Statistics from Altmetric.com
ELEVEN weeks into the public consultation on the draft Veterinary Medicines Regulations and changes to the initial position have started to appear. In a statement on its website last week, the Veterinary Medicines Directorate (VMD) indicated that, in the light of comments received to date, it was proposing to amend its proposals on the advertising of POM-Vs (prescription-only medicines — veterinarian) and on the supply of such products by post (see p 362 of this issue). The changes — which will have the effect of removing the proposed ban on the supply of POM-Vs by post and of extending advertising of POM-Vs to professional owners and keepers of animals — are significant in themselves. They also raise a question of wider significance: if the VMD is prepared to move so far on these aspects of the proposed regulations, how flexible might it be on others?
The question is important, not least because other aspects of the proposed regulations might usefully be improved. Most notable among these are proposals concerning prescriptions for products in the other proposed POM category, POM-VPM (prescription-only medicine — veterinarian, pharmacist, merchant). This category has been built into the draft regulations in an attempt by the VMD to reconcile Britain’s existing system of medicines distribution, in which products in the current PML (pharmacy and merchants list) category can be obtained without a veterinary prescription from pharmacists and agricultural merchants, with a European requirement that all products used in food-producing animals should be prescription-only medicines. The European legislation does not specify that the prescription should be written by a veterinarian, defining 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’, so the VMD’s solution has been to propose two categories of POM: POM-V and POM-VPM. Like existing POMs, products in the POM-V category will only be available on prescription from a veterinary surgeon. Products in the POM-VPM category will also require a prescription but, in a significant departure from current practice, prescriptions will be available from a registered pharmacist or a registered ‘suitably qualified person’ (SQP) as well as from veterinary surgeons. Precisely which products will be assigned to which category has still to be decided. However, the VMD’s intention is that the POM-V category should broadly correspond to the current POM category, while PML products will become POM-VPM.
This might be seen as a neat administrative solution to matching the UK’s supply arrangements to the EU requirements, but it will undermine the value placed on a prescription, which it would be reasonable to assume should be based on a clinical assessment of the animals concerned. If, as is proposed for POM-VPM products, a clinical assessment will not be necessary, what is that prescription then worth?
In this context, a proposal from the BVA’s Practitioner Medicines Liaison Group (PMLG), which is coordinating the BVA’s response to the consultation, deserves to be taken seriously. While not wishing to limit the choice of supplier, the PMLG 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. To this end, it has suggested 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 ensuing 12 months (VR, March 12, 2005, vol 156, p 359). The prescription would be permissive in nature, and could be fulfilled by the other suppliers listed in the draft regulations, so the range of potential suppliers would be maintained. Importantly, the problem of prescriptions being written without any knowledge of the animals concerned would be avoided. With the prescription being integrated into farm animal health plans, the scheme proposed could give much needed impetus to the Animal Health and Welfare Strategy, providing a practical example of what ‘joined-up’ government is supposed to be about.
Other aspects of the draft regulations demand attention. They include questions about what will constitute an SQP and how SQPs will be regulated; how far a duty of care might extend to vets dispensing other vets’ prescriptions; and requirements for medicinal batch number recording and audit. The proposed record-keeping requirements will have practical and cost implications for practices, and therefore cost implications for the client, and at the very least a substantial lead-in period will be needed so that a workable solution can be found. And then there is the question of how the regulations will be melded with draft legislation aimed at implementing the recommendations of the Competition Commission, which is currently the subject of a separate consultation being undertaken by the Department of Trade and Industry (VR, February 26, 2005, vol 156, pp 261, 262-263). The Competition Commission’s recommendations never made sense in terms of animal health and welfare, and that has not changed with the passage of time. With both sets of legislation due to be implemented at the end of October, the regulators need to be flexible. If they can change their position on postal supply and advertising, there should be potential for changes in other areas, too.