Olwyn Enright (Laois-Offaly, Fine Gael)
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Question 38: To ask the Minister for Agriculture and Food the status of the animal remedies regulations; the discussions to date with the EU on the issue; and if she will make a statement on the matter. [23626/06]

Mary Coughlan (Donegal South West, Fianna Fail)
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As the Deputy is aware, the EU Directive 2004/28, which was transposed into law through the 2005 Animal Remedies Regulations, provided that veterinary medicines for food producing animals may only be supplied on the basis of a veterinary prescription, unless exempted from this requirement under criteria to be drawn up at EU level before 1 January 2007. However, I decided to avail of another provision in the Directive which permitted Member States to retain existing national prescription arrangements pending a decision at EU level on the exemption criteria. In effect, this enabled all existing 'off-prescription' medicines to remain off-prescription until the end of this year and farmers are continuing to get such medicines over the counter at pharmacies and licensed merchants.

The European Commission began a public consultation phase on draft exemption criteria last February. Our analysis of the draft criteria suggested that they would place severe restrictions on the range of medicines which could remain 'off prescription'. In view of this, my Department made a submission to the Commission in March last setting out the disadvantages associated with their draft criteria and arguing in favour of a more flexible regime under which greater discretion would be given to Member States in determining, on a scientific basis, the appropriate route of supply for veterinary medicinal products based on the risk/benefit profile of individual products.

Although the draft criteria were considered by experts from Member States at the end of March, the Commission has not yet adopted the draft criteria as formal Commission proposals. When they are eventually formally adopted by the Commission, they will be subject to further consideration and vote at the regulatory committee in Brussels. We will continue to press its position and seek to have criteria adopted which give the maximum discretion to Member States in determining whether individual veterinary medicines should become prescription only.

During the negotiations on the regulations last Autumn, I gave a commitment that I would review the national distribution arrangements in consultation with stakeholders in the light of the outcome of the exemption criteria aspect and, in particular, to consider whether persons other than vets should be permitted to prescribe veterinary medicines. In light of this, it is evident that, if the criteria are not altered significantly, my Department will revisit the prescribing aspects of the 2005 Regulations.