Dáil Éireann - Volume 606 - 29 September, 2005

Written Answers - Veterinary Medicines.

[1130]   118. Mr. Penrose asked the Minister for Agriculture and Food if she will confirm that a significant number of persons have been in contact with her Department in relation to proposals under the prescription only medicines; if the regulations as proposed are not appropriate for Irish farming conditions; if, in the context of correspondence which was replied to (details supplied), she will consider the various points made therein and amend the regulations accordingly; and if she will make a statement on the matter. [26139/05]

  Mary Coughlan: My Department circulated draft regulations in relation to veterinary medicines for consultation in early August of this year and has received written submissions from most of the main stakeholders. My Department has also subsequently met with many of these stakeholders concerned as part of the consultative process. In addition, as required by the relevant legislation, the animal remedies consultative committee will meet shortly to consider the draft regulations, following which I will make final decisions on the issues involved so that the regulations can be brought into force by the transposition deadline of 30 October 2005 specified in the EU directive concerned, Directive 2004/28.

The draft regulations concerned are primarily designed to implement EU legislation but, insofar as is possible, in a way that is most appropriate for Irish farming conditions. In relation to the ‘prescription only’ issue, the position is that EU Directive 2004/28 provides that all veterinary medicines for food producing animals must be subject to prescriptions. However, the directive also includes a provision for exemption criteria to be adopted at EU level, which will provide a mechanism for certain categories of medicines to be exempted from the prescription requirement. The EU has not yet adopted a decision on the exemption criteria but must do so before 1 January 2007. Pending this decision, existing national prescription and distribution arrangements may remain in place.

My Department intends to avail of the exemption clause to the maximum extent possible and has made a submission to the European Commission with a view to retaining ‘off prescription’ in Ireland all products, other than intramammaries, which currently enjoy this status. The draft regulations published by my Department provide that veterinary medicines, such as wormers and certain vaccines, will continue to be available off-prescription until a decision is taken at EU level on the exemption criteria. In practice, this means that, apart from intramammaries, my Department is retaining the essence of our existing national prescription and distribution regime. In view of this, the concerns set out in the Deputy’s letter [1131] are unfounded and the question of extending the range of persons who may be permitted to prescribe does not need to be addressed at this stage in the context of the regulations scheduled to come into force at the beginning of November of this year.

The EU directive provides that prescriptions may be written by “a professional person qualified to do so in accordance with applicable national law”. When the exemption criteria issue is resolved in the course of next year, I will review the regulations and, in particular, the provisions relating to the categories of persons who would be permitted to prescribe veterinary medicines, in light of the outcome, with a view to ensuring competition in the marketplace and to avoid imposing unnecessary costs on farmers. Full consultations will be held with all stakeholders on the matter at that stage before final decisions were taken.