Select Committee on Innovation, Universities, Science and Skills Minutes of Evidence

Examination of Witnesses (Questions 20-39)


17 MARCH 2008

  Q20  Mr Cawsey: So should one body, for instance, HSE, take responsibility for all aspects of the regulation of pathogens, including anti-terrorist provisions and transports, to give laboratories a single point of contact?

  Sir Bill Callaghan: It may well be going a bridge too far to say that HSE would take on all of the work of the security services. I am told that there is good contact between HSE and colleagues in the security services, and that is absolutely right, and is an issue perhaps you would want to address to my former HSE colleagues, but I do know on other issues where matters of national security have emerged that HSE has always played a responsible part in activities of Cobra and its associated committees.

  Professor Griffin: There is another very interesting and important aspect here as well. if you consider there are four different types of laboratories at P3 and P4 level—there are diagnostic laboratories in hospitals, there are academic laboratories in university institutions doing research, there is the Ministry of Defence with biodefence, or bioattack, whatever you want to call it, and that is three of them—and each of those are inspected. In the Hospital Diagnostic Service inspections are carried out by private organisations who will come once a year at the request of the hospital diagnostic facility, and they will inspect the hoods and the procedures and so on and sign those off, and if the hospital is happy with that then they continue. So there is a private sector involved in this. The fourth arm of this, of course, is industry—the big pharma, antibiotic development growing dangerous pathogens. So you have four main sectors from government through to big pharma operating, each using the same regulations but being inspected maybe in different ways, and that should be joined together.

  Q21  Chairman: Bill, just briefly, what I certainly did not fully understand, and perhaps you will clarify this, is that at the moment a university can apply for a licence. It satisfies the criteria and it gets a licence. It can then use in a variety of laboratories a particular pathogen, let's say a Level 3 facility. In fact, it can use that pathogen in a number of different laboratories without having to have each of those laboratories licensed. Are you saying that under your new proposals there would be a risk assessment of each of those laboratories before, in fact, they were licensed? Is that the process that you describe?

  Sir Bill Callaghan: At the moment under SAPO licences are given, as I understand it, to individuals to work in a particular laboratory. Under COSHH and GMO (Contained Use) there has to be notification, and Mr Cawsey was bringing out the different bases of who was, as it were, given the notification. What we are suggesting is that, for work on all pathogens, both animal and human, there should be a risk assessment conducted by the duty holder that should then be submitted to HSE.

  Q22  Chairman: So it will be, if you like, the biosafety officer who would be responsible wherever those pathogens were being used, rather than the individual?

  Sir Bill Callaghan: Well, I am not sure it would necessarily be the biosafety officer; it would be the body corporate, the university, the hospital, the research institute, and of course one issue which we touch on is who is the controlling mind where you have a number of organisations on one site, but there is someone clearly in charge who has to put in the application and in health and safety law who would be responsible. There are then clear responsibilities on the BSO and other members of staff, but it would not be the BSO, in my understanding at least, who would be putting in the application: it would be the body corporate.

  Professor Griffin: At the moment in academia, and I am sure Dr Gibson will concur with this, it is the head of the institution who is finally responsible, and if there is a serious incident or accident then the head of the institution is the one who would bear the brunt.

  Dr Gibson: But here it is often the registrar who delegates his authority to some minion who then gets the boot thrown at them, and that is quite legal. That is how they slip out of their responsibility.

  Q23  Mr Boswell: I have two questions about classification. The first one is, are the current risk classifications of pathogens accurate and sufficiently comprehensive? Have they in turn been properly risk assessed, and maybe at that point also is the regime there coming together between zoonoses, human pathogens and animal pathogens?

  Professor Griffin: The risk groupings are looked at each year by ACDP in the light of new information. For example, if there were to be a change in resistance patterns to an antibiotic or an antiviral drug, then the category of risk for an organism could be moved upwards.

  Q24  Mr Boswell: Or virulence of the organism?

  Professor Griffin: Exactly.

  Q25  Dr Gibson: How would you know there is a resistance?

  Professor Griffin: Because there is surveillance going on all of the time. For example, in routine endemic influenza we know that the main drug, Tamiflu, many of the ordinary strains of influenza now are resistant to Tamiflu, so it is not just the H5N1 bird flu which is the serious strain of flu. There is on-going surveillance and assessment.

  Q26  Mr Boswell: Without talking about, as it were, the whole medical profession, which is a separate issue, in terms of those who are needing to work with these pathogens, your change of assessment or your annual review of assessment, that information, would be known to them?

  Professor Griffin: Very much so, yes.

  Q27  Mr Boswell: And the animal pathogens under this new regime would tend to adopt the same pattern, and you would advise the veterinary profession?

  Professor Griffin: Yes. When the assessment is made you take into account many factors. Virulence is a major one, of course. If there are drugs which can combat the infection, if there are vaccines against that infection, all of that comes in, and the CL4 ones are the ones with no drugs and no vaccine.

  Q28  Mr Boswell: So what at least I think you have reassured me on is that it is not as if there has been some assessment done in, say, arbitrarily, 1956 about the virulence of F&M, or indeed a human pathogen like influenza which is now still applicable. It is looked at every year.

  Professor Griffin: Absolutely.

  Q29  Mr Boswell: Secondly, how logical and evidence-based are the current classifications of laboratories under SAPO, COSHH and GMO(CU)? How well are they understood? That is partly the training issue, but are they logical and rational in themselves? You cannot look at them every year, for example.

  Sir Bill Callaghan: We did find some confusion, I must say, talking to laboratories about the different classifications, but I think foot and mouth disease virus is at the extreme end of the spectrum as something which has the highest level of SAPO classification and the lowest level of ACDP classification because it is unlikely to cause human disease. One of the reasons for perhaps bringing this together in the round is that if you say that something is Level 1 it sounds as if it is not really important, and my opening remarks were trying to address this issue, that failure at Pirbright led to considerable harm.

  Q30  Mr Boswell: Following on from that, are the principles of design and operation for containment laboratories at the different levels based on evidence? This presumably includes economic risk as well as human risk.

  Professor Griffin: Yes, there is good scientific evidence for the procedures carried out. In fact at the very highest level they are based on good evidence and they are so secure that they often have failsafe procedures, such as the heating that we were talking about.

  Q31  Mr Boswell: Finally, on the international perspective of all this, you operate as ACDP and you will clearly be in contact with professionals in other countries, and there is a European Directive as well that we are aware of. There is a huge interest, of course, across the world—easy transmissibility by air travel, for example. How much can we be reassured that there is a common approach to this, even if legal forms or slight regulatory differences occur, across the major developed countries at least, and that we are not going to have difficulties where something gets through because somebody, it may not be in the United Kingdom, is a weak link in a regulatory chain in relation to a particular pathogen?

  Professor Griffin: This, I must say, is a concern. We heard three or four weeks ago of the American gentleman, Dr Sharma, and really we are ahead of the States in my view in our regulation of CL4, and I will be visiting some of their sites soon. There is no doubt, however, that we have a much tighter framework than that in the States, and you remember he said that anybody who wants to have a CL4 can just build one on their facility with little in the way of regulation. So we are ahead in that. In terms of Europe there are two main sites, one in Marburg and one in Lyon, and there are European regulations which deal with this, as you say, which keep the developed world as safe as it could be. At the end of the day, of course, a single individual travelling on an aeroplane with a pathogen is not covered by COSHH or SAPO; they are covered by themselves.

  Q32  Mr Boswell: At least if we take the specific answer you gave me earlier about your annual update of pathogenicity, that information would be immediately transmitted to your counterparts, and they would take it into account, and if you had some aberrance or new experience that would go through the community internationally pretty quickly?

  Professor Griffin: Yes.

  Q33  Dr Iddon: In your view do we have enough capacity in the United Kingdom for handling research on dangerous pathogens, either now or projecting into the future?

  Professor Griffin: I do not know at the moment, and I am just conducting a review on behalf of the Medical Research Council; it has just started to look at this. The MRC are charged to look at newly emerging pathogens and dangers to public health from these, so there must always be surge capacity available when something like bird flu or another of the emerging viral infections happens. There probably is enough at the moment but we are not well endowed. The Ministry of Defence has a facility at Porton which is largely doing biodefence, of course. There is spare capacity there, we know, and we would be able to use that if necessary. The MRC is thinking of a new facility when it moves in NIMR, as I mentioned, and the question is where would that be sited. In Boston they have a CL4 facility in the middle of the city, which is causing great perturbation at the moment, and this may well be a very important guiding factor for the siting of future facilities in the United Kingdom.

  Q34  Dr Iddon: I am coming to that aspect in a moment. What about the handling of large animals? Can we do that in Britain adequately?

  Professor Griffin: We can do that in limited places. We can handle small primates at Porton at the HPA facility for TB and HIV research and vaccine research. In terms of large animals such as horses, cows, and maybe sheep, the Pirbright facility, the new one that I hope you saw, will be able to do that. Up to that time the only facility in the world, as I understand, for very large animal Containment Level 4, post mortem, was in Australia where they were doing work on Hendra virus, but the new facility at Pirbright when commissioned and tested will be able to work on cows.

  Q35  Chairman: They, in fact, said that that would not be able to --

  Professor Griffin: For cows?

  Chairman: Yes. At level 4.

  Q36  Dr Iddon: For the CL3 and 4 laboratories, in your opinion, from what you know and what you have seen in your experience, is there enough maintenance money to maintain these facilities in good condition?

  Professor Griffin: In academia, which is my own place of work, there is not. We have to beg and scrape and get money for routine maintenance; every year we have to have inspection of cabinets, replacement of filters, and this is costly, very costly, and this, by and large, has to come out of either research grants or out of the consumables which the university has. It costs a great deal of money to keep these facilities going.

  Q37  Dr Iddon: You have mentioned the HSE a number of times as being a regular agency in this sphere. Do we know how many CL3 and 4 laboratories we have in Britain and where they are situated? Who has that knowledge? Who has the strategic overlook?

  Professor Griffin: That is a very simple question with a complicated answer, I am afraid. If you look at CL4 there are elements of security and so on, and so these lists are not easily available for newspapers and so on for obvious reasons. Defra has a list of CL4 and SAPO4 which we have all seen but is not for public consumption; I have a list for the MRC for this Committee that I am looking at at the moment; there are two industrial sites which do CL4 work, two vaccine companies, Merial and Schering. The rest are either government or academe, so we do know what there is in terms of CL4. In terms of Containment Level 3, the exact number is round about 350, I do not have that list, and that is made up of diagnostic facilities in hospitals, of industry, farmer, academe and government facilities.

  Q38  Dr Iddon: Should there be one body that overlooks this, like the HSE which you have mentioned?

  Professor Griffin: I think that would be incredibly useful and important.

  Sir Bill Callaghan: In our report we note the number of ACDP CL4 facilities, which are eight in GB, and 352 CL3 facilities. For SAPO there are 68 laboratories with a SAPO licence, and 10 are for work on pathogens categorised as Category 4. In my previous existence I was part of a Commission recommendation to take this information on laboratories out of the public domain. This was after 9/11, for security reasons.

  Q39  Dr Iddon: Professor Griffin, you hinted at the fuss over a CL4 facility in the middle of Boston. I understand the Germans are quite happy to have one in the middle of Berlin, and we are considering putting one in the middle of London. What is your advice to the authorities on the presence either of CL3 or 4 in the middle of large conurbations?

  Professor Griffin: I will give you better advice in about three months' time when I have been around, but at the moment I would try to avoid it, to be quite frank. I would wish to have high security outside of a major city.

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