The specific proposal referred to forms one part of a package of proposals brought forward by the European Commission in July of this year in the context of a major reform of the EU legislation regulating both the human and veterinary medicines fields. This package of proposals falls to be dealt with under the co-decision procedure involving both the European Parliament and the European Council. As such, best estimates indicate that it will be at least two years before final decisions on the Commission's proposals will be taken by parliament and the council.
The Commission's proposals have not yet been discussed in detail. My initial approach to such discussions will be to obtain clarification from the Commission on its proposal to make all medicines for food-producing animals subject to veterinary prescription, given that currently there is an absence of harmonization at EU level as regards the operation of prescription regimes. I might add that Ireland has already, prior to the emergence of these proposals, asked the Commission to address the harmonization issue in order to improve regulation of the EU veterinary medicines market. Among the key issues yet to be clarified are the principles which would govern prescribing activity and supply of medicines by veterinarians, the dispensing of prescriptions and also the specific range of products which would come within the scope of the prescription requirement. In the absence of such details, it is not possible to carry out a meaningful assessment of the potential effect of the Commission's proposals on the Irish regime which, I am glad to acknowledge, has by and large been working satisfactorily.
