Consideration of Bill, as amended in the Public Bill Committee
New Clause 1
Review of the impact of the Act on pricing, research and development, and innovation
“(1) Within six months of this Act coming into force, the Secretary of State shall commission a review on the impact of the Act on—
(a) the pricing and availability of medicines and other medical supplies,
(b) research and development, and
(c) the NHS’s legal duty to promote innovation
and shall lay the report of the review before each House of Parliament.”—(Justin Madders.)
This new clause would place a duty upon the Secretary of State to place a report before Parliament on the impact of the Act on the pricing and availability of medicines and other medical supplies, research and development and the NHS’s legal duty to promote innovation.
Brought up, and read the First time.
With this it will be convenient to consider:
Amendment 8, in clause 1, page 1, line 14, at end insert—
“(2A) In exercising functions in relation to the controls on the costs of health service medicines, the Secretary of State must ensure that any payments made by manufacturers or suppliers to whom the scheme relates calculated by reference to sales or estimated sales of medicines are utilised solely for the purpose of reimbursing the NHS for expenditure on medicines and medical supplies.”
This amendment would confirm that the Secretary of State has a duty to reinvest rebates in improving access to new and innovative medicines and treatments.
Amendment 9, in clause 5, page 4, line 5, at end insert—
“(7) Before making regulations under Clause 5 the Secretary of State must conduct a consultation on the potential effect of this clause on the maintenance of quality of those medical supplies, and seek representations from manufacturers, suppliers and distributors of medical supplies as part of the consultation.”
Government amendments 1 to 6.
Amendment 10, in clause 6, page 7, line 11, at end insert—
“(1A) Information provided by virtue of section 264A must be disclosed by the Secretary of State to persons listed in subsection (1)(a) to (i) at that person’s request.”
Government amendment 7.
I rise to speak to new clause 1, which stands in my name; to amendment 8, which is in the name of my hon. Friend the Member for Burnley (Julie Cooper); and to the other amendments in the group. The Opposition do not oppose the Bill. Our proposals are a constructive attempt to help the Government to achieve their stated aims, and to close the growing gap between the UK’s record on developing new drugs and the ability of NHS patients to access them.
New clause 1 would put a duty on the Secretary of State to commission a review within six months of the Act coming into force, focusing on its impact on the pricing and availability of drugs and medical supplies; on research and development; and on the NHS’s legal duty to promote innovation. The pharmaceutical industry in this country employs more than 70,000 people, in predominantly high-skilled and well-paid jobs—just the sort of jobs Members on both sides of the House would want to encourage and see more of.
This country’s record in the pharmaceutical sector has been one of our great success stories, but we cannot take that success for granted, particularly because investment decisions are often taken by parent companies in other parts of the world. There is considerable unease in the sector about the relatively low take-up of new and innovative medicines by the NHS compared with that in comparable nations, and about the ongoing uncertainty surrounding the future of the European Medicines Agency. A number of major companies have based themselves here because of the EMA, and the worry is that they might wish to follow it if it relocates following Brexit.
The impact assessment for the Bill states, as we might expect, that there will be an impact on the revenue of the pharmaceutical sector, and that it could lead to a reduction in investment in research and development and consequent losses for the UK economy estimated at £l million per annum.
While we fully agree with what the Government seek to achieve with the Bill, we are mindful of the storm clouds on the horizon. We therefore believe that prudence requires that such a review takes place within a reasonable timeframe to ensure there are no unintended consequences and that we can remain confident that the pharmaceutical sector in this country will continue to be at the forefront. We face competition not only in Europe but from emerging nations such as Brazil and China. We also need to ensure that the NHS does not trail in the take-up of the new drugs. Worryingly, the Office of Health Economics studied 14 high-income countries and found that the UK ranked ninth out of those14 across all medicines studied.
Successive studies have demonstrated relatively low take-up of new medicines in the UK compared with other countries. That is bad for patients and bad for our pharmaceutical industry. The Bill therefore needs to achieve a balance. We need to ensure the best possible patient access to medication at the fairest price, but we also need to encourage the pharmaceutical industry to invest in research and development.
I am intervening in my capacity as chair of the all-party group on diabetes. The diabetes drugs bill is enormous: it runs into hundreds of millions of pounds. I accept what my hon. Friend says—that we need to ensure that pharmaceutical companies are able to invest in the provision of new drugs for diabetes—but there are other choices, such as those relating to lifestyle. Does he agree that they need to be investigated while we look for new drugs?
I thank my right hon. Friend for his question. Indeed, if I had known he was in the Chamber, I would probably have anticipated it. He is absolutely right to raise the issue of diabetes drugs and the need for more measures to improve prevention. I attended the launch of the all-party group’s report last week, at which there were a number of interesting initiatives. The “diabetes village” is an interesting concept, which in the long term will hopefully reduce the cost of diabetes treatment for the NHS.
The review would look at the impact of the Bill on the pricing and availability of medicines and other medical supplies. We would gently point out to the Minister that two years ago, when the previous voluntary agreement was introduced, the Government said that it would
“provide an unprecedented level of certainty on almost all the NHS branded medicines bill.”
Evidently that has not come to pass. The review would enable us to identify any issues at an early stage and take the appropriate action. I know that the Government were not willing to commit to such a review in Committee. The Minister referred us to a clause in the draft regulations, referring to a review one year on from the introduction of the regulations. However, that is simply not the same thing as looking at the impact of the legislation in its totality. The way the regulations are currently drafted means that there is more than a little of the Minister being able to mark his own homework, so to speak. The draft regulations talk about the review in a much narrower sense: enabling the Minister to set out the objectives intended to be achieved by the regulations in the report itself rather than at this point, and only specifically mentioning whether those objectives could be achieved with less regulation.
Does my hon. Friend find it strange that the regulations that might be made pursuant to the Act—the Government have helpfully given us a draft—talk about a review being carried out? Paragraph 14(2) states that the report must in particular
“set out the objectives intended to be achieved by these Regulations”.
Would one not expect those objectives to be set out before the regulations were made? Are the Government not putting the cart before the horse?
My hon. Friend is absolutely right. That is why there is anxiety that we may end up with a self-fulfilling prophecy with these reviews. No doubt the Minister can address that when he replies.
There is nothing to assess the potential impact of the Bill and the regulations on research and development investment, nothing on the potential impact on innovation, and nothing on the availability of medicines and other medical supplies. We believe our anxieties in these areas are well founded, so I hope the Minister will reconsider his stance on this proposal, or at least provide us with some reassurance that these areas of concern will be carefully monitored.
Amendment 8 would to compel the Government to reinvest the rebate from the pharmaceutical sector for the purpose of improving access to new and innovative medicines and treatments. On Second Reading, the Secretary of State confirmed that £1.24 billion had so far been returned to the Department of Health through and it is anticipated that the sum to be received annually will increase when the Bill is enacted.
Although numerous questions have been asked throughout the passage of the Bill, we have still not been able to pin down the Government on exactly where this money has gone, other than into the general pot. It is our fear that this new money, which could have delivered a step-change in access to treatments to the benefit of patients and the life sciences sector, will instead be simply added to the baseline, with every £1 from the pharmaceutical sector meaning £1 less coming from the Treasury. Given the often heated exchanges across the Dispatch Box about the true sums being put into the NHS, it would aid transparency if it were made clear that this money was being put in over and above Government funding and was ring-fenced for a specific use. In Scotland, rebates are already ring-fenced and reinvested to provide new treatments and medicines. Nothing that the Minister has said has dissuaded us from believing that that is the correct approach.
According to James Barrow from the Cystic Fibrosis Trust, using the rebate in this way provides both the access and transparency that are lacking in the rest of the UK. He cites the example of the medicine Kalydeco, which increases the lung capacity of people with cystic fibrosis by up to 10%. It has meant that some patients who were previously housebound are now able to run up to 5 km. Patients in England are unable to access this drug, whereas patients across comparable nations in Europe and in Scotland can benefit from its transformative effect. He points out:
“There is no comparable fund in England. Having the new medicines fund in Scotland provides a much greater chance for patients to be able to access these medicines. We just don’t see a clear pathway in England for how patients can access these medicines.”
There are many other similar examples.
The NHS is our proudest national achievement, but it is to our shame that people in England are deprived of vital drugs and treatments on the basis of financial, rather than clinical, judgments. In Committee, the Minister suggested that the fluctuations in income could have adverse consequences, but we understood the purpose of the Bill was to deliver certainty. In any event, ring-fencing does not preclude additional resourcing if required. For all those reasons, I hope the Government will give serious consideration to this proposal.
Turning finally to the remaining amendments, we welcome the further improvements tabled by the Secretary of State in relation to the devolved Administrations. However, questions perhaps have to be asked about the consultation process if such changes are being introduced by the Government at such a late stage. Perhaps this will be reflected on when it comes to future legislation.
We welcome the amendments to clauses 5 and 6 tabled by the Scottish National party. In particular, we welcome the call for a consultation on the potential impact of controls on other medical supplies. Those provisions were notably lacking from the initial consultation, so there is still considerable anxiety within the sector about how the controls will be used. I understand that this is a matter for future regulations, but it is less than satisfactory for the Government to ask us for powers before telling us how they will be used. We would say this is another reason for us to seriously consider setting out now the kind of review envisaged by new clause 1.
I will not detain the House for long. I know that that normally means the start of a very long speech, but I will be very brief. I declare an interest as the chair of the all-party group on diabetes and as a type 2 diabetic.
I welcome the proposals put forward by my hon. Friend the Member for Ellesmere Port and Neston (Justin Madders) from the Labour Front Bench. I hope the Government accept them. They are reasonable proposals that are designed to look at the impact of the Act and ensure it achieves what it hopes to achieve. That is not always the case with legislation.
There is a lot of agreement on the Bill, and the Minister should be commended for how he has introduced it. The reason for the Bill is the ever-rising cost of drugs to the national health service. We know of the work done by The Times in particular. It is always a battle for diabetics, especially when we meet in informal circumstances, as happened last week when the new report of the all-party group was launched by the Secretary of State for Health. I think the Minister was due to come—I may have gone before he arrived. [Interruption.] He is nodding. [Interruption.] No, he didn’t come. I am sorry, Madam Deputy Speaker. I know you do not like Members tempting sedentary interventions. But certainly the presence of the Secretary of State and departmental officials was very helpful to the all-party group.
Our concern is the ever-increasing cost of diabetes drugs to the NHS. As the House knows, diabetes complications cost the NHS 10% of its budget—a huge amount of money—while the drugs bill is about £900 million. The problem is the desire of local GPs to prescribe drugs instead of looking for alternatives. That is why I support the duty to promote innovation in subsection (1)(c) of the new clause. This is extremely important as far as diabetes is concerned. Exactly one week ago, at the invitation of the Steno centre in Denmark and the Leicester diabetes centre, one of the foremost diabetes centres in the country—I pay tribute to Professors Heather Daly, Kamlesh Khunti and Melanie Davies—I spoke at a conference in Copenhagen on innovation. The NHS innovating, as proposed in subsection (1)(c), will result in a reduction in the overall cost of the drugs budget.
When I was diagnosed with type 2 diabetes, the first thing my GP did was put me on metformin. My mother had diabetes before me. There is usually a family history—not always and not in respect of type 1 diabetes, but certainly in respect of families from the south Asian community, though of course diabetes affects all communities. My mother had it, but I was not aware of what it meant, because at the time I was Minister for Europe and flying around better integrating Britain into the EU—unlike 15 years later when all that has changed—and I never had the opportunity to sit down with my mother, who subsequently died, and find out more about what diabetes meant. Unfortunately, most families fail to do that. As a result, my diabetes was caught very late, exactly 10 years ago.
Had I been told by my doctor, “I’m not putting you on tablets. You’re not going on metformin. I’m going to send you off to the gym. I’m going to prescribe gym for an hour, and you’re going to walk for an hour, and you’re going to make these kinds of lifestyle changes,” I might not have stopped the type 2 diabetes affecting me, but perhaps I could have delayed its onset, and in the long run I would have saved the taxpayer a huge amount of money. That is why innovation is so vital to what is being proposed. Innovation permits so much to be done to reduce the cost to the taxpayer. I know that that is not all the Government aim to do in the Bill, but it is a big chunk of it. If we can reduce the huge amount of taxpayers’ money spent on drugs and given to pharmaceutical companies, in the long term it will help the taxpayer.
My hon. Friend is absolutely right. We both serve on the Administration Committee, and whenever banqueting is raised, we all highlight the need to make sure that the food MPs get, especially in the Tea Room, is compatible with decreasing obesity and calorie levels. You will know, Madam Deputy Speaker, when you have your cup of tea, that on offer are Club biscuits and Victoria sponges and all these other things. I am not saying that all this comes within subsection (1)(c) or that it could be regarded as a question of innovation; I am simply saying that innovation is not just about new technology.
None the less, there is incredible new technology around as far as diabetes is concerned, as I saw for myself last week. People no longer need to do the finger prick test. The HbA1C test can be bought at the local chemist. It costs slightly more than a finger prick test, which is obviously free for diabetics, but it allows us to test our diabetes without having to fast, and it gives a three-month reading. Moreover, there are now machines that clamp to the side of one’s arm and which, when a mobile phone is put to them, will give a glucose reading. These incredible innovations show why the new clause is worth accepting. It has been carefully thought out by my hon. Friend the Member for Ellesmere Port and Neston, who is doing an amazingly important job on the Front Bench on these matters.
The new clause would benefit the taxpayer. Innovation is very important as far as an illness such as diabetes is concerned, but, as I said, the solution is not just about the technological revolution; it is also about lifestyle changes. I notice that the SNP spokesperson, the hon. Member for Central Ayrshire (Dr Whitford), is here. Scotland is highly advanced in terms of diabetes monitoring. One can get diabetes statistics centrally in Scotland, whereas here we cannot get them even if we write to our local clinical commissioning groups. That is why new legislation of this kind, designed to bring down the cost of drugs to the taxpayer, is very important, and why I support subsection (1)(c) and the review.
Finally, in respect of research and development, as mentioned in subsection (1)(b) of the new clause, pharmaceutical companies make an enormous amount of money—they are some of the biggest companies in the world—and we need to encourage them to plough back a good proportion of their profits into research and development. The Steno centre in Denmark only exists because of money from Novo Nordisk, one of the biggest diabetes drugs companies in the world. A person can go to the Steno centre, and in the first room they can have their blood taken by a diabetes nurse; in the next room, they can have their feet looked at by a podiatrist who is an expert in diabetes; in the next room, they can have their eyes tested—those of us with diabetes have eye problems; in the next, they can have their consultation with a GP; and if necessary, they can see a consultant. That is what I meant when I talked about the diabetes village. It comes from the concept of the Steno centre. At the moment, as a diabetic I have to go to different centres and hospitals to see my GP and others. In one case, I had to carry my own blood—
In a little test tube! I carried my own blood to the laboratory, because it was the quickest way I could get a reading. Incidentally, from the look of him, my hon. Friend carries his blood very well. We want this innovation and research and development. The drugs companies should be able to plough back profits within the industry, and in the long run this innovation will make a great deal of difference.
When I went to New York for a meeting on Yemen, I stopped in at the diabetes centre of the Mount Sinai Hospital, and was told about the incredible innovation in diabetes in the US. I also went to see Mayor Bill de Blasio’s diabetes team. As Members will know, New York cut the level of sugar in soft drinks, as we are doing now, but the centre of its diabetes initiative is the lifestyle coach, not the GP.
As we look at these provisions, we see every opportunity for a cogent and coherent review that will particularly help—this is my main argument today—those with diabetes, but also others with similar problems connected with their illnesses. I urge the Minister, who I know has been extremely reasonable on this Bill, to look seriously at the new clause. If he cannot accept new clause 1 itself, will he at the very least give an undertaking from the Dispatch Box that the points embodied in it will be reported back to Parliament in a few months’ time?
Like the shadow Health Minister, we will not obstruct the Bill, because we support the basic aim to control prices in order to achieve a good return to the NHS from the drugs that it uses.
We also support in principle new clause 1. Six months might be a little early technically to bring things together, and there should not be just a single report because we will only see change over time. To look at the success of these actions, we need to see a price being controlled, and to spot when prices are sliding out of control. I would therefore suggest looking at the data and information on an annual basis and perhaps laying it before Parliament to show that the Bill’s aim is being achieved and that the concerns of the official Opposition are being allayed.
We support amendment 8 because it advocates the same approach that we have in Scotland. While the Cancer Drugs Fund in England is welcome and has clearly helped many patients, it is limited in the sense that if people do not have cancer they cannot access the medicines fund. That means that people with rare diseases are left somewhat abandoned. Frankly, if it were left solely to NHS England, those people would be left in the desert. It is important that significant money will be released, and the provision could gain support from the pharmaceutical industry if it sees that the money it is returning is enabling innovative medicines to come to the NHS earlier. Sometimes when we compare certain illnesses such as cancer, we find that the gap is in relation to people with more advanced diseases struggling to access the newest medicines. If the amendment helps to address that, we would support it.
The Scottish Medicines Consortium was reformed in 2014, and Scotland has now moved up from passing 53% of all applications to 77%, with a further review going ahead at the moment to see how to improve this further. The aim is not to avoid using drugs; the aim is to access them at a decent price. If the pharmaceutical industry is returning money to the NHS, it should enable earlier access.
Amendment 9 was tabled by SNP Members and we put it before the Public Bill Committee. It deals with clause 5, which extends a power that in fact already existed but was never used—to control the price of medical services and medical supplies as well as drugs. I am slightly disappointed that we did not manage to get this amendment adopted, so I raise again the issue of quality control and ask the Government to consult on it.
I know I spoke extensively in Committee about surgical gloves, but they provide a good example in that the range of quality is vast, and if poor quality gloves are used, there is likely to be extra cost to the NHS either when gloves have to be changed two or three times within one operation or more subtly if a surgeon is exposed to blood at the end of an operation from a tiny pinhole that was not visible. The same point applies to gowns and drapes. Taking off a gown that is meant to be protective and discovering that you are soaked to the skin in blood is a pretty unpleasant experience, and it obviously increases the risk to staff. The idea that surgeons are not exposed to diseases such as HIV or hepatitis B and C is naive. I knew colleagues over my career who suffered from those conditions, which they caught from patients. There is clearly a responsibility to staff and to patients to avoid any possibility of cross-contamination. I mentioned in Committee, too, some fairly cheap items such as gauze swabs, because if they are shedding threads, it can lead to intra-abdominal infection—something that we do not want. This amendment is about consultation and looking further at the mechanism.
In Scotland, we have the national procurement and logistics system, which takes right to the ward level a sort of Amazon-style system whereby the ward will order the medical supplies it needs, and they will be picked from 9,000 items held by national procurement and delivered by national logistics all the way to the ward. The supply chain, as it is called in England, has 600,000 items, which suggests that Professor Carter’s proposal to limit what is used and to look more at procurement is not yet happening. We need to ensure that that comes about, and it would probably be the point at which quality could be assessed. Anything going into the supply chain list would be rigorously tested by staff, with feedback, and it would be for a national procurement group to decide whether to stock it.
Finally, our amendment 10 is designed to focus on the sharing of information that is going to be collected by the Secretary of State, ensuring that any such data that relates to the devolved Administrations—essentially, their data—is freely accessible to them. The Minister mentioned the memorandum of understanding, and I would like to hear where we are with that and whether it will mean real-time access to a database that would be given to authorities listed here or whether they would have to put in a request. It is vital to provide data to the devolved Administrations when they request it, and not on some fixed annual date chosen by the Secretary of State. If those Administrations perceive that there is an emerging problem, they can then deal with it. Having been involved in clinical data collection, I know that there is nothing more frustrating for a team than to be doing the work to gather data, but having no option to access the data when it needs to interrogate them. I simply ask the Minister again to clarify where we are with the memorandum of understanding. I would welcome his commitment to this as we go forward.
As hon. Members know, overall I welcome the Bill, which is broadly a socialist Bill. It reinforces price controls and profit controls on big pharma, when appropriate. I always like to encourage the Conservative party, sadly now in government, to come a little further down the socialist road. They claim to be the workers’ party, and that is good.
New clause 1, tabled and moved by my hon. Friend the Member for Ellesmere Port and Neston (Justin Madders), is central to what we should be talking about in many spheres of public life—namely, evidence-based policy. All too often in this House—this applies to Governments of both colours—policy appears to be made on a political whim.
I remember in, I think, 2008 the then Leader of the House, the right hon. Member for Blackburn, Jack Straw, writing certainly to Labour MPs asking what we wanted in the Queen’s Speech that year—[Interruption.] We were in government, but perhaps he should have written to the right hon. Member for Chelmsford (Sir Simon Burns). I replied, because I believe in evidence-based policy, that in that year’s Queen Speech I wanted not a single piece of legislation. I said that after 10 years of a Labour Government, I wanted Parliament to spend a year on scrutiny, looking at the legislation that we had introduced over that period to see what had worked and what had not worked.
To my astonishment, the Leader of the House did not accept that proposal, as those who were Members then will recall, and we had another full legislative programme. Let me add, as an aside—if you will grant me a small bit of latitude, Madam Deputy Speaker—that by the end of the Labour Government I had stopped voting on crime Bills because we had had so many. Some of them—this may have happened under the previous Conservative Government—repealed parts of earlier crime Bills introduced by a Labour Government which had never been brought into force. That was extraordinary.
I urge the Minister to recognise that evidence-based policy making is encouraged by new clause 1. I hope that, in the context of innovation, which was so eloquently addressed by my right hon. Friend the Member for Leicester East (Keith Vaz), he will say a little about the way in which the National Institute for Health and Care Excellence operates.
As the Minister may know, there is an issue involving cystic fibrosis and the drug Orkambi, which NICE turned down owing to a lack of sufficient data. I understand that, because it is NICE’s job to weigh the evidence, such as it may be. The drug is registered for use in this country, but it is not available on the NHS. Since NICE decided that the cost-benefit analysis did not stack up, some long-term data from the United States, which I understand to be robust, has been made available. I gather, although I may be wrong, that NICE has not yet reviewed its decision on Orkamb, although the evidence from the United States suggests that in certain cases it can be extremely effective in treating cystic fibrosis. I hope that when we are discussing processes, innovation, efficiency and policy-based decision making, the Minister will say a little, not necessarily about Orkambi itself, but about the process whereby NICE might, in the light of new evidence, promptly—I stress the word “promptly”—review its decisions.
There is an additional issue. Drugs or treatments are being passed by NICE but not actually introduced. Either they are rationed and limited to a certain number of patients a month, as is the case with hepatitis C drugs, or the decisions are being left to clinical commissioning groups, which means that we are enshrining postcode prescribing instead of getting rid of it.
I entirely agree with the hon. Lady, who, as ever, speaks with authority on these issues. I am a bit of a centraliser, because I do not like postcode lotteries. We will already have that in a cross-border sense—between England and Wales, Scotland and Northern Ireland—but it is a great deal worse when just some CCGs in England are making a drug available when it has been signed off by NICE as safe for use but it is not mandatorily available, and not every patient for whom it is medically appropriate can obtain it from every CCG. That sort of postcode lottery undermines the “national” part of the national health service, which is regrettable.
Amendment 8, tabled by my hon. Friend the Member for Burnley (Julie Cooper), would ring-fence savings made through the provisions of this Bill and earlier legislation so that the money thereby saved, or paid into the pot by a pharmaceutical company, can be retained for expenditure on medicines and medical supplies. I hope the Government will support that. All too often we hear that Governments do not like ring-fencing, and I understand why: it fetters their discretion. Earlier this afternoon, however, I asked the Secretary of State for Justice whether the education budgets devolved to prison governors would be ring-fenced, because I feared that a prison governor who was under other budgetary pressures might not spend the money on education and prison education would not improve as it needs to. I was greeted with a very welcome one-word answer, which was “Yes.” I hope that, in a slightly different context, the Minister can give the same assurance this afternoon, because this is an excellent amendment which clarifies a slight gap in the Bill.
As for amendment 9, about which the hon. Member for Central Ayrshire (Dr Whitford) spoke so eloquently, efficiency is of course important, but so is quality. I do not know whether the old saying “Penny wise and pound foolish” is used in Scotland—she is nodding—but it certainly is in my part of the west midlands. We have seen that time and time again with privatisations. When services are privatised they go to the lowest bidder, and what do we find? Either the service is not up to scratch, or, all too often—I think this happened when Circle ran Hinchinbrooke hospital—the companies go bust because they find that it is not as easy as they thought it would be to make a profit out of, in this case, the health service. That may happen to other suppliers as well. Quality matters, and the national health service is not a commercial organisation.
I am listening carefully to what the hon. Gentleman is saying about Hinchinbrooke hospital. Might I suggest, tactfully, that he go and look at that hospital? Patients in Huntingdon would say that the hospital had vastly improved, but because of the conditions, it was not possible to make a financial success of it. The company did not go bust; it decided to withdraw. However, in the view of the patients who used it, the quality of the care provided by what had been a failing hospital had vastly improved. Moreover, the trade unions agreed to the deal that was done to put Circle there.
I am grateful to the right hon. Gentleman for making my point for me. This is about quality; it is not just about price. That company got its price wrong. It said that it could provide a quality for a certain price, and it did provide the quality but not for that price, and it jacked the contract in.
I think that what the hon. Gentleman said at the beginning of his comments on Hinchinbrooke —we will know for certain when we see the Official Report tomorrow—showed that he was using that example inaccurately to make a point about privatisation. He said that privatisation caused quality to go down, but that in this case the company had gone bust. He was wrong on both counts.
The right hon. Gentleman may well be correct on that specific point, and I fully accept that. There is in privatisations, however, a nexus between quality and price, and very often—although not always—the companies that promise a quality at a certain price are unable to deliver it. They cannot deliver the quality of service, and/or they cannot do so at the price at which they promised to do so. He can correct me on this if he wishes, but we see that time and again when rail franchisees come back to the Government and say, “We promised a certain level of service for a certain price. We cannot do it: we need a bigger bung.”
I think that the hon. Gentleman may have stumbled into a quagmire in referring to Hinchinbrooke. The Public Accounts Committee, of which, as he may know, I was a member for four and a half years, found that pricing was not the significant issue that led to the end of the franchise of the private provider Circle. The significant issues involved the wider healthcare economy, and the failure of the strategic health authority to discharge its duties in respect of clinical business for the hospital.
The hon. Gentleman has considerably more knowledge than I have. I have talked about evidence-based policy making, and I am entirely prepared to accept the evidence that he presents. However, the company could not make a go of it, although I accept that that may not have been the company’s fault,
Amendments 1 to 5 come as a package. Amendment 3, which is a substantive amendment, refers to a
“person who provides primary medical services”.
I hope that the Minister can talk us through that, in the light of a trend that is starting in some parts of England and is most advanced—if I may make a value judgment—in Salford, where the GPs who provide primary services are directly employed by the hospital trust. So the hospital trust is no longer just secondary or even tertiary; it is primary. I just wanted to unpick the wording to make sure that that development of service delivery in England has been taken into account and that the amendments do not assume that the existing silos between primary and secondary continue, because that development has now arisen in Wolverhampton, which I represent. There are three GP practices in Wolverhampton that are piloting their staff being employed by the excellent Royal Wolverhampton NHS Trust. I say it is excellent because it is one of the 15% of hospital trusts in England that does not have a deficit, and I think part of that is related to the fact that it has only £15 million of private finance initiative. But that is another debate that I will not get into now.
The Scottish National party’s amendments 9 and 10 reprise amendments proposed in the Bill Committee, on which I had the pleasure to serve, and I hope that the Minister can give us an explanation, particularly in relation to amendment 9. I had understood him, perhaps wrongly, to say in Committee that he liked what the SNP was putting forward in terms of quality, but he did not think the wording was quite right, so he hoped to be able to come back on Report with an amendment relating to quality. I may have misunderstood or misremembered what he said, but if my memory is correct, I hope that he can explain why I cannot see on the amendment paper a Government amendment relating to quality. Perhaps he proposes to table an amendment at a later stage.
I am bemused by amendment 7, which is about the definition of medical supplies, but no doubt the Minister will, in his usual way, be able to elucidate later. I hoped in Committee to be able to persuade the Government to clarify the definition of medical supplies in section 260 of the National Health Service Act 2006. It is my understanding that that definition relates only to England. Amendment 7 relates only to Wales, but the two seem to me to be on all fours.
Section 260(5) of the 2006 Act states:
“medical supplies” includes surgical, dental and optical materials and equipment”.
When I look at the part of this Bill that relates to Wales, I see that clause 7 would insert proposed new section 201A into the National Health Service (Wales) Act 2006. It says:
“‘medical supplies’ includes surgical, dental and optical materials and equipment”.
That is the same wording, this time applying to Wales, as in section 260(5) of the NHS Act 2006, which applies to England. Amendment 7 amends the Welsh legislation, very understandably, to clarify the definition of medical supplies. In Committee the Government did not see the need to clarify the definition of medical supplies as it applies to England, but today are seeking to clarify the same definition of medical supplies as it applies to Wales. I am therefore bemused.
My hon. Friend’s analysis of medical supplies is very interesting. I would have thought that pharmaceuticals, for example, would be classified as medical supplies, given that they have always been a contentious area of negotiations over costs. I am surprised that they are not included in the definition.
Medical supplies in this part of the Bill seem to be to do with physical equipment. But, again, what is equipment? We can refer to the definitions, which state:
‘medical supplies’ includes surgical, dental and optical materials and equipment”.
Drugs are dealt with elsewhere in the legislation.
I think the Minister has got the point, but I will repeat it very briefly. He is seeking clarification for the Wales legislation through amendment 7 when I understood him to say that he did not think such clarification was needed for the same definition contained in the legislation pertaining to England. I would like him to explain that apparent anomaly. If it is not an anomaly, perhaps he could tell the House that he is going to clarify the definition as it relates to England in the later stages of this Bill.
I rise to speak to the new clause, the Government amendments and all other amendments tabled on Report. I want to start by expressing my gratitude to the Opposition Front-Bench spokesmen, who both confirmed their intent to continue in the spirit of constructive dialogue we have had thus far in our consideration of the Bill. I am pleased that they support the Bill’s objectives, and I will seek to respond to their amendments.
Hon. Members will recall that we debated at length in Committee the issue raised in new clause 1. I want to take this opportunity to provide some additional reassurance that this is an important issue for the Government. We have already included in the illustrative regulations for both the statutory scheme, in regulation 32, and the information regulations, in regulation 14, an annual review of the regulations and a requirement to publish our report of each review. These annual reviews go further than the specific single review proposed by the hon. Member for Ellesmere Port and Neston (Justin Madders) in new clause 1, the effect of which would require the Government to only undertake a single review within six months of the Act coming into force.
We accept that reporting is an important principle. However, setting out the requirements in primary legislation is too restrictive. We believe that the proposed single review within the first six months of the Act coming into force would provide an insufficient timeframe in which to assess the impact of the provisions, whereas the annual reviews we have set out in the illustrative regulations in effect place a duty on the Government to review both the statutory scheme and the information regulations to ensure their effectiveness, and to do so every year. Of course these provisions will be subject to consultation as part of the wider consultation on the regulations.
Over time we expect that both the statutory scheme and the information requirements will be amended through their respective regulations to reflect changing circumstances. It is essential that the review and reporting arrangements are able to be similarly flexible so that they remain appropriate to the schemes in operation.
The hon. Member for Ellesmere Port and Neston asked whether objectives should be set out before the regulations come into force. As I have said, the Government will consult on regulations before they come into force. The objectives of the regulations will be explored in the consultation and set out in the Government response to that consultation. I hope that addresses his point.
The illustrative regulations require an annual review to set out the objectives of the scheme, assess the extent to which they have been achieved, and assess whether they remain appropriate. These requirements will be tested through the consultation on the regulations, and we will of course take account of those views.
First, I say again that I am very grateful to the Government for publishing the illustrative draft regulations to help us debate the Bill. Let us consider the provision of information in connection with the draft health service products regulations 2017. Regulation 14(2)(a) states that the report must in particular
“set out the objectives intended to be achieved by these Regulations”,
and then regulation 14(2)(b) says it must
“assess the extent to which these objectives are achieved.”
It seems a bit odd to say that in one review we are going to set out the objective and then decide whether the objective has been achieved or not. That seems, temporally, to be a bit wrong.
As I have indicated, we intend to undertake these reviews every year. It will probably be impossible to assess in the first review whether the objectives have been achieved—there might be some ability to assess it—but in subsequent iterations we will be able to look back and see how well they have been achieved.
I notice that the right hon. Member for Leicester East (Keith Vaz) is heading for the exit—[Interruption.] He has now resumed his seat. This is not specifically the right point in my speech to pick up on the points he has raised, but I would like to respond to his characteristically constructive contribution on the subject of diabetes. He is the chair of the all-party group on diabetes, and he might recall that I used to be the vice-chair of that group, as I have family members with type 1 and type 2 diabetes. I have considerable sympathy with the points that he made about the importance of adequate advice for individuals who might be unaware that they have diabetes. He also talked about the importance of adopting innovation through NHS treatment of the condition. We share that objective, and nothing in the Bill will do anything other than to continue to encourage innovation. I will be making further remarks, perhaps when the right hon. Gentleman is not with us, on the subject of innovation, but I just wanted him to be aware that I had taken his points on board. He might be disappointed by my conclusion on the specific amendment, but I shall go on to explain how his point is being addressed in other ways.
Returning to new clause 1 and the question of regulations, I wish to make a further point. Much of the information provided to the Secretary of State will be commercially confidential. We touched on this in Committee. I am sure that suppliers have every confidence that the Government will maintain that confidentiality in anything we publish, but it is important to reinforce the principle. This means that there is a limit to the level of detail we are able to publish, and I am sure that the hon. Member for Ellesmere Port and Neston will appreciate the commercial sensitivity reasons involved. Any information we do publish will be at a consolidated level, protecting suppliers’ confidentiality but allowing the Secretary of State to be clear on the basis of the conclusions of his review. We will of course be able to use supporting information to evidence our conclusions.
Turning to the detail of the new clause, its requirements reflect the duties placed on the Secretary of State in the Bill, but I must be clear that the content of such a report should not be restricted and must be able to address the key issues arising during the year that may affect the operation of the schemes. The other significant element of the new clause, which I have touched on in response to the right hon. Member for Leicester East, was discussed at length in Committee. This was the question of whether it would be appropriate for such a report to address matters relating to the NHS duty to promote innovation.
The Government’s position is clear that it is not appropriate to link the measures in the Bill, which relate purely to the cost of medicines and medical supplies, to the NHS duty to promote innovation. Promoting innovation is a high priority not only for the Government and the NHS but for many other stakeholders. Promotion of innovation quite properly requires action across many different fronts, and it would not be possible to quantify the contribution of the schemes in the Bill to that endeavour in any meaningful way. The NHS is already doing great work to promote innovation, and I would like to draw hon. Members’ attention to the latest data from the innovation scorecard, a quarterly data publication showing the uptake of innovative drugs and medical technologies following NICE approval in England. This is now a nationally published statistic.
The hon. Member for Wolverhampton South West (Rob Marris) asked specifically about this in his remarks. I can tell him that the latest publication, on 12 October this year, shows that the rate of uptake for 85 medicines recommended by NICE is increasing, that 77% of those medicines had positive growth uptake between March 2015 and March 2016, and that 54% of the 85 medicines had a growth uptake greater than 10%. These data are made available on a quarterly basis, and hon. Members can follow their progress through the official national statistics.
The Government are taking broader action to secure the UK’s future as an attractive place for the life sciences sector, particularly in the light of the EU referendum and the consequent Brexit. We are clear in our commitment to the life sciences, and to building a long-term partnership with industry. The hon. Member for Wolverhampton South West also asked me to address the question of the NICE process and whether this takes evidence into account. He also asked about the process for the subsequent review of previous decisions. This is a continuous process. It does not happen for every drug all the time, but there is a routine procedure under which, on the basis of new evidence, NICE will look again at a decision and decide whether to uphold or amend it. That procedure could allow drugs that had previously not been approved to become approved on the basis of new evidence, and NICE will look at evidence from wherever it comes. I hope that that reassures the hon. Gentleman.
I should also like to draw Members’ attention to the accelerated access review, which made recommendations on the reforms to accelerate access to innovate medicines and medical technologies for NHS patients. The Government and our partners are considering those recommendations, and we will respond in due course. We want to make the UK the best place in the world to design, develop and deploy life science products. We do not believe that the Bill will have any material impact on that effort, other than the minor impact noted in the impact assessment. That belief is backed by independent evidence, which suggests that there is no obvious reason why NHS pricing policy for pharmaceuticals, or the time taken to make decisions on reimbursement, should significantly affect decisions to invest in research and development in pharmaceuticals in the United Kingdom. Instead, the evidence suggests that the most important attraction for companies to invest in research in the UK is the availability of world-class scientific expertise, and this is the focus of the Government’s effort to ensure that the UK remains at the forefront of global research and development.
The hon. Member for Ellesmere Port and Neston asks for our reports to be laid before Parliament. We will be publishing them on an annual basis, and I am happy to commit to laying the first one before Parliament. When we see how much interest it attracts, we will be able to decide whether to do that again in subsequent years or simply to publish the reports in the normal way. On that basis, I hope that he will withdraw his new clause.
Amendment 8 aims to require the income from the voluntary scheme and the statutory scheme to be ring-fenced to reimburse the NHS for expenditure on medicines and medical supplies, in order to increase access to new and innovative medicines and treatments. We are committed to ensuring that patients have faster access to new and innovative medicines and treatments. We know that investing in new, innovative medicines and treatments, where they are proven to work and are a clinical priority, and has the potential to transform the care of patients and improve outcomes. However, it is a fundamental principle of the NHS that funding should be allocated according to clinical priorities, based on the judgment of clinical commissioners. That might include new treatments, but it might just as easily include the scaling up of older effective treatments or investing in more staff. We understand the intention behind the amendment, but it is for NHS England and clinical commissioning groups to determine clinical priorities and spend the money on what is clinically most important.
The hon. Member for Central Ayrshire (Dr Whitford) has supported this amendment, and while it is not for me to comment on the policies of the Scottish Government, we know that the NHS in Scotland has raised concerns that the new medicines fund, to which she referred, only funds medicines at the end of life or for rare diseases, meaning that funding for other areas is not getting the same priority.
No, it is not only for end of life, but also for rare diseases. That was my understanding, but I stand corrected. However, my main point is that it should be for clinicians to decide what is spent across the range of activity. If money is ring-fenced into a specific fund for new medicines, that might not always be the right clinical decision.
The new cancer drugs fund was set up specifically to provide funds to deal with one of the most common causes of mortality in the country, and was a priority of the previous Government; I will not go into the reasons for that.
Returning to amendment 8, it was suggested that what happens to the receipts is not clear, but all income generated by the voluntary and statutory schemes is reinvested in the NHS. Estimates of income from the pharmaceutical payment regulation scheme are part of the baseline used in the Department’s spending review model. The model was used to calculate the funding increase that the NHS sought at the time of the 2015 spending review, and it helped to secure the £10 billion of real-terms funding over the course of this Parliament. The income from the voluntary and statutory schemes can and does fluctuate; that is the biggest problem with ring-fencing, which could bring risks in this area. For example, the annual income from the PPRS has varied between £310 million and £839 million in a full financial year in England, so there is the potential for the income that it generates to vary widely, which could disadvantage patients by making treatment dependent on income from a pricing scheme with unsteady income generation.
I understand where the Minister is going with that, but I want to caution him. He spoke earlier about flexibility—my word, not his—and his example was that a clinical commissioning group or a medical body might want to spend some of this money on staffing. Owing to the fluctuation to which he refers, however, spending funds on staffing is probably not a good idea.
I am grateful to the hon. Gentleman for his advice, but I am afraid that I do not think it is relevant to my point about the fluctuation in income coming from the scheme. It is relevant in relation to whether NICE or politicians make such decisions. They need to be made by clinicians.
I thank the Minister for kindly giving way. The cancer drugs fund has a budget of some £350 million, so if he is saying that the money that can be retrieved varies from £300 million to over £800 million, that would allow for the expansion of a new medicines fund.
It might if the move was always in the same direction. My concern is that the amount could decline between one year and the next; it may not always go up—certainly not up in a straight line.
Separately from the Bill, the Government are taking action to secure the UK’s future as an attractive place for the life sciences sector and to support faster patient access to medical innovations. I have already touched on the recently published accelerated access review, which sets out ways to increase the speed at which 21st-century innovations in medicines, medical technologies and digital products get to NHS patients and their families. The review’s recommendations included bringing together organisations from across the system in an accelerated access partnership, and creating a strategic commercial unit within NHS England that can work with industry to develop commercial access arrangements. We are considering those recommendations with partners and will respond in due course.
NHS England and NICE are jointly consulting on several proposed changes to NICE standard technology appraisals and highly specialised technology appraisals, including around speeding up the appraisal process. The Department of Health continues to work closely with NHS England and other stakeholders to improve uptake of new medicines. A key element of that is the innovation scorecard that I have already referenced. With those comments about our concerns about what is proposed in amendment 8, I ask the hon. Member for Burnley (Julie Cooper) not to press her amendment.
Turning to amendment 9, tabled by the hon. Member for Central Ayrshire, the Government recognise that section 260 of the National Health Service Act 2006 does not explicitly state that the Government are obliged to consult industry. However, I am aware that the Act does explicitly state that there is an obligation on the Government to consult when it comes to controlling the cost of medicines. A similar amendment was tabled by the hon. Lady in Committee. I want to reiterate that I am happy to consider with her how we could best introduce a general requirement to consult industry in section 260. Indeed, my officials have been in discussions with her, and I am grateful for her time and constructive comments.
I note the hon. Lady’s reference to the effect of any pricing controls for medical supplies on maintaining the quality of those supplies. I assure her that the Government would take into account all relevant factors, including any concerns raised by industry about the quality of medical supplies, when making and consulting on any price controls for medical supplies. The Government would not however be in favour of putting one of those many factors in the Bill.
The Medicines and Healthcare Products Regulatory Agency is responsible for the safety, efficacy and quality of medical supplies, and the Bill will not change that. The MHRA has assured me that any use of the price control powers in the Bill would not affect any of the quality or safety requirements that must be met before medical supplies can be placed on the market.
The hon. Lady referred to the procurement system in Scotland; I assure her that the Government are committed to improving procurement across the NHS. She will be well aware of the Carter report, which concluded that there is considerable variation in the value that trusts extract from their expenditure on goods and medical supplies. NHS Supply Chain is working hard to deliver procurement efficiencies, to meet recommendations to increase price transparency, to lower costs, and to reduce the number of products and suppliers used across the NHS to deliver economies of scale. The hon. Lady referred to 600,000 products, but it has had success in reducing the range in the catalogue down to 315,000 to help NHS organisations purchase products more efficiently. It continues to work to reduce that number. I am aware of similar work in Scotland. In England, we are using the Carter review to deliver that.
While I understand the intent behind the hon. Lady’s amendment, I am not fully convinced that, as drafted, it would have the desired effect. If she will continue to work with me and my officials, the Government would be happy to consider, while the Bill is in the other place, how we could best introduce the requirement to consult into section 260. On that basis, I invite her not to press her amendment for now.
I am afraid that I must press on to cover the Government amendments.
Government amendments 1 to 5 address a possible loophole in the Bill. Clause 6 amends the National Health Service Act 2006 to give the Secretary of State the power to make regulations to obtain information from any UK producer that is not an excepted person. A “UK producer” is defined in the Bill as anyone involved in the manufacture, distribution or supply of health service medicines, medical supplies and other related products required for the purposes of the health services in the United Kingdom. An “excepted person” is defined in the Bill as any person providing pharmacy or GP services for the health services in Scotland, Wales and Northern Ireland. The purpose of these provisions was to reflect the agreement with the devolved Administrations that, for devolved purposes, they would collect information from pharmacies and GP practices in their nation. However, there may be circumstances in which a company supplies products in the devolved Administrations and also in England, and could claim that the provision, as drafted, would allow it to become an excepted person, because it was operating in the devolved Administrations. That is clearly not the intent of the Bill, so we have proposed these amendments to address this loophole.
Government amendment 6 is a minor consequential amendment that was unintentionally omitted when the Government tabled amendments in Committee. The amendment relates to clause 6, which provides the Secretary of State with the power to disclose information to the list of bodies set out in proposed new section 264B. The amendment clarifies that the list of people to whom the Secretary of State can disclose information includes those persons providing services to the Regional Business Services Organisation in Northern Ireland; it had previously been omitted. I hope that hon. Members will accept these amendments.
I have a couple of remarks about amendment 10, which was tabled by the hon. Member for Central Ayrshire. New section 264B in clause 6 enables the Secretary of State to disclose the information that is collected to a range of bodies, including NHS England, special health authorities, NHS Digital, other Government Departments and the devolved Administrations. The Government have concerns about this amendment, as we are dealing with confidential and commercially sensitive information that can be used only for specific purposes. We are therefore reluctant to introduce a requirement to disclose information to, for example, any Government Department or NHS England. It is important that the Government can be trusted with the information that they collect, and that there are sufficient safeguards to ensure that it is treated as confidential or commercially sensitive.
I would like to conclude this point for the hon. Lady, as I hope it will satisfy her. Her concern is about how the Government will behave in response to requests from devolved Administrations; we recognise that we need to give reassurance to the devolved Administrations that, in the light of the constructive conversations we have already had with them, they will have full access to all relevant data that the Government collect. We are quite happy to do that. We have indicated that we will enter into a memorandum of understanding, which will be discussed and agreed with the devolved Administrations. Those discussions will cover whether they have automatic access to this information—in real time, or in some other format—and whether that is done through giving them direct access to the systems, or by forwarding the data that we collect, immediately on request. We need to get into the detail of that in discussion on the memorandum of understanding, rather than committing that to the Bill at this stage. On that basis, I hope that the hon. Lady will not press her amendment to a vote.
I welcome the Minister’s comments, and I am happy not to press the amendment if we can reach the point of a clear memorandum of understanding. I just point out that all my amendment does is to say that the groups listed by the Bill should be able to ask for data on request; it does not add anyone else. I understand that my attempt at the amendment in Committee included groups that it should not have, but that has been corrected. This amendment does not spread confidential information any more widely.
I am grateful to the hon. Lady for that clarification. I think this is best addressed through a memorandum of understanding, rather than in primary legislation, in case we need to adjust the memorandum in subsequent years.
Finally, I wish to address Government amendment 7, which provides a definition of “equipment”. The hon. Member for Wolverhampton South West took us through the drafting on the definition of “medical supplies”. The amendment gives a definition of “equipment” in the National Health Service (Wales) Act 2006 to ensure consistency with the National Health Service Act 2006. “Equipment” is defined as including
“any machinery, apparatus or appliance, whether fixed or not, and any vehicle”.
When taken in tandem with the common definition of “medical supplies”, the definition is broad enough to capture any medical supplies on the market, from bandages to MRI scanners. The point of distinction was not so much the definition of “medical supplies” as the definition of “equipment”, which is a subset of the medical supplies definition. I hope, therefore, that hon. Members will accept the amendment.
I have spoken at length on these amendments. I hope I have made my position clear, that Opposition Members will not press their amendments to a vote, and that the House will accept the Government amendments.
I beg to ask leave to withdraw the motion.
Clause, by leave, withdrawn.
Provision of information to Secretary of State and disclosure
Amendments made: 1, page 4, line 12, leave out from “products,” to end of line 13.
This amendment is linked to amendments 2 to 5. It is directly consequential on amendment 4.
Amendment 2, page 4, line 17, at end insert—
“(subject to subsection (6A)).”
This amendment is linked to amendments 1 and 3 to 5. It flags that the provision made by section 264A(2)(a) and (b) of the National Health Service Act 2006 is subject to the provision made by amendment 3.
Amendment 3, page 5, line 47, at end insert—
“(6A) Regulations under this section may not do any of the following—
(a) require any person who provides primary medical services under Part 4 of the National Health Service (Wales) Act 2006, or any person who provides pharmaceutical services under Part 7 of that Act, to record, keep or provide information relating to any Welsh health service products which are supplied by the person in providing the services in question;
(b) require any person who provides primary medical services under section 2C(1) of the 1978 Act, or any person who provides pharmaceutical care services under section 2CA(1) of that Act, to record, keep or provide information relating to any Scottish health service products which are supplied by the person in providing the services in question;
(c) require any person who provides primary medical services or pharmaceutical services under Part 2 or 6 of the Health and Personal Social Services (Northern Ireland) Order 1972 (S.I. 1972/1265 (N.I. 14)) to record, keep or provide information relating to Northern Ireland health service products which are supplied by the person in providing the services in question.”
This amendment is linked to amendments 1, 2, 4 and 5. It ensures that regulations under section 264A of the National Health Service Act 2006 may not require the persons specified to record, keep or provide the information specified.
Amendment 4, page 6, leave out lines 3 to 15.
This amendment is linked to amendments 1 to 3 and 5. It is consequential on the new provision made by amendment 3.
Amendment 5, page 6, line 36, leave out “(8)(d)” and insert “(6A)(b)”.
This amendment is linked to amendments 1 to 4. It is a consequential amendment.
Amendment 6, page 7, line 8, leave out “(h)” and insert “(i)”.—(Mr Dunne.)
This amendment makes a change which is consequential on the amendments made in Committee. The effect is to allow the Secretary of State to disclose information to a person who provides services to the Regional Business Services Organisation in Northern Ireland.
Provision of information to Welsh Ministers and disclosure
Amendment made: 7, page 9, line 38, at end insert—
“(and for this purpose ‘equipment’ includes any machinery, apparatus or appliance, whether fixed or not, and any vehicle).”— (Mr Dunne.)
This amendment provides a definition of “equipment“ for the purposes of the definition of “medical supplies” in section 201A(8) of the National Health Service (Wales) Act 2006.
I beg to move, That the Bill be now read a Third time.
As we have already discussed today, it has been a pleasure to take this short, albeit technical, Bill through the House with such a wide degree of consensus from all participating parties.
We have had a very constructive debate. Points have been raised by hon. Members from both sides of the House through amendments and in debate, and we have sought to take them on board. We will look to take some of them forward as the Bill moves to the other place.
I thank Opposition Members for their contributions. They include the hon. Members for Ellesmere Port and Neston (Justin Madders), for Burnley (Julie Cooper), who is just about in her place, and for Central Ayrshire (Dr Whitford), who leads for the Scottish National party. We have had some strong contributions from Back Benchers, including the hon. Member for Wolverhampton South West (Rob Marris), who served on the Committee in his usual diligent fashion, and the right hon. Member for Leicester East (Keith Vaz). We have also had contributions from Government Members. In particular, I thank my hon. Friends the Members for Peterborough (Mr Jackson) and for Torbay (Kevin Foster), who was active in Committee. I also thank my Parliamentary Private Secretary, my hon. Friend the Member for Halesowen and Rowley Regis (James Morris), and the Whips on both sides of the House.
More than £15.2 billion has been spent on medicines in the most recent full year—an increase of nearly 20% since 2010-11 and of over 7% since last year. The purpose of the Bill is to close loopholes to ensure that the NHS secures as much value for money as it can from this very significant spending on pharmaceutical and medical products. We are looking to clarify and modernise provisions to control the cost of national health service medicines and to ensure that sales and purchase information can be appropriately collected and disclosed.
Briefly, the Bill puts it beyond doubt that the Secretary of State can require companies in the statutory scheme to make payments to control the cost of NHS medicines. That is expected to save the health service across the UK some £90 million a year.
Secondly, the Bill would enable the Secretary of State to require companies to reduce the price of an unbranded generic medicine, or to impose other controls on that company’s unbranded generic medicine, even if the company is in the voluntary scheme—currently the 2014 pharmaceutical price regulation scheme—for its branded medicines.
Members will recall the examples raised on Second Reading and in Committee of companies charging the NHS unreasonably high prices for unbranded generic medicines. Without competition, companies have raised prices totally unreasonably—in the most extreme case by as much as 12,000%. Companies can do that because we rely on competition to keep prices of unbranded generic medicines down. Although that generally works well, the Government need the tools to be able to address the situation in which a small number of companies are exploiting the NHS, patients and the taxpayer by raising prices when there is no competition.
Thirdly, the Bill enables the Secretary of State to make regulations to obtain information on sales and purchases of health service products from all parts of the supply chain, from manufacturer to pharmacy, for defined purposes. These purposes are reimbursement of community pharmacies and GPs, determining the value for money that the supply chain or products provide, and schemes to control the costs or prices of medicines. By bringing these requirements together, the Bill streamlines and clarifies all the relevant requirements currently in place, providing a statutory footing for them all. This includes the existing statutory requirements already in the NHS Act 2006, and those agreements that currently have a voluntary basis only.
In Committee, the Government tabled a number of important amendments to reflect the views and requests of the devolved Administrations on how they want to apply the information power in their territories. We tabled the amendments following constructive discussions that resulted in agreement that the UK Government will collect information from wholesalers and manufacturers for the whole of the UK. It would not make sense for each nation to collect its own information from wholesalers and manufacturers, which would lead to duplication of effort and unnecessarily increase costs across the system.
We have also agreed that each nation will collect information from its own pharmacies and GPs. The devolved Administrations will have full access to all the information that the Government collect. I have committed to develop a memorandum of understanding to underpin these arrangements, and my officials are working closely on that with officials in the devolved Administrations.
To ensure that the Bill makes the Government’s intentions absolutely clear, we tabled a small number of minor and technical amendments on Report to close a potential loophole that would have enabled some companies not to provide us with any information if they also provided pharmacy or GP services to the devolved health services.
This is a relatively small Bill, technical in nature, which has received considerable support from across the House, for which I am extremely grateful. The Bill will help to secure better value for money for the NHS from its spending on medicines, while ensuring that the decisions made by the Government are based on more accurate and robust information.
I thank you, Madam Deputy Speaker, for presiding over today’s debates. I also thank the members of the Panel of Chairs, especially my hon. Friend and neighbour, the Member for Telford—
I stand corrected—my hon. Friend the Member for The Wrekin (Mark Pritchard), under whose chairmanship I served for the first time. Finally, I thank the parliamentary Clerks and counsel, Hansard and the Doorkeepers for helping us to bring the Bill to its conclusion today.
As the Minister said, the Bill is designed to enable the NHS better to control the cost of medicines and medical supplies and to close some of the loopholes in the system that have been the subject of blatant abuses in recent years. In seeking to achieve those aims, the Government have our support.
I wish to place on the record our appreciation for the amiable way the Minister dealt with our probing of the Bill. Although he has not accepted our amendments, he has explained why not in a reasonable and constructive manner. I would also like to record my appreciation of the work of the members of the Bill Committee, including my hon. Friend the Member for Burnley (Julie Cooper), who ably assisted me in tabling and speaking to Opposition amendments, and the hon. Member for Central Ayrshire (Dr Whitford), who spoke on behalf of the Scottish National party. Particular thanks go to my hon. Friend the Member for Wolverhampton South West (Rob Marris), who has been engaged and informed in equal measure throughout the Bill’s passage through this House.
Expenditure on medicines accounts for a significant and growing proportion of the NHS budget, standing at £15.2 billion in England in 2015-16, which is an increase of more than 20% since 2010-11. That reflects the incredible advances that continue to be made in the development of new and innovative medicines, often by our own life sciences industry here in the UK. Although we welcome and celebrate those developments, it is clear that taxpayers and patients have not always been well served by the market. It is important that we do all we can to secure value for money for the NHS, especially in the current financial context following six years of historic underinvestment by normal standards.
When the most recent five-year pharmaceutical price regulation scheme was agreed in early 2014, the Government said it would provide unprecedented certainty, but as we know and as was reported in February by the then Life Sciences Minister, the hon. Member for Mid Norfolk (George Freeman), estimated incomes in the UK from PPRS payments for 2016-17 were £647 million—a considerable reduction on the £800 million received in 2015, particularly at a time when the overall drugs bill has been increasing apace. Those figures and the fact that we are debating this Bill show that the original scheme has not gone entirely to plan.
There is much in the Bill to be welcomed. We certainly want an end to the playing of the system that has been going on. We hope that the Bill will finally put an end to such antics and deliver a mechanism that ensures consistency in appropriate circumstances. We support the rationale behind aligning the statutory and voluntary schemes, which will create a more level playing field between companies and offer a much better chance of delivering greater savings and value for money to the taxpayer.
We support measures to tackle the small number of cases where we have seen companies disgracefully exploiting loopholes in the regulations to hike the price of medicines, sometimes by more than 10,000%. As we know, the investigation undertaken by The Times in the summer found that the price of medicines was inflated by £262 million a year as a result of this practice. That continues to impact on patients, often those with rarer conditions.
An example is Keveyis, a drug that has been found to be extremely effective in treating some of the symptoms of muscular dystrophy. Until 2012 it was relatively inexpensive, costing around £100 a box per patient. Unfortunately, it was discontinued by its previous manufacturer. Recently Taro Pharmaceuticals obtained the rights under orphan drug status and is now manufacturing it once again. However, its forecast price in the EU is approximately £35,000 per patient per year, despite the fact that no new research and development costs have been incurred by the company. It is therefore very difficult to see what justification there can be for such a significant price increase. Because of the rise in price, the NHS in England is refusing to provide reimbursement for the drug, which means that patients lose out. It is this deliberate manipulation of the system that we want to see dealt with and we hope that this Bill will once and for all put an end to such scandalous practices.
Although we support the broad aims of the Bill, we have had a number of concerns, some of which we have touched on already, about what is perhaps missing from the Bill and about the Government’s policies more widely on access to medicines and treatments. Despite this country’s world-leading pharmaceutical sector, which we are all rightly proud of, successive studies have demonstrated how there is a relatively low take-up of new medicines by the UK compared with other high-income countries. Members across the House will no doubt have received many pieces of correspondence from constituents concerned about the lack of availability of medicines that they or their relatives are trying to obtain. We also see clinical commissioning groups rationing medicines and treatments in ways that would previously have seemed unthinkable.
If we are to create a level playing field for drugs companies, we should be trying to do the same for patients as well. One measure that we have proposed to tackle this issue is to ring-fence future rebates from the sector and invest them in improving access to medicines and treatments. We know that £1.24 billion of new money has been returned through the rebate since it was established. Surely there can be no more logical use for this money than to tackle the gulf between the UK’s record on developing new drugs and patients’ ability to access them.
We know that the Government were not willing to back our amendments, but I urge the Minister to look again at how a similar measure has worked in Scotland. As we heard in the debate today, there seems to be some difference of opinion about that. The hon. Member for Central Ayrshire spoke strongly in support of it.
We note that a number of amendments tabled by the Government during the passage of the Bill mean that the devolved Administrations are subject to the same arrangements, although it was pointed out in Committee that there appear to be no equivalent arrangements for the devolution of health in Greater Manchester. I recall that when the Minister responded to my questions on this point, he suggested that ring-fencing the appropriate amount of the rebate for Greater Manchester might lead to chaos, as its allocation from NHS England already includes an element of income from the rebate. I think the Minister underestimates his ability to resolve the issue and overestimates the difficulty that would ensue.
The annual health budget negotiated for Greater Manchester is about £6 billion, around half the Scottish budget and around a billion pounds less than the Welsh budget, so the size of the budget is not the issue. What is an issue, though, is transparency and consistency. I do not expect any late change of heart from the Minister, but we will be watching future developments in English devolution and the accompanying budgets with interest.
The other aspect about which we have concerns is how these proposals will impact upon the future of the pharmaceutical industry in the UK, in a climate where there is already considerable anxiety in the sector about the future of the European Medicines Agency as a result of Brexit. Clearly, we will be keeping a close eye on both the operation of the scheme and the general health of the sector, particularly in terms of future investment in research and development.
To conclude, we support the broad aims of this Bill and the Government’s aim of better controlling the costs of medicines. However, we should be doing more to tackle the present situation to prevent patients from missing out on innovative treatments, particularly when we compare our record to that of countries with similar wealth. We hope that the scope of the annual review envisaged in the draft regulations is sufficiently broad to enable us to judge the Bill’s effectiveness on this issue and on the others that we have raised, and we look forward to considering the Government’s response once the consultation on the draft regulations has been completed.
As the Minister said, this is a small Bill, but the sums at stake are large. We hope to see a positive outcome for the NHS as a whole. Thank you, Madam Deputy Speaker, for chairing our proceedings today. I thank the Members who served on the Bill Committee, the Chairs and all the staff and civil servants who successfully led the Bill’s passage through the House.
I will open my remarks with thanks, because this is the first Bill that I have helped to take through the House, and I am therefore very grateful to you, Madam Deputy Speaker, the Chairs of the Public Bill Committee and all the staff who have worked on this, particularly those in the procedural hub; as a newbie, being able to go and ask them what happens next has been immensely helpful.
Obviously, we welcome the basic premise of the Bill, particularly clauses 1 to 4, which give the Secretary of State the power to control the price of drugs and avoid the excesses we have seen recently, as was highlighted in the article in The Times, particularly by those companies that are in the voluntary scheme but also produce generics, and therefore the price of those generics is not controlled. There are also those companies that have picked up drugs that have orphan status—they are no longer produced by anyone else—and basically robbed the NHS by increasing the price by many thousand per cent. That is just unacceptable.
When we accept relatively high prices for new drugs, we often excuse that on the basis of research and development. We need to realise that not all research and development is done by big pharmaceutical companies; they often collect drugs by buying small, spin-out companies from universities. With regard to generic or repurposed off-patent drugs, the R and D is usually done by clinicians within the NHS, or by academics in university departments. Companies have admitted in the past that they do not always price drugs in relation to their R and D costs; they sometimes do so simply by what they think the market will bear. We must not always allow them the excuse that they are spending huge amounts on R and D, because that is simply not always the case.
I tabled two new clauses in Committee. Now that the Secretary of State will have this power, I hope that the two issues raised by my new clauses will be dealt with. One is the issue of specials, which are simply hand-made preparations, usually an ointment for dermatological use. I arranged for the briefing from the British Association of Dermatologists, which highlighted companies that had a Scottish price list and an English price list, to be sent to the Minister. I therefore hope that those powers will be used. In Scotland it is done by using an NHS producer who makes the drug and therefore keeps the price down, rather than simply paying a pharmaceutical company or a pharmacy company, because the pharmacy with which the patient is dealing might have a mother or sister company and they are simply taking a very high price from them.
The other issue, which was raised last November, is that of repurposed off-patent drugs. As the shadow Minister explained at the time, an off-patent drug may be picked up by a new company and used for its new purpose, such as simvastatin for multiple sclerosis, but with the merest tweak it could be put out as if it is a new drug, and suddenly at a price that people cannot access. That also touches on the hierarchy whereby doctors must prescribe a licensed version before an unlicensed one. If a licensed drug came on the market that was actually just a version of an off-patent drug, doctors would be under pressure to prescribe it.
I understand that work has gone ahead since last year’s Bill, but I exhort the Minister, and through him the Secretary of State, to ensure that the powers given by this Bill are used in all these circumstances to ensure that prices are controlled. Otherwise, what happens is not a matter of expenditure to the NHS on its own, but usually that CCGs will not allow these drugs to be accessed, which is what is happening in the case of specials. We now have the powers. We welcome that, but hope that they will be used.
I propose, Madam Deputy Speaker, not to take the remaining three hours. Earlier, when the Minister would not take an intervention, he seemed to think there was a rush on time. My reading of the Order Paper is that we have another three hours for the Bill, but I will not take that long.
I want to put the Bill in context, because this is a socialist Bill. It builds on the Labour Government’s National Health Service Act 2006, which applied to England. Looking around, Madam Deputy Speaker, I think you and I may be the only Members present who voted for the 2006 Act—that was obviously before you were in your esteemed position. In putting the current Bill in context, it is worth reviewing what it is building on.
The 2006 Act made reference to the voluntary schemes for price control that existed then. The current voluntary scheme, of course, is the 2014 pharmaceutical price regulation scheme—the PPRS. Those voluntary schemes were to do with limiting the profits of pharmaceutical companies. Now, I stress to the House that the Labour party and I are not opposed to pharmaceutical companies per se; they do fantastic research, and there are probably millions of people alive now who would not otherwise have been alive, because of the research and development done by pharmaceutical companies—many of them, happily, based, or having major operations, in the United Kingdom. The companies are very welcome here, but they have to play by the rules, and so do those that buy up off-patent drugs, horse around with them and put up their prices by hundreds and hundreds of per cent. Sometimes, it is a minority of private equity companies that are doing that, and they are not welcome here.
Pharmaceutical companies must act responsibly, and they may need statutory encouragement to do so. The 2006 Act started the process of statutory encouragement with a statutory scheme, which enabled Her Majesty’s Government, in appropriate cases, to limit prices and the profits of pharmaceutical companies—that is why I say this is a socialist scheme. Before those on the Government Benches get all aerated about this, let me say that the Labour party and I do not wish to nationalise or control the prices in every corner store in the country—not at all—but there are certain big operations where market intervention is helpful and is needed when there is market failure. It was perceived—rightly—by the Labour Government that there was some market failure, and they needed some stern measures to sort it out.
The Bill builds on that work from 10 years ago because, as adverted to by the Labour Front-Bench spokesperson, my hon. Friend the Member for Ellesmere Port and Neston (Justin Madders), some medicine supply companies—again, a minority—were, frankly, taking the mickey. They were leaving the voluntary scheme in favour of the statutory scheme because that was more advantageous to them. I understand why they would do that—they wished to maximise their profits—but they must act in a responsible way, and if they will not do so as a result of being urged to show corporate social responsibility, which some of them will not, we need statutory measures, and that is what the Bill puts in place. One of the things the Bill does is to address the issue of companies leaving the voluntary scheme to go into the statutory scheme because it is a better deal. The Bill resets the schemes, as it were, to make sure that a company is not encouraged to do that, because there is not that comparative advantage.
The Bill also makes provision for a new power to enable the Secretary of State for Health to require a company in the voluntary scheme to pay sums due under that scheme. Even though it is a voluntary scheme, the Bill will give the Secretary of State the power to pursue non-payers through the courts. I regard that as progressive legislation. For those companies that are not acting responsibly—that are taking the mickey, as I characterised it—that is a good thing. This Government have come down the socialist path to agree with such market intervention.
The Government have also come down the Labour party path in wanting to marshal information so that we can treat these companies equally and fairly, and so that they treat the society in which they operate—refracted principally through their supply of medicines to the NHS—equitably and fairly. Under the Bill, the Secretary of State will have the power to make regulations for the marshalling of information, building on the work done in the NHS Act 10 years ago.
That is important, but on the context of the Bill, I would like to tempt Health Ministers a little further down the socialist path. The Minister described it in his opening remarks as a technical Bill, which it broadly is. However, it also has an ideological or philosophical aspect, which I have tried to set it out, because it is broadly a socialist Bill. One of the things it seeks to do is to save money for the NHS and to raise money for the NHS through clawbacks on overpriced medicines or medical supplies because the NHS—this is the context of the Bill, which is not purely technical—is in serious financial difficulty. The Minister referred to the extra £10 billion of funding for the NHS over the lifetime of this Parliament, but even the Health Committee does not accept that calculation. It is a sleight of hand.
Part of that sleight of hand relates to what is being done on social care, which is leading to a growing problem of delayed discharges. Social care is not being properly funded in this country, and the precept that councils in England are allowed to charge is in effect a mandatory charge because the Government calculate the revenue support grant and all such local government things on the assumption that councils will raise the precept. That is having an effect on the NHS because of delayed discharges.
In the context of the crisis in social care, although the extra funding it will provide for the NHS is welcome, the Bill comes nowhere near addressing the underfunding of the NHS. In the financial terms of what it will raise or save for the NHS, the Bill—in relation to what the NHS needs and, coupled to that, what councils in England need for social care—is a drop in the ocean. The Bill will encourage a certain level of efficiency in the production, purchase and procurement of medicines and medical supplies. All of us in the House would sign up to the concept of efficient procurement. We might sometimes have different definitions of what does and does not constitute efficient procurement, but procurement is central to the Bill.
Although the NHS can, like any massive organisation, almost always act more efficiently—I hope the Bill will encourage the NHS to do so—we must bear it in mind that, in international comparisons, the NHS is one of the most efficient organisations in healthcare delivery in the world. If we look at healthcare delivery in the United States of America, for example, we can see that it spends, as a proportion of GDP, as much on public health as the United Kingdom. However, because its public health system is not run efficiently, as it is all fragmented, the USA spends the same proportion of GDP again on private health—
Order. May I remind the hon. Gentleman that the Bill is quite specific and that this is a Third Reading debate? He is venturing into areas that are not specifically in the Bill, and he may wish to come back to what is in the Bill.
I am grateful to you for your guidance, Madam Deputy Speaker. As I have said, I am putting the Bill in the context of the NHS and its effect in addressing the much deeper problems of the NHS. I was simply adverting to some of those deeper problems, but I take your guidance.
I repeat to Ministers that the Government have come some way, as the Bill demonstrates, down a socialist path for the delivery of healthcare, and I encourage them to come back with another Bill, building on this one, to abandon privatisations and let us have a public NHS.
Question put and agreed to.
Bill accordingly read the Third time and passed.