UNCORRECTED TRANSCRIPT OF ORAL EVIDENCE To be published as HC 360-ii

House of COMMONS

MINUTES OF EVIDENCE

TAKEN BEFORE

INNOVATIONS, UNIVERSITIES, SCIENCE AND SKILLS COMMITTEE

 

sUB-committee ON BIOSECURITY IN UK research LABORATORIES

 

MONDAY 31 march 2008

PROFESSOR CHRIS THORNS, DR JOHN STEPHENSON, SIR LESZEK BORYSIEWICZ

and MR STEVE VISSCHER

PROFESSOR MARTIN SHIRLEY, PROFESSOR ROBIN WEISS

and MR MICHAEL STEPHENS

 

Evidence heard in Public Questions 173 - 298

 

 

USE OF THE TRANSCRIPT

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Oral Evidence

Taken before the Innovation, Universities, Science and Skills Committee

on Monday 31 March 2008

Members present

Mr Phil Willis, in the Chair

Mr Ian Cawsey

Dr Ian Gibson

Dr Brian Iddon

________________

 

Examination of Witnesses

Witnesses: Professor Chris Thorns, Science Director, Veterinary Laboratories Agency (VLA), Dr John Stephenson, Director of Research and Development, Health Protection Agency (HPA), Sir Leszek Borysiewicz, Chief Executive, Medical Research Council (MRC) and Mr Steve Visscher, Chief Executive (interim), Biotechnology and Biological Sciences Research Council (BBSRC), gave evidence.

Q173 Chairman: Good afternoon and could I welcome everyone to the penultimate session of the Innovation, Universities, Science and Skills Committee's sub-committee on biosecurity in the UK research laboratories. I welcome very much indeed our first panel of witnesses, Professor Chris Thorns, the Science Director of the Veterinary Laboratories Agency, Dr John Stephenson, the Director of Research and Development at the Health Protection Agency, Sir Leszek Borysiewicz, the Chief Executive of the Medical Research Council and Mr Steve Visscher, the interim Chief Executive at the Biotechnology and Biological Sciences Research Council. We are pleased to have you with us this afternoon. The Callaghan inquiry recommended a unified regulatory framework for work on dangerous pathogens. Do you all agree that that was the right way forward?

Professor Thorns: The VLA and myself do agree that this is a welcome development. The Veterinary Laboratory Agency has a large number of laboratories both at SAPO level and ACDP level and we welcome this change. We feel that it removes any potential conflicts of interest that existed up to now. We are, as I am sure many others are, aware of some subtle differences between the two schemes in that both schemes restrict the organism to the environment in any possible way but of course with ACDP you are as much concerned about separating the operator from the organism where as with SAPO you are not quite so because it does not cause disease in humans. Nevertheless we feel it is a welcome change and we look forward to working with the Health and Safety Executive under a harmonised scheme.

Q174 Chairman: Chris, did you make any representations for this sort of arrangement before Pirbright?

Professor Thorns: We were aware of the separation, indeed some of my veterinary colleagues at the VLA were SAPO inspectors seconded by Defra but I think as an organisation VLA felt that the inspectors and indeed Defra inspectors were under quite a lot of resource pressure at times.

Q175 Chairman: So the answer is no.

Professor Thorns: The answer is no, yes.

Q176 Chairman: John, are you similarly robust in your support of the Callaghan recommendations?

Dr Stephenson: Indeed so. I have discussed this with my colleagues at Porton where most of our Category 4 facilities are and we support if for three reasons. Those of us who have worked in these facilities have found the slight differences between the SAPO 4 regulations and the ACDP 4 regulations confusing sometimes and difficult to move from one to the other. I think in terms of clarity from the workers that will be welcomed. Secondly, recent history says that most of the novel human pathogens are in fact zoonoses and it makes a lot of sense therefore to merge the regulatory framework for animal pathogens and human pathogens. Also we welcome the recommendation that the regulatory authority is distanced from the authority which is responsible for running those laboratories. I think that will be a welcome move which we would strongly support.

Q177 Chairman: You are perfectly confident that this unified framework to regulate animal and human pathogens, as recommended by Callaghan, is the right way forward.

Dr Stephenson: In principle; I have not seen the details of those recommendations.

Q178 Chairman: "In principle" worries me because it means there must be something which is lurking in the back of your brain which says there is a problem here.

Dr Stephenson: No, I only say "in principle" because I have not seen the final details of those recommendations. I can see no real reason why they should not work.

Q179 Dr Gibson: When you talk about pathogens, do you include prions in that as well? Do you just lump them altogether?

Dr Stephenson: I would not lump them altogether particularly in terms of the decontamination processes because I think, as some of you know, prions are particularly resistant to some of the chemical inactivants and are also resistant to thermal inactivation which is our major mechanism of inactivating conventional pathogens. I think special recommendations would have to be made - and indeed are already in place - for handling certainly human prions which are particularly resistant to both chemical and thermal inactivation.

Q180 Dr Gibson: Would the health and safety department do that then? Would they put them in place? Who would put them in place?

Dr Stephenson: The ones which are operating at Porton have been set up in conjunction with the Department of Health?

Q181 Chairman: Sir Leszek and Steve Visscher, do you support the Callaghan proposals? Do you feel that a single regulatory framework is the right way forward?

Sir Leszek Borysiewicz: Yes, with one proviso, and that is the proviso that the introduction of the regulatory system does not actually end up making it more bureaucratic and confusing. I think all the research councils in their response are quite happy with the Callaghan proposals but it is quite a minefield of bureaucracy when you actually get involved in it. I would hope that this conjunction would lead to a simplification of the bureaucracy as well.

Mr Visscher: We support it too. We are keen to see transparency in the process and ensure that there is full expertise within the regulator, and consultation in the development of the detailed regulations with researchers who are working in the field.

Q182 Chairman: Sir Leszek, you talked about simplification of the regulation and one regulatory framework rather than two seems to be a simplification. The other key aspect of the Callaghan report was that the new system should be based on risk assessment and notification. Do you feel that that is the best solution? Will that lead to less regulation?

Sir Leszek Borysiewicz: I think the risk assessment should be at the heart of all these developments in relation to protection and we have to have responsibilities that are very clear on all of the agencies so far concerned, firstly a risk assessment in relation to the operator and a risk assessment in relation to leakage, spillage and then the security assessments that have to take place. Those are inherent. It is essential that we continue a risk assessment based on the purpose of a particular facility because, for example, as we have already heard, if you raise the issue around prions there are specific aspects that have to be brought in in relation to prion research that are very different from even the standard Category 4 facilities because of the very nature of the pathogen you are dealing with.

Q183 Chairman: MRC are awarding a significant number of grants through university responsive grants. Do you feel that permission should be required before work begins or should it simply be based on the institution taking a risk assessment approach? That is the bit that perhaps worries us a little.

Sir Leszek Borysiewicz: That is what I was saying, that the system has to be relatively simple for the investigators themselves so as not to discourage their involvement in this research because we do have to remember that the reason for investigating these dangerous pathogens is because they are dangerous and therefore it is very important that we actually have more information about them. At the present time it is to make sure that you have ownership of the work that is in progress, be it a university or an institute in our case, that it is very clear that somebody is willing to pick up the responsibility for ensuring that the facilities are correct. We also have to ensure that the staff who operate those facilities are both cognisant with the regulations but also able and have the capacity and training to be able to handle this material safely, catalogue it and make sure that we can actually deal with it, particularly in some of the other areas that the Callaghan review looked at.

Q184 Chairman: You were nodding your head so I presume you agree with what Sir Leszek was saying, but the other issue for us was brought forward at one of the hearings we had with Dr Paul Logan of HSE who indicated that there was still a significant number of bodies that were actually involved with regulating work on dangerous pathogens and their transport to and from laboratories. Should there be a one-stop shop? Should there be one point of entry in terms of that in that organisation? How do we actually streamline that so that we not constantly have different bodies looking at different parts of the organisation? Do you share that concern?

Dr Stephenson: Absolutely. That is one of the reasons why I think this is a golden opportunity to merge all those regulations and those various authorities. Like Sir Leszek we are concerned about the bureaucratic burden which is constantly being placed upon researchers. We have an opportunity here to merge those various regulatory bodies and those instructions coming to the laboratory workers such that they are not over-burdened by the amount of bureaucracy and the number of people that they have to contact in order to start the work.

Q185 Chairman: Chris, do you share that?

Professor Thorns: Yes, and another important factor I think with the single body is that when VLA started working on BSE - mad cow disease - we worked quite closely with the Health and Safety Executive and they provided help and advice and support in terms of how to deal with that particular prion. Indeed, as Sir Leszek has said, it came about that he was given a certain derogation in terms of some of the activities and they were much stricter ways of dealing with it in other activities. I feel that many of us have good relationships with the HSE and it should be a proactive approach as well as a reactive approach by them.

Q186 Chairman: Callaghan was obviously talking about bringing two regulatory systems together and everybody seems to be in broad agreement with that, given the comments made about not adding to the overall bureaucratic burden. In terms of actually bringing in all the other organisations involved, who should be pulling that altogether? Should it be Defra? Should it be research councils? Should it be the HSE?

Mr Visscher: Going back to my earlier comment about consultation, I think it would be helpful for one body and I think we would see HSE as being the fulcrum for this going forward and for that body to hold the ring in the discussions with all interested parties. I think the interactions between the Institute of Animal Health and HSE are developing and are more involved than they used to be - and quite rightly so - with the way the new regulations are evolving. I think that would be the right way forward.

Q187 Chairman: HSE should be the fulcrum in your view.

Mr Visscher: Yes.

Q188 Chairman: Do your colleagues share that view?

Professor Thorns: Yes, except that I think some transportation materials often go outside UK borders and I do think some of the regulations we have to deal with are based on worldwide legislation so maybe there is a slightly broader role for bringing this together as well.

Q189 Mr Cawsey: I would like to ask a few questions on Pirbright and the experience and where we are following last year's events. I will ask Steve first, as Chief Executive of BBSRC. As the sponsor of IAH Pirbright, employer of its staff and owner of the site, how much blame should BBSRC accept for the release of the foot and mouth disease last summer?

Mr Visscher: As previous reports that have been published on this show, there were a range of events leading up to the believed route of the release of the virus. One of the key issues for BBSRC was the way in which the regulation was exercised and for us there was one big surprise and that was that it was permitted, under the licensing terms, for live virus to be in the drains even after there had been some treatment. That was an agreement between Merial and the regulator. Why that was a shock to us was that the drains were not designed in the first place with that in mind. Secondly, we had also put in place arrangements between ourselves and Merial to have a lease prohibiting the release of noxious substances into the drains. Despite all that, we also had a fall-back mechanism in place, a so-called chemical treatment plant which is there in the event of a virus getting into the drains. The BBSRC had endeavoured to put in place a framework and agreements and it was a surprise to us that it was possible for the virus to be released into the drains. Had we known otherwise then I think our risk assessment would have been different.

Q190 Mr Cawsey: Why was that unknown to you?

Mr Visscher: One of the lessons learned from the overall experience of Pirbright is the sharing of information between the parties was not as much as is in place now. The licences were regarded as confidential and it was then left to whether the parties chose to exchange those between themselves or not. I believe that as IAH and Merial had existed on the same site for some years there was an understandable expectation that the same regulations would be applied to both parties, given that they were handling the same material. That proved not to be the case.

Q191 Chairman: Mr Visscher, you are in charge of this site; it is a BBSRC site.

Mr Visscher: It is BBSRC owned site which is leased to the Institute of Animal Health and the Institute of Animal Health sub-leases it in part to Merial Animal Health.

Q192 Dr Iddon: I find what you have just said surprising, that it is permitted for live viruses to be in the drains. Do any of our panel know whether any other licences exist where live viruses are allowed into the public drainage system?

Mr Visscher: It had been, it is not now.

Q193 Dr Iddon: That is Pirbright but are there any other sites where we might have licences in force which allow live viruses to get into the public drain system?

Sir Leszek Borysiewicz: To the best of my knowledge within the MRC that is certainly not the case within the units that we operate in. We expect inactivation of the agents before they are actually released.

Q194 Dr Iddon: So Pirbright was the exception.

Dr Stephenson: That is my understanding. It is certainly true of the Health Protection Agency. All of the material coming out of the Category 3 and Category 4 laboratories were autoclaved on site within the same building, and for the Category 4 facilities within the same laboratory suite. The only exception to that was a vaccine manufacturing facility and the HSE insisted that the chemical inactivation plant was too large to actually go into the suite but was located adjacent to the suite on the Porton site and there was a secure conduit from the production facility into the inactivation chamber. That was a very short distance indeed; I am talking about yards and that was within the secure site at Porton. That was for a production facility, not for a research facility.

Q195 Mr Cawsey: I am slightly worried that the three of you have answered the question about Pirbright being exceptional but there is bit of "it is my understanding", "as far as I am aware", not very definitive from this side of the table. Who is the person who would be able to advise the Committee on that if it is none of you eminent people?

Sir Leszek Borysiewicz: Category 4 and Category 3 facilities do not have any inactivated agent leaving them from the sites that we operate because that is usually within the standard operating procedures of all of these facilities and it is inherent in them. We do not have an industrial production facility of that level operating with any of our materials. I can be quite definitive on that point.

Professor Thorns: I can be quite categorical about VLA.

Dr Stephenson: I can be quite categorical about the HPA as well.

Q196 Chairman: I want to bring Mr Cawsey back to BBSRC because it just seems to me it is a little bit like Pontius Pilot here, that you have washed your hands and said, "We own the site but other people actually operate it, - two other organisations operate it - and therefore it is not us, guv".

Mr Visscher: Our approach, as a major sponsor and funder of the Institute of Animal Health, is to provide a framework and support, whether that is through guidance or funding or additional infrastructure. Coming back to the regulation point, we were aware that IAH operated a procedure that was based on inactivation through chemical means in the laboratory and in the belief that that would not lead to any live virus in the drains. In the unlikely event of that happening there was this failsafe mechanism of a chemical treatment plant that was designed in the laboratory procedures of the IAH to inactivate the virus in the laboratory using only very small quantities of the virus whereas in contrast the arrangements which we are now aware of that were operating within Merial and with the approval of the regulator - as was outlined in the Spratt report - did permit live virus to be in the drains. BBSRC, through its various mechanisms of guidance, was working on the premise that there was inactivation within the IAH laboratories. We had made the erroneous assumption that the same would be happening in Merial and wee have subsequently put in place, working through the Institute of Animal Health, a clear agreement with Merial for the exchange of information, for all the processes to be validated, the results of those validation tests to be shared and any incident which did occur in the future for there to be immediate notification between both the parties. In terms of the lessons learned, that is an improvement that has been put in place between the parties subsequently.

Q197 Mr Cawsey: Would you accept that those people who were on the receiving end of the outbreak - I represent people who were indirectly affected because of what it did to the pig industry - would be staggered to learn that this agreement was in place?

Mr Visscher: What BBSRC had done was to put in place a lease that prohibited the release of these viruses and we had placed, perhaps with the benefit of hindsight, undue reliance on the regulator not permitting live virus into the drains.

Q198 Mr Cawsey: We visited Pirbright and one thing that struck all of us when we were there was that it is an old facility that looks a bit beyond its sell by date and needs to be redeveloped. We spoke to staff who had frustrations about that as well. What can you tell us about the re-development programme? Have all those who are funding this agreed to meet their share of what are now increased costs to the project?

Mr Visscher: The project was formally agreed in 2005 between DTI and Defra with BBSRC involved as well. At that time the budget was £121 million. Subsequently, partly due to redesigns and partly due to inflation, the cost of the project has risen. We have been in discussion with our sponsoring department, DIUS and with Defra over the funding of the additional costs. We have received strong indications that that additional funding will be made available. The details of it are still be worked through because with the increased capital costs come some increased running costs in terms of capital charges. I think it is entirely appropriate that all the parties are clear that sufficient running costs are available for the facility as well as the capital costs.

Q199 Mr Cawsey: When do you expect that finally to be put in place?

Mr Visscher: In terms of formal agreement on the funding, within months; we are close to that now.

Q200 Mr Cawsey: Chris, do you have anything to add to that?

Professor Thorns: The VLA is an important stakeholder in this because our virology department is co-locating to the Pirbright site. We very much welcome this but we have similar concerns. We feel that the cost is spiralling almost out of control in terms of capital investment. We have concerns on the effect that would have on reducing the scope of the project but also, as Steve said, we are most concerned that any future CSR bid includes the running costs of these organisations. For me one of the major lessons learned from Pirbright is that these facilities cost an awful lot to run and maintain and often organisations like ourselves are given the capital investment but then everybody forgets the extra money needed to run these capital charges.

Q201 Chairman: You are not even being given the capital funding. It appears to me as Chairman of this sub-Committee that out of site out of mind yet again. We had a major problem last summer; everyone runs around like the proverbial, everybody accuses everybody. We have X number of reports which have come from Callaghan et al and here we are saying nine months later that we cannot put the capital funding together even though the site at Pirbright is like a building site at the moment. Do you share my frustration?

Professor Thorns: The VLA does share your frustration. It is common knowledge that VLA, whilst very much welcoming this, we have always preferred - as the Anderson review says - a complete merger between VLA and IAH in a new organisation with a new identity, but nevertheless we fully support this. We, like Professor Martin Shirley, are finding that more and more of out budget is going to fixed costs like the maintenance and less and less to the science.

Q202 Mr Cawsey: You mentioned Anderson and the idea that there should be National Institute of Infectious Diseases. Is the future of the IAH now decided or is this still up for grabs and, if so, would that be a desirable move?

Mr Visscher: In terms of being decided, no is the firm answer. There is one other review which is on-going at the moment which was commissioned by BBSRC and Sir John Beringer. This was to look at the risk management funding and future governance of the Institute of Animal Health. In that context it follows on very much from the Anderson review which, as you say, was suggesting a single institute for infectious disease. We feel that is a move in the right direction and as to the detail of how that institute is put in place we very much hope the work of the Beringer Panel will be able to help us find some good solutions to that. Professor Beringer presented his interim conclusions to the BBRSC Council in February and he will report formally next week. I am sure that is a report that can be made available to the Committee if you are interested. Some of the key messages I expect will flow from the Beringer report are the importance of having a stable, sustainable funding stream with a profile of three to five years forward look so there is continuity in funding. The governance arrangements do need to be clarified and there are some suggestions emerging for an interim way of possibly, through the IAH governing body, inviting BBSRC to act as a corporate trustee in the short term pending long term arrangements. I think Beringer will also propose that there is a clear animal health and welfare strategy for the science related to this area. That is something that is missing at the moment and we regard as very good advice. In the longer term I think he may well float the idea of bringing together a new agency that pulls together the various interests both for surveillance and research and tackling outbreaks into an expert group. If that were to happen then one model would be for that expert body, with its stable funding stream, to be responsible for managing and overseeing the new institute with funders such as BBSRC providing funding on a reliable basis.

Q203 Mr Cawsey: It strikes me that we are perhaps putting the cart before the horse here. Should we really not be deciding whether or not we have the IAH or we have a National Institute before we get too bogged down with the capital and the revenue funding of it. We seem to be going down one line at Pirbright, trying to get the additional funds to make that re-build work, but you seem to be saying that you need something else anyway. Should we not make that decision first?

Mr Visscher: I think all these components have to come together. The funding which has been going into this area from the BBSRC has been rising and is set to rise because we recognise it as an area of huge importance. I know from talking with colleagues in Defra today, the Defra budget is under some pressure and that poses real challenges going forward both in terms of a long term view and the ability to commit when there is still on-going funding uncertainty. I think all the components of us being sure on the infrastructure and the funding for that, the running costs and clear governance and a clear strategy for the whole area are absolutely crucial to the way forward. We believe we have a real opportunity here to put these new arrangements in place which will serve the UK well for the future.

Q204 Chairman: We have had reference to this lack of certainty over funding in terms of the replacement for Pirbright and the Institute of Animal Health and Veterinary Laboratory Agency, et cetera. Do you think we have sufficient capacity in the UK for research on dangerous pathogens now and in the future?

Sir Leszek Borysiewicz: That is a good question and it is one I posed originally to ensure that we created a group with the Health Protection Agency to examine how much capacity and what is the projected requirement for capacity for the very reasons already identified, which are that the costs of running these facilities are extremely high and we have to make sure we use them effectively. I am looking forward to receiving that particular report. For the work the MRC is currently undertaking, there is sufficient capacity. We would obviously invest in more if there was a greater call for it. At the present time our Category 4 and Category 3 facilities deal with the capacity that we require as a research council.

Q205 Chairman: Dr Stephenson, do we have sufficient capacity in your view, particularly at Level 3 and Level 4 containment facilities?

Dr Stephenson: At the moment, if all the facilities which we have in hand are capable of running at full capacity I believe we do, but that is a very big "if". As Sir Leszek has pointed out, the MRC and ourselves are running a review right now chaired by Professor George Griffin, Chairman of ACDP, to find out exactly what the capacity is and what the future requirements are.

Q206 Chairman: Do you not find it strange that we do not know that? The Government does actually not know that. We found it difficult finding out how many laboratories there actually were and where they were situated. Do you not find it strange that we now have to have George doing a full inquiry to try to find out whether we have sufficient capacity?

Dr Stephenson: I think that we have sufficient capacity for what we want to do at the moment. At Porton we are in the position that our current facilities are ageing and that is why we have a site development plan which I think you saw on your visit a few weeks ago. We are looking ahead and at the moment we are finding that because those facilities are ageing the downtime for refurbishment and maintenance is getting longer and longer and longer. At the moment we are just about okay but looking into the future - which is what this review is focussed on - we want to ensure that we have capacity. Crystal ball gazing is difficult and therefore we want to include as many people in that as possible. We have a variety of pressures upon that. In the last 20 years there have been 60 new human pathogens which have been discovered, some of them with fundamentally different biological properties - as Dr Gibson pointed out for the prions - where we cannot use our standard inactivation procedures so we have to have different inactivation procedures. With global warming coming on the scene as well there will be more pathogens coming into this country which we do not have the facilities to handle at the moment. We want to look to the future and that is what this review is about. If we do it now then hopefully we will not wrong footed.

Q207 Chairman: Professor Thorns, let us just say that there is a huge expansion of blue tongue, the virus really starts to spread. There are 40 million sheep in the UK and if we get the sort of outbreak that is quite possible, do we have the capacity to deal with that?

Professor Thorns: I think we do.

Q208 Chairman: At the same time African horse sickness suddenly starts to appear.

Professor Thorns: I would not want to see an explosion of CL 3 and CL 4 facilities in this country; I would rather see the current facilities maintained and updated properly. IAH and VLA working together have demonstrated that we can deal with large animal disease crises such as foot and mouth disease and blue tongue and I think we should focus on the facilities that we have, making sure that we have not just the facilities but the skills and expertise of the experts in dealing with that. For me Professor Griffin's review will be extremely informative.

Q209 Chairman: Should we have one strategic organisation that looks after all Level 4 animal and human containment laboratories so there is one organisation that pulls all that together? Is that your solution?

Professor Thorns: No, I think there should be a strategic overview where people can interrogate that database or whatever it is to identify where those facilities are. I think it is more about smarter using of what we have and maintaining to the top notch quality what we have.

Q210 Chairman: Between your two organisations are you quite capable of doing this? Do you speak to each other?

Dr Stephenson: Indeed we do. In fact there has been a major new grant on pandemic flu which is funded by the Department of Health, a peer review carried out by the Medical Research Council which has substantial input from both the Health Protection Agency and our Centre for Infections and from the VLA laboratories at Weybridge. We work very closely together. I sit on the Statutory and Exotic Viruses Committee for the VLA and there are many, many cross-fertilisations there. I think there is a difference between setting up a common regulatory framework; I think that is viable and highly desirable. To set up one enormous organisation to cover everything I think would be too big; the demands on the veterinary community are different from the demands on the human community and that would be too large to be workable. We need to continue to work closely together as we are doing at the moment.

Q211 Chairman: Let us human pathogens in large animals. There was going to be a new facility at Pirbright which was going to deal with that area of research; this has now been shelved. Does that mean that we do not regard that as a threat? Or is it purely because UK plc can no longer afford to have these high level facilities?

Professor Thorns: I am sure you will ask Martin Shirley afterwards. My understanding was that there was never to be an ACDP 4 large animal facility in the new Pirbright programme. Currently there are plans for a small research laboratory and a small animal facility for working on mice and small animals like that. I have to question whether we need a large animal facility for ACDP 4 in this country. I think we would need to consider facilities in Europe and elsewhere.

Q212 Chairman: As far as the human health research community goes you feel there is sufficient level for facilities and therefore you would not be looking for a new one with any new facilities.

Sir Leszek Borysiewicz: At the present time what is important is that we actually maintain the facilities that we have got, bearing in mind the specific needs. I would like to come back to the example that you gave about blue tongue becoming endemic in the United Kingdom. What would happen then is almost certainly the categorisation of blue tongue would also drop down and therefore you could handle it in facilities that are much lower than Category 3 and Category 4. What is really important with Category 3 and Category 4 is to be able to predict how many of these facilities we require in order to handle those rare and very dangerous pathogens. Over and above that we much make sure we have the right security systems around those as they are developed. That is why I say that at the present time the MRC is quite confident with the capacity that we have got. We are also confident about expanding that capacity within the experimental frameworks in which we operate. When you get into the large questions, that is precisely why we joined with HPA to carry out this review.

Q213 Dr Iddon: To carry on the Chairman's line of questioning, could I ask you whether it would be possible to carry out a post mortem, if it proved necessary, on either a large animal or a complete human being in any of these Category 4 facilities, assuming it was a Category 4 virus?

Mr Visscher: In terms of human beings post mortems would not be carried out in the Category 4 research facilities but we have one high containment hospital at Coppetts Wood and we are developing another high containment hospital on the Royal Infirmary site at Newcastle. At Coppetts Wood there is the possibility to carry out a post mortem on a whole human body but not in research facilities, they are not designed to do that and that would not be the appropriate place to do it.

Q214 Dr Iddon: What about animals?

Professor Thorns: In animals there is very limited facility to deal with post mortems at Category 4 level.

Q215 Chairman: Is there any?

Professor Thorns: I do not believe there is any in this country. That particular situation will often be dealt with in situ where the animals may well be incinerated or buried or whatever.

Q216 Dr Iddon: Is it not considered necessary by the professionals to have such facilities for animals?

Professor Thorns: It is not my particular expertise but nobody has come to me yet to say that we need large animal Category 4 facilities.

Q217 Dr Iddon: I think I have seen photographs of one such facility in Germany.

Professor Thorns: Yes.

Sir Leszek Borysiewicz: Could I just add one thing? Where it is a Category 4 pathogen for animal transmission alone, I would be very much in favour if we require this sort of pathology where the safety of the operator is a concerned - where there is a possibility of transmission between species, particularly to the operator - that there is a need for that Category 4 facility. I do not think anyone would be implying that we would carry out such a post mortem in the field and put operators themselves at risk.

Q218 Dr Iddon: Let me turn now to the location of Category 3 and Category 4 facilities. We obviously cannot give the positions of where they are at the moment, but are they in the right places at the moment or is there any consideration being given to perhaps putting one where one is thought necessary but absent now?

Professor Thorns: For me I think the location of Category 3 and Category 4 laboratories is part of an overall risk assessment. It is one important component. There are other equally important components which include availability of scientific and support expertise, the availability of maintenance staff, the closeness to emergency services and other support teams and communication links. Also what is very important is getting the right builders and designers in the first place. For me the location does not always have to be in the middle of a city or a suburban area; it is part of the risk assessment. Personally I do not have a problem with a Category 4 facility sited in a fairly highly densely population provided the risk assessments are transparent and have been carried out properly.

Q219 Dr Iddon: Is that the general view or do other panel members dissent from that? First of all, are they in the right place? Should we have them in large cities? We have met some controversy about this from other people giving evidence and everybody knows, Sir Leszek, that your organisation is thinking of bringing one into central London, although there are, we are told facilities in central London now.

Sir Leszek Borysiewicz: There are and I would just repeat my previous comments in relation to this. At the present time, as I stated at a previous meeting of the Committee, we have not put in a specific proposal in that regard. We are awaiting the considerations of a scientific committee to determine whether that science is actually necessary on that site and obviously before going further full security and other requirements would have to be considered. It is very important that we are not pre-judging the need or otherwise of such a facility as I made clear on a previous occasion.

Q220 Dr Iddon: Turning to universities, do you know of any universities who have asked for a Category 4 facility on their site - again we need not name sites - or is the general feeling that if universities need to handle Category 4 viruses there are enough facilities around the country for them to share other Category 4 laboratories or Category 3 if necessary?

Sir Leszek Borysiewicz: I know of at least one university which is considering an application or has already submitted an application in that regard. There are decisions that have to be made as part of the forward planning process and this is so important. We have seen an increase in categorisation of pathogens where the category of pathogens, particularly of human pathogens, is always escalating because, quite rightly, we want to operate to the highest possible safety standards for operators and any release. In certain situations it is interesting but also quite good that universities might also be forward planning and thinking that that might become a requirement in the future. Yes, it does happen; yes, there are European universities that have such facilities on site as well in very major conurbations around Europe although I obviously cannot name them directly.

Q221 Mr Cawsey: I would like to ask you something we have already asked other people and have had completely contradictory advice so we would be genuinely interested to know what you would say about this and it is about training for those working with dangerous pathogens. Should training be provided locally or should there be a nationally prescribed set of competencies, perhaps linked to certification? If so, who would run that?

Sir Leszek Borysiewicz: When you are looking at a Category 3 or a Category 4 facility - I have actually worked in one for the science I have undertaken so I am pretty well aware of Category 3 facilities firsthand - what is really important is that you have a system where you have biological safety officers who are a very important group of people who regulate, often within an organisation, how safety matters are actually managed. You need a facility manager to make sure that everybody is competent and you need the actual operators on site as well as principal investigators who may or may not be directly involved in the work concerned. The bottom line is that all of them have to be trained but they all have to be trained to a different extent in the different elements that are necessary to operate safely within this environment. At the present time the MRC for biological safety officers provides the only formal training course and we have a lot coming in from industry and elsewhere to the courses that we organise. I understand that we are in step with ISTR and this may well transfer and be part of the course that they are contemplating in this area. I think it would be helpful to have a system whereby there is certification of people's training at different levels. However, there is something we must not overlook and that is where the primacy of the responsibility for the safety of the individuals actually participating and working in such an environment actually resides. I can only give you a personal anecdote, but if I were running a Category 3 facility I do not care how many bits of paperwork a technician or a member of staff actually has, until they prove to me they are competent and are not endangering themselves or others I will not sign off that individual to actually operate within that sector. Yes, certification goes part of the way in showing general competence, but I still believe that over and above that the people primarily responsible have to take the responsibility and can assure themselves that that person is not a danger to himself or to others.

Q222 Mr Cawsey: Some people think a blank canvas is the best starting point.

Sir Leszek Borysiewicz: Some might, but I think you have to have a level of competence and knowledge; you have to understand to a greater or lesser extent. A technician may not need to understand the regulatory framework in quite the same detail as a biological safety officer but to have no knowledge of that I believe would not be very helpful in the current climate or actually in any good regulatory climate. I would be in favour of having core training programmes that would be available to these individuals, but at the end of the day the sign off for somebody actually running and operating and working within such a facility would still have to be the responsibility of the investigator proposing to undertake this work. You cannot escape that. That would be the view that we would take.

Q223 Mr Cawsey: Is that generally agreed?

Dr Stephenson: I would fully support the MRC's position. In fact in the Health Protection Agency we run a cascade system of training for pathogens. Everybody coming into the Agency starts with a training package at Category 2 and then up to Category 3 and only those people who have been fully trained in Category 3 and have substantial experience - I am talking about several years' experience - would then be allowed into Category 4. Paper is a useful start but we operate exactly the same principle that the people who are operating within those facilities are always trained alongside a trained and experienced operator and in fact in the Category 4 facilities - and in fact most of the Category 3 facilities - nobody every operates alone, you are always operating with other people. We too run formal training courses both for the NHS and for commercial partners and we will be building in the very near future a purpose built training facility on the site at Porton Down to train people right up to Category 4 in biological containment and emergency response and a lot of other things as well. I think our position is pretty much in parallel with the answers already given.

Sir Leszek Borysiewicz: Just to add one point, it is not just the training, it is maintaining CPD. We need to make sure that people are current because the regulations are changing and the pathogens you handle are changing. There is a difference between the generic training that you can give and specific training which has to be given on site. Every one of these facilities handles different pathogens. If you are working in a prion facility, as Dr Gibson has already raised, you have to have very specific training and frankly there is only one place you can get that in the United Kingdom at the present time and that is why the sign off has to be there. It is a mixture of generic and specific and I think to be reasonably well certified in the generic would be a help but that does not absolve anybody from the very specific training that is required.

Q224 Dr Gibson: There is a view that new diseases are going to creep up on us. Are we ready for that?

Sir Leszek Borysiewicz: One cannot argue that that might be one direction. At the present time hopefully that is not the majority view, but I think disease will always remain a risk, particularly now that we have seen that they can jump species in the way that they can and it is something we have to keep on board all the time. It has happened once. Could I guarantee it would not happen again? Of course not.

Dr Stephenson: There are new biologies out there which we are unfamiliar with so we must be prepared for the unexpected.

Sir Leszek Borysiewicz: We also have to be careful as to how agents are handled within these facilities and there the regulations are very important. We know, for example, flu can jump if you get multiple infections because of the very nature of its genome. A great deal of care and training is required specific to the pathogens and not just the prions, although prions are a very good specific example.

Q225 Chairman: We keep moving to prions but can I come back to trainees? Dr Stephenson, do you feel that we have sufficient numbers of trained staff at Category 3 and Category 4 in the UK?

Dr Stephenson: I can only speak with any authority for the HPA and at Category 3 that is certainly true. I am not so confident about Category 4. We have only three or four people in the HPA who are fully trained and experienced to Category 4 and we have another five who are coming through the process. They are coming through that training process but they are not sufficiently experienced to operate alone or to be in charge of a programme.

Q226 Chairman: Chris, do you agree?

Professor Thorns: On the animal side at the VLA we have enough people at CL 3, SAPO 3 and ACDP 3. With regard ACDP 4 we are looking ahead and we have a person spending six months in the United States - Texas, I believe - looking at some of the ACDP 4 facilities there.

Q227 Chairman: Sir Leszek?

Sir Leszek Borysiewicz: Actually I think we have some shortage and I think the shortage is because we have to think of the totality of what this means for the UK. We have a very important sector that is going to be dealing with this and they are going to require trained personnel, particularly if categorisation of pathogens continues to be increased. From my point of view I think the areas that are really of concern to me are trained managers and biological safety officers to ensure that we have actually got the safety profile. I would like to see an increase in the numbers of people we have with these capabilities built into the system. I think we do need more staff, particularly in those two senior positions. We will train operators as need arises and that can be done in this area, but I think it is these others who have to take the broader purview of running these facilities. I do think we need some expansion.

Q228 Chairman: Is it a priority for you, Mr Visscher?

Mr Visscher: I think the availability of expertise is thin in some areas. I think Professor Shirley will be able to give you a better answer to this, but in areas of blue tongue where IAH leads the world it is a very small team of people in practice who are holding that level of expertise.

Dr Gibson: Mr Visscher, do you think with migratory birds carrying these things about the world? That is what every government minister seems to say when you ask them. Do you believe that? Are you having a laugh at government ministers?

Q229 Chairman: We want a definitive answer from you; your whole future depends on it!

Mr Visscher: You are of course addressing the one person on this panel who is not a qualified scientist.

Chairman: You need a policy maker to make these decisions. This session comes to an end amid laughter and we thank very much indeed Professor Chris Thorns, Dr John Stephenson, Sir Leszek Borysiewicz and Mr Steve Visscher. We are very grateful to you.

Examination of Witnesses

Witnesses: Professor Martin Shirley, Director, Institute for Anima Health (IAH), Professor Robin Weiss, President, Society for General Microbiology (SGM) and Mr Michael Stephens, Institute of Safety in Technology and Research (ISTR), gave evidence.

Q230 Chairman: Good afternoon and we welcome very much indeed Professor Martin Shirley, the Director of the Institute for Anima Health, Professor Robin Weiss, the President for the Society for General Microbiology and Mr Michael Stephens from the Institute of Safety in Technology and Research. Welcome to you all. Professor Shirley, we have heard an awful lot about the Callaghan report, about the regulatory framework for animal and human pathogens coming together being a logical step. Do you agree? Why was this not suggested before if it is such a logical step?

Professor Shirley: In answer to your first question the answer is yes, we do agree. This is a discussion we have had at the Institute. We agree for a number of reasons, many of which have been said in the previous session. It clarifies and straightens out the current arrangements, ie it will remove any conflict of interest from the current regulator, which is a very important point. What we would like to see is a regulator that is properly resourced and we have commented that the HSE will be resourced in that way. There will be staff with a lot of expertise. I think we also look forward to some of the transparency and consistency across a site such as the one we have at Pirbright. For a number of reasons we are welcoming this.

Q231 Chairman: You have not answered the question as to why it was not suggested before?

Professor Shirley: I really do not know what it has not been discussed before. It probably takes something like the incident at Pirbright to concentrate minds and to make this a catalyst of change.

Q232 Chairman: Michael Stevens, in terms of safety clearly we are moving - I think everybody has accepted the Callaghan recommendations - to a system which is based on risk assessment and notification as the best solution. However, should there be permission required before anyone starts work on any of these pathogens or is that quite sufficient in your view?

Mr Stephens: I think it has worked exceedingly well up until now and it is fully sufficient. I do not see the necessity to go towards, let us say, laboratory certification or individual certification, for example, as they do in other countries.

Q233 Chairman: You think it is perfectly sufficient.

Mr Stephens: Yes.

Q234 Chairman: Do you, Professor Weiss?

Professor Weiss: Yes.

Q235 Chairman: So we did not have a problem last summer at Pirbright.

Professor Weiss: Nothing is perfectly sufficient; yes, we did have a problem last summer. I should declare an interest here, I used to be Chair of the governing body of the Institute of Animal Health but stepped down well before that but I am familiar with the situation.

Q236 Chairman: Are you satisfied that the current regulations - the regulations post-Callaghan that are coming in - are watertight or are there any gaps we should perhaps flag up in our report?

Professor Shirley: I think they are probably watertight because the HSE and Defra are certainly working well together and they are spending quite a lot of time in our company as well. I think there is a very good dialogue on the ground now to make this transition period work before we go into the final phase.

Q237 Chairman: What about keeping inventories and missing pathogens and things of that nature? Are they all watertight?

Professor Shirley: The Institute for Animal Health operates to a code of practice for research and clearly keeping stocks under control is part of that inventory system. I suspect that no system is ever going to be watertight because one can never legislate for malicious behaviour, but on the whole it is now done as well as it can be.

Q238 Chairman: Professor Weiss, what about the classification of dangerous pathogens? We have received some evidence that there is some confusion at times about what constitutes a particularly dangerous pathogen at a particular level. Do you feel further work needs to be done on that or are you perfectly satisfied as well that that is okay?

Professor Weiss: I think there is a danger of incremental creep that Sir Leszek has already touched on. It is of crucial importance to keep the really dangerous pathogens controlled. If we keep upping pathogens that can be dangerous in certain individuals or in certain situations up to Category 3 and then Category 4 then we are going to get clogged up and we need to keep an eye on this. It has already been mentioned that if blue tongue becomes endemic in the UK then it becomes less dangerous in containment in the laboratories because it is already out there. This is a situation that changes over time and I would be concerned that we do not keep upping the ante but we do a proper risk assessment with the situation at that time for individual pathogens.

Q239 Chairman: Do you share that, Michael?

Mr Stephens: I do. I think there is a real danger with this creep, as Professor Weiss has said, that pathogens that are not truly Category 4 can creep into Category 4 and dilute the risk perception on individual scientists working on it.

Q240 Chairman: You feel there should be a sufficiently rigorous risk assessment process which should avoid that happening.

Mr Stephens: Absolutely, yes.

Q241 Chairman: Martin, we heard from the previous panel that a common agreement to have all the regulatory organisations brought together with a common point of entry was something which they broadly supported. Is that something you would broadly support?

Professor Shirley: I think it is. The Pirbright experience has clearly shaped my judgment on many things and the more uniformity and standardisation we have in these areas the better, quite frankly.

Professor Weiss: For laboratory research yes, but we cannot lump humans and animals together all the way along the line. If there is an outbreak of a dangerous pathogen in animals we cull animals, but we do not cull humans. If we are talking about laboratory containment, yes, that would make sense, otherwise we have to use common sense.

Q242 Mr Cawsey: Martin, I want to talk, as I did to the previous panel, about the outbreak at Pirbright last year which is of course something you went through. Looking back at it now, was it a failure of the regulatory system or was it a failure of the people operating the site?

Professor Shirley: I think a lot of words have been spoken about foot and mouth 2007 and I think probably Iain Anderson got it about right in looking at a number of areas where perhaps there were responsibilities. The whole of Pirbright was complex in terms of its regulation, the licensing arrangements, the lack of transparency between what was a government funded research laboratory handling small amounts of virus and an industrial pharmaceutical company next door. I think the reasons were multifactorial and certainly we were not sitting idly before the outbreak not proactively looking at the biosecurity arrangements and looking at risk assessment for the Institute. There was no clear transparency of the arrangements with SAPO licence vis-à-vis the IAH and Merial next door. What surprised us - you heard this from the earlier session - was the lack of consistency in terms of what was permitted under the SAPO licence. Certainly we tried to get to grips with that to find out what the conditions were. We have never been told that so our risk assessment was based on the fact that next door the amount of virus going into the drains was close to zero. I think we were as shocked as everybody else was to discover that with some of the non-validated processing of virus production up to one thousand million virus particles were being discharged from a production batch of vaccine. That was very illustrative of the complexity of the situation at Pirbright and I think there were other factors at play as well, including - as you saw in the Anderson report - the complexity of governance and ownership. All these things came into play with some very long leases underpinning some of this, going back almost 20 years. It was a situation that probably needed to be reviewed objectively and more timely than it in fact had been done.

Q243 Mr Cawsey: Do you think the introduction of a single regulatory framework under the HSE would be sufficient to ensure that such an outbreak does not happen again?

Professor Shirley: I think there have been a lot of changes since August and certainly there has been further layering of biosecurity, for example, in the Institute for Animal Health and covering a number of areas. We certainly welcome the new regulatory body because what will happen is that it will provide a further kick-start to the way we work; it will bring consistency with the animals and the human pathogens which I think is welcome; it will bring in another standard. I think there will be real positives coming out of the lessons learned from Pirbright.

Q244 Mr Cawsey: Do other members of the panel think that as well?

Mr Stephens: Yes, certainly.

Professor Weiss: Yes.

Q245 Mr Cawsey: Martin, in a previous panel we had quite a good discussion about the re-development programme and who is going to pay for what and if they ever will. I thought you might welcome the opportunity to tell the Committee how important you feel that investment in the Pirbright idea is.

Professor Shirley: How long have you got? I think this is really, really, really important as a national facility and what the UK needs, I believe, is a proper facility focussed on these increasingly important pathogens of livestock, facilities dedicated to these pathogens such as foot and mouth or blue tongue or African swine fever and many others which are now coming to our shores. This facility has to be properly funded into the longer term. Professor Thorns was talking about the capital cost, but what I want to say is that a facility devoted to animal health research which is not necessarily focussed just on the exotics but brings together for the benefit of the UK fundamental, strategic and applied sciences around important pathogens but also bring together the important biologies around that. That must be properly funded in terms of state of the art facilities which I think our science deserves. The Institute for Animal Health is world-class but we are not operating in world-class facilities. We need to have proper capital funding but beyond that we have to have clear transparency over the running of a facility such as the IAH in the national interest. We are serving the national interest and we are protecting the UK against a number of disease incursions which are in fact coming to our shores more and more frequently. It is absolutely vital that we have this facility, that it is properly funded and it is funded into the future so we are not in any way living from hand to mouth.

Q246 Mr Cawsey: Do you therefore agree with the Anderson idea then?

Professor Shirley: I have no problem with the Anderson review. What I would want, as Director of the Institute for Animal Health, is a national facility wherein there is complete clarity over governance and funding and it is assured into the future so everybody can plan effectively over the next five to ten years.

Q247 Chairman: We are not going to get that, are we?

Professor Shirley: I hope we are going to get it. The worry would be that we do not get it and we continue to live trying to run a national facility with some of the funding coming in on a one yearly basis, which is only negotiated into the start of the next financial year or into the current financial year. I believe we have to have this long term-ism because we are dealing with long term diseases. We only need look at the blue tongue story to understand exactly where the science is coming from and this goes back maybe a decade to the recognition of climate change and global warning when the Institute was in a position to deliver science through to Defra to help bring the 2007 outbreak under control, be in a position to inform government as to how to deal with the impending epidemic in 2008.

Q248 Dr Gibson: Robin, you have done some work on retroviruses and they are a special category of virus. Are there special dangers perhaps or special hazards? Have you ever worried about any implications or working with that and the health of the people who have worked with you?

Professor Weiss: The Aids pandemic is in a special category; malignancies caused by retroviruses too. In terms of handling them as dangerous pathogens, they are not that special. They are an example, as we put in our evidence, where the HSE regulations for Category 3 laboratories - they are usually Category 3 but they are bit lower in the United States - predicated on engineering and air flow and the dangers of needlestick injuries like working with hepatitis B and other human pathogens. When we first started working on HIV - it was newly discovered a few months earlier in Paris - we were very nervous. We devised a test that went into the blood banks.

Q249 Dr Gibson: Was this pre-Category 4 facilities?

Professor Weiss: It was about 2.5; it has never been Category 4, it has been Category 3. You just have to get up and do it. We were very nervous. We were gowned up and in there and we used to test ourselves every three months because we already knew how it was transmitted - by blood and by sex - but we did not want to pass it on if we caught it.

Q250 Dr Gibson: How did the HSE behave in this whole period of time? What was their attitude to it?

Professor Weiss: This goes back 24 years. They were a mixture of being very helpful and covering their own backs.

Q251 Dr Gibson: And now?

Professor Weiss: There is a wealth of experience now. We helped to train officers within HSE and now they help to train us.

Q252 Dr Gibson: How often did you see them and how often do you see them now? Has there been a frequency change?

Professor Weiss: Yes, less often.

Q253 Dr Gibson: Could you be more specific on that?

Professor Weiss: Not without going back over the records, no.

Q254 Dr Gibson: Do they come once a year, once every ten years, once every 24 years?

Professor Weiss: You mean to my laboratory?

Q255 Dr Gibson: Yes.

Professor Weiss: About once a year, or communicate once a year.

Q256 Dr Gibson: They see you once a year.

Professor Weiss: Less than once a year they actually visit on site; more like once every two years I would think.

Q257 Dr Gibson: Do you know they are coming?

Professor Weiss: They have a perfect right to arrive unannounced.

Q258 Dr Gibson: Do they?

Professor Weiss: No, but our own biological safety officer does.

Q259 Dr Gibson: Who is the biological safety officer? How trained are they? Have they worked with the viruses?

Professor Weiss: No.

Q260 Dr Gibson: But you have every confidence in them.

Professor Weiss: People who do not actually handle virus and pipette them out themselves should have a knowledge about containment of pathogens generally. The danger is when the people in the laboratories suddenly lose their funding. For instance, I lost my MRC funding with one month's notice on 29 February so I should be closing my laboratory today because tomorrow there is no funding. We have put emergency procedures in place.

Q261 Dr Gibson: Are you going to lie in and listen to Radio 4?

Professor Weiss: No, I will be in Edinburgh at the SGM.

Q262 Dr Gibson: Are you saying that the inspectors are amateurs?

Professor Weiss: No.

Q263 Dr Gibson: Real professionals, do you think? Would they spot anything? Would they be able to argue with you or with any of your staff?

Professor Weiss: Yes, I think so. Their generic techniques in handling pathogens when you propagate them in a laboratory, one does not differ very much from the other with the exception of the prion diseases that you have already raised.

Q264 Dr Gibson: Are there such things as near misses in your work?

Professor Weiss: There are laboratory accidents that do occur.

Q265 Dr Gibson: Such as?

Professor Weiss: Needlestick injuries, so we do not take needles into our Category 3 laboratories and we take the minimum of glass. We usually take plastic but, as you know, you can cut yourself on a piece of paper or a bit of plastic.

Q266 Dr Gibson: Is that recorded or should it be recorded?

Professor Weiss: That is recorded and there is a system with HIV where, if there is an accident, the laboratory person can go onto emergency anti-retroviral therapy. We do not stock those drugs in the laboratory but we have a hotline to the nearest HIV clinic which is in our university.

Q267 Dr Gibson: Does the biological safety officer add up the near misses and present them to the inspectors when they come?

Professor Weiss: Yes.

Q268 Dr Gibson: Give me an idea of how many there are in a year.

Professor Weiss: In my 24 years of working with HIV we have had one and one where the operator thought she had a near miss but she had not. You could call that two if you like.

Q269 Dr Gibson: In your experience do you believe that some laboratories seek to cover them up? It is an embarrassment after all. If they had 50 near misses in a year because it is a sloppy laboratory - and there will be one or two sloppy laboratories I guess somewhere - would they cover them up?

Professor Weiss: I am not aware in my experience of an organisation or a laboratory covering up but I can imagine that an individual - a student working in a laboratory or a young scientific worker - would feel that that was damn stupid and conceivably would clear it up and maybe not report. In my experience that has not happened.

Q270 Dr Gibson: Martin, in your experience is there anything you would like to add to that?

Professor Shirley: I would like to add that this is where the culture of an organisation is incredibly important. You have your full risk assessment and operating systems in place, but deeply embedded within the organisation is the culture to do things right and to succeed and to be the best and to be very professional. That is what you need through the laboratories so that if mistakes are made they are recorded and everybody is very honourable about it.

Q271 Dr Gibson: If they were anonymous you might get more. Would you accept that? If people did not have to say, "Ian Gibson, I cut my hand and I spilled some of the viral fluid over it" or something, if I did not have to put my name to it and just said that this had happened, is that possible?

Professor Shirley: I guess it is a possibility, but the reality may be a little bit different. I think with the right culture people are not afraid of coming forward.

Professor Weiss: As has already been mentioned you would have more than one person working in a Category 3 laboratory at a time. An accident might not be realised until a bit later. In the one incident that we had, the near miss, a phial which was plastic not glass broke in a high speed centrifuge because the wrong one was used in the centrifuge. You could say that they were not trained properly but that kind of mis-judgment can happen.

Q272 Dr Gibson: What did you do to prevent that happening again?

Professor Weiss: We actually excluded that type of plastic phial from the laboratory altogether.

Q273 Dr Gibson: What do you think about anonymous reporting? Do you not think that is feasible in an environment like that?

Professor Shirley: I think it is feasible but I think it is deeper than that. I think it is a matter of culture within the laboratory.

Q274 Chairman: Michael, the HSE is clearly going to have a much more significant role in terms of inspection Level 3 and Level 4 containment facilities. Do they, in your opinion, have sufficient expertise to be able to do that or are they going to be entirely dependent on the likes of Robin and Martin?

Mr Stephens: It depends what they are going to be asked to inspect for. If it is biosafety or biological containment, I have every confidence in the inspectors that I have met over 30 years. If it is biosecurity then I think that is a different matter.

Q275 Chairman: Why is it a different mater?

Mr Stephens: It is a different game, if you like. Biocontainment is about keeping the bugs in; biosecurity, if you will forgive me, is about keeping the buggers out and it is about ensuring that those who do not wish to misuse or misappropriate pathogens can get at them. It is a different discipline and that is where certainly these gentlemen and myself would use the likes of NaCTSO and local counter terrorism security advisers.

Q276 Chairman: So we cannot leave that to HSE. Would you agree with that?

Professor Shirley: I think that is probably right. It is horses for courses. It is a specialised activity, it is going to have to be done very professionally and if it is outwith the HSE expertise then we will need to rely on those experts.

Q277 Dr Iddon: For running high containment laboratories, do the funding organisations provide you with enough money for the high operating costs of maintaining those facilities? Obviously they need maintenance from time to time as we heard from the previous panel.

Professor Shirley: I think the long term funding is a critical issue. We have just been talking about security checks and this is something that is also going to layer on the cost for the future so this is something that will add to the burden of a large organisation. I think what the last speaker here was saying from the VLA is that we could end up by having the most marvellous facilities which are highly secure but without the funds to do the science on the inside. That is the worry I have into the long term future, that we have to recognise as a country that if we wish to have these facilities - and I believe passionately that we do - then they have to be properly resourced to allow us to maintain the facilities, that they are safe, they are state of the art and also they are able to deliver the science as well. I think that is a recognition that has still to be made.

Q278 Dr Iddon: That is a qualified no. Professor Weiss?

Professor Weiss: It is very seldom the case that there is enough funding to support everything that is worthy of support.

Q279 Dr Iddon: These facilities are rather special, are they not?

Professor Weiss: Yes, they are. If we are talking about a national resource for animal pathogens and zoonotic pathogens - the sort Martin was just talking about - there absolutely needs to be long term funding. If we are talking about the kind of work I do which is response load funding it has to be damn good to get funded; it has to be imaginative, innovative and not just a national security matter. The ways in which you cost your research today with so-called full economic costing with a portion coming from university central support, the research part of the DIUS and the research councils or the medical research charities supporting the bulk of it, the onus is on the scientist who is making the application to cost it properly. Sometimes we find that it gets scratched away or these extra costs are not justified so you have to keep bashing away, saying that these are necessary.

Q280 Dr Iddon: Michael, looking at it from a safety point of view, what is your opinion?

Mr Stephens: From the safety point of view but also the on-going costs, I was discussing this very issue of on-going costing with some colleagues from the States at a conference last week and it seemed to be a reasonable rule of thumb there that although a Category 4 facility, for example, may occupy one per cent of the floor space of a laboratory building it may actually eat up up to ten per cent of the on-going maintenance and utility cost annually of the whole building and that is really quite substantial.

Q281 Dr Iddon: We queried the previous panel on the capacity that we have presently for high containment work, Category 3 and Category 4. Is it your view also that we have adequate capacity at the moment? Do you agree with members of the previous panel that there are gaps, for example for handling large animals with dangerous viruses contained within them?

Professor Weiss: I think there is just about capacity but I think some of the plant is ageing as I have seen at HPA and IAH and elsewhere. That is why this new build at Pirbright is so important for animal work. With the increasing number of emerging pathogens - even those that are genuinely high category - we have to be aware that we can handle them. I think research scientists should also be inventive and just as there has been pressure, for instance, to reduce the total amount of animal procedures to get more in vitro where possible, we can try to do that sort of thing when handling dangerous pathogens. There is some work that currently has to be done at CL 4 with avian influenza, for instance, but it can be done with disabled versions of the virus. There is some work going on in my laboratory in collaboration with both the VLA and with the HPA where we have invented a little technique - it is not rocket science - that allows certain tests that would otherwise have to be done at CL 4 to be done at CL 2. To what extent that would relieve pressure on the very high category laboratories remains to be seen because it takes an awful long time to go through the regulatory procedures and to get permission from the WHO and OIE - the international agencies - to say that this test can be accepted. I think those approaches are merited and we need to be inventive in asking what we can take out safely that will not reduce our knowledge level but would increase our knowledge level.

Q282 Chairman: The little bit I do not understand - it goes back to the previous question that Brian Iddon asked as well - is this issue of how do you actually maintain in terms of revenue costing very, very expensive facilities and whether you are going to use then once or ten times is irrelevant, is it not? You still have to maintain those facilities at a very high order, and the question is where should that cost fall? It clearly cannot fall in terms of full economic cost on a particular grant application because the cost of that would be extraordinary in terms of that application. Who should maintain these facilities? The problem that has arisen at Pirbright - it may well happen in terms of human pathogens in the future - indicates to us as a Committee that there ought to be some plan or some vision as to how in fact you provide and then maintain these laboratories so that they are there when they are necessary. Is that an unreasonable proposition?

Professor Weiss: I think there may be a difference between CL 4 which have to be few and far between and national if not international, and Category 3 which can be built locally in universities and maintained if there is a sufficient body of people in that institution who need to use them and have a good chance of funding. Again it depends on how much you invest. I visited the Cambridge Veterinary School a couple of weeks ago; they are putting in a Category 3 laboratory with steel doors that no-one will be able to prise open. Anyone could gemmy their way into our laboratory if the so desired, or are we all going to end up with Fort Knox laboratories because then universities will not be able to afford them? It is not to contain the pathogens inside; it is to prevent malicious entry. How far do you go? How much do you spend? Who should spend it? These are unanswered questions.

Q283 Dr Gibson: Is the reason for this animal experiments or what?

Professor Weiss: No, it is just that these are being built new with containment facilities. It is post 9/11 and anthrax; it is a concern about terrorism.

Q284 Dr Iddon: Chris Thorns suggested that we have present capacity to deal with a major outbreak of blue tongue disease; would your staff at the Institute of Animal Health agree with that conclusion?

Professor Shirley: No, they would not. We had this discussion last week, in fact, and there were serious concerns expressed to me that not so much in infrastructure but scientific capacity and technical capacity we might struggle during the course of 2008. I picked this up so strongly that I wrote to Defra last week to put this point to them, that I felt that we would not have the capacity necessarily to deal with a full blown outbreak in 2008 of blue tongue.

Q285 Dr Iddon: That is a capacity shortage due to a lack of skill, is it?

Professor Shirley: What we have is clearly surge requirement potentially during 2008 and we have staff who we could bring across from other areas of science, for example, who are not working on blue tongue. The point is that if we do need to have expertise to deal with blue tongue diagnostics we should begin to get that expertise in place now, so we have the technicians able to service a fully blown outbreak in 2008 if that were to happen and of course we hope it does not happen.

Professor Weiss: Could I add to that that there are certain disciplines in science and medicine that are endangered and one is medical entomology. There are very few people now who know sufficient about the insect and other vectors that can transmit a disease, including blue tongue. Maintaining that level of expertise when you get into specialities is quite difficult.

Q286 Dr Iddon: I am sure we will make a note of that point. Do you think that there should be one body overseeing the provision of Category 3 and Category 4 laboratories? Should it be HPA or VLA or HSE or are you happy with the present arrangement?

Mr Stephens: Can I ask for some clarification? When you say "oversee" do you mean regulatory or strategically?

Q287 Dr Iddon: Certainly in terms of the location and ensuring that the condition and the maintenance is kept up, irrespective of what people think locally. We got the feeling from the previous panel that people were not awfully sure where some of these facilities were and how many we had. You heard the Chairman's remark previously. It seems to be just a lack of coordination.

Professor Weiss: I would say that CL 4 facilities will have to be known if they are not known now and must be national. Category 3 is a lower level of build and I can understand that a full audit of how many they is less clear.

Q288 Dr Iddon: We heard that the HSE would have to approve a planning permission wherever a Category 4 was being built, for example here in central London. Is that correct? If it is correct the HSE have some overlooking capacity there.

Professor Shirley: They would certainly be involved in planning the facility, whether they have to give planning permission I am not quite sure where their remit ends, but we would expect to engage with the HSE as we do the Home Office when we are thinking of having new accommodation built. We get them in early so we can get their understanding and input so we are building the right facility.

Q289 Dr Iddon: Where do we go for Category 3 permission? Do we just go to the local planning authority?

Professor Weiss: With HSE approval, if I am correct.

Q290 Dr Iddon: You do not seem very sure of this, or are we just asking the wrong people?

Mr Stephens: We would be notifying HSE that we were proposing to build a Category 3 or Category 4 and ask for their input as early in the project as possible.

Q291 Chairman: Is it mandatory?

Mr Stephens: Not for Category 3. Not to my knowledge.

Q292 Dr Iddon: My final question relates to something Sir Leszek said in the previous panel. He said that one university to his knowledge was thinking of providing a Category 4 facility. Do you think universities should be allowed to provide Category 4 facilities or should they share with already existing Category 4 facilities?

Professor Shirley: I guess it is an expanding area of science, certainly the one that we are in, and I think there could be an argument that given the threats we are currently in the work we are doing if we have buildings that are full to capacity there may not be the ability to engage with us work which a university department might wish to do, therefore it seems quite reasonable that they should perhaps go their own way to do their own studies. Providing that biosecurity is adhered to and the buildings are fit for purpose then there seems to me no reason why they should not do so.

Q293 Dr Iddon: Professor Weiss, do you agree with that view?

Professor Weiss: I agree with it in principle; I think in practice Category 4 is such a big investment that one university going it alone without conferring with other agencies or universities would have to have a very serious long term guaranteed investment to do so.

Mr Stephens: Yes, I would agree with that. There is no reason why universities, so long as they have the initial funding and the continued funding to keep the facility up to scratch, so long as the appropriate risk assessments are done, so long as the appropriate management controls are in place, there should be no reason why not.

Q294 Chairman: Level 4 large animal containment facilities; I understood when we went to Pirbright that that was part of the original plan.

Professor Shirley: Yes, it was.

Q295 Chairman: Why was it dropped?

Professor Shirley: The same reason I am afraid, high cost.

Q296 Chairman: Just cost.

Professor Shirley: When you say "just cost" the cost to provide the facility would have been itself a large sum of money, but you are then into the recurrent costs of maintaining that facility and maintaining the scientific and technical expertise to maintain that facility. That was the real killer cost.

Q297 Mr Cawsey: You will have worked out by now that one of the advantages of being the second panel is that you get to hear some of the questions earlier on. In my own view you should all have to sit there like a game show with headphones on listening to piped music so that it comes to you new. I am still interested in this issue of training which we discussed with the first panel when we were talking about much training is necessary for people who are going to work with dangerous pathogens, should it be done on site, how much should be prescribed training so it is coordinated on a national basis and if that were the case who would be responsible for doing that?

Professor Shirley: I think we give very good training in situ. There are a number of hurdles new staffs have to go through to be trained so there is quite a formal process that they have to engage with. They also have a buddy system as well to monitor them to make sure they are working effectively during their initial weeks of employment and they are signed off as they go through the whole process. Then their books are available for inspection through our quality system. Whether there should be a national type of qualification is an interesting point. Again I see good reason why maybe there should be something that gives a professional recognition for the training that these individuals have undergone. I think the greater the status they have for this type of activity the better. I would be in favour of a more formal system but it is also important to have the hands-on experience with the pathogens you are actually going to be working with in the laboratory.

Professor Weiss: I agree. You can have formal training courses but you must handle those particular pathogens. There is training also in your habits. There has to be a culture of proper hygiene with pathogens as Martin has already emphasised. You can have a brilliant young scientist or medical scientist come in and pass all his training exams and everything else but you do not know that he is going to take his gloved hand out of a safety hood and scratch his eye and that would not be a good thing. Those things have to be done in situ.

Q298 Chairman: In principle you agree with having a national recognised training scheme that an institution builds on.

Professor Weiss: Yes, but a national training scheme should be minimalist rather than maximalist or they will have passed onto the next job by the time they are trained.

Chairman: On that note can we thank you all very much indeed, Professor Martin Shirley, Director of the Institute for Animal Health, Professor Robin Weiss, the President of the Society for General Microbiology and Mr Michael Stephens from the Institute of Safety in Technology and Research. Thank you all very, very much indeed.