Human Fertilisation and Embryology

Paul Beresford Excerpts

Tuesday 3rd February 2015 Commons Chamber

[Fiona Bruce (Congleton) (Con)]

I want to speak against the Government motion, and I draw the House’s attention to my alternative motion in part 2 of the Order Paper—page 54—although it is not votable.

Human mitochondrial disease is a dreadful condition and, as a caring society, we must do all we can to address it, and do so as sensitively as we can for those families affected by it. As a caring society, however, we must also do so in an ethical manner and with proper regard for safety. I believe that the regulations we are considering today fail on both counts—ethics and safety—and that they are inextricably interlinked.

Let me be straightforward: I do oppose these proposals in principle. However, that should not prevent my concerns regarding their safety from being given a fair hearing. One of the two procedures that we are being asked to sanction today—pro-nuclear transfer—involves the deliberate creation and destruction of at least two human embryos, and in practice probably more, to create a third embryo, which it is hoped will be free of human mitochondrial disease. Are we happy to sacrifice two early human lives to make a third life?

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

I question my hon. Friend’s definition of “embryo”. We are talking about two ova being used to create one embryo.

[Fiona Bruce]

Let me put it this way. Some may take the view that at such an early stage of human life, it is acceptable deliberately to create human embryos to then destroy them. However, the truth is that once upon a time I was an embryo and so was every other Member in this Chamber.

This debate is about the principle of genetically altering—indeed, genetically creating—a human being, and no matter how well meaning the motives, and my heart goes out to the families with mitochondrial disease, this technique will not cure that disease. That answers the question asked in the intervention on the hon. Member for Liverpool, Wavertree (Luciana Berger), the shadow Minister. This technique will not cure that disease.

--- Later in debate ---

[Mr Speaker]

I will come to the hon. Gentleman—how could I not?—but first of all, I will take the point of order from Sir Paul Beresford.

[Sir Paul Beresford]

Further to that point of order, Mr Speaker. The hon. Gentleman that introduced the point of order has conveniently forgotten that he spoke in the Back-Bench debate on just this cause, as it is in his case. He was one of the leading Members at that debate.

[Mr Speaker]

Well, that was—dare I say it?—a meaty point of order, or even a toothy one, but it was certainly a useful point of order and I am grateful to the hon. Gentleman. We must not delay indefinitely, but we must take Dr McCrea.

Blood Safety (Variant Creutzfeldt-Jakob Disease)

Paul Beresford 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.

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

I will try to be succinct after such a full introduction. That is probably possible. I can hear some puffing from the right hon. Member for Holborn and St Pancras (Frank Dobson), who was the leading light on this issue in the early days. I am delighted to see the Minister in her place, and I am sure that she is delighted to be here as well—at least she is trying to smile. She is probably aware of my long-term interest in and deep concern about the subject. I congratulate the Committee on the report, although I thought that the Department of Health’s response was at best cavalier.

I need to declare a potential interest as a dentist. For example, if the simple cold sterilisation that could be made available were brought in, as I wish it would be, as part of sterilisation of surgical instruments, it would land on me a miniature addition to my own surgical sterilisation costs.

It is probably worth spelling out what variant CJD is, as anyone reading the report of this debate will not understand that unless they have a deep interest in the subject, although perhaps one would not read the debate if one did not. Nevertheless, variant CJD is a fatal neurodegenerative disease originating from exposure to bovine-spongiform-encephalopathic-like prions; as has been mentioned, prions are small particles of protein. Prion infections are associated with long—very long—clinically silent incubations and cause a spongy degeneration of the brain with a horrible and untimely death. By long incubation, I mean decades.

It is also notable that it is probable, although not certain, that carriers might not produce the disease. Given the long incubation period, some will die of other causes first, but as we are living longer we cannot be certain that in time, after decades, the disease might not strike all carriers. Of course, carriers may unwittingly pass the prion on through blood transfusions and on surgical instruments.

Variant CJD is an appalling disease with no cure. The number of asymptomatic individuals with variant CJD prion infection is unknown, but recent research estimates carrier numbers at one in 2,000 adults, a strikingly small number. The disease poses a risk to others via blood transfusion, blood products, organ or tissue grafts, and contaminated medical and dental instruments. The response of this Government, and of the previous Government—with one notable exception further around the table—has been almost bipolar.

To make an exaggerated simplification, the first position in the bipolar response is the idea that as we have not had many recent cases there is no problem; let us wait and see. The second position is that there might be a problem so we should apply the precautionary principle. We cannot have both: wait and see is not a precautionary principle. I hope that when the Minister takes no action she recognises that the absence of evidence is not evidence of absence. Research says that one person in 2,000 is a carrier, the incubation period may be decades, some individuals are more susceptible and some may not be susceptible, although in time that may be proven wrong. Research also says prions are transmittable by blood products and by contaminated surgical instruments, as the prions resist sterilisation on stainless steel.

Over the years, the precautionary principle has been applied, and still is being applied, but only partially. Much has been done slowly over many years. Leucodepletion was introduced, synthesised clotting factors have been provided for haemophiliacs, the prion research unit was set up in Queen square, single-patient use of stainless steel endodontic reamers was made mandatory and non-UK blood supplies were sourced for those born after 1 January 1996.

The application of the precautionary principle indicates that the previous and current Governments accepted that there was or might be a problem. However, they have been partial in its application. The prion unit, with DuPont, have produced RelyOn soak, which deactivates the prion on stainless steel surgical instruments. The report questions the Government’s position on the soak and the Chairman of the Committee has done so today as well. The Government’s response on that matter was poor; I thought the last paragraph of that section was a complete dodge.

DuPont is no longer producing the soak as there is no market. There is no market simply because hospitals, clinics and surgeries in this country are not required to use it; if they were, there would be a market. DuPont and others that are developing the product might then have reason to change the soak so that it could be installed in surgery washer disinfectants, rather than being an additional stage of cleaning. In a Department of Health letter, the Government required dentists to adopt the single-patient use of stainless steel endodontic reamers. The same approach could be applied to the soak through the Care Quality Commission.

Another major failure is in the sourcing of blood products. If one was born after 1 January 1996 and needed blood products such as a transfusion, one would get non-UK-sourced plasma that was virtually certainly prion free. If one was born before 1 January 1996, one would get UK plasma and have to pray earnestly that the donor was not the one in 2,000. Imagine having two children born either side of that date. If for some horrible reason they both needed a blood transfusion, one child would get prion-free plasma and the other would take the risk. If we had a test, we could be fairly sure about excluding the one in 2,000. Professor Collinge and his prion unit team have developed a test, which has been checked by a research programme in the US and proven not to produce false positives. The final stage of that research needs to checked and tested on a large batch of anonymised UK blood samples, which needs funding. The test is one of our greatest hopes, but Ministers and the Department appear to me, and perhaps to the Chairman of the Select Committee, to have sent the test into the long grass of a series of committee inquiries where, if there is any daylight at the end of the tunnel, it is too far away to be seen. If we had the test, blood donors who were carriers could be winnowed out and special measures taken for surgery patients who proved to be carriers. Hence, three small requests to the Minister.

Will the Minister please ensure that the field is set up to enforce the use of RelyOn or its equivalent? If there is an opening for it, and if businesses know that it will be there, I am convinced that they will produce a non- frothing RelyOn that can go into the dishwashers—that is effectively what they are—that every dentist, hospital and clinic will soon be required to use.

I would like to be sure that the prion unit’s last test will be funded, because it does not look like that will happen at the moment.

We must recognise that all patients need to be treated equally from the point of view of blood products. Either everyone has UK plasma or all get non-UK plasma. Because of the evidence, until we have a test, the first alternative is a non-starter. Until we have the test, the same precautionary approach of using non-UK blood plasma for all, regardless of date of birth, is a basic requirement.

I do not want my grandchildren to be the generation that sees the re-emergence of vCJD and to ask me, if I am still around, why my generation did not act. That is not a big ask.

--- Later in debate ---

[Luciana Berger (Liverpool, Wavertree) (Lab/Co-op)]

It is a pleasure, as always, to serve under your chairmanship, Sir David. I thank the Chair of the Select Committee on Science and Technology, my hon. Friend the Member for Ellesmere Port and Neston (Andrew Miller), and the other Committee members for their extremely thorough and valuable report, and for ensuring that we have the opportunity to debate this important issue.

I think that we all agree that variant Creutzfeldt-Jakob disease is a deadly illness around which many uncertainties remain. The report “After the Storm?”, the Government’s response and this debate are welcome contributions to parliamentary and public understanding of vCJD, transfusion and prion diseases, and the Government’s action in response to those risks.

The history of blood transfusion in this country is impressive and important. The principle of freely given, unremunerated blood donation operating within the NHS, free of commercial considerations, has served this country well. It was Richard Titmuss who famously described that arrangement as “the gift relationship” and blood as

“a bond that links all men and women in the world so closely and intimately that every difference of colour, religious belief and cultural heritage is insignificant beside it.”

We have come a long way since the UK’s first voluntary blood service was founded by the British Red Cross to help the treatment of servicemen in 1921. Today, approximately 2.2 million whole blood product donations are made in the UK each year and screened for a variety of different pathogens. Those donations are tested, processed and distributed by one of the country’s four blood services. The success of the system hinges on an assurance of the very highest level of safety and risk avoidance. Sometimes, an element of honesty is important on the part of the potential donor, but even more important are procedures to protect recipients of blood and blood products from risk. We should be proud that our UK blood supply has been proven to be extremely safe. In the vast majority of cases, the benefits of receiving a transfusion far outweigh the risk of acquiring a transfusion-transmitted infection.

Sadly, however, we have reached that point only after significant tragedy. Last week, the House debated a report by the all-party group on haemophilia and contaminated blood that looked at support for the thousands of haemophiliacs who were treated with blood that carried the hepatitis C virus in the 1970s and ’80s. In the ’80s and early ‘90s, contamination of the UK blood supply with HIV led to a further 1,200 infections. Since those tragedies, all UK blood donations have been tested for HIV and hepatitis C. Those experiences are relevant to this debate, because the safety measures were implemented only after those mass infection events.

The report “After the storm?” makes a helpful distinction between the known risks that can be well mitigated and the known risks that cannot. Our existing blood safety measures are largely focused on the known risks that we can easily mitigate through measures such as testing and screening. Unfortunately, as we have heard, prions, which are responsible for variant CJD, are invulnerable to those methods, so we need to develop new ways to mitigate those risks. The key question that we have debated today is how far the Government should prioritise such research and development.

It is extremely difficult to draw conclusions, because so many uncertainties remain. However, there are several things that we know. Although it is extremely rare, variant CJD is invariably fatal, and most people die within a year of first experiencing symptoms. Recent studies indicate that tens of thousands of people in the UK could be silent carriers of the prions responsible for the disease, and they may transmit those prions to others. Cases of transfusion-transmitted variant CJD are known to have occurred although, as has been pointed out, that happened 15 years ago. The Government have acknowledged that risk.

Currently we do not use a test to detect the presence of prions, but there are emerging technologies that could mitigate the risk, such as prion filtration and the prototype variant CJD blood test. It is natural to hope that the Government will adopt a precautionary approach and support the development and introduction of technologies that have the potential to mitigate those risks. The report “After the storm?” makes concerning reading in that regard. I take on board the Government’s response that they have not reduced any of the significant steps taken since the late 1990s to reduce the potential for secondary transmission. It is also welcome that the Department continues to allocate its only ring-fenced research budget to research related to prion disease, but the question is whether that is sufficient. In her covering letter to the Government’s response to the report, the Minister wrote:

“There are competing research priorities for our limited funding”.

That must be true, but surely there can be no greater priority than assuring the safety of patients receiving blood transfusions.

The Science and Technology Committee examined several possible technologies that might be developed to militate against the transfusion of variant CJD, and I will discuss some of them briefly. The Chair of the Science and Technology Committee, like the hon. Member for Mole Valley (Sir Paul Beresford) and my right hon. Friend the Member for Holborn and St Pancras (Frank Dobson), spoke about those technologies, but I have further questions about them for the Minister. The development of a test for the presence of the prion is of enormous importance, given that data suggest that the prevalence of sub-clinical disease and infection may be as high as one in 2,000 people. Although this is disappointing, I appreciate that the Government may not be in a position to commit to a prevalence test yet. It is welcome that they have committed to seeking the views of the transmissible spongiform encephalopathy sub-group of the Advisory Committee on Dangerous Pathogens on the scientific and technical issues involved in developing such a test and on the potential value of a blood prevalence study. I would welcome an update from the Minister on how that work is progressing and when the Government will be in a position to make a decision about the value of a prevalence study.

The report examined ways to mitigate the risk of transmission of prions by surgical instruments and the Committee expressed concern about the implementation of guidance on the decontamination of surgical instruments. It is indeed alarming that such concerns exist. As we have heard from the Committee Chair and the hon. Member for Mole Valley, it should be part of local clinical governance arrangements that such a fundamental patient issue should dealt with, reviewed routinely and reported to the board of the trust.

The Government stated in their response to the very reasonable recommendation of the Science and Technology Committee:

“Accordingly, the Department will discuss with the CQC the need for the implementation of decontamination guidance to be addressed in its regulatory activity”.

I find that use of the word “discuss” a matter for concern. Decontamination should be mandated, inspected and assured. Patients might find it worrying that all the Department of Health is prepared to do is to “discuss” with the CQC the need for action on the matter. I would be grateful for the Minister’s assurance that the proper sterilisation of medical instruments will be dealt with as a matter of urgency.

[Sir Paul Beresford]

To be fair, I think that the hon. Lady should recognise that the RelyOn is not in a state in which it can be simply used. It is a wash, but if the opportunity were there, it might well be developed for the market so that it could be put into washer-disinfectors. I think that that is perhaps what the discussion is about.

[Luciana Berger]

I thank the hon. Gentleman and hope that the Minister will deal with that point. She could perhaps directly task the newly appointed regional public health directors of Public Health England to review instrument sterilisation in all trusts and report directly to her on the matter.

Prion filtration is another possible method of mitigating the risk of transmission of variant CJD. That is the process through which prions are physically removed from blood through the use of highly specific resin ligands. After recommending the use of the technique in 2009, the Advisory Committee on the Safety of Blood, Tissues and Organs decided in 2012 to rescind its initial recommendation, so prion filtration has not been adopted in the UK. The scientific decision making of the committee must of course be respected, so I do not seek to challenge its decision, but the Select Committee’s report raises important questions about the process that is followed through such reviews, and makes some important recommendations.

The report recommends, for example, that the health technology appraisals conducted by the advisory committee should use the same methodology and meet the same high standards as those undertaken by NICE, the UK’s centre of excellence for that activity. The Government have said that work to explore the differences in appraisal methodology between NICE and other health-related bodies, including the Advisory Committee on the Safety of Blood, Tissues and Organs, is being carried out through an appraisal alignment working group. I reiterate the question asked by my hon. Friend the Member for Ellesmere Port and Neston: will the Minister please give us an update on how the work is progressing and when the group will report?

The “After the storm?” report raised concerns that the scientific advisory committees are not currently independent of the bodies to which they provide advice. In response, the Government also said that they would review the terms of reference of the Advisory Committee on the Safety of Blood, Tissues and Organs and ensure that they are clarified appropriately. They said that the advisory committee is planning to amend its code of practice so that future working groups and sub-groups will not be chaired by someone who holds a senior policy-making position in an organisation if the topic under consideration relates directly to that organisation’s interests or activities. Has that work now been completed?

We should all agree that protecting the public from potential harm by transmission of the prion that causes variant CJD—or, indeed, from the transmission of any serious threat to health via our blood service—should be given the highest priority. The Science and Technology Committee has raised valid concerns that some recent Government decisions signal a change from the precautionary approach to variant CJD risk reduction of the late 1990s to a more relaxed approach today. As we have heard, significant questions remain, so I look forward to the Minister’s response.

--- Later in debate ---

[Jane Ellison]

I will say a few words about some aspects of the Collinge work later, but I want to focus on giving an update on some of the work on the assays.

[Sir Paul Beresford]

In the early days of research, a number of different tests were brought forward. To my knowledge, all have fallen by the wayside bar one. Have any of the 18 research projects come up with tests that look fruitful?

[Jane Ellison]

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

[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—

[Sir Paul Beresford]

Of course, the results would be anonymised, so the effect on individuals would not be apparent.

[Jane Ellison]

Let me move through the second question; I will be very happy to pick up on any further things in my additional response to the Committee.

The second question that the ACDP was asked was whether it would replace its current UK prevalence estimate of 1:2,000, which is based on data generated by a blood study using the MRC Prion Unit assay. In response to that second question, the ACDP also agreed that the answer to the question—whether to replace the current prevalence estimate—was no. It gave that answer because it is uncertain as to what the blood assay would measure in a general population. Even in the event that a prevalence result lower than the current 1:2,000 figure were found, the precautionary principle, which the Select Committee rightly emphasised in its report, would still apply and the 1:2,000 figure would continue to be used.

Thirdly, given its negative answers to the first two questions, the ACDP was asked what further data it would need to develop confidence in the outcome of any study using the assay. In summary, it suggested that in the first instance the assay developers work with the National Institute for Biological Standards and Control, and with others, to show that the assay can be used to identify asymptomatic infection, and with the blood services to develop the throughput of the assay. If that work progresses successfully, the ACDP will, of course, look again at the issue and we will take its advice on any potential use of the assay.

I turn briefly to the RelyOn issue, as it has been raised. RelyOn is the protein removal soak developed by DuPont, which Members have discussed. Members will recall that this technology has been fully considered by the Rapid Review Panel, which assesses new products that may be of value to the NHS in improving infection control, on two occasions.

Although the RRP raised specific points on the application of the product in practice—my hon. Friend the Member for Mole Valley well described the challenges around it being a soak—it considered that it would be a

“useful addition to available decontamination products”

if it could be correctly formulated. Obviously, it is for the developers to make a commercial decision to market the product, although I have noted what has been said about where DuPont is with that. It is not within the remit of the RRP to influence procurement and the uptake of products in the NHS, but we would always be willing to discuss with manufacturers the potential for adoption of all effective technologies.

The Minister for life sciences, my hon. Friend the Member for Mid Norfolk (George Freeman), takes seriously the ensuring of rapid access to innovative therapies. It is a large part of his portfolio, and that is why he launched the major review of the pathways for the development, assessment and adoption of innovative medicines and medical technology. That very much goes to the point made on whether the process can be speeded up to make it more easily usable.

The review will consider how to speed up access for NHS patients to cost-effective new diagnostics, medicines and devices. It will set out short and long-term options for action by the Government and relevant bodies, including the National Institute for Health and Care Excellence, the Medicines and Healthcare products Regulatory Agency and NHS England. That will make a major contribution to the policy debate and may well answer some of the points made on this piece of technology.

[Sir Paul Beresford]

I thank the Minister and apologise for being persistent. DuPont undertook the work because it thought there was a market. When the Department backed away from the market and it became apparent that, if developed, the product was not going to be put through as a requirement, perhaps through the Care Quality Commission, DuPont stopped. There was no market and no interest, so it stopped the project.

[Jane Ellison]

I understand the point. We have debated it before, and it was explored in the meeting with him and Professor Collinge. As I said, the Department was happy to discuss the potential for adoption with manufacturers, but the hurdle was the Rapid Review Panel’s rating. That work is ongoing and has moved on in the past year or so. The new Minister for life sciences acknowledged that there are sometimes challenges around the adoption and the speed with which large organisations can adopt these things, and I am happy to keep Members updated on that work.

There is a well established process whereby the Rapid Review Panel assesses potentially useful products. Those achieving a level 1 rating are suggested as suitable for NHS use. It was acknowledged by the DuPont representative on 5 March that RelyOn had reached only the level 2 rating and more work was needed. It would be unfair on the manufacturers of other level 2-rated products to change unilaterally the RRP processes for one product. As it stands, it is not formulated in a way that could be used in standard NHS decontamination processes.

In my remarks, I have offered a potential route forward and an assurance that the area is being carefully looked at by my colleague the Minister for life sciences. He is looking not only at soaks, but devices, other diagnostics and other medicines. I am happy to draw to his attention the view of the Committee and other Members that this product might be an example of where adoption has been delayed or held up.

We have undertaken to give the Committee a detailed update before the end of March on the other points that have been raised. I thank the Committee again for bringing this subject for debate. I am glad I have had another chance to put before Members some of the recent and ongoing developments and to commit to continuing to use our extensive research strategies. I stress, particularly to the Chair of the Committee, how seriously this Government and successive Governments have taken the subject. It was interesting to hear some of the history from the right hon. Member for Holborn and St Pancras. We will update Members shortly.

Thank you, Sir David, for giving me the opportunity and reminding me that I had time available to respond in a little more detail than I thought I could. I thank you, the Committee and Members who have attended the debate.

General Dental Council

Paul Beresford Excerpts

Tuesday 9th December 2014 Westminster Hall

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

I am delighted to have the opportunity to air my concerns—although, because of the time restrictions, only some of them—about the General Dental Council. I am particularly delighted to see the Health Minister who is responsible for, among other things, regulation. I fear that, due to a quirk in the law, he may not be able to help me too much today, but any general hints will be gratefully received.

I must commence with a small selection of declarations of interest. First, as a registered dentist, I am subject to the dental regulators. Like other dentists in my position, I pay their annual fees and I am subject to their regulation. Secondly, I have a link with Lockton, an insurance broker specialising in professional indemnity, including insurance, for a growing number of dentists. Thirdly, I chair the all-party group on dentistry. Finally, as one can imagine, because of all that, I am under considerable pressure from a number of dental groups, some of which I am a member of, numerous dentists—the e-mails flooded in when this debate was announced—and dentistry-related organisations that wish this debate to take place.

As the Minister is aware—although you may not be, Mr Hollobone—the two main regulators of registered dental practitioners are the Care Quality Commission and the General Dental Council. They serve slightly different functions, although there is a feeling among the profession that they overlap. Both are funded by fees paid by dental professionals.

Virtually every registered dental professional, along with their organisations and registered staff, accepts and believes—as do I—in the need for dental regulation. On arrival as inspector of dental surgery, the CQC, although initially feared, spent some time finding its way. Many practitioners may not agree, but my personal feeling is that the CQC has become progressively more proportionate and tends to encourage the raising of standards, rather than riding in on practices in a heavy-handed way. In comparison with the GDC, the annual fee that I paid to the CQC for the next financial year dropped by 20%.

Also in contrast to the CQC, the reputation of the GDC has drastically deteriorated among the profession over the last year or so. The situation was foreseen in 2009, when Rick Haythornewaite, the then highly respected chairman of the Risk and Regulatory Advisory Council, gave a lecture to the GDC entitled “A practical approach to risk for 21st century regulators”. It is worth quoting a fairly long paragraph from that speech:

“When regulators get it right the customer and the public enjoy the advantage of choice, feel the benefit of unseen protections; when they get it right these people who serve the customer and public, whether they be company employees or they be professional service providers such as yourselves or whoever else, feel motivated, they feel empowered to perform, to innovate, to adapt. When they get it wrong though, the customer and the public feel the straitjacket of unnecessary regulation, the weight of disproportionate interventions and the frustration of curtailed civil liberties.”

That last sentence should be printed in a large font, framed and placed on every wall in every room at the GDC.

The Professional Standards Authority regularly reviews the GDC. Its most recent report stated that the GDC failed to meet two out of five standards for registration and six or seven standards out of 10 for fitness to practise procedures. Although I have not delved deeply into this, it would appear that the report indicated that the independence of the GDC investigating committee was in danger of being compromised. If so, that could reflect both on public protection and on fair consideration for referred dental practitioners. Among the profession at least, and to some degree outside it, there is a feeling that the GDC is—to use a hackneyed phrase—not fit for purpose.

Concerns were bought to a head when on 30 June the GDC embarked on a consultation concerning the proposal to raise its annual retention fee by 64%—and this in an atmosphere throughout the nation of financial restraint, with enormous pressure by Government to restrain fee rises among public bodies and organisations. As someone with considerable interest in the efficiency of local authorities, so as to keep local taxes down—which, incidentally, most have managed to do in the current environment—I believe that any increase over 1% is irresponsible. The outcry among the profession was considerable, particularly as many registrants do not normally criticise the GDC because their vocational life or death depends on it. The vast majority of complainants asked the GDC to justify the increase, as did leading dental organisations, including the British Dental Association.

At the last minute, the GDC postponed its decision and announced that it had commissioned KPMG to prepare an independent and “full review” of the assumptions underlying the suggested fee increase in the consultation. On behalf of its members, the BDA sought sight of the instructions to KPMG and a list of documents provided for its assessment—not an unreasonable request, bearing in mind that the BDA represents dentists who have to pay the fee. They were not forthcoming and freedom of information requests were refused.

The BDA had definite suspicions that there was a paucity of clear figures and that misleading data had been included. It maintained that no clear business case had been made for any increase. It was not alone in those suspicions, which were later compounded when the KPMG report apparently—although I have not had access to it—assessed that many of the key assumptions contained

“high levels of estimation uncertainty”.

The Australians have a short, sharp phrase to cover that English expression. In the event, the GDC lowered the increase from 64% to 55%. The bill is sitting on my desk at the moment.

KPMG’s advice alone leads to questions about the original proposal and the thinking behind it. I understand that the main reason given by the GDC for the rise is that it is because of the substantial rise in patient complaints and the immense cost of fitness to practise investigations and procedures. To my horror, I discovered that many investigations take 18 months, leaving the patient and dentist hung out to dry for the whole period.

In case the public were unaware, the GDC took out a full-page advertisement in one of the national papers encouraging complaints—or, perhaps I should say, “advising patients how to complain”—to the GDC. From my years of experience in indemnity protection, I know that the first and most successful avenue of complaint from a patient is the dentist or dental professional. Most, if not all, dental and medical indemnity providers assist practitioners in resolving complaints. They are exceptionally competent at that, and resolution covers many of the complaints, which therefore do not need to progress to the GDC, unless it is encouraged. As any MP will understand from their experience of constituency complainants, dental professional complaints vary from the deeply serious to the vexatious and the frivolous.

Many years ago, when I used a purple-coloured impression material, one of my lady patients claimed the next morning that the whole of her mouth and lips had turned purple overnight. I immediately asked her to return to the surgery. Approximately an hour later, she telephoned to tell me that it had all gone away as she drove from the heights of Hampstead towards central London. She put it down to the change of air pressure as she came down from her elevated Hampstead home. Needless to say, on completion of her work and after submitting an account, she replied with a writ. With the assistance of my then indemnifying organisation, we arranged for a senior consultant to review her situation. The problem was resolved when the consultant referred her to Guy’s hospital for dental and psychiatric treatment. The bill remains unpaid.

The resolution approach is implicitly encouraged by the CQC, which requires practices to keep a complaints file setting out complaints and how they are dealt with by the practice. Complaints to the GDC about private dentistry go through a triage and resolution system. As a result, many do not progress further. In particular, they do not progress to fitness to practise hearings. However, it appears that national health service complaints to the GDC almost certainly plough straight into the full procedure, leading to fitness to practise hearings. For the patient and the practitioner, these are generally long, drawn out and draining. For the dentist and his or her indemnifier, the costs can be ghastly, adding to the professional’s fear and emotional trauma.

Particularly in these days of complicated dental procedures, I have severe doubts on occasions that the committee members, whether lay or professional, have sufficient knowledge to make a decision without help. That help is drawn by the GDC from experts—or, should I say, so-called experts. In a few cases, the so-called experts are making a career professional career out of producing condemnatory reports for the GDC.

One practitioner I know well, who has considerable postgraduate expertise combined with the appropriate degrees from that postgraduate work, was taken apart by a so-called expert who did not appear to have the appropriate degrees or experience. I looked at that expert’s website, which contained considerable references to the large numbers of reports that he undertook for the GDC. He appeared to be making a side career out of aggressive reports on behalf of the GDC against the professionals. After a protest to the GDC, it accepted a second expert report, which was dramatically different and was to the benefit of my colleague.

I accept that, at last, the GDC is taking, or seeking to take, steps to reduce costs. It claims that it needs legal changes to be able to use the same service for private dentists as it does for to the NHS. I find that a little wrong; nevertheless, the Government have accepted that to some degree and are introducing a section 60 order that will legalise that change. That does not seem to be reflected in the GDC estimate and predictions. It claims that the increase in complaints will require an additional £18 million.

My experience of cost-cutting in the public service tells me that some lateral thinking on expenditure, by looking at small as well as large costs for efficiency improvements, can be productive. On small costs, this example may not apply now, but a few years ago I helped to organise a reception for an international oral surgery cancer symposium. I was offered the opportunity to attend for free, but on looking at the agenda, I realised that, in spite of my not inconsiderable understanding of oral cancer, the proceedings were beyond my education. Imagine my surprise to hear that two or three lay members of the GDC were attending the two or three-day conference. The likelihood of their education on the microscopic structure of various oral cancers being of any use to their role on the GDC was, to say the least, remote. However, I assume that the GDC paid for their not inexpensive hotel rooms, plus travel and two or three meals a day, as well as the cost of attending the conference.

In a more substantial area, I understand—again I am a little cautious, because I may be wrong—that the GDC is undertaking a total review and refurbishment of its property. The funding for that, I understand, has come from balances rather than through a loan or mortgaging system, which would have spread the costs and allowed its balances to be used to buffer expenditure as new procedures and cost savings, which it claims to be looking for, were installed.

I am interested the GDC’s involvement in allowing—I use that word carefully—the Department of Health and the Minister to look at its finances, savings and its justification for the proposed increase in the annual retention fee. That interest extends to whether the legislation on health regulators, which has been drawn up for possible implementation after the election, will for the first time allow direct Government and ministerial influence on the GDC and, in particular, its fees. I fail to be convinced that it has really looked sufficiently at its costs and procedures in seeking savings. It appears to me that, under attack, the GDC has started to become reclusive and adopted a bunker mentality. I understand that hearings and council meetings are increasingly held in private, which is all the more alarming when its chairman, in delivering the annual Malcolm Pendlebury lecture, appeared to be seeking to expand its areas of operational interest.

Good professional dentistry and medicine is built on good relationships with patients and on trust and confidence between the professional and their patients. This has improved dramatically over the last few years. The GDC should have a role in that, but its image in the eyes of the profession—and, I believe, as consequence of its procedures, patients—has reached an all-time low. The dental profession’s trust in this regulator has gone. I suspect that the patients’ trust will follow in due course.

--- Later in debate ---

[Dr Poulter]

As I said, under legislation, I am unfortunately powerless to intervene directly on fee setting. We recognise the independence of health care regulators and would not want them to be micro-managed by Government; that would be wrong. However, my view is very clearly, as I have outlined, that a strong evidence base is needed to justify a fee rise. Given that other health care regulators faced with similar challenges have not raised their fees to the same unprecedented degree, I have not myself been convinced that the evidence base is strong enough to justify this fee rise. I hope that that answers the hon. Gentleman’s question.

In that context, it is worth drawing attention to the section 60 order currently in progress in the House, and to the consultation process that has been taking place. The fee rise is perhaps all the more surprising as we are making good progress with the GDC on bringing in the legislative changes that will reform the way that it operates. Those changes, in the form of a section 60 order, will assist with reducing its operational costs by an estimated £2 million a year through potential efficiency savings. My hon. Friend the Member for Mole Valley made the point that all regulators need to look at better ways of working and efficiency savings in their own practice. Of course, that, as well as patient protection, is a benefit of introducing a section 60 order: it will help to reduce the running costs, potentially, of the GDC and streamline processes.

The public consultation on the GDC-related section 60 order recently closed, and the vast majority of respondents were supportive of the proposals. We therefore intend to proceed with the measures and will publish our response to the consultation in due course. My hon. Friend may be surprised to learn, as I was, that the GDC did not wait for the outcome of the section 60 order consultation before announcing the fee rise.

The changes proposed in the section 60 order will: enable the GDC to delegate the decision-making functions currently exercised by its investigating committee to officers of the GDC, known as case examiners; enable both case examiners and the investigating committee to address concerns about a registrant’s practice by agreeing undertakings with that registrant, which have the same effect as conditions on practice, without the need for a practice committee hearing; introduce a power to review cases closed following an investigation—rules to be made under that power will provide that a review can be undertaken by the registrar if she considers that the decision is materially flawed, or new information has come to light that might have altered the decision and a review is in the public interest—introduce a power to allow the registrar to decide that a complaint or information received did not amount to an allegation of impairment of fitness to practise; introduce a power to enable the investigating committee and the case examiners to review their determination to issue a warning; and ensure that registrants can be referred to the interim orders committee at any time during the fitness to practise process.

Very similar section 60 orders have been laid before Parliament in conjunction and consultation with other regulators, and a great benefit of those orders is that they are about not just protecting the public but supporting the regulators to have more streamlined processes and reducing costs. Of course, when costs are reduced, we would always expect the savings to be passed on to the people who pay the annual fee.

[Sir Paul Beresford]

Is there evidence that the other registering organisations have reduced their fees, or keep them down, in the light of the anticipated savings, which would be sensible?

[Dr Poulter]

If we look at similar organisations, we see that the GMC, for example, has similar practices and processes. The Nursing and Midwifery Council has a very small fee rise, but has seen a similar section 60 process take place. All those regulators, in my view, have taken every step possible to look at their annual fee in the context of the section 60 orders, and with the mindset that any fee rise needs to be fully evidence based and appropriately proportionate. From my conversations, and from the practice of other health care regulators, I think that there is very good evidence that that is a consistent pattern of behaviour. As I said, the GDC’s fee rise is unprecedentedly large, and its behaviour is not consistent or in keeping with that of any of the other health care regulators, from what I can see.

In addition to the GDC-related section 60 order, the Government are taking forward a number of key pieces of secondary legislation in this Parliament to address priority areas that we have identified after discussion with the regulatory bodies and other stakeholders; I mentioned other section 60 orders. We are also working on a response to the Law Commission’s valuable work on proposals for more wide-ranging reforms.

I am aware that the decision not to progress a professional regulation Bill in the current Session has come as a disappointment to interested parties. However, that decision provides an opportunity to invest time in ensuring that that important legislative change is got right, for the benefit of those who will ultimately be affected by it. My hon. Friend outlined very articulately some of the challenges that need to be considered in putting together the Bill. We are committed—I would like to put this on the record again—to bringing forward primary legislation to address wider reforms to the system of professional regulation when parliamentary time allows, but in the meantime, working with the regulators, we have put in place, or have in train, a number of section 60 orders. They are about streamlining processes, providing efficiencies to the regulators and, most important of all, protecting patients and the public.

Let me say a quick word about the GDC’s general performance. It is very important that the GDC manages its rising volumes of complaints as well as the other issues raised by the Professional Standards Authority as part of its annual performance review. In due course, the GDC will need to demonstrate what it has done to address the recommendations made.

Hon. Members may be aware that the Professional Standards Authority is also conducting an investigation of the GDC after claims were made by a whistleblower about the management and support processes of the GDC’s investigating committee. I understand that the Professional Standards Authority has concluded the evidence-gathering phase of the investigation, is in the process of compiling the investigation report, and will provide that report to the Select Committee on Health and publish it on its website in due course.

I have outlined a number of issues and concerns about the unprecedentedly high rise in the GDC fee. As we have discussed, it is out of keeping and inconsistent with the behaviour of many other health care regulators. I am not convinced, from the evidence that I have been presented with, that there is a strongly evidenced case to support that fee rise, and it goes against Government policy, which is to encourage regulators to set appropriate and proportionate fee rises, to show restraint where appropriate and to be mindful of the effects of fees on registrants.

I want to make it clear, in drawing to a conclusion, that I am not raising any doubt about the fact that the GDC continues to fulfil its statutory duties. However, it will need to make significant improvements to meet the challenges set out in the annual performance review undertaken by the Professional Standards Authority. Registrants, patients and the public need to be able to have confidence in the performance of the GDC and to see improvements in its operation, effectiveness and efficiency. I hope that I have answered all the points raised in the debate, and I again thank my hon. Friend the Member for Mole Valley for raising a very important issue that I am sure is filling many MPs’ postbags.

Mitochondrial Replacement (Public Safety)

Paul Beresford Excerpts

Monday 1st September 2014 Commons Chamber

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

Perhaps I could turn the last comment the other way round. I do not want to be standing here, or sitting at home in my dotage, saying, “Why didn’t we do something when we could have?” That is what we are looking at. We have the same problems with many issues relating to human fertilisation and embryos. We have heard these arguments in the House before. We have heard the speculation and the unsupported fears. Although I congratulate my hon. Friend the Member for Congleton (Fiona Bruce) on raising this debate, the scares that she raised are as unsupported as anything we have ever heard. I also congratulate my right hon. Friend the Member for Havant (Mr Willetts) on his contribution. He saved us an enormous amount of time because he covered the key points and nailed them to the floor. The right hon. Member for Holborn and St Pancras (Frank Dobson) reminded us just how long we have been examining this issue. Action is now overdue. I will now completely ruin the political career of the hon. Member for Cambridge (Dr Huppert) and say that I support him.

Today, we are talking about a real opportunity to help thousands of children by taking out of the system, over time, an inherited condition. We are talking about a gene transfer through nuclei, and the 0.1% that was mentioned is motor functional; it is not inherited genes. It is an opportunity to have two parents and not, as the media would have it, three parents.

The media has to take some of the blame. We have discussed these complex issues of fertilisation and embryos and so on, and the scaremongering has been appalling. There is scaremongering not only by individuals—I am not necessarily talking about the ones who write in green ink—but by the media. I was shocked to hear this nonsense about three-parent babies, on which the hon. Member for Cambridge touched. We are not talking about three-parent babies. This is an opportunity to put through these regulations. We are a bit early because we have not yet seen them or the results of the consultation. We have not even seen the Government’s reaction to them. None of us here—not even the hon. Member for Heywood and Middleton (Jim Dobbin) who spoke about the American situation—knows what will happen or is an expert on the matter. None the less there are experts who are reviewing this and coming forward with recommendations. They know and understand the subject a lot better than we do. We have to take their guidance and expertise. By the way, a comment was made about the Americans putting this matter on the backburner, but that was a different situation from what is under discussion now.

[Steve Baker (Wycombe) (Con)]

My hon. Friend is making his argument with characteristic force. I am just mindful that in the Library brief there was a particular insight from an evolutionary biologist suggesting that there was a real danger of DNA mismatching between the mitochondrial DNA and the nuclear DNA. Is he satisfied that the insights of evolutionary biology have been fully and adequately taken into account in this area?

[Sir Paul Beresford]

If my hon. Friend looks at the research, I think he will find that that will have been looked at. From my limited knowledge—my knowledge is limited but it may be slightly greater than that of my hon. Friend—I suspect that such a mismatch would mean that the nucleus and the cytoplasm with the mitochondria would fail and an ovum would not be produced from it, but I could be wrong. I am speculating in the same way as my hon. Friend did. At the end of the day, we have an opportunity to change the rules to allow this research to progress. We must recognise that we have some of the best teams in this field in the world. We lead the field, and this provides us with an opportunity to continue to lead for the benefit of those many children. It will enable us carefully to continue with the research with the appropriate safety factors built in, so I am adamantly opposed to the motion.

[Several hon. Members]

rose—

Head and Neck Cancer

Paul Beresford Excerpts

Tuesday 1st July 2014 Commons Chamber

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

I thank my hon. Friend the Minister for coming. She is smiling slightly, because we have had this discussion on a number of occasions and it will continue, at least until I get my way, if that is at all possible over the coming years.

I must begin by declaring a short list of potential interests. I am still a part-time practising dentist—very part-time. I am also chairman of the all-party parliamentary group on dentistry and the APPG on skin, which has a link to this debate.

In an earlier debate, I focused on oral cancer and, in particular, on the causative role of the human papillomavirus. I have been trying to persuade the Minister to encourage the Joint Committee on Vaccination and Immunisation, or JCVI for short—don’t the medicos always do that?—to broaden its horizons beyond the inoculation of teenage girls against cervical cancer. The results in relation to cervical cancer are very encouraging, but the virus is key to the cause of many other cancers, and that applies predominantly to two variations of it.

In a previous debate, the Minister was very nice, and explained sweetly that I must rely on the advice of the JCVI—or, at least, that she must do so. She explained that the committee was expanding its sights. Although it was enlightening to hear that it would be examining the HPV-related effects of men having sex with men, it did not help me very much because I am looking beyond that. I think that the committee should be looking above the waist, and, more specifically, looking at the trauma of pain, suffering and death—a very horrible death—as well as at the financial costs to the NHS of the existence of the virus elsewhere in the human body. I am aware that the virus plays a part in skin cancer, but I have decided to concentrate on the head and neck.

A quick cruise through the latest papers on head and neck cancer makes for frightening reading. Despite the reduction in smoking, the number of head and neck cancer cases is rising steadily and rapidly. The stark reality is that the number of new cases is growing year on year, at a much higher rate than the experts expected. Some are talking of an epidemic. The problem is now so acute that one form of cancer which falls into the “head and neck” category, oropharyngeal cancer, is the fastest-growing cancer in Scotland, and is a significant and growing problem in the rest of the United Kingdom.

[Jim Shannon (Strangford) (DUP)]

I congratulate the hon. Gentleman on raising this subject. In the past year in Northern Ireland, 1,218 people have been diagnosed with head and neck cancers, and 64 people die of such cancers every year. Does he think that that is because this is seen as a lesser cancer—if that is the right way in which to put it—than others which seem to catch the eye of the public? If so, does more need to be done to increase the focus on head and neck cancer?

[Sir Paul Beresford]

I am focusing on it, because worldwide it constitutes about 5% of cancers and causes 6% of the deaths, and because, as I think is generally accepted, in a large proportion of cases HPV is a causative agent, or the root cause. There is a way of dealing with that and I think that we ought to adopt it.

In the United Kingdom, the latest findings put the incidence of HPV at 23.5% for oral cancer, 35.6% for oropharyngeal cancer, and 24% for laryngeal squamous cell carcinomas. I have no data for skin cancer, but obviously it applies to head and neck skin. On a personal note, my brother-in-law recently died from a squamous cell carcinoma on his head, which was undiagnosed and untreated, and when it was found it was too late. Head and neck cancers are fifth in the global rankings of cancer incidence, and sixth in the global rankings of cancer deaths.

The cost of oropharyngeal cancer to our health services is enormous. A new report is due to be published following extensive research on the economic cost of head and neck cancer. The findings of the research suggest that the official estimate of the burden placed on the national health service is significantly less than the actual total. The data I have seen of the report that is coming out soon conclude that the cost of oropharyngeal cancer was approximately £115 million at 2011 prices, laryngeal cancer £96 million and oral cavity cancer £98 million. The total at 2011 costs is just under £310 million. We must add that that is almost certainly low because of under-reporting, that we have three years of inflation and, worst of all, three years of increasing numbers of cases. I am not sure, but I suspect that that does not include peripheral rehabilitation costs such as physiotherapy and speech therapy and some cosmetic dentistry in appropriate cases, nor does it cover the unquantifiable cost to quality of life, with the pain and disfigurement that much head and neck cancers produce, and the treatment that is required peripherally for patients.

Perhaps what is most surprising—I have only just discovered this—is that these cancers are more prevalent in men than women at a ratio of approximately two to one. It is common knowledge that the NHS is under immense financial pressure. In fact, demand for access to the NHS is at unprecedented levels. The Government have taken commendable steps towards ensuring that the health service is protected from spending cuts, which have been necessary in so many other areas, but that does not mean budgets have not come under pressure and resources have not been stretched. It is therefore a matter of the very gravest concern that the full economic burden of head and neck cancer, and by extension HPV, is not taken into account. It should be. The whole of the problem of HPV and the way it infects different parts of the body should be addressed by the Joint Committee on Vaccination and Immunisation.

Australia has a policy of vaccination of both males and females. That is producing what is called a herd immunity. Although I am specifically looking at head and neck, with the role of the HPV virus, it is quite clear that there could be a dramatic reduction in a number of cancers, including head and neck cancer, over time with gender-neutral vaccination. Clearly, men currently face a significantly greater, and rising, risk of HPV-associated head and neck cancers.

I therefore again put it to the Minister that it is not fair, ethical or socially responsible to have a public health policy that leaves 50% of the population vulnerable to infection. Such vaccination, combined with early detection and action on smoking and heavy drinking of alcohol, could save a huge number of lives just as we are facing a dramatic increase in head and neck cancer. I hope that the Minister will be able to persuade the JCVI to broaden its horizons and to look at the human suffering, as well as the total costs of HPV to our national health service.

[The Parliamentary Under-Secretary of State for Health (Jane Ellison)]

I congratulate my hon. Friend the Member for Mole Valley (Sir Paul Beresford) on securing this debate on this important issue and on continuing to champion it. It shows Parliament at its best when Members bring to bear here the expertise and insight they have acquired outside this place, and that is certainly what my hon. Friend is doing and I commend him on it.

Let me set the scene before dealing with some of my hon. Friend’s specific concerns. As he said, we have debated this issue before and I am anxious to try to keep him up to date with any developments as well as to make sure the House has a general picture of what we are doing in this area.

The Government want England to lead the world in tackling cancer. That is why our 2011 cancer outcomes strategy set the ambition to save a further 5,000 lives a year from cancer by 2014-15, including head and neck cancer. As my hon. Friend rightly said, the incidence of head and neck cancer has been increasing since the 1970s, with over 6,500 people in England diagnosed with oral cancer alone in 2012. That is due to the prevalence of the major risk factors for oral cancer, such as heavy alcohol consumption and smoking. Chewing betel quid, which is more common among south-east Asian communities, is also a risk factor for oral cancer and that may have contributed to the trend. As the House knows, we have major programmes of work in place to tackle smoking and excessive alcohol consumption —and it is heartening that, although there is a long way to go yet, we did see smoking prevalence rates dip below 20% for the first time in England in the most recent figures.

There is now growing evidence that HPV, already linked to the development of nearly all cervical cancer in women, is also a major risk factor for oral cancer. That is not disputed. The types of HPV that are found in the mouth are almost entirely sexually transmitted, and they have been associated with about a quarter of head and neck cancers. So if we can reduce the incidence of HPV in females through a high uptake of the national vaccination programme, a reduction of other HPV-associated cancers in females and males is likely to follow. I note, however, that my hon. Friend feels that that herd immunity is not going far enough and there is further to go. It is worth restating that the aim of the current HPV vaccination programme is to prevent cervical cancer related to HPV infection—that is where it started. When introducing the vaccine in 2008 the Joint Committee on Vaccination and Immunisation, which advises the Government on all immunisation matters, did not recommend HPV vaccination for boys because the reasoning was that once 80% coverage among girls had been achieved there would be little benefit in vaccinating boys to prevent cervical cancer in girls.

Judged by any standard, the HPV immunisation programme has been very successful. More than 7.8 million doses have been given so far in the UK since 2008, and we have among the highest rates of HPV vaccine coverage achieved in the world. I encourage hon. Members to look at their own local statistics, because although we achieve a very high average vaccination rate, there is some local variation. That matter is worth pursuing, particularly with schools, as this vaccine is delivered in schools almost universally. Some 86% of girls who are eligible for routine vaccination in England in the 2012-13 academic year have completed the three-dose course and 90% have received at least two doses, but in some schools the rates are lower and we want to get those up.

There is an increasing evidence base on the association between the HPV infection and oral, throat, anal and penile cancers, and on the impact of HPV vaccination on those infections. As a result, the JCVI issued a call for evidence in August 2012 to inform a review of HPV vaccination. The JCVI is very much aware of the issues concerning HPV vaccination for men who have sex with men, and at its October 2013 meeting recognised that the current immunisation programme may be of little benefit to those men and agreed to create an HPV sub-committee to consider the evidence for extending that vaccination programme. The sub-committee will aim to identify and evaluate the full range of options.

[Sir Paul Beresford]

The Minister has just talked about extending the programme, but to what or to whom?

[Jane Ellison]

On to my next paragraph. The sub-committee will look to identify and evaluate the full range of options for extending the protection from HPV infection to men who have sex with men, including by vaccinating them, and the potential extension of the programme to include adolescent boys. That deals with the point my hon. Friend was making. The JCVI HPV sub-committee—I apologise for all the acronyms but they are inevitable in a health debate—met for the first time on 20 January 2014 to review the available evidence on the impact and cost-effectiveness of potential extensions to the HPV programme. Any recommendation by the JCVI must be based on cost-effectiveness; there is a particular formula it uses to look at that within our health economy. The sub-committee will report its findings to the JCVI following consideration of a yet to be completed study by Public Health England into the cost-effectiveness of extending the HPV vaccination in both those directions. I hope I can give my hon. Friend some reassurance by confirming that the study will consider the impact of vaccination against penile, anal and oropharyngeal—head and neck—cancers and genital warts. Those things definitely form part of the studies that will be made and of the calculation about cost-effectiveness. There is no evidence to suggest that the current HPV vaccines will offer protection against skin cancer—I do not know whether he wishes to develop things further in that area, but we are aware of no evidence that makes that link.

The decision on the vaccination of adolescent boys requires the development of complex models to determine whether or not it would be cost-effective. Obviously, this would mean extending an already big programme to a much larger group. These models may identify a need to generate additional evidence, and therefore a decision on vaccination of adolescent males is not likely before 2015 at the earliest.

[Sir Paul Beresford]

One difficulty with models is that they take absolutely no account of the unpleasantness of the disease and the damage it does. Head and neck cancer is one of the most frightful conditions to deal with and to live with.

[Jane Ellison]

My hon. Friend makes a good point, but I will have to come back to him on it. I will not speculate at the Dispatch Box. Many factors go into these calculations, but I will make inquiries with regard to other JCVI decisions. I think that the severity of effect is taken into account and is part of the calculation, but I will clarify that and come back to the hon. Gentleman. None the less, he is right to remind the House of that matter.

The evidence to support a decision on a selective programme to target men who have sex with men may become available at the end of this year, which is earlier than expected. Obviously, the Department will consider carefully the advice from JCVI once the Committee has completed its assessment. As that is all in the future, it is worth talking about some of the things that we have at our disposal now in terms of early diagnosis. In addition to taking steps to tackle unhealthy lifestyle factors and the virus linked to head and neck cancer, we have also set out, through the mandate to NHS England, a clear ambition for the NHS to improve outcomes for all people with cancer.

One of the most common symptoms of oral cancer is a persistent sore or lump on the lip or in the mouth, so there is an opportunity for both doctors and dentists to play a role in supporting earlier diagnosis.

Since 2005, the referral guidelines for suspected cancer, published by the National Institute for Health and Care Excellence, has supported GPs to identify symptoms of oral cancer and urgently refer patients. The National Institute for Health and Care Excellence is currently updating that guidance to ensure that it reflects the latest available evidence.

[Sir Paul Beresford]

With great respect, on the question of the sore or the ulcer, the problem with cancer is that it is not sore until it is too late.

[Jane Ellison]

I will reflect on that point. I do not pretend to have the hon. Gentleman’s professional expertise. He has corrected the record, if he feels that it needs correcting. I hope that he will not disagree with me when I say that dentists have a key role to play in the early detection of oral cancer.

[Sir Paul Beresford]

indicated assent.

[Jane Ellison]

All dentists are trained as undergraduates to look for such signs during routine check-ups and to pay close attention to patients’ self-reported history of smoking and drinking—both key risk factors. A new patient pathway, currently being piloted in 94 practices, includes an oral health assessment, which requires dentists to examine the soft tissue of the mouth; assess a patient’s risk in relation to oral cancer; and offer advice on lifestyle changes.

I am also pleased to say that the General Dental Council has confirmed that improving early detection of oral cancer is to be included as a recommended topic in its continuing professional development scheme.

The hon. Gentleman will also be aware that the Department has run a series of “Be Clear on Cancer” campaigns, and we keep all forms of cancer under review to see whether they might be considered within that campaign. As he made the case that oral cancers and head and neck cancer are becoming more common, they too will be kept under review.

As I have mentioned in previous debates, the NICE improving outcomes guidance in head and neck cancer, which was published in 2004, provides advice on the organisation of health care for adults with those cancers. Head and neck cancer has also been referred to NICE as a topic for quality standard development.

The NICE guidance has informed the development of NHS England's service specification for head and neck cancer, which was published last summer. This clearly sets out what NHS England expects to be in place for providers to offer evidence-based, safe and effective services.

Of particular relevance to patients with oral cancer is the £23 million radiotherapy innovation fund, which supports the radiotherapy centres across England to deliver increased levels of intensity-modulated radiotherapy. That is a more precise form of radiotherapy, which reduces the risk of patients with oral cancers suffering from a permanent dryness of the mouth as a result of treatment.

NHS Investigations (Jimmy Savile)

Paul Beresford Excerpts

Thursday 26th June 2014 Commons Chamber

[Mr Hunt]

I agree with the hon. Gentleman. I think that we need to change the balance in the NHS, so that the safest thing for people to do if they want to avoid litigation is to report concerns rather than sitting on them. That is an interesting lesson that has been learnt in other industries, such as the airline industry, and I hope that the follow-up review by Sir Robert Francis will help us to understand it better.

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

I thank the Secretary of State for what he has said about the reports. In his statement, he referred to the importance of the changes that have come about over the past few years, both under this Government—and there are more to come—and under the last Government. Many of those changes have derived from advice given by specialist police forces or by teams within police forces.

The Association of Chief Police Officers runs courses, and collects expertise for the purpose of those courses. Its aim is to catch the individuals concerned, to help those who have been attacked by them and to monitor those individuals after they have been put on the sex offenders list. Does the Secretary of State think that it would be useful to ask ACPO whether it could provide any more advice for the Government to consider? I know that the Metropolitan police’s Jigsaw team is currently considering changes that would help it to monitor and control sex offenders once they have been detected and put on the list.

[Mr Hunt]

My hon. Friend has made an important point. Of course we need to co-operate very closely with the police service, and the Home Secretary is doing a huge amount of work to establish what needs to be done to increase conviction rates for sexual offences. The point for the NHS to consider, however, is that the disclosure and barring scheme will only work properly if NHS organisers comply with it—as they are obliged to do—and report incidents, because that enables other NHS organisations to find out about them. I am not satisfied that the levels of compliance are as high as they should be.

Tobacco Products (Standardised Packaging)

Paul Beresford Excerpts

Thursday 3rd April 2014 Commons Chamber

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

I obviously have an interest in this particular area. May I say to those hon. Members who are protesting that if I could arrange for them to come into an operating theatre and see the damage that oral cancer does to people, they might actually change their mind?

[Philip Davies]

Ban it then. Ban smoking.

[Sir Paul Beresford]

I am ignoring the interruptions. I am particularly pleased by what the Minister has said and I thank her for it. I encourage her to move this nation ahead first, as I hope she will, rather than to wait for the Australians.

[Jane Ellison]

I thank my hon. Friend for his comments and support. He speaks from a position of knowledge, which is always a good position from which to speak. Sir Cyril and his team visited Australia, and hon. Members can find reflections on the Australian experience to date in the report. We are proceeding on our own timetable, not waiting for the end of Australian litigation on this subject.

Cancer Treatment and Prevention

Paul Beresford Excerpts

Tuesday 11th March 2014 Westminster Hall

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

I am delighted to be in a position to receive your advice once again, Mr Gray. I congratulate my hon. Friend the Member for Mid Derbyshire (Pauline Latham). She is pushing a subject that I would normally push myself as chairman of the all-party parliamentary group on skin, but I will not repeat what she said. I am delighted to see the Minister here, along with all the usual suspects, including me, who try to persuade her of various things. I am also chairman of the all-party parliamentary group for dentistry and a very part-time dentist. I will refer to and slightly repeat what I said in my Adjournment debate on oral cancer of 13 January and question the Minister’s response.

As I said during the January debate, some 6,000 new cases of oral cancer are reported annually in the UK, with 1,800 deaths each year. It is an appalling, disfiguring disease that affects sufferers’ quality of life. Early diagnosis, which everyone is pushing, can solve many cases, but it must be early. The total number of cases has been rising steadily over the past three decades, with 35% more new cases a year now than 30 years ago. The problem has become so acute that oropharyngeal cancer is the fastest growing cancer in Scotland—the only place for which I could find figures—but it is also a huge problem in the rest of the UK. The British Dental Association said:

“No other cancers have shown such a significant increase in their incidence. Furthermore, treatment of many cancers is showing impressive improvement in survival, but oral cancer continues to have high death rates.”

There are four factors that would help to restrict or perhaps even to defeat the disease. The first is early diagnosis through education of clinicians and increasing patient awareness, which greatly improves the opportunity for effective and positive treatment. The other three are purely preventative. Carcinogenic substances such as betel nut and, much more commonly, tobacco are major factors in oral and other cancers. Excessive alcohol, particularly combined with tobacco smoking, is a huge causative factor. We are all well-versed in and applaud the actions of various Governments to persuade people to reduce alcohol intake and to secure, hopefully and eventually, a collapse in tobacco usage.

I will concentrate on the human papillomavirus, which I touched on during the debate on 13 January. I want to refer to the two main ones—there is a huge family—that cause particularly unpleasant cancers throughout the body. We know about cervical cancer and the related penile cancer, but there is also oral cancer. The latest figures that I quickly managed to find on cases of HPV-related cancers for the UK are from 2009, when 7,538 females and 6,484 males were affected. It is not quite 50:50, but it is getting there.

In 2010, 2,016 males and 2,253 females died in the UK as a result of HPV-associated cancers, including cervical, penile, vaginal, vulval, laryngeal and oral. For males in the UK, the greatest proportion of new cases and deaths were as a result of oral cancer. In females, oral cancer is a relatively close second to cervical cancer. The number of annual cases of HPV-related cancers in men is rising significantly and it is not just oral cancer. Indeed, if recent trends continue, annual cases of HPV-positive oropharyngeal cancers may surpass annual cases of cervical cancers by 2020.

This country, along with several others, has an inoculation programme for HPV. A full inoculation programme would, in a manner not too dissimilar to that of polio, effectively reduce and then cut out transmission of the HPV virus. It would produce what is known as herd immunity, as has happened in Australia. Here, however, HPV inoculation is available only for girls and not for boys. The Minister correctly pointed out on 13 January that the Joint Committee on Vaccination and Immunisation, after considering the matter at two meetings in February, will be reporting later this month, hence my pre-emptive strike. She also stated that the JCVI agreed in October last year to set up a sub-committee on HPV vaccination to assess, among other things, extending the programme, as a priority, to men who have sex with men—I do not quite see the relevance of that—to adolescent boys or to both. Obviously, I hope that an inoculation programme for boys and girls should be made available and promoted.

In my area of Surrey, where parents take health and health protection seriously, only 60% of the girls who could and should be receiving the HPV vaccine do so. Assuming a 50:50 split of boys and girls at inoculation age, only 30% of the Surrey population that could and should be inoculated are being inoculated. A full spread of inoculation would, as with polio, bring herd immunity over time. It is irrelevant whether these kids grow up to pass on the HPV virus by heterosexual or homosexual sex. What is important is that, whether the JCVI agrees or not, the Government take early action, as Australia has done. I put it to the Minister that it is not fair, ethical or socially responsible to have a public health programme that leaves 50% of the population vulnerable to infection just because the vaccine is not made available to boys.

As I said, my speech is a pre-emptive strike, and I wait to hear what the JCVI and the Minister have to say.

Oral Cancer

Paul Beresford Excerpts

Monday 13th January 2014 Commons Chamber

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

I am particularly delighted to see my hon. Friend the Minister on the Front Bench because she understands my unusual form of English, which is really quite helpful.

I must first declare a double interest as chairman of the all-party parliamentary group on dentistry and as a very part-time practising dentist. This means that I am a member of the profession that faces the detection and treatment of the appalling disease of oral cancer. Over the years I have detected perhaps seven cases among my patients. We picked them up at a very early stage, and I believe that as a result those involved were all successfully operated on and treated without disfigurement, and survived.

I recall being called in by a colleague for a second opinion on a patient who was very well known in the media. I confirmed my colleague’s opinion that the small growth behind the lower right wisdom tooth was cancer. My colleague referred him to a specialist oral surgeon. The patient then disappeared off our horizon. He did not return for regular check-ups or go to the oral surgeon. As I said, he was a famous media personality. About two years later, news reports stated that he had died in spite of late treatment involving massive oral surgery disfigurement. As we later discovered, he had not wanted to hear my advice or my colleague’s. He went to see his GP, who gave him a bottle of some green fluid to paint on the ulcer, thus allowing the cancer to grow. This sad example indicates the first problem of oral cancer—that there is insufficient awareness among the public, among general medical practitioners, and even, regrettably, within the dental profession.

Last November, there were two cancer campaigns. The campaign on prostate cancer—Movember—caught the public imagination thanks to the proliferation of sometimes quite hideous hairy growths just under the nose on predominately male faces. The other campaign was an oral cancer awareness campaign. It was very successful within the dental profession but did not catch the public awareness. This is deeply disturbing, first, because prevention and cure is possible if the disease is found easily and early, and secondly, because of the increasing prevalence of the disease.

The latest available reports and figures relating to oral cancer do not make encouraging reading. In short, the problem is worsening each year and is set to continue to do so unless decisive action is taken on a national level. Across the globe, oral cancer is now one of the 10 most common neoplasms. About 6,000 new cases of oral cancer are reported annually in the UK, with 1,800 deaths related to the disease each year. The total number of new cases per annum has been steadily rising for the past three decades, to the extent that there are now 35% more new cases a year than 30 years ago. The problem has become so acute that oropharyngeal cancer is the fastest growing cancer in Scotland and is a similar, significant problem in the rest of the UK. To quote the British Dental Association:

“No other cancers have shown such a significant increase in their incidence. Furthermore, treatment of many cancers is showing impressive improvement in survival, but oral cancer continues to have high death rates.”

As I alluded to earlier, a key factor is late diagnosis, which brings me to my first point. Public awareness would be a huge help. Yawning is really dangerous, Mr Speaker, from a dentist’s point of view. That lump—that ulcer—in the mouth, particularly if it is painless, needs to be seen by a dentist. More dentists should be aware and look at the soft tissue, not just the teeth.

The second and third factors are tobacco and excess alcohol, particularly when the two are combined. I will not dwell on them, because the Minister, the Government and previous Governments are well aware of the detrimental health factors relating to both. Dentists have a role to play, particularly in persuading their patients to give up tobacco smoking. I suspect that the Minister will enlighten us a little further on that in due course.

The fourth factor, and the one on which I believe decisive action can be taken, is tackling the human papillomavirus. It is a very large family of viruses that infect the skin and lining of the cervix, vagina, anus, mouth and throat. There are two groups. One group—HPV 6 and 11—is relatively low risk, causing laryngeal and genital warts, while the other group carries a high risk of causing cancer. They are key in causing 13 different types of cancers, but of these viruses perhaps HPV 16 is the most dangerous.

The last figures I have quickly managed to find on new cases of HPV-related cancers in the UK are from 2009, when 7,538 females and 6,484 males were affected. In 2010, 2,016 males and 2,253 females died in the UK as a result of HPV-associated cancers, namely cervical, penile, vaginal, vulval, laryngeal and oral. In UK males, the greatest proportion of those cancers involved new cases and deaths as a result of oral cancer. In females, oral cancer is a relatively close second to cervical cancer.

The number of annual cases of HPV-causing cancers in men is rising significantly. They are not just oral cancers; they cover other areas as well. Indeed, if recent incident trends continue, the annual number of HPV-positive oropharyngeal cancers may surpass the annual number of cervical cancers by 2020.

Obviously, that trend will be affected by the success of HPV vaccines, which are advocated in this country for women but not for men. That is a little odd, because it appears that fewer men than women produce an immune response to HPV infection. HPV vaccines protect against HPV infection and disease, including cancers, in men as well as women.

Australia’s policy of vaccinating both males and females is producing herd immunity. The effect on HPV diseases, including cancers, has been quite dramatic. The last chart I happened to see showed a 90% decline in the number of patients—both men and women—diagnosed with genital warts, caused by HPV, at a Melbourne sexual health centre between 1 July 2004 and 30 June 2011.

HPV plays a role in oral cancer and it is clear that gender-neutral vaccination would lead to a dramatic reduction, over time, in a number of cancers, including oral cancer. Immunising boys and girls would achieve real herd immunity for all such cancers.

The burden of HPV-associated cancers is now almost the same on men as it is on women. Men currently face a significant and rising risk of HPV-associated diseases. I therefore put it to the Minister that it is not fair, ethical or socially responsible to have a public health policy that leaves 50% of the population vulnerable to infection. Such vaccination, combined with early detection and action on smoking and heavy drinking of alcohol, could save a huge number of lives just as we face a dramatic increase in oral cancer. I repeat that the next procurement round is in the offing: the moment and the opportunity is here now.

Hospices (Children and Young People)

Paul Beresford Excerpts

Wednesday 18th December 2013 Westminster Hall

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

I congratulate my hon. Friend the Member for Pudsey (Stuart Andrew) on securing the debate. He has covered much of what many Members would say. There are 49 hospices in the United Kingdom, so there will be probably be 49 interventions and press releases.

I need to declare an interest, as I shall focus on Shooting Star CHASE, which is a fantastic organisation that serves south-west London, west London, Surrey and West Sussex. My interest in it is that I have a family member deeply involved in it. I am stunned—merely going on to the website is such an education. It looks after 600 families in the area, 365 days a year, 24 hours a day. The basic cost is £23,000 a day, because it is not just about what is done at its hospices. They are out helping the families and so on. They are working outside, right across the board in the area—in the homes and in the various organisations outside that support them. I shall focus, because everybody is hankering to get in, only on some of its costs.

At the moment, Shooting Star CHASE does not appear, from my research, to receive any money apart from charitable funding and from the Government. As has been mentioned, NHS England provides £10.7 million, which is shared among 49 organisations, but that money has remained the same since 2007. Shooting Star CHASE receives £630,000 a year for its programme. A quick back-of-the-envelope or iPhone calculation will indicate that huge amounts of money have to be found over and above that. It is vital not only that that money is there, but that it gets charitable backing.

As has been mentioned, it is not unreasonable that the coalition Government have decided that they want to review how all hospices—by that, I mean adult and children’s hospices—are funded by the state. As has been mentioned, the review was launched in 2010. The aim was to produce a new per-patient funding system. NHS England, as I understand it, has set up a series of pilots across children’s and adult’s hospices to collect the data so that the tariff can be developed. I get the impression that the children’s hospice movement agrees that a consistent and rational method is needed. We are still waiting for that—it has been three and a half years to date.

Staying with that development, it is perhaps worth emphasising how I see it, as someone who has worked in the national health service in dentistry. I have watched review after review, and I have seen how they have become more complicated and more difficult for organisations, such as those hospices, to understand. It is absolutely vital that the resulting method of funding is not complex, nor should it be—as is classic with the national health service—over-bureaucratic. An adequate process for transitional funding is also necessary, because the new funding method will undoubtedly bring in changes and shifts, with dips and rises in funding.

I am sure that the Minister in her heart of hearts will agree, even if she cannot say so, that funding has not been increased since 2007, and that we need to recognise inflation and the changes in service that many such organisations have made. A tapering increase in funding could perhaps reflect inflation and even the increase in service delivery.

In terms of the new scheme, it is vital that there is no sharp change—I mean positively rather than negatively; I hope that there will not be any negative changes. With any changes, we need a commitment to transitional funding, so that there are no sharp bumps in the funding. It is progressive—these organisations are looking after children over a long period and any sharp bump would mean a dramatic change.

Let me go to my back-of-the-envelope calculation. This one small, two-unit facility, plus all the group’s work outside, gets £630,000 from NHS England. That is vital. Three hundred and sixty-five days at £23,000 a day comes to about £8.4 million. This Government, the previous Government and future Governments must be thankful that they are not being landed with the full bill. It is vital that we recognise that we should move with the times, that we should give people results, and bring in the transitional funding to buffer them, as well as having a system of funding that is sensible, non-bureaucratic and easily understood—soon.

--- Later in debate ---

[The Parliamentary Under-Secretary of State for Health (Jane Ellison)]

I congratulate hon. Members on an excellent debate. I congratulate my hon. Friend the Member for Pudsey (Stuart Andrew) on securing it, and on speaking, not for the first time, with great passion and knowledge on this subject. The debate rather gives the lie to the lazy cliché that MPs bring no real-life experience to the House. It has been enormously informed by the life experience of a number of Members, and I congratulate everyone who has taken part. I will do my best to respond to the various questions put to me, but if by chance time defeats me, I undertake to write to colleagues. The Minister of State, Department of Health, my hon. Friend the Member for North Norfolk (Norman Lamb), is sorry that he cannot respond to this debate. As Members will have observed a few minutes ago on the Annunciator, he is otherwise engaged in the main Chamber.

Hospice care and palliative care for children and young people is an important and sensitive subject. From what the shadow Minister said, I can see that there is a good degree of cross-party consensus on the need to take the subject seriously and to sustain the way we serve the sector. The coalition placed great emphasis on palliative care in the coalition agreement, which included several specific commitments, such as a commitment to placing hospice funding on a more transparent and sustainable footing—that has been the subject of many comments today—and to introducing a new per-patient funding system for all hospices and providers of palliative care, so that the most gravely ill children and adults can receive care in the setting of their choice.

We have committed £10 million a year to support children’s hospices, as well as an additional £7 million in this financial year to support capital projects. In 2012, that allocation increased by over £700,000 to support new providers entering the sector, and we are keen to continue that substantial level of support now that responsibility has transferred to NHS England. We recognise the need for change in how children’s hospices are commissioned and funded. While a new funding system will be introduced in 2015, and while we have provided money to support hospices until then, we know that more needs to be done to support effective local commissioning. That, rightly, has been the focus of many of the speeches today.

Many hospices do not have as effective a relationship with their local commissioners as they might like, and funding from health commissioners is a relatively low proportion of the incomes of most children’s hospices and hospice-at-home providers. That is not universal, however. There are examples of local good practice where primary care trusts, formerly, and clinical commissioning groups, currently, have entered into funding arrangements with their local children’s hospice. My hon. Friend the Member for Salisbury (John Glen) has not returned from the main Chamber, but he spoke about the arrangements in his area for Naomi House, which has a per patient, per night tariff that has been arranged with the local CCG in Wiltshire.

We want the principle of CCGs supporting children’s hospices to be embraced widely across England. Monitor and NHS England are looking to include the arrangement between Wiltshire CCG and Naomi House in the national tariff document as a case study of good commissioning arrangements. Obviously, it is important that any nationally mandated or recommended tariff is based on a robust body of national evidence and provides clarity for commissioners on the services provided. I know that the working group has discussed the Naomi House example.

The charitable sector and the excellent fundraising work it does will always have a role. It has made an absolutely magnificent achievement over many years in all parts of the country; we have heard about that today. We are keen to see more effective and sustainable commissioning for hospices. We want commissioners to assume a more active role with their local providers, and we are keen to engage with the sector to see how we can support that. A lot of work is going on to develop that new model.

As has been referred to, the independent palliative care funding review, which reported in 2011, found that the absence of a clear funding model, or even a proper understanding of the costs of palliative care, was a major impediment to developing that care. The right hon. Member for Rother Valley (Mr Barron) mentioned the “stunning” absence of good data on the costs of palliative care, and the first step in developing a new funding system had to be improving the evidence base. We established eight pilots to collect a range of data and to test the review’s recommendations. The pilots—seven for adult palliative care, and one for children’s palliative care—are running for two years, and will provide the evidence to underpin decisions on how best to transfer to a fair and transparent funding system, which we intend to introduce in the 2015-16 financial year.

Hon. Members challenged us on the implementation plan and its timings. As part of the development of the tariff, there will be a plan for testing and implementation. Once we have clarity on the funding model, we will continue to ensure that the stakeholders are involved. Many of the hospices and their umbrella groups are closely involved in that work, and they will continue to engage in it.

I have heard the mood of the House on consultation. Although this is an NHS England lead, and I cannot commit it to carrying out a consultation, I can strongly encourage it and relay the mood of the House. The details of the tariff are still being worked on, but given that the new system will come into effect in 2015-16 and the sector needs to be able to plan ahead, we hope that that will happen in autumn 2014. That should be feasible, but I cannot commit to it. The sector is closely involved in that work and will be closely involved in the timing arrangements as well. It is key to say that we will not let this issue drift. The hospices are involved in the data collection and the discussion, and are key to the NHS England working group. The Government have made a commitment on that; we are conscious of that, and Members are right to push us on it.

NHS England is leading the work, and more than 80 organisations are involved. Barbara Gelb, the chief executive of Together for Short Lives, is a member of the Secretary of State’s children and young people’s health outcomes forum, so there is good read-across there. I emphasise how closely the sector is involved in the work, and how important it is to ensure that it supports the new funding model, which will be simple and non-bureaucratic—all the things that Members have alluded to today.

Having that clear, quality-assured information on the real costs of providing complex, costly care to a relatively small number of children will make a significant difference to commissioners. That has been emphasised by a number of Members. Concerns have been focused on that transitional period and the commissioning guidelines. The Department will consider in the coming months how we might further support that local understanding and preparedness among not only CCGs, but local authorities, as commissioners of social care.

[Sir Paul Beresford]

rose—

[Jane Ellison]

I will struggle to respond to the points made in the debate if I give way. I hope my hon. Friend will forgive me, but I am happy to pick up points after the debate.

We realise that health and wellbeing boards need to be involved, and that sits firmly in my area of public health. I will think about how we can take that forward and publicise that more.

The transitional period and the challenge for older children and young adults was referred to a great many times, and has given much food for thought. The Department of Health has given section 64 funding to Together for Short Lives to support development and research around appropriate pathways and the transition to adulthood. The National Institute for Health and Care Excellence has been commissioned by the Department to develop guidelines around that transition. A number of areas of Government policy come back to that same challenge of how we deal with transition, and stop there being a cliff edge when a child becomes an adult. We all recognise that in real life that is not a cliff edge. In other policy areas, in other Departments, people are looking closely to see where we can get that right.

The Government have made short breaks a priority, and have put money, albeit not ring-fenced, into local authorities. We have introduced the short breaks duty, which requires all local authorities to provide a range of short break services for disabled children, young people and their families. A statement has to be developed in consultation with families and published. That is one thing that local authorities can be judged against. My hon. Friend the Member for Mid Dorset and North Poole (Annette Brooke)spoke about Julia’s House, which is an interesting case in that regard. We will ensure that that is brought to the attention of the national clinical director. I will bring all the points that have been made in this debate to their attention.

In the final few seconds that I have left, I wish to put on record my thanks to all the volunteers and staff who work in this sector. I know that in the coming weeks, which will be a difficult time of year for families with a loved one who is ill, they will bring both comfort and joy to the people they care for, and for that we thank them very deeply.