Hormone Pregnancy Tests

Baroness Thomas of Winchester Excerpts

Thursday 16th November 2017 Lords Chamber

[Lord O'Shaughnessy]

I thank the noble Baroness for her questions. The most important thing to stress is that this report was the product of an expert working group of scientists and included an independent member in Nick Dobrik, who is a noted thalidomide campaigner and certainly not a government yes man. The chair of the families group, Mrs Lyon, was an observer. We are beholden to take the evidence of those who are best qualified and who have given their view on what link there may or may not have been between these pregnancy tests and the abnormalities. The conclusion they have come to is that, in their view, there is no causal association on the basis of the evidence they were able to consider.

The noble Baroness asked about transparency. Every single member of the expert working group signed a confidentiality agreement. That is common to all such groups in the Commission on Human Medicines. Mrs Lyon was not alone in that. That expires at the point of publication, so she is now absolutely free to say whatever she wants, as indeed is any other member. I can reassure her that there was no particular or unusual treatment for her compared to other members of the panel or to other panels that have operated in similar ways. The minutes of all the meetings will be published. As the Statement pointed out, the full evidence set will also be published, once it has gone through due diligence.

Changes to the draft were suggested by the Commission on Human Medicines and accepted by the expert working group. There was no interference from me or anyone else—it was a discussion between those two bodies. The report was unfortunately delayed. That was in order to make sure that it was as clear and as digestible as possible for non-experts. I think the report is a very thorough and comprehensible piece of work. I recognise that it is not the response that families were looking for. In some cases, they have experienced horrendous events—they have either lost babies or, in some cases, their children have extremely severe deformities—but I come back to the point that the task of the group was to look at whether there was a causal association. The group had scientific expertise. It has given its advice, and we are following it and the recommendations that it made.

[Baroness Thomas of Winchester (LD)]

My Lords, how do the Government intend to restore the trust and confidence of those left feeling betrayed by the lack of transparency and openness surrounding this inquiry that the Minister has just talked about?

[Lord O’Shaughnessy]

As I pointed out in response to the noble Baroness, Lady Thornton, transparency is there in the evidence and minutes that will be published. The report that has come out is big and chunky and contains a huge amount of information. There was an independent member in Nick Dobrik, the thalidomide campaigner, and Mrs Lyon, who chairs the families group, was an observer. We touched on confidentiality agreements. As I said, there is nothing out of the ordinary in that. I think transparency is there. I come back to the point that the working group was set up to examine all the available evidence scientifically. The department provided its scientific and non-scientific papers for that effort. I know the report has not come up with the conclusions that the families wanted, but it is the right group to have made that judgment.

Older Persons: Human Rights and Care

Baroness Thomas of Winchester Excerpts

Thursday 16th November 2017 Lords Chamber

[Baroness Thomas of Winchester (LD)]

My Lords, I speak from the Liberal Democrat Front Bench tonight. I was going to declare an interest as an older person, but I am in such good company I will just declare an interest in having a small amount of self-funded care. To the noble Lord who said we must look after our care workers, I would say that I have my care worker’s children here to do some work experience, and we are very good friends in other ways too.

This debate is extremely welcome but could last several days rather than two hours because of the number of issues raised by the excellent report from the noble Lord, Lord Foulkes. What age does age discrimination start at? What are we going to do about social isolation? Is there abuse of older people in all care settings to some extent? Perhaps, but we do not know. Then there are all the different kinds of care an older person might receive, either in a care home or their own home.

Sadly, the time we hear most about the mounting difficulties in this area is when hospitals report that an elderly person has been ready to be discharged for months but no suitable arrangements can be made. It is classic bed-blocking, as the noble Lord, Lord Foulkes, mentioned. This makes all elderly people feel vulnerable because it is entirely negative—a word referred to in the report and this afternoon in the debate. This negativity, allied to a feeling of guilt at being old at all, and therefore a burden, is not a good place for anyone’s mental health. The mental health of elderly people is one thing we have not talked about much.

Although the financing of care is not the focus of this debate, it is bound to be one of the headline issues, as we have heard from some of the telling speeches so far. I see that it is the fifth bullet point in the noble Lord’s report. There is no doubt that someone looking down at Great Britain from outer space would think we were mad to be spending less in real terms on social care than we were seven years ago, in spite of the recent injection of some money in the spring Budget. This is at a time when the number of people getting older and needing care is growing.

We must have known about this demographic for years now, as the noble Lord, Lord Foulkes, said. Is it due to the fragmentation of care services that the message does not seem to be getting through with enough urgency? Responsibility for adult social care is split, with health, local government, the benefits system and equalities all involved. Whatever the reason, the human rights of older people would be much better protected in the care system if there were more money to spend on as high quality care as possible, with properly trained and better paid care workers spending as long as is necessary to do their job.

We also need far more suitable supported housing for those who can live independently into old age. In order to put funding on a sustainable financial footing, my party would put a penny in the pound on income tax to raise some cash immediately for both the NHS and social care systems. The noble Lord, Lord Haskel, spoke particularly about that. We advocate establishing a cross-party health and social care convention to carry out a comprehensive review of the sustainability of NHS and social care finances, and a monitoring agency similar to the Office for Budget Responsibility. The latter would report to see how the whole system was getting on, and how much was needed to meet the costs of projected increases in demand and any new initiatives, in order to make sure that changes in services are properly costed and affordable.

In general, we agree with the report about bringing NHS and social care together into one seamless service, pooling budgets in every area and developing integrated care organisations—an aspiration shared by many other groups. After all, where does the NHS’s responsibility end and that of the care services begin?

We would guarantee the right of all NHS and social care service staff who are EU nationals to stay in the UK. The UK needs 1.6 million health and social care workers up to 2022 to replace those leaving the profession, including European nationals who have already jumped ship. While on the subject of care workers, the ones I know who travel to people’s homes are trying their very best to do all they can for their clients, against the odds. They are not paid for travelling between clients so they often have an impossible task, particularly in rural areas, in trying to fit an hour’s work into half an hour, or half an hour into fifteen minutes.

It is not always recognised how important home carers are in an elderly person’s life. They often have to contact a doctor, a neighbour, the next of kin, or sometimes the police, so they really are on the front line, and we pay them very poorly. They also tell me that they often have to listen to some outspoken comments from those they care for who may come from a different ethnic group. But they do not complain because they make allowances for the person’s age and state of health. If that person goes into hospital, a home, or dies, then the carer from that moment is not paid. There is no period of grace.

In many ways, talking about the human rights of older people reminds me of the debate around the human rights of disabled people, which has never sat very comfortably in the Equality Act. The aspect which is familiar to me from that agenda is the right to independent living—the right to have a life, basically—and if possible, a working life for disabled people, paying taxes rather than only picking up benefits. However, each group also needs to have a social life. It cannot be right for older people needing care not to be able to get out and about, go to events, see people, go shopping, et cetera. It should not be enough just to help them wash, dress and eat, and then for society to forget about them. This is surely where communities or neighbourhoods might step in, as they have in the remote Scottish islands of Rum, Eigg and Muck.

We are, in general, a more caring society than people think, and not as good sometimes as some much poorer countries in looking after our elderly citizens. But someone has to take a lead in taking the concept of care beyond the minimum. A lot of churches do this, but what about the increasing number of mayors in our country? Could they not be asked to oversee this sort of involvement and undertake some social activities for elderly people? When I arrived in London 42 years ago, I joined my local contact group, which took elderly people living on their own out to tea once a month to someone’s home. My cell was organised by a barrister’s wife, who managed to capture as many judges as she could as they usually lived in big houses in picturesque surroundings. They quite often opened a bottle of wine in the kitchen afterwards—though I should not say that.

The noble Lord’s report says that member states or civil society should foster and promote human rights in this field. The challenge is how to begin the process of involving the whole community in this endeavour. We owe a huge debt of gratitude to the noble Lord, Lord Foulkes, for initiating this debate today.

Health: Rare Diseases

Baroness Thomas of Winchester Excerpts

Tuesday 3rd March 2015 Lords Chamber

[Baroness Thomas of Winchester (LD)]

My Lords, I acknowledge at the outset that the two matters I am mainly going to speak about tonight are not drug treatments for rare diseases, but they are certainly treatments in the wider sense of that word. I, too, am very grateful to the noble Lord, Lord Turnberg, for asking this Question, which can never be asked too often. I am also very pleased that the noble Lord, Lord Walton of Detchant, spoke about the new drugs coming on to the market for some Duchenne muscular dystrophies. I should at this point declare an interest as I have a rare disease. The two matters that I wish to raise are cough assist machines and hydrotherapy.

Last week, Muscular Dystrophy UK published a new report called Right to Breathe, highlighting the vital need for access to specialist respiratory care for people with muscle-wasting conditions. The report found that respiratory infections have been a primary factor in deaths for certain muscle-wasting conditions with, shockingly, a third of families being repeatedly turned down for equipment by local NHS commissioners, even when it has been requested by consultants or specialist physiotherapists.

Each cough assist machine costs in the region of £5,000, which is equivalent to a 48-hour stay in an intensive care unit. They are considered to be of vital importance by respiratory specialists and are routinely used during hospital stays for patients. An example of what can happen is the case of Freddie Kemp, who had Duchenne muscular dystrophy. He was turned down by his local NHS for a cough assist machine, which would have helped keep his lungs clear. Tragically, in November he died, weeks after leaving hospital following a serious chest infection. This essential piece of equipment may not be a treatment in the way that a new drug is, but it can still save lives. What assurances can my noble friend give that people with muscle-wasting conditions who require a cough assist machine will be provided with one by their clinical commissioning group? This matter of spending a relatively small amount of money on the right equipment for vulnerable people in order to save an expensive hospital stay later on crops up time and again. Surely, something should be done to point this out to CCGs.

Hydrotherapy is a highly effective form of therapeutic exercise in a warm water pool for people with muscle-wasting conditions. For many, particularly boys with Duchenne or anyone with serious mobility problems, it is the only exercise they might be able to manage. The benefits are perhaps obvious, but I will spell them out. The first include a sense of freedom from the confines of a wheelchair, a greater range of movement with the relaxation that very warm water gives and, very often, the alleviation of pain. Secondly, the psychological effect on a person’s well-being should not be overlooked. Perhaps the provision of hydrotherapy should be partly assigned to the mental health budget because of its effect on a patient’s sense of well-being. One young woman with congenital muscular dystrophy told the all-party group some time ago that she felt much better for days after a hydrotherapy session.

However, accessing hydrotherapy is ridiculously hard. If a local hospital does have a pool—many have closed or are in danger of closing in order to save money—patients are told that they are entitled only to a block of six sessions. If you have a progressive condition and this is the best way of keeping you well, a block of six sessions gets you only so far. It is fine for a broken leg, but those of us with progressive conditions will never have what is called “an outcome”. It is not easy to measure the effect of hydrotherapy on those with progressive conditions, but we all know that it is good for us. A study into the provision of these pools in the south-west of England a few years ago by Khurm Arshad, whose brother Auzair has Duchenne muscular dystrophy, found that there were more hydrotherapy pools for horses than for people. Muscular Dystrophy UK is undertaking an audit into hydrotherapy provision for people with muscle-wasting conditions across the country. Will my noble friend encourage the NHS to work in partnership with Muscular Dystrophy UK to compile this audit in order to improve access to hydrotherapy pools?

Muscular Dystrophy UK’s Fast Forward campaign is looking at potential new drug treatments, in particular to ensure that cutting-edge, high-cost potential treatments are not being held up due to lack of funding. That will be the leitmotiv throughout this debate this evening. I am sure that I know the answer to this, but I must just ask whether there are any plans to re-establish a ring-fenced fund for rare disease drugs.

National Health Service

Baroness Thomas of Winchester Excerpts

Thursday 8th January 2015 Lords Chamber

[Baroness Thomas of Winchester (LD)]

My Lords, belatedly all political parties are waking up to the fact that the future of the NHS is top of most people’s agendas in this country, which is why it is going to be prominent in all manifestos for the coming election. The country is also recognising that not only is the population getting older, needier and more disabled but disabled people like me are living longer than we probably would have done some time ago. Boys and young men with Duchenne muscular dystrophy only 15 years ago were dying in their teens, yet today, thanks largely to night-time ventilation, they are living into their 30s and 40s.

The lessons in the field of rare neuromuscular conditions—the field that I know best—are clear. Money spent wisely now by commissioners on access to specialist support and better care in the community for people with these conditions will save a significant sum later in unplanned emergency hospital admissions. That was the finding of a 2011 audit by Professor Michael Hanna of the National Hospital for Neurology and Neurosurgery in Queen Square, yet it appears that commissioners are not prepared to invest in this way to save in the future. I count myself lucky that I live in the capital, near a centre of excellence in this field, but there are significant gaps around the country in specialist care. The ideal is the development of managed clinical neuromuscular networks that bring together consultants, physiotherapists and family care advisers. An example is the one in the south-west, which co-ordinates service provision and the sharing of skills and expertise.

I now turn to research, which was a hugely important but largely unrecognised part of the Health and Social Care Act: the Act places a duty on the NHS, for the first time in statute, to promote research. A future NHS must do more to promote research and ensure that the UK has the clinical trials infrastructure to attract investment from pharmaceutical companies wishing to conduct trials. That was mentioned also by the noble Lord, Lord Turnberg. With the right support, the UK could become a world leader in this field—for example, through support for patient registries and databases for rare diseases. At present, the Muscular Dystrophy Campaign funds the NorthStar database and the national neuromuscular database, but this arrangement does not guarantee long-term security. Does my noble friend agree that if the NHS is to promote research, it should provide support to databases and registries for rare diseases?

I now turn briefly to funding for new treatments. The NHS will face an increasing challenge to deliver innovative but high-cost treatments with advances in genetic medicine. Will increased competition for funds mean that treatments for rare diseases lose out? To avoid that situation, will the Government introduce a ring-fenced fund for rare disease drugs, as has been done in Scotland?

That brings me to my last point, which is that the NHS must have a clear and transparent means of approving new treatments. I am sorry to say that the experience of the Duchenne treatment Translarna does not bode well, with one of the final stages of the process being held up. I know that my noble friend’s colleague, the Minister for Life Sciences, has been closely involved in helping to find a solution. Will my noble friend encourage his colleague to redouble his efforts to help steer through an interim solution that would allow patients access to this drug, which is available in Europe, by April of this year? It is effective only in boys who can still walk. There are many parents who watch in despair while the days pass, knowing that without a drug such as Translarna eventually their young sons will take their last steps.

Hospitals: Voluntary Sector and Emergency Readmissions

Baroness Thomas of Winchester Excerpts

Monday 1st December 2014 Grand Committee

[Baroness Thomas of Winchester (LD)]

My Lords, I am very grateful to my noble friend for raising this important question. I am just very sad that we do not have a great raft of speakers because this is such an important subject, particularly the matter of the ageing society. That is going to happen more and more. Partners will be left on their own, and they do not always plan for it; they get to old age and find that they need a major operation and there is no one left in their families to care for them afterwards. If they are not given the right care after a stay in hospital, the next thing that happens is that they will be readmitted. I was struck very much by the case of my brother-in-law, who is 88 and on his own. He needed a major operation and had to have a stoma. This is quite a complicated thing for somebody of that age to cope with. Luckily, when he came out of hospital, he could board in a care home for a week and then he went to his daughter, who was nearby. So he has had very good care and very good neighbours. I am thinking of someone who is not in that position.

My noble friend and I were both at the event recently held by the RVS in the River Room here, at which it launched its report to which my noble friend referred, Going Home Alone. It was an absolutely brilliant campaign. For anyone who wonders what the RVS is, it is the WRVS without the W, because men are now admitted. It is worth saying that because I have tested it on people and they do not know what the RVS stands for.

It is worth reiterating what the RVS says are the six essentials, because, if it aims to reduce readmissions by half, it is worth the Government and local authorities taking them on board, along with others in the care business. The RVS says that, first, the older person must be told the plan for their return home from hospital. They must be accompanied before 10 pm to a “warm, well-lit house”, and they must be able to collect their prescriptions and get their follow-up appointments. After all, that is going to be one of the most important things. They may have forgotten what they were told in hospital, with all the trauma. Then someone must be there to help them shop so that they will not be hungry. They will be used to people doing things for them. They will be used to having meals provided and if meals are not provided someone will have to help them get ready meals. Finally, the RVS says that they need a friendly face to turn to for help. That is very important. Obviously, where there are family members and good neighbours, that is fine, but an awful lot of people in our towns and cities do not have such people. I suggested to the RVS that it might want to try a pilot in some areas where they are short of volunteers by putting a leaflet through everyone’s house. I have found that many people, particularly in my road in London, are only too happy to help if they know that help is needed. This could help in many areas where there is a great deal of untapped potential.

The Government should not leave it all to the voluntary sector; the voluntary sector should look to the Government for help, too. This could be a good partnership. I am pleased that it was raised by the RVS and that it has been raised today by my noble friend Lady Scott.

National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) (Amendment) (No. 2) Regulations 2014

Baroness Thomas of Winchester Excerpts

Tuesday 6th May 2014 Lords Chamber

[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.

Health: Innovative Medicine

Baroness Thomas of Winchester Excerpts

Tuesday 1st April 2014 Lords Chamber

Asked by

[Baroness Thomas of Winchester]

To ask Her Majesty’s Government what steps they are taking to ensure early access to innovative medicine for life-threatening conditions.

[Baroness Thomas of Winchester (LD)]

My Lords, I am grateful to have attracted such a stellar cast for the important matters that we will be talking about in this short debate this evening. I hope that it might build on the interesting debate on 13 March on regenerative medicine, in which my noble friend Lord Willis of Knaresborough said:

“The King’s Fund estimates that by 2070, 20% of the UK’s GDP will be spent managing long-term conditions”.—[Official Report, 13/3/14; col. 1944.]

Such a situation would be unsustainable and unaffordable, and we must ensure that new treatments and technologies are found so that the quality of life of those with long-term conditions is as good as possible.

The very next day after that debate last month, the Government announced the early access to medicines scheme, which offers a way by which unlicensed medicines can be made available to patients before approval of a licence to benefit public health. The scheme has been warmly welcomed by many of us who are involved with rare-disease patient groups and their families. Indeed, with the support of the Muscular Dystrophy Campaign, the All-Party Parliamentary Group for Muscular Dystrophy, in its report last year, highlighted the need for such a scheme. Ground-breaking research for potential treatments for rare diseases is set to grow and this scheme should ensure that patients will, in future, be able to get the treatments that they need at a much earlier stage of the process.

Professor Dame Kay Davies of the department of physiology, anatomy and genetics at Oxford University is leading the development of a potential treatment for Duchenne muscular dystrophy, which is currently in early clinical trials. She said:

“The introduction of a ‘fast-track’ system offers an exciting opportunity to intervene in a safe way and ensure effective medicines reach the people who need them as early as possible. It is good news for families affected by Duchenne muscular dystrophy, who are deeply anxious about the speed at which future potential therapies will reach their children. Several potential treatments are in clinical trials and further laboratory research projects are underway—the prospect of accelerating the progress of approaches that show particular promise is a very welcome one”.

This view is supported by many families of boys with Duchenne, who say that every second counts and time is not a luxury that they have.

Professor Dame Sally Davies, the Chief Medical Officer, said that the scheme would allow drug-makers to demonstrate the value of unlicensed medicines, improving their chances of eventual approval by regulators and NICE. Obviously, allowing patients early access to medicines is not without some risks, which is why the Government were right to be clear that sufficient data must be available to demonstrate safety before a drug can be considered under the early access scheme.

The Minister will know that I was bound to mention the dismay of many of us in this field at the fact that AGNSS—the Advisory Group for National Specialised Services—was being disbanded, along with NHS Specialised Services. AGNSS was responsible for the appraisal of very rare drugs, while NHS Specialised Services had responsibility for the commissioning of services for very rare diseases, as well as a ring-fenced fund to subsidise treatments for the drugs to treat these diseases. AGNSS’s duties have transferred to NICE—the National Institute for Health and Care Excellence—while NHS England has taken over the NHS Specialised Services role. However, little clarity was given on what the new appraisal and commissioning processes will look like and there was widespread concern that NICE’s “cost per quality-adjusted life year” approach to the appraising of new drugs will effectively exclude, on the grounds of high costs, treatments for small patient populations.

NICE has now established its highly specialised technology programme, responsible for the appraisal of orphan drugs. Unfortunately, early indications of its outlook on high-cost treatments do not appear promising, although it is still at an interim stage. A current example is the approval that NICE is considering for Soliris, a treatment for atypical haemolytic uraemic syndrome, a rare blood disorder that may be inherited. Before Soliris, there was no treatment available to prevent death or organ damage and up to 25% of patients would die following their first attack. Soliris was recommended for approval by AGNSS, based on its effectiveness in halting the progress of the disease and its low cost per quality-adjusted life year. It was assumed that, as a result of this recommendation, the drug would be available to patients from October 2012. However, in January 2013 the Government announced that Soliris would be subjected to a second assessment, under the new system for specialised services within NICE, and Alexion Pharmaceuticals, which developed the drug, has been asked to explain the high cost of Soliris.

NICE has also asked for advice from NHS England on what considerations relating to the management of its specialised commissioning budget it considers should be taken into account in formulating a recommendation. I hope that the fears that many people voiced when AGNSS was disbanded that treatments for rare disorders might be denied on grounds of high costs are not going to be realised. After all, patients with rare and life-threatening conditions deserve access to treatments just as much as those with more prevalent conditions.

The next matter that I wish to raise is the clinical trials process, which must be speeded up. One way of achieving this could be to authorise a process of study approval whereby various stages of clinical trials can be conducted in parallel with one another. This would avoid a lengthy sequential process. For example, in the case of exon-skipping technologies for Duchenne, each drug or molecular patch will treat only certain specific mutations causing the condition and, under current procedures, future molecular patches would have to go through the same lengthy requirements. Will my noble friend the Minister urge the Medicines and Healthcare products Regulatory Agency and NHS England to consider such a study approval process?

Another important consideration is the clinical trial infrastructure, including additional specialist centres to enable more patients to participate in clinical trials. During the APPG inquiry, we were concerned to hear about the cutting of administrative support by some hospital trusts. It is a false economy to cut back on this infrastructure, such as patient registries. At present, many patient registries are charity-funded, with little or no long-term funding security. With limited back-office support, some centres are finding that there is no one available to input patient data. Consequently, such cuts can seriously damage the ability of centres to carry out large-scale clinical trials. Will my noble friend say what steps the Government are taking to ensure that centres and clinics across the UK have the resources required to manage patient registries and for clinical trials to be carried out?

Finally, in last month’s debate my noble friend said that consideration of the Health Research Authority’s business case to bring together and streamline NHS approvals and local ethics approvals should be completed shortly. Will he update us on that? Will he also endorse the need to streamline NHS approvals so that unnecessary regulation and delays are avoided? We must always look forward with great optimism in the search for treatments for intractable conditions. The early access to medicines scheme is a very welcome initiative, which must not be allowed to fail because of bureaucratic obstacles in its path.

[Baroness Jolly (LD)]

I remind noble Lords that we are tight for time this evening. Six minutes is the limit and, as soon as the clock reaches six, your time is up.

Ageing: Public Services and Demographic Change Committee Report

Baroness Thomas of Winchester Excerpts

Thursday 17th October 2013 Lords Chamber

[Baroness Thomas of Winchester (LD)]

My Lords, I cannot remember when I last enjoyed two maiden speeches so much as those which we have heard today.

I, too, congratulate the committee on what must be one of the most important reports ever produced by a Select Committee of this House. Why has this whole question of our ageing population not been at the top of the agenda for successive Governments in the recent past? After all, we have known about the figures for many years. I am glad that at last we are having a proper debate about the whole subject of our ageing society. This report gives us a most welcome route map, and must be seen in conjunction with some of the health reforms and, of course, the Care Bill which simply would not have happened without the former Minister, Paul Burstow, whom I salute today.

Paragraphs 37 and 54 of the report both state:

“Central and local government, housing associations and house builders need urgently to plan how to ensure that the housing needs of the older population are better addressed”,

because the housing market is delivering much less specialist housing for older people than is needed. The Government’s response is encouraging. They acknowledge that more designated specialised housing for older people and disabled adults is needed, and highlight the capital grant of up to £300 million for the care and support specialised housing fund. Perhaps my noble friend could tell us more about how that money is being allocated.

However, many older people want to keep their independence by staying in their own home. Although I acknowledge that the Government have increased their funding of the disabled facilities grant over the past two years, I worry about the bureaucracy involved. In his oral evidence, the managing director of Care and Repair Cymru in Wales says that the first thing they try to do is to make sure that people do not have to use that system for smaller things such as handrails, grab rails or even a stairlift. That plea is echoed by occupational therapists because, they say, the DFG process is long and bureaucratic. That sounds ridiculous. Is my noble friend convinced that the DFG process is working as well as it should? Surely it should be simplified because a long bureaucratic process must cost a lot of money to administer—if for no other reason.

This brings me to the role of the social services departments of local authorities. The spotlight is often thrown on to social workers when tragedies occur involving the death of young children, but the other vital professional group we hardly ever hear about are the occupational therapists, who are the first port of call when an elderly person rings their local authority to say that they can no longer get out of their bath safely or climb the stairs. What may not be so well known is that local authority OTs advise people in all forms of housing on how to stay independent as they age. They manage the long waiting lists of assessments and are the key workers in providing early interventions, preventive approaches and reablement. That assesses what people can do for themselves with their existing support, helping them to set weekly goals, and reablement workers support the person in meeting those goals.

However, the occupational therapists’ workload grows ever heavier, while local authority budgets are shrinking. OTs deal with between 35% and 45% of local authority referrals yet make up only 2% of the workforce. The importance of their intervention is illustrated if one looks at what happens when an elderly person has a fall which leads to a hip fracture. That costs the public purse around £28,665, which is more than four and a half times the average cost of a major housing adaptation and more than 100 times the cost of fitting hand and grab rails to prevent falls. There are many other savings to be made when OTs become involved at an early stage, and I urge the Government to do all they can to make sure that guidance is given to the relevant authorities to involve occupational therapists in designing and commissioning services.

The two other functions these invaluable people undertake are also getting busier. These are advice for people with dementia on strategies and techniques for managing problems, and in the public health field, advising people with long-term conditions on how to manage their health and well-being. The more OTs are employed in the public service, the more money will be saved.

NHS: Specialised Services

Baroness Thomas of Winchester Excerpts

Wednesday 18th July 2012 Lords Chamber

[Baroness Thomas of Winchester]

My Lords, I am grateful to my noble friend Lady Jolly for this debate. I do not have to declare an interest because, although I have a rare disease, I do not have an ultra-orphan disease. There will be a lot of repetition in what we are saying but perhaps the very fact that we all want the same thing will send a powerful message to the Government. That message has been particularly loud and clear from all the groups that have been lobbying us and are very worried about the future of the commissioning of services for these very small populations of patients with ultra-rare diseases. They all want a version of AGNSS to continue its invaluable work and they do not want its expertise and experience to be lost when the NHS Commissioning Board takes over the responsibility of commissioning specialised services.

It is something of an irony that as medical research finds more and more treatments for these ultra-rare diseases, and as improvements in diagnosis mean that more people will have a correct diagnosis and therefore potentially live longer because their condition can be treated, the actual drugs and therapies they need might be deemed unaffordable. That is why we need AGNSS more than ever at this point where research is at the forefront of the Health and Social Care Act. That Act now gives the Secretary of State, for the first time I believe, the duty to promote research in the NHS. This will inevitably mean that new therapies will be found for rare disorders. This should be great news, but will it be for the very small proportion of the population who have these ultra-rare conditions? Will they be denied access because of the high cost of treatment? The key question is what value-based pricing, due to be introduced in January 2014, will mean for high-cost low-volume drugs and whether these can be adequately assessed within a new value-based pricing framework.

The Department of Health says that the new system will give patients and clinicians greater access to clinically effective and cost-effective medicines. But experts are not convinced that the system will work without the AGNSS framework, particularly given the situation in Scotland where AGNSS does not operate. The last thing we want is to go back to the old days when people diagnosed with Pompe disease, for example—an ultra-rare but treatable neuromuscular condition which affects fewer than 100 people in England—were not always certain that enzyme replacement therapy would be licensed in England because NICE had to be satisfied that it would be cost-effective. Through the leadership of Sir Michael Rawlings, national commissioning of such orphan drugs was transferred to an advisory body which later evolved into AGNSS, and the dreaded threat of a postcode lottery was removed.

In its short life, as we have already heard this evening, AGNSS has garnered high praise for its thorough evaluation process, which is seen to be open and transparent, using the uniform expertise to evaluate funding for service provision and therapies, thereby avoiding inefficient and artificial separation of commissioning for drugs and services. It is likely that this good practice has led to the UK being looked on favourably as a destination for pharmaceutical industry-sponsored clinical trials. Surely we all want this to continue and develop. Can the Minister say what the timescales are for confirming the future work of AGNSS and can he confirm that the Secretary of State for Health has the duty under the new Act to provide specialised services for all who need them, however rare their disease?

Health: Neurological Conditions

Baroness Thomas of Winchester Excerpts

Thursday 8th December 2011 Lords Chamber

[Baroness Thomas of Winchester]

My Lords, I, too, am extremely grateful to the noble Lord, Lord Dubs, for introducing the debate and for allowing us to widen it a bit into, for example, the costs of being disabled.

The term “neurological conditions” covers a huge number of conditions, as has already been said. From motor neurone disease to autism, there are hundreds and hundreds. In the family of neuromuscular disorders, of which I know a little, there are also a huge number of conditions, even though they are considered rare or very rare diseases, with a cohort of only about 70,000 people altogether. I shall return to these particular conditions in a moment.

The noble Lord, Lord Dubs, resisted the temptation to rerun some of the debates in Committee on the Welfare Reform Bill about the personal independence payment, which is the replacement for disability living allowance from 2013. However, I shall give into temptation just a little bit, which I hope will be acceptable. Having to save 20 per cent of current expenditure could mean that some people with quite serious, but, say, fluctuating neurological conditions such as MS, which we have heard quite a bit about this afternoon, might not qualify for the award of PIP in the future—I declare an interest in that I receive DLA. This is why it is so important to get the PIP assessment criteria right before it is rolled out.

I am particularly tempted to say something about the Government's intention to take the aids, adaptations and appliances that disabled people use into account when assessing someone's eligibility for PIP, which could mean that the more determined a disabled person is to get out and about, the more they are penalised. We do not want a situation to develop whereby those who use, say, manual wheelchairs will not qualify because they do not get enough points on assessment, but those who use electric wheelchairs do. They may both need as much extra heating in their homes, or help with accessible transport such as taxis. Many of these people will have neurological conditions such as MS or Parkinson's disease. We need real clarification about how the use of aids, adaptations and appliances will be used to assess people who apply for PIP.

I will not say any more about the ramifications of the Welfare Reform Bill at this point, and will instead concentrate on the report just out, put together by my own consultant, Professor Michael Hanna of University College London Hospital’s NHS trust. His report analysed 266 unplanned hospital admissions for 200 patients with a neuromuscular disease across eight NHS trusts. The key finding of the data analysed was that 37 to 41 per cent of all emergency admissions could have been avoided, thus saving the NHS up to £31 million a year.

Neuromuscular conditions are progressive, so it is essential for patients to receive ongoing input from a co-ordinated multidisciplinary team of specialist health professionals to manage changing symptoms, to reduce complications and to provide expert advice on equipment and treatments. Many patients are still unable to access the right medical equipment and specialist physiotherapy, which can keep muscles supple and reduce the risk of falls.

At present, there are just 31 expert care advisers to support the 70,000 people with neuromuscular disease. This is half the number recommended by the Walton report in 2009, which criticised the NHS care of people with the various forms of muscular dystrophy as inadequate. However, the number of expert care advisers has more than doubled since 2008, following campaigning for these key roles by the Muscular Dystrophy Campaign. Having a neuromuscular care adviser in post can actually save the NHS money by, for example, allowing them to take on administrative tasks otherwise done by a consultant or GP, signposting patients to local services and liaising with other service providers. Dr Majumdar, paediatric neuromuscular consultant at Frenchay Hospital in Bristol, estimated that the neuromuscular care adviser there saved over 80 hours of consultant time per Duchenne muscular dystrophy patient over the lifetime of the condition.

The experience of the MDC with neuromuscular care advisers is mirrored by the experience of other groups. We have already heard how important the MS nurses are. The MS Society says that such nurses are a vital source of support, from managing relapses to giving advice on drug treatments, and, as with neuromuscular care advisers, acting as a gateway to other specialist services. As the noble Baroness, Lady Gardner of Parkes, said, 40 MS nurse posts are currently under threat in England, but the MS Society points to the savings that the NHS will make if there are enough such specialist nurses. Specifically, these nurses promote self-management and often prevent long hospital stays.

The same is true about Parkinson's disease nurses. They are an invaluable local source of expert knowledge and can help those who are newly diagnosed come to terms with the diagnosis. They can offer guidance on managing medication and make appropriate referrals on to other professionals, such as speech and language therapists and physiotherapists. Similarly, epilepsy nurses have the same sort of role and provide a source of expert knowledge and guidance. These specialist nurses and care advisers, as we have already heard, are the great unsung heroes of the National Health Service and their roles must be recognised for the tremendous support that they provide.

Turning back to Professor Hanna's report, I should say that, obviously, not all emergency admissions can be prevented. For example, although my condition is a muscular rather than a neurological condition, I myself had an emergency admission to St. Thomas's Hospital when I fell while trying to get into a taxi outside the Peers' Entrance four years ago. I am not sure that anything would have prevented my fall except for me to have been thinking more about what I was doing. However, the report's findings were broader, and showed that many emergency admissions could have been prevented with better planning. The four main factors that Professor Hanna identified in preventing emergency hospital admissions for those with a neuromuscular disease were: a delay in access to neuromuscular services; a lack of ongoing surveillance of the condition; the lack of an emergency plan; and the provision of appropriate equipment.

These findings backed up a report produced by the Muscular Dystrophy Campaign earlier this year, Invest to Save: Improving services and reducing costs. Tracey’s case is cited as a good example of a lack of planning. Her son has Duchenne, one of the most severe neuromuscular conditions. Despite being admitted to hospital with pneumonia, he was not assessed to be able to start treatment at home. With such treatment, his hospital admission could have been prevented. She said:

“My son’s first chest infection was pneumonia; in hindsight other professionals should have known he needed to start night time ventilation. Even after antibiotics and a 10-day stay in hospital, my son did not have assessments to determine his home ventilation needs. We should have been given instructions on chest physiotherapy and we should have had antibiotics at home to start treatment early. The hospital took several days to diagnose his chest infection believing it was a heart condition”.

Another shocking story about the same condition, but making a different point, illustrates why health professionals must find out about any emergency plan a patient has. Phillippa Farrant is from Eastbourne and has a 20 year-old son, Daniel, with Duchenne muscular dystrophy. He is seen at the Lane Fox unit at Guy’s and St Thomas’s Hospital in London. Speaking about Dan’s experience at the local hospital, Phillippa said:

“Dan goes in and out of hospital quite often and has received some good care but other times it has been horrifying. Boys with Duchenne … are prone to chest infections, partly because they become unable to cough and clear their lungs. This August, when I took Dan into the hospital with a chest infection they said it was just pain caused by him coughing a lot—a ridiculous idea as he has been physically unable to cough for years. I told them they were wrong and asked them to call the specialist but they refused. Delays in treatment like this are really dangerous for boys like my son. I am furious they played with his life in this way”.

I fear that the refusal or reluctance of healthcare professionals to co-operate in this way across different hospital trusts is all too common, and must change if patients’ lives are not to be put at risk.

I shall end with some positive news. Thanks to the MDC, a national neuromuscular work plan has been undertaken by the specialised commissioning groups across England since April of this year. They presented the results of the work they have done so far towards the national plan at a workshop in Cambridge this week. So we move slowly forward, but there are many challenges ahead in the complex and varied field of neurological conditions. It is vital that, in the new NHS landscape being created, no one is left behind.