Oral Answers to Questions

Justin Madders Excerpts

Tuesday 19th December 2017 Commons Chamber

[Mr Hunt]

I met the chief executive in person last week and was able to congratulate him on several important changes that are happening. He will be pleased that we were able to find £1.9 million more for East Sussex in the Budget. My hon. Friend is absolutely right that it is not just about money. The difference between the Government and the Opposition is that they say it is all about money whereas we know that quality of leadership makes a critical difference in turning around our hospitals to make them the best in the world.

[Justin Madders (Ellesmere Port and Neston) (Lab)]

In the past few weeks, Simon Stevens, Sir Bob Kerslake, Sir Bruce Keogh, Jim Mackey, Chris Hopson and a number of other senior public servants have all told the Government that the NHS does not have the funding that it needs. It is patently obvious that, with most performance targets being missed, treatments being rationed and hard-working staff completely demoralised after seven years of pay restraint, funding levels are not sufficient. Arguing with celebrities on Twitter is not going to change that. Even though the Secretary of State has a new-found enthusiasm for 280-character statements, all I ask from him today is one word. Is the NHS getting the funding it says it needs—yes or no?

[Mr Hunt]

What I want to ask the hon. Gentleman requires a one-word answer. Is he happy—

Healthcare Optimisation Plan: Kirklees

Justin Madders Excerpts

Tuesday 12th December 2017 Westminster Hall

[Justin Madders (Ellesmere Port and Neston) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Hollobone. I pay tribute to my hon. Friend the Member for Dewsbury (Paula Sherriff), who has been an assiduous campaigner on health issues since her election to this place. She has fought NHS downgrades in her area and, as a former member of the Select Committee on Health, forensically scrutinised the Government’s health policies. She has rightly gained a colossal reputation across the House for her committed campaigning. Today, she has turned her attention to another extremely important issue, which, as we heard, affects not only her constituents but millions of people up and down the country, and made a typically strong case.

My hon. Friend is right to categorise this as a dangerous time. Financial priorities are taking precedence over clinical judgments. Her CCG has been candid about the health optimisation programme being one of 21 cost-cutting measures that it is required to introduce. She highlighted the absurdity of that policy with the example of two patients who would be treated at the same hospital but live 9 miles apart: apparently, one would be entitled to surgery and the other would not. She is absolutely right that the decision about whether to operate should always be made by the consulting surgeon. I know that some people in the Government do not have a great deal of time for expert opinion, but that is a clear example of something on which there ought to be unanimity about the way ahead.

My hon. Friend gave examples of the questions that the CCG asked during the consultation on the health optimisation programme. As she said, nowhere was there a question about that very policy. As my hon. Friend the Member for York Central (Rachael Maskell) said, denying surgery is a draconian measure and an important matter. It was a real abdication of responsibility by the CCG not to ask that specific question but to couch it in general terms. What can the Minister do to ensure that the standard of consultation by CCGs is such that we can be assured that the resulting decisions are robust and supported by the public? What is the Government’s view on the consultation standard that is currently used throughout the country?

My hon. Friend the Member for York Central also said that the public and patients are being failed, and highlighted the fact that other CCGs use a different BMI level. Indeed, my CCG uses a different one again, which highlights the totally arbitrary nature of these policies. She was absolutely right to say that people need help to stop smoking and lose weight. Those are not easy things to do. Sadly, public health cuts have made assistance much more limited. She highlighted well how losing 10% of body weight can mean entirely different things to different people, depending on what their weight is to start with; how the system fails people by not supporting them to make healthy choices; and how people are failed again when it comes to referral. She also illustrated well how the capped expenditure process in her area undermines the very basis of the NHS. I totally agree that it is time for the Minister to step up to the plate and challenge the many inconsistencies that we have heard about.

The proponents of this scheme can dress it up however they like, but we should be very clear about what it is: rationing of treatment for financial reasons—no more, no less. As we know, we have a growing population with longer life expectancy, and medical advances continue. Those are of course welcome developments, but they increase demand across the board and in this area led to a 27.5% increase in finished admissions between 2006-07 and 2016-17. The NHS has made enormous efficiency improvements to cope with that demand at a time of financial restraint. I am sure that the Minister agrees and will join me in paying tribute to the hard work of NHS staff, who made those efficiency improvements possible. However, it is clear that we have reached the limit of what can be achieved through efficiency alone—in fact, we are now moving well beyond that point.

As my hon. Friend the Member for Dewsbury said, just this week Lord Kerslake resigned as chair of King’s College Hospital NHS Foundation Trust because, he said, the NHS is under-resourced and we “desperately need…a rethink” amid unrealistic demands for savings—the kind of unrealistic demands that lead to the nonsensical and counterproductive policies we have heard about. In the aftermath of the Budget, the national medical director, Sir Bruce Keogh, said that the failure to close the funding gap would

“force a debate about what the public can and can’t expect from the NHS.”

While that was an extraordinary comment for a public servant to make, it is also something of an understatement, as it is clear to everyone—we have heard it today—that CCGs are already debating those issues and deciding what treatments should be available. So far, however, the Government have refused to acknowledge the debate or even engage with it.

I will give some further examples of where rationing is already happening. In February this year, the CCG in West Kent implemented a policy to suspend all elective surgery until the end of the financial year in an attempt to save £3.2 million. More recently, Cambridgeshire and Peterborough CCG proposed a new policy requiring patients to wait a minimum of 12 weeks for surgery. While that decision was later reversed, it is a worrying example of the kind of policy we may see spreading across the country as the financial situation of the NHS continues to deteriorate. It is not just in surgery where such rationing applies: earlier this year, I responded to a debate in Westminster Hall on infertility treatment, and it was revealed that of 209 CCGs in England, just four follow in full the National Institute for Health and Care Excellence’s guidelines on IVF treatment.

The individual funding request process, once reserved for rare conditions, is routinely applied by CCGs for a range of treatments. In some areas, including east Berkshire, routine hip and knee replacements are now being considered only if an individual funding request is made. Analysis by The BMJ found that the number of individual funding requests has increased by 47% in the past four years. As my hon. Friend the Member for York Central said, that shifts the burden on to the patient to prove that they need treatment, which is not what the NHS is there for. The Minister may well say that these are matters for individual CCGs, but there has to come a point where the Government must take responsibility and accept that the rationing of treatments taking place on their watch can be traced back to central Government funding decisions.

To turn to the matter at hand in Kirklees, when responding to these debates on behalf of the Opposition I have never failed to be impressed by the euphemistic names for schemes that no doubt are dreamed up by handsomely paid consultants but actually limit patient access. I have to say that the use of the term “health optimisation programme” to describe a system that could delay treatments for a year, leaving patients in chronic pain, is well placed to win my 2017 award for worst use of NHS management-speak. In Kirklees, as we have heard, about one in four people will be affected by the new restrictions based on weight, while 14% of the population are smokers. As the Royal College of Surgeons has pointed out, while obesity leads to poorer health outcomes, its relationship with post-operative success is less clear, and there is a lack of evidence that rapid weight loss before surgery makes much difference. It goes on to point out that there is evidence of a lower risk of post-operative cardiac and respiratory complications among obese patients.

It is clear that this policy, which will leave patients in unnecessary pain and discomfort for a prolonged period, is not motivated by medical considerations or necessity. Indeed, in many cases, patients are actually prevented from losing weight effectively as a result of the debilitating condition that they are seeking treatment to correct in the first place. Given that that goes against NICE guidance, will the Minister explain why CCGs are being permitted to pursue a course of action that causes so much discomfort and has no clear clinical benefit? As my hon. Friend said, we all want levels of smoking and obesity to be reduced, but leaving people in excruciating pain for months on end is simply not the right way to do it. If the Minister disagrees, I ask him to point out even one piece of evidence that suggests that denying access to surgery helps patients to improve their behaviour.

We all know that the best way to see sustained improvements in smoking cessation and obesity reduction is though well funded, consistent public health policies, which is why it is very disappointing that the Government chose to cut significant funds from public health budgets, a move that the King’s Fund described as

“the falsest of false economies.”

In 2015, Kirklees lost £1.6 million of public health funding, which could have been used to tackle the issues we have been discussing in a much more positive way.

Concern has also been expressed about the use of BMI as a measure. As we have heard, it is a particularly crude and unsophisticated way of estimating excess body fat by simply comparing weight and height. We gave the example of a professional rugby league player, I believe, who has a BMI of over 30. It is clear to anyone that if my BMI were to be in any way elevated, that would be as a result of body-building rather than any consumption of alcohol. As the Minister will know—I say this with the greatest of respect to him—there are people far healthier than either of us who happen to have a higher BMI. Will he therefore advise whether the Government support the use of such a crude measure to determine whether someone is allowed to undergo surgery?

Of all the inequities of this scheme I have referred to, the greatest is the fact that it applies to children aged just 5 and over. Is the Minister really prepared to stand by while children in primary school, who have no say over their own diet, are being left in pain while they wait for operations, or does he agree that they would be infinitely more likely to improve their fitness if they were not suffering from a medical condition in the first place?

Just as public health cuts are a false economy, as my hon. Friend the Member for Dewsbury said, delaying treatment will cost far more than it saves in the long term. There is a clear risk of patients developing complications if their treatment is delayed. A National Audit Office report on the costs of clinical negligence highlighted that 39% of claims are related to failures or delays in diagnosis or treatment of a condition, and it stated that that is likely to

“increase if waiting times are longer”

and treatment is arbitrarily rationed. I know the Government are committed to reducing the cost of clinical negligence in the NHS, but this policy seems to run counter to such intentions.

These episodes of localised rationing are becoming far too commonplace and creating a postcode lottery for patients. It is a lottery that patients did not ask to enter and one that leaves them suffering in pain. If we are truly to have a national health service, I hope that the Minister will reflect on what has been said today and take meaningful steps to end this unnecessary, unfair and counterproductive rationing of treatments.

--- Later in debate ---

[Mr Dunne]

I will come on to that. The short answer is that I agree that the relevant clinicians should make those decisions.

Going back to where the CCGs are in this process, as I said earlier, they have not yet introduced the proposal. They have been working with the local population and with Healthwatch Kirklees, and have held a number of engagement events with local authorities and interested stakeholders to try to understand the reaction of those parties to the proposal. An engagement event was conducted in March and April of this year, and one with Kirklees Council in August and September of this year.

The CCGs have listened and responded to some of the points made. They have made several changes to their original proposals, including exempting children from the programme. They also recognise the limitations—amusingly identified by hon. Members in their contributions—of using BMI as a measure of body weight. Therefore, for example, people with high muscle mass should be excluded from the BMI calculation for the reasons that were well explained earlier in the debate.

The CCGs are including safeguards in the proposals, and they intend that, in exceptional circumstances, normal individual funding request processes will continue to apply. Hon. Members have criticised that as imposing an undue obligation on the individual to seek that route to secure treatment. That is effectively an appeal mechanism that applies across the NHS and is a well-worn and well-understood path for clinicians to support individual funding requests for patients where needed, which we should continue.

Both the hon. Member for Dewsbury and the hon. Member for York Central used the expression “lives at risk”. I would gently say that there is absolutely no intention that policies such as this should lead to lives being at risk. They are about trying to put individuals in a position where their own circumstances would lead to better outcomes from the proposed surgery. The hon. Ladies have called for evidence supporting the proposition —it was raised by the hon. Member for York Central when we met at the end of last month. I have asked for that evidence. A number of research papers support the propositions made by the CCG, in particular on the question whether obesity at the time of surgery is associated with a wide range of problems. Sustaining weight loss is the key. Rapid weight loss followed by rapid weight gain clearly do not help the patient, but the evidence from the research papers provided to me is that maintained weight loss or cessation of smoking undoubtedly and clearly have clinical benefits for the patient. There is evidence to support that.

I will come back to the point raised earlier on by the hon. Member for Dewsbury and the hon. Member for York Central, but I absolutely recognise that the clinician primarily responsible for the care, whether that is the GP or the secondary clinician, should have discretion to ensure that a referral is made, should a non-referral of a patient or a delayed procedure outweigh any benefits from a period of improving health and reducing risk factors prior to a routine operation. We will encourage the CCGs to ensure that that is in their final proposals, once those are made.

[Justin Madders]

The Minister says he will encourage CCGs to listen to clinical advice when making referrals. Is there any mechanism by which he will actually ensure that that happens?

[Mr Dunne]

As the hon. Gentleman knows, CCGs are subject to appraisal and are accountable to NHS England, which is accountable to Ministers. It is not for Ministers to direct individual CCGs as to how they should enact their policies, but there is a route through which we can provide some encouragement to NHS England to ensure that these policies reflect its national position. That is what we will do.

On where the process is, in October the two CCGs presented details of the proposed plans to Kirklees Council’s health and social care scrutiny committee. The committee requested that the CCGs undertake a further six weeks of engagements, especially with hard-to-reach communities in the area of the hon. Member for Dewsbury. The CCGs have assured me that they are committed to that further engagement with the local community to ensure that the plan is fit for purpose, so there is a continuing opportunity to reflect on the revised iteration of the proposals. I am also advised that the CCGs have not yet made firm decisions on the plans. Instead, as a result of the engagement with local stakeholders, they are considering four options, and variations on the four options, for implementing the proposed plan, including not proceeding with the programme, which remains on the table.

Those options include: first, a phased approach, beginning with applying the programme initially only to patients who smoke and subsequently rolling it out further to obese patients if appropriate; secondly, only implementing the plan for smokers; thirdly, introducing health optimisation periods across clinical thresholds and pathways, in line with NICE guidance; or fourthly, moving away from implementation of the plan as previously defined and focusing on a strengthened education campaign to reinforce the benefits to patients of stopping smoking and losing weight. Those options remain on the table and there will be a further period of engagement. A decision on which option will be taken forward is due to be made by the CCGs in January, and further engagement on the implementation of the recommended approach will then take place later in the new year.

I said earlier that the plan is not a blanket ban on treatment. Instead, the intention is to encourage patients who are obese or who smoke to lose weight and/or quit smoking. There is evidence that that will have benefits, in terms of both surgical outcomes, as I have said, as well as reduced risk for general medical conditions, and there are clearly also benefits to patients’ general health in the long term. Hon. Members can be assured that the CCGs are providing support to the patients on weight loss and smoking cessation, and have agreed to invest £133,000 a year in such services to account for any health optimisation-related increase in uptake.

The hon. Member for Dewsbury asked how we will assure that the plan is in accordance with national guidelines. As she would expect, NHS England has been closely reviewing this and similar proposals where they have been made to ensure that there is robust supporting clinical evidence and appropriate safeguards. The Government expect NHS England to ensure that the responsible CCG is not breaching its statutory responsibility to provide services that meet the needs of the local population. I can confirm to hon. Members that NHS England has had ongoing discussions with both CCGs about the health optimisation plan and will continue to do so to ensure that it works in the best interest of patients. That is the right approach, in terms of both protecting patients and both encouraging the population to put themselves in a condition to maximise the benefits from surgical procedures, without allowing CCGs to introduce an inappropriate blanket ban.

NHS England carries out regular assurance of CCGs and holds them to account through the CCG improvement and assessment framework to ensure that they are fulfilling their statutory requirements, and NHS England can and will intervene if a CCG is failing to discharge its key responsibilities. NHS England’s regional teams also have regular discussions with CCGs about their commissioning activities and plans.

It is important in a debate like this, in which there are allegations of there being a postcode lottery, that we recognise that it is down to clinicians at a local level, through their CCG bodies, to make decisions that affect their local population, rather than, as has happened in the past, central diktat from Whitehall. Those may lead to perverse consequences and a less relevant healthcare capacity and treatments for patients on the ground.

Medicines Regulation

Justin Madders Excerpts

Tuesday 21st November 2017 Westminster Hall

[Justin Madders (Ellesmere Port and Neston) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Davies. I congratulate my hon. Friend the Member for Bishop Auckland (Helen Goodman) on securing this extremely important debate. It is sad there are not more Members here, but—as always—there are competing interests. She has been assiduous in asserting the rights of Parliament to scrutinise the terms of our exit from the European Union, and today’s debate is no exception to that.

In common with the vast majority of Members—whatever our views on the European Union—my hon. Friend spoke with a genuine desire to ensure that our departure happens on the best possible terms. I am sure we can all see that one priority is to ensure that our economy is able to thrive and that patients are able to access all the medical treatments that they need, as every hon. Member has said. Most of them also mentioned the decision to relocate the European Medicines Agency from London to Amsterdam. I do not know whether the debate was timed with that in mind, but it is certainly apposite.

When my hon. Friend began her speech, she said there had been no explanation, no policy statement, no impact assessment and no opportunity to debate the many issues we have discussed today. Of course, she has a considerable constituency interest in this subject area, but, as we have heard from most Members, the issue affects every single person in this country. The importance of it cannot be downplayed.

My hon. Friend said that regulation is one of the major costs to the industry. I share her frustration that we do not have a clear steer from the Government on what the future of that vital component of the industry will be. As she said, investment decisions are being made now and we are already beginning to lose out. I totally agree with her that the Minister should make it clear that we are putting patients and public safety first.

My hon. Friend the Member for Lewisham East (Heidi Alexander) gave a passionate and well-informed speech on the merits of the EMA. She summed it up very well when she said that the EMA’s leaving us is bad, but our leaving the EMA will be far worse. She was right to highlight the risk of delays for patients accessing new medicines. She said that business and patients need clarity, which is something that has come through clearly from all the Members who spoke today.

My hon. Friend the Member for Barrow and Furness (John Woodcock) spoke with great sincerity about the important business in his constituency. He is a fervent advocate of other businesses and sectors there, so we know that he will not let the matter lie. The announcement in the summer must have come as a real blow, given that Ulverston, and his constituency, are quite isolated from other populations, and in the light of the potential for damage to the local economy when so many high-skilled jobs are at risk. My hon. Friend will obviously want to ask the Minister to be clear about the assistance necessary to get the best from a pretty bad situation. The conversations that he will want to have with Ministers will be similar to those that every Member will have about industries in their constituencies affected by the Brexit decision.

The hon. Member for Central Ayrshire (Dr Whitford) spoke, as always, with great authority on health matters. She highlighted the fact that we are already slipping down the pecking order, and spoke from personal knowledge. In addition to the certainty that patients and businesses need, she highlighted the fact that universities, as well as EU nationals, need certainty. We should not forget, either, the 61 people working for the EMA who may be transferring to Amsterdam. They, too, need certainty about their future. The hon. Lady noted the risk of tariffs being introduced on drugs that have come into the market in the past seven years, if we crash out of the EU on WTO terms. It would be useful to hear from the Minister whether any assessment has been made of the potential cost of the tariffs, and whether he envisages that that cost would be dealt with by the Department of Health, or that individual patients would be expected to pay more for the inevitable additional cost of the drugs.

I doubt whether, when our constituents cast their votes in the referendum, the many issues that we have discussed today would have been at the forefront of their minds. Regulation of medicine is an integral part of our relationship with the EU, but it was not mentioned on any buses. The closest that we got to any debate on the impact of Brexit on the health sector was the £350 million a week that would be spent in addition to existing expenditure. It is sad to see that no advocates of leave are here today to explain how the situation fits into the big picture that they were so keen to propound at the time. Of course it has become apparent since June 2016 and from today’s debate that there is a threat to jobs and investment in the science and research sector. As my hon. Friend the Member for Torfaen (Nick Thomas-Symonds) succinctly pointed out at the start of the debate there is also a threat to access to new medicines; that is a serious unintended consequence. I certainly have not heard any Brexiteers suggesting that our current system is not advantageous to us as well as the other 27 EU member states. It is therefore difficult to overstate how critical the future of medicines regulation is to the economy and, more importantly, to the millions of patients in the UK who will need the medicines whether we leave the EU or not.

It might seem a long time ago now, but in July last year, just after she was appointed to her present role, the Prime Minister said:

“It is hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry”.

That of course remains very much the case. As my hon. Friend the Member for Bishop Auckland said, we have been exceptionally successful in that sector. The industry has a turnover of more than £60 billion per year, generates exports worth £30 billion and gives us a trade surplus of £3 billion. It employs 220,000 people in this country, and 25% of the world’s top prescription medicines were discovered and developed in the United Kingdom. It is of huge economic importance, and it says something about the sorry state of affairs we are in that Members feel the only way to get any clarity on the future of that vital industry is to have Ministers come to Westminster Hall to debate the issues.

Together with the direct economic impact is the effect on millions of patients, who rely on our co-operation with the rest of the EU to get access to safe, effective and affordable medicines. As we have heard, 45 million patient packs of medicine a year move out of the UK to the EU and 37 million move in the opposite direction. That is an awful lot of movement on which we need the Government to provide clarity. Those benefits, and others that hon. Members have spoken about today, are under threat not only from the relocation of the EMA, but from our exit from the EU if that is not handled more carefully.

Losing the EMA from London is of course a huge blow, not just to the economy of London but to our pharmaceutical sector more widely, for the reasons we have heard. The benefit that it brings to any national economy is evident from the fact that 19 other cities across Europe were in the running to become its new host. In addition to the loss that we will experience from the agency’s physical removal, it also poses a number of challenges and threats to medicines regulation across the EU. Indeed, The Pharmaceutical Journal recently warned that

“a worst-case scenario could permanently damage the medicines regulatory system, leading to a public health crisis”.

Although the EU27 decided not to relocate the EMA in eastern Europe, after a survey of staff found that an alarming 70% to 94% of them would not be willing to relocate there, the move to Amsterdam could still present a risk, in the sense that the survey found that up to 40% of those currently employed at the agency would not be prepared to move.

As my hon. Friend the Member for Lewisham East said, it is not an easy process to move an office wholesale. Some things will stop, and there will be a loss of some highly skilled specialist staff, who will be difficult to replace. An EMA spokesperson said that

“while some job losses can be absorbed within the business continuity plan...beyond a critical threshold, the Agency will no longer be able to fulfil its mandate to protect the health of European citizens.”

I am sure that no one voted for that on 23 June 2016. Good staff will inevitably leave the EMA rather than relocate their homes, their children’s schools and the careers of their partners. That will be an important factor. As the journalist Dr Ben Goldacre put it,

“these highly specialist staff are like trees: they take a long time to grow, and they put down roots.”

In the short term we may benefit from some of those specialist staff staying in the UK, possibly at the expense of the EMA and the future success of European regulation; but let us be in no doubt that in the long term it will be to our detriment, because we will struggle to attract the best.

Before the Brexit talks even move on to the future of medicines regulation, the Government have a duty to act now to protect our vibrant life sciences sector. One of the key reasons why so many countries were competing to host the EMA is that its presence makes pharmaceutical companies far more likely to locate in the host city. Many of those companies will have a UK base, and, as has been mentioned, will be beginning to think about future plans; so what steps are the Government taking today to persuade those companies to stay in this country, and not just to retain their staff but to make investment decisions that will benefit the economy? As my hon. Friend the Member for Bishop Auckland said, the industry is international and highly mobile, and we cannot afford to lose investment through the big hole of current Government policy. When we leave the EU, we will potentially face a divergence from the current medicines regulation system across Europe. The challenge for the Government is to keep that divergence to a minimum or eliminate it altogether.

One of the first issues, which we have already discussed, is the likelihood that the Medicines and Healthcare Products Regulatory Agency will lose up to a third of its income, as that comes from its work as a rapporteur body for the EMA. Can the Minister confirm that that funding gap will not have to be bridged from the existing, already insufficient Department of Health budget? What estimate has been made of additional resources that may be required in the worst-case scenario?

We have already heard that in July a letter from the Health and Business Secretaries in the Financial Times confirmed that the Government will prioritise achieving regulatory co-operation in the article 50 negotiations, and that was welcome, although, as the Financial Times is not a party to the negotiations, it could be argued, from a cynical point of view, that it was merely window dressing. We take it at face value, however, and as a clear commitment to try to achieve as much co-operation as possible. Perhaps when the Minister responds he will say what progress has been made since that time. Will he also say whether Ministers or officials from the Department of Health form part of UK representations in negotiations with the EU? I appreciate that he will not be able to go into some of the details, but given the shared desire across the House to make progress and achieve as much harmony as possible in that area, can he put some flesh on the bones and say what exactly the Government will seek to achieve as we move forward? The Minister will understand that the big pharma companies are looking for a clear indication of the likely shape of the future relationship as soon as possible, and as we have heard, decisions are being made now. I hope that he can shed some light and provide clarity on that when he responds.

Will the Minister address Members on the jurisdiction of the European Court of Justice? If it cannot be used to adjudicate on licensing appeals, as appears to be the Government’s position at the moment, how will the two systems closely interact? Is there any possibility of a joint adjudication process? Operating alone in our own separate market would be not only extremely costly, but inevitably disastrous for patients. If pharmaceutical companies are forced to go through a separate regulatory system, as well as the NICE process, just to access what will be, in the big scheme of things, a fairly small market, we could find ourselves at the bottom of the list when new medicines are released. Pharmaceutical companies might view the UK as a lower priority than getting drugs into the bigger markets of the US, the EU or Japan. That might be a particular concern where the potential market for medicines is naturally small, such as with those for rare diseases. As already stated, we are already becoming a less attractive market for the life sciences sector, both for companies in the UK and for future investment decisions.

That is a very serious and bleak picture, and I hope that when the Minister responds he can reassure the House that ideology will not trump the best interests of our economy and our health service. My hon. Friend the Member for Bishop Auckland had seven questions—I lost count of the number asked by my hon. Friend the Member for Lewisham East, but there were many. I have a few of my own, and hopefully they will be a little more straightforward to answer—yes or no will probably do for most of them. In particular, I would like the Minister to guarantee today that after 1 April 2019 patients will have the same access to medicines as they do now, and that they will not face longer waits to access new treatments. Can he also guarantee that another part of the Department of Health’s budget will not be used to make up any shortfall in MHRA’s finance?

The Minister may not be aware that we held a debate on this subject just over a year ago, and many of the concerns raised then have been raised again today. All Members today have spoken with one voice about the need for clarity and certainty, and I hope that the Minister can provide us with that now.

[Geraint Davies (in the Chair)]

A lot of questions have been asked, and fortunately we have the time for a lot of answers.

--- Later in debate ---

[Steve Brine]

I share the hon. Lady’s concern. As I said, so much about this is still subject to negotiation. I cannot give her the exact assurance that she wants at this time.

The hon. Lady also asked about the EU exit transition. The Government are clear that we want to continue collaborating with the EU in the interest of protecting patient safety. The detail of any future relationship is, of course, subject to that negotiation. That is nothing new. We recognise completely that new arrangements can take time to implement, and we will work closely with the industry and key health system partners to ensure smooth implementation. The European Union (Withdrawal) Bill, which is going through the House at the moment, will ensure that a known legal framework is in place immediately after we leave the EU.

The hon. Lady talked about the Secretary of State “flirting” with leaving the EMA for the FDA. Earlier this year, the Secretaries of State for Health and for BEIS published a letter in the Financial Times setting out our aim to retain a close relationship in respect of medicines regulation. The FDA has been clear that it would not let another country “join” FDA processes even if we wanted to, but if we are outside EU processes, we will certainly look at how we can co-operate more closely with other global regulators.

The hon. Member for Lewisham East (Heidi Alexander) asked whether we had had contact with Australia and New Zealand. The chief executive of the MHRA chairs the International Coalition of Medicines Regulatory Authorities, and we of course have had discussions through that group on a contingency basis with Canada, Australia and others about the potential for greater collaboration once we have left the EU.

The hon. Lady asked whether I can guarantee that the adverse effects of drugs will be detected quickly. She also asked about orphan drugs and clinical trials. Increasingly, information about the adverse effects of drugs is shared at a global level. The EMA collaborates with many third countries. There is no need for a broad deal to agree to share safety information. We want to continue collaboration with the EU on orphan drugs for rare diseases, which she rightly pointed out are a subset of the wider issue. If we are outside EU processes, we will need to consider incentives for orphan drug development, and we are doing that. Clinical trials all receive national approval today, and they will receive approval under the EU clinical trials regulation, which is due to come into force in late 2019. The UK will remain a leading centre for clinical trials. There is no reason why multi-country trials cannot include the UK after Brexit.

Several Members, including the shadow Minister, the hon. Member for Ellesmere Port and Neston (Justin Madders), asked about MHRA resources. Some 90% of medicines on the UK market already have a national licence from the MHRA; fewer than 10% come via work that we do for the EMA. We have world-renowned scientific assessors at the MHRA. Some work and workloads may change post-Brexit, but I do not think that claims of fundamental change are correct. MHRA has full contingency planning in place.

[Justin Madders]

On that point, can the Minister confirm that Department of Health budgets will not be used to fund any additional MHRA costs?

Hormone Pregnancy Tests

Justin Madders Excerpts

Thursday 16th November 2017 Commons Chamber

[Steve Brine]

I thank my right hon. Friend—one of my predecessors in this role—for her question. I appreciate that she will have met constituents who have been affected by this in her surgeries and that that must have been very difficult. The report’s conclusions do not detract from the suffering experienced by the families, and we recognise that the families may find those conclusions hard to accept. Birth defects occur naturally in up to four in every 100 babies, and the existence of a birth defect in a baby exposed to a medicine during pregnancy does not necessarily mean that it was caused by the medicine.

As for the question of any future parliamentary discussion of this subject, I suspect—in fact, I know—that my right hon. Friend is more than capable of seeking such opportunities.

[Justin Madders (Ellesmere Port and Neston) (Lab)]

This decision has rightly been met with disbelief by campaign groups. It has been called a whitewash, an injustice and a betrayal. It is clear from the reaction to yesterday’s report that real anger remains about the way in which the affected families have been treated. Have we learnt nothing from previous scandals and cover-ups? The chair of the campaign group, Marie Lyon, has said:

“I could go to prison if I divulge what was discussed.”

Does the Minister not agree that that is as far away as possible from transparency? How can Marie Lyon or any of the other campaigners say that their views have been properly taken into account? Will the Minister tell us what conversations he has had with the affected families about the results of the report and what further action they want to take?

A draft of the report, which was published in October, stated

“Limitations of the methodology of the time and the relative scarcity of the evidence means it is not possible to reach a definitive conclusion.”

However, that sentence was removed from the final version. It is critical that the Minister answers these questions: why was the sentence removed; why was there a delay of a month; and did he speak to the authors of the report about the sentence before its removal? The inquiry has answered a question that it was not asked to answer, and it has reached a conclusion not supported by the evidence. What is the Minister’s view of the various studies that have been referred to that show a causal connection?

When he set up the inquiry, the previous Minister for life sciences, the hon. Member for Mid Norfolk (George Freeman), said that he wanted to

“shed light on the issue and bring the all-important closure in an era of transparency”. —[Official Report, 23 October 2014; Vol. 586, c. 1143.]

The reaction that we have seen will demonstrate to the current Minister that on that measure the inquiry has failed. Will he look again at holding a full, independent review, so that families can feel they have seen justice done and we can be sure that this will never happen again?

[Steve Brine]

The hon. Gentleman referred to a “whitewash”. As I have said, this was a comprehensive, independent, scientific review of all available evidence by experts on a broad range of specialisms who, with respect, are far more qualified to consider the subject than either him or me. It was a rigorous, important and impartial review conducted over the best part of two years, and the experts were given access to all the available documents.

As for the families and issues relating to disclosure, yes, Mrs Lyon was on the panel. However, it is standard procedure for expert working groups to sign such an agreement, as all members of the panel did, in order to keep the process free from external influence and to prevent it from being constantly discussed in the media. The companies did meet the group and gave evidence to it. Having discussed the matter briefly with members of the Medicines and Healthcare Products Regulatory Agency this morning, I have to say that I think the families could have been treated a great deal better when they met the group. I thought that the layout of the room was intimidating. Not everyone is like a Minister or a Member of Parliament who can sit in front of a Select Committee and know how to handle it. I think that the process could have been handled better, and I made that very clear.

As for Ministers and meetings, my noble Friend Lord O'Shaughnessy, who ultimately has responsibility for the MHRA and whom I “shadow” in the House of Commons, has met the all-party group and the families group. He will meet them again on 6 December, now that the report has been published. The APPG is also meeting the chair of the expert working group.

The hon. Gentleman mentioned other research. He might have been referring to Dr Vargesson, an Aberdeen-based researcher who is, I believe, working on the components of Primodos in fish. He was invited to give evidence to the group, and he did so, but he did not want to leave his work and the evidence, which he said would shortly be published, with the expert working group. As far I am aware, that work has still not been published, but I know that the MHRA will be keen to look at any new work that is published.

Oral Answers to Questions

Justin Madders Excerpts

Tuesday 14th November 2017 Commons Chamber

[Mr Dunne]

As I said to the hon. Member for Keighley (John Grogan), the trust, which would consolidate subsidiaries in its accounts, would publish the accounts of subsidiaries as part of its consolidated accounts each year.

[Justin Madders (Ellesmere Port and Neston) (Lab)]

On Sunday, the Secretary of State said that

“good public services are the moral purpose of a strong capitalist economy”,

yet trusts are so strapped for cash that they are creating private companies to get around VAT laws. Not only does this take money away from the Exchequer, meaning that other parts of the NHS are effectively subsidising these trusts, but it also removes vital protections for staff, who will find that they no longer work for our national health service. Be in no doubt: this is another step down the road of privatisation. Will the Minister set out, therefore, what protections are in place to prevent any of these companies from being sold off in the future to the highest bidder?

[Mr Dunne]

I am afraid that the hon. Gentleman, for whom I have considerable respect, is trying, yet again, the tired old approach of weaponising the NHS by alleging privatisation—seeing privatisation fairies where there are not any. This is about responding to the review of Lord Carter—one of his hon. Friends in the other place, I remind him—of driving efficiency through the NHS, which I know he supports, and about finding the right structures to allow, for example, the back offices of different NHS bodies in an area to be combined. That requires a structure, and a number of foundation trusts are setting up subsidiaries to provide those services to each other.

Mental Health Units (Use of Force) Bill

Justin Madders Excerpts

2nd reading: House of Commons
Friday 3rd November 2017 Commons Chamber

[Justin Madders (Ellesmere Port and Neston) (Lab)]

I thank my hon. Friend the Member for Croydon North (Mr Reed) for introducing the Bill; he certainly made a powerful case for it. Everything we have heard has made it clear why the Bill is necessary. I congratulate Opposition and Government Members for the constructive way in which they have contributed to the debate so far. There is broad support for the measures in the Bill and I hope that if there are disagreements, they can be ironed out in Committee.

My hon. Friend the Member for Croydon North spoke movingly about the case of Seni Lewis, who, as we heard, tragically died after being restrained face-down in a mental health hospital. We have heard other examples of the issues that the Bill is designed to address. Sadly, Seni’s case was not an isolated incident. Restraint is still used far too regularly, despite Department of Health guidelines that state it should be used only as a last resort. Guidelines state that the dangerous practice of face-down restraint should be phased out, but unfortunately the technique is still used widely. There is significant variation in the use of restraint on mental health patients.

[Eddie Hughes (Walsall North) (Con)]

rose—

[Justin Madders]

I am not going to give way. Many other Members wish to speak and there are other items of business that we want to get to.

As Members have highlighted, there is an issue with unconscious bias. Young black men are statistically more likely to be seen as having psychosis or schizophrenia, and are at risk of being subject to inappropriate use of force, as are women.

[James Cleverly (Braintree) (Con)]

Will the hon. Gentleman give way?

--- Later in debate ---

[Justin Madders]

No, I have already made the point that many Members wish to speak so I shall not be giving way.

Metropolitan police figures show that in London, 36% of the 12,605 uses of force between April and June involved black people, despite the group accounting for just 12% of London’s population. Research has shown that women, who make up 46% of patients, are subject to more than half of all incidents of face-down restraint. Women and girls’ mental health conditions are often related to experiences of violence or abuse. The use of physical restraint on a survivor of sexual or physical abuse risks re-traumatising the patient.

It is essential that we take steps to reduce the use of force and address the unconscious bias currently reported in the system. My hon. Friend’s Bill seeks to do that in four key ways: through transparency, evidence, accountability and justice. The Bill will increase transparency. Currently, data are not collected uniformly so accurate data on how often restraint is used, and on how restraint is used disproportionately against certain demographics, are hard to collate. The Bill requires a registered provider to keep a record of any physical restraint of a person at any of its mental health units. That will include the place, time and duration of the restraint, the gender, age and ethnicity of the person who has been restrained and, critically, justifications for the use of restraint. Recording in a uniform way when, how and why restraint is used, who it is used on and what steps were taken to avoid its use, will increase transparency. It will allow us to take steps to improve the system where issues of unconscious bias or the overuse of restraint occur.

The Bill introduces steps to build and improve the evidence available when force or restraint are used. Currently, many forces require officers to wear operational body cameras, but not all. The Bill will require all police officers to wear such a camera when they are called to a mental health unit for any reason, unless there are clear operational reasons for not doing so. Research carried out at the University of Cambridge found that the use of police body-worn cameras made the use of force 50% less likely. Furthermore, the research found that the number of complaints filed against officers reduced tenfold. The evidence shows us that body-worn cameras work. They increase public trust in the police and protect our police officers from spurious complaints. The Bill would therefore improve overall accountability.

The Bill creates two further duties: it requires the responsible person to make and maintain a written policy for the use of physical restraint and take steps to ensure that physical restraint is used only in compliance with that policy, and it requires training to be provided to all frontline staff.

The Bill also seeks to improve access to justice. We want to ensure that tragedies such as those we have heard about today do not happen again. The bulk of the Bill works towards that goal. When tragedies such as what happened to Seni occur, we need to make sure that they are properly investigated and that the families of the victims receive justice. The Bill makes it compulsory for an independent investigation to be carried out whenever a death occurs in a mental health unit and the person has been physically restrained. This will end the scandal of families not knowing the circumstances of their loved one’s death.

The Bill is a step towards a model of care, rather than one of containment. Its measures will support mental health patients, their families, and emergency service workers. It will increase public trust in the emergency services and promote dignity and respect in mental health services. Restraint is used too often and disproportionately in certain sections of society. This cannot be allowed to continue. When she responds, I hope the Minister will support the Bill and allow it to be sent to Committee.

Oral Answers to Questions

Justin Madders Excerpts

Tuesday 10th October 2017 Commons Chamber

[Justin Madders (Ellesmere Port and Neston) (Lab)]

Although we support moves to broaden access to nursing, these measures are effectively an admission that the scrapping of bursaries has been a disaster, but whatever recruitment strategies there are, the Government need to improve retention. The Royal College of Nursing recently reported that half of nurses surveyed said that

“staff shortages are compromising…care”.

What steps are the Government taking to ensure that nurses can do their jobs properly right now?

[Mr Hunt]

The hon. Gentleman is right to bring that up. One thing we can do a lot better is to improve the opportunities for flexible working. We have announced that we will be making new flexible working arrangements available to all NHS staff during this Parliament. We are also expanding programmes to encourage people who may have left the profession to come back into nursing.

Baby Loss Awareness Week

Justin Madders Excerpts

Tuesday 10th October 2017 Commons Chamber

[Justin Madders (Ellesmere Port and Neston) (Lab)]

This has been a compelling debate, which has once again shown the House at its best. I welcome the fact that we are discussing these issues again in the Chamber as part of Baby Loss Awareness Week. I hope that these extremely valuable debates will become an annual fixture, because they provide us with a very valuable opportunity to raise awareness of the work of the 40 baby loss charities who work together as the Baby Loss Awareness Week Alliance. They also give us the opportunity to assess what progress has been made in meeting our shared ambitions to improve prevention, treatment and bereavement care.

I recognise the work of the all-party group on baby loss. It is true to say, as a number of Members have today, that it has played a key role in ensuring that this issue is kept at the top of the Government’s agenda, and that some of the taboos that have so often surrounded this subject are broken down. There have been a number of excellent contributions from Members on all sides and I am grateful for the opportunity to be able to draw attention to some of them.

The hon. Member for North Ayrshire and Arran (Patricia Gibson) mentioned coroners’ inquests and fatal accident inquiries for stillbirths—an issue she has raised on a number of occasions. I pay tribute to her for her persistence in that campaign. She certainly made a compelling case that such inquiries would inform good practice and, more importantly, bereaved parents may get answers that they have not previously had.

The hon. Member for Colchester (Will Quince) spoke with great passion and personal experience, and in his capacity as the co-chair of the APPG. He touched on a range of issues and highlighted the importance of mental health. I was rather troubled by what the hon. Member for Banbury (Victoria Prentis) said. I certainly recognise her description of a culture of defensiveness in certain trusts. She was absolutely right that most parents want answers, not compensation. We need to do more about the way in which the NHS handles these issues.

My hon. Friend the Member for Nottingham South (Lilian Greenwood) told us about her constituents, Jack and Sarah, who have recently spoken publicly about the tragic circumstances of the death of their daughter, Harriet. They felt that what they were told was not correct and want coroners’ inquests to be available for stillborn children. As my hon. Friend said, there seems to be growing cross-party support for such a move. I assure her that the Opposition Front Bench will do what we can to assist in making that campaign a reality.

The hon. Member for Eddisbury (Antoinette Sandbach), who also co-chairs the APPG, was right to pay tribute to the NHS staff who have really taken up the challenge laid down by the APPG of improving the experience for parents. She rightly drew attention to the wider public health factors that we need an awful lot more work on, and raised an important point about the need for CCGs to commission bereavement counselling consistently across the board. It is often a concern that CCGs do not commission services consistently across the country, so more examination and accountability is required.

My hon. Friend the Member for Kingston upon Hull North (Diana Johnson) spoke about her constituent’s son, William, whose ashes were scattered without his family’s knowledge. She spoke about this in the debate last year, so I am sorry to hear that there are still many unanswered questions. I hope that she does not have to come back to this debate next year to raise the same issues.

My hon. Friend the Member for Slough (Mr Dhesi) spoke about the terrible circumstances affecting one of his constituents and the need to improve awareness of group B strep. In last year’s debate, the right hon. Member for Mid Sussex (Sir Nicholas Soames) advised the House that one baby a day develops group B strep. We should be able to do a lot more about that, given that it is a largely preventable infection.

The hon. Member for Thirsk and Malton (Kevin Hollinrake) highlighted well the gaps in the law on bereavement leave. I wish him success with his private Member’s Bill. He made the valid point that we are also employers, so it is probably worth us examining the Independent Parliamentary Standards Authority terms and conditions following the debate to see whether there is anything more we can do to ensure that we are an exemplar.

We were privileged to hear from the hon. Member for Sleaford and North Hykeham (Dr Johnson), given her professional experience. She conveyed well how difficult it is for staff in some of these situations. Her reflections on her last 16 years in practice were informative and positive, and she made some excellent points about areas in which we can do better. I hope the Minister will take those points on board.

As we have heard from many hon. Members’ contributions today and in previous debates, the efforts of people here and among the public have gone a long way towards breaking down taboos. I pay tribute to those who have done so and the efforts of others in the public eye to raise awareness. For example, “Coronation Street” had a storyline involving a stillbirth earlier this year. I am sure that such television programmes have an even greater reach than Parliament TV. What made that storyline so poignant was that Kim Marsh, whose character portrayed the stillbirth onscreen, herself suffered a bereavement eight years before. She said of the broadcast that

“sharing is absolutely imperative to being able to put the pieces of your jigsaw back together”.

That is incredibly sound advice.

Many parents have spoken of the isolation they can feel, and we have heard from hon. Members today about how that has been a taboo subject for a very long time and about the difficulty people can have in discussing the loss of their child for what seems like many years. A constituent of mine, Nicole Bowles, is in that situation. She has set up a campaign, called Our Missing Piece, to make it easier for parents to let other people know that their family is missing a loved one. She has designed a badge for bereaved parents to wear as a way of telling the world that they are dealing with child loss. Her ambition is very simple but could have a very positive impact. She says:

“I hope that by creating this badge it helps to show that: It’s OK to talk to us; It’s okay to ask if we’re alright; It’s okay to say their name.”

I commend her campaign and I hope that this debate has gone some way to conveying the sentiments she expresses about the need to talk about these issues and break down the barriers that have been there for too long.

We know from the recent review of stillbirths and neonatal deaths in the UK that of the 782,720 births in 2015, 3,032 were stillbirths and 1,360 were neonatal deaths. This amounts to about 12 stillbirths or neonatal deaths every day. That is a huge number of families each and every week experiencing one of the biggest, if not the biggest, tragedy of their lives. It is a difficult figure to process, particularly because, as the hon. Member for Witney (Robert Courts) said, sometimes these deaths could have been avoided.

It is of course positive that perinatal mortality has decreased in this country, but the level of progress has not been good enough. According to The Lancet, the annual rate of stillbirth reduction in the UK has been slower than that in the vast majority of high-income countries. One of the key reasons for that is the high level of variability in the services offered. This country offers some of the best neonatal care in the world, along with some exemplary psychological and bereavement support, but unfortunately that is not available equally to everyone. Last year, NHS England reported a 25% variation in stillbirth rates across England. That is a startling figure, but it demonstrates that we have the capability to meet and exceed the Government’s target to reduce the number of stillbirths by 20% before 2021 if we ensure that everyone has access to the very best care and treatment. I welcome the progress the Minister referred to earlier towards meeting that target, and I hope that he will be able to update us annually on progress. I also invite him to consider whether it would be appropriate to expand the scope of the Government’s ambitions to focus also on reducing the number of premature births, given that prematurity contributes to a significant number of stillbirths and neonatal deaths each year.

As well as variability, another area where we need to make significant progress is ensuring safe staffing levels at all times on all neonatal units. The 2015 Bliss report “Hanging in the Balance” found that 64% of neonatal units did not have enough nurses to meet the national standards on safe staffing and that 70% of neonatal intensive care units regularly looked after more babies than was considered safe. As we know from exchanges this morning in departmental questions, there are huge challenges in the workforce at the moment, and the Government have set out their strategy to deal with them, so I hope that we will see progress. It is certainly something that we will be monitoring closely.

Finally, I turn to the key theme of this year’s Baby Loss Awareness Week, which the hon. Member for Colchester referred to: bereavement care. This is an area that stretches from the level of support available immediately following a neonatal death to the medium and long-term support available to families. I welcome yesterday’s announcement on the national bereavement care pathway, which will see 11 sites in England trial the use of new materials, guidelines and training for professionals. The trial, leading to a full roll-out in a year’s time, has the potential to tackle long-standing and unacceptable variances in bereavement care and ensure that all bereaved parents are offered equal, high-quality, individualised, safe and sensitive care, which is something everyone in the House wants to see.

I suspect that the challenge of a successful roll-out will be ensuring that sufficient time is set aside for the training that staff will need. I welcome the news from the Minister about the funds and support that will be available for the delivery of that training, but we must recognise that training is a continuing process, and we must keep an eye on progress in the years to come. As I said earlier, another big challenge is ensuring that the workforce are in a position to deliver the pathway. Last year, Sands found that 38% of maternity units did not have a specialist bereavement midwife based there, while Bliss has found that 30% of neonatal units do not have access to any psychological support.

There is also a need for capital investment. We have heard from a number of Members today about the importance of bereavement suites, and we know that one in three trusts and health boards does not have a dedicated bereavement room in each maternity unit. I am aware that the Government have ambitious plans to release significant parts of the NHS estate, and I should be grateful if the Minister could reassure us that there will be consideration of the shortfall in the number of bereavement suites before any disposals proceed.

There is much more to be done, but I think the hon. Member for Eddisbury (Antoinette Sandbach) summed up the position well when she said that, for the first time, there was some hope. Let us continue to move forward in that spirit.

Oral Answers to Questions

Justin Madders Excerpts

Tuesday 4th July 2017 Commons Chamber

[Mr Hunt]

Westmorland general hospital has a very important future in the NHS and I am happy to give the hon. Gentleman that assurance. I do not think he should be concerned about STP footprints covering both rural and urban areas. However, where there is an issue in his constituency, and many others, it is the response times for ambulances in the most remote areas, and we are looking at that.

[Justin Madders (Ellesmere Port and Neston) (Lab)]

Another threat to A&E units is the capped expenditure process, which will mean hundreds of millions of pounds cut from NHS budgets. That was sneaked out during the election, but so far we have had nothing but silence from this Government. It is time that we had the truth: when did the Secretary of State sign off these plans and when is he going to publish them?

[Mr Hunt]

The capped expenditure process is an NHS England initiative to meet its statutory duty to live within its budget, and I support the principle that in a period where real expenditure on the NHS is going up by £5 billion, those benefits should be spread fairly among patients in all parts of the country.

Health Service Medical Supplies (Costs) Bill

Justin Madders Excerpts

Tuesday 25th April 2017 Commons Chamber

[Justin Madders (Ellesmere Port and Neston) (Lab)]

I thank the Minister for approaching the outstanding areas of concern in a constructive and conciliatory manner that has allowed us to support the Government’s proposal, and hence to support the Bill as a whole. We too are keen for the NHS to gain better control of the cost of medicines. We are anxious to close loopholes in the system which have been the subject of blatant abuses over the last few years, and which we have discussed during the Bill’s passage. The negotiations on the amendments were, by their nature, speedy, but they were no less effective for that. I doubt that we will be so fortunate with the Brexit discussions in the future.

During the passage of the Bill, we have heard very clearly that the current state of affairs is not serving patients or the taxpayer as well as it could. As we have heard, expenditure on medicines has constituted a significant and growing proportion of the NHS budget, standing at £15.2 billion in England in 2015-16. That is an increase of over 20% since 2010-11. Had that been applied to health spending across the board, many of our exchanges across the Dispatch Box during the last 12 months or so might have been a little less lively.

The Minister will be aware, however, that despite that increase in spending, serious concerns are still being raised about the availability of new treatments. I should like to take a few moments to raise some of the specific concerns expressed by patients about the introduction by the National Institute for Health and Care Excellence and NHS England of a “budget impact test”, which could cause the introduction of new treatments costing more than £20 million a year to be delayed by up to three years. We fear that some patients with particular conditions will be disproportionately affected. Let us take just one condition: type 2 diabetes. There are several drugs for that condition that already cost the NHS more than £20 million a year owing to the patient numbers involved, including Exenatide, which costs £21 million, Liraglutide, which costs £41 million, Sitagliptin, which costs £77 million, and human analogue insulins, which cost £70 million.

Can the Minister tell us what estimate has been made of the number of patients in England who could be affected by delays in accessing treatments owing to the introduction of the budget impact test? Can he also comment on what impact that might have on patients’ right to treatment under the NHS constitution? We have already seen the 18-week commitment effectively abandoned; does the Minister now consider the constitution to be an optional extra? It is also of particular concern that the test could apply to important end-of-life drugs: in the case of those patients there is, of course, no time to waste. What can the Minister do to ensure that valuable time is not wasted when drugs hit the impact test for that group of patients?

Returning to the Government amendments, we are content that they take us to more or less the place that our previous amendments did, without binding the Government’s hands totally. We welcome the concessions made, which enable us to support this proposal, because by requiring the Secretary of State to consult, in particular on the consequences of enacting any powers on the life sciences sector and, most importantly, patients, we now have an extra safeguard that we hope will ensure that the right balance is struck between controlling cost, promoting our life sciences industry and making sure patients get access to new treatments as quickly as possible. The Bill has always addressed the first of those three areas, but we consider it just as important for the other two areas to be clearly factors to be taken into account when new rules are developed. We believe this is important because we have significant concerns about the current system denying patients access to new treatments and stifling investment. As we have said previously, the imminent departure of the European Medicines Agency from our shores should be set against the worrying backdrop of investment in research and development in the sector falling by 20% in just over three years.

The reduction in investment does not just impact on growth and jobs in the country; it also has a profound impact on patients. The “International Comparisons of Health Technology Assessment” report published in August by Breast Cancer Now and Prostate Cancer UK shows that NHS cancer patients in the UK are missing out on innovative treatments that are becoming available. For every 100 European patients who can access new medicines in the first year that they are available, just 15 UK patients have the same access; we must reverse that. We hope that this amendment will go some way to reversing that trend, as a consultation process that requires the Secretary of State to specifically consider these issues will mean that if the consultation is genuine, open-minded and involves a complete, conscientious and considered examination of the responses to it, we will hopefully see a system that protects and supports our industry, and, most importantly, reaffirms one of the founding principles of the NHS: that treatment should be available to all and be free at the point of use. That is a principle that we on the Labour Benches are very keen to defend.

In conclusion, we will support this amendment and keep a close eye on the many issues raised today, which are not going to go away just because there is now a general election.

On that point, I hope that you will allow me a small indulgence, Madam Deputy Speaker: this will be my last appearance in the Chamber before the Dissolution of Parliament and I want to thank you and your Clerks for the time and courtesy you have afforded both me and other new Members as we have learned the intricacies of this place. A lot goes on behind the scenes to ensure that these debates have a coherence and fluency; that might appear effortless to the outside world, but we can assure people that that certainly is not the case. I have found everyone who works behind the scenes here to be very helpful and welcoming, which has made it easy for me to do my job.

This has been much more than a job to me; it has been an absolute privilege of my life to be here and represent the people of Ellesmere Port and Neston. I hope that after the election I have the opportunity to continue to do that.

[Several hon. Members rose—]