John Browne (Wexford, Fianna Fail)

I thank Deputies on both sides of the House for their constructive contributions to the debate. I am aware of the concerns of farmers in particular about the possible implications of the draft regulations for the supply and cost of veterinary medicines, but I emphasise that most of these concerns are based on a misunderstanding of the real position which the Minister explained in considerable detail last evening. These concerns arise, in particular, from the requirement in the EU directive that all veterinary medicines for food producing animals must be subject to prescriptions. However, implementation of this provision is being postponed until a decision is taken at EU level on the criteria for exempting certain medicines from this new requirement or until 1 January 2007 at the latest.

In the meantime, in so far as the issue of prescribing veterinary medicines is concerned, the only change arising from the draft regulations is that apart from intramammaries, all other off-prescription medicines will remain off-prescription until 1 January 2007. The suggestion was made during the debate last night that some of the POME medicines could be classified by the Irish Medicines Board as prescription only before 1 January 2007. Given the nature of the work involved in the re-classification of medicines and the overall policy of my Department that the status quo should be maintained in so far as possible, these medicines will not be reclassified in advance of a resolution of the exemption criteria issue.

The Minister made it clear that she intends to avail of the exemption clause to the maximum extent possible and the Department has made a submission to the European Commission with a view to retaining off prescription in Ireland all products, other than intramammaries, which currently enjoy this status. There is no reason to believe, as was suggested by Deputy Naughten, that the criteria will not be adopted until November 2006. As the Minister said yesterday, the Commission has undertaken to publish the criteria next spring and my Department will continue to press it to honour this commitment.

The suggestion that we should provide in the regulations at this stage to permit qualified professionals, other than vets, to write prescriptions is both mistaken and defeatist. In essence, what is being suggested is that my Department should throw in the towel before the fight, or in this case before the negotiations on the exemptions criteria start. It is not practicable to take a decision to extend the range of prescribers until we know what additional medicines will become prescription-only. In any event, it would be extremely foolish to provide at this stage for prescriptions to be written by people other than vets because to do so would also necessarily oblige me to designate as prescription-only some medicines currently off prescription.

More importantly, it would completely undermine our negotiating position on the exemption criteria if I were to re-categorise unilaterally at this stage some off-prescription medicines as prescription-only. My Department's approach of deferring a decision on whether it will be necessary to extend the range of prescribers until the exemption criteria issue is resolved is the best approach to take in the circumstances I have outlined. The Minister has undertaken to consider this issue next year in light of the EU decision on the criteria for exempting certain products from the prescription only requirement.

Our overall objective in making these regulations is to put in place a workable and competitive system for the distribution of medicines within the parameters of the EU directive which at the same time protects public and animal health, facilitates our food export trade and minimises costs for producers. We have achieved a delicate balance between all of these competing objectives. In particular, the draft regulations include a range of measures designed to make the arrangements for prescribing and supplying medicines more farmer-friendly and to introduce a greater degree of competition into the market for veterinary medicines.

The most important of these are as follows. We are removing the general requirement on veterinary practitioners to examine animals clinically before prescribing, thus according greater weight to professional judgment. We are extending the period of validity of prescriptions from 31 days to six months. We are introducing a new requirement that veterinary practitioners must, in all cases, issue written prescriptions even if the practitioner supplies the medicine. Also, the vet must issue the client with an invoice for supplying the product which is distinct from the invoice in respect of the provision of professional services. We are providing for the first time that prescribed veterinary medicines may, with certain exceptions, be supplied by licensed merchant outlets. These amendments will result in a regime which is more coherent, effective and workable. I commend the amendment to the House.

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