Government Response to Marsh: NOAH welcomes support for cascade
The National Office of Animal Health has welcomed the Government'sformal response to the Independent Review of Dispensing by Veterinary Surgeons (the MarshReport). In particular, it is pleased that the Government hasrejected the proposal that would have allowed veterinarians to prescribe humanmedicines for companion animals in place of a properly authorised animal one.The Government believed that "the increased risk to target animal safetyand the added disincentive to the development of new animal medicines outweighsthe possibly reduced costs".
Building on the many positive points of the InterimGovernment Response made in December 2001, the formal responsecontinues to suggest positive and practical recommendation to improve howanimal medicines are made available to animal owners. Although to some extentovershadowed by the ongoing European Veterinary Regulatory Review and theCompetition Commission (due to report in January) which affect 5 of Marsh'soriginal conclusions, the Government has agreed with 8 points made by Marsh andrejected the suggestion to scrap the cascade for companion animals.
Philip Sketchley, NOAH chief executive said: "We are particularlypleased with the support given by the Government to the authorisation systemfor animal medicines. Cats and dogs have just as much right to properlyresearched and specifically formulated animal medicines as food producinganimals. The regulatory system is there to protect animals, and it would havebeen unfair to the nation's pets to abdicate that responsibility and say thatusing unauthorised products (which is what human generics are in a veterinarycontext) would have been as good - it is not."
However, it is very important to differentiate between veterinarygenerics (which are perfectly legitimate, and already come at the"top" of the cascade where the vet chooses the most appropriateauthorised veterinary product from those available) and human generics; thelatter are often, confusingly, simply referred to as "generics" -indeed they are in Recommendation 8.
"Human products may have the same active at the same concentration- though this is often not the case with tablets, leading to risks of incorrectdosing - but the excipients used may not be suitable for all animal species.
"Most members of the public would be reluctant to use animalmedicines on themselves, and we should continue to offer the same safeguards toour animals," said Mr Sketchley.
In addition, freedom to use human medicines would present a barrier tocompanies developing new animal medicines. "There is little incentive fora company to conduct research into new animal medicines if it knows that humangenerics could be used with impunity as soon as its licence had been grantedand used under the dosage recommendations established by a veterinarymanufacturer. We are pleased that the Government has rejected this proposal andhave made the same points to the Competition Commission," said MrSketchley.
NOAH also welcomes thesupport given to farm health plans and the recognition that all sectors of theanimal medicines distribution chain have their part to play in the developmentof these. This support gives further weight to the European Parliaments recentvote on the Veterinary Regulatory Review in favour of a proposal whichwould allow the UK PML distribution system to continue.
Mr Sketchley said: "We support the need to work together to improvefarm animal health and reduce the need for animal medicines. This approachechoes the work already being done by the RUMA Alliance indeveloping guidelines across the species for responsible medicine use."
He added: "We also look forward to discussing with DEFRA in moredetail the Government thoughts on disposal of farm waste, including medicinalwaste. We welcome acknowledgement that farmers' and professional organisationsshould be involved and suggest that it is vital that the manufacturers ofanimal medicines, through NOAH, should also be included. We have already askedto be involved with the Agricultural Waste Stakeholders' Forum and look forwardto finding out how this grouping, and the discussions outlined in theGovernment response to Marsh, will link together."
17 December 2002
Notes for Editors
1. For further information contact Phil Sketchleyor Alison Glennonat NOAH, tel. +44 (0)20 8367 3131, or visit the NOAH website.
2. The National Office of Animal Healthwas formed on 1 January 1986 to represent the UK companies which research,develop, manufacture and market licensed animal health products. Theassociation has 36 corporate members and 12 associate members.In 2001 NOAH's members accounted for around 95% of the 359 million UK animalhealth market, with additional valuable exports.
3. The Government's formal response tothe recommendations contained in the Report of the Independent Review ofDispensing by Veterinary Surgeons of Prescription Only Medicines was publishedon 10 December and is available from the VMD and on its website www.vmd.gov.uk.
4. The effect of accepting the 8 Marshrecommendations will be to:
encourage veterinary surgeons toissue prescriptions for Prescription Only Medicines and to improve theirbusiness practices
encourage farmers and veterinarysurgeons jointly to introduce farm health plans, which should lead to improvedflock/herd health and a reduction in the amount of medicines used
improve the availability of trainingfor those employed in the care of animals
increase the range of medicinesavailable to treat minor species
increase the number of outletsauthorised to dispense cat and dog wormers classified as PML
increase the number of medicines availableto treat horses not intended for human consumption