NHS: Sustainability and Transformation Plans

Baroness Walmsley Excerpts

Monday 20th March 2017 Lords Chamber

[Lord O'Shaughnessy]

As the noble Baroness has pointed out, it is important that there is sufficient capacity in the social care service and in the NHS. In fact, the NHS accounts for more of the delayed discharges, for example, than does social care. Simon Stevens, the head of NHS England, has been clear that, in addition to the four reconfiguration tests, any bed closures would need to show that there was redundancy in the system, that there is alternative provision—to come to the noble Baroness’s point—and that there is clear potential for efficiency. It is clear that the STPs must be able to plan ahead and provide alternatives if there are going to be changes to A&E or other services.

[Baroness Walmsley (LD)]

My Lords, given that 50% to 60% of patients attending A&E in some hospitals hit the four-hour target, how many more hospitals will hit the target when some adjoining hospitals close their A&E departments? This does not sound like excess capacity.

[Lord O'Shaughnessy]

The noble Baroness is right to point out that the four-hour target is critical for the NHS and it is committed to making sure that that target is hit. Some A&E closures have been mooted but only seven areas, according to the Health Service Journal, have clear proposals, and that is before there has been any public engagement and any application of the reconfiguration test. I point the noble Baroness to the comments of Simon Stevens about the importance of demonstrating alternative provision and that it cannot be a case of closing beds without that being in place.

End of Life Care

Baroness Walmsley Excerpts

Tuesday 14th March 2017 Lords Chamber

[Baroness Walmsley (LD)]

My Lords, as the King’s Fund report Understanding NHS Financial Pressures commented yesterday, terminally ill patients have very little political voice. Therefore, I am delighted that the noble Baroness, Lady Finlay, has spoken up for them this evening. Indeed, I am very grateful that I live in Wales and will probably die there.

Over the last five years, we have seen several reviews of palliative and end-of-life care with multiple recommendations. Therefore, I hope that, at the end of this debate, the Minister will be able to provide us with an update on progress towards meeting those recommendations. For example, the Government’s response to the review of choice made two commitments that are particularly relevant to the topic we are debating today—namely, to,

“engage with clinical commissioning groups and Health and Wellbeing boards on improving end of life care provision through local strategic planning and commissioning”;

and,

“to provide commissioners with data, tools and palliative care currencies to help identify palliative care needs in local areas and the best ways to commission services to meet those needs”.

I hate jargon, so I looked up what “palliative care currencies” means. I found that it refers to payment models for palliative care. As the Minister will know, the majority of community palliative care providers in England, which are largely in the voluntary sector, are currently commissioned by block contract, and a lot of hospices in particular have been working within the same cash envelope for many years. Indeed, yesterday’s report from the King’s Fund commented that one of the factors that make some services particularly vulnerable is that block contracts have not been adjusted to match rising demand, and that demand is continuing to rise.

In 2010, Marie Curie’s review of funding recommended that the NHS move to a per-patient funding model, defined by phase of illness, so that providers would be paid more for patients with more complex care needs. One of the major difficulties encountered was the fact that most voluntary sector providers have a mixture of NHS and charitable funding, so it was difficult to identify which aspects of care were NHS-funded and which were charitably funded. Therefore, moving every provider to per-patient funding has its problems. Can the Minister now confirm that NHS England will provide a number of different palliative care currencies so that commissioners can choose which method is right for their locality? If that is the case, how will value for money be audited and by whom?

We have heard that palliative care in this country can be the best in the world. However, successive national care for the dying audits have found wide variations in the quality of care in different hospitals. I welcome the fact that end-of-life care is now a key area for assessment in the Care Quality Commission’s inspections of hospitals, but can the Minister update us on the plans in place for those that perform badly to learn from the best?

However, poor patient and family experiences are often due to poor commissioning, planning and co-ordination, as well as insufficient provision for family support, rather than poor delivery. Clinical commissioners have a vital role in co-ordination because it is increasingly rare that individuals’ needs will be met by one service alone and they often need to be moved from one location to another as their needs change. Co-ordination is particularly crucial when terminally ill patients wish to die at home. Last year I spoke in your Lordships’ House about a particularly distressing case that I know of where that all went wrong. Obviously it makes sense to get services right in the community rather than have the patient admitted to hospital when the family can no longer cope.

Despite the numbers needing these services, according to Marie Curie, just over half of health and well-being boards in England made no mention of palliative care in their strategies, only a third had comprehensive plans, and 30% of STPs made no mention of end-of-life care at all. Given that NHS England says that it requires local leaders and professionals to ensure that a strategy for end-of-life care is in place, this is pretty disgraceful, and, having made that statement, it does not audit what is in place, so there is no accountability. Therefore, I ask the Minister how CCGs and health and well-being boards are being held to account for this state of affairs.

Finally, I want to raise clinical training. A professor of palliative care who is a friend of mine told me recently that some medical graduates have no more than one day of training in end-of-life care. In other places, such as Royal Liverpool University Hospital, students spend three weeks in local hospices, which equips them much better. Although we need palliative care specialists, we also need generalists with enough knowledge of pain management and other issues linked to end-of-life care, including how to help the bereaved. I understand that Health Education England’s end-of-life care core skills education and training framework—what a mouthful—is soon to be published. Can the Minister say how soon it will be implemented?

Nursing and Midwifery (Amendment) Order 2017

Baroness Walmsley Excerpts

Tuesday 28th February 2017 Lords Chamber

[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.

Health Service Medical Supplies (Costs) Bill

Baroness Walmsley Excerpts

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

[Lord Lansley (Con)]

My Lords, I do not propose to detain the House. I merely wish to thank my noble friend the Minister for the further clarification that Amendments 1 and 2, in particular, give to Clause 9.

I was among those who raised a concern. Although the industry completely understood that in order to make the PPRS effective there was a requirement for a scheme for the acquisition of data in aggregate, as my noble friend described, the powers would have enabled there to be a lot of demands for information which went beyond what had previously been required and which had the potential to be very intrusive. Under those circumstances, an information notice system, with proper details supplied to companies and with a potential appeal right, was required. We discussed that and I am very grateful to the Minister for taking it on board and putting in place something which I think will give considerable reassurance to the industry that the scheme will not be as burdensome as it could have been.

[Baroness Walmsley (LD)]

My Lords, we on these Benches are also happy to support the amendments. Like the noble Lord, Lord Lansley, I have no intention of detaining the House with long-winded thanks. However, I want to voice my recognition that the Minister, in his new role, has both understood and responded to the issues raised on the Opposition and Cross Benches about the shortcomings of the Bill, which had been through the House of Commons without anybody noticing or trying to amend its unintended consequences, rather like the Article 50 Bill that we debated in this House on Monday and Tuesday.

[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.

National Health Service: Nurses

Baroness Walmsley Excerpts

Wednesday 22nd February 2017 Lords Chamber

[Noble Lords]

Order!

[Baroness Walmsley (LD)]

My Lords, are there any plans for post-qualification training grants for specialist nurses in some of the shortage areas, such as psychiatric nursing, and/or golden handcuffs to keep them in their jobs?

[Lord O'Shaughnessy]

The noble Baroness is quite right to raise the issue of retaining nurses and bringing them back into the profession. That is why, last year, to aid retention, there was an average 3% increase in pay for nurses. Health Education England has also introduced a return to practice campaign, which has brought 900 nurses back to the front line in the last three years.

Hospital Beds: Availability

Baroness Walmsley Excerpts

Thursday 9th February 2017 Lords Chamber

[Lord O'Shaughnessy]

I thank my noble friend for that question. He is quite right that integration of services is the main thrust of policy and has been under successive Governments. This is happening in two ways. First, the Better Care Fund is pooling health and social care budgets at local authority level in order to achieve what he is asking for. Also, NHS England is producing sustainability and transformation plans, several of which are moving towards what is called an accountable care organisation, whereby a single grouping takes responsibility for all the healthcare needs of a population, rather than it being split into different services.

[Baroness Walmsley (LD)]

My Lords, integration is of course very important, but has the Minister ever met anybody in the health service who does not believe that you will never fix the pressures in the health service until you put more money into social care? That means helping areas with low-value properties, not just those with high-value properties, such as in leafy Surrey.

[Lord O'Shaughnessy]

The noble Baroness is of course quite right about the need for more money. I re-emphasise that an additional £7 billion or more for social care is going to councils during this Parliament. Councils have the ability to raise council tax, although the leverage obviously varies from place to place. This is why the Better Care Fund was created—to provide extra help to areas that do not get the same income from council tax increases as the better-off places.

Nursing and Midwifery: Student Applications

Baroness Walmsley Excerpts

Tuesday 7th February 2017 Lords Chamber

[Lord O'Shaughnessy]

I am sorry to hear that the noble Lord no longer supports a higher education policy of loans and fees that was originally instigated by a Labour Government. He is right about the differing impacts in Scotland and Wales, which have different systems. He also knows that, whenever fees have been introduced in the past, there has been a dip and then a rebound. Two of those rises in fees happened under Labour Governments. There are around 37,000 applicants for around 23,000 places at this point in the cycle. As he knows, there will be further applications directly to universities and through clearing. He may also be reassured by the words of the head of policy at the Council of Deans of Health, which represents the universities affected. She said:

“The scale of the fall in application numbers is not the critical factor for universities or the health and social care sector. Courses that were previously heavily oversubscribed can survive a significant dip in application numbers as long as the quality of applicants is good, and our members report that this remains so”.

[Baroness Walmsley (LD)]

My Lords, filling the places is one matter, but the level of attrition is another, and that is dreadful. Apparently, one in four student nurses leaves during their training, and in the first two years after qualification two out of five leave the profession. Part of the problem is that the data are not consistently collected. If they were, we would be able to know which settings are very poor at keeping their young nurses. Will the Government do something about collecting those data in a consistent way so that something can be done about the level of attrition?

[Lord O'Shaughnessy]

The noble Baroness makes an important point about attrition. It is one of the reasons that, within the new package of support, there is extra support for living expenses, both for mature students, who feature particularly in the case of nursing, and in cases of hardship.

Health Service Medical Supplies (Costs) Bill

Baroness Walmsley Excerpts

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

[Baroness Masham of Ilton (CB)]

My Lords, I thank the Minister for his helpfulness and the work he has done on this amendment about specials. I also thank him on behalf of my noble friend Lady Finlay of Llandaff, who has to help her pregnant daughter who has had an emergency health problem. She had hoped to be here. I hope this amendment will help patients get the specials they need at a reasonable price.

[Baroness Walmsley (LD)]

My Lords, the noble Baroness, Lady Finlay, is so grateful to the Minister that she asked two of us to convey her thanks for the time he has given to addressing her concerns. She is very happy with these amendments.

[Baroness Wheeler (Lab)]

My Lords, I am the third person to congratulate the Minister. I add the support of these Benches for these amendments, which address unlicensed special medicines, and I congratulate the noble Baroness, Lady Finlay, on her tenacity in pursuing this issue and securing an important concession from the Government. I am sorry she cannot be here, but we can be pretty sure she will be reading Hansard to make sure we have got it right.

It has been hard to understand why the Government were refusing to recognise the need for urgent action on medicinal specials, particularly in view of the substantial price variation between hospital and community care, the many patients in community and primary care who are currently denied access to some specials, and the potential savings across the NHS that introducing a cheaper and more cost-effective whole-market procurement system will provide.

We are very pleased that the Minister has now recognised the need for the Bill to address this important issue in England and Wales. I welcome the legislative framework he has presented. As he pointed out, he has an extensive consultation exercise to conduct on all parts of the Bill, and this will certainly be included in that.

--- Later in debate ---

[Lord Warner (CB)]

My Lords, Amendment 3, in my name and those of the noble Lords, Lord Patel and Lord Hunt of Kings Heath, and the noble Baroness, Lady Walmsley, is very straightforward. At the start of the Bill, it would lay a clear duty on the Government, in discharging the Bill’s provisions, to have full regard to promoting and supporting a growing UK life sciences sector and to ensuring patients have rapid clinical access to new medicines approved by NICE through its technical appraisal process.

This is to ensure that the Bill does not just focus on driving down the price of NHS drugs regardless of other considerations—which, in my view, there is a clear danger of given the way the Bill is framed. I made absolutely clear at Second Reading and in Committee that I fully support the Government acting through the Bill to prevent the NHS being blatantly ripped off under the statutory scheme when a branded drug comes off patent, as happened with Flynn Pharma when a Pfizer anti-epilepsy drug came off patent. The ABPI has never challenged actions in cases of this kind. However, the broad wording of the Bill goes well beyond closing this particular loophole. The Bill gives the Government the power, in the statutory scheme, to replace a list-price discount system with one in which a company repays the Government a percentage of net sales, with as yet no clear indication of what this level will be.

That might well be an acceptable approach if the system was applied solely to the statutory scheme, but not if it is then used in the voluntary PPRS. The industry’s concern is that this statutory scheme provision will create a precedent that could be applied later by the Government to the voluntary PPRS. My reading of the Bill is the same as that of the ABPI, namely that the legal precedent could enable a future Government to try unilaterally to apply the same approach to the voluntary scheme when a PPRS period ends, whatever assurances the current Minister may give. This would effectively abort a negotiated system of settling NHS drugs prices and encouraging research and innovation that has worked well for industry, UK plc and successive Governments for over 50 years. Ministerial assurances that this will not happen have not convinced the pharmaceutical industry or me that this could not happen. We both believe that stronger legislative safeguards are needed.

I think I can speak with some authority on this issue, having been a Minister with responsibility for the pharmaceutical industry and NICE, and having had, perhaps unlike the Minister, to negotiate a PPRS settlement with the industry, which achieved a 7.5% price cut in branded drugs prices for the NHS. I do not think anybody in the industry would see me as a soft touch for big pharma, but I knew that my job, like the Minister’s, was to balance a number of factors and not just get the cheapest drugs for the NHS. These factors involve the safety and value for NHS money of new medicines, but they also involve helping the UK life sciences industry to grow and flourish and to secure speedy access for patients to new drugs approved by NICE.

The Government have not done a spectacularly good job with their consultations on the Bill in showing the industry that they understand this balancing act. They certainly have not convinced the industry, and suspicions have been raised by the inclusion of elements that were not in the 2015 consultation on the Bill. The effect has been to foster distrust within an industry that UK plc badly needs to nurture at this time of massive economic uncertainty. This has been made worse by a negotiation currently taking place with the industry to slow the introduction of NICE-approved drugs if they exceed a certain financial threshold. Why is this so important? Why should the Government not just focus on getting the cheapest drugs they can for the NHS at this time of financial constraint?

The pharmaceutical industry invests over £4 billion a year in R&D in the UK, more than any other sector. It employs 62,000 people with a geographical spread outside London and the south-east. Pharmaceutical manufacturing employees have the highest gross value added of any high-technology industry, at over £330,000 per employee. One in four of the world’s top prescription medicines was discovered and developed in the UK. All this will be put at serious risk by Brexit, as the Prime Minister seems to recognise in the new industrial strategy that she recently announced.

We know that through Brexit the UK will lose the European pharmaceutical regulator, the EMEA, but there are also many other threats to the UK life sciences industry from Brexit. We could lose market access for our innovative products and there could be a flight of researchers and research. At such a time, the last thing this highly successful UK sector needs is a rather indifferent piece of legislation proposing what are in my view unnecessary regulatory burdens and creating uncertainty about the future arrangements of settling NHS prices for new drugs.

The second leg of the amendment covers the issue of speedy patient access to new drugs approved by NICE. I will not detain the House on this issue because others will probably want to say more about it. However, I remind the House that we already have a poor record on the take-up of new NICE-approved medicines. For every 100 European patients who can access new medicines in the first year that they are available, just 15 UK patients have the same access. Even when NICE has approved drugs and treatments, the NHS take-up still lags behind what it should be, despite the legal obligations.

To be fair to the Government, they seem to recognise the threat to the UK life sciences industry that Brexit poses. In the industrial strategy they identify life sciences as one of the five world-leading sectors that they wish to cultivate, and they have asked Sir John Bell—I can describe him only as brilliant—to lead work on early deals in this sector. That only makes the timing of this rather scrappy piece of legislation all the more surprising. However, we are where we are. The best thing we can do is put a protective overarching duty at the beginning of the Bill, and that is what Amendment 3 does. I hope the Minister considers that the amendment is helpful to the Government’s industrial strategy and the work Sir John is doing, as well as being a reassurance to the life sciences sector. It also needs to be the first clause in the Bill. I beg to move.

[Baroness Walmsley]

My Lords, in supporting the amendment, I reiterate my support for the general purpose of the Bill, which is to ensure good value for the NHS. However, there is a danger that it could result in reduced access for UK patients to new drugs and treatments if badly handled by the Government in future. As usual, the devil is in the detail—and, in particular, how the Government use the powers given to them in the Bill. That is why I support the imposition of a duty to ensure the continued growth of the life sciences sector and to protect access for patients to new medicines and treatments.

I share the concerns of the noble Lord, Lord Warner, about the effect of Brexit, which I mentioned in my Second Reading speech. In the light of the hard Brexit on which the Prime Minister is intent—without a mandate—there are many hazards to this industry, on which we depend for a major contribution to our economy, and to the future of medicine in the UK, so it is vital that the Government have that in mind when operating the Bill when it becomes an Act.

I have in mind as an example the new biosimilar medicines that the noble Lord, Lord Carter, pointed out in his report have the potential to save the NHS a vast amount of money while providing the same or even better treatment. He said that one new biosimilar drug alone can save the NHS £60 million a year. These biologic drugs currently account for six out of the top 10 medicines by spend in the UK, and I gather that five out of the top seven biologics will come out of patent by 2020—so there will be enormous potential for the development of generic biosimilars for many diseases. These drugs cost about 100 times more to research and develop than other generic drugs, but the current pricing system does not take that into account. They are different and, because of their enormous cost-saving potential and the competitive environment in which they will be marketed, which could bring down the cost even further, I think that they need special consideration from the Government.

Amendment 7, tabled by the noble Lord, Lord Lansley, which I support, could achieve this if the Government were inclined to use it, but I think we need to go further and put at the heart of the Bill a duty on the Government to protect future cutting-edge medicines when they first come into the market. Unless that is done, UK patients could become the last in the developed world to get these medicines. We want to be first, not last.

A healthy, competitive market will deliver tremendous cost savings to the NHS in the long term, but this requires sufficient—not excessive but sufficient—financial returns to compensate for the high cost of R&D. Otherwise, we will not have enough companies prepared to compete over a long period. This will prevent the NHS benefiting from the potential savings offered by these medicines. For those reasons, I support the amendment.

--- Later in debate ---

[Lord Lansley]

My Lords, I am grateful for the further opportunity to touch on an interesting issue which we discussed in Committee. On Report, I have proposed a different amendment that tries to meet some of the considerations that were quite properly raised in Committee. This relates to where the method of procurement for a branded medicine or product to which the statutory scheme would apply would be through a tender process and there would be an expectation that the best available price would be obtained through that process. I completely accept that previously we were looking at possibly exempting tender processes generally. The Minister quite rightly said that sometimes the tender process is used not to secure the best price, but to secure supply or procure products which are not directly comparable and where price competition would not be expected to be available.

I completely understand that, so this amendment says not that the Secretary of State under any circumstances is obliged to exempt a tender which has delivered a price outcome but that he may do so. Why do I think it is useful to do that? It is because there will sometimes be products where, for reasons of security of supply, it is important to undertake a tender process. At the moment, all companies in the statutory scheme or the voluntary scheme will have the implications of the PPRS pricing and rebate structure applying to them. As we have heard previously, the way that applies to individual products may be subject to price modulation depending upon how the company overall is affected by the scheme. It may therefore have a distorting effect on products that are offered through the tender. That is undesirable. We should want the tender process to be as transparent as possible and the price, supply and other considerations of the tender to be as self-contained as possible. That is perfectly possible to achieve if the Secretary of State has the discretion to exempt a tender process from the scheme.

As the Minister told us in Committee, the Government intend that framework agreements agreed before the regulations come into force will be exempted in any case. This amendment would helpfully give the Secretary of State the ability to exempt specific tenders from the application of the scheme. I do not want to anticipate too much, but the Minister may respond that the Secretary of State has the power to do that. If he says that the Government will actively assess where we may use such discretion to make it clear that tenders should be conducted in that way, I would be content. My noble friend instanced von Willebrand factor, where there are very similar products which are not necessarily competing on price. There is a general problem with plasma protein therapies because the cost structure that applies to them does not reflect the cost structure over the life of a product as it is reflected in patented, branded medicines generally. There is a good case for looking at an exemption in relation to products which have that high level of fixed cost rather than applying the price control and rebate in the way that happens now. I hope my noble friend will be able to say positive things about how we can maintain competition in the tender process and recognise the cost structures of certain medicines, because there is likely to be the application of the same principles to those products whether or not the company has opted into the voluntary scheme. Therefore the Government should be more willing under the statutory scheme to apply exemptions to those companies which have not opted into the voluntary scheme. I beg to move.

[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 O'Shaughnessy]

My Lords, I am grateful to my noble friend for his amendment and for providing the opportunity to talk about this important issue. It is important to note that the substance of this amendment is different from the substance of the amendment that was tabled in Committee, which would have given a blanket exclusion, while this is much more about providing the Secretary of State with the opportunity to exercise his or her judgment to exempt a product.

I absolutely appreciate the intent of the amendment, and reassure my noble friend that we believe it unnecessary. Due to the powers in the 2006 Act, the Secretary of State already has the ability to exempt individual products or groups of products from the terms of any statutory scheme, so this amendment would duplicate existing powers. For example, the Secretary of State uses these powers in the current statutory scheme to exempt products already under a contract or framework agreement. It is currently the Government’s intention that under the new statutory scheme, products procured under framework agreements that were entered into prior to the regulations coming into force would be exempt from the pricing controls and payment mechanism. However, branded products procured after the regulations come into force would be subject to the pricing controls and payment mechanism. Like any other cost, companies would be able to take this into account when proposing a price in response to a new tender. The regulations will of course be subject to consultation.

The point here is that there may well be cases where an exemption is required, and noble Lords have given examples of what that might look like. I hope your Lordships would agree that it would not be responsible for me to try and set out a list of them now, but clearly there will be occasions where that might be necessary. Any statutory scheme must of course also be sensitive—as indeed the legislation demands that it is—to the differing R&D costs that apply to the development of different medicines.

I hope that provides some reassurance on the points that noble Lords have made. We would be able to use the powers that already exist in the creation of the new statutory scheme for whichever purposes are desired at the time. On that basis, I ask my noble friend to withdraw his amendment. I hope those reassurances have done the trick.

[Baroness Walmsley]

My Lords, before the noble Lord sits down, is he able to respond to the issue about biosimilars, which I raised in an earlier debate and which the noble Lord, Lord Hunt, has just raised?

[Lord O'Shaughnessy]

I thought I had, when I talked about taking into account the differing R&D costs, which I think was the substance of the point made by the noble Baroness and the noble Lord, Lord Hunt. We have to take into account both getting a good price and the R&D costs, and that needs to be reflected within a statutory scheme, and would clearly apply to the case in point.

--- Later in debate ---

[Lord O'Shaughnessy]

My Lords, I beg to move Amendment 13 and am grateful to the noble Baroness, Lady Walmsley, for putting her name to this amendment and to the others in my name.

The amendments relate to the report and recommendations of the Delegated Powers and Regulatory Reform Committee, and I am extremely grateful to the committee for its scrutiny of the Bill—which, I believe, together with the government amendments, will lead to improved legislation. In my response to the committee, I confirmed that the Government would accept all four recommendations and would table amendments to take forward these actions. Once again, I am grateful for the work of the noble Baronesses, Lady Walmsley and Lady Finlay, and the noble Lord, Lord Hunt, for continuing to highlight the issues raised in the report.

I shall take each recommendation in turn. First, the committee concluded that the general power in new Section 264B(1)(l) proposed in Clause 6 to prescribe in regulations any person to whom information may be supplied is too wide, with insufficient justification. The government amendment clarifies this issue by confining the ability to prescribe in regulations to any health service body already listed in Section 9 of the NHS Act 2006 and NHS foundation trusts which are not listed in Section 9. This would have the effect of enabling government to prescribe in regulations the sharing of data with other health service bodies such as clinical commissioning groups, but not enabling other persons to be included by means of subsection (1)(l). We have made this change, as we would want to be able to share information with local health bodies, such as CCGs or hospital trusts, if we had concerns about prices—but not with others.

The committee concluded that the power in Clause 7 to enable Welsh Ministers to make regulations that make provision for payment of a penalty if a provider of pharmaceutical or primary medical services contravenes regulations requiring them to record and provide information about health service products which are required for the health service in Wales, should be consistent with similar provisions in the 2006 Act. In particular, the committee recommended that the maximum penalty which may be imposed under what would be Section 201A of the National Health Service (Wales) Act should be set out in the Bill, and that a power to increase this maximum by regulations should be made subject to the affirmative regulations. I am pleased to say that, following discussions with the Welsh Government, an amendment has been tabled which would amend Section 201A(5) to introduce maximum penalties into the National Health Service (Wales) Act 2006. We will amend the Bill to enable through regulations the power to increase the maximum penalty, and these regulations will be subject to the affirmative procedure.

Noble Lords will appreciate that, in the case of penalties, the powers in relation to Wales are different from those in relation to the UK as a whole in so far as Welsh Ministers will be able to impose penalties only on providers of pharmaceutical and primary medical services. By contrast, the 2006 Act allows for penalties to be imposed on manufacturers and distributers, and the size of any penalty should reflect this. It would therefore be disproportionate if the level of maximum fine allowed for in the 2006 Act were to be replicated in the NHS Wales Act. To address these concerns, the government amendment would limit the single penalty to £10,000 and the daily penalty to £100.

I turn to the amendment which would remove the provisions allowing Welsh Ministers to disclose information to persons prescribed in regulations. Welsh Ministers have agreed that the Bill should be amended to limit the types of bodies with whom information may be shared. The government amendment would specify the following persons to whom information may be disclosed by virtue of Section 201A. They include: a local health board or other person appointed under Section 88(3)(b) of the National Health Service (Wales) Act 2006 to exercise the functions of a determining authority under Part 7 of that Act; a National Health Service trust established under Section 18 of the National Health Service (Wales) Act 2006; any person who provides services to Welsh Ministers or to any person falling within paragraph (a) or (b); and any body that appears to the Welsh Ministers appropriate to represent Part 4 providers or Part 7 providers, as defined by Section 201A(8).

I turn to the amendment from the noble Lord, Lord Hunt, which seek to put those bodies that represent UK producers on the face of the Bill instead of in regulations. The Government will prescribe these bodies in regulations; the illustrative regulations we published merely provided some examples of representative bodies that the Secretary of State may disclose information to, and I assure the noble Lord that further work will be done on this list. We will discuss the list with stakeholders and we will, of course, publicly consult on the list to ensure that we get it right. I know that that was a concern of his.

Finally, we are proposing to table technical amendments to the Bill at Third Reading to reflect the fact that the Northern Ireland Assembly was not able to pass its legislative consent Motion on the Bill before it dissolved, despite the relevant committee having approved it. We will seek to amend the Bill to enable the Northern Ireland components of the Bill to be commenced separately through regulations once it has been possible to secure legislative consent.

As I hope your Lordships will see, the Government have addressed the concerns of the DPRRC. I also hope that I have addressed the concerns of the noble Baronesses, Lady Walmsley and Lady Finlay, and the noble Lord, Lord Hunt. I ask noble Lords who have tabled amendments not to press them and support the amendments in my name and those of the noble Baroness, Lady Walmsley.

[Baroness Walmsley]

My Lords, I am grateful to the Minister for what he has just said and for the conversations that we had about this group of amendments at Richmond House. As noble Lords will see, I have added my name to the government amendments in this group, because they achieve exactly what I was hoping to achieve when I tabled amendments in Committee. I am grateful to the noble Baroness, Lady Finlay of Llandaff, for supporting me in that intention. Unfortunately, when I withdrew my amendments in favour of the Government’s amendments, my message to the noble Baroness, Lady Finlay, did not get through, so she has unfortunately failed to withdraw her name. That is why she has asked me that, when the amendments in her name come to be put in order, I should make it clear on her behalf that they are not moved, which will achieve our joint intention. I know that the committee is also grateful to the Minister for hearing our concerns and taking action.

Health: Neurological Services

Baroness Walmsley Excerpts

Tuesday 31st January 2017 Lords Chamber

[Baroness Walmsley (LD)]

My Lords, I too congratulate the noble Baroness, Lady Gale, on introducing this important debate. It has highlighted a number of serious issues in relation to the provision of treatments and services for people with neurological diseases. These diseases may be incurable in many cases but there are many treatments and services that can improve symptoms, and improve the quality of life and death, for these patients. It is important that we look at the reasons why many are not getting them.

There is clearly a great deal of variability in the quantity and quality of care and services received by patients in different parts of the country. One of the demands made in the briefings that we received asked for a national service review, so that we can be aware of the state of services across the regions. It would be interesting to know how many of the STP plans include a local review of demand and service provision.

The briefings that we have received from various organisations are agreed about many of the issues. They are agreed that the current confusion as to who is responsible for these patients must be cleared up immediately. Since 2013, as the noble Baroness, Lady Gale, pointed out, there has been confusion because NHS England is responsible for specialised commissioning and the CCGs are responsible for other treatments and services. However—sadly—many CCGs have assumed that the whole responsibility lies with NHS England and this has resulted in patients suffering.

The evidence for this is clear. Only one CCG in five even knows the extent of neurological disease in its area and therefore the others have no strategy for addressing this. As we have heard, there is contradictory information in the manual for prescribed specialised services and the adult neurosciences service specification. The DH can do something about this right away. Will the Minister now set in train the process of launching the new national service standard along with—and this is important—a plan for promoting it among the commissioners? There is no point in it sitting on someone’s shelf. Will he also put in place a process for collecting information about whether commissioning for neurology has improved as a result of this change?

This leads me to the issue of data, on which there is also considerable agreement. Of course, if we do not collect data in an appropriate and consistent format, we will never be able to assess whether there have been improvements and where the gaps are. That is why I welcome the creation in 2014 of the Neurology Intelligence Network. Its work has already helped commissioners and other groups so I ask the Minister whether this work will be supported in the long term. This information is vital if we are to develop better treatments and even cures for some serious neurological diseases. It is also important that plans are put in place to improve the linking of health and social care data, because these help us to understand whether the well-being of patients is improving.

Clinical leadership is another issue that has been raised. Can the Minister explain why the National Clinical Director for adult neurology was scrapped, despite the good work done? How does the DH believe that the drive for better neurology services is being led in the absence of the clinical director—somebody who can really put some drive behind improving services—or has neurology simply been given a low priority?

I am aware that, since the post was scrapped, the Neurological Alliance has worked with the NHS to set up the National Neurological Advisory Group consisting of several senior experts. This is welcome, but will the Minister say how this group’s advice is being put into practice and whether it will continue to be supported? How is the advice being evaluated and disseminated? Will there be, as others have demanded, a national plan for neurology?

Talking of national plans leads me to mention the national stroke strategy. I wondered whether I could legitimately speak about stroke in this debate but I came to the conclusion that I could because although strokes are caused by vascular breakdown, they result in neurological problems that are often severe. The difference, however, between stroke and some other neurological diseases is that many stroke survivors can recover well and go back to their old life, becoming once more productive contributors to society—that is, as long as, once they leave hospital, they have the necessary rehabilitation which may involve speech therapy, physiotherapy, occupational therapy, mental and emotional therapy and much more.

The national stroke strategy has been a great success. Not only has it led to reconfiguration of services in many places, where centres of excellence are saving more lives and leading to far less disability, but there has also been more provision of the rehabilitation that patients need to help them get well and not feel so isolated. We can label it a great success. However, as with rehabilitation, which needs to carry on in the long term or patients can go backwards, the national stroke strategy, which comes to an end soon, needs to be continued or replaced with a new strategy to build on the achievements of the old one. What plans do the Government have to replace or extend the national stroke strategy to ensure that we do not lose the improvements that have been made to services over the past few years?

Rehabilitation is also important for other neurological conditions—for example, for people who have had a tumour removed. It seems that it is quite fashionable to raise money for flashy scanners for diagnostics. These are, of course, important because early diagnosis is vital. However, it seems that this is more important to some than to recruit, train and pay for the skilled people who are needed to help people to get over the effects of stroke and other neurological problems. I fear that the effect of Brexit is going to be dire on the supply of many of these people and on the supply of radiographers and radiologists who can interpret the results of the scans. These are vital for the recovery of so many patients.

Sustainability and Transformation Plans

Baroness Walmsley Excerpts

Thursday 26th January 2017 Lords Chamber

[Lord O'Shaughnessy]

I thank the noble Lord for that question. STPs are voluntary groupings of all the relevant people—whether that is at the acute level, in primary care or local authorities—coming together under leadership to create the changes. Those then turn into operational plans that are delivered by individual hospitals, primary care settings and so on.

[Baroness Walmsley (LD)]

My Lords, these plans were supposed to have got under way last October. Have any of them actually started transforming services in their area, or are they still too busy figuring out how to balance the books?

[Lord O'Shaughnessy]

All 44 sustainability and transformation plans have now been published and are being scrutinised by NHS England, which is helping to ensure that they are as successful as possible. Operational plans will then come forward from April 2017 onwards.