Licensing of Medical Devices

Owen Smith Excerpts

Tuesday 12th February 2019 Commons Chamber

[Owen Smith (Pontypridd) (Lab)]

I rise to talk this evening about medical devices and the way in which they are licensed and regulated. They are a very important and growing part of medicine, and they can save and transform lives—indeed they have done for millions of patients over many generations. However, when faulty or poorly designed or poorly looked into and proven, they have also damaged, and indeed ended, the lives of many thousands of patients around the world. My principal point is that the regulatory system for medical devices in our country, and across Europe and arguably the wider world, is simply not fit for purpose and must be properly reformed.

The term “medical devices” is rather vague. It refers to everything from bandages to syringes through to heart pacemakers and artificial joints, and I want to be clear that what I am talking about is the more complex end of the spectrum: the more high-risk, class III as they are called, implantable devices.

[Mark Tami (Alyn and Deeside) (Lab)]

I want to put on record my thanks for all the work my hon. Friend has done on mesh. Does he agree that we must be careful that what might appear to be a relatively cheap quick fix can turn out to be a massive problem for a lot of patients?

[Owen Smith]

I thank my hon. Friend for his thanks, and I will talk about mesh shortly as it is illustrative of the wider problem.

The problem is best summed up not in my words but those of the Royal College of Surgeons, which said at the tail end of last year, in response to a big journalistic investigation, that we need to see in our country urgent and drastic regulatory reform and in particular that we need to start with the creation of a compulsory register for all new devices and implants that go into patients in the UK. Will the Minister commit to that?

Let me give a couple of examples of what I am talking about. Last year alone in the UK surgeons operated on patients for 80,000 knee joints, 60,000 hip replacements, 50,000 pacemakers and 7,000 usages of surgical vaginal mesh, down from its height in 2008 when there were 14,000 instances of surgical vaginal mesh inserted into women. Let me pause for a moment to talk about that example of vaginal mesh and why its use has declined so precipitously. The answer lies in what I am talking about—in the development and marketing, and the fact that, as with so many of these devices, their true safety and efficacy is only revealed in the real world once they have been implanted into patients, and sometimes after many years. Many of the variants of vaginal mesh, like most of the other devices now on the market, are developed without any real clinical trials, and certainly without the randomised controlled clinical trials we are familiar with in respect of medicines; that is an extraordinary fact. We understand why that is the case, but there are other ways in which the device manufacturers could ensure their devices were safer and definitely not going to harm patients.

[Paul Masterton (East Renfrewshire) (Con)]

I pay tribute to the hon. Gentleman for the work he does as chair of the all-party group on surgical mesh implants. He will be aware that when the Medicines and Healthcare Products Regulatory Agency appeared before the Public Petitions Committee in the Scottish Parliament it admitted that its verification process for use of mesh implants amounted effectively to a two-week desktop exercise carried out by three people at a cost of £20,000. Does he agree that that example fundamentally shows that the way the MHRA is reviewing these devices is not fit for purpose, is completely inadequate and, as we know from the work of the APPG, puts patients, and in the case of mesh implants lots of women across the UK, at risk?

[Owen Smith]

The hon. Gentleman, who has also done excellent work on mesh as co-chair of the group, is completely right.

Our regulatory system for these devices, including mesh, is more akin to the system that applies to toasters or plugs, and the way in which they get kitemarks, than to the way in which medicines are approved. It is so problematic that, last year, the journalist I was talking about applied to get a kitemark—known as a CE mark—for surgical mesh. However, the item in question was a bag that had previously been used to keep oranges in, but they still succeeded in getting a CE mark for it. It obviously was not put into a woman, but real mesh has been and is being put into thousands of women all over the world, including those suffering from organ prolapse and stress urinary incontinence. The real impact of the mesh has been revealed in the chronic pain, disability and even death suffered by many women as a result of the mesh warping, breaking, morphing, changing its constitution and cutting into organs inside the body. This was revealed only after years of sales.

[Mr Paul Sweeney (Glasgow North East) (Lab/Co-op)]

My hon. Friend is making a powerful speech about the devastating impact that mesh has had on women. I discovered the real impact of it when a constituent came to visit me on Friday. Wendy talked about the impact that it had had on her life. She said that she had been concerned about the mesh and had discussed it with her surgeon, who had insisted that it was not mesh but tape. She was therefore misled by a medical professional. Does my hon. Friend agree that that is another worrying aspect of how these medical devices are being marketed and communicated to patients?

[Owen Smith]

Yes, I absolutely agree. There are many instances of similar mis-selling of these products to women. We need to examine the relationship between the doctors who are selling or marketing these products to their patients and the companies that develop them. Some have an interest in those companies, and others are getting a money benefit through doing this in the private sector. All these things desperately need to be looked at.

The terrible truth is that the surgical mesh scandal that is unfolding is just one of the scandals relating to medical devices. We had the metal-on-metal hip joint scandal, with metallosis poisoning people’s bodies. We had the scandal of textured PIP breast implants poisoning women’s bodies. Those implants are now connected with increased incidences of cancer. We had spine-straightening devices for children that were only ever tested on corpses. We had pacemakers such as the Nanostim, which was designed to sit inside the heart and work for up to 19 years. It has now been removed from the market because the batteries started to break down and cease to work and, worse, it was giving people electric shocks. The devices are now being cut out of people. Between 2015 and 2018, UK regulators alone received reports of 64,000 adverse events involving medical devices. A third of those incidents resulted in serious medical repercussions for patients, and 1,004 resulted in death.

[Ann Clwyd (Cynon Valley) (Lab)]

I would like to pay tribute to the tremendous work that my hon. Friend has done on mesh. Quite a number of people in my constituency have suffered as a result of the use of mesh, and they are extremely grateful for the work that he has been doing. About 20 years ago, we had the scandal of silicone implants, and someone in my constituency had a double mastectomy because the silicone had leaked inside her body. These problems are still happening. We set up a register, but suddenly the register disappeared. I am glad that my hon. Friend has made a point about the register and asked for the Minister’s commitment on this.

[Owen Smith]

I am grateful to my right hon. Friend for her kind words. She is completely right to say that there are devices on the market here and across the world that are still causing grave medical problems for patients. The question we have to ask is: how did these things get on to the market in the first place? How have we got so many of these devices that are causing such significant problems? The common problem that unites mesh with all the other device scandals in our country and across the globe is the weakness of the regulatory system in the UK, in the EU and, to a lesser extent, in America, where the pathway for testing approval, marketing and surveillance of such devices just is not good enough.

How does the system work? It will shock people to hear that we do not have a central body that is responsible for checking out, authorising and licensing devices in the same way as for medicines. If a company in the UK wants to create a new prosthetic hip joint, it does so and then it shops around among a group of what are called notified bodies. These are effectively commercial organisations that are in turn licensed by the MHRA to be a body that checks safety and efficacy through the clinical data provided by the companies and then gives them their conformité Européenne—their EU kitemark. Once a company has received that mark, the device can be sold all across the EU.

Companies do not need clinical trial data in order to substantiate their claims that devices are efficacious and safe. Quite often—this is true of a remarkable proportion of the devices on the market—they do not even have to undertake first-hand clinical evaluations themselves and can rely on being follow-on products that go through a regulatory pathway that is termed as being “substantially equivalent” to the products that have gone before. For instance, there are examples of mesh on the market now that are the 61st iteration of an original licensed mesh that is no longer on the market because it was proven to be dangerous. There is no real mandatory post-marketing surveillance of these devices.

Given that the difficulty of randomised control trials versus placebo for a device—someone cannot put a wooden heart into one patient and a pacemaker into another in order to see which one works—means that there will be a degree of risk in testing such things in the real world, one would think that we would have a system that would test how devices are doing in the real world and get companies or the Government to monitor them, but we do not, which is in stark contrast to the regime for medicines. Changes are coming into effect, however. A new medical devices regulation was launched across the EU in 2017 and will come into effect in May 2020. It was introduced with the acknowledgement of many of the problems that I have highlighted.

[Jim Shannon (Strangford) (DUP)]

I congratulate the hon. Gentleman on securing this debate on an issue that is important to many of us. With the EU’s new medical device rules coming into place in May 2020, as he says, does he agree that the number of available notified bodies is already diminishing? The Government must be aware of that and must work to find a way to secure acceptance of UK notified bodies as part of any arrangement, allowing for the smooth transition of notified bodies and product certification.

[Owen Smith]

I agree in part with the hon. Gentleman. One thing that I did not say earlier is that there are 50 notified bodies across the EU, so if a company goes with its new artificial hip to one body and says, “Will you approve this for my CE mark, because I would like to sell it in the EU?” and the body says no, because it does not think the data is good enough, all the company has to do is go to the next notified body, and if it says no, the company can go to the one after that, and if the third body says no, the company can go to the fourth one. Neither any of the notified bodies nor the manufacturer are under any obligation to disclose that the device had been turned down earlier. I agree that fewer notified bodies would be a good thing, but there are big questions for us in the UK because we will have no notified bodies once we have left the EU.

There are other problems with the new directive, which is a strengthening of the regulations, but it is not strong enough. For example, it now says that companies should summarise their clinical trials data, that they should take clinical data that is, if possible, sourced from clinical investigations carried out under the responsibility of a sponsor—meaning something more akin to randomised control clinical trials—and that they should ordinarily have a quality management system and a post-market surveillance system that should be proportionate to the risk class of the device in question. However, the point is that none of those things is mandatory.



There is no mandatory requirement to conduct proper trials or to max out the tests that are done. There is no mandatory requirement to publish data. There is no mandatory requirement to publish all data, including negative data. There is nothing to stop the companies continuing to conceal data, or shopping around between different notified bodies, and there is nothing to stop the companies doing the bare minimum on surveying how their product is doing in the marketplace. The directive is a strengthening but, unfortunately, it is not the strengthening we need.

If we leave the EU, the directive will not necessarily apply in all regards in the UK. The Government have tried to respond to the concern voiced by others before me by saying that they will effectively apply the regulation in future, but that would bring difficulties in and of itself. As I said, we would effectively be accepting products that are kitemarked and approved elsewhere in Europe, and not by our own notified bodies, because we will not be part of that system any longer. I assume we will be using the European database on medical devices, which is designed to work right across Europe, but we will not be part of the expert panels that reflect on the findings reviewed through that database.

Crucially, I assume that the MHRA will be filling some of those gaps. It will already have an almighty job on its hands in trying to fill the gap on medicines once we are outwith the purview of the European Medicines Agency. I fear that devices will once again be the Cinderella of the medical game. We did not have regulations for devices at all before 1990, and we may find that we are playing catch up with the European Union in future.

Whichever way Brexit turns out, and in reflecting on the flaws in the regulatory system I have highlighted, I ask the Minister, first, to try to get the MHRA, or whatever replaces our current regulatory pathway, to go back to the first principles of protecting patient safety at all times. There is too much talk in Europe of maintaining our advantage over other markets as an early adopter of innovation. Well, early adoption can go wrong if the innovation has not been adequately tested, and mesh is a great example.

Secondly, will the Minister do what the Royal College of Surgeons has asked her and the Government to do and set up a national registry of all “first implanted into a man or woman” devices—the innovations—so that we can track what happens with those devices, as we should have been able to do with mesh? Thirdly, will the Minister make sure that whatever system we have imposes much more stringent obligations on companies to undertake the most rigorous tests in respect of such medicines? In any new system, we should rule out anything like the substantial equivalence model that has been deployed in Europe for so long. It seems crackers to have a system that is basically a paper-based exercise without any real-world tests.

Lastly, I would like our Government to follow the example of the Australian Government, where the Minister’s counterpart, Greg Hunt, issued a national apology to the many women whose lives have been ruined by the debilitating effect of pelvic mesh implants:

“On behalf of the Australian government I say sorry to all of those women with the historic agony and pain that has come from mesh implantation, which have led to horrific outcomes”.

Our Government should similarly apologise to women damaged by surgical mesh. Irrespective of how Brexit turns out, they should pledge to radically reform the regulatory pathway for this class of medicines in order to make sure that no patients, men or women, suffer, as patients have in the past, as a result of medical devices.

Oral Answers to Questions

Owen Smith Excerpts

Tuesday 23rd October 2018 Commons Chamber

[Owen Smith (Pontypridd) (Lab)]

Every week in this country, two children are born with spina bifida or anencephaly, and I am delighted that the Minister has just announced the consultation on the fortification of flour, which could stop 70% of those birth defects. Can he tell the House how quickly he hopes to bring about the conclusion of the consultation?

[Steve Brine]

Let me just pay tribute to the hon. Gentleman for the work that he has done, bringing this matter to the fore and really pushing it forward. The answer is as soon as possible. I also want to make sure that I can involve the other agencies. Public Health England will be very important in this, because, of course, not every woman eats bread and therefore takes the flour supplement.

Fortified Flour

Owen Smith Excerpts

Wednesday 16th May 2018 Westminster Hall

[Owen Smith (Pontypridd) (Lab)]

I beg to move,

That this House has considered the mandatory fortification of flour with folic acid to prevent spina bifida and anencephaly.

I am delighted to serve under your chairmanship, Mr Hanson, in this important debate on the potential for the mandatory fortification of flour with folic acid to prevent neural tube defects. Every week in this country two children are born with a neural tube defect, most commonly spina bifida and anencephaly, and every day two pregnancies are terminated as a result of the diagnosis of such conditions in the womb.

The neural tube is the structure in the embryo that becomes the brain and the spinal cord. It should close between the 18th and 28th days after conception. Failure of the neural tube to close completely and properly leads to conditions such as spina bifida, affecting brain development, mobility, and bladder and bowel dysfunction—other right hon. and hon. Members have personal experience of that and will talk with great knowledge about it—and anencephaly, a fatal condition in which the brain does not develop.

In 1991 a seminal piece of research on prevention of neural tube defects for the vitamin study group of the Medical Research Council by Professor Sir Nicholas Wald showed conclusively that supplementing the diets of women with folic acid, a naturally occurring nutrient found in spinach, liver or Marmite, prior to conception and during the first trimester of pregnancy could reduce the incidence of NTDs by up to 70%. In response to the data, the Conservative Government at the time introduced new guidelines that recommended that all women should take supplements of folic acid prior to conception and during the first 12 weeks of pregnancy.

Eighty-one other countries around the world, however, including the United States, Brazil, Australia, South Africa, Nigeria, Indonesia, Argentina and Canada, took a far bolder position, mandating the fortification of flour and flour-based products in their countries with folic acid as a public health intervention for whole societies. They did so having recognised the data and the long-established fact that at least 40% of pregnancies are unplanned, so NTDs might develop in the womb often even before those women realise that they are pregnant.

The recommendation of voluntary supplementation in our country led to an initial increase in the number of women taking folic acid before conception. The proportion went up to 35% in 1999,but by 2012 it had started to fall back, to just 31%, with much lower numbers seen in the more deprived socioeconomic sectors of society and in black and minority ethnic communities. Among pregnant women aged less than 20, on average just 6% supplement their diet before conception.

In short, the position that we have taken in our country under successive Governments has led to increasing health inequalities, with poorer, more marginalised and younger women having greater risk of their children being born with spina bifida or other conditions. By contrast, in the United States, which in 1998 started mandatory fortification of rye and wheat flour, and in 2016 introduced a new programme to fortify corn flour so as to target the Hispanic population, we have seen a reduction in NTD pregnancies of almost 30%. In Canada, one study of the prevalence of NTDs showed a drop from 4.56 births per 1,000 to 0.76 per 1,000 after fortification. Had we in this country followed the same route as Canada or the US, we would have seen 2,000 fewer pregnancies with a neural tube defect between 1998 and 2012. That is a sobering thought for the advisory committee in the UK to consider.

In fact, the scientific evidence in the case for fortification is not really contested. That is why the Scientific Advisory Committee on Nutrition to this Government and previous ones—it used to be called COMA, the Committee on the Medical Aspects of Food Policy, but understandably changed its name—back in 2000 responded to the evidence and to the US move by recommending that our country should go down the route of mandatory fortification. SACN repeated that recommendation in 2006, in 2009 and in July of last year.

The most recent SACN report, surveying all the evidence available around the world about the benefits and the possible adverse consequences of folic acid fortification, stated:

“Conclusive evidence from randomised controlled trials…has shown that folic acid supplementation during the early stages of pregnancy can reduce the risk of the fetus developing neural tube defects”.

It goes on to maintain its view, expressed consistently by scores of scientific advisers to the committee over the years, that Britain should be fortifying our flour to prevent NTDs. The key question as far as I am concerned—not as a clinician or expert, but as someone who understands the value of evidence-based policy making—is this: why have this Government and previous Governments not acted on the advice and the evidence to take similar steps in our country?

The principal excuse offered by Ministers is that the evidence is mixed and that some studies have shown some possible risks associated with having higher levels of folic acid or folates in our bodies. In particular, two risks have been talked about: first, that higher levels of folates may mask vitamin B12 deficiencies in individuals, possibly leading to anaemia and neurological damage; and secondly, that higher doses of folic acid might run the risk of increasing the likelihood of certain cancers. As far as I can see, however, all the evidence and the science produced over the intervening 25 years have largely debunked such concerns.

The SACN has looked at all the evidence in last year’s review and previous ones and stated, on the issue of B12, that folic acid intakes up to 1 mg per day are not associated with neurological impairment in older people with low vitamin B12 status. The most recent SACN review stated that

“studies of folic acid supplementation and observational studies, indicate either no relationship with cognitive decline or a lower risk associated with higher folate status.”

It goes on to note:

“The prevalence of vitamin B12 deficiency with or without anaemia did not increase after mandatory fortification in the USA.”

Since the SACN provided that evidence, a further, critical study has been done by Professor Sir Nicholas Wald, who produced the original research suggesting the use of folic acid in flour, and Professor Sir Colin Blakemore, who is well known to right hon. and hon. Members. The study shows definitively that there is no evidential base for the suggestion of a maximum tolerable level for folic acid. The question of it masking vitamin B12 is therefore no longer taken seriously by the scientific community in our country or overseas as a reason for not introducing folic acid into flour.

On the potential connection between high folate levels and overall cancer risk, again I quote the SACN’s latest review:

“Findings from the different study types are inconsistent but overall do not suggest an adverse association. RCTs”—

randomised controlled trials—

“show no effect of folic acid supplementation on overall cancer risk. The MTHFR genetic studies suggest higher folate concentrations reduce overall cancer risk.”

Again, observed data from America, Canada and other societies do not show any adverse effects of increased cancer risk.

Support for the notion of mandatory fortification comes not just from our country or the SACN, but from a volume of organisations that I shall reference at some length: Shine, the brilliant spina bifida and hydrocephalus charity in this country; the Royal College of Obstetricians and Gynaecologists; the Royal College of Paediatrics and Child Health; the Royal College of Midwives; the British Maternal and Fetal Medicine Society; the Faculty of Sexual and Reproductive Healthcare; the British Dietetic Association; the Governments in Wales, Northern Ireland and Scotland, where only last year the Scottish Government said that they wished to introduce mandatory fortification but were unable to do so on a Scotland-only basis; the chief medical officers in England, Wales, Northern Ireland and Scotland; Public Health England; Public Health Wales; NHS Health Scotland; Health and Social Care in Northern Ireland; the Faculty of Public Health; the Food Standards Agency; Food Standards Scotland; Colin Blakemore; Nick Wald; Jeff Rooker; and me.

There are many people who think this is a very clear case where the evidence should lead to a policy change. Why do the Government not agree with their own advisers and with the overwhelming majority of scientific opinion? Why, in the light of the evidence, do they appear to have dragged their feet—not just this Government, but the previous Labour Government and, indeed, the Conservative Administration before that?

On 2 May, in response to a written question from my hon. Friend the Member for Coventry South (Mr Cunningham) on the case of mandatory fortification, the Minister said:

“No assessment has been made of potential merits of adding folic acid to flour on pregnant women or children.”

That seems to be slightly at odds with what I have been saying for the past 10 minutes—that there seems to be a lot of evidence in support of it. He went on to say that the recent SACN report, which was published in July 2017,

“made recommendations in respect of folate levels and developing foetuses. Ministers are currently considering the issue of mandatory fortification and will set out their position in due course.”

We find ourselves here because I am looking for the Minister to set out the Government’s position in due course. They have had a quarter of a century to mull over the position, in the light of the evidence. I know the Minister, who I have great regard for, is a man of action. I look forward to him setting out the Government’s case and getting on with it.

--- Later in debate ---

[Owen Smith]

I thank the Minister for his response, but I have to say that I am disappointed by it. I am disappointed principally because I do not think he has taken the action that he could have on the basis of the evidence that has been presented both today and, more importantly, by the scientific community in our country and around the world over the past 25 years, as well as the lived experience of the 80-odd communities, societies and Governments around the world that have undertaken mandatory fortification with no evidence recorded in any studies of any of the potential adverse events in their populations that have been referred to in a few scientific papers.

The Minister concedes that the current process is not working because of low uptake of the advice and because so many pregnancies are unplanned. I am pleased that COT is looking at the Wald paper on tolerable upper limits and the evidence it presents that there is not one, because excess folic acid is excreted. However, I am intrigued to know—I will write to the Minister on this—whether COT has advised the Government not to introduce mandatory fortification and not to follow the advice from their other advisory body, SACN, formerly known as COMA. If it has not offered advice to that effect, I cannot understand where Ministers are getting the advice that tells them not to introduce mandatory fortification.

The only formal advice that Ministers have had from 2000 to 2017 is to do what all Members here and the scientific community have recommended and to get on with mandatory fortification. It is a mystery to me why the Government continue to suggest that there are serious scientific reasons for not doing it. I do not believe that the Government have illustrated that and I do not think that the Minister illustrated that today; unfortunately, I do not think successive Ministers in all Governments have illustrated that.

Today has been a missed opportunity. However, I leave the Minister under no illusion that we will continue to raise this issue and to push for mandatory fortification. I look forward to debating it with him again in the future.

Question put and agreed to.

Resolved,

That this House has considered the mandatory fortification of flour with folic acid to prevent spina bifida and anencephaly.

Surgical Mesh

Owen Smith Excerpts

Thursday 19th April 2018 Commons Chamber

[Dr Wollaston]

My right hon. and learned Friend is absolutely right, and his point applies not only to medical devices. When it comes to relatively rare conditions, we need to look at the widest possible population base in order to detect any complications. It is also important to use the widest possible population base when detecting rare complications. I thank him for highlighting that.

If we are to have informed consent for women, it has to be based on high-quality, balanced and evidence-based information, and that has been lacking. We also need to be clear that if a medical device is altered in any way, it must be part of a clinical trial. That was entirely lacking in this situation. The types of device, including the size and thickness, were changed without anyone properly recording or following up on those changes. That has to be the key lesson for the future.

[Owen Smith (Pontypridd) (Lab)]

The hon. Lady is making an extremely important point. Does she agree that the issue here is that all one effectively has to prove for a follow-on device is its equivalence with the original device? There is therefore a fundamental flaw in how we license devices versus the far more rigorous way in which, for example, we license molecules.

[Dr Wollaston]

I absolutely agree. It strikes me that there has been a kind of wild west out there, with representatives saying, “Why don’t you try this one? This is probably going to be better”, without organisations setting up clinical trials from the start so that we could compare different devices, and without women giving properly informed consent that a different kind of device would be used. Lessons have to be learned not just for mesh surgery, but for other medical devices. Just because something sounds like it might be better, it does not mean to say that there will not be serious complications. Those complications may also happen at a late stage. We need databases such as EUDAMED so that we have access to the widest possible population base and clear device tracking.

--- Later in debate ---

[Owen Smith (Pontypridd) (Lab)]

I congratulate my hon. Friend the Member for Kingston upon Hull West and Hessle (Emma Hardy) on securing today’s debate. This is the first occasion on which we have debated this issue on the Floor of the House—in the main Chamber—and it is a very important moment in the campaign.

I thank and congratulate all the women who have been campaigning on this issue, long before it was raised by any of us in Parliament—particularly the indefatigable Kath Samson, who has led the Sling the Mesh campaign quite brilliantly in recent years and made this such a salient issue in the media, and now in Parliament. From a personal perspective, I very much thank my own constituent, Carolyn Churchill, who came to see me about this issue several years ago and revealed to me the scale of the suffering and trauma—life-changing trauma—that she had experienced as a result of having mesh implanted. We campaigned to have her mesh removed, and that has been life-changing for her. I am delighted to see her with us today in the Gallery.

It would be easy to be extremely angry and passionate about this, but I do not want to do that today, nor do I want to list the many life-changing, debilitating ways in which people have been affected. I am sure that many other Members will speak about that. I want to speak a little more dispassionately about how we have got to where we are, the history of mesh, and some of the wider lessons. While this is a tragedy for individuals, it is clear, as the hon. Member for Totnes (Dr Wollaston) highlighted, that it also speaks to deep, substantive issues not just about mesh but about licensing, monitoring and the diffusion of devices into the health marketplace more generally.

So what is the history of mesh? Mesh was introduced in the 1970s, and withdrawn because it was not felt to be an effective way of addressing issues and because many doctors felt that there were too many side effects associated with it. Like many devices, it was then improved marginally, and it was reintroduced in the late ’90s and early 2000s. As my hon. Friend the Member for Kingston upon Hull West and Hessle said, it was marketed incredibly aggressively among doctors because it was perceived as being quick and easy—day case keyhole surgery as opposed to much more invasive, difficult and costly means of treating stress-related urinary incontinence, in particular, through colposuspension and autologous sling, using individuals’ own tissue to raise the bladder to deal with incontinence.

One understands why, in that set of circumstances where mesh was seen as safe and effective, doctors picked it up in huge numbers. In 2008-09, 14,000 women had an implant—the high point, as it were, of the usage of mesh. As my hon. Friend said, we have seen a general decline in usage over a period. Throughout that period, the Medicines and Healthcare Products Regulatory Agency, the National Institute for Health and Care Excellence, the royal colleges and Ministers in this place and elsewhere have said, in effect, that it is safe, with side effects in only 1% to 3% of patients—perhaps 3% to 5%, they have conceded on occasion, but still relatively small numbers and arguably, they say, within the bounds of acceptability for surgery.

[Bambos Charalambous (Enfield, Southgate) (Lab)]

Does my hon. Friend agree that had doctors not sold mesh aggressively to women, many women may not have chosen it as a way of solving their problems and may not have had the problems and complications they have now?

[Owen Smith]

Yes. The long and the short of it is that this has become such a widespread problem because younger women, in particular, were told by their doctor that there was a quick and easy way in which a minor inconvenience for many women—although a major inconvenience for some—could be dealt with.

Clearly, the scale of the side-effects was not apparent, for all the reasons my hon. Friend the Member for Kingston upon Hull West and Hessle listed, but notably because there is no long-term trials data in respect of devices. The sorts of complications that we now see emerge over a long period. That is why, in our country and across the world, such widespread concern about mesh has been emerging in every health market.

[Mark Tami]

My hon. Friend mentioned removal of mesh. Does he agree that there should have been a lot more research about how easy it is to remove, because it is actually very difficult and only a few surgeons will undertake that work?

[Owen Smith]

My hon. Friend is right. The whole point of mesh is that it is designed to induce scar tissue in order to fuse the mesh with the muscle, and therefore trying to excise the mesh is incredibly difficult. That is why there are partial removals and some women are left with pieces of mesh inside them, even after surgery. Those sorts of complications are clearly very worrying. They ought to have been explained properly to women, but obviously were not, in very many cases.

[Dr Julian Lewis (New Forest East) (Con)]

The hon. Gentleman is making an excellent speech, and I thank him for his work. Will he go back to what he said a few moments ago about the idea of it being acceptable that 1% to 3% of cases might go wrong? It might be acceptable if we are dealing with a small overall total, but when we are dealing with over 100,000 cases, we are saying that it is acceptable for 1,000 to 3,000 people to suffer devastating, life-changing injuries as a result of this procedure. Surely that is anything but acceptable.

[Owen Smith]

It absolutely is not acceptable. I hope that the Minister is not going to repeat what other Ministers have said in written statements and in this place, which is that 1% to 3% is the sort of failure rate, or complication rate, that one would expect with all sorts of surgery. The reality is that the numbers are far greater than that—far, far greater—as the audit this week shows. I will come on to address that.

[Lloyd Russell-Moyle (Brighton, Kemptown) (Lab/Co-op)]

Does my hon. Friend share my concern that some hospitals are still advertising low failure rates, particularly for tape? That disguises the issue, particularly when they refer to failure rates in the first year and do not talk about long-term studies.

[Owen Smith]

Yes. We have heard that many women have this undertaken in private clinics—perhaps half of them, although we do not know how many that means. Those clinics advertise success rates very widely; we can find it all over the internet. The fact that this is described as mesh, sling, tape or ways to uplift the bladder obfuscates what we are really talking about and makes it difficult for women—and indeed, I suspect, occasionally doctors—to know the nature of what they are dealing with. What has emerged, as evidence has come through, is that there are greater problems than was appreciated. That is why, given that mesh was originally licensed to treat stress-related urinary incontinence and then extended to pelvic organ prolapse, we should be deeply concerned. Mesh is already effectively banned in our country for pelvic organ prolapse—that happened just last year. It is now to be used in research only, which is tantamount to a ban. That is happening in countries all over the world—just last year New Zealand effectively banned mesh for both SUI and POP, although I gather it may lift the ban in future. This is a worldwide problem.

We have had the audit results this week. Let us be clear that we only had an audit because of the great campaigning by Sling the Mesh, the APPG and other bodies. We asked Ministers directly to conduct it, they were good enough to do so, and I am pleased they have. The results show that far from there being just a 1% to 3% occurrence of serious complications, there is a 4% rate for complete removal of mesh. Five hundred and fifty out of the 14,000 women who were given mesh in 2008, the first year of the study, have had it removed at some point in the last decade. That is not rates of complications such as pain or sexual dysfunction: the mesh is so problematic that women have had to go back under the knife to have it cut out.

As for the complications, which the audit has tried to measure by looking at the volume of outpatient appointments, the 100,000 women who have had mesh inserted have needed almost 1 million outpatient appointments. They have gone to their GP to say they have a problem and been referred to a consultant for an outpatient appointment, whether for pain management, residual gynaecological problems or some other problem—trauma, in some instances. That must be indicative of the scale of the problem and the cost to the NHS, as illustrated by the work done for the APPG by Carl Heneghan. Some £250 million may have been spent in a decade to sort out the problems.

Mesh is a much bigger problem than has been appreciated by the clinical community, which has been incredibly defensive in dealing with it. The community must be much more open and honest about it. We have to address the issues of licensing: it cannot be enough for follow-on devices to only have to prove equivalence, or for a registry to be run simply by the royal colleges, which have been resistant in the past to having a registry. We should have a standardised process to put a registry in place to follow patients. Crucially, NICE must also get its act together. Why have we waited three years for NICE to bring forward new guidelines? It is still saying that that will not happen until next year—it needs to be done this year. This issue needs to be dealt with tomorrow.

--- Later in debate ---

[Dr Julian Lewis (New Forest East) (Con)]

I start by saying that I think the steps taken in Scotland, as described by the hon. Member for Glasgow North (Patrick Grady), sound extremely sensible as interim measures until final decisions can be taken. I echo the thanks due to the hon. Members for Kingston upon Hull West and Hessle (Emma Hardy) and for Pontypridd (Owen Smith), their associates in the all-party group, and Sling the Mesh campaigners. I also thank my three constituents, Emma, Eileen and Helen, who have all shared with me their harrowing experiences of the procedure.

There is no doubt that when vaginal mesh procedures go wrong, the results can be truly catastrophic. A letter from the Minister states clearly that

“women have suffered atrocious and debilitating complications”

from these implants. Her counterpart in the Upper House, Lord O’Shaughnessy, has conceded this:

“While these treatments can be effective, in a small minority of cases meshes can cause serious long-term injury and disability, and prevent or reduce the ability of affected women to work.”

According to a letter from the Health Secretary to parliamentary colleagues in February:

“Clinical experts here and abroad agree that, when used appropriately, many women gain benefit from this intervention, and hence a full ban is not the right answer.”

I find it difficult to follow that logic. There might be an acceptable argument if we were talking about a procedure in which the numbers of interventions were in the hundreds, but, as I said in an intervention and as the hon. Member for Pontypridd (Owen Smith) endorsed, we are talking here about over 100,000 people. When we are talking about over 100,000 people, if even the Government’s low figures of 1% to 3% going badly wrong are right, that is still 1,000 to 3,000 people. I have been given, by my constituent Emma, a leaflet from Sling the Mesh that says that its estimate is that at least 15% of people are seriously and badly affected. On that scale, we are talking about over 15,000 people being seriously damaged by this procedure.

[Owen Smith]

I thank the right hon. Gentleman for giving way and for his kind remarks. Would he be surprised to learn that the chief medical officer, Dame Sally Davies, speaking alongside the Health Secretary in a Facebook Live broadcast just a few months ago, said that she thought the serious complication rate was between 15% and 20%? I have written to her asking where she got those numbers, although as far as I am aware she has not replied to me, because that is at odds with all the previous comments by Ministers and officials.

[Dr Lewis]

Indeed. I would be surprised at that, because if that is what Dame Sally believes she ought to be making different recommendations.

I have been given a particular study, which is described as the largest study of surgical mesh insertions for stress urinary incontinence. Over 92,000 women were surveyed in this particular examination, including all NHS patients in England over an eight-year period. The conclusion states:

“We estimate that 9.8% of patients undergoing surgical mesh insertion for SUI experienced a complication peri-procedurally within 30 days or within five years of the initial mesh insertion procedure. This is likely a lower estimate of the true incidence.”

I reiterate my point about acceptable and unacceptable percentages. When we are talking about these very large numbers, even relatively low percentages make the procedure too risky to be used in anything other than last-resort circumstances similar to those described by the hon. Member for Glasgow North.

In the past decade, my constituent Emma has undergone X-ray-guided injections, ultrasound scans, MRI scans, in-patient stays, tests galore, more and more scans, and, eventually, a biopsy. She has been refused referral to a mesh specialist centre. It seems highly likely that she should never have been given a mesh implant in the first place after the trauma of such a difficult birth, which leads me to the next point about inadequate warnings. I understand from my constituents that they were given little warning, and in many cases no warning at all, about the potential dangers.

--- Later in debate ---

[Kevin Foster (Torbay) (Con)]

It is a pleasure to be called to speak in this debate, and I congratulate the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) on securing it. It has been quite something to listen to the many stories that have been repeated here this afternoon. My involvement in this issue was prompted not only by conversations with my former colleague in the Ministry of Housing, Communities and Local Government, my hon. Friend the Member for Eastleigh (Mims Davies), but by the case of my constituent, Mrs Beverley Jelfs, who had mesh inserted for a prolapse.

When she emailed me, she said:

“My life has changed so much since having this device inserted in me in 2011. I can no longer work due to pain, fatigue, not able to sit or stand for long. The mesh eroded through my vaginal wall, which 7 weeks later had to have part removal. I have no intimate relationship with my husband, due to the mesh damaging me…I have gone from a very busy and socially active life, to being a depressed lady.”

That sums up the impact that the issue has on her. Although her work was done at a local private hospital, I also asked my local Torbay Hospital—the main NHS hospital serving my constituency—for details of the approach it adopted.

Given the age demographics of Torbay, I had expected slightly more cases to be raised with me. Those that have been raised involve people who have been treated at a particular private hospital. Given that this is a wider issue, I do not think that it is constructive to bring the name of the hospital into the debate, but it is interesting to note that that is where these queries come from.

I was pleased to get a detailed response from Julian Barrington, the consultant in obstetrics and gynaecology at the hospital, giving me some of the figures for the work he has done. I am pleased to note that the failure rates reported back on some of his cases have been a lot lower than some of the averages, but in his letter he makes the point that none of the patients in Torbay has been treated with Ethicon meshes, over which most of the concerns and complications have arisen. His other comment is welcome: given some of the issues being raised, since October 2017 he has suspended all vaginal surgery using synthetic mesh until the results of the NICE recommendations are published and until professional medical bodies make a decision.

[Owen Smith]

The hon. Gentleman is making an incredibly interesting point. Does he agree that it is inexplicable that NICE continues to say that it cannot produce its new guidance until the spring of 2019, when we and the medical fraternity have been asking for it for the past two years?

[Kevin Foster]

I think that the comments make it clear that medical practitioners are waiting to hear what the guidance is and would like it as soon as possible. As politicians in this Chamber, we should not necessarily look to say what the NICE guidance should be and should not put pressure on NICE to come up with particular outcomes, but NICE should look to resolve this uncertainty.

I welcome the pre-emptive approach that my local hospital has taken, but that then leads to a debate about whether other practitioners are continuing and whether my hospital is taking the right approach—I believe it is, and I suspect that Opposition Members who have been involved with this issue believe that it is, too. It is clear that guidance needs to be produced as quickly as it sensibly can be to allow hospital clinicians dealing with patients day to day to know that they are making the right decisions. I welcome the fact that my hospital has made a pre-emptive decision, but agree with the hon. Member for Pontypridd (Owen Smith) that it makes sense for NICE to try to resolve the issue as quickly as possible and provide clarity.

It would be interesting to hear from the Minister whether it is becoming common practice in the NHS for individual hospitals and surgeons to adopt the approach taken by Torbay and South Devon NHS Foundation Trust. Is it more common or does it involve only a small number of hospitals? Is there an emerging body of medical opinion on this matter? Although I might welcome what Torbay Hospital has done, if individual hospitals effectively start forming their own policy that will raise questions in other locations.

Given the concerns raised with me, I welcomed the review announced in February 2018. I can remember being in the Chamber to listen to the Secretary of State’s statement on this and a range of issues affecting women’s health, as well as on whether some of the processes we have in place are as strong as they are in other areas. To reflect on the point made by the hon. Member for Glasgow North West (Carol Monaghan), given the issue, many of those affected are reticent about making a noise. I sought direct permission from my constituent to mention her name and condition in the Chamber, but one wonders whether there are a number of people who do not want to make a noise about this—through embarrassment, to put it bluntly—which makes it different from concerns about other treatments.

I would also be interested to hear from the Minister what liaison is taking place between the UK Government and the Governments of New Zealand and Australia, who have adopted an approach that is similar to my hospital’s. What impact is that having? I have not had complaints from people about not being able to have a procedure for a particular problem while this treatment is suspended, and that tells me that the hospital’s decision has not had a negative effect. I would be interested to know the experience of clinicians in other jurisdictions that are incredibly similar to ours, particularly those from New Zealand.

Reading the motion, I can understand the call for a public inquiry. My only reticence is that such inquiries can become lawyer-fests. I would much rather we were dealing with the situation now, and getting guidance to clinicians in place quickly. We could decide at a later date, perhaps, whether such an examination of what happened would be appropriate. For me, the priority is to get action towards a resolution and for those women and men who have been affected to find medical solutions that can deal with their existing, ongoing pain.

I welcome the debate. It is good to have had contributions at such a level. I am pleased to note the approach my local trust has taken, and I would be interested to see whether that trend is emerging across the NHS and, if it is, what impact it is having on statistics for those who are negatively affected. Does it have any impact at all on waiting times for a particular treatment? If it does not, the pre-emptive approach would seem to be right clinically, in dealing with the problems we have heard about today and in preventing more people from being affected.

I hope that today’s debate will also give hope to those who are suffering that their plight has not been ignored—it is not something that has been talked about quietly somewhere else because of any perceived embarrassment. I hope that lessons will be implemented that prevent others from having to go down the same path as my brave constituent, Mrs Jelfs. I know that her priority in speaking out and having her story relayed was to prevent at least one other person going through what she has been through over the past seven years.

--- Later in debate ---

[Dr Whitford]

I thank the hon. Gentleman for his intervention. In fact, there are studies showing how difficult it is even to explain risk, let alone risk-benefit, to patients. Certainly in the cancer field, in which I spent so much time, patients will go through really appalling treatments even if there is only a relatively small chance of cure. As a clinician, it is difficult to explain a lot of this.

Sufficient information has not been given to the medics, and therefore clearly not to the patients. We have heard this described as a “minor, straightforward procedure”.

[Owen Smith]

Does the hon. Lady agree that part of the problem is that mesh was marketed so widely as being a quick fix? Previously, far more expert urogynaecological surgeons would have undertaken what was far more difficult and invasive surgery—colposuspension or autologous sling. When it went to day-case surgery and, effectively, keyhole surgery, a much wider range of less expert surgeons was suddenly involved.

[Dr Whitford]

I would echo that. We should always be a little suspicious whenever an impression is given that an operation is easy and quick. We hear talk within the medical system of the problems of specialisation and how, actually, we need to go back to having more generalists. The depth of knowledge on breast cancer now would make it impossible for a general surgeon, who might also be doing upper gastrointestinal and lower gastrointestinal surgery, to keep up with that knowledge. That is why we will always need specialists. The danger is when something is thought to be trivial and straightforward.

Although it has been mentioned that the two problems—pelvic organ prolapse and stress incontinence, and particularly the latter—are very minor, there is a broad range. There will be patients for whom the condition is incredibly distressing and who simply cannot leave the house because of their incontinence. We should not put everyone in the same basket.

As has been mentioned, the traditional repair for prolapse would have been colposuspension, which lifts the womb and then buttresses the muscular tissues of the pelvis. The surgeons thought that by adding mesh to muscle that is clearly weakened—that is why prolapse happens in the first place—they would make the muscle stronger.

There was a perception that the results of colposuspension were poor, and a big American paper in 1997 suggested that prolapse recurred in 29% of women. As a surgeon, that seems like catastrophic failure, but, reading the small print of that paper, two thirds of those women were hugely obese and one third had bronchitis and were coughing all the time. There was also a high rate of smoking. It was not the average range of women with prolapse; it was actually a particularly high-risk group. Unfortunately, the paper seems to have dominated the profession’s perception for years.

The problem right across this is that not enough trial work and research were done at the beginning and that the follow-up was far too short. What we have seen is that the mesh problems emerge only after time goes on. There was a Cochrane review in 2007 looking at multiple smaller studies, and it showed no benefit from the use of mesh in prolapse. Since then, we have seen a slow decrease in the use of mesh, but the recent review shows that 2,500 women with prolapse in England had mesh put in last year. That means the issue is still happening.

A 2011 EU study showed no benefit from mesh in prolapse even for recurrence, and one of the few prospective studies, in which the data is collected as time goes on, also shows no benefit. That prospective study was published in 2016, so the information has not been available for decades, and it found that the mesh complication rate at two years is 12%. That is at two years, so the rate can only go up. The Scottish review of 20 years of data from 1997 to 2016 shows only a 4% recurrence of prolapse after the traditional repair. Mesh is no better at avoiding recurrence.

Colposuspension has surgical complications: a surgeon might damage something; a surgeon might injure the bowel or bladder, which is much more common; or a patient might get a wound infection. Those complications fade as time goes by whereas, as has been reported in the Chamber today, the mesh complications do not occur early, but occur as time goes on. In Scotland, after the review, the advice is absolutely clear: mesh should not be used in cases of prolapse as a routine first procedure.

We have heard about stress incontinence and the option of physiotherapy has been talked about. That option should have been used much earlier; there should have been trials of it. As has been said, this is about getting to women in the post-childbirth period so that we have the chance of strengthening their pelvic muscles. The initial repair for stress incontinence was the tension-free vaginal tape, which developed in the late 1990s. A randomised controlled trial was carried out in 2002, with the one-year follow-up report finding only a 1% complication rate and finding that the patients had less pain, and that they recovered more quickly and went home more quickly. This seemed like a great solution, which is part of why the surgeons were so convinced by it; it seemed quick and easy. They were talking about a keyhole approach and the way we deal with gallbladder and other procedures.

The problem that has gone on since has been talked about. We have had the morphing of one tape into another, and one material and so on changing, with little other research having been done and little follow-up. When that trial did follow up its patients, it found that at 10 years the mesh complication rate was 5%. Because the focus was on not injuring the bladder, we find in clinical terms that that has been the focus of the clinicians, because that is what they knew from colposuspension. The idea that two, three, four or five years later people would develop mesh complications was something the clinicians were not expecting and certainly not looking out for.

The incidence of bladder injury for the retropubic tension-free tape was about 10%, which is why the transobturator developed. Someone who has seen an X-ray or a pelvis skeleton will know that the front of the pelvis is made of two struts, so that we are not so heavy that we cannot actually stand up, and the obturator is that hole. The idea was to keep away from the bladder and therefore reduce bladder injuries, and indeed this did that.

Bladder injuries were reduced from 10% to 1%, so, again, everybody was patting themselves on the back. But what happens is the spikes—the trocars—used to put these things in are going through muscle and close to nerves, and are coming out in the groin; they are coming near the muscles that allow people to pull their thighs together. That is where a lot of the side effects and complications have come, and there was definitely a huge upswing and surge in these complications after the obturator tape became the common approach. We also had such slow recognition of what was happening. Many of us women in here, particularly us women of a certain age, will recognise that old story of women simply being dismissed, patted on the head and patronised.

An odd quirk of regulation is that the Federal Drug Administration’s regulation 510(k) allows any similar devices to pass through in a very simple fashion and they are not re-examined. Class I is low risk, and initially these tapes were all classed as class I, which means no research had to be done. They are now class III, which means a randomised controlled trial is required, and we see that Johnson & Johnson, and others, are withdrawing; they are stopping making these things because they would have to go back to carry out trials. The problem is that the tape and the trocars might have looked similar, but when the move was made from tension-free retropubic to a transobturator tape, we were talking about a totally different operation, and there was simply no evidence to show that this was either similar or better.

If something has been passed by the FDA, it tends to get passed in Europe, and the Medicines and Healthcare Products Regulatory Agency tends also to accept it without doing anything else. The European CE mark is only a mark of the quality of production; it does not imply anything about research. As my hon. Friend the Member for Glasgow North (Patrick Grady) mentioned, there is a plan to develop the EU medical devices regulation system from 2020, but, unfortunately, the UK will not be part of that, unless there is a specific negotiation.

The problems began to be recognised in 2012, because of the campaigners, their persistence and their speaking out. In 2014, the then Cabinet Secretary for Health and Wellbeing, Alex Neil, advised all health boards in Scotland to suspend meshes until there was some degree of clarity. It might have been stimulated by that, but certainly at the same time the Australian Therapeutic Goods Administration started to look at its products, immediately de-licensing a third, reviewing a third and, initially, keeping a third as standard. But last November it de-registered all prolapse meshes, so these materials are simply not available in Australia.

The Scottish independent review was set up from 2014 to 2017, and its advice was unequivocal: there should be no routine use of mesh for prolapse, and as regards incontinence, if mesh was being used, registration was made mandatory. There has been discussion about where this registration will occur. Obviously, the colleges have been developing a registration, but we need to know about everyone who had a mesh in. This could be done through scanning the barcode off the mesh and registering it in the notes—that is the obvious way to do it. Having had to review all the case sheets of breast reconstructions after the PIP— Poly Implant Prothèse—silicone implants scandal, I know that it is really important that if something is being left permanently in a patient, we know how to recall it and who had that done.

As has been mentioned, we had the NHS England review and a paper was produced last year, using hospital episode statistics, that showed a 9.8% complication rate at five years. Again, we can expect that to climb. The review published on Tuesday showed that about a third of the 72,000 patients who were treated for prolapse were treated by mesh; that is between 2008 and 2017, and we see a fall over time, so the rate might be higher during the earlier period between 2000 and 2008.

We have seen a 13% drop over that time in prolapse meshes, but, as I say, in prolapse they have utterly no benefit and therefore there can be only loss, so it is hard to justify why so many patients in England are still having prolapse meshes. Some 100,000 women have had mesh incontinence tapes, and this has decreased by 48%, meaning that the overall decrease in the use of mesh over that period is about 32% in England. Since the Scottish inquiry, the reduction in the use of mesh has been 94%—and that is continuing.

The hon. Member for Kingston upon Hull West and Hessle mentioned Dr Wael Agur, whom I am lucky enough to have as our local gynaecologist. I have been able to meet him and get information with him. The only places that are using incontinence meshes are the two specialist units in Glasgow and Edinburgh. In Scotland, a consent process has been developed, which is now being looked at by the colleges so that it can be rolled out, and, obviously, we are talking about usage in tiny numbers here.

Even though registration is mandatory, none of the other health boards is doing this, so it is not expected that Scotland will have many patients registered. What Dr Wael Agur and other colleagues are using is a small piece of rectus sheath, which is the tough tissue we have in front of our muscles. Those who are lucky enough to have a six pack—I do not see many in here— will find that that is very strong tissue. [Interruption.] We do not ask anyone to show them, please. Only about 6 cm of this is required. So we are using the patient’s own tissue and we will be back to an autologous repair, where there might be complications, wound infections and failures, but we would not see this progressive problem.

So what went wrong? Not enough research was carried out and, categorically, there was not enough follow-up. The survey that was reported on Tuesday now gives NHS England a denominator of how many patients have had mesh, but I am sorry to say that just using hospital episode statistics does not give a numerator as to how many women have problems, so I suggest a survey of all those patients or a review is necessary, in order to know how many, even within the NHS, have got these problems.

In addition, as we have heard, there was poor information on which people could base their consent; as I say, the clinicians did not know, because no detailed trials were being done of these new techniques and certainly there was no decent audit. Women were being dismissed and patronised. The regulatory system was far too complacent, simply taking things from the FDA all the way to the MHRA and not looking at changes in technique. The audit was very poor, with a recent survey showing that only 27% of patients who had had meshes were registered.

Finally, the yellow card system failed, yet again. The hon. Member for Congleton (Fiona Bruce) mentioned the other scandals associated with sodium valproate and Primodos. Unless patients are aware of the yellow card system and unless GPs and doctors have it literally in the front of their brains, people will not send a yellow card until they are sure that the drug or the mesh caused the problem. For any new drug, for any new technology that is being implanted, and for any baby born to a mother on medication, there should be a yellow card, because the whole point of the yellow card system is that someone centrally is able to notice. That is why we need more of these yellow cards. There is clearly a problem, so we need better registration and reporting, so that we do not have to have another similar debate in future.

--- Later in debate ---

[Jackie Doyle-Price]

It is actually an issue of rigorous process. We need to make sure that NICE guidance has clinical integrity. The guidance to which the hon. Gentleman refers comes at the end of a longer process of other guidance that is going through the system. None the less, that intelligence is shared throughout—it is an entirely consultative process. The issues that we need to settle are all part of the public debate. Essentially, the publication of the NICE guidance comes at the end of that. The important thing is that everyone knows the issues and that we are very clear about the context in which this is an appropriate treatment. The guidance is very clear: this treatment should not be offered as a routine first intervention.

[Owen Smith]

I am not sure that that answer is correct, in as much as we know that there is no new clinical evidence to be produced in this area; there are no outstanding trials. Therefore, there is no reasonable reason why NICE cannot bring forward that guidance, and it certainly does not make sense for it to wait another year.

Finally, was the Minister surprised when the chief medical officer, who was sitting next to the Secretary of State, said on Facebook Live that she thought that the rate of complication in respect of mesh was between 15% and 20%—a stark difference from all previous estimates by Ministers or officials?

[Jackie Doyle-Price]

Let me emphasise that it is the robustness of the process that is at issue here. The guidance will be published for consultation later this year, and completed next year. There is a robust process for doing so.

The hon. Gentleman is right that the CMO suggested that there was a 15% to 20% complication rate, but I understand that she has written to him explaining that she misquoted the statistics and that the situation is more complex. That is one reason why the retrospective audit is so important. We now have a body of evidence that we can properly analyse, and as has been mentioned, my noble Friend Lord O’Shaughnessy has tasked the CMO with properly analysing the audit published this week so that we might more quickly draw conclusions.

[Owen Smith]

That is very interesting. I do not believe I have received a letter from the chief medical officer explaining that she got the statistics wrong. May I press the Minister to make sure that when the CMO looks at the register she offers a proper narrative analysis of what the numbers mean? We still have contested analyses of whether they show a bigger problem than we thought or whether it is the same. I think it shows a much bigger problem, but we need to understand the numbers.

[Jackie Doyle-Price]

I can absolutely give the hon. Gentleman that assurance. It is crucial that we address the matter transparently—that is very much the spirit in which I want to take this forward.

Surgical Mesh Implants

Owen Smith Excerpts

Wednesday 18th October 2017 Westminster Hall

[Owen Smith (Pontypridd) (Lab)]

This is an important debate for me and for so many hon. Members because of what our constituents are telling us. I pay tribute to my hon. Friend the Member for Kingston upon Hull West and Hessle (Emma Hardy) for giving voice, with great eloquence and passion, to an issue that so many of us feel strongly about. We have wanted a debate in this House for a long time, and I am pleased that she secured it.

My hon. Friend spoke for the women, many of whom are in the Gallery watching the debate, who want and need us to amplify their voice. One of the most heart-rending things for them has been the sense that they have not been listened to and their voice has not been heard. Our job is to listen and to be as brave as them by speaking in this debate and amplifying their voice. This topic has not had the coverage that it deserves, because it is complex, clinical and disputed. It is difficult to see a way through the clinical evidence and feel that we, as non-clinicians, can make sensible remarks without scaremongering, but we need to be brave and engage intellectually to try to understand it.

In truth, the story is quite simple. Since 2000, these products have been diligently marketed by the devices industry as a quick fix—an easy solution to stress-related incontinence or other problems for young women who want to maintain active lifestyles post-childbirth by doing exercise and other ordinary things that we take for granted. The products, which had not been widely used by the clinical world, became used all over the world. Approximately 130,000 women in the UK have had devices implanted.

The regulators and the clinical guidelines said that the risk was between 1% and 3%. However, behind those statistics, the reality has emerged that for a significant number of women—not the majority, but a significant minority—the devices have resulted in chronic, life-changing adverse effects such as sexual dysfunction, loss of mobility, and inability to work. Those effects ought to be taken seriously by us and by the medical fraternity. Instead, they have been dismissed and, worse still, women have been patronised by being told that their problems were unique, which is not the case.

There are questions to address, and the Minister needs to come up with some answers—I know that she is engaging seriously with this debate. If a medicine marketed to deal with incontinence led in one out of 10 cases to sexual dysfunction or the inability to walk or work, it would not be on the market. Surely she agrees that that is how we need to look at it. In Health questions last week, I think she said that the NICE guidelines are expected in 2018—next year. That is not what NICE is saying. Will she clarify whether the guidelines are coming forward to next year, as she implied? I am not sure whether she simply misspoke.

Finally, will the Minister ensure that, as the Government’s representative, she listens to the women who have been mis-sold these devices and lied to about the relative risk? They now feel that they are being listened to at last, but they need their Government to listen and to take action. Guidelines should be brought forward and mesh should be suspended until we know what the real risks are.

NHS and Social Care Funding

Owen Smith Excerpts

Wednesday 11th January 2017 Commons Chamber

[Mr Hunt]

We did know that information and that is why we thought it was totally irresponsible to want to cut the NHS budget in 2010, and not to back the NHS’s own plan in 2015. As a result, we have 11,000 more doctors. In the hon. Lady’s local hospital, 243 more people are being treated within four hours every single day.

[Owen Smith (Pontypridd) (Lab)]

rose—

[Mr Hunt]

I will make some progress and then give way. I could have put what I said on Monday another way. I could have said:

“We have to persuade those people not in medical emergencies to use other parts of the system to get the help they need”.

I did not actually say that, but I will tell the House who did. It was the then Labour Health Minister in Wales, Mark Drakeford, in January 2015. Frankly, when the NHS is under such pressure, it is totally irresponsible for the Labour party to criticise the Health Secretary in England for saying exactly the same thing that a Labour Health Minister in Wales also says.

[Owen Smith]

Will the Secretary of State give way to a Welshman?

[Mr Hunt]

I would be privileged and honoured to give way to a Welshman.

--- Later in debate ---

[Owen Smith]

The Secretary of State has sowed confusion in the House and in the country on this question this week, and he is doing so again today. If he is saying the same as my friend the former Health Minister in Wales—that we want to divert people who do not need to go to A&E from doing so—I am sure that everybody in this House would support him. But we suspect that he is saying that the four-hour wait target will be disapplied to some people turning up to A&E, and that that is the downgrading he is talking about. If that is the case, the Secretary of State should come clean, and he should be clear about whose job it will be to disapply the target to some people with minor ailments.

[Mr Hunt]

I did not say that because we are not going to do it. As we have had an intervention from a Welshman, let me tell the hon. Gentleman a rather inconvenient truth about what is happening in Wales. Last year, A&E performance in Wales was 10% lower than in England, and Wales has not hit the A&E target for eight years. We will not let that happen in England.

I noticed that the shadow Health Secretary quoted a number of people, but one that he did not quote was the Royal College of Emergency Medicine. I wonder whether that was because of what it said about Wales this week. It said:

“Emergency care in Wales is in a state of crisis…Performance is as bad, if not worse, as England, in some areas.”

There we have it: in the areas in which Labour is in control, these problems are worse.

--- Later in debate ---

[Owen Smith (Pontypridd) (Lab)]

I do not intend to take too long, because I am mindful of the fact that the motion refers largely to NHS England, but I am goaded to speak by the repeated references by the current Secretary of State, the previous Prime Minister and the current Prime Minister to the relative performance of the NHS in Wales. I want to take a few minutes to set the record straight and give a clearer illustration of the relative performance of the two NHS systems.

Before I do that, I want to reflect on the interesting, thoughtful speech that the Prime Minister gave earlier this week about her desire to create a “shared society”, as she put it, in Britain. I read the speech, as many Members did, and felt that it set out precisely what all Governments ought to be doing at all times. In one passage, the Prime Minister said:

“That is why I believe that…the central challenge of our times is to overcome division and bring our country together.”

She said that she wanted to create

“a society that respects the bonds that we share as a union of people and nations.”

I completely agree with her about that, but I find it impossible to reconcile that stated objective and rhetoric with how she and, in particular, her predecessor have sought to divide this country on the NHS. They have illegitimately demeaned the performance of the NHS in Wales, demoralised its staff and destroyed confidence and faith in it among Welsh citizens. With a few statistics, I hope to illustrate how misleading some of the representations in recent years have been.

The first statistic is that the previous Prime Minister referred to the NHS in Wales in a disparaging fashion 37 times, on every occasion as a political attempt to militate against criticism of the NHS in England. That broke the important bonds between different parts of the UK. I will state a few of the facts. The entire budget for Wales is about £15 billion per annum, and £7.1 billion of that is spent on the NHS. That is 48% of all spending by the Government in Wales. The difference between that and the situation in England is enormous. In England, the NHS budget is £120 billion, and the entire budget of the country is about £750 billion, so 16% of the budget is spent on the NHS in England and 48% in Wales. The Welsh Government’s headroom to expand spending on the NHS instead of other areas is therefore dramatically less than in England. That is the first illegitimate way in which the Government have manipulated statistics on the issue.

Secondly, over the past six years, the Government have repeatedly referred to the lesser spending on the NHS in Wales than in England per head or in percentage terms. We have heard that three times today already. The truth is that in 2010 the Welsh Government, with the lower headroom that I have mentioned, chose to reduce spending on the NHS by 1% compared with the previous year. In England, there was flat cash spending. That 1% reduction was made to increase and prioritise spending on education in Wales. Since then, we have seen successive rounds of investment by the Welsh Government: £80 million was announced this week for a new treatment fund; last week, there was £40 million for capital spending. It is now broadly comparable in percentage terms. In fact, last year in Wales we spent £2,026 per head, while England spent £2,028. The difference is negligible. If we add health and social care together, we find that Wales spent 6% more per head than England. These are the realities of the comparative spending.

What has this given us in outputs? There are some things that the Welsh NHS does worse. In Wales, we wait longer for some diagnostic treatment. There is a need to spend more on more MRI scanners and CT scanners. Part of the issue, however, relates to an older and sicker post-industrial population, rural sparsity and a lesser ability to attract people to some of the more far-flung hospitals—all perfectly explicable and reasonable. In England, over the past nine months, we have seen the biggest rise in waiting lists for nine years.

In other areas, Wales does well. On the crucial eight-minute ambulance response time, 77% of calls meet it in Wales, against only 67% in England. Most would agree that the 62-day cancer treatment target is vital, but in England it is consistently missed. In England, on average, 81% of people are treated within the target time; in Wales, the figure is currently 86%. There are other areas I could turn to. A&E is the crucial area we are looking at today. In Wales, 83% of patients are currently seen within the four-hour target. In England, the figure is 88%. There are 150 A& E departments in England and only six or seven in Wales, so this is another completely ludicrous and, in many respects, meaningless statistical comparison. Thirty seven of the 150 A&E departments in England are below the Welsh average. Several of the Welsh trusts are up at the 95% or 98% mark. This is a further illustration of how meaningless, misleading and frankly abusive it has been of the Tories to use the Welsh NHS as a stick to score political points.

In conclusion, the truth about the Welsh NHS is that it performs excellently in some areas and that it could be improved in others. As the OECD said, in a 10-year study of all the healthcare systems across the country, no one part of Britain performs demonstrably better or worse than any other. That is the truth about the differences between our NHS in this country. The Minister, the Prime Minister and the Secretary of State need to remember that they are Ministers for the whole United Kingdom, not just England. Their duty is to increase the bonds of solidary, not destroy them.

Mental Health and NHS Performance

Owen Smith Excerpts

Monday 9th January 2017 Commons Chamber

[Owen Smith (Pontypridd) (Lab)]

The Secretary of State could not resist making his customary political attack on the Welsh NHS. This weekend, I had cause to visit my local hospital A&E department with a family member, and we received a brilliant, speedy and expert service. Will the Secretary of State join me in congratulating the staff at the Royal Glamorgan hospital? Will he also congratulate the Welsh Labour Government on not having to call the Red Cross to any hospital in Wales, and will he further congratulate them on their long-standing emphasis on mental health? Wales spends more on mental health provision per capita than England or, indeed, any part of the United Kingdom, notwithstanding the £2 billion that he has cut from the Welsh budget in the past six years.

[Mr Hunt]

In the hon. Gentleman’s long list of statistics, what he was not prepared to say is that people wait twice as long for a hip replacement in Wales, more than double the proportion of the population is on a waiting list for NHS care—that is one in seven people in Wales, compared with one in 15 in England—and those in Wales are 40 times more likely than those in England to be waiting too long for a diagnostic test result.

Health and Social Care (Re-committed) Bill

Owen Smith Excerpts

Wednesday 7th September 2011 Commons Chamber

[Paul Burstow]

I am grateful to my hon. Friend for that intervention. If he listens carefully to what I am saying, he will hear that I am developing an argument that will go towards answering that question. Rather than trying to answer it in a very small way now, I would rather answer it in a comprehensive way through reference to what I had planned to say to the House.

As I was saying, hon. Members should ask themselves how the Secretary of State would be able to wash their hands of the NHS while simultaneously being legally required to deliver on all the duties I have just outlined. Crucially, the Secretary of State also retains the duty to promote a comprehensive health service, which dates from the Act that founded the NHS in 1946 and has been unchanged by this Bill. The Secretary of State will also have the duty to secure that services are provided for that comprehensive health service and will have failed in that duty if they are not.

The Secretary of State also has the ability—the obligation, in fact—to set goals and priorities for the NHS through the mandate. That will set out what the Secretary of State wants the NHS to deliver, which will be updated every year. It will be widely consulted on and Parliament will scrutinise it, for the first time ever giving Parliament a detailed say in what the NHS is tasked to deliver.

The Secretary of State has further powers in addition to the mandate to impose standing rules by which the NHS commissioning board and the clinical commissioning groups must operate, which will be subject to scrutiny and control by Parliament—a power Parliament does not currently have. What is changing, however, is the Secretary of State’s relationship with the NHS in terms of the role of Ministers in the commissioning and provision of services to the NHS. The Government believe that it should not be the job of Ministers to provide directly or commission NHS services, either. It should be the role of front-line professionals, who should have the freedom to focus on driving up quality of care, free from interference by Ministers in operational decisions—something that all parties in this House have said that they want to see.

We understand that all Government legislation has a responsibility to foresee the unforeseeable, to ask questions about the worst-case scenario and to ensure that the answers stand up to scrutiny. That is why this Bill contains a number of back-stop provisions to make it absolutely certain that any future Secretary of State will not be able to turn a blind eye to failings of service provision, so we have ensured that the Secretary of State has the power to step in if the board, or Monitor, is failing to deliver on its duties, including any duties imposed on the board through the mandate.

Finally, in the event of a significant emergency such as a pandemic, the Secretary of State will have powers to direct any commissioner or provider of NHS services.

[Owen Smith (Pontypridd) (Lab)]

In the event where there is not an emergency, will the Minister confirm that under the new provisions the Secretary of State will not have the power, as he has, to direct a commissioning group to do what he thinks is appropriate for the people in that area?

[Paul Burstow]

No, he will not have powers of direction. Of course, powers of direction are not subject to any form of parliamentary scrutiny and can be issued by a Secretary of State by fiat. In future, this House, through regulations, will be able to look at and agree—or not—standing rules that in most effects will have the ability to direct clinical commissioning groups and the NHS commissioning board on a wide range of matters. I direct the hon. Gentleman to clause 17, which sets those out at great length.

--- Later in debate ---

We are also making a range of technical amendments to these clauses, with which I will not detain the House. If Members wish to have further information about those matters, I should point out that they were the subject of detailed briefings published last week to accompany the amendments.

[Owen Smith]

I am grateful to the Minister for his contribution. Questions about the Bill just keep coming. That is how I feel on rising to speak. We have had eight months of debate on it. So far, more than 1,500 amendments have been tabled and we have learned today that more are coming, which was news to us at least. We have two—soon to be three—versions of the Bill, as well as a very real issue between Ministers and the Opposition over how it ought to be interpreted and what tone we ought to take when debating it. I would like to address some of those questions and talk about the tone. I also want to outline how we are interpreting the Bill and state that we feel very sincerely that the Government are misrepresenting what is in it.

By way of illustration, I shall pick up on a few things that the Minister said, which I feel either raise further questions or misrepresent what is in the Bill. I want to discuss in particular the issue that was debated by him and my hon. Friend the Member for Warrington North (Helen Jones)—whether, under the aegis of the Bill, the meetings of CCGs are to be held in public. He was very clear about that. In fact, he was so clear that he had his Liberal Democrat friends bouncing up and down, shouting, “Must, must! They must meet in public. Haven’t you read the Bill?” He went on to suggest that my hon. Friend had perhaps read an earlier iteration of the Bill. I know her well enough to know that she does her homework and she will indeed have read the second version of the Bill. There have been so many that it is quite easy to lose track. She will also have read schedule 2 of that Bill, which states—I will quote directly; I will not just make it up, like the Minister—

“The provision made under sub-paragraph (3) must include provisions for meetings of governing bodies to be open to the public, except where the consortium considers that it would not be in the public interest to permit members of the public to attend a meeting or part of a meeting.”

Meetings will therefore be held in public unless the consortium decides on a whim that it is not in the public interest for the public to come to the meeting—that is, for the meeting to be held in public. That is the tone that Ministers have set throughout the Bill. It is misrepresentation. It relies on the fact that there are thousands of words, acres of clauses and endless amendments. Ministers are trying to bore people into failing to look at the details, but I am far too much of an anorak; I will keep reading the Bill, keep looking at the amendments and keep drawing them to the public’s attention.

[Helen Jones]

Does my hon. Friend agree that experience shows that when bodies are left to determine when it is in the public interest not to know what is going on, they usually do so on the basis of what would be embarrassing to them? Does he not fear that when difficult decisions are to be taken, commissioning groups will shut down public debate by making their meetings not open to the public?

[Owen Smith]

One needs to look at the top of institutions in this country—at the Government, and the extent to which Governments of all stripes choose what they are going to reveal to the public and what they deem not to be in the public interest. That standard is set and applied throughout public and private bodies in this country and elsewhere.

I have no doubt that there will be many instances when CCGs will determine that it is not in the public interest that the public be admitted to their meetings—in particular, for example, when they are discussing hospital reconfigurations or closures, and changes to public services that people consider to be vital in those areas. CCGs must consider all those crucial issues, but they must do so in a transparent manner, which is what we said in Committee last time round, on the previous iteration of the Bill. We have said it again and the Government still have not answered the point to our satisfaction. I call upon the Minister to amend schedule 2 once more. There is time to do so in the other place and he may well want to give that consideration.

[Mr David Ward (Bradford East) (LD)]

As a shadow Minister, is the hon. Gentleman aware that there is a standard clause in the standing orders or constitution of every public body and every local authority throughout the country? It is for those bodies to justify what is in the public interest. That is standard in public sector organisations across the country. He is trying to make something out of nothing.

[Owen Smith]

No, I am trying to make a point about what the Minister said at the Dispatch Box not five minutes ago, which was that CCGs must meet in public. I am pointing out that that is not accurate. They do not always have to meet in public; they may choose not to. Whereas that may apply across the board in other public institutions, these are crucial new bodies about which there are grave concerns. We on the Opposition Benches are concerned to ensure that they should be obliged to meet in public on all occasions.

[Paul Burstow]

My hon. Friend the Member for Bradford East (Mr Ward) is right. That is why the outrage was expressed as it was. This part of the Bill and the schedule have the same effect as the Public Bodies (Admissions to Meetings) Act 1960. That Act does not say in a blanket way that every meeting must be held in public. It allows local authorities to exercise judgment about confidentiality. We are applying the same principles in that regard in exactly the same way as to PCTs, with the additional provision that for the first time all these arrangements must be published.

[Owen Smith]

I am grateful to the Minister for that further intervention, just as I assume that he is grateful for the intervention of the civil servants in the Box, who must have passed him a note. Clearly, he was not aware of that earlier. When he said that CCGs must meet in public, he was under the impression that that was the case.

[Nicky Morgan (Loughborough) (Con)]

Will the hon. Gentleman give way?

[Owen Smith]

No. I shall move on now. We have debated the topic long enough.

[Andrew Gwynne (Denton and Reddish) (Lab)]

My hon. Friend is right to be concerned about the way this part of the Bill is drafted. It is incredibly open-ended for the consortium to decide what is exempt from public knowledge. That is quite different from the situation in local government in England, where the Local Government Act 1972 prescribes what is exempt from the press and the public.

[Owen Smith]

Indeed. The key difference is that it is for the clinical commissioning groups, in establishing their constitution, to determine what the rationale will be for allowing the public in or not. That is not set down in statute or in direction from the Minister or the Secretary of State. It is for individual CCGs to determine when they should let the public in. I give way to my colleague on the Bill Committee.

[Nicky Morgan]

I am grateful to the hon. Gentleman. I remember discussing with him whether he was a lawyer, and he was proud to say that by background he was not a lawyer. As he knows, there will be occasions when a clinical commissioning group is considering a matter which is sub judice. It could be an employment law matter; it could be a confidential matter relating to a patient—for example, a mental health patient for whom there has been very sensitive care. There will be times when it is appropriate and in the public interest and that of relatives—[Interruption.] I am making the point to the hon. Gentleman, not to those on the Opposition Back Benches. There will be occasions when it is appropriate for the CCG not to meet in public, as I am sure he will concede as a matter of common sense.

[Owen Smith]

I will not dispute that there may be occasions when it will be appropriate for the CCG to meet in private, but that is not what the Minister said. My point was to do with the tone and the misrepresentation that has been systematically applied by those on the Government Benches. That is the difference.

[Dr Wollaston]

rose—

--- Later in debate ---

[Owen Smith]

I shall not give way any more on that issue. [Interruption.] I was enjoying it too, although I would be surprised if the Minister was. I shall move on, if I may, to questions. As I said, there are many questions.

The Minister said today with his usual candour and clarity that the vast bulk of health care will in future be delivered by NHS services. That is a new one on me—“the vast bulk of health care”. That raises two questions. Will he characterise what he means by “the vast bulk”, and what he means by “NHS services”? In a world in which we will have a much more mixed economy, with a much greater mix of public and private providers working under the banner of the NHS, it is far from clear whether those things will be provided through what we have understood traditionally to be a public NHS or through some new hybrid NHS that the Minister is cooking up in the laboratory at the Department of Health.

The Minister said a moment ago that there were many amendments. He is a master of understatement, as ever. There are about 100 amendments in the first group, and a further 100 or so to be debated later today—part of the 1,000 amendments that have, extraordinarily, been tabled at this stage of the Bill, eight months after it first appeared.

--- Later in debate ---

[Paul Burstow]

Is it still the Opposition’s policy to seek a division between the role of commissioning or purchasing health services and the provision of those services? Does the hon. Gentleman believe in that split?

[Owen Smith]

Yes. The current situation is clear: the Secretary of State has a legal duty placed upon him in the legislation to secure and provide—not just to promote—a comprehensive health service in this country, and to issue direction to PCTs and SHAs, such that they so do. Those two crucial aspects of the current legislation are being changed in the Bill, and I intend to discuss them in a moment.

In version 1 of the Bill, the Government were less coy, because it actually excised section 1 of the original 1977 Act. After the deluge of criticism, however, they decided that they needed to put it back in, making it explicit, as they put it, that the Secretary of State will be responsible, as now, for promoting a “comprehensive health service”.

Section 1 of the Act was duly reinstated, as was the duty to promote, but there was a critical change, in clause 1(2) of the new Bill, which diluted the traditional duty to provide and secure. Ultimately, it placed a duty on the Secretary of State only to

“exercise the functions conferred by the Act so as to secure that services are provided”.

I shall come on to the reason why that is significant, but equally significant and allied to it was the retention—against the advice of Opposition Members and many others—of clause 10, which amends section 3 of the 2006 Act, thus keeping commissioning bodies, not the Secretary of State, as the parties with a legal duty to provide health care in England.

The net effect of those changes—despite what the Minister said earlier, and despite what the Secretary of State has said on several occasions, including notably on Second Reading—is no change. The Secretary of State is still, as the Minister put it, washing his hands by divesting himself not of the NHS but of a direct duty to provide a comprehensive health service. That is the distinction which the Minister failed to make today. The Secretary of State is palming off that precious duty, which has been placed upon successive Secretaries of State, and handing it on, via the mandate, to a quango and to unelected commissioning bodies.

[The Secretary of State for Health (Mr Andrew Lansley)]

If the shadow Minister is so concerned about the Secretary of State’s legal ability directly to provide services, will he answer me a question? Does he know the last time the Secretary of State for Health actually directly provided any services? In the Department of Health, we cannot find out when it was.

--- Later in debate ---

[Owen Smith]

With the greatest respect to the Secretary of State, who I have to confess knows a lot about the NHS and about the health service in this country, I think that that question is completely erroneous—a total red herring. As I said earlier, the practical reality is that the Secretary of State delegates—[Interruption.] No, no, no. The Secretary of State delegates to PCTs and SHAs his powers to provide, but, as I am going to tell the Secretary of State, he will know that under the aegis of this new Bill he will not have the power to direct clinical commissioning groups to do what he says, so he will not have a direct personal duty to provide. On the courts, we heard another interesting thing earlier from the Minister of State. He said that it was okay, because the Secretary of State will be able to justify in court when he directs a CCG to act. That is very important, and I am keen to hear the Secretary of State’s response to it, but I do not think that he has one that will convince us.

[Mr Lansley]

The hon. Gentleman has admitted that for decades the Secretary of State has not directly provided services, and I know that that is true. The issue is about having a legal duty, not to provide services but to secure the provision of services. He admits that that is done through delegation, which is in the structure of the Bill through the delegation of that responsibility to the national health service commissioning board and the CCGs. The mandate, which my hon. Friend the Minister has clearly explained, is much more transparent and accountable to Parliament for the manner in which the Secretary of State secures the discharge of those duties.

[Owen Smith]

With respect, there is not a legal duty on the Secretary of State to provide, as there has been in successive health Bills. When Bevan talked about hearing the bedpan dropped on the ward in Tredegar, he did not mean that he wanted to pick it up. [Interruption.] I do not know whether the Secretary of State wants to listen. Bevan did not mean that it needed to be picked up by the Secretary of State, but he certainly meant that he would like to be able to direct those responsible operationally for picking it up so to do.

The critical difference in this Bill is that the Secretary of State will divest himself of not only the duty to provide that service, but the power to direct the operational parts of the NHS, save for—[Interruption.] The Minister is waving his head, nodding or something; I know what he is going to say. Under the Bill, save for in cases of crisis or emergency, the Secretary of State will not have responsibility for running the day-to-day operations of the NHS.

[Paul Burstow]

The hon. Gentleman is wrong again. Unlike the previous Government, who were happy to have directions that did not have any parliamentary accountability, this Government are putting in place the ability, through regulations, to set the standing rules for the NHS, which, as set out clearly in clause 17, include all the issues that the hon. Gentleman is concerned about and show that the Government are committed to ensuring that there is a comprehensive health service.

[Owen Smith]

As the Minister has just confirmed by omission, there will be no power to direct and therefore no power to deliver absolutely a comprehensive, universal health service as we have come to expect and understand it. Those are the key differences. [Interruption.] The Minister can shake his head, but that is an accurate interpretation of what has happened.

[Rosie Cooper]

My hon. Friend has been talking about mandates. Will he explain under what mandate and how the Secretary of State is implementing all these structural changes? The House has not voted on them and the process started before the Bill came to the House. You are making structural changes, damaging the health service and making it impossible—

[Rosie Cooper]

Forgive me. I am for ever doing that, and I must stop. In essence, I am saying that the Secretary of State and Ministers keep talking about mandates and what they will and will not do, yet they are disregarding everything because they are implementing the Bill before it has been sanctioned by the House or the other place.

[Owen Smith]

I am grateful to my hon. Friend for that intervention. As she will know, the Government have no mandate for any of these things—they were not in the manifesto, the election or the coalition agreement. There is a mandate, but not one to effect these sorts of changes. That is another disgrace given how large the changes are.

I am going to move off this issue, but I will conclude by reading back to the Government their own words, which make it absolutely clear what they are doing in getting rid of direction. Paragraph 66 of the explanatory notes states:

“Currently, the Secretary of State is directly responsible for providing or securing the provision of all health services as set out in the NHS Act, a function which is largely delegated to Strategic Health Authorities and Primary Care Trusts…However, the new commissioning structure proposed by the Bill means that this would no longer be the case.”

The explanatory notes also state that

“functions in relation to the health service are conferred directly on the organisations responsible for exercising them”.

Effectively, the Secretary of State will move on and his focus will shift to public health.

[Paul Burstow]

I want to be absolutely clear about this. The hon. Gentleman is happy with an arrangement that allows the Secretary of State to make directions to the NHS that do not require him to come to this House to account for his actions—is that correct?

[Owen Smith]

I am happy—we are happy—with the Secretary of State being properly, publicly accountable through this House and having a legal duty placed on him to secure and provide politically accountable health services in this country. We are deeply concerned that the changes envisaged in the Bill, which radically alter the nature of the NHS, will not be able to be held to account through the Secretary of State in future Parliaments. That is our profound concern about the line of direct political accountability that so many of the Minister’s hon. Friends share, which is why they have tabled amendments to that effect and why they have repeatedly raised these concerns in the Bill Committee and elsewhere. The Minister does not have those concerns, but many other Liberal Democrats do.

[Andrew George]

I have to say that I entirely respect my hon. Friend the Minister. The hon. Gentleman’s point echoes what I said earlier in contradicting the Department of Health’s claim that the original 1946 Act did not have a requirement to provide or secure services. My quote provided evidence that that requirement has always been there. The Department also claims that because of the changes it is no longer legally acceptable for the Secretary of State to have that responsibility, but that issue has not been properly addressed. Would the hon. Gentleman care to deal with the point that it may no longer be legally acceptable for the Secretary of State to have that duty?

[Owen Smith]

As I said earlier, or rather as somebody said on my behalf, I am not a lawyer—I am a historian. As a historian, I agree with the hon. Gentleman that the 1946 Act does indeed say:

“provide or secure the effective provision of services”.

He was entirely right in that, and I could not understand the response from the Minister.

The key thing is that eight months, two Bills and 1,500 amendments later, we are still debating clause 1 and its legal interpretation. That is testament to just how badly botched this Bill has been and just how alarming it is for many people—patients and NHS staff—that we, the legislature, do not understand, or have divided views about, our understanding of the critical responsibility of the Secretary of State.

[Steve McCabe]

Before my hon. Friend moves on to the next section of his speech, perhaps I can return to the question of a mandate. Given that this is such a botched Bill, given what he says about the tone of the proceedings, given that at this stage nobody seems to understand exactly what are the implications of some of the Government’s claims, given the fact that the Government are not willing to entertain people’s legitimate concerns, and given that there is no mandate in either Government party’s manifesto for this Bill, the other place is presumably not bound by the Salisbury convention, and if the Government will not entertain those concerns here, it will be the duty of the other place to address them.

[Owen Smith]

It will. I have no doubt that the very many lawyers in the other place will have a field day in addressing these issues—just as, we fear, lawyers the length and breadth of this land will have a field day, not only during the passage of the Bill but for many years to come. That is because so many things will be contested, not only relating to the issues we are debating but, far more importantly, in relation to competition, which we debated yesterday, where it is undoubtedly the case that decisions that have hitherto been made to provide services from within the family of the NHS will be challenged by carpetbaggers—profit seekers—from outwith the NHS. Under the future provisions, those issues will need to be tested in the courts. The Government have conceded that on several occasions, and I am sure that they would do so today if they were asked.

Finally on the issue of the Secretary of State, and once again to hammer home the point that this is not just Labour scaremongering and that lawyers will be involved at every step of the way, I draw Members’ attention to the independent legal opinion that was provided by Stephen Cragg QC. Paragraph 1 of the executive summary states:

“It is clear that the drafters of the Health and Social Care Bill intend that the functions of the Secretary of State in relation to the NHS in England are to be greatly curtailed.”

It goes on:

“Effectively, the duty to provide a national health service would be lost if the Bill becomes law. It would be replaced by a duty on an unknown number of commissioning consortia with only a duty to make or arrange provision for that section of the population for which it is responsible.”

It states that the Bill is

“fragmenting a service that currently has the advantage of national oversight and control, and which is politically accountable via the ballot box to the electorate.”

That was the view of an independent QC on reading the Bill. It is a view that I and the Opposition share. I suggest that Ministers read it very carefully and do not dismiss it, as they have done today, as an inaccurate reading of the Bill.

[Nicky Morgan]

Is that the independent legal advice given to the campaign organisation, 38 Degrees? If it is and if the hon. Gentleman has any influence over that group, can he persuade it to release and make public the instructions given to counsel, because any instructing solicitor who instructs counsel to give advice usually gives very clear guidelines on, or an indication of, what they want the advice to say?

[Owen Smith]

I am ever so grateful to the hon. Lady for that intervention, because it is profoundly rich for anybody on the Government Benches to suggest that we should prevail upon an independent organisation to publish the instructions that it offered to an independent QC, when the Government will not even publish the independent advice that they have commissioned. They have refused to do so repeatedly. They will tell us that they do not agree with this independent opinion, but they absolutely will not publish their own. I suggest that she makes representations to those on her Front Bench, and I will do the same to 38 Degrees if I have a chance.

The independent legal advice goes on to say:

“Encouraged by the structure and clear intention of the Bill to give consortia autonomy from the Secretary of State,”—

which is, of course, in clause 4 of the new Bill—

“there is a real risk of an increase in the ‘postcode lottery’ nature of the delivery of some services, depending on the decisions made by consortia.”

That increase in the postcode lottery takes me on to the second set of proposals that I wish to touch on, which we believe would stop the Government effectively legislating to hardwire the postcode lottery into our NHS. We accept that it is already too variable across the country and that there needs to be greater equity and standardisation, with excellence provided to everybody across the country. That will become all the more difficult with the new provisions.

New clauses 10 and 11, which were tabled by the Labour Opposition, are designed to combat some of the possible malign consequences of the changes that hand to clinical commissioning groups the ability to determine the needs of the local health population and to set their priorities without interference or support from the Government, or indeed from regional strategic health authorities.

[Dr Poulter]

rose—

[Owen Smith]

I am delighted to give way to the hon. Member for Central Suffolk and North Ipswich (Dr Poulter), who has such an acute interest in Wales.

[Dr Poulter]

The hon. Gentleman is making some good points. Does he accept that within a national framework of gold standard and good treatment, there will be regional or local variations in the needs of patient groups? For example, given health care inequalities, mental health and the higher rates of cardiovascular problems in ethnic minority populations, patients in Bradford may have very different health care needs and priorities from patients in the area of rural Suffolk that I represent. Does he agree that the Bill goes some way towards allowing local flexibility that will better address some of the different local health care needs?

[Owen Smith]

I accept that there are obviously different needs and that there is a good case for a needs-based assessment model being used by PCTs in the current situation or by CCGs. Indeed, one of the amendments tabled by Liberal Democrat Members on a needs-based assessment is excellent and I wish that we had tabled it. However, the crucial difference, which I alluded to earlier, is that previously the Secretary of State has had a direct duty under section 3 of the National Health Service Act 2006 to provide and secure a whole range of relevant and necessary pieces of the health ecosystem, such as hospitals, within a given area. Under the Bill, that duty will pass to clinical commissioning groups. That is a further crucial removal of responsibility and accountability from the Secretary of State and transference of them to CCGs.

Under the aegis of the Bill, many CCGs may well plan well for their local population, and perhaps better than primary care trusts, but what if they do not? What if they get it wrong and determine for clinical reasons—or, dare I say it, because in this new world they are sitting cheek by jowl in the boardroom with commercial players who have a stake and a skin in the game financially—that they no longer feel it is “reasonable”, as the Bill puts it, to provide certain services? I think that is perfectly foreseeable.

We already know that because of the cost pressures that PCTs are under, they are having to make difficult decisions about which services they will provide and which they will not. They have always had to do that. It is just possible that CCGs will make duff decisions with which local residents disagree. As we heard earlier from my hon. Friends on the Back Benches, they will not be able to be held to account in the way that the Secretary of State, and eventually PCTs through the Secretary of State, can currently be. Those changes are critical, and I suggest that the Minister reflects on them.

Another crucial change to the Bill that we would like to be brought about is in respect of the costs of bureaucracy. We are changing from 150 PCTs to more than 250 clinical commissioning groups and counting. The latter are smaller and less strategic, and certainly less experienced in commissioning, than PCTs or strategic health authorities, and they are arguably too small to compete equitably with very large and financially powerful foundation trusts. That is a real risk. Crucially, they will also increase transaction costs, bureaucracy and administration costs.

That is why, in new clause 11, we have decided to ask the Government to put their money where their mouth is. The Minister asked earlier why we had chosen an “arbitrary” figure of 45% for a cap on the volume of expenditure on administration by CCGs. The answer is simple: it was the number that the Secretary of State came up with. He said that that was how many percentage points he was going to trim off the administration and bureaucracy costs of the NHS. He boasted that he could deliver 45% savings, so we are calling on him today to put his money where his mouth is and legislate for that. Let us measure him against that, because there is not going to be much else that we can hold him accountable for.

We have tabled new clause 10, on waiting times, because targets and standards absolutely matter in the NHS. No matter what the Government keep telling the public, we still believe in clinical targets, including some that the Government would denigrate as “bureaucratic” or “administrative” targets. In new clause 10, we ask the Government to take the power to set transparent regulations relating to waiting times. Waiting times are going up under this Government. There have been 400,000 people with long waits since the Tories came to power. The trajectory and the sense of history repeating itself are depressingly clear to me and my hon. Friends.

[David Tredinnick (Bosworth) (Con)]

I think the hon. Gentleman might inadvertently have misled the House. He said that waiting lists were going up in the NHS. My recollection is that they are going up in Wales. He is shadow Wales Minister, I think.

[Owen Smith]

I was waiting for that intervention and looking forward to it. I was slightly concerned, when the hon. Member for Central Suffolk and North Ipswich intervened and failed to mention the fair and beautiful country of Wales, that I was not going to get the opportunity to put the record straight. I hate to tell the hon. Member for Bosworth (David Tredinnick) this, but he is wrong. Waiting lists in Wales are coming down. We have been hitting 95% of our target week in, week out, month in, month out since September 2009.

--- Later in debate ---

[Paul Burstow]

I have said that before.

[Owen Smith]

The Minister has not said it before in a public realm of which I am aware. He certainly did not say it in the Public Bill Committee, all 40-odd sessions of which I feel I sat through. The Minister knows that the issue is crucial, because the Future Forum that he commissioned said so. Indeed, it said that

“one of the most widely voiced criticisms of the proposed changes was a deeply felt concern at the risks to healthcare education and training in England posed by the fast pace of change.”

The Government responded by saying:

“we will introduce an explicit duty for the Secretary of State to maintain a system for professional education and training as part of the comprehensive health service.”

We are still waiting. What will that duty look like? [Interruption.] The Minister says “We have said that we are going to do it”, but here we are, eight months and 1,500 amendments later. How long must we wait? Are we sure that we will see the duty introduced in the House of Lords? Are we positive about that? I must say that I am not certain about it.

[Paul Burstow]

The shadow Minister rarely criticises the Government for telling the House again what they said in the response to the Future Forum, which is that we would introduce that explicit duty. We will introduce it in the House of Lords, as I have told the House today. We are committed to doing so, having listened carefully to the concerns of NHS professionals.

[Owen Smith]

The very simple question to be asked is “Why the delay?” Why could the Minister not have introduced it earlier? We have known about the problem for eight months and more. The Secretary of State, who has been keen on changes such as this for a long time, must have given some thought to what he was going to do about staff training and work force planning in the NHS.

[Mr Barron]

It was clear from the day of its publication that the Bill, which abolishes the structure that had kept education and training in place, would create chaos in the national health service. Here we are, hundreds of amendments later, with a resubmitted Bill. Our debate on the outcome has been crammed into two days, which is wholly unsatisfactory, and the Government still cannot tell us what will replace the structure that has been in place for so many years. That is a nonsense.

I listened to the Minister’s speech earlier. He was telling people—people outside, including professionals who want this kind of professional development on a continuing basis—to have faith in what might happen at some stage. I have to say that I have little faith in what the Government have done with the Bill from the very beginning.

[Owen Smith]

I entirely agree, and my faith is diminishing by the minute. I do not understand why the Government cannot simply concede that they have signally failed to deal with this crucial aspect of the Bill. It took them months to produce the revised failure regime. They managed to drag that out in time for Report, but they have not produced the impact assessment, they have not produced any figures showing how much this will cost the public purse, although we know that the amount is rising—I should love the Minister to tell us by how much—and they have not produced a solution to the crucial problem of staff training and work force planning. That is a disgrace. They could have and should have done it by now.

New clause 13 would place a further duty on providers, related to what is in the earlier new clause. It would oblige them to make provision for training and work force planning for their own staff, thus filling another gaping hole in the Bill. As the Minister might say if he intervened on me, Monitor may well have powers, under the pricing clauses, to pay less under the tariff to providers who do not engage in training, but nothing in the Bill compels new entrants—especially private providers—to give their staff any training, or to deal with any costs that the NHS has traditionally had to bear for the education of the work force.

We all know that in the incredibly fast-moving and innovative world of health care, keeping staff up to date is absolutely crucial. That is why—I hate to say it—despite the news that we are to have an amendment ín the Lords, we will attempt to press amendment 7 to a vote. It proposes the retention of SHAs until and unless we know precisely what the Government will put in their place in respect of training and administration.

NHS staff is another group that is profoundly concerned by the shambles, chaos and confusion that Ministers have overseen. Under the Bill, they are described as assets and will be transferred lock, stock and barrel between new providers. The new providers may be a private company—such as Helios, Bupa, UnitedHealth, or whoever else decides it is interested in running the NHS in future—and the staff may be transferred to the new providers. The Minister shrugs, suggesting that that is a misrepresentation, so I challenge him to intervene on me and state what he seemed to imply earlier: that what I have just said is not the case.

Schedule 23 makes that explicit, however. It provides for the transfer of NHS staff and other assets. It allows such so-called assets to be passed in future from NHS entities to the new CCGs. That can happen to any

“person who provides services as part of the health service in England and consents to the transfer”.

Under schedule 23, any NHS member of staff—or a building or intellectual property—can, so long as they agree, be transferred to anybody else who is licensed to provide services to the NHS. I find that extraordinary, but not quite as extraordinary as the next provision, which refers to NHS bodies being able to transfer all such assets—what a delightful way to refer to people—to a “qualifying company”, whatever that means. I will be delighted if the Minister tells us what the term “qualifying company” in schedule 23 means.

[Alison Seabeck (Plymouth, Moor View) (Lab)]

Does my hon. Friend join me in sharing the concerns of many public health consultants in this regard? They sometimes cover three areas of work, so in one area they could go to the commissioning board, in another they could go to children’s health commissioning, and in another area of their job they could go to the local authority. What are those people supposed to do? I suspect some of them will leave the service.

--- Later in debate ---

[Owen Smith]

My hon. Friend is close to health workers and health professionals in her constituency, and she knows that people are leaving the service in droves. It is not just managers who will be sacked from primary care trusts or transferred across to they do not know what kind of organisation elsewhere. Clinicians are also deciding that they no longer think the job is worth the candle, because of the endless top-down reorganisation—something we were told we would not see from this Government, although it just keeps on coming. I fear that the situation will get worse in coming months. We will have to wait and see what the capacity of these new CCGs—and, potentially, the national commissioning board—will be, because we do not yet know who will be left standing at the end of this endless round of changes.

In summary—[Interruption.] It is a long summary, and if hon. Members keep talking it will get longer. In summary, we have had eight months of debate in this place, two—and soon to be three—versions of the Bill, with 1,500 amendments, hundreds of protest meetings across the country, and 450,000 signatories to a petition trying to “kill the Bill”. Those extraordinarily high numbers are a reflection of the importance of the NHS to the British people, to the NHS workers and to us, the Labour party.

For many in our society the NHS remains the shining symbol of the civilised collectivist values that first informed its creation 60 years ago, and they rightly view its continuation and their stake in it as part of their British birthright. We in the Labour party view it as a cherished part of our heritage. It also shines a light for us to the future, and we will not stand by and let how we have known it to be for these past 60 years fall into the pages of history. In 1946 we legislated to realise the vision of a collaborative and comprehensive national and public service, as part of the essential glue of that post-war society. This Bill promises instead to give birth to a denationalised NHS—a denatured NHS—divided by competition law, and conquered by profit seekers and carpetbaggers from across the globe.

Ministers, especially the Secretary of State, should remember that it is never too late to change one’s mind—it is never too late to save the NHS. We are appealing for them to do so and they would do well to do so. They should remember, too, the dire and, I trust, accurate prediction and warning given by the man who was proud to be the midwife to the NHS—the Welshman, Nye Bevan—in 1946. He said that

“no government that attempts to destroy the Health Service can hope to command the support of the British people.”

That was true when he wrote it in 1951 and it will be true in 2015 when the Prime Minister asks the people to trust him on the NHS. I hate to tell the Secretary of State and, indeed, the Prime Minister this, but no amount of Ashcroft-funded airbrushed billboards pleading with people to trust the Tories on the NHS will count, because the evidence of their perfidy is written in black and white throughout this Bill, and it will be remembered at the next election.

[Guy Opperman (Hexham) (Con)]

I wish to start by making it clear that I am a big supporter of the NHS. I probably should declare an interest, because I have spent too much of the past six months discovering it from the inside. As is commonly known, I had a brain tumour in April, which was removed by the national hospital for neurology and neurosurgery in Queen square, where I received outstanding care and treatment from the doctors and nurses.

That was not the first time that I had had my life saved by the NHS. Although my girth would deceive hon. Members, I used to be a jockey, and when I was trying to win a race at Stratford, the second last fence proved too much for the horse and me, we turned over and on my left hand side I was entirely crushed by a steeplechaser. I broke about 11 bones and cut my left kidney in half. I had a splenectomy and a very good doctor at Warwick hospital saved my life. I also wish to make the point that I have an NHS background: my grandmother was a matron in a district hospital, and we have spent an awful lot of time in the Hexham constituency supporting the Hexham hospital and the Freeman hospital, in particular.

I support the Bill, and I wish to touch on a couple of the points that have been raised. For a time I earned a living as a barrister, reviewing health care bodies and public bodies of a general nature. I hope that that qualifies me to discuss competition law briefly. If hon. Members were to read, as I have had to over the past few months, some of the representations that have been made about competition, they would believe that it is a new evil being introduced into the NHS. However, that is manifestly wrong, as the Enterprise Act 2002 and the Competition Act 1998 were introduced under the previous Government and have been operating in the health service for a considerable time. I see some hon. Members shaking their heads, but the argument supported by the shadow Minister cites that exact point: in the form of a variety of institutions and undertakings, the UK health service is subject to competition law under the 2002 Act, the 1998 Act and European community laws on competition. This is therefore not a new thing, nor should it be, because it was introduced by the previous Government and large parts of the Bill follow on from what was done previously.

I shall touch briefly on procurement, because the issue has been raised in this House. It is not a new thing for procurement matters to be challenged or to be subject to judicial process. Judicial process itself is not a bad thing. I have heard people say countless times in these past two days of debate, “This is going to be a den of iniquity for lawyers. It will be so bad that there will be lawyers all over this case. It will be really difficult for people to proceed with the health system.” I brought a case against a primary care trust in 2005, 2006 and 2007, with a view to trying to change the law and the way in which that PCT was operating. Before anyone jumps up to discuss that approach, I am pleased to say, first, that we changed the law to assist the patients, secondly, that the whole case was conducted entirely pro bono—for free—and thirdly, that two separate Labour Attorney-Generals gave me national awards to support my efforts. I do not expect that to happen again in a hurry. The point is that if we operate the process correctly—I shall talk about the process briefly in a second—we, and the commissioning consortia, will not be the subject of legal challenge.

That will always be the case with any public body: if it operates in a statutory and well-authorised way and provides the degree of consultation that it should, it is not open to challenge. It is not myself or the Government who would decide that, but a High Court judge considering a matter of judicial review. But if the public body—in the form of the NHS or the commissioning consortia—does not act properly, behaves beyond its powers or breaches natural justice in any way, it should and will be open to judicial review and other legal process. That is entirely proper.

I therefore do not believe that this will be a process through which huge numbers of judicial reviews will arise, as new issues for the NHS. I do not think that that will be the case at this stage. The hon. Member for Pontypridd (Owen Smith) talked at great length about the commissioned barrister’s opinion and 38 Degrees, but that barrister’s opinion makes the simple point:

“The Bill does nothing to make the system more amenable to challenge in the courts”.

Let me finish my points about competition and the duty to provide. I suggest that there is no fundamental change whatsoever. That is also the suggestion that the individual counsel made clear. I make the point that he is a junior counsel, not a Queen’s counsel, and there is no disclosure of instructions, the conference notes or any of the other things that would be vital to an understanding of the opinion. It has been wholly misrepresented by 38 Degrees, and there is no change—

[Owen Smith]

rose—

[Guy Opperman]

I am sorry, but I am going to keep going. The hon. Gentleman had about an hour to talk, and there are an awful lot of people who would like to talk about these matters.

I suggest that there is no fundamental change, and this is clearly a way forward that is being implemented for the benefit of patients. We are concerned with patient care and the quality of outcomes. I as a patient, like many other people in this House, am not concerned with the quality of outcomes other than to ask, “Is it a good outcome?” That is the important thing, and to suggest that private provision of the outcome and of the service provided is fundamentally bad is simply wrong. Such provision was introduced and brought in by the previous Government, and it assisted the public provision. The two can work together, and that is a good thing. I shall support the Bill, and I make this point to finish: the NHS is clearly a wonderful institution that all in the House cherish and support, and this is a Bill that supports it.

--- Later in debate ---

[Joan Walley]

We have just had an awfully long debate about precisely that issue. Many of us would say that the PCTs were not operating accountably, but Members of Parliament could have influence and bring pressure to bear. The last resort is through the Secretary of State, and it is important that that should be retained in the Bill.

[Owen Smith]

Does my hon. Friend agree that the critical points are that there is an unknown into which we are stepping with the Bill and that the presumption is that the culture will be different? There will be a presumption of autonomy, being hands off, less accountability and more localised decision making. It is therefore perfectly reasonable to presume that we will have less input.

[Joan Walley]

That is right and it comes back to the fact that, somehow or other, under the new regime, whatever it ends up being, there will not be the fairness or the universal provision. In certain areas—perhaps those such as mine, which have much greater deprivation and much greater health inequalities than others—things will be more difficult.

Health and Social Care (Re-committed) Bill

Owen Smith Excerpts

Tuesday 6th September 2011 Commons Chamber

[Mr Lansley]

I had better give way to the hon. Member for Pontypridd (Owen Smith) first, as no Opposition Front-Bench has previously intervened.

[Owen Smith (Pontypridd) (Lab)]

Is it not disingenuous of the Secretary of State to keep repeating that the application of competition law is not expanded or changed by the Bill? We know that the change in the architecture of the NHS—the use of competition law, the writing of competition law into the architecture of the NHS, and the entry of lots of other providers into a genuine marketplace—will lead to competition law increasingly being used by people who wish to provide NHS services, breaking up the NHS. Labour Members have repeatedly stated that, and it has been confirmed by independent legal advice. That is our point. It is straightforwardly the case, and I suggest that it is disingenuous to say competition law does not apply.

[Mr Lansley]

I did not say that competition law does not apply; if the hon. Gentleman is going to attack me, he might at least get what I said right. I said that the Bill does not change the extent of the application of competition law. The House should know that the debate about the extent to which competition law, and in particular EU competition law, is applicable within the NHS is a matter of debate among lawyers. That is because it has not been tested in courts, but it was always going to be tested in courts and it is much more likely to be tested in them if we do not pass this measure, which not only gives Monitor a responsibility to be the concurrent competition jurisdiction, but, through its licensing powers, allows it to take ex-ante steps. The hon. Gentleman therefore misses the point; the point is that by introducing the private sector into the NHS before the last election, his party’s Government inevitably extended the application of EU competition law in respect of NHS providers—not NHS commissioners, I might add. To that extent, he has therefore missed the point. EU procurement rules have applied, and continue to apply. We cannot change that.

--- Later in debate ---

[Mr Lansley]

No.

The implication of these proposals is that we are not continuing with our previous proposals to have a system of prior designation. We are also withdrawing our proposals to apply insolvency law, including the health special administration procedure, to foundation trusts, so I hope that Opposition Members will not press amendments 29 and 30.

I hope that that explanation of the purpose of the substantive group of Government amendments will help the House. In a moment, I shall turn to some of the additional amendments that have been presented by other colleagues.

[Owen Smith]

Let me clarify a remark that the Secretary of State just made to my hon. Friend the Member for Easington (Grahame M. Morris). The Secretary of State said that there would be no instances where NHS properties might be transferred to private companies, but he will know that under schedule 23 there is provision for precisely that. Such companies are described there as a “qualifying company”. A licence holder could be a private company to which NHS material—even staff—and other liabilities might be transferred. Is that not right?

[Mr Lansley]

The point I am making is that we are not transferring foundation trusts or NHS trusts into the private sector. We are not planning to do that. The particular case to which the hon. Member for Easington (Grahame M. Morris) referred was misrepresented as a proposal to transfer the ownership of NHS organisations. There is no such proposal; we are not planning to do that.

As I have described, the Bill would establish a comprehensive system of regulation focused on protecting and promoting patients’ interests and applicable to all providers of NHS services. The purpose of part 3 is to protect our health services from the unrestrained operation of market forces—otherwise, why would we want this structure of regulation? That is why it is there. The provisions will ensure that services are not destabilised or undermined and will protect the public and patients’ interests.

Let us consider the implications of the Labour party’s amendment 10, which would remove part 3 of the Bill. The impact of removing part 3 would be to expose the NHS to the full force of competition law, as I described earlier, without the safeguard of a health sector regulator and without any sensitivity to the needs of patients, health services and our NHS. It should not be beyond the wit of Opposition Members to recall the impact on the health service and, in particular, on pharmacy services, when the Office of Fair Trading undertook an inquiry into the provision of pharmacy services from a competition perspective without any reference to the health perspective.

--- Later in debate ---

[Paul Burstow]

These Government amendments will make important changes to extend Monitor’s intervention powers over all foundation trusts until 2016. This would give additional time for foundation trusts’ governors to build the capability that they need to be able to hold their boards to account.

As my right hon. Friend the Secretary of State has described, through part 3 of the Bill, Monitor as the sector regulator would have permanent intervention powers over all providers, including foundation trusts. These will allow it to fulfil its duty to protect and promote the patient’s interest and its functions include supporting commissioners in securing continuity of services. That is why we believe that Opposition amendment 17 is not only ineffective, based as it is on non-existent terms of authorisation, but also redundant.

My right hon. Friend the Secretary of State has already confirmed that we agree that it is essential that Monitor, as health sector regulator, can take action to secure patients’ continued access to NHS services, and our plans ensure this. Monitor would have powers under its licensing regime to require a provider to take specific actions if it gets into difficulties. These will be effective safeguards to protect patients’ and taxpayers’ interests, and will support commissioners in securing continued access to services that patients depend on for their care. I hope, therefore, that the hon. Members who tabled the amendment will not press it.

However, the NHS Future Forum raised concerns about the current readiness of foundation trust governors to take on the strengthened role that the Bill provides for them in holding foundation trusts to account as autonomous NHS providers. In response, the Government have agreed that Monitor’s intervention powers should apply to all foundation trusts until 2016, to allow time for their governance arrangements to become fully effective. The amendments provide for the transitional powers to continue until 2016. They also make corresponding amendments to clause 117 on licence conditions supporting use of the powers, and remove clause 116, about identifying which foundation trusts would be subject to the powers.

The amendments do not change the nature of the transitional intervention powers set out in clause 117. Monitor will continue to have the power to remove or suspend members of the board of directors or members of the council of governors. Monitor would also be able to direct a foundation trust to do or not to do specific things within a specified timetable. These powers are similar to those currently available to Monitor in its role as foundation trust regulator, and would allow Monitor to continue to protect the taxpayers’ interest in foundation trusts.

The powers go beyond those that Monitor would have over all providers, under part 3, as sector regulator. They will help to ensure a smooth transition from the current arrangements for NHS foundation trusts. The amendments would allow the Secretary of State to seek further parliamentary agreement to extend the powers beyond 2016 for all or some foundation trusts for up to two years at a time. That power could be used, for example, if there was a significant remaining concern about the governance of some foundation trusts.

If it were decided to extend the powers for some, but not all, foundation trusts, Monitor would be required to go through a process similar to that originally envisaged in clause 116. It would have to publish the criteria that it would use to decide which foundation trusts would remain subject to its intervention powers. Those criteria would be subject to consultation and would require approval from the Secretary of State. The amendments will ensure that the transitional regime proposed in the Bill provides a more secure safety net while foundation trust governors develop the skills and capabilities necessary to hold their boards to account.

The amendments would enable Monitor to rectify avoidable difficulties at a foundation trust while foundation trust governance arrangements developed, ahead of normal regulatory intervention through the licensing regime. They also provide for the extension of the powers, should that prove necessary. I commend them to the House.

[Owen Smith]

I do not intend to take long, because we must get on to the important next group of new clauses and amendments, which is on the private patient cap; there will be huge interest in that outside this place, and there is far too little time to discuss it. I shall say right at the outset that we will not press amendment 17, because we accept that, as the Minister said, it is effectively made redundant by other amendments that have been tabled.

In some respects, the amendments in the group before us tell the story of the Bill in microcosm. Throughout the progress of the Bill, the Government have responded in two ways. One has been to bolt endless obfuscation and compromise on to the Bill to obscure its true intentions. There was clarity at the outset, in the Bill’s first iteration; it clearly aimed to break up a publicly owned, collaborative NHS and replace it with a competitive, market-driven NHS. The Government have sought to obscure that throughout the Bill’s progress, and have done so relatively effectively. Certainly, more gullible Government Members, perhaps even including the Deputy Prime Minister, have bought into the double-speak about this now being a question of preventing anti-competition, as opposed to promoting competition, but we Labour Members still do not buy that.

Nor do we buy the idea that the other amendments that we have considered today add clarity. In truth, they add to the confusion—the chaos, indeed—that will follow the implementation of the Bill. As the Minister has outlined, the clauses that we are considering effectively extend Monitor’s existing compliance and regulatory roles over foundation trusts to all FTs through to 2016. That is what the Future Forum recommended to Ministers, but they did not do that last time, although they did get rid of the arbitrary 2014 deadline that they had introduced. They are now going a step further and extending Monitor’s compliance functions. That might not be such a bad thing, and perhaps many people will agree with the idea; certainly the Future Forum will. The trouble with it, of course, is that it extends the critical conflict of interest that is at the heart of Monitor’s role.

There is a conflict between what is clearly Monitor’s principal function—as an economic regulator, designed to prevent anti-competitive behaviour and facilitate the exit of providers, such as hospitals, from the marketplace—and its compliance role, which is ostensibly about allowing FTs to flourish, and making sure that they do not fail. How will the Government deal with that apparent contradiction? To use their own words as set out in the original explanatory notes, how will they

“mitigate and manage potential conflicts of interest”

between the transitional functions and Monitor’s new functions? Well, rest easy, because the Government have made a very simple suggestion as to how Monitor should square that circle, which I am sure all Members will find satisfactory, as I do. Clause 62(3), subtly amended by Government amendment 89, explains that Monitor must simply

“ignore the functions it has under section…117 when exercising…its functions”

relating to competition, price-setting, or the licensing of NHS services.

So there we go: in Monitor there are to be Chinese walls, as Ministers colourfully put it in Committee. Monitor retains its role in trying to keep FTs from failing, but it also takes on a role in exiting them from the market and helping other providers—Bupa, perhaps, or Helios, which we know are sniffing around the Department of Health right now—to step into the breach. Chinese walls, competition and confusion: those are the key words for this botched Bill.

Question put and agreed to.

New clause 3 accordingly read a Second time, and added to the Bill.

New Clause 4

Orders under section [Duration of transitional period] that apply to only some trusts

‘(1) Where the Secretary of State proposes to make an order under section [Duration of transitional period] in reliance on subsection (2)(b) of that section (“a section [Duration of transitional period](2)(b) order”), the Secretary of State must notify Monitor.

(2) Monitor, having received a notification under subsection (1), must set the criteria that are to be applied for the purpose of determining to which NHS foundation trusts the order should apply.

(3) Before setting criteria under subsection (2), Monitor must—

(a) consult the Care Quality Commission and such other persons as Monitor considers appropriate, and

(b) obtain the approval of the Secretary of State.

(4) If the Secretary of State approves the proposed criteria, Monitor must—

(a) publish the criteria,

(b) determine, by applying the criteria, to which trusts the order should apply,

(c) notify the Secretary of State of its determination, and

(d) publish a list of the trusts concerned.

(5) If the Secretary of State does not approve the proposed criteria, Monitor must propose revised criteria; and subsections (3)(b) and (4) apply in relation to the proposed revised criteria as they apply in relation to the criteria previously proposed.

(6) If, having received a notification under subsection (1), Monitor proposes to set criteria the same as those it set on the last occasion it received a notification under that subsection, it need not comply with subsection (3)(a).

(7) A section [Duration of transitional period](2)(b) order—

(a) must apply to all the trusts that are determined under subsection (4)(b) as being the trusts to which the order should apply (and to no others);

(b) may specify the trusts to which it applies by reference to their inclusion in the list published under subsection (4)(d).

(8) Subsection (9) applies where —

(a) a section [Duration of transitional period](2)(b) order is in force at a time when there is in existence an NHS foundation trust authorised after 1 April 2014, and

(b) the initial two-year period in relation to that trust has yet to come to an end.

(9) Monitor must—

(a) determine, by applying the criteria it applied under subsection (4)(b), whether section 117 should continue to have effect in relation to the trust after the end of the initial two-year period,

(b) notify the Secretary of State of its determination, and

(c) publish its determination.

(10) If Monitor determines under subsection (9)(a) that section117 should so continue to have effect, the trust is to be treated as if it had been authorised on or before 1 April 2014 and as if the order referred to in subsection (7)(a) applied to it; and section [Duration of transitional period] (5) is accordingly to apply in relation to the trust.

(11) If Monitor determines under subsection (9)(a) that section 117 should not so continue to have effect, section 117 ceases to have effect in relation to the trust immediately after the end of the initial two-year period.’.—(Paul Burstow.)

Brought up, read the First and Second time, and added to the Bill.

New Clause 5

Repeal of sections [Duration of transitional period] and [Orders under section [Duration of transitional period] that apply to only some trusts]

‘(1) Sections [Duration of transitional period] and [Orders under section [Duration of transitional period] that apply to only some trusts] are repealed immediately after section 117 is repealed; and in consequence of that—

(a) in section 62(2)(a), omit “or under sections 117 and [Orders under section [Duration of transitional period] that apply to only some trusts] of this Act (imposition of licence conditions on NHS foundation trusts during transitional period)”,

(b) omit section62(3),

(c) in section 94(4), after paragraph (a) insert “and”,

(d) in section 94(4), omit paragraph (c) and the preceding “and”, and

(e) omit section 302(5)(e) and (8A).

(2) This section is repealed immediately after sections [Duration of transitional period] and [Orders under section [Duration of transitional period] that apply to only some trusts] are repealed.’.—(Paul Burstow.)

Brought up, read the First and Second time, and added to the Bill.

New Clause 19

NHS Foundations Trusts: phasing out of provision of private health care

‘The Secretary of State must make regulations which provide for NHS Foundation Trusts to be prevented from providing services other than those of the health service in England within three years of Royal Assent of this Act.’.—(Andrew George.)

Brought up, and read the First time.

[Andrew George]

I beg to move, That the clause be read a Second time.

Hospital Finances

Owen Smith Excerpts

Tuesday 19th July 2011 Westminster Hall

[John Pugh]

I was handed this leaflet during a meeting on Sunday in Southport. A number of inaccuracies were expressed within the room, but I do not know how they were generated or who is chiefly responsible.

[Owen Smith (Pontypridd) (Lab)]

Does the hon. Gentleman also agree that the Minister could clear up today any uncertainty on the question whether failing trusts might be dealt with by privatising or franchising through privatisation? The Minister could tell us what Matthew Kershaw at the Department of Health meant the other day when he told the Health Service Journal that private franchises might be one way to consider dealing with failing trusts.

[John Pugh]

I am sure that the hon. Gentleman can ask his own questions when the time comes. The point that I am making, which could be made about several hospitals, is that financial trouble is not necessarily coupled with clinical trouble, as it is in the case of the hospital that I am discussing. Sometimes they go hand in hand, but in this particular case there is a clear pattern of good clinical delivery, which we all want to see sustained. However, most of us know, even if we do not want to name individual hospitals, that about 20 hospitals—17, 18 or 19 of them—will not be in good shape for foundation trust status, largely because of the financial problems that they currently face.

The issue is how we address these problems without the kind of collateral political damage that we saw in Kidderminster. The solution is not obvious. Mergers between different trusts do not always work well. Nigel Edwards, the previous chief executive of the NHS Confederation, said that no merger has ever done the trick of resolving the problem—not by itself anyway. Neither is it possible to do things and get away with it by shepherding other NHS custom in the direction of those hospitals that are financially challenged. I believe that that is the concern of hon. Members in Warrington apropos what may happen at Whiston. If the facility is PFI and expensive, there is an argument that that will be the one that is maintained. Indeed, the previous Government were accused of doing precisely that in connection with Burnley hospital, where Blackburn was the more expensive proposition in capital terms. I do not think that that is the way to do it.

I do not think we can go back to what used to be called brokerage, whereby basically some hospitals do well, some do badly and the strategic health authority comes along at the end of the year and masks the whole procedure by handing out money. That is a discredited tool that has long been dropped. Plenty of loans are available, however, which hospitals are sitting on and which they have to repay. A few years ago, under the previous Government, if a deficit was incurred, an equivalent amount was taken off the following year’s allowance, but, happily, that scenario no longer exists. This is not a situation in which immediate and obvious solutions exist.

To some extent, the modern view of the NHS—namely, that we need to encourage private autonomy to allow the strong to merge with or to acquire the weak, or to allow the weak to simply fail via a variety of different market adjustments—has some appreciable weaknesses, which I would like to discuss. If we let a hospital’s culture or ecology sort itself out as best it can in any particular area, we may find that at some point in time there will be a conflict with the Secretary of State’s duty to secure a comprehensive health service, because how it turns out might not actually do that. In crude terms, there are many situations in which we would take the view that we cannot let an acute hospital or a district general hospital fail.

The problem, however, persists and our failure as politicians to address it in a mature, sensible way has been subject to a fair amount of criticism. I refer hon. Members to an article in The Times initiated by comments made by Dr Peter Carter of the Royal College of Nursing, who said:

“In our metropolitan areas we have far too many acute hospitals. That’s a drain on the system and it has got to change”.

Dr Carter, of course, represents the nurses. He went on:

“People are going to have to be brave to make these decisions. Some of those hospitals that we have known and loved, and which were performing appropriately in their day, are no longer appropriate.”

In the same article in The Times on 17 June, Chris Ham from the King’s Fund—we know him well—said:

“For too long politicians have not been willing to show the leadership that the health service needs.”

That is a kind of allegation of almost wilful political inertia, which in the view of those experts seems to be compounding the problem.

Politicians are subject to a twofold accusation. The first is of being inert, cowardly and fearful, and the other is that they agree to certain things in private, but take a completely different stance in public. Under the previous Government, we saw the spectacle of one Minister proposing and supporting radical upheaval in the NHS, while another, the right hon. Member for Salford and Eccles (Hazel Blears), opposed it. Similar points are made by many think-tanks, which do not need to get their hands dirty with the business of reconfiguration.

[Owen Smith]

In a similar vein, does the hon. Gentleman agree that, before the last election, it was less than helpful to see the current Secretary of State standing outside various hospitals with a placard protesting that they would not close on his watch?

[John Pugh]

I have direct experience of the Secretary of State coming to my constituency to support his own party’s candidate and taking the same stance as me on the local configuration issue. He has ample experience of that. To be fair, the Secretary of State has told me that doctors are not necessarily completely blameless. Apparently, some doctors say privately that certain things need to be done, but they are not prepared to attend public meetings to say so, which is understandable. Certainly, some people in the clinical community will propose a reconfiguration, while others will oppose it—often citing differing clinical evidence.

To pull things together, the reality is that this is a tricky problem and solving it by central diktat or dirigisme is attractive only to think-tanks, never to politicians or people who have to work in real time in the NHS. It is probably also insufficient to simply set tests or parameters and let the thing unfold, if we want to end up with a comprehensive service in all areas. The Government are never quite out of the equation, however much they might wish to exit and leave it to the health economy to sort itself out. They are not a bit player in any sense. Hitherto, but maybe not henceforward, they have influenced the tariff, which has an immediate effect on the viability of hospitals. They have subsidised acute sector competition and opened access to alternative providers, all of which impact directly on the acute sector.

More importantly, the Government’s drive—this is accepted as the drive of not only this Government, but the previous Government—to make NHS providers autonomous has reduced opportunities to cut costs across the whole acute sector. I will give three straightforward examples. A lot of NHS property is essentially dormant and not needed at present, and companies would manage it to better revenue and capital effect on the budget. These companies, however, deal in property portfolios, not in isolated plots of land held by an individual hospital. Properly managing the dormant and surplus estates of the NHS is an extraordinarily good way of benefiting the acute sector, but it is difficult to progress when the acute sector is divided into specific, autonomous and relatively small units.

Similarly, we would all regard savings in procurement in the acute sector as relatively painless. If we can, it would be far easier to make savings in procurement rather than in staffing or in actual services, which are more painful to progress.

The recent National Audit Office report established that the autonomy that hospitals individually possess militates to some extent against them making some of the savings that we clearly would wish them to find. I shall read briefly a couple of sections from the NAO report:

“The local control of procurement decisions and budgets in the NHS contrasts with the direction that is being taken for central government procurement.”

It points out that Sir Philip Green has saved appreciable amounts of money across central Government by achieving large-scale efficiencies in procurement. The report goes on to state that

“this approach does not apply to the NHS which operates as a discrete sector, increasingly driven by a regulated market approach, in which the government does not control providers such as hospital trusts. Central government, by contrast, operates as a single body of departments where consistent and collaborative procurement arrangements can be pursued.”

If we read the report and analyse the net effect of that, we realise that NHS hospital trusts pay widely varying prices for the same thing. The NAO report gives examples of hugely different procurement exercises that have resulted in very strange outcomes. It states that

“the 61 trusts in our dataset issued more than 1,000 orders each per year for A4 paper alone.”

It points out that procuring on a scale greater than individual trusts will have benefits. I know that there are procurement hubs and so on, but essentially, as the NAO analyses the problem, it thinks that the current NHS structure means that we are missing out on across-the-board savings within the acute sector. It concludes by saying:

“We estimate that if hospital trusts were to amalgamate small, ad-hoc orders into larger, less frequent ones, rationalise and standardise product choices and strike committed volume deals across multiple trusts, they could make overall savings of at least £500 million, around 10 per cent of the total NHS consumables expenditure”.

--- Later in debate ---

[Owen Smith]

Does the hon. Gentleman agree that having listened to or sat through, as I did, 40-odd sittings on the Health and Social Care Bill, it is precisely such fragmentation that we are worried will get worse and will be compounded by the Bill’s measures? Is he concerned that the sort of centrally planned savings that he describes as being achieved through procurement will be forgone?

[John Pugh]

The scenario that the NAO and I have described was actually created by the advent of foundation trusts and the architecture put in the place by the previous Government as much as by anything that the Bill might do. The Bill will not substantially worsen the opportunities for savings. However, we might wish to consider the following issue in the context of the Bill. The NAO states:

“Given the scale of the potential savings which the NHS is currently failing to capture, we believe it is important to find effective ways to hold trusts directly to account to Parliament for their procurement practices.”

That is a perfectly valid point. It is not a political point; if anything, it is a housekeeping point.

The NAO has produced another recent report entitled “Managing High Value Equipment in the NHS in England”. We are talking here about things such as MRI scanners that cost millions of pounds. The NAO points out that, in reducing the costs of high-value equipment and maintenance, it is far preferable if the whole exercise is strategically planned, rather than planned within each individual trust. It concludes that

“the planning, procurement, and use of high value equipment is not achieving value for money across all NHS trusts.”

In other words, NHS trusts are looking after themselves, rather than considering whether there is spare capacity in the equipment of a neighbouring trust, simply because they are, by and large, poised in a competitive relationship. Already the drive to secure quality, innovation, productivity and prevention savings and the rationalisation that follows from that is being hampered—if not blocked—by a degree of obduracy from the foundation trusts, who are looking after themselves rather than the whole health economy. The drive to secure such savings is also being hampered to some extent by the need to satisfy competition requirements, which I should say, in case the hon. Member for Pontypridd (Owen Smith) is going to intervene, were already in place.

I have given the example of Merseyside where centralising pathology, which is a wholly sensible thing to do, has had to get over the hurdle of impressing the co-operation and collaboration panel. It was apparently satisfied when it discovered that pathology could be obtained in Wigan. That was enough competition and was okay. However, the fact that those involved had to get over that hurdle delayed the savings and some of their impact. I pause for a second to ask hon. Members to speculate about something. If Marks & Spencer behaved in exactly the same way with regard to all its separate stores, we would consider that to be an imbecilic business practice. There is no reason why we should not query it when we see it within the NHS.

[Owen Smith]

I have a great deal of respect for the hon. Gentleman, but does he not agree that it is slightly ironic that he should be making this argument now, given that Opposition Members consistently argued throughout the passage of the Health and Social Care Bill that the sort of fragmentation he is talking about will get worse once we get rid of all strategic planning at a regional and national level? If we get rid of strategic health authorities and primary care trusts, that will be a major problem and will compound the issues he is talking about.

[John Pugh]

I am not wholly convinced that we will get rid of that level of planning. Instead, it will go through another avatar or incarnation and reappear as a subset of the national commissioning board’s activities. That organisation is rapidly developing regional tentacles, some of which look very similar to parts of the strategic health authorities. Yes, there is the need for some strategic look at how savings are to be achieved if we are going to make savings across the acute sectors; otherwise, we are missing some very soft savings in times of severe financial restraint. It is not me saying that; it is those people who have looked at the matter in the greatest depth—in this case, the NAO.

However, one cannot roll back the clock; we are where we are. I suspect that there will be a fair amount of merging among trusts so, perhaps with the evolution of super-trusts, we will get real economies of scale. The key question I ask and the reason behind this debate is: what can the Government actually do to manage this process of change, given that all the financial information coming our way now and next year will illustrate that there will be change and that significant problems need to be addressed in London and other parts of the country? The way I see it is this. There is a yawning gap between what the public would like to see and what hospital administrators consider to be financially expedient or workable, and what doctors see as clinically desirable. There is sometimes a tendency to confound the two. I have seen many cases for change based on financial expediency that are represented as cases about promoting a clinically desirable framework. That has always created a degree of cynicism on the part of the public, who see the money rather than the clinical needs of the services driving change.

Financial expediency and clinical desirability are different. None the less, they are both forces that we can do nothing specific about as they stand. Those forces are driving change even though the public, particularly in London, are probably reluctant to accommodate that. One very bad way of resolving such a dilemma—and it will be a difficult dilemma for whoever has to deal with it—is simply to do the politically expedient thing and work out which option loses fewest votes. That does not necessarily produce anything like a desirable situation and it creates a lot of bitterness, particularly if political leverage is used to benefit candidates of one or another party, however tempting that may be.

To make a positive suggestion for a way forward, I accept that this is a very difficult environment, and one that is only going to get more difficult, but I would like to draw attention to what I have picked up in most of the debates I have had, in this Chamber and elsewhere, on reconfiguration, often in parts of the world that I was not directly informed about. In those debates—I remember a well-attended debate, with many Conservative hon. Members, about reconfiguration in the Watford area—the fundamental issue that crops up time and again is access. People spend far more time talking about the way to the service than about the shape of the service—far more time talking about traffic than about clinical processes. We have to draw a lesson from that.

It seems fairly straightforward that people who have serious life-threatening diseases have one primary consideration, which is to get the best conceivable service they can to save their life. Recognising that, they will go to where that best service is. For example, in my constituency of Southport people who contract cancer often have to travel to Clatterbridge hospital in the Wirral for some of the specialist cancer services that are not available in Southport. Although they would rather have those services on the doorstep, they would sooner have the best conceivable service. On the other hand, asking people who are travelling for very complex, life-critical services to also travel in order to get triage should they have some mishap, or to travel if they want to do something very ordinary like give birth to a baby, or if they want to attend a clinic, or if they want to get their chronic condition attended to or assessed, or if they want some sort of initial diagnosis of their symptoms, or if they want a routine stay in hospital, then to suggest that they should not go local, that they should travel further, creates uproar. Frankly, if they are asked to travel further than other people and prolong an anxious journey, or encounter some tortuous route, that will enrage them significantly.

A lot of debates about hospital reconfiguration in this place have been about the fears of one community about the basic, simple services for which they will unfairly be made to travel further than other people—fears that, in a sense, they have been rejected and that some other community has been selected to have services on its doorstep. The tendency of many people in the health service is to think that that is an issue, but not a health issue—the Department of Health does not do highways.

I can give a classic example of that in my constituency. There are two hospitals in my local trust—one in Southport and one in Ormskirk. The services were configured, I think largely for political reasons, in a rather strange pattern. A and E for adults is in one hospital, and A and E for children is in another. Theoretically, if there is a car crash with both parents and children involved, they would go off in different directions. That strikes many people as almost perverse. When people in Southport, complain very vocally and emphatically, as they still do, about having to traipse over to Ormskirk even for the most minor ailment affecting a child, they have a legitimate grievance. I have to say that that appeared to be a grievance that was shared by the Secretary of State. When he was campaigning for the Conservative candidate in my constituency, he agreed with me on precisely that point. If one reads the fine print of the Shields report, which did that configuration, one finds a very short sentence saying, in effect, “this is a fine configuration which I, Professor Shields, medical man, wish to stand by.” He treats the weakness—that there is a long and tortuous road between the two communities—as though that really was outwith the particular suggestions that were being made.

I recall similar issues with regard to the debate that we had about hospitals in the Watford area. People said that the configuration had not recognised the fact, unbeknownst to the health authorities, that it may have been possible to get from one part of the community to another at 10 o’clock or mid-afternoon, but not at peak time. That would not work or be satisfactory for the people who would have to negotiate dense traffic and no direct road. I looked at the Secretary of State’s four tests for acceptable configuration. They show progress in the right direction, but the one thing that they did not mention was physical access and time taken in access to health services.

In conclusion, I would like to make a positive suggestion. When we think about configuration, we need to lay down access standards that offer some kind of basis of what people can rationally, reasonably expect: to test proposals coming forward against access standards; to ensure that access is, as far as we can get it, fair for all; to have goals for access that allow for variations in people’s condition, whether life-critical or standard; to allow to some extent for differences in rural and urban environments; and to allow even for factors such as population density. People in London would be flattered, to some extent, by the picture they see of access arrangements in London. They probably feel that they are not as good as they might be, but in comparison with rural environments they are markedly different.

If the Department of Health could take access seriously, then the huge political problems that are on the horizon, and not very far on the horizon, can be resolved in a less politically contentious way. We could then convince people that some of the reconfiguration that may have to be done is fair, if not welcome. Until we do that, we are going to get into precisely the same territory as Dr Taylor and David Lock in Kidderminster. It is the failure on the part of the NHS, I guess, to talk to the department of highways and the Department for Transport effectively. It is a failure to take into account what it means for the ordinary patient, and how it looks from the ordinary patient’s point of view, that really makes these difficult issues absolutely explosive.

[Owen Smith (Pontypridd) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Betts. I congratulate the hon. Member for Southport (John Pugh) on securing the debate, albeit at an hour and on a day when there is a little competition for the attention of the House and perhaps of the media, too. Maybe the media are watching, but I have my doubts.

I will start on a note of agreement with the hon. Gentleman, and, I am sure, the Minister, on the need to make savings in the NHS. There was widespread agreement before and after the general election that the NHS needs to make significant savings of £15 billion or maybe £20 billion in the spending period, which is vital. Equally, the NHS needs to find ways to achieve those efficiencies to achieve productivities that will allow those savings to be sustained over a longer period. There is also widespread agreement that there is a massive challenge in achieving those savings, and addressing perennial problems that have persisted in the NHS under successive Administrations.

Some trusts, as the hon. Gentleman has said, are consistently in the red and have been for a while. They seem to have persistent and perhaps insurmountable problems with their finances. There has been an evolving but still too opaque process of dealing with that, with bail-outs or loans from the SHA or the PCT to trusts that have struggled. Despite the efforts of successive Governments, and particularly the previous Labour Government, there remains too much variability in the quality of service offered and prices paid across the NHS. I also agree with the hon. Gentleman that there have been persistent political obstacles in the way of achieving the reconfiguration of services, which we all recognise may be required to deliver some of the proposed savings.

Since the Government came to office more than a year ago, they have been right to try—rhetorically, at least—to address those issues and to spell out some of the challenges and potential solutions. First, we all agree that there needs to be greater transparency on accounting, on design decisions about services and, in particular, on reconfigurations of acute services. Secondly, there has been widespread agreement over a long period that clinicians need to take greater responsibility for redesigns and, as the Government would put it, to be at the heart of decision making in ways that force them to take account of issues and be responsible about engaging in the ongoing debate. Finally, there is agreement that we need a more effective means of dealing with failing trusts, so that we have a failure regime that allows whichever party is in government to reconfigure vital services in a way that protects them.

The Government want to do all those things, and they are right to want to do them, while increasing quality at the same time, but the problem is that their prescription for achieving them is entirely inappropriate. It is the wrong prescription for the NHS, and it will not achieve what the Government want; in fact, it will compound the problem. The past year has been a wasted year, in which many of the decisions that the Government say they want to take and that they want the NHS to take have been put off. The health service has had to deal with the chaos of having to wait and wonder what the future will hold for individuals and institutions across the NHS, as the Government’s shambolic Health and Social Care Bill passes slowly and tardily through the Commons.

The principal reason why the Government have introduced the Bill is that they still have an entirely misguided belief that competition in the NHS between providers will result in a more efficient allocation of resources, drive productivity and lead to innovation in the NHS, which is not the case. The planning that the hon. Gentleman has mentioned is vital in the NHS, and that is particularly true of planning that militates against injudicious decisions being taken by parts of the NHS that are more autonomous than they were previously.

Ultimately, the chaos we have seen over the past year has been worse than not allowing the NHS to take the necessary financial decisions and steps towards reconfiguration to achieve better financial outcomes. Worse still, it is compromising patient care. The quality agenda that the Government profess to support and pursue above all else, even in respect of competition, is not letting the NHS improve as quickly as it has done in the past. The Minister is looking quizzical, but I would point to the fact that the figures for 18-week waiting times, for four-hour waits at A and E and for the time people wait to receive vital diagnostic tests are all increasing.

[Mr Simon Burns]

indicated dissent.

--- Later in debate ---

[Owen Smith]

Yes, they are. The Minister says they are not, and if he wants to intervene, I would love to hear what he has to say.

[Mr Burns]

I know that the hon. Gentleman does not want to misinterpret the facts, and even he will have to accept, if he looks at the facts, that the median waiting time remains stable. Even someone he loves to quote—Chris Ham of the King’s Fund—has acknowledged that in recent weeks.

[Owen Smith]

The King’s Fund explicitly said that, for the months from February through to March, numbers for the 18-week wait were at a three-year high. The Minister talks about median waiting times, but we need to talk about overall waiting times. He cannot disagree with the fact that the figures for the other waiting times that I have mentioned—the waiting times for diagnostic testing and for four-hour waits in A and E—are at their highest levels since their inception. That is where we are, and I fear that is where we will be for a long period unless the NHS is allowed to concentrate on clinical targets, which are crucial to the quality of service that patients receive, rather than having to worry about future configuration and structure.

How has the vital question of savings been dealt with over the past year? The hon. Member for Southport has discussed the need to save between £15 billion and £20 billion, and service reconfiguration is one way to do that. We do not know exactly how we are doing on savings right now, because the Government have not told us where we are or whether we are on track to realise those savings. We know that trusts are being asked to make savings of about 4% a year, but we do not know how many actually are. We fear that we are behind the curve in achieving that figure, which Monitor’s report of September last year suggests that 63% of trusts are failing to do. The King’s Fund tracker, which came out only last week, said that half the managers it surveyed feared that they would not hit the 4% target, and an even greater proportion feared they would not hit the 6% target that they are setting for themselves.

[Mr Burns]

Will the hon. Gentleman accept—I am sure that he knows this—that the King’s Fund work was only a snapshot? It surveyed only 29 finance directors out of 165, and 27 of them made the comments that he has described. However, the latest quarterly NHS performance statistics, which are an actual look at what is going on across the NHS rather than a snapshot, show that 20 of the 21 indicators are being reached. Of those, 14 show improvements, whether that is on bowel and breast cancer screening or on times for admission for minor strokes. That gives a more accurate assessment of what is going on.

[Owen Smith]

Of course, the baseline for those outcomes is relatively new, because this is a new set of indicators. More importantly, however, the Minister will accept that I was talking specifically about financial data and whether services will hit their financial targets. I acknowledge that the King’s Fund tracker is but a snapshot and that, as the Minister has said, it uses only 29 NHS trusts. However, the Monitor survey of September last year, which I have mentioned, related to all 100-odd foundation trusts, and it found that 63% of them are behind the curve in achieving the 4% target. It is not, therefore, inexplicable or out of the realms of possibility that the King’s Fund survey might be entirely accurate, even though it is a snapshot. Of course, the Minister can clear this up for us right now by saying precisely how many foundation and non-foundation trusts are on target to meet the 4% target for productivity savings this year. He can clear that up for us, and we will have no further questions about it. He could publish a tracker to keep things clear for us.

After quality and savings, the third issue that I want to discuss is transparency, because the Government have persistently said that more transparency in the system will allow decisions to be taken in a better way and to be scrutinised, as well as allowing an improvement in productivity and quality. Other Opposition Members and I have pursued this issue during the seemingly endless sittings on the Health and Social Care Bill. I have said repeatedly that the fog around this issue has not got any thinner; in fact, it was approaching pea-soup status towards the end of our sittings.

We have no real idea how the Government will address the apparent shortcomings in the 17—or is it 20 or 25?—trusts that are currently in trouble and do not have the requisite stability to achieve foundation trust status. We do not know exactly what the Government are doing to bring them up to foundation trust status. Nor do we know precisely what will happen if one of them goes bust. We do not know what the failure regime is—

[Mr Burns]

You will.

[Owen Smith]

Well, as we said in Committee, we wait with bated breath to hear what the failure regime will look like. It is a crucial piece of the jigsaw if the Government are to be trusted with the NHS and if we are to know precisely what regime they will put in place to protect services that, as we have heard across the country, are considered vital for communities.

We do not have any idea, really, how many of the existing foundation trusts are overspent, and therefore in breach of their authorisation. The Minister could inform us about that. He could be a little more transparent about precisely what the situation is. I mentioned this earlier, but the Minister could clear up persistent concerns, in particular on the Labour side of the House, that the Government think that private sector management might be a means to improve the productivity, efficiency and, indeed, perhaps even the clinical quality, of some of the failing trusts. I do not think that that fear is wholly misplaced. We simply need to listen to the words of Matthew Kershaw, who is employed in the Department of Health to oversee that very process, and who told a Health Service Journal conference just the other day—it was reported only a week ago—that it was perfectly possible that we might look at means by which private sector companies might come in to run, through franchise, some failing trusts.

[Mr Burns]

The hon. Gentleman really takes the biscuit. He raises the possibility of private sector companies providing a manager or managers where the management in an NHS hospital are failing to help pull it round and return it to stability. He conveniently forgets that there is only one instance, to the best of my knowledge, where that is happening in the NHS, and it is—possibly, provided it is all finalised—at Hinchingbrooke hospital in Huntingdon. That was set in progress not by a Conservative Government, but by his party’s Government, under the right hon. Member for Leigh (Andy Burnham), prior to the general election. To complain about something that his own party’s Health Secretary did is somewhat rich.

[Owen Smith]

The difference, of course, is that that is one instance in a system where there is still strategic management, planning and control, both at the centre and in the regions. The difference under the new dispensation, as envisaged in the Health and Social Care Bill, will be that we shall have a fundamentally disaggregated, fragmented NHS with more autonomy and with the ability for more trusts to choose what to do. That runs the risk that the Secretary of State will have far less control over those private providers, if they are running franchises.

[Mr Burns]

The hon. Gentleman can wriggle as much as he likes. The fact is that he has been holed below the waterline. A Labour Government set up the only example in the health service in England of what he said, specifically, it was unacceptable to do. He could at least have the decency to come clean and accept it, and, if he feels so strongly now, he could apologise.

[Owen Smith]

I am not sure that I am the most celebrated politician being asked to apologise today. I do not need to apologise and do not feel that I am holed below the Plimsoll line, because clearly a very different future scenario is being painted as a result of the changes that the Minister and the Government are pushing through in the Bill. Our grave concern is that the local populace, politicians, and, indeed, Parliament, will have far less control over and insight into what different parts of the NHS will be doing after they are afforded that much greater autonomy. Of course, there will also, ultimately, be a far greater ingress of private companies into the NHS at many levels.

[John Pugh]

Does the hon. Gentleman accept that his argument is an argument for all seasons? He can use it whenever he criticises the Government for something and then finds out that his party’s Government have done it; so he has rendered himself undefeatable in argument, but somewhat meaningless.

[Owen Smith]

I would love to be undefeatable in argument, but I am not sure whether that is true. However, I will add one thing before I move on. I did not say—this is the principal reason why I do not need to apologise to the Minister—that the idea of a private company coming in and running an NHS service should never be countenanced. I suggested that in the world envisaged in the Health and Social Care Bill, where there will be a significant increase at many levels in the number of private sector providers in the NHS, there is an immediate local concern, in addition to the far more substantive problems of competition law becoming the norm for organising the NHS and, crucially, dismantling it. The local concern is that there will be less control over a greater proportion of the NHS, once we have more private providers. That clear concern is widely felt across the House and outside it.

The hon. Member for Southport touched on how NHS bureaucracy allows tough decisions to be taken. He talked about politicians not being prepared to take tough decisions, and about the NHS’s own clinicians, bureaucrats and managers being unable to do so. That needs to be recognised, because there are difficulties with an organisation as big, and arguably as unwieldy, as the NHS, with so many different moving parts and so many different agendas in play. However, as to the labyrinthine bureaucracy that the Health and Social Care Bill will create, with the welter of new organisations—the national commissioning board at national and local levels, consortia, senates, clinical networks in addition to the ones that we currently have, health and wellbeing boards, HealthWatch, the Office of Fair Trading and the Competition Commission—it is beyond this simple politician to see how that much more complex architecture will facilitate easier decision making in the NHS about tough reconfigurations. I just cannot see how it will get easier with far more complex architecture.

I thought that the hon. Member for Southport talked interestingly about how, at a more aggregate level, one might imagine better ways to manage what he called the “dormant surplus estate” of the NHS, which is an interesting point. There are ways in which dormant bits of hospitals and dormant land could be better managed. I have grave concerns about the world that I envisage will pertain in several years, if the Bill unfortunately passes, in which different parts of the NHS will have much greater autonomy in making those decisions, and there will be a much greater risk that the motivation behind them will be financial as opposed to clinical. I find it impossible to believe that the likelihood of aggregated strategic decision making in respect of that estate will be improved by allowing the NHS to break up, as I fear it will. The National Audit Office report that the hon. Gentleman prayed in aid was not on precisely that territory, but it pointed to a risk that always attends autonomy—that it results in less strategic decision making, because decisions are made at a more micro level. That risk clearly attended foundation trusts, and it will get worse, not better, under the Bill.

Lastly, the Minister has talked about clinicians sitting at the heart of the decision-making process. Again, I use the analogy of a labyrinth in the NHS; I cannot see how in that new labyrinth clinicians will be at the heart of decision making. It is a labyrinth that would challenge Theseus, let alone the NHS. Those clinicians will be in the maze with many bureaucrats, some of them perhaps rebadged and shifted from primary care trusts and strategic health authorities into consortia, the NCB or the NCB’s regional arms, and some perhaps from BUPA, Assura Medical or one of the other bodies that will no doubt help to manage commissioning for consortia, and, potentially, for acute care.

In reality, the previous Government funded the NHS from a point where it was on its knees. They tripled the funding of the NHS, radically increased capital spending and raised some of the issues that the hon. Member for Southport has mentioned about the private finance initiative—we could have a long debate about that and how we should reconsider some of those capital projects.

[Mr Burns]

The hon. Gentleman just said that the previous Government tripled funding on the NHS. Will he share with the Chamber how much NHS funding was in financial year 1996-97?

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[Owen Smith]

My recollection is that in 1996-97 NHS funding was around £39 billion, and it has now gone up to around £111 billion.

[Mr Burns]

How is that triple?

[Owen Smith]

Well, it is not far off. With the greatest respect, funding pretty much tripled—the figure might be £10 billion short, but it is pretty close.

[Mr Burns]

That is a lot of money.

[Owen Smith]

Okay, let us call it 2.8 times, as opposed to three times, but the increase was rather large. It was certainly reflective of the enormous need when the Labour Government came to power in 1997, following the chronic underfunding of the NHS presided over by the Government in which the right hon. Gentleman was a Minister. Some of the capital spending and its mechanisms, as I have said, need to be opened up and debated, so transparency ought to be a good thing in that case. That capital investment was undoubtedly required, because we needed new hospitals and investment, which were not provided by the previous Tory Government and which the Labour Government delivered.

In the latter years of the Labour Government, after the 2006 White Paper and, crucially, Lord Ara Darzi and his review, we started to look carefully and in a structured fashion, given the difficult nature of the task in hand, at how clinician-led reconfiguration of the NHS could come about and, notably, at greater integration between primary and secondary care and at delivering more of the services traditionally delivered in secondary and tertiary care in the primary care setting. That was the legacy that we left this Government, who have, with respect, blown it. They have wasted the past year, instead of moving on with that positive heritage. They have shifted into their misguided belief that competition in the health service, as for utilities, white goods or whatever other analogy they want to use, will drive more efficient decision making, innovation and better productivity. The Minister is wrong about that, and that will not happen. I am absolutely certain that that is the case.

In pursuing the illusion of competition, the Minister is running two risks in the reconfiguration and financial agenda that we are debating today. First, the increased short-term risk is of ill-considered cuts and reconfigurations in the NHS as a result of managers with their eye only half on the ball, and, as Sir David Nicholson has conceded, half their time spent wondering and worrying about their personal and professional future. There is a real risk that short-term decisions are being taken in that worrying, troubling atmosphere.

In the longer term, the far more profound risk is that the sort of competition that the Minister believes will drive greater efficiency and the disaggregation of the NHS will result in an NHS that delivers worse, more fragmented care, with more variability in the price paid for care, which is a licence for a postcode lottery. My grave concern is that the Government are prepared to countenance such a future and prepared to take such risks with the NHS.

[John Pugh]

The hon. Gentleman is right to say that competition is not a panacea for developing efficiency in all places, but nor was the Darzi prescription, which he has just mentioned and which was written in the same way for everyone throughout the land. My own constituency ended up with a Darzi clinic, which was in the community but actually further away for more people in Southport than the district general hospital—we are now struggling to fill it and to find a use for it. Although I accept that competition is not a universal panacea, there is a problem with top-down prescription.

[Owen Smith]

Darzi was not only about polyclinics—that they were the principal prescription that he came up with is one of the myths. There was a much broader agenda in play which, as I have said, was about integration and pushing more services into primary care, although not necessarily into polyclinics. All I was suggesting was that the Government could legitimately have pointed to that area as a legacy of the previous Government that they could have picked up and run with—one they could have made significant inroads on in the past year. Instead, they have misrepresented the direction of travel as one wholly driven by a belief in market forces, as the ultimate way to get efficiency in the NHS. That is what led to this wasted year.

Finally, I entirely agree that politicians need to be a lot braver about the NHS. Politicians of all stripes need to take difficult decisions about how services must be restructured and reorganised for the 21st century. The way to go about it is not the Government’s method, whereby they abdicate a greater degree of responsibility for the NHS—pushing it, at arm’s length, to the NCB and others, including the private sector. Nor is it wise for the current Government to have come into office with so many hospitals able to parade a photo of the current Secretary of State or local Tory MPs holding placards saying, “We will not allow this service or that hospital to close.” That was not wise, and it might have sown false hope for some hospitals, which I suspect that the Government will come to rue in future.

[The Minister of State, Department of Health (Mr Simon Burns)]

May I also say what a pleasure it is to serve under your chairmanship this afternoon, Mr Betts?

I congratulate the hon. Member for Southport (John Pugh) on securing the debate and on his particularly interesting and thoughtful speech. I have some sympathy with him, but he is right: sadly, events elsewhere on the parliamentary estate are securing more attention. However, I hope to reassure him by saying that this debate had quality rather than quantity.

It is a particular pleasure to have the hon. Member for Pontypridd (Owen Smith) with us. We have got used to him, while in Committee on the Health and Social Care Bill, and he is beginning to invent—or rather, reinvent—himself as some sort of cheeky chappie, who talks the talk that is fed to him by his party elders. One has to admire him because, more or less, most of the time, he manages to stop that smile completely breaking out on his lips—he clearly does not believe a lot of what he is telling us, because it flies in the face of reality. If one needed an example taken to its typical extreme, it would have been his accusations about private managers helping to secure and turn around any NHS hospital, because the only example will probably be Hinchingbrooke, which was of course set on its way by the right hon. Member for Leigh (Andy Burnham). We have to admire the hon. Member for Pontypridd for bringing up an example as fraught with danger for him as that.

The subject of the debate is interesting and, as the hon. Member for Southport said on a number of occasions, difficult in many ways. Before engaging in it, however, I pay tribute to those doctors, nurses, ancillary staff and others who work day in, day out in hospitals up and down the country doing a fantastic job for patients. All too often, because the quality of their care for patients is seamless, it goes unnoticed, which is a reflection of the high standards that they set for themselves in providing that care.

We believe that we must have a sustainable national health service in this country—one that can evolve with the times and changing situations, whether medical or financial. The report this week from the independent Office for Budget Responsibility has underlined the importance of the Government’s commitment to long-term fiscal sustainability for the NHS. It also demonstrates the critical importance of responding to our ageing population. Consequently, health funding will need to rise in the coming years, and the Government are totally committed to its doing just that.

As hon. Members know, we gave a commitment in our election manifesto to provide a real-terms increase in funding in every year of the Parliament while we are in government—the lifetime of this Parliament. We have honoured that, and we will continue to do so in subsequent years. The only trouble is that because of the horrendous economic situation that we inherited from the last Government, the available money is far more restricted, because we must take some extremely tough decisions to sort out the mess that was left to us. That has meant that the real-terms increase in NHS funding has been modest, albeit a real-terms increase, and has presented a challenge to the NHS, as the hon. Members for Pontypridd and for Southport said.

[Owen Smith]

Will the Minister say how much less that amount of money will be as a result of the pause and listen exercise, and the increased cost resulting from the Health and Social Care Bill?

[Mr Burns]

The answer is no. It is not, “No, I will not give an answer”; it is no to the fundamental question. The hon. Gentleman is aware from previous discussions that the cost of the listening process and the Future Forum was modest, and the impact assessment for the Bill, which he studied, will be updated, as he well knows, when the Bill leaves this House and goes to another place. The current impact assessment shows that the one-off cost of the modernisation and improvement of the NHS is about £1.4 billion. By the end of this Parliament, the savings generated by that modernisation process and the changes will be about £5 billion, and £1.7 billion a year thereafter until the end of the decade, of which every penny will be reinvested in front-line services. There will be a subsequent impact assessment, probably in about six or seven weeks, subject to progress in this House, and if there are any changes or updating we will see them in that impact assessment, and there will be an updated figure.

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[Owen Smith]

I look forward to it.

[Mr Burns]

The hon. Gentleman says he looks forward to it. Let us hope that he does when he sees the figures, because in my experience he rarely looks forward to anything that flies in the face of his arguments or is not helpful to his arguments, because he finds that disappointing. I hope that he will be disappointed when the new impact assessment comes out.

To return to my original point, the increase in real terms that we will make in every year of this Parliament will mean a £12.5 billion increase in funding for the health service over the lifetime of this Parliament.

The report from the Office for Budgetary Responsibility emphasises the importance of constantly increasing productivity within the NHS and other public services. As the hon. Gentleman knows, in every year of the last Government there was a fall of between 0.2% and 0.4% in productivity in the NHS, which is unacceptable, and ultimately would become unsustainable because we need to generate growth and productivity to drive improvements in patient care, outcomes and the overall performance of the NHS in providing patient care.

As the hon. Gentleman and the hon. Member for Southport said, we embraced and accepted the quality, innovation, productivity and prevention agenda challenge set out by the right hon. Member for Kingston upon Hull West and Hessle (Alan Johnson), which involved savings of £20 billion over three years originally, but we have extended it to four years. By cutting out inefficiencies, and enhancing and improving best practice that can be shared within the NHS, we can make savings that can be ploughed back into patient care.

The extra £12.5 billion to finance the increase in the health service over the next few years will not alone be enough to meet the rising demand for health care and its increasing costs. We need to find savings of up to £20 billion during the lifetime of this Parliament that we can reinvest, and that is the crucial challenge facing the national health service. I am confident that it will meet that challenge over the next three to four years.

The overall strategic health authority and primary care trust surplus of £1.375 billion during the last financial year will act as a sound financial platform for the NHS. Every penny of that surplus should be used to help to improve health outcomes for patients, and to meet the challenges and demands as we move to the new, modernised NHS, subject to approval in this House and another place. The challenge for every NHS organisation is to improve the quality of care that it offers while ensuring that money spent on care is spent effectively and efficiently, because that is what matters to patients and to the public.

The hon. Member for Southport referred to the crucial move to community-based services, which is already happening, and will continue to happen where it is clinically appropriate. The hon. Gentleman spoke about the impact on hospitals of reducing hospital-based activities and delivering more services in the community. That is a crucial area, and a valid issue to raise. As I said, where it is clinically appropriately and when it can lead to demonstrable improvements in patient outcomes, more services should be provided in the community—for example, in GP practices or even in the home. All of us as constituency MPs and those of us with a particular interest in the NHS and health care know of examples and more and more practices where home and community settings are being used to meet the demands and needs of local populations, because the vast majority of people in this country would prefer, when it is clinically appropriate and feasible, to be treated in the community in their own homes instead of having to go to a perhaps inappropriate hospital setting for treatment. The QIPP long-term conditions workstream seeks to ensure that patients can be cared for effectively in their home or community, avoiding unplanned, unnecessary and expensive admissions. That is better for the patient, better for the NHS and better for taxpayers. It is also an opportunity for hospitals.

Increasingly, the best hospitals think of themselves no longer as just a physical place of bricks and mortar, but as providers of excellent health care. For example, Croydon Health Services NHS Trust provides both hospital and community services through a number of community and specialist clinics throughout the area. It is effectively becoming a health care trust instead of simply a hospital trust. That is the way for the future.

A considerable amount of the debate was spent on reconfiguration, and I would like briefly to address that. As society and medicine change, so must the NHS. The hon. Gentlemen said that tough decisions will have to be taken, and that people will have to be brave, honest and realistic in addressing the issues. I totally agree.

The NHS has always been responsive, whether to patients’ expectations or improving technologies. As lifestyles, society and medicine continue to change and evolve, the NHS must also change to meet those challenges. As technology and clinical practice get better and better, some services that were previously provided only in acute hospitals can now be safely provided in other places. A local health centre, a GP surgery or even the patient’s own home may, when appropriate, be the setting for health care and treatment that were previously not possible or feasible in such places. That shows how our health care is constantly evolving and improving.

[Owen Smith]

I hope the Minister will forgive me as I have asked this sort of question many times. Does he feel that in the world envisaged by the Health and Social Care Bill, where there is more competition between different providers in local health economies, it will be more difficult rather than easier for the sort of integration he speaks of to come about?

[Mr Burns]

In the light of the hon. Gentleman’s question, I will preface my reply by the words, “If he will forgive me.” We have had these conversations frequently—to be polite—during the course of the 42 sittings of the Health and Social Care Bill, and I fundamentally disagree with him. As we modernise the NHS, we are seeking through the Bill to put the patient at the centre of their experience, so that they are totally involved in their treatment and needs, are talked with rather than talked to, and can be part of the decision-making processes by which we are driving up the quality of patient care and improving outcomes. We will ensure those things through a comprehensive national health service, greater integration and far greater collaboration.

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[Owen Smith]

rose—

[Mr Burns]

There is no point in my giving way to the hon. Gentleman; I have only 10 minutes left and whatever I say he will not accept publicly because it runs contrary to the mantra that he and his hon. Friends constantly spout as they seek to undermine the procedures that will ensure a first-class national health service to meet the demands of our citizens.

Returning to my original point, at the same time as one will see different settings for appropriate care, other services that need highly specialist care will be centralised at larger, regional centres of excellence where there is clear evidence of improved health outcomes. Reconfiguration is about modernising treatment and improving facilities to ensure that patients get the best treatment as close to home as possible, thereby both saving and improving lives. That is an essential part of a modernised NHS, but it should not be enforced from above.

There will be no more impositions of the kind that saw a GP-led health centre in every PCT, whether it was wanted or not. Instead, the reconfiguration of services will be locally driven, clinically led and will have public support. It will be change from the bottom up, not the top down. The reconfiguration of services should—and will—be a matter for the local NHS. There is no national blueprint for how health care should be organised locally, and services need to be tailored to meet the specific needs of the local population. Effective local engagement will ensure that services continually improve, based on feedback from local communities. In an NHS that is built around the patient, changes to services must begin and end with what patients and local communities need. Last May, my right hon. Friend the Secretary of State introduced four tests, and current and future reconfigurations must be along the lines of the four basic premises in those tests. Local plans must demonstrate: support from local GPs; strengthened public and patient engagement; a clear clinical evidence base; and support for patient choice. The tests make sure that any changes to health services will be true to the spirit of “No decision about me, without me.”

The hon. Member for Southport also raised the important issue of the private finance initiative. We have seen evidence from around the country of significant problems in a number of hospitals as a result of decisions taken by the previous Government to approve what were sometimes extremely expensive PFI schemes that became a drain on a trust’s annual income. As the Government confirmed at the end of last year, where PFI schemes can clearly be shown to represent good value for money, we remain committed to public-private partnerships, including those delivered by PFI, and they will play an important role in delivering future NHS infrastructure. We also believe, however, that there have been too many PFI schemes, and that some were too ambitious in scope. In addition, we have also had serious concerns about the value for money of some PFI contracts signed in the past.

The Treasury has reviewed value for money guidance for new schemes, and looked at how operational schemes can be run more efficiently. In January, the Treasury published new draft guidance, “Making savings in operational PFI contracts”, which will help Departments and local authorities to identify opportunities to reduce the cost of operational PFI contracts. As part of that savings initiative, my noble Friend Lord Sassoon, Commercial Secretary to the Treasury, launched four pilot projects to test the ideas in the Treasury’s draft guidance. One of those pilots was a hospital PFI scheme at Queen’s Hospital in Romford. The focus of the Romford pilot was to find efficiency gains and savings within the PFI contract, allowing the quality of care for patients to remain the top priority. Earlier today, Lord Sassoon announced the results of three of the four pilots, including that at Romford hospital. The Romford pilot showed that savings of 5% could be made to the revenue cost of the PFI scheme.

I welcome the Treasury’s findings, but we have yet to consider them in detail. I understand that the Treasury has now placed updated value for money guidance on its website. I hope that that will help trusts with operational PFI schemes, and trusts that are planning PFI schemes, to make significant savings. Every penny of those savings will be retained by the trust to be reinvested in improving patient care.

[Owen Smith]

rose—

[Mr Burns]

I will briefly give way for the last time.

[Owen Smith]

I have a basic factual question for the Minister. Will the results of that survey lead to an attempt to reopen or renegotiate any of those contracts?

[Mr Burns]

As I said to the hon. Gentleman a few moments ago, the pilot schemes and investigation published by my noble Friend Lord Sassoon show that there is potential within existing PFI schemes to make some savings—I cited the figure of up to 5%. We are going to study that report. It was published earlier today and we need time to look at it and see how those savings can be realised within the context of the existing PFI scheme, rather than by reopening it and starting again.

In conclusion, there are many challenges to the NHS, but those concerning finances will be assisted and helped by our commitment to a real-terms increase in funding. The hon. Member for Southport said that the reconfiguration programme must be driven by local demand and needs, and I agree with him. He raised the issue of access to facilities being part of those considerations, and it may console him that I am able to assure him that access will form part of any consideration. Local people will determine where their local services should be placed and, together with a number of other factors, the issue of access should be considered. Such decisions must be determined by what the local community needs and what meets its requirements in the provision of health care. In many ways, such decisions will be determined with the same checks and balances, and with the involvement under a modernised NHS of health and wellbeing boards, and in certain circumstances, the national commissioning board. Overview and scrutiny committees will have the opportunity to refer plans to the Secretary of State.

As the NHS is modernised, the changes outlined by the Secretary of State will begin to take effect and give clinicians and the local NHS greater control over decision-making processes, rather than having politicians micro-managing on a day-to-day basis from Richmond House. That will provide a future for the NHS that can meet the requirements of enhancing and improving patient care and, most importantly, improving outcomes for patients.