CFG
17/05
Letter dated 11 July
2005 from Foodaware to Mr. John Fitzgerald, Veterinary Medicines Directorate:
Dear Mr. Fitzgerald
VMD Consultation on the Draft Veterinary Medicines Regulations
Foodaware members welcomed the streamlining of the UK legislation,
and note that the timetable for implementing EU Directive 2004/28
by the end of October 2005 is very tight.
Advertising and Food producing Animals
At the feedback meeting, you acknowledged that advertising is one
of the key issues, and remains controversial. We remain strongly opposed
to the proposal that POM-V medicines may be advertised direct to farmers.
As a result, pressure may be exerted on vets to prescribe a certain
drug that has been advertised to the farmer whether or not it is needed
or in the best interest of a particular animal. We are particularly
concerned that this may result in excessive and unnecessary antibiotic
use and exacerbate problems of resistance in both animals and humans.
This must be avoided. POM-V products should not be allowed to be advertised
direct to animal owners. Members also think that there may be some
advantage in achieving equivalence between the advertising restrictions
for human and animal prescription only medicines, and we ask you to
consider the practicality of this. We would also support a formal
ban on the use of inducements to promote the purchase of particular
medicines rather than reliance on National Office for Animal Health’s
(NOAH) voluntary code of practice.
Internet sales remain a problem and we strongly support the VMD in
its efforts to increase monitoring and encourage prosecution of those
who breach UK legislation by selling or knowingly purchasing illegal
medicines over the internet. We are particularly concerned that such
sales could result in illegal use in food producing animals and welcome
the new offence of buying through an illegal system.
Transparency and public information
As the VMD moves forward to consider the reclassification of medicines
to comply with the new legislation, we consider it is most important
that the decisions taken are clear, open to scrutiny, and based on
safety data which can be subject to peer review. We are very disappointed
to find that the proposed ‘Memorandum of understanding‘
between VMD and NOAH will allow no information on safety to be disclosed
other than that which is already included in published literature.
It is now generally accepted that advisory committees and other public
bodies should not rely, in making decisions which affect public health,
on safety assessments which are not in the public domain and which
cannot be peer reviewed. It is not acceptable for the public to have
to make special applications under the FOI Act for the VMD to decide
on a case by case basis whether such information can be released.
With regard to decisions on the safety of medicines particularly for
food producing animals, the safety data and assessments should be
in the public domain.
Bees and Honey
At the feedback meeting, concern continued to be expressed by commercial
bee keepers and others, that the value of bees in agriculture was
far greater than the economic value of edible honey and to that extent
an exception should be made to allow bee-keepers to medicate their
hives. Foodaware members are aware that the number of bees are declining
and acknowledge their importance in the environment. Limiting disease
spread within the bee population is clearly important. Officials suggested
that there should perhaps be a light touch regime allowing bee-keepers
to be deemed SQPs, or that the UK should seek an exemption from the
EU regulations for bees. We would oppose the exemption route, as this
could open the door to other specialist suppliers and we believe that
an understanding of the pharmacological properties of particular medicines
should be among the criteria for appointment of SQPs. They also need
to understand the implications for residues in food and the actions
necessary to keep them within legal limits.
Enforcement
Enforcement of the new regime in regard to the supply and use of medicines
will be the responsibility of the State Veterinary Service, and the
Veterinary Medicines Inspectorate who must be adequately resourced
to carry out their responsibilities. Their staff is, however, not
authorised to take tissue samples for residue testing, as this remains
within the remit of trading standards officers and the FSA. In response
to a question, it was suggested that these powers should fall to Defra/VMD
under an amendment to the Residues Regulations. We do not agree. It
is important that there is effective co-ordination between the FSA
and Defra regarding enforcement of medicines legislation in food producing
animals, but the protection of public health must remain paramount,
and is at the heart of the FSA’s responsibility.
Foodaware is content for this response to be made publicly available.
Yours sincerely
Susan Knox
Chairperson
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