EU Directives.

Dáil Éireann Debate, Tuesday - 17 October 2006

Tuesday, 17 October 2006

Questions (106, 107, 108)

John Deasy

Question:

178 Mr. Deasy asked the Minister for Agriculture and Food the status of the animal medicine exemption rules at EU level; and if she will make a statement on the matter. [32738/06]

John Perry

Question:

180 Mr. Perry asked the Minister for Agriculture and Food the status of her application to the EU commission for an exemption list under the animal remedies regulations; and if she will make a statement on the matter. [32747/06]

Written answers

Minister for Agriculture and Food (Mary Coughlan)

I propose to take Questions Nos. 178 and 180 together.

EU Directive 2004/28, which was transposed into Irish law last November, included a provision that all veterinary medicines for food producing animals should 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. My Department was instrumental in securing the insertion of the latter provision into the Directive.

An EU Directive on the exemption criteria was adopted by the relevant EU Standing Committee on 10 October. While decisions on the classification of veterinary medicines are ultimately a matter for the Irish Medicines Board, I am satisfied that the exemption criteria, as adopted, mean that current off-prescription veterinary medicines will not have to be reclassified as prescription only. This is a very positive outcome to this matter from Ireland's perspective and represents a substantial improvement on the draft criteria which were published by the Commission last February. During the intervening period, my Department had made very strong representations to the Commission for a more flexible approach so that decisions on the appropriate classification of veterinary medicines could be taken by regulatory bodies, such as the IMB, based on a scientific evaluation of the risk benefit profile of individual products. I am pleased that the Commission has taken my views into account.

As the criteria will not require any current off-prescription medicines to be made prescription only, farmers will continue to get these medicines on the same basis as at present and it will not now be necessary to amend the existing regulations to extend the range of prescribers. This represents a more favourable outcome to subjecting the medicines concerned to the increased restrictions, which would be necessitated by any form of prescription regime, even if additional categories were to be allowed to prescribe.

Jack Wall

Question:

179 Mr. Wall asked the Minister for Agriculture and Food the steps she is taking to ensure the ban on animal medicine advertising; and if she will make a statement on the matter. [32890/06]

Minister for Agriculture and Food (Mary Coughlan)

The ban on the advertising of prescription only medicines derives from EU Directive 2004/28 and has been transposed into Irish law via the Animal Remedies Regulations 2005. My Department has written to all relevant companies in the veterinary medicines sector in Ireland drawing their attention to the advertising ban and to the penalties for which they are liable for failure to comply with it.

I should point out that, since the advertising ban is restricted to prescription only veterinary medicines, the impact of the ban will be substantially reduced as a result of the favourable outcome which I have secured on the exemption issue.

Question No. 180 answered with QuestionNo. 178.