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.