Enda Kenny
Question:8 Mr. Kenny asked the Minister for Agriculture and Food his plans to restrict the supply of farm medicines; and if he will make a statement on the matter. [13929/03]
Other Questions. - Animal Medicines.
The sale and supply of veterinary medicines is governed at European Union level by a comprehensive and detailed framework of legislation which member states are obliged to implement in the interests, primarily, of the health of consumers of animal products and also of animal health and welfare. These EU obligations are embodied in national regulations which have been enacted under the Animal Remedies Act 1993. Under this legislation, the competent licensing authority is the Irish Medicines Board, except in the case of veterinary vaccines where competence rests with my Department.
It will be generally accepted that an area such as this must be subject to an appropriate degree of regulation, which necessarily imposes certain restrictions on what otherwise would be a free market. For example, it is necessary to ensure that the quality and safety of individual products are in accordance with current scientific principles before they are licensed for the market. Furthermore, it is recognised that a medicine which may have potentially harmful effects for users or consumers, or where a professional diagnosis is necessary to determine the precise product to be used in a given circumstance, must be subject to restrictions appropriate to the product concerned.
It is also necessary to ensure that distribution systems meet requisite standards in terms of storage and record-keeping in the interests of ensuring full traceability of products being used. That said, the restrictions imposed in respect of products or categories of products must be no more than what is reasonably required to safeguard public and animal health and welfare, and must not be used by any interest group to maximise profit or indulge in restrictive practices.
On a more specific level, the House will be aware from replies to a series of parliamentary questions that the Department of Agriculture and Food is currently considering how best to implement a recommendation from the Irish Medicines Board that intramammary antibiotics for the treatment of mastitis should be brought under prescription control. There has been wide consultation on this issue with a view to designing a regime which is sensible and workable for all concerned, while ensuring that public health and animal health and welfare are protected. It is my intention to reach final decisions on this issue at an early date.
As regards veterinary vaccines, it was necessary to review all existing licenses which had been issued under outdated legislation. In terms of determining routes of supply in the context of issuing the updated licenses, I again stress that the Department, as competent authority in this instance, does not have a general policy approach to exclude any of the sales categories currently provided for in the legislation. Rather a decision is taken on the basis of the characteristics of the individual product, taking account of the relevant recommendation from the Irish Medicines Board, and the objective criteria specified in the Animal Remedies Regulations, 1996.
Finally, there is currently under way a fundamental review of the EU legislative framework governing both human and veterinary medicines on the basis of proposals from the European Commission. The proposals contain many positive aspects, not least to improve the availability of treatments which has been acknowledged to be an ongoing problem in the veterinary area generally. The proposals would, for example, be very helpful to the further development of our horse industry. However, we have difficulty with the Commission's proposals to bring all veterinary medicines for food-producing animals under prescription control. In discussions at technical working group level, Ireland has raised the difficulties we see with the proposal, but it is evident at this stage that we do not have majority support for this position, with only three other member states sharing our perspective to some extent. We will, however, continue to press the issue as the package of proposals moves forward through the co-decision process.
In a long and detailed answer, the Minister has not addressed the question everybody is asking, namely whether the Government will bring change in this area. With recent changes in agriculture, farmers dealing with medicines are now very professional and are specialists in every relevant area. I would go so far as to say that some of them are more specialist than some of those left in place to handle the issue. I challenge the Minister to look again at this area.
Many young people are now educated in the agricultural area. They have green certificates and otherwise, and are top class dairy and sheep farmers and horse breeders. Why is there such need to introduce this change?
Veterinary medicines, including veterinary vaccines, are regulated under comprehensive EU legislation. We must abide by the decisions imposed upon us. There are two distinct areas: the intramammary legislation for the control of mastitis and the three co-operative outlets licensed by the health boards, from where veterinary surgeons supply medicines to their clients, and the pharmacists. The Irish Medicines Board makes the recommendations to the Department of Agriculture and Food.
The Department has tried to be practical and to bring in a regime that is acceptable to all. First, we are responsible for public health and, second, for animal health and welfare. Third, we want to bring in a regime that is acceptable to all the stakeholders, particularly the farmer. The Department does not want to impose another cost on farmers if it can be avoided and for that reason we are trying to find a practical solution to the problem.
In the area of vaccines, the Minister for Agriculture and Food has control but he has to do that with the recommendation of the Irish Medicines Board. Some 160 to 170 products are currently licensed under the Department of Agriculture and Food and we do not always accept the recommendations of the Irish Medicines Board. In the past, we rejected some 20 out of 60 proposals put forward. While living up to its responsibilities, the Department of Agriculture and Food is also trying to introduce a practical regime here that is acceptable to farmers, which is a concern. I emphasise that the first priority is human public health, followed by animal health and welfare and then cost.
May I ask a brief—
Acting Chairman (Mr. McGinley): I am afraid we have far exceeded the time for this question, Deputy.