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Anyone for medicines?

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They can't quite match the excitement or history of Wimbledon; however, consultations by the Veterinary Medicines Directorate (VMD) on how the Veterinary Medicines Regulations should be updated have quickly become established as another British annual event.

The regulations were introduced in 2005 following the most substantial overhaul of UK veterinary medicines legislation in 35 years. A key feature is that they have to be revoked and remade each year, so that the rules can be updated as necessary. The regulations run to more than 100 pages, and are accompanied by 30 separate guidance notes, so this is no small task, but it is important to keep up with developments nonetheless. With the annual cycle of revision now in its fifth year, the VMD is currently seeking views on the changes proposed for the next set of regulations (the Veterinary Medicines Regulations 2010, due to come into force on December 1), and has produced a substantial consultation package to assist in this process.

Among the changes proposed is that the regulations should be amended to indicate that antimicrobials should only be advertised to veterinary surgeons, veterinary nurses and pharmacists. This change has been prompted by concerns about antimicrobial resistance and the need to maintain the effectiveness of the antimicrobials available. It would bring the situation in the UK more into line with the rest of Europe and would prevent antimicrobials being advertised to farmers.

The VMD explains that the change is intended to ensure that antimicrobials are used responsibly and to preserve their efficacy for the future. It suggests that current controls on the distribution and advertising of antimicrobials are no longer sufficient to enable veterinary surgeons to ensure prudent use and that advertising to farmers can lead to pressure on veterinarians to prescribe new products which provide economic benefits when established older products may be a better therapeutic choice. It believes that, by encouraging prudent use, the proposed change will ultimately lead to a reduced risk of premature development of resistance to new generation antimicrobial products, extending the availability of these substances as effective clinical treatments in animals and reducing the risk of transfer of resistant bacteria to humans.

Another proposal aims to improve controls on sales of veterinary medicines via the internet. The VMD notes that internet sales of veterinary medicines have increased rapidly in recent years and that there are many reputable websites that are professionally run and offer an efficient and competitive service. However, it says, there are also a number of websites selling veterinary medicines to the public ‚without sufficient regard to the regulatory requirements for retailers’ meaning that some medicines are being sold without any advice being provided - or substandard or unauthorised or even counterfeit medicines being sold by “rogue” traders'.

To get round this, it suggests a website accreditation system, similar to one operating for human medicines. Under the scheme proposed, internet dispensing and supply of veterinary medicinal products would be legal only from approved websites. To be approved, online retailers would need to demonstrate compliance with the requirements set out in the Veterinary Medicines Regulations, with the sites being inspected by the VMD for internet retailing authorisation. Registered websites would display a logo containing a unique identification number. This would link back to the VMD website, providing a way for customers to confirm the approved status of the website.

Among various other changes proposed is clarification of the regulations to allow pharmacists and veterinarians in the UK to supply a prescription veterinary medicine to a retail customer in another EEA country, or in the UK against a valid prescription from a veterinarian in the EEA. A further change would formalise an existing policy under which the VMD's fees are waived when dealing with licensing variations which seek to remove or reduce tests involving animals.

The annual update of the Veterinary Medicines Regulations is a somewhat laborious process, as indeed is trying to keep up with the changes. However, veterinary medicines need to be used appropriately and, in a changing environment, it is important to achieve the right balance between availability and control. The European Commission is currently consulting on the framework for veterinary medicines regulation in the EU (see VR, May 1, 2010, vol 166, p 540); in the light of some of the changes being considered in Europe, it is important that the UK legislation remains fit for the task.

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