Oral Answers to Questions

Stephen Mosley Excerpts

Tuesday 24th February 2015 Commons Chamber

[Dr Poulter]

I know that the Labour party is full of professional politicians, but medical students do not just leave medical school and straight away become GPs; they become foundation doctors. As I have outlined, 50% of the people leaving their foundation training will become GPs in future, which will increase the number of GPs by 5,000. Under this Government the number of GPs in education, training and working in the NHS has increased by 1,000, which is a move in the right direction.

[Stephen Mosley (City of Chester) (Con)]

3. How many CT scans were performed at the Countess of Chester hospital in (a) 2010 and (b) 2014.

[The Parliamentary Under-Secretary of State for Health (George Freeman)]

I am delighted to report to the House that the number of CT scans performed at the Countess of Chester Hospital NHS Foundation Trust increased by 67% between 2010 and 2014. In December 2014, only 0.6% of patients waited more than six weeks from referral to test at the trust—that is rather better than the figure we inherited in 2010 of 4.9%, and I hope that the Opposition will welcome it.

[Stephen Mosley]

I welcome those fantastic figures at the Countess of Chester hospital. Will the Minister confirm that early and accurate diagnosis is crucial for dealing with many conditions, and that we are seeing the results of that in improved survival rates for conditions such as cancer?

[George Freeman]

My hon. Friend is absolutely right to say that diagnostics play a key role in our drive to improve cancer survival, which is why we have committed £750 million to deliver our cancer strategy, including £450 million to achieve better diagnosis of cancer, and better awareness and access to diagnostic tests. Projections show that that is working; we are on track to see 12,000 more cancer patients a year surviving for at least five years in 2015, which is more than double the target of 5,000 we set ourselves in January 2011. I hope that the Labour party will agree that these are real benefits for cancer patients in the NHS today.

NHS Major Incidents

Stephen Mosley Excerpts

Wednesday 28th January 2015 Commons Chamber

[Mr Hunt]

I can confirm that there is no difference in any guidelines issued for hospitals in special measures and for hospitals not in special measures. This is a good example of a trust with deep, pronounced problems over many years. There was a terrible tragedy in 2007, I think, when someone gave birth sitting on a toilet seat. This Government have said that we are going to tackle those problems and put the trust into special measures. It has more doctors and nurses: 230 more hospital nurses in the past four years in that trust. We are making a real difference—we have a new management team—and I think that things are beginning to get better in that trust in a way that has not been the case for many years. I hope that the hon. Gentleman would welcome that.

[Stephen Mosley (City of Chester) (Con)]

The shadow Secretary of State called on the Secretary of State to intervene to stop political interference in the NHS. May I ask my right hon. Friend to ignore such siren voices and rely instead on local doctors and local health professionals to make the best choices for our local NHS?

[Mr Hunt]

My hon. Friend eloquently points out the great irony in what we have heard from the Opposition Front Bench. We do not want an NHS in which every single operational decision is made from behind the Secretary of State’s desk. We want to trust people on the ground. Why do we want to do that?

A and E (Major Incidents)

Stephen Mosley Excerpts

Wednesday 7th January 2015 Commons Chamber

[Mr Hunt]

As I mentioned earlier, I have talked to the chief executive of South Western ambulance service about the particular pressures it has faced, such as the 25% increase in 999 calls. We are doing a lot of things, including helping to recruit more paramedics. We have 40 more paramedics starting for the London ambulance service this month, and we are doing what we can to help the South Western ambulance service as well.

[Stephen Mosley (City of Chester) (Con)]

About a third of the patients attending A and E at the Countess of Chester hospital are from the Welsh side of the border. They choose to go there because they know they will get treated a lot quicker in England than they will in Wales. Why is that the case?

[Mr Hunt]

The main reason is that Labour in Wales chose to cut the NHS budget, whereas in England we chose to protect and increase it.

Oral Answers to Questions

Stephen Mosley Excerpts

Tuesday 21st October 2014 Commons Chamber

[Mr Hunt]

I will tell the hon. Gentleman exactly what we are doing. The Dudley Group NHS Foundation Trust has 350 additional nurses this Parliament, and it has got them because this Government took the difficult decision to protect and increase the NHS budget, because those of us on the Government Benches know that a strong NHS needs a strong economy. We are taking measures, but there is more to do. I recognise that the staff on the front line are working very hard, but I think that he should also give credit when things are starting to move in the right direction.

[Stephen Mosley (City of Chester) (Con)]

My right hon. Friend will be aware of the strains placed on the budgets of the Countess of Chester NHS Trust because of the need to treat thousands of patients every year who are fleeing the disastrous management of Labour in Wales. What action is my right hon. Friend taking to ensure that hospitals on the English side of the border get a fair share of resources?

[Mr Hunt]

My hon. Friend is right to talk about that intolerable pressure on hospitals on the England-Wales border. For every one English patient admitted for treatment in a Welsh hospital, five Welsh patients are admitted for treatment in an English hospital, which creates huge pressure for them. I have written to the Welsh Health Minister to say that the NHS is happy to treat more Welsh patients, but the trouble is that NHS Wales is not prepared to pay for it. That is why Welsh patients get a second-class health service. [Interruption.]

--- Later in debate ---

[Norman Lamb]

I thank the hon. Lady for that question. We have drawn up a statement of principles, we have been discussing them with the devolved Administrations and we hope very much that we will be able to achieve an agreed statement of principles in November. I cannot guarantee it, but that is absolutely our objective.

[Stephen Mosley (City of Chester) (Con)]

T7. Healthwatch England recently released a report, “Suffering in silence”, that found that almost two thirds of people felt that their complaint about the NHS was not taken seriously and half ended up not receiving an apology or even hearing the word “sorry”. What action is my hon. Friend taking to ensure that complaints are taken seriously in the NHS?

[The Parliamentary Under-Secretary of State for Health (George Freeman)]

My hon. Friend makes an excellent point. Following the appalling systemic abuse and neglect described in the Francis report, our response, set out in “Hard Truths”, focused relentlessly on hearing the patient voice, learning tough lessons on patient safety and care, and, in particular, the creation of the new independent chief inspector of hospitals, who is looking closely at all complaints. The health ombudsman has increased its caseload and we are also taking measures to display information on how to complain in every hospital and ward across the country.

NHS

Stephen Mosley Excerpts

Wednesday 5th February 2014 Commons Chamber

[Andy Burnham (Leigh) (Lab)]

I beg to move,

That this House is concerned about recent pressure in Accident and Emergency departments and the increase in the number of people attending hospital A&Es since 2009-10; notes a recent report by the Care Quality Commission which found that more than half a million people aged 65 and over were admitted as an emergency to hospital with potentially avoidable conditions in the last year; believes that better integration to improve care in the home or community can relieve pressure on A&E; notes comments made by the Chief Executive of NHS England in oral evidence to the Health Select Committee on 5 November 2013, that the NHS is getting bogged down in a morass of competition law, that this is causing significant cost and that to make integration happen there may need to be legislative change; is further concerned that the competition aspects of the Health and Social Care Act 2012 are causing increased costs in the NHS at a time when there is a shortage of A&E doctors; and calls on the Government to reverse its changes to NHS competition policy that are holding back the integration needed to help solve the A&E crisis and diverting resources which should be better spent on improving patient care.

Our purpose in calling this debate is twofold. First, we want to help the House to develop a more sophisticated understanding of the underlying reasons for the sustained pressure in accident and emergency departments throughout England. Secondly, we want to remove what we see as the major barrier to a lasting solution in A and E.

What has been happening in A and E over recent years? Between 2007 and 2010, attendances at A and E were fairly stable, although they rose slightly. Over those three years, attendances at hospital A and E departments increased by 16,000. Between 2010 and 2013, something changed. In the first three years of this Government, attendances at A and E increased by a staggering 633,000.

What is going on? It is all too easy to reach for simplistic answers. In truth, the picture is complex and a range of factors has contributed to the rise. However, it is possible to point to underlying causes. One of those is clearly the general economic climate. People have been living under greater pressure and are struggling with the cost of living. A and E has become the last resort for people who are not able to cope for a range of reasons. If Members speak to A and E staff, they will be told that there has been a rise in people arriving at A and E who have a range of problems linked to their living circumstances, from people who have severe dental pain because they cannot afford to see the dentist, to people who are suffering a breakdown or who are in crisis, to people who cannot afford to keep warm and are suffering a range of cold-related conditions.

[Stephen Mosley (City of Chester) (Con)]

The right hon. Gentleman is explaining why there is increased pressure on A and E. Does he not accept that A and E performance has improved since the general election? The average waiting time is down from 77 minutes under the last Government to 30 minutes.

Oral Answers to Questions

Stephen Mosley Excerpts

Tuesday 14th January 2014 Commons Chamber

[Mr Jeremy Hunt]

I am very happy to look into the issue that the hon. Lady raises. Obviously, some very big changes are happening in the Staffordshire health economy, and the purpose of those is to improve services for everyone, so if she gives me the details of her concerns, I will happily look at them.

[Stephen Mosley (City of Chester) (Con)]

T3. At the end of last year, the Prime Minister hosted the very successful G8 summit on dementia. What plans does the Secretary of State have to continue, and indeed enhance, the UK’s global leadership on tackling dementia in 2014?

[Mr Hunt]

My hon. Friend is absolutely right. That is a critical job that we must do this year. The purpose of the G8 summit was to wake up the world to the huge threat posed by dementia, as the world woke up to the threat of HIV/AIDS in the 1980s and the threat of cancer in the 1960s. We need to continue that work. Summits will be going on in America, Canada and Japan over the course of the next couple of years, and we need to keep up the momentum, because everyone agrees on the need to do such work.

Health Services (North-West)

Stephen Mosley Excerpts

Thursday 11th July 2013 Commons Chamber

[Mr Hunt]

I am keen to resolve that issue as soon as possible. Indeed, I think that it is really important, given what we heard this morning from NHS England about the big challenges facing the NHS, that we try to take these difficult decisions much more quickly than normally happens. When we have paralysis and decisions being put on hold, that creates uncertainty and the worries that the hon. Member for Stretford and Urmston (Kate Green) talked about, so I want to ensure that we decide these things as quickly as possible.

[Stephen Mosley (City of Chester) (Con)]

Dr Nigel Guest, chief clinical officer at Trafford clinical commissioning group, has said that making these changes to services at Trafford general hospital

“is vital to secure a long and vibrant future for the hospital.”

Can my right hon. Friend reassure the House that that will be the case?

[Mr Hunt]

Yes, and I hope that what we have announced today will give my hon. Friend that reassurance. We have announced a future for Trafford general hospital as a centre of excellence for elective orthopaedic work. We have also announced a significant increase in investment in community services, an extra £3.5 million that will pay for community matrons, community geriatricians, a 72-hour rapid response team and better support in A and Es for people with mental health needs. This is a very big step forward, but it is part of the country that has gone further and faster than many others in delivering integrated care. This announcement will take that further and will mean that it stands out as a beacon of what good care can look like in an ageing society.

Cross-border Health Care (England and Wales)

Stephen Mosley Excerpts

Tuesday 25th June 2013 Commons Chamber

[Jesse Norman (Hereford and South Herefordshire) (Con)]

I start by thanking Mr Speaker for kindly granting this debate on a topic of great importance to many of my constituents and to many others living in English counties on the border with Wales.

I am grateful to two of my colleagues, my hon. Friend the Member for Monmouth (David T. C. Davies) and the Minister for Immigration, my hon. Friend the Member for Forest of Dean (Mr Harper), who have both worked with enormous diligence on behalf of constituents of theirs who have been similarly affected. I pay tribute to my constituent the indefatigable Patti Fender for bringing this issue to my attention, and to Action4Our Care, the action group which has pressed the matter so hard in Gloucestershire.

The basic problem can be simply stated. There are more than 20,000 NHS patients who are resident in England, yet registered with a Welsh general practitioner. Of these, some 3,500 are resident in my county of Herefordshire. Many of these people, like my constituents in the village of Welsh Newton—a Welsh name, but an English village—have no choice but to register with a Welsh GP because no English practice covers their location.

These people live in England, but they are being denied access to hospital services in England. That is grossly unfair, especially as for many, if not all, of them Hereford hospital is the closest and the best place to be treated. The situation also has the damaging knock-on effect of depriving Hereford hospital of revenue from patients who are being treated in Wales. The result is a double whammy: the patients cannot receive the health care that they want and need, and Hereford hospital, already undermined by the deeply iniquitous NHS funding formula, must suffer an unexpected additional financial burden. This burden is already becoming evident. Outpatient treatments for patients living in England but registered with a Welsh GP fell by 10% to 11% in March, April and May this year compared with the same period in 2012, and the hospital expects them to fall further in the months to come.

[Stephen Mosley (City of Chester) (Con)]

Is my hon. Friend aware of the situation in Chester, where the Countess of Chester hospital serves large numbers of people who live in north Wales? One third of the people presenting at accident and emergency at the Countess of Chester live in north Wales. There is no funding available for them so people in Cheshire are losing out. Does my hon. Friend think that is fair?

[Jesse Norman]

It is interesting to have the parallel case, and I thank my hon. Friend for bringing it to the attention of the House.

Let us look at the issues in more detail. The relevant NHS regulations state that legal responsibility for these patients remains with the relevant clinical commissioning groups in England, but that local health boards in Wales take day-to-day responsibility for their care. The English and Welsh NHS take their guidance from the protocol for cross-border health care services, the latest version of which was agreed by Welsh and English Ministers in April this year. However, it appears that the protocol does not give full effect to the law. Specifically, point 14 of the current protocol implies that patients from England who are treated in Wales are to be seen and treated within the maximum waiting time targets of the NHS in Wales, which are of course rather different from those of the NHS in England. Why does this matter? It matters for three particular reasons.

First, as we have seen, these South Herefordshire patients struggle to get referred to the hospital of their choice. The Welsh Assembly Government Minister for Health and Social Services has openly stated that choice is not the basis of the health system in Wales.

Health and Social Care

Stephen Mosley Excerpts

Monday 13th May 2013 Commons Chamber

[Andy Burnham]

Government Members are just embarrassing themselves. When they cannot answer a question, they try to raise another one or go on about Europe. It is just not good enough. The answer is—though the hon. Gentleman cannot admit it—that Andrew Dilnot said this Government had cut the NHS. It is there in black and white. That is what they have done, and they stood on a manifesto promising the opposite. I secured a budget to protect the NHS at the last election. I said that I could not give real-terms increases because that would be irresponsible; and as it turns out, nor can the hon. Gentleman. His party was writing cheques that it simply could not cash, and that is a fact.

The Care Bill does nothing for those hit by the coalition’s dementia taxes right now. Since this Government came to power, the average care user has paid £655 a year more for home care than when they came into office. Overall, that is around £6,800 a year. Dial-a-ride transport services have doubled in price over the same period, from an average of £1.92 to £4.12. Meals on wheels now cost an extra £235 a year, while people in Conservative areas pay more for each service on average than friends and family in Labour-controlled areas—on average, £15 a week or £780 a year more for home care. That is the record of this Government.

[Stephen Mosley (City of Chester) (Con)]

rose—

[Andy Burnham]

I will give way one last time.

[Stephen Mosley]

The right hon. Gentleman has been speaking for more than 10 minutes and he has not once said what Labour would do. Will he come to what the Opposition propose we should do?

[Andy Burnham]

I assure the hon. Gentleman that I will come on to that, but I have a job to do in holding this shambles to account and that is exactly what I am doing.

Under this Government, people are paying more out of mum or dad’s bank account for care, which often does not come up to the standards that they want, because their council has been cut to the bone. What are they meant to make of a promised, far-off cap of £72,000, or £144,000 for a couple? The Government are giving a little with one hand, while with the other they are grabbing a fortune from people’s bank accounts.

--- Later in debate ---

[Stephen Mosley (City of Chester) (Con)]

We are now three years into the coalition Government and there is much that we can be proud of—health, welfare, police and education reforms; this has been one of the most radical Governments in a generation, but there is still much to do. It is not only about ensuring that our country is on the right economic track; the British people must know that the Government are on their side.

Recent local elections have shown that a sizeable minority are disaffected, disillusioned and dismayed by politicians and political parties, and the Prime Minister, Deputy Prime Minister and Leader of the Opposition have been bombarded with advice, often from their own Back Benchers. Often—surprise, surprise—the advice from those Back Benchers seems to be that the only way we can re-engage the trust of the electorate is by taking over their pet project. My advice to my party leader is that there is no magic bullet to winning over the electorate. Voters are cynical and fed up of political spin. They will spot a phoney a mile off. My right hon. Friend should be himself, be natural and not pretend to be something he is not. He should be proud of what we have achieved.

Things can sometimes be difficult in a coalition. Compromises need to be made. Sometimes our friends in the Liberal Democrats have had to make compromises; sometimes Conservatives have had to do so. However, at long last, Britain is moving in the right direction again. I urge the Government to hold their nerve, do what they believe to be right and ignore the siren voices calling for a change of direction. Some in the Chamber shout loudly, but that does not mean they are right, or that they have the support of the majority of their colleagues.

The Government should stay calm, because the foundations of future prosperity have been laid in the past three years, but we must not be complacent. The measures announced in the Queen’s Speech are another step on the journey to national recovery. I am particularly pleased that the Queen’s Speech tackles head-on two tricky problems that were classified as too difficult to touch by the previous Government. Both problems—reform of social care and reform of pensions—involve helping people in their old age.

Twenty years ago, Britain had the best pensions provision in Europe. Our pensions savings were the envy of the world. Millions of workers were signed up to excellent final salary pension schemes. Schemes were in surplus, and workers could look forward to retirement with a good, inflation-proof income. All that changed in 1997. The scrapping of advance corporation tax relief blew a massive hole in the value of pension schemes. That measure cost more than £5 billion a year—it has now cost pension schemes more than £100 billion, and the average worker has lost around £100,000.

Labour’s raid on pensions was just one nail in the coffin of final salary pension schemes. People are living much longer, and the global recession, the turmoil in the eurozone and our massive deficit have not helped matters—they have resulted in historically low interest rates, meaning that pensioners get less income from their savings.

Reform is urgently needed, which is why I warmly welcome the inclusion of the pensions Bill in the Queen’s Speech and the introduction of the single-tier pension. To ensure that future pensions remain affordable, people will have to work a year or two longer, so the Bill will bring forward the increase in the state retirement age and introduce a five-yearly independent review to ensure that the state pension remains sustainable. The current pension system is complex and confusing. It is almost impossible for people to work out how much they will receive. Under the new single-tier pension, people will qualify for the full pension of £144 a week provided they have made 35 years of national insurance contributions. Millions of future pensioners will be removed from poverty, and people who have saved for retirement will be able to enjoy the full benefit of their savings.

The proposals will address the inequalities in the current pension system. The Bill will support women who have taken time out to raise a family, and support low earners. The national insurance contributions of the self-employed will count towards a pension for the first time. Future generations will also benefit from the option of a workplace pension, with a contribution from both their employer and the Government. The pensions Bill will provide a clear, straightforward and fair pension for all—one that is secure as we face the problem of an ageing population.

Another big worry for people as they get older is who will look after them in their old age. The cost of care can be astronomical. For many, the fear of running out of money or being forced to sell their home to pay care charges causes huge concern. It is only natural for people to want to leave something behind for their children and grandchildren, and only natural that, after a lifetime of working hard and paying taxes, people want and expect the Government to be there to help. I therefore warmly welcome the announcement of the social care Bill and the reforms to long-term care funding. A cap on social care costs will help to ensure that the elderly do not have to sell their homes to meet their care bills, and that old people do not feel that they are a burden on others as their lives draw to a close.

The Bill will make a great many other improvements to the social care system, such as standardised thresholds for determining whether individuals are eligible to support from a local authority. It will include a duty on councils to inform residents about care provision, and a new right for carers to receive more support. For too long, Governments have found the problems of social care too difficult to tackle, and consequently tried to ignore them. I am proud that this Government are tackling the problem head-on and proposing a long-term solution that will benefit millions.

I warmly welcome the Government’s programme outlined in the Queen’s Speech. We have begun the long and hard process of restoring our nation’s finances to order. We must now turn to strengthening our society. We have achieved a massive amount in the past two Sessions of this Parliament, but a great deal more needs to be done. This year’s Queen’s Speech is an excellent step in the right direction.

Medical Implants (EU and UK)

Stephen Mosley Excerpts

Wednesday 6th March 2013 Commons Chamber

[Andrew Miller (Ellesmere Port and Neston) (Lab)]

It is a pleasure to speak to the Select Committee’s report today. I start by paying tribute to my fellow members of the Select Committee on Science and Technology who work extremely hard on very technical matters such as this one. I particularly want to pass on our thanks to staff of the House, such as Committee Clerks and specialists, who have done such a wonderful job supporting the Committee in this Parliament.

I would like to focus on the health issues considered in our report on the regulation of medical implants in the EU and UK, which was published in October last year. It was prompted partly by the scandal over PIP breast implants and the less publicised but equally concerning problem with metal-on-metal hip implants. In addition, the European Commission has drafted proposals to revise the medical devices directive, and we hope not just to influence but to assist the Government in developing a strong negotiating position on that directive.

Under the directive, a medical device is used in health care for diagnosing, preventing, monitoring or treating illness or disability. The definition does not include medicines, which have their own regulatory structure. Nevertheless, medical device regulations cover a wide range of products, from pacemakers to spectacles. Devices are classified according to the risk that they pose to patients. A device such as a stethoscope or a dental filling is a class I or a class II, while medical implants are always class IIb or class III. The classification determines how much assessment is required.

Medical implants must be verified by a notified body before they can be placed on the market. Notified bodies are overseen by a competent authority in each member state. I use the word “competent” loosely, because there are some questions about that. In the United Kingdom, the competent authority is the Medicines and Healthcare products Regulatory Agency, which oversees six notified bodies. They are private organisations which assess high-risk devices and ensure that an implant complies with the essential requirements specified by the directives—the main one, of course, being the medical devices directive.

When an implant has been given the stamp of approval, the manufacturer places the CE mark on the device, and is free to put it on the market in all European countries without further controls. I should emphasise that point, because it shows how crucial it is to get the pre-market approval process right. Once the implant has been approved by one notified body in one EU country, it can go on the market anywhere in the EU. Manufacturers can approach a notified body in any member state to get approval; what is more, if a manufacturer has previously approached a regulator who has said “That device is not up to scratch”, and then approaches another and gets approval, the first part of the information is, ridiculously, regarded as commercial in confidence. That must clearly be changed.

There are more than 70 such notified bodies in Europe. I am pleased to say that the Committee heard no evidence criticising those in the United Kingdom, but we did hear concern expressed about the possibility that those in other countries might not apply the same high standards. Such differences are open to exploitation, as a manufacturer can choose to approach a notified body that is more likely to provide approval, a practice that is sometimes described as forum shopping. There is a real lack of transparency, and we simply do not know how widespread the problem is.

A useful insight was provided on 24 October last year by The Daily Telegraph and the British Medical Journal. Notified bodies were approached to approve a metal-on-metal hip implant that was known to be faulty. Shockingly, bodies in Slovakia and the Czech Republic were prepared to approve it. Many Members will remember the names of the authors of the article in The Daily Telegraph, because they have previously been involved in stings affecting Members of Parliament, but on this occasion they did an extraordinarily important job. I have gone on record as giving credit to those journalists for uncovering what I think was a trail of deception. I hope that, in his negotiating stance, the Minister will ensure that we have a mechanism that avoids that kind of risk in the future, and I intend shortly to illustrate to him a way in which procurement can be developed to avoid it.

I am pleased that the Commission has recognised the need to improve the scrutiny of notified bodies. For example, it has been proposed that manufacturers should be unable to apply to more than one notified body at a time. Our report made a number of recommendations about notified bodies, chiefly calling for a record of all approaches by manufacturers and supporting the Commission’s proposals to use teams of experts from member states to oversee the designation of notified bodies.

These notified bodies also audit manufacturers, and that includes an assessment of their facilities. In the PIP implants story, it was the inspection of the manufacturer’s facility that led to the discovery that an unapproved implant filler was being used. Although the PIP scandal was a case of deliberate fraud, not of the failure of the regulatory system, it demonstrated the importance of inspections and audits. We were therefore supportive of the Commission’s proposals to enforce unannounced audits of manufacturers and we further recommended that audits should take place at least annually.

Another key flaw in the current system is the overuse of equivalence data in approving implants. We now come to the key difference between medicines and medical devices. Every new human medicine has to go through rigorous clinical trials to test for efficacy and safety, but medical devices do not. The clinical data that the manufacturer must provide can come from clinical investigations of that particular device or from equivalence data, which are clinical data on another device that is similar. That may sound reasonable, and in most cases it probably is reasonable, but the problem is that even a small change to the design or material of a device can radically change how it behaves in the body. Also, if we keep approving devices on the basis of equivalence but with a small change each time, we will end up approving devices that are very different from those originally envisaged.

It is not practical to demand a clinical investigation of each and every device, as there are hundreds of thousands of devices in the EU, and doing so would not necessarily pick up the problems of wear and tear that happen over a long period of time or take account of how patients interact with their implants, but we were unimpressed by the extent to which reliance on equivalence data appeared to be acceptable for high-risk devices such as implants. We concluded that revisions of the directive should draw a clear distinction between where equivalence data are and are not acceptable.

Before moving to the second half of the regulatory system, which is the post-market surveillance, I want to make a point about the transparency of clinical data. Very little information about a device is public. Clinical data are generally not published, which makes clinical decision-making and informing patients difficult. I think we would all agree that patients have a right to know what is being put inside them and the associated risks. The Commission proposed to make manufacturers of high-risk devices publish summaries of safety and performance with key pieces of clinical data. We did not think that went far enough and called for all clinical data to be made available for both new implants and those already on the market. Similar transparency issues are being explored in our current inquiry on clinical trials, which starts very soon.

I said I would offer the Minister a practical solution to address the challenges of what is a very complex regulatory structure. We need to ensure that both doctors and patients have the fullest possible information about any product that is being used and inserted in a person as a medical device. It seems to me that the answer lies very much with the Minister. I had this discussion when some of his support team came to see me recently with Sir Bruce Keogh, who is doing the work on some of the medical implant devices, particularly those relating to cosmetic use. It strikes me that there is an obvious way forward, and it is a way in which other countries operate European procurement rules. Whoever sets out the procurement process—in whichever trust or at whichever level in the NHS—should simply make a requirement that anyone bidding for the contract must provide the fullest and most transparent data about the trials that have been conducted, the design of the product and the regulatory processes it has gone through, including the ones where there has been a failure. That is a perfectly reasonable regulatory requirement for the Minister to impose on anyone seeking to sell products that are to be used in the NHS.

[Stephen Mosley (City of Chester) (Con)]

It is worth saying that the Committee also saw the importance of ensuring that negative data are released and made available. We often find that similar products are available and if something is failing in one product, there will often be a similar problem in another product. If we do not produce those negative data to show where problems are with some products, we may miss problems with other medical implants.

[Andrew Miller]

The hon. Gentleman, who works hard on the Select Committee, is absolutely right in what he says. I stress to the Minister that not only was this report unanimously endorsed by the Committee members, but we were angry at the lack of available information. That was no fault of the Minister or his predecessors; it resulted from a system that had grown, as the use of implants had grown, into a mechanism that was not fit for purpose. The Minister is rightly participating in the process of revising the directive, but some urgent requirements mean that he has to take a proactive approach and encourage—indeed, instruct, if he has that power—procurement offices of the NHS to set a new standard. They should simply require anyone tendering for a product in this category to provide, as part of the tendering process, totally transparent information about the process and the regulatory regime it has gone through.

[Andrew Miller]

The hon. Lady, another hard-working member of the Committee, is absolutely right and that could take us on to a much more complex debate about how we move from where we are in today’s medicine to future developments in stratified medicine and so on. The way in which our medical profession works in such a strong collegiate manner helps to maintain standards at the highest level. Lessons can be learned in that regard that underline the importance of the NHS as the lead body in this area.

Post-market surveillance is a crucial element of the regulatory system and is technically the responsibility of the manufacturers. However, the notified bodies also have some oversight through auditing. The Medicines and Healthcare products Regulatory Agency investigates adverse incidents once they have been reported. Again, we called for greater transparency by recommending that manufacturers publish the results of post-market surveillance studies. We proposed that a system such as the MHRA’s black triangle system, which flags up new medicines approved on limited clinical data, should be adopted for devices approved on equivalence alone. We found some evidence that clinicians under-report adverse incidents, so we wanted the Government to consider making reporting mandatory.

One place to keep post-market data is a registry. The National Joint Registry for England and Wales—meaning joints in the body, not joint between England and Wales—is a success story. It collects data on all joint replacements in the NHS and the private sector and is the biggest such register in the world. The NJR provided data on the DePuy metal-on-metal hip implant, which was then recalled worldwide in 2010.

Registries do not always succeed. Between 1996 and 2003, we had the national breast implant registry, but that failed, partly because of the unwillingness of patients to give follow-up information. Nevertheless, our colleagues on the Health Committee called for Sir Bruce Keogh to pursue the creation of a register of breast implants in his review of PIP implants. I hope that the Government will put in place measures to ensure that any new registry learns lessons from the NJR’s successes.

I recently went through a minor medical procedure and was asked to provide data as part of a broader clinical dataset and to allow them to be used. The form started off by saying how to opt out of providing that data, rather than explaining to me as the patient why it was beneficial for those data to be collected. When such registers are produced, I hope that the Minister will agree that the starting point should be that the authorisation form should not start with the negative procedure of how to opt out but start with positive information about why such data are beneficial to the individual and to society more broadly.

[Stephen Mosley]

The NJR is a fantastic resource that is very well used, but it might be worth while pointing out that problems with metal hips were first detected in Australia in 2007 because there is a registry there that allowed them to be noticed. The metal hips were withdrawn in Australia in 2009, but it took until 2010 for the problems to be noticed by the British registry and they were withdrawn in the UK. Although it can be a good system, it is not perfect and it needs people to monitor it and ensure that any problems are picked up.

[Andrew Miller]

You will be pleased to know, Mr Deputy Speaker, that the hon. Gentleman has just taken the next paragraph out of my speech. He is absolutely right, but the interesting point is that the Government told us that the Australian regulator did not communicate its data to the MHRA or other international regulators and the MHRA first learned of safety concerns in April 2010. Although it is not necessarily the MHRA’s job to keep an eye on adverse incidents worldwide, we must remember that over those two or three years many risky implants were put into patients, with some devastating consequences. The hon. Gentleman’s observation is spot on.

The European Commission and the UK Government must seek to improve the speed of reaction to incidents such as the two adverse ones that were picked up outside the EU and I will be interested to hear the Minister’s suggestions about how that can be achieved. I believe there is general agreement between the Committee and the Government on the broad principles of the system and what needs to be changed. I hope hon. Members will agree that our inquiry shed some light on important issues affecting UK patient safety.

In conclusion, I will sum up our inquiry on the regulation of medical implants in the EU and the UK as a call for two things: better use of evidence in implant approvals and more transparency throughout the system. I hope we can find a way forward.

--- Later in debate ---

[Stephen Mosley]

The hon. Gentleman has gone through almost the entire checklist of points that I wanted to make. However, one aspect that he has not covered yet is self-reporting by patients. We heard examples in Committee and we suggested that it would be good practice if patients self-reported, which might allow problems to be picked up earlier than they are through the formal channels. Does the hon. Gentleman have any comments on self-reporting?

[Andrew Miller]

I have some ideas about how that can be developed. That angle, although not central to the inquiry, is important for the development of a registry. I gave an example of people being invited to opt out of a registry before anything else is put to them. What needs to be explained to them are the health benefits of working in a more collegiate way and sharing data, and they should be encouraged both for their personal health and for broader societal benefit to self-report. That is a hugely important area that we need to develop through better engagement between clinician and patient at the point when the procedure is about to start.

This is a complex subject and I do not envy the Minister his task in negotiating on it. Unfortunately, some regulators have demonstrably not maintained the standards that occur in most of the 27 countries, but in the interests of patient safety and the advancement of medical science it is vital that we work together and solve the problems that the report has highlighted.