Kettering General Hospital A and E

Annette Brooke Excerpts

Wednesday 26th June 2013 Westminster Hall

[The Parliamentary Under-Secretary of State for Health (Anna Soubry)]

As ever, it is a pleasure to serve under your chairmanship, Mrs Brooke. I congratulate the hon. Member for Corby (Andy Sawford) on securing the debate. He quite properly brings forward his constituents’ concerns about their hospital. I am delighted that he is working with two other Members of Parliament whose constituencies are served by the hospital.

I am especially grateful to the hon. Gentleman, if I may say so, for having contacted my office and spoken to my officials before the debate. If only all hon. Members took such a positive step, because it assists hugely. He is quite right to make the point that this is not the stuff of party politics. I fear that I may not be able to answer some questions that he quite properly asked. If that is the case, I or my officials will write to him to ensure that all the matters he raised and all the questions he asked are given proper and full answers.

I am very pleased that the hon. Gentleman will meet the Under-Secretary of State for Health, my hon. Friend the Member for Central Suffolk and North Ipswich (Dr Poulter), on 16 July, with my hon. Friends the Members for Kettering (Mr Hollobone) and for Wellingborough (Mr Bone). I am sure that there is no connection, but having said that, a frog has entered my throat. I am going to stop for a minute.

[Annette Brooke (in the Chair)]

That would be wise.

[Anna Soubry]

I am sorry.

The hon. Member for Corby has raised important issues about accident and emergency services, although I will not be dealing with the national situation. As we know, there have been some issues and problems in emergency departments throughout the country, many of which have been well rehearsed in this place.

Underlying themes and problems are often common to all our accident and emergency departments. Undoubtedly, many of the problems at Kettering’s accident and emergency are exactly the same as those that have caused so much difficulty in other A and E departments in this country. I am pleased that huge progress has been made and that overall performance is improving across the country as might be expected, especially given my Department’s efforts.

The hon. Gentleman has pointed out how health services are under pressure in his constituency and having a knock-on effect at Kettering, and those pressures are being experienced across the whole system. He quite properly identified that the reasons for that are complex. Dealing with those pressures means looking at the underlying causes, which the Department has been doing by working with NHS England.

The hon. Gentleman pointed out that Kettering General Hospital NHS Foundation Trust is experiencing many of the issues that I have highlighted. I am aware that, as he told us, the trust has not met the A and E standard. It has struggled with that difficulty for some time. He will know that Monitor, as the regulator of foundation trusts, has unfortunately found that the trust is in breach of its licence in relation to its A and E performance, as well as wider financial and governance issues. That will cause concern not only to the people who use the hospital, but to its outstanding staff.

Monitor has required the trust to implement an urgent care action plan to ensure that it can return to compliance against the A and E standard. The deadline for that is 1 July, so it will not be long before the trust has to implement it. Monitor is working with local commissioners and NHS England to support the trust to meet that requirement.

I appreciate that the hon. Gentleman feels that further investment is needed to expand facilities at the trust to improve its position. It is right that, as I understand it, he has had meetings with the chair of the trust and other Members of Parliament, and that letters have been written, to request assistance in securing extra capital funding. Some £5 million to £10 million has been requested, so that the trust can redevelop and expand its A and E department.

Of course it is for NHS foundation trusts to develop and take forward their own capital investment proposals, and trusts such as Kettering can apply to the Department for a capital investment loan. We understand that the trust has allocated some of its capital budget this year to make improvements within A and E, and it has worked with commissioners to redesign what we call pathways to improve flow. Hot clinics and ambulatory pathways have been developed, which divert patients away from A and E and avoid GP admissions, which, as we know, often stack up in the Department.

On the matter of whether Kettering has ever closed its doors, I am told that its accident and emergency department has never done so, and it is important to put that on the record. I am told that there was a period in February when the hospital trust effectively advised members of the public—I think that this sounds like a sensible piece of advice—to ensure that they only went to A and E if they had had an accident or an emergency. In other words, to use the jargon, they were told to use the department appropriately, because the trust had become aware of a sudden and acute rise in people using A and E. Actually, that is a good message for all of us to take back to our constituents. The department is not called “accident and emergency” for no good reason; it is for accidents and emergencies.

When we had a debate on A and E in the main Chamber, Members from both sides told stories about people presenting at A and E when they could have gone to the pharmacy or just taken a paracetamol. The point I am making is that, often for understandable reasons, people attend A and E when they cannot get the appointment they want at the GP surgery. There is this wider issue that perhaps we do not do what we used to do in the past, which was to self-administer, take advice from our brilliant pharmacies or ring the GP surgery for advice before simply turning up at A and E.

As I have said, meetings have taken place, and, as I understand it, the trust has been working with local commissioners in the way that I have described. The hon. Gentleman mentioned the new Corby urgent care centre. I think I saw it before I was in this position—I was there for other reasons which I am sure the hon. Gentleman will understand—when it was in the process of being constructed. I am delighted that it is now open. It is called an urgent care centre. To be frank, we do not always use the best language when it comes to naming places where patients can go. In fact, the review, which is being conducted in the Department of Health, is looking at the sort of language that should be used, so that people understand where they have to go when they have a particular problem. I am delighted that the centre has opened in Corby and is providing additional urgent care services to the hon. Gentleman’s constituents, which should help to ease the unnecessary attendances at the A and E department of Kettering General.

I also want to mention the East Midlands Ambulance Service NHS Trust, because it is of concern to all of us who represent seats in the east midlands. I know that the hon. Gentleman has rightly talked about how problems with EMAS have affected services in his constituency.

Oral Answers to Questions

Annette Brooke Excerpts

Tuesday 11th June 2013 Commons Chamber

[Anna Soubry]

I refer my hon. Friend to answers that I have given beforehand. I know the great work that he does on lung cancer and I am pleased to see that, yet again, we will have a national campaign following the great success of the last one. We can talk further.

[Annette Brooke (Mid Dorset and North Poole) (LD)]

This is cervical screening awareness week. What plans does the Minister have further to encourage women aged 60 to 64 to attend cervical screening, given the declining levels of screening uptake and the increasing levels of incidence in this age group?

[Anna Soubry]

Screening is one of the most important aspects of the work of Public Health England and we are keen to make sure that it is addressed both nationally and locally. Great work can be done by local authorities in making sure that women have this vital screening.

Oral Answers to Questions

Annette Brooke Excerpts

Tuesday 16th April 2013 Commons Chamber

[Mr Speaker]

The Minister can report to his family just how popular a fellow he is.

[Annette Brooke (Mid Dorset and North Poole) (LD)]

T3. The all-party group on global tuberculosis has just published a report on rising rates of drug-resistant TB. One recommendation is for a national strategy for TB in the UK. Will the Minister comment on that? The officers of the all-party group would also be grateful if he fitted us into his very busy schedule of meetings.

[Anna Soubry]

My hon. Friend the Member for North Norfolk (Norman Lamb) is having a break on that one. The continuing outbreaks of TB cause a lot of concern, especially in certain communities. I have no hesitation in agreeing to meet my hon. Friend to explain what NHS England is doing and the development of a national strategy.

Oral Answers to Questions

Annette Brooke Excerpts

Tuesday 15th January 2013 Commons Chamber

[Dr Poulter]

My hon. Friend makes an excellent point. Community hospitals can provide a good focus for palliative care, respite care, intermediate care and step-up and step-down care close to home, particularly for people in rural communities who may otherwise have to travel very long distances to attend hospitals. I hope the community hospitals in my hon. Friend’s constituency will have a long and vibrant future.

[Annette Brooke (Mid Dorset and North Poole) (LD)]

T1. If he will make a statement on his departmental responsibilities.

[The Secretary of State for Health (Mr Jeremy Hunt)]

We want to make 2013 the year we break down the stigma associated with dementia and transform the care and treatment received by the one in three over-65s who will get the condition at some stage. Today, the Alzheimer’s Society published a map showing the totally unacceptable variations in dementia diagnosis across the country, with some areas diagnosing fewer than a third of people who have the condition, thereby denying them the medicine and support that would help them live happily at home for much longer. We are determined to put this right.

[Annette Brooke]

Given that next week is designated as cervical cancer prevention week and we know that many women ignore, or do not recognise, the early symptoms of cervical cancer, what action will the Secretary of State take to raise awareness of cervical cancer symptoms?

[Mr Hunt]

That is a very important point. Every year we screen about 3.5 million women for cervical cancer and we think we save about 4,500 lives, but we could save many more. Our “Be Clear on Cancer” campaign is highlighting the four clear symptoms people need to watch out for: unexplained bleeding, weight loss, pain, and lumps.

Nursery Milk Scheme

Annette Brooke Excerpts

Monday 5th November 2012 Commons Chamber

[Annette Brooke (Mid Dorset and North Poole) (LD)]

I want to start by saying how important the nursery milk scheme is. All children under five years old in a day-care or early years setting for two or more hours a day are eligible to receive a free daily drink of milk. Milk is full of important nutrients for children. Their free third of a pint portion contains calcium for strong bones and teeth, protein for growth and development, vitamins such as B2, B6, B12 and folate, and the minerals iodine, phosphorus, potassium and zinc.

The Education Act 1944 provided free milk—a third of a pint a day—in schools to all children under the age of 18. I have some personal recollections from the 1950s of the milk in one-third pint bottles left in the sun all day and served in such a way that I am still not very good about drinking my milk, which may be why my bones are a bit fragile. In 1968 Harold Wilson’s Labour Government withdrew free milk from secondary schools, and of course it is well known that in 1971 Margaret Thatcher withdrew free school milk from children over seven.

I saw first-hand the benefits of free school milk for under-fives on my visit to Hayeswood first school in Colehill in my constituency on world school milk day. It was interesting to go to a school, because we have to appreciate that now that children are starting school when they are four, they are accessing the milk at school. I was impressed with the numbers and the uptake at that school, and also with the fact that, through the particular scheme that was operating, older children could have the milk purchased for them at £15 per term.

[Jim Shannon (Strangford) (DUP)]

World school milk day came to my area too. Castle Garden primary school participated and more than 100 young children were present. The important aspect of that visit was that young children who had not taken milk regularly said that they were encouraged by those who were there to participate in taking milk rather than fizzy drinks. Did the same thing happen in the school that the hon. Lady visited?

[Annette Brooke]

Absolutely. Indeed, I was talking to one of my local nurseries—a nursery that is registered for milk. The owner of the nursery had discussed with parents whether they wanted the milk or not. Parents had voiced concerns about participating because their children would not drink milk at home, but they said, “Well, we’ll give it a try,” and to their surprise, every child in the nursery drinks their milk in the group setting.

However, in the past few years the costs of the scheme have been rising. In 2007-08 it cost the Government £27 million, but by 2010-11 the amount had risen to £53 million. Increased costs could be due to greater uptake, growth in the number of under-fives in day care settings or increases in the price of milk. The Department of Health has predicted that costs could rise as high as £76 million by 2016 and so recently set up “Next Steps for Nursery Milk”, a consultation to review the current system and consult on how to make efficiencies.

A significant number of day-care providers are effectively paying over 90p a pint for school milk. I know that we must ensure that the scheme can operate as efficiently as possible while ensuring the greatest access for entitled children. There is clearly also a need to add as little as possible to the burden of bureaucracy on child-care providers and schools. I want to take this opportunity to say how pleased I am that the Department has stated its commitment to this universal benefit for under-fives and that it is fully committed to keeping it as such. The options offered in the consultation are: to leave the scheme as it is; to cap the price that can be claimed for milk; to issue e-voucher cards with economy incentives; or for day-care providers and schools to arrange the direct supply of milk themselves.

There are a number of important aspects to consider when thinking about changing the current scheme. First, it is important that as many eligible children as possible receive their allocation of milk. The Department’s own figures show that roughly 40% of the total number of under-fives currently receive milk at their day-care setting. Whatever system is put in place must be easy to use for day-care providers so that as many as possible take part in the scheme. Given the percentage of children who currently do not receive milk, I ask the Minister to look at how the Government can increase the number of children receiving the milk to which they are entitled. I appreciate that that might be counter to the idea of reducing the costs of the scheme, but I was personally rather disturbed that perhaps only 40% of eligible children access the milk.

[Kerry McCarthy (Bristol East) (Lab)]

Is the hon. Lady aware that many children are lactose intolerant and that there have been links between the consumption of dairy products, particularly milk, and the development of childhood asthma—there is no firmly proven link, but it has been suggested that there is a connection? Are there alternative sources of calcium, such as soya milk, available to children who perhaps should not be drinking dairy milk?

[Annette Brooke]

I absolutely take on board the point that some children are allergic to cow’s milk. I am sure that is an issue the Minister could address when he sums up.

[Mark Lazarowicz (Edinburgh North and Leith) (Lab/Co-op)]

Although different schemes operate in Scotland, Wales and England, this is, unusually, a GB-wide consultation, and obviously I have an interest as a Member who represents a Scottish constituency. The Scottish Pre-school Play Association has written to all Scottish MPs and is very much in favour of what has been called option 2, which would allow access to local Scottish suppliers and milk producers. Is that the option the hon. Lady would favour of the ones set out in the consultation?

[Annette Brooke]

I thank the hon. Gentleman for that intervention. I will not say which option I prefer, because I want to air all the issues, which I think are rather complex, and it is very important that they are all considered.

To return to my point about the variability in how children access free school milk, I have some figures from Bournemouth, Poole and Dorset, three local authorities, for the percentage of under-fives accessing Cool Milk, which is the agent that provides it, so it is possible that there are other ways of getting the milk. The figures are interesting: for Dorset it is 89.8%, for Bournemouth it is 25.5% and for Poole it is 46.3%. It would be worthwhile to get all the figures from the local authorities, rather than receive the answer, “This information is not collected centrally.” Some worthwhile statistical analysis could be carried out to make sure that our most disadvantaged children actually access the milk, because that is not automatically the case.

The School and Nursery Milk Alliance raises serious concerns about the knock-on effect that changes to the nursery milk scheme could have on the over-fives scheme. It is worried that a reduced take-up among under-fives will result in fewer over-fives moving on to school milk and that, if providers are no longer supplying nurseries in other settings, it will be harder for them to supply schools as part of the over-fives milk scheme.

Another point to consider is the administration process for child-care providers. At present, child-care providers or the agent they use, such as Cool Milk, which operates in my constituency, are reimbursed for the costs of the milk after they have purchased it. Whatever scheme is put in place must not put more of a burden on child-care providers, but be simple and easy to use so that nurseries and other settings are not put off taking part in the scheme.

We must consider how the milk will be delivered to the care providers. It is, of course, more expensive to deliver to nurseries in small and rural areas and to childminders working in difficult to access places.

[Mr Mark Williams (Ceredigion) (LD)]

I congratulate my hon. Friend on securing this debate. As has been said, the issue’s ramifications go much wider than England. On rurality, I represent Ceredigion and she also represents a rural constituency, and there are particular challenges when nurseries and child-care providers are based in a rural setting, where the operational costs are that much greater than in urban areas. The Member for Edinburgh North and Leith (Mark Lazarowicz) asked my hon. Friend whether she would support option 2. If she went along with that and a cap system, I would hope that she would ask for guarantees that the operational costs could be factored in so that rural people were not put at a disadvantage.

[Annette Brooke]

It is important that we take on board the additional costs in rural areas, which would become highly relevant if a capping system were to be introduced. I agree with the points that have just been made.

In any new system, it is important that nurseries and child-care settings are still able to make a choice about where they procure the milk. It is important that a supplier can ensure a suitable delivery time so that the quality of the milk remains high. In many settings the location of the milk provider will be important, with nurseries choosing a local, trusted supplier.

It is also important, when considering how best to progress and how to ensure best value for money, that we consider the requirements of the child-care providers. The consultation document repeatedly refers to pints of milk, but it must be remembered that children receive a third of a pint a day. Many settings do not have facilities to wash drinking cups, so they require milk to be supplied in single-serve packaging, and many would not be able to serve children milk if it was not delivered in those sizes, which is another cost factor. It is also important to consider special types of milk, such as kosher milk, that might be needed for religious or cultural reasons or, indeed, as an alternative if children have an allergy. I was particularly impressed with the cartons that I saw on my school visit on world school milk day, because they were really attractive and it literally was cool to drink milk.

I have received representations from a number of different organisations from the child-care and dairy industries. Although they understand why the Department is conducting a review, many of them, such as the School and Nursery Milk Alliance, are concerned that, while the Government are committed to protecting the entitlement of children to milk in early-years settings, proposed changes to the scheme could reduce the actual number of children receiving the milk. It is important that we maximise the number of children taking up the offer.

I know that the organisations will have submitted detailed responses to the consultation, so I just want to touch briefly on the different options and some of their pros and cons. Under option 3—the e-voucher system—child-care providers would no longer have to pay for milk and then claim reimbursement. They would instead be credited with a prospective monthly payment equal to the number of pints required multiplied by a fixed reimbursement rate, which would be set at an average market price per pint. The National Day Nurseries Association has voiced concerns that this kind of scheme might place additional administrative responsibility on providers. I ask the Minister to consider that, particularly given the Government’s commitment to reducing the burden on early-years settings that is currently being consulted on by the Department for Education.

Having garnered opinions, it seems that option 4—direct supply—is least favoured by those in the industry. Anticipated problems that have been raised with me include the cost of the operation; the fact that a national tender may quickly become uneconomic because while the supply of larger settings may be relatively straightforward, cost is quickly added when significant numbers of smaller, local, rural deliveries are required; denial of choice; the impact on local suppliers and dairy farmers; and the impact on the quality of the milk—I have heard time and again about the importance of fresh rather than UHT milk being supplied.

Bodies such as Dairy UK, Dairy Crest and the National Day Nurseries Association favour option 2—capping the price paid for milk—but they are concerned that a cap at the levels suggested by the Department might mean that many settings are not able to afford to have milk delivered at that price and so will opt out of the scheme, meaning that fewer children receive their milk. Dairy UK has suggested a single price cap in the region of 65p to 69p per pint, which it hopes would allow for the delivery of one-third of a pint packages of milk to smaller, rural and remote settings.

I am very pleased that the Government are committed to keeping free milk for all children under five years old in a day-care or early-years setting for two or more hours a day. I understand the need for a review of the scheme to ensure value for money, and I look forward to reading the Government response to the consultation, which I am sure will have taken into account a number of the concerns that have been raised in the House today. I urge the Minister to use this review as an opportunity to widen participation in the scheme so that more eligible children receive the milk to which they are entitled. I strongly believe that everyone who is entitled to the milk and wants it should be able to have it, as that is beneficial to the child and ultimately to the nation, with perhaps fewer costs and burdens on the NHS. As a final request to the Minister, will he say whether any European Union money or subsidies would be available to support this excellent scheme?

--- Later in debate ---

[Dr Poulter]

My hon. Friend is absolutely right, and that is why the Government launched the consultation in the first place. The scheme was devised in the second world war, and its provisions mean that the Department of Health currently has no role in active procurement. The Government embarked on the consultation in view of the rising costs, and my hon. Friend will rightly feel concern for dairy farmers in her area of Somerset. Profits from this scheme are going to intermediate companies, and the cost has recently escalated out of control. My hon. Friend also highlights the fact that farm-gate prices have not improved as a result of those increased prices and profits for intermediate suppliers of milk.

It is worth pointing out that an important factor contributing significantly to the scheme’s accelerating costs seems be embedded in its design. No mechanism exists to incentivise child-care providers to economise and search for the highest attainable value for money in their local markets, to support their local farmers or to source their milk from a certain provider. Over the last three years, the average price paid for a pint of milk in a supermarket has been 50p, but the average charged by agents is 78p, which is well over 50% higher. That shows that the scheme is rapidly becoming unfit for purpose, which is exactly why the Department embarked on the consultation.

[Annette Brooke]

Until recently, at least one school was not registered in the scheme because it feared the bureaucracy would be too great. A balance must therefore be struck to ensure that schools and child-care providers participate in the scheme.

[Dr Poulter]

My hon. Friend makes a good point. As part of our consultation, we are looking at a number of options as to how we can maintain an effective scheme and ensure that the one we offer and deliver is better value for money.

It is worth looking at the three options in the consultation. The first option was to cap the price that can be claimed for milk. Under that option, an upper limit on the price that could be claimed for milk would be introduced and increased each year in line with inflation in the retail price of milk. In special circumstances, arrangements would be put in place to vary the cap for child-care providers that, perhaps because of geographical isolation and rurality, to which hon. Members have alluded, do not have access to milk priced at the normal market rate.

The second option was to issue e-voucher cards with or without devolved incentives for child-care providers to buy milk economically. Under that option, child-care providers would no longer have to pay for milk and then claim reimbursement from the nursery milk reimbursement unit. On joining the scheme, child-care providers would indicate how many children would normally be attending for two hours or more per day. They would then be credited with a prospective monthly payment equal to the number of pints required, multiplied by a fixed reimbursement rate, which would be set at an average market price per pint.

The final and third option was to contract a company or consortium of companies for the direct supply and delivery of milk to all child-care providers. Under that option, the Department of Health would take a much more active role in procurement. It would contract a company, or a consortium of companies, for the direct supply of milk to all child-care providers registered with the scheme at an agreed price per pint supplied. That is one way to avoid the bureaucratic burden to which my hon. Friend has referred.

Oral Answers to Questions

Annette Brooke Excerpts

Tuesday 23rd October 2012 Commons Chamber

[Mr Hunt]

Four years ago I voted with my conscience, as I am sure she voted with hers, but I did so as a Back-Bench Member of Parliament and we have made it clear that it is not the policy of the Government to change the abortion law. My job as Health Secretary is to implement the elected will of the House, which voted in 2008 not to reduce the abortion time limits.

[Annette Brooke (Mid Dorset and North Poole) (LD)]

T2. What steps is the Department taking to tackle the growing incidence of drug-resistant cases of TB, which increased by more than a quarter in the past year?

[The Parliamentary Under-Secretary of State for Health (Anna Soubry)]

We are funding TB Alert to raise public and professional awareness of TB. We also expect the NHS organisations and their partners to ensure early detection, treatment completion and co-ordinated action to prevent and control TB. The Health Protection Agency maintains diligent monitoring of all types of TB and the National Institute for Health and Clinical Excellence also includes specific guidance on treatment and rapid contact tracing of people in contact with any type of drug-resistant TB.

Oral Answers to Questions

Annette Brooke Excerpts

Tuesday 21st February 2012 Commons Chamber

[Mr Lansley]

The hon. Gentleman just does not know what is happening around the country. All over the country doctors taking clinical leadership in foundation trusts and NHS trusts, and GPs and their nursing and medical colleagues taking responsibility in the new clinical commissioning groups, are demonstrating that they can improve the quality of care for the patients they serve. They hear what is said by the hon. Gentleman and some of his colleagues and think they are completely out of touch with the world in which they live.

[Annette Brooke (Mid Dorset and North Poole) (LD)]

T5. I appreciate that the Government have allocated additional funding for social care, but what more will and can they do in the short term not only to address the current crisis in funding and ensure that funding is used creatively and efficiently locally, but to cater for those with lower-level needs through preventive measures and early intervention?

Health Services (Disabled Children)

Annette Brooke Excerpts

Thursday 15th December 2011 Commons Chamber

[Annette Brooke (Mid Dorset and North Poole) (LD)]

I am extremely pleased to have the opportunity today to raise directly with the Minister, who I recall from previous debates has a significant interest in the area, a number of concerns about services for children with disabilities.

Earlier this afternoon, I hosted a function for the Council for Disabled Children, at which its young ambassadors presented a film that they had made. Their message was, “Young, disabled and in control”. They wanted to be seen as individuals, to be listened to and to have their views and needs taken on board. The function made me reflect on what I had written in my speech, because we should remember that I am talking about lots of precious individuals. It sounds generic, but, when one has the great honour and privilege of meeting amazing young people who are achieving so much, one realises that there is so much more that we as individuals can do for them. Indeed, one of them referred to the use of personal budgets, and as we bring health and social care together that will all become part of the same discussion.

Throughout my long political career locally and nationally, I have been very much aware that families with disabled children face constant battles to secure support, help and access to services. Not so long ago, I was supporting a family to make sure that they were supplied with sufficient and adequate incontinence pads for their growing child, and I asked myself, “Hasn’t anything changed over the years?” There have always been issues when services such as education and health have been brought together, with cross-service battles over who picks up the bill, rather than people putting the needs of the child first.

Given the coalition’s proposed policy changes, there are some potentially amazing opportunities—specifically within the Health and Social Care Bill, and in the delivery of the single assessment process, the education, health and care plan and the local offer, which are proposed in the “Support and aspiration” Green Paper. But we need to grasp those opportunities and address the issues that are seen as threats, and in that respect I hope that the Minister will be able to provide some reassurances today.

Disabled children and those with complex health needs are disproportionate users of health services, but they face long-standing barriers to accessing both universal and specialist health services. The evidence from professionals, the voluntary sector and families with disabled children is clear: if local areas are not required to have a clear focus on child health, disabled children are not given the requisite priority by local decision makers. As a mother of a child with complex health needs put it:

“What’s so sad is that years have been lost because there doesn’t seem to be any clinical leadership for services for disabled children or even children in this area. And there haven’t been any targets that they need to reach so they are not interested. They’re only interested in targets and services for adults.”

Sir Ian Kennedy’s recent report “Getting it right for children and young people” stated:

“Those caring for children ‘are not the biggest players in the clinical system’ and are not well placed within professional hierarchies. They often lose out to other, more powerful, professional and patients’ groups in the contest for resources and the attention of senior management.”

The Health and Social Care Bill represents an ideal opportunity to address these issues. However, it does not include measures to ensure that the Secretary of State, the NHS Commissioning Board, clinical networks and senates, health and wellbeing boards, clinical commissioning groups, HealthWatch or monitoring bodies will prioritise child health. There is a concern that that will perpetuate a system that is designed for adult health and social care but does not work for children’s services.

Campaigners feel that the Health and Social Care Bill has not indicated how health services for disabled children will be configured within the new system and wish to make sure that there is no confusion on the ground as primary care trusts close and health and wellbeing boards and clinical commissioning groups are set up.

I am aware that some issues should be resolved as part of the Department for Education’s “Support and aspiration” Green Paper pathfinder programme. But there are concerns that that is a long-term agenda that will not produce results for at least 18 months. In the meantime, there is already widespread confusion about how health service reform will affect disabled children. There has also been no demonstrable evidence that health and wellbeing board early implementers and clinical commissioning group pathfinders have been asked to link their work with the “Support and aspiration” Green Paper pathfinders.

There are particular concerns that the overarching proposals set out in the “Support and aspiration” Green Paper will not be deliverable unless the structures set up by the Health and Social Care Bill provide clarity on commissioning structures and accountability for child health. For example, the Green Paper proposes an education, health and care plan for disabled children and an overarching “local offer”, but the Health and Social Care Bill does not require health and wellbeing boards to include that in their local strategies.

I know that there are many concerns about the fact that although there is currently a statutory duty to provide education services identified in a statement, there is not the same statutory duty for the provision of health services. It is always difficult when professionals from two different cultures and backgrounds are asked to work together, but a number of issues could be resolved earlier. The Bill also does not provide a platform for education providers to take part in local decision making at health and wellbeing board level, which will make integrated commissioning more difficult. I would be really grateful for the Minister’s views on that.

The current scrutiny on the health service created by the Health and Social Care Bill represents a unique opportunity to address long-standing problems with the services used by disabled children. Families with disabled children describe these barriers in the latest report from Every Disabled Child Matters and The Children’s Trust, Tadworth entitled “Disabled Children and Health Reform”. They include delays in getting equipment—wheelchairs, for example.

This afternoon I met Becky, who is at university. She drives her own car and has a specially adapted wheelchair that comes apart. She puts all the wheelchair’s parts into her Mini. It is amazing how she has been able to use her skills and aptitude and access a university education, but the NHS could not provide that specialist wheelchair for her. That makes us think that we need to do more for so many children.

I have already mentioned the restrictions on vital support; it is just dreadful when a family contacts you to say that they cannot get large enough, or enough, nappies for children with continence issues. There are disputes over who funds the service, poorly co-ordinated appointments, poor communication across the system and a cliff edge in support at transition to adult services.

Some parents are quoted in the “Disabled Children and Health Reform” report. On the complexity of the health service, one said:

“I’ve had really good experience of Health and individual Paediatricians…The problems arise from the complexity of the system and the different services your child needs”.

There is always so much praise for the individuals who are doing the work, but it is about pulling it all together and the structures. On the delays to getting vital equipment, another parent said:

“My daughter has a helmet and boots supplied by the Child Development Centre. She’s outgrown the helmet now and it took them two months just to make an appointment to measure her head. In the meantime, she’s confined to her wheelchair. They said they had the money to do it, but didn’t have the means to order it.”

We know about the disputes over who funds the service. A parent said:

“Sometimes the local authority says, ‘Well, that’s a Health issue and so the PCT should pay.’ Then the PCT turns round and says, ‘No, actually that’s an Education issue.’ It feels like we’re having to fight and it wastes valuable time because we have to wait for the local authority and the PCT to meet somewhere in the middle about something which could be helping and making a difference now.”

Another parent commented:

“What’s so sad is the years that have been lost because there doesn’t seem to be any clinical leadership for services for disabled children or even children”.

There is a lack of targets and a focus on adults.

Then there are the problems with transition between child and adult health services, on which one parent said:

“My daughter’s been seen by 2 consultants at least twice a year for the last 17 years so it shouldn’t be a surprise to anyone that she’s going to need continued monitoring and support from Health as she moves into adult services. But the divide between health services for children and adults is significant. Many of the professionals we have come to rely on shake their heads about it…but there’s nothing they can actually do beyond offering to attend a meeting with us where they can hand over to someone who works for adult services.”

In the past few years, we have spoken a great deal in the House about the transitional period. We are aware of the issue but we must keep working at it.

The Health and Social Care Bill does not provide any clarity on how the reformed system will affect the child health system. Child health services operate on a separate system to that of adults, with separate structures and relevant partners—for example, education providers. Consequently, child health requires specific attention within the reform process, which the current legislation does not appear to provide.

The Every Disabled Child Matters campaign is very concerned that, unless specific attention is given to the health processes and professionals who work within child health, the modernisation of the NHS will perpetuate a system that fails children, particularly disabled children and those with complex and/or palliative care needs. The campaign believes that there is a clear choice: act now and use the opportunity of reform to create a system that works for disabled children, or proceed with reform concentrating solely on adult services and leave families with disabled children still struggling to fill the gaps.

The EDCM campaign asks for national leadership. It would like the Secretary of State to be required to set priorities for child health as part of his mandate to the NHS Commissioning Board. As a matter of urgency, it would like the Department of Health to set out a clear vision for the way in which the reformed system will meet the needs of disabled children and children with complex health needs. On commissioning, it would like an overarching clinical network for disabled children's health to be created in order to address long-standing issues, including barriers to commissioning specialist health care services. It would like health and wellbeing board early implementers to be asked to test and report on integrated working for the delivery of services for disabled children which includes all relevant partners. It would also like careful consideration to be given to the impact of current reforms on the commissioning of specialist health services for children and young people with high-cost, low-incidence conditions. The campaign would like information and support to be provided to disabled children and young people and their families to ensure that they understand the way in which the changing health system will affect them.

The report poses 10 key questions, which I would like to pose to the Minister. What role will the NHS Commissioning Board play in improving the national delivery of health services for disabled children? Where will the responsibility lie for designing care pathways and shaping local services for disabled children within the modernised system? How will clinical networks and senates support clinical commissioning groups to deliver high quality universal and specialist health care for disabled children? What practical steps are being taken to ensure that the experiences and interests of disabled people and families with disabled children are represented as an integral part of patient involvement at every level of the reformed NHS? How will the success of the modernised NHS in meeting the needs of disabled children be monitored in local areas and how should that information be published? How will health and wellbeing boards work with local HealthWatch and clinical commissioning groups to achieve integrated care for families with disabled children who use health, social care and education services? How should awareness of the particular needs of disabled children be built into the work force development programme being developed by health education England? How will the modernisation of the NHS work with pathfinders of the “Support and aspiration” Green Paper, particularly in the development of a single education, health and care plan and a local offer? What plans are being made to improve the collection of information about disabled children? Finally, how will families seek redress if the package of care for their disabled child is not delivered or integrated with other care, or if the quality of the health care they receive is poor? There are so many questions. We should try to provide answers and to improve the legislation that is going through Parliament, or at least the guidance that will go alongside it.

In the rest of my time, I would like to touch on two areas. Of course, one could talk about every possible condition and make lots of points, but I will touch on two areas that have been on my agenda over the past five years or so. The House has debated the provision of mental health services for children, with particular reference to autism. There has been improved provision of child and adolescent mental health services over recent years, but I believe that the gap between needs and provision remains. I would be grateful for the Minister’s comments on the future provision of these vital services. So often, as we know, mental health services have been a Cinderella service. If we can intervene early with children, we can save a great deal of money, pain and anguish later on.

Specifically on autism, what steps will the Government take to ensure that child and adolescent mental health services staff are trained in autism and that specialist support is available? On a previous occasion, the House has discussed the problem that even when parents have accessed CAMHS, they have not had satisfactory outcomes because of the lack of training.

I would also like to touch on speech, language and communication needs. To return to my starting point, the lack of joint working between education and health has, over the years, been apparent in speech and language therapy and in the battles over who pays. Will the Minister comment on the importance of integrated commissioning for speech, language and communication services, not just within the health sector, but between health and education commissioners? What role will health and wellbeing boards play in ensuring that there is effective and co-ordinated commissioning of children’s services? Will the Minister confirm whether health and wellbeing boards will be encouraged to consider the use of pooled budgets and joint commissioning arrangements for speech therapy services for children?

As an aside, I would like to mention some adult speech therapy that I have seen. I was privileged to visit Poole hospital following the lobbying by the Royal College of Speech and Language Therapists in Parliament. A display had been set up for me and patients had been invited in to cover all the aspects of speech therapy for adults in the health sector. I would like to tell the Minister and place on the record how impressive that was.

Returning to the subject of children’s services, there is so much that could be said, but I have one overriding question for the Minister. Will she and the Secretary of State do everything they can to improve the provision of services for children with disabilities and special needs, and to ensure that the new structures deliver what is needed so greatly?

Low Dose Naltrexone

Annette Brooke Excerpts

Thursday 8th December 2011 Commons Chamber

[Annette Brooke (Mid Dorset and North Poole) (LD)]

I congratulate the hon. Member for Llanelli (Nia Griffith) on securing this debate. I am sure that, like me, she has a number of constituents who are benefiting from this drug—I refer particularly to members of the Purbeck and Wareham multiple sclerosis group. It is so frustrating that they cannot get hold of something, through the NHS or in some form that is easily accessible, given that it is definitely making a difference to their lives. I am sure that she would agree that there is a fear that they might not be able to get it one day. What do they do then?

[Nia Griffith]

The hon. Lady is quite right. These people fear that if they change from one GP to another, or if people are less sympathetic towards this drug—obviously this is something that people have to be convinced about—they may well not be able to get hold of it. Unless there is some form of authorisation and some form of making it an official drug that is more widely available, they do run the risk that she describes.

The problem is that many patients feel let down because what they see as perfectly good therapies, which are cheap but out of patent, are being withheld when patients want them. When doctors cannot refuse a patient’s choice, they can still deny it to them, because clearly the issue of their professional conduct is involved. If the NHS recommends another treatment, quite possibly one that costs thousands and has drug company support, it is often difficult to get the research done to prove the validity of a drug such as LDN.

Some 5,000 people in the UK with multiple sclerosis use LDN, and a few thousand more use it for other conditions, such as Crohn’s disease, cancers, fibromyalgia, autism and so on. Their GPs usually prefer not to sign NHS prescriptions for LDN—indeed, they may refuse to do so—but there are instances of GPs then charging patients for private prescriptions, explaining that they are worried that NHS prescribing guidelines would prohibit them from prescribing LDN and so they would end up in serious trouble if they did so. One GP in Glasgow who prescribes a lot of LDN was reported to the General Medical Council for doing so recently. My constituent Andrew Barnett has told me that his GP has said that his lawyers advised against it, so he writes my constituent a private prescription and charges him £8.50 a quarter for doing so. My constituent then also has to pay for the LDN itself, at a cost of £17.50 a month.

Some 100,000 people in the UK have MS, only 12% of whom use drugs offered by the NHS. Some of the drugs available are risky and very expensive, and there are questions about how effective they are. Yet some 5% of MS sufferers choose to use LDN, because they feel that it helps them and does not have the risks of some other treatments. LDN has proved to be safe in trials at very high doses, but it is unpromoted and hard to get. Because people are now making this choice, there must be a way to get this treatment legitimised on the NHS for patients who ask for it. However, we are told that without substantial trials that is not possible. It is very difficult to find a way to fund any such trials because the drug itself is already licensed and therefore drug companies would not be able to recoup the cost of funding the research by marketing the drug; there would be no money in it for them.

We live in an age where information, including real scientific papers and trials reports, is easily available. Patients who are really determined to make the most of their lives, despite terrible illnesses, and who have the wherewithal to look into the research do seek out information and solutions. We have been using LDN in the UK for some 11 years. Naltrexone has been trialled at high doses to treat heroin addiction and is known to be safe, so the only real thing missing is the marketing authorisation from the Medicines and Healthcare products Regulatory Agency—MHRA—for a formulation of low-dose naltrexone, perhaps in liquid or capsule form. A trial would add proof—or not—of its efficacy.

The cost of a trial is probably considerably lower than the cost of a high-tech drug, because the drug itself is so cheap. Estimates suggest that a single trial can be done with some £7 million, but that is just an estimate based on £1,000 per patient a year for the monitoring specialists, plus up to £3,000 a year per patient for LDN. There would be the costs of recruiting 500 to 800 patients and then something to cover the analysis of the results.

There are no systems available, however, for patients to translate their choice of therapy into a legitimate request, even when they vote with their feet in large numbers. Doctors do not see any danger in the choice except that they worry they might be denying people a more effective option, but, as patients have pointed out, if they need what is perceived to be a more effective option, they can take it alongside LDN anyhow.

My constituent Andrew Barnett, who is highly intelligent, scientifically minded and analytical, has made the assessment that LDN seems to have stopped his disease developing further. The constituents of the hon. Member for Mid Dorset and North Poole (Annette Brooke) have confirmed the same belief. My constituent regrets very much that he did not start using it earlier. If he had done so, perhaps some five years ago, he feels that he would still be working and contributing actively to the economy.

Doctors have to be able to say no to treatment choices for the sake of the patient, but when they have no reasons to deny an option, as is the case with LDN, that should not happen. We should try to ensure that we enable them to prescribe LDN. Doctors all tell us that without the trial, they do not have the confidence to prescribe, so patients face the potential loss of supply of prescriptions if they change doctor, quite apart from the cost of private prescriptions, which is hurtful for many patients who have been reduced to living on income support by sickness or disability.

So, the substance of the debate is about patient access to therapies that cannot get the trials they need for reasons such as not being patentable or the lack of profit in the therapy, especially when the therapy is known to be safe. LDN seems to be the most prominent, in that there are no sensible arguments to deny it to patients who want it and those patients report great satisfaction with it in most cases. It is frankly a disgrace that such options are denied to informed patients who ask for them on the NHS. It would save the NHS so much money to allow this. LDN can be supplied for as little as £17.50 a month, compared with some other expensive drugs, such as £60,000 for Copaxone, £15,000 for Avonex or £90,000 a year for another drug that was recently in the news.

The question is how we can get the trials and get people interested. Academics often rely on backing from pharmaceutical companies to put together their plans and proposals for a research project. It is very difficult to find academics who want to spend that time and energy if they do not know that they will get the backing. They could put in a lot of work without getting any funding for any proposal.

We must face up to the problem of what systems we have in place to provide licensing for drugs such as LDN. One doctor I have talked to, Dr Lawrence from Swansea, tells me that LDN not only seems to have acceptable uses for people with multiple sclerosis but, he feels, has enormous potential for the treatment of cancer. That would be a very worthwhile investigation, considering that we spend so much on looking for answers and on treating the various cancer diseases. Sanctioning the use of LDN would also allow doctors to collect clinical data that could be used to monitor and help prove the effectiveness of the drug.

Naltrexone is already an approved drug at higher doses and research and clinical trials have already shown its effectiveness at low doses to treat auto-immune diseases. Patients have difficulty in getting their GPs to write prescriptions and have to get the treatment privately, but it would be preferable for patients to work with their GPs so that their GPs can monitor them. GPs have had to seek legal advice to find out whether they should be prescribing it and lawyers have advised against it, putting them in a very difficult position.

Among the supporters of LDN are GPs, neurologists and oncologists who have seen patients’ diseases not get worse and there are cases where such specialists have supported its use for the patient and stated that in a written letter to the GP. Even then, the GP has felt unable to prescribe the drug for fear of being considered unprofessional.

Campaigners have worked with local health boards and PCTs to try to determine what knowledge there is about LDN and whether GP practices have heard of it or are using it. The responses came back negative. What can we do so that LDN is offered in addition to other drugs currently prescribed on the NHS? This is about patient choice. It would be nice to be able to make LDN available to patients on a much wider basis, but it is important that patients are monitored by their GPs when using any medication, so we do not simply want a free-for-all. We want the proper medical trials, proof and backing that is needed to show whether it is an effective drug, which will enable it to be made more widely available, but there is a real difficulty, despite the fact that the orphan drug could be a cheap option for the NHS, in funding the sort of research needed to trial it. I return to my initial request and ask the Minister whether there is any way he can make LDN more widely and easily available to patients.

[The Minister of State, Department of Health (Mr Simon Burns)]

I begin by congratulating the hon. Member for Llanelli (Nia Griffith) on securing the debate and hope that by the end of my comments, particularly the last section, she will feel that there is a mechanism and a way forward that she will find helpful. Like her, I am well aware of the interest in the subject from those who feel that LDN is a suitable treatment for a number of conditions, including multiple sclerosis, HIV and various cancers. I am grateful to her for the opportunity to clarify the Government’s position.

I will begin by talking about the process for licensing drugs in general. An unlicensed medicine is not necessarily illegal in the way an unlicensed driver is; it just means that the regulator has not yet been given the evidence it requires to support a routine place in the market. The Medicines and Healthcare products Regulatory Agency is responsible for the regulation of medicines used in the UK, which includes authorising applications for clinical trials and granting licences for medicines. MHRA gives licences for medicines only after evidence has been submitted to demonstrate the quality, safety and efficacy of the product for the conditions it is intended to treat. That system, whereby licences follow evidence, protects patients and means that there is always a robust, systematic and independent assessment of the safety and suitability of licensed medicines.

In the UK, naltrexone is currently only fully licensed in 50 mg tablet form. That dosage is used to help patients remain free from dependence on heroin, methadone and similar opiates and to help those who are dependent on alcohol, but the drug is not currently licensed at any dose for the treatment of the other conditions that the hon. Lady rightly mentioned, because the evidence necessary for a licence does not exist. However, naltrexone is being prescribed by some doctors in doses of up to 7 mg on an individual patient basis. This is referred to as low-dose naltrexone.

The reason MHRA has not looked into licensing LDN is that it has not received any application or evidence to support it, which means LDN is currently unlicensed. That does not mean that it is necessarily unsafe; it is just that a licence for its use in this country does not exist. The current position is that when a patient needs a medicine an appropriate licensed product should be used. If it is not available, doctors can prescribe a different licensed medicine if they think that it will do the job. If neither of those options is available, an unlicensed medicine may be considered. LDN currently falls into that last bracket. As it involves a significantly lower dose than the licensed form of naltrexone, and as it is untested, it is regarded as an unlicensed medicine.

Legislation supports clinicians when they want to prescribe an unlicensed medicine that they think is necessary to meet a patient’s particular needs. The MHRA checks that the medicine is being manufactured to the right standards, in a safe environment and with suitable materials. Any unlicensed product manufactured in the UK must be manufactured to the specification of the doctor, nurse, dentist or whichever professional prescribed it in the first place. The important point is that the use of an unlicensed medicine is the direct personal responsibility of the professional who prescribed it. They are aware that it is unlicensed, and they prescribe it with that knowledge. The position is reflected in professional guidance, including that of the General Medical Council.

Given that a licensed LDN product is not available in the UK, it can be supplied only as an unlicensed product either manufactured in the UK or imported from somewhere else. Most of the LDN used in this country is manufactured in the UK, but anyone who wants to import it must be authorised by the MHRA. In the UK, manufacturers produce a number of formulations, including LDN capsules, at strengths ranging from 1 mg to 6.5 mg, and these are produced under a “specials” licence.

The importation of any medicinal product not licensed in the UK must be in compliance with the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005, which provides for the import of products when a special clinical need exists for individual patients and when the regulatory authority has not objected to the import. Objections may be made on grounds of known safety or quality issues, or if an equivalent UK licensed product is available. In the case of LDN, there is no ban on the import of products of acceptable quality and safety, and I hope that those comments go some way to reassuring the hon. Lady on her point about the fears of some GPs who had been or were not prescribing the drug.

When medicines are unlicensed, such as LDN, the National Institute for Health and Clinical Excellence does not generally assess them, so it has not issued any guidance on the use of LDN in the NHS. When NICE guidance on a particular drug for a particular condition does not exist, it is for local primary care trusts in England to make funding decisions based on their own assessment of the available evidence. On behalf of their patients, doctors can, through an individual funding request, request treatments that are not usually funded, if they feel that there are exceptional clinical circumstances.

In this situation, a special panel that includes clinicians would carefully consider individual cases. They would use the latest available evidence and make a decision on the basis of a patient’s individual circumstances, but we recognise that there is demand from the NHS and from patients for better access to information about drug treatments, particularly when no licensed product is available, so we are keen to explore whether more can be done to support clinicians, NHS commissioners and patients in their own decision-making by giving them easier access to the best available information. That is why the Department of Health asked NICE to provide a service to support the NHS in deciding whether an unlicensed drug can be used to address an unmet need. Under our plans, NICE will commission expert assessments of the evidence that supports—or does not support—the use of unlicensed medicines, including in rarer conditions. That will help clinicians make decisions about effective treatments and address one of the access problems that patients face. As I said earlier, it is important that we preserve the integrity of the medicines licensing scheme, which is so vital to protecting patients. Any information provided will be designed to inform doctors’ decision making and patients’ choices, not to provide a simple yes or no recommendation.

The Medicines and Healthcare products Regulatory Agency is responsible for the enforcement of the advertising regulations—another important area with regard to this subject. There are also self-regulatory controls operated by the industry body—the Prescription Medicines Code of Practice Authority—and general controls on advertising operated by the Advertising Standards Authority. Regulations state that

“no person shall issue an advertisement relating to a relevant medicinal product which is a medicinal product in respect of which no marketing authorisation or traditional herbal registration is in force”.

The regulations apply to any person and are not specific to the pharmaceutical industry. This prohibition does not prevent independent patient charities from providing balanced and factual information about treatment options, including any that are not licensed. The MHRA has published guidance on its website. The MHRA would investigate any complaint about a breach of the legislation, but has not received any complaint about the advertising of low-dose naltrexone. Whether a charity or another third party was promoting a medicine or providing non-promotional information would be decided on the facts of any specific case.

The hon. Lady will no doubt appreciate that it is in everyone’s interest to see a booming medical research industry in the UK that is successful, is meeting its requirements, and is pushing forward our development and use of advanced medicines to help to bring relief to those suffering acute illnesses or long-term conditions and to help them to manage those conditions better.

[Annette Brooke]

The Minister is being very clear in his exposition. The question that my constituents continually ask is why the NHS is not in the least bit interested in a treatment that is so cheap, costing about 50p a day, and appears to defer care costs into the bargain. A constituent of mine has been with their consultant to see the prescribing committee of the local PCT, but we still do not have this drug on NHS prescription.

[Mr Burns]

I am grateful to the hon. Lady for raising that point on behalf of her constituents. The short answer is that it is simply because there have been no clinical trials to assess the drug in its low-dosage levels, and so the conditions of the NHS, under the ways in which we operate in the provision of drugs for patients, have not been fulfilled at this stage. If she will wait for a minute or two, I will get to the nub of the point made by the hon. Member for Llanelli about how we could move forward to seek to address that situation. I hope that the hon. Member for Mid Dorset and North Poole (Annette Brooke) will find the way forward helpful and positive.

The hon. Member for Llanelli will no doubt appreciate that it is in everyone’s interest to see a booming medical research industry in the UK, because that leads to real improvements in the lives of patients, their families and carers, and we are determined to support it. We demonstrated our commitment to health research by increasing spending in real terms up until 2015. In August, my right hon. Friends the Prime Minister and the Secretary of State for Health announced a record £800 million, five-year investment in a series of biomedical research centres and units, which will translate fundamental biomedical research into clinical research that benefits patients and the NHS.

The coalition Government are committed to the promotion and conduct of research as a core function of the health service. The Health and Social Care Bill, which is now passing through another place, will turn this into reality by placing appropriate powers and duties on my right hon. Friend the Secretary of State for Health, NHS organisations, Monitor, and local authorities. We will make sure that the systems and processes for commissioning by the NHS Commissioning Board and by clinical commissioning groups promote, support and fund clinical research. The Government will consult on amending the NHS constitution in order to support patients to have access to novel treatments and to be part of the development of wider patient benefits, so that there is a default assumption, with an ability to opt out; that data collected as part of NHS care can be used for approved research, with appropriate protection for patient confidentiality; and that patients are content to be approached about research studies for which they may be eligible to enable them to decide whether they want a discussion about consenting to be involved in a research study.

The clinical practice research datalink will be introduced by the MHRA in partnership with the National Institute for Health Research, building on the NIHR’s research capability programme. This £60 million investment will offer data services, including providing access to data for researchers, data matching and linkage services, and data validation, to support the clinical trial and observational study work of the life sciences research community.

The NIHR will launch an updated UK clinical trials gateway in spring 2012. That website will enable patients and the public to access information about clinical trials and will be a development of the test site launched in March 2011. To increase the number of patients who can benefit from being involved in trials via the gateway, the NIHR has also developed a free smartphone app, which is available for iPhone users and will shortly be available for Android users. It provides a practical and innovative way for patients to access information about clinical trials.

I will now turn to the question of clinical trials that the hon. Member for Llanelli raised and that the hon. Member for Mid Dorset and North Poole raised, by default, in her intervention. I think that this explanation may provide the hon. Member for Llanelli with the basis for making progress in her quest. Clinical trials are a fundamental part of the drug development process, as she accepts. Trials and health research more generally are funded by a range of groups in the UK, in particular by the NIHR, the Medical Research Council, medical research charities and industry. The NIHR welcomes high-quality funding applications for research into any aspect of human health, including the use of LDN. Such applications are subject to peer review and are judged in open competition, with awards being made on the basis of the scientific quality of the proposals. As she has suggested, a new clinical trial will be required to support a licence for the use of LDN.

The MHRA regulates clinical trials on medicines when they are carried out in the UK. That includes granting approval to conduct a clinical trial and ensuring, through inspection, that the highest possible standards are maintained. However, the MHRA does not initiate clinical trials. A clinical trial needs a sponsor. Sponsors have usually come from industry, the NHS or academia. The hon. Lady is seeking Government funding for a clinical trial to prove the efficacy and safety of LDN. I can tell her that funding is available and that university-based researchers can apply for it.

The efficacy and mechanism evaluation programme is funded by the Medical Research Council and managed by the NIHR. It funds evaluation of the clinical efficacy of treatments. If evidence from such evaluations is promising, larger-scale trials can follow. That is one of the purposes for which the NIHR funds the health technology assessment programme. That programme produces evidence on the effectiveness, cost and broader impact of treatments and other types of health care intervention. In the case of LDN, as with all other novel treatments, I cannot prejudge how successful that pathway of research might be, but I can tell the hon. Lady that a pathway does exist, as I have described.

In addition, the hon. Lady expressed concern about whether the systems in place make provision for patients to say what research they would like to happen. I can assure her that patients can make a suggestion for the efficacy and mechanism evaluation programme to consider. Topics prioritised for funding may be advertised, inviting researchers to submit proposals for clinical trials in those topical areas.

I am grateful to the hon. Lady for raising this subject and giving me the opportunity to explain the background to a matter of considerable interest to many people, not least some of her constituents and those of the hon. Member for Mid Dorset and North Poole. I hope the last part of my speech in particular, in which I have explained an existing avenue that they and others interested in LDN may wish to pursue, will be helpful to them.

Congenital Cardiac Services for Children

Annette Brooke Excerpts

Thursday 23rd June 2011 Commons Chamber

[Annette Brooke (Mid Dorset and North Poole) (LD)]

Representing part of Poole, I am aware of the strong feelings there. Equally, however, I take on board the need for clinically driven decisions. Many Members are raising concerns about flaws in the proposals, so it makes a lot of sense to proceed with the motion, because whatever happens we want to be sure that the best decisions are being made. Does my hon. Friend feel that there is great uncertainty?

[Mr Syms]

I agree with the hon. Lady. It is important to get this right, rather than to rush. Clearly there are concerns. I know that the Minister is a sensible soul and will respond—[Laughter.] Well perhaps he was once a sensible soul. I am sure that he will respond to Members’ concerns. The important thing is that many people out there have concerns that we need to address if we are to deliver a first-rate service that our constituents feel is good for them.