Denis Naughten (Longford-Roscommon, Fine Gael)
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Question 114: To ask the Minister for Agriculture and Food the status of the review of the draft animal remedies regulation; the steps she is taking to ensure effective competition within the market place; and if she will make a statement on the matter. [26536/05]

Mary Coughlan (Donegal South West, Fianna Fail)
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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.

Denis Naughten (Longford-Roscommon, Fine Gael)
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The proposed regulation, as currently drafted, would dramatically increase the cost of medicines and significantly reduce access thereto. Will the Minister consider the provisions that have been put in place in the United Kingdom, including across the Border in Northern Ireland, regarding the same directive where competent persons, not only veterinary practitioners, can issue prescriptions?

What would happen if no veterinary practitioner were available in north Mayo, for example? This problem is becoming more frequent throughout the country. Is it not the case that the Competition Authority has already criticised these proposals in the belief that they will reduce competition? What will be the cost of these prescriptions to farmers?

Mary Coughlan (Donegal South West, Fianna Fail)
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A number of issues arise. The United Kingdom proceeded much faster than expected——

Denis Naughten (Longford-Roscommon, Fine Gael)
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Than the Minister would have liked.

Mary Coughlan (Donegal South West, Fianna Fail)
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I do not really care because I have taken the opportunity for consultation on this matter. As I indicated previously all the organisations and individuals involved put their views and I am awaiting the consultative committee who will advise me on this matter. I will make further announcements over the next two to three weeks. I agree that cost is an issue and on that basis and because I am not happy with the regulation I may introduce other aspects into it. One of the issues presenting difficulties for all of us is that the exemption list is not being dealt with prior to the full implementation of the directive. There will be no changes up to 1 January 2007. In the interim I will examine the issues of competent authorities and of education and I will take the cost factor into consideration. I will also take the black market into consideration. This is a situation of which those of us living in the Border counties are acutely aware. To make a practical and balanced decision, I will take into consideration many of the views expressed by Members on both sides of the House and by all those involved.

There will be no change up to 1 January 2007 except for intramammaries with which I will deal in the next two to three weeks following the receipt of recommendations from the consultative committee. I will also reflect on a number of practical and pragmatic issues that I hope will address the balance between supporting the cost factor for the farmer and the health, safety and welfare of the animal and of the consumer.

Denis Naughten (Longford-Roscommon, Fine Gael)
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Are not the current proposals for animal remedies the exact opposite to the Department of Health and Children's proposals for the deregulation of human medicines because of the significant costs involved? Is it not the case that all 25 member states must agree to the contents of the exemption list? The Minister's officials have stated that if she fails to achieve a decent and expanded exemption list, she will go back to Brussels and propose licensed merchants and pharmacists be permitted to issue prescriptions. What is the feasibility of going back to Brussels and looking for a downward revision once the regulation has been implemented?

Mary Coughlan (Donegal South West, Fianna Fail)
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I as Minister will make that decision and not the Department.

Denis Naughten (Longford-Roscommon, Fine Gael)
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I will hold the Minister to that.

Mary Coughlan (Donegal South West, Fianna Fail)
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I know the Deputy will ensure I am held politically responsible.

As I indicated in my initial response, the exemption list has been forwarded to the Commission. The Deputy is correct in saying the exemption list must be agreed by the 25 member states. If this agreement is not forthcoming between now and 1 January 2007, I will in the interim reflect on the implications and make a balanced decision on what is required to address the concerns expressed. I will await the publication of the exemption list and listen to my advisory committee. I will consider alternative arrangements if the outcome is not to our satisfaction.