§ The Countess of Mar
asked Her Majesty's Government:
Why, in view of the requirements for training, personal protective equipment, engineering controls and disposal in connection with organophosphate sheep dips, these products do not fall under Article 4.3(b) of Council Directive 90/676/EEC so as to be required to be dispensed by veterinary prescription. [HL2847]
§ Lord Donoughue
The Government are advised on the authorisation of veterinary medicinal products by the Veterinary Products Committee (VPC). In considering the distribution of products, the committee has regard to the criteria in Article 4 of Directive 81/851/EEC, as amended by Directive 90/676/EEC and implemented by Regulation 3 of the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994.
Whether organophosphorus (OP) sheep dips should be Prescription Only Medicines (POM) has been considered by the VPC. In its report on the effectiveness of the Certificate of Competence Scheme and other matters, which was published on 17 February 1997, the Committee advised that the PML (Pharmacy and Merchants' List) classification remained the most appropriate for OP sheep dips and the Committee gave the following reasons for its advice. Sheep farmers were experienced in the handling of sheep and no specific veterinary expertise was required for dipping. While it was a requirement that POM status should apply where particular veterinary expertise was needed to avoid unnecessary risk to the animal, operator, consumer or the environment, it was considered that the reclassification of OP sheep dips to POM status would not significantly improve the protection of human safety. Sheep dips are often used prophylactically by farmers and the committee further considered that a POM classification could discourage this, possibly leading to a further increase in the level of ectoparasitic diseases in sheep.