Penrose Inquiry

Andrew Miller Excerpts

Thursday 26th March 2015 Commons Chamber

[Jane Ellison]

Yesterday’s written ministerial statement was just what I said it would be in the Backbench business debate on 15 January: an interim response to a very long and detailed report. All matters will have to be considered in a substantive response by the next Government.

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

Will the Minister reflect carefully on paragraphs 111 to 113 of the Science and Technology Committee’s Legacy report on variant CJD? The Minister gave compelling evidence to our inquiry; the one area of difference was the long-term protection of research funding to give public confidence. Will she look carefully at that and put her response in the public domain?

[Jane Ellison]

I will certainly look at that matter, but I fear that I may not have time to put a response in the public domain. I can give an assurance to the Select Committee that were I to be in office in the next Parliament I would be happy to respond to that in detail. As the hon. Gentleman knows, we have had detailed exchanges on such matters over the past year.

Human Fertilisation and Embryology

Andrew Miller Excerpts

Tuesday 3rd February 2015 Commons Chamber

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

The hon. Member for Congleton (Fiona Bruce) set out her case clearly and I respect her beliefs, but I do not agree with her conclusions. If we took them to the logical point, we would ban any intervention that introduces some part of one person to another. It would mean boycotting blood and organ transfers, simply because—[Interruption.] I listened with courtesy to the hon. Lady and I hope that my hon. Friend the Member for Stoke-on-Trent South (Robert Flello) will listen to me with courtesy. When these pioneering techniques started, nobody knew the answers for certain. People made judgments—scientific judgments—on the best available evidence, and it turned out that people’s fears were ill-founded.

The trials that have been undertaken on this work have led the scientific community—a powerful group of scientists with an extraordinary degree of knowledge in this area—to conclude that the risks are small but worth taking because the benefits on the other side of the equation are enormous. In all cases where there are risks, we need to consider the risks as against the benefits. I put it to the House that there are potential benefits for the about 2,500 families affected by mitochondrial disease up and down this nation, and they deserve our support. Of course we have to assess the risks, as we do with all risks, but that has to be done in a rational and balanced way.

[Richard Drax]

I am listening carefully to the hon. Gentleman. Everyone in this House wants the best for these families—there is no doubt about that—but it is the speed of the introduction of the regulations that concerns us. As for experimentation, I heard today that no trials are being carried out on primates, which are as close to us as can be. This process has proved successful on mice, but on primates—a standard part of this procedure, apparently—it has not been carried out, and that is interesting.

[Andrew Miller]

The hon. Gentleman makes an interesting point, but there are plenty of occasions when such tests are not carried out. In central Africa we have been testing Ebola vaccines without first testing them on primates, because the benefits outweigh the risks. We are in that position already. My hon. Friend the Member for Stoke-on-Trent South referred to research undertaken in China 10 years ago. He rightly said that that work took place, but I put it to Members of this House that the ethical and scientific rigour applied to experimentation in the UK far exceeds anything in China 10 years ago. Indeed, the technologies have also moved on to a very high degree since then.

[Dr Huppert]

Some critics of this approach have pointed out that this country would be the first to go ahead with it. Does the hon. Gentleman agree that we should be proud to be leading the world in medical treatments and that, as he says, we can provide some of the best ethical safeguards in the world?

[Andrew Miller]

The ethical basis on which science is conducted in this country is world leading. The hon. Gentleman is right to say that we should be immensely proud of the successes—again—of our scientific community in a range of life science disciplines. This one affects a very small group of the population but does so in such a profound way. Although there are issues that need properly regulating, the regulatory structure that we have created does that properly. The Minister was asked about, and indeed mentioned, the issues associated with designer babies. Of course this House would want to impose limits, but we are considering a specific set of regulations about dealing with mitochondrial disease—they do nothing else. I, for one, would not stand here to defend the concept of designer babies and people choosing eye colour and so on. Today, we are dealing purely with those terrible illnesses.

[Steve Baker]

Will the hon. Gentleman give way?

[Andrew Miller]

No, as it would not be fair on other people. In case colleagues have not seen them, let me commend the e-mails sent to all Members by the Muscular Dystrophy Campaign; Jonathan Kingsley wrote to us all, and the Lily Foundation has written to us all in very powerful language. Those people who have sat and listened to some of the families will understand, and colleagues who have constituents affected by mitochondrial disease will understand the message.

We are in a society where people are entitled to have their beliefs, and I respect those beliefs; everyone should be entitled to express their opinion. But this is about focusing on the needs of that small part of the population that I mentioned. I urge the House, in coming to a conclusion this afternoon, to think about those families, to focus on their needs and to set aside general beliefs in the overwhelming interest of that small part of the population who have suffered immensely and who have an opportunity at their disposal because of the extraordinary science that has been advanced.

Blood Safety (Variant Creutzfeldt-Jakob Disease)

Andrew Miller Excerpts

Thursday 29th January 2015 Westminster Hall

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

On behalf of the Select Committee, let me say that it is a pleasure to introduce our report “After the storm? UK blood safety and the risk of variant Creutzfeldt-Jakob Disease”, which was published last July. We considered the ongoing health risk posed by variant CJD and examined the steps taken by the Government to ensure that any further transmission of this deadly disease through blood transfusion or other medical procedures is brought to a halt.

This will probably be the last time before I leave Parliament that I will address one of our reports in Westminster Hall, so it would be wrong of me not to put on record my thanks to not only my Committee, but its staff. Dr Stephen McGinness and his team have supported the Committee extremely well during this Parliament. There is someone with a listening pair of ears next to you, Mr Weir, and although he never speaks in these debates, he knows that I have told him how important it is that we have scientifically qualified members of staff supporting Committees such as mine so that our considerations take an evidence-based approach.

I should point out that the report’s title includes an inconspicuous piece of punctuation—a question mark. Throughout our inquiry, the Government expressed optimism that the storm to which our title alluded had in fact gone away. Unfortunately, as our report demonstrates, that optimism might prove unfounded. Like the Government, we hope that the storm is over, but the scientific evidence demands the inclusion of that question mark.

It may not be immediately clear what variant CJD has to do with UK blood supply. In the initial wave of cases, which were related to meat infected with bovine spongiform encephalopathy, the media stories were exemplified by that famous picture of the then Agriculture Minister, John Gummer—now the noble Lord Deben—feeding a burger to his daughter. Although that is the image that people have, three of the nearly 200 deaths attributed to variant CJD are known to have been caused not by consumption, but by blood transfusion.

Transfusions always carry some risk of infection, although in most cases that can be well mitigated. Donations are tested for a variety of pathogens before anyone is cleared for transfusion, and processes are in place to remove or kill the majority of microbes that might be lurking. Donors who are considered to pose a particularly high risk of infection are prevented from donating altogether. The Committee saw those processes on a visit to a major centre in Bristol.

However, several unusual features of variant CJD make it essentially impervious to those risk-mitigation measures. The infective agent of variant CJD is not a virus or a bacterium, as is the case for most contagious diseases, but a prion, which is a type of abnormally folded protein. Proteins, of course, are endemic throughout the body, which makes prions extremely difficult to detect and almost impossible to destroy. If one is to avoid also destroying the useful proteins, one has to be particularly careful. Variant CJD also has an unusually long incubation period—the time between infection and the onset of symptoms—meaning that people could unknowingly carry the disease for many years and give blood many times before appearing to be sick.

It is thought that 67 patients received blood or blood products from donors who went on to develop variant CJD, and three of those patients went on to contract, and then die from, variant CJD themselves. In total, 50% of the exposed patients who were later tested for variant CJD post mortem were found to have been infected. Those are tragic statistics but, thankfully, the numbers are small. As the Government were keen to point out, there have been no recognised cases of transfusion-related transmission of variant CJD since 1999, so the storm, in their eyes, appears to be over. However, the evidence suggests that another may be brewing.

In October 2013, the British Medical Journal published the results of a large research study that inspected more than 32,000 samples of archived appendix tissue for signs of variant CJD infection. Prions were detected in 16 of the samples, suggesting that about one in 2,000 people in the UK—about 30,000 people in total—could be silent carriers of variant CJD. Many of those people are likely to be blood donors. The implications of those findings are, frankly, not clear. However, they are undeniably a cause for concern and, in our view, they warrant further investigation. That was why one of the major recommendations of our report was that the Government should lend their support to research intended to reduce uncertainty about the potential level of silent infection across the UK blood donor pool.

I will give some background about the proposed research. As I have explained, prions are notoriously difficult to detect. A test for variant CJD has remained elusive for many years, but in 2011, a team of researchers from the Medical Research Council prion unit at University college London announced that it had developed a prototype blood assay capable of detecting variant CJD at a dilution of one part to 10 billion. When the assay was tested on 21 blood samples from known variant CJD patients, it accurately identified 70% of them as positive. More importantly, the test returned no false positives from a much bigger group of samples known not to be affected by variant CJD.

It is widely agreed that the next stage of the test’s development would be to carry out a larger study using UK blood donations, which might provide further information about both the effectiveness of the test and the level of silent infection in the UK donor pool. However, the Government appear reluctant to support that study. In their response to our report, they alluded to unspecified “scientific and technical issues” that would need to be overcome and told us that they would seek the views of the relevant scientific advisory committee before making any promises.

[Sir David Amess in the Chair]

Welcome to the Chair, Sir David. That last point is important because the Government’s response failed to mention that the committee in question had already made it known that it was strongly in favour of such a study. It is tempting to conclude that the Government would rather not know the extent of the problem that they might face. To return to my previous analogy, there are clouds on the horizon and a weather forecast is available, but the Government are choosing not to look at it.

Bad weather, to use the same analogy, looms at some of our hospitals. I shall not rerun some of this week’s discussions, which have been adequately handled, but to focus on variant CJD, an unusual feature is that the prions that cause the disease stick avidly to metal surfaces—so avidly, in fact, that surgical-grade stainless steel is used in research laboratories as a tool for transmitting variant CJD. Contaminated surgical instruments therefore offer a very efficient route for person-to-person prion transmission.

[Sir Paul Beresford (Mole Valley) (Con)]

As a slight variation on the hon. Gentleman’s theme, it is not metal, because actually the prion sticks to stainless steel—that is the real difficulty. That is also the basis of the test that Professor Collinge is using.

[Andrew Miller]

The hon. Gentleman follows this matter with great care. He is absolutely right, but I am trying to simplify what is an incredibly complicated subject. The underlying science is very hard to communicate, but I am grateful for his observation.

This issue is known, because there have been several cases of classical CJD being passed on through contaminated surgical instruments. Following two separate incidents in 2011, 59 patients had to be notified that they were at risk of developing the disease because they had been operated on with instruments that were also used on someone who was later found to have been suffering from CJD.

Guidance is in place to help to reduce that risk, but evidence suggests that compliance is poor. Worryingly, it seemed that the Government were not aware of that. They have since promised to work with the Care Quality Commission to ensure that best practice is followed in future, so I look forward to receiving an update from the Minister on that important work.

Ultimately, however, such guidance can be only partly effective, because prions are known to be impervious to standard decontamination processes. The Government told us that that they had spent nearly £10 million since 2001 on trying to solve that problem and they have come very close to doing so. A product initially developed using public funds, and later commercialised by DuPont, has been shown to reduce the risk of surgical transmission more than a million-fold. We were therefore astounded to discover that that product had not been put to use in the NHS, in large part because its use would add an additional step to the decontamination process. That seems to be an example of institutional inertia trumping common sense.

Unsurprisingly, DuPont has ceased development of that potentially valuable product. During our inquiry, we came across other examples of commercial developers withdrawing investment because of the Government’s failure to take up much-needed technologies. I hope that the recently announced innovative medicines and medical technologies review will go some way towards resolving that problem. In the meantime, I look forward to hearing from the Minister how she plans to ensure that those undergoing surgery in UK hospitals are not needlessly exposed to potentially deadly prions. I stress that I am not trying to be alarmist. I have been through medical procedures myself, and I would not want people to be put off in any way from having necessary medical procedures.

Decisions about whether the NHS should adopt particular technologies are currently spread among a number of bodies. The National Institute for Health and Care Excellence is, of course, the largest such body, and is recognised as a world leader in health technology appraisal. However, during our inquiry, we found that similar decisions are being made by a variety of other scientific advisory committees and panels using a range of techniques. We found that a little troubling. If the Government are serious about wanting to ensure value for money for the NHS, all health technology appraisals should be carried out to the same high standard and according to the same basic methodology, wherever they are performed. We therefore recommended that the Department of Health should work with NICE and the Government Office for Science to ensure that best practice is more consistently applied.

The Government have set up a working group to explore differences in appraisal methodology and to set out options for closer alignment. We welcome that move, but we were surprised to find that the group had been set up under the auspices of the Department’s chief economist, seemingly with no input from the Government Office for Science, the Department’s own chief scientific adviser or from the chief medical officer, Dame Sally Davies. When I pointed that out to the life sciences Minister, the hon. Member for Mid Norfolk (George Freeman), I think that he was equally surprised.

The Government explained their decision by stressing that the review would be about the methodological approach to a valuation, not the science itself, which seems nonsensical to me. Health technology appraisal tests rest on an evaluation of both cost and clinical effectiveness. The chief economist is, I am sure, well placed to comment on the former part of the equation, but Dame Sally is vastly more qualified to comment on the latter part. It is simply not possible to remove science from the process. I hope that the Minister has had time to reconsider the Government’s position on the matter. I also want to hear what progress the working group has made.

The Government’s claim that science is peripheral to the process of health technology appraisal is somewhat belied by the fact that it is often the Department’s scientific advisory committees that carry out the appraisals. Almost 70 such committees are dotted around Government, and they are governed by a common code of practice that sets out minimum requirements regarding communications and transparency. Few of those requirements were being met by the SACs that we came across during our inquiry.

The Rapid Review Panel, a SAC responsible for assessing innovative infection prevention and control products, had an extremely limited website at the time of our inquiry and did not seem to publish either an annual report or a statement of members’ interests. Not even the membership of the panel was clearly stated. The Government explained the failures by stating that the panel was not and never had been an SAC, meaning that it did not have to comply with the code of practice. That presumably came as news to the Government Office for Science, which included the panel in its list of SACs, and to the chief scientific adviser, who told us that he met all SAC chairs regularly.

We came across other issues when assessing the work of another Department of Health SAC, the Advisory Committee on Dangerous Pathogens. This time the Government gave us another excuse, claiming that sub-groups and working groups of SACs were technically not themselves SACs, and therefore were exempt from the code of practice. That might technically be true, but it flies in the face of the Government’s reported commitment to openness, which was absolutely reinforced in the document on science and innovation strategy published by the Government just before Christmas.

I began the debate by drawing attention to the question mark in our report’s title—“After the Storm?” We all hope that the storm created by variant CJD has now passed, but the reality is that uncertainties remain. In the six months or so since our report was published, we have seen little evidence of action by the Government to reduce our concerns. The Minister has told us that she is optimistic, but optimism is not a good basis for policy. I hope that she can reveal what the Government plan to do to make our question mark obsolete.

I reinforce a point that I made earlier: statistically, we are dealing with tiny numbers of people. However, at the end of the day, the families affected are real human beings and we should not simply brush aside action in the area because we are dealing with such a tiny group. I hope that the House will take the report as seriously as our Committee and the many brilliant scientists who gave evidence to us.

--- Later in debate ---

[Jane Ellison]

I will come on to talk about the assay in some detail.

[Andrew Miller]

I find the Minister’s remarks somewhat surprising. As I said in my opening remarks, the Government response alluded to unspecified “technical issues” that they would refer to the relevant advisory committee, but that committee had already recommended that the study should go ahead.

[Jane Ellison]

I will update the Select Committee further. We have already committed to submit an additional piece of work before the end of the Session.

I will say a few words about the work undertaken so far. The chief medical officer and I gave evidence to the Committee last April. The report was published in the summer and the Government response in October. In that response, the Government committed to responding with a further update report to the Committee. I subsequently received a letter from the Committee with more than 20 further questions, to which I responded in November. The Select Committee then held a legacy hearing on 3 December at which Professor David Walker, the deputy chief medical officer, and I gave further evidence.

I am extremely grateful to all members of the Committee who have put the issue on Parliament’s agenda and maintained a close interest in it, something that has been clear to me in the relatively short time I have been in post. I will write to members of the Committee, as we have undertaken to do, before the end of March with further updates on some work. That will include an update on the CQC issues that have been raised, which I will not give an update on today.

Let me focus on the potential use of the vCJD blood test. In the response, we made a commitment on that, so I can focus largely on it today. There is the potential to use a prototype variant CJD blood assay, developed by Professor Collinge and his team. He leads the relevant unit, and as hon. Members might know, the MRC is concluding its latest quinquennial review of that unit.

I am pleased to report that—along with two of my Public Health England officials, Professor Noel Gill and Dr Katy Sinka—Professor Marc Turner and Dr Lorna Williamson, the medical directors of, respectively, the Scottish and the English national blood services, met Professor Collinge and his team in October 2014 to discuss the potential use of the prototype assay. At the meeting on 13 November 2014 of the transmissible spongiform encephalopathy sub-group of the Advisory Committee on Dangerous Pathogens, Professors Turner and Gill presented a paper on the possibility of using the assay to carry out an anonymised blood prevalence survey for asymptomatic vCJD, as recommended by the Select Committee.

Members might recall that the ACDP is the independent scientific advisory committee that provides the Government with authoritative advice on all forms of TSE, including all forms of CJD. During the presentation to the sub-group, the professors asked three specific questions. I will update Members on those questions and the ACDP’s responses.

First, with a view to the ability of the assay to detect sub-clinical vCJD infection in otherwise healthy individuals, the ACDP was asked if it had confidence in three qualities of the assay. The first was sensitivity, which is the ability of the assay to give true positive results; in this case, that is the true number of asymptomatic cases that the test could identify in any population. The second was specificity, which is the ability of the assay to give true negative results; in this case, that is the true number of unaffected individuals that the test would identify in any population. The third was reproducibility, which is the ability of the assay to be reliably and repeatedly reproduced outside the centre in which it was developed.

Basically, that process would be to find out whether the assay could be used to identify people with asymptomatic infection, and those who showed no clinical signs of vCJD but who would be presumed at some stage to be potentially infective and/or go on to develop clinical symptoms. My hon. Friend the Member for Mole Valley (Sir Paul Beresford) said that symptoms could develop over a very long period.

The ACDP’s sub-group discussed the issue and agreed that the answer to the first question had to be no, because it has seen no published data on the assay when used in any human or animal samples from individuals without clinically diagnosed disease. Members might recall the February 2011 paper in The Lancet that first gave detailed information on this assay. That paper provided evidence that the assay can give, in seven out of 10 cases, a positive result in blood samples taken from patients with known and clinically diagnosed vCJD. Unfortunately, however, that is not what we need if we are looking for evidence of vCJD in those with no clinical signs. There is no published evidence that provides assurance that the assay, if used in the general population, would give true positive results in those who might be carrying the infection but are asymptomatic.

If a test for this very rare disease—it has been noted that we have had only 14 new cases in the UK since 2005, and only one was after 2010—is used in presumed healthy individuals, it is essential that it is accurate. We have no evidence that the MRC assay can identify vCJD infection in an asymptomatic individual. Those in Westminster Hall with a keen interest in science will understand that undertaking a test of large numbers of individuals when we do not know what a test result means—either for those individuals or, as in this case, for the development of effective public health measures—is not the best use of limited resources.

The second question that the ACDP was asked—

--- Later in debate ---

[Andrew Miller]

I thank right hon. and hon. Members for participating in the debate, which has been about a hugely important subject.

I respect the integrity of the Minister on this matter. She needs to be probing some very serious questions. I hope that she insists that her officials get those responses to the Committee and to Members participating in the debate as quickly as possible; it would be unfortunate to leave such an important issue simply hanging because we had the small matter of a general election campaign coming up.

Any chemical assay evolves. I developed some techniques in the world of geology years ago. When I was in Imperial college earlier on, in the school of mines—admittedly speaking to the Labour club—I was reminded of some of the work that I did when I did a proper job a long time ago. Some of the analytical techniques that we were developing then, from a theoretical basis and given the knowledge available to us at the time, have been refined to a very high degree since then because of the development of techniques and technology. Brushing aside issues around the assay on the three questions that the Minister posed is not a satisfactory way forward.

I have heard the story told by my right hon. Friend the Member for Holborn and St Pancras (Frank Dobson) before—of how he told Prime Minister Blair as he left the room about spending £100 million, and the language expressed at that point. However, it takes courage in a Minister and necessary leadership to get things to happen. The hon. Member for Mole Valley (Sir Paul Beresford), too, has been absolutely consistent and persistent in his views and I congratulate him on that.

Given the short time available, it might be sensible if I used the Minister’s good offices to set up a meeting between me, and perhaps other Members participating in the debate, and the life sciences Minister, because some of the issues are worth pursuing.

I remind the Chamber of the conclusions and recommendations of the report. We start:

“Blood transfusions save lives and we should be proud, as a nation, of our long tradition of altruistic donation”—

a point made by my hon. Friend the Member for Liverpool, Wavertree (Luciana Berger), the shadow Minister.

The report is intended not as a scare story, but to increase enthusiasm in participating in this altruism, so that the next generation of people requiring blood products can be confident that they are safe. There is no politics in that. It is a question of driving the science forward, which should not be done simply on the basis of a cost-benefit analysis in the Department of Health. We ought to look at the costs at a societal level.

We have met people in tragic circumstances who have suffered diseases—not only vCJD, but others—as a result of contaminated blood products. The tragedies that they represent, although small in number, carry an enormous cumulative cost to society. We have a moral responsibility to those people to address such very challenging issues. I thank the Minister for her contribution, but ask her to go much further in this hugely important debate.

Question put and agreed to.

Mitochondrial Replacement (Public Safety)

Andrew Miller Excerpts

Monday 1st September 2014 Commons Chamber

[Fiona Bruce]

Absolutely. I thank my hon. Friend for his intervention.

The HFEA has repeatedly told the Government that further research is required before we can proceed.

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

rose—

[Mr Deputy Speaker (Mr Lindsay Hoyle)]

Order. Nineteen Members wish to speak and other Members are trying to catch my eye to intervene. It is an important debate and we need to allow the allotted speakers in, so Members should think very hard before trying to intervene.

--- Later in debate ---

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

This is a fascinating debate. I should like to place on the record a definition that has not been used:

“Mitochondrial donation is a fundamentally humanitarian intervention designed to help people affected by a devastating disease to fulfil one of the most basic human aspirations: to have a healthy family.”

Regrettably, I cannot claim copyright on that, because it belongs to the Wellcome Trust, so one of the pre-eminent organisations on scientific research in this country very much supports the regulations that will come into force.

It is a pity that the debate is polarised because of the different views on the ethics of intervention. Although it is legitimate to explore the ethical issues, one should do so without misusing the scientific evidence. I fear that that is what is happening.

It is clear that safety is at the heart of the proposals. The hon. Member for Congleton (Fiona Bruce) referred to the HFEA. When we pass the regulations, safety will remain of paramount importance, as it always has been. The technique has received unprecedented scrutiny by the HFEA’s specially convened expert review panel. Never before has a new medical technology been subjected to such thorough investigation—my right hon. Friend the Member for Holborn and St Pancras (Frank Dobson) described the history.

It is clear that, if Parliament passes the regulations, it will not immediately become possible for clinics to treat patients using those techniques. When the regulations are passed, responsibility will pass to the HFEA, which will decide, based on safety and efficacy evidence, whether or not to license individual applications for use. That tried and tested process has been used over a number of years. My point is that we decide the ethics, and the HFEA determines the specific use.

Nothing is being rushed. We have been going on for such a long time, but time is precious—it is precious to those potential parents. Let us not waste time today, and let us reject the motion.

Tobacco Products (Standardised Packaging)

Andrew Miller Excerpts

Thursday 3rd April 2014 Commons Chamber

[Jane Ellison]

The Government are not proposing to take away anyone’s freedom. Our tobacco control measures aim to prevent children from taking up smoking in the first place, which is quite a different thing. On my hon. Friend’s detailed point, Members of Parliament will, like anyone else, be able to make submissions to the final consultation. Once Members have had the chance to read the report thoroughly, any submissions they may wish to make will, of course, be most welcome and they will be considered.

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

I welcome the hon. Lady’s statement and although she is right to take into account factors other than the health of the nation that have been raised by hon. Members, will she confirm that her primary consideration in handling this policy will be the health of the nation and that she will drive it through as quickly as possible?

[Jane Ellison]

I am the Minister for public health and as I said in my statement we are currently minded, based on the compelling evidence to which Sir Cyril alludes in his report, to proceed, but the hon. Gentleman will understand that policy is made in the round.

[Andrew Miller]

Health is what is most important.

[Jane Ellison]

Health is, of course, very important, particularly the health of our nation’s children, and I welcome the hon. Gentleman’s support.

G8 Summit on Dementia

Andrew Miller Excerpts

Thursday 28th November 2013 Commons Chamber

[Tracey Crouch]

I agree entirely with my hon. Friend. The all-party group on dementia recently produced a report on diagnosis. Shockingly, only about 42% of people get diagnosed, which leaves a massive diagnosis gap. The earlier people are diagnosed, the better their treatment and pathways.

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

I congratulate the hon. Lady on introducing the debate. I hope she will hear later some of the evidence that the Science and Technology Committee has taken on variant Creutzfeldt-Jakob disease, and of the important work of the Medical Research Council prion unit, which could lead to exciting new possibilities for the treatment and diagnosis of people with all sorts of dementia. Does she agree that it is important to maintain such research programmes?

[Tracey Crouch]

I agree entirely with the hon. Gentleman, and I will hear more later of the initiatives his Committee is examining. The importance of research is very much the basis of my speech.

Hon. Members may talk about many aspects of dementia, but I shall address four, the first of which is investment. The statistics are gloomy, but there is a good-news story underlying the negative numbers: people are living longer and people can live well with dementia. We need to capitalise on best practice and ensure that we maximise people’s ability to maintain long-term well-being, despite their debilitating condition. Although we do not have a cure for dementia, we have come on leaps and bounds in recent years. A cure is hopefully no longer a lifetime away, but to ensure that we make that cure happen, we need to take action.

Dementia costs the UK economy £23 billion a year, which is more than cancer, stroke or heart disease, but the annual research spend on dementia is about £51 million. The research spend on cancer is £521 million —10 times more—yet dementia costs society much more than cancer annually. I therefore welcome the increase in investment in dementia research through the Government’s themed initiatives, which has resulted in Government investment more than doubling over four years. However, the investment comes from a low base and represents less than 1% of the overall science budget.

--- Later in debate ---

[Sarah Newton]

I am a member of the Science and Technology Committee, and I am delighted that my Chairman, the hon. Member for Ellesmere Port and Neston (Andrew Miller), is here and has intervened. I would like to draw the Minister’s attention to some excellent work that our Committee has been doing this year. I think that some of the reports we have published will help him to prepare for the summit. We undertook a very good investigation into clinical trials and also produced a report called “Bridging the valley of death”. Both reports highlighted a very significant issue facing research, not only in the UK but globally.

As Members will know, we have an absolutely world-class science base in our country. The main challenge facing it is to overcome regulatory environments, many of which are international, to enable it to take its first-class research across the valley of death and into the development of ways of diagnosing dementia and therapies for treating it. It is very important to learn the lessons from our very extensive inquiries to enable more of this research to be commercially developed in order to find its way into the marketplace.

[Andrew Miller]

Does the hon. Lady agree that it would be helpful if the Minister could revisit the Government’s response to our inquiry on clinical trials, because we could then be a world leader and show real leadership at the summit?

[Sarah Newton]

Only yesterday, we took evidence from Professor Collinge from University College London and Professor Ironside from Edinburgh, who are leaders in the field of degenerative brain disease. They provided us with even more compelling evidence of the increasing difficulties of getting from the research stage to being able to secure enough commitment from the pharmaceutical industry and other bodies that fund research into developing the science into diagnostic and therapeutic techniques. They reported that the pharmaceutical industry, which is a massive investor in research and its outcomes, is getting far more risk-averse and, as a result, is putting many more burdens on to the research of scientists in universities—burdens that they are not really capable of taking on board. The G8’s focus on getting the companies and clinicians, as well as researchers, around the table to look at the pathways from the science into scaleable, commercialised solutions is vital.

It is important that we do this not only in our own country but internationally, because most of the regulations are international. Where there is not international agreement, that in itself becomes a barrier to research and its commercialisation. The work done at the G8 will enable there to be much larger markets, meaning that very many more people will be helped and that money will flow into the research and make it more widely available.

The transcripts from our findings yesterday will be available in a couple of days’ time. That should give the Minister a good opportunity to look at the evidence we were given by those very eminent researchers, who are undertaking research into prions, as well as looking into developments on variant CJD, which is a form of dementia, and how that links to other types of dementia such as Alzheimer’s. We need that sort of joining up across the process to enable diagnostic and preventive procedures, and therapies, to be developed. All the various scientists—

Hospital Mortality Rates

Andrew Miller Excerpts

Tuesday 16th July 2013 Commons Chamber

[Mr Hunt]

I absolutely intend to do that. As my hon. Friend knows, I have been to the George Eliot hospital, working part of a shift in its accident and emergency department. I thought the staff there were working extremely hard, under great pressure. I noticed that the hospital did not have the systems in place that others have; I believe that hospital had 16 IT systems, which meant that if someone in the A and E department needed a blood test, all the details would have to be re-entered on a different system. That takes up a lot of clinical time, so making changes in these areas can make a big difference. But I do think it is important, as we expose these problems, that we recognise that even at the 14 hospitals mentioned today good care is being provided every day and the staff in those hospitals are working very hard. We need to back them, and the best way of doing so is to give them confidence that we are going to turn around their hospital.

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

Management systems that are run on a blame culture inevitably create cover-ups and lead to people disguising the facts. Will the Secretary of State now show some leadership by trying to eradicate that from the health service? Will he take the advice Professor Ashton gave on Radio 4 this morning, because he expressed a firm way forward for the NHS? Will the Secretary of State stop playing these silly political games and follow Professor Ashton’s advice?

[Mr Hunt]

It is not playing silly political games to expose poor care; it is doing my duty as Health Secretary, and that is what I will continue to do. Improving systems, such as making sure there is safe staffing, is very important. It is ridiculous in this day and age that someone can be admitted to A and E but that department cannot access their GP record, and cannot see whether they are a diabetic or whether they have mild dementia. Those are things we are determined to sort out.

Health Services (North-West)

Andrew Miller Excerpts

Thursday 11th July 2013 Commons Chamber

[Mr Hunt]

I follow the procedures of the House, and the right hon. Gentleman should know that we did nothing different from what he did when he was Health Secretary.

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

The Secretary of State cites social deprivation as a justification for his decision on the configuration for Cumbria and Lancashire. I fully support that principle, so will he take it further by ensuring that those of us who represent constituencies in which health outcomes are much worse than those in the south of England, for example, get larger allocations of cash in future distributions of moneys? If he is going to use the principle once, he must do so consistently.

[Mr Hunt]

That is already built into the funding formula. We made reducing health inequalities a duty of NHS England in the NHS mandate, and that needs to be done in a way that is also fair to socially deprived people living in the countryside, in rural areas and even in the fringes of affluent areas. We have to find a way of ensuring that the process is fair to everyone who is socially deprived and to do what we can to reduce health inequalities.

Medical Implants (EU and UK)

Andrew Miller 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.

[Sarah Newton (Truro and Falmouth) (Con)]

Perhaps the hon. Gentleman will elaborate on some of the positive examples that the Committee found, which included the groups of orthopaedic surgeons who voluntarily shared information on different hip replacement devices and could contextualise the outcomes. The implant itself is not always responsible for the outcome—that could result from other factors to do with the medical condition of the patient or all sorts of other circumstances—but these people were able to contextualise that information in large enough sample sizes to help other surgeons to come to the right decisions about the right implants for their patients.

[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.

[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.

--- Later in debate ---

[John Pugh]

I certainly cannot. There are occasions when we talk about general topics, but I think that I am right in saying that the reasons we have estimates days is so that Parliament, as well as the Treasury, can scrutinise the nation’s accounts. I regard that as highly desirable in this age of austerity, when we need to count every penny and record the overspend, underspend, virement and so on.

I will now turn to the subject that appears to be the subject of this debate but is not actually on the Order Paper: medical devices and implants. I would like to make a few observations on what the hon. Member for Ellesmere Port and Neston (Andrew Miller) calls post-market surveillance, which we agree needs to be improved. That is obviously wholly desirable because it will eliminate problems, improve patient security and so on. I would not disagree with a single word voiced by him or his Committee. I agree that there should be more transparency and more feedback from patients and clinicians so that devices are safe and do exactly what they are supposed to do. However, we can improve regulatory vigilance. The MHRA has done a good job so far, but it obviously could do better. There is clearly a role for increased manufacturer responsibility. That is all very important.

The simple point I want to make about implants—I am not allowed to talk about the huge sums of money we are voting through—is that detecting failings is quite a complex matter. It is not as simple as it was with the breast implants, which was a case of the wrong substance being provided, which is fraud. I will illustrate my point with a real-life example. I am familiar with a case in Nottingham involving a number of unfortunate episodes that followed heart surgery in which a particular type and brand of stent was used. A number of people were called back for second operations because the stents leaked. I believe that there were a number of deaths and some litigation. Initially it was thought that the device was at fault, because it looked as though the people who had the device experienced certain problems and complications, and there had been other problems with it elsewhere. It was subject to a court case and prolonged investigation. Ultimately, the blame was attributed—this bears out the point made by my hon. Friend the Member for Truro and Falmouth (Sarah Newton)—to the surgical procedure, rather than to the device itself.

Therefore, there is a particular problem when it comes to post-market surveillance. Is it the equipment or how it is used that is responsible, because the equipment is only as good as its user? That is a particular issue in surgery, because surgeons up and down the land are very particular about what bits of kit they use and what type of equipment they work with.

[Andrew Miller]

The hon. Gentleman is making a perfect case for a proper registry. If a proper registry were maintained, one would be able to see whether the patterns of failure related to a location, which would mean it was a surgical failure, or a particular type or brand of product. He is underlining one of the Committee’s key recommendations.

[John Pugh]

I am grateful to the hon. Gentleman and pay tribute to his Committee for the work it has done. My simple point is that post-market surveillance is complex, because devices need to be judged alongside the patient experience and the clinician experience, and that gets more complex and difficult if the market for a particular device is relatively small. In the Nottingham case, the patients could not get fully informed feedback because it was neither in the manufacturer’s nor the surgeon’s interest to incriminate themselves. There was the added problem, as there is often is, that the manufacturer was in a different country from the user of the device. That is partly why products that have been found over time to be faulty in one country can still be used in another country because its regulatory body has not picked up on the problem.

This is not an easy matter, and I applaud the Committee’s efforts to get things right. I am slightly disappointed that we cannot have a wider debate on the nation’s finances. I hope that the Minister will explain what the £1.2 billion of expenditure that we are agreeing is all about, because that will be a blessing to the House.

--- Later in debate ---

[The Minister of State, Department of Health (Norman Lamb)]

I thank the hon. Member for Ellesmere Port and Neston (Andrew Miller) for the clarity with which he presented the Committee’s findings, and I thank the Committee for its valuable work.

The shadow Minister, the hon. Member for Copeland (Mr Reed), made some interesting points about the challenge of diabetes. I note his diagnosis of type 1 diabetes and the impact it has had, particularly in the run-up to the general election. It beggars belief that he had to cope with that in the middle of a campaign. He made a point about the potential power of science and devices to make a difference to patients’ lives and to save the system money—a double win that we are all after.

Before I go on to talk about points raised in the Committee’s report, let me deal with the specific point about Northern Ireland, which was raised by the hon. Member for Strangford (Jim Shannon). Most issues relating to the regulation of medical devices are UK-wide, and the MHRA operates across the UK. Some issues are devolved if they relate to the operation of the health service, and officials at the MHRA work closely with their counterparts in all the devolved Administrations. I hope that reassures the hon. Gentleman.

I will set out briefly what is currently being done to improve the regulatory system for medical devices. In October 2012, the Government began negotiations with other EU member states to revise the regulatory framework for medical devices, including implants. That will mean completely overhauling the regulatory system that has been in place for more than 20 years. The changes will take effect in 2017 at the earliest. In the interim, member states and the Commission are tightening up the most critical aspects of the current legislation. On top of the legislative changes, member states are implementing a voluntary programme of action that takes on board the lessons learned from the PIP scandal, which was mentioned earlier. However, we are not merely relying on the EU. The UK is taking its own action, including putting in place the recommendations of Earl Howe’s report, which was published in May last year. In addition, Sir Bruce Keogh’s review of the regulation of cosmetic interventions is due to report later this month.

Let me now turn to the issues raised in the Committee’s report. First, I would like to talk about the requirements on clinical data for medical devices. There are legitimate concerns about the quality of manufacturers’ clinical evidence, as well as about how rigorously notified bodies then evaluate the evidence they are presented with. The Government’s response highlights how the Commission’s proposal will address those concerns. In particular, we consider that the requirement on notified bodies to have in-house clinical expertise will be a big and important step forward that will ensure that notified bodies really scrutinise and challenge manufacturers on the quality of their clinical evidence.

I am pleased that the draft legislation requires manufacturers to comply with clear rules on clinical evaluation. It is also much clearer on when manufacturers can use clinical data from an equivalent device when conducting their own investigation—one of the issues discussed during this debate. None the less, by the end of the negotiations, we should have legislation that goes even further to ensure that notified bodies have access to high-quality clinical expertise. We do not have any detailed proposals, at this stage, but one idea is to establish an approved list of clinical experts that notified bodies must consult when assessing clinical evidence.

In addition, clinical data must be transparent, so that the procurement of devices is based on solid evidence. The hon. Member for Ellesmere Port and Neston raised concerns about this point. Current practice in the NHS means that clinicians take into account several factors before using a device, including the clinical evidence provided and the track record of the manufacturer. In the light of issues identified with some brands of metal-on-metal hips, the chief medical officer and the NHS medical director wrote to all NHS trusts in England last March asking them to ensure that there was sound clinical governance of procurement decisions about joint implants—this is the important point I want to make in response to what he said. I would expect these principles for the procurement process to apply to all medical devices used in the NHS.

It is worth highlighting how the UK is taking action, over and above the requirements of EU legislation, to support the safe introduction of new hip and knee implants into the market. Manufacturers, including Johnson & Johnson, Stryker and Biomet, have applied to participate in a pilot scheme that will give surgeons earlier and more accurate data on how well new hip and knee implants performed. This project involves close co-operation with clinicians, the NHS and the UK’s national joint registry. The MHRA is currently considering how this pilot could add value to other categories of device.

[Andrew Miller]

Will the Minister confirm that it would be perfectly reasonable, as part of the regulatory process a device must go through, for a procurement officer to ask to be notified of any failed applications to other countries?

[Norman Lamb]

It would be absolutely in order for a procurement officer to do that. The more searching their inquiries, the better, given the importance of what we are trying to achieve. We welcome the hon. Gentleman’s opinions on this issue and will consider how the system can be further strengthened. He makes a valuable contribution to our considerations.

The Government agree with the Committee about the need to improve the environment for clinical trials in this country, and we are doing a lot of work on that already. Things such as the life sciences strategy are making it easier for patients to get involved in research, and we have also set up the Health Research Authority, which is simplifying the approval process for ethical research.

To return to a point made by the shadow Minister, we wholeheartedly agree on the importance of transparency, which brings numerous benefits. I have always strongly believed that it empowers patients, informs and liberates health care professionals and builds trust in industry, notified bodies and public authorities. The proposed new European regulations will increase transparency, giving the public, patients and clinicians access, first, to clear information on the safety and performance of devices; secondly, registration information on devices and the companies that make, distribute and use them; and thirdly, information on the electronic traceability system for devices.

Furthermore, the outcome of peer reviews between different national authorities—reports from each member state on how they have monitored their notified bodies and statements from notified bodies on their independence and impartiality—will also be made public. The hon. Member for Ellesmere Port—I apologise for abbreviating his constituency—drew attention to concerns about the quality of different authorities across the EU, so this is an important step. The UK is already pushing for improvements in transparency in negotiations with other member states. For example, as we highlighted in our response, we would like to see clinical data from post-market surveillance published, so that the available information on the safety and performance of devices always remains up to date. We can do more as well. The Government’s public consultation on the proposed regulation closed on 21 January. It provided us with a lot of useful ideas, which we are currently considering in detail.

Let me turn to the issue of notified bodies and pre-market assessment. Strengthening the quality of notified bodies is absolutely one of the most important ways to improve the regulatory system. The Government agree with the Committee’s recommendations in this area. We are pleased that the Commission’s proposal goes a long way towards addressing the current weaknesses in the system. Competent authorities will review each other and share ideas on how to improve the way in which they monitor notified bodies. The Commission can take action in response to a member state’s concern about a particular notified body. There is significantly more detail on the criteria that notified bodies must fulfil, and teams of experts from different competent authorities will audit notified bodies every three years. The Government agree with the Committee that a new layer of European bureaucracy is not the solution to problems with notified bodies. We need to focus not on who carries out pre-market assessment, but on how it is carried out.

Regardless of all that, we cannot just sit back and wait for the revised legislation to come into place—it is some way off yet. As I outlined previously, we are acting before then to ensure that notified bodies improve as soon as possible. Interim action is being taken across Europe. It includes, first, joint audits of notified bodies on a voluntary basis. The first of these took place in the UK in January and many more are planned for 2013. Secondly, all member states are auditing the quality of their notified bodies that assess high-risk devices. Thirdly, rules on notified bodies and how they audit manufacturers, including undertaking unannounced inspections, are being put together.

While we strengthen the pre-market assessment of devices, it is equally important that adequate post-market surveillance and vigilance procedures are put in place. My hon. Friend the Member for Southport (John Pugh) entertained us and educated us on some important issues. He drew attention to the complexity of identifying the cause of a problem and whether it is the equipment or how it is used. That is not always easy, and the court action he referred to very much drew attention to the complexity of these issues. I am afraid that I am unlikely to be able to satisfy him on the £1.2 billion, but I liked the effort on his part.

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[Andrew Miller]

With the leave of the House, I thank the Minister for his response and thank the Members who have contributed to this short but important debate, which has underlined the value of our Select Committee structure. We have produced a report that has genuinely informed the House and that has, I hope, helped progress some difficult areas of negotiation being undertaken by the Government.

The hon. Member for Strangford (Jim Shannon) made an important point about small businesses. Next Wednesday, he will be interested to read the Science and Technology Committee’s next report on bridging the “valley of death”, which is such a complex issue for many of our high-tech businesses. The same can be said about any of the businesses described by the hon. Gentleman, which find it so difficult to grow organically in a complex business environment.

I thank my hon. Friend the Member for Copeland (Mr Reed) for his kind comments and for adopting the same spirit as we did in trying to deal with the issue in a collegiate way. Although UK plc is sometimes renowned for being the awkward squad with regard to matters European, this is an issue on which we are in a very strong position, and many of our European partners—I use that word deliberately—recognise the value of what we have done to maintain standards. We have worries with regard to only a minority of European countries.

My only concern with the Minister’s response was in respect of the black triangle issue, but perhaps we can deal with that offline at a more convenient time. I thank him and other Members who have contributed to the debate, and once again thank my Committee and its staff for their contribution to this important discussion.

Question deferred (Standing Order No.54).

[Thomas Docherty (Dunfermline and West Fife) (Lab)]

On a point of order, Mr Speaker. You, of course, are the guardian of good debate. You will have heard the comments of the hon. Member for Southport (John Pugh) about not being clear about what is and what is not in order to discuss on estimates day. Do you have any advice for Members on how we can stay in order when discussing estimates?

Oral Answers to Questions

Andrew Miller Excerpts

Tuesday 23rd October 2012 Commons Chamber

[Anna Soubry]

We know that 9% of all radical radiotherapy treatment should be delivered using forward-planned IMRT and that that should be used for and will benefit breast cancer patients. A survey of radiotherapy centres was carried out in preparation for the launch of the new fund that showed that 26% of radical activity was being delivered using forward-planned IMRT. The hon. Gentleman might say that that does not exactly answer his question and I am more than happy to make further inquiries and, if necessary, to write to him in full detail.

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

What is the Minister doing to ensure that such investments are equally accessible to people across the UK?

[Anna Soubry]

That is important. I have recognised in the short time in which I have been in my post that there is often disparity across the country and in certain areas, frankly, the service is not as good as that in others. One of our aims is to ensure that regardless of where someone lives they will get good treatment from the NHS.