National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) (Amendment) (No. 2) Regulations 2014
(10 years ago)
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Lord Hunt of Kings Heath
That this House regrets that the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) (Amendment) (No. 2) Regulations 2014 create arrangements for the management of services for very rare conditions that are much more fragmented than those in place prior to the Health and Social Care Act 2012; and further regrets that the process by which services for rare and very rare conditions are considered by the Prescribed Specialised Services Advisory Groups and NHS England for commissioning nationally are unclear and lacking in openness and transparency. (SI 2014/452)
Lord Hunt of Kings Heath (Lab)
My Lords, I am grateful to have the opportunity to debate services for very rare conditions. The House has long had an interest in those rare conditions and, indeed, in specialised services more generally. During our debates on the Health and Social Care Bill in 2012, we had extensive discussions about how to protect specialised services. Of course, the funding of those services is at the moment the subject of much debate because of the overspending under the auspices of NHS England. That clearly emphasises some of the problems arising because of the changes brought about by the Health and Social Care Act 2012.
Rare diseases are more of a feature of healthcare in the United Kingdom than many people think. Indeed, I understand that there are reckoned to be about 6,000 such diseases, and it is calculated that 6% of the population have such a rare disease, but each separate disease can affect fewer than 500 people. Those diseases can often involve some of the most vulnerable patients; given the small patient numbers and clinical complexity involved, it can be difficult to plan and manage. I understand that work has shown that four in 10 patients with a rare disease report difficulty in getting a correct diagnosis and then face similar challenges with obtaining suitable treatment.
Prior to the 2012 Act, these services were commissioned by a single national specialised commissioning team, subject to approval by Ministers on advice from the Advisory Group for National Specialised Services. That single commissioning team could draw on advice from the advisory group’s broad multidisciplinary membership to ensure high-quality service developing. The advisory group itself benefited from the bespoke ethical decision-making framework appropriate to considerations of products and services for such small patient populations.
Under the new system, responsibility for highly specialised services has been fragmented in a number of ways. Services are planned by an advisory group within NHS England called the rare diseases advisory group, while new highly specialist technologies are due to be developed and evaluated by NICE under a new methodology currently under development. Separately, the prescribed specialised services advisory group advises Ministers which services to instruct NHS England to commission, including new highly specialised services, such as in the statutory instrument that we debate this afternoon.
Apart from the complexity of these new arrangements, a number of problems have been identified by the Specialised Healthcare Alliance. First, the separation of these complex and interrelated functions between different national agencies risks the loss of efficiency and expertise in planning highly specialised services. As an example, links between NICE and NHS England would need to be extraordinarily close given that many highly specialised services are heavily dependent on high-cost, low-volume drugs.
Further, changes to the commissioning of these services present additional causes of concern. Rather than retaining a single national commissioning team to manage relationships with providers of highly specialised care across the country, delivery is now delegated, I understand, through NHS England’s four regional offices, with contracts held by the 10 area teams with responsibility for specialised commissioning which have providers on their patch. The alliance has expressed concern that cohesive oversight of these services is likely to be undermined in the process and may even introduce a greater degree of clinical risk. The efficiency of the arrangements, moving from one national to 15 different teams with a greater or lesser involvement, also seems highly debateable. As an example, where access to a service across the country is dependent on only three or four providers, problems at one will have an immediate consequence on the others as well as on patient referrals.
The prescribed specialised services advisory group advises Ministers on changes to the scope of specialised services to be prescribed in regulations for direct commissioning by NHS England. Under the terms of the 2012 Act, Ministers prescribe services for NHS England to commission directly, including specialised services, while all the other non-prescribed activity falls to clinical commissioning groups to commission for their local populations. In prescribing a service as specialised, four factors in the Health and Social Care Act 2012 are taken into account: the number of individuals who require provision of the service; the cost of providing the service or facility; the number of persons able to provide the service or facility; and the financial implications for clinical commissioning groups if they were required to commission the services or facility themselves. Ministers receive advice from the advisory group hosted within the Department of Health to inform such changes. However, this has not been at all transparent. Indeed, in its first year of operation, the advisory group was hidden from public view. It was not until 2 May 2014 that the first details of its membership, decision-making processes and recommendations were published. A few members of the alliance have campaigned to secure inclusion of their services as specialised services but were taken by surprise by the publication of this statutory instrument as they did not know that the advisory group had issued a recommendation to Ministers.
The noble Earl may have good news for us about the publication of a report on this matter either today or in the past few days. As it reached me by e-mail this morning, I have not had time to read it, and it is certainly not available in the Printed Paper Office. That is a pretty poor do if we were meant to have it in time for this debate. It is very important that this work is transparent. I hope the noble Earl can give us more assurance on that this afternoon.
Will the noble Earl respond to the evidence given by the NHS England chief executive to the Commons Select Committee on 29 April, in which Mr Simon Stevens suggested that the scope for specialised services had been overextended and needed to be reviewed? The noble Earl will know that the overspend by NHS England is causing great concern in the health service not only because it suggests that NHS England has lost control over the commissioning of specialised services but because the resources have had to be taken from other parts of the health service. Clearly, this position is not sustainable. I would be grateful if the noble Earl would respond to that question.
Baroness Brinton (LD)
My Lords, the regulations, which address an important Cinderella service in the NHS that not many know about, are extremely important. I thank the Specialised Healthcare Alliance for its briefings, which have provided an extremely helpful background. I know that the noble Lord, Lord Hunt, has provided a couple of figures, but it might be worth pointing out that there is a clear distinction between “rare” and “very rare” diseases. It sounds silly to say, but those with very rare diseases would welcome having, for the one in 17 or fewer of the population who will be affected by a “rare” disease—that is the ratio—a reasonable coverage throughout the country, although it may be in specialised areas. However, “very rare” diseases may affect fewer than 500 patients in the UK and, in the case of one or two diseases, may affect perhaps only one or two patients.
With the implementation of the new clinical commissioning groups it has obviously been important to reassess how treatments for rare diseases are commissioned. I do not have to declare an interest because I do not have a rare disease but, as someone who has to access rare biological medicines, I know that my local CCG and many others are struggling with the whole issue of prescribing expensive drugs. However, they cost pocket money when compared with the cost of medicines and treatments that we are looking for as regards rare and very rare diseases. The key is that one-size commissioning will absolutely not fit all, even within the definition of one rare disease, because it would be very unusual to find one clear clinical route. These days, the personalisation of drugs based on genes identification—80% of rare diseases have a genetic component—and the range of co-morbidities with most of these diseases mean that we absolutely must have clear and individualised treatment routes, with a much higher level of understanding of the diseases.
That is why I welcome the prescribed specialised services advisory group, which, for brevity, I shall refer to from now on as the PSSAG—I do not know what the Department of Health is calling it but we may as well add something else into the alphabet soup. It is important that the Secretary of State consults the PSSAG. The regret Motion was laid prior to the publication last week of the recommendation from that special advisory group. Inevitably, the timing is unfortunate, but life is like that. However, I believe that the publication of this report significantly reduces the concerns in the regret Motion about fragmentation and transparency. For example, the sections on membership and process on pages 7 and 8 of the report, some of which the noble Lord, Lord Hunt, referred to, make it very clear that both lay members and representatives from the royal colleges, as well as members with financial and technical expertise who can offer assistance, will come together to look at things. The noble Lord referred to what has to be reviewed but the other elements are equally important. The PSSAG must also consider how activity can be identified to enable separate contracting, monitoring and payment, which I think addresses the noble Lord’s point about what happens when things are devolved to a regional level. It also has to address the running costs associated with separate and direct commissioning, as well as consider defining elements of service to be commissioned. Therefore, I think that I am more reassured than the noble Lord, Lord Hunt.
It will be very important to monitor implementation, partly because, certainly in the early days, it will be difficult to budget for it, in part because of what I said about the personalisation of treatment routes and medication but also because, as we and the commissioners become much more familiar with the changes taking place in the treatments, particularly the gene therapy treatments, we may find that the costs of associated treatments are significantly reduced quite early on if the biologics and other superdrugs, as well as stem cell drugs, begin to work. Therefore, I would be grateful if the Minister could reassure the House about monitoring the situation once the PSSAG gets fully into its stride and commissioning starts to take place.
I have one area of concern, which is perhaps where more than one of the specialist groups that are going to be looking at treatment routes are involved in commissioning a patient’s treatment. Often two, three or possibly even four specialist groups are likely to be involved. In cystic fibrosis there would obviously be a principal neurological one but blood and kidney specialist groups might be involved as well. My fear is that we may end up, as we have done in the NHS in the past, with the position where a patient in a hospital sees lots of different consultants but does not know who has overall responsibility for holding the ring. Is there an equivalent in this sector to make sure that one group has a specific responsibility, partly so that clinicians and therefore their patients are not passed from pillar to post among these different specialist advisory groups?
Lord Walton of Detchant (CB)
My Lords, I am grateful to the noble Lord, Lord Hunt, for raising this crucial matter. This issue of rare diseases is of increasing importance with the developments in knowledge and in new forms of treatment that are beginning to emerge. For many years in the NHS, doctors and scientists recognised that there were a good many rare diseases, but those received comparatively little attention save for supportive treatment because no effective drugs were available that were curative or that would at least alleviate significantly the effects of such diseases.
Of course, one has to recognise that many rare diseases still exist in medicine but every single disease, even if it is incurable, can have its effects modified to some extent by pharmacological, psychological and physical means. However, that was not particularly brought to public attention until the past few years, when developments in molecular biology—not least in genetics—highlighted by the rare diseases consortium and by the Genetic Alliance UK meant that in a very large number of rare diseases the causal gene was identified, isolated and localised in the genome. In addition, drugs have begun to emerge which will alleviate or overcome the effects of the genetic defect. For those patients who have a rare disease, affecting up to several thousand individuals, these are known as orphan drugs; for those affecting a few hundred or a few dozen patients, these are known as ultra-orphan drugs, which are very expensive. The number of patients likely to benefit is relatively small so the commercial viability of these remedies is at least a matter of grave concern.
While there are important things to take on board here—we were talking about R&D and AstraZeneca a little while ago—we must recognise the fact that Britain has an outstanding record in medical research and development. As I have often said, today’s discovery in basic medical science and in applied science brings tomorrow’s practical development in patient care. People with rare diseases can be helped by these remedies that are now coming on stream much more rapidly than has been the case in the past. The important thing is this: as the noble Lord, Lord Hunt, said, before the Health and Social Care Act was passed, we had the Advisory Group for National Specialised Services which commissioned services for some people with rare diseases. When the Act was passed, we—those who debated it extensively in this House—were reassured by the knowledge that there was an agreement that highly specialised services would be commissioned by NHS England. In recent debates with the noble Earl, he has been able to reassure us that that organisation has a rare disease advisory group, advising it on the management of these conditions. He was also able to reassure us about the early availability in this field, and in others, of unlicensed drugs in specific circumstances that may be effective in the management of many conditions in medicine—not just for cancer but for rare diseases, too. That is crucial.
However, as the noble Lord, Lord Hunt, said, we are concerned that the services are somewhat fractured in the sense that I have been unable to find out with any great clarity the terms of reference of the prescribed specialised services advisory group. It is not at all transparent at the moment. As the noble Lord said, nothing has been clearly published about its membership, its modus operandi and how it will function, or to what extent it has a relationship, if any, with NICE on the new procedures that NICE is introducing for the examination of orphan and ultra-orphan drugs. We need reassurance and more information on how this group works and, in the interests of public scrutiny, how it makes an effective contribution to health service decision-making. These are matters of great importance because rare diseases, though rare, are a major blight on people in the community. However, we cannot assess human suffering in purely numerical terms. The suffering resulting from many of these rare diseases is in many ways serious and exceptional and deserves very special attention.
For that reason I was very concerned, and I hope that I have misinterpreted the remarks of the director of NHS England, Mr Simon Stevens, in his report to the Commons Health Select Committee. He said that he thought there was a need for the scope of specialised services to be reviewed because he thought that they had been overextended. This is a phase in medicine in the UK when that would cause great concern to patients and their families and to many doctors who are concerned about the treatment of these diseases.
Baroness Thomas of Winchester (LD)
My Lords, I am grateful to the noble Lord, Lord Hunt, for initiating this debate and giving us the opportunity to talk about the new health service arrangements as they affect rare and very rare conditions. As other noble Lords have done, I shall range wider than the regulations—only briefly—because it is not often that this subject comes up for debate. The opportunity should not be missed to say something about those of us with a rare disease, in my case muscular dystrophy, and how it is faring as the new NHS arrangements are being put in place. I declare that interest.
All muscular dystrophies are rare diseases and some are very rare and there has been a great deal of uncertainty about how existing services for patients would fit into the way that services are commissioned, planned and delivered in the new NHS landscape. However, the situation was far from perfect before the changes. Some patients might not see a consultant for several years and many found it very difficult to access the right respiratory and heart checks, physiotherapy—especially hydrotherapy—and emotional and practical support. It was very much a postcode lottery. I had to discover for myself, 20 years ago, how helpful an exercise regime was, and this is now advised by healthcare professionals.
The new NHS set-up has provided not just a challenge but an opportunity to get things right from the beginning. The Muscular Dystrophy Campaign has worked closely with NHS commissioners on both a national and regional level and has achieved significant and encouraging progress in developing a dedicated neuromuscular standard through a specific annexe in the specialised neurosciences service specification. This has ensured that there are now more than 40 neuromuscular care advisers and specialist nurses funded by and embedded in the NHS, who provide invaluable support and advice to those with muscle-wasting conditions and their families. More are still needed, particularly to help guide patients and families through the transition from childhood to adulthood.
Another valuable initiative is Bridging the Gap, a Department of Health-funded project run by the MDC which began last July to help shape the future of neuromuscular services in England. This project brings together NHS commissioners, clinicians and health professionals through regional patient-led neuromuscular forums. Already it is bearing fruit, such as the development of GP online modules and emergency care plans, which it is hoped will improve the quality of care and support of people with neuromuscular conditions.
Clinical reference groups have been a positive step overall towards the effective commissioning of specialised services, although there are still problems. First, there is a disparity of CRG arrangements for rare diseases. Cystic fibrosis, for example, has its own CRG for children and adults and works well, but neuromuscular diseases are spread across three CRGs. I am taken with my noble friend Lady Brinton’s suggestion of there being a designated clinical lead so that everyone knows who to turn to. I believe that a one-off meeting has been arranged by NHS England to bring together these CRGs, but a long-term plan is also needed to work out how they will work together in the future.
Secondly, the main neuromuscular service specification prepared over the past three years, which covers children, transition and adults, mainly sits in the adult neurosciences CRG, which has adult-only expertise. It is a very welcome and recent step in the right direction that the paediatric neurosciences CRG has agreed to adopt the neuromuscular annexe of the service specification, but further work is needed here. I look forward to my noble friend’s reply.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I am well aware that the noble Lord, Lord Hunt of Kings Heath, retains a keen interest in this topic, and I thank him for bringing it to the Floor of the House. I was naturally disappointed to hear that he feels that the new commissioning arrangements for specialised services which were put in place through the Health and Social Care Act 2012 are fragmented, and that the process for determining which services are considered to be specialised is unclear and lacking in openness and transparency.
Let me begin by emphasising that the Government continue to uphold the principle that no one is left behind, no matter how rare their condition, and that people with rare conditions should receive the same access to high-quality care as people with more common conditions. The Health and Social Care Act 2012 established the NHS Commissioning Board, now known as NHS England, and gave it responsibility for commissioning, among other things, specialised services. These services are prescribed in the regulations that the noble Lord has referred to. The arrangements for managing the commissioning of these services replace a system whereby 10 specialised commissioning groups and one national commissioner were responsible for commissioning both specialised and highly specialised services. Under that previous system, it became clear that there was variation in the range of services which some specialised commissioning groups were commissioning and the policies that were being applied to these services. This led to an inequity in access to services. Furthermore, the lack of standard contracts across the 10 specialised commissioning groups meant that the quality of services across the country was inconsistent.
All that has been replaced with a new system whereby one national commissioner is responsible for commissioning all specialised services for people with rare and very rare conditions. NHS England has developed standard service specifications and policies for commissioning these services, and these are underpinned by detailed identification rules that allow the commissioner of the activity, either NHS England or CCGs, to be determined. NHS England has implemented a robust process for developing and consulting on commissioning specifications and policies that includes public consultation. NHS England works with the 10 area teams responsible for the delivery of this work to ensure that highly specialised services continue to be commissioned in an effective way at the national level. I understand that all those involved in commissioning these services meet on a monthly basis to discuss any issues arising and how they might be resolved.
The noble Lord, Lord Hunt, raised the issue of the separation of functions carried out previously by AGNSS. I note his concerns that the system will be worse off without AGNSS. As a consequence of the 2012 Act, AGNSS ceased to have a role and its key functions have been picked up by other groups. From April last year, Ministers retained the power to decide which services should be commissioned, but NHS England became responsible for determining the number of centres and levels of funding in commissioning all specialised services. The prescribed specialised services advisory group has been established to provide Ministers with advice on whether services are specialised and should be directly commissioned by NHS England. NHS England worked with the former chair of AGNSS to consider how best it might receive high-quality clinical advice on highly specialised services. The Rare Diseases Advisory Group was set up by NHS England to provide it with this advice. The assessment of very high-cost drugs for patients with rare conditions was the final strand of AGNSS’s work which needed to be properly secured for the future. Ministers decided that NICE was best placed to offer this advice. I hope that that gives clarity to the arrangements that are now in place and the reasons why we considered this to be a compelling set of arrangements.
As I am sure noble Lords will acknowledge, the changes that were made through the Health and Social Care Act were extensive. With change being made on such a broad scale as this, one might expect that the processes for setting up the reformed commissioning arrangements will take a little time to settle in.
There are a variety of reasons for the trend in spending on specialised commissioning, which the noble Lord, Lord Hunt, mentioned, including increased demand for specialised services and increasing demand for high-cost drugs. NHS England is taking steps to address budget management and reviewing the opportunities to reduce costs while maintaining the quality of services, which I know it attaches great importance to doing.
I remain confident that these new arrangements will lead to high standards for all patients needing to access specialised services, wherever they live and no matter how rare their condition is. I listened with care to my noble friend Lady Brinton. The intention and ultimate effect will be to ensure that patients in need of specialised services receive consistent access to high-quality care, wherever they live, and that services are organised and delivered as efficiently as possible.
Our agenda is very much one of continuing improvement. Although I am aware of the concerns expressed by the Specialised Healthcare Alliance, neither I nor NHS England accepts the premise that the changes we have made are leading to greater fragmentation. However, I am grateful to noble Lords for drawing these issues to my attention. I assure noble Lords, not least my noble friend, that I share their wish to see joined-up, consistent services across the country. I can give an assurance, too, that I will monitor the provision of specialised services over the coming months.
The noble Lord, Lord Hunt, said that the process by which services for rare and very rare conditions are considered by PSSAG for commissioning nationally are unclear and lack openness and transparency. That concern was echoed by the noble Lord, Lord Walton. It may be helpful if I talk a little about the group and its role. The National Health Service Act 2006, as amended by the 2012 Act, requires that before making regulations setting out which specialised services are to be prescribed, and thus made the commissioning responsibility of NHS England, the Secretary of State must obtain advice appropriate for that purpose and consult NHS England.
PSSAG was established in 2013 as a Department of Health expert committee to provide this advice. Its role is to provide advice to Ministers on whether services are specialised and should be directly commissioned by NHS England rather than by clinical commissioning groups. The appointment of this group helps to ensure that the Secretary of State has appropriate advice when exercising functions under Section 3B of the NHS Act 2006. The group met for the first time in September 2013.
The noble Lord, Lord Walton, asked about the group’s terms of reference. It has working terms of reference, which are currently being further developed and will be signed off at a future meeting. As part of the exercise in advising Ministers, the group will also consider proposals for NHS England on the formulation of its service descriptions, which are used to explain what NHS England is providing under the different headings for the specialised services provided for in the regulations. The group will provide advice to Ministers on whether the service descriptions and any proposed changes are appropriate in respect of the prescribed service.
Evidence, supporting information and activity in respect of those services currently prescribed in legislation for direct commissioning by NHS England, along with any new services identified as potentially specialised and warranting commissioning by NHS England, are all made available to PSSAG from a range of sources. These sources may include clinical reference groups—CRGs—patient groups, clinicians, commissioners and members of the public. The proposals that the group considers are in large part generated by NHS England through its CRGs, which cover different areas of clinical practice. As PSSAG is still relatively new, the processes for enabling services to be referred to the group for consideration, and the annual cycle for considering whether services are specialised or not, are still being refined.
Lord Hunt of Kings Heath
My Lords, first, I thank the noble Earl for his response, and the noble Baronesses, Lady Brinton and Lady Thomas, and the noble Lord, Lord Walton, for taking part in the debate. I say to the noble Baroness, Lady Brinton, that of course the Motion was drafted well before the publication of the report. In fact, I received notification of the report only this morning. She seems to have got hold of it before me. Obviously it is helpful to have the report, which I have no doubt we will study, but I hope that this will be the start of an engagement between the advisory group and Parliament, and I hope that the advisory group will offer an open meeting for parliamentarians in the near future where we could discuss these matters with it.
The noble Lord, Lord Walton, was absolutely right to remind us of the increasing importance of ensuring that we have appropriate mechanisms for providing services and funding for these very rare diseases, particularly as technology advances and given the likelihood of orphan drugs being required more in the future.
I had hoped that I might identify a way to fund some of these services, but the Minister has told me that the money has perhaps been discounted and is already in the system. I say to him, however, that the low uptake by the NHS of innovative new medicines is a major problem. Alongside the issue of AstraZeneca, we have to persuade and cajole the NHS that it has to change its approach to new medicines. My own experience is that increases in staffing, in units and in medical equipment are all regarded as a good thing but that an increase in the drugs budget is seen per se as a bad thing. This, frankly, is nonsensical given what many drugs can bring to the public. The fact is that we have a hugely innovative R&D and pharmaceutical industry in this country which we should be very proud of, but the NHS has a lamentable record in investing in the output of that R&D industry. This is a very serious issue from the point of view both of patients and of our continued success—one hopes—as a country in attracting that R&D investment in the future. My understanding is that, in research and clinical trials in the future, unless we are able to compare innovative new drugs with what would in many countries be the normal drug usage, we will find it even more difficult to have clinical drugs started in this country. This is a very serious issue and we have collectively to tackle it.
I note what was said by the noble Baroness, Lady Thomas, who made some very powerful points. The noble Earl, Lord Howe, believes that the current system is not fragmented in the way that I described. Obviously, we will have to see whether this proves to be the case in the future, but there is a risk, with four regional and 10 area teams, of pretty widespread inconsistency within those teams and areas. We need to keep that under very close review.
I am very grateful to the alliance for its briefing and the work that it does. I wonder whether Ministers would be prepared to meet the alliance to discuss our debate and the advisory group’s report. I have already asked whether the advisory group would be prepared to meet parliamentarians. I am grateful to the Minister for expanding on the comments made by Simon Stevens to the Health Select Committee about the overspend on specialised commissioning. NHS England is not very visible in the Palace of Westminster and it should become more so. Before it makes pretty fundamental decisions on specialised commissioning, it would be very good if it was again to agree to meet parliamentarians to discuss it. This has been an excellent debate. I beg leave to withdraw my Motion.