National Health Service (Licensing and Pricing) Regulations 2013

Baroness Finlay of Llandaff Excerpts

Wednesday 10th July 2013 Grand Committee

These regulations will help to enable Monitor to undertake fair and proportionate regulatory action, and will support a fair and transparent system for setting tariff prices. I commend the regulations to the Committee.

[Baroness Finlay of Llandaff]

I have a short query, which I hope that the Minister can clarify for me. It relates to the cross-border flow between England and Wales, either of providers or patients as users of services where NHS Wales is paying for services provided by NHS England or a provider in England. I would like reassurance that there will be no way that the experience of patients going from Wales into England, or the ability for providers from Wales to provide services to patients along the border, are in any way jeopardised within these arrangements and that they have equality within the provision.

[Lord Hunt of Kings Heath]

My Lords, I declare an interest as chair of an NHS foundation trust, president elect of GS1 UK and a consultant and trainer with Cumberlege Connections. I am grateful to the Minister for his explanation of these regulations. I want to put a few points to him.

I start with Part 2 on licensing, specifically paragraph 3 concerning monetary penalties. Can I ask the Minister about the logic of fining providers, when all that happens is that worse care will be provided for patients as the organisation will have less money? I think that the figure of up to 10% of turnover would virtually bankrupt most providers. While I certainly accept the need for penalties and consequences for failure, I wonder whether they would be better being not financial, as the reality is that they will not happen in many cases because the people who suffer will be those who get services. I just wonder about the logic of that.

It took NHS England months to wake up to the fact that the A&E problems were to do with the failure of systems, but for months it was pressing CCGs in some parts of the country to fine hospitals for poor A&E performance. I think that NHS England has completely lost the plot when it comes to understanding what is happening in the health service. I cannot think of a more hopeless response to the crisis than to come along and say, “We should fine hospitals”. I worry about this whole approach to fining. I say to the Minister that there are very limited signs that systems understand the winter problems and there is a real reluctance to get to grips with what needs to happen. This is a worry for the future which may not have much to do with the regulations, but my seeing the Minister here represents a good opportunity to raise them with him.

Does the Minister think that fines and targets can lead to some perverse incentives? Of course, it is right to issue targets, but I wonder whether the Minister might comment on a very interesting section of the Chief Medical Officer’s Report for 2013, published earlier this year, where she refers to the low number of instances of MRSA and C. diff. I do not think that there is any doubt that the targets that were set for the health service have been responsible for the focus that has led to this very welcome improvement. My understanding is that part of the response to this by the NHS has been to use antibiotics which should have been reserved for hard-to-treat infections. There is now real concern that the antibiotics that go with those hard-to-treat infections have been used rather widely, which is causing great problems in more general infection control. According to the CMO, while the typical, large, 1,000-bed acute NHS hospital has two to three MRSA bacteraemias per year and 50 to 60 C. diff cases, 400 to 500 bacteraemias involving Gram-negative bacteria can occur in a 1,000-bed-type hospital, 10% to 15% of them being due to strains resistance to those antibiotics for hard-to-treat infections. You can reach a point where individual targets become counterproductive because the focus of the NHS is simply on C. diff and MRSA and not on the wider infections which clearly need to be tackled as well.

Will the regulations lead to more specific targeting which can in turn lead to perverse incentives, or is a more sophisticated approach likely to be taken? It is clear that the Chief Medical Officer is concerned about the way in which some MRSA and C. diff targets are leading to perverse behaviours.

On Part 3, the rationale for each of the thresholds described for penalties, prices and licence changes has not been explained in relation to an evidence base. In other words, why are the thresholds where they are? What work has been done to suggest that those are the right thresholds? Of course, now they will only be tested post-implementation, but it would have been good to have seen a clearer review mechanism that enabled a sensible approach.

In respect of the mechanisms to lodge an objection to the pricing methodology, my understanding is that the Foundation Trust Network has stated throughout the development of the policy that the 51% threshold for an objection, together with the denominator comprising all tariff services, is too high a threshold to be met. Is the noble Earl prepared to look at this? That might be a reasonable approach for general objections to the general approach, but it is insufficiently sensitive to address sections of the tariff that may be inadequately compensated—cancer services, for example. The noble Earl will be aware that there were issues around the tariff for children’s services and women’s services. My reading of that is that if you were a specialist adviser your chances of reaching the 51% threshold would be very limited. Could this be looked at?

If my noble friend Lord Warner were here I am sure he would raise this. It is the question of what happens to non-foundation trusts. I know that Monitor is working closely with the NHS Trust Development Authority, but I would welcome clarity about what will happen to trusts outside Monitor’s remit to ensure that there is an even-handed approach across all providers in the sector. No one is more admiring of the work of Sir Peter Carr as chair of the NHS Trust Development Authority. The noble Earl knows that Sir Peter has held chairmanships under both Governments for many years. While he is a marvellous person, there is a fear that he will hold the chairmanship of the NHS Trust Development Authority for many years to come because of the issue about what on earth will happen to those non-foundation trusts that are clearly not going to reach FT status any time soon.

The noble Earl mentioned the Competition Commission.

--- Later in debate ---

[Earl Howe]

I take the noble Lord’s point about uncertainty and confusion that I know exists in certain parts of the health service as to what all this means. I can tell him that officials in the department have had some very productive discussions with both the OFT and the Competition Commission to ensure that their approach need not set unnecessary hares running as regards apprehensions that a purist competition-based approach will be taken by these bodies. I am satisfied that that will not happen. My advice is that the Competition Commission, in particular, has welcomed the input of departmental officials in terms of the factors that need to be brought into play when making a judgment on what is in the best interests of the health service and patients.

At the same time I am aware that a number of useful events and conversations took place within the health service itself when we clarified with providers the considerations that the OFT and the Competition Commission will look at in proposed mergers. We are ensuring that when proposals are made the benefits of mergers are clearly defined in terms that will resonate with the competition authorities. The noble Lord is right that we are in new territory in many senses, but I am optimistic that the system will work in the way that it should. It is certainly about looking at competition aspects but, more pertinently, looking at the criteria that I mentioned earlier, such as the public interest in the case of licence modifications, the test of appropriateness in pricing methodology, and in the case of mergers, the interests of patients in the health service. The OFT and the Competition Commission must take into account the benefits of a proposed reconfiguration if they consider it under the Enterprise Act 2002. I remind noble Lords that that is the governing Act, so in theory at least, we have been in this situation for more than 10 years. In doing so the competition authorities must consider whether those benefits would outweigh any substantial lessening of competition that they find.

The noble Lord asked about the tariff, and in particular, primary care. We agree that payment mechanisms need to be aligned to drive better outcomes and better value for patients. They also need to be responsive and flexible, for example to enable services to be provided in an integrated way. Monitor and NHS England will work together to move the tariff in this direction. They are best placed to do that given their different roles.

The noble Lord asked me what would happen if the tariff proved to be inadequate. We expect the tariff in future more closely to relate to the costs of providing particular services. If the price payable for a service would make it uneconomic for a provider to provide a service, Sections 124 and 125 of the 2012 Act provide for a process for local modifications of the price payable.

My advice is that NHS England and Monitor are working very well together in this regard. Guiding principles have been defined and six shared principles for pricing have been agreed: that the pricing mechanism should enable and promote improvements in care for patients and taxpayers; that it should enable efficient providers to earn appropriate reimbursement for their services; that it should have regard to sustain the NHS offer in the long run; that it should not preclude the delivery of the Secretary of State’s mandate for NHS England; that it should have regard to the principles of better regulation; and that it should support movement towards a fairer playing field for providers.

I hope that I have answered most if not all the questions, but I undertake to write to noble Lords if I have failed to do that.

[Baroness Finlay of Llandaff]

I seek a small point of clarification. I take the example of a Welsh provider that is providing services for Welsh patients and that is also licensed to provide for patients coming across from England. In the event of them being deemed not to meet the conditions and therefore a fine potentially being levied at 10%, would that be only 10% of the contract issued on behalf of the English patients? Two very different healthcare systems will be operating.

I realise that this is complex, but the two healthcare systems are becoming more divergent yet the population on the border has to access both sides, I am concerned that these are some of the things that need to be clarified. It is a detail, I know.

[Earl Howe]

My Lords, it would only be the turnover relating to English patients that would govern that particular equation.

Health: Diabetes

Baroness Finlay of Llandaff Excerpts

Wednesday 3rd July 2013 Lords Chamber

[Earl Howe]

I would be happy to meet the noble Lord. I am aware that the whole area of the cataract threshold and, perhaps more importantly, the interpretation of that threshold, is one that NHS England is now actively looking at to ensure greater consistency around the country.

I do not agree with the noble Lord’s interpretation of the screening figures. The UK countries, I believe, lead the world in the area of diabetes eye screening. This is the first time that a population-based screening programme has been introduced on such a large scale. The latest figures show that up to March 2013, 99% of people with diabetes who were eligible for screening were offered it in the previous 12 months.

[Baroness Finlay of Llandaff]

My Lords, given the importance of prevention, have the Government been monitoring the progress of access to insulin pumps for children with diabetes, in order to prevent eye problems later in life, given that they have better control with insulin pumps?

[Earl Howe]

My Lords, that tends to be a matter for provider trusts, working in conjunction with clinical commissioning groups. I am aware that there is concern about the variability of access to insulin pumps. Of course, they are not a universal remedy for every diabetic patient, but where they are appropriate they should be commissioned. If I can give the noble Baroness the latest information on that, once I have consulted NHS England, I would be happy to do so.

NHS: Accident and Emergency Units

Baroness Finlay of Llandaff Excerpts

Wednesday 19th June 2013 Lords Chamber

[Earl Howe]

My Lords, the noble Baroness is absolutely right. There is no doubt from Sir Bruce Keogh’s urgent and emergency care review, published this month, that attendance at an A&E department often reflects the lack of availability or the lack of awareness of alternative sources of help. Some patients may default to A&E departments when they are unsure about which service is most appropriate to their needs. That has to be addressed and is being addressed in Sir Bruce’s review. It will look at the entire system of emergency care and how we can make sure that it provides the right care, in the right place and at the right time.

[Baroness Finlay of Llandaff]

Will this review include an audit of the number of patients who are in A&E but cannot be sent back to their normal place of residence, whether that is their home or a care home, because of the lack of immediate transport and an absence of immediate referral systems to community services that could monitor and review the patient back in the community?

[Earl Howe]

My Lords, yes, the whole patient journey should be looked at, including the role of social care in making sure that patients who are not seriously ill but need care can be looked after in their own homes or in a suitable residential setting.

Health: Children's Heart Services

Baroness Finlay of Llandaff Excerpts

Wednesday 12th June 2013 Lords Chamber

[Earl Howe]

My Lords, I pay tribute to the work done in Newcastle in this extremely complex area of surgery. The noble Lord knows that hospital better than anyone in this House, and I understand the disappointment felt in Newcastle about this decision. Nevertheless, I would slightly qualify the comment that he made at the beginning. Although I agree that the decision must depend on outcomes and the quality of care, it must also bear in mind the sustainability of the service into the future. While we can recognise good care when we see it now, we must be sure that the service is capable of being sustained on that level into the future.

[Baroness Finlay of Llandaff]

Is the Minister able to tell us how many vacancies currently exist among highly specialised staff in children’s heart units and what NHS England is doing to monitor vacancies? During a time of uncertainty, when staff do not know what their future will be, recruitment problems can arise, and where vacancies occur at a very senior, highly specialised level, that in itself can threaten the quality of the service and indeed jeopardise long-term sustainability.

[Earl Howe]

I do not in fact have any statistics on vacancies, although if I can acquire them I shall certainly pass them on to the noble Baroness. However, the central point that she makes is of course right, and the second recommendation made by the IRP relates to the need to have sufficient staff in place to deliver a safe service. It says that patients should receive this service,

“from teams with at least four full-time consultant congenital heart surgeons and appropriate numbers of other specialist staff to sustain a comprehensive range of interventions, round the clock care”,

and, interestingly,

“training and research”.

I think that that sends a signal that will resonate with many noble Lords in the context of debates that we have had in the past about centres of excellence in the NHS.

Medicine: Experimental Drugs

Baroness Finlay of Llandaff Excerpts

Monday 10th June 2013 Lords Chamber

[Earl Howe]

My Lords, I agree with my noble friend, and it is one of the reasons why the NHS constitution contains a pledge to inform patients of research studies in which they may be eligible to participate if there is a promising new medicine in the pipeline.

[Baroness Finlay of Llandaff]

My Lords, in light of the proposed EU directive that is being led by MEP Glenis Willmott to facilitate clinical trials and the work done by Empower: Access to Medicine, led by Les Halpin, are the Government working with the Halpin protocol, which aims to overcome the legal barriers—real or perceived—to early access to, and development of, medicine in the UK?

[Earl Howe]

My Lords, the Medicine and Healthcare Products Regulatory Agency is at the forefront of the negotiations at European level to ensure that the new clinical trials regulation, which will replace the current directive, is much more conducive to companies directing their clinical trials towards Europe, in particular, we hope, the United Kingdom. This needs to happen. The trend over the past 10 years has been in the wrong direction and we want our own market share to increase; there are already signs that it is doing so.

Care Bill [HL]

Baroness Finlay of Llandaff Excerpts

Monday 10th June 2013 Lords Chamber

[Lord Sutherland of Houndwood]

My Lords, I very much support the intention behind the amendment. It points us where we should be going. It is evident that the way in which professionals are trained deeply affects how they carry out their duties for the rest of their lives. That is a sign of good education. The noble Lord, Lord Warner, has been pointing the direction in which health and social care will and must go. It is essential to lay down the basis so that professionals accept that it is the shape of things to come.

[Baroness Finlay of Llandaff]

My Lords, for many years in medicine, there has been a move to try to ensure training in the community, but its implementation has been woeful. It has not been instigated as rapidly as people have been campaigning for over many years. I hope that the Government will look favourably on the spirit behind the amendment, although, in an odd way, the wording may be a little too restrictive. It is a very important move to ensure that, as more patients are moved out to be cared for in the community, community services can deliver what they need. With very sick people in the community, a different skill set will be needed from that which is currently available.

[Baroness Wheeler]

My Lords, I support my noble friend Lord Warner’s amendment. There will of course be further debate on integration in the wider context of the Bill, but the amendment is important because it underlines that Health Education England must have the strategic overview and understanding of the workforce requirements across the boundaries of health and social care if it is to undertake its role effectively.

Our stakeholder meetings have shown that there is considerable concern among stakeholders on that issue. They want the links between HEE and the social care sector to be more explicit. The noble Earl’s reassurances last week in that regard concerning Clause 88 were helpful, and I look forward to hearing from him further on how HEE is to work with integrated care delivery. I hope that he will concede that my noble friend’s cross-reference in his amendment to Clause 85 is necessary, because it links the HEE’s duty in Clause 88 to have regard to promoting integration to its key role of ensuring that there are sufficient skilled healthcare workers available.

The Health Education England mandate acknowledges that the future needs of the NHS, public health and care system will require a greater emphasis on community, primary and integrated health and social care. HEE is essential in that. Staff must be trained and developed in the skills that are transferable between different care settings and in working in cross-disciplinary teams in a range of different health and support settings. It must also work closely with the social care sector by developing common standards and portable qualifications across the NHS, public health and social care systems. The local LETB role, linking up with the health and well-being boards, is particularly important in that respect.

It is worth briefly mentioning two recent reports on integration, both of which, among other things, reinforce how much awareness and understanding of each other’s roles must take place for integrated services to happen and to be delivered. The shared commitment statement under the National Collaboration for Integrated Care and Support was drawn up by an impressive mix of national partner organisations, including government departments, the HEE itself, regulatory bodies, the Association of Directors of Adult Social Services, National Voices and other stakeholder groups. It pledges to help,

“local organisations work towards providing more person-centred, coordinated care for their communities”.

There is not time to go into detail, but National Voices’ A Narrative for Person-centred Coordinated (“Integrated”) Care, which sets out what integrated care and support looks like from an individual perspective, for both the cared-for and for carers, is a powerful vision for the future. It underlines how closely staff across primary, community, NHS and social care will have to work if this is to be achieved. The section of the narrative on communication describes professionals talking to each other, and patients always knowing who is co-ordinating their care, always being informed about what is going on, and having one point of contact. This in itself would be nirvana to most patients, service users and carers.

The recently published Nuffield Trust report, Evaluation of the first year of the Inner North West London Integrated Care Pilot, looks at developing new forms of care planning for people with diabetes and people over the age of 75. It underlines the importance of staff having a high level of commitment to the pilot and to the care planning process in particular. Initial results show that work on care planning and multidisciplinary groups resulted in improved collaboration across the different parts of the local health and social care system.

On public health, the HEE mandate itself states:

“The health of people in England will only improve in line with other comparable developed countries when the entire NHS, public health and social care workforce genuinely understands how their services together can improve the public’s health”.

Does the Minister accept that the HEE mandate supports the case for the Bill to include an explicit reference on the overall strategic context?

HEE’s role is to provide national leadership for workforce training, planning and development, ensuring that we have skilled, committed staff in the right place, in the right specialities and numbers. We need to meet these challenges of the future and of the changing face of healthcare provision. How to ensure an integrated approach to education and training across the NHS, public health and social care is a very strategic issue. I hope that the Minister will reassure the House on this by responding positively to the amendment.

Care Bill [HL]

Baroness Finlay of Llandaff Excerpts

Tuesday 4th June 2013 Lords Chamber

[Lord Warner]

My Lords, I support these amendments. I will pick up the point made by my noble friend Lord Hunt about managers. The public sector needs all the quality management it can get and many of its problems rest on the fact that we do not have a cadre of managers to take many of our public services through the difficult years ahead. The NHS is no exception.

For too long—and my own party has been guilty of it in the past—we have dismissed managers as men, and indeed women, in grey suits who are dispensable. We have to give some strong messages to HEE that if the NHS is to develop and evolve and cope with the problems ahead, we need a strong cadre of managers and we have to develop them over time. It is not too early to start now because we have a real problem not just in staffing chief executives now but in staffing the next cadre of chief executives and the middle management and development programmes for that. The Government would do well to give some strong messages to HEE and possibly even consider strengthening the legislation on this issue because it would be a missed opportunity if we do not strengthen that body of people to help us run the NHS in the coming decades.

[Baroness Finlay of Llandaff]

My Lords, I will briefly add my support, particularly to the amendment in the names of the noble Lords, Lord Turnberg and Lord Patel. I will draw the House’s attention to the wording, that it is,

“expertise in medical education and training”

that is being asked for, not just medical education, and that the expertise in research is not tied to medicine.

I understand the arguments that HEE must not be too tied or have a board that is too rigid, but if it is to meet the enormous challenges that it faces—and it has come from many, many discussions—to be able to have questions asked at board level about education and training will be essential if we are to have a workforce that can adapt rapidly as new technologies and new ways of providing care come along. It will need to have people with expertise and understanding of the most efficient and effective ways to upskill the workforce in particular areas, because there are enormous unknown challenges ahead.

National Health Service (Procurement, Patient Choice and Competition) (No. 2) Regulations 2013

Baroness Finlay of Llandaff Excerpts

Wednesday 24th April 2013 Lords Chamber

Tonight is another opportunity for my noble friend, as he has done so often in the past, to give some comfort to those who are anxious about these proposals. I admire the diligence of the noble Lord, Lord Hunt, who so often scrutinises these regulations. This needs to happen, but I share some of the views expressed by my noble friend Lady Williams that there has been so much misinformation. These regulations have caused so much angst and worry, which has been a real pity and unnecessary. However, there is room for clarity and I think this is on its way. Some further guidance, too, is necessary to enable a proper understanding of the regulations. Perhaps my noble friend would comment on that.

[Baroness Finlay of Llandaff]

My Lords, the hour is late and many of us are extremely keen to hear from the Minister. He took a brave decision in withdrawing the original set of regulations, and now we have these laid before us. Many people have posed questions and I hope that he will address them all head-on in his summing up. The lead question that has been asked tonight is why there is a such disparity between the centre here and how it is interpreted out there. Therefore, what will the Government do to make sure that there is no panic about challenges, that this does not become a lawyers’ charter and that integration works in the best interests of patients? Clause 2 suggests that it should take precedence over Clause 5 and that integration is key, because it will secure the best services for patients today and those of tomorrow. We have education, research and training in the Act and these also need to be secured for long-term stability. I suggest that we now need to hear from the Minister.

[Baroness Jolly]

My Lords—

Health: Cardiology

Baroness Finlay of Llandaff Excerpts

Wednesday 6th March 2013 Lords Chamber

[Earl Howe]

My Lords, the noble Lord makes a very good point. Again, as the CVD outcomes strategy sets out, basic life-support skills could be more widely taught as part of volunteering programmes; for example, in schools and the workplace. I am aware that bystander CPR doubles survival rates yet is attempted in only 20% to 30% of cases. There is scope for all emergency service personnel to be trained in CPR, and for basic life-support skills to be taught more widely.

[Baroness Finlay of Llandaff]

Are departmental advisers working with the new chief coroner, whose appointment has been widely welcomed, to ensure that there are minimum standards at post-mortem, so that when a young person has had a sudden cardiac death the risk to other family members can be appropriately identified? It is important that specimens from the heart of a deceased young person are not lost because the post-mortem has not been done to a high enough standard.

[Earl Howe]

The noble Baroness makes a very important point. My department supported the formation of the UK Cardiac Pathology Network in 2006 to provide local coroners with an expert cardiac pathology service and to promote best pathological practice in sudden death cases. A national database on sudden arrhythmic death was launched in November 2008, allowing pathologists to record information on cases referred to them. In the longer term this could be very helpful in building a deeper understanding of the problem.

Health: Medical Innovation

Baroness Finlay of Llandaff Excerpts

Wednesday 16th January 2013 Lords Chamber

[Baroness Finlay of Llandaff]

My Lords, I, too, congratulate the noble Lord, Lord Saatchi, for having described, in a very moving and clear speech, the reality and the horror for patients of illness and treatment, and the difficulty that many patients and their families face while in the shock of realising that life is not as they hoped it would be and has changed in an instant.

The noble Lord, Lord Saatchi, has highlighted the push and pull of the dilemma of innovation in medicine. We have a push from research councils to innovate; we have a push in academic medicine, principally in secondary care in specialist services, to innovate, to think and to instigate new trials; and we have a push from industry to come up with developments. However, we have a pull, which is a risk-averse system that is frightened of taking the decision to go with something that looks as if it might be high-risk or to go with the unknown. It is that tension between the push and pull that I think we are caught in the middle of today. Perhaps this debate is really timely, because we need to think about how we should handle that.

I was involved in some of the early trials to which the noble Lord, Lord Willis, referred, of children with leukaemia. I remember some of the children who were in the arms of the failing drugs; I remember them as if it were yesterday. I can see in my mind’s eye the room and the face of the child who then died and having to talk to those parents. However, it was through those trials, through every child taking part, that the face of childhood leukaemia has completely changed. I sincerely say, thank God that it has, because there was a terrible toll before those trials were properly instigated.

Another problem for patients, when they are faced with a disease for which there does not seem to be a conventional treatment on offer, is that in desperation they go off and try to find their own treatment and therapy. It is worth remembering that about half, or possibly more than half, of patients with malignant disease of any type seek help and treatments outside of conventional medicine, going for complementary or alternative medicine—often taking treatments for which there is no evaluation. Some years ago, it was a great difficulty for my team to cope with people who were coming in and saying that they were taking shark’s fin. The ecological disaster, the cruelty to sharks and the total lack of evidence of any efficacy made us come up with a form of words that we could use to dissuade patients from ever even thinking along those lines and discuss with them their use of alternative therapies or medicines. Some things that they pinned great hope on really had no benefit.

I also congratulate the noble Lord, Lord Saatchi, on having focused our minds on the patient in the context of themselves as a person and their whole family. He put me in mind of a patient I had at one time who was in exactly that situation. She was a young woman with a rare disease who was clearly dying. We discovered that her children had been fundraising at the school gate for a treatment that they had found on the internet. This treatment had been shipped over from America and she wanted it given to her. There was no evidence base that I could find for it, and I discussed it at length with her and her family, documenting everything—pages and pages of documentation of those conversations. She knew she was dying but she wanted to try it because she knew that her family could live afterwards if she tried it; but if she had not done so, they would not have been able to. Therefore, I undertook to take the whole responsibility on myself for administering it, equipped myself with drugs for every adverse event that might occur, and gave her one dose. There was no adverse effect but there was no benefit either, but after her death her children, who had fund-raised at the school gate, were able to cope better and were glad that she had at least tried it.

We have a system in medicine called the N of 1 trial, which is underused and should be used, particularly where we have rare conditions and genetic disorders, and where we could document and should be documenting what we do. There is a problem, though, for those who instigate such trials in getting them published. I would like to address the publication difficulty in my closing remarks—the difficulty of pooling all the little bits of information that can come from different aspects of medicine.

I think that the N of 1 trial will have an increasing place as we get further into rare genetic conditions and personalised medicine, but the NHS, with its push to embrace research as a core component, is going to have to look at a kind of buffer zone for funding the additional bits of work that need to go along with doing that properly. We also need to have good publication of negative results and we need to publish all the results, including all the adverse effects, when trials fail. Unless all of those emerge, we really will not know the full picture and what we are dealing with.

I make a plea that in this push-pull with which we are faced in medical innovation, there is a real push to have a repository for the results of some of these N of 1-type studies, and a repository for negative results and those that are currently going unpublished.