Mary Coughlan (Donegal South West, Fianna Fail)

The draft regulations on veterinary medicines, which were circulated by my Department in August for consultation, are designed to give effect to EU Directive No. 2004/28 and to reform aspects of the existing national regime for consultation. The Department received written submissions from most of the main stakeholders and subsequently met many of them as part of the consultative process. In addition, as required by the relevant legislation, the animal remedies consultative committee will meet shortly to consider the draft regulations, following which I will make final decisions on the issues involved so the regulations can be brought into force by the transposition deadline.

I am aware of views that have been expressed about the possible impact of the draft regulations on competition in the supply of veterinary medicines, in particular from the requirement in the EU directive that all veterinary medicines for food-producing animals be subject to prescriptions. However, the directive also includes a provision for exemption criteria to be adopted at EU level. These will provide a mechanism for certain categories of medicines to be exempted from the prescription requirement. The European Union has not yet adopted a decision on the exemption criteria but must do so before 1 January 2007. Pending this decision, existing national prescription and distribution arrangements will remain in place under the directive.

It is my intention to avail of the exemption clause to the maximum extent possible and the Department has made a submission to the European Commission seeking to retain off prescription, so to speak, in Ireland all products, other than intramammaries, which currently enjoy this status. The draft regulations published by the Department provide that veterinary medicines, such as wormers and certain vaccines, will continue to be available off-prescription for the time being. In practice, this means we are retaining the essence of our existing national prescription and distribution regime except in the case of intramammaries. Accordingly, it is not necessary at this stage, for competition reasons, to extend the range of persons who may be permitted to prescribe.

While the regulations in this area must, of necessity, give primacy to the protection of public health and animal health and welfare, I am acutely aware of the need to minimise costs to the farming sector and to ensure effective competition in the area of veterinary medicines. With this in mind, the Department has included a number of important changes in the draft legislation to achieve this objective. Among these are the removal of inflexibilities in the existing prescribing regime which will reduce the need for mandatory farm visits by practitioners. This will also anticipate needs, particularly for management-type products, by extending the life of a prescription from the current 31 days up to six months. This will facilitate the farmer and his or her veterinary practitioner, where appropriate. Another change is the new requirement for veterinary practitioners to issue written prescriptions in all cases to ensure that farmers are made aware of the cost of medicines as distinct from the professional service given, and to facilitate the purchase of medicines at premises other than that of the veterinary practitioner. Another change is the permitting of licensed retailers to supply prescription-only medicines for the first time.

Additional information not given on the floor of the House.

It is evident from the foregoing that my Department is doing everything possible, in so far as it has the flexibility to do so, to create an environment in which in can ensure that there continue to be competition in the supply of veterinary medicines. When the exemption criteria issue is resolved in the course of next year, I will review the regulations and, in particular and in light of the outcome, the provisions relating to the categories of persons who would be permitted to prescribe the current range of so-called off prescription veterinary medicines with a view to ensuring competition in the marketplace and to avoid imposing unnecessary costs on farmers. Full consultations will be held with all stakeholders on the matter at that stage before final decisions are taken.

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