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Reclassifying medicines

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IN developing the new Veterinary Medicines Regulations, which are to be introduced in November, the Veterinary Medicines Directorate (VMD) has taken a pragmatic approach throughout. Its latest consultation document on the subject, which appears on the VMD’s website (www.vmd.gov.uk) and was sent to more than 500 stakeholders at the end of last month, takes a similarly pragmatic line. The document is relatively brief, but is no less important for that. It seeks views on how medicines should be allocated to the various distribution categories proposed under the new regulations. This will affect how tightly the use of different animal medicines is controlled, so the outcome will be crucial in determining how well animal health and welfare, and also public health, are protected in the future.

In developing the regulations, the VMD has had to reconcile the demands of European legislation, which requires that all products used in food-producing animals should be prescription-only medicines (POMs), with the at times conflicting recommendations of the Marsh and Competition Commission inquiries, which sought, where possible, to make products more readily accessible to the end user. It has also tried to ensure that the broad range of distribution outlets currently available in the UK is maintained.

The VMD’s solution has been to propose new medicines distribution categories which broadly correspond to the existing POM, Pharmacy and Merchants List (PML) and General Sales List (GSL) categories. However, making use of a provision in the European legislation that defines a 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’, it plans to introduce two categories of POM products: POM-V (POM – veterinarian) and POMVPS (POM – veterinarian, pharmacist, suitably qualified person).

POM-V products, like products in the existing POM category, will require a prescription from a veterinary surgeon, which only veterinary surgeons and registered pharmacists will be able to dispense. The POM-VPS category will include medicines intended for food-producing animals in the current PML category; these products will require a prescription but prescriptions will be available from registered pharmacists and ‘suitably qualified persons’ as well as from veterinary surgeons, all of whom will be able to supply these products. In addition, there will be two further categories of products: NFA-VPS (non-food animal – VPS), corresponding to non-food animal medicines on the current PML list, which will be available from veterinary surgeons, pharmacists and suitably qualified persons without a prescription; and AVM-GSL (authorised veterinary medicine – general sales list), which will be available from any retailer. The current Pharmacy (P) category of medicines will disappear under the new regulations and the 12 products currently included in this category will be reallocated.

The VMD’s consultation document indicates that there will be no wholesale reallocation of products as a result of the review. Specifically, it states, ‘The vast majority of products will not change their position in the classification ranking under the new regulations.’ It also excludes a number of product groups from the review for safety or policy reasons, namely general anaesthetics and products used for euthanasia, antimicrobials and antibiotics, cardiovascular agents, reproductive hormones and beta agonists, and prostaglandins, all of which will be POM-V, and oral minerals and vitamins and fluid replacement agents, which will remain GSL. Products authorised under the EU’s centralised licensing procedure will also be excluded. Nevertheless, this still leaves scope for other products or product groups to be reallocated, and the consultation document indicates that this will be considered if a sufficiently strong case can be made. As well as seeking views on proposals for reallocating the 12 products included in the current Pharmacy category, it invites interested parties to identify products or groups of products that they consider warrant reclassification, and to provide a case in support of the proposed change.

The document sets out the criteria that will have to be met if a product’s distribution category is to be changed, and notes that any change would have to have ‘a favourable risk/benefit balance’. Significantly, following one of the Competition Commission’s recommendations, it notes that ‘a benefit could relate to increased availability or the reduced cost of the product’.As the document makes clear, cost is by no means the only factor to be considered when classifying products. However, it also draws attention to the Competition Commission’s recommendation that benefit could result from a review of the distribution classifications of flea products for companion animals, which, the Competition Commission suggested, ‘could provide a particularly effective stimulus to competition from pharmacies in the supply of one of the most widely used veterinary products’.

It is perhaps reassuring that the VMD is broadly seeking to maintain the status quo, but there is no room for complacency. The veterinary profession must make its position clear, not least because other interested groups may have their own ideas about how products should be classified. Despite its limited scope, the review offers an opportunity to reconsider the classification of some groups of medicines, and thought might be given to the position of anthelmintics, particularly in view of continuing concerns about resistance. With these, as with other products, including flea treatments, the overriding concern must be for animal health and welfare, as well as public safety.

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