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THE closing dates for comments on proposed new legislation on veterinary medicines are fast approaching: in the case of the draft Veterinary Medicines Regulations 2005, which have been drawn up by the Veterinary Medicines Directorate (VMD) to implement European legislation (VR, January 8, 2005, vol 156, pp 30-31), the deadline is May 5; for the Supply of Prescription Only Medicines (Veterinary Use) Order 2005, which has been put together by the Department of Trade and Industry (DTI) in an attempt to implement the Competition Commission’s recommendations (VR, February 26, 2005, vol 156, pp 262-263), the cut-off date is May 13. The BVA, through its Practitioners’ Medicines Liaison Group, which includes representatives from all of the BVA’s specialist divisions, has worked effectively over the past few months in developing the Association’s response to the proposals. Its recommendations, which are about to be submitted, were approved by BVA Council at the end of last month and reflect a broad spectrum of veterinary opinion.
The VMD has made a good fist in attempting to square the requirements of the European legislation with the existing arrangements for medicines distribution in the UK, but there is no doubt that its proposals could be improved. This particularly applies to proposals concerning the new POM-VPM category of products, which it envisages will broadly correspond to the current PML category. To meet European requirements that all products used in food animals should be POMs, the draft regulations propose that prescriptions will be required for these products but, in a significant departure from established practice, that prescriptions should be available from registered pharmacists or registered ‘suitably qualified persons’ as well as from veterinary surgeons. This will undermine the value placed on prescriptions and result in prescriptions being written without any knowledge of the animals concerned.
While in no way wishing to limit the choice of supplier, the BVA believes that animal health and welfare, and the spirit of the EU legislation, would be better served by ensuring a greater veterinary input into whether the use of medicines is appropriate, which medicines are purchased and how they are used. In this context, it has proposed that products in the POM-VPM category should be supplied in the context of an annual prescription from a veterinary surgeon for the animals under his or her care, based on a veterinary risk assessment of the likely health challenges to those animals over the next 12 months. The prescription would be permissive in nature, and could be dispensed by any of the other suppliers listed in the draft regulations. The BVA’s proposal would avoid the problem of prescriptions being written without any knowledge of the animal and reduce the risk of products being used inappropriately. Also, with the prescription being integrated into farm animal health plans, it could help get the Animal Health and Welfare Strategy off the ground.
On the postal supply of medicines, the VMD has changed its position significantly since it published the draft regulations in January. Having originally proposed that POMs should not be supplied by post and would have to be supplied in person to those intending to use them, it has since suggested that postal supply of POMs should be allowed, provided that anyone supplying them fulfilled their professional and legal responsibilities (VR, March 19, 2005, vol 156, p 362). The BVA recognises that in some areas and some sectors, particularly pigs, poultry and fish, it would not be practical to insist on medicines being supplied in person but, at the same time, believes the VMD has moved too far from its original position. Its response suggests a number of options which could allow postal supply where there was no alternative but which would maintain the intent of the original proposal, that is, to ensure that medicines are used safely and effectively. Face-to-face supply potentially has important additional benefits in preventing medicines being distributed illegally.
The BVA’s response comments on many other aspects of the proposed regulations. On the matter of batch number recording, it draws attention to the cost implications for practices and clients and gives good reasons why the proposed requirements are impractical.
The proposed Order from the DTI has been drafted around the Medicines Act 1968, which will cease to apply when the new regulations proposed by the VMD come into effect. It is impossible to determine the true effect of the Order because POMs, which were the subject of the Competition Commission’s inquiry, will have a different meaning under the new regulations. For this reason, the BVA believes that the Order should not be considered by the Government until after the Veterinary Medicines Regulations have been finalised. It believes that a waiting room notice will comply with the requirement to make clients aware that prescriptions are available, obviating the need for lengthy discussions in the consulting room. It is concerned that a requirement to give anyone price information on medicines sold by the practice is open to abuse, particularly with regard to controlled drugs, and suggests that such information should only be available to bona fide clients. On the matter of free prescriptions, it believes the DTI’s proposals to be fundamentally flawed in terms of transparency and fairness to clients, and suggests that the provision should be scrapped. The fundamental principle that must apply to both sets of legislation is that animal health and welfare, as well as human health, should be protected in practical terms – and this should not be forgotten as the details are thrashed out.