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Medicinal merry-go-round

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IT IS less than six months since the Veterinary Medicines Regulations 2005 came into force and already the Veterinary Medicines Directorate (VMD) is seeking comments on changes that it plans to make in the autumn. For those still trying to get to grips with the new regulations, which were introduced last October after the most comprehensive revision of veterinary medicines legislation in more than 35 years, this might seem a trifle premature, but it is a process everyone will need to get used to. One of the aims of the VMD’s legislative redrafting exercise was to pull all the provisions relating to veterinary medicines into a single statutory instrument, providing a ‘one-stop shop’ for regulation in this area. It is important to ensure that the legislation is clear and stays up to date and, with this in mind, the decision was taken to revoke and remake the regulations each year. For those concerned about the details, this could be somewhat arduous; the regulations run to 130 pages and need to be considered in conjunction with 26 separate guidance notes. However, in its consultation package (available at the VMD has attempted to ease the pain by providing a draft of the regulations with the proposed amendments shown as tracked changes, along with a summary of what is intended. Such openness and transparency is commendable, but anyone suffering from information overload is unlikely to be consoled by the thought that the process will have to be repeated annually.

Many of the proposed changes, most notably those concerning licensing fees, will primarily affect manufacturers. However, it is in the nature of the medicines supply chain that measures affecting any one link inevitably affect another and ultimately affect the end user. The VMD is required to recover the full costs of its licensing services and charges manufacturers accordingly. There are other costs involved in getting a product licensed, but this, in turn, can affect the availability of products, particularly in cases where the potential market for a product or a particular use of a product is small. If the cost is too high, it may be uneconomic for companies to seek the necessary marketing authorisation. In its consultation document, the VMD proposes increasing its fees, as well as the Animal Medicines Inspectorate fees, to take account of inflation. In addition, it seeks views on whether it should introduce a new ‘menu-based system’ for the fees charged in relation to applications for new marketing authorisations. It also proposes changing the balance of fees for licence variations by ‘increasing the fee for minor variations and reducing the fee for major ones so that the fees relate better to the amount of work’. Some of this may simply sound like housekeeping, but the proposals need to be considered carefully, with a view to encouraging applications so far as is possible.

Other proposed changes will affect practitioners more directly. They include clarifying the regulations in relation to the retail supply of medicines by registered qualified persons (RQPs – that is, veterinary surgeons, pharmacists and suitably qualified persons), ‘reintroduction’ of requirements for recording specific batches of veterinary medicinal products administered to food-producing animals, and new requirements on the labelling of medicines at the time of retail supply.

The proposals regarding RQPs aim to eliminate confusion about an RQP’s authority to delegate tasks when supplying medicines, and to set out their responsibilities more clearly when supplying medicines against a prescription they or others have provided. The proposals on labelling, meanwhile, are intended to ensure that safety information is clear whether the product is supplied in an authorised or unauthorised container (see p 386 of this issue).

The proposed provision on record-keeping in relation to food-producing animals reinstates a provision that had long been included in previous legislation, but which was inadvertently omitted when the 2005 regulations were drafted. Given all the effort that went into the new regulations – and the number of people who were consulted – it is surprising that nobody noticed. This may reflect the scale of the exercise and information overload it engendered, but it does emphasise the need for everyone with an interest to examine proposed changes to legislation carefully, however overwhelming the paperwork may be.

Regarding sheep dips, it is proposed that the requirement for people purchasing dips to hold a certificate of competence in using them safely should be extended to those actually involved in dipping sheep. This measure is intended to reduce incidents of pollution of watercourses in cases where sheep dips are disposed of inappropriately and to underpin DEFRA’s ‘high-level’ objectives with regard to the environment. Environmental concerns feature increasingly prominently in pronouncements from DEFRA. Its concerns about the disposal of sheep dips were demonstrated earlier this month when the marketing authorisations for dips containing cypermethrin were abruptly withdrawn (VR, March 4, 2006, vol 158, pp 282-283).

The VMD describes most of the proposed changes as ‘minor modifications of current procedures that, although necessary, will have only a small impact on current practice’. This may be true in the context of the regulations as a whole, but some of those affected may feel otherwise. What is clear is that change did not stop with the introduction of the Veterinary Medicines Regulations 2005, and that the situation continues to evolve. There is a need, constantly, to keep abreast of developments and to respond appropriately.

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