Mary Coughlan (Donegal South West, Fianna Fail)

Full consultation will be held with all stakeholders on the matter at that stage and before a final decision is made. If I had not made these public statements, I could perhaps understand the reason the motion was framed in the terms before us. However, in view of the terms in the draft regulations and the clarification I have given, the motion is entirely without substance.

Before I deal with the specific points raised in the motion, I will set out the background to the draft regulations which, as I previously indicated, are designed to provide for changes to national legislation and the transposition of EU Directive 2004/28 into national law this month. My overall objective in making these regulations is to put in place a workable system for the distribution of medicines within the parameters of the EU directive which also protects public and animal health, facilitates our food export trade and minimises costs for producers.

Those elements of the regulations which propose changes to our national legislation stem from a comprehensive review undertaken by my Department, in consultation with stakeholders and other interested parties, of the Animal Remedies Regulations 1996 which constitute the current control regime for the sale, supply and use of veterinary medicines in Ireland. This review took account of operational experience and a number of important and relevant developments during the period since the regulations were adopted.

The perspectives on public health issues of relevance to veterinary medicines have developed significantly over the past decade and the consumer expects effective regulation in food related areas. In particular, issues such as concerns about antimicrobial resistance have come much more to the fore. In addition, operational experience of the regulations brought to light a number of areas where inflexibilities could lead to adverse animal welfare or failure to follow appropriate vaccination practices, the latter potentially leading to greater use of antibiotic treatments. In addition, a number of specific developments which have taken place since the regulations were first brought into force will have had a bearing on the review. These include improved standards of residue testing, better arrangements for animal identification and improved regulation of the veterinary profession.

In light of the review, I propose to make a number of changes to the regulations, the more important of which are as follows. The legal requirement on veterinary practitioners to examine animals clinically before prescribing will be removed, thus according greater weight to professional judgment regarding diagnosis and prescription. At the same time, it is intended to retain the bona fide relationship between practitioner and client as the context within which prescriptions will be issued. A new requirement is being introduced that practitioners must in all cases issue written prescriptions and if the practitioner supplies the medicine, he or she must issue the client with an invoice for supplying the product which is distinct from the invoice for the provision of professional services. The 1996 regulations are being amended to remove the exception for intramammaries from the general rules on antibiotics and decouple intramammaries from controls under poisons legislation. Prescribed veterinary medicines may, with certain exceptions, be supplied by licensed merchant outlets with appropriately trained personnel and by pharmacies and veterinarians. Such exceptions would, for example, apply to injectable antibiotics and sedatives. The "Prescription Only Exempt" category from the sales categories provided for in the legislation will be removed. The Irish Medicines Board, IMB, will be designated as the competent authority for veterinary vaccines in addition to its existing role for other medicines. These amendments will result in a regime which is more coherent, effective and workable and operates in the interests of both consumers and producers while continuing to respect the legitimate interests of other stakeholders.

I wish to comment specifically on the issue of intramammaries. For many years, Ireland has been virtually on its own in the European Union in having this category of antibiotic medicine available off prescription. The House is no doubt aware of the growing concerns about the growth of antibiotic resistance, particularly over the past ten years. This has led to many influential bodies at EU and international levels, including the World Health Organisation, recommending that all antibiotic medicines should be subject to prescription control. The Irish Medicines Board has also recommended that prescription controls be applied to intramammaries.

In approaching this issue, I fully recognise that the milk industry in general was quite successful in regulating the use of intramammaries under the existing mechanisms. Nonetheless, the IMB, having examined the position, noted in its report that: "allowing the existing situation to continue is not satisfactory and does not conform with current international scientific opinion on the prudent use of antibiotics". Accordingly, I concur with the view reached by my predecessor that there is no option but to introduce an alternative system. In doing so, however, we should retain what is best in the existing system. Thus, with appropriate veterinary intervention the milk industry, with its ready access to relevant data, can continue to be fully involved in this area and farmers will be able to get reasonable access to necessary treatments. It is also worth mentioning the crucial role that veterinary treatments play in modern food production. Such treatments are also important for protecting the health and welfare of the increasing number of animals kept as companion animals and pets. In terms of food production, the innovations in veterinary treatments have provided the basis for modern animal production systems, leading to the safe and secure food source we now take for granted in this part of the world. Antibacterial treatments are a case in point because without them we simply would not be able to manage current production systems that would produce safe food at an economic price.

As a country which is so dependent on export markets, we must ensure that we maintain our reputation for safe, wholesome and quality food. This is, in essence, another dimension of our competitiveness. To maintain our reputation, I must ensure that any decisions I make at this time will not in any way undermine our hard won reputation on foreign markets. I need only remind the House of the capital which was made by competitors of problems encountered with hormones and antibiotics some years ago to demonstrate just how fragile this reputation can be and of the need to ensure that our control regimes enjoy the confidence of both regulators and buyers in overseas markets.

I wish to make a few remarks on the background to the legislation which we are obliged to transpose into national law by the end of this month. The review which led to the new EU regulation was comprehensive and embraced both the human and veterinary sectors. The main objectives of the review were to improve the protection of human health as well as animal health and welfare and also to improve the competitiveness of the EU pharmaceutical industry, particularly with a view to increasing the availability of veterinary medicines in all member states.

The only element of the directive which has received any publicity in Ireland is the requirement that any veterinary medicines must come under prescription control. However, the directive also includes a range of measures which will have a positive effect in securing an innovative pharmaceutical industry in the EU and also the continued availability of an adequate range of treatments. Some of the measures, especially those relating to the mutual recognition and cascade regimes, will bring particular benefits to small peripheral markets such as Ireland's.

I now turn to the specific issues referred to in the motion, many of which are overlapping and exaggerated out of all proportion. As I said earlier, they are all based on the false premise that the draft regulation will significantly extend the range of veterinary medicines which must be prescribed by a veterinary practitioner.

There is no substance to the suggestions that the draft regulation will impose unimplementable and unworkable restrictions on farmers, that they are overly bureaucratic or that they would seriously restrict the availability of animal medicines. The opposite is the case. The draft regulation includes a number of important changes to the existing rules which are designed to make the arrangements more farmer friendly. Apart from those mentioned earlier, I also propose to extend the life of a prescription from its current period of validity of 31 days to six months. Taken together, these proposals are specifically designed to simplify the procedures surrounding the prescribing of veterinary medicines and to reduce the cost of the prescription requirements.

With regard to the additional cost which it has been suggested the draft regulations will impose on farmers, I would be interested to know how the framers of the motion arrived at a figure of €80 million. As is the case with the motion generally, this figure is completely unfounded, particularly in the context of the overall value of the veterinary medicines sector, which has been estimated by APHA at €96 million in 2004. The only additional cost which the draft regulations might possibly impose on farmers arises from the reclassification of intramammaries. I already outlined the changes I am introducing in the prescription regime in order to limit the impact of this decision, which will be minimal. In particular, the removal of the requirement on a veterinary practitioner to inspect an animal prior to prescribing a medicine is specifically designed to enable prescriptions for intramammaries to be written without a prior examination. My Department is also looking at various suggestions for a more flexible approach to prescribing intramammaries, particularly in the context of mastitis control programmes, which I fully accept have made a major contribution to the reduction of antibiotic residues in milk.

I am also proposing other changes in the draft regulations to increase competition in the supply of veterinary medicines with the ultimate objective of reducing costs. For example, I am requiring veterinary practitioners to write prescriptions and to provide a separate invoice to the farmer. These changes will serve the dual purpose of introducing transparency into the system and at the same time permit farmers to shop around for best value in veterinary medicines. Furthermore, I am proposing to permit, for the first time, licensed merchants to supply certain prescription medicines to encourage increased competition with veterinary practitioners and pharmacies.

The Competition Authority expressed certain reservations about the draft regulations. However, the authority was operating under the same misapprehensions as to the nature of the draft regulations as the framers of the motion before the House. My Department has written to the Competition Authority to remove those misapprehensions. However, I assure the House that I attach considerable importance to ensuring that the regulatory regime encourages competition in the market for veterinary medicines while at the same time providing the necessary protections for animal health and welfare and human health and I will take the views of the authority into account in the review of my regulations next year.

In view of the limited scope of the draft regulations in terms of the additional veterinary medicines which will be brought under prescription control, there is no basis for the suggestion that the draft regulations will discriminate against the competitiveness of Irish agriculture. In most member states in the EU, apart from the UK, the writing of prescriptions is generally confined to veterinarians and the information available to my Department is that they do not intend to depart from this practice. Intramammaries have been subject to prescriptions for some time in the United Kingdom and the draft regulation will merely bring us into line with practice there.

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