Olwyn Enright (Laois-Offaly, Fine Gael)
Link to this: Individually | In context

Question 47: 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. [5614/06]

Mary Coughlan (Donegal South West, Fianna Fail)
Link to this: Individually | In context

The Animal Remedies Regulations 2005, S.I. No. 734/2005, were signed into law on 17 November 2005. I emphasised at that time that the provisions in EU Directive 28/2004 which required all veterinary medicines for food producing animals to become prescription only would not come into effect until the EU had adopted criteria for the exemption of certain products from this requirement.

In view of this, I decided to avail of another provision in the directive to retain existing national prescription arrangements until I January 2007, which means that, in effect, the regulations do not require any current off-prescription medicines to be made subject to prescription until 1 January 2007. Accordingly, these regulations confine the writing of prescriptions to veterinarians. However, I have given a commitment to review the regulations in light of the EU decision on the exemptions criteria, particularly to consider whether persons other than vets should be permitted to prescribe veterinary medicines.

With regard to the exemption criteria, the EU Commission began a public consultation process on the exemption criteria on 9 February by publishing draft criteria on its website. Consultation on this document, which is not yet a formal Commission proposal, will last until 17 March next. While my Department is currently examining the document, a preliminary analysis indicates that, as currently drafted, the criteria would place severe restrictions on the range of medicines which could remain off-prescription.

My Department had already made a submission to the Commission on this issue and will make a further submission with a view to having the draft criteria adapted to better reflect the risk and-or benefit profile of categories of products and to facilitate decisions in this regard being taken on a scientific basis. It is, of course, open to other stakeholders to engage with the Commission under the public consultation process and I would encourage them to do so.

As I have already stated publicly, I will, in consultation with stakeholders, review the national distribution arrangements in light of the outcome of the exemption criteria. A decision as to whether persons other than veterinarians may be permitted to prescribe veterinary medicines will be made when the exemption issue has been resolved with a view to ensuring competition in the marketplace while at the same time protecting public and animal health.