Shake up of medicines law underway

Big changes in the law on veterinary medicines are under debate. The Veterinary Medicines Directorate (VMD) has published an informal discussion document suggesting new distribution categories to replace the familiar POM, PML, P and GSL categories. 

The VMD's proposals have been prompted by changes in the European medicines legislation. The amended Directive calls for a "veterinary prescription" for medicines for food animals. However, there is more to this than meets the eye. The Directive defines "veterinary prescription" as "any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law". The new classification scheme outlined by the VMD would require a prescription for all medicines for food animals, but not necessarily a prescription as we know it now. The new scheme would divide medicines into four categories (see below). 

The RCVS has suggested to VMD that POM-V medicines should be prescribed by veterinary surgeons who have the animals under their care. The VMD's suggestion that they should be prescribed only after diagnosis is rather narrow and would not, for example, be appropriate for vaccines. What matters is that these medicines should be prescribed on the basis of veterinary assessment of the needs of animals for whose care the prescriber is responsible. 

Medicines in the POM-VPM category would need a prescription, because that is what the amended Directive says. The prescription would only mean, however, that the person dispensing the medicine was satisfied that the person administering it was competent to do so. The VMD suggests that the dispenser should also be satisfied that the use of the medicine "is necessary for the routine control or treatment of endemic disease", but we have advised against this. Only a veterinary surgeon with the animals under his or her care could make such a judgement. 

As the law stands, veterinary surgeons can only dispense medicines for animals under their care. Under VMD's suggested scheme they would be free to dispense medicines in any of the four categories without having any connection with the animals in question. This would be in accordance with recommendations of the Marsh Report and the Competition Commission. The RCVS has advised against this change so far as POMs are concerned, on the ground that it would confuse the responsibilities of the prescribing and dispensing veterinary surgeons. 

When the VMD has digested the comments received it is expected to consult formally on revised proposals.