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Catching up on medicines

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IN most years you can almost mark the seasons by the progress of the Veterinary Medicines Regulations. The regulations have to be revoked and remade each year, so that the rules can be updated as necessary, and this process normally follows a regular cycle, with the Veterinary Medicines Directorate (VMD) consulting on proposed amendments in the spring/early summer and the new regulations being introduced in the autumn. In 2010, however, the cycle was broken; despite a consultation in June (VR, July 10, 2010, vol 167, p 36), the new regulations did not come into force on October 1 as originally planned, and the VMD now hopes that they will be introduced on April 1 this year. The delay is perhaps understandable given that 2010 saw a General Election and change of government, although the controversial nature of some of the proposals may also have contributed.

In a report discussing the results of the consultation, published just before Christmas, the VMD notes that most of the comments received related to three of 20 changes proposed. Most of the changes have since been approved by ministers, but one or two have been dropped. Notable among these was a proposal that would have removed permission for antimicrobials to be advertised to farmers. Having been put forward with the intention of ensuring that antimicrobials are used responsibly and to preserve their efficacy for the future, this proposal, the VMD reports, proved controversial, raising a strong response from the agricultural press and the farming community, with the agricultural press running a campaign against it. In the light of the comments received, ministers have decided ‘not to proceed with this proposal at this time’.

The decision has been welcomed by the animal health industry and the farming press (see p 64 of this issue). However, the BVA, which supported the original proposal, has expressed disappointment (VR, January l/8, 2011, vol 168, p 3). In its response to the consultation, the Association emphasised the need to ensure that antimicrobials are used prudently and responsibly to reduce the risk of resistance developing. It pointed out that a number of factors have to be considered when deciding whether to use a particular antibiotic and suggested that stopping advertising to farmers would remove a potential obstacle to responsible use.

The fact that advertising to farmers is to continue makes it all the more important to continue to work to ensure that antimicrobials are used responsibly, as outlined in the BVA's poster on responsible use of antimicrobials in veterinary practice, which was published in 2009 (VR, November 21, 2009, vol 165, p 607). The poster, along with more detailed guidance notes, is available on the BVA's website, at www.bva.co.uk/activity_and_advice/1633.aspx.

Responsible use is not only necessary to help preserve the efficacy of products for use in animals and humans; it also makes sense politically if products are to continue to be available for veterinary use in the future. In his annual report for 2008, the then Chief Medical Officer, Sir Liam Donaldson, suggested that the use of some classes of antimicrobials should be banned in animals to help maintain their efficacy for use in people. Similarly, in a consultation on EU veterinary medicines legislation in 2010, the European Commission asked whether the legal framework should be changed to provide a specific provision to restrict the use of antimicrobials that are critical for human medicine (VR, May 1, 2010, vol 166, p 540). In view of such developments, it is questionable whether allowing advertising to farmers to continue is a good idea.

Of the other two proposals attracting most comment, plans to introduce controls on online retailing of veterinary medicines, which have been approved by ministers, are welcome, although it is a pity that the proposed accreditation system can only apply to online retailers based in the UK (VR, January 1/8, 2011, vol 168, p 3). A proposal to amend the regulations to allow UK vets and pharmacists to dispense prescriptions from vets and pharmacists from European Economic Area (EEA) countries has been put on hold in the light of concerns that this could cause problems in terms of ‘duty of care’ obligations and the regulation of veterinary surgeons. However, as an interim measure, VMD guidance is to be amended to allow medicines to be dispensed against EEA prescriptions for use in the country of origin of the prescription, excluding the UK.

How soon the process of revising the Veterinary Medicines Regulations gets back to its normal cycle following last year's delay remains to be seen. The regulations have to be kept up to date, but the process of revoking and recasting them each year is somewhat laborious, and some of the changes have been substantial. It will be interesting to see how extensively they are revised in future years, given the new Government's commitment to cutting ‘red tape’.

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