Denis Naughten (Longford-Roscommon, Fine Gael)
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Question 321: To ask the Minister for Agriculture and Food the main points made to her in a recent letter by the Competition Authority in respect of proposed veterinary medicine regulations; her views on the points made by the authority; and if she will make a statement on the matter. [23090/05]

Mary Coughlan (Donegal South West, Fianna Fail)
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In my reply to Parliamentary Question No. 535 of 28 June, I outlined my general views on the points raised by the Competition Authority in its recent letter to my Department.

With regard to the specific points raised in the letter from the Competition Authority, I fully accept the need to promote competition in all sectors of the economy. In this regard, my Department proposed certain amendments some time ago as part of a reform of the existing national arrangements and, in particular, to improve the existing rules relating veterinary medicines. These included in particular measures to require veterinarians to issue prescriptions and also to provide for a wider availability at retail level of prescription only medicines, thus stimulating competition and lowering costs. I intend to include these proposals in the legislation referred to above.

As regards the points made in the letter relating to the transposition of the EU directive and, in particular, the provisions of the EU directive governing the prescription of veterinary medicines, I should point out that the prescription only rule for all veterinary medicines for food producing animals was introduced by the EU and not the Department of Agriculture and Food. My Department opposed this proposal in the discussions at EU level and succeeded in securing an exemption mechanism in the directive which provides for certain categories of medicines to be exempted on the basis of criteria to be adopted at EU level. Pending decisions on the criteria, existing regimes can remain in place until January 2007.

My Department has made the case to the Commission for many of the existing range of off-prescription medicines to be granted an exemption and it would be premature to at this stage to consider an extension of the range of prescribers until this issue is resolved. If successful, this would mean that farmers could continue to purchase the relevant products from existing outlets. In the event of some or all of these products failing to qualify for an exemption, the decision on whether interests other than veterinarians should be permitted to supply prescribed veterinary medicines will be taken in consultation with the relevant authorities such as the Department of Health and Children, the Irish Medicines Board and the FSAI. My Department will, of course, follow Government policy on competition and will endeavour to ensure effective competition having regard to animal and human health considerations and the requirements of the EU directive.

With regard to the comments in the letter about its proposals "strengthening the close relationship which veterinarians and farmers typically enjoy", I would not characterise our approach in this way. What has been proposed is a reformulation of how prescribing rules would operate by removing some of the rigidities in the 1996 regulations so that farmers will not be burdened with the expense of repeated visits by their veterinary practitioners. As regards the profit earning potential of vets as sellers of medicines, stated Department policy is to achieve a broadening of the range of retail supply outlets and we have proposed that the licensed merchant category should for the first time be enabled to sell prescription only medicines, with certain exceptions, on foot of a veterinary prescription.

Having regard to the overall thrust of my Department's proposals, which is to make the prescribing regime more workable and to broaden the range of sales outlets, I find it difficult to see how our proposals will, as suggested in the letter, lead to "reduced choice and increased costs" for farmers and others. With regard to the distinction drawn in the letter between preventative and therapeutic products, we have to keep in mind that, from a public health perspective, the distinction is somewhat meaningless because both carry risks if not properly used.

My Department is aware of the proposals from the UK veterinary medicines directorate and will, of course, monitor developments there. I should point out, however, that the proposed UK model is not being followed in other member states.

With regard to prescriptions, my Department has already indicated its intention to require veterinary practitioners to issue written prescriptions and to show the cost of medicines separately from the cost of professional services. This will enable clients to better judge the value for money they are getting from various suppliers and to shop around for best value.

On the question of the particular product to be prescribed, my Department's approach is that the lowest cost product should be indicated consistent with the needs of the particular animal. Under the licensing regime implemented by the IMB, each medicine is allocated a VPA, veterinary product authorisation, and we would not have a difficulty with prescriptions being issued on this basis. However, there would be concerns about prescribing only an active ingredient, particularly in a situation where non-veterinarian pharmacists are permitted to fill such prescriptions. There could be serious issues relating to public health and responsibility if the wrong choice of product, which either did not adequately treat the animal or indeed damaged or killed the animal, were to be supplied.

In conclusion, I should point out that the main objective of the EU directive is to protect human and animal health. In transposing the directive, my intention will be to provide for the highest standards of public and animal health protection in this complex area in a way which is workable and which meets relevant EU requirements and underpins our export-orientated agriculture and food industries.