Dáil Éireann Debate, Wednesday - 23 June 2004
87 Dr. Upton asked the Minister for Agriculture and Food if his attention has been drawn to the outcome of a District Court case (details supplied); the implications of this decision for the enforcement of the Animal Remedies Regulations 1996 and other relevant legislation; and if he will make a statement on the matter. [18807/04]
View answerThe case in question involves a criminal prosecution in the District Court which has not concluded. The District Court judge has referred a question of law to the High Court by way of a case stated and the matter will return to the District Court when the High Court has given its ruling. The State will strenuously contest the arguments raised by the defendant against the regime in the High Court. In the interim, normal inspection etc. activity by my Department will continue.
88 Dr. Upton asked the Minister for Agriculture and Food the reasons for proposing changes to the Animal Remedies Regulations 1996; the implications of his proposals if implemented including the implications for the ready availability and costs of such products from a farmer’s perspective and the health and safety risks of allowing for the first time licensed merchants and others to dispense these remedies on foot of prescriptions; and the timeframe within which he hopes to complete his consultations on the issue and make the revised regulations. [18808/04]
View answerIn the almost ten years during which the Animal Remedies Regulations 1996 have been in force, there have been a range of developments impacting both directly and indirectly on the control regime for veterinary medicines. Prominent among these have been improvements in the regulation of the veterinary medicines market through the licensing regimes operated by the Irish Medicines Board and my Department, as well as improvements in the areas of residue surveillance and animal identification. My Department, through its inspection and enforcement activities, has also gained valuable experience in the operation of the legislation, which while mainly positive, also revealed scope for improvements particularly in the areas of traceability and record-keeping.
In reviewing the regulations, I had to take into account the tendency for an increasing range of veterinary medicines to come under prescription control, including the recommendation to this effect from the Irish Medicines Board in regard to intramammary veterinary medicines. In addition, my Department had been made aware of the negative effects, particularly in the area of animal welfare, resulting from certain inflexibilities in the current national prescribing rules which have been among the strictest in the EU.
Against this background, I announced in mid-February my intention to make certain changes to the national control regime to make it more effective and relevant to the current climate. I would stress that paramount among my concerns in this regard is the protection of public health. These changes include amendments to prescribing rules to enable veterinary practitioners to exercise an appropriate degree of professional judgment, improvements in record-keeping, transfer of certain licensing functions to the IMB as well as certain changes to distribution arrangements referred to by the Deputy.
In regard to this latter aspect, it is important to stress in the first instance that the decision on the use of any prescription medicine, or on the particular product to be used, would continue to be reserved to the professional judgment of a veterinary practitioner, who, for the first time, would be required to issue a written prescription in all cases. I have proposed that retail outlets licensed under the regulations would for the first time be allowed to supply a limited range of prescription medicines on foot of a written prescription. However, where I am satisfied that there is a need for the supply of particular categories of prescription veterinary medicines to continue to be reserved to pharmacies and veterinary practitioners, these restrictions will remain.
The proposed changes will make for a more balanced control regime appropriate to current circumstances and will provide a basis for a greater degree of price competition in the supply of medicines while retaining the essential control elements. Following detailed briefings given by my Department to stakeholders following my announcement, submissions were received as well as requests for follow-up meetings. I am anxious to conclude this process at the earliest possible date so that the revised legislation can be in place by the autumn of this year.
