Health: Liver Disease

Earl Howe Excerpts

Tuesday 6th May 2014 Lords Chamber

[Lord Brooke of Alverthorpe]

To ask Her Majesty’s Government whether they will produce a strategy to reduce liver disease.

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

My Lords, improving outcomes for people with liver disease is a priority. Public Health England has a wide-ranging programme aimed at tackling its three major causes—viral hepatitis, alcohol abuse and obesity—through strengthening local action, promoting healthy choices and giving appropriate information to support healthier lives.

[Lord Brooke of Alverthorpe (Lab)]

My Lords, I gather from that that the Government are not prepared to consider introducing a strategy, which is a great pity given that liver disease is now the fifth biggest killer and we have some of the worst figures in the whole of Europe. How does the Minister see a more general approach, rather than a specific target in a strategy, producing a change in the terrible figures which we now see in the number of deaths, given that the deprived areas of the country where most of them occur, such as Manchester, had a reduction in the funding to commissioners and GPs for this purpose last month?

[Earl Howe]

My Lords, as the noble Lord is aware, NHS England is responsible for the overall national approach to improving clinical outcomes for people with liver disease. At the moment, it has no plans to produce a strategy specifically for liver disease, but it is adopting a broad strategy to reduce premature mortality, including mortality from liver disease. There is a major emphasis in the work being done by NHS England and Public Health England on prevention. They are supporting clinical commissioning groups and local authorities with a suite of tools to help them maximise the best possible outcomes for their local communities, such as local authority profiles. That can help local authorities and CCGs indentify the significance of liver disease in their area compared to the rest of the country, and the actions they could take to tackle it.

[Noble Lords]

My Lords—

[Baroness Gardner of Parkes (Con)]

Can the Minister identify more clearly for me his definition of liver disease? He cited various things. Do his liver disease figures include the metastases from cancers, which are often a terminal condition? Are they treated separately or classified as part of the existing numbers?

[Earl Howe]

My Lords, there are over 100 types of liver disease, which together affect at least 2 million people in the UK. The main ones are derived from alcohol misuse, viral infection, being overweight and obesity, and there are conditions that are inherited as well as those which attack the immune system. As regards metastases, I would need to be advised but I would imagine that that falls under the general heading of “liver cancer”, which is certainly included in my remarks to the noble Lord opposite.

[Noble Lords]

My Lords—

[Baroness Billingham (Lab)]

My Lords, given the sad news that we have had in the past 48 hours of the death of Elena Baltacha, one of our best young tennis players—I have no idea about the history of her illness, but I know it has gone on for many years—what is the availability of liver transplants? That is a question that will cross many people’s minds. It would seem to me that if it was available and she was a suitable candidate, that could have been looked at. Can the Minister give us any assistance on that?

[Earl Howe]

My Lords, I, too, learnt with great sadness of the death of Elena Baltacha, and was also unaware of the history of her medical condition. It is not appropriate for me to comment at the Dispatch Box on whether she should have received a liver transplant. However, I can say that transplant services are very active in this country. More and more liver transplants take place compared with a few years ago, and there are better techniques to ensure their tolerability in patients. If I can find out some more information, I will be happy to write to the noble Baroness.

[Baroness Finlay of Llandaff (CB)]

Do the Government recognise that a strategy needs to be far wider-reaching than health, given that alcohol abuse results in two-fifths of crimes being alcohol-fuelled and in a cost to society of £55 billion a year? That sum would be recouped in part if the unit price of alcohol was raised by 10%, which would help to decrease the binge drinking which results in young people ending up in liver units with fulminant end-stage liver disease.

[Earl Howe]

I agree with the noble Baroness that if we are to tackle liver disease we need to look as broadly as we can at the causes of alcohol misuse. We remain concerned about the wide availability of cheap, discounted alcohol and will soon take action to ban sales of alcohol below cost, where the price is equivalent to duty plus VAT. As regards minimum unit pricing, that remains a policy under consideration, but it will not be taken forward at the moment while we gather further empirical evidence. We do not want to launch a policy that may have unintended consequences.

[Noble Lords]

My Lords—

[Baroness Manzoor (LD)]

My Lords, the incidence of liver cancer and liver disease is increasing significantly in young people, and it is the only cancer that continues to increase. Can my noble friend state whether there is a high-profile health education strategy that will help to tackle alcohol abuse and raise awareness among young people, who now talk about getting “preloaded” before they go out to drink alcohol, and which will highlight the issue of obesity? We need a high-profile health education campaign in that area.

[Earl Howe]

My Lords, as my noble friend knows, there is of course scope to include alcohol awareness in relevant lessons in secondary schools. However, I take my noble friend’s point. I am encouraged by recent figures which show a drop in binge drinking, but that is no cause for complacency. It still takes place, and too many young people end up in specialist care and sometimes lose their lives. That is very much on Public Health England’s radar.

[Lord McConnell of Glenscorrodale (Lab)]

My Lords, Elena Baltacha had a remarkable career—

--- Later in debate ---

[Baroness Wheeler]

My Lords, I, too, pay tribute to Elena Baltacha, who was a truly remarkable and very brave woman. One in five people in the UK is at serious risk of liver damage, but a recent government response shows that the Secretary of State has not met any external organisations to discuss liver disease since May 2010, and current Ministers have not met representatives of people living with liver disease since September 2012. Can the Minister commit urgently to remedying this situation, particularly as it is in such stark contrast to the 130-plus meetings the Government have had with the drinks industry?

[Earl Howe]

My Lords, liver disease is very much in the sights of my honourable friend the Minister for Public Health, as is evidenced by the document we published last week, Living Well for Longer, in which there is a whole section on alcohol and liver disease, and by what NHS England and Public Health England are doing to tackle them.

National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) (Amendment) (No. 2) Regulations 2014

Earl Howe Excerpts

Tuesday 6th May 2014 Lords Chamber

[Baroness Thomas of Winchester (LD)]

My Lords, I am grateful to the noble Lord, Lord Hunt, for initiating this debate and giving us the opportunity to talk about the new health service arrangements as they affect rare and very rare conditions. As other noble Lords have done, I shall range wider than the regulations—only briefly—because it is not often that this subject comes up for debate. The opportunity should not be missed to say something about those of us with a rare disease, in my case muscular dystrophy, and how it is faring as the new NHS arrangements are being put in place. I declare that interest.

All muscular dystrophies are rare diseases and some are very rare and there has been a great deal of uncertainty about how existing services for patients would fit into the way that services are commissioned, planned and delivered in the new NHS landscape. However, the situation was far from perfect before the changes. Some patients might not see a consultant for several years and many found it very difficult to access the right respiratory and heart checks, physiotherapy—especially hydrotherapy—and emotional and practical support. It was very much a postcode lottery. I had to discover for myself, 20 years ago, how helpful an exercise regime was, and this is now advised by healthcare professionals.

The new NHS set-up has provided not just a challenge but an opportunity to get things right from the beginning. The Muscular Dystrophy Campaign has worked closely with NHS commissioners on both a national and regional level and has achieved significant and encouraging progress in developing a dedicated neuromuscular standard through a specific annexe in the specialised neurosciences service specification. This has ensured that there are now more than 40 neuromuscular care advisers and specialist nurses funded by and embedded in the NHS, who provide invaluable support and advice to those with muscle-wasting conditions and their families. More are still needed, particularly to help guide patients and families through the transition from childhood to adulthood.

Another valuable initiative is Bridging the Gap, a Department of Health-funded project run by the MDC which began last July to help shape the future of neuromuscular services in England. This project brings together NHS commissioners, clinicians and health professionals through regional patient-led neuromuscular forums. Already it is bearing fruit, such as the development of GP online modules and emergency care plans, which it is hoped will improve the quality of care and support of people with neuromuscular conditions.

Clinical reference groups have been a positive step overall towards the effective commissioning of specialised services, although there are still problems. First, there is a disparity of CRG arrangements for rare diseases. Cystic fibrosis, for example, has its own CRG for children and adults and works well, but neuromuscular diseases are spread across three CRGs. I am taken with my noble friend Lady Brinton’s suggestion of there being a designated clinical lead so that everyone knows who to turn to. I believe that a one-off meeting has been arranged by NHS England to bring together these CRGs, but a long-term plan is also needed to work out how they will work together in the future.

Secondly, the main neuromuscular service specification prepared over the past three years, which covers children, transition and adults, mainly sits in the adult neurosciences CRG, which has adult-only expertise. It is a very welcome and recent step in the right direction that the paediatric neurosciences CRG has agreed to adopt the neuromuscular annexe of the service specification, but further work is needed here. I look forward to my noble friend’s reply.

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

My Lords, I am well aware that the noble Lord, Lord Hunt of Kings Heath, retains a keen interest in this topic, and I thank him for bringing it to the Floor of the House. I was naturally disappointed to hear that he feels that the new commissioning arrangements for specialised services which were put in place through the Health and Social Care Act 2012 are fragmented, and that the process for determining which services are considered to be specialised is unclear and lacking in openness and transparency.

Let me begin by emphasising that the Government continue to uphold the principle that no one is left behind, no matter how rare their condition, and that people with rare conditions should receive the same access to high-quality care as people with more common conditions. The Health and Social Care Act 2012 established the NHS Commissioning Board, now known as NHS England, and gave it responsibility for commissioning, among other things, specialised services. These services are prescribed in the regulations that the noble Lord has referred to. The arrangements for managing the commissioning of these services replace a system whereby 10 specialised commissioning groups and one national commissioner were responsible for commissioning both specialised and highly specialised services. Under that previous system, it became clear that there was variation in the range of services which some specialised commissioning groups were commissioning and the policies that were being applied to these services. This led to an inequity in access to services. Furthermore, the lack of standard contracts across the 10 specialised commissioning groups meant that the quality of services across the country was inconsistent.

All that has been replaced with a new system whereby one national commissioner is responsible for commissioning all specialised services for people with rare and very rare conditions. NHS England has developed standard service specifications and policies for commissioning these services, and these are underpinned by detailed identification rules that allow the commissioner of the activity, either NHS England or CCGs, to be determined. NHS England has implemented a robust process for developing and consulting on commissioning specifications and policies that includes public consultation. NHS England works with the 10 area teams responsible for the delivery of this work to ensure that highly specialised services continue to be commissioned in an effective way at the national level. I understand that all those involved in commissioning these services meet on a monthly basis to discuss any issues arising and how they might be resolved.

The noble Lord, Lord Hunt, raised the issue of the separation of functions carried out previously by AGNSS. I note his concerns that the system will be worse off without AGNSS. As a consequence of the 2012 Act, AGNSS ceased to have a role and its key functions have been picked up by other groups. From April last year, Ministers retained the power to decide which services should be commissioned, but NHS England became responsible for determining the number of centres and levels of funding in commissioning all specialised services. The prescribed specialised services advisory group has been established to provide Ministers with advice on whether services are specialised and should be directly commissioned by NHS England. NHS England worked with the former chair of AGNSS to consider how best it might receive high-quality clinical advice on highly specialised services. The Rare Diseases Advisory Group was set up by NHS England to provide it with this advice. The assessment of very high-cost drugs for patients with rare conditions was the final strand of AGNSS’s work which needed to be properly secured for the future. Ministers decided that NICE was best placed to offer this advice. I hope that that gives clarity to the arrangements that are now in place and the reasons why we considered this to be a compelling set of arrangements.

As I am sure noble Lords will acknowledge, the changes that were made through the Health and Social Care Act were extensive. With change being made on such a broad scale as this, one might expect that the processes for setting up the reformed commissioning arrangements will take a little time to settle in.

There are a variety of reasons for the trend in spending on specialised commissioning, which the noble Lord, Lord Hunt, mentioned, including increased demand for specialised services and increasing demand for high-cost drugs. NHS England is taking steps to address budget management and reviewing the opportunities to reduce costs while maintaining the quality of services, which I know it attaches great importance to doing.

I remain confident that these new arrangements will lead to high standards for all patients needing to access specialised services, wherever they live and no matter how rare their condition is. I listened with care to my noble friend Lady Brinton. The intention and ultimate effect will be to ensure that patients in need of specialised services receive consistent access to high-quality care, wherever they live, and that services are organised and delivered as efficiently as possible.

Our agenda is very much one of continuing improvement. Although I am aware of the concerns expressed by the Specialised Healthcare Alliance, neither I nor NHS England accepts the premise that the changes we have made are leading to greater fragmentation. However, I am grateful to noble Lords for drawing these issues to my attention. I assure noble Lords, not least my noble friend, that I share their wish to see joined-up, consistent services across the country. I can give an assurance, too, that I will monitor the provision of specialised services over the coming months.

The noble Lord, Lord Hunt, said that the process by which services for rare and very rare conditions are considered by PSSAG for commissioning nationally are unclear and lack openness and transparency. That concern was echoed by the noble Lord, Lord Walton. It may be helpful if I talk a little about the group and its role. The National Health Service Act 2006, as amended by the 2012 Act, requires that before making regulations setting out which specialised services are to be prescribed, and thus made the commissioning responsibility of NHS England, the Secretary of State must obtain advice appropriate for that purpose and consult NHS England.

PSSAG was established in 2013 as a Department of Health expert committee to provide this advice. Its role is to provide advice to Ministers on whether services are specialised and should be directly commissioned by NHS England rather than by clinical commissioning groups. The appointment of this group helps to ensure that the Secretary of State has appropriate advice when exercising functions under Section 3B of the NHS Act 2006. The group met for the first time in September 2013.

The noble Lord, Lord Walton, asked about the group’s terms of reference. It has working terms of reference, which are currently being further developed and will be signed off at a future meeting. As part of the exercise in advising Ministers, the group will also consider proposals for NHS England on the formulation of its service descriptions, which are used to explain what NHS England is providing under the different headings for the specialised services provided for in the regulations. The group will provide advice to Ministers on whether the service descriptions and any proposed changes are appropriate in respect of the prescribed service.

Evidence, supporting information and activity in respect of those services currently prescribed in legislation for direct commissioning by NHS England, along with any new services identified as potentially specialised and warranting commissioning by NHS England, are all made available to PSSAG from a range of sources. These sources may include clinical reference groups—CRGs—patient groups, clinicians, commissioners and members of the public. The proposals that the group considers are in large part generated by NHS England through its CRGs, which cover different areas of clinical practice. As PSSAG is still relatively new, the processes for enabling services to be referred to the group for consideration, and the annual cycle for considering whether services are specialised or not, are still being refined.

Mental Health: Young People

Earl Howe Excerpts

Monday 7th April 2014 Lords Chamber

[Lord Patel of Bradford (Lab)]

My Lords, on behalf of my noble friend Lady Goudie, and at her request, I beg leave to ask the Question standing in her name on the Order Paper.

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

My Lords, through our action plan Closing the Gap we are supporting schools to ensure that mental health problems are identified early, improving outcomes. Children’s mental health is a priority, and we have invested £54 million over the four-year period 2011-15 in the children and young people’s improving access to psychological therapies programme, known as CYP IAPT, to transform child and adolescent mental health services—CAMHS—improving young people’s access to the best evidence-based care.

[Lord Patel of Bradford]

I thank the noble Earl for that reply. Is he aware that the Royal Society for Public Health, together with the Prince’s Trust, published a report in this year’s annual Youth Index that showed an extremely high correlation between unemployment and mental illness among young people? In fact, a startling 40% of young people who were unemployed had signs of mental illness and were developing self-harm issues and even suicidal thoughts. Can the Minister say what the Government are doing about that report? Following on from the earlier Question, I suppose that the simple answer would be more jobs for unemployed people, but can the Minister say more about what the Department for Education is doing? Schools have a responsibility to introduce mental health and well-being classes formally within education but they are very reluctant to work with health services, particularly mental health services, to deliver that. Can the Minister say what is being done at a national level between the Department of Health and the Department for Education, as well as in encouraging local mental health services to work with schools?

[Earl Howe]

My Lords, I am aware of the study to which the noble Lord refers. It ties in quite closely with the findings of the Marmot report of a few years ago, which correlated quite closely the link between socioeconomic deprivation and children and young persons’ mental ill-health. Helping people, especially young people, get back into employment is a key priority for the Government. We know that young adults with mental health issues are underrepresented in the labour market. We aim to enable more young people with mental health needs to find and keep a job. There is an ongoing government programme to drive whole-system and cultural change, led by the Department for Work and Pensions. We are working with health and social care services to support young people to become economically active, not least through the CYP IAPT programme.

As regards schools, very briefly, schools can raise awareness of mental health through PSHE. Mental health is not a compulsory part of the curriculum. However, I note that the new national curriculum will see children aged five to 16 taught about internet safety in a sensible, age-appropriate way, which is a really important step to help children and young people understand some of the issues facing them.

[Baroness Meacher (CB)]

My Lords, I very much welcome the announcement of the increased investment in improved access to psychological therapies for children and young people. Can the Minister tell the House what percentage of children diagnosed with depression and anxiety and displaying serious conduct disorders will receive treatment as a result of the Government’s increased investment?

[Earl Howe]

Children with the conditions mentioned by the noble Baroness are most certainly eligible for CYP IAPT, not least cognitive behavioural therapy for emotional disorders, which include anxiety and depressive disorders. The programme covers services available to 54% of England’s population aged nought to 19—our target is 60%—and that is successfully giving children and young people improved access to the best evidenced care. NHS England is planning for a countrywide extension of the programme and the Government’s aim is that all of England should be involved by 2018.

[Lord Mawhinney (Con)]

My Lords, regarding my noble friend’s statement that £54 million has been made available over four years, although there will be plenty in the department and some in the NHS who know of this project, can he tell your Lordships’ House how information around the services paid for by this project are brought to the attention of young people themselves and their parents?

[Earl Howe]

My noble friend clearly has a close insight into this area because he is spot on in asking that question. CYP IAPT is rather different from the adult IAPT programme. It is a programme that aims to ensure that those working with CAMHS work much more closely with children and young people and with their parents and their families. The services have to enable children and their parents to have a say in designing the service that they receive, and they must also introduce and use regular outcome measures that help the child or young person and their parents and therapist to understand how well the child is doing. Therefore, involving the parents is absolutely integral.

[Baroness Wheeler (Lab)]

My Lords, a recent survey found that more than half of young carers reported having a mental health problem, including feelings of stress, anxiety and depression, eating and sleeping problems and risk of self-harm. What are the Government doing to support these dedicated young people? What guidance will be given in the Children and Families Act and the Care Bill on how local authorities should work with mental health services to ensure that young carers get the support they so clearly need and deserve?

[Earl Howe]

The noble Baroness is absolutely right and the pressures and strains on young carers have been well recorded. It is fair to say that compared with a few years ago, not least thanks to the efforts of the previous Government but also the work that we have continued, GPs and others working with families are much more alert now to the needs of young carers and can signpost them to appropriate support. The CYP IAPT programme is designed no less for young carers than it is for others.

Tobacco: Packaging

Earl Howe Excerpts

Thursday 3rd April 2014 Lords Chamber

[The Parliamentary Under-Secretary of State, Home Office (Lord Taylor of Holbeach) (Con)]

This is a just-in-time delivery, if I may say so.

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

My Lords, with the leave of the House I shall now repeat a Statement made earlier today by my honourable friend the Minister for Public Health in another place on standardised packaging of tobacco products. The Statement is as follows:

“With permission, Mr Speaker, I wish to make a Statement about the publication of Sir Cyril Chantler’s report on the standardised packaging of tobacco products.

Smoking kills nearly 80,000 people each year in England alone. One out of two long-term smokers will die of a smoking-related disease and our cancer outcomes stubbornly lag behind much of Europe. Quite apart from the enormous pressure this creates on the NHS it is a cruel waste of human potential. Yet we all know that the vast majority of smokers want to quit and, even more tragically, we also know that two-thirds of smokers become addicted before they are 18. As a nation, therefore, we should consider every effective measure we can to stop children taking up smoking in the first place.

That is why, in November last year, I asked Sir Cyril Chantler to undertake an independent review as to whether or not the introduction of standardised packaging of tobacco is likely to have an effect on public health, in particular in relation to children. Sir Cyril has presented his report to me and to my right honourable friend the Secretary of State, and we had the benefit of a personal briefing from Sir Cyril yesterday, in which he highlighted the key conclusions of his review.

Having reviewed Sir Cyril’s findings, I was keen to share this important report with the House without delay, as I recognise the significant interest that many Members have shown in this issue. I will of course place copies in both House Libraries. The evidence has been examined, the arguments for and against have been thoroughly explored and their merit assessed by Sir Cyril, who also visited Australia in the course of his review. I asked in particular that the report focus on the potential for standardised packaging to have an impact on the health of children.

It is clear that smoking is a disease of adolescence and we know that, across the UK, more than 200,000 children aged between 11 and 15 start smoking every year. In other words, around 600 children start smoking in the UK every day. Many of these children will grow up with a nicotine addiction that they will find extremely difficult to break. That is a tragedy for these young people, their families and for the public health of our nation. Sir Cyril points out that if this rate of smoking by children were reduced even by 2%, for example, it would mean that 4,000 fewer children take up smoking each year.

Sir Cyril’s report makes a compelling case that, if standardised packaging were introduced, it would be very likely to have a positive impact on public health and that these health benefits would include health benefits for children. The Chief Medical Officer, Dame Sally Davies, has read Sir Cyril’s report and sent me a letter with her initial views. Dame Sally said:

‘The Chantler review only reinforces my beliefs of the public health gains to be achieved from standardised packaging’.

I have placed copies of Dame Sally’s letter in the House Libraries. Importantly, the report highlights that any such policy must be seen in the round, as part of a comprehensive policy of tobacco control measures. That is exactly how I see the potential for standardised packaging to work in this country.

In the light of this report and the responses to the previous consultation in 2012, I am therefore currently minded to proceed with introducing regulations to provide for standardised packaging. However, in order to ensure that that decision is properly and fully informed, I intend to publish the draft regulations, so that it is crystal clear what is intended, alongside a final, short consultation, in which I will ask, in particular, for views on anything new since the last full public consultation that is relevant to the final decision on this policy. I will announce the details about the content and timing of that very shortly but would invite those with an interest to start considering any responses they might wish to make now. The House will understand that I want to move forward as swiftly as possible, and Parliament gave us the regulation-making powers in the Act.

Finally, I should like to pay tribute to the excellent job that Sir Cyril and his team have done in preparing such a thorough analysis of the available evidence on standardised packaging of tobacco products. I believe the report will be widely acknowledged both for its forensic approach and its authoritative conclusions. We want our nation’s children to grow up happy and healthy and free from the heavy burden of disease that tobacco brings. I commend this Statement and Sir Cyril’s report to the House”.

That concludes the Statement.

--- Later in debate ---

[Earl Howe]

My Lords, I am grateful to the noble Baroness for her welcome of Sir Cyril’s report. I share with her my admiration for the thoroughness with which he tackled a task in a short space of time, considering how much work he had to do.

Sir Cyril has produced a compelling report, and I urge noble Lords to take the opportunity to read it; it is extremely readable, as well as persuasive. As I said, he has made a compelling case on the public health evidence. However, to make robust policy in this area, it is essential that we follow a careful process. I understand the noble Baroness’s impatience to make progress on this issue, and we share that desire. However, we have to look at everything in the round if we are to make policy that is considered and well thought through. We have to give everybody who has a stake in the decision an opportunity to make their case. Therefore, I cannot stand here now and say that the Government will definitely proceed to make regulations. We must now take stock of Sir Cyril’s report and look at it alongside the other, non-health-related issues that need to be considered.

On that issue, we will hold a six-week consultation to ensure that our decision is properly and fully informed by any further relevant views and, very importantly, that it will be capable of withstanding the greatest scrutiny, including in the courts. The noble Baroness was absolutely right to mention the strong potential for matters of this kind to end up in legal action; the Australian Government are already in the courts on this issue. We want to be able to demonstrate to all stakeholders that the process has been fair and thorough and that we have moved at a pace that is reasonably rapid but which at the same time enables us to develop robust policy.

The consultation will include draft regulations for consideration. Far from this being a repeat of the previous consultation, it will enable people to look at the precise proposals that would be contained in regulations, if approved by Parliament. The timing of the consultation will be announced shortly and details provided on the Department of Health website. As to when we will bring in regulations, should the Government make a final decision to go ahead with standardised packaging, we would need to consider the timetable. However, our aim would be to make the regulations before the end of this Parliament. I hope the noble Baroness will accept that, far from kicking the issue into the long grass, as she put it, we have every intention of doing the opposite.

I believe that I have addressed most of the noble Baroness’s questions and points, but I shall write to her if there is something I have missed out.

[Baroness Tyler of Enfield (LD)]

My Lords, I strongly welcome Sir Cyril’s report, which is an extremely thorough piece of work. The central message from it is crystal clear and compelling; the introduction of standardised packaging would reduce the number of children and young people taking up smoking. I look forward to reading the draft regulations and the consultation, which I hope will be short. I would be grateful if the Minister would confirm that he talked about six weeks. Does he agree that, if the Government introduce this, we are going very much with the grain of public opinion? A new poll, issued today by YouGov, found that 64% of adults in Great Britain support or strongly support plain, standardised packaging, with only 11% opposed to the measure.

[Earl Howe]

I am very grateful to my noble friend. I confirm that we intend to have a consultation period of six weeks. That is as long as we think it needs to be to enable everyone with an interest, both for and against this measure, to make their views known and to enable us to factor in any considerations we may not yet have had an opportunity to consider. Although I have not seen the YouGov report to which my noble friend refers, I suspect she is absolutely right that public opinion is moving in the direction that Sir Cyril has advocated, and that we are going with the grain of what most people think. Most right-thinking people want children to be protected from the harms of tobacco. I hope that we will have public opinion behind us, should we decide to go ahead with this.

[Baroness Finlay of Llandaff (CB)]

My Lords, like the noble Baroness, Lady Tyler, I strongly welcome this report. It is an extremely readable, clearly laid out and very balanced review. I remind the House that it is 60 years since the original Doll and Peto observations that tobacco was linked to an early death. Their follow-up study, 50 years on, showed that those men who smoked only cigarettes and continued smoking had a life expectancy 10 years shorter than non-smokers. There is a long history behind this.

Looking at standardised packaging, it is worth noting that, as this report has highlighted,

“the pack has become the main promotional platform for the tobacco industry to recruit and retain customers”.

As has been said, the evidence from Australia is that plain packaging gives the impression that the cigarettes are lower in quality and less satisfying than those in the previously marketed packaging.

I would like to ask the Minister about standardised packaging, which comes from having listened to the debate in the other place after the ministerial Statement. I am concerned that there may be scaremongering going on over jobs. This type of standardised packaging is complex packaging and anti-counterfeit measures require complex design and printing techniques which this country is extremely good at. Our printing and packaging industry probably is one of the world leaders in developing really good types of packaging where anti-counterfeit measures can be included.

It is of concern that the term “plain” is still being used, which is completely different from complex standardised packaging. HMRC inspectors are clear that they can detect counterfeit standardised packaging more easily than the current commercial types of packaging when those are counterfeited. I seek reassurance from the Minister that the regulations will include the inability for the tobacco industry to do what is being done in Australia. One or two extra cigarettes are included as a loss leader for the same price as a packet of 20 as a promotional activity to make the packet more attractive. I also seek reassurance that the standardised packaging will be standardised on the outside; that there will be a standardised number of cigarettes inside; and that there will not be the ability to include tempting extra gifts, whether that is cigarettes or anything else. Does the Minister have any idea when the six-week consultation that he outlined will start and when the completion date is likely to be?

[Earl Howe]

The noble Baroness has raised a number of important points. As regards the effect on jobs, this is exactly the sort of question that we want people to address when responding to the consultation. If there are legitimate concerns about jobs, we want to hear about them. We want to understand exactly what the concerns consist of and whether they are robustly supported by evidence. The noble Baroness drew attention to the word “standardised” and asked me whether by that term we intended it as an antithesis to the word “complex”. I would rather say that standardised is the opposite of branded because it is the branding that is in focus here. As she will have seen from Sir Cyril’s report, he makes some very powerful points about the effect of branding. He said that,

“industry documents show that tobacco packaging has for decades been designed, in the light of market research, with regard to what appeals to target groups. Branded cigarettes are ‘badge’ products, frequently on display, which therefore act as a ‘silent salesman.’ Tobacco packages appear to be especially important as a means of communicating brand imagery in countries like Australia and the UK which have comprehensive bans on advertising and promotion”.

The word “standardised” is intended to signify a commonality of rather bland packaging, subject of course to European Union rules. I am sure that the noble Baroness is aware that the draft tobacco directive makes provision for a number of features to be included in the packaging; for example, 65% of the surface area of a packet of cigarettes will need to comprise of warnings. The minimum size of a packet of cigarettes will go up to 20 cigarettes and packets of 10 will be illegal. Other provisions are designed to prevent tobacco companies from using their packaging in whatever way to entice people to smoke, which includes free gifts and other features.

[Baroness Finlay of Llandaff]

Before the noble Earl sits down, may I remind him that I asked about the timescale?

[Earl Howe]

I beg the noble Baroness’s pardon. It is a little early for me to be specific on that. I have been as specific as I can on the timescale in which we hope to introduce regulations, but I will need to come back to the noble Baroness on the timescale for their implementation.

[Baroness Wall of New Barnet (Lab)]

My Lords, I want to briefly add my congratulations on and support for the report, and to associate myself with the frustration that I think my noble friend on the Front Bench has portrayed. Many other people, including clinicians in my own hospital, are already seeing the effects of smoking on children as young as 11, which is very worrying.

I should like the noble Earl to think about two things. First, has the breadth and depth of the consultation been different from and wider than the previous consultation, which was not very long ago? Secondly, the noble Earl made a comment along the lines that we must make sure that we do not end up in litigation because we want to ensure the fairness of this. I must advise the noble Earl that consultation will never be strong enough to prevent litigation. We must do all we can to consult everybody, but we shall be waiting for ever if we wait for something that will prevent people pursuing litigation when they really do not want these things to happen. I am sure the noble Earl is aware of this, but please let this consultation not be so exhaustive that we include everything that will stop the courts taking up some of the issues.

[Earl Howe]

The noble Baroness makes a good point about litigation. My response is that if it comes to litigation, and of course we hope it will not, we will have the strongest possible defence against any accusation that we have somehow skimped or not taken account of evidence. In defence of the Government, I also point to the other measures we are taking to bear down upon the prevalence of smoking. The noble Baroness knows very well that we have had some excellent debates on smoking in cars, proxy purchasing of tobacco, and prohibiting the sale of electronic cigarettes to under-18s. I hope the good faith of the Government is not in doubt here and I share her wish to see progress made as swiftly as possible.

On the subject of the timetable, I did not make clear that while we believe that we have sufficient time to allow regulations to be introduced within this Parliament, we shall move to give both Houses our final decision on whether we are going ahead with this before the Summer Recess.

House adjourned at 5.38 pm.

Abortion

Earl Howe Excerpts

Thursday 3rd April 2014 Grand Committee

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

My Lords, it is right for me to begin by thanking my noble friend Lady Knight for her powerful contribution to this important and emotive subject. I express my appreciation to all speakers in this debate. A large number of points have been made and questions have been asked, so I hope noble Lords will forgive me if I do not manage to answer all of them. I undertake to do so, in so far as I do not cover the points in my speech, in a subsequent letter.

The Abortion Act 1967 sets out the terms under which abortion is legal. Since it was passed in 1967, there has been a long-standing tradition that any legislation on this issue is put forward from the Back Benches and is subject to a free vote. I was asked by the noble Lord, Lord Hunt, and others whether the law needs clarifying in the light of events and the statement from the Crown Prosecution Service, which my noble friends Lady Barker and Lady Tonge asked about, making changes to the law. Clarification of the law remains a matter for Parliament, not for government. I say to my noble friend Lord Patten that there is no scope for secondary legislation to amend the grounds on which abortion takes place. It would be a matter for primary legislation.

It is vital for everyone, regardless of their views on abortion, to be assured that the law on abortion is operating as Parliament intended. This is particularly important for clinicians directly involved in certifying and performing abortions who need to know that they are operating within the law and for women seeking an abortion who need access to safe, legal, high-quality abortion services.

The Chief Medical Officer has written twice to all doctors involved in abortion provision to remind them of the need to make sure that they work within the law at all times. It is also important for doctors to be able to explain and evidence their decisions and to record how they have formed an opinion on whether grounds for abortion are met. A number of noble Lords, including my noble friend Lady Knight, raised the issue of doctors forming an opinion on grounds for abortion without seeing or examining the woman. Since the Abortion Act 1967 was passed, the law has required that two doctors certify in good faith that there are lawful grounds for any abortion, and that must be based on understanding the facts of a woman’s case whether or not they personally see or examine the woman.

My noble friend Lord Gordon asked whether we can provide figures for the number of abortions performed without a doctor seeing or examining the woman. I am advised that we do not have figures for that. The 46% figure quoted was wrong, I am sorry to say, and was withdrawn by the department. It is not possible to quantify the figure, but I can say to the noble Lord, Lord Campbell-Savours, that forms being pre-signed is a clear breach of the law and if it is found to be happening, a prosecution should be brought.

I can say to the noble Lord, Lord Gordon, that the Care Quality Commission will continue to cover this issue as part of its inspections and compliance action will be taken against any provider where there is evidence of pre-signing. The CQC has put in place information for its staff to help identify if pre-signing or other instances of non-compliance are taking place to make sure that they would be picked up during inspections.

My noble friend Lady Knight and a number of other speakers expressed concerns about gender-selective abortions, particularly the abortion of foetuses simply because they are female. My right honourable friend the Prime Minister has referred to this practice as “appalling”. The Government’s view has been clearly stated on many occasions—that abortion on grounds of gender alone is illegal. My noble friend Lady Knight stated that the Act is not clear on this point. I confirm to the noble Lord, Lord Hunt of Kings Heath, that the grounds for abortion are set out in the Abortion Act 1967. It is true that these grounds make no reference to gender. While there is an extremely limited number of circumstances in which gender may be a factor in considering other grounds—for example, a gender-related abnormality—the department has made a number of recent public statements through the CMO letters, Answers to Parliamentary Questions and media lines, stating our view that abortion on grounds of gender alone is illegal, and we firmly stick by that view.

Analysis conducted by the Department of Health indicates that birth ratios—that is to say, the ratio of boys born as compared with girls—in this country are within normal limits. This is true for the population overall, and is also true for births to women born abroad who now live in this country. This analysis was first conducted and published in May 2013. This is being updated and we intend to continue to conduct a similar analysis on an annual basis, because we regard this issue as extremely important. We are determined to monitor the situation regularly and remain vigilant. I am also aware that some individuals and organisations have offered anecdotal evidence of gender-selective abortions taking place. I urge anyone who thinks that the law may be being broken to contact the police with their evidence.

The noble Baroness, Lady Hollins, and the noble Lord, Lord Singh, may be interested to know that Department of Health officials recently met representatives from Gina International. The meeting was very useful and Gina International has been signposted to relevant organisations, including abortion providers, with which it can discuss its concerns. The meeting concluded that both sides share the same aims—namely, to spread the message that abortions on the grounds of gender alone are illegal.

The Daily Telegraph first brought this issue to light during its investigation in February 2012. I am aware that the announcement in September 2013 that the Crown Prosecution Service declined to prosecute two of the doctors involved in this issue has been disappointing for some. In explaining why it felt that prosecution was not in the public interest, the Crown Prosecution Service noted that it could be difficult to determine whether doctors had worked within the Act in forming an opinion in good faith. It felt that further guidance to doctors on this issue would be helpful for doctors themselves, as well as for any authority who may need to investigate an allegation of poor practice or lawbreaking. The department therefore intends to issue further guidance for doctors, which will set out the Government’s interpretation of the law on gender-selective abortions, as well as further information about reaching and recording an opinion formed in good faith. We intend to issue this guidance shortly.

I say to the noble Baroness, Lady Hollins, that we believe that the department’s analysis, which is based on birth registrations, is more accurate than the Independent’s analysis, which was based on household composition. The department’s analysis showed that birth ratios were within normal limits.

All abortion providers must be registered with the Care Quality Commission, and independent sector providers must also be approved by the Secretary of State for Health. In order to be approved, independent sector providers must adhere to the required standard operating procedures. There has been considerable concern that the consultation that the department has recently completed on updating these procedures has somehow changed the legal position on abortion. As I have highlighted, the legal requirements on abortion are set out in the 1967 Act. Nothing has changed. A response to the consultation will be published once all the responses have been analysed.

[Lord Patten]

My noble friend, for whom I am full of admiration in every way, has said that the law forbids abortion on grounds of sex selection, and forbids pre-signing. However, there has never been a successful prosecution or, indeed, a prosecution of any sort. It seems to me that nothing at all is actually being done.

[Earl Howe]

That is not the case but, if my noble friend will forgive me, I will respond to that point in a letter. I can assure him that things have been done. It is not a case of these issues not being followed up.

[Lord Campbell-Savours]

Could we all see a copy of that letter?

[Earl Howe]

I shall copy all letters to all Peers who have spoken in the debate. My time is now running out but I know that concerns have been expressed, not least by the noble Lord, Lord Alton, about the way that foetal remains are sometimes disposed of. A recent investigation by the Channel 4 “Dispatches” programme examined this issue. The type of situations highlighted in the programme, where foetal remains were incinerated rather than buried or cremated in line with what the woman would have wanted, are totally unacceptable. Any such practices should cease immediately. A letter has gone to all trusts to make that point emphatically clear.

My noble friend Lady Bakewell asked about hospitals revealing the sex of the foetus at routine ultrasound scans. Disclosing the sex of a foetus is a local decision and should be based on clinical judgment about the certainty of the assessment and the individual circumstances of each case. It is not something that the Government can mandate from the centre.

My noble friend Lady Knight asked about the NHS not employing midwives who would not be willing to perform abortions. The Act allows professionals, including midwives, to opt out of participation in any treatment to which he or she has a conscientious objection. That conscientious objection should not be detrimental to the careers of health professionals. I think I am over my time.

[Lord Popat]

You have two more minutes.

[Earl Howe]

Sorry, I will carry on. The noble Lord, Lord Alton, made some powerful points about repeat abortions. We are working to reduce repeat abortions through promoting access to the most effective methods of contraception following abortion. Care pathways should be in place to contraceptive services following any abortion.

The noble Lord, Lord Hunt, asked about recording the sex of a foetus on the HSA4 form. We have no plans to record the sex of the foetus on the form. It is not usually possible to identify the sex of a baby until the second ultrasound scan, which takes place at around 18 to 21 weeks’ gestation. In 2012, nearly 98% of abortions were performed before 18 weeks’ gestation, so the gender of the foetus is not known for most abortions. I strongly agree with him that a challenge to attitudes and discrimination against women is a good thing. That is what our parliamentary system is based on. I will write to him further on that, as I will on the question of education.

I close by emphasising again that we are not complacent on these issues. We remain and will continue to be very vigilant.

[Lord Popat]

My Lords, I suggest we take a break for five minutes in view of the fact that we do not have all the speakers for the next debate.

NHS: Mental Health Funding

Earl Howe Excerpts

Wednesday 2nd April 2014 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, I beg leave to ask the Question standing in my name on the Order Paper, and refer noble Lords to my health interests.

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

My Lords, our aim is to ensure that mental health has equal priority with physical health. We have made this an objective of NHS England. The mandate of NHS England makes it clear that everyone who needs it should have timely access to the best available treatment, including in mental health services. We enshrined in law the equal status of mental and physical health in the Health and Social Care Act 2012.

[Lord Hunt of Kings Heath]

My Lords, that is all well and good, but the noble Earl knows that NHS England has not carried out the instructions in the mandate, and in the tariff for this year it has discriminated in the funding of mental health services. In our most recent debate on this, the noble Earl said that we should not worry about it because clinical commissioning groups will be heavily monitored. But the Government have no power to instruct clinical commissioning groups to make up for this rather perverse decision by NHS England. So I ask the noble Earl: will he not intervene and tell NHS England to reverse this funding policy?

[Earl Howe]

My Lords, as the noble Lord will know, the tariff for mental health services is determined locally. Having said that, we are clear that it is important that these tariffs and the priority given to mental health are scrutinised very carefully indeed, which is why my honourable friend the Minister of State for Care and Support has said he will do just that in the case of every single clinical commissioning group. If he determines that the plans are unsatisfactory, we as Ministers will work with NHS England, which we do regularly, to ensure that there is indeed that progress to parity of esteem that we all want to see throughout the country.

[Baroness Hussein-Ece (LD)]

My Lords, is my noble friend aware that there is significant evidence that two-thirds of local authorities have reduced their child and adolescent mental health service budgets since 2010, draining money from early intervention services, which, I think he will agree, is short-sighted and stores up problems for the future? Will he ensure that NHS commissioners and councils provide comprehensive services to address the deepening damage caused by further cuts to children and young people’s mental health services?

--- Later in debate ---

[Earl Howe]

My Lords, I share my noble friend’s concern. I am aware that some local authorities are not giving the necessary priority to this very important area of service. It is an area that local health and well-being boards should focus on. Our aim must be to support children and young people with mental health problems, wherever possible, in the community where they live rather than seeing them go into acute settings. Admission to hospital should be a last resort. While we have no direct leverage over local authorities, we shall endeavour through NHS England and joint working with area teams to ensure that this message is not lost.

[Baroness Uddin (Non-Afl)]

My Lords, on this seventh World Autism Awareness Day, will the Minister join me in paying tribute to the parents and campaigning organisations? I ask him, on behalf of the one in 100 autistic individuals in this country who are disproportionately affected by mental illness: given the actual reduction in cash investment in mental health services, do the Government agree that funding for mental health must encompass funding for the prevention of illnesses among those most at risk rather than responding to crises that can be prevented by early intervention?

[Earl Howe]

I agree with the point made by the noble Baroness. Prevention is much better than having to cure. I pay tribute to those organisations that champion the cause of those with autism. It is a tribute to the previous Government that they published the Autism Act, part of which involves collecting evidence at local level about the population affected by autism and, in that way, focusing minds at local level—principally the health and well-being boards—to direct services appropriately.

[The Lord Bishop of St Albans]

Given the significant disparity in mental health diagnosis, treatment and outcomes between minority ethnic groups and the general population, what steps are being taken not only to uphold parity of esteem between mental and physical health but to reflect that in the provision of accessible and effective mental health services for all people?

[Earl Howe]

The right reverend Prelate raises an important dimension of this whole issue. We have been looking at ways to overcome inequalities in access to services, which includes better access for black and minority ethnic communities to mental health services. For example, we know that people from BME communities have been less likely to use psychological therapies. To tackle that, the department is working with the Race Equality Foundation and other stakeholders to understand why that is so and to understand inequalities around access to other mental health services and what can be done to improve that. NHS England is also working with BME community leaders to encourage more people to use psychological therapies.

[Lord Patel (CB)]

Has the Minister any comment on the fact that Monitor and NHS England have recommended, pro rata, 20% greater cuts in funding for mental health services than for acute services?

--- Later in debate ---

[Earl Howe]

I can only repeat what I already said to the noble Lord, Lord Hunt. We have expressed our dismay at ministerial level about that decision and will therefore scrutinise local commissioning plans to ensure that, if cuts are implemented and there is freedom not to do so, outcomes and access to services are not damaged.

[Baroness Pitkeathley (Lab)]

My Lords, there are three times as many deaths from suicide as from road accidents. The prescription of antidepressants went up by 10% last year and still only one-quarter of people with a mental illness are in treatment. Are the Government satisfied with the level of funding for preventive and psychological support services?

[Earl Howe]

This is the very reason that we have placed such emphasis on the IAPT programme, into which £400 million is going over the course of this Parliament. I am pleased to say that we are broadly on track to deliver a step change in access to those services.

Health: Folic Acid Fortification

Earl Howe Excerpts

Wednesday 2nd April 2014 Lords Chamber

[Lord Rooker]

To ask Her Majesty’s Government when they expect to be able to make a decision in respect of folic acid fortification of white bread flour as part of a policy to reduce pregnancies affected by neural tube defects.

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

My Lords, we have previously stated that we were waiting for data on the folate status of the population from the National Diet and Nutrition Survey before making a decision with respect to fortification of flour with folic acid. The noble Lord is aware that delivery of these data has been significantly delayed. However, we will make a decision by Easter and will communicate it as soon as possible thereafter.

[Lord Rooker (Lab)]

That is very good news because the congenital anomaly register, which the Minister will be aware of, currently shows that, on average, every week in England and Wales, 13 pregnancies are terminated due to neural defects and three babies are born with spina bifida and other conditions. Two-thirds of those tragedies could be avoided by fortification. Although the delay in the checking of samples is to be criticised in some ways, is it not ironic that British blood samples have been sent to America for checking and delaying, when America has fortified flour since 1998 based on the UK’s Medical Research Council’s work in the 1990s? When are we really going to get a decision so that we can use this for the benefit of our own people?

--- Later in debate ---

[Earl Howe]

My Lords, we will announce a decision by Easter. I am aware, as the noble Lord is, of the impatience that many people have shown about this matter. However, it is right that the Government balance both the risks and the benefits of a policy that would see the mandatory fortification of a staple food. I think that that is a responsible course to take.

[Lord Ribeiro (Con)]

My Lords, is my noble friend convinced that the evidence for introducing folic acid into white bread flour is irrefutable, given the fact that successive Governments have tried to introduce fluoride into water for all of us but have failed to do so?

[Earl Howe]

My Lords, there are risks associated with the fortification of flour with folic acid. That was pointed out by the scientific committee and was why its recommendation was conditional on certain things taking place. As it pointed out, there is a potential for significant numbers of the population to be pushed above the guideline upper limit for folic acid. We have to take those issues seriously in reaching a balanced decision.

[Lord Walton of Detchant (CB)]

My Lords, does the Minister agree that it is time for this important public health development and this important contribution to preventive medicine to be enacted, as it has been in many other countries? I am aware that there are likely to be those who object to this addition to flour. Surely it would be possible to meet those objections of a minority if a limited amount of bread free of folic acid were to be marketed to meet that concern.

[Earl Howe]

My Lords, I note the noble Lord’s helpful suggestion but it is important that the Government take a decision on folic acid that is right for our own population, rather than anyone else’s. It is worth remembering that no other country in the European Union has taken the decision to fortify flour with folic acid. We need to do this by evaluating the risks and the benefits, as I said, based on the most up-to-date data we can get.

[Lord Hunt of Kings Heath (Lab)]

My Lords, we know that 50 countries have introduced folic acid. On the fluoridation question, the legislation is for local people and local authorities to decide, so there is a clear difference. It is clear that the Government have already briefed out that they will agree to this. We are going off on a very long Easter Recess. Joy would be unconfined if the noble Earl told us now what we know the Government have agreed to. Why does he not come clean on it?

[Earl Howe]

Because I have been told I cannot.

[Baroness Brinton (LD)]

My Lords, pending that decision, and even with the fortification of flour, the fact is that not all women planning to get pregnant will have the right level of folic acid. Are the Government planning a media campaign to encourage mothers about this? I mean not just the information on NHS pages but radio and magazine advertisements for young women so that they start to think about it when they begin to consider having their families.

--- Later in debate ---

[Earl Howe]

There is a range of routes whereby we ensure that, as far as possible, women are advised on folic acid intake, particularly those women of childbearing age who may be thinking of starting a family. That includes the Start4Life information service and other media routes. I am not aware of specific media campaigns in this area, but if I can be enlightened on that I will write to my noble friend.

[Lord Patel (CB)]

The Minister commented that no other European country has adopted fortification. Does he agree that the reason for that is that no other European country has the same incidence of neural tube defects as we have here in the United Kingdom? The incidence is far greater in the United Kingdom.

[Earl Howe]

That is an issue that we will of course weigh up as we look at the risks and benefits and take a decision, as we will in the next few days.

[Lord Swinfen (Con)]

My Lords, what are the risks of adding folic acid to flour?

[Earl Howe]

My Lords, the scientific committee pointed to several risks. One is that an overdose of folic acid may mask vitamin B12 deficiency, particularly in the over-65s—and this may be an issue in which a number of us wish to declare an interest. The committee also pointed out that although there was no specific evidence of a link to bowel cancer, there are nevertheless experts who believe that the evidence is equivocal in that area, and we need to take the balance of opinion very seriously.

Health: Innovative Medicine

Earl Howe Excerpts

Tuesday 1st April 2014 Lords Chamber

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

My Lords, I congratulate my noble friend Lady Thomas on securing this debate and I am grateful to her for providing the opportunity to update your Lordships on, in particular, the early access to medicines scheme. It is just one way in which the Government are supporting improving patients’ access to new medicines.

I begin by making it clear that our priority is to ensure that patients, including those with rare and life-threatening or life-limiting conditions, have access to new and effective treatments on terms that represent value to the NHS and the taxpayer. I agree with the noble Baroness, Lady Masham, that it is essential that people get the medicines and treatment that they need. That is why we have set up the cancer drugs fund and why we have NICE to give evidence-based advice to clinicians and the NHS.

On 5 December 2011, the Prime Minister announced a new strategy for UK life sciences. One of its commitments was that,

“early in 2012 the MHRA will bring forward for consultation proposals for an ‘Early Access Scheme’”.

I am pleased to be able to say that, following public consultation co-ordinated by the Medicines and Healthcare products Regulatory Agency—known as the MHRA—and engagement with patient groups and industry, we announced the early access to medicines scheme on 14 March. The purpose of the early access to medicines scheme is to support access in the UK to promising new, unlicensed or off-label medicines in areas of unmet medical need. Under the scheme, the Secretary of State for Health, acting through the MHRA, will provide a scientific opinion on such medicines to treat, diagnose or prevent life-threatening or seriously debilitating conditions that do not have adequate treatment options. This could include patients with advanced cancer or children with Duchenne muscular dystrophy.

MHRA is responsible for managing the scientific aspects of the scheme, which will follow a two-step process. Step one involves giving a new medicine a promising innovative medicines designation, known as a PIM designation, which will provide an early indication that a product may be a possible candidate for entry into the early access to medicines scheme, based on the available clinical data. Companies that wish to move to step two must hold a PIM designation and provide further relevant data on their product’s quality, safety and efficacy. At step two, the MHRA will produce a scientific opinion describing the benefits and risks of the medicine, based on information submitted by the applicant after sufficient data have been gathered from the patients who will benefit from the medicine.

The scientific opinion will be made available on the MHRA’s website to assist clinicians and patients in making treatment decisions and to support informed consent by patients by informing them of the risks and benefits of the product. The scheme will be launched and ready to receive applications from Monday of next week, 7 April 2014. I understand that full details, together with guidance, will be published on the MHRA website at this time.

The noble Lords, Lord Kakkar and Lord Hunt, asked about equal access for patients under the scheme. EAMS medicines will be provided for free by the company concerned. The scientific opinion will be available on the MHRA website, as I have mentioned, to allow doctors and patients to make treatment decisions. That will provide an equitable platform for patient access.

The noble Lord, Lord Kakkar, also asked about academic science input into the scheme. The scheme is open to academics, industry and charities, provided that the criteria are met. Step one, the PIM designation, would also be open to academic research units such as at UCL. As the noble Lord mentioned, academic health science networks could well have a role in promoting the scheme. All AHSNs are now up and running and their funding is assured for the immediate future.

It is important to recognise that the early access to medicines scheme is a UK-only scheme that relates to unlicensed medicines en route to market. It is always better for a patient to receive a licensed medicine where possible and for companies to have the legal certainties that come with a marketing authorisation. For this reason, the MHRA continues to engage at both European and global level to explore how the medicines licensing process can become more efficient. We welcome the European Medicines Agency’s launch of its adaptive licensing pilot on 19 March 2014, as the MHRA has had a leading role in the preparation of the pilot and accompanying guidance.

Adaptive licensing is a prospectively planned, adaptive approach to bringing drugs to the market. It seeks to maximise the positive impact of new drugs on public health by balancing timely access for patients with the need to provide adequate evolving information on benefits and harms. Adaptive licensing uses the regulatory processes and flexibilities within the existing EU legal framework, such as conditional marketing authorisation. The pilot will explore the strengths and weaknesses of all options for development, assessment, licensing, reimbursement, monitoring and utilisation pathways in a confidential manner and without commitment from regulator or company. I plan to meet relevant government and industry partners later this month to ensure that the UK can capitalise on the pilot. I hope that UK-based companies will be at the forefront of those presenting products to the EMA.

The noble Lord, Lord Kakkar, asked about the draft Medical Innovation Bill, which aims to encourage responsible innovation in certain circumstances and to discourage irresponsible innovation. I echo the noble Lord’s thanks to my noble friend Lord Saatchi for putting these concepts before your Lordships’ House previously. We are currently consulting on this draft Bill. The consultation paper was published on 27 February and the consultation runs until 25 April. For that reason, I am afraid that I am not yet in a position to make a definitive pronouncement on the Bill’s provisions.

The noble Lord, Lord Kakkar, asked about equality of access to specialised services. NHS England, as he knows, is now responsible for commissioning prescribed specialised services across England, so patients should know what services they can expect. The Government remain totally committed to making the UK a world-leading place for life sciences investment. The noble Lord was right to say that trialling drugs is an expensive business, but good progress is being made through the life sciences strategy to build a better life science ecosystem to attract and develop talent, to reward innovation and to overcome barriers to innovation. The Strategy for UK Life Sciences states:

“It has become increasingly challenging for life sciences companies, particularly SMEs, to discover, develop and commercialise medical innovation”.

AHSNs, as the noble Lord rightly said, have therefore been set up as a key response to these challenges, acting as the link between the NHS and industry. I think that the universal coverage of AHSNs has had multiple benefits in terms of potential UK growth.

The noble Lord, Lord Walton, and my noble friend Lady Thomas mentioned ultra-orphan drugs. We are aware of the challenges posed by treatments for the very rare conditions, with small patient populations, for which these drugs are made. My noble friend expressed particular worry about eculizumab, or Soliris. From April 2013, NICE has been responsible for the evaluation of selected highly specialised health technologies. It issued draft guidance on 27 February which does not recommend the drug’s use. Stakeholders had until 25 March to submit comments to NICE. I must stress that NICE has not yet issued its final guidance on eculizumab to the NHS and I understand that that is expected in July. While NICE undertakes its evaluation, NHS England has developed an interim commissioning policy to enable patients with aHUS to receive eculizumab. To clarify, AGNSS found that eculizumab was clinically effective but that further information was needed to demonstrate its cost-effectiveness. That is why we tasked NICE with evaluating it.

All candidate medicines have the potential to induce toxicity. I will address the interesting speech of my noble friend Lord Colwyn by reminding noble Lords that medicines must undergo a series of rigorous assessments, progressing from small cohorts of patients in rigorously controlled conditions to larger and more diverse groups of patients, thus ensuring quality, safety and efficacy. We have three phases of clinical trials to ensure that those things are assured.

It is possible to run adaptive licensing design studies that allow for modifications as the trial progresses; for example, the numbers of different treatment arms can be tried out. Such designs have the potential to speed up clinical development and can use resources more efficiently. There is regulatory guidance on adaptive designs. I respond to my noble friend Lady Thomas by welcoming many features of the new clinical trials regulation, which provides for a more streamlined approach, with the introduction of combined clinical trial and ethical approval and a single portal for all EU applications.

I share the enthusiasm and excitement of the noble Lord, Lord Walton, about the developments in genetic medicine. That is why we have established Genomics England, a development that has put us firmly at the head of the field.

The noble Lord, Lord Hunt, asked what we are doing to ensure the rapid uptake of NICE-recommended drugs in the NHS. Innovation, Health and Wealth, a document that we published in 2011, set out a range of measures to support the rapid uptake of NICE-approved medicines in the NHS, including the establishment of the NICE Implementation Collaborative, the automatic incorporation of NICE-recommended drugs into local formularies and the introduction of an innovation scorecard to compare local uptake. Good progress has been made in delivering those commitments, but we recognise that more can and should be done. We are committed to seeing Innovation, Health and Wealth progress.

There are variations in drug usage among CCGs. As the report points out, there can be many reasons for variation. Different areas may have different health needs and it is right that the treatments used should be decided by doctors and patients. As I have said to the noble Lord before, we are committed to tackling unjustified variation in the usage of medicines and we encourage NHS organisations to consider the findings of the report in the context of the needs of their populations.

As my time is running out, I will have to write to noble Lords to cover those issues to which I have not yet managed to reply. However, in conclusion, I was pleased to announce yesterday my approval of the business case presented by the Health Research Authority and the funding that goes with that to enable it to fulfil its remit. The HRA will provide a single approval for research in the NHS to radically streamline and simplify how studies are set up. I believe that the UK’s approach of allowing patients access to promising but as yet unlicensed medicines while encouraging greater use of European licensing flexibilities will provide much earlier access to a number of innovative new medicines, in particular in areas of unmet need. We can be proud of the leading role that we play in ensuring that the UK remains one of the leading countries in which to develop medicines and to see them reach the patient’s bedside in clinical use.

NHS: Bed Capacity

Earl Howe Excerpts

Thursday 20th March 2014 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, I beg leave to ask the Question standing in my name on the Order Paper, and refer noble Lords to my health interests.

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

My Lords, moving patients between wards overnight should happen only for good clinical reasons, because it can be a distressing experience for them and their families. We have asked NHS England’s medical director, Sir Bruce Keogh, to write to all hospital trusts requesting that they minimise transfers that are not aimed at improving patient care. As the Government’s response to the Francis inquiry highlighted, listening to and learning from patients to improve care is a top government priority.

[Lord Hunt of Kings Heath]

My Lords, it is all very well the Minister’s telling the NHS not to do it any more, but does he agree that the real problem here is the pressure on hospital services, particularly on A&E services, which then leads to a desperate search for beds, which then causes patients to be moved in the night time, as this survey has reported? Do Ministers have a response to the more general issue of the acute pressures on our acute hospitals at the moment?

[Earl Howe]

My Lords, many hospitals have been under pressure, particularly during winter, as they always are. It is telling that if one looks at the tell-tale signs of pressure, such as bed occupancy, the rates have remained stable for a number of years. In fact we have more clinical staff on the front line, particularly in A&E, than we had a few years ago. There is no doubt that there are times when hospitals feel acutely under pressure. However, despite rising demand, average waits for assessment in A&E are around 30 minutes at the moment, compared with over 70 minutes in 2009-10.

[Lord Laming (CB)]

My Lords, would the Minister use his good offices to reinforce again with the National Health Service that all unplanned moves that are not determined by clinical need, be it during the day or at night, have the potential to cause disorientation to patients and considerable distress to their relatives?

[Earl Howe]

The noble Lord is absolutely right. That is why my ministerial colleague, Dr Poulter, has written to Sir Bruce Keogh. This issue lies at the heart of the NHS constitution: the patient’s dignity and shaping care around the needs and preferences of patients is absolutely at the centre of the constitution. This is why it is entirely appropriate for Ministers to make their views known and for Sir Bruce to ensure that all hospitals are aware of this principle.

[Baroness Barker (LD)]

My Lords, does the Minister agree that it is possible to discharge patients from hospital in the evening safely and that there are some patients for whom that is the best clinical option, but that hospitals are not good at ensuring that frail older people are discharged at the best time when they live on their own? Could he include that in the review carried out by NHS England?

[Earl Howe]

My noble friend is quite right. As she knows, there are far too many frail elderly people who end up in hospital in the first place. We must get better at the discharge arrangements for them and not keep them in hospital too long. This is the focus of much of the work going on in the department and NHS England at present concerning vulnerable older people. We will announce a comprehensive plan around this later in the year.

[Baroness Masham of Ilton (CB)]

My Lords, apart from distressing patients, is not moving them around bad for infection control, particularly if the beds are not properly cleaned?

[Earl Howe]

Yes, my Lords. As ever, the noble Baroness makes an extremely good point. It is heartening that infection rates have come dramatically down in hospitals over the past few years, but we can never be complacent and it is important that when a patient is moved the infection question is always considered.

[Lord Turnberg (Lab)]

My Lords, is it not the case that we have the lowest number of beds per head of population of any OECD country, bed occupancy rates of approaching 90%—a dangerously high level—and, despite all that, the shortest lengths of stay of any European country? Does the noble Earl agree that the idea of closing wards or hospitals can only worsen the situation, unless, of course, we are able to build up the community services before we do any of that?

[Earl Howe]

I agree with the principle that the noble Lord has articulated. Certainly, commissioners and providers of care should reduce beds only where it is clinically safe and appropriate to do so. The NHS is very experienced at flexing the number of beds it has available; it does this every year and every winter. As a principle, I would agree with the noble Lord but I come back to the point that bed occupancy rates have, in fact, remained stable over the past 10 years, fluctuating between 84% and 88% on average, and increasing slightly over the winter period.

[Lord Geddes (Con)]

My Lords, further to the question from my noble friend Lady Barker, is it mandatory for the NHS to advise next of kin before discharging frail patients?

--- Later in debate ---

[Earl Howe]

I am not aware that it is mandatory. It is certainly good practice for hospitals to inform families, just as they should inform patients. Every decision taken about the patient should be explained to that person.

[Lord Hunt of Kings Heath]

My Lords, can I come back to the point raised by my noble friend? The noble Earl will know that Monitor is requiring foundation trusts to make five-year plans ahead. My understanding is that almost all such plans made by acute trusts are predicated on reducing bed capacity in order to keep within the budgets that they are likely to have over that period. Can he assure me that as those bed numbers are reduced, community care and social care provision will increase in order to enable patients to be discharged appropriately?

[Earl Howe]

It is for that very reason that we are setting up the Better Care Fund as from April 2015, so that health and social care are more joined up, people are kept out of hospital and we can therefore safely reduce the number of beds. We have to take an all-systems approach to this; it is no good looking at one part of the system—health and social care have to be looked at together.

Health: Local Healthwatch Funding

Earl Howe Excerpts

Wednesday 19th March 2014 Lords Chamber

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

The Government have made no assessment. We welcome transparency in funding for local Healthwatch—something we called for in response to the Francis inquiry report—and Healthwatch England’s findings are a helpful contribution to that. We remain of the view that local authorities are best placed to decide local funding arrangements based on local needs and priorities, which is why the funding made available to them is not ring-fenced for a specific purpose.

[Lord Harris of Haringey (Lab)]

So the noble Earl is telling the House that £10 million—almost a quarter of the money that his department allocated for local Healthwatch—has disappeared midway through the Department for Communities and Local Government to local government and not reached local Healthwatch. Was that not predictable and predicted? Why do the Government not now recognise that providing a local voice for the users of the health service is critical to the development of the health service and ensure that the funds are channelled through Healthwatch England for it to commission local services? If they cannot do that because it would require legislation, perhaps the Government could publish an indicative statement of what each local authority ought to be spending on local Healthwatch.

[Earl Howe]

My Lords, I would say that it is not the role of the Government to dictate what local authorities should be doing. It is up to local authorities to make judgments about what are the needs and priorities of their areas. I would also say that there cannot really be any direct comparison between the money made available by central government and the funding provided to local Healthwatch. It is not the case that £10 million has somehow disappeared. It is, rather, that councils have made local funding decisions which mean that £33.5 million was invested in local Healthwatch last year. What matters here is the transparency. That is what we very much welcome. It enables local Healthwatch to hold local authorities to account for their funding decisions and thereby, perhaps, influence them to give them a bit more money if that is required.

[Baroness Brinton (LD)]

My Lords, in the light of the Minister’s response, what assessment have the Government made of the extent to which local authorities are meeting those needs?

[Earl Howe]

My Lords, we will not have a comprehensive picture of the impact that local Healthwatch has made until it publishes its annual reports later in the year. At the moment, we have anecdotal reports of some considerable successes around the country, but until we have those annual reports, it would be premature for me to make a general comment.

[Baroness Pitkeathley (Lab)]

My Lords, it is surely disingenuous to think that local Healthwatch can properly represent the interests of patients—the Government made very strong commitments about that during the passage of recent health Bills—when it is being starved of cash. What discussions have been taking place between the Department of Health and the Department for Communities and Local Government to ensure that the money gets to the right place?

[Earl Howe]

I simply say to the noble Baroness that it is too soon to say whether local Healthwatch has been starved of cash. What matters most to local communities is the difference that their local Healthwatch is making, such as rooting out poor practice, ensuring that the views of local communities are heard in inspections and helping to improve local services. It is only after a period of time that we can make the relevant judgments. I can tell the noble Baroness that Healthwatch England is playing the role that it was designed to do: overseeing and supporting local Healthwatch where necessary.

[Baroness Masham of Ilton (CB)]

My Lords, does not the Minister agree that this is an example of where money should be ring-fenced? The people who work for Healthwatch are volunteers. They should not be out of pocket and they need their expenses for travel.

[Earl Howe]

I agree with the noble Baroness that, in the normal course of events, expenses should be reimbursed, but I say again that it is not the role of Ministers to second-guess the judgments of local authorities. We believe in local autonomy. There are plenty of other ways in which many local authorities are supporting voluntary groups in their areas apart from Healthwatch, and making a difference in that way.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I refer noble Lords to my health interests. I can hardly believe what I am hearing. Of course I understand why the noble Earl’s department does not want to tell local authorities what to do, but surely this is a question of upholding propriety in the use of public money. His department allocated more than £43 million to the DCLG to distribute to local authorities for Healthwatch. Somewhere along the line, either in the DCLG or in local authorities, someone has nicked £10 million. Does the department not want its money back?

[Earl Howe]

I do not believe that anybody has nicked £10 million, my Lords. The issue here is the one raised by the noble Lord, Lord Harris, and others: the absence of ring-fencing should not be seen as something negative. It has enabled councils to take a strategic approach to allocating their resources, in line with local needs and priorities. It has given them freedom to deploy their resources across the piece to achieve value for money. It is now, as I said earlier, up to local communities, but also local Healthwatch itself, to hold their local authority to account and thereby to demonstrate the impact that they are having, and make the case for more money if they feel that they merit it.

[Baroness Hussein-Ece (LD)]

My Lords, the Minister said that this was about transparency, which of course it is. However, is it not also about consistency? There must be regions, boroughs or councils that are not using the money that has been allocated, which is surely to the detriment of the local community and to patients there. Surely we need to know where that money is not being spent and where patients and users of the health service are being sold short.

[Earl Howe]

We do need to know if people are being sold short. I would say to my noble friend that that is one of the reasons why local Healthwatch has a seat at the table of the health and well-being board, where it is eminently able to make its voice heard if it feels that it does not have sufficient resources to do the job which local authorities are legally obliged to commission.

[Baroness Hollis of Heigham (Lab)]

My Lords, can we therefore have an assurance from the Minister that if local authorities do not spend all the money allocated on Healthwatch, they will not find their funding for Healthwatch proportionately reduced next year?

[Earl Howe]

I can give that assurance. We have allocated a fixed sum of £43.5 million for next year, and that will be paid.