asked Her Majesty’s Government what are their aims in reviewing Part IX of the Drug Tariff, with particular reference to stoma and incontinence products.

The noble Earl said: My Lords, I am the first to acknowledge the somewhat specialist nature of the subject matter. It is, however, a subject of life-changing importance to a large number of people. Because of that, and because I shall not give a winding-up speech at the end of the debate, I hope that the House will forgive me if I overshoot my time allocation by a couple of minutes.

There are some 300,000 users of incontinence products and services alone, many of them extremely vulnerable. We are talking about people with spinal injuries, MS or disability resulting from a stroke, and about the frail elderly as well as about a sizeable group of children and young adults. A wide range of appliances and products is available on prescription to enable these patients not only to manage their condition but in many cases to lead regular lives without having to worry about the risks and difficulties that they would otherwise experience. If someone can manage their own incontinence condition at home, this will obviously reduce demands on primary and community care as well as on hospitals.

For the past two years, there has been a series of consultations reviewing the arrangements whereby manufacturers in this field are reimbursed for their products and services. It is important to make it clear straightaway that I completely support the Department of Health in seeking to secure better value for money for the taxpayer and in trying to identify areas of the budget where justifiable savings can be made. I also recognise that any process of that kind is bound to be tough and to include some hard bargaining. Businesses that find the heat turned on them in this sense will never find it comfortable and will naturally object to anything that might threaten their profit and loss account. Unfortunately, not much can be done about that. I therefore say to the Minister that a review of these reimbursement arrangements is not objectionable. On the contrary, when it started its review the department articulated several aims with which none of us could possibly disagree. The principal aims were to maintain, and where applicable improve, the quality of care to patients; to secure value for money for the NHS; to ensure equitable payment for services and transparency in pricing; to facilitate innovation; and to maintain local choice—all very admirable objectives.

The problems have arisen in the way in which the review has been conducted. The system proposed would classify products and appliances into categories. In each category, the cheapest product, as long as it had a certain very small market share, would set the benchmark price. That benchmark price would determine the maximum price for any product in the same category; namely, 20 per cent higher, subject to a maximum price reduction of 35 per cent for any product. The alternative proposal is simpler: a straightforward price reduction across the board of 12 per cent. Either of these formulae would deliver budget savings of around £25 million a year.

The striking feature of these proposals is their arbitrary character. Neither of the proposed approaches appears to have any rationale beyond a desire to save a pre-determined amount of money. However, the system of product classification also defies logic. What the Commercial Directorate has done is classify high-quality, specialist appliances alongside inferior items that are priced at a lower level. If I were to place three types of incontinence bag on the Table, noble Lords might at first glance see little difference between them. However, one of them would be a cheap bag designed to be thrown away after a single use. Another, by contrast, would be a more expensive bag, designed to be used and re-used for a week or longer. The third would be a bag, also of a more sophisticated design, intended for use at night. The cheap, single-use bag would be the price-setter in that category.

Under the department’s proposals, no recognition is given to either the quality or the cost-effectiveness of the other products. Nor are the benefits to patients in having a more sophisticated product and thereby a better quality of life anywhere taken into account. The result of lumping into one category all articles falling under the heading of urine collection bags, where there is a very wide range of quality and functionality, is that you are bound to end up with a classification that is frankly bogus. The very fact that there would be a cap of 35 per cent on the price reduction borne by any one product is a tacit recognition of that.

The consequence of these proposals, if they were implemented, would be the withdrawal from the market of many specialist products and appliances. They would no longer be economically viable to make and distribute. These products would almost certainly be the ones that are the most innovative and technologically advanced. The losers in that situation would, of course, be the patients who have come to rely on them. It is difficult to believe that such patients would see their choice as having been enhanced.

There would also be the practical consequences for the NHS. Every patient who was obliged to start using a different product would have to be assessed and, alongside that, there would be a significant cost attached to nursing and nurse training. Cheaper products bring with them a higher risk of infection and other complications. To the extent that patients experience such complications, the burden on GPs and accident and emergency departments will be the greater.

The department is also proposing a capped and banded payment structure for remunerating the various services provided to those who use incontinence and stoma products. We are talking here about home delivery, telephone helplines, nurse advisory services and items provided to patients at no charge, such as refuse bags and wipes. People who suffer from spinal injury and other serious medical conditions often have impaired mobility and are confined to their homes for long periods. Many are dependent on home delivery and help from nurses if anything should go wrong. The advice I have received from product manufacturers is that the reimbursement being proposed for these services would make them, in many cases, uneconomic. That is of huge concern, not least for patients living in rural areas who find it difficult or impossible to get to a pharmacist, even if they have a pharmacist who is open at the necessary times.

The system of product classification leads to a further very grave concern. When the consultation first began, one of the stated objectives of the review was to facilitate innovation. Since then, however, the commercial directorate has made it clear that the product classification it is proposing would be a once-and-for-all exercise. If you ossify a classification in this way, there is no means by which new and innovative ideas will be able to get a look-in. Indeed, it is far from clear how a new product that is not compatible with one of the existing categories will be listed at all. One of the hallmarks of UK manufacturers has been their ability to respond to the needs of patients by producing innovative solutions. The interim report published by the noble Lord, Lord Darzi, emphasised the importance of harnessing new treatments and technologies as swiftly as possible. I simply do not see how the department’s current approach is consistent with that aim.

The department’s position is apparently that manufacturing costs have gone down, but the NHS is not benefiting from these efficiencies. That view ignores the GDP deflator, which forms part of the existing arrangements for Part IX. The deflator has generated an effective price reduction of 11.5 per cent in the decade leading up to the start of the review. Since then, there has been a price freeze, which has tightened the squeeze on manufacturers even further, and, in the last three or four years, a marked rise in the cost of raw materials, such as plastics.

It is not the position of manufacturers that I am principally concerned about, but the position of patients. In preparing for this debate, I spoke to a number of patient groups, including the Spinal Injuries Association. Thirty years ago, a large proportion of people with spinal injuries died not from their injuries, but of bladder and kidney infections. Average life expectancy for a paraplegic was 10 to 15 years. Since the introduction of better and more sophisticated products, such as sterile catheters, thousands of lives have been saved. If these catheters were to be withdrawn from the market, it is no exaggeration to say that there would be a risk to the lives of many wheelchair-bound patients. The damage to their quality of life would also be significant. The single biggest cause of relationship breakdown among spinally injured people is incontinence. It was quite extraordinary to hear from the association that no impact assessment of the department’s proposals has yet been carried out. Although there was supposed to be a consultation with users, the consultation document is so technical as to be unintelligible to anyone other than a professional. It is true that the association was permitted to meet the Commercial Directorate, but only to discuss a list of questions submitted in advance. No supplementary questions were allowed. That does not seem to me to be an approach that could be described as open or patient-friendly.

Another group of patients I want to talk about briefly is children. Bowel and bladder problems affect three main groups of children: namely, those who are not toilet trained because they are slow developers; those with spinal injury or congenital problems, such as spina bifida and cerebral palsy; and those with a learning disability. All three groups combined number about half a million children across the UK. Many of those children will have lifelong problems. Every single one will need individual assessment and a service that can deal with more complex needs when they arise. Industry, once again, has responded to those needs, not least for incontinent children with congenital defects or spinal cord injury, many of whom are able to become independent and to take responsibility for themselves at a very young age.

In the old days, a child who required a catheter had to have it permanently inserted with collection apparatus attached to his or her legs. That, quite apart from any psychological trauma, brought with it a very high risk of renal damage. The single most important innovation in the past 30 years has been the low friction hydrophilic catheter. It is essentially a lubricated device which can be inserted into the urethra when the bladder needs emptying and then can be removed. The incidence of renal failure since the introduction of that product has fallen dramatically.

The difference in price is between a basic item, not dissimilar to a length of windscreen washer tubing, which costs 40p, and a more modern, fit-for-purpose product that is priced at £1.47. For many years, only the first of those was available. The basic product, if used regularly, would commonly scratch the urethra causing bleeding and scarring, even sometimes wearing a hole in the side of it. In boys, an indwelling catheter would not uncommonly result in the complete splitting open of the penis. I could tell a similar story for bowel incontinence. The sad irony was that these things were not often thought to matter since the life expectancy of such children was short. Very much thanks to the newer appliances, that is no longer so, which is why to turn back the clock now would be wholly unforgivable.

I mention those unpleasant details to emphasise one point: any review of the reimbursement system for stoma and incontinence products has to be more than just an accountancy exercise. The Commercial Directorate is full of people from Deloitte who I am sure know about money, but they may not know quite as much as they should about the reality of living with incontinence as a wheelchair-bound person or the major advance in patient safety and quality of life that the newer technologies have offered.

If the inadvertent result of this review should be the imposition of suffering and risk on patients, that would be quite unacceptable. The department’s pronouncements on the matter, though superficially reassuring, leave their ultimate intentions opaque. It is unsettling that a number of the aims that were articulated at the very start of the exercise appear to have been abandoned. I hope very much that the Minister, with her customary understanding and good sense, will wish to look into the concerns I have raised and will make sure that the worst fears harboured by some of us are not borne out.

My Lords, I congratulate the noble Earl on securing this debate and on the small, but very select, number of speakers he has assembled to discuss a rarely mentioned topic but one which is of immense importance to huge numbers of people, and their families, who have difficulties with continence. The changes proposed clearly are complex and I do not pretend to understand whether they will have the effect described by the noble Earl. But I know many people fear that they will have this effect. I, too, have spoken to quite a lot of people who are using those products.

I should like to ask the Minister to ensure that in her response she addresses and gives reassurance on issues such as the loss of specialist products from the Drug Tariff, which will reduce patient choice; the increased chances of medical complications such as infection by a change of the use of a product and the lack of sufficient guidance in a new product; the removal of incentives to innovate, as mentioned by the noble Earl, which are of great importance where techniques are developing so fast; and the possible removal of the additional services which are currently provided by dispensing appliance contractors. I know that that delivery and collection of appliances is of immense value to those who use these products.

I have two major areas of interest in this topic, the first a personal one as someone who at one time, because of a colostomy, was a user of stoma products and a receiver of services from stoma nurses. I was among the fortunate ones able to have a reversal after a few months, but I have never forgotten those months and how dependent I was on the effectiveness of the products and the efficiency of the service providers.

My second interest is on behalf of carers. There are 6 million people with continence problems, and we can depend on possibly half of those having a family member or friend who helps them. Incontinence is a major factor in the failure of care at home. There are statistics which show that incontinence, especially faecal incontinence, may be the factor that prevents informal carers from being able to continue caring, resulting in admission to care home or hospital. Services which are easily accessible, products which can be delivered to the home and support staff who can advise and help are almost as important to carers as they are to sufferers. Many a carer has been surprised that incontinence can be treated as well as contained, and delighted by the effects the treatments can sometimes have. For this reason it is important that innovation and the development of stoma and other products are not stifled at this time.

I hope it will be apparent that ensuring that those services continue to be provided makes sound economic as well as moral sense in this context. I am sure all noble Lords are familiar with the figure that I never hesitate to give this House, that carers save the nation £87 billion per year. They give care willingly and with love, but often with severe financial strain to themselves and their families. Carers are often required to give up paid employment to care, but the most frequent explanation given by carers for their worsening financial situation is the extra costs of disability and illness. These are many and varied. As we know, caring for someone with incontinence can double the cost of laundry, bedding and clothing. Carers have difficulty getting out to do the shopping, let alone to collect incontinence supplies, and value home deliveries hugely—as do the users of stoma products.

Remember, too, that the experts who advise on the choice and use of these products are as important as the products themselves. We must ensure that access to specially trained nurses and technicians is maintained and improved.

I hope that when any changes in services are considered, Ministers will ensure that what results is an improvement not a curtailment and that we will bear in mind the financial circumstances of the families who deal with this problem—usually in silence and often in secret. We must ensure that they are supported, recognised and not given yet another problem to face in the emotional, practical and financial difficulties they are already wrestling with.

My Lords, I support my noble friend Lord Howe on the Front Bench and compliment him on raising this debate on the Government’s aims in reviewing Part IX of the Drug Tariff for the provision of stoma and urology appliances. In his opening speech he examined the review in great detail and presented valid criticisms of its methodology. I shall not follow him down that path. I raised some issues about the review in Questions for Written Answer last year when the Government received such a volume of responses to their consultation that they postponed changes planned for last July.

Before I proceed, I declare my interest as a patient user of stoma items and have been for a decade. I hope that my personal experience and account of it will give noble Lords a clearer insight into the sensitivities involved in this area. Ten years ago, I was diagnosed as suffering from diverticulitis and underwent a colostomy operation, which resulted in the removal of the sigmoid section of the colon. The operation left me with a stoma which enables excretion through it into a bag on my lower left side. I would have wished to spare the House these medical details, but they have to be presented to enable anyone who is unfamiliar with a colostomy to appreciate what is involved in the physical management of the resulting stoma.

Over the 10 years I have had no significant problems, which I attribute in no small part to the high quality of the prescribed items used, from the flange surround of the stoma, which has to be changed weekly, to the bag attachment, which I change as necessary, at least on a daily basis and sometimes more frequently. I must also commend the reliability, celerity and smoothness of the home delivery service providing these essential items, without which I really do not know how I could live a near normal life. In my case, the items are supplied by an assembly and distribution company at Fittleworth in West Sussex. The items include some made by ConvaTec, a Bristol-Myers Squibb company, which has a manufacturing plant in north-east Wales—a plant that I opened 25 years ago.

In the early stages of managing my stoma, there were accidental mishaps, all due to my own inexperience or lack of care. Mercifully, none occurred in public. I can only imagine one’s consternation and others’ disgust if these accidents happened coram publico. Such accidents are, of course, always possible, but the excellent quality of the items supplied means that one can depend on and be confident in their reliability, which is clearly of vital importance.

When one reads about the history of this lengthy review, and the Minister’s reply to me on 9 May last year that savings might be made of some £27 million in the total cost of Tariff List items of some £169 million, one cannot but wonder what is to be sacrificed. One hopes that it will not be the quality or reliability of the products. My noble friend on the Front Bench in his opening speech gave us an indication where those cuts might occur. The suppliers, who numbered about 68 last year, are fearful that all kinds of sacrifices will be required of them to the disadvantage of their patient customers. Coloplast, one of the major suppliers, is especially concerned; it believes that it will bear a disproportionate part of the cost cut and will have to abandon the making of certain products. Research and care services are also at risk.

The Minister at the Department of Health last year was the noble Lord, Lord Hunt of Kings Heath, who told me on the Floor of the House:

“Let me make it absolutely clear that the last thing I want to do is to inhibit the provision of the kind of services that he”—

that is, me—

“has described. This is about value for money and ensuring that we move away from the difficult-to-understand financial regime and payments to the various contractors to a transparent system that is based on value and enhancing the service to the public. We should make sure that that happens”.—[Official Report, 24/4/07; col. 556.]

There were other assurances to the same effect. On 12 June, he told me in a Written Answer:

“In conducting this review, a key objective has been to maintain and improve the quality of patient care”.—[Official Report, 12/6/07; col. WA 243.]

Like my noble friend, I sincerely hope that the Government adhere to the principle that the object of the review is to improve patient care.

I hope that the Minister will reassure us today that the quality of the service will not deteriorate—and I am sure that my hope is endorsed by the 450,000 patients who receive the 4.5 million dispensed items covered by the tariff lists. Those figures were given to me by the Government, so they must be right. Many of those patients are victims of other illnesses and are highly vulnerable. We must make certain that we do not add to their suffering.

My Lords, I am extremely grateful to the noble Earl, Lord Howe, for initiating this important debate and for his excellent opening speech. I declare an interest: along with nearly everyone with a spinal cord injury, I have had to use continence products—in my case for 40 years, after I broke my neck while a student at university. Sadly, this debate was announced at short notice, so not as many people were available to speak as would have liked to. There is deep, widespread concern about what is proposed. I hope the Minister will do all she can to ensure that these concerns are addressed.

Surely there is no condition that is more humiliating than incontinence. Few afflictions make you more depressed, more isolated and less socially acceptable than not being in control of your bladder or bowels. Imagine being at a party and suddenly finding a pool beneath your chair—or the horror of a man who goes up to accept an award in his wheelchair, leaving a trail of diarrhoea behind him. If you cannot control your bladder and bowels, you are condemned to a life sentence of housebound isolation. It is impossible to lead a normal social life, let alone go out to work. Incontinence can place a far greater limitation on our life than not being able to walk, yet such is our embarrassment about the subject that it is rarely mentioned.

About 20 years ago, I was one of a group of 16 tetraplegic and paraplegic women who wrote a book called Able Lives: Women’s Experience of Paralysis. It was based on responses from 205 women with spinal cord injuries. We each wrote a chapter on one aspect of the condition and mine was incontinence. Reading it again for this debate was encouraging, in a way, because the range of provision has improved so much. The chapter set out the way in which incontinence could rule our lives. Katharine, one of the contributors, said,

“it dominates 99.9 per cent of my time”.

The book also reminded me how little help was available then. Twenty years ago, if you wanted a discreet and efficient pad, you had to make your own, which meant spending countless hours wrapping cotton wool and cellulose wadding into squares of gauze. Innovation and investment by the market has transformed the products and appliances available—and that is what is so worrying about the Department of Health proposals, which threaten to return us to the embarrassing uncertainty of relying on products that do not properly meet our needs.

The clear message from the book Able Lives was that what worked for one person did not work for another. The struggles that each woman went through in finding a method and products that worked for her meant that, once a satisfactory solution was found, it was a devastating prospect if for any reason that had to change. It is this hard-won security that is being threatened by the drug tariff proposals.

The Department of Health Commercial Directorate has been conducting this review over two years with five consultations, yet there remain major concerns about the latest range of proposals and the negative effect that they will have if implemented. There has been a shameful lack of user involvement in conducting this review, as the three user organisations—the Spinal Injuries Association, the Urostomy Association and Incontact—pointed out in the letter that they sent to the Minister last July. They said that,

“the Directorate is continuing to ignore the needs and views of patient users of continence/urology appliances”.

They continued:

“Healthcare professional and patient use of products is different and education is a two way process”.

They also said:

“Most long term patients rarely see a specialist nurse and therefore the latter are often not fully aware of the need for some products. Most professionals only know of a limited number of appliances/catheters”.

As we have heard, there are many concerns. The Urology Trade Association warns that the size of the proposed cuts will make many products economically unviable to produce and will stifle innovation. People who have used the same trusted product for decades are likely to find that it has gone out of production and they will be thrown back to the early days of utter insecurity while they try to find a product that suits them. Again their continence will dominate 99.9 per cent of their time. What hope is there of maintaining your social life, let alone your employment, in the mean time?

There are further major concerns with the way in which goods have been classified within the proposed category-based system, as we heard. Products have been misclassified, with the result that high-quality, specialist appliances have been classified alongside inferior items at a low price. That could lead to serious medical complications for some users, let alone humiliating embarrassment. For instance, superficially similar urine bags may be more or less vulnerable to splitting depending on the materials that are used in their construction.

User groups such as the Spinal Injuries Association have been assiduous in providing feedback on the Commercial Directorate’s proposals, yet the proposals remain full of errors. For example, latex and latex-free products are confused, which could have devastating and potentially life-threatening consequences for anyone with an allergy to latex.

One of the most worrying of the industry’s concerns about these proposals is its warning about their effect on the help and support that will be available. The Department of Health has proposed a capped and banded payment structure for remunerating service provision. The industry warns that suppliers will no longer be able to provide those services that are essential in giving users reassurance and peace of mind in managing their condition, such as the telephone helplines and nurse advisory services. Other services that are threatened are those that help to reduce your frustration, to maintain your dignity and to save invaluable time, such as prescription collection, the wonderful discreet, fast and efficient home delivery services and provision of all the necessary complementary items such as wipes and disposal bags. These services enable you to deal with your incontinence as just an inconvenient but minor facet of your life. Take them away and incontinence once again becomes a major issue of organisation and management that dominates everything that you do.

Will my noble friend tell the House whether any work has been done to assess the impact that these proposals will have on other aspects of government policy? If these proposals are implemented in their present state, as user groups fear, patient choice, which is rightly at the heart of government policy, will obviously be dramatically reduced. What about the impact on employment policy and the drive to reduce the numbers of disabled people dependent on benefit?

I have concentrated on the experience of spinal cord injured people whose ability to find employment is certainly dictated by whether they can manage their continence. You do not see the people who are not managing, because they cannot leave their homes. The difference between two catheters may seem immaterial to people who do not use them, but if one of them leaks and the other does not, that changes your whole life.

Finally, what assessment has been made of the impact on the health service, with the inevitable increase in repeated medical consultations, the resulting health complications and hospital admissions? I hope that my noble friend the Minister will do all that she can to ensure that these concerns are properly understood and comprehensively addressed, and bring some hope after the misery of this interminable, unsatisfactory review.

My Lords, the noble Earl, Lord Howe, deserves an unusually large pat on the back for bringing this subject forward. It is one of those unpopular, unsexy subjects that has to be addressed.

As I was thinking about what to say, I found that most of what I thought of had already been mentioned. The noble Baroness, Lady Royall, and I have a little game in which we talk about the follow-on costs of government spending. They were mentioned by everyone involved in the debate today. The noble Baroness, Lady Wilkins, gave the best example when she summed up her remarks by saying how what we were doing tied in with the rest of government policy. The Government are spending a great deal of money on welfare to work interviews and so forth for disabled people, which was in the last Welfare Bill. If you remove a product that works, that means people are not mobile. Are you not then counteracting another part of government policy? I will leave that point there because I have made it dozens of times.

The last time we spoke about this I mentioned kicking through the Chinese walls in Westminster to try to get the Government to realise what was happening. That still applies. To concentrate purely on the Department of Health, has the department assessed what it would cost to change a product that is satisfactory at the moment to something does not work in 10 per cent of cases? That is a reasonable question.

If the department finds itself having to provide other services, such as emergency services and admissions to hospital, what would that do to the pricing structure? The general consensus from the briefing that I have received—and people have been on their toes—seems to be that the system is delivering happy customers, patients, clients; call them what you like. There seems to be a degree of satisfaction with the current system. The phrase, “If it ain't broke don't fix it” comes to mind.

Whatever criticisms have been made of the Conservative Benches, being wasteful of public money as a matter of principle is not one that we can readily throw at them—certainly not in theory. One’s normal allies in cost-cutting are saying, “Wait a minute, there may be a problem about the implementation of this. It may stop the innovation. Patients who are stable and able to carry on with the rest of their lives will make fewer demands”. Has that been factored in? Is that on the balance sheet and, if so, where?

If the Government can answer these questions and address some of these concerns most of us will say “fine”. If some of the other services that are provided—the follow-on costs in this process—can be factored in, the answer would probably still be “fine”. How will the Government address these concerns? Please let us know, because I have very seldom received, for any debate, briefing that says, “Please don't touch it: it's working reasonably well”.

I advise the Government to tread very carefully here because they may incur greater costs further down the line and affect people’s lives in a negative way, which would counteract many of their other areas of activity. Can we please be assured that those considerations have been factored in? If they have not, a well intentioned step may counteract good activity in other areas. Can the Government make sure that they address these fears up front in future? At the very least they would save time and energy in Parliament by making sure that parliamentarians—if not people in the outside world—know what is coming. Either the Government’s policy or their presentation is wrong. Can they please tell us exactly what is the thinking behind this measure and how they factored in the considerations to which I referred, if they did so? If they did not, I advise them to back off and think again.

My Lords, I am grateful to the noble Earl, Lord Howe, for enabling us to debate some crucial issues today. Until very recently, and through gross ignorance, I was not aware of the vital importance of these matters to thousands of people—the individuals who use stoma and urology products but also, as my noble friend Lady Pitkeathley so eloquently pointed out, their carers and their families. I pay tribute to the noble Lord, Lord Roberts of Conwy, and to my noble friend Lady Wilkins for the honesty with which they dealt with this rather difficult subject today. That certainly helps us, and I hope helps the Government, to appreciate the problems that have to be overcome. Those of us who do not suffer these problems do not realise how much we have to be thankful for.

I have spoken to colleagues in this House who use stoma and incontinence products every day, and to those who have used them for months or perhaps years. No matter how long or short the period of use, people require products that suit their needs, fit, do not cause skin problems and are user friendly. They want a choice of products and follow-up care.

I reassure noble Lords that no decisions will be made as an outcome of the Part IX review that compromise the quality of care. Part IX is complex. It consists of more than 5,000 items and there is no transparency between what is reimbursed to dispensing appliance contractors for these items and the moneys that they receive for service provision. Dispensing appliance contractors and pharmacists also have different terms of service. The review seeks to unbundle these costs, define services and ensure that the NHS, and taxpayers, are receiving value for money from the £240 million that is spent in this area. However, I, of course, acknowledge that the review has caused a great deal of concern not only among users of the appliances but also among dispensing appliance contractors and those who manufacture these products. The noble Lord, Lord Addington, said, if it ain’t broke don’t fix it. That is an attractive idea but I understand that Part IX has not been reviewed for 20 years and I think that it is beholden on government to look into these things from time to time.

Bladder and bowel problems and incontinence are common problems, particularly among older people, people with disabilities and many children. They are of a very sensitive nature and impact significantly on a person’s quality of life. The department estimates that about 450,000 individuals use stoma and urology appliances. Some will need them intermittently but the majority will be dependent on them. Quality of life is of primary importance to these patients. All want to be as independent as possible and to contribute fully to the overall well-being of the economy. As the noble Earl said, these appliances ensure that patients can lead regular lives and reduce demand on primary and community care, and as my noble friends said, that makes good economic sense to individuals and families.

Noble Lords are, of course, aware that my noble friend Lord Darzi is leading a wide-ranging review of the NHS to ensure that a properly resourced NHS is clinically led, patient-centred and locally accountable. His vision for the NHS is that it should be fair, effective, personalised and safe. The overarching aims of the Part IX review are fully consistent with that, and every effort has been made throughout the review to engage with patient groups to reassure them and to listen to their concerns.

My noble friend Lady Wilkins expressed concern that there has not been adequate patient and stakeholder engagement. Such engagement is vital and there can never be enough, but I assure noble Lords that officials have met representatives from the Ileostomy and Internal Pouch Support Group, the Spinal Injuries Association, InContact and the urology association. My right honourable friend Dawn Primarolo, the Minister for Health, has agreed to meet with a consortium of patient organisations representing users of urology appliances. Officials have also met representatives from the NHS, particularly those specialised in the area of stoma and incontinence care, such as the Royal College of Nurses and the World Council of Enterostomal Therapists. They have also met nurses who specialise in childhood incontinence, as such patients have very special needs. The noble Earl cited the specific problems relating to paraplegics and children and the advances that have been made so that their lives can have real quality. He is right that this review must not only be about value for money but about valued lives for individuals. I will certainly ask the department to look into the cases that he raised. Officials have also met trade bodies representing the dispensing community and manufacturers.

Given our understanding of patient concerns, the department has sought to reassure patients and industry that the maintenance of their care is a key aim of the review. We want to ensure that, no matter where in England a user of stoma or incontinence appliances lives, they are all offered the same standards of service. Such services include home delivery and home visits made by specialist nurses employed directly by dispensing appliance contractors—DACs—and pharmacists. While we recognise the important contribution that these individuals make to patient care, we believe that their role is to complement the work of NHS specialist nurses. As such, we need to ensure that they are suitably qualified to deal directly with patients.

Currently, the invaluable services provided by DACs and pharmacists are not service requirements, so they are not provided by all and to all, and, where they are provided, it is not necessarily to the same standard. Our proposals seek to embed in legislation agreed standards of service delivery and ensure fair remuneration, thus creating a level playing field and a wider choice for patients. Standards of service must include proper information about the product and advice thereafter.

However, dispensing appliance contractors have expressed concerns that there is not enough money currently in the system to cover the services that we propose that both they and pharmacists should provide. They are concerned that services could be at risk. Such views are being taken very seriously, given our aim to maintain and, where appropriate, improve patient care. Given the role of specialist nurses employed directly by providers to complement the work of NHS specialist nurses, we will discuss that with interested parties when we meet shortly.

Noble Lords have referred to the proposed classification of items that the department put forward for comment. Our aim was to make it easier for prescribers to identify the appropriate product to match a patient’s medical need. I fully understand that each patient is an individual with individual needs. In order to arrive at a proposed classification, officials worked with specialist healthcare professionals. The overriding criterion was not one of price, but was to ensure that items were classified according to their ability to meet similar medical needs. I note the concerns expressed by the noble Earl. The review is certainly not intended to stifle innovation and new technologies; quite the opposite. I will take up those important issues with the department.

A key aim of the review is to ensure that the NHS is receiving value for money; hence the proposed reduction in reimbursement for items. Some manufacturers have told the department that the proposed reductions in reimbursement for items could lead to a large number of items being discontinued. Items are routinely de-listed by manufacturers from Part IX; in fact, 379 items and 121 ranges were deleted in 2007. I understand that patients are anxious to ensure that their preferred products are maintained on the list and that they have real choice. We are therefore in discussion with industry to identify a level of adjustment that is affordable to industry.

The department acknowledges that the Part IX review in respect of stoma and incontinence appliances seems to have gone on for a long time. This is because Part IX is a complex sector. Given the highly sensitive and personal nature of the conditions for which these products are used, we needed to take time to arrive at new arrangements that are right not only for the NHS and providers but, most importantly, for patients.

The last consultation closed on 28 December and officials are analysing the responses. However, my right honourable friend Dawn Primarolo, the Minister for Health, has agreed that officials should sit down with dispensing contractors and manufacturers to discuss the best ways in which to conclude the review. These meetings have begun and are due to conclude by the end of February. Once the discussions have concluded, the department will publish a full impact assessment and interested parties will be given an opportunity to comment.

I note all the concerns that have been expressed about the assessment and the desire that it should cover issues such as the impact on other government departments and on employment, for example. I do not know what the assessment has covered, but I will certainly look into this and come back to noble Lords with further information.

In conclusion, we welcome this short debate. I regret that it has been so short. The Government recognise the importance of the issues raised and truly are committed to ensuring that patient care is not compromised because of the review. I hope that this debate will assist not only in reassuring patients, but will encourage others to speak out about these issues, which are intensely personal, but about which there should be no embarrassment. In the mean time, I will ensure that the people undertaking the review are given a copy of the report in Hansard of this debate and I will ask them to take into account all of the points raised. This is a complex issue, but essentially it is about dignity and quality of life for patients as well as about value for money for taxpayers.

House adjourned at 6.02 pm.