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

Examination of Witnesses (Questions 299-319)


21 APRIL 2008

  Q299 Chairman: Could I welcome our panel of ministers for this, the final session of the Innovation, Universities, Science and Skills sub-committee work on biosecurity in UK research laboratories. We welcome this afternoon the Rt Hon Dawn Primarolo MP, Minister of State for the Department of Health, Ian Pearson MP, the Minister of State for the Department of Innovation, Universities and Skills and obviously for science, the Rt Hon Lord Rooker of Perry Bar, the Minister of State for the Department of Environment, Food and Rural Affairs and, last but by no means least, the first time we have met you at this committee or indeed my previous committee, Lord McKenzie of Luton, the Parliamentary Under-Secretary of State for the Department for Work and Pensions. This is probably the first time that we have had four ministers from different departments on one inquiry, but we are very, very grateful to you for giving your time. I wonder if I could perhaps start with you, Ian, this afternoon; if you could chair your panel and if you feel that a question should be deflected elsewhere could I just ask you to accept that responsibility, if it is a difficult question it can go to one of your colleagues, depending on whether they are on the left or right of the party. We have obviously obtained a lot of evidence about biosecurity and I wonder if we could start by saying who do you think is actually in charge within the Government for biosecurity. We have received, obviously, a memorandum from four different departments here but who actually is in charge, who pulls it all together, who actually cracks the whip when things are not going well?

  Ian Pearson: The first thing to say, Chairman, is thank you for the invitation to attend this Committee; the fact that you have got four Government ministers here shows that this is very much a joint responsibility and, as Spratt reports and Anderson reports, it is clearly demonstrated with the recommendations that they made there are lessons we have all learned from the outbreak at Pirbright. First and foremost, obviously it is the responsibility of individual facilities to ensure that they conform to good biosecurity practices, whether that is in an institute or whether it is in a university research laboratory, and it is the responsibility of regulators to make sure that sites are operating in conjunction with the terms of their licence. We have had a number of different reports into this at the moment and the clear conclusion from those reports is that there are lessons for all of us to learn.

  Q300  Chairman: But who pulls it together, Ian?

  Ian Pearson: We are actually learning those lessons and you will see that we have actually responded very positively to Spratt and, recently, we have seen the publication of the Beringer report and you will be aware of BBSRC's response to that in the form of the press statement which was issued on Friday of last week.

  Q301  Chairman: When you say "we" you obviously mean the Government in its collective state but who actually within Government pulls the thing together? Is it you, is it DIUS, is it you, Dawn, within health, is it you, Jeff, within Defra? Who is it?

  Ian Pearson: Perhaps if you can explain what things you are talking about pulling together then we can try and help you.

  Q302  Chairman: Following the Pirbright situation we have clearly had, for instance, an independent review that has highlighted Defra's conflict of interest over the shortcomings of the SAPO regime; who was responsible for picking that up, was it you in Defra, or was it a mistake that had been made in Defra, was it an oversight? The point I am trying to make is, is there nowhere within Government where you all come together as a group, the four different departments, and actually share information and actually have some co-ordinating organisation to make sure that biosecurity and biosafety is something that pervades every aspect that you are responsible for?

  Lord Rooker of Perry Bar: In a way you have asked a question specific to biosecurity wich is why I do not think you will get the specific one size fits all answer that maybe you are looking for. Within our individual departments we have got laboratories that are our own laboratories, they may work with others but nevertheless—that happens in Defra, some of which I am ministerially responsible for, but Pirbright I am not because it is not a Defra laboratory, we are a customer. We were also the regulator, we were also the inspector and probably we were the major customer of course. That perceived conflict had probably been identified some time before when we were looking at the review of where laboratories were fitting within Government, but then the laboratories themselves have their own networks within departments and across departments and they are looking at things other than biosecurity—they are looking at the service to customers, research facilities and capital investment programmes—maybe where they can be shared—but when it comes down to the actual nuts and bolts of the biosecurity, wherever the laboratory may be located,, some of it is pretty basic. If you go back to the Health and Safety Commission report published in September, when even the vehicle numbers going on our Pirbright site were not being recorded and times on and off the site were not being recorded, about as basic as you can get, no regulator and no inspector can actually carry the managerial responsibility for that, that has to be imposed on the site operator and it has to be imposed by the person either regulating or as the customer giving the set of parameters, but the actual function of that has got to be the actual site operators themselves.

  Q303  Chairman: The point we are trying to make here is that whoever is operating the site, under the aegis of whichever Government department, there perhaps should be common standards which in fact prevail right across the piece. Is that not reasonable?

  Lord Rooker of Perry Bar: It will vary from site to site—the location of the site, the risks around sites: some may be urban, some may be rural for various historical reasons or indeed customer orientation reasons, but the basic principles of biosecurity, whether it is a laboratory or indeed a farm, are quite well known. We do not have to write and invent the process here. I get annoyed when I go on farms and it is only when there is a disease outbreak that you get some biosecurity at the front of the farm. Occasionally there are farms which have got it 365 days a year and you could argue that that would be good preventative practice.

  Q304  Chairman: The Callaghan review made it absolutely clear that Defra, the Department of Health, Health and Safety Executive and other interested parties should work together much more closely than they were doing at present; you seem to be giving the impression that all is well, we just do our own thing and it does not matter.

  Lord Rooker of Perry Bar: No, I do not seek to give that impression at all. First of all, we fully accept that lessons can be learned both from this outbreak and indeed others right across Government—this goes way beyond Government and as Bill might tell you in a way, as a result of all this, the input of the Health and Safety Executive is much greater on these areas than hitherto in the past. We can learn lessons and all I am simply saying is you are asking a question: who is in charge nationally of biosecurity? Frankly, you cannot get an answer to that.

  Q305  Chairman: But I can get an answer to the basic question as to who within Government actually pulls it together when there is a need to do so, to make sure that there are not in fact errors or in fact problems which are occurring in particular areas. We do not need another Pirbright, do we, before we start looking at all this again?

  Lord Rooker of Perry Bar: We do not, but Pirbright is fairly atypical of laboratories. Government departments have their own laboratories and Pirbright of course is effectively a charity, partly funded by the Science Research Council, and it is outwith that normal flow with a separate governing body I understand. We are a customer as I say, it is not a Defra laboratory like the veterinary laboratories agency. When you look at your own laboratories you clearly are responsible as the department, as the minister, to make sure of the operation of the laboratory as well as the focus on the finance and the actual research contracts as well as the other issues relative to biosecurity, but that does not therefore cover across Government.

  Q306  Chairman: I know that Tim is wanting to come in here and I know Bill that you are wanting to come in and so is Ian; can I bring you two in and then bring in Tim?

  Lord McKenzie of Luton: I just wanted to comment briefly, if I can. In answer to the question who is in overall charge, as my colleagues have said, it depends in charge of what. It seems to me that some clear issues that came out of the Callaghan report are that there should be a single regulatory framework and there should be a single regulator; therefore, in terms of that part of the equation the way forward is clear, those recommendations are right and certainly recommendations which cross-Government we support. That component of it, therefore, it seems will be in place but at the moment it is split: there is more than one regulator and the regulations that apply are not identical within the framework to get one framework.

  Q307  Chairman: I am looking at one stage before the regulator because the regulator regulates something and it is who pulls together, if you like, the conditions under which the regulator then inspects and makes sure that they are applied. Ian, did you want to come in?

  Ian Pearson: Just to emphasise the point that Bill was making really, which is that one of the clear conclusions that come out of the Callaghan report that has been accepted by Government is that there does need to be a single regulatory regime. You have heard very clearly from the people who have submitted evidence to you and been examined orally as well that there is very strong support for that approach, and that is exactly what as a Government as a whole we are doing at the moment.

  Q308  Chairman: Dawn, on this initial question?

  Dawn Primarolo: I absolutely accept and welcome the Callaghan review points, particularly around the question of biosafety and who should be, if you like, the regulator in that. I was listening carefully to the dual point about are safety and security the same thing in all circumstances and should they be done by the same body? From the Department of Health's point of view there is a clear line on safety and on security, the one on safety is through the HSE, buttressed by the COSHH regulations, and security is done through the national counterterrorism security office, Home Office, inspected by the police. What I was reflecting on briefly as this starts is whether those two things are exactly the same and whether they should or could be done by the same body, or how they interlock. All of us have said in submissions to the Committee that we think on the regulation side, the safety side, whilst it is the responsibility of the particular authorities—HPA as an agency for the Department of Health—to make sure they have got safety, that has got to be regulated and inspected and the HSE is the way forward. I am not saying it cannot be done by the same body, I am questioning what exactly do we mean? Some of the security is very specific and requires different skills, but that still begs the question that you started with though, which I do not have an answer to, should there be one body? Given that it is cross-government and we have all got—those of us represented here—particularly Class 4 laboratories, how do you get that departmental link and tie-in?

  Chairman: The line of my questioning will become more apparent as we move through the questions this afternoon, because there are other issues we have raised which actually bring us back to that business of who co-ordinates it all, but you have been very patient Tim.

  Q309  Mr Boswell: Can I begin by apologising to ministers for being a touch late but I have literally come up by train because I wanted to talk to you about this. It would not really be appropriate perhaps if I glossed on what the Chairman said but I could perhaps introduce a concept which Lord McKenzie will be familiar with from HSE philosophy about the controlling mind. It is understandable that in the individual laboratory, be it owned by Defra, a research council, the Department of Health or one of its agencies, it would be quite wrong to say that site security should not be the responsibility of an individual ultimately and of the management to whom that individual reports, but I would like to take you on a little further about this idea of what might be termed strategic biosecurity, by which I am really feeling after how one would get a better mechanism across government for setting a set of standards which a single regulator that you have referred to would then implement, having a discussion about it and possibly taking that forward into the future. If I could say one more thing to make it one question for you to respond to, please do not think that as far as I am concerned this is all raking over the past, although obviously we are all interested in learning the lessons of the past. If we are looking forward—and you will get some more questions about this in a little bit—we may be wanting to ask perfectly sensible questions across the public sector about how many category 4 laboratories we need and how we should have a plan for those—it is a perfectly proper planning function for government. We cannot do that by a series of itemised decision-making, somebody has to take the lead on that and then have a discussion and take advice from HSE as the regulator—I can see Dawn in particular responding. I wonder if you could just take me through those thoughts and give me some comfort as to how we might get a single structure for looking at some of these issues on a fairly principled basis within Government or within the public sector.

  Dawn Primarolo: I was nodding in terms of some of the work that I know the MRC has commissioned that the HPA is working with, and there is a steering committee and then an independent review. I am happy to join in or answer it, but I do not know, Ian, whether you want to say what the MRC decided to do and how this might actually take us down the path of exactly what this Committee is talking about.

  Ian Pearson: Let me comment on that but firstly let me amplify some of the points that have been made about security and what we are talking about here. It is right to draw a distinction between biosecurity in the sense of safety that we have accepted should be a unified regulatory regime with the responsibility of the Health and Safety Executive and the security aspects that would deal with potential threats through counterterrorism or through proliferation, and it would not be sensible to put those together into a single regulatory regime but we do as a Government think it right that the Health and Safety Executive take responsibility for what you might call the biosafety aspects. With regard to your broader question about containment level 4 facilities and how many of them do we need, the Medical Research Council has commissioned, as Boris said to you during his evidence session, a study that will look at with regards to the MRC and I believe the BBSRC as well the scope and likely future requirements when it comes to category level 4 facilities, but again it is important that we be clear what we are talking about here because the sort of research that you might want to do for medical research or biosciences research or veterinary research can be very different to some of the other research fields that might have more of a security aspect to them.

  Mr Boswell: To link in with ministers, if I might—because that is a helpful answer—presumably albeit it is an MRC show this will report to some kind of inter-ministerial machinery so that you will make a decision on whether you need to make a collective decision on some of these issues or whether it is really too difficult or inappropriate.

  Q310  Chairman: It is a point here that we do not know of any inter-ministerial group that works in this area despite these big issues.

  Ian Pearson: The situation is that Research Councils are responsible for making detailed decisions on the level of research that is required across their communities and they will be responsible for making that assessment and ensuring that facilities are put in place to meet those, and that is one of the reasons why the MRC has been actively looking at the future situation and trying to make an assessment, given that these are very expensive facilities, whether there are sufficient resources. As you heard in evidence previously the feeling is that with regards to the Medical Research Council and the BBSRC as well there is a sense that the resources that are available at the moment are adequate for the tasks that are currently envisaged and funded, but the issue is what might happen in the future which is why the research has been commissioned.

  Q311  Mr Boswell: That again is helpful but I am not sure it quite meets my point because you started off by responding to my question about whether there was a single controlling line of government by saying the MRC is conducting a survey, and that we understood, but as you went on to refine that you made it increasingly clear that that was a study which was confined at least to the relevant research councils and did not extend across government. I am just wondering, again taking up what the Chairman said, there is a single body which is prepared to stand back and say, look, we are a country of a certain size, there is a distribution of population and we need X number of facilities. We have got more or less or we could rationalise them in this or that way or make better use of our facilities, and generally plan the system. I do not think you have quite given me that.

  Ian Pearson: Firstly let me put back to you the fact that the sort of research that you might want to conduct at Porton Down is very different to the sort of research that you might want to conduct at Pirbright, we always need to bear that in mind. When it comes to the quantum of research that any particular institute might want to do and whether that research should be funded, we then come back to a peer review process and so the MRC will take some detailed decisions on what it thinks is the best peer reviewed research that it wants to undertake, and it will be up to the MRC within its delivery plan that gets approved by Government to make those decisions.

  Q312  Chairman: We do understand that Ian. May I just ask you all one very simple question? As far as this inquiry is concerned have you ever met as a team of ministers on this issue of biosecurity or biosafety? Have you ever met?

  Ian Pearson: No.

  Q313  Dr Gibson: The Health and Safety Executive is the regulator and that has been agreed; do you think they have enough resources to do all the things they might have to undertake or are there going to be limitations and will they need other kinds of support, do you think, or are they self-sufficient?

  Lord McKenzie of Luton: It is an important point and the expectation is that resources will be sufficient. You will be aware that Sir Bill Callaghan's report proposed a three-phase approach; phases one and two for the additional work that the HSE would be undertaking, looking at the SAPO regulation, that Defra has agreed to fund and in relation to phase three Bill's recommendation was that we enter into a charging process just like the COMAH sites at the moment; that obviously creates some challenges, it will be a sensitive issue and will need a lot of discussion, but that would certainly provide a route for additional resources. If you looked overall at the settlement for the HSE under CSR07 it has been the subject of some comment only just today when the DWP Select Committee probed that in some depth, but I would summarise again the outcome as being that the three year review gives the HSE in aggregate something like a little bit better than flat cash in comparison to the 04 settlement. In the context of the DWP's minus five per cent real year-on-year you will see that we have tried to resource the HSE appropriately. In terms of personnel, at the biological agents unit which provides the staffing for that I am advised that staffing has increased over the last six or seven years from about six originally up to 17 including the three recruitment exercises that are under way, so in terms of personnel we believe there will be sufficient personnel to carry out the tasks. I understand that although the HSE is currently focused on human pathogens, we are really dealing with containment technology and processes here and they are broadly common to animal and human pathogens; therefore, since there is not a hugely new learning curve I guess the final point I would make is that if you look at the number of institutions for Level 3 containment that HSE is engaged with at the moment it is overall the highest proportion of those facilities that exist. The number of those that are SAPO-only regulated is quite small and of the ten level 4 containment facilities only two of them are currently SAPO-only regulated, so the HSE is already significantly engaged with most of them. The answer is yes it will be sufficiently resourced to do the task.

  Q314  Dr Gibson: If I decided to set up a laboratory of some kind to investigate disease would they come in and help plan and prevent the problems that might happen, rather than just picking up the problem once it happens?

  Lord McKenzie of Luton: It depends in part, I guess, on the structure of the regulatory framework that we end up with because the approaches under COSHH and the GM containment regulations are slightly different—one is a permissioning regime, the other is a notification regime whereas SAPO is a licensing regime. Whichever of those processes is eventually adopted Bill recommends against a licensing regime.

  Q315  Dr Gibson: But there is a bit of uncertainty in that area, is there, about how it might end up?

  Lord McKenzie of Luton: The final structure of that regulatory framework is the subject of discussion at the moment but certainly Sir Bill recommended against a licensing approach; the extent to which there should be a permissioning approach or a notification approach should be the subject of on-going discussion. However it ends up, there would inevitably be an iterative process between those proposing the establishment and the HSE because at the end of the day those who propose it want to know that they are going to get whatever approvals or agreements they have that the thing can be safely operated.

  Q316  Dr Gibson: Has the HSE cut their ties with Defra for example, who have a heck of an experience in this area, in certain fields anyway?

  Lord McKenzie of Luton: It is working closely with Defra at the moment or has worked through stage 1 and as stage 2 kicks in at the end of this month there is a good working relationship. Obviously those ties will not be cut and if there is need in particular for veterinary expertise that would be available and would presumably be brought in, so we do not see that as being a particular problem.

  Q317  Dr Gibson: Could somebody somewhere walk into an office and look at a sheet of paper or a map about where these pathogens are going to be localised across the country? Is there going to be a centralisation in HSE or what?

  Lord McKenzie of Luton: It is right to say at the moment with the existing regulatory structure one way or another the HSE ends up with a pretty significant database of what work is going on where across the country. I would hope that means that somebody could not just wander in and have a browse at it, but in fact that data does exist and is with the HSE at the moment.

  Q318  Chairman: You mean it does exist now.

  Lord McKenzie of Luton: I believe it does.

  Lord Rooker of Perry Bar: It is just not published.

  Q319  Dr Gibson: Is there a reason why it is not published? Is it just being remiss or is too risky?

  Lord McKenzie of Luton: Some of it would be I guess highly sensitive, some of it might be commercially sensitive, and obviously there are national security issues associated with some of it.

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