Tobacco: Packaging
Earl Howe Excerpts(11 years, 3 months ago)
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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.
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?
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.
NHS: Mental Health Funding
Earl Howe Excerpts(11 years, 3 months ago)
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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?
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?
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?
Health: Folic Acid Fortification
Earl Howe Excerpts(11 years, 3 months ago)
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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?
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?
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.
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.
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(11 years, 3 months ago)
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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
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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?
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
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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?
Mental Health: Funding
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Baroness Brinton
To ask Her Majesty’s Government what steps they are taking to protect the provision of mental health beds and funding, in the light of their commitment to parity of esteem between physical and mental health.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, we are clear that acute beds must always be available for people who need them. Providers have a responsibility to listen to patients and to offer care in the community as well as in hospitals, when appropriate. The mandate to NHS England sets its specific objectives, including on mental health. It is for NHS England and clinical commissioning groups locally to determine how best to allocate funding in commissioning services to meet local need.
Baroness Brinton (LD)
I thank my noble friend for that Answer. Before these cuts come in April the reality is that it is already very difficult to find an urgent mental health bed. Ten days ago in Kent, no emergency level 4 mental health beds were available. Given that the cuts in mental health services are 20% more than for hospital trusts and given David Nicholson’s statement last week that NHS England will not review them, what specifically can the Government do to remedy the situation?
Earl Howe
My Lords, my honourable friend Norman Lamb has expressed his concern that the cuts to the mental health tariff have taken the form that they have. I can tell my noble friend that the department will be scrutinising the commissioning plans of clinical commissioning groups and the draft budgets of mental health trusts to make sure that they reflect the central importance, as set out in the Government’s mandate to the NHS, of making measurable progress towards parity of esteem. We know that there are regional differences in access and we are setting up a new national mental health intelligence network to provide comprehensive and up-to-date information about mental health and well-being.
Lord Patel of Bradford (Lab)
My Lords, can the Minister confirm that, despite having very clear guidance and legislation in place, we still have an unacceptable number of 16 and 17 year-olds being admitted to psychiatric wards and that, worryingly, many children under the age of 16 are being placed on adult wards many miles from their families and homes? I am sure the Minister will agree that this is totally unacceptable and extremely harmful to the children concerned and their families. What plans do the Government have to put a complete stop to this harmful practice and provide the resources that are clearly needed for appropriate places for young children in mental health services? Does he have an approximation of the number of children we are talking about?
Earl Howe
I do not have a figure to quote to the noble Lord, but our aim, as he says, must be to support children and young people with mental health problems wherever possible in the community in which they live. Admission to hospital should be a last resort for a young person. We have done a great deal to improve mental health services for young people in the community. We also recognise the difficulties for young people and their families if they are treated in hospitals some way from home, but the decision about where they are treated is bound to depend on what is available and what facilities are needed to meet their particular clinical needs.
Baroness Corston (Lab)
My Lords, given that there should be parity of esteem not only between mental and physical health services but between people in the community and those in prison, and given that up to 70% of women in our prisons are mentally ill, what provision is now given under the Health and Social Care Act regime for the commissioning of those services for these women?
Earl Howe
My Lords, the principle of parity of esteem applies in every clinical setting, including prisons. We have made it very clear in our document Closing the Gap that these matters are not only important in the wider community but also in prison. We will be monitoring the situation very closely, not least in women’s prisons.
Lord Elystan-Morgan (CB)
My Lords, does the Minister accept that successive Governments have shown a remarkable lack of kindness in giving information concerning the apportionment of funds between physical and mental health matters? Does he accept that what is asked for is not a detailed breakdown under various headings, but a broad, ballpark figure that will allow the public to judge whether or not mental health has been less than equitably dealt with in this situation? The failure to give this information, which clearly must be shared by all departmental Ministers, will only add to that suspicion.
Earl Howe
My Lords, the Government are committed to the principle of transparency in these areas. I can tell the noble Lord that last month NHS England published expenditure data from its programme budgeting data set for 2012-13 which show that expenditure on mental health in that year was £11.28 billion.
Lord Hunt of Kings Heath (Lab)
My Lords, the noble Earl cannot escape his own responsibility and that of his ministerial colleagues. He sets the mandate for NHS England. NHS England has specified that for the next financial year mental health trusts are to be discriminated against as compared to acute trusts. Ministers cannot evade their responsibilities. Why do they not intervene?
Earl Howe
My Lords, we have intervened. I have already referred to the action my honourable friend Norman Lamb has taken, making it very clear that not only would there be ministerial oversight of clinical commissioning group plans but that we would ensure that every decision made by a clinical commissioning group with regard to its mental health patients could be justified.
Lord Cotter (LD)
My Lords, I welcome the Minister’s repetition of the parity issue but, in practice, many young people nowadays—one in four, perhaps, as has come out in recent surveys—are suffering from mental health problems. I have evidence, which I would be glad to give to the Minister for his intelligence network, that there is no parity when it comes to young people. For example, one GP said that it is a “DIY service”. There are major concerns about mental health across all ages, particularly young people. I would welcome a response from the Minister now but I would also like to give him some evidence to be looked into with regard to specific areas in this country.
NHS: Midwives
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Lord Harrison
To ask Her Majesty’s Government what steps they are taking to ensure that a sufficient number of midwives are trained, employed and retained by the National Health Service.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, this Government are committed to improving maternity care. That is why we have charged Health Education England with ensuring that training numbers meet service demand. By reducing attrition rates, record numbers of midwives will be available to the NHS. Since May 2010 the number of full-time equivalent midwives increased by around 1,800 to nearly 22,000. A record number of midwives, some 6,000, are currently in training. New midwife training commissions by HEE for 2014-15 number 2,563.
Lord Harrison (Lab)
My Lords, given that the Commons Public Accounts Committee believes that there is a shortfall of around 2,300 midwives and that the NSPCC has computed that number at 5,000, does the Minister acknowledge that we are beginning to get anecdotal evidence, certainly in Chester in the north-west, of maternity services under real pressure? With regard to maternity services, does he recognise that three out of four such services lack any trained mental health midwives to deal with perinatal mental illnesses, which I am afraid are associated with as many as 10% of all pregnancies? Will the Minister look in particular at the question of the training of midwives, where all too often the perinatal mental health services are left off the agenda?
Earl Howe
My Lords, I agree that in certain parts of the country maternity services are under pressure, but it is encouraging that the ratio of births per midwife has improved nationally. Indeed, since 2010 the number of midwives has increased by 4% and the number of births by 1%. However, the noble Lord is right to attach importance to mental health services. Improving diagnosis and services for women with pregnancy-related mental health problems is one of the Department of Health’s objectives for maternity care. That is why Health Education England has been tasked with working with partners to ensure that pre-registration and post-registration training in perinatal mental health is available to enable specialist staff to be available to every birthing unit by 2017.
The Earl of Listowel (CB)
Is the Minister aware of the excellent model of best practice at Chelsea and Westminster Hospital, where there is a mental health team working hand in hand with the midwives, and how important that is to retention? Is the supervision of midwives being looked at—whether they feel well supported and wish to carry on in the profession because they have a mentor who can support them?
Earl Howe
I thank the noble Earl for bringing the example of the Chelsea and Westminster to my attention. I am sure it is a model of good practice, as I know how good that hospital is. With regard to supervision, the noble Earl is right. This bears upon the whole question of midwife numbers, to ensure that we have enough midwives not only looking after women about to give birth and giving birth, but also to ensure good practice in our hospitals and midwifery units.
Baroness Manzoor (LD)
My Lords, I congratulate the coalition Government on two facts. One is that there are many more midwives than there were in 2010. The second, as my noble friend says, is that there are 6,000 more student midwives in training. There is, however, an issue regarding the attrition rates of student midwives leaving before the end of their three-year training. Can my noble friend state what the Government are doing to understand why the attrition rate is as high as one in four students leaving, and whether this information is being collected by exit surveys?
Earl Howe
My noble friend is right to draw attention to the attrition rate. NHS England is focusing on this very closely. It is not always possible to predict the attrition rate because midwives leave practice for varying reasons—for instance, to take a career break. It is, however, very important that the motivation of midwives should be maintained. There is a great deal of work going on to ensure that we do not lose highly qualified and skilled midwives from the NHS.
Baroness Wall of New Barnet (Lab)
Does the Minister accept that the issue is trying to work out how many vacancies there are? The ratio that is defined in the area depends on the hospital. For instance, Barnet and Chase Farm Hospitals, of which I am chair, has 30 births to one midwife, whereas in other parts of London it could be 28 or fewer. What we have tried to do, in looking at whether we should have a lower ratio, is work with the midwives’ associations. I think it is difficult to establish the number of vacancies because that ratio dictates what is paid for.
Earl Howe
The noble Baroness is quite right. Helping commissioners to reduce unwarranted variation in service delivery is one of the key roles of the maternity and children strategic clinical networks, as I am sure she is aware, which are being established and supported by NHS England. Clinical commissioning groups are responsible for commissioning maternity services locally, but they work with local authorities and in conjunction with provider partners to give assurance that processes and service specifications are in place which ensure that midwifery staffing is appropriate for the locality.
Lord Turnberg (Lab)
My Lords, the number of births has gone up by 25% in the past 10 years. The vacancy rate among midwives is about 11%. That is the long-term vacancy rate. There seems to be a problem with recruitment and retention. Despite the figures that the noble Earl has cited, we are in some difficulty.
Earl Howe
The noble Lord is right. We recognised that issue at the outset of the Government, which is why we were determined that the number of midwives in training should be increased. It is now at a record number of 6,000. The number of trained midwives is increasing—that is, full-time equivalent midwives practising in the NHS rather than just on the register. We are heading in the right direction, but there is a long way to go.
Baroness Finlay of Llandaff (CB)
Will the Minister assure the House that the report from the Royal College of Obstetricians and Gynaecologists on the unique learning environment of the labour ward has been addressed in the curricula and the learning environments by HEE? That report highlighted bullying by some senior midwives of junior and student midwives and of medical students, which was making the learning environment particularly difficult and stressful and accounted for some of the high attrition rates.
Earl Howe
The noble Baroness raises the extremely important issue of bullying. Bullying is not to be tolerated in any environment in the NHS. I am not aware of the extent to which Health Education England has factored that particular point into its plans. I would be amazed if it had not, but I will write to the noble Baroness with an answer.
Baroness Wheeler (Lab)
My Lords, does the Minister accept that the Public Accounts Committee report on maternity services was pretty damning, not just in terms of midwife shortages but on the lack of overall government accountability and strategy for maternity services, the increasing clinical negligence bill and substantial regional and demographic inequalities and variations in maternity care? What are the Government doing about this and when can we expect a coherent plan in response to these issues?
Earl Howe
The noble Baroness is right: the PAC raised a number of very important issues, many of which we agree need close attention. I have already mentioned the work that we are doing to improve recruitment and to reduce variation in the quality of services around the country. This requires more than just government; it requires all the arm’s-length bodies with an interest to pull together and, of course, local commissioners to do their bit as well.
Medical Act 1983 (Amendment) (Knowledge of English) Order 2014
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Earl Howe
That the draft orders laid before the House on 30 January and 12 February be approved.
Relevant documents: 21st and 22nd Reports from the Joint Committee on Statutory Instruments, 31st Report from the Secondary Legislation Scrutiny Committee, considered in Grand Committee on 11 March.
Regenerative Medicine: S&T Committee Report
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, first, I congratulate the noble Lord, Lord Patel, on securing this debate and congratulate the Select Committee on Science and Technology, chaired by the noble Lord, Lord Krebs, on its excellent work in highlighting the important issues associated with the development of the regenerative medicine sector in the UK. The Government welcome the committee’s report and recommendations and agree that it is very important that the translation and commercialisation of research in this area in the UK is enabled.
As noble Lords recognised, regenerative medicines have enormous potential to treat and cure diseases, including in areas where no cure yet exists, to improve the quality of people’s lives and generate significant economic benefits for the UK. The Government remain committed to developing this important field of medicine, which we recognise as one of the UK’s eight great technologies. As the noble Lord, Lord Patel, acknowledged, the UK, with its strong science base, research funding and regulatory frameworks, and access to patients provided by the NHS, retains a strong international position to support the successful commercial translation of regenerative medicines. That said, more can be done to support and enhance the development of regenerative medicines in the UK.
I am grateful to the committee for the recommendations that it made on ways in which this area of medical science can be better supported. The actions that the Government are taking are set out in detail in our response to the report, but I would like to take this opportunity to highlight a number of areas of important activity.
The Government are continuing to invest to support translational health research on regenerative medicines, and this remains a high priority. A number of noble Lords, including the noble Lord, Lord Patel, asked for some reassurance that the NHS was ready for regenerative medicine clinical trials. As he knows, the Department of Health’s National Institute for Health Research—the NIHR—funds infrastructure in the NHS for translational research in regenerative medicine, in particular, as my noble friend Lord Willis mentioned, through biomedical research centres and units. These are established in leading NHS and university partnerships to drive progress on innovation and translational research in biomedicine into NHS practice. In 2011, the Government announced £800 million of NIHR funding for five years from April 2012 for 11 biomedical research centres and 20 biomedical research units. As part of this, the NIHR is investing more than £9 million annually in research programmes within its BRCs and BRUs that involve significant cutting-edge translational research in regenerative medicine across a range of disease areas.
This approach is already bearing fruit. For example, scientists at the NIHR biomedical research centre at Guy’s and St Thomas’s, and King’s College London have, for the first time, identified the unique properties of two different types of skin cells, including those responsible for repairing skin wounds. This research could pave the way for new and effective treatments to repair injured skin and reduce the impact of ageing on skin.
In addition to these centres and units, the NIHR funds infrastructure for regenerative medicine studies through its clinical research facilities and the Clinical Research Network. The Government’s response to the committee’s report highlighted work to implement changes to the organisational structure of the Clinical Research Network to take effect from 1 April, and I can report that these changes are on target.
The noble Baroness, Lady Greenfield, in her highly informative speech, spoke about the development of regenerative medicines to treat neurodegenerative diseases, including dementia. The Government have established the new National Institute for Health Research Dementia Translational Research Collaboration to pull discoveries from basic science into real benefits for patients. This brings together resources within the NIHR biomedical research centres and units.
As part of the collaboration, the NIHR Queen’s Square Dementia Biomedical Research Unit recently held a workshop on the use of stem cells in dementia and other neurological diseases, without—as the noble Baroness emphasised—conflating very distinct conditions. In addition, the NIHR Clinical Research Network will be responsible for delivering clinical research studies across a full breadth of specialties, which will include dementia and neurodegenerative diseases. Studies in regenerative medicine will be supported within the relevant specialty.
Regenerative medicine research has also benefited from the Regenerative Medicine Platform, the Technology Strategy Board and the Biomedical Catalyst, which have made significant investments in this area. Furthermore, noting the committee’s observation that there are a large number of different research and development funders, I am pleased to report, particularly to my noble friend Lady Sharp, that a single, interactive research “funding portal” is in development. We anticipate that it will be rolled out this spring. This portal will support researchers across academia and industry to identify and access relevant funding opportunities. As noble Lords have suggested, there should be a clear pathway from development to delivery of regenerative medicines in the NHS. This will aid the growth of this sector so that effective regenerative medicines become readily available and provide benefits to patients.
The healthcare system in the UK has already been delivering regenerative medicines successfully for decades, as shown through stem cell or tissue transplantation and through medicines such as erythropoietin. As the noble Lord, Lord Patel, pointed out, it is important to remember the breadth of the therapies that fall under a regenerative medicine definition, ranging from well established bone marrow transplantation procedures through to those at early-stage research. Each regenerative medicine product that is developed will differ by its mode of action, cost and therapeutic application.
My noble friend Lord Selborne referred to some new therapies appearing over the horizon. For new innovative therapies we are implementing recommendations from the Innovation, Health and Wealth report to spread innovation quickly and at scale throughout the NHS to improve outcomes and quality for patients and the NHS. I recognise fully the concern of the noble Lord, Lord Hunt, about the pace of uptake in the NHS of NICE-approved medicines; it is a concern that I share.
NHS England’s Commissioning through Evaluation programme provides an opportunity to strengthen the information we have available to inform commissioning policy for procedures or treatments that show significant future promise, but for which the evidence base on clinical and cost-effectiveness is currently insufficient to support routine commissioning. This is particularly important for rarer or smaller-volume treatments, such as some regenerative medicine treatments, where randomised controlled research evidence may be less readily available. We have also asked NICE to develop multiple-technology appraisal guidance on autologous chondrocyte implantation, a regenerative medicine for repairing symptomatic articular cartilage defects of the knee.
As noble Lords mentioned, in order to develop an NHS pathway for regenerative medicines, we have established a Regenerative Medicine Expert Group, as recommended by the committee, to develop an NHS regenerative medicine delivery readiness strategy and action plan. We are pleased that Professor Sir Michael Rawlins has agreed to chair this group, which is of a multidisciplinary nature with all the key stakeholder groups represented within the membership, including NHS England, the National Institute for Health and Care Excellence, regulators, industry, researchers, patient representatives, NHS Blood and Transplant, the Scottish National Blood Transfusion Service, the Welsh Blood Service and the Cell Therapy Catapult.
The noble Lord, Lord Patel, asked about the group’s terms of reference. These can be found on its website, which is located on the Department of Health’s website. However, in essence, we have tasked the group with considering all the important elements of the pathway of regenerative medicines into the NHS, including licensing and regulation of a product, evaluation, commissioning and reimbursement, as well as practicalities such as manufacturing and distribution. I can tell the noble Lord that the group has been asked to report to the Secretary of State by the end of this calendar year, and its work is well under way. It will deliver an NHS regenerative medicine delivery readiness strategy and action plan.
I am sure that the noble Lord, Lord Turnberg, will be glad to know that as well as NHS delivery we have also tasked the Regenerative Medicine Expert Group with looking at the regulatory system for regenerative medicines. My noble friend Lord Selborne referred to this, as did my noble friend Lady Sharp and other noble Lords. The Government recognise, as did the committee, that regulation in this area may act to stifle innovation and thus that we should endeavour to simplify systems to provide support for those developing regenerative medicines to navigate regulatory pathways. With these aims in mind, the main regulatory bodies are working closely with one another to streamline the regulatory system and provide support to help guide applicants with regulatory submissions—for example, the Health Research Authority is undertaking work to streamline research approvals and has a new website to guide researchers. Also, we can look to the joint working of the MHRA and the Human Tissue Authority as a result of the McCracken report recommendation on the regulation of tissue for applications aimed at developing regenerative medicines. I hope that those initiatives will be of particular comfort to my noble friend Lord Willis.
I should like to emphasise to him, to my noble friend Lady Sharp and to the noble Lord, Lord Hunt, that the Government remain committed to streamlining research approvals.
Lord Willis of Knaresborough
Before my noble friend leaves that point, I asked specifically—as did the noble Lord, Lord Turnberg—when a decision will be made on the initiative of the Health Research Authority to bring together and streamline NHS approvals and local ethics approvals. The decision has been awaited since October.
Earl Howe
My noble friend anticipates some news that I was about to convey. He is right: the Health Research Authority is the organisation created to deliver the streamlining of research approvals. It has completed its feasibility study. The results demonstrated that NHS R&D assessments could be integrated with elements of the research ethics committee review into a single HRA assessment for the approval of all research in the NHS. Department of Health officials are scrutinising the business case submitted by the HRA as part of standard governance processes, and approval of the case is subject to the proposals demonstrating value for money. Consideration of the business case is well advanced and we would anticipate that this process will conclude shortly.
The noble Lords, Lord Patel, Lord Turnberg and Lord Hunt, asked me about support for manufacturing, in particular as regards large-scale trials. The Cell Therapy Catapult has recently completed its survey of regenerative medicine manufacturing capacity in the UK, and an appraisal of national capability is planned on an annual basis to keep abreast of the evolving needs of the area and to ensure that the UK remains globally competitive. The 2013 survey and analyses that the Cell Therapy Catapult compiled have been shared with stakeholders. The key findings of the survey, including a demand forecast, have been shared at various meetings in the UK, including at the Regenerative Medicine Expert Group, and at meetings of the advanced therapeutic products manufacturing community and will be published shortly. The survey output, along with analysis of demand, was used to make a proposal to BIS for further investment to fill the cell manufacturing gap and support late-stage clinical trials. The investment proposal is currently being assessed.
The noble Lord, Lord Patel, asked what action UKTI has taken to improve the chances of the UK being a location for the development and manufacture of regenerative medicine therapies. UKTI has consulted extensively with UK stakeholders and has developed a new UK regenerative medicine sector proposition, which was launched in December 2013 at the World Stem Cell Summit in San Diego. Training on the materials has been rolled out to a number of its overseas teams, with more training to follow in the coming months.
The noble Lord, Lord Hunt, made some criticism of the MHRA in the context of progress on adaptive licensing. This issue was also raised by the noble Lord, Lord Turnberg. The MHRA has been involved with a discussion group at the European Medicines Agency in developing guidance, case studies and draft calls for expressions of interest to go out this year. One has to remember that work on adaptive licensing must be conducted within the context of European law. We had hoped that this would be issued last year but there has been a delay, as the European Commission has wanted to be satisfied that proposals can be accommodated in the existing regulatory flexibilities. I can tell the noble Lord, Lord Hunt, that we continue to be actively involved in pushing the EMA in bringing this work forward, and I have been personally involved in overseeing that.
Distinct from the concept of adaptive licensing is the early access to medicines scheme. This is designed to enable earlier UK patient access to highly promising medicinal products before they are licensed. This is expected to be announced very soon. It will operate within the current regulatory structure, and is voluntary and non-statutory. The MHRA will provide a scientific opinion on promising new medicines that will treat, diagnose or prevent life-threatening or seriously debilitating conditions without adequate treatment options before the medicines are licensed. Further details will be announced in the near future.
My noble friend Lord Willis asked about NICE’s value-assessment process. NICE, in consultation with stakeholders, keeps its methodologies under review to ensure that they remain fit for purpose. Our priority is to make sure that we get the best possible results for all NHS patients with the resources that we have, which means using taxpayers’ money responsibly and getting good value for money. We have asked NICE to look at how drugs are assessed so that patients can get the treatments that they need at the best value for the NHS and so that the price that the NHS pays is more closely linked to the value that a medicine brings. NICE will carry out a full public consultation before implementing any changes. I would just add that NICE is a key member of the Regenerative Medicine Expert Group, which will look at and provide recommendations on the evaluation and commissioning of these novel medicines and their adoption in the NHS.
My noble friend Lord Selborne and the noble Lord, Lord Turnberg, referred to developments in Japan. We are aware of the Japanese plans, and the report on the approach is being considered by the expert group. As noble Lords have mentioned, the Japanese Government are exploring ways in which the regulatory process there might be changed to support earlier evaluation of the clinical effectiveness and adoption of regenerative medicines within their health system following evidence of safety. Earlier this year, a Department of Health official, along with Foreign Office officials, attended a conference in Japan where the plans were discussed. The details have yet to be worked out but a watching brief will be maintained with the contacts that were made. A report of the conference has been made available to the expert group for consideration.
The Government look forward to receiving the Regenerative Medicine Expert Group’s strategy and action plan. We anticipate that this will provide a platform to help ensure that the UK will be in the lead in realising the exciting medical and commercial potential of these cutting-edge treatments.
Lord Patel
My Lords, I thank the noble Earl for his detailed response and all other noble Lords who have taken part in this debate. It has been a very good debate, which went wider than the inquiry report. I look forward to another debate when the report of the expert working group comes out; we will know then whether progress has been made.