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.

Mental Health: Funding

Earl Howe Excerpts

Tuesday 18th March 2014 Lords Chamber

[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?

--- Later in debate ---

[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.

[Earl Howe]

I share my noble friend’s concern about this and would be happy to receive the information to which he refers.

NHS: Midwives

Earl Howe Excerpts

Monday 17th March 2014 Lords Chamber

[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

Earl Howe Excerpts

Monday 17th March 2014 Lords Chamber

Moved by

[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.

Motion agreed.

Alcohol: Calorie Labelling

Earl Howe Excerpts

Thursday 13th March 2014 Lords Chamber

[Lord Brooke of Alverthorpe]

To ask Her Majesty’s Government, further to the answer by Earl Howe on 11 February (HL Deb, col. 535), whether they will publish a list of the alcohol producers and retailers who have pledged themselves voluntarily in the Responsibility Deal to display the calories and sugar content of the drink on the labels of their alcohol products.

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

My Lords, we welcome companies such as Sainsbury’s, which have taken action in this area. While there is no responsibility deal pledge to voluntarily display energy and sugar content on the labels of alcohol products, we will continue to consider what more can be done through the responsibility deal to improve public health, including through consumer information.

[Lord Brooke of Alverthorpe (Lab)]

I am truly grateful to the noble Earl for the efforts he has been making to try to persuade the drinks industry and the supermarkets that they have to accept some responsibility for the damage to health that alcohol causes. From the pledges he has been given by the producers and the supermarkets, can he say how many have as yet actually displayed calories and sugar on the labels of their lagers and beers? While I acknowledge that progress is happily now being made with wine, will he say what he intends to do, given that Tesco and Morrisons have now publicly stated that in no way will they go down this route?

[Earl Howe]

My Lords, I mentioned Sainsbury’s, which is setting a very good example in this area, but I can tell the noble Lord that Waitrose and the Co-op have also taken steps to display calories on their own-brand alcohol labelling. Naturally, we hope that others will follow their lead. As yet, none has, and it is a pity that Tesco has said that it will not, but we will continue to work on this issue. Work is also going on at a European level, and the noble Lord may like to know that the UK pressed for mandatory energy declarations during negotiations on the EU Food Information for Consumers Regulation. It met with significant resistance, and we did not succeed, but we are still pressing for that.

[Baroness Sharples (Con)]

Does my noble friend have any estimate of the number of shoppers who actually read the labels?

[Earl Howe]

No, I do not, but it is worth noting that 49 businesses have signed up to the voluntary responsibility deal pledge on awareness of alcohol units, calories and other information. Those organisations have published calorie information on their websites about every single alcohol product. If one is buying online, it is possible to compare one product with another.

[Lord Turnberg (Lab)]

My Lords, is the noble Earl aware that alcopops are rearing their heads again? These sweetened drinks have sugar added to them to make them attractive, in a cynical attempt to bring the young on board to alcohol. They contain more than 170 calories a bottle—about the same as a sweetened chocolate milk drink—as well as the alcohol. Is there anything we can do to bring this to the attention of the supermarkets? I believe Sainsbury’s has alcopops on its shelves now.

[Earl Howe]

My Lords, in fact, sales of alcopops are in marked decline, to such an extent that the market for these products looks like disappearing in the next few years. Nevertheless, I take the noble Lord’s point. It is always a concern if people are putting their health at risk by drinking too much alcohol or consuming too much sugar. At the same time, one should not always assume that an alcopop is a high-calorie drink. For example, ready-mixed gin and tonic is technically an alcopop, but very often low-calorie tonic goes into it.

[Lord Taverne (LD)]

My Lords, there is an unfavourable contrast in the behaviour of the UK alcohol industry as compared with the French when it comes to social responsibility. The UK alcohol industry strongly markets super-strong beers and lagers as the cheapest way of getting alcohol, whereas the French industry has suppressed access to low-quality wines and other cheap drinks through pricing. Would my noble friend urge the industry in the UK, as part of the social responsibility deal, to follow the French example?

[Earl Howe]

My noble friend may like to know that, in fact, 125 companies have pledged, under the responsibility deal, to help people drink within the guidelines. Perhaps the most significant pledge that has been made is the one by more than 30 alcohol retailers and producers to remove 1 billion units of alcohol from the market—around 2%—by the end of 2015. Companies, pub chains and retailers have also made a whole range of other pledges. We are making significant progress in this area.

[Baroness Armstrong of Hill Top (Lab)]

My Lords, I wonder whether the noble Earl is aware of quite how much this costs the NHS. Abuse of alcohol is very damaging to families and to individuals but also costs the NHS a fortune. Is it not about time that we, and the Government, took responsibility by backing the consumer, the patient and the taxpayer rather than siding with the drinks companies? Is it not about time not only for labelling, as my noble friend has called for, but for a minimum pricing policy?

[Earl Howe]

The noble Baroness raises a number of areas. We believe that this issue can benefit from action on a number of fronts. One of them is the responsibility deal to persuade the industry to take voluntary action. We are making significant progress in this area. Of course, the other is behaviour change by individuals and the choices that people make. Ultimately, people need to take control of their own behaviour, and the Chief Medical Officer is currently overseeing a review of the alcohol guidelines so that people can make informed choices about their drinking at all stages of their life.

[Lord Lawson of Blaby (Con)]

My Lords, my noble friend Lord Taverne asked my noble friend the Minister to commend the French for their high-price wine policy. I commend them for their low-price wine policy. At home in France, I buy a very good everyday drinking wine from my local wine grower for €8 for a five-litre box.

[Noble Lords]

Oh!

[Earl Howe]

My Lords, I would love to receive details but, once again, it is a question of how much my noble friend consumes rather than how much he pays.

[Lord Harrison (Lab)]

My Lords, the Minister may recall that last September I shared with him my concern at the ever-rising alcoholic content of wines that are on sale in supermarkets and the need for greater provision of lower percentage wines so that the consumer can indeed make a choice. What progress has he made in that area?

[Earl Howe]

My Lords, this area is currently under scrutiny by my ministerial colleagues in the Treasury.

[Lord Hunt of Kings Heath (Lab)]

My Lords, the noble Earl mentioned the Chief Medical Officer. Did he see her comment last week that the Government ought to consider a sugar tax? What response have the Government made to their own Chief Medical Officer?

[Earl Howe]

My Lords, as I have just indicated to the noble Lord, Lord Harrison, taxation is always an instrument that Governments consider. We continue to keep the international evidence on that under review, but we think that for now the voluntary action we have put in place is delivering results. We will keep a close eye on progress but taxation is always an instrument that Governments can deploy.

Regenerative Medicine: S&T Committee Report

Earl Howe Excerpts

Thursday 13th March 2014 Lords Chamber

[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.

Contracting Out (Local Authorities Social Services Functions) (England) Order 2014

Earl Howe Excerpts

Tuesday 11th March 2014 Grand Committee

Moved by

[Earl Howe]

That the Grand Committee do consider the Contracting Out (Local Authorities Social Services Functions) (England) Order 2014.

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

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

My Lords, I remind the Committee that in 2011 an order was passed by noble Lords under the Deregulation and Contracting Out Act 1994 to allow local authorities taking part in two pilot schemes to contract to outside organisations certain adult social service functions.

The House agreed to amend the original order in November 2012 to allow local authorities to continue this contracting-out activity in respect of the pilot programmes beyond the period provided by the original order. The pilots were: adult social work practices pilots and right to control pilots. The order before noble Lords today seeks to set out the policy intentions for general delegation of functions in relation to adult social care, and will in effect mark the end of the social work practice pilot programme.

I am presenting this order today, not to extend the social work practice programme itself but instead to roll out the general policy intentions for delegation of statutory functions in adult care and support. There are three main reasons why this order is required: first, to ensure that organisations set up under the SWP programme can continue to operate legally and carry out statutory functions on behalf of the local authority; secondly, to give any other local authority the power to delegate specified functions to a third party; and thirdly, to support our policy intention for delegation, bearing in mind the general power of delegation within the Care Bill.

I shall now set out more detail on each of the three points. The social work practice pilots were announced in 2010 and saw the creation of seven social worker-led organisations, which discharge the functions of the local authority in providing adult social care services. Five of these organisations continue to exist today. On a day-to-day basis, the pilots were independent of the local authority but worked closely with it and in partnership with other providers. The local authority paid for the services provided but maintained its strategic and corporate responsibilities though its contract with the social work practices.

We were looking at the pilot sites to test the potential benefits of the social work practices and delegation of statutory functions, and whether these innovative approaches improve outcomes and experiences for the people who use them. The intention of the programme was to bring people who need health and care support closer to those who provide the services they need by reducing bureaucracy, encouraging innovation and increasing the personalisation of services. The pilots were an opportunity to test different models to see what works well, and they were fully evaluated by King’s College, London.

My officials have now seen the draft final evaluation report. On the whole, the evaluation was positive, finding some evidence that the SWP model could work well. Because each pilot was set up and operated differently, it was difficult to make generalised findings, but the evaluation found evidence of better continuity of care and co-ordination; a more personalised “offer” to people in need of care and support; opportunities for reducing bureaucracy, often through greater autonomy; and increased job satisfaction and empowerment for staff working in the pilots. Ultimately, the evaluation found that the success of the SWP was largely dependent on the quality of the contract and the relationship with the host local authority. It found nothing to negate our policy intention to make such powers available to all local authorities.

This order is crucial to allow the organisations set up under the SWP programme to continue to operate legally, subject to contractual arrangements with the host local authority. Not creating the order would mean that the functions would have to come back to local authority control, undermining the hard work and progress made under the pilot programme and potentially impacting on people receiving services through this route.

As the evaluation was largely positive, this new order seeks to extend the powers of delegation to all local authorities. We know from working closely with the Cabinet Office mutual support programme—a £10 million fund to support the creation and growth of public service mutuals—that several local authorities are already keenly watching the SWP programme, as they are also interested in gaining these powers. Others have contacted us about early adoption of such powers to support them in preparing for implementation of the Care Bill. The order will allow them and others to put in place necessary mechanisms to develop innovative service models, such as mutuals, to serve local populations in advance of the Care Bill. The findings from the SWP evaluation will be beneficial to all local authorities, and we shall publish them in full in due course.

This proposed extension to all local authorities is also consistent with the future policy of delegation of certain statutory adult social care functions. Clause 78 of the Care Bill provides for a general power of delegation of adult social care and has been developed through engagement with local government colleagues and wider social care stakeholders. Indeed, it has been part of the Bill from the very first iteration that we published. Furthermore, this clause has also been agreed by noble Lords and in the other place. The order therefore also bridges the policy gap until the Care Bill comes into force. Subject to Parliament, we plan for this to be on 1 April 2015. When enacted, Clause 78 will provide for a general power of delegation and the order will serve only for any transitional arrangements.

We know from working with the SWP pilots and through the evaluation that setting up a contracting-out process takes time. The order allows interested local authorities to begin this process now to assist them in preparing for implementation of the Care Bill, as well as providing security for the existing SWP sites. We are also currently working on statutory guidance to accompany the Care Bill, and the findings from the evaluation will be valuable in informing the guidance on delegation. We are working closely with adult social care stakeholders on the development of this guidance and will publish it for consultation in May of this year. This will also be useful for any local authorities seeking to consider use of this power in advance of the Care Bill being enacted.

In considering the need for the order, we have listened to the advice of representatives from the SWP sites, to ADASS and to colleagues from the Cabinet Office mutuals programme. In conclusion, we see the order as one that fully supports the aims set out in the Care Bill and the general adult social care reform programme. It will allow the continuation of existing innovative ways of working and the creation of new ones in order to benefit individuals and communities as a whole. I commend the order to the Committee.

[Baroness Brinton (LD)]

My Lords, it is encouraging that the results from the social work practices pilots are very positive. Phrases like “innovative”, “flexible” and “less bureaucratic” are very important to begin to change the culture in the way people work. It is also as important that the real personalisation of services is balanced by the job satisfaction of staff.

The Explanatory Notes that accompany the order are almost entirely positive. I picked up a slight nuance in the Minister’s comments. I wonder if there were any identifiable less positive or concerning features about which it might also be worth advising local authorities in how they are going to be commissioning work in the future. Apart from that, it is inevitably unfortunate that there is a short notice period that this is intended to cover, before the Care Bill comes in. At least there will not be a gap now, which is to be praised.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I should have declared on the previous order—and do on this order—my chairmanship of the Heart of England NHS Foundation Trust and that I am president of GS1 and a consultant and trainer with Cumberlege Connections. I am happy to support this order. I think it is the third time the noble Earl has been before the Committee to present such an order and, as I understand it, it is an interim measure until the Care Bill is enacted; the noble Earl has said that that is expected to be on 1 April 2015.

To pick up the point raised by the noble Baroness, Lady Brinton, I suppose it would have been helpful if we could have seen the draft of the final evaluation report at this point—it is now not going to be published until April. The noble Earl referred to some of the main findings of the draft final evaluation report from King’s College. He said that it was mainly positive although there were clearly some issues, which are identified in paragraph 7.6. Perhaps he might like to say a little more about that.

Perhaps I could also ask the noble Earl about right to control. This was considered in the previous order, and in this order a reference is made to the fact that decisions on the future of the right to control pilot scheme have yet to be made and hence no provisions are included in the new order in this regard. When we debated this on 20 November 2012, the noble Earl referred to the interim evaluation of the right to control programme, published in February 2012, which showed that disabled people were benefiting but there simply was not enough evidence to make a decision on a wider rollout. He went on to say:

“Clearly, an extension of the kind that we seek will give us more evidence. The early signs are positive but that does not provide the basis for a robust decision on permanent arrangements”.—[Official Report, 20/11/2012; col. GC 150.]

Has the department now given this further consideration? Can the noble Earl say why no decisions on the future of right to control have yet been made and when he thinks such decisions will be made?

[Earl Howe]

My Lords, I am grateful to both noble Lords for their comments and questions. They both asked whether in the draft report from King’s we found any negative advice about the results from the pilots. I think the answer is no but it is worth repeating what I alluded to in my initial remarks—that King’s commented that the success of the pilots critically depended on the quality of the contract and the relationship with the local authority. The pilots that worked best were those where those two things had been got right. However, there was nothing to negate our general policy intention to roll out the right of delegation more widely. When the evaluation is published—I, too, have not had the opportunity to have sight of it yet—I am confident that it will be helpful to local authorities looking to delegate functions and I am sure we can be grateful to the team who put the report together for a very thorough piece of work.

The noble Lord, Lord Hunt, asked me about the right to control pilots. As he will have noticed, the order before us does not cover the right to control them. The pilot finished in December 2013. It was considered that there was no need to continue the pilot, which is currently being evaluated. Unfortunately, I cannot tell him when an announcement will be made on that issue but as soon as I am made aware of the date I will be happy to inform him of it. However, we were clear that the order before the Committee today need confine itself only to the matters to which I have already referred.

Motion agreed.

Medical Act 1983 (Amendment) (Knowledge of English) Order 2014

Earl Howe Excerpts

Tuesday 11th March 2014 Grand Committee

Moved by

[Earl Howe]

That the Grand Committee do consider the Medical Act 1983 (Amendment) (Knowledge of English) Order 2014.

Relevant document: 21st Report from the Joint Committee on Statutory Instruments, 31st Report from the Secondary Legislation Scrutiny Committee.

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

My Lords, this Government recognise that overseas doctors make a valuable contribution to the NHS, and we are keen to ensure that highly skilled professionals do not face unnecessary barriers. However, it is vital that all doctors practising in the UK have the necessary English language skills in order properly to care for and communicate with patients.

Due to the legislation that governs the regulation of doctors, the General Medical Council is not able to apply language controls to applicants from the EU as a pre-condition to registration as a medical practitioner. This is of great concern to the Government and to the General Medical Council, as it raises a clear risk to patient safety.

The same restrictions in law do not apply to international applicants from outside the EU. Therefore, the General Medical Council is able to require all international applicants to provide evidence of their English language capability—for example, by taking an English language test—before being registered and given a licence to practise in the UK.

We have worked with the General Medical Council to identify a system of language controls which provides greater patient safety while being compliant with European law. We believe that the proposed legislative changes contained in the draft order will achieve this outcome. The draft order gives the General Medical Council appropriate powers to ensure that only those doctors who have the necessary knowledge of English to do their jobs safely and competently are able to practise medicine in the UK.

The draft order makes changes to the Medical Act 1983 to do two things: first, to give the General Medical Council the power to refuse a licence to practise in circumstances where a medical practitioner from within the EU is unable to demonstrate the necessary knowledge of English; and, secondly, to create a new fitness-to-practise category of impairment relating to language competence. This will strengthen the General Medical Council’s ability to take fitness-to-practise action where concerns are identified.

The licensing amendments will enable the General Medical Council to require evidence of English language capability as part of the licensing process where language concerns have been identified during the registration process. This is compliant with EU law, which sets out under the mutual recognition of professional qualifications directive that a professional’s qualifications must be recognised by the host member state before any language checks can take place.

The order makes amendments to Section 29G of the Medical Act 1983 which will require the General Medical Council to publish guidance setting out the evidence, information or documents which a medical practitioner must provide to demonstrate that they have the necessary knowledge of English. Any person who is refused a licence to practise on the grounds that they have failed to demonstrate they have the necessary knowledge of English will have a right to appeal.

The process for determining whether a person has the necessary knowledge of English will be set out in the General Medical Council (Licence to Practise and Revalidation) Regulations, which will be amended by the GMC in due course to enable the policy to be implemented.

With regard to the fitness-to-practise amendments, a new category of impairment relating to English language capability will be created. This will allow the General Medical Council to request that a doctor undertake an assessment of their knowledge of English during a fitness-to-practise investigation where concerns have been raised, which it is currently unable to do. These changes will strengthen the General Medical Council’s ability to take fitness-to-practise action where concerns about language competence are identified in relation to doctors already practising in the UK.

The proposed amendments to the Medical Act 1983 are designed to complement and further strengthen the existing language controls imposed through the responsible officer regulations, performer list regulations and checks undertaken by employers at a local level. These amendments will enable the General Medical Council to carry out proportionate language checks where there is cause for concern, and ensure that all doctors practising in the UK have the necessary knowledge of English to do their jobs well and reduce the risk to patient safety. I commend this order to the Committee, and beg to move.

[Lord Walton of Detchant (CB)]

My Lords, I cannot say how welcome this order is. Forty-three years ago I was elected dean of the medical school of the University of Newcastle. By virtue of that election, I was immediately appointed to the General Medical Council. I became a member of its education committee and three years later I became the chairman of that committee. By virtue of being chairman of the education committee of the GMC, I was then appointed, under the new arrangements for the European Union, to the Advisory Committee on Medical Training, which met twice a year in Brussels and was required to make recommendations on basic medical education, specialist medical education and the mutual recognition of qualifications.

That was an interesting experience. Under the treaty of Rome, the first directive derived from that treaty said—I am not quoting exactly but the meaning is clear—that in the movement of doctors across the European Union there should be mutual recognition of qualifications and registration should be granted, but that it should be up to the host country to see to it that the incoming doctor had such ability to communicate with patients to make him or her safe to practise. That seemed to give us at the GMC full authority to embark upon establishing a language test.

At that time, for historical reasons, some doctors from outside the European Union—from Commonwealth countries such as Australia, New Zealand, the West Indies and many others—had enabled the General Medical Council to inspect their examinations and qualifications so they were automatically granted full registration under the Medical Act. But doctors from many other countries who had not had that ability to have inspections were required to apply for temporary registration if they wished to come to the UK, and they had to take a test set by the Professional and Linguistic Assessments Board, which established tests of not only clinical and academic competence but language capability. That was the so-called PLAB test.

It is important to make the point that the rights of doctors graduating in any other member country of the European Union applied only to those who had graduated in those countries but who were also nationals of EU member states. For instance, if a doctor from a country outside the European Union graduated from, say, Heidelberg, they were not entitled under that treaty to come to the UK and had to go through the same procedure as a doctor from India, Pakistan or other parts of the world.

Indeed, there was one such doctor, an Iranian, who qualified in medicine in Heidelberg. He applied for registration with the General Medical Council and was turned down. He took the GMC to a judicial review. Of course, he lost because he did not qualify. The result of this was that I was interviewed by Special Branch because he had made serious threats against my person, including threats of violence. However, we will leave that alone for a moment.

The point I wish to make is that it is so important that we have this language test. We at the GMC, having read what the directive said, tried to impose a language test on incoming doctors from the European Union, but we were threatened with being taken to the European Court because we were told very clearly by our lawyers and by the lawyers from Europe that this was contrary to the treaty of Rome. We tried again 10 years later when I became president of the General Medical Council, again with a total lack of success. All we were able to do then was to persuade the employing authorities in the UK, through the Department of Health, that they could impose a language test as a condition of employment. Regrettably, that agreement with the Department of Health was never properly or widely fulfilled across the UK, so a language test as a condition of employment for European doctors was not widely employed. Our attempts at that time were lost.

The great thing about this order is, first, that it makes it clear that the GMC can properly design and employ a test of the language ability of an incoming doctor from the EC as a condition of registration. Secondly, the responsible officer can make certain that any doctor coming up for revalidation speaks English adequately. Finally, when any doctor who is already a specialist from the EC or is working either in general practice or in a specialist grade and is brought before the GMC on the question of fitness to practise, the fitness-to-practise procedures can take note of the doctor’s ability to speak English. These are extremely welcome developments. Perhaps I am wrong about the condition of registration but the GMC, I think, is hoping that that is the effect of this order. Perhaps the Minister can clarify it for us. The whole process set out in this paper is extremely welcome and long awaited.

--- Later in debate ---

[Earl Howe]

My Lords, I am very grateful for the welcome that this order has received from all noble Lords who have spoken. Perhaps I may begin by making clear one critically important point relating to the order prompted by a comment made by the noble Lord, Lord Walton. It is important to understand that the English language test is not a condition of registration. If a language test is required of a doctor, it would be a condition for that doctor receiving a licence to practise. Registration is granted on a full basis and language is assessed after registration.

The noble Lord, Lord Turnberg, questioned the quality of the training of specialists who come from other EU countries and asked what was being done to assure the safety of those doctors. If the specialism of a doctor is listed as a specialism under the directive then he or she will be required to comply with the minimum training standards set out in the directive. However, I will seek the advice of the GMC on this matter and will write to the noble Lord accordingly. A similar point was made by the noble Lord, Lord Kakkar, around the competency of EU doctors. I am sure he will know that it is not possible for the GMC to assess the competency of an EU doctor on registration. However, the council could assess an EU doctor’s competency in fitness-to-practise proceedings if questions are raised about the competence of that practitioner.

The noble Baroness, Lady Finlay, asked who would bear the cost of the fitness-to-practise case where there were language concerns. I can confirm that a doctor will not be required to pay for his or her own assessment in fitness-to-practise cases. The GMC has confirmed that it will bear this cost. She made the point, rightly emphasised by a number of noble Lords, including my noble friend Lady Brinton, that good communication skills are about more than just language competence. The issue is one that falls squarely to the GMC and we look to the council to ensure that it is addressed in guidance. If communication skills result in deficient professional performance, that matter could certainly be considered as part of a fitness-to-practise issue.

The noble Baroness spoke with her customary experience about the International English Language Test. On 25 February, the GMC announced a change in the score it requires in the English language test. As she pointed out, this is a test that many international medical graduates currently use to demonstrate their knowledge of English when they apply to join the register. Currently, IMG applicants must achieve a minimum score of seven out of nine in each of the four elements, and an overall score of seven. From the middle of June 2014, doctors will have to achieve a higher overall score of 7.5. They will continue to have to achieve scores of at least seven in each of the four domains. The new requirements for IELTS will be the same for all those applying to join the register. This move follows research commissioned by the GMC which suggested that the level should be enhanced. Moreover, IELTS will be one of the pieces of evidence that European doctors can use to demonstrate that they have the necessary knowledge of English.

My noble friend Lord Bridgeman asked about the extent to which the principle behind this order will be extended to other medical professionals, including nurses. The Government believe that in order to maximise patient safety, nurses coming to work in the NHS should not be able to work unless they have the necessary knowledge of English to perform their job well. Departmental officials are having ongoing detailed discussions with the NMC to seek to establish a system that will enable them to carry out proportionate language checks which are in line with EU law. I cannot give him further detail at this point but I can assure him that this matter is very definitely under scrutiny.

It must also be remembered that registration with the Nursing and Midwifery Council does not guarantee employment in the UK. Individual organisations are responsible for ensuring that the people they employ have the necessary skills for the post for which they are applying. EU legislation does not prevent the employer from assuring themselves that the nurse being recruited is competent, safe to practise, has up to date and contemporary knowledge, and has the necessary language and communication skills.

The noble Lord, Lord Hunt, raised the concern that the test for language competence should not be abused, and asked what safeguards the GMC was proposing in this area. As I mentioned, the GMC will be issuing guidance to provide absolute transparency of what evidence and documents are needed to demonstrate the necessary language competence. That should provide not only the necessary clarity for all applicants but also minimum scope for the kind of abuse that he referred to. It is for the GMC as the independent regulator of medical practitioners in the UK to decide the necessary knowledge of English to practise safely in the UK. As regards the guidance, in its recent consultation it suggested that where there is a cause for concern, similar evidence may be required to what is currently required for IMG doctors—for example, the required score in the academic version of IELTS or that the doctor has a primary medical qualification taught and examined in English. But, of course, in making that determination, the GMC will need to be mindful of EU law and ensure that such requirements are necessary and proportionate in view of the job to be performed.

The noble Lord, Lord Hunt, also asked whether the language requirements will be in any sense new. Systematic language checking is not permitted under the new directive. Any testing, as I mentioned, must be proportionate, and we anticipate that the new directive is likely to come into force in January 2016.

As regards the noble Lord’s other question, about the quality of language tuition where a doctor has been found to be deficient—and he asked whether the GMC will be signposting such doctors to good language schools—I have no doubt that this is an issue that the GMC will consider. However, it is ultimately an issue for it.

I hope that I have succeeded in answering most if not all of noble Lords’ questions. If I have not I will of course write. I conclude by thanking noble Lords for their very constructive and helpful comments.

Motion agreed.