Local Authorities (Public Health Functions and Entry to Premises by Local Healthwatch Representatives) (Amendment) Regulations 2017

Lord Hunt of Kings Heath Excerpts

Thursday 30th March 2017 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am very grateful to the Minister for explaining the intent of this statutory instrument. The Opposition supported the transfer of public health functions from the NHS to local government, including those for children from birth until the age of five in public health services. Indeed, that was the only bit of a lamentable Act of 2012 that we did support. We also support the provision of a universal health visiting service and the prescribed reviews, which are elements of the healthy child programme. The noble Lord has said that this decision was supported by the outcome of the PHE review, and I would like to come back to that.

I want first to refer him to the question of resources. He mentioned the changes in local government funding but he will be aware that, overall, the Government’s record in funding public health services has been lamentable. In February 2017, the Department of Health told local authorities that an average 3.9% real terms cut to health service budgets per annum would take place until 2020. This is a large reduction, as it accumulates. According to the King’s Fund, which has done an analysis of the impact that has had, as a result of these reductions stop-smoking services and interventions have lost 25% between 2015-16 and 2016-17, while other areas such as the health check programmes and sexual health services lost 7% to 14% of their funding. As the Local Government Association said, given that the Government issued a firm commitment to the NHS five-year forward view, with prevention put very much at its heart, to then make significant cuts to the public health service budget over the next five years sends entirely the wrong message and could undermine the objectives that we all share to improve the public’s health and keep pressure off the NHS and adult social care.

Recent work by the King’s Fund on sustainability and transformation plans—an Orwellian phrase, if ever there was one—points out that what is actually happening on the ground is going in the opposite direction to that which was set out in this plan. It is the same in public health. I would therefore like the Minister to explain a little more about how the Government justify the reductions in funding for public health services.

I refer the Minister to table 29 on page 58 of the report by Public Health England. It is a summary of written feedback from professional representative and membership organisations. Comments were made by the Society of Local Authority Chief Executives on the issue of the mandation of services, about which clearly local authorities have some reservations. It suggests that the Government collect and review all mandated public health services next year, including health visiting, when the overall position on local government funding and business rate reforms is clearer. In a sense, the Local Government Association has made the same request. Will the Minister inform the House whether the Government are going to respond to that?

On the outcome of services so far and the PHE review, it says that there was a statistically significant increase in the eligible population reach by a universal service during 2015-16. It states also that, largely, there is a positive national picture of progress with statistically significant improvement observed in many relevant outcomes over the lifetime of the national health visiting programme. However, it points to some large local variation and trends in the rates of breastfeeding, which it says are disappointing. It points also to the fall in the number of health visitors in employment in 2015-16. Will the Minister comment on the issue of disappointing rates of breastfeeding on the one hand and the fall in the number of health visitors on the other? What action do the Government intend to take on that?

[Baroness Walmsley (LD)]

My Lords, I am delighted to support these regulations because I am an enormous fan of a universal health visitor service, and in particular the healthy child programme. Our economy is never going to keep up with the demand for health services unless we pay more attention to the issue of prevention. That really is the public health agenda. Any doctor will tell you that you really must lay the foundations for a healthy body, lifestyle and habits in the early years or you will get illnesses later on. The review of the programme so far has been very positive. As the noble Lord, Lord Hunt, said, there have been significant improvements in the populations reached. However, we will not see the true benefit of this programme until we are years down the track and find that those young children who have been given a healthy foundation grow up to have fewer of the terrible but preventable chronic diseases that are costing the country so much.

I am very proud of the coalition Government’s vision of improving the health outcomes of children, young people and their families. Transferring the responsibility to local authorities was part of that: it gives them the chance to combine services, right up to the age of 19. However, as the noble Lord, Lord Hunt, said, there are serious questions to be asked. The first, of course, is about resources. Although these services are mandated, and although the Minister may say that the money has been ring-fenced, budgets have been cut and are going to be further cut. Local authority councillor friends of mine tell me that it is getting more and more difficult for local authorities to provide even those services which they are mandated to provide because things are getting so tight financially. I hope the Minister can give us some encouragement on that, although I somehow doubt it.

The other question on resources is about people. We have heard from the Minister about the number of health visitors in training. Are they going to be enough to serve rising demand? We have a rising population and a lot of additional young people and families who require services. A universal service is terribly important because you do not just get health problems among the most deprived. However, there is a great deal of poverty in this country and the need for these services is growing. How confident is the Minister that we will have enough sufficiently trained nurses, given the stresses on all health service staff and given that so many people are leaving and retention is getting more difficult? Are we going to have enough people?

Are there any plans to extend these services a little further up the age range? I am particularly concerned about the large number of children who are starting school between the ages of four and five already overweight, obese or with poor eating habits. So, although the healthy child programme and the reviews that are mandated here in these regulations go up to the final check at two to two and a half years, it is really important that we do it again just before the child goes to school, because at that point they are already at a disadvantage. Many of these children are from a disadvantaged background and sadly these problems occur more frequently in those backgrounds. They get to school and they are already developmentally a good deal behind children from more advantaged backgrounds. I think the proof that we have had over the few years that this programme has been in place is sufficiently convincing to tell us that perhaps we ought to extend it a little bit further.

Alcohol Abuse

Lord Hunt of Kings Heath Excerpts

Thursday 30th March 2017 Grand Committee

[Lord Hunt of Kings Heath (Lab)]

My Lords, I welcome the debate. My noble friend made a very powerful statement about the major challenge that we face over alcohol abuse and the knock-on impact on the National Health Service. He opened by asking for an honest debate about funding. The report of the Select Committee of the noble Lord, Lord Patel, will be issued on Wednesday, and I hope that it will lead to an open debate. However, no one can be in any doubt about the seriousness of this situation for the NHS. This morning, the chief executive of the NHS Confederation said that there now has to be a trade-off between, for instance, fast, efficient emergency care and non-elective surgery. That shows the state that we have got to. Clearly, the impact of alcohol abuse on the NHS is significant.

My noble friend’s speech was particularly persuasive in relation to low prices. Public Health England produced a very good report on the public health burden of alcohol and the cost-effectiveness of alcohol control policies. That report had a lot of good things to say. The noble Baroness, Lady Walmsley, has already referred to the £20 billion a year cost to our society in relation to criminal justice, the economy and the health service. In addition, there is the fact that we now have over 1 million alcohol-related hospital admissions per year, and the kind of pressure it puts on the health service and the emergency services, as the noble Lord, Lord Smith, referred to. PHE points out that the average age at death of those who die from alcohol-specific causes is 54.3 years, compared to 77.6 years for death from all causes. The other very striking statistic is that more working years of life were lost in England as a result of alcohol-related deaths than from cancers of the lung, bronchus, trachea, colon, rectum, brain, pancreas, skin, ovary, kidney, stomach, bladder and prostate combined. Therefore, the scale of this disease, as we need to call it, is very striking indeed.

My noble friend obviously did not dwell much on taxation and price regulation, because he covered a much wider canvas. However, the analysis by Public Health England said:

“Implementing a minimum unit price is a highly targeted measure which ensures any resulting price increases are passed on to the consumer, improving the health of the heaviest drinkers”,


is surely right. As PHE points out:

“The MUP measure has a negligible impact on moderate drinkers”—


who we do not want to undermine—

“and the on-trade”.

I hope that the Minister will be able to say something about where the Government are on the MUP.

I pick up the point raised by my noble friend and the noble Baroness, Lady Walmsley, on labelling. Post Brexit what the Government do about labelling will be entirely in their hands. As the Minister is responsible for the Department of Health’s response to Brexit, can he say what work is now being done by either his department or Public Health England to look at what the Government are going to do when they have control over labelling? Potentially, we could be much more effective than current EU regulations allow us to be.

Finally, I acknowledge a very good briefing that I had from the British Medical Association on this issue. It has set out a number of requests—principally, that the Government should:

“Publish a new updated alcohol strategy”.


Will the Minister agree to do that? It mentions minimum unit pricing and reducing,

“the affordability of alcohol through taxation measures”.

It makes an important point about ensuring that health,

“is a key factor in licensing decisions”.

I know that we will receive a Select Committee report on the implications of the big change in licensing 10 or 12 years ago. However, this obviously needs to be considered very carefully. The BMA also goes on to ask for an implementation of,

“evidence-based measures to reduce drink driving levels”,

and,

“a range of measures to reduce and better manage pregnancies affected by alcohol”,

and makes a number of other requests. At heart, there is a request to the Government to take stock of the pressures that we face, update the current alcohol strategy and take some courage in their hands and be prepared to move on from the rather insipid voluntary approach that we have to a tougher approach, in which they must look at taxation and a minimum unit pricing policy.

Nursing and Midwifery (Amendment) Order 2017

Lord Hunt of Kings Heath Excerpts

Tuesday 28th February 2017 Lords Chamber

Moved by

[Lord Hunt of Kings Heath]

At end insert “but that this House regrets that the draft order abolishes the statutory midwifery committee; and calls on Her Majesty’s Government to ensure that robust arrangements are in place to ensure the continuation of supportive clinical supervision and leadership for midwives.”

[Lord Hunt of Kings Heath (Lab)]

My Lords, I thank the Minister for introducing the order.

It is fair to say that we debate midwifery regulation at a time of great challenge for the profession. I was looking recently at the fifth State of Maternity Services Report, produced by the Royal College of Midwives, which shows so clearly that we are in the eye of a perfect storm: the number of births is going up; there are fewer births to younger women and more to older women, which puts extra pressure on services; and we need more midwives.

We also need more midwives because of the age profile of the profession and the attrition rate of newly qualified midwives. One in three midwives are in their 50s and 60s. Even though, as the Minister has said, the number of training places is going up, the RCM estimates that the net annual increase at the moment is only about 100 midwives per annum. The RCM argues that, to deal with this, the NHS needs to do much more to retain existing staff and ensure that newly qualified midwives are employed quickly.

I very much share the Minister’s view that it is important we have an effective regulatory system alongside effective supervision of the profession, with clear and visible leadership at local, regional and national levels, but this is at the heart of my concerns about the order. The Minister explained very well the background to the order and the various reviews emanating from the serious incidents in Morecambe Bay. The NMC subsequently commissioned advice from the King’s Fund, which took as its basis that midwifery is regulated differently from other healthcare professions. The King’s Fund also undertook a review, to which information provided by the overseeing Professional Standards Authority cited,

“a lack of evidence to suggest that the risks posed by contemporary midwifery require an additional tier of regulation”—

that is, the supervisors—

“bringing into question the proportionality of the current system when compared to that operating for other professions”.

The PSA also stated that,

“the imposition of regulatory sanctions or prohibitions by one midwife on another without lay scrutiny is counter to principles of good regulation in the post-Shipman era”.

As the Minister has said, the core recommendation arising from that work of the King’s Fund was that,

“The NMC as the health care professional regulator should have direct responsibility and accountability solely for the core functions of regulation. The legislation pertaining to the NMC should be revised to reflect this. This means that the additional layer of regulation currently in place for midwives and the extended role for the NMC over statutory supervision should end”.


As we have heard, the NMC has accepted that core recommendation, which is reflected in the order before us.

I understand clearly the logic behind the recommendation and the order that we have tonight, but I think it is worth looking in detail at the King’s Fund report. It acknowledged that, if you removed the supervisory role and restricted the role of the NMC to purely that of a regulator—which I do not disagree with—you would leave a gap. As the King’s Fund said,

“While clearly valued and of benefit to midwives, the functions of support and development, leadership of the profession and strategic clinical leadership are not the role of the regulator. We believe that others in the health care system should take on responsibility for ensuring these functions continue”.


The report laid out a number of options and acknowledged that this was not guaranteed. It therefore recommended that the Department of Health,

“should consider how best to ensure access to ongoing supervision and support for midwives … Organisations providing maternity care should consider how they will continue to provide access for service users to discuss aspects of their care … NHS England … should assure themselves that they have adequate facility for accessing strategic input from the midwifery profession into the development of maternity services”.

Essentially, the point of my regret Motion is to ask the Minister to spell out exactly what progress is being made—

[Lord Willis of Knaresborough (LD)]

The noble Lord has raised an incredibly important point. Would he accept that the department, and indeed NHS England, together with the regulator, have moved very quickly to have the chief nursing officers from the four countries charged with the responsibilities, which quite rightly they should have, for actually putting in place adequate supervisory arrangements in order to support the midwives? Does he not feel that that is sufficient? If not, what else could be done?

[Lord Hunt of Kings Heath]

I am very grateful to the noble Lord for his intervention. I fully accept the point he raises. The noble Lord knows a very great deal about nursing and midwifery, and has done some very valuable work in this area, but he mentioned the word “nursing”. He will know that there is an issue about how midwifery leadership is undertaken under the banner of nurses. That is really what I want to come to, but I think his point is very valid.

I am not suggesting that the Government—essentially, we are talking about four government departments—have not looked into this issue, but there are some issues about the visibility of professional leadership of the midwifery profession which I worry about. We know that midwives are subsumed under nursing leadership, and that has some consequences when it comes to priorities and resources. It is also worth saying to the noble Lord that, of course, often these directors can be described as directors of nursing and midwifery, but to get to a director level in the NHS, even at NHS trust level, midwives have to become directors of nursing and therefore they need a nursing qualification. My understanding is that only 30% of midwives are also nurses, so there is almost a glass ceiling for many members of the midwifery profession.

--- Later in debate ---

[Lord Willis of Knaresborough]

I enjoy this better than listening to great long tirades. Is the noble Lord not pointing to a system failure in our health service? Is he not falling into the trap of saying that, unless you have a protected silo, you cannot have an adequate voice? Surely, given his own thinking in Birmingham, which has been quite outstanding, and given what is happening in Manchester, we are looking at health economies where we are putting together groups of professionals working as teams, rather than perpetuating the idea that, unless we have a silo, we cannot move forward.

[Lord Hunt of Kings Heath]

My Lords, I understand where the noble Lord is coming from. I would never want to propose a situation of a silo, but there are instances where it is necessary to give—I do not think that “protection” is exactly the word—some kind of underlining to the importance of a particular profession. The noble Baroness, Lady Cumberlege, is here, and it seems to me that the fact that she had to undertake a review recently is a visible sign of the problems that we have had in getting midwifery issues to the top of the table. I am not seeking to create a whole hierarchy of new directors at a cost of money and to silo it, but I think that we have some problems at the moment.

This issue was raised in the other place when the order was debated there. I actually think there is a case for there to be a chief midwifery officer at government level. In the other place, the Minister said that the Government consider that,

“the chief nursing officer is the professional lead for both nursing and midwifery and we intend that to continue. That role is supported by the head of maternity in NHS England, which will continue to be the case. … There will be a regional maternity lead and a deputy regional maternity lead in each of the four NHS England regions”.—[Official Report, Commons, Delegated Legislation Committee, 22/2/17; cols. 9-10.]

I must say that I do not like the term “maternity lead”, as it seems to understate and undermine the position. I know that you cannot say that everything is in the title, but “maternity lead” to me means a lower status—it is quite clear to me that you use “maternity lead” to indicate a lower status.

Let me be clear that the current head of midwifery in NHS England is a distinguished and highly respected midwife—there is no question about that—but I think that there is a problem. What does “head of midwifery” mean? Why do we not use the word “director”? There is an issue about authority and status. At the end of the day, as I understand it, the head of midwifery is the head of the profession in England, and I think that NHS England should recognise that in that person’s title and position.

It is very important that midwives as a whole look to the chief midwife for that essential professional leadership. It is clear from what the NMC has said, and from the order before us, that the NMC cannot provide that professional leadership. It is there to regulate, so we need strong professional leadership. I hope that the Minister will give this some further consideration. I am not seeking to create a whole new edifice; I am concerned about the voice of midwifery not being heard at the highest level.

That brings me to the proposed abolition of the midwifery committee. Again, I am the last person to believe that, if you have a committee, everything is well. Of course, I understand entirely why the NMC does not like the statutory midwifery committee. I completely get that; no chief executive of any body ever likes to have a statutory committee, particularly if the other bits of the area that it regulates do not have one. We all understand that, but you have to look at the fact that the NMC currently has 640,000 nurses on its register and 40,000 midwives. Inevitably, issues to do with nursing are bound to dominate the NMC consideration. So the benefit of having a statutory committee is again to give some kind of protection and recognition that midwifery needs to have some consideration within this very large regulatory body.

As a result of discussions, for which I am grateful, the NMC has given various assurances about the strategic midwifery panel and the number of advisers that will be appointed. Can the Minister ensure that Parliament is kept informed of the work of the NMC and, in particular, about how it will ensure that it is fully apprised of midwifery matters by the new arrangements? He said earlier that the NMC would keep these matters under review—and I think that he referred to the new disciplinary procedures—but I took that to mean these arrangements in general. “Under review” falls within governance and quango-land; it is not really a high status. Could he ensure that, at the very least, the NMC reports to Parliament on a regular basis on how it ensures that midwifery issues are fully heard by the council?

In conclusion, in moving this amendment I do not seek to criticise the NMC. I believe that the current chief executive inherited a mammoth challenge. I have been impressed by the progress that she has made, but the distinctive role of midwifery should be recognised, particularly at a time of extreme pressure on the profession. It is important that we do not dissipate its voice. I would welcome some reassurance from the Minister. I beg to move.

[Baroness Walmsley (LD)]

My Lords, midwives have a very special role in the local medical and nursing team. They should be seen as an integral part of that team; their role should not necessarily end at the point of birth. I know from many cases that the personal relationship built up between a mother and her designated midwife during the antenatal period can be enormously valuable at a time when she is very vulnerable. The mother often has the confidence to confide in the midwife if she has any health or personal security worries. I am talking here about domestic abuse, which so often occurs when a woman is pregnant. It is important that this relationship is nurtured and nothing gets in the way of a midwife adding all the value of which she or he is capable. I would hope that in future there would be more integration between the midwife, the health visitor and the district nurse. There is a lot of potential for that.

No debate about midwives and nurses is complete without talking about numbers. The noble Lord, Lord Hunt, mentioned rates of attrition. A couple of weeks ago, at Oral Questions, I asked the Minister how data are collected on the rate of attrition. It is not consistent. It makes it very difficult to know which areas of the country are good at keeping their midwives and nurses and which are not, so that we can see and spread best practice.

We have an enormous number of nurses from EU countries and, indeed, from other parts of the world. Brexit is looming and there is uncertainty—which we debated in this House yesterday and on other occasions—over the status of people from other EU countries working here. At the same time, we have a Government who are trying to reduce their immigration rates to a maximum of 100,000 a year, which could affect midwives coming from countries outside the EU. This is a big concern and we must not ignore it when we are talking about regulation.

I turn to the order before us and the amendment in the name of the noble Lord, Lord Hunt. We on these Benches are broadly supportive of the order, which will bring more flexibility into the regulation of nurses and midwives, in line with the way in which the GMC and other medical regulators are able to carry out their fitness-to-practise processes. It is right that the regulator should be able to deal more proportionately with cases where there is a finding of “no case to answer” and where the person concerned accepts that the practice in that case falls short of what should be expected. There is currently no power for examiners to consider alternative ways of resolving these cases. However, the Secondary Legislation Scrutiny Committee raised some questions about the new power to issue a warning. It accepted that this power is permissive but felt that, if examiners are to use the power to give a warning, and guidance is intended to direct users as to how terms should be interpreted, then the detail of the threshold for issuing a warning should either be in statutory guidance or in the order. What is the Government’s response to the committee’s suggestion?

Turning to the role of midwives in the governance of the NMC, it is important that the particular role of midwives is both recognised and catered for. However, if you are taking away the role of development support and supervision, and separating it from regulation, you do not necessarily need the existing structure of the midwifery committee. It is important and right that regulation and supervision are separated. I understand that there is to be a new midwifery panel which should be consulted and that supervision is to be replaced by new support and supervision structures in the four countries of the UK. There is also to be a new senior midwifery adviser. I take the point of the noble Lord, Lord Hunt, about status, which is important, particularly to the morale of the midwifery profession. Concerns have been raised that the new structures for support and supervision will not be ready in time for the changes at the end of March. I understand that, of the four nations, only Wales is ready to take over. What can the Minister tell us about the state of readiness of the other three nations?

I recognise that the new structures that the Government are proposing present a challenge to the midwifery profession. This is right, in response to the reviews discussed earlier. There are concerns that the new structures within the NMC cannot, for example, put midwifery matters on the council’s agenda. Can the Minister assure us that specific midwifery issues will be appropriately dealt with under the new structures?

The effectiveness of the proposed new structures will take a while to be demonstrated, so it is right that we seek these reassurances at the outset. In the end, patient safety must be at the forefront and that depends on the quality of development, training and supervision of the midwives. It is a challenge for the profession, and it is only right that we give midwives the opportunity to demonstrate that they can rise to that challenge. However, it is right that the powers and structures of the regulator are up to date and able to cope with the workload in an appropriate manner at a time when, as the noble Lord, Lord Hunt, said, the demand is rising.

--- Later in debate ---

[Lord O'Shaughnessy]

I thank noble Lords for an extremely high-quality and very well-informed debate on both this order and the amendment. I will do my best to deal with the many questions and important issues that were raised by noble Lords.

First, I welcome the welcome that this order has broadly received. As the noble Lord, Lord Willis, pointed out, the separation of the professional interest and regulatory functions is best practice; that is how we expect regulation to take place these days. Unfortunately, in Morecambe Bay that lack of separation was one of the contributing factors, and that obviously has been a spur to change. I also welcome the words of support for the fitness-to-practise changes, which I think will bring in a quicker, more flexible and more proportionate system.

I turn to some of the points made by the noble Lord, Lord Hunt. There is undoubtedly an issue about the workforce, as he pointed out. There has been an increase in the number of births, and more is being done both to recruit existing staff and to retain them. But at the heart of this are three issues. The first is the point about silos versus integrated care. Of course we all want integrated care; that is the direction of travel. At the same time, necessary changes are taking place to the regulatory structure to deliver the kind of separation and clarity that we also want to happen. The concern being raised is whether, in doing so, we will in some way change the status of the profession, if you like—not intentionally, but by virtue of the removal of various statutory arrangements and so on. I can understand why some might draw that conclusion, but it is clearly not the intention of what is happening here, and I hope to set out a few reasons why that is the case.

The proposed changes do not alter the status of midwifery as a distinct profession with its own standards. There will be no change to the protected title of midwife, and delivering a baby remains a protected function for a midwife or medical practitioner; it is incredibly important to set that out at the beginning. As the noble Lord, Lord Hunt, pointed out, there are various tiers of representation, if you like, below Chief Nursing Officer: head of maternity, NHS England regional heads, deputy heads and so on. I do not know the specific reason why that is called maternity, not midwifery. I imagine that it might be because of integrated care and because, although it might have midwifery as the major focus of it, it might also involve other aspects of the birthing arrangements. I shall certainly endeavour to find out and write to the noble Lord about it.

The other issues were around whether the profession is getting the attention and respect that it deserves and indeed is properly represented at the right levels and in the right bodies. There is a midwife on the NMC. That is not a statutory requirement but the council ensures that it happens. It is also fair to say that we have a Secretary of State who is taking the issue of maternity safety incredibly seriously. I mentioned the national ambition, but we also had the publication of Safer Maternity Care in October and I will come on to some of the issues raised by my noble friend Lady Cumberlege as well. A lot is going on to support the profession.

One important part of that is making sure that this new supervisory function takes place properly and replaces statutory supervision. I quite understand why noble Lords will be concerned that that should take place. While on the one hand we have all agreed that the separation of regulation and supervision needs to happen and that the order creates greater clarity, there must be something to replace the supervisory arrangements that we agree need to change.

I reassure noble Lords that the four countries in the UK have been working together since 2015 to take account of the new employer-led models of supervision. In England, the NHS has evaluated the model in seven pilot sites to inform the model and its implementation, and there has been an education programme. Those pilots began last November and will complete in March, so they are informing the arrangements that go on in England. In the other countries, systemic reviews of the new system are taking place, on slightly different timeframes in different countries. But I reassure noble Lords that that will be happening. Not only is there preparation for the new system, there will be reviews into its effectiveness. Given all the points noble Lords have made about our experiences in Morecambe Bay and elsewhere, it is clearly essential that that happens.

A reasonable question was asked by the noble Baroness, Lady Walmsley, and my noble friend Lady Cumberlege about whether midwifery issues would be properly dealt with by the NMC and whether it has the capacity to do so, given its past problems. It received a much more positive performance review from the Professional Standards Authority, which found improvements down the line. Clearly, there is still one outstanding issue resulting from Morecambe Bay, but it is now an improved regulator and we can have confidence that it will do the kind of job that we now ask it to do.

My noble friend Lady Cumberlege raised the issue of the right level of insurance for independent midwives. I know that is incredibly important for maternal choice. Insurance is clearly a hot topic at the moment, but I will certainly write to her and find out exactly what the regulator is doing to give proper guidance, because that must happen. She is quite right to raise the example of Sweden. We know that there is a lot more to be done to improve maternity services in this country. Change is going on. My noble friend also mentioned the consultation going on with regard to regulatory redress. There needs to be a change of culture so that it is less adversarial and less litigious, and designed to increase learning and bring that to bear much more quickly on the process. We are undertaking that set of reforms and I pay huge tribute to her for her work in making that happen. My noble friend asked a set of other questions and I will certainly write to her so that I can answer her properly if I have not done so in the answers I have given already.

I end by paying tribute to the profession itself. The noble Lord, Lord Willis, made an excellent point, which goes beyond the scope of the order but is important. There is more that midwives can—indeed, must—do if we are to have a properly integrated system. We all want a healthcare system that, in the end, involves a personalised pathway. Whatever your experience, whether you are an older person, a young person, a mother or whatever, you can have someone by your side, leading you through that experience. Clearly, many pregnant women will want that to be a midwife, so I absolutely take the point about integrating with health visitors and many others besides. I hope changes are going on. That is perhaps not a subject for debate tonight but for another time. On that basis, I ask the noble Lord, Lord Hunt, to withdraw his amendment.

[Lord Hunt of Kings Heath]

My Lords, I am very grateful to the Minister. I totally agree with the noble Baroness, Lady Walmsley, about the importance of the midwife being an integral part of the team. The noble Lord, Lord Willis, is right, as is the Minister, that one of the lessons of Morecambe Bay is the problem of different professions being completely unable to relate and talk to each other. Frankly, this is an issue that the health service suffers from and the Minister is right that, in a sense, it could be argued that the NMC is putting forward a more integrated approach to regulation. The risk is that, because of the disparity between the number of nurses and midwives—and we have often seen this before—integration could mean the marginalisation of certain people. This is the risk that we need to guard against—the unintended consequence.

The Minister has given a very good assurance that this matter will be kept under clear review; he emphasised that this would be a proper review and I very much welcome that. However, I still believe that, in the end, the answer to the question that he posed—“Are midwives around the right table?”—is that the experience of the health service is that they are never around the table at all. This is the problem. Whether the meetings are at board level of an English NHS trust, at the top level of the senior management team of a regional office of NHS Executive, at the NHS Executive itself, or at the department, they are never there. The big problem of how we get midwifery input at those top levels is one that we are still struggling with.

It is ironic that, having debated only two weeks ago the need for an approach to health regulation that covers all professions, we are now debating one profession. The noble Baroness, Lady Cumberlege, is absolutely right about this. I am indebted to the barrister Kenneth Hamer from Henderson Chambers who wrote to me after our last debate to point out that the Supreme Court is now using the Law Commission’s work on regulation to inform its own judgments. If there is any argument for the Government to produce a Bill in relation to unified health regulation very quickly, that is it.

On the loss of the midwifery supervisor, everyone agrees that the regulatory function needs to be separated off, and it is absolutely right that that is what the NMC should be concerned with. But there is concern about the loss of the supervisor at the local level. For me, the issue is safety. We know that NHS trusts are coming under huge pressure in relation to staffing levels from NHS Improvement because of pressure to reduce the deficit. The question, which I pose rhetorically, is who, given this pressure and given that midwifery does not have a voice at the board table, is going to defend the safety of the profession in terms of numbers when it comes to kind of hard decisions that are going to be made? That is my concern and frankly it has not been answered.

On the NMC’s performance, I remain of the view that the current chief executive has done a very good job trying to deal with the huge problems that she inherited. I hope that, whatever review is undertaken, it will not destabilise the NMC and that she will be given the time she needs to continue to make improvements.

The Minister said that he would exchange letters on the issue of independent midwives. I hope he will agree to go a little bit further and discuss this matter with his noble friend and the NMC. This issue has now been around for years, but it could clearly be sorted. A number of people are involved—the department, NHS England, the NMC and, I suspect, the NHS Litigation Authority—but if Ministers banged their heads together this would be sorted; that needs to happen. Frankly, even post the calamity of the 2012 Act, which has created such a discordant structure, Ministers can, in the end, determine something to happen here. That is what we need.

There is no question about it: I am not interested in silo professional behaviour or in whether a statutory committee is the right way to go forward. But I am convinced that the voice of midwifery needs to be heard at the highest level. I hope that this excellent debate—I am grateful to the Minister, too, for his response—has been helpful in just making that point. I shall not press my amendment to the Motion.

Amendment to the Motion withdrawn.

Tobacco Control Plan

Lord Hunt of Kings Heath Excerpts

Thursday 23rd February 2017 Lords Chamber

[Lord O’Shaughnessy]

My noble friend makes an excellent point. Indeed, the Royal College of Surgeons of Edinburgh has just started a campaign to encourage clinicians to help their patients to stop smoking, and making sure that that happens is clearly going to have benefits for the kind of major surgery that some of the people who are suffering severe effects of smoking will need to have.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I noted that the Minister said the tobacco control plan will be published shortly and that it was in an advanced state of preparation. That was the same answer that his honourable friend the Public Health Minister gave in another place on 15 November 2016. The last tobacco control plan actually ran out at the end of 2015, so the new one is 14 months late. When exactly will it be published, and what has been the delay? Could the reason have been the decimation of the public health budget for local authorities, which has had a devastating effect, with reductions in preventive programmes at a local level?

[Lord O'Shaughnessy]

I understand the frustration at the delay in publishing the plan. That does not mean that action has not been taking place: all the action set in train under the previous plan has been taking place throughout that period. As I said, the new plan will be published shortly. I look to my noble friend Lord Ahmad, who has given several master classes in the use of words to describe “shortly” in different ways. I will save a few of those for any future Questions and stick with “shortly” for now.

Health Service Medical Supplies (Costs) Bill

Lord Hunt of Kings Heath Excerpts

3rd reading (Minutes of Proceedings): House of Lords
Thursday 23rd February 2017 Lords Chamber

[Lord Warner (CB)]

My Lords, I thank the Minister for listening so intently during the proceedings and for his response. I am also grateful to those on the Front Benches opposite for their co-operative approach—they are a shining example to their colleagues in the Commons of how to be effective in persuading the Government to change their mind. I hope the Minister’s emollient approach will continue when the Bill leaves this place in relation to the new clause that we have put in at the front of the Bill, despite the advice he was given. I hope that good will will continue to operate as the Bill completes its passage through both Houses of Parliament.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I too welcome the amendments. Clearly, the Opposition will support them. I must remind the House of my presidency of the Health Care Supply Association and GS1 UK.

First, I thank the Minister and his officials for their warm co-operation. The ability to have a number of meetings has been much appreciated. This has been a very good example of cross-House co-operation. Various noble Lords, including the noble Lord, Lord Warner, and the noble Baroness, Lady Walmsley, worked very hard together on the core issue of ensuring that NHS patients get access to effective new medicines. I say to the Minister that I hope Clause 3 will remain in the Bill when it comes back to your Lordships’ House, if indeed it needs to come back—I take the point of the noble Baroness, Lady Walmsley, that this House has done the job it is here to do: it has revised and scrutinised the legislation. I would have thought that the other place should simply accept the Bill as it is, and I hope the Minister will be able to confirm that when he responds. I also thank my noble friend Lady Wheeler for her tremendous support, and Dan Stevens, our health researcher.

It seems to me that the Minister has shown himself adept at handling health legislation in your Lordships’ House, and so we look forward to the next health Bill. If he is looking for suggestions, we are going to have the great repeal Bill and perhaps we can look forward also to the repeal of the Health and Social Care Act 2012. That would bring great joy to many.

[Lord O'Shaughnessy]

I am very grateful to noble Lords for their support for these amendments. I am also grateful to my noble friend Lord Lansley, one of the architects of this new approach to information notices; that was extremely useful and we have ended up in a good place. I am grateful to the noble Baroness, Lady Walmsley, who I have enjoyed getting to know through the process of this Bill. She is quite right to emphasise the vital role that this House plays through its proper constitutional role in revising legislation—I will not say anything more than that. I thank the noble Lords, Lord Warner and Lord Hunt, both of whom have been in my shoes in the past. Good will will certainly operate, and I hope that both noble Lords, and indeed the noble Baroness, Lady Wheeler, have found me to be open, open-minded and willing to work with them. Throughout the passage of the Bill I have been keen to ensure that it is a proportionate response to tackle this challenge, and I think we are all agreed on that.

To conclude, I am delighted that we have come this far on the scrutiny of the Bill and are now debating the final amendments to bring it to a close. As we end Third Reading I would like to take this opportunity to place on record my thanks to all noble Lords who have taken part in the debates, beyond those I mentioned just now, throughout all stages in this House. It is fair to say that the collected efforts of this House in bringing together different views have paid dividends in the improvements that we have seen. It has been a good example of the rigour and attention to detail that this House is known for.

I particularly thank the many officials involved in the Bill, who have worked not only to support me but to ensure that noble Lords are briefed and that any concerns are addressed, within what at times have been very tight timescales. They have done a tremendous job and I am sure the House will join me in paying tribute to them.

Although this may not be the final word on the Bill, I am convinced that the House is sending it back to the other place having been significantly improved in key respects.

National Health Service: Nurses

Lord Hunt of Kings Heath Excerpts

Wednesday 22nd February 2017 Lords Chamber

[Lord O'Shaughnessy]

I thank my noble friend for that question. We should be looking at attrition rates in training and in the profession itself, and I would certainly be happy to work with him on that. I know he is particularly anxious about the turnover of nurses within certain training settings.

[Lord Hunt of Kings Heath (Lab)]

My Lords, what is the current deficit that NHS providers are running in the health service? Can the Minister assure me that the NHS will actually have the money to spend on more nurses next year?

[Lord O'Shaughnessy]

I do not have to hand the figures the noble Lord asks for. He will know that the Government are putting in £10 billion over the five-year forward view period in order to support the world-class NHS that we all want to see.

National Health Service Commissioning Board (Additional Functions) Regulations 2017

Lord Hunt of Kings Heath Excerpts

Tuesday 21st February 2017 Grand Committee

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am very grateful to the Minister for his comprehensive introduction to the regulations before us this afternoon. I was interested when in his opening remarks he referred to the NHS Commissioning Board, more commonly known as NHS England. What struck me is that, when challenged on NHS funding, the Minister and his predecessor have been fond of saying that the NHS got the extra money that it had asked for. But what he really meant to say is that the NHS Commissioning Board put forward a five-year forward plan which talked about a £30 billion gap between the resource needed and the resource that was likely to be got, on the projections then published. We know that it was then told by the Treasury how much it could actually ask for. When we come to debate the NHS and its funding, it would give a much better reflection of the actual position if the Minister were to say that the figure which the Government have produced is what the NHS Commissioning Board was told to put into the five-year forward view.

I was puzzled by the way in which NHS England changed the name of its organisation to be that. Much of the two years we spent debating the 2012 Act was around the work of the NHS Commissioning Board. I was a little surprised that a quango took it upon itself simply to change its name and give itself the kind of title to which, statutorily, it clearly had no right—nor is it in its remit. It is interesting that when it comes to regulations such as these, which we have frequently, they have to relate to the NHS Commissioning Board. I suspect that very few people know what it is. At the end of the day, either the Government should regularise this by legislating to call NHS England by that name or it should revert to being the NHS Commissioning Board. As a matter of principle and practice, it is not a good idea to use a name that has not been given in legislation.

These are interesting regulations because, in a way, they take us back to our debates in relation to the Health Service Medical Supplies (Costs) Bill. Much of those debates have been on the cost of medicines, and the operation of the PPRS scheme and the statutory scheme alongside it. I guess that the question I would put to the Minister is: since negotiations with the pharmaceutical industry currently lie principally with the Department of Health, what implications does the transfer of this unit to NHS England have for the department’s own capacity to negotiate agreements in future? Does it essentially mean that NHS England will take over those negotiations?

I have obviously seen the Explanatory Memorandum and the reference back to the Carter report. I understand the reasons why my noble friend Lord Carter, thought that the CMU would be best placed within NHS England. But does this transfer equate at all to the recommendation in the Accelerated Access Review, which called for the creation of a strategic commercial unit to be established within NHS England? Would I be right in thinking that the transfer of the CMU is, in essence, the strategic commercial unit that the accelerated access review called for? What it actually said is that it wanted an SCU to,

“have the capacity and capability to consider a range of flexible pricing models as part of a commercial dialogue with innovators”,

and envisaged:

“Win-win scenarios, where innovators benefit from earlier, and, in some cases, guaranteed market access and the NHS and patients benefit from better value through a reduced price”.


In a sense, that takes us back to our debates during the passage of the Bill about whether we can develop more of a win-win relationship with innovators so that patients get access to innovation at a much earlier stage—but also, because the NHS is moving from a culture that is very often opposed to the introduction of innovation to one that embraces innovation, it therefore gets the advantage of better value for money in the end. If that is not to be the case, does the Minister think that the CMU has the capacity, capability and expertise to agree new and innovative commercial arrangements with companies? Will those processes support improved patient access to medicines and will NHS England consult on any new methodology or guides that will support the commercial unit role? How will the reconstituted CMU within the NHS interact with NICE and the adoption of NICE-approved medicines? If it has an active role, will that affect a patient’s right to NICE-approved medicines as covered by the NHS constitution?

Clearly, the experience of companies dealing with NHS England at the moment is that it is inflexible and is interested not in quality and outcome but simply in price. I have had many representations to that effect. My understanding is that NHS England simply has not got the capacity to negotiate these rather more innovative approaches to innovation, adoption and value for money. At heart, the question is this: will the transfer of the CMU to NHS England enhance the capacity of that organisation to move from a crude bottom-line approach to purchasing to one which looks at best value, innovation and adoption?

Apart from that, I will be interested in the Minister’s responses. As this is about procurement, I should remind the Committee of my presidency of the Health Care Supply Association and of GS1, the bar-coding association.

[Lord O'Shaughnessy]

I am grateful to the noble Lord for his questioning which was, as usual, precise. I will attempt to respond to his questions as best I can. I shall start where he started. I do not think I can take any blame for any confusion that may be caused around rebranding the NHS Commissioning Board Authority as NHS England. It clearly has a commissioning role, and in that commissioning role there is clearly a good fit with procurement. That is what the noble Lord, Lord Carter, concluded. Bringing together specialised commissioning, general procurement capacity and the role of the CMU was a good fit and it might deliver better value for money for the NHS, which I know the noble Lord wants as much as I do, so we can clear that out of the way.

The noble Lord’s big question was about enhancing the capacity of NHS England to become more sophisticated. In one sense, he is getting slightly ahead of things because the regulations do not transfer the entirety of the functionality. Some of the functionality will continue to be in the department as it pertains to public health responsibilities—vaccination, for example, or the procurement of emergency treatments. However, those that are to do with the ordinary activities of the health service are moving over. From that point of view, therefore, there is no change: the framework agreements transfer and people transfer. It is simply transferring a unit from one place to another, but clearly with the idea that there will be an enhancement in everyday activities as a result.

The noble Lord is quite right to refer to the issue of access—we talked about that a lot during the Bill’s passage—and it may well be that in future, when we are thinking about what comes after the PPRS, the kind of things that he is talking about would be within the remit. It would be wrong for me to comment on that now, not least because the PPRS commits us to certain activities and behaviours on simplicity of pricing discounts and so on, and clearly the kinds of things he is talking about—the more sophisticated value-based pricing models—do not currently fall within that scope. I am clear, however, that the Government and the department will continue to take a lead in any future discussions about replacements that leverage capacity across the system.

In answer to a couple of the noble Lord’s other questions, there is no particular impact on NICE from these regulations. We know that within the PPRS there is a commitment to fund after three months: that is part of the agreement. I hope, therefore, that he is reassured about that. To repeat, this is, in essence, quite a simple measure that takes a set of responsibilities from one place to another with the aim of providing greater efficiency—by procuring framework agreements, and so on. That is separate, in a way, to what we have been discussing in the Bill, but it may be that in future the transfer and enhancement of that capacity could set the tone for the kind of negotiations that he would like. However, I hope that he will understand that it would not be right for me to make any commitment on that at the moment, bearing in mind the relationships that we have. If he is satisfied with those responses, I commend the order.

Health Service Medical Supplies (Costs) Bill

Lord Hunt of Kings Heath Excerpts

Report stage (Hansard): House of Lords
Tuesday 7th February 2017 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, first, as we are entering Report, I declare my interests as president of the Healthcare Supplies Association and of GS1, the barcoding organisation.

Like the noble Baroness, Lady Walmsley, and the noble Lord, Lord Warner, I make it clear that in supporting the amendment, the Opposition support the core purpose of the Bill. The recent fines imposed by the Competition and Markets Authority on two companies, which essentially exposed a loophole, left the Government with no option but to act—we agree with that. I have to say that it is interesting to note that the powers that the Government have taken upon themselves in the Bill will give them draconian influence over drug prices in future.

The Bill allows the Government to institute price controls. It states that the Government may have reached a voluntary agreement with industry over pricing but can none the less come in and impose price controls over that agreement. To cap it all, it massively extends the Government’s powers to ask for information about any health service product sold to the NHS. Such information could cover prices, discounts, rebates, revenues and profits, and could apply to millions of products every year.

It is a socialist dream of state intervention. Speaking here as a great believer in central state intervention, my heart warms to the Minister’s vigour and enthusiasm for regulation. It gives an idea of the nirvana of post-Brexit, light-touch regulation from this Government. Perhaps we should dream of EU directives in future, because this Government are so bent on their home-grown regulation.

We will come to the issue of proportionality, because many of our later amendments involve whether the Government have been proportionate. For me, this amendment is essentially about access, because I do not think you can talk about price controls on drugs without talking about patient access to innovative drugs and treatments. At the moment we are seeing an unprecedented level of rationing, both locally and nationally. Locally, clinical commissioning groups are making some really perverse decisions, ranging from cutting out health promotion programmes to being incredibly restrictive on operations and restricting access to innovative drugs.

A fairly recent report that I read by leading charities Breast Cancer Now and Prostate Cancer UK, for instance, showed that NHS cancer patients are missing out on innovative treatments that are available in any comparable country to the UK. One example is the PrEP drug. The reluctance of NHS England to fund the use of this extraordinary preventive drug in relation to the treatment of HIV is another example of the problem that we have. When the previous Labour Government set up NICE, it was designed to speed up the introduction of innovative new treatments. But since 2010, access to new drugs approved by NICE has been increasingly impeded, which has culminated in the current consultation that if a NICE-approved treatment is expected to exceed a cost of £20 million in any of the first three years of its use, NHS England can ask for a longer period for its introduction.

We also have a consultation on the introduction of a QALY threshold of £100,000 for evaluating highly specialised technologies. My understanding is that no other country in the world uses such a threshold in evaluating ultra-rare disease treatment. The almost universal view is that this form of assessment is not appropriate and would effectively stop the flow of new medicines reaching patients with rare and complex processes.

Of course, the noble Lord, Lord Warner, is right that the drugs budget cannot be open ended and that the NHS must achieve value for money—and I, too, have engaged with industry over the years in seeking to get the drug budget down. We all understand that. The tragedy is that a ground-breaking agreement reached by the last Government in 2014 with drug companies could have led to many new drugs being introduced. The pharmaceutical industry guaranteed to hold down drug costs for a five-year period and, if the costs went over the agreed limit, the industry would pay back a rebate every quarter. To date, £1.5 billion has been handed over.

I know how irritating it is to point to Scotland and Wales and say that they are doing something better—but something like the Scottish fund that has been established from the rebates to fund the introduction of new medicines would have been a preferable way in which to go forward in the situation that we have in England, where restriction after restriction is taking place in the use of better drugs for patients.

You then have to link the issue to our investment in R&D and life sciences. Sir John Bell, regius professor of medicine at the University of Oxford and chair of the Office for Strategic Coordination of Health Research, who is playing an absolutely pivotal role in this area, spelled this out recently. As he said, the last 30 years have witnessed an unprecedented number of major innovations in healthcare that have resulted in significant extensions in life expectancy and quality of life. The problem is that the National Health Service has been unable to adopt this new innovation effectively and, as a result, many improvements in healthcare have been put in jeopardy.

This is not an easy issue. Sir John Bell says—and I agree—that one problem is that our current model too often layers the cost of supporting the innovation needed to help discover new healthcare innovations on top of existing practice. So, unlike in other sectors, in the health service innovation always seems to cost money. This is a very important issue when it comes to thinking about how we can afford the kind of changes that will fall to health and social care in future.

I will also quote Keir Woods, head of oncology at the major pharmaceutical company Merck. He points to that company’s investment in the UK—20% of its global venture capital is invested in the UK—and he celebrates the UK’s position as a global power in health, with our world-class universities, centres of excellence in clinical research and some of the top medical journals, which has a positive impact on investment. We are home to 4,800 life science companies, with the largest pipeline of new discoveries in Europe. That is something to celebrate. Dr Woods says that we can build on that, but there are two provisos. First, we have to be able to secure the cream of international talent. The discussions around Brexit are very important in relation to that. Secondly, we have to increase the uptake of these new innovations in the UK.

The frustration that I and many others have is that the UK is a wonderful place for innovative and ground-breaking new treatments and drugs, but the fruits are increasingly being enjoyed by patients in other parts of the world. Currently, the UK has developed around 14% of the top 100 global medicines. That is something to celebrate—but 20 years ago we were responsible for about one-quarter of the global medicines that had been developed. The noble Lord, Lord Warner, referred to the £4 billion invested by pharma R&D. However, up to 2011 it was £5 billion—so we are seeing a deinvestment that is very much linked to the hopelessly poor record of adoption of new medicines in this country.

I know that the Minister will talk about some of the initiatives he is taking and I am sure that he will mention the accelerated access review, which aims to make the UK the fastest place for the design, development and widespread adoption of innovations. This is entirely laudable, but the problem is that this approach will take a few items and accelerate access while the NHS goes about crudely rationing a whole host of other innovations and putting at risk our life sciences, R&D investment and, of course, the quality of patient care.

That is why this amendment is so important. We support the Bill and its aims, but what has been lacking so far is any recognition by the Government that there are three planks to this. The first is better value for money in terms of drugs and health service products; the second is the quality, range and health of our life sciences and R&D investment; and the third is access to treatment by patients. So far the Government have not been prepared to grip this last issue. That is why the amendment is so important and I support it.

[Lord Lansley (Con)]

My Lords, I will speak briefly on this amendment, although there are later ones in my name which will allow me to say more about the way in which the Bill proposes that the Secretary of State exercises his or her duties. The idea that it is not part of government strategy—back in 2014 or now—to promote the life sciences sector through the structure of the PPRS is absurd. It is self-evidently the Government’s intention, and was in 2014. The structure of a negotiated, voluntary PPRS was designed to achieve that. The issue that has emerged since 2014 and the application of the new voluntary scheme is that the industry was looking for stability for the Government in terms of the budget; freedom to price at introduction, and action on access to new medicines. It is in that third area that there has been a lack of progress. In many ways, I agree with what noble Lords have been saying about the desirability of achieving that access. It has not been restricted since 2010, although the noble Lord, Lord Hunt, tended to construct it that way. For example, we introduced the cancer drugs fund in 2010 precisely because prior research by Mike Richards had demonstrated that patients in this country were failing to have access to new cancer medicines at the time when patients in other European countries did. It is not a new problem: it has been around a long time. The cancer drugs fund was intended to meet that gap by 2014 and the PPRS should have taken over, but it did not. After Innovation, Health and Wealth in December 2011, and the accelerated access review now, we are now seeing efforts to try to make that happen and they should be thoroughly supported.

The second limb of the amendment does not help, because it is just about access for patients to those new treatments which have been approved and recommended by NICE. That is only one part of a much wider issue about the adoption and diffusion of new technologies across the NHS more generally, often in circumstances where NICE has not been involved. I find the new consultation proposal on NHS England’s budget impact threshold something of a double-edged sword. The measure could erect another hurdle to be cleared before patients can access new medicines, and we have to avoid that. However, it may have the positive effect of encouraging NHS England, as the budget holder, and NICE, as its pharmacoeconomic evaluation mechanism, to work together with companies at an early stage to arrive at a negotiated price at an early point. That would be much to the benefit of the industry and the NHS given that we are aiming, through this legislation and beyond, to obtain patient access to medicines on reasonable terms that the NHS can afford. If the measure were used in that way, it would have the right benefit. However, I fear that this amendment, particularly its latter limb, does not take us any further in that direction.

--- Later in debate ---

[Lord O’Shaughnessy]

The treatments become available throughout the NHS from three months after the appraisal.

[Lord Hunt of Kings Heath]

My Lords, given that I took the order through Parliament many years ago, I can confirm that the whole intention was that the NHS had 90 days to prepare for funding a medicine that had been designated by NICE as both clinically and cost effective. The problem is that, subsequently, in particular over the past few years, clinical commissioning groups have done everything they can to avoid this responsibility. Alongside that, the purity of the 90-day rule is being eaten into, and that is at the heart of the concern of this amendment.

[Lord Warner]

My Lords, I am grateful to all my colleagues for the powerful support they have given to the amendment. I do not doubt the Government’s commitment to the life sciences, which I acknowledge from what they have put in the industrial strategy and the person they put in charge of leading that work. However, they have not convinced the industry with the Bill. They seem to be sending out separate messages.

The amendment is meant to tackle the two issues of supporting a flourishing life sciences industry and guaranteeing patient access to drugs that have been approved by NICE. It is very clear that that second part is not working well and is getting worse. It does no harm whatever to reinforce that message in the Bill with this amendment.

On life sciences, I say to the Minister that it is a funny way to show he is supporting that industry, at a critical time for this country, by bringing along a Bill that, as the noble Lord, Lord Hunt, made very clear, overdoses on regulatory requirements, price control and information requirements. This is a pretty strange message to say to a load of international companies when you want them to settle here and do your research.

I have listened to the Minister very carefully. I am much more persuaded by my colleagues’ supportive speeches, for which I am grateful. I wish to test the opinion of the House.

--- Later in debate ---

[Lord Lansley]

My Lords, even though the House has just divided, the Bill has been characterised by a substantial measure of agreement on the purposes we are trying to achieve and I am sure that will be reflected in the further amendments that are to be discussed. I neglected earlier to draw attention to the register of interests and, in particular, to my position as an adviser to MAP BioPharma, which is not itself a participant in the PPRS in any way.

Let me make the purpose of Amendment 4 clear to noble Lords. The Government, in bringing this legislation, were prompted in part by the fact that expenditure on medicines was rising somewhat faster than the Government had anticipated, the amount of the rebate being achieved by way of payment back to the Government was less than was anticipated, and the difference was, in part, explicable by virtue of the transfer of certain products into the statutory scheme. In the statutory scheme they had a price cut applicable but no rebate scheme applicable and the Government did not feel that they had the necessary power to amend the statutory scheme to make a rebate apply.

The purpose of the legislation is to make the two schemes broadly equivalent. As the Minister told the Committee, the Government’s intention was to make the revenues being rebated back to the Government from the two schemes broadly equivalent. However, in my view that would potentially have the perverse impact that certain products in the statutory scheme would end up with a much higher rebate percentage being applied to them as a consequence—or, alternatively, that products outwith the price control under the voluntary scheme, because they were introduced after December 2013, would have the price control applied to them under the statutory scheme. So a discontinuity would apply, potentially either way, by applying the broadly equivalent proportion of cost of sales being returned to the Government in the form of a rebate.

I have therefore suggested that it is a perfectly reasonable principle on the Government’s part, as we explored in Committee, to try to make the two schemes equivalent so that there cannot be gaming, as it were, by moving into one scheme rather than the other. That should be applied, as the amendment specifies, by means of asking the Government, wherever a voluntary scheme is in place—which is an important caveat—to ensure that a statutory scheme should seek, so far as is practicable and relevant, and it will not be precise, so I do not think it can be regarded as too rigid, to make it so that the equivalent effect is applied at a product level: not at a company level or a whole-scheme level, but in relation to the individual products. Individual products, whether they are in the voluntary scheme or the statutory scheme, should expect to have broadly the same overall treatment applied to them. The net effect would therefore be that the schemes will become equivalent and the scope for gaming will be reduced. I hope that explains the amendment and I beg to move.

[Lord Hunt of Kings Heath]

My Lords, the noble Lord, Lord Lansley, has raised a very important point. For me, the question is: what is the future of the voluntary scheme? Over the years it has clearly served its purpose well. In Committee, the noble Lord acknowledged the benefit of the PPRS, which is the voluntary scheme, and said that it showed how Government and industry could work together to develop solutions. I draw the noble Lord’s attention to a piece written by Sir John Bell recently. When talking about what we have just discussed, the dynamic between access, cost and life-science investment and the problem the NHS has in investing in innovation, he said:

“A solution for both parties is necessary and must come from healthcare systems and innovators working more closely together, sharing risk and cost and attempting to use innovation to take cost out of health systems wherever possible”.


This is a wider issue than drug costs and PPRS, but it would be good to hear about the context in which the Minister thinks a potential new PPRS is going to be agreed. Many in industry think that the Government are not really committed to a new PPRS. It would be interesting to get some sense from the Minister as to where he thinks things are going.

[Lord O'Shaughnessy]

My Lords, I am grateful to my noble friend Lord Lansley for bringing this amendment and for the opportunity to talk about the intentions of the Bill. He is quite right to highlight that the reason for bringing the Bill forward is to stop the behaviour of switching between schemes in order to reduce liabilities. That has characterised behaviour in the past few years and has had an impact on the successful operation of the PPRS. I will discuss the PPRS towards the end of my speech.

Amendment 4 is about the relationship between the voluntary and statutory schemes. I thank noble Lords for their views in this area. This amendment would require us to secure that, for any given product, the voluntary and statutory schemes would have an equivalent impact. It presents a slightly different approach to securing equivalence between the voluntary and statutory schemes, but I understand that, fundamentally, equivalence is what the amendment is seeking to achieve. I gave my views on this matter in Committee and I am happy to respond in similar terms on this occasion.

The Government’s intention is for the two schemes to deliver a broadly equivalent level of savings as a proportion of the total sales covered by each scheme. However, to require the terms of each scheme to be the same, in so far as possible, is inappropriate and would restrict the scope of the two schemes to operate in a complementary manner. Requiring equivalence to operate at product level, as the amendment suggests, would be even more restrictive.

The voluntary scheme is a matter for negotiation with industry. As such, there is scope to have a range of measures included that reflect the priorities of both sides at any point. It may be helpful to the House if I reiterate some of the examples I set out in Committee. The current voluntary scheme, the PPRS, includes a range of provisions, developed through negotiation with industry, that sit alongside the payment mechanism. This includes price modulation, which enables companies to put prices up and down as long as the overall effect across their portfolio is neutral. This has commercial value to companies, which may be willing to accept a higher payment percentage as a result.

In another example, while new medicines in the PPRS are excluded from PPRS payments, the PPRS payment percentage level itself is set at a level to achieve the agreed level of savings across both new and older medicines. This means that each company’s share of the income due to government will vary depending on the balance of new and old products in their portfolio, with companies that have mainly new products paying less than companies with mainly old products. However, it would be very challenging to replicate this model in the statutory scheme, as many fewer companies are affected by the statutory scheme regulations than are members of the PPRS. As a result, there is a much smaller pool of companies with older products. To achieve the same level of savings overall from the statutory scheme as from the PPRS while exempting newer products would require an extremely high payment percentage. This provides an example of where minor differences in terms may be required in order to deliver an equivalent level of savings across the two schemes overall. As noble Lords know, as we discussed in Committee and as I now repeat, the detail of how any future statutory scheme will work will be subject to further consultation.

As was discussed here and in the Commons, the freedom to negotiate the voluntary scheme has been valued greatly by both industry and government. As the noble Lord, Lord Hunt, reminded us, I said as much in Committee. Our intention for the future of the PPRS is to work collaboratively and constructively with industry on future medicines pricing arrangements when the current PPRS comes to an end.

[Lord Hunt of Kings Heath]

This time, will NHS England be a full partner in the discussions and negotiations? Clearly, unless it owns the solution as well, you have the problem that an agreement can be reached but it does not quite translate itself into action on the ground. I realise that this is traditionally a negotiation between the Department of Health and the industry but it would be useful if NHS England were fully part of that.

[Lord O'Shaughnessy]

The noble Lord makes an excellent point. Clearly, as the budget holder, NHS England ultimately must be a key part of negotiations for any future schemes. We intend that any future voluntary scheme should be established through negotiation in this way, but linking the payment mechanisms would inevitably place a restriction on that freedom.

I am grateful to my noble friend for raising this issue and I hope I have reassured him on equivalence, while also explaining why I believe the amendment goes too far by focusing specifically on products. On that basis, I ask my noble friend to withdraw his amendment.

--- Later in debate ---

[Baroness Walmsley]

My Lords, as I mentioned in the debate on Amendment 3, I support this amendment because it gives the Secretary of State a bit more flexibility to take account of the specific circumstances of a company with very high fixed costs, in the interest of making sure that we have security of supply and patient access to the particular products that it produces. I do not think it undermines any of the objectives of the Bill in any way, and because of that, I hope that we will hear something encouraging from the Minister.

[Lord Hunt of Kings Heath]

My Lords, in Committee the noble Lord said that he did not think that biosimilars should be excluded from the voluntary or statutory pricing schemes, as competitive tendering would not generate sufficient levels of price reductions. I had a note from one of the companies involved, Sandoz, which says that one of the issues here, alongside the fact that fierce competition is already driving significant price reductions for the NHS, is that development costs of generic medicines do not compare with those of biosimilars. Those costs can be up to 100 times those of generic medicines, partly because of the licensing process and the time needed for development. I hope the noble Lord will be able to address that and explain how the Bill aligns with recent NHS policy, which has expressed support for the uptake of biosimilar medicines, particularly through the intention for specialised services commissioning. The noble Lord’s comments in Committee on biosimilars caused some disappointment, and if he could respond more positively now that would be helpful.

[Lord Warner]

My Lords, from time to time I have been approached by plasma companies and vaccine companies about supply issues, particularly where there have been changes in the structure of the industry and a reduction in the number of producers of some of these products, and sometimes on the point of whether British companies may start to go out of business because of some of those structural changes. My question to the Minister is whether the amendment would actually help enable the Secretary of State to deal with some of those supply problems when this becomes an issue. It becomes an issue for those patients who really need that particular product when no other will do. Is this the kind of amendment that would help with these supply problem areas, which to my knowledge have been experienced from time to time, particularly in plasma and vaccine areas?

--- Later in debate ---

Moved by

[Lord Hunt of Kings Heath]

8: Clause 6, page 5, line 35, leave out “revenue or” and insert “product revenue and aggregate UK”

[Lord Hunt of Kings Heath]

My Lords, I will speak very briefly to Amendment 8 and then allow the Minister to explain his amendments. I can then perhaps come back at wind-up to refer to my own Amendment 12 to his Amendment 11.

We have discussed whether the Bill is proportionate, and this is particularly apposite in relation to this clause. There is concern that the powers may be too intrusive in requiring companies to submit profit-level information on individual products, which I understand from many of the companies involved that they consider complex and onerous to provide, and not necessary routinely for the Government. My amendment attempts to deal with this in a way which I think is proportionate and not intrusive, but which should provide the kind of information the Government want. I will be very interested to hear what the Minister says about his amendments. I beg to move.

[Lord Warner]

My Lords, my name is on this amendment and I support it. I want to emphasise the point about the UK, which is in this amendment from the noble Lord, Lord Hunt. Members of the industry are concerned that they will be brought into a conflict between them and their headquarters over the pricing of particular products in the UK. The point that the noble Lord has made in his amendment about specifying the UK is extremely important.

--- Later in debate ---

[Lord Lansley]

My Lords, I reciprocate my noble friend’s thanks. In Committee he said he was going to think very carefully about the subject of information and the circumstances in which it is required from companies. Having done so and engaged us in a conversation about it, he has come forward with an amendment that seems specifically designed to meet the concerns raised in Committee. From my point of view, and this is very simply put, there must be a general scheme to acquire information, but when one goes beyond it the company has a right to expect that the information notice must be specific, itemised and additional, and that, as is now provided for, there should be a right of appeal in relation to that. My noble friend has very kindly listened and brought forward an amendment to do in substance the things that we were looking for, so I am grateful to him.

[Lord Hunt of Kings Heath]

My Lords, I thank the Minister. I am grateful for his amendments, because he clearly listened to the debate. I just want to encourage him to go that little bit further. I am glad that we have a government amendment on Third Reading, because that means that we can continue this debate: his amendment is amendable, which is always the issue for noble Lords on Third Reading.

The Minister said on my Amendment 12 that he was anxious not to put particular conditions into the Bill, but my reading of his Amendment 11 is that he imposes particular conditions. Its first four lines state:

“Regulations under this section must require the Secretary of State to give a UK producer an information notice if information is required in respect of the costs incurred by the producer in connection with the manufacturing, distribution or supply”.


All I want to do in my amendment is add the word “access”. I am just taking his elegant drafting and adding a bit to it. I beg leave to withdraw Amendment 8.

Amendment 8 withdrawn.

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Moved by

[Lord Hunt of Kings Heath]

12: Clause 6, in subsection (5), before “manufacturing” insert “access to, ”

--- Later in debate ---

[Lord Hunt of Kings Heath]

My Lords, I am grateful to the Minister for the way he responded to Amendment 14 in my name. I am satisfied that the Government will consult closely on the list of bodies.

Amendment 13 agreed.

Health: Neurological Services

Lord Hunt of Kings Heath Excerpts

Tuesday 31st January 2017 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, it is a great pleasure to thank my noble friend for inaugurating the debate and for the persuasive case that she put across on the need to improve neurological services. To echo the noble Baroness, Lady Noakes, I commend the three excellent briefings that I received from the Motor Neurone Disease Association, the Neurological Alliance and Parkinson’s UK. My noble friend spelled out some of the key issues. To summarise, what she is saying is that one way or another we have lost national leadership. Whether it is through the national clinical director or the strategic clinical networks, at a national and local strategic level we do not seem to have the leadership required to drive through improvements in neurological services.

At the local level, the stunning evidence provided by the noble Baroness and by the Motor Neurone Disease Association is that because NHS England clearly does not regard neurological services as a priority, clinical commissioning groups have taken that as a signal to disengage themselves. That is why the data collected by the Neurological Alliance have shown that CCGs are so uninterested in these services.

This should not come as a surprise. Looking back at the various reports written in the last two or three years, I am particularly struck by the Committee on Public Accounts in February 2016. It said then that with over 4 million people alone in England having a neurological condition,

“Services for people with these conditions are not consistently good enough, and there remains wide variation across the country in access, outcomes and patient experience”.


Other noble Lords have made that point. The committee made a number of important recommendations, including on information. I echo the point made by the noble Baroness, Lady Walmsley, about that. They hark back to the core issues raised.

What is going to be done to make the best use of available neurologists and reduce the variations in access, which seem unacceptable? The second issue is the role of national clinical director for adult neurology. I hope that the Minister is not going to say that that is a matter for NHS England, because ultimately he will find that he will take responsibility for the decisions that NHS England makes. The contrast with now is that when national clinical directors were appointed, they were appointed by Ministers to serve in the Department of Health. They worked in Richmond House. They had direct access to Ministers. NHS England clearly does not like the concept of national clinical directors because when they were established by NHS England they were often very part-time roles, they were given virtually no administrative support, and we can see that time after time it has sought to reduce their influence and add to their nominal responsibilities.

The beauty of national clinical directors is to have front-line clinicians involved at the most senior level in the development of policy. This has all been lost in the way that it has been handled by NHS England. I hope that we will not be told that these matters are best done locally through CCGs, as we have seen that CCGs simply do not have the capacity to think through and commission neurological services. It is quite clear that the moment they get a signal from NHS England that it is no longer very important—and clearly that is a signal that NHS England has given—they simply will not engage. That is why the CCG returns have been so lamentable.

The noble Lord, Lord Ribeiro, made a point about the numbers of neurologists and neurosurgeons. Is Health Education England reviewing this and what are we going to do about the variation throughout the country? Can the Minister confirm that waiting times are slipping? Do Ministers now accept that in fact the targets for patients who require neurological or other services are never going to be met? I will also pick up the point the noble Lord made about animal research. I agree with him that it was the march by students that completely turned opinion in this country in favour of responsible animal research, where other means are not possible. I am sure that he, like me, supports the three Rs, whereby animal research is used sparingly and responsibly but none the less has an important role to play. I hope the Minister will affirm that that continues to be the Government’s view.

The noble Baroness, Lady Masham, raised a very important point about specialist nurses. My impression is that the number of specialist nurses is going down and that they have become a very scarce resource. The noble Baroness, Lady Walmsley, also made a point about the implications of Brexit—could the Minister comment on that? Brexit itself, the fact that people who would have come from the EU may feel that the UK is not as welcoming as it used to be, and the economic downturn which I think will inevitably come our way over the next few years could all have consequences in the future. Can he at least say what the Department of Health is doing to work out the impact of Brexit in terms of staff movements? That would be very welcome indeed.

The noble Baroness, Lady Masham, said that the Minister brings youth and energy. I hope after a year or so in his post answering such debates, he will still bring youth and energy. This is a very important subject, and I also hope he will agree to the request from my noble friend for a meeting with her and representatives of the sector.

Sustainability and Transformation Plans

Lord Hunt of Kings Heath Excerpts

Thursday 26th January 2017 Lords Chamber

[Lord O'Shaughnessy]

The noble Lord asked about funding and I want to provide him with an answer. The plans are backed by a £1.8 billion sustainability and transformation fund and £19 billion of capital spending over four years to help make these changes.

[Lord Hunt of Kings Heath (Lab)]

My Lords, the Minister has talked about the public being involved. Why then have the public, local authorities and clinicians been excluded from the STP process so far, as shown by the King’s Fund? These plans depend on investment in primary care, community care and social care. Where on earth is the money going to come from to invest in those services, when the acute sector is under such pressure?

[Lord O'Shaughnessy]

Clinicians and local authorities are involved in these plans. The whole point of the plans is that they bring everybody together within an area to create changes that are driven from the bottom up, so as to provide a much more efficient service. The noble Lord knows full well that more money is going into both primary care and the service overall.