Oral Answers to Questions
Steve Brine Excerpts(7 years ago)
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Melanie Onn (Great Grimsby) (Lab)
The Parliamentary Under-Secretary of State for Health (Steve Brine)
As the Secretary of State has set out, our ambition is for the NHS to be the safest place in the world to give birth. Information on prevention and the implications of a group B streptococcus infection is available on the NHS Choices website. Just today, the Royal College of Obstetricians and Gynaecologists published a new patient information leaflet that, from the new year, will be given to all pregnant women for the first time. Because it is Christmas, I have a copy here for the hon. Lady. [Interruption.] I see she has one, too.
Melanie Onn
I thank the Minister—he has anticipated my question. I reassert that, on average, two babies die each month from complications relating to group B strep. Awareness of the effects of that infection is incredibly low. Will the Minister meet me and Group B Strep Support to discuss how we can get this leaflet to mums-to-be at the earliest possible stage?
Steve Brine
I know this is a subject about which the hon. Lady cares greatly. I would be very happy to meet her and to bring together the people I work with from Public Health England to see how we can make the best of this new leaflet and ensure it is the best and most important Christmas present.
Mims Davies (Eastleigh) (Con)
I welcome the Government’s focus on reducing stillbirths, and I welcome the maternity safety strategy. I particularly welcome this focus on group B strep. Will the Minister outline how he is working locally with hospitals such as Southampton to make sure they are aware of this new focus?
Steve Brine
I thank my parliamentary neighbour for that question. Public Health England is one of the most effective arm’s length bodies with which we work in government, and it will be working with commissioners and trusts across our country to make sure that this new information is out there with pregnant mums and the most at-risk groups. Members of Parliament have an important role to play with local commissioners and trusts, and I know my hon. Friend will play her part in that.
Sir Greg Knight (East Yorkshire) (Con)
Ms Marie Rimmer (St Helens South and Whiston) (Lab)
The Parliamentary Under-Secretary of State for Health (Steve Brine)
Ensuring all our constituents—particularly the vulnerable and the elderly—are getting an adequate diet is critically important. That is why, for instance, we have given half a million pounds in funding to a special Age UK taskforce to reduce malnutrition among older people, and we will continue to train NHS staff so that early action can be taken.
Ms Rimmer
A merry Christmas to you, Mr Speaker, and to the Ministers on the Front Bench—maybe they will answer my letter soon.
In the world’s sixth largest economy, it is damning that, under this Government, we have seen a 122% increase in the overall numbers admitted to hospital with malnutrition. It is clear that more action is needed to ensure that we eradicate malnutrition in our society. The Department for Work and Pensions and the Health Department must work together so that, rather than introducing measures such as universal credit eligibility criteria, which will see at least 1 million children lose free school meals, we commit as a country to tackling this issue head on. Will the Minister use his power and influence to ensure that this issue is addressed immediately and that we see an end to this failure to axe malnutrition in the 21st century?
Steve Brine
Happy Christmas to St Helens as well. I agree that we need to work together. The Healthy Start programme, for which I am responsible, provides a nutritional safety net to hundreds of thousands of pregnant women and families with children under four. There is a slight increase in cases being reported in recent years. In part, that is due to much better diagnosis and detection. Some 1.1 million children get free school meals in England, and the Government are investing £26 million in breakfast clubs. Only last week, Kellogg’s was here with its breakfast club awards—an excellent innovation.
Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)
That being said, it is disgraceful that under this Government’s watch we have seen a 54% increase in children admitted to hospital with malnutrition. Instead of seeing malnutrition rising, we really should be eradicating it. As the festive period is upon us and it is the season for good will and giving, will the Minister give this House an assurance that he will seriously address this matter to ensure that no child in this country ever experiences malnutrition?
Steve Brine
Of course we want no child in our country to experience malnutrition. I mentioned the Healthy Start scheme and the breakfast clubs. Healthy Start is an excellent programme run by Public Health England that encourages a healthy diet among hundreds of thousands of families with children under four. It is exactly that which is helping us to tackle this issue.
Andrew Bowie (West Aberdeenshire and Kincardine) (Con)
The Parliamentary Under-Secretary of State for Health (Steve Brine)
The recently announced life sciences sector deal draws significant investment into the sector from across the world, ensuring that the next wave of breakthrough treatments, innovative medical research and technologies—and highly skilled jobs, of course—are created right here in Great Britain.
Andrew Bowie
In Scotland today there are over 600 life sciences organisations employing more than 30,000 people, making Scotland one of the largest life sciences clusters in Europe, so they too will welcome the announcement the Minister mentions. Will he give the House some more detail on the sector deal and industry investments that could give even more strength to this world-leading industry across the United Kingdom?
Steve Brine
The sector’s commercial activity is very broadly spread across the whole of the UK—my hon. Friend’s concern. There are a number of strong emerging life sciences clusters. The deal highlights successes around the UK in Manchester, Leeds, Sheffield, Glasgow, south Wales, and the south-east, so it is a very broad spread.
Daniel Zeichner (Cambridge) (Lab)
Medical research charities play a key role in developing new medical treatments, yet the Charity Research Support Fund, which enables universities to unlock investment from the sector, has been frozen since 2010. Will the Minister heed the call from the Association of Medical Research Charities to enhance CRSF in real terms, in line with inflation and with charity investment?
Steve Brine
I can come back to the hon. Gentleman in more detail on that. As part of the life sciences sector deal, there is just over £210 million of industrial strategy challenge funding for early diagnosis. This includes funding to build on the UK’s leadership in genomics, where we are very strong, and to establish programmes in digital diagnostics and artificial intelligence in healthcare.
Jeff Smith (Manchester, Withington) (Lab)
Craig Tracey (North Warwickshire) (Con)
The Parliamentary Under-Secretary of State for Health (Steve Brine)
My hon. Friend asks an important question. We have just commissioned Warwick University to investigate the links between breast density and breast cancer. If the findings suggest that there should be any changes to the national breast screening programme, the UK national screening committee will of course consider that, as it does with any new evidence that helps it to target screening appropriately and make women aware of any increased risk of breast cancer. I will be watching this like a hawk.
Mr Jim Cunningham (Coventry South) (Lab)
Mark Pawsey (Rugby) (Con)
Steve Brine
The truth is that we do not yet know enough about e-cigarettes. I welcome the Science and Technology Committee’s investigation into them. We have asked Public Health England to include messages about the relative safety of e-cigarettes in its Quit Smoking campaign next month, but it is for local organisations and businesses to implement their own policies on e-cigarette use in the workplace.
Kate Green (Stretford and Urmston) (Lab)
Mary Robinson (Cheadle) (Con)
Steve Brine
As the House knows, cancer is a huge priority for me and for the Government. Survival rates are at a record high, but we know there is much more work to do. Early diagnosis is key, and that is never more true than with oral cancers. We are supporting dentists to play a vital role in spotting mouth cancers early. I was discussing this very point just last week with the British Dental Association, which shares our passion on this issue.
Mr Adrian Bailey (West Bromwich West) (Lab/Co-op)
Mr Alistair Carmichael (Orkney and Shetland) (LD)
Steve Brine
There is huge interest in this subject in the House. Over the past three years, there has been extensive work to communicate advice on the risks of valproate in pregnancy, through a huge number of channels, to help professionals and patients. It is evident from monitoring activities that providing health professionals with information, even when repeated constantly through multiple sources, is not changing prescribing behaviour sufficiently to minimise harm to children exposed to valproate in pregnancy. The expert working group of the Commission on Human Medicines is informing the UK position in European negotiations and advising on the national action required within the UK health system. [Interruption.] Sorry, Mr Speaker.
Mr Speaker
Forgive me. I did not mean to be unkind to the Minister who was attending closely to his answer. It is just that we want the whole House to get the benefit of it.
Ms Angela Eagle (Wallasey) (Lab)
On admissions to hospital for malnutrition, will the Minister tell me what has been happening at Wirral University Teaching Hospital? Admissions for malnutrition went up from 21 in 2009-10 to 707 in 2014-15. They went up again to 728 and this year currently stand at 586. That seems very, very high. Can anyone tell me what is going on? If not, will Ministers write to me to explain these huge figures?
Steve Brine
There is £2.8 million in extra winter funding, but I will write to the hon. Lady with the details she asks for.
Jessica Morden (Newport East) (Lab)
Those with erythropoietic protoporphyria cannot be exposed to sunlight or even some artificial light without extremely painful and violent skin reactions. Trials of the drug Scenesse have proved life-changing for constituents such as James Rawnsley, who, for the first time, can now take his kids to school and go on holiday. The decision to make it available on the NHS will be taken soon. Please will the Minister look at it?
Steve Brine
EPP has a devastating impact on a person’s health and quality of life, and is something that the hon. Lady has discussed with me before. We will of course take the matter seriously, and I am very happy to talk to her more about it.
Dr Matthew Offord (Hendon) (Con)
Given that my own brother’s funeral will be held later today, may I ask the Secretary of State what help and support he is giving to the families of drug and alcohol abusers?
Rachael Maskell (York Central) (Lab/Co-op)
The NHS patient declaration form for free dental care and prescriptions requires patients to determine the difference between contribution and income-related employment and support allowance. Getting it wrong attracts really hefty fines. Will the Minister ensure that patients first get the opportunity to make the right choice before fines are applied?
Steve Brine
Yes, of course. The NHS Business Services Authority issues the penalty charge notices for incorrect claims for exemption from NHS dental care and prescription charges. We have recently increased the number of checks, however, because ultimately this is taxpayers’ money, and we need to ensure that it is spent properly and legally.
Mims Davies (Eastleigh) (Con)
Some 50% of young people do not use a condom with a new partner and one in 10 young adults never uses one, which means the chance of an unwanted pregnancy or, indeed, a sexually transmitted disease. Please will the Department do something to ensure that people are aware of the benefits of condoms?
Steve Brine
Men may not be very good at wrapping at this time of year, but they need to get this one right. I welcome Public Health England’s “protect against STIs” campaign, which was launched last week and aims to reduce rates among 16 to 24-year-olds, and I encourage young people having fun this Christmas to do so sensibly.
Alison Thewliss (Glasgow Central) (SNP)
There is an increasing trend for women to share breast milk over the internet with no recourse to the milk banking guidelines from the National Institute for Health and Care Excellence. Will the Minister meet me, and other members of the all-party parliamentary group on infant feeding and inequalities, to discuss the matter further and to ensure that breast milk can be used safely?
Hormone Pregnancy Tests
Steve Brine Excerpts(7 years ago)
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The Parliamentary Under-Secretary of State for Health (Steve Brine)
Let me start by saying that this debate has been carried out with a tone and style that do great credit to this House and to the families who have campaigned so hard for so long. The shadow Minister, the hon. Member for Washington and Sunderland West (Mrs Hodgson), and I are becoming known for the non-partisan way in which we approach some of the issues in our portfolio, and long may that continue.
Let me congratulate my right hon. Friend—I also congratulate him on his elevation last week—the Member for Hemel Hempstead (Sir Mike Penning) on securing a further debate on this important issue. I pay tribute to the Members who continue to campaign tirelessly on behalf of those who were given hormone pregnancy tests. I was struck by what the hon. Member for Liverpool, Riverside (Mrs Ellman) said—she mentioned that this was first raised in the House in 1978, when I was four. I hope that we can achieve closure before it is that long again.
Let me be crystal clear from the very start. The Government’s utmost priority is and always will be—my right hon. Friend the Secretary of State has done more than most—the safety of NHS patients. We have listened to the concerns of patients and their families. We have certainly listened to parliamentarians on the matter of hormone pregnancy tests over many years, and we will continue to do so over the coming weeks and months.
Time and again during today’s debate we have heard that there is a lack of trust and a lack of faith in this process—the hon. Member for Manchester, Withington (Jeff Smith) said this clearly; I thought he made a very good speech—contrary to the words of my hon. Friend the Member for Mid Norfolk (George Freeman) that the shadow Minister quoted. That troubles me, so let me be clear. We have ruled out no options at this time.
The report of the group published on 15 November represents the culmination of a rigorous piece of scientific work by a group of experts all well respected in their field. It is the most exhaustive investigation of the issue undertaken to date. However, it is clear to me that many Members and the families for whom they speak have concerns about this issue. We are committed to listening to them and acting on them. Although we differ on many points, there are surely a couple of things on which we can agree at the outset. The first is that the safety of mothers and their unborn children has to be paramount. The second is that standards in medicine, science and regulation have changed beyond all recognition in the last 50 years.
My hon. Friend the Member for Ayr, Carrick and Cumnock (Bill Grant) and the hon. Member for Liverpool, Riverside said that drugs were handed out from the GP’s desk drawer, and indeed it says that on page xii of the report. The footnote says:
“Today, there are strict requirements for the supply of free samples of medicines to prescribers, as set out in section 6.12 of the MHRA Blue Guide”.
That is why I say that medicine, science and regulation of prescribing have changed hugely in the past 50 years. It is imperative for me that we continue to seek improvement in this area. That is why we have tasked the Medicines and Healthcare Products Regulatory Agency with implementing the recommendations of the expert group. They are quite wide. They are not just nice to haves; they are valuable initiatives that should permanently benefit the millions of women who use medicines in pregnancy.
Several themes came up in the debate. My right hon. Friend the Member for Hemel Hempstead mentioned Mr Dobrik. I apologise if Mr Dobrik feels that his name has been used inappropriately; I think that is the right thing to do. He was invited, as an advocate for families facing these issues, and made a strong contribution throughout. Let me be clear as the Minister. We thank him for his contribution. He is a campaigner who rightly has wide respect across our country and the world, and I know that that will continue to be the case.
My right hon. Friend spoke about the name of the inquiry. I am told that the group was reminded from the start that it had been set up not as a statutory inquiry but as an expert group of the Commission on Human Medicines. It was important to be clear on that at the start because formal inquiries have a very different structure and statutory powers. I do not think that there was an inconsistency there, but we can continue that debate. Almost all those who spoke mentioned the terms of reference—“causal” versus “possible”. The terms of reference set out the scope of the review, and I do not believe that they changed. They were endorsed by the CHM in December 2014 a few weeks after the previous debate, and confirmed by the then Minister, my hon. Friend the Member for Mid Norfolk, in a letter to the all-party group in September 2015. In the same letter, the all-party group was informed:
“it is important to review the scientific evidence to establish whether there is any causal association between use of HPTs and subsequent birth defects in the child.”
It is implicit and integral to any scientific assessment of evidence on medicines and associated harms to see whether the medicine is actually responsible for causing the harm rather than simply being associated with it.
The hon. Member for Manchester, Withington and others mentioned changes to the expert group report. I know that many Members are concerned about differences in the draft and final reports, and especially over the removal of the sentence that said:
“limitations of the methodology of the time and the relative scarcity of the evidence means it is not possible to reach a definitive conclusion.”
That sentence in the draft report was followed immediately by the group’s overall finding
“that the available scientific evidence does not support a causal association between the use of HPTs such as Primodos, during early pregnancy and adverse outcomes.”
The CHM quite rightly considered the two sentences together to be misleading, and advised that the report should be revised to better reflect the scientific—I stress, scientific—conclusion of the group, and that is set out on page 100 of the final report.
The hon. Members for Bolton South East, (Yasmin Qureshi), for Manchester, Withington and for Makerfield (Yvonne Fovargue) and others spoke about historic actions. Ministers have always been clear that issues of historic regulatory process were outside the scope of this review because there first needed to be clarity on whether there might be a link between HPTs and birth defects. That point was made by the much-mentioned former Minister for Life Sciences—my hon. Friend the Member for Mid Norfolk—in his letter to the all-party group in September 2015, when he said:
“the review will include a chronology of events, but the EWG”—
the expert working group—
“will not be asked for its advice on systemic or regulatory failures”.
The hon. Member for Washington and Sunderland West and a number of other Members said that that should have been different. As I said to the hon. Member for Bolton South East, I am listening, but the report that I inherited on my desk this summer had that as its guidance. The group was not set up to look at those historic actions. Whether or not it should have is a matter of debate.
The hon. Member for Bolton South East—while we are talking about her—and the hon. Member for Makerfield mentioned the transparency issue and the “gagging order”. As I said during the urgent question, I can assure the House that, in being asked to sign a confidentiality undertaking, Mrs Lyon, who is here today—and I pay great tribute to her for her work—was not in any way treated differently from other panel members. This is standard procedure so that discussions can be held freely and openly in the group without external interference or a running commentary in, God forbid, the media. Despite being an observer throughout the review, Mrs Lyon was invited to speak after every agenda item and asked to give a presentation to the group on the evidence she had provided for the review.
The hon. Member for Bolton South East mentioned the evidence from Dr Dean and the Royal College of General Practitioners that was ignored. The interactions between Dr Dean and the RCGP are fully described in the annexes to the report, and I will come back to that in just a second before I close.
My hon. Friend the Member for Eastleigh (Mims Davies) and the hon. Members for Livingston (Hannah Bardell) and for Bolton South East mentioned the interactions with the families. I was clear the last time I was at the Dispatch Box on this subject that the families were not treated with the respect and the dignity that I would expect as the Minister from a body that I am responsible for. I have made that very clear to the members of the group, and I have asked them to report back to me as to how they will do things better next time. I look forward to seeing that, and they know that I mean it when I say that.
I mentioned the transparency issue. Minutes of the meetings and declarations of interest were published last week. I can update the House that annexes to the report, all documents from the national archive and studies conducted by Schering have been published today. The remaining documents, including those from the German archive, will be published sooner than originally agreed, once they have been checked for any personal data that needs to be removed due to confidentiality owed.
I am going to close there and give the sponsor of the debate a chance to close. I thank Members for their contributions. Nothing is off the table, and I am listening.
Stroke Services
Steve Brine Excerpts(7 years ago)
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The Parliamentary Under-Secretary of State for Health (Steve Brine)
What a pleasure it is to see you, Madam Deputy Speaker; it has been a while. I knew that my hon. Friend the Member for Southend West (Sir David Amess) would get in a mention of Southend becoming a city. I was only disappointed that it did not happen earlier in his speech, but he managed it in the very last line. I will show great diplomacy and leave that matter to the Ministers responsible. I congratulate him on securing another Adjournment debate—we have done this before—which is on stroke services this time. As ever, he set out his case brilliantly and with such passion. He gives newer parliamentarians a real lesson in how to handle debates in this House.
As my hon. Friend said and as so many of us know, stroke is a devastating disease for patients and their families. He is right that there are currently 1.2 million stroke survivors in the UK, with more than 1,350 in my hon. Friend’s constituency alone. The hon. Member for Strangford (Jim Shannon), who is in his place as always at these debates, is absolutely right that stroke is predominantly a condition that affects older people. But it does affect younger people. I have met people of my age and younger who have been affected by stroke. Obviously, it is clinically debilitating, but it also comes as a great shock to their friends and families, who are taken aback by this happening to young people.
So many NHS staff work in multidisciplinary teams on stroke, and I pay tribute to them. There are nurses, consultants and speech and language therapists—the speechies, one of whom I am married to, so I will get brownie points for this—as well as physios, occupational therapists and specialist nurses, who all do so much when somebody suffers a stroke. The Stroke Association, which has already been mentioned, is an absolutely first-rate charity and a real partner for the Government. I also commend my hon. Friend the Member for Southend West for his strong work in driving improvements to stroke services both nationally and within his constituency. I know that he has taken a long interest in health matters, including stroke, as an MP. I reiterate his comments about the high-quality service provided by Southend stroke unit—more on that in a moment.
My hon. Friend will no doubt agree—he said this of course—that, in general, stroke services across the country are performing really well. Let me just reiterate some of the figures. Thirty-day mortality has dropped from 30% in 1998 to just over 13% in 2015-16—a huge improvement. The percentage of patients scanned within one hour of arriving at hospital, which is so critical, has increased from 42% in 2013-14 to over 51% in just three years, and the percentage scanned within 12 hours has increased from 85% to 94% in the same period.
There are many public health campaigns that we remember throughout the years, but the Act FAST campaign that public health campaigners and the Stroke Association have done is something we see and do not forget, and that, of course, was the intention.
Excellent progress has been made in the treatment of stroke over recent years. It is important that this programme continues and that the gains are built on, especially given the demographic changes we know are coming down the track with our much talked off and much publicised obesity challenge and our ageing population. That is why we published the cardiovascular disease outcomes strategy in 2013.
There is ongoing work in virtually all parts of the country to organise acute stroke care to ensure that all stroke patients have access to high-quality specialist care, regardless of where they live or what time of day or week they have their event. Although the national stroke strategy comes to an end shortly, as my hon. Friend said, NHS England continues to lead an effective programme of work on prevention and treatment. We are continuing to work closely together to improve acute treatment through the centralisation of care in centres that can provide the highest level of care and treatment at all times of the day and night.
Decisions on whether the strategy should be renewed are, of course, a matter for NHS England, but in liaison with Ministers. My understanding is that NHS England does not have current plans to renew it in the same form, but it is a subject that I, as the relatively new Minister, encouraged, of course, by my hon. Friend’s debate, plan to discuss with NHS England early in the new year. I would welcome my hon. Friend’s involvement —and that of other Members—if he wishes to feed into that.
Jim Shannon
I thank the Minister for his comprehensive response. One thing that is sometimes overlooked is research and development—the work that is done by universities in conjunction with health groups to try to find better ways of caring for people with strokes. Does he have any information on how critical that is to the whole care package that is given to those who have had strokes?
Steve Brine
I echo the hon. Gentleman’s sentiment that that work is critical. I mentioned the Act FAST campaign, which was a heavily evidenced public health campaign showing that the quicker we act after the event, the better the outcome, so he is absolutely right to highlight that issue. However, I am conscious of time, so I am going to press on.
My hon. Friend rightly spoke about mechanical thrombectomy, which he called a game-changer, and he is absolutely right. To continue and build on our stroke service success and to address the costs associated with stroke in England, which was one of my hon. Friend’s first asks, it is imperative that we keep identifying and developing innovative treatments and cutting-edge procedures.
In mechanical thrombectomy, or MT as we shall know it, we have an innovation that we believe can significantly improve patient outcomes, and my hon. Friend spoke about that. In April this year, NHS England announced that it will commission mechanical thrombectomy so that it can become more widely available for patients who have certain types of acute ischaemic stroke, which is a severe form of the condition. My understanding is that work by NHS England is now under way to assess the readiness of 24 neuroscience centres across the country. It is expected that the treatment will start to be phased in later this year and early next year, with an estimated 1,000 patients set to benefit across the first year of introduction. Overall, this will benefit an estimated 8,000 stroke patients a year and save millions of pounds in long-term health and social care costs—my hon. Friend was absolutely right to point out the rising costs to NHS England around this condition.
As the clinical director for stroke at NHS England has said, we are committed to fast-tracking new and effective treatments that will deliver long-term benefits for patients. For me, this treatment is just one example of many that we believe have the potential to tangibly improve patient care and to address rising costs.
Steve Brine
I am going to press on, because we have to finish at a certain time, but I thank my hon. Friend for her contribution earlier.
Stroke services are an important part of the range of vital services delivered in the part of Essex represented by my hon. Friend the Member for Southend West. It is important that his constituents have the right access to the right care at the right time, which in this case means specialist acute and hyper-acute stroke units. As he knows, and as we have discussed in Adjournment debates previously, there is a lively debate in his local area about the best way to configure services in order to meet these needs. As ever, he makes a powerful case for Southend, which he says has shown itself to be both safe and effective, and I have no reason to doubt his word.
My hon. Friend’s second big question was about what we are doing to transform services. Sustainability and transformation partnerships are absolutely key in this regard. STPs cannot but help in improving stroke services; they have a huge part to play. STPs should bring the local population, NHS organisations and local authority bodies together to propose how they, at a locally designed level, can improve the way that their local health and care is planned and delivered. These local areas have been encouraged to take a collective view of the local health system so that they can explore how best services within the local area, including stroke services, can be streamlined and centred around the patient, and determine what configurations are necessary within each local area to deliver the best possible care. My hon. Friend’s description of turf wars does not surprise me, although it does disappoint me. If he wishes to raise anything specific with me, I ask him to write to me about it. As the Minister responsible for STPs, I do not want to see this happening, and if I can help with it, I will certainly do so.
Much guidance has been issued to the system from us at the centre to help support STPs in making these crucial local reconfiguration decisions. My hon. Friend’s associated STP, Mid and South Essex, is making good progress and has recently been rated through our STP dashboard as being in the top half, so it is a top-half-of-the-table team among STPs. Mid and South Essex’s stroke services compare very well with the best, in many ways, but, as he says, we could be doing much better. One area that it has identified for improvement is that none of the three existing hospitals currently has the right number of specialists to provide the level of specialist stroke unit care that is being proposed. That goes to the heart of some of the examples that he gave from the consultant he has been speaking to.
I welcome the fact that organisations within my hon. Friend’s area, and other STP areas across England, are working in partnership to develop proposals that can really benefit those who matter most—the patients. There are proposals currently out for consultation in his area, which obviously my hon. Friend the Member for Rochford and Southend East (James Duddridge) takes a very close interest in as well. I look forward to seeing the results of that consultation in due course. Knowing my hon. Friends, I feel almost certain that we will be back here discussing that at some point.
I mentioned the tangible progress that has been made in improving both the quality and delivery of stroke services, with evidence-based public health campaigns and really strong, well-organised local services, but there is so much more to do. Patient mortality has indeed fallen, compliance with the standards has risen, and patient experience and satisfaction continues to improve. This is a pathway on which I expect us to continue. New services that my hon. Friend is absolutely right to raise, such as mechanical thrombectomy, can really help us in achieving this. He said what a fascinating piece of medical technology that is. Putting the mesh into the groin for it then to travel through to have such an impact is truly incredible. We are very clever, in many ways.
How this is being delivered is changing, and that is important. The STPs are providing a new way of working. They can be controversial because they involve difficult decisions around reconfiguration, but they should involve local organisations, local services, local people, and local MPs. Local MPs who are not involved in their STPs should ask themselves why not. STPs, and the whole reconfiguration process, are a huge opportunity for us. Locally led commissioning enables local need to be taken into account in decision making about the shape of all services. It can result in very strong local services that can meet these needs, and nowhere is that more important than in stroke care. It is a system that drives improvement in all patient care, and that is what we are about. I thank my hon. Friend for bringing this debate to the House, and other hon. Members who have contributed.
Question put and agreed to.
Draft Pharmacy (Preparation and Dispensing Errors - Registered Pharmacies) Order 2018
Steve Brine Excerpts(7 years ago)
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The Parliamentary Under-Secretary of State for Health (Steve Brine)
I beg to move,
That the Committee has considered the draft Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018.
I do not believe we have danced before, Mr Brady, so it is very much a pleasure to serve under your chairmanship. The order was laid before Parliament on 13 November and extends to the whole of the United Kingdom. Its purpose is to create, for registered pharmacy professionals working in a registered pharmacy, new defences to the criminal offences set out in sections 63 and 64 of the Medicines Act 1968. The order makes those defences available in defined circumstances to pharmacy professionals making genuine dispensing errors. This marks an important step forward in addressing barriers to providing a safer, higher-quality service. Let me make it clear that the order does not cover pharmacy professionals working in non-registered hospital pharmacies. That will be addressed in a separate order that we intend to consult on early next year.
The Mid Staffordshire inquiry highlighted the importance of putting patient safety at the heart of everything we do and achieving a careful balance between assuring accountability to the patient and developing a culture of openness and transparency, so that we learn from errors and improve practice and safety. Indeed, Professor Don Berwick stated:
“The most important single change in the NHS in response to this report would be for it to become, more than ever before, a system devoted to continual learning and improvement of patient care.”
The order very much follows that philosophy.
Pharmacy professionals are highly regulated individuals —in relation to dispensing errors, more so than any other healthcare professionals. Indeed, they are subject to triple jeopardy in the event that they commit a dispensing error. They face prosecution for strict liability offences under sections 63 and 64 of the Medicines Act 1968, prosecution for offences under general criminal law and sanctions under professional regulation requirements. That can lead, we believe, to defensive practices. It has been demonstrated in other industries where safety is critical that working under such threat of sanction is a hindrance to the reporting of errors and accidents and therefore to wider learning.
Evidence suggests that patient safety and service quality can be improved through increasing the rate of reporting and learning from dispensing errors. That will have benefits to patients locally and throughout the NHS. By removing the fear factor of a strict liability offence for inadvertent dispensing errors, our aim is to create a much more open and transparent culture, which in turn should help to improve learning and prevent mistakes from happening in the first place. We will be working closely with pharmacy regulatory and professional bodies across the UK to make that a reality.
Let me be clear that registered pharmacies already have a range of systems and procedures in place to prevent dispensing errors from occurring. More than 1 billion prescription items are dispensed every year, and it is a testament to the professionalism of pharmacy staff that errors occur in only a very small proportion of cases. Dispensing errors can, however, occur within a registered pharmacy for a variety of reasons. For example, there are many thousands of medicines, and some have very similar names and brandings. Medications may also have complicated dosing schedules.
The order is not about accepting the inevitability of error in the system. It seeks to ensure that we collect information on errors that do occur and think hard about how they can be prevented in the future, including through spotting trends at a national level. That may involve improving systems and procedures and designing out errors as far as is practicable, but without knowledge of what has gone wrong that is just not possible.
We are not removing all safeguards for patients. There will remain offences under general criminal law—for example, in cases of gross negligence and manslaughter—and sanctions under professional regulation, as I have said. In such circumstances, the professional regulators, the General Pharmaceutical Council and the Pharmaceutical Society of Northern Ireland, can still subject individuals to regulatory fitness-to-practise procedures. Sanctions would depend on the circumstances of the error but could ultimately include the individual being removed from the professional register and no longer being permitted to practise.
The order is well supported: it was overwhelmingly endorsed during the public consultation, including by patients, the public and groups such as Action against Medical Accidents, who will now want to see pharmacy professionals play their part and demonstrate increased learning from, and reporting of, errors. The order has also been some five years in gestation, so I am pleased to attempt to land it today through the Committee. I am fully committed to ensuring that that happens, and we have already taken action in that regard.
In each of the four home nations, a number of initiatives to support reporting and learning have been introduced, such as medication safety officers or champions, and national reporting systems. Regulatory and professional bodies in pharmacy have also put in place standards and guidance to support the desired culture change, with community pharmacy trade bodies encouraging their members to follow those standards and encouraging pharmacy teams to report, learn, act, share and review.
Action is also being taken in each of the home nations on medication error more generally throughout their healthcare systems. It is a sobering fact that 5% to 8% of all hospital admissions are medication-related. In September, the Secretary of State for Health and the chief pharmaceutical officer for England launched an initiative that focuses on reducing prescribing and medication errors throughout the national health service in England. The programme will look at a number of areas, including how we use technology, understanding how best to engage patients in their medicines and advancing the transfer of information between care settings.
As I mentioned at the start, while the order provides a defence for pharmacy professionals working in registered pharmacies, it is important to recognise that pharmacy services can occur outside of those settings, and therefore that not all pharmacy professionals will be able to avail themselves of the defences set out in the order. That is deliberate. Work is progressing to develop similar measures for pharmacy professionals working in hospitals and other care settings. That will ensure that, regardless of their position in the healthcare system, pharmacy professionals will be encouraged to report and learn from errors.
In summary, the order supports improved patient safety by encouraging a culture of candid and full contributions from those involved when things go wrong. Within that culture, pharmacy professionals—I have to say, they are some of the most motivated and professional people I have met in our national health service during my time as an MP and a Minister—can increase their learning from dispensing errors and identify mitigating actions to make reoccurrence much less likely. I commend the order to the Committee.
Steve Brine
I thank my shadow, the hon. Member for Burnley, and the hon. Members for Central Ayrshire and for Newport West for their contributions and their support for this measure.
I am well aware that the hon. Member for Burnley has in-depth understanding and knowledge of this issue from her previous life supporting her partner, a community pharmacist. She is absolutely right to highlight the wide portfolio that community pharmacists hold. I sometimes think it is even wider than mine, and I have said in the House, and will say again now, that community pharmacists are absolutely central to me and to the primary care objectives that I hold in this job for primary care and for the public health and prevention agenda. Primary care and public health are pulled together under my portfolio for a reason, and community pharmacists sit together as a hub in the middle of those two bits of my work.
The hon. Lady is absolutely right to say that the order will be welcomed—I think alongside the hashtag #abouttime. For many people in the community pharmacy sector, the changes are long overdue. I spoke to the Royal Pharmaceutical Society’s conference in the summer—I suspect she was there—and I said that this was long overdue and that I would sort it. I have tried to remain true to my word, and I have.
I think the defences in the order strike the right balance, which the hon. Lady outlined coherently, while not leaving the door wide open. We still have to make sure that patient safety is protected—the current Secretary of State above all would say that—but I do believe that it strikes the right balance. I note her request for early work in respect of hospital pharmacists, and I am very amenable to that. I do not want that to drag on for many years; I want it sorted quickly, and officials know that.
On read and write access to patient records, many pharmacists already have read access and some already have write access. I am interested in making the change, and I am exploring more with officials how to make it happen; it is of some frustration to me that it seems to be an IT issue as much as anything else. If pharmacists are to be integrated within our primary care system as much as I want them to be, I suggest that that is very important.
Julie Cooper
This all centres on acknowledging that pharmacists are the experts when it comes to medication. I think that most GPs who work alongside pharmacists day in, day out will hold their hands up and say that. GPs used to be regularly on the phones to us saying, “Can I just ask you about this? I am thinking of prescribing this, but I am not sure. Is this best, or would it be better with something else?” That is good teamwork between people who are specialists in their areas.
In the light of that, it is quite ridiculous that pharmacies cannot record their advice and intervention on a patient record for other health professionals to see. It would be entirely in the patient interest, and in the interests of making sure that patients do not fall through the gaps between the different health professionals.
I will make one further point about recognising that expertise, if you will allow me to, Mr Brady. Pharmacists could be used to do more, as I have said many times in the House. When he talked about protections, my hon. Friend the Member for Newport West reminded me of the work that is happening on antibiotics and a recent Westminster Hall debate on their overuse and the development of antimicrobial resistance. Pharmacists could lead on that in the interests of wider patient wellbeing and safety.
Steve Brine
The hon. Lady is absolutely right. Pharmacists have been absolutely brilliant, focused and motivated supporters of the “Keep Antibiotics Working” campaign. I responded to that Westminster Hall debate on antibiotics, as she knows.
On the hon. Lady’s wider point, I believe, and I believe the evidence backs me up, that in the best health economies, the three planks—secondary care, primary care and pre-primary care, which is where we could see a community pharmacy as being—work hand in hand. The sustainability and transformation partnerships are supposed to be a one-NHS solution for different areas and different health economies to help the population achieve good health when they become unwell, but also to practise good preventive health. I absolutely agree with her that pharmacists know their patients and customers, and that they spot things because they see those patients much more regularly than GPs do. That is why they are absolutely central.
On the point about the obligation to report, which was mentioned by the hon. Members for Central Ayrshire and for Burnley, I said in my opening speech that the Government are already working with the regulators and professional bodies to ensure that pharmacy professionals are supported in the implementation of the order. An absolutely critical part of that is making sure that they report errors, because if they do not, this will all be somewhat wasted. There are a huge number of examples that I could give; maybe I can write to the hon. Member for Burnley with the details. The national reporting and learning systems were established in England to collect data and report on safety incidents. The health service safety investigations Bill, which is in draft and undergoing pre-legislative scrutiny at the moment, also adds power to this argument.
I think that, with this order, we have something of a rare gem in Committee Room 9: it is something that we all agree is needed. We are delivering it as a Government, as I promised we would. It will add further impetus to the work already under way to reduce medical errors across the health service and will provide much-needed assurance to pharmacy professionals that they can do their job with confidence. I know they have that confidence, but there has been this little niggling thing undermining them. I hope the order addresses that.
As the Whip next to me coughs—I am sure that was purely accidental, as opposed to a hint—I will finish by saying that, should both Houses approve the order, commencement orders will be drafted to enact the changes in England, Scotland, Wales and Northern Ireland. I thank hon. Members for their attentiveness, their interest and their contributions, and I commend the draft order to the Committee.
Question put and agreed to.
Deafness and Hearing Loss
Steve Brine Excerpts(7 years ago)
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The Parliamentary Under-Secretary of State for Health (Steve Brine)
I thank all hon. Members very much for their contributions. There are many ways I could spend a Thursday afternoon, but I have really enjoyed this debate and I have learned a lot. This has been a consensual debate, and I thank the shadow Minister, the hon. Member for Burnley (Julie Cooper), for the excellent tone of her comments. I really enjoyed what she had to say as well.
Like everyone else, I congratulate the hon. Member for Poplar and Limehouse (Jim Fitzpatrick) on securing the debate through the Backbench Business Committee, and also our signers. Thank you for doing what is a first and for working so hard. I cannot sign, but I can imagine that it is quite hard work to do it for three hours. There are two signers and they have worked really hard. Thank you for that.
I do not have a hearing problem, but I do have a sight problem, which is why I have a lectern in front of me. The papers are far too far away from me without it, which is why I always put it into play.
I thank the all-party parliamentary group on deafness, a number of whose members have spoken today, for all the work that it does in the House in raising awareness and improving the way we provide support. I cannot remember in my time in the House a debate on this subject, so it was certainly long overdue. All-party groups can do this; the Backbench Business Committee is excellent.
As we have heard, hearing loss is widespread, affecting one in six of the UK population, and it has a massive impact on the lives of our constituents and, indeed, some Members of the House. We have heard today really incredible contributions and—I agree with the hon. Member for Burnley—really moving contributions, especially from the hon. Member for West Lancashire (Rosie Cooper). There was not a dry eye in the House when she was speaking—thank you for the way you put things. I was going to intervene to give her a chance to have a drink, but she was brilliant in the way she put things. I thank her for that.
I shall highlight the key steps that the Government are taking to support those with hearing loss and deafness and then move on to the other important points raised by hon. Members during the debate. I apologise in advance in case I do not cover them all; I will write to hon. Members about any points that are not covered.
As we heard from the hon. Member for Poplar and Limehouse, in March 2015 the Department of Health and NHS England published “Action Plan on Hearing Loss”. That is a statement of intent for action across the health and care sector. There is an ongoing programme of work that the action plan has initiated. There are 20 separate outcome measures, which the hon. Gentleman touched on.
In September 2017—working with the Department for Work and Pensions, the Department for Education and hearing loss charities—NHS England issued a series of “What Works” guides, providing examples of what we know works in supporting individuals with hearing loss throughout their lives. Those guides, aimed at organisations, providers and commissioners, cover hearing loss and employment, the transition to adulthood for young people with hearing loss, and hearing loss and healthy ageing.
A key point in the plan is the need for clear guidance for commissioners, and in July 2016 NHS England published “Commissioning Services for People with Hearing Loss: A framework for clinical commissioning groups”—snappy titles we do not do in the NHS, as I have learned since arriving there as a Minister. As the Minister responsible for public health, I am very pleased that that framework recognises hearing loss as a “major public health challenge”, because that is exactly what it is. The framework is a major step forward in focusing local commissioners on tackling uncorrected hearing loss and on addressing the variation in access to and the quality of services across the country.
The framework has been developed with a range of stakeholders, including voluntary sector groups and professional representative groups, such as Action on Hearing Loss, which has been mentioned today, and the British Tinnitus Association—ditto—which are members of the Hearing Loss and Deafness Alliance. The guidance is crucial in ensuring consistency across CCG commissioning in England and supporting commissioners as they make decisions on what is effective and good value for their local populations. In turn, it will help to reduce inequalities in access to and outcomes from hearing services. I recognise the need for us to maintain momentum and to ensure that the action plan secures positive outcomes for those with hearing loss and deafness.
Let me turn to the points—all of them, I hope—that have been raised. In response to the speech by my right hon. Friend the Member for Hemel Hempstead (Sir Mike Penning), who I know had to run away—he is my former boss—I say this: not only am I not the Minister for Education, DWP, DCMS or others; I am not even the Minister within the Department of Health covering this area, but never let that stop a happy Minister.
I really enjoyed listening to the debate. The smartest way to respond will be to take the points that have been raised the most. The hon. Member for Poplar and Limehouse, in opening the debate; the hon. Member for Bristol East (Kerry McCarthy), who mentioned her constituent; my right hon. Friend the Member for Hemel Hempstead and pretty much all other speakers mentioned the Access to Work scheme. I recognise hon. Members’ concerns about the impact of changes to Access to Work. I understand that the hon. Member for Poplar and Limehouse will meet with the Minister for Disabled People, Health and Work early in the new year to discuss in more detail Access to Work and concerns he has about it.
Members will realise that I am not that Minister, who is my hon. Friend the Member for Truro and Falmouth (Sarah Newton), but I spoke to her at lunch time ahead of this debate and I was on the Front Bench with her this afternoon for the statement on the new Command Paper. We will speak after this debate to ensure that she is fully up to date with everything raised that comes within her portfolio.
I think it is worth putting it on record that resources for Access to Work were increased in real terms in the 2015 spending review. I appreciate that hon. Members have all spoken positively about Access to Work as a scheme, but resources within a publicly-funded health service are still finite and they need to be allocated to the growing numbers coming to the scheme—8% more people had Access to Work provision approved last year than the previous year, including 13% more deaf people. Last year, we spent £104 million on Access to Work grants, an increase from £97 million the year before. As has been said by a number of hon. Members, Access to Work is a demand-led scheme and therefore the number and level of awards will reflect that. We intend for it to continue to meet demand, and with that the numbers continue to go up.
I do not accept that the maximum level of support is too low. The help an individual may receive from Access to Work depends on their individual needs and their personal circumstances—up to the current maximum of £42,100 per year rising to £43,100 from April 2018. That is 1.5 times the average salary, which is far more than most of my constituents, and those of every hon. Member here, earn.
Transitional arrangements are in place for existing recipients and those who made a claim before October 2015. The changes do not apply until April 2018, provided that needs remain the same. People will receive annual reviews of their progress and support in the transition to the award level. The Government continually monitor the application of the cap and consider whether any further flexibilities might be required. That is another point I discussed with my hon. Friend before the debate; she is acutely aware of the situation.
It is not often that a Minister is able to stand up in a Westminster Hall debate on the day that something new has been announced and touch on something new. This Command Paper “Improving Lives: The Future of Work, Health and Disability” sets out our response to last year’s Green Paper consultation. In this document—a weighty tome that hon. Members and I will want to study—we set out how those users with the greatest needs, such as some British Sign Language users, will be offered new managed personal budgets, as well as workplace assessments involving their employers, to help to meet their needs within their award level. Deaf customers will also be supported by a dedicated team of special advisers.
The hon. Member for Eastbourne (Stephen Lloyd) had to get away, but he has returned. He is indeed a friend from the grand old days of the coalition, as he put it. I have noted his incredibly well-made point about SMEs. My right hon. Friend the Member for Hemel Hempstead made the point that those employing disabled people get a lower churn and a number of hon. Members reflected that message in their comments. I think it is absolutely right. A company based in my constituency called Microlink PC was mentioned in the Chamber during the statement. It works with large and small organisations—big banks in the City and small SMEs across the country—and the focus of its business is to use technology to help disabled people into work. That absolutely includes people with deafness and hearing loss. Many people across the charities sector also work to help that to happen.
I saw the hon. Member for Poplar and Limehouse during the statement earlier, standing on the back row, and I knew exactly what he was going to say, and he did not disappoint when he raised the issue of the cap. All I can say is that I wrote on my notes the comments of the Secretary of State—which I know the hon. Gentleman will have noted, too—and that I know the hon. Gentleman will bring the matter up with my hon. Friend the Minister for Disabled People, Health and Work when he meets her. The Secretary of State said he would continue to review, continue to look at the evidence. I encourage the hon. Gentleman to press on that and to continue to look at the evidence, because he has that there in black and white from the Secretary of State.
The hon. Gentleman also mentioned—as did the hon. Member for Eastbourne and the hon. Member for Blaydon (Liz Twist), who has also gone, and many other hon. Members—the legal recognition of British Sign Language and the case for a BSL GCSE. It is not entirely clear to me which Department would lead on legal recognition of British Sign Language, which is the problem that so many people have referred to today. I am sympathetic to the calls for strengthening the role of British Sign Language. We want to see as many people trained and providing support as possible. At this time, Her Majesty’s Government are not yet convinced that the way to achieve that is through legislation. The Department for Work and Pensions undertook an extensive market review, of which the final report was published in July, which demonstrated that communication requirements should be addressed on an individual basis and that there is no universal approach to addressing these needs.
We have protections of the legal rights of people who are deaf in the Equality Act 2010 and in the duties of the NHS—the mandate that I am responsible for giving to NHS England and publicly funded social care organisations—to conform to what we call the accessible information standard. I am happy to take that point away. It came across clearly from many hon. Members in this debate. All I will say is that the private Members’ ballot is a wonderful thing.
On the subject of the GCSE, any change to the school curriculum, particularly the establishment of new GCSEs, is a matter for the Department for Education and something that the all-party group will have to take up with it. I know from talking to the Department before the debate—I suspected that this would come up—that there are no plans at this time to introduce further GCSEs beyond those to which the Government have already committed, but something tells me that the hon. Member for Poplar and Limehouse, my right hon. Friend the Member for Hemel Hempstead, the hon. Member for Eastbourne and other hon. Members who have spoken today will, with their usual determination, follow this through with Ministers at the Department for Education, who will no doubt note their comments today.
The hon. Member for Poplar and Limehouse and the right hon. Member for Wolverhampton South East (Mr McFadden) talked about the assessment criteria for cochlear implants. Those were debated in March when the hon. Member for Poplar and Limehouse had an Adjournment debate in which he highlighted the report of the Ear Foundation and he called for NICE to review its cochlear implants technology appraisal. As the hon. Gentleman will know, NICE is an independent and expert body that advises us at the Department, and it has discretion to review its guidance in the light of any new evidence.
NICE is working on a list review for this particular technology appraisal and will consult with stakeholders in 2018, so I will make sure that he and all other hon. Members who have raised this matter get early sight of that and do not have to go looking for it or hear about it in the media. I am absolutely sure that this will include consideration of thresholds and criteria for getting cochlear implants. I understand that NICE is planning this consultation because of its recognition of how important this is, going beyond the usual review process. Although that does not give the hon. Gentleman the clarity he wants, I hope it is helpful to him in some way.
The hon. Gentleman and my hon. Friend the Member for Milton Keynes South (Iain Stewart)—who spoke excellently about this—talked about the provision of functionally equivalent telecoms services and video-text relay services. Obviously telecommunications does not sit within the Department of Health—no matter how big our remit, I do not think we have that one—but it is very good to hear that companies such as 3 and deafPLUS are at the forefront of delivering equivalent services for their hard-of-hearing customers. I wish deafPLUS all the best in the Helpline awards, which it has been nominated for. I understand that the Department for Digital, Culture, Media and Sport has previously considered the issue of provision of telecoms services, despite it being a commercial decision for the public-facing companies. This has included the Department engaging with companies and industry, and Ministers writing to the FTSE 100 companies seeking views. I hear that the feedback from that included the view that there were better means of meeting the needs of consumers with less reliance on video relay services. I am happy to raise the issues highlighted by Members with DCMS colleagues and see what further engagement there can be, and will of course recommend that they look at the Australia example that my hon. Friend the Member for Milton Keynes South spoke about in such glowing terms.
The Member leading the debate, the hon. Member for Poplar and Limehouse, raised the Deaflympics. I understand that the Under-Secretary of State for Digital, Culture, Media and Sport, my hon. Friend the Member for Chatham and Aylesford (Tracey Crouch), has instructed officials in her Department to look into how we can ensure greater recognition for the Deaflympics in this country, and she will consider their advice in due course. She is a very accessible Minister, and I know the hon. Gentleman knows her and will no doubt take that matter up with her as well.
A number of people, including the hon. Gentleman, my hon. Friend the Member for Waveney (Peter Aldous) and the hon. Member for Bristol East talked about improving paediatric audiology services through the Improving Quality in Physiological Services—IQIPS—scheme. Concerns have indeed been raised in relation to accreditation of paediatric audiology services. The independent process of accreditation—the IQIPS services —is there to ensure all providers meet a common standard. We want all providers to have completed accreditation as quickly as possible. The commissioning framework encourages clinical commissioning groups to require providers to have completed the IQIPS self-assessment tool, and to have applied for and achieved accreditation, within the duration of their contract. Commissioners must be the ones who drive this forward. For us, the accreditation process is an effective means of testing against the standard. If during an assessment mandatory findings are raised that show nonconformity with any part of the standard, the service agrees appropriate improvement actions with the United Kingdom Accreditation Service team to rectify that and prevent it reoccurring.
The hon. Member for Poplar and Limehouse and many others raised the issue, which I even question myself on, of which Government Department leads on British Sign Language. I completely appreciate the frustration. There can only ever be one Minister at the Box, but what we really need is a triumvirate of me merged into my hon. Friends the Members for Truro and Falmouth, and for Chatham and Aylesford—that would be an interesting sight! I totally appreciate the frustration with the fact that no single Department leads on British Sign Language. I suppose, although this will probably just make it worse, it would depend on the context; if it is in education, that would be for the Department for Education; if it was how BSL is used in health settings in line with the accessibility standard that I mentioned, that would be for my colleagues in the Department of Health. I get the hon. Gentleman’s point, and will take it away.
The hon. Member for Eastbourne, whom I know well and is welcome back to the House, talked about screening for hearing loss in adults. He made the point very well that we do not focus just on people with complete hearing loss. He said to me the other day that he feared the debate would be about the deaf-deaf, as he put it, and he wants to ensure that people with partial hearing loss get the support they need. He made the point very well that people begin to lose their hearing later in life, as age catches up with us all, but accept it as part of the natural ageing process. They are often reluctant to admit they have a hearing problem, do not seek support as promptly as they might with other conditions and, as we have heard and as he said, often wait years before going for a hearing test. We heard his call for the introduction of a hearing loss screening programme for people at the age of 66, once they reach retirement, and as part of the NHS health check for people aged 40 to 70. I am responsible for the health check programme.
The advice from the UK National Screening Committee, the expert group that advises Ministers on all aspects of screening, is that the evidence does not demonstrate that universal screening would provide any hearing-related improvement in quality of life in comparison to hearing loss identified through other channels. However, the hon. Gentleman makes a persuasive argument that we can do more to identify hearing loss as people reach older age. He said that the general election had intervened, but as he also said, he is back, and I do not doubt that I will be hearing from him again on this subject, probably at Health questions in a couple of weeks’ time. I will be more than happy to do so, to be honest. He also mentioned that CCGs commission the audiology services. NHS England’s commissioning framework captures the importance of audiology, and monthly waiting time data for audiology is collected and can and should be used by Members and the public to hold commissioners to account.
I touched on my hon. Friend the Member for Waveney, who spoke about support for children with hearing loss, and about his constituent’s son, Daniel. I was the vice-chair of the all-party parliamentary group on autism for many years when I was on the Back Benches, and we often used to hear about the so-called middle-class parents with sharp elbows who managed to get their children what they needed. That is, of course, human nature; but it should not be the sharp elbows of the middle classes or of anybody else that gets children what they need—that is what the state is for, in my opinion.
Children with a special educational need as a result of their deafness will benefit from the more integrated approach to meeting their needs. Since 2014, a new framework has required CCGs and local authorities to make joint arrangements for assessing the range of eligible children’s needs, and the development of what my hon. Friend rightly referred to as the education, health and care plans to provide necessary support. Every Member in this debate and in this House has casework on EHCPs. These arrangements are transforming the support available to children and young people by joining up services for zero to 25-year-olds—that is their scope—across education, health and social care and by focusing on positive outcomes. He is right to take up the casework, as I would myself. I think the performance of local authorities is vastly different across the country. I know from speaking to him outside this debate that he is working very closely with his local authority, as I would expect, and that he has been impressed by the improvements it has made. I do not doubt that that is because of the pressure that he has put on it.
In my hon. Friend’s speech he used the term, which I wrote down, “The right support right from the start”. I do not think that was an accident, because as a Member of Parliament I had an invitation today, as we all did, from the National Deaf Children’s Society, which he referred to, requesting the pleasure of my company at an event called: “Technology and deaf children: Getting the right support, right from the start”. Mr Speaker has very kindly allowed that to be in the state rooms in Speaker’s House at lunchtime on 10 January. I think that will be an excellent event, and I hope it is well attended; I suspect it will be by all Members in this room.
My hon. Friend touched on special educational needs funding as well. The implementation of the new SEN system has been supported by significant new investment. That includes £70 million in ’14-15, £113 million in ’14 through to ’17 in the implementation funding, and £45 million in the same period for independent supporters for families. Ofsted and the Care Quality Commission are reviewing how all local authorities—authorities know about this—and their CCG partners work together to meet the needs of children with SEN as the EHCPs come into force. The assessment criteria are there, and are very much on their shoulders.
My hon. Friend the Member for Rochester and Strood (Kelly Tolhurst) gave a brilliant and very personal speech, if I may say so. It is never easy to do that in this place. It gets lots of retweets, but that is the easy bit; it is really hard to do it. She mentioned her mum’s story, and I thought she spoke brilliantly. She used the term invisible disability, which the hon. Member for Burnley also used. My hon. Friend said that deafness could take many different forms and have impacts physical and mental. I thought she made the case really coherently.
To touch again on my right hon. Friend the Member for Hemel Hempstead, my former boss, for the record, I do not mind at all when former Ministers come to debates that I am responding to, especially when they are former Ministers for a Department that I am not responsible for. I thought he made the point very well about the scale of the issue and the hidden deafness in this country, and he gave his example of industrial causes of deafness.
The hon. Member for Edinburgh East (Tommy Sheppard) told us about the BSL Act in Scotland and the ensuing national action plan, which he directed colleagues to look at. I will direct colleagues in the UK Government to look at that. Hats off to him for his attempt at signing the start of his speech. I thought that was a very brave move, and I thank him for his remarks.
The hon. Member for Erith and Thamesmead (Teresa Pearce) spoke very well about loneliness. I wonder whether the loneliness commission that our former colleague Jo Cox set up touched on the issue of deafness and its impact on loneliness; I would be interested to learn from those involved whether it did. The hon. Lady spoke about Jacob and the crowdfunding in her constituency for his cochlear implant. I do not know the details of his case, so it would be unfair for me to comment, but it sounds as though her community is showing incredible grace to that little boy. It would be wonderful to see him in the House when he has had his implant. She also raised the issue of the Access to Work cap again. My Department for Work and Pensions colleagues and I will write to her about her specific questions on numbers.
The hon. Member for West Lancashire spoke about her kidnap by the deaf community. Again, hers was a very emotional speech. I so wish she had done what she threatened to do and signed her entire speech, as long as she had given me a copy of it beforehand. I like to think I can cope, but I would not have coped with all of that. I thank her for her well made comments, especially about a single gateway. She is a member of the Health Committee, and I suspect that she is also a member of the all-party group, so perhaps she will make that suggestion to the new Minister for Disabled People, Health and Work and will talk about the cap on Access to Work when the group meets her. The hon. Lady also referred to invisible disability.
The hon. Member for Linlithgow and East Falkirk (Martyn Day) made points about the gender gap and EU law post-Brexit. They definitely do not fall within my remit, but I will write to him. We have the European Union (Withdrawal) Bill, or the repeal Bill as it is colloquially known, and in the past week or so, we have had a taste of the issues relating to animal rights. I have to say, as a Government MP and a Government Minister, I take slight umbrage with the suggestion—although not by the hon. Gentleman—that somehow we need the EU to have good rights relating to looking after animals in our country, let alone our citizens. I do not buy that for a minute. We will import that regulation through the Bill and then look at it as a sovereign Parliament and decide how we can improve on it. I am sure there are ways to do that. From what Members have said on the subject in this debate, and given the other Members who are interested, I somehow do not think that the issue will go unheard.
I will leave a few minutes for the hon. Member for Poplar and Limehouse to sum up. In conclusion, we have had a very interesting, honest debate. I hope I have been able to demonstrate to hon. Members that across my now expanding portfolio, we have a strong frame- work for supporting people with hearing loss through a set of quality and commissioning criteria—within a restricted budget, of course; that will always be the case. Setting the expectations for commissioners and providers is what we in the Department of Health are most interested in. The dedicated action plan on hearing loss is being spearheaded by NHS England, for which I am responsible, and the multi-agency approach is enshrined in the action plan.
We are doing a lot, but we can always do more. Some really good points have been made in today’s debate. Whether more people are watching today’s debate than “Pointless”, I do not know, but if more people watched debates such as this, they would have a far better opinion of Parliament than some of them do. We have had a really good debate and have covered a huge amount of ground. I very much thank hon. Members for their contributions, which have all been from the heart and incredibly well informed. I look forward to following up on many of the issues that have been raised.
Medicines Regulation
Steve Brine Excerpts(7 years, 1 month ago)
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John Woodcock (Barrow and Furness) (Lab/Co-op)
It is a pleasure to serve under your chairmanship, Mr Davies. It is unfortunate that I am following two superb contributions. I congratulate my hon. Friend the Member for Bishop Auckland (Helen Goodman) on securing this important and timely debate. She and my hon. Friend the Member for Lewisham East (Heidi Alexander) spoke powerfully and persuasively about the risks that the UK pharmaceutical industry in its entirety faces. I am not going to attempt to add to what they said and the questions they asked. Rather, I am going to focus on the cephalosporins business, which is carried out on three sites, two of which are in the UK—in the constituency of my hon. Friend the Member for Bishop Auckland and in Ulverston in my constituency, where there is a genuinely world-class sterile facility where the drugs are created. They are then placed in a powder form in Barnard Castle and in vials in Verona.
As the Minister is surely aware, there was great celebration in Ulverston, and it was heralded by the then Prime Minister and Chancellor, David Cameron and George Osborne, when David Cameron visited the day after the 2012 Budget and made a Budget roll-out announcement that GSK was going to be investing at least £350 million in a new biopharm pharmaceutical facility, largely as a result of the patent-box tax legislation, which the Conservative Government continued from Labour’s innovative tax policy, introduced by Prime Minister Gordon Brown. In July, GSK announced—out of the blue, for all intents and purposes—that it is going to pull that investment and scrap the entire project, leaving our community devastated. Not only that, but it is launching a strategic review of the existing cephalosporins business, which has been running for decades across both sites and is growing in profitability and potential.
Although cephalosporins are not a new product, they are well established. British manufacturing of such products in Ulverston and Barnard Castle, and across into the EU in Verona, has enabled them to penetrate new markets and benefit many more critically ill patients in hospitals. They are the very strongest antibiotics, and are typically used in hospitals for people with very serious vulnerabilities and infections. That business had and has a great future, but GSK has clearly signalled at a corporate level that it wishes to divest. Officially, that is a review of the business, but the company at the highest level is clear that it wants to find a new buyer.
When the company dropped its bombshell in July, it was clear and categoric that the decision was not as a result of Brexit. The company took care to say that, and we have to take it at its word. We can detect the thinking of the new chief executive officer, Emma Walmsley—a Barrovian, by the way, which has made the decision all the more stinging—that GSK wants to focus on fewer products, completely cutting some and potentially divesting itself of others. Although Brexit may not have triggered that deeply worrying blow to pharmaceutical manufacturing in the north of England, however, it is certainly a significant factor in whether we will be successful in finding a new buyer for the plant who is prepared to invest and to take the business to new heights, sustaining the employment of people in my constituency and in Barnard Castle, as well as creating more jobs in the decades ahead.
Every business, in no matter what sector, operates on the basis of wanting certainty and stability and of not liking uncertainty or the potential risk in what is at the moment the complete lack of clarity that the Government can give on the future of the regulatory environment for medicines in this country. I therefore really hope that the Minister is listening to what we are saying.
In another sector that is enormously important to our regional economy, civil nuclear, we do get a sense that, at the ministerial level at least, the Government are working hard to overcome this—I absolutely agree with my hon. Friends—absolutely nonsensical decision to rule out anything based on ECJ jurisdiction, thereby creating all the problems. We need to hear from the Minister that he is prepared to do whatever it takes to ensure that the transition is seamless. He should not only produce something a year down the line but give a level of certainty now, ready for GSK in Ulverston to attract new buyers to the site.
The Minister might be aware that I have formed the GSK Ulverston taskforce—which brings together community stakeholders and the site directors, with input from the Department for Business, Energy and Industrial Strategy and the local authorities—to ensure that we all maximise the chances of attracting a new investor. The decision will principally be a commercial decision, of course, but the Government can help in many ways. I would say that they have a duty and a responsibility to help, given the level to which they heralded the new jobs that have now been cancelled.
Other important areas include infrastructure, but I do not expect the Minister to go into those today. He can, however, acknowledge the difficulty that uncertainty causes to attracting new investors. I hope he will give more certainty today, and he should certainly undertake to go away and come back in short order to inform Parliament of what the relationship will be, so that the Government and we as a taskforce can better communicate that to the stakeholders.
My final request is that the Minister or his counterpart in the other place, Lord Howe—
The Parliamentary Under-Secretary of State for Health (Steve Brine)
Lord O’Shaughnessy.
John Woodcock
Lord O’Shaughnessy—apologies, the previous Minister in the Lords has moved on. I thank the Minister here for the correction. I hope that he or Lord O’Shaughnessy will meet with me, my hon. Friend the Member for Bishop Auckland and other members of the taskforce. Lord Prior was really helpful when he spoke to me on the day of the announcement but there has been significant progress since then and many more challenges need to be met. If the Minister undertakes to make that happen, it will be very helpful.
The Parliamentary Under-Secretary of State for Health (Steve Brine)
I will do my best, Mr Davies.
I congratulate the hon. Member for Bishop Auckland (Helen Goodman) on securing this debate. Medicine regulation is a critical issue that I know she has raised many times in the House. This is probably the quietest Westminster Hall debate that I have responded to, but that does not mean that it is not one of the most important—there are competing issues in the main Chamber today. The fun that we are missing!
Modern medicine is transforming. We are moving from an era in which drugs and devices were mass produced and marketed to millions of patients globally, to one in which new medicines and therapies will increasingly be designed and personalised for individual patients. The chief medical officer’s annual report earlier this year on genomics was a landmark piece of work, and it set out how that will revolutionise our ability to diagnose and treat illness in the future. It is within that context that we discuss medicines regulation. Put simply, if the future regulation of medicines does not keep up with the pace of development for those medicines, patients in the UK, and internationally, will not have access as quickly as they should to transformational new treatments. That would be a bad thing.
While answering as many questions as I can, let me outline the world-leading work of our domestic medicines regulation, the Medicines and Healthcare Products Regulatory Agency, as well as our plans for the future in the context of Brexit. The MHRA has been our national regulator for more than 30 years, and it has acted as the lead regulator for more than 3,500 medicines now on the EU market. It is recognised globally as an authority in licensing, inspections and batch release and through its pharmacovigilance—a great word—and medical devices regimes. It plays a leading role in protecting and improving public health through the regulation of medicines, medical devices and blood components for transfusion services. In addition, the agency hosts two organisations that, although little known, play an important role in supporting the development and use of medicines. The agency’s clinical practice research datalink uses anonymised NHS clinical data to keep patients safe and aid the development of new drugs, and the National Institute for Biological Standards and Controls develops global standards for the use and control of more than 90% of biological medicines used globally.
Helen Goodman
When preparing for this debate, it occurred to me that some of these issues apply also to animal health. Is there any responsibility for animal health in these institutions, or do we need to ask DEFRA Ministers about that separately, on another occasion?
Steve Brine
I think it is the latter, but I will check and come back to the hon. Lady on that point.
Dr Whitford
The veterinary medicines division is part of the EMA, so it comes under that—I am not sure whether that is what the hon. Member for Bishop Auckland (Helen Goodman) was asking.
Steve Brine
I thank the hon. Lady; she is always there when we need her.
As I was saying, those skills and expertise have allowed the MHRA heavily to influence global practice and regulations, which is why I say it is a world leader. A majority of medicines available in the UK—around 90%—already receive a national UK licence issued directly by the MHRA. It also leads the assessment of more than 20% of new medicines licensed by the EMA, with particular expertise and specialism in more complex new drugs that come to market. Similarly, on medical devices, five of the EU’s 55 notified bodies are in the UK, and they undertake a disproportionate amount of work. We estimate that they assess between 50% and 60% of the highest-risk devices on the EU market—a big player.
The strengths of our world-leading regulator are similarly reflected in the UK’s life sciences sector. The UK has one of the strongest and most productive life sciences industries in the world, with more than 5,000 companies, more than 233,000 employees, and an eye-watering turnover of more than £63.5 billion each year. It also provides products that the NHS and patients rely on every day—I know that the constituency of the hon. Member for Bishop Auckland has seen the benefits of that productive industry.
GlaxoSmithKline announced this year an investment at its Barnard Castle facility in Teesdale, as part of a wider £140 million investment in the expansion of manufacturing HIV and respiratory medicines. However, we cannot be, and are not, complacent, and we must continue to work hard to support the industry, and we have done just that. The industrial strategy Green Paper was launched in January this year, and it set an “open door” challenge to industry to come up with proposals to transform their sectors through various sector deals.
Heidi Alexander
I am grateful to the Minister for his exposition of the current state of life sciences in the UK, all of which we could probably find out if we typed a few words into Google. May I bring him to one of the first questions, which is of pressing importance? What will the regulatory environment be for pharmaceutical companies that wish to get a pan-European licence in April 2019, during the so-called transition period envisaged by the Prime Minister, following the conclusion of negotiations on article 50?
Steve Brine
We should always try to be courteous to one another in this House, if we can manage that. To refer to the previous point, DEFRA is responsible for animal medicines policy; EMA covers both human and animal medicines. The Department of Health and DEFRA work incredibly closely together; therefore, DEFRA Ministers answer on applications for animals. I can assist with that at any time.
We are working with Sir John Bell and others in the life sciences sector to consider the industrial strategy in more detail, and specifically what action can be taken by Government and industry in partnership through an ambitious sector deal. At the launch of “Life Sciences: Industrial Strategy”, the Secretary of State for Business, Energy and Industrial Strategy, who has been much spoken of already in this debate, reiterated the Government’s commitment to the sector by announcing the first phase of their investment—£146 million for leading-edge healthcare, which is expected to leverage more than £250 million of private funding from the industry.
Leaving the EU, with all its challenges, allows us to make fresh choices about how we shape our economy and presents an opportunity to deliver a bold industrial strategy that prepares us for the years ahead. Our approach to the EU exit negotiations for medicines regulation is focused on building on the strengths of the MHRA and the UK life sciences sector that I have just set out. As the UK leaves the EU, both parties will have the shared aim to protect the health of patients across Europe and to ensure the safe and timely access to medicines and medical devices that I know concerns hon. Members as it concerns me. It is in the interests of patients and the life sciences industry for us to find a way to continue UK-EU co-operation and to ensure continued sharing of data, even if our precise relationship with the EU will, by necessity, change.
Earlier this year, the Secretary of State for Health and the Secretary of State for Business, Energy and Industrial Strategy published an open letter in the Financial Times setting out Government’s aim to retain a close working partnership in respect of medicines regulation after the UK leaves the EU. Our approach is underpinned by three key principles, which are worth stating. First, patients should not be disadvantaged; secondly, innovators should be able to get their products into the UK market as quickly and simply as possible; and thirdly, the UK should continue to play a leading role in promoting public health.
Yesterday, obviously, the new location of the EMA was announced; in 2019 it will move to Amsterdam. Both the UK and the EU have a collective responsibility to make sure that the process is as seamless as possible, in order to minimise disruption to existing regulatory procedures and public health protection. There are no benefits to UK or EU patients in tearing up the sort of close working relationships that get crucial drugs on the market as fast as possible, share early alerts about problems with medicines or allow patients to benefit from new scientific discoveries earlier. As the Prime Minister has said, there is also no need to impose tariffs where we have none now, which is the case for medicines and medical technologies.
Continued collaboration is in the interests of public health and safety across the continent of Europe, and in the UK for our constituents, because we all know that health is different. Medicines and med tech are different from other consumer products. Patients who need an innovative treatment cannot simply pay more or consume less but otherwise carry on as they were, marginally worse off. We recognise that it could be the difference, as has been said, between life and death. We look forward to discussing these issues as early as possible with our EU counterparts as part of the negotiations.
John Woodcock
Presumably the Minister recognises the need for cross-border manufacture with European nations to remain absolutely seamless. The issue of cephalosporins in GSK affects not only in Barnard Castle and Ulverston but Verona, which obviously is in Italy.
Steve Brine
Yes, of course. I want to come on to the many different questions asked. The hon. Member for Central Ayrshire (Dr Whitford) said that Scotland would have bid for the EMA if it had voted yes a couple of years ago. I do not think that it would have done, because it would not have been a European Union member state.
Heidi Alexander
I am grateful to the Minister for giving way. Mr Davies, I hope that it is not out of order to say that the Minister does not quite seem himself. If he is poorly, and my earlier remarks were somewhat curt, I apologise for them.
It would help everyone here to understand the Government’s overriding objective for medicines regulations in a post-Brexit environment. Do we intend to automatically follow EU authorisations in future, or does the Minister foresee divergence from EU regulations?
John Woodcock
On a point of order, Mr Davies. If the Minister is struggling and feeling unwell, is there a way in which we could bring the debate to an earlier close and he could write to us in response to our questions? I am concerned by how he seems.
Geraint Davies (in the Chair)
The Minister is the last speaker. He can stop the debate at any time, at which point I will ask Helen Goodman to make her closing remarks for two minutes. Feel free to end whenever you feel is appropriate, Minister.
Steve Brine
Thank you; I am not feeling unwell at all.
In the event that it is not possible to reach a deal that secures ongoing, close collaboration between the UK and Europe, we will set up a regulatory system in the UK that protects the best interests of patients and supports industries so that they can grow and flourish, as set out in the letter in the Financial Times. We will ensure that our system is robust and does not impose any additional bureaucratic burdens. Our successful past should give us confidence in achieving a prosperous future, whatever form that takes. I want to be clear that that is not a threat to the EU27. I must be honest and transparent in saying that if it is not possible to secure close collaboration, we will of course look to put in place an effective system and work with international partners in a way that best protects patients and supports industry and innovation.
I will attempt to answer some of the many questions that the hon. Member for Bishop Auckland put to me. I can rule out a free-standing structure incorporated into the FDA. She asked how much the EU expects us to pay towards the cost of relocating the EMA. The arrangements for withdrawing from the EU, including any financial settlement, is a matter for the withdrawal agreement, as she knows, as part of the ongoing article 50 process. The Government are absolutely committed to working with the EU to determine a fair settlement for Britain’s exit and the best deal for UK taxpayers. As part of the exit negotiations, the Government will discuss with the EU and other member states how best to continue co-operation in the field of medicines regulation, in the best interests of business, citizens and patients in the UK and the EU. I do not think that it would be appropriate, nor is it possible, for me to prejudge the outcome of those negotiations. There are many who would love that crystal ball, but I do not have it.
Helen Goodman
One can envisage a situation in which medicines are assessed in the European Union and in the UK and there is an agreement for mutual recognition between those institutions. That, one can picture. But what I cannot understand, if we are not all in one system, is how—down the track when medicines are used—if something goes wrong, the Europeans can have a claim on us or we could have a claim on them if we do not share the ECJ institutional machinery.
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?
Steve Brine
I know that the hon. Gentleman asked that question. I cannot confirm that today—I am sorry—but when I can, I will.
A couple of Members, including the hon. Member for Central Ayrshire, talked about the absence of impact assessments of the health implications of leaving the EU. I fully concur with Members’ concern that complex discussions about the future of medicines regulation were not at the forefront of the referendum campaign. That is obvious. That is the problem with referendum campaigns. That is about as far as a diplomatic Minister can go. Sadly, the subject did not feature on the side of any buses. However, as part of our work on preparing to make a success of our departure from the EU, we are carrying out a full suite of economic analyses, as any Government would be expected to do. That means looking at 58 sectors, including life sciences, and at cross-cutting regulatory, economic and social issues. It will of course take time to collate that information and ensure that it is informative and accessible. We will provide it to Parliament as soon as possible.
Dr Whitford
Is the Minister aware of whether an impact assessment is being done with regard to health, not as part of the economy but as a benefit to people in the UK?
Steve Brine
There is a huge body of work going on in the Department about the impact of Brexit on every single area of every single Minister’s responsibility.
Heidi Alexander
What assessment has the Minister made of how staying in the European economic area might impact medicines regulation, were we to go down that route instead of the one the Government are currently pursuing?
Steve Brine
The hon. Lady asks me to visualise all the different scenarios for the current negotiations. We have been clear that we want a comprehensive deal. A number of Members mentioned that no deal is some sort of ideological obsession for some Government Members. That may be true, but they do not speak for Government policy. We are not looking for no deal; we are looking for a comprehensive deal.
The hon. Member for Barrow and Furness (John Woodcock) asked about meeting my colleague Lord O’Shaughnessy. I cannot speak for my colleague’s diary, but I will speak to him. If he cannot meet the hon. Gentleman and his taskforce, I will. The hon. Gentleman always speaks passionately for his constituency, and I am more than happy to try to sort that out for him.
The hon. Member for Central Ayrshire raised a concern about safety data. That absolutely should always be shared at a global level. The MHRA leads about a third of the EU’s pharmacovigilance work. The EMA already shares data with third countries. It is in all our interests for that to continue. If we are outside EU regulatory procedures, we will ensure that the UK remains an attractive market and that regulation does not delay patient access. A number of Members expressed concern about that, and it is a concern of mine, which is why it is a priority for us.
Dr Whitford
Does the Minister recognise the data protection issue? Some people have suggested that the UK will be in a position to follow its own line on utilising data. Ending up on the outside as an untrusted country—or as an untrusted set of countries within the UK—would obviously kill our ability to take part in clinical trials and research.
Steve Brine
It would. That is why, as the hon. Lady knows, we are working extremely hard not to be in that position. As ever, she makes her point well.
Whatever our future relationship with the European Union on the regulation of new drugs, the MHRA, our world-leading regulator—I have mentioned some of the reasons why it is world leading—will be empowered to protect patient safety both in the UK and internationally. We will also ensure, as everyone said, that patients are at the forefront of our thinking and do not get new drugs any slower than they do now.
Draft Greater Manchester Combined Authority (Public Health Functions) Order 2017
Steve Brine Excerpts(7 years, 1 month ago)
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The Parliamentary Under-Secretary of State for Health (Steve Brine)
I beg to move,
That the Committee has considered the draft Greater Manchester Combined Authority (Public Health Functions) Order 2017.
It is a pleasure to work with you, Ms McDonagh. This important order will confer local authority public health functions on the Greater Manchester combined authority, as agreed in the devolution deals, and support Manchester’s wider programme of public sector reform.
The Government have already made good progress in delivering their commitment to implement the historic devolution deal with Greater Manchester. Since agreeing the first deal in November 2014, we have passed the Cities and Local Government Devolution Act 2016, followed by a considerable amount of secondary legislation for Greater Manchester. That includes legislation to establish the position of elected Mayor— and, as this is my first chance to do so, I congratulate Andy Burnham; I have worked very closely with him in the House, and I know he will do a good job—and to confer new powers on housing, planning, transport, education and skills, to transfer fire and rescue functions and assets, and to set out the operation of the police and crime commissioner function, with the transfer to the Mayor on 8 May.
The order provides a further significant step for Greater Manchester, which has rightly identified public sector reform and population health improvement as priorities. The order provides for the conferral of certain local authority public health functions on the combined authority. If the order is agreed to, the combined authority will be able to exercise those public health functions concurrently with the 10 metropolitan district councils in its area.
The main new function is a conferral of a local authority’s duty to take such steps as it considers appropriate to improve the health of the people in its area. The effect of the order will be to treat the combined authority as if it were a local authority, with the same duty to improve population health, the same consequential requirements to comply with guidance and the NHS constitution and the ability to enter into partnership arrangements with local authorities and NHS bodies.
The conferral of local authority public health functions will primarily do four things. First, it will enable a Greater Manchester-wide strategic leadership approach to the delivery of agreed public health functions and commissioning responsibility—for example, public health intelligence, health needs assessments and health protection measures. Secondly, it will support a Greater Manchester-wide strategic approach to tackling variation in health inequalities, quality and service improvement to promote fair and equitable access, and achieving an upgrade to health outcomes for the population of the wider Greater Manchester area. Thirdly, it will support strengthened collaborative decision making for population health through the identification of Greater Manchester-wide commissioning priorities and intentions underpinned by shared principles and common commissioning standards—for example, commissioning for whole-system sexual health and substance misuse services. Finally, it will enable population health to be embedded across Greater Manchester’s health, social care and wider public services through the Greater Manchester strategy and the population health plan.
The statutory origin of the draft order is the governance review and scheme prepared by the combined authority in accordance with the requirement in the Local Democracy, Economic Development and Construction Act 2009. Greater Manchester published that scheme in March 2016 and, as provided for by the Act, the combined authority consulted on proposals in the scheme. The combined authority ran that consultation from March 2016 to May 2016 in conjunction with the 10 local authorities in its area. The consultation was primarily conducted digitally, including promotion through social media. In addition, of course, respondents were able to provide responses on paper, and posters and consultation leaflets were available in prime locations across Greater Manchester. As statute also requires, the combined authority provided the Secretary of State with a summary of the responses to the consultation in June, and the Secretary of State concluded that Greater Manchester’s consultation was sufficient and no further consultation was necessary.
Before laying the draft order before Parliament, the Secretary of State considered the other statutory requirements in the 2009 Act. The Secretary of State considers that conferring these functions on the Greater Manchester combined authority is likely to improve the exercise of statutory functions in the area, and he has had regard to the impact on local government and communities, as he is required to do. Also, importantly, the 10 constituent local authorities and the combined authority have all consented to the draft order being made, as is required by statute.
The draft order, if approved, will confer local authority public health functions on Greater Manchester combined authority and enable it to play a key role in improving the health of the population of Greater Manchester. I commend the draft order to the Committee.
Hormone Pregnancy Tests
Steve Brine Excerpts(7 years, 1 month ago)
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Yasmin Qureshi (Bolton South East) (Lab)
(Urgent Question): To ask the Secretary of State for Health to make a statement on the recently published “Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests”.
The Parliamentary Under-Secretary of State for Health (Steve Brine)
Yesterday, the Commission on Human Medicines published the report of its expert working group on hormone pregnancy tests. As I said at Health questions on Tuesday, this subject demands the utmost sensitivity and I will do my best.
Based on its extensive and thorough review, the group’s overall finding, endorsed by the Commission on Human Medicines, is that the available scientific evidence, taking all aspects into consideration, does not support a casual association between the use of hormone pregnancy tests, such as Primodos during early pregnancy, and adverse outcomes of pregnancy with regard to either miscarriage, stillbirth or congenital abnormalities. Ministers have accepted the advice of the Commission on Human Medicines. A written ministerial statement was published yesterday, along with a copy of the report.
In the UK, hormone pregnancy tests first became available for diagnosing pregnancy in the 1950s. Between then and 1978, when Primodos was withdrawn from the market in the UK, a number of studies that investigated a possible link between women being given a hormone pregnancy test to diagnose pregnancy and the occurrence of a range of congenital anomalies in their babies was published. Although there was never any reliable evidence that HPTs were unsafe, concern about the issue, coupled with the development of better pregnancy tests, meant that a number of precautionary actions were taken to restrict the use of HPTs. The tests were voluntarily removed from the market by the manufacturers.
The body of information subsequently accrued by the Association for Children Damaged by Hormone Pregnancy Tests and other campaigners led to a parliamentary debate in 2014, I think in Westminster Hall, during which the then Minister for life sciences, my hon. Friend the Member for Mid Norfolk (George Freeman), stated that he would instruct that all relevant documents held by the Department of Health be released. In addition, he determined that an independent review of the papers and all the available evidence was justified. The purpose of the review was to ascertain whether the totality of the available data, on balance, supported a casual association between use of a hormone pregnancy test by the mother and adverse pregnancy outcomes. It also considered whether, alternatively, the anomalies could have been due to chance alone, or other factors.
The final report summarises the scientific evidence that was considered by the expert working group, its conclusions on the evidence, and its recommendations. All the available relevant evidence on a possible association has been extensively and thoroughly reviewed with the benefit of up-to-date knowledge by experts from the relevant specialisms. The evidence reviewed by the expert working group will be published in the new year, once it has been rightly checked in line with the legal duties of data protection and confidentiality.
In addition to the overall conclusion, the expert working group has made a number of recommendations to safeguard future generations through strengthening the systems in place for detecting, evaluating, managing and communicating safety concerns about the use of medicines in early pregnancy. I recognise that the conclusion of the report will be a disappointment to some, but I hope that they will see the recommendations as positive. They are a credit to the efforts of the Association for Children Damaged by Hormone Pregnancy Tests and the all-party group on oral hormone pregnancy tests, which is chaired by the hon. Lady, and also a lasting legacy.
Yasmin Qureshi
I am so disappointed with the Minister’s response. Clearly he is just reading what his staff and the Department have been telling him. I wish the Minister would actually go through the documents submitted to the inquiry and those documents that we had, because if he had read them, he would never have to come the Dispatch Box and said what he has said.
You will be aware, Mr Speaker, that I have raised this issue in Parliament on a number of occasions. In 2014, an expert working group was set up to look at a possible association—not a casual link or a causal link. I am sure that hon. Members agree that that means that a lesser burden of proof is required. The first thing that the commission did was to say that it had found no causal connection, but it was never asked to do that—it was asked to look for a possible association. In 2014, the then Minister made promises about statutory oversight. From the papers we had, there appeared to be a clear criminal responsibility regarding the statutory body, the Committee on the Safety of Medicines, and the people who ran it, given that so much evidence was adduced to them. They were alerted to the fact that Primodos was causing deformities and miscarriages in women, but they totally ignored that evidence. In fact, the person in charge actually said that he wanted to cover it up so that nobody could be sued. It is therefore highly surprising that the commission has come up with this recommendation.
The commission was shown evidence from many studies, the majority of which showed conclusively that when the drug was given to rabbits and rats—mammals, like ourselves—the tissues were damaged. There were—
Mr Speaker
Order. I beg the right hon. Lady’s pardon. First, let us hear the Minister respond to the statement made by the hon. Member for Bolton South East (Yasmin Qureshi). It was an important statement; it just did not contain a question.
Steve Brine
You are, indeed, a friend of the House, Mr Speaker.
I have the utmost respect for the hon. Member for Bolton South East (Yasmin Qureshi), with whom I have served on Select Committees, and I will try to help her out. I have seen some of her public criticisms in the past 24 hours. I know that she has been very consistent about this, but I am not just reading notes put before me; I am citing evidence from an expert working group. It really would come to something if Members suddenly started to second-guess expert, scientific and medical evidence. I am not just quoting what is before me. The review’s conclusions do not take away—I do not pretend for one minute that they do—from the very real suffering experienced by these families. This was a comprehensive, independent, scientific review of all the available evidence carried out by the best experts in a broad range of specialisms. Ministers are confident in the report and the review process, and the focus now must be on implementing the recommendations.
Anna Soubry
On Friday, two constituents came to my surgery to speak to me about exactly this. The mother had taken one of these pills and her daughter was born with deformities. This is not the Minister’s report—he is just giving his explanation and doing his job—but may I suggest that we have a proper Back-Bench debate in which we can exercise all these issues? With great respect to the working group, and having had some experience as a former public health Minister and knowing about contaminated blood, I am afraid to say that I smell something like a very large rat in all of this. I think that there have been cover-ups.
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.
Sir Mike Penning (Hemel Hempstead) (Con)
I know the Minister very well. He is a passionate and caring Minister, but I am afraid that I disagree with many of the things he said this morning. The families do—I think, rightly—feel that the report is a whitewash. Material has been removed from the draft, and the group looked into matters that were not within its remit. The question of a causal link was not in its remit. The question was whether there was link with a drug that was often given to our constituents with no prescription: a drawer would be opened, and it would be handed out to them so that they could find out whether they were pregnant. An open inquiry was needed, but I am afraid that the families, and many Members who are present today, will not feel that that was what happened. Will the Minister please meet the families again, with members of the all-party group, and try to understand why they are so upset? Will the Minister please also watch last night’s report on Sky News, which exposes much of what has being going on over many Parliaments? No matter who was in government, Governments have ignored these people, and we cannot continue to do so.
Steve Brine
My right hon. Friend and I do know each other very well, but I am afraid we will have to agree to differ on this; I do not agree that this is a whitewash. At the request of the Association for Children Damaged by Hormone Pregnancy Tests, an expert, Nick Dobrik, who the House and outside world will know well as a respected and well-known thalidomide campaigner, attended all meetings of the expert working group and was invited to give a statement to the Commission on Human Medicines. Mr Dobrik is many things, but the notion that he is some sort of Government yes-man who would have allowed a whitewash to go on does not stand up to much scrutiny, if any at all.
Hannah Bardell (Livingston) (SNP)
A constituent of mine has had one of the most traumatic experiences over the past 24 hours. She was invited to come down and hear the results of that report, and she was not able to travel. Like many other such families, they have children who, they believe as a result of taking this drug, require them being at home to care for them. Does the Minister think 24 hours is a reasonable period of time in which to ask a family to travel to London, often from quite rural parts of the country? Does he also think it appropriate that the hon. Member for Bolton South East (Yasmin Qureshi) and I were locked out of yesterday’s Medicines and Healthcare Products Regulatory Agency press conference? That in itself smacks of a cover-up.
A number of relevant documents were not included in this inquiry, so it is not fair to say that it was comprehensive and independent. Will the Minister consider looking again at the process? A significant amount of public money has been used, and we must make sure, and have confidence that, it was used appropriately.
As we know, “causal link” and “possible link” are two very different terms. Does the Minister think it appropriate that an expert working group changes the goalposts halfway through a process, when it is looking at a matter that is, as he says, so serious?
Steve Brine
First, may I correct myself? I might have said that the expert working group met “companies”, not “families”. If I said “companies”, I wish to correct the record.
I agree with the hon. Lady that the notice the families were given was not good enough. I and my colleague in the other place have made that crystal clear. Some notice was given to Mrs Lyon on Friday last week that there was likely to be an event on Wednesday, but that was not confirmed until Monday, so that was the notice the family got, and I do not think that is good enough; I have made that very clear.
On the hon. Lady and the hon. Member for Bolton South East (Yasmin Qureshi), who chairs the all-party group, being locked out of the press conference, I cannot imagine how that happened, and again I have sympathy on that. I expect the MHRA to look into that and explain that to me, because, while we may disagree, I can see how that merely feeds the conspiracy theory that some have around this subject.
Bob Blackman (Harrow East) (Con)
My hon. Friend is clearly struggling to defend this position. I urge him to look at the scope of this review and all the evidence that was presented to it, as all the evidence that was available should be looked at and looked at again. Without that, many people across this country will not be satisfied that justice has been done.
Steve Brine
With respect, I do not think I am struggling at all; I am just setting out a very clear position. Ministers are confident in the report and the review process. I say again that this was a comprehensive independent scientific review of all available evidence by experts across the expert working group who have a broad range of specialisms.
Liz McInnes (Heywood and Middleton) (Lab)
It is my understanding that in the research on fish, the researcher was reluctant to submit the findings because they had not been peer-reviewed. Is the Minister confident that all the animal studies that were considered in this review were properly and adequately peer-reviewed?
Steve Brine
I can only give the House the facts. Dr Vargesson’s research was there, and he presented it orally, and orally only, to the group. The expert group felt that it wanted more than that, and he has not been able to provide it. At some point, if he does, I am sure that the group will be more than happy to look at it.
Kevin Foster (Torbay) (Con)
One of the key points here is transparency. What work does the Minister think he can do to increase people’s confidence and to share more information to dispel the image that things are being kept secret?
Steve Brine
As I have said, I think that I have been very honest about the way in which the families have been handled, about the notice that they have been given and about Members being able to attend report launches. There is no great secrecy here, but I can see how events like that merely feed that notion.
Mrs Madeleine Moon (Bridgend) (Lab)
Like the right hon. Member for Broxtowe (Anna Soubry), I am reminded of the contaminated blood inquiry, which is ongoing. In 1975, the regulator knew that there was a potential 5:1 risk of the drug causing deformity. They told the manufacturers but not the patients, and papers were deliberately destroyed by the chief scientist. It is deeply worrying to the families that there is not an open and transparent investigation into this matter. Does the Minister know whether the Berlin archive papers were examined as part of this inquiry, because they demonstrate the cover-up that has happened over many years?
Steve Brine
No, I do not. I will write to the hon. Lady about that, but I can tell her that issues relating to the historical regulatory process were outside the scope and remit of this review.
Mr Philip Hollobone (Kettering) (Con)
I come to this having had no constituency involvement in this issue at all, but I have been listening to the exchanges this morning and it is quite clear that the level of concern on both sides of the House is sufficient for the Government to call a debate on the matter in Government time, so that all these issues can be properly explored.
Steve Brine
All I can say is that, right on cue, the Leader of the House has arrived and is sitting right next to me, and I suspect that she has heard my hon. Friend’s request.
Martin Whitfield (East Lothian) (Lab)
Is the Minister aware of the study in 1979 from Primodos that concluded that the visceral malformations should be considered to be drug-related? The manufacturer seems to have made a link that does not appear to have been dealt with in the report. Does he acknowledge that serious concern is being expressed on both sides of the House about the transparency of this report and that it behoves us all to try to make it transparent and understandable and, above all, to get to the correct answer?
Steve Brine
Yes, of course we all want to get to the correct answers. Science and clinical practice have moved on significantly since the 1970s. As the hon. Gentleman knows, there have been far-reaching advances in the regulation of medicines. One of the reasons that the report has been delayed is that it was felt that it needed to contain far more human-speak, rather than official-speak. That is why I said that Ministers now had confidence in the report and the review process and that we are now going to focus on implementing the report’s recommendations.
Mims Davies (Eastleigh) (Con)
This is simply a matter of confidence. My constituent, Charlotte Fensome, her parents and her brother Steven simply do not have confidence in this report. I trust the Minister, who I know is thoughtful about these matters and wishes that all the families and parents had had their concerns properly taken into account, but the report that was brought forward yesterday falls incredibly short when it comes to inspiring confidence. That is a great shame. I am thoroughly dissatisfied with the complete lack of transparency and with the preparation of the report. We had only 24 hours’ notice of this. Will he meet me and other members of the all-party parliamentary group, so that he can hear from the campaigners and truly listen to their concerns?
Steve Brine
I take the comments of my hon. Friend and parliamentary neighbour on board. As I have already said, my hon. Friend Lord O’Shaughnessy is meeting the all-party group on 6 December, and I am sure that she will be more than welcome to attend that meeting.
Paul Flynn (Newport West) (Lab)
The report must be judged against the background of the fact that the thalidomide scandal involved only 20 birth defects in America and 2,000 in this country, that we are still misinforming and under-informing mothers and potential mothers about the valproate scandal and that GlaxoSmithKline was fined $3 billion for distorting the results of its research. The Minister must tell us how many members of the expert group are present or past employees of the pharmaceutical industry.
Steve Brine
I cannot give the hon. Gentleman that information at the Dispatch Box, but he mentions the thalidomide tragedy and I have already said that Nick Dobrik attended all the meetings of the expert working group as an invited expert at the request of the Association for Children Damaged by Hormone Pregnancy Tests. Nick is most certainly not a Government placeman or yes-man.
Rehman Chishti (Gillingham and Rainham) (Con)
I have a constituent who has been affected by this issue, and they want justice. Based on what I have heard today, justice has fallen short in this case. In any normal circumstances, justice must not only be done, but it must be seen to be done. If the criteria have not been applied correctly, we would in normal circumstances have a review to get the correct decision in the end. Will the Minister look at the matter and get it reviewed?
Steve Brine
My hon. Friend is right to speak up for his constituent. At the risk of repeating myself, the patient voice was present throughout, and the members of the expert working group were deeply moved by the experiences of the families involved. However, the conclusions do not take away from the real suffering of the families and nothing can. Nothing can turn the clock back. Ministers are confident in both the report and the review process, and we now have to implement the recommendations.
Jo Platt (Leigh) (Lab/Co-op)
I have been contacted by my constituent Adele, whose mother has suffered immense guilt over the loss of a child, which she now believes to be related to the Primodos hormone pregnancy test. To add further upset, when victims were brought to the inquiry, they were given only half a day to be interviewed. I implore the Minister to listen to individual cases, such as the one I describe, and to explain what steps the Government will take to ensure that the women get the answers they so desperately seek.
Steve Brine
The step that we will take is to implement the report’s recommendations. As I have already said, the way the families were handled when they came down to speak to the expert working group could have been a lot better, which is the understatement of the day, and I apologise for that on behalf of the MHRA.
Alex Cunningham (Stockton North) (Lab)
A constituent who took one of the Primodos tests and whose son was born deaf visited my surgery on Friday, and she is deeply disappointed with the latest outcome. The Minister said a few minutes ago that checks had to be made before the final report was published, so what hope can he offer her and other parents that the matter will not be swept aside, that work will continue to flush out the truth and that the affected families will be properly supported?
Steve Brine
All I said is that there were checks to be made to ensure that the report was as readable and as accessible as possible. We are confident in the report, and we are not going to sweep it away and forget about it and move on to the next story; we will implement the recommendations.
Jim Shannon (Strangford) (DUP)
Will the Minister outline what support is on offer to those who took Primodos and were traumatised by stillbirth when it was not possible to carry out genetic testing because the baby had died and the remains were gone? We understand the Minister’s compassion, but where is the redress for the still-grieving parents? Where is their support? Where is their help?
Steve Brine
I repeat that we cannot turn the clock back. The conclusions of any review, no matter how it is done, cannot take away from the suffering of families and constituents. I repeat that the review of the evidence by the expert working group was comprehensive, independent and scientific. We are confident in the report and in the review process, and we will now get on with implementing the recommendations.
Mr Dennis Skinner (Bolsover) (Lab)
Is the Minister aware that in all the years that I have been here, I have never heard of such a decision, particularly one made by this party, presented by a Minister of Health who is constantly telling us all about the Stafford inquiry and how important the last Stafford inquiry was? It is time that he considered the possibility of having this thing reviewed, bearing in mind that we are dealing with drug firms that have millions and millions of pounds. He should start all over again from the beginning. It will otherwise be a bad day for the Government if he is allowed to say what he has without listening to the people from both sides of the House who have rubbished the report.
Steve Brine
I could have sworn I heard the hon. Gentleman bring the word “party” into this. That is deeply unfortunate, and I do not think it is helpful to anybody. Last time I checked, there have been Governments of both colours since the 1950s.
As for bringing Stafford and patient safety into this, the Secretary of State for Health takes many criticisms but he has placed patient safety and getting to the bottom of the issues around Stafford at the heart of his agenda. It is because we do not bury our head in the sand and sweep these things under the carpet—as, I am sorry to say, happened in the past—that we are uncovering this and doing the best for the families with the report’s recommendations. Nothing can turn the clock back and nothing can undo the suffering of these families.
Mr Speaker
As has been said, this is absolutely not a party matter. Colleagues have expressed their interest in a debate on this matter, and I can simply say from the Chair that, one way or the other, through one vehicle or another, this matter will be debated if Members want it to be debated.
World Antibiotics Awareness Week
Steve Brine Excerpts(7 years, 1 month ago)
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The Parliamentary Under-Secretary of State for Health (Steve Brine)
In a rare and welcome twist for a Westminster Hall debate, I think I will have time to cover pretty much all the points that colleagues have raised.
Let me congratulate my hon. Friend the Member for York Outer (Julian Sturdy) on successfully securing this debate in World Antibiotics Awareness Week. As everyone has said, it gives us a great opportunity to draw attention to an important issue—or the important issue. On the way in, I said to my right hon. Friend the Member for Chipping Barnet (Theresa Villiers), “I didn’t know you were interested in this subject,” and she said, “This is a critical issue.” It has come on to her radar, so she has come to speak—brilliantly, I thought—in today’s debate. Say to many Members across the House, “We have a debate on AMR this afternoon,” and they would ask what that is. I do not think that will be the case for much longer, nor should it be, and I thank everyone for their contributions. Raising awareness of the importance of preserving antibiotics through their appropriate use and preventing infections in both humans and animals is part of the challenge.
Lord O’Neill has been rightly lauded and much mentioned this afternoon for his review of AMR, which was published last year. I agree that it is an excellent and accessible piece of work. The former Chancellor of the Exchequer, George Osborne, and David Cameron deserve great credit for having the foresight to ask him to do it. His review said that, by 2050, an estimated 10 million deaths a year could be caused globally by AMR if no action is taken. In comparison, cancer causes 8.2 million deaths per year—I am also the cancer Minister for England —and diabetes causes 1.5 million, to put that in context.
AMR is part of the Darwinian process of natural selection, as microbes adapt following exposure to antimicrobials. The problem is greatly amplified by the inappropriate use of antimicrobials—in particular, antibiotics. All Members who have spoken today mentioned public education. It was one of the four points made by my hon. Friend the Member for Stafford (Jeremy Lefroy). While he spoke, I googled Swab and Send—I was listening at the same time; I can multitask, contrary to popular belief—which looks absolutely excellent. I look forward to finding out a bit more about Dr Adam Roberts’ project; he has done excellent work.
If any Members or constituents wish to find out more about the science of AMR, I heartily recommend the new “Superbugs” exhibition at the Science Museum in London. It explains both what AMR is and how we are using science to tackle it. The exhibition is an excellent example of the cross-sectoral collaboration that has enabled the UK to take such a leading role in tackling AMR.
While I am on the subject of science museums, may I give a shameless plug to my constituency—this does not happen often for a Minister? Public awareness is critical and that was a key point in the O’Neill report. A few weeks ago, I went to the Winchester Science Centre, which has just launched a new partnership with the University of Southampton. It has a brilliant new exhibit on AMR called, “The most dangerous game in the world”, which gives children—it is mostly children who visit the centre—the chance to understand what AMR is. They play an interactive game to try to understand the threat it poses to us and what we are doing to tackle it. Through the Association for Science and Discovery Centres—there are science centres all around the country; some will be in the constituencies of Members here today—we have the chance to raise the profile of the public education role that is needed for AMR. I suggest that raising awareness among our young people would be a brilliant place to start.
This debate is timely as it follows the publication last week of the all-party group’s antibiotics report, which was mentioned by my hon. Friend the Member for York Outer. The report made recommendations for us and others to consider in our development of future action plans to combat AMR. I thank the group for the report. Its recommendations will be useful as we develop the refreshed UK AMR strategy and the new action plan; the current one comes to the end of its five-year life at the end of 2018. In addition, the UK strategy makes the commitment to assess the effectiveness of the implementation plan at the end of the five-year period. The policy innovation research unit at the London School of Hygiene and Tropical Medicine is undertaking a full evaluation of the current UK five-year strategy, looking at the evidence underpinning the key mechanisms of change across human and animal health sectors. Its work will further inform the development of the refreshed strategy.
It is World Antibiotics Awareness Week and European Antibiotics Awareness Day is on Saturday 18 November. The two events take a “one health” approach, with human and veterinary health professionals working closely to give a unified message on the subject. They provide opportunities to engage with healthcare professionals and the public on AMR and what we can all do to help to address it. As part of World Antibiotics Awareness Week, letters are sent from the chief professional officers for England and other national leaders inviting colleagues who are working in the NHS, local authorities, universities and professional organisations to support activities for the week. Links are provided to a wealth of AMR-related resources.
Our chief medical officer, the much mentioned—rightly so—Professor Dame Sally Davies, works closely with her opposite numbers in Edinburgh, Cardiff and Belfast. She falls within my responsibility and I see her regularly. We always talk about this, and her book, “The Drugs Don’t Work”, which was mentioned by my hon. Friend the Member for Stafford, is a brilliant piece of work. I recommend it to anybody with an interest in the subject.
The national Keep Antibiotics Working campaign was launched across the country last month by Public Health England, for which I have ministerial responsibility, to raise awareness of AMR and, using TV, radio and social media advertising, to reduce demand for antibiotics by the public. I hope that Members have seen, heard and watched that campaign.
In addition, the antibiotic guardian scheme, which was mentioned by the hon. Member for Glasgow North (Patrick Grady), was launched in 2014, providing brilliant tools for healthcare professionals to raise awareness. That has now signed up more than 50,000 individuals, of whom I am one—people pledge personally to commit themselves to use antibiotics more prudently. When I signed up I did not see in the drop-down options a dram of whisky, but why not? The people behind that website are probably listening or watching, so surely it is only a matter of time.
The debate is also timely in that the Government are due to publish shortly the third annual progress report on implementation of the UK five-year AMR strategy. The report will set out the range of activity that went on through 2016—we look at the year before—to implement the strategy and points to the reduction in antimicrobial use in 2015 throughout the UK. Data for England in 2016, published just last month, show a continuing reduction in antimicrobial use in humans. Significantly, the annual sales data for antimicrobial use in animals, published last month, show a 27% drop in the use of antibiotics in food-producing animals since 2014. That meets the Government commitment two years ahead of target.
At this point I want to touch on colistin, which my hon. Friend the Member for York Outer referred to. Sales of colistin decreased by 83%—below the maximum target recommended by the European Medicines Agency—during the lifetime of the plan so far. On whether a review is looking into colistin use, I am not aware of any specific review, but its use is highly restricted and controlled now; it has dropped by 83%, as I said, and we continue to monitor it extremely closely, I am sure he will be pleased to hear.
This is just the beginning; our work is by no means complete. Last month, Responsible Use of Medicines in Agriculture launched a set of sector-specific reduction targets that we aim to and will deliver by 2020. The Government have also set challenging ambitions to halve the number of healthcare-associated gram-negative bloodstream infections and the inappropriate use of antimicrobials in humans by 2020-21. Gram-negative infections are growing in incidence. Gram-negative bacteria are more resistant to antibiotics and are increasingly resistant to most available antibiotics.
E.coli infections, for example, make up the bulk of the healthcare-associated gram-negative bloodstream infections we aim to reduce. A report published by Public Health England last month revealed that four in 10 patients with an E. coli bloodstream infection in England cannot be treated with the antibiotic most commonly used in hospitals; that relates to a point made by the hon. Member for Burnley (Julie Cooper). In 2017-18 we aim for a 10% reduction in all E.coli infections. Just two days ago, on Tuesday, the Secretary of State hosted an event with over 200 frontline staff from primary and secondary care to share good examples of actions to tackle such infections—I am sure that colleagues from Lancashire were there—and to develop improvement plans for 2018.
The consumption of antibiotics is a major driver of the development of antibiotic resistance. We have implemented a range of initiatives to help prescribers to improve their use of antibiotics, including the provision of guidance and tool kits and the use of behavioural change initiatives and financial incentives. AMR local indicators are provided in the Public Health England Fingertips portal, bringing together local information on prescribing and infection rates to allow local teams to benchmark their performance against others in similar areas so they can develop strategies for improvement that are appropriate for their local circumstances.
That gives me a chance to touch on the point made by my right hon. Friend the Member for Chipping Barnet, who mentioned sustainability and transformation partnerships. We absolutely expect AMR to be included, and it was included in the planning guidance for developing STPs. Take-up in local areas has been limited, but I suggest that MPs apply pressure to their local STPs by encouraging the STP leads to consider AMR. For the record, STPs that are in my good books—the apples of my eye—are Cheshire, Wider Devon and the Black Country. If Members wish, they can refer their STP leads to those as places to look for good practice that are involving AMR in their planning.
Most Members who have spoken have touched on new drugs; my hon. Friend the Member for Stafford certainly did so at great length. Although preventing infections and protecting the antibiotics that we have are the first two pillars of any approach to tackling AMR, the third is promoting the development of new drugs and alternative treatments. However, as has been said, no new treatments have been brought to market for many years. We fully support action to address this market failure through market incentives such as market entry rewards, championed by the O’Neill review, and other solutions, and we welcome the commitment made this year by G20 leaders to consider how such solutions could be implemented regionally and internationally. My hon. Friend’s ideas are welcome, and he is dead right in calling for a co-ordinated approach and for us to give them a bit of a push, to use the expression that he used.
Jeremy Lefroy
My hon. Friend’s commitment to the subject shines through; it is great to see his leadership. I gently suggest that although global work and co-operation are extremely important and will, in the end, produce the kind of results that we need, we could take a step ourselves as the United Kingdom. The amount of money required to start something like, for instance, the Medicines for Malaria Venture is not great, particularly if it comes from a combination involving Government. The UK has provided 20% of the funding, as I said, alongside the Gates foundation. Sometimes it takes quite a time to get the world to work together. Perhaps we could consider doing something ourselves with as many co-operators as we can, and getting it going right now. As my right hon. Friend the Member for Chipping Barnet (Theresa Villiers) said, we could consider using the official development assistance budget, because this is for the benefit of everybody in the world, and it certainly is for poverty reduction.
Steve Brine
My hon. Friend is quite right. I have made a note and passed it back to the team. There are many pulls, of course, on the UK aid budget—that is a topical subject about which he knows far more than I do—but I will definitely take away that point and speak to our colleague, the new Secretary of State.
That point fits neatly into where I was going next. Although it will take time to develop an appropriate global model on the pull incentives, we are making significant progress on the push side. The UK has committed £50 million over the next five years to the global AMR innovation fund, which has been discussed in the House many times. The first tranche of £10 million will fund a bilateral UK-China AMR research collaboration, which we expect to open next spring.
At the same time, we are working with pharmaceutical companies through the joint Government-industry working group. A number of Members have said that this cannot all be left to the public sector, and it absolutely cannot. Through the working group, we are seeking to develop a NICE health technology assessment-based reimbursement model—another snappy title. As my hon. Friend the Member for Stafford said, that means that we would pay for antibiotics based on their value. A team at York University—I know that this will be of great interest to my hon. Friend the Member for York Outer—is working on the evaluation process and will report back to me in the spring. We will then decide on and announce the next steps. I hope that that is useful to Members.
To return to international issues, last week I attended the G7 in Milan—the presidency is held by Italy this year—to discuss international health matters. AMR was one of the three key items that we discussed, which shows the importance of taking a “one health” approach. It was a meeting with many challenging conversations as we attempted to produce a communiqué, which we did in the end, but I can report that the AMR discussion was not one of them. All attendees—the seven Governments, international bodies such as the World Health Organisation and other non-governmental organisations—were in complete alignment that AMR is an urgent global issue and the problems that it raises cannot be solved by individual countries. There was unanimity.
This was the third time that AMR had been prioritised on the G7 agenda, which shows our continued dedication to tackling it and the importance of countries working together. I had an interesting bilateral conversation with the Health Minister from Canada, which will assume the presidency next year in January. I urged her to keep the issue at the forefront of her mind; I hope that that went in. Each country needs to take action to tackle AMR, but we are obviously stronger together.
Our chief medical officer, to refer to Sally again, works tirelessly to raise the profile of AMR in the WHO and international circles. She travels far more than I, and ensures its place not just as a health and agricultural issue but as a political and financial one; a number of Members have mentioned the fiscal cost of AMR. The United Nations declaration secured in September last year made it clear that we will not be able to deliver the sustainable development goals if we do not tackle AMR. As a number of Members have been kind enough to mention, we have been at the forefront of shaping action on AMR through proactive engagement, and Dame Sally has an awfully big role to play in that.
Indeed, at the G7, the OECD recognised and acknowledged that the UK is leading the way in providing experience on how to tackle AMR. Although many challenges will come as a result of our decision to leave the European Union, in this area, as in so many others, we lead the world, and it is very much in the world’s interest to continue working closely with us and benefiting from our experience. The bottom line is: why wouldn’t they?
I will also mention the Japanese, who are passionate about tackling AMR and with whom I had conversations around the G7. I was pleased to learn that they are as dedicated as we are to addressing AMR. This week, our chief medical officer attended an AMR conference that they hosted in Tokyo with other Asian countries. I understand it went well and look forward to getting a formal readout when she returns.
Good global surveillance is essential to provide a co-ordinated global response, as underlined by last week’s G7 discussions. For that reason, we support low and middle-income countries through our £265 million Fleming fund to improve their surveillance capacity and capability. UK official development assistance will improve in-country laboratory capacity for AMR surveillance through a “one health” approach. It has already supported 31 countries worldwide to develop AMR national action plans that follow on closely from what we have done.
Many hon. Members have mentioned that a cross-Government approach is needed in Whitehall. That goes without saying. The officials advising me today are from the Department of Health and from the Department for Environment, Food and Rural Affairs. We work closely with officials and Ministers across Departments. AMR is a global problem that will not be addressed in the lifetime of any single strategy. Although the UK has led the way and made significant progress at home and overseas, this is a long-term, serious and urgent problem. I welcome initiatives such as World Antibiotics Awareness Week that enable us to continue to discuss the issue, give us a media hook to hang it on, keep it high on the agenda for professionals across all sectors and, vitally, keep it in the minds of members of the public.
Hormone Pregnancy Tests: Expert Working Group Report
Steve Brine Excerpts(7 years, 1 month ago)
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The Parliamentary Under-Secretary of State for Health (Steve Brine)
My hon. Friend the Parliamentary Under-Secretary of State for Health (Lord O’Shaughnessy) has made the following statement:
Today, the Commission on Human Medicines has published the report of its expert working group on hormone pregnancy tests. Based on its extensive and thorough review, the expert working group’s overall finding, endorsed by the Commission on Human Medicines, is that the available scientific evidence, taking all aspects into consideration, does not support a causal association between the use of hormone pregnancy tests, such as Primodos, during early pregnancy and adverse outcomes of pregnancy, either with regard to miscarriage, stillbirth or congenital anomalies.
In the UK, hormone pregnancy tests first became available for diagnosing pregnancy in the 1950s. Between the 1950s and 1978, when Primodos was withdrawn from the market in the UK, a number of studies were published which investigated a possible link between women being given a hormone pregnancy test to diagnose pregnancy and the occurrence of a range of congenital anomalies in the offspring.
Although there was never any reliable evidence that HPTs were unsafe, concern about this issue, coupled with the development of better pregnancy tests meant that a number of precautionary actions were taken to restrict the use of HPTs. The tests were voluntarily removed from the market by the manufacturers.
The body of information subsequently accrued by the ‘Association for Children Damaged by Hormone Pregnancy Tests’ and other campaigners, led to a Parliamentary debate in 2014 during which the then Minister for Life Sciences, George Freeman MP, stated that he would instruct that all relevant documents held by the Department of Health be released. In addition, he determined that an independent review of the papers and all the available evidence was justified.
The purpose of the review was to ascertain whether the totality of the available data, on balance, support a causal association between use of a hormone pregnancy test by the mother and adverse pregnancy outcomes. It also considered whether, alternatively, the anomalies could have been due to chance alone or due to other factors.
An expert working group of the Commission on Human Medicines was established in October 2015 to conduct the review with the benefit of up-to-date scientific expertise.
The expert working group was subject to a strict conflict of interest policy and comprised experts from a broad range of specialisms, together with lay representation. The terms of reference of the expert working group, were as follows:
To consider all available evidence on the possible association between exposure in pregnancy to hormone pregnancy tests and adverse outcomes in pregnancy (in particular congenital anomalies, miscarriage and stillbirth) including consideration of any potential mechanism of action.
To consider whether the expert working group’s findings have any implications for currently licensed medicines in the UK or elsewhere.
To draw any lessons for how drug safety issues in pregnancy are identified, accessed and communicated in the present regulatory system and how the effectiveness of risk management is monitored.
To make recommendations.
The final report summarises the scientific evidence that was considered by the expert working group, its conclusions on the evidence, and its recommendations. All the available relevant evidence on a possible association has been extensively and thoroughly reviewed with the benefit of up-to-date knowledge by experts from the relevant specialisms.
In addition to the overall conclusion, the expert working group has made a number of recommendations to safeguard future generations through strengthening the systems in place for detecting, evaluating, managing and communicating safety concerns with use of medicines in early pregnancy. These recommendations can be found in the report. The Medicines and Healthcare Products Regulatory Agency will co-ordinate their implementation, in collaboration with relevant organisations; and the Commission on Human Medicines, together with its expert advisory group on medicines for women’s health, will ensure progress is regularly monitored.
The evidence which has been reviewed by the expert working group will be published in the new year once it has been checked in line with the legal duties of data protection and confidentiality.
Attachments can be viewed online at: http://www. parliament.uk/business/publications/written-questions-answers-statements/written-statement/Commons/2017-11-15/HCWS245/.
[HCWS245]