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Revising the rules on medicines

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AN interesting feature of the UK's Veterinary Medicines Regulations is that they can be revoked and remade each year to keep them up to date. From 2005, when the regulations were introduced, to 2010 the annual cycle of public consultation and then revision of the regulations was so regular that one could measure the seasons by its progress. That changed after the General Election in 2010; the last consultation was in June 2010 and the regulations were last revised in 2011. However, the cycle now appears to be back on track and the Veterinary Medicines Directorate (VMD) has just launched a public consultation on new regulations that should come into force in October.

The regulations run to more than 100 pages, and are currently accompanied by 20 separate guidance notes, so keeping track of the changes each time the regulations are revised is no easy task. Nevertheless, it is important to keep abreast of developments and, as in 2010, the VMD has done its best to make the process as simple as possible by both summarising the changes and showing tracked changes in the documents themselves. It is sobering, when examining the documents, to reflect on how much effort has to be put in to ensuring that medicines are safe and effective, and on the responsibilities on veterinary surgeons to ensure that they are used appropriately. These responsibilities may not always be appreciated by the public, but they must be discharged daily, as a matter of routine.

The consultation document highlights 14 proposed changes to the regulations. Among them is an amendment to provisions relating to the importation and possession of an unauthorised veterinary medicine, intended to allow the VMD to take enforcement action not only against those who are physically importing or in possession of an unauthorised product but also anyone benefiting from these activities. Another proposal relating to illegal supply would allow inspectors to seize anything they have reasonable grounds to believe is a veterinary medicine. This is intended to help deal with situations where a product might have been decanted into an unlabelled bottle ready to be relabelled and marketed.

Of specific relevance to veterinary practices is a proposal to introduce a clause to allow the removal of a veterinary practice premises from the register of practices held by the RCVS if it does not meet the expected standards for storage and supply of veterinary medicines. This, the VMD explains, is to rectify a situation whereby although all other premises authorised to store and supply medicines can have their licences revoked if they do not meet the required standards, this is not the case for veterinary practices. In an impact assessment, the VMD notes that it takes ‘an escalator’ approach to enforcement, which aims initially to deal with non-compliances at the lowest appropriate level. It indicates that, in line with this policy, any practices falling below the required standard would be given plenty of opportunity to take corrective action.

It is also proposed that the fees for inspections of practice premises should be increased, from £250 to £350, to cover the costs to the VMD of carrying out the inspections. At the same time, the annual fee for registering practice premises with the RCVS is to be reduced, from £40 to £34 – a change made possible, the VMD explains, because the costs of operating the register are now lower than when it was set up in 2009. Under the current arrangements for inspections, premises under the ambit of the RCVS Practice Standards Scheme are not subject to routine inspections by the VMD, as the scheme's standards meet the VMD's inspection criteria.

Other changes discussed in the document relate to matters such as marketing authorisation fees, and fees applied to manufacturers and distributors of feedingstuffs. The draft regulations and relevant guidance note also indicate how, to comply with European legislation, the VMD intends to implement a ban on the advertising of antimicrobials to farmers and other professional animal keepers, and of prescription-only medicines to owners and keepers of horses, as announced by the VMD in October (VR, October 20, 2012, vol 171, p 384).

Under new government rules, the VMD is allowing six weeks for consultation on the changes to the regulations, which are described in the consultation document as minor. It will be interesting to see whether this continues to be the case in future years. When the Veterinary Medicines Regulations were introduced in 2005, this was partly in response to the recommendations of the Marsh review of medicine distribution categories and the outcome of an inquiry by the Competition Commission, and partly in response to an overhaul of EU legislation. The European Commission is again in the process of reviewing veterinary medicines legislation and more substantial changes could lie ahead.

▪Public Consultation on the Veterinary Medicines Regulations 2013. www.vmd.defra.gov.uk/public/vmr_consultation.aspx. Accessed January 8, 2013

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