NOAH calls for tighter controls on use of human medicines by vetsThe draft Veterinary Medicines Regulation provides an ideal opportunity to ensure all animals benefit from fully authorised animal medicines, says the National Office of Animal Health. And the association believes the Veterinary Medicines Directorate are sympathetic to this view. NOAH has, at a consultation meeting with the VMD, suggested changes to the proposed regulation that would curtail the supply and advertising by wholesalers of medicines for use in animals (which happen to have an authorisation for use in humans) – unless, of course, there is no suitable alternative. An alternative solution would be that the only person able to dispense a human medicine would be a pharmacist – as long as the vet does not need to administer the medicine himself. NOAH has proposed this option in its formal submission to the VMD. “We need to be clear we are not talking about generic animal medicines”, says NOAH chief executive Phil Sketchley. “The veterinary medicines industry has no concerns about the use of licensed veterinary generic medicines – those which have a full veterinary Marketing Authorisation, after undergoing full bio-equivalence within the proper regulatory process, as controlled by the VMD. “Our real concern is the use of human medicines, whether they are generic or not, to treat animals when those medicines have not been evaluated for safety, efficacy and quality in the target animal species. There are some situations where a human medicine is the only option for a vet to use to treat an animal – cytotoxic medicines for cancer treatment spring to mind – and of course we would not wish to see the veterinary surgeon’s ability to treat using these medicines hampered in any way. It is when there is a licensed animal medicine available, and a vet chooses to use a human alternative instead, that we feel the animal and its owner may not be getting the best deal.” “Some vets may claim that human generics are cheaper – but apart from the fact that this isn’t always the case, they are laying themselves wide open to claims from unhappy owners,” Mr Sketchley points out. “In particular, tablets which have been developed for the human digestive system have a density – and often a sugar coating – which have not been tested for safety or efficacy in dogs or cats. There are many documented instances where a human antibiotic designed to travel through the 26 feet or so of the human gut has gone through the canine intestinal tract and emerged unscathed without having made any contribution at all to the medication of the patient. “Therefore animals do not always get a medicine properly developed to treat them, and their health and welfare, as well as speed of recovery from infection or whatever condition is being treated, may be impaired or compromised. Vets are also leaving themselves open to legal challenge. We are urging the VMD to help stamp out this illegal use,” he adds. Ends
20 April 2005 Notes for Editors1. For further information contact Phil Sketchley or Alison Glennon at NOAH on 020 8367 3131, or by email noah@noah.co.uk or look at the NOAH website www.noah.co.uk 2. The National Office of Animal Health was formed on 1 January 1986 to represent the UK companies which research, develop, manufacture and market licensed animal health products. The association has 32 corporate members and 13 associate members. In 2004 NOAH's members accounted for well over 90% of the £420 million UK animal health market 3. The term ‘generic’ medicine is poorly understood and often misquoted. A generic medicine is not simply an ‘out of patent’ medicine, nor necessarily a human medicine. A generic animal medicine is a ‘copy of an out-of-patent medicine for which bioequivalence has been demonstrated in the target animal species’ – and that is the really crucial point. Generic substitution of a veterinary medicine with a human medicine is not permitted by EU law under the prescribing cascade. | 