Dáil Éireann Debate, Wednesday - 22 February 2006
295 Mr. Naughten asked the Minister for Agriculture and Food if the exemption list submitted to the EU Commission under the new animal medicine rules will be published; when she expects to have a decision from the Commission on the exemption; and if she will make a statement on the matter. [7405/06]
Amharc ar fhreagraOn 9 February last the European Commission began a public consultation phase on the criteria for exempting categories of medicines from the general mandatory rule under the relevant EU legislation that all medicines for food producing animals should be brought under veterinary prescription control. The Deputy will recall that the provision for exemptions was introduced in response to concerns from Ireland and a small number of other member states when the relevant directive was being finalised. The draft exemption criteria, which are not yet formal Commission proposals, are available on the Commission's DG enterprise website and the consultation period lasts until 17 March next.
While my Department is currently examining the document, a preliminary analysis indicates that, as drafted, the criteria would place severe restrictions on the range of medicines which could remain "off prescription". My Department had already made a preliminary submission to the Commission on the issue in March of last year and a further submission will be made by my Department with a view to having the draft criteria adapted to better reflect the risk-benefit profile of products and to facilitate decisions in this regard to be taken on a scientific basis. It is, of course, open to other stakeholders to engage with the EU Commission under the public consultation process and I would encourage them to do so.
Given that this is a European Commission procedure, it is difficult to predict a precise timeline for decisions. However, in view of the likely stages to be gone through following the end of the public consultative phase — initial discussion with member states scheduled for the end of March, formulation of a formal Commission proposal, submission to the Commission standing committee procedure and so on — the process will take some time to complete.
As I have already stated publicly, I will review the national distribution arrangements in consultation with stakeholders in light of the outcome of the exemption criteria and, in particular, to consider whether persons other than vets should be permitted to prescribe veterinary medicines. My intention is to complete the consultative process in time to permit decisions on this issue to be taken well in advance of the 1 January 2007 deadline provided for in the EU legislation.
