Health Service Medical Supplies (Costs) Bill

Baroness Finlay of Llandaff Excerpts

Wednesday 5th April 2017 Lords Chamber

[Lord Lansley]

I am perfectly happy if the Minister wants to reply but, from my point of view, I do not regard the PPRS as state aid. If R&D tax credits are available, they should be made available. When the Office of Fair Trading reviewed the PPRS back in 2008-09, I think, it concluded that it was neither a state aid nor a spur to innovation but was actually all about managing the drugs budget. That is what this legislation is all about: managing the drugs budget.

It is, however, important to recognise that the statutory duties in Lords Amendment 3 do not include the one which the Secretary of State should have specific regard to: affordability. It is deficient in not providing for that. Noble Lords will recall that, at an earlier stage, I tabled an amendment the purpose of which was to insert a more complete set of statutory duties for the Secretary of State to have regard to. Affordability must form part of that, but it is not present in this amendment. I am therefore against the amendment.

In the course of this legislation we have discussed other important issues which are still coming to a head. It is absolutely right, as my noble friend said, that the Government are setting out to promote innovation and the life sciences sector, and there are many ways of doing that. The Conservative Party manifesto of 2015 stated:

“We will increase the use of cost-effective new medicines and technologies”.


It also stated:

“We will speed up your access to new medicines”.


It is important that we do that as it is in the interests of patients, our life sciences industry and ourselves as a world leader in science in this area. However, we have on the stocks the accelerated access review—which, ironically, took too long to be produced, was delayed in its publication and has not yet been replied to. We also have a life sciences strategy. The many positives in that run the risk of being negated by the way in which NHS England and NICE have gone about the consultation.

As I said at an earlier stage, it is possible to see how NICE and NHS England can work together in ways that would give industry greater confidence as it would mean that it could get early engagement with NHS England about the managed entry of new medicines into the NHS, including, as my noble friend said, on issues of importance to industry, such as the volume of purchasing of new medicines in the early stages of access. However, the budget impact test, at £20 million, is probably not one-fifth of all new medicines; it is one-fifth of all new medicines regarded as cost effective by NICE. Therefore, this is not a case of any old medicine that might be very expensive; it just happens to be medicines which are cost effective but have relatively high volumes, which is exactly the point to which the noble Baroness, Lady Walmsley, referred.

However, the issue for NHS England should not be the cost of introducing new medicines that are cost effective and in the voluntary PPRS, as the purpose of the pharmaceutical price regulation scheme, as currently designed, is—through the clawback—to give government assurance about the overall increase in the drugs budget. As a consequence, that money is made available as part of the overall funding provided to NHS England. Therefore, NHS England should in theory have in its budget the money that is necessary to meet the drugs bill, including new medicines as they come on stream, because there is clawback for that.

We have this Bill in front of us partly, but not entirely, because the drugs budget was rising much faster than anticipated, and much of that growth was outside the voluntary PPRS. This Bill plugs that gap and sorts that out. However, in doing so—and here we are at the beginning of April—once this Bill is on the stocks and secures Royal Assent and the Secretary of State is able to align the statutory PPRS with the voluntary PPRS, there is no reason why NICE and NHS England should continue to apply an overall budgetary impact test. I say to my noble friend that I think the Government should step in at that point and say, “Where this product has come through a PPRS where a clawback is applied and we have a budgetary mechanism in place—redress—for any extra cost to the drugs bill in the course of this PPRS through to the end of 2018, NHS England should not interpose any extra delay, or seek any extra delay, through NICE in introducing that medicine to the NHS”. I am afraid that if it continues to do so in the way that it is at the moment, that will have a severe negative impact on the view held by the boards of major corporations in relation to the take-up of new medicines by the NHS.

I am sorry to say to the noble Lord, Lord Warner, and other noble Lords that the remedy is not contained in this amendment. The remedy is in the Government’s hands if they choose to make that point very clearly to NHS England in relation to what this legislation enables us to achieve in controlling the drugs budget.

[Baroness Finlay of Llandaff (CB)]

My Lords, I thank the Minister for the way in which he has conducted all the previous stages of the Bill, the amount of discussion and negotiation that he has had with all of us, and for accepting many of the amendments. It might be helpful to the House, if, when he sums up, he could clarify how much of the 7% increase is due to new NICE-approved drugs coming through into the system.

It would also be helpful to know whether NICE has the ability to refuse to go along with the budget impact test on this estimated one-fifth of medication that it deems to be cost effective if it feels that a new medicine coming on line is extremely cost effective and that its cost efficacy will have a major impact on those with life-limiting or life-altering conditions. I am talking about people with a disease that will progress at quite a rate, meaning that over a 90-day period they will be likely to experience a significant decline without the intervention of whatever the new medication might be.

It would also be helpful if the Minister could tell us how the independence of NICE will be assured with this budget impact test. In many parts of the world NICE has been viewed as exemplary in deciding how a medication is approved to come on line, but there are problems with it. If it were viewed as having its independence eroded, that would seriously undermine public confidence in the whole process, particularly among those who have serious and life-limiting or life-altering illnesses.

[Baroness Masham of Ilton (CB)]

My Lords, I am all in favour of bringing down the price of drugs where possible, but patients’ access to new drugs is very important. For a long time, NICE has been very slow to approve drugs and that has caused great frustration for patients and the industry. What can the Minister do about orphan drugs? Not having them can be life-threatening for patients, but NICE has taken some of these drugs off the list. That is really serious for patients for whom they are a lifeline. Does Scotland not have a better system?

End of Life Care

Baroness Finlay of Llandaff Excerpts

Tuesday 14th March 2017 Lords Chamber

Asked by

[Baroness Finlay of Llandaff]

To ask Her Majesty’s Government how they intend to ensure that Clinical Commissioners respect the undertakings made in Our Commitments to You for End of Life Care: The Government Response to the Review of Choice in End of Life Care.

[Baroness Finlay of Llandaff (CB)]

My Lords, I thank the Government for having provided time for this important debate and declare my interests in palliative medicine, particularly as national clinical lead for Wales from 2008, chair of the National Council for Palliative Care and a vice-president of Marie Curie.

Cicely Saunders founded the modern hospice movement 50 years ago, with activity underpinned by evidence. It was she who said:

“You matter because you are you, and you matter to the last moment of your life. We will do all we can to help you, not only to die peacefully but to live until you die”.


That scientific evidence has shown that morphine, given regularly at the right dose at the right time, can safely get on top of pain. Sometimes, other effective interventions, ranging from expert use of modern sophisticated analgesics to nerve blocks, are needed. Acute breathlessness and acute anxiety can now be managed. Open, calm and honest conversations with patients about their illness, their needs and what lies ahead can transform their experience as death approaches.

Care of the family, including children deeply affected by a person’s death, is core to good person-centred care. It means thinking ahead, planning for “just in case” rather than simply responding. Those facing the uncertainty of life-threatening illness must not feel abandoned, must know that continuity of care at all times will meet their needs, and that unexpected crises will be responded to urgently. Disease does not respect the clock nor the calendar. Help and support must be available whenever and wherever people need them.

I have had thousands of difficult, honest conversations with patients, listened to the grief and pain of parting, to fears and to deep, unresolved guilt. I have seen how those in despair can live well again with appropriate care, often amazed at finding meaning again in their lives when they had given up all hope.

However, it is not easy. Palliative care is not like taking a course of antibiotics that either works or does not. It requires constant review, carefully helping people as they adapt to their new reality. It means “being there”, and patients knowing that help is there for them at home and not just being rushed to A&E.

Relatives who have experienced gentle dying are not usually moved to tell the world of their reassuring experience, but a small number of bad deaths make headlines. Media coverage dramatises difficult situations as “human interest” stories. They sell papers, but they also paint a misleading picture of death and dying normally. Bad care should never happen. The failures identified in the ombudsman’s 2015 report will be addressed only by adequate service provision, tasked with driving up improvements everywhere.

Palliative care has gradually become mainstreamed. In 2008, the Department of Health’s End of Life Care Strategy set England’s plan to improve end-of-life care. A similar planning group, led by Viv Sugar, set out Welsh goals for palliative care services. This created a natural experiment.

In Wales, an investment of £6 million per annum recurring allowed a funding formula to be developed that targeted services to plug gaps and ensure fair access to specialist palliative care wherever a person lived. It has provided face-to-face specialist palliative care across seven days a week and consultant advice to all health and social care professionals on a 24/7 basis. Services into hospitals are proportionate to the number of beds and, across the community, proportionate to the population size. Recent outcome evaluations in Welsh hospitals suggest that this is bearing fruit and that communication is better managed. Pain is being managed. In the last five years, more than 8,000 patient and family evaluations have shown outstanding ratings of their specialist palliative care experience overall. The average is high.

In any one year, 0.75% of the population overall will have palliative care needs. Death is ubiquitous and inevitable. In 2015, almost half a million people died in England and more than 33,000 in Wales.

Reports since 2008 include the NICE quality standards, an independent funding review and One Chance to Get It Right. Then in 2015 a collaborative of providers published six high-level goals in Ambitions for Palliative and End of Life Care. In 2015 Claire Henry, commissioned by the Government, published What’s Important to Me—A Review of Choice in End of Life Care. People have clearly stated that they want the right care, at the right time, from high-quality, well-trained staff. They want honest conversations, not unrealistic expectations. They know that disease does not respect the clock or the calendar. People want to be involved in discussions about their care; they want to make sure that staff know their wishes and that all needs—physical, emotional, social and spiritual—are addressed. People facing dying want to know that their families are supported and involved.

The Government’s response last year addressed much of the report, showing synergy with the main themes of both the choice review and the ambitions framework. However, the review called for an investment of £130 million. The Government declined, stating instead that end-of-life care was to become a core priority within the NHS transformation programmes:

“Improvements to end of life care should not occur in isolation. They should be threaded through the most effective New Models of Care that will deliver the new, transformed NHS. Sustainability and Transformation Plans (STPs) should fully take into account the contribution that sustainable, efficiently designed end of life care services can make to achieving better outcomes for dying people”.


I was unconvinced that this was happening, so in 2015 my researcher and I analysed responses from all 209 clinical commissioning groups to a freedom of information request about their specialist and other palliative care services. We found wide variations across England in the core data that they collect and a disparity in the responsibility of service provision between clinical commissioning groups, trusts and local voluntary sector hospices. The decision-making devolved down to clinical commissioning groups suggests that palliative care is not being considered as a core service in some parts of England, despite much evidence of its cost-efficacy.

Two important randomised controlled studies of specialist palliative care input have shown that patients have a higher quality of life and better moods. Not only do they live better, but they also, surprisingly, live longer with good palliative care support, at no additional overall cost. Good palliative care saves money.

The Government’s vision in 2009 created Dying Matters to empower people to talk, live and plan. A national conversation started with a focus on wills, how to get help, and how to ensure that someone can speak up for you if you cannot. Compassionate communities are growing, encouraging people to look out for each other, do what they can, and not shy away from those who are ill or bereaved.

But then came the sustainability and transformation plans. Preliminary analysis looks grim: they do not reflect the Government’s stated intention. Almost half make no mention of end-of-life care at all, or only transiently, and only six of the 44 STPs actually embed end-of-life care as a strategic priority.

Public Health England has just published guidance on Cost-effective Commissioning of End of Life Care. It is a worthy review, but it does not provide a clear template to plug gaps. The Government’s commitment of last July was that,

“every person nearing the end of their life should receive attentive, high quality, compassionate care, so that their pain is eased, their spirits lifted and their wishes for their closing weeks, days and hours are respected”.

However, gaps remain. Today’s King’s Fund report shows the impacts of financial constraints on patient care, particularly in the community. So I respectfully ask the Government whether they will now look again at a framework funding formula that works in conjunction with voluntary sector providers—who do so much—to make sure people everywhere can access the care they need rather than depend on the lottery of commissioners’ views.

Health: Neurological Services

Baroness Finlay of Llandaff Excerpts

Tuesday 31st January 2017 Lords Chamber

[Baroness Finlay of Llandaff (CB)]

My Lords, I congratulate the noble Baroness, Lady Gale, on her ongoing and persistent work on behalf of neurological patients. Up to a fifth of acute medical admissions are neurological problems. The second national survey of acute neurological services is about to be published and despite indications of some improvement in the past two years, we still lag way behind Europe and the US overall. With around a sixth of the neurological workforce of Europe the NHS cannot cope, let alone deliver optimum care. The hospitals surveyed reported limited access to neurologists overall. The 28 neuroscience centres have seven-day consultations, but over a quarter of general hospitals have a neurologist on for only three or fewer days a week, while a fifth of clinical commissioning groups offer no neurological services at all—yet accurate diagnosis is key.

Neurology input leads to a revised diagnosis and new management plan in 79% of patients—that is, four in five. Time matters: neurological emergencies can become permanent disability in minutes or signal a devastating progressive diagnosis. Open conversations must start early. As disease advances, specialist palliative care can dramatically improve quality of life and ensure a calm and dignified death. With specialist planning, and I declare my interests, those deciding to stop interventions such as ventilation have breathlessness and distress controlled. They are not left gasping and choking, as the press horror stories portray. Everyone with advancing neurological disease should be offered access to specialist palliative care; currently, only a minority are.

The Association of British Neurologists is working closely with NHS England, through Professor Adrian Williams, but there is only so much that they can do. Will the Government now establish a national strategy for acute and chronic neurological services to address the variations in care, and will they ask Health Education England to increase training opportunities in neurology and in specialist palliative care?

Sustainability and Transformation Plans

Baroness Finlay of Llandaff Excerpts

Thursday 26th January 2017 Lords Chamber

[Lord O'Shaughnessy]

On public scrutiny, all the sustainability and transformation plans have had public involvement. They were published and consulted on. I do not recognise the picture that the noble Baroness paints in relation to cancer drugs. This Government created the cancer drugs fund in order specifically to fund innovative cancer drugs and bring them to market more quickly. She will know that decisions on availability and funding of drugs are properly taken by NICE on a clinical basis.

[Baroness Finlay of Llandaff (CB)]

In July last year, the Government’s response to the national end-of-life choice offer was that end-of-life care would be part of all transformation programmes, yet 20 of the plans make fleeting or no reference whatever to end-of-life care and only six have clearly stated plans. That is despite approximately a quarter of a million patients dying each year in hospital. While some cases are acute, a large number of patients have a period where they need their care improved. What action are the Government taking?

[Lord O'Shaughnessy]

I thank the noble Baroness for making that point. The purpose of NHS England’s review of the STPs is to make sure that they account for all the priorities set out in the Five Year Forward View. Clearly, that involves end-of-life care, and NHS England will work hard to make sure that it is properly reflected.

Health Service Medical Supplies (Costs) Bill

Baroness Finlay of Llandaff Excerpts

Committee: 2nd sitting (Hansard): House of Lords
Wednesday 25th January 2017 Grand Committee

[Baroness Finlay of Llandaff (CB)]

My Lords, I have some sympathy with the amendment of the noble Lord, Lord Warner. It strikes me that the information being asked for in the Bill requires a degree of detail that probably is not going to reflect reality. This is very often a global industry, so defining a “UK producer” will be quite difficult. If we make the information requirements too difficult, I see a risk of some of the larger companies deciding to produce more offshore rather than here.

The other difficulty with the pricing of any medical treatment that comes to market is that it has often had a very long lead time—over years. So the true cost of that particular item becomes almost impossible to disaggregate from all the other costs. Then, once it is produced and packaged, there are distribution costs, the mark-up at wholesale level and so on. I can see how a producer, in wanting to keep a cost high, could potentially move around its budgeting line to protect itself. But the problem is that if you do not have a trigger, you may get so much data that you cannot actually extract the true knowledge and the important information from them. I understand why you would want to have a lot of data to be able to move the cost and map it efficiently, but there is only any point in mapping it if it has accuracy attached to it.

I have a question for the Minister. In all these information requirements, how will a “UK producer” be defined, as distinct from an international producer from elsewhere? I may have missed it, but I could not find it defined in the Bill; I can see only products defined.

It will become almost impossible to know where the true cost is, but if a cost is going up, that becomes counterintuitive. Generally, for medication that is out there on the market, the cost should fall. Usually, production costs drop, because, for example, antibiotic production used to be incredibly expensive and is now very much cheaper because of efficiencies and the way that the science has moved forward. So you would expect, with bulk sales and technological advances, that the cost should come down. I therefore have a question for the noble Lord, Lord Warner, on the trigger mechanism. Is his price absolute—in pounds—or is it also considered relative to other products in that field that may be on the market? For example, we have seen some major discrepancies with ophthalmic products. Eye drops for glaucoma have been incredibly expensive compared to exactly the same substance that is being used in oncology and has been priced at a much lower rate. The question has to come up as to whether the price is being held and maintained inappropriately, rather than having gone up.

[Lord Warner]

In response to the noble Baroness’s point, I would not claim to have actually considered the detail of what level of pricing we will use. My point in this amendment is to try to establish the principle of a trigger mechanism, and I am happy to be advised on ways of improving it.

Health Service Medical Supplies (Costs) Bill

Baroness Finlay of Llandaff Excerpts

Committee: 1st sitting (Hansard): House of Lords
Monday 23rd January 2017 Grand Committee

Controlling the cost of drugs and trying to ensure that new drugs are available to patients is obviously key. However, we are still in a situation in which there is a vast degree of overprescribing. We still face the serious challenge of antibiotics being overprescribed. I would welcome, in the Minister’s response, an assurance that, in the round, some of these issues are going to be addressed. It seems that they are all a key part of solving the problem and ensuring that we have an effective drugs policy inside the NHS that is doing two things: encouraging the innovation of new drugs within British companies and ensuring the effective use of these drugs. There is such variation across different trusts, so looking at best practice and where we are getting good value for money is also a key part of the equation. I hope that these points have been of some value.

[Baroness Finlay of Llandaff (CB)]

My Lords, I support this amendment. I have a real concern that the whole process of pricing and costing of drugs is very poorly understood. I was lucky enough to hear a lecture at the weekend by Jack Scannell, an economist who understands quite a lot about drug pricing. He pointed out that there are four reasons why drugs are expensive: one is cost; one is perceived value; another is power; and the fourth is the prize that they can deliver. It is all in a paper that he wrote about the four reasons why drugs are expensive, two of which he labelled as false: the cost and the so-called value. The reason is that a company will start to explore different chemical substances that might have an effect; 90% of these never progress but remain in various test tubes and are stored. One day they might be of use.

The problem then is that, even if they develop something and take it through the different trials, there are fairly arbitrary examples of where the benchmark is set in different sectors. A clear example of this came up with the drug Campath, which came from Cambridge. It was developed for leukaemia, but was found to be remarkably effective for multiple sclerosis. The drug company then withdrew the drug because it was being prescribed off-licence: it was not licensed for multiple sclerosis. It took the trials through, licensed it for multiple sclerosis under a new name—Lemtrada—and the price was much higher because the benchmark of prices for multiple sclerosis was much higher than that for drugs for leukaemia. The chemical was the same. Actually, when a drug goes out and is priced, it really is, in a way, a guess on behalf of the pharmaceutical industry at the outset.

Another problem arises that relates to the importance of having trials in this country. Trials have to be done on the population to which the drugs are going to apply. It is quite interesting that with different healthcare systems, clinicians see patients at different stages of disease, so with a late diagnosis, you might have a much larger disease burden requiring treatment than you would have had if there had been an earlier diagnosis.

If the trials are conducted in this country, therefore, within the NHS and the real care system—the real world in which these drugs are going to be used—and as near as possible on the very population on which they are going to be used, you get the most accurate results. They can guide NICE in determining how effective a drug really is.

If you have a study on a population with a very early diagnosis, and therefore a relatively low disease burden, you might get a false impression of efficacy, which could lead NICE to believe that the drug was being actually more effective than it will turn out to be in our population. The converse is also true.

That leads me to stress the importance of supporting a flourishing life sciences sector, because we need to be developing drugs in this country, within the care setting in which they will be prescribed and for the population to whom they will be supplied. Any attempt at pricing must, importantly, not disincentivise the pharmaceutical industry to develop the 90% of drugs that go nowhere to find the 10% that will go somewhere.

I hope that the Government will take the new clause very seriously, because it signals an important intention up front in the Bill.

[Baroness Redfern (Con)]

My Lords, I declare my interests as recorded in the register and formally welcome my noble friend Lord O’Shaughnessy as the Minister this afternoon. Although the Bill is modest in size and has few clauses, it will deliver an important role in securing better value for money not only for the NHS but for patients.

Pressures on the NHS increase year on year because of our ageing population, new technology, and development of new procedures with advanced drugs, resulting in an increase in spending over the past five years of 20%. We spend more than £15 billion a year on pharmaceutical products, and we are acknowledged by those companies to be a reference market for many other countries that do not have such a large or well-organised supply chain as we do.

Patients request access to innovative and cost-effective medicines, so the Bill delivers value for money and does not support the drug companies, which have a commanding monopoly position, to push up their prices. I am pleased to see a strengthening of the ability to collect data on the cost of medicines, medical supplies and other related products from across the supply chain, which the Bill would amend by extending the provisions of the 2016 Act.

The statutory scheme has delivered significantly lower than expected savings for the NHS, with concern as to whether competition in the market is sufficient to control prices, so with new powers to be established under the Bill, there will be opportunities for more competition for unbranded generic medicines and to apply price controls for companies that are members of the PPRS. Particularly when companies can charge unreasonably high prices for unbranded generic medicines when competition does not keep the prices down, the Bill closes a current loophole in the legislative framework.

Clause 6 requires information from more producers and companies but, importantly, any information that they supply which may be commercially sensitive cannot be disseminated beyond the prescribed bodies. We may therefore be better informed on a more consistent basis, particularly to assess whether the supply chain as a whole or a specific sector provides value for money for the NHS. The world is changing, and personalised medicine is an important development for us all—but, again, it needs to be delivered both effectively and affordably.

At all times, we must make sure that the UK is seen as an attractive place for the life science sector—research being seen as a vital component in the sustainability of the NHS, as we have heard from previous speakers. To balance the control of the price of medicines and innovation for pharmaceutical companies, there should not be a lack of motivation to invest in the extensive R&D that we all want. In order to stimulate continued investment, it is appropriate for the industry to see a stable marketplace here as significant and important.

If we are to create a level playing field for drug companies, should we not be trying to do the same for patients? I therefore ask my noble friend whether one measure to tackle the issue could be ring-fencing possible rebates or a percentage from the sector to invest in improving access to medicines and treatments—particularly when we read that a fifth of new drugs face rationing under tighter NHS cost-cutting plans. With a budget impact threshold, that has the potential to slam the brakes on the most effective new treatments and technologies just before they get to patients.

Finally, although we promote innovation, that is not only a priority in the NHS for the Government but for many other stakeholders in the industry. As I said, the Bill is modest in size but it carries the opportunity to ensure that this country is not left behind in access to the newest and best treatments, and that it delivers best value for money.

--- Later in debate ---

[Lord Lansley]

The short answer is yes. We should aim for what is a price paid by the NHS to the industry for the medicines that it uses that is reflective of value and is designed to promote innovative medicines—that is, as we will discuss in a later amendment, those that meet unmet need or add substantially to therapeutic benefit and are not the “me-too” drugs that are very similar to existing medicines but have a slightly different method of operation or delivery. Paying for what innovation gives by way of therapeutic benefit is where we want to be.

However, the amendment is right in the sense that one has to do that alongside supporting the life sciences sector. That is where freedom of pricing at introduction is important. I have accepted the principle of a PPRS which delivers a budget to the NHS and delivers freedom of pricing to the industry. We are not legislating precisely for the structure of the PPRS, but let us assume that those are continuing features. However, through the operation of the rebate or some other means, it seems perfectly possible to incorporate some of the criteria that will be the subject of our discussions on a number of amendments, as is reflected in the second limb of the amendment.

[Baroness Finlay of Llandaff]

The noble Lord referred to me-too drugs. I hope that he agrees that it is important to recognise that such drugs have often been developed in parallel. They do not take a molecule and just copy it; they develop a new molecule or delivery system, often to minimise side-effects and to maximise efficacy. But they also have a production cost behind them. They are not just copies of something previously produced and marketed differently; they have innovation behind them as well.

[Lord Lansley]

I understand that. There is a perfectly good argument for the benefits that are derived from incremental innovation. Not every innovation is a step change compared to what has gone before, so that is a perfectly valid point. One objective that we should arrive at, as I hope my own Amendment 10 will later reflect, is that the structure of value has to understand what those benefits might look like. New medicines will come through that are similar but are significantly better, for example in terms of compliance for patient populations, because they are administered differently. One might say, “Well, it’s a very similar drug”, but one has to look at what the overall benefit might be, which is part of the value.

--- Later in debate ---

[Baroness Finlay of Llandaff]

Let me thank the Minister for that comprehensive reply and for his openness in discussing things with us all. He talks about having discussions with the industry. I hope that he is aware that there is a move by the industry to consolidate into three major hubs, or potentially four. The fourth would be the Oxford-Cambridge-London axis, the other three being those in Boston, in California and in Basle in Switzerland. We are at a critical time, because a lot of change is going on—hence the motivation for so many of us to support the amendment, as we are aware that things are potentially fragile.

[Lord O'Shaughnessy]

I thank the noble Baroness for that point, with which I completely concur. This is obviously a big moment in time, for several reasons. Our current price regulation systems for pharmaceuticals run until the end of 2018 and, in 2019, we will leave the European Union. These things are bundled together and co-dependent; making the right decisions on each of the factors will have a knock-on effect on the rest. I very much understand the point. As I said, my job has the tension of both responsibilities, including health, and the trick is to square the circle.

--- Later in debate ---

[Lord Warner]

My Lords, I support these amendments, to which I have added my name. I do not want to go over again what has just been said, but the issue of access is critical. It is why companies have invested in this country. They criticised NICE when it was first set up; they were highly hostile but have been wooed over, have stayed with the game, played in it and continued to make products which are of great benefit to NHS patients. However, having jumped that hurdle they now see a new one, which is driven not by cost-effectiveness but by cost—a straightforward capping of expenditure at an arbitrary figure of £20 million. The noble Lord, Lord Hunt, was a little critical of NHS England. I would be if I thought that it was only NHS England but I do not believe that the Government are not behind this, putting pressure on it. We already have a massive difference of view between the Conservative chairman of the Health Select Committee and the Prime Minister over how much extra money has actually been put into the NHS. The noble Lord, Lord Lansley, winces, but such measures are being introduced basically to stop the NHS carrying out a legal obligation to implement NICE recommendations. I totally support the amendments in the name of the noble Lord, Lord Hunt, because they are a way of trying to ensure that, where repayments are made, they go back to where they should be, which is in the NHS and helping patients to access new drugs.

[Baroness Finlay of Llandaff]

I have added my name to the first of the amendments. I would have added it to the second, but there was not room—there were already four names there. I strongly support them. The debate so far has related to the pharmaceutical industry, to pharmacies—that is, chemists in the community—and to the NHS but these amendments go to the heart of it, which is access for patients.

One problem with what will feel to a patient like almost arbitrary rationing is that they will know that they have a disease or condition and that there is a drug which, if they lived in other parts of the world or had more money, they would be able to access and which, for one reason or another, they cannot. We must recognise that any costing system for medicines is relatively arbitrary and does not cost in all the social costs of disease progression, or of more severe versus less severe forms. Nor does it factor in the cost to the whole family of the distress somebody feels when they need medication and cannot access a drug which has gone through an appraisal process and whose criteria they can see they fit.

I hope that the Minister will look sympathetically at the principles behind this amendment. If you save money but do not put it back into access to medicines, you are effectively bleeding that area to plug other gaps or deficits in the NHS. As for the patient with the condition who knows that there is medication that probably would help them, although they are well aware that they could be a non-responder, no one should underestimate the anguish to them and their families, or the knock-on effect on society in the long term of failing to ensure access to effective medications.

--- Later in debate ---

[Baroness Finlay of Llandaff]

In light of the noble Lord’s remarks, I wonder how he sees there being flexibility. The problem with establishing a value-based price, however one works it out, is that we do not have a crystal ball. A product may be used for a whole lot of different indications. One example is Rituximab, which was developed for lymphoma but is now widely used for at least seven other indications. Some of those are chronic conditions, so there is long-term use.

Obviously, the company produced a product and a price was fixed estimated on a certain amount of use, but then its sales went up hugely. That represents an enormous profit. In the system that the noble Lord envisages, how much flexibility would be built in to allow for volume sales and a dramatic lowering of the production costs? That has happened with a lot of things that were initially expensive to produce, but where production costs dropped dramatically over time. We must not inadvertently get locked into pricings that over time become inappropriate.

[Lord Lansley]

There is a risk of making this debate too extended, but the amendment is not about the whole structure of pricing but about what criteria should be taken into account. In the context of a PPRS scheme such as the present one, the point I made previously was that it would be possible, for example—and this is only an example—to modulate the rebate by reference to any gap between the price charged to the NHS by a company and the value as disclosed by a comparative assessment.

Of course, if there are a number of different indications, the value may vary according to those indications, but that is no problem in itself because all you are doing is trying to understand to what extent a company would be required to contribute a lot to the rebate because there was a big gap between the price charged and its relative value. Some companies may contribute virtually nothing to the rebate because there is no disclosed gap between the price charged to the NHS for a product and its relative value. That is merely an example of how a scheme could be adapted using this sort of value assessment. I beg leave to withdraw the amendment.

--- Later in debate ---

Moved by

[Baroness Finlay of Llandaff]

15: After Clause 5, insert the following new Clause—
“Specials
After section 260 of the National Health Service Act 2006 (control of maximum price of medical supplies other than health service medicines) insert—“260A Specials(1) When commissioning the production of ”specials”, National Health Service clinical commissioning group, hospital trust and community pharmacies must seek no less than three quotes for non-tariff items, at least one of which should be from a National Health Service manufacturer.(2) Unless there are over-riding reasons not to accept it, the cheapest quote must be selected.(3) When setting the tariff price for “specials”, NHS England, in its tariff-setting process, should seek prices from National Health Service, as well as private, manufacturers.(4) For the purposes of this section, a “special” is an unlicensed batch of a medicine prepared or extemporaneously dispensed.””

[Baroness Finlay of Llandaff]

My Lords, I will now move into a very different area, but one that is integrally related to the Bill: that of “specials”. Concerns relating to specials and obtaining them have been brought to my attention by the British Association of Dermatologists, the Royal College of Ophthalmologists, the Royal College of General Practitioners and others—so the issue goes more broadly than simply dermatology.

Specials are unlicensed medicines manufactured or procured specifically to meet the clinical needs of an individual patient. They may be put on the skin; they may be alternative ways of making a medication that can be ingested when there are swallowing difficulties: for example, in babies fitted with a fine-bore nasogastric tube, and so on. The most frequently prescribed specials are made in small batches, but sometimes there are only one or two patients at any one time in the country who need this particular preparation.

--- Later in debate ---

In conclusion, I hope that I have reassured the noble Baroness that we are engaged in considerable work to improve the value for money that the NHS gets in the procurement of specials. This Bill provides a key element of that ongoing work by enabling us to get information from NHS manufacturers to achieve the result that the noble Baroness and, I believe, all noble Lords seek. However, I have concerns about the impact that the first part of her amendment would have on the cost of operating the system and on prompt access by patients to specials. On that basis, I ask the noble Baroness to withdraw her amendment.

[Baroness Finlay of Llandaff]

I am grateful to the Minister for his very full reply, which I intend to study in detail. While he has made several points, I have ongoing concerns about leaving this unaddressed in the Bill. In light of what he said, I still do not understand why some manufacturers quote different prices for Scotland and England. Their production costs are exactly the same, so why are they quoting higher prices for England? It does not make sense. England is then paying a higher price than Scotland.

The dispensing fee that goes to the community pharmacists is the same, irrespective of the price paid. I worry that the bureaucratic burden of the clinical commissioning group refusing to pay for something because it seems inordinately expensive is a short-term view in the interests of immediate budget containment, and does not take a long-term view over the life course of an illness that could be contained by using something specifically designed for that patient so that, in the long term, there could be a decreased cost to the NHS. I remain concerned.

I have absolutely no intention of there ever being delays in accessing things in an emergency, but only where a patient is not in an emergency situation. In the community, the pharmacist often does not have things in stock anyway and has to order them. The patient or their representative has to come back the following day or 48 hours later, when something has arrived. I am not convinced that the bureaucratic burden would be that great. I can see that three quotes may be too many, but an alternative quote might be a way forward. In the meantime, I beg leave to withdraw the amendment.

Amendment 15 withdrawn.

NHS: Community Pharmacies

Baroness Finlay of Llandaff Excerpts

Tuesday 6th December 2016 Lords Chamber

[Lord Prior of Brampton]

My noble friend has made a very good case in support of community pharmacies, which provide a fantastic service. My own local community pharmacy provides an extraordinary service for people living in the part of rural Norfolk where I come from. They have an important role in public health as well.

[Baroness Finlay of Llandaff (CB)]

Will the Government undertake to review the funding model for community pharmacies? If they are undertaking more diagnostic services and reviews and giving more advice, while also rationalising the medication people are on, they are effectively advising themselves out of a source of income when they are reimbursed with dispensing fees. If they are going to lose income, it is very difficult for them to advise people to come off a range of medication.

[Lord Prior of Brampton]

My Lords, we have just looked again at the community pharmacy funding model and have decided to go from a purely volume-based payment structure to one with much more quality embedded in it, and to remove the permanent establishment fee over time. At the same time, we are developing the pharmacy integration fund, so that in future pharmacies will provide some of the care currently provided by highly pressurised GPs and NHS 111 services.

Health and Social Care

Baroness Finlay of Llandaff Excerpts

Thursday 24th November 2016 Lords Chamber

Moved by

[Baroness Finlay of Llandaff]

To move that this House takes note of the implications for the health and social care workforce of the result of the referendum on the United Kingdom’s membership of the European Union.

[Baroness Finlay of Llandaff (CB)]

My Lords, I am grateful to have been able to secure this debate. I will use the term EU collectively to cover the non-UK parts of the European Union and the European Economic Area, as only 230 health and social care staff come from the latter.

We spend about the same percentage of our GDP on publicly funded health as is spent on average by the 14 nations who acceded to the EU before 2004, yet an Organisation for Economic Co-operation and Development report published today shows that we are the sick man of Europe for doctors and beds. Our heart attack and stroke survival is mediocre, cancer survival poor, we desperately need more doctors—Germany has 50% more than us—and we need more, not fewer, beds.

Our struggling health and social care sector has unfilled posts, increased demand and funding pressures. Until now, reciprocity of qualifications and free movement has brought us Europeans, from the top-flight academics and clinicians with unique skills to the lowest-grade care workers. Now, with Brexit, we must decide what we want to negotiate for.

Twenty-nine major health and social care professional bodies, royal colleges, unions, employers and skills and learning organisations have formed the Cavendish Coalition to ensure a sustainable workforce supply and thereby maintain excellent standards of care.

Around 160,000 current NHS and social care staff are EU nationals—58,000 in the NHS and 90,000 in social care, which is 6% and 7% of the workforce respectively. Most are in posts that would otherwise have gone unfilled; they are essential to sustaining services and to our research enterprise. Unless we respect staff at every level and the NHS and social care become good employers, we will not attract the next generation here into the care sector.

Salary alone is not a proxy for worth. “Worth” is knowing that you are valued in society and respected as doing an important, complex and at times difficult job because you have unique skills. After Luxembourg, the UK is the largest net importer of healthcare professionals who qualified in other parts of the EU, particularly in some specialist NHS trusts such as the Royal Brompton and Harefield, where more than 15% of staff are from the EU.

Let me start with my own profession, doctors, of whom a quarter overall are non-UK graduates. Some 11% of registered doctors in the UK—just over 30,000—gained their primary medical qualification in another European country. That is one in 10 of our NHS doctors. We are so under-doctored that 40% of advertised consultant vacancies are unfilled, usually through lack of suitable applicants. Well over a quarter of current consultants report,

“significant gaps in the trainees’ rotas such that patient care is compromised”.

The very welcome increase of 1,500 medical student places will take a decade or more to feed through to supply specialists. In the meantime, we must continue to recruit from outside.

What about beyond medicine? Overall, the NHS vacancy factor is running at 6%, particularly in nursing. Almost a fifth of midwives in parts of London—it is 6% across the UK—are EU nationals. We rely on Europe. There is already a tension between safe levels of nursing staff and financial pressures against using agency staff. I know my noble friend Lady Watkins will address the nursing workforce further. Access to dentistry is also already a problem but I will not the steal the thunder of the noble Lord, Lord Colwyn. We rely on physiotherapists from overseas, 7% of whom are EU qualified. As service demand grows, so recruitment becomes more difficult. The Chartered Society of Physiotherapy—I declare my interest as president—has workforce modelling showing we need at least 500 extra physio student places each year for the next three years.

In social care, one in 20 social workers and more than one in 10 other professionals, particularly nurses, are from the EU, but the greatest crisis looms in domiciliary social care. Turnover rates are already incredibly high: currently well over one in three, 37%, leave their role each year. This churn leads to lack of continuity and concomitant problems. When will the current workforce be told they have indefinite leave to remain—with their children? We cannot continue to defer such assurance which must apply regardless of how long they have been in the UK.

This workforce provides care and support to aid people’s independence, and prevent ill health and unnecessary hospital admission. They care for people when they are most vulnerable. The mood music is positive but that is not enough. These people we depend on need legal certainty and we need that clarified quickly to mitigate the risk of staff leaving. Such rights, including any cut-off period post-Brexit, must be communicated in a way that actively supports community cohesion and reverses the detestable aggressive and xenophobic attitude seen in recent months. If EU workers continue to feel unwelcome and decide to leave, some NHS and social care services will simply have to put up a closed sign.

On staff numbers, I focused on the large number of EU nationals working here in health and social care but more than double that number are non-UK, non-EU staff. Blanket calls for tighter immigration controls overall will simply cripple NHS and social care at a stroke. Make no mistake: the current five-year rule for a permanent UK residence card would exclude thousands. More than a quarter of all adult social care workers are from outside the UK.

The current tier 2 visa system needs review. With a fixed quota of tier 2 work permits, applicants score more points for higher-paid jobs; it is not a level playing field. Financial services staff enter in preference to low-paid health and social care staff, yet we desperately need the latter. Will the Government undertake to urgently revise both the residence requirement and the tier 2 visa points for future health and social care staff?

We must continue to recruit and retain health and social care staff from the EU and beyond while we try to increase domestic supply. To fill vacancies, more specific occupations than just nurses and midwives need to be added to the Migration Advisory Committee’s shortage list. Yet a word of caution: we must not compensate for fewer Europeans by selfishly raiding professionals from developing countries. That would further destabilise our world.

The Medical Training Initiative is a mutually beneficial scheme, run by the Academy of Medical Royal Colleges. It gives junior doctors from all over the world the opportunity to work and train here under a tier 5 visa while giving trusts a high-quality, longer-term alternative to locums for filling rota gaps. Will the Government support extension of this proven effective scheme?

We need special arrangements for Ireland. Professionals flow freely between north and south across the land border. Many doctors in Northern Ireland graduated from a university in Eire. Are the Government looking to Ireland to be our friend at the table when we leave the EU, in the same way that Norway relies on Denmark?

In employment policy and practice we benefit from remaining in concert with Europe, not disconnected from advances that safeguard staff such as TUPE protection during service reconfigurations and the manual handling directive. The European working time directive is in UK law and junior doctors’ working hours now average 48 a week. No one should contemplate increasing hours post-Brexit but we could introduce more flexibility over rest breaks and work patterns to enhance work/life balance and improve training. This can be done if and only if there is no tightening of immigration numbers in health and social care.

The General Medical Council would like the opportunity to test the competence of all doctors coming to practise here from Europe, to check they meet the same standards as UK graduates and so better protect patients. To make this possible, will the UK Government amend the GMC’s powers as set out in the Medical Act 1983? Will regulation and training across professions be integral to Brexit negotiations?

Currently, medical and research staff particularly benefit from training experience in EU countries. Will the Government remember to keep the door open for UK doctors wishing to work in the EU once the UK is no longer a member state? It is not only doctors but nurses, physiotherapists and all our other professionals.

Let us not forget biomedical research, in which we have been a world leader. Our global collaborations keep us ahead of the field. To date, the UK has been a net beneficiary of European research funding. From 2007 to 2013, we received €8.8 billion but contributed only €5.4 billion. The Prime Minister’s announcement this week of an extra £2 billion research development spend is incredibly welcome but we need to be able to employ the right talent to optimise research output.

Overall, one in five of the UK’s academic community is an EU national, although more than three-quarters of the winners of the prestigious BMA medical research grants this year originate from other European countries. Brexit risks our being excluded from the Erasmus and Marie Curie research training schemes and from invaluable collaborative experience in communicable disease management at the European Centre for Disease Prevention and Control. We cannot exclude ourselves from this expertise. Infection and toxins know no political barriers. World epidemics are and will remain a looming threat to our nation’s health.

The impact of Brexit, with falling scientific recruitment and disrupted Horizon 2020 research, was reported in Nature in August. Is the Government’s plan that we try to remain part of EU research systems and contribute funds to the European grants schemes so that we can apply for them? Will the Government ensure that our future regulatory framework enables cross-border research and clinical trials, even though we may well wish to be more nimble in the newer research fields, such as genomics?

The challenges are huge. To grow our own we must attract people into health and social care. That means valuing staff at every level, both in the workplace and in society, for the complex job they do and the personal risks to which they are very often exposed. Society’s attitudes to the sick, the vulnerable and the frail must change, and those who care for them should have proper working conditions—not thanklessly be worked into the ground. Only then will we attract our school leavers into caring roles and only then do we stand a chance of being self-sufficient in health and social care. I beg to move.

--- Later in debate ---

[Baroness Finlay of Llandaff]

My Lords, I thank everyone who has spoken in this debate. I wish I could go through each contribution individually but time will not allow that.

I am very sorry that the Minister thought the debate was a moan, because it really was not. I do not think anyone here has moaned; rather, everyone has laid out facts and figures to try to demonstrate the problem that we have to tackle. The Minister spoke of huge opportunities, and it is to be regretted that no one who campaigned to leave was here to spell out what those opportunities might be, which they could have done. I offered up a couple and asked a question about them, but got no response. I look forward to the Minister perhaps writing to me in future and answering them—simply about the GMC’s powers and so on.

The debate has demonstrated that there is indeed a gaping gap. We risk haemorrhaging staff. A perfect storm is brewing, as has been spelled out today. Yes, we need to train our own staff, but this is not just about training places; this has to go right back into schools and across society to change attitudes, as has been said, so that care is viewed as esteemed work to go into. Our research cannot happen unless the regulations and routes for collaboration are in place and wide open and people feel welcome. I am sad that we have had no assurance on that today.

The phrase “addicted to overseas staff” is absolutely correct. Perhaps this debate has demonstrated that cold turkey is going on, as we realise that they are not going to be there in future and we cannot carry on with that addiction. The heart of our country is indeed at threat. The prejudice that people have experienced has been ugly. We are at a tipping point if we are going to lose that 5% to 10% of qualified European staff, who are certainly feeling uncomfortable and getting cold feet about remaining.

To close, I simply wish to say that I do not believe this was a negative debate. People were trying to be very constructive and lay out the problems. Unless you know the problem, you cannot find a solution. We cannot simply come out with bald statements along the lines of, “Don’t worry, it’ll be okay in the longer term”.

I thank most sincerely everyone who contributed. I beg to move.

Motion agreed.

Mesothelioma

Baroness Finlay of Llandaff Excerpts

Thursday 27th October 2016 Grand Committee

[Baroness Finlay of Llandaff (CB)]

My Lords, I am most grateful to the noble Lord, Lord Wills, for securing this important debate, and the noble Baroness, Lady Couttie, for outlining the clinical scenarios that people face, often when they are young, as they suddenly realise that they have this devastating disease. More than 2,500 cases are diagnosed each year.

I will focus initially on the iceberg effect; we are seeing just the tip because of asbestos in schools and the worry about that. Some 94% of cases of mesothelioma are effectively preventable because they are associated with chronic exposure to asbestos in one way or another, and we know that three-quarters of our schools have asbestos in place. The number of teachers dying of mesothelioma has been going up from around three a year in the early 1980s to 22 in 2012 alone. That is a marker of developing mesothelioma following chronic exposure.

The Committee on Carcinogenicity of Chemicals in Food, Consumer Products and the Environment has pointed out that we do not know whether children are intrinsically more susceptible to developing mesothelioma following asbestos exposure. However, it seems that the lifetime risk if they are exposed at the age of five is about five times that of someone aged 30 who is exposed to the same amount of asbestos. Therefore it seems that exposing children is storing up problems for the future.

I would like to coin the term “pre-mesothelioma” for the number of people in the population who will probably go on to develop mesothelioma but have no idea about it at all. If we are undertaking research, we have to get to earlier diagnosis, so we have to find ways much earlier on of picking up the markers of transformation to malignancy in the areas where asbestos fibres are stored. At the moment we do not know of any actionable drivers of the disease in order to pick up and identify early markers. There are multicentre trials, as the noble Baroness has just outlined, but the problem is that they are very disparate. That is why there is a desperate need for a single centre in the UK to co-ordinate them. That reminds me of when I was a very junior doctor and the MRC co-ordinated trials into the leukaemias, and it was from those that some advances were made. There needs to be a driver with just about everybody being recruited into a trial if that is at all possible. Currently, patients have to find out about trials and they do not really know where to go. They want to contribute because they do not want the same thing to happen to other people. The other problem is that of course while the MesobanK is in place and the cell lines are coming along, they are not there yet. We need to identify how tumour surface antigens are expressed and detect better markers of early disease.

I remind noble Lords that 60% of patients diagnosed with mesothelioma are dead within a year; in other words, they are palliative care patients. I am afraid that some clinical commissioning groups are not commissioning specialist palliative care services adequately, not at a level that allows them to be integrated with cancer and chest disease services. That is essential to provide psychosocial support as well as support for the rest of the family, and to deal with the devastating symptoms of the disease. Those groups of specialists also want to research some of the effects of the disease when it is not curable.

Lastly, we need data. I declare an interest as chairman of the National Council for Palliative Care. I was very concerned to discover that Public Health England does not plan to carry on collecting a minimum dataset from specialist palliative care services. Without that data we will not know whether what we are doing is improving services for patients. It would cost only £200,000 to refresh the collection and data management process, which in the greater order of things is nothing. Without good data on the number of patients, the people who transform from what I would call pre-mesothelioma into mesothelioma, and the numbers that need palliative care services, we will have no idea whether we are improving.

Breast Cancer: Innovative Drugs

Baroness Finlay of Llandaff Excerpts

Monday 24th October 2016 Lords Chamber

[Lord Prior of Brampton]

My noble friend makes a perceptive point. There is always going to be tension between new drugs and affordability, although there are new drugs and new medical devices that can, in the long run, actually save money. The whole purpose of the Accelerated Access Review is to try to square the circle. There are three factors that we have to consider: first, we want a strong and vibrant life sciences industry in this country; secondly, we want to bring forward new drugs as soon as possible if there are big patient benefits; and thirdly, it must be affordable.

[Baroness Finlay of Llandaff (CB)]

Following the statement of the Academy of Medical Royal Colleges this morning urging caution over chemotherapy in advanced cancer, does the Minister agree that it is very important that, at the time of diagnosis, patients have a serious illness conversation and are prepared for what might come so that they are not hanging on with false hopes for drugs which might not be of benefit to them but can have treatments that are appropriately targeted to the individual patient and their needs?

[Lord Prior of Brampton]

The noble Baroness is describing good clinical practice. One would hope that that conversation would take place between a doctor and patient. What was disturbing about the report from the Academy of Medical Royal Colleges was its overall estimate that £2 billion a year was being wasted on unnecessary tests, drugs and the like. The issue that the noble Baroness raises is where people’s lives are prolonged right at the end but they are not given any quality of life at the same time.