Denis Naughten (Longford-Roscommon, Fine Gael)
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Question 535: To ask the Minister for Agriculture and Food further to Question No. 179 of 21 April 2005, when she intends to publish the ministerial order to implement the EU animal medicines directive; when this will be implemented under EU law; and if she will make a statement on the matter. [21911/05]

Denis Naughten (Longford-Roscommon, Fine Gael)
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Question 547: To ask the Minister for Agriculture and Food if she will respond to points raised in correspondence (details supplied); and if she will make a statement on the matter. [22241/05]

Mary Coughlan (Donegal South West, Fianna Fail)
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I propose to take Questions Nos. 535 and 547 together.

The directive referred to by the Deputy, directive 2004/28, entered into force with its publication on 30 April 2004. Member states are obliged to transpose this directive into national law by 30 October 2005. My Department is drafting legislation to transpose this directive and it is my intention to meet the 30 October deadline for the transposition.

With regard to the date of implementation, the majority of the provisions of the directive must be implemented from 30 October. However, as the Deputy is aware, the directive includes an exemption clause to provide a mechanism for specific categories of medicines to be excluded from the mandatory prescription requirement. Decisions at EU level on exemptions are required to be taken by 1 January 2007, pending which existing national distribution arrangements may remain in place.

With regard to the points raised in the letter from the Competition Authority, I fully accept the need to promote competition in all sectors of the economy. In this regard, my Department proposed certain amendments some time ago as part of a reform of the existing national arrangements and in particular to improve the existing rules relating to veterinary medicines to require provision of prescriptions and to provide for a wider availability at retail level of prescription only medicines, thus stimulating competition and lowering costs. I would intend to include these proposals in the legislation referred to above.

As regards the points made in the letter relating to the transposition of the EU directive and, in particular, the provisions of the EU directive governing the prescription of veterinary medicines, I should point out that the main objective of the directive in question is to protect human and animal health. In transposing the directive, which sets down specific requirements relating to the prescribing of veterinary medicines, my Department is obliged to take account of the views of bodies such as the FSAI, the Department of Health and Children and the Irish Medicines Board as well as, of course, the views of the Competition Authority and stakeholders. In particular, it is my intention to implement the directive in such a way that it protects public health and animal health and welfare; meets the requirements of relevant EU legislation, in particular, directive 2004/28; does not unnecessarily restrict the availability of veterinary treatments for farmers and others from a cost and animal welfare point of view and in so far as possible fosters competition and reduces the potential for anti-competitive practices by various commercial players; and underpins our export-orientated agriculture and food industries.

In summary, my intention is to provide for the highest standards of public and animal health protection in this complex area in a way which is workable and which meets relevant EU requirements and underpins our export-orientated agriculture and food industries.