Role of the VPC
25. The VPC was established in 1970 under Section
4 of the Medicines Act 1968 with the following terms of reference:
- to give advice with respect to safety, quality
and efficacy in relation to the veterinary use of any substance
or article (not being an instrument, apparatus or appliance) to
which any provision of the Medicines Act is applicable;
- to promote the collection of information relating
to suspect adverse reactions for the purpose of enabling such
advice to be given.
We have no doubt that the VPC has acted conscientiously
in reaching its decisions on OP sheep dips, given the information
available. However, a number of witnesses raised issues with us
which suggest that there is room for improvement in the way in
which the committee operates. These include criticism from the
OP Information Network (Scotland) of the source of information
submitted to the VPC, with the claim that "a system that
relies solely on the data of producers is unacceptable towards
enforcing these aims of 'safety, efficacy and quality'".[111]
Others pointed to the lack of openness by the Committee which
had made its advice late last year such a shock to the industry.[112]
Finally, the Environment Agency argued that the VPC's membership
"could be usefully extended to include a further environmental
scientist",[113]
thereby broadening the range of expertise and of considerations
taken into account when formulating advice.
28. We raised these matters with the VPC Chairman,
Professor Aitken, who accepted that information supplied by manufacturers
"constitutes a considerable part of the information presented",
albeit not "exclusively".[114]
Other information came from reports and questions raised by the
committee.[115]
In general, he argued that the VPC "does, in the process
of authorising any application that comes before it, go through
a very rigorous exercise of judging its quality, safety and efficacy".[116]
He went on to say that information before the Committee also came
"from the knowledge of its individual members".[117]
We argued earlier in this Report that it would be more appropriate
for the Environment Agency to advise the VPC directly to ensure
that environmental issues were properly considered. We also believe
that the VPC must consider how to broaden the range of information
on the possible harmful effects of products under examination
and that it must be more open in its approach. Its proceedings
in this instance have not been conducive to a good working relationship
with any part of the industry and we are further concerned by
allegations that its report was made available to some but not
all interested parties.[118]
The VPC has an important role to play and greater transparency
would encourage faith in its conclusions.
Role of the Minister
29. Ultimately, the decision on whether to act on
advice from the VPC or any other such committee rests with Ministers.
In this case, the advice to recall containers of OP dips went
to the licensing authority, "a collection of ministers"
including Baroness Hayman.[119]
These Ministers "had to consider whether to take that advice:
whether to do something less onerous", such as allow the
products to remain in use while containers were being redeveloped,
or to do "something more draconian", such as permanently
revoke the licences.[120]
Baroness Hayman regarded the advice she received from the VPC
as "unequivocal",[121]
although she also accepted that it was not "an easy decision".[122]
She defined her role as "trying to get the most sensible
assessment of the appropriate way forward given one's responsibilities
as a licensing authority and the advice that one has a responsibility
to consider".[123]
There is of course little point in having expert advisory committees
if their advice is constantly overruled. However, in this instance,
we are concerned that insufficient attention appears to have been
paid to the practical and economic consequences of the decision.
On balance, we accept that the right decision was made but that
it could have been handled more effectively both prior to and
following the announcement and we welcome Baroness Hayman's willingness
to reconsider her decision in the light of possible future advice
from the advisory committees.[124]
111 Ev. p. 37. Back
112 eg
Ev. p. 47. Back
113 Ev.
p. 56. Back
114 Q
18. Back
115 Ibid. Back
116 Q
17. Back
117 Q
18. Back
118 Ev.
p. 47. Back
119 Q
8. Back
120 Q
40. Back
121 Q
40. Back
122 Q
45. Back
123 Q
107. Back
124 Q
86. Back
