about what we are doing to support CCGs to increase the data collected in their local communities to help inform mental health commissioning for deaf people. Our goal is to create the most open and transparent healthcare system in the world. To support this ambition, we need to build a truer, more up-to-date picture of mental health and well-being, both nationally and in each area. The current level of information collected on IAPT represents the gold standard of data collection. We have robust information on the numbers of people accessing services, how long they wait, how many recover or improve as a result of treatment and the cost of these services, which is a genuine world first in mental health. Our ambition is to bring the same standard of information to all mental health services over time.
My noble friend and the noble Baroness, Lady Hollins, asked about the supply of medically skilled interpreter services. It is clear that we need to work across government and with the voluntary and public sectors to encourage more people to come forward to train and qualify as BSL interpreters. We know that it takes at least three to five years to train a person in BSL to level 3, which is a basic requirement for a therapist/clinician. NHS England advises us that this will be addressed within a framework for workforce planning.
My noble friend Lord Borwick spoke with tremendous authority about the mental health needs of deaf children. Children and young people’s mental health is a key priority for the Government, as I hope he knows. In August 2014, we launched the children and young people’s mental health and well-being task force. That task force brings together a range of experts. It is looking at how to improve the way children and young people’s mental health services are organised, commissioned and provided and at how to make it easier for young people to access help and support, including in schools, through voluntary organisations and online. That very definitely includes deaf children with mental health problems.
My noble friend Lord Addington spoke very powerfully about the use of technology. As he will understand, this is a decision for individual providers, but the NHS’s ambition is to embrace technology as part of its drive to offer modern, convenient and responsive services to patients, their families and their carers. General practices are leading the way on that. The NHS is working with local commissioners and is undertaking a number of pilots to redefine and improve the design of the future NHS 111 service, which includes improvements to the text relay service, making it easier for text relay users to navigate to a service provider. As regards the delivery of psychological therapies to deaf people, we are currently exploring the commissioning of online BSL or text-based models of delivery.
The noble Lord, Lord Hunt, asked me about the UCLH project. University College, London, has developed a case with the Deafness Cognition and Language Research Centre on what a deaf cognitive service should look like. We understand that proposals for the future of the services are under discussion.
I hope that in the time available I have been able to reassure the noble Lord, Lord Ponsonby, and indeed the House, of this Government’s continued commitment to meeting the specific needs of deaf people and that we take this issue very seriously.
Medical Innovation Bill [HL]
Earl Howe Excerpts(9 years, 10 months ago)
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Lord Hunt of Kings Heath (Lab)
My Lords, I, too, welcome the amendment and thank my noble friend for his efforts. I also thank the noble Lord, Lord Saatchi, for the way in which he has been prepared to listen and to support amendments which we see as improving the Bill. This amendment goes a long way to meeting some of the concerns expressed by medical bodies about what might be described as unintended consequences arising from the Bill.
I do not agree with the noble Baroness, Lady Gardner, that this amendment could be seen as delaying action. I think it is rather the reverse. Having this provision and the need to act within it would give confidence to doctors. I think the definition of,
“a representative body of respectable medical opinion”,
is a question of you know what it is when you see it. I would have thought that doctors would have no doubts about to which responsible body they should turn.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, my interpretation of the amendment moved by the noble Lord, Lord Winston, is that it aims to ensure that in obtaining the views of one or more appropriately qualified doctors, a doctor is carrying out a test equivalent to the Bolam test. I recognise that these words are carefully chosen, and I listened closely to what the noble Lord, Lord Winston, said. However, I do not believe that the language of the amendment accurately reflects the requirement of the Bolam test.
To go a bit further, I am concerned that the amendment would create more confusion than clarity for both doctors and the courts. In particular, how would a court determine what is meant by the phrase “command the respect of”? It certainly does not mean agreement. If Noble Lords want an illustration of the difference, I deeply respect the noble Lord, Lord Winston, but, as in this case, I do not always agree with him.
Like my noble friend Lady Gardner, I question what might count as,
“a representative body of responsible medical opinion”.
Again, this wording is not in the Bolam test. The Bolam test sets out that a doctor is not negligent if their decision is accepted as proper by a responsible body of medical opinion. Bolam accepts that a doctor is not negligent merely because there is a body that would take a contrary view. Therefore, the courts recognise that there is not necessarily a representative body of medical opinion. The wording of the amendment would be open to interpretation by the courts.
I recognise that the noble Lord’s aim in tabling this amendment is thoroughly worthy and is to ensure the protection of patients. I assure him that the existing provisions in the Bill seek to achieve that same aim. Therefore, the Government do not consider the amendment moved by the noble Lord, Lord Winston, necessary. The Bill’s provisions boil down to one key test: a test of responsibility. Clause 1(2) states:
“It is not negligent for a doctor to depart from the existing range of accepted medical treatments for a condition if the decision to do so is taken responsibly”.
This objective test of responsibility ensures that the decision about whether a doctor has been negligent is based on the same premise as the existing Bolam test: has this doctor acted responsibly? Patient safety is an integral part of this test. Clause 1(3) makes clear that the risks of any innovative treatment must be considered, so if the treatment was likely to compromise patient safety unacceptably, it is highly unlikely that it would be considered a responsible decision when later judged in court. Furthermore, the Bill does not require doctors simply to obtain the views of experts in the field; it requires a doctor to take full account of those views in a responsible way. As such, a doctor could not simply listen to, or note, the views of colleagues and then proceed to disregard those with which he or she disagrees. A doctor can fully expect a court to scrutinise closely how they have taken account of those views and consider whether they had acted on the views in a responsible way.
It is that requirement which ensures that the Bill is the nearest equivalent to that of the Bolam test. I fear that the amendment of the noble Lord, Lord Winston, despite its best intentions, would not add to the operative provisions of the Bill but would only risk creating confusion as to the language of the existing Bolam test. It is not just that the Government consider this amendment unnecessary—which we do—but that we also have serious concerns about whether the language of the amendment will create confusion for doctors and, indeed, the courts.
Lord Saatchi (Con)
I thank noble Lords who have addressed this amendment. I happily added my name to the amendment of the noble Lord, Lord Winston, because I believe that it provides helpful additional clarity for Peers and those outside the House about the intention and effect of the Bill.
Your Lordships will be aware that on a number of occasions I have tried to stress that the intention and effect of Clauses 1(3)(a) and (b) are not, as my noble friend was just saying, that a doctor can just ignore the views of anyone who disagrees with the proposed treatment or that he or she can choose to consult only those who are known to agree. I agree with my noble friend that Clause 1(3)(a) and (b) contain a legal duty to obtain views and take proper account of them, and that that is a serious and effective threshold. However, I wonder whether I may encourage my noble friend to share with me the observation that a number of noble Lords, including the noble Lords, Lord Winston and Lord Turnberg, were anxious to see this set out more expressly in the Bill in language that at least resembles, if not copies completely, the wording of the Bolam test, as described by the noble Lord, Lord Pannick. I believe that the amendment of the noble Lord, Lord Winston, does that in a manner that will not change the substantive policy of the Bill, as already agreed by your Lordships, but will perhaps give greater clarity about the intention for those Peers and others who want to see this language expressed in the Bill in the closest approximation possible to the existing Bolam test, which is what we are all trying to preserve.
As your Lordships know, the Bill is all about giving greater clarity and certainty to patients and doctors at the point of treatment, and not forcing them to wait for the unpredictable outcome of possible litigation or disciplinary proceedings. I can only welcome any amendment designed to enhance clarity and certainty about the effect of the Bill itself. I am therefore very happy to support it.
Lord Winston
My Lords, briefly, I support the amendment of my noble friend Lord Hunt of Kings Heath as well. I was reminded by the noble Lord, Lord Ribeiro, of laparoscopic surgery. Of course, we gynaecologists were doing that 20 years before the noble Lord was and we did not have as many deaths. Having said that, what the surgeons did with laparoscopic surgery and recording those events was really important in bringing down the complication rate and the haemorrhages that occurred. That is a very good example and the noble Lord is to be thanked for bringing it to the House. It is exactly what would be covered here.
I would be astonished if the Government seriously opposed this amendment. I was very unconvinced by the noble Baroness, Lady Jolly, in the previous stages of the Bill. She did not seem to take on board exactly what we were trying to say about the need for keeping proper records, which is important in all sorts of ways. If you keep a record and it is done under this Bill then you are effectively legally protected. For that reason if no other that would be important, but in any case we have to build up the knowledge of our experience. We do that automatically in the laboratory. Every single thing we do in the laboratory, whether negative or positive, we record in our laboratory books. If we do not, we are not doing good science or science useful to the public. Here in innovative medicine, we are—whether we like it or not—doing a form of science because we are exploring our knowledge about what a treatment means. That is what science means. I urge the Government to support the amendment. I feel very strongly about this. If the Government were reluctant to support it and my noble friend Lord Hunt were to divide the House, I would certainly join him.
Earl Howe
Perhaps I may deal briefly with the question posed by the noble Baroness, Lady Masham, who asked whether the Bill would apply to patients receiving private treatment. The answer is yes. Any departure from the accepted range of medical treatments for a condition, whether that patient be receiving NHS or private treatment, would be covered under the Bill.
The amendment of the noble Lord, Lord Hunt, would change the test of negligence under the Bill. If accepted—and assuming that the appropriate professional requirements were created—the amendment would require a doctor to comply with any professional requirements as to registration of the treatment; that is, to register the treatment with a scheme for the purposes of taking a responsible decision to depart from the existing range of accepted medical treatments for a condition. In other words, registering details and results of an innovative treatment on a data-capturing scheme would form part of the steps that a doctor has to take under the Bill.
Lord Woolf (CB)
I hope the Minister will forgive me for saying that I do not think he is right in saying that the amendment would in any way change the standard. It is only adding a requirement to keep records. That does not change the standard of care which is required. It puts on the doctor an obligation to do something in addition, but I suggest with respect that it does not change the standard.
Earl Howe
I am grateful to the noble and learned Lord. Obviously, I must take account of his expert view, but the fear that I was about to articulate is that if you require a doctor to register the details and results of whatever innovative treatment he or she may have administered on some kind of data-capturing scheme in the way suggested by the noble Lord, Lord Hunt, that would constitute part of the requirement for the doctor to demonstrate that he or she has acted responsibly, and thus not negligently. Therefore, if the amendment were accepted, the result could be that a failure to record would be part of the picture when deciding whether a doctor had acted negligently.
If that point is accepted—I expect the noble Lord, Lord Pannick, to take me to task on it—my submission is that that would be a disproportionate requirement.
Lord Pannick
I understand the noble Earl’s concern that if there is an obligation to report the results, that might have an effect on the common law Bolam test, but surely it would not, because of the contents of Clause 2(1), which states:
“Nothing in section 1 … affects any rule of the common law to the effect that a departure from the existing range of accepted medical treatments for a condition is not negligent if supported by a responsible body of medical opinion”.
I therefore understand that under the Bill—the noble Earl can tell me whether I am right or wrong—the doctor has two means of defending himself or herself. One is the Bolam test at common law; the other is to take advantage of the procedures of the Bill. If one of the procedures of the Bill is a duty to report, that does not affect the general Bolam test under Clause 2(1).
Earl Howe
My Lords, I take the point made by the noble Lord, Lord Pannick. My point was not that the amendment would alter the effect of Clause 2(1). It would not have an effect on the common law, but it would create a more burdensome test under the Bill. That is troublesome to me, because to do that would in itself impose requirements which go beyond the current Bolam test of negligence. It would mean that the test of clinical negligence was more burdensome under the Bill than under the common law.
Lord Woolf
There are provisions as to machinery and provisions that deal with standards of care. I think that this is a machinery requirement. You could not sue the doctor because he had not reported something. It is something that the law requires but I do not think it is intended that this should be enforced by criminal sanctions. There is certainly no specific provision of that sort.
However, it would exclude the ability to take advantage of Clause 1. You have to do Clause 1 in a way that complies with the Act, and the requirement that is now being inserted says that if you are going to do so, you have to do this. The implication is that if you do not do it, you will not get the benefit of Clause 1. This does not mean that the doctor is going to be liable for negligence just because he has not signed the register. As the noble Lord, Lord Pannick, has made clear and those who have taken part in the debate so far have emphasised, the common-law position remains the same. This is an additional mechanism to allow innovation. I therefore suggest that a machinery provision does not do anything else than act on a requirement that you have to go through if you want to take advantage of the Bill.
Earl Howe
My Lords, I have been in the House long enough to know that when the noble and learned Lord, Lord Woolf, opines on something, it is a matter that all noble Lords would do well to listen to, and I am grateful to him. I agree that the amendment does not change the standard of care, we are agreed on that, but our concern is that a court might look at the requirements under the Act—and this is one of the requirements—as part of the picture that it would form as to whether or not the doctor had acted responsibly. It is merely part of the picture.
If we are agreed on that, and I hope that we are, it does not seem sensible to me that we should impose requirements in the Bill additional to those under the existing law, as that could risk deterring doctors from innovating under the Bill. Let us not forget that a doctor does not have to follow the Bill if he or she does not want to; they can simply rely on the Bolam test later on if they are challenged. Do we want to deter doctors in the form of a test or requirement that obliges them to go further than they would otherwise go? If they were deterred by that, it would defeat the whole object of the Bill and result in less benefit to patients, so I worry about that.
The amendment from the noble Lord, Lord Hunt, specifies that the use of a scheme be enforced through professional requirements. We have sought advice from the GMC about whether professional requirements in the form of guidance might be a suitable route to enforce the sharing of learning from innovation. The GMC has been clear that it is very happy to consider anything it can do to be helpful. However, from those initial conversations, it seems that this may not in fact be an effective route. The GMC’s statutory power is to provide advice. Doctors must be prepared to justify their decisions and actions against the standards set out in its guidance.
Serious or persistent failure to follow the guidance would put a doctor’s registration at risk. So on the one hand, were we to go down this route, a doctor who failed only once to use a data registry might not face any consequences; that would be okay for the doctor. However, this would not address noble Lords’ concerns that the results of each and every innovative treatment, whether or not successful, should be recorded. On the other hand, if a doctor persistently failed to use the data registry, this could result in fitness to practise proceedings being brought against him or her for not having recorded information on an online database designed to foster the sharing of learning from innovation. Should a doctor’s fitness to practise be called in question simply on those grounds, that really does not seem a proportionate response.
For the reasons that I have outlined today—namely, the difficulty of relying on professional requirements and the link, which I hope noble Lords will accept, to the test of clinical negligence—the Government would not be able to support this amendment.
Lord Giddens
I am not a medical specialist but I have followed this all the way through. What kind of structure would the Minister envisage being put in place if there is not a formal requirement of this sort? If you do not have some kind of system of dealing with the data produced, the whole thing becomes an erratic exercise and therefore does not contribute to the overall fund of medical knowledge.
Earl Howe
I would not disagree with the noble Lord at all. I was about to say that on Report, my noble friend Lady Jolly suggested that there should be a registry and made a commitment to that effect. I would like to clarify that the Government are committed to exploring what may be useful in the data registry. The key here is to establish what could be workable and beneficial. The Government have heard a range of views on the topic of a data registry from those who argue, as many of your Lordships do, that this is essential to the Bill to others, including eminent clinicians, who argue that informal methods of sharing learning are more effective and that a compulsory registry would be overly burdensome.
With thanks to the contribution of your Lordships, the Government have started this conversation and are committed to continued engagement with relevant bodies. Any method of learning that should develop from the Bill must surely work for doctors to be of benefit to patients and the wider medical community. That is no simple task. It is crucial that any mechanism to encourage learning should be developed with a sufficiently light touch so that clinicians see it as facilitative of good practice, rather than burdensome and bureaucratic. It is also important to consider the costs of a method of learning and how this can be encouraged in the most cost-effective way. While I do not take issue with the end-point which noble Lords want to reach, I really believe that it is wise for us to remain open to all possibilities, rather than committing in legislation to an approach which may discourage doctors from innovating under the Bill and therefore not be of benefit to patients in the longer term.
This is a beguiling amendment and I understand the motivation behind it but I hope that noble Lords will join me in questioning the wisdom of having such an amendment in the Bill and accept instead our preferred approach: to continue to discuss this issue with relevant parties as the Bill progresses and, should the Bill pass, to engage with the medical community as to the best way to ensure that innovation can be translated into learning.
Baroness Masham of Ilton
Before the Minister sits down, to do research surely one needs data to see what benefits patients because these are new procedures that we are talking about.
Earl Howe
I would just say that the Bill is not to do with research but with innovative treatment, which is rather different. There is no question of the noble Lord, Lord Saatchi, promoting another form of clinical trial so while I accept the principle that the gathering of data is a very good idea, we must be clear that this is not for clinical research.
Baroness Gardner of Parkes
Before the noble Earl sits down, from the outset we have been very clear that this was to be recorded. Everyone has wanted someone reputable to come forward and say that they were going to record it. To see that this will possibly now not happen is just unbelievable because what is the benefit, unless people in the future can benefit from it and it is accurately recorded? I am sorry to say that I cannot accept the view that this amendment should not be accepted by the Government.
Lord Winston
Before the noble Earl sits down—although I do notice that he has managed to take his seat on the Front Bench—I would argue that of course it is not research; we accept that completely. But it is science within the meaning of the Latin word, which has the notion of knowledge, and of course it is wrong for us to exclude knowledge being dispersed and promulgated. Of course, the Medical Innovation Bill hopes to do this, and that is the point of supporting it. Otherwise, I fear that the Bill when enacted will be almost useless. This has been an issue of great concern and was the cause of correspondence this week from many different medical sources. I hope that the Government will consider that very carefully.
Earl Howe
Of course the Government will consider this carefully. Let me make it clear that I do not want to sound negative about the idea of data gathering. I am the first to recognise that that could be a major advantage of the procedures that my noble friend Lord Saatchi is encouraging within the scope of the Bill. I would not dispute that for a moment. My concern is that to build a further requirement into the test of negligence would be the wrong course to take, because that is how this amendment is framed.
Also, what would be the benefit if we do not engage fully with the medical community to make sure that doctors are able to use any registry that might be created easily and simply? If it does not work for doctors, there will be no benefit—so I think that we need to take longer over this. It is not a case of kicking it into the long grass, but in the time available we have not been able to come up with a precise solution, despite our best endeavours in our discussions with the GMC.
Lord Brown of Eaton-under-Heywood (CB)
My Lords, before the Minister finally sits down, does he agree that it would be desirable that any professional requirements of registration should deal not only with innovation,
“under the provisions of this Act”,
but also with innovation that may well be outside the provisions of this Bill but are covered by Bolam and expressly contemplated in Clause 2(1): namely,
“a departure from the existing range of accepted medical treatments”.
That, too, needs to be recorded and registered because it may point the way ahead. As matters stand, that is not within the compass of the proposed amendment to Clause 1.
Perhaps I may further ask the Minister whether he agrees with me that the real purpose of this Bill is to carry Bolam a stage further. Bolam applies if a proposed innovation is,
“a departure from the existing range of accepted medical treatments”,
and is,
“supported by a responsible body of medical opinion”.
Clause 1 of the Bill, as was made plain by the first proposed amendment, deals with a situation where,
“a departure from the existing range of accepted medical treatments”,
may not actually be supported by, but has the respect of,
“a responsible body of medical opinion”.
In other words, the,
“responsible body of medical opinion”,
may not support it, but, taking that into account and having regard to patient safety, none the less respects it and therefore implicitly allows it to go forward as a responsible treatment. That is outside Bolam but within the compass of the Bill.
Earl Howe
I will reply very briefly, with apologies to noble Lords for speaking so often. I have been troubled by the fact that if we were to build this amendment into the Bill, it would apply to those innovative treatments covered by my noble friend’s process and not to other innovative treatments. It would seem inherently odd if we did not have a database that captured all innovative treatments—so, again, we need to consider that, and the noble Lord, Lord Hunt, referred to that issue himself.
On the second point made by the noble and learned Lord, my concern is that—going back to the previous amendment we were discussing—there was a mismatch of wording that does not quite conform to the Bolam test. However, I will consider what he said carefully and come back to him, if I may.
Lord Saatchi
My Lords, I am so grateful to all noble Lords who have spoken on this amendment. I will not in any way detain your Lordships by reciting again what has been brilliantly and articulately expressed by other noble Lords. I will say only one thing about this amendment, which is to pay tribute to Oxford University, whose original concept it was—I refer to Professors Alastair Buchan and Stephen Kennedy at Oxford—that a database should be created to record the results, positive and negative, of innovation under the Bill. The reasons were, as expressed by noble Lords today, to advance scientific knowledge, as the noble Lords, Lord Giddens and Lord Winston, said, and to protect patients with full disclosure and full transparency.
A number of individuals and organisations have told me that any doubts that they had about the utility of the Bill would be removed by the emergence from it of this new and exciting initiative in data collection and sharing. This database will, I hope, be a significant—perhaps enormously significant—development in the field of medical practice. I am confident that my noble friend and the officials in the Department of Health will be able to devise a suitable system, in collaboration with the medical profession and the regulatory bodies, which will achieve what is wanted here.
I will end by saying that I do not remember ever seeing your Lordships’ House in full agreement, on all sides of the House, on one amendment. We have not just had that once, on Report, but have had an exhibition of exactly the same unanimity and strength of feeling again. I very much hope that my noble friend the Minister will not consider voting against the amendment should it be put, but will, as he said, take forward the Government’s commitment to ensure that the register happens and is put in place, and that he will be able to encourage the noble Lord, Lord Hunt, and all the rest of us here that that will happen.
Alcohol: Impact on Accident and Emergency Services
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Lord Brooke of Alverthorpe
To ask Her Majesty’s Government what discussions they have had with the drinks industry about contributing to National Health Service accident and emergency costs.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, the alcohol industry has responsibilities to reduce harm caused by its products. We have challenged the industry to deliver action through the responsibility deal. It is important to recognise that individuals also have responsibility for their behaviour. The Government set the legislative framework, and the United Kingdom has relatively high taxes on alcohol, which are the main way to compensate society for its costs. Our alcohol strategy seeks to prevent and reduce harm from alcohol.
Lord Brooke of Alverthorpe (Lab)
My Lords, I am grateful for the pleasant words from the Minister, but I omitted to pick up on just what action the Government intend to take. Does he share the concern of his new CEO for the NHS, Sir Simon Stevens, that more than 1 million people are now presenting at A&E each year with alcohol problems? Not only that, but they are in the main accompanied by their friends and often family, who swell the numbers and are equally intoxicated. They are creating great difficulties for nurses, doctors and other A&E patients. Many of those people do not come from their home; they come from drinking establishments from which some of them have been ejected. Many of those establishments have personnel there looking after security for the protection of the interests of the drinks industry. If the drinks industry can pay for those people to protect its interests, why cannot it be required to pay to protect the interests of nurses, doctors and other people in A&E who are intimidated by people who are drunk?
Earl Howe
My Lords, alcohol-related attendances at A&E are certainly a matter of concern; we fully recognise that. Having said that, there is no evidence to suggest that current pressures in A&E departments are related to trends in alcohol-related attendances. We are taking a range of actions to prevent and reduce harm both nationally and in many local areas. We are certainly not just treating this as a financial issue. This is an issue to do with people’s health, and it is important. The industry is playing its part through the responsibility deal, which is already yielding some encouraging results.
Baroness Finlay of Llandaff (CB)
Do the Government accept that currently, the cost to the NHS of these attendances is about £120 per taxpayer for England? The arguments for minimum unit pricing are very strong, given that the attendance range peaks between the ages of 35 and 55 and yet, in that age group, you can drink your whole maximum weekly recommended amount of alcohol for less than £10 with the current pricing system. Minimum unit pricing might bring in more money to cover the cost to the NHS.
Earl Howe
My Lords, we are keeping the developing evidence on a minimum unit price under review. It has only ever been part of our alcohol strategy—which, as I said, includes a range of actions. We acknowledge the need to give careful consideration to any possible unintended consequences of MUP, such as its potential to impact on the cost of living, the economic impact of the policy and, importantly, a possible increase in illicit alcohol sales that could ensue.
Lord Avebury (LD)
My Lords, is it necessary to refer to the alcohol industry for measures to alleviate the £21 billion-worth of harm that it causes? Should my noble friend not instead refer to the calculations by the University of Sheffield showing the amount by which alcohol harm can be reduced by increases in taxation?
Earl Howe
My Lords, we have taken a strong policy on taxation in recent years, particularly to reduce the availability of cheap, strong alcohol. Since the 2010 general election, duties on spirits have risen by more than 18%, which is well above RPI, and on wine by more than 21%, again well above RPI. We have also introduced a ban on the sale of below-cost alcohol, which should stop the worst cases of cheap and discounted alcohol sales.
Lord Hunt of Kings Heath (Lab)
My Lords, can I ask the noble Earl about the attitude of the drinks industry? He said that it is responsible but can he confirm that the long delay in the publication of new guidelines from the Chief Medical Officer on safe drinking levels is because she wants to reduce those levels but the drinks industry objects, and the Government have given in to it?
Earl Howe
Not at all, my Lords. As I explained the last time the noble Lord asked that question, the reasons were purely technical and nothing to do with a disagreement. The CMO is overseeing a review of the alcohol guidelines so that we can ensure that people make better-informed choices. That is now under way and in its second phase. During the review we will look at any significant new evidence that relates to pregnancy, in particular, to consider whether our advice needs to be updated. We expect to consult on new guidelines by the middle of this year.
Lord Garel-Jones (Con)
Would my noble friend consider obliging the purveyors of this habit-forming, hallucinatory drug to place a government health warning on their products?
Earl Howe
My Lords, again, there has been a great deal of progress in alcohol labelling. Independent research published in November showed that just under 80% of bottles and cans of alcohol on shelves now have the correct health labelling: a clear unit content, the CMO’s lower-risk drinking guidelines and a warning about drinking when pregnant. That fulfils an industry-wide responsibility deal pledge.
Lord Singh of Wimbledon (CB)
My Lords, does the Minister agree that the drinks industry should bear the cost of treating people with alcohol-related sickness and illness who end up in A&E that is proportionate to their number? For example, it is 80% in some hospitals on a Saturday evening.
NHS: Clinical Negligence
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Lord Sharkey
To ask Her Majesty’s Government what are the causes of the £3.1 billion increase in the National Health Service’s potential liabilities for clinical negligence to £25.7 billion between 31 March 2013 and 31 March 2014.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, there are several factors behind this increase. These include the rise in numbers of patients cared for and the complexity of their care. In addition, there has been a general rise in litigation across a number of sectors, including the NHS, which is driven in part by no-win no-fee agreements. High costs incurred by claimants in bringing civil litigation have also played a role in the increasing clinical negligence cost and associated provisions.
Lord Sharkey (LD)
In the last five years, NHS spending has grown by 12%. In the same period, liabilities for negligence have actually doubled. With the current rate of growth, they will take only six years to reach around £50 billion. The Medical Defence Union thinks that is unsustainable and has suggested reducing liabilities by changing the law. It suggests allowing courts to take account of the fact that the NHS and local authorities can provide some of the treatments required by successful claimants. Does the Minister agree that this is part of the way forward?
Earl Howe
My Lords, moneys paid in settlement of clinical negligence claims cannot be reclaimed or recycled in the way that my noble friend appears to suggest because, in the nature of NHS care, it is free from the patient’s perspective. We are, however, concentrating on various ways to reduce the number of clinical negligence incidents and, indeed, to improve patient safety, which is of course part of the way in which we can reduce the number of claims in the first place.
Lord Hunt of Kings Heath (Lab)
My Lords, what view have the Government taken of the Medical Defence Union recommendation for repeal of the Law Reform (Personal Injuries) Act 1948? In essence, that would mean defendants could buy NHS healthcare packages as opposed to the more expensive private care packages, and, presumably, would reduce some of the cost of the claims that are currently going through.
Lord Willis of Knaresborough (LD)
My Lords, following the passage of the Health and Social Care Act, there are now some 350 other qualified providers. Will my noble friend confirm that they all get support through the Department of Health for any clinical negligence claims? If that is so, how much was paid out in 2013? Further to the point made by the noble Lord, Lord Hunt, if a claim is made within the private sector or third sector, will such providers be prevented from providing that claim within their organisations if negligence was proven?
Earl Howe
My Lords, potentially, independent sector providers may elect to be members of the negligence scheme, although only in respect of their NHS services. Therefore, only NHS-related liabilities would be covered in those circumstances. It is a pay-as-you-go pooled scheme, and I do not therefore have the figure that my noble friend requested. If I can get the figure disaggregated for him, I would be happy to write. In answer to his last question, I take it that he is asking whether the provider would be allowed to continue treatment, having been found to be negligent or having admitted negligence. That decision would be clinically led, with the patient exercising choice in each individual case.
Lord McFall of Alcluith (Lab)
My Lords, may I suggest an examination of the area of clinical governance? I and my family are not alone in having a negative experience of a disjointed, rather than an integrated, clinical governance network, where communication between departments and individuals was virtually non-existent. The admirable Reith lecturer, Dr Atul Gawande, examined the concept regarding why doctors fail, and one of the main reasons he came up with was that policies that fragment a unified system rather than cohere the system were in the interests of neither patients nor the NHS, as can be seen with these claims.
Earl Howe
The noble Lord makes a series of good points. He may be interested to know that part of the series of pledges that form the Sign up to Safety campaign, which hospitals can apply for, can include the principles of being transparent with people—including about any mistakes that have been made and what is being done to tackle safety issues—and collaboration, by taking a leading role in supporting local collaborative learning, so that the system genuinely can work together and learn together.
Lord Phillips of Sudbury (LD)
My Lords, is my noble friend satisfied—I am thinking, for example, of the scandal of whiplash claims—that the legal resources available to the NHS are sufficient for the task?
Baroness Finlay of Llandaff (CB)
My Lords, does the Minister agree that complaints need to be dealt with rapidly, preferably by a phone call or home visit, rather than in the current slow systems that often compound the anger of those who feel that they have been wronged by the NHS and which therefore make the procedure of litigation more likely? There should, rather, be rapid settlement, a very sincere apology and lessons learnt with follow-up.
Earl Howe
I agree with the noble Baroness. We view it as important that NHS organisations manage complaints in a positive manner and use the information obtained to improve service delivery. Saying sorry is important. People who complain often want an apology, an explanation and an assurance that the same thing will not happen to someone else.
Lord Roberts of Llandudno (LD)
My Lords, do the figures we have been given today include Wales, Scotland and Northern Ireland? Are those claims included in the total figure?
Health: Human Papilloma Virus
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I begin by congratulating the noble Lord, Lord Patel of Bradford, on securing this debate and on bringing this important subject to your Lordships’ House. I understand the noble Lord’s concerns on this issue. Vaccines provide vital protection from a large number of diseases, including the human papilloma virus. We need to ensure that they are used as effectively as possible and that those who would most benefit from them are included in any vaccination programmes that we implement.
As has been mentioned, the Government are advised on all immunisation matters by the statutory body, the Joint Committee on Vaccination and Immunisation. The JCVI keeps all immunisation matters under review, providing advice and recommendations to Ministers on all current and potential vaccination programmes. It is, therefore, to the JCVI that we look for expert advice when considering issues such as those raised today.
The UK’s current HPV vaccination programme, based on advice from the JCVI, began in 2008, and its aim is to prevent cancers relating to HPV infection, specifically cervical cancer. HPV is a sexually transmitted disease. Our main objective, therefore, is to provide HPV vaccine to young women before they reach an age when exposure to HPV infection increases and vaccination would become less effective because many would have already been infected. For that reason, the vaccine is offered to all girls in school year 8—that is, at ages 12 to 13 years. As HPV is responsible for virtually all cases of cervical cancer, prevention of this disease remains the primary aim of the current programme.
The UK’s HPV vaccination programme has been a considerable success. Almost 8 million doses have been administered across the UK since 2008 and this country has among the highest rates of HPV vaccine coverage achieved in the world. In England, 86.7% of girls eligible for routine vaccination in the 2013-14 academic year completed the three-dose course and 89.8% have received at least two doses of vaccine.
The noble Baroness, Lady Hollins, asked about herd immunity. When recommending introduction of the programme in 2008, the JCVI considered that once 80% coverage among girls was achieved, which we have now attained, the vaccination of boys was likely to provide little additional benefit in preventing cervical cancer in girls. As the noble Lord, Lord Patel, made clear, with high uptake of HPV vaccine among girls, many boys will also be protected against other HPV-related cancers such as anal cancer and head and neck cancers, because transmission of HPV between girls and boys should be substantially lowered.
However, as I mentioned, the JCVI keeps all vaccination programmes under review and has recognised that under the current programme the protection that accrues from reduced HPV transmission from vaccinated girls may not be provided to men who have sex with men, or MSM, because they are less likely to have sexual contact with vaccinated women. Given increasing evidence of the association between HPV infection and oral, throat, anal and penile cancers, and the impact of HPV vaccination on such infections, the JCVI set up an HPV sub-committee in October 2013 to consider a number of key issues around HPV vaccination, including the question of potentially extending the programme to MSM and adolescent boys—that is, to protect those who may go on to become MSM—or to both. The committee has also noted the public, parliamentary and third-sector concern about this issue and agreed that evaluation of potential extensions to the programme to include MSM, adolescent boys, or both, should be a priority.
Your Lordships may be aware that last November, following very careful consideration of the evidence, the JCVI published for consultation provisional advice that a targeted HPV vaccination programme should be introduced for MSM aged between 16 and 40 years attending genitourinary medicine and HIV clinics. The JCVI consultation ended on 7 January 2015 and we await the committee’s final advice on this matter.
The JCVI’s HPV sub-committee is also giving consideration to work modelling the impact and cost-effectiveness of extending HPV vaccination to adolescent boys. I am advised that it is currently anticipated that a model being developed at Warwick University could be presented to the sub-committee in the second half of this year. A separate model being developed by Public Health England may not now be completed until early 2017. I also understand that the JCVI and its HPV sub-committee may need to consider both studies before taking a final view on the impact and cost-effectiveness of extending HPV vaccination to adolescent boys and may therefore not be in a position to do so before early 2017. The JCVI has noted that the cost-effectiveness of an HPV programme for adolescent boys is not certain, because the high coverage rates achieved for adolescent girls are highly likely to interrupt HPV transmission and provide indirect protection for boys to such an extent that there may be little additional benefit to be accrued from extending the programme. However, the committee agreed that a detailed cost-effectiveness analysis was required to fully understand the potential benefits of any proposals.
The noble Baronesses, Lady Gould and Lady Wheeler, asked why there has to be this two-year delay. Work to model the impact and cost-effectiveness of vaccinating adolescent boys with HPV vaccine is dependent on the completion of work by PHE on an individual-based model for HPV screening, as the intention was to use the completed screening model as a basis on which to model adolescent male vaccination. An individual-based model is critical to proper assessment of an adolescent boys’ vaccination programme. Individual-based models are very complex and mathematical; they simulate the impact of an intervention on individuals within a population through time and take a considerable amount of time and resource to develop. The screening model is now not due to be completed until early this year. Although disappointed that modelling work on the cost-effectiveness of HPV vaccination of adolescent boys by PHE will not begin until early 2015, the JCVI agreed that in order to expedite the work it would not be advisable to take any shortcuts, which could undermine the validity of the outputs. As I said, the PHE model may not now be completed until early 2017. The HPV sub-committee will meet during 2015 to review the progress of these studies and will report its findings to the JCVI following consideration of work modelling the impact and cost-effectiveness of extending HPV vaccination to adolescent boys.
Your Lordships will be aware that the NHS budget is a finite resource. New vaccination programmes and extensions to existing programmes will usually represent a significant cost to the health service, in terms of both vaccine purchase and its administration to individuals. It is therefore essential that any advice or recommendations from the JCVI on changes to the national vaccination programme be supported by evidence to show that they would be a cost-effective use of resources.
The noble Lord, Lord Patel, asked about an equalities assessment. An equality impact assessment was completed in 2008 for the introduction of the national HPV vaccination programme for girls. At that time, vaccination for boys for HPV was considered to be not cost-effective for the prevention of cervical cancer.
The noble Countess, Lady Mar, raised the issue of the Japanese experience. HPV vaccines, in fact, remain licensed for use in Japan and continue to be available for girls and women who wish to receive them. The decision of the Japanese authorities temporarily to stop their active recommendation for immunisation due to reports of chronic pain was a precautionary move while they gathered more data. However, EU regulators have reviewed the issue and concluded that there is currently insufficient evidence to indicate that HPV vaccines may be a cause of chronic pain or chronic pain syndrome, which has also been associated with needle injection itself—that is to say, not specific to the vaccine. It remains the case that a causal relationship with HPV vaccines has not been established.
The Countess of Mar
My Lords, I am sorry to interrupt, but even the manufacturers recognise autoimmune dysfunction as a result of their vaccines.
Earl Howe
My Lords, I will take that point away and respond to the noble Countess in writing, as I do not have briefing on it. Suffice it to say, lest there be any doubt, we consider vaccine safety to be of paramount importance. The Medicines and Healthcare products Regulatory Agency has closely evaluated the safety of the HPV vaccine since it was first introduced in this country. The agency takes every report of suspected adverse reactions very seriously and keeps safety under continual review. Again, the view remains that there is currently insufficient evidence to indicate that illnesses are a side-effect of the vaccine.
The MHRA recently completed an epidemiological study of myalgic encephalomyelitis and chronic fatigue syndrome following HPV vaccination. This found no evidence to suggest that the vaccine may be a cause of the condition. The results of the study were published in a peer-reviewed scientific journal in 2013, as I am sure the noble Countess is aware. It is estimated that more than 30 million females worldwide have been vaccinated with HPV vaccine. The United States health authorities have also extensively reviewed HPV vaccine safety and the World Health Organization is assured by its safety.
Time is against me, so I will write to noble Lords on those points that I have not been able to cover. Let me just say that this is very much work in progress. Clarity on timelines cannot be achieved until the JCVI HPV sub-committee has met and reviewed the available evidence. We anticipate that sufficient evidence for the JCVI to be able to offer final advice on the vaccination of men who have sex with men will become available during 2015 but that sufficient evidence for the JCVI to be able to offer advice on the vaccination of adolescent boys may not now become available until 2017 at the earliest. I am afraid that I cannot give any comfort on an earlier date. I recognise that 2017 seems a long way off. However, I hope that the noble Lord will agree that it is essential that the JCVI does its work thoroughly and comprehensively before finalising its advice to the Government. He asked whether Ministers will meet the JCVI to discuss this. I will pass that recommendation to my honourable friend Jane Ellison MP, the Minister for Public Health.
The noble Baroness, Lady Hollins, requested that the issue of men with learning difficulties should specifically be brought to the attention of the JCVI. All girls are covered, regardless of disability, so this is an issue that could be brought to the attention of the JCVI and officials will do that.
Finally, I thank the noble Lord once again for initiating today’s debate. I very much hope that the discussion has been helpful in providing reassurance of our commitment.
Meals on Wheels
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Lord Touhig
To ask Her Majesty’s Government what estimate they have made of the number of elderly people who have received meals on wheels in the past year.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, the Health & Social Care Information Centre does not collect comprehensive data on numbers receiving meals; it only collects a subset of this group: those receiving meals as part of a formal package of care. I understand from the information centre that in 2013-14, 31,950 people received meals from councils with adult social services responsibilities as part of a formal care package. Some 29,605 were older people aged 65 or over.
Lord Touhig (Lab)
My Lords, 220,000 fewer elderly people received meals on wheels last year than in 2010, when this Government came into office. Why?
Earl Howe
My Lords, as I have indicated, there are a variety of reasons for this. The data collected by the information centre include only people who receive meals in their homes as part of a council-arranged formal package. They do not include informal arrangements such as the provision of meals at day centres or via daycare, or indeed those who pay the council for their meals, as many do.
Baroness Greengross (CB)
My Lords, I declare an interest as patron of the National Association of Care Catering. The association recently did some research that showed that, over 10 years, the numbers of people receiving meals on wheels has gone down from 40 million to half that number. That is really very worrying. Can the Government explain whether it would be better to have a statutory requirement for someone to provide these services to the huge numbers of older and vulnerable people within the community?
Earl Howe
My Lords, I do not recognise the figure of 40 million that the noble Baroness mentioned; perhaps she and I could confer after this Question. I think that what matters here is that those with eligible needs receive the service they require. It is up to local authorities to determine eligibility criteria, but the latest available data from ADASS show that all local authorities are setting their eligibility criteria to ensure that they meet at least critical and substantial levels of need.
Baroness Gardner of Parkes (Con)
My Lords, some years ago I was a chairman of social services, and many elderly people did not like the meals that came. I wonder whether that is still the position. I also wonder whether the position in hospitals is similar, as we have found that more people suffered from malnutrition after they had been in hospital than before. That happened because people could not feed themselves adequately and the maid or carer who delivered the food to them would come in and say, “Oh, you didn’t like your lunch, dear”, and take it away. Of course, they have found ways round that, but have they found ways to ensure that people are getting meals that they like, and is someone seeing that they actually eat them?
Earl Howe
My noble friend makes a series of important points. I do not have information on how many people dislike their meals on wheels, but the fact that many purchase them must indicate that the quality of those meals in many areas is of a high standard. There is also charitable provision, which I should have mentioned as well. The context here is surely the new regime that will be ushered in by the advent of the Care Act, which builds support around the individual and their needs and preferences.
Lord Kinnock (Lab)
My Lords, the figures used by my noble friend Lord Touhig were obtained by freedom of information means from local authorities in England. Those figures cover years in which there was a substantial rise in the number of over-65s in the United Kingdom, yet they show a decline of about a quarter of a million in the number of people receiving meals on wheels. I repeat my noble friend’s question: why?
Earl Howe
My Lords, I was not seeking to doubt the figures obtained through a freedom of information request; they just do not happen to be available to my department. However, it is worth noting that the data on the numbers using services also reflect longer-term trends. For example, the proportion of older people in receipt of local authority-supported social care has been declining steadily for the last 10 years. Among those receiving meals on wheels, the numbers have also been declining steadily over 10 years.
Baroness Barker (LD)
My Lords, Age UK County Durham runs an innovative scheme called “Come Eat Together”, which addresses not only the issue of older people having the right food but matters such as loneliness as well. Does the noble Earl consider that that is the sort of innovation that local authorities should bring to social care under the Care Act?
Earl Howe
My noble friend makes an important point—that it is not only the value of the meal that is important to elderly people; it is the relief from isolation and loneliness. Many of the solutions to that lie with local authorities. However, what the Government centrally have been able to do is to raise awareness of the impact of isolation and loneliness and encourage local commissioners to tackle that. To that end we have funded a digital toolkit for local commissioners, which has been supporting them in understanding and mapping commissioning for loneliness and social isolation in their communities.
Lord Foulkes of Cumnock (Lab)
My Lords, I declare an interest as a trustee of Age Scotland. May I try to answer my noble friend’s question for the Minister? The reason why there has been such a dramatic reduction in the number of meals on wheels is the swingeing cuts imposed by the coalition Government—and, indeed, the Government of Scotland—on local authorities and voluntary organisations, and it is about time they were reversed.
Earl Howe
My Lords, local authorities’ funding through central revenue support has indeed reduced, but spending on adult social care has been relatively protected compared with nearly all other local authority services. In cash terms, councils have reported only a small reduction in money spent on adult social care since 2010, despite the tough public funding climate. It is up to the party opposite to explain where the money would come from—if it will increase local authority spending—given that the shadow Chancellor has ruled out increasing local government spending if Labour is elected at the general election.
Lord Touhig
Perhaps I may help the Minister. Could it be due to the fact that the average cost of a single meal has gone up 22% since this Government have been in office? How do the Government justify that?
Earl Howe
My Lords, local councils do not have to charge for meals; they may provide them free of charge or at subsidised rates if they want to. If they charge, they must—as is the case for any non-residential social care service—follow the statutory guidance. That guidance ensures that, where they do charge, the charge is consistent and fair.