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Round 3 on medicines

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IT hasn't quite reached the stage where you can set your watch by it, but the annual consultation on the Veterinary Medicines Regulations has quickly established itself as a regular event. The regulations were introduced in October 2005, following the most significant overhaul of uk veterinary medicines legislation in 35 years. Brought in to take account of changes in European legislation, as well as recommendations from the Marsh Review and the Competition Commission, they introduced new medicines distribution categories, changing the routes by which veterinary products could be sold and supplied. They also consolidated many separate pieces of relevant legislation into a single statutory instrument, providing a ‘one-stop shop’ for regulation in this area.

A significant feature of the regulations is that they must be revoked and remade each year, so that the rules can be updated as necessary. Given that the regulations run to more than 100 pages, and are accompanied by 27 separate guidance notes, this is no small task. Nevertheless, it is important to keep up with developments because the regulations have to be complied with and the changes can have significant consequences. Since the regulations were introduced in 2005, two cycles of revision have been completed. The Veterinary Medicines Directorate (vmd) has just launched a public consultation on the 2008 regulations, to take effect from October 1, so the third cycle of revision is under way.

Among the proposals in this latest consultation round are that suitably qualified persons (sqps) should be allowed to supply veterinary medicines to retail customers from pharmacies or registered veterinary premises without these premises having to be registered with the Animal Medicines Inspectorate. This is intended to avoid duplication of effort given that pharmacies are already registered and inspected by the Royal Pharmaceutical Society of Great Britain and that, following a change written into the regulations last year, registration of veterinary premises will be required from April 2009. Another proposal is that a new type of Animal Test Certificate should be introduced for small-scale clinical trials by veterinary surgeons. The intention here is to help clarify some of the issues surrounding such trials, which have recently been the subject of debate.

Other changes highlighted in the consultation document include proposals to clarify the position in relation to the supply of blood products from blood banks; to introduce new controls on the collection and supply of equine stem cells; and to clarify some of the controls on medicated feeds and feed additives. There are proposals to introduce more flexible labelling requirements for manufacturers of products marketed under the Small Animal Exemption Scheme, as well as to introduce additional requirements for reporting suspected adverse reactions to such products.

In addition to these and other ‘key changes’, the consultation document draws attention to various other amendments, mostly aimed at correcting or clarifying previous drafts and (perhaps not before time) making the language of the regulations ‘gender neutral’. As in previous years the vmd has helpfully provided a copy of the regulations with the proposed amendments shown as ‘track changes’. Even so, for those not used to reading statutory instruments, which is probably most people, it can be hard to keep on top of all the changes and maintain a clear idea of what is happening.

That the evolution of the regulations is a continuous process is illustrated by the fact that although the requirement for veterinary premises to be registered was included in the 2007 regulations, it is only in this year's consultation that details are given of how that requirement might be implemented. The rcvs has undertaken to help with registration and the rcvs Council recently agreed on how this might be achieved (see VR, March 15, 2008, vol 162, p 330). The vmd reports that practices will be charged £40 to register their premises, and £40 per year to remain on the register, but that these fees will not apply to practices in the rcvs Practice Standards Scheme. It is envisaged that practices will be inspected at least every four years. Practices in the Practice Standards Scheme will already be subject to medicines inspections by the rcvs, and the vmd plans to work with the College to develop an inspection regime that avoids duplication of effort. However, in cases where the vmd itself undertakes the inspections, it is anticipated that the cost will be £250 each time. The vmd intends to consult further on the arrangements in the first quarter of next year.

Other matters on which views are sought in this year's consultation include a preliminary proposal that legal provisions relating to controlled drugs, which are currently included in Home Office legislation, should instead be incorporated in the Veterinary Medicines Regulations. The aim of this would be to ensure that recommendations made following the Shipman Inquiry are properly applied in the veterinary sector. The vmd also asks for views on whether a hard copy of a prescription should always be required before products are dispatched, although it says that it has received no evidence that electronic prescriptions are being abused and therefore sees no need to include such a requirement at present.

It remains an interesting feature of the Veterinary Medicines Regulations that, although the annual cycle of revision was intended to facilitate minor amendments, it also allows more substantial changes to be made relatively easily. For this reason alone it is important to keep an eye on developments and ensure that the changes proposed are appropriate.

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