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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