Mary Wallace (Meath, Fianna Fail)

The Animal Remedies Regulations 2005, which are designed to transpose EU Directive 2004/28 as well as to amend certain provisions in our national legislation, came into effect on 17 November last. The EU directive provided, among other elements, that veterinary medicines for food-producing animals may 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.

However, the directive also included a provision permitting member states to retain existing national prescription arrangements pending a decision at EU level on the exemption criteria. My Department has decided to avail of this provision, which is reflected in the 2005 regulations. In light of this, all existing off-prescription medicines will remain off-prescription until the end of this year and farmers are continuing to get such medicines over the counter at pharmacies and licensed premises.

With regard to the exemption criteria, the European Commission began a public consultation phase on draft criteria last February. Our analysis of the draft criteria suggested they would place severe restrictions on the range of medicines which could remain off prescription. In view of this, my Department made a submission to the Commission last March setting out the disadvantages associated with its draft criteria and arguing in favour of a more flexible regime under which greater discretion would be given to member states in determining scientifically the appropriate route of supply for veterinary medicinal products based on the risk benefit profile of individual products.

Although the draft criteria were considered by experts from member states at the end of March, the Commission has not yet adopted the draft criteria as formal Commission proposals. When they are eventually formally adopted by the Commission, they will be subject to further consideration and vote at the regulatory committee in Brussels. My Department will continue to press its position and seek to have criteria adopted which give the maximum discretion to member states in determining whether individual veterinary medicines should become prescription only.

Additional information not given on the floor of the House.

During the negotiations on the regulations last autumn, the Minister gave a commitment to review the national distribution arrangements in consultation with stakeholders and 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. In light of this, it is evident that, if the criteria are not altered significantly, my Department will revisit the prescribing aspects of the 2005 regulations.

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