Select Committee on Agriculture Minutes of Evidence


Examination of Witnesses (Questions 40 - 59)

TUESDAY 11 APRIL 2000

BARONESS HAYMAN, MR RAY ANDERSON AND PROFESSOR IAN AITKEN

  40. Did you consider any alternatives?
  (Baroness Hayman) Yes. As I understand my responsibilities as part of the licensing authority, which is a collection of ministers, the responsibility is to take account of the advice of the VPC but equally the responsibility is with ministers and one does not have to accept that advice. The advice I received was unequivocal. The VPC stated, "We consider that the hazard of exposure to concentrated dip is sufficient to warrant recall of its existing containers". Together with colleagues I had to consider whether to take that advice: whether to do something less onerous—and one of those possibilities would have been to allow product to remain in use or on the market while parallel activity was going on to improve container design. Equally I could have done something more draconian, not accepted the advice that OP sheep dip should be available in any way and have permanently revoked licences. Together with colleagues, a range of options were considered and obviously there were all sorts of factors ranging from whether one should take an extreme precautionary approach, given 50 years of concern about the danger of OPs, or whether one should take a more pragmatic approach given the concerns that would obviously be amongst the farming community and those concerned with animal welfare, if OP sheep dips were not available. In the end, my decision which was taken together with other ministers responsible for regulatory action in this area, was to follow very closely the advice of the VPC.

  Chairman: We are going to focus a little bit now on that decision.

Mr Mitchell

  41. You did not ask for a second opinion at all?
  (Baroness Hayman) I am not sure I would settle for second opinions from other ministers!

  42. But you did not consult with the Committee or any other body to give you an opinion on the issue?
  (Baroness Hayman) We received advice from the three regulatory committees that Jeff Rooker announced in July we would ask for advice from on the COT report and that was the Advisory Committee on Pesticides because there is pesticide use of OPs, the Committee on Safety of Medicines because there are human health applications of OPs, for example, for head lice, and the Veterinary Products Committee but I certainly did not go to anyone else to second-guess the statutory adviser, and I do not think that would have been appropriate.

  43. Were other alternatives considered like detailed labelling on the concentrates?
  (Baroness Hayman) The labelling issue is one that is on-going—I do not think it was considered as an alternative—and the compulsory certification issue was one I received advice on from the Health and Safety Commission but it was not seen as an alternative to container design improvements.

  44. And there is no air of panic about this decision-making process?
  (Baroness Hayman) No.

  45. It is not the culmination of a long period of doubt which suddenly makes you decide, "Wham, bang we must do something about it"?
  (Baroness Hayman) Unfortunately there is not a lot of "wham bang" in this; there is a lot of detailed accumulation of evidence. But when I came to this job in July it was set out for me very clearly that the IOM report had then been received, the government had undertaken to ask the Committee on Toxicity to review it and review policy on OPs, we would then consult the regulatory committees and as a group of ministers we would then have to take a government review before the end of the year and that was made clear, so there was no sense of panic, as far as I was concerned. It was a process which was laid out and I was involved with. I am not saying it was an easy decision because there are not such clear-cut areas to allow you to say simply, "I know I am right and no one could possibly dispute it". Whether one was right or not has been disputed from both sides of the argument if I can put it that way.

  46. I see that from the evidence we have. I say an air of panic because the Environment Agency seems not to have been consulted. Should it have been consulted under normal procedures?
  (Baroness Hayman) Not as a regulatory progress. The environment agency through DETR were involved.

  47. The Environment Agency says, "Given our statutory responsibilities to protect the environment, it is imperative we are fully consulted in future." That would indicate a bit of sulking to me.
  (Mr Anderson) If I can help, the Environment Agency does, where appropriate, act as adviser to the VPC, as officials, but that is done through the Department of Environment, Transport and the Regions and their officials were in attendance throughout the process of the VPC's deliberations.

  48. One final question on the VPC, it seems unrepentant after all this time on the OP issue. You said you were not going on revoke it for ever. That means that, as soon as new containers come out, you would continue as before, does it?
  (Professor Aitken) If containers of a satisfactory design are brought forward, and we still have to get that information which I hope will happen in the course of the next ten months, then there is no scientific justification for not having them back on the market place provided they are used with all the safety measures that have been identified and are strongly recommended to users.

Chairman

  49. What is the time for the approval of a new container?
  (Professor Aitken) That is not something you can identify with any certainty. We still have not seen the new proposals but it depends upon the actual substance of the container and the methodology by which the concentrate will be delivered. The main concern would be to ensure that the product, in any new container, remains stable over the period for which it will be used. If there were something which was up and running and ready to go, then stability data should be generated within a matter of months but it would mean that the shelf-life of that product was limited to months. As time progresses, so stability data would generate additional information and extend the shelf life. At a practical level it would perhaps be over-optimistic to suggest that they might be back in the autumn of this year and more realistic to anticipate it will be about this time next year, but I cannot predict it because we have not seen the plans from the companies on the revisions.

Mr Drew

  50. On the process of the implementation of the decision, could you take me initially through the lead up to 21 December when the decision was actually announced and who was consulted and how they were consulted?
  (Baroness Hayman) You have to start the process with the announcement in July of the interim advice from the Veterinary Products Committee on the IOM report and manufacturers being told that they should submit plans to improve container design within three months. Those proposals went forward in November. At the same time it would have been made clear that the Committee on Toxicity report would be sent to the government's statutory advisers when it was received. It was received in November: it was made public, and the chairman of that committee gave a press conference quite clearly stating what their conclusions were. Then the process of receiving advice from the Veterinary Products Committee and the Advisory Committee on Pesticides and the Committee on Safety of Medicines took place over the next two or three weeks: it depended when their meetings were which ones came in when. When we had those pieces of advice all together I consulted with other ministers; we met on I think two occasions and there was a fair amount of correspondence. There was also advice from the Health and Safety Commission. This was, however, regulatory action: I was being advised and we were being advised about regulatory action. It was not, therefore, an appropriate situation in which to start consulting with people as to the way forward. Having received the advice, ministers had to decide what to do about that advice and take it forward. I was conscious that a lot of people wanted to know what the response would be: that we had received everything we said we needed to receive and that ministers had reached conclusions about what should be done which was the four-point action plan and I announced that as soon as possible, which I wanted to do while Parliament was still sitting—obviously—and it was announced on 20 December.

  51. How many meetings took place at that period of time with representatives of the industry?
  (Baroness Hayman) None with me.
  (Mr Anderson) No meetings took place between the industry and ministers or the Veterinary Products Committee after the meeting which Mr Rooker had with the industry on 7 July. However, in developing their plans, manufacturers were allowed the facility of coming to see officials of the Veterinary Medicines Directorate in particular to establish what data they might have to produce to demonstrate the continued stability of their products in any new planned containers. There were two meetings which took place about August and following that, of course, the plans were submitted and went to the Veterinary Products Committee but those were purely technical meetings to assist the manufacturers in planning what data they might need to produce to support plans for new containers.

  52. So you are asking the industry to come up with new containers and yet, effectively—it depends how you define a technical meeting but effectively—because this is the accusation, as you know, of the industry—the 21 December decision was a shock: they did not know it was coming. I see you smiling. I think it is important that we know and we tease out what was expected of the industry in that period up until the revocation and, if it was not happening, what messages were going backwards so we can get some certainty that the right process was being pursued.
  (Baroness Hayman) The meetings that took place in the interim were based on the fact that the manufacturers knew from July that we had asked for plans to improve container design, and I think appropriately we were working with the manufacturers through the Veterinary Medicines Directorate to help them come up with appropriate solutions. Equally it was absolutely explicit that the Committee on Toxicity was considering this subject: that ministers were committed to acting on the recommendations that we got from our statutory advisers, including the Veterinary Products Committee on that report and, as I said, that report was made public in November. I honestly do not believe that we can be accused of not informing the manufacturers of what was going on but the withdrawal of a marketing authorisation, even temporarily, is a formal regulatory action and it would not be appropriate for ministers to announce that or to try and negotiate that with the manufacturers affected in advance. After the decision, which we took on the advice of the committee, I certainly did respond to a request from manufacturers to meet them, together with representatives of farming and other interests, and there have been on-going meetings since then. The point was put to me clearly at that meeting that they were concerned that the working group of the Veterinary Products Committee did not perhaps appreciate the effects on animal welfare and I arranged for a meeting between the subcommittee and those groups so there has been plenty of contact since then. On the point of pre-warning what the regulatory decision would be, no, there was no pre-warning of that and I think that was correct.

  53. Were you expecting the industry to work to a timescale? Obviously the industry were not working to that timescale because, unless somebody has got this completely wrong, the industry are shocked on 21 December. They just do not see this coming.
  (Baroness Hayman) Well, they were working to a timescale and they met it in terms of submitting plans in November.

  54. They did that but obviously the timescale was insufficient for them to get this right?
  (Baroness Hayman) Well, they were working to submit plans by the middle of November and they did that so they knew what that timeframe was; they knew very well that ministers had committed to making decisions on the basis of the COT report and the advice on that before the end of the year and there were six weeks between that and that so there is not a lot of doubt about the timeframe.
  (Professor Aitken) When the industry representatives presented their plans for new containers in November, at least two of the plans—both for the shorter and the longer term—were very promising and very likely to progress to satisfactory outcomes. The others had defects and deficiencies which I am sure have now been relayed or were relayed in November to the companies. Because of other events, those promising lines of development have not been able to progress. Had they been, then I suspect or believe that there might well have been OP dips available from this summer but other circumstances dictated that that could not happen.
  (Baroness Hayman) And those are circumstances unrelated to regulatory action.

  55. Can you take me through December 21 when the announcement was made? How was it made? Who was informed? Without going into the practicalities of removing the materials, were how were people supposed to know, down to the level of the farm that OPs, were being revoked?

Chairman

  56. For example, advice to regional service centres?
  (Baroness Hayman) Shall I start with the Parliamentary? It was announced in terms of a Parliamentary answer in both Houses. There was equally a press release that went out and I think that it went on to the MAFF website immediately which then takes you into the regional service centres, and individual manufacturers were informed on the same day and informed of responsibilities in terms of withdrawal on the farm. Equally, obviously, the farming press immediately covered the issue—I seem to recall doing an interview for Farming Today—so there was coverage of it. Again I would not pretend to the Committee that doing this in the week before Christmas would have been the time I would have chosen to do it if I had had complete control over the timetable, but there were certain decisions to be made about when Parliament was sitting, the fact that we had the advice available and that decisions had been reached that I felt it inappropriate, having been advised to take regulatory action to protect human health, to delay so doing.

  57. Did you send a note to the Regional Service Centres, saying, "This is how you answer farmers' queries if they question you", "These are the sort of answers to give"? On the 21st, I guess the Regional Service Centres were probably lightly manned over the holiday period, as most offices would be, so if farmers did ring up and say, "When would be the earliest, say, that we can use them again", and those sorts of practical questions, how available was that sort of advice, do you think, for people just seeking to know, "What does it mean for us"?
  (Baroness Hayman) Well, I suspect that the factors you have identified meant that over the Christmas period that was not easily available and we can possibly learn from that and make sure that regional service centres are more specifically informed on such issues.

Mr Jack

  58. Just following that line of questioning, in the evidence to the Committee the National Office of Animal Health Limited referred to a fax of the 24th December which they sent to you which said that no company heard the VPC's judgment until the 20th December. What did you reply to that fax? How did you rebut this allegation that nobody really knew what was happening until the 20th December?
  (Baroness Hayman) Well, that was absolutely true. Nobody knew. Parliament did not know what the regulatory action was until the 20th December.

  59. I am quoting from NOAH's evidence to this Committee: "As explained in my fax of the 24th December, no company heard the VPC's judgment until the 20th December", and I can only quote what they tell us.
  (Baroness Hayman) That is absolutely true, and, as I say, nor did you as a parliamentarian hear until the 20th December. They heard on the same day as Parliament.



 
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