Denis Naughten (Longford-Roscommon, Fine Gael)
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I move:

That Dáil Éireann,

notes the recent publication by the Minister for Agriculture and Food on the Draft Animal Remedies Regulations 2005 and recognises that:

—Ireland must legislate for EU Directive 2004/28 by 31 October 2005;

—the Government's proposals will impose unimplementable and unworkable restrictions on farmers;

—the current proposals are over-bureaucratic and will seriously restrict the availability of animal medicines;

—the regulations will add an additional €80 million to the cost of veterinary medicines in this country;

—the Competition Authority has expressed serious reservations regarding the implementation of the EU directive in its current manner;

—it will seriously discriminate against the competitiveness of Irish food production and farming;

—the proposals will facilitate the creation of a monopoly in the sale of animal medicines;

—it will hinder good farming practice and have a negative impact on animal welfare;

—it is becoming progressively difficult to maintain veterinary practices in certain parts of the country;

—Northern Ireland has taken a more farmer-friendly interpretation of the EU directive which may promote a cross-Border black market for such products;

—the regulation will inhibit the development of an all-Ireland animal health regime;

and calls on the Government and the Minister for Agriculture and Food to:

—allow qualified professionals, other than but including vets, to issue prescriptions;

—implement a regulation similar to that of the UK authorities, which will eradicate the potential for cross-Border trade in animal remedies;

—retain the wide availability of animal medicines while ensuring that Ireland continues to produce food to the highest standards;

—publish the proposed exemption list which has been submitted to the European Commission;

—review the draft regulation to introduce a simplified system of compliance; and

—allow Irish farming publications to advertise and provide detailed information regarding the efficacy of animal remedies in line with similar UK publications circulating in Ireland.

On 10 August, the Department of Agriculture and Food published draft regulations on the issuing of animal remedies. Many believe the proposal highlights the Government's blatant disregard for Ireland's food industry. The Government is more interested in attracting transient foreign investment than in supporting indigenous employers. Sadly, this view has been copper-fastened by the publication earlier this year of the enterprise strategy action plan, the blueprint which will guide the development of Irish enterprise for at least the next ten years. It made no mention of our agrifood industry, the gross value of which to the economy is estimated to be more than €11 billion per annum.

Currently, red tape is strangling many farmers. It is no wonder that producers are losing confidence in a Government and a Minister for Agriculture and Food who have failed to realise the significance of the continual and persistent over-regulation which has a serious impact upon the competitiveness of our food industry. Over the last ten years, half of our abattoirs have gone out of business. Others in this sector are considering their future due to the shifting sands of regulation, which continually require expensive re-investment to meet existing food standards. This is further compounded by proposals to ban the sale of meat from butchers into the catering industry, the backbone of the business of small processors.

It is now vital that the Government reviews the array of new rules and their associated costs before we price our food sector out of business. Since 2002, the Government has introduced an array of stealth taxes which have facilitated massive increases in charges for services such as electricity prices, motor charges, VAT and VHI that are essential to the farming community. At the same time, farmers do not even get the basic cost of production back from the marketplace. This is at least partially caused by the undercutting of our food by cheap imports. Stealth taxes which increase the cost of production in Ireland are facilitating the importation of more and more produce from third countries, compounding the problem. As if this was not bad enough, veterinary expenses are now 44% more expensive than they were ten years ago. The Government seems intent on squeezing farmers' pockets even more by introducing further restrictions allowing only veterinary surgeons to issue prescriptions for animal medicines.

For many, the Minister for Agriculture and Food's interpretation of EU Directive 2004/28, which will implement the new animal medicine regime, is the final straw. According to the directive, the definition of a veterinary prescription is any prescription for a veterinary medicinal product issued by a professional person who is qualified to do so in accordance with applicable national law. It is thus the responsibility of each member state to designate who is qualified to prescribe different medicines. Under the terms of the directive, it is possible for Ireland to maintain its current system, which is a model for the rest of Europe and has gained Irish farmers an international reputation as high quality food producers.

While the Minister has stated that these new rules will not come into force until 2007, this is not correct. From the end of this month intramammary products will only be available from a veterinary practitioner. This will have a significant impact on the cost of these vital treatments. Furthermore, the prescription only medicine exempt category, which allows pharmacists and veterinary practitioners to prescribe designated animal remedies, will be abolished immediately. This will mean that some treatments such as vaccines and immunological and non-immunological products, which had been available without prescription, will now only be available from a veterinary practitioner on prescription. This is deceptive and contrary to comments which have been made to date by the Minister on the regulation and the implementation timeframe.

It should also be pointed out that the prescription only medicine directive was opposed tooth and nail by the Government through two readings in the European Parliament and Council of Ministers. The then Minister for Agriculture and Food, Deputy Walsh, was browbeaten into accepting the prescription only medicine directive as part of a wider compromise package agreed by the then Minister for Health and Children, Deputy Martin. Under pressure, Deputy Walsh agreed to sacrifice our hard won system of veterinary medicine prescription in the interests of securing a deal on the human medicines directive and regulation, which was seen as a priority for the Italian Presidency.

The same Department of Agriculture and Food which now puts forward these proposals was vehemently opposed to this directive at the time of its final sign-off as a last minute achievement of the Italian Presidency. Its about turn on the likelihood of securing exemptions is both mind-boggling and inexplicable.

The Minister is trying to create a false sense of security by gambling that the Commission will grant exemptions from the prescription requirement to all of the products that are currently available from licensed merchants. Currently, there is no EU-wide definition of a veterinary prescription and no common procedure for dispensing such a prescription. The implications of these differing approaches will become clear when the Commission's standing committee convenes to draft this list of exemptions from the prescription requirement, which has become the Department of Agriculture and Food's Holy Grail.

During negotiations, the only other countries who had a similar regime and worries to our own were the United Kingdom and the Netherlands. While to a lesser extent Spain and Portugal were sympathetic, the other member states pushed for a strict application of the prescription only medicine directive because it was a codification and an endorsement of their existing systems and because it is easier and cheaper to obtain a prescription in these countries than it is in Ireland. I understand from Avril Doyle MEP's discussions with EU colleagues that in their firm opinion, this approach is unlikely to succeed, especially in the light of objections raised in the Council and the European Parliament during the drafting of the veterinary medicines directive in 2003.

However, the Minister has given a vague commitment that if she fails to get a satisfactory result on the proposed exemption list, she will review the situation and will consider redrafting the regulation to allow pharmacists and licensed merchants to issue certain limited prescriptions.

This tactic will give rise to serious problems. First, in the unlikely event that we do secure such exemptions, this list will be closed. New drugs developed in the future will automatically be prescription only medicine and must be prescribed by a vet, whether they warrant a prescription or not. Second, most people with any knowledge of the workings of the EU believe it is very unlikely that Europe will allow a member state to return with a watered down proposal, after it has already submitted a comprehensive and extremely restrictive law. Third, this revised proposal will be submitted very late in the day, over 12 months after each member state is meant to have its law in place.

Realistically, it will be at least November 2006 before any agreement, if there is to be one, will be in place on the exemption list. This will leave approximately four weeks for our Government to draft a new regulation, enact it in the Houses, submit it to Brussels and gain the EU's approval before the new rules come into effect on 1 January 2007.

The most sensible and straightforward approach is the reclassification of medicines into different categories of drugs that can be prescribed by registered persons qualified and authorised to do so by the Irish authorities, including licensed merchants and pharmacists. This is the approach taken by the authorities in the United Kingdom. The United Kingdom has designated vets, pharmacists and licensed merchants to issue prescriptions within the confines of the EU directive.

If the Minister for Agriculture and Food maintains her current position, there will be cross-Border distortions of the market in veterinary medicinal products, which will have a detrimental effect on the food chain through the development of a black market. A similar legislative approach must be adopted on both sides of the Border, thus avoiding the development of a cross-Border black market, which is essential for the maintenance of the ongoing integrity of veterinary medicinal practices. The divergent approaches taken on both sides of the Border will be a serious and significant impediment to the goal of developing an all-Ireland animal health regime, which is vital for the future promotion of Irish food products.

The Competition Authority has expressed serious reservations regarding the implementation of the EU directive by the Minister for Agriculture and Food in this manner. It believes the regulation may be anti-competitive and lead to increased costs for farmers. It is estimated the additional cost to farmers will be in the region of €80 million per annum. The Competition Authority has highlighted the Government's policy, as laid down in the White Paper, Regulating Better, that new regulation be introduced only on clear need. However, there is no evidence of such a need for the regulation of preventative medicines and the authority believes putting all farm animal medicines on a prescription-only basis would be a disproportionate means of addressing public health concerns. It goes on to say this new law will effectively increase the exclusive profit earning potential of vets and will lead to reduced choice and increased costs for farmers.

Another key question that the Minister has ignored is where are farmers going to find vets. This is a genuine issue on the tips of farmers' tongues across the country. We all know the growing difficulty in getting vets. We have already seen significant problems in places such as counties Mayo and Donegal where it is extremely difficult to gain access to veterinary practitioners. If there is no local network via the vets to distribute medicines, many parts of the country will not be able to avail of animal remedies. Is it the Minister's intention to pay vets to provide a service in peripheral parts of the country, as is the case with doctors? This is a critical question. Will she guarantee the availability of vets throughout the country to provide this service?

Another significant barrier to competition will be the requirement that vets identify a particular brand on a prescription. In cases where an equally effective substitute exists, this potentially allows for the closure of the animal medicines market to new medicines that may not have a widely recognised brand name or where the vet is tied into an arrangement with a particular manufacturer. This directly contravenes the directive itself, which specifically and categorically states the implementing legislation cannot hinder the development of industry or the legitimate trade in medicinal products.

This type of problem has existed for years in Ireland's medical profession and in order to address the problem, the Department of Health and Children introduced the indicative drug target saving scheme in 1993. Under the scheme, the Department incentivises GPs to refrain from naming branded products on prescriptions and instead opt for generic brands because of the massive cost implications involved for the health service. To date, in excess of €90 million has been paid out nationally to participating doctors by the Department under this scheme. The Department of Agriculture and Food is now proposing a structure similar to what was in place for human medicines prior to 1993, claiming that it will not impact on cost or competition. Of course, the Department will not need to pick up the bill for increased costs in this instance as it will be borne directly by farmers across the country.

The excuse for introducing such draconian rules is that it will protect public health. The Competition Authority has pointed out that the proposed regulation would not provide any significant benefits to public health. This is supported by a study carried out in Denmark where 90% of the incidents of antibiotic resistance in human cases was caused by imported non-EU meats. Obviously, whatever medicines are being used in third country meats have the potential to significantly affect human health. Therefore, if the Minister wants to eradicate antibiotic residues in food and protect public health she, along with her EU counterparts, should focus on these imports rather than try to make Irish farmers less competitive and thereby promote the consumption of further risky food from third countries. They were trying to make scapegoats of Irish farmers who have clean bills of health and where there is no issue in respect of residues. The only such issue highlighted within the European Union was in Denmark, where it was clearly shown to be due to imported non-EU meats.

If the Minister wants to do something, she should start by addressing the issue of the huge anomaly in relation to substantial transformation. Sadly, she has not done so to date. She said she has discussed it with her EU colleagues but she still has not addressed it or the issue of labelling within the catering trade, which is within her competency, in order to ensure a watertight system is put in place and no allegations are made against Irish food, allegations that are completely erroneous and doctored due to the fact we have an anomaly within the food labelling regime that allows for the relabelling and reprocessing of food from third countries to be passed off as Irish food products.

Two key factors in protecting the food chain are, first, ensuring high levels of animal health and welfare by encouraging farmers and animal owners to take a preventative approach where veterinary medicines are concerned. This can best be done by enabling them to procure and administer routine management drugs as easily as possible. This avoids the use of antibiotics in the first instance and, therefore, avoids residues altogether. The second key factor is observance of the withdrawal period for each veterinary medicine administered. As long as the withdrawal period is observed, the maximum residue levels established for each drug will not be present in the animal at slaughter. Observance of withdrawal periods has absolutely nothing to do with whether a medicine is prescribed. This will not be addressed by the proposed regulations. For the Minister to say she is bringing these proposals forward on the basis of public health is an inaccuracy that should be corrected when she has the opportunity to do so.

If we want to protect public health and the consumer, it is imperative we provide farmers, who are professional keepers of animals, with as much information as possible about preventative care, animal medicines and their withdrawal periods. However, the regulation does the exact opposite. For the first time in legislation, the farmer is not defined as a professional keeper of animals and the only information to be provided concerning how animals should be medically treated is a prescription to do so through vets. The farmer is not entitled to have even the most basic information but the Department would be very quick to prosecute farmers if they did not have their documentation and did not monitor and implement the withdrawal periods set in place for each of these medicines. The Department is asking farmers to implement rules and regulations without giving them the basic information they require.

It is essential that farmers are in a position to easily inform themselves of the various options available, whether it be through reading specialist farm press, which should include responsible advertisements for veterinary medicinal products, or through consultation with animal health professionals who are qualified to advise them. However, under the proposed regulation, farmers will not be able to avail of such information, which will be solely confined to veterinary professionals.

Advertisements for lice and other topical treatments will be banned but similar advertisements for humans are legal and appear on a daily basis. Since advertisements for animal medicines in the UK media will be legal, will a number of officials from the Department of Agriculture and Food be deployed to go into every newsagent which sells the UK Farmers Weekly magazine to remove the offending pages carrying advertisements? Is that the intention of the Minister? Obviously, censorship is still part of the Government psyche.

I am disappointed the Minister tabled an amendment to this fair and reasonable motion. The amendment refers not only to implementing this directive but also to implementing changes which arise from a review of existing national legislation. Perhaps that is the reason the Minister has tabled these proposals and she is merely using the directive as an excuse and a vehicle to do so.

These proposals will significantly increase the cost of medicines to farmers, which will have a direct impact on animal husbandry and the cost of food production. I accept that in the case of some medicines, veterinarians are the most appropriate people to write a prescription. However, this should be limited to a restricted number of medicines and should not apply across the board. I call on the Minister and her backbench colleagues, who have stated that they are opposed to this proposal, to use their feet when they walk through the lobbies and support this motion. I commend the motion to the House.

Paul Connaughton Snr (Galway East, Fine Gael)
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The introduction next week of the EU directive and its implementation in Ireland is causing great apprehension. The Minister and Government backbenchers are aware of what is involved. Unfortunately I do not have enough time to discuss all aspects of it, but I wish to put a number of points on the record.

The Government seems to think it can impose new austere proposals on the farming community but a time will come when farmers will not put up with it. Farmers want an animal welfare environment where the best possible attention is given to the health of the livestock in the context of producing the healthiest foods for consumers. Every farmer worth his or her salt supports that.

These draft regulations deal with the supply, sale and administration of properly documented farm drugs to be administered by competent people trying to do a job at several levels. I will return to that. No farmer I know, including me, wants to have access to drugs that should be and are within the control of highly trained professionals such as vets and chemists. I do not have any trouble with that. I have lived a lifetime with it and most farmers would not have an issue with it.

However, it is vital that farmers produce beef, lamb and pigmeat free from drugs and hormones and that a highly efficient screening procedure is in place to protect the consumer. Reason, balance and good sense must also come into the equation, and I will explain to the Minister what I mean by "good sense". I do not want a situation whereby the everyday animal husbandry products I need to keep my cattle healthy are available only on prescription from my vet. Last Saturday week, when I dosed my calves to prevent hoose, I expected to be able to get that dose from my merchant chemist or vet. Each year when I dose my cows for worms I expect to be able to purchase the ordinary run of the mill doses from the same outlets with which I have done business for years.

I am lucky because should it happen that one of my suckler cows gets mastitis on a Saturday evening, I live beside my vet. However, for thousands of people it will not be possible to get a vet on a Saturday evening. I would not expect to have to allow that cow to become poisoned with resulting pain and suffering because I could not get an intramammary to help to solve the problem. I am glad the Minister has returned to hear that important point.

There is no reason that outlets other than vets cannot supply such products and several others referred to by Deputy Naughten that I do not have time to discuss. The Minister should examine the enormous increase in veterinary fees experienced by farmers in the past five years. Most farmers' bills quadrupled during that period. If the merchants, chemists and other outlets are removed from the equation, it will be a licence to print money. The Minister and the Government are softening Irish farmers for another smack in the face. Next week, she will be hiding behind the coat tails of the eurocrats in the European Union.

Mary Coughlan (Donegal South West, Fianna Fail)
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I never hid behind any man's coat tails and have no intention of doing so.

Denis Naughten (Longford-Roscommon, Fine Gael)
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The Commissioner is female.

Mary Coughlan (Donegal South West, Fianna Fail)
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I certainly will not be hiding behind that.

Paul Connaughton Snr (Galway East, Fine Gael)
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We will get another tearful response from the Minister stating she is sorry for what happened, that she does not like it but that she can do nothing about it. That will be the long-playing record for the next 12 months. Of course the Minister can do something about it. Now is the time for strong leadership and good sense to prevail.

Tonight we give an opportunity to the Fianna Fáil backbenchers in particular. They travelled throughout the country during the past 12 months and said on local radio and in local newspapers that they will make certain the Minister will ensure no change occurs. I listened to them day and night. We will soon find out what the change will be. All I can hope for——

Mary Coughlan (Donegal South West, Fianna Fail)
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The Deputy certainly will.

Paul Connaughton Snr (Galway East, Fine Gael)
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I hope what the Minister does is what the Fianna Fáil backbenchers told Irish farmers. I will be the first to congratulate her.

Mary Coughlan (Donegal South West, Fianna Fail)
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I will have a great weakness after that.

Paul Connaughton Snr (Galway East, Fine Gael)
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I will be the first to congratulate the Minister if I can treat my farm animals with the products I described next month, next year and during the next five years as I have during the past year. That will be the litmus test.

Simon Coveney (Cork South Central, Fine Gael)
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I welcome this motion and the fact that the Minister has made it back from Brussels to participate. I hope she had a successful day and that she made strong statements on what the Commissioner for trade, Mr. Peter Mandelson, has stated in particular. He has taken on a role to which he has no entitlement. We should not allow the French alone to do the dirty work. I hope the Irish Government makes strong statements.

This motion is extremely focused and I do not understand why the Government has not accepted it but come forward with an amendment. For the non-farming sector, issues surrounding the purchase, supply and usage of veterinary medicines may seem like a trivial matter. For the thousands of farmers throughout Ireland who keep livestock, this is an issue of major concern.

Ireland is required to legislate for Directive 2004/28/EC by the end of this month. The directive began life dealing with issues surrounding the supply and sale of medicines for human use and the rules surrounding prescription and supply. It was then extended to the area of animal medicine. In reality, the system as it stands in Ireland is not bad. For the more serious medicines used on farms a vet is required to give an analysis and then a prescription. Farmers can buy many of the lesser medicines and medical treatments off the shelf with advice from someone in the co-op or the pharmacy, as long as the medicine is approved.

My understanding of what has been proposed by the Government is that it is intended to implement the directive in a manner which in principle would require all veterinary medicines to have a prescription. We would then seek a derogation of the rules for certain commonly used medicines so farmers will not have to call out a vet to receive a prescription each time they want a drug. This approach is both flawed and dangerous. The Government assumes we will get a derogation for the list of commonly used veterinary medicines to allow their sale without prescription. We can put forward a list but the decision will be made by an expert group of people in a standing committee linked to the Commission. The Irish Government does not make that decision. We are gambling on the fact that this supposed derogation list will be successful. Each EU country has a different system for prescribing veterinary medicines. As it happens, the Irish system is stricter than that of many other European countries. Introducing a system of prescription only veterinary medicine is more difficult and restrictive for Irish farmers than in many other European countries.

The UK has recognised this problem and come up with a solution that may be applicable to Ireland. A more sensible approach should be taken by Government, as the UK has done. We should reclassify medicines into different categories of drugs so that they can be prescribed by registered persons qualified and authorised to do so by the Irish authorities. This approach is accepted by the EU.

To achieve the overarching goal of safeguarding animal health and welfare through giving farmers timely, cost-effective and equitable access to medicines and animal health advice, the draft regulations must be amended to shift the emphasis from an excessive reliance on securing a list of exempt products at EU level. This is what the UK has done and if we change our tactics it could result in an all-Ireland approach towards the issue. The emphasis should be to reclassify or re-categorise medicines with a corollary and appropriate training or registration for the relevant professionally qualified person, as the Government decides, whether it be a pharmacist, merchant or in some cases, a vet. This is about taking a sensible approach, because there are significant implications for farmers across the country.

Olwyn Enright (Laois-Offaly, Fine Gael)
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I thank my colleague, Deputy Naughten, for bringing this matter before the House and for giving Members the opportunity to vote on this issue. It is one that may not be laid exclusively at the door of Europe, as is frequently the case.

This is an issue of great concern to many farmers, particularly in my constituency. I have met individual farmers as well as the farming organisations on this matter. Red tape is already strangling Irish farmers. It is the single largest issue they consistently raise and it is responsible for the anger and frustration many of them feel. The Minister for Agriculture and Food fails to realise the difficulties that this continuous and persistent over-regulation puts in the way of farmers. The current proposals for prescription only animal remedies are among the most recent of many examples of bureaucratic burdens.

I cannot understand why the Minister continues with this proposal as it stands. It is ludicrous to allow these animal remedies to be available on prescription from vets alone. As Deputy Naughten rightly asked this evening before the Minister arrived, where does she suggest the vets are going to come from? The nature of veterinary practice in Ireland has changed considerably, with many being attracted into small animal practice. As a result a greater concentration of vets will be located in towns and larger urban areas for the future, leading to a shortage in many parts of rural Ireland. This will result not only in financial hardship for the farmer, but there is real danger that it will mean unnecessary suffering for animals as well. I cannot imagine a situation where these prescriptions for all veterinary medicines will be issued without a charge. This will be yet another financial burden on the farmer.

Under the proposed regulations, there is a significant onus on the vets to retain records of prescriptions for five years. This may well require more investment in data and storage technology, with further costs to be passed on.

The Minister for Agriculture and Food is not the only person with key questions to answer on this issue. The Progressive Democrats constantly claims to be a party that is pro-competition. However, its deafening silence on this issue appears to tell a different story. That party is allowing a situation to develop which is the direct opposite of competition and which will affect both price and availability, despite the clearly enunciated views of the Competition Authority on this issue. A direct consequence could be the development of a black market for animal medicines as the only affordable option for some. This is not something I condone, but the Minister must look at the realities of her decision. If farmers are unable, by reason of cost or accessibility, to get the medicines needed to treat their animals, it is the health and welfare of animals that will suffer in the long run.

The existing system, which is strict, has worked well. Under the cost compliance procedures for the single farm payment, farmers face extremely tough record keeping standards and their produce is subject to rigorous testing under strict food and feed controls. The Minister should accept that it is the imposition of strict financial sanctions for non-observance of a withdrawal period of a drug that will ensure the sanctity of the food chain and protect consumers, not the simple fact that it was prescribed. The Minister is effectively saying she no longer trusts Irish farmers. She does not see them as the professional keepers of animals and insists that the sole provider of information must now be the vet.

In the last three and half years, this Government has introduced an array of stealth taxes, which have allowed large rises in charges for essential services to the farming community, including VAT, ESB, rising motor costs and even VHI. The backdoor charges have had a major impact on farm families. Neither can one take these costs in isolation, they must be added to the additional costs coming down the tracks associated with the single farm payment, implementation of the nitrates and looming phosphates directives and prospective grain proposals. By taking the stealth charges, rising fuel, fertiliser and even water charges, one can see the massive rise in import costs. Compare this to the farmers' profits. These have fallen by a quarter during the lifetime of this Government.

I am sure that the Minister does not want to be remembered as introducing the additional costs that may well be the straw that breaks the camel's back. I hope she rethinks this issue and has something more positive to offer the House and Irish farmers this evening. Hoping for a derogation and acting on that basis is a dangerous gamble.

Pat Breen (Clare, Fine Gael)
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Like my colleagues, I am delighted for the opportunity to speak on this Private Members' motion. Many of my constituents are farmers who have very strong feelings on this issue. I commend my colleagues, Deputies Naughten and Crawford for tabling this motion in the House.

Under this new EU directive, all veterinary medicine will become prescription only. Imagine the chaos in the country if all human medicines that can be bought off the shelf in local foodmarkets, were to become prescription only. This is happening to animal medicines. This is only a directive, not a regulation. As Deputy Naughten said, Britain, Northern Ireland and other EU states are taking a more liberal approach in allowing suitably qualified persons to issue prescriptions, including licensed merchants and pharmacies. Ireland is fast becoming a country of regulation after regulation. The Government is driving this new regulation which will destroy the livelihoods of many farmers, young and old, and in turn drive many people off the land.

When I was growing up in County Clare every village had a butcher shop and small abattoirs supplied them with their produce. Meat was sourced locally and was almost all organic. These abattoirs and butchers gave local employment but, as a result of over-regulation, they were removed from the countryside, just like the corncrake. Now we do not know where the meat we eat is sourced. Brazilian and Argentinian beef is labelled as Irish, with little regulation or disease control. We all know about the foot and mouth epidemic that is currently affecting Brazil. The same may be said of poultry products imported from Thailand and other countries in the Far East. I hesitate to even mention the bird 'flu scare.

We have the best beef and lamb in Ireland. The regulations the Minister proposes will lead to an explosion in the costs of preventative medicine and a drop in the use of essential medicines. Irish beef is widely recognised as a high quality product. The use of antibiotics is strictly monitored. Farmers are committed to these high standards and the vast majority of them adhere to the withdrawal periods. If they do not they pay dearly, with heavy penalties. This regulation will not improve farm health. It will have a negative effect on Irish farming. The law is anti-farming and is a charter for the veterinary profession, giving it a monopoly over farm medicines.

We cannot blame the veterinary profession for creating this situation; it has lobbied as expected. However, the responsibility lies with the Minister and the Government for allowing this over-rigorous interpretation of a directive, which recognises in its wording the flexibility required for it to be adopted in different jurisdictions within the EU. The Minister for Social and Family Affairs, Deputy Brennan, has acknowledged that "Rip-off Ireland" exists. I do not know whether the Minister for Agriculture and Food acknowledges this. However, if her proposed regulations are implemented, they are a recipe for ripping off Irish farmers and I urge her to withdraw them. They are a licence for one sector to print money and will add to the competitive pressures on farmers, lower standards and encourage black market medicines. Vet only prescriptions are expensive and have rocketed in cost in recent times. The same will happen to routine medicines such as vaccines, worm and fluke control doses and mastitis control products. This could add up to €80 million to veterinary costs.

The Fine Gael Party understands how important agriculture is for the economy. This type of red tape is nonsense and an unnecessary and costly regulation in an industry that is constantly under pressure, with little profitable reward. Ask any farmer who bought cattle this springtime if he or she made a profit. The answer is "no". He or she will lose substantial money on such an investment. Live exports trade must be kept alive and factories must give farmers a fair price for their produce.

I ask the Minister to take on board the Fine Gael motion. She should listen to the lobby groups. If she does, she will have served her brief well. Otherwise, these regulations will add to the Government's considerable reputation in recent weeks for turning the screw on people struggling to get by, while millions are flittered away on consultancy fees and white elephant projects.

Mary Coughlan (Donegal South West, Fianna Fail)
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I move amendment No. 1:

To delete all words after "Dáil Éireann" and substitute the following:

"—notes that the draft regulations relating to veterinary medicines circulated by the Department of Agriculture and Food for consultation with the animal remedies consultative committee and stakeholders are designed both to implement changes arising from a review of existing national legislation and to transpose EU Directive 2004/28 into national law;

—agrees that the objective of the new regime should be to put in place a workable system for the distribution of medicines within the parameters of the EU directive while at the same time protecting public and animal health, minimising costs for producers and facilitating export trade;

—accepts that the existing national prescribing arrangements should remain in place pending the adoption at EU level of criteria for exemption of certain medicines from the requirement that all medicines for food producing animals become prescription only;

—notes the provisions to simplify procedures for writing prescriptions and provide for greater competition in the market for veterinary medicines;

—notes the undertakings by the Minister for Agriculture and Food to review the arrangements for prescribing veterinary medicines in the light of the outcome of the EU decision on the exemption criteria with a view to ensuring competition in the marketplace while also protecting public and animal health; and

—accordingly approves the overall approach being taken by the Minister for Agriculture and Food in relation to veterinary medicines."

The motion proposed for debate this evening demonstrates in a stark manner a serious misunderstanding on the part of its proposers of the draft regulations which my Department published and circulated for consultation on 10 August last. It also fails to take account of public statements which I have already made on the draft regulations and in reply to parliamentary questions in the House in which I clearly set out the scope of these regulations.

The position is that these regulations are primarily designed to transpose EU Directive 2004/28, which provides, inter alia, for all veterinary medicines for food producing animals to be made subject to prescriptions. However, the directive also includes a provision for exemption criteria to be adopted at EU level which 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 can remain in place.

I have made clear that I intend to avail of the exemption clause to the maximum extent possible and my Department has made a submission to the European Commission with a view to retaining off prescription in Ireland all products, other than intramammaries, containing antibiotics which currently enjoy this status. Under the draft regulations published by my Department, veterinary medicines such as wormers and certain vaccines would continue to be available off prescription for the time being and, in practice, apart from intramammaries, we would retain the essence of our existing national prescription and distribution regime. In light of this, it would be unwise at this stage to extend the range of persons who may be permitted to prescribe.

I have already stated publicly on numerous occasions that I will review the regulations, in particular the provisions relating to the categories of persons who would be permitted to prescribe veterinary medicines in light of the outcome of the exemption criteria, with a view to ensuring competition in the marketplace and avoiding the imposition of unnecessary costs on farmers.

Denis Naughten (Longford-Roscommon, Fine Gael)
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It is a pig in a poke.

Mary Coughlan (Donegal South West, Fianna Fail)
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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.

Denis Naughten (Longford-Roscommon, Fine Gael)
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The Minister is not making a strong case for the exemption.

Mary Coughlan (Donegal South West, Fianna Fail)
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The suggestion that the draft regulations will facilitate the creation of a monopoly in the sale of veterinary medicines is equally groundless. Intramammaries are the only current products which will become prescription medicines as a result of the draft regulations. I am also introducing other countervailing changes in the existing regulations to encourage a more transparent and competitive market in veterinary medicines.

There is nothing in the draft regulation which will hinder good farming practice or have a negative effect on animal welfare. Pending the adoption of the exemption criteria at EU level, farmers will continue to be able to access veterinary medicines, with the exception of intramammaries, on the same basis as at present.

On the availability of veterinary practitioners in certain parts of the country, veterinary practices are primarily commercial entities and their location is driven by commercial realities. In so far as Government involvement is concerned, I draw attention to measures in the new Veterinary Practice Act which should help to address any shortages in Irish trained veterinary practitioners. For the first time, the Veterinary Council is being enabled to recognise qualifications from applicants in third countries generally. This, taken with the recent enlargement of the EU, should make for the improved availability of practitioners from outside the State to meet any shortfalls in the supply side. In addition, Údarás na Gaeltachta is providing funding to subsidise veterinary practices in remote areas.

Much has been said about the impact of the draft regulations on the possible development of a cross-Border black market in veterinary medicines. It has been suggested, for that reason, that we should adopt the same approach as the United Kingdom to the implementation of the directive. I remind those who make this suggestion that in the United Kingdom prescriptions for intramammaries may be written only by veterinarians and may only be supplied by veterinarians and pharmacies. Is that the view being proposed? The system which I am proposing for intramammaries is more flexible, particularly in that licensed merchants will continue to be permitted to supply these medicines.

With regard to the suggestion that qualified professionals, other than veterinary practitioners, should be permitted to write prescriptions, I will consider that suggestion next year in light of the EU decision on the criteria for exempting certain products from the prescription requirement. The simple fact of the matter is that there is no need to take a decision to extend the range of prescribers until we know what additional medicines will become subject to prescriptions.

Denis Naughten (Longford-Roscommon, Fine Gael)
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Why is the Minister passing the regulation at the end of the month?

Mary Coughlan (Donegal South West, Fianna Fail)
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The Deputy does not like to hear the truth. At one extreme, if my Department is successful in securing criteria which permit us to retain most of the existing range of medicines off­prescription, it may not be necessary to extend the range of prescribers. On the other hand, if a substantial number of products which are currently off-prescription become prescription medicines, I will have to take that situation into consideration in my decision on the issue.

It would be extremely foolish to provide at this stage for prescriptions to be written by non-veterinary practitioners because to do so would necessarily also oblige me to designate as prescription only some of the medicines which are now off­prescription. It is simply not practical to provide for prescriptions for certain products to be written by non-veterinary practitioners without at the same time identifying those products which they would be permitted to prescribe. As I said earlier, my Department is seeking to secure exemption status for all existing off-prescription medicines, with the exception of intramammaries. It would undermine our negotiating position if I were to re-categorise unilaterally at this stage some off-prescription medicines as requiring prescriptions. My Department's approach of deferring a decision on whether it will be necessary to extend the range of prescribers until the exemption criteria issue is resolved is the best approach to take in these circumstances.

As far as the exemption criteria are concerned, the European Commission has indicated that it intends to submit its proposals to the standing veterinary committee early next year. We will press the Commission to honour this commitment because we recognise the need for an early resolution of this matter to enable us to take our decisions on the prescribing issue well in advance of 1 January 2007. My Department intends to engage actively with the various stakeholders prior to any decision being made.

With regard to compliance, Directive 2004/28 specifies the requirements with which farmers are required to comply in terms of record keeping. Specifically, records are required of purchases and use of medicines. The draft regulations simply give effect to these requirements. The new requirements on vets to issue written prescriptions in all cases will facilitate the farmer in keeping this record and the keeping of a computerised record, which is something that has been sought by farming organisations.

On the issue of advertising, the ban on advertising of prescription products to the public was inserted at the behest of the European Parliament. Therefore, let Deputies take their censorship and talk to the man who has just left the House. I share the views of the farming organisations and others that this is not a particularly sensible provision and that it is unwise to seek to reduce access by farmers to information on veterinary medicines, in particular new products. The Commission has already indicated in writing to my Department it considers that farmers fall within the term "general public".

Denis Naughten (Longford-Roscommon, Fine Gael)
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It must have written a different letter to the UK authorities.

Mary Coughlan (Donegal South West, Fianna Fail)
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However, we have gone back to the Commission pointing out the consequences which could flow from a ban. I have asked the Commissioner to consider a more flexible interpretation.

The House will be aware that my Department has sought and received written submissions from most of the main stakeholders. It also subsequently met many of them as part of the consultation process. In addition, as required by the legislation, the animal remedies consultative committee met yesterday to consider the draft regulations. Clearly, a number of issues have been raised with regard to the draft regulations. I will take final decisions on these issues in light of the recommendations of the consultative committee as well as other stakeholders.

I am aware of the views that have been expressed about the possible impact of the regulation on competition in the supply of veterinary medicines arising in particular from the requirement in the EU directive that all veterinary medicines for food producing animals must be subject to prescription. However, I have clarified first that in so far as the issue of prescribing veterinary medicines is concerned, the only change arising from the draft regulations is that intramammaries will be subject to prescription at this stage. I will review the draft regulations next year in light of the decision at EU level on the criteria for exempting veterinary medicines from the prescription requirement, specifically with a view to taking decisions on whether it will be necessary to extend the range of persons permitted to prescribe veterinary medicines. I commend the amended motion to the House.

Denis Naughten (Longford-Roscommon, Fine Gael)
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That is a great work of fiction.

Mary Coughlan (Donegal South West, Fianna Fail)
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The fiction is on the other side.

Ollie Wilkinson (Waterford, Fianna Fail)
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I am delighted to have the opportunity to speak on this amendment. Ireland has always been a country with a strong agricultural base and this remains the case with our 135,000 farm families. While many aspects of agriculture have changed and evolved, it is still an integral part of the dynamic economy. Agriculture and the agri-sector include every region of the country and are of major national, economic and social importance.

The Irish beef industry is worth €1.4 billion in foreign earnings to the economy annually. Ireland produced 560,000 tonnes of beef in 2004, exporting 495,000 tonnes and with a domestic consumption of 86,000 tonnes. With such an excess of production over consumption, Ireland is the number one exporter of beef into Europe. Irish companies are major suppliers throughout Europe and have gained a top class portfolio of retail accounts there. To put this in context, Ireland's agrifood sector accounted for 9% of gross domestic product in 2004. Jobs in the sector accounted for 9% of total employment. Exports of agrifood products accounted for 8.4% of total exports in 2004, with an estimated value of more than €7 billion.

In recent years, the focus of the Irish beef industry has been to broaden and expand its market reach at EU retail level, shifting its orientation away from international commodity markets into the higher priced internal EU marketplace. It is encouraging to note that our beef exports to the premium continental EU markets more than doubled in recent years from 72,000 tonnes in 2001 to 174,000 tonnes last year. In 2004, we exported 264,000 tonnes to the United Kingdom. This contrasts with the situation that prevailed during the 1990s when the industry exported 50% of its products to non-EU markets. It is important we protect this market.

The Irish beef industry must continue to build further sustainable market share in continental Europe. I would expect to see us expanding our reach to at least 230,000 tonnes within the next two years. This is a major marketing challenge, but it must be tackled to secure the future of the Irish beef industry. It is a task made all the more urgent by the inevitable increase in beef supply in Britain in the immediate aftermath of the cessation of the over 30 months scheme, scheduled for the end of this year, as Ireland is currently the dominant import supplier to the UK retail sector. For the future therefore, we must continue to enhance the position and image of Irish beef in the European marketplace.

In this connection, Bord Bia recently launched its Irish Beef in Europe autumn campaign. This pan-European campaign which runs from now until the end of November will see on-pack promotions in 8,000 stores across nine countries, stores frequented by some 40 million shoppers every week. The promotion has been tailored appropriately for maximum impact in each country. Bord Bia is investing €10 million over three years in its European retail marketing initiative aimed at building sales of Irish beef in European supermarkets and to establish the Irish brand firmly in the minds of consumers there.

Consumer requirements must be top of the agenda for the beef industry, as well as for the agrifood sector in general. Consumers are entitled to full assurance about the food they eat. They also want information on the origin of the meat they consume. In respect of beef, we already have in place a full identification, traceability and labelling system under comprehensive EU regulations. The labelling requirements under those regulations extend up to and including retail level and to the point of delivery into hotels, restaurants and catering establishments.

The Minister's priority in this area is to extend the existing beef labelling laws to require information on the country of origin of beef to be provided to all consumers in the restaurant and catering sectors. Specific proposals were put to Government at the end of June for a legislative framework to facilitate this by way of an amendment to the Health Act 1947. This will be introduced under the Irish Medicines Board (Miscellaneous Provisions) Bill 2005 which will come before the Oireachtas this session. The appropriate regulations are being worked on and it is intended to have these cleared at EU level as soon as possible. When the Act is amended and the regulations made, country of origin information will be available to consumers in respect of all beef served in restaurants, hotels and the catering sector in Ireland on a mandatory basis.

In the meantime, the various representative bodies in the sector, following discussions with the Department, have agreed in advance of the mandatory legal requirement to commend to their members the introduction on a voluntary basis of a mechanism for giving consumers on their premises information on the country of origin of beef. I support the Minister's endeavours in this regard. My comments indicate clearly the need to keep Ireland's exports clean and green, which is the industry's strongest selling point.

John Browne (Wexford, Fianna Fail)
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Hear, hear.

Mary Upton (Dublin South Central, Labour)
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Having listened to the Minister's robust defence of her position on this issue, I find it difficult to counter-attack on some of the issues.

Willie Penrose (Westmeath, Labour)
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I will do that.

Mary Upton (Dublin South Central, Labour)
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She will be pleased to hear that I will be seeking some clarity on certain matters. My colleague, Deputy Penrose, has assured me he will ask many questions.

Mary Coughlan (Donegal South West, Fianna Fail)
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He might put in the boot.

Seymour Crawford (Cavan-Monaghan, Fine Gael)
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He will be entitled to do so.

Mary Upton (Dublin South Central, Labour)
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The single most important aspect of the prescribing of animal remedies is the need to assure consumers that the food derived from animals which have received such remedies is safe and of good quality. Consumer confidence, which is a top priority, must not be compromised. It is equally important that the welfare requirements and health status of animals being treated must not be marginalised. As some of my colleagues have said, the consequences of a long delay in providing appropriate treatment for an animal need to be taken into consideration. Our export market must be protected.

The Minister referred to the problems encountered by Ireland when hormones and antibiotics were misused in days gone by. It is fair to say that hormones were never intended to be on prescription anyway. The question of their being prescribed or otherwise by certain people did not arise. It was cowboy territory and highly illegal. It was not a question of who had the right to say whether the hormones should have been prescribed. Many cases found their way into the courts. It was cowboy territory and did not have anything to do with prescriptions.

We need to balance the differing needs of the various stakeholders. Consumers, who are entitled to safe food, are the most significant stakeholders in the long run. The rights of the farming community, which can have great difficulty in accessing appropriate medicines for animals within a reasonable timeframe and at an acceptable cost, should not be compromised. Many of the Minister's remarks seem to be reassuring on the surface. I am sure we will pick some holes in her response later in the debate.

As I understand it, the most significant change proposed in the draft regulations is the requirement that all veterinary medicines, not just anti-inflammatory medicines and antibiotics, will be upgraded to prescription-only status. It is likely that vets will have a monopoly on prescriptions, so it seems probable that they will have a monopoly on the provision of veterinary products. I am glad that the Minister has raised her concerns with the Competition Authority. It seems that the information which was initially provided appears to suggest that the change was anti-competitive and that a monopoly situation was likely to evolve from it.

Questions have been asked about the possibility of other interests invading the market. The Minister spoke about the possible development of a black market, which is a likely outcome. It is a difficult aspect of the problem. A black market will develop, not for the first time or the last time, if proper means of enforcement are not put in place. Certain conditions must be put in place to ensure that no such scenario evolves.

It has been suggested that people other than vets be allowed to prescribe animal remedies. It could be argued that those who work closely with animals are in a position to determine the need for a particular animal remedy. Equally, it could be argued that the vet treating the animal under his or her care is the only person entitled to make a recommendation. I do not think that is necessarily the case, however. The concept of herd health is an important one. One of the flaws in these proposals is that vets will have the right to issue prescriptions on the basis of the examinations of herds which they will make once a year. Although many things can happen over 12 months, I understand that under the proposed regulation vets will not be required to examine herds more often than that. This aspect needs to be considered.

Some Deputies have raised serious concerns about the availability of vets. I agree that we need to consider the number of veterinary practitioners and surgeons available. Members who represent rural constituencies and places like my native territory of west Clare will be familiar with the difficulties encountered by people in such places when they try to access vets at certain times.

The Minister said that Údarás na Gaeltachta offers a subsidy — I heard an interesting spat about that precise matter on the radio last week — but she did not quite answer the question. Subsidies are being considered but they do not represent a solution. There are large gaps in the availability of veterinary services in some parts of the country. I understand that the dearth of vets may be caused by lifestyle considerations. It may be much more attractive for vets to get involved in small animal practice. As that attitude will not change, the matter will have to be addressed in an alternative manner.

I am not sure whether the Minister mentioned pharmacists who have a background that allows them to make judgments in many cases on the suitability of particular medicines. I hope we continue to allow them to make such judgments, particularly in consultation with farmers. We need to be given a definition of the phrase "suitably qualified persons". As a general principle, such persons should be allowed to write prescriptions, bearing human health and animal welfare considerations in mind. Farmers are entitled to a choice of supplier and to healthy competition in the marketplace, which is most important. The definition of "suitability qualified persons" is the key question in this context.

Changes have been made in the training of veterinary surgeons and other associated professions. Those who study agricultural science at UCD, for example, take courses which are also taught to those studying veterinary science. It should be possible to accommodate such changes and to ensure that courses appropriate to each category of student take account of the need for professional skills in dealing with animal health. The level of training offered to students should be designed to ensure that they are suitably qualified to advise on the need for a particular treatment. This proposal has been made by a number of interest groups which have addressed the Joint Committee on Agriculture and Food. Common courses are taught to students of animal science, food science and veterinary science. We should bear in mind that those who practice such professions share a common understanding of animal welfare needs, etc.

I understand that the proposed list system, to which the Minister referred, depends on total agreement at EU level. It is not a matter for just one EU member state. We need to address the real risk that the list which is currently accepted will become smaller and that a number of the animal remedies which are available without prescription will be removed from the list. There are good commercial reasons for ensuring that pharmacists can write prescriptions. I have mentioned the lack of veterinary expertise in some parts of the country. One is much less likely to encounter such a lack of expertise among pharmacists. There are good commercial reasons pharmacists can remain in practice when veterinary practitioners are unable to do so or might not want to remain in a particular part of the country where it can be difficult to deliver the practice.

Food safety, consumer protection, animal welfare and economic implications need to be borne in mind when decisions are being taken on the proposed regulations. As Deputy Naughten said, there is a chance that new drugs coming on the market will be excluded. It is important that we take action in that regard. This country stands firmly behind its clean and green image. None of us wants to do anything that compromises that image in any way. We need to ensure fair play for the farming community, veterinary practitioners and other qualified people without engaging in any form of compromise that would be detrimental to us.

I do not know whether the Minister, Deputy Coughlan, and the Minister of State, Deputy Browne, are fans of "The Simpsons". It is worth noting the course of action taken by Marge Simpson in the episode in which she discovered that the Simpsons' dog had fleas. Rather than putting a flea collar on the dog, Santa's Little Helper, she put it on her children. Although it was a novel way of dealing with an animal health problem, I would not endorse such a prescription from a veterinary point of view.

John Browne (Wexford, Fianna Fail)
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Deputy Penrose watches "The Simpsons".

Willie Penrose (Westmeath, Labour)
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The Minister, Deputy Coughlan, said this motion was fatuous and not required. Nevertheless, it was worthwhile to gain clarification from the Minister on a number of issues. I did so because I know the Department of Agriculture and Food officials. I dealt specifically with the Diseases of Animals Act 2001 and spent hours in the House on it. I was given commitments through the Minister by the officials that they would consolidate and codify the 1966 Act with the 2001 Act. That was almost five years ago but nothing has happened.

Mary Coughlan (Donegal South West, Fianna Fail)
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They are nearly finished.

Willie Penrose (Westmeath, Labour)
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It has taken five years. Are they that busy?

Mary Coughlan (Donegal South West, Fianna Fail)
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They are.

Willie Penrose (Westmeath, Labour)
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I am surprised to hear that because a lot of work has moved from that Department, given the new system of payments.

What worries me is that one often sees the stamp of bureaucrats in the implementation of regulations. It is important we, as politicians, ensure that what emerges is practical. It is fine to propose theories but some of the measures implemented in the 2001 Act should be scrapped because they have served their purpose and it is time to get rid of them. Otherwise, as with the emergency legislation of 1939, it will be reviewed on an ongoing basis and never come to an end. It is time we faced up to the reality that some of the measures in place are no longer required. There is no longer an emergency. I debated this legislation ad nauseam and put forward amendments to remove its most draconian aspects. It has achieved its objective and I would like to see areas of it revisited. Perhaps some will not like my saying this but I must do so on behalf of the people who elect me.

This matter was debated in 2002 during the period in office of the Minister's predecessor. I made the point that sometimes we are almost too good as Europeans. We rush to the headland to make sure we implement the exact wording of regulations and transpose them verbatim without taking cognisance of particular circumstances. We could learn from the French in this regard. They are good at making sure that all regulations and directives are amended to suit them.

Deputy Upton was the first to call for proper labelling of goods, including not only the country of origin but the place of origin, whether it be Wexford, Waterford or the townland of Kilmeaden. She wanted every ingredient to be on the label. I went to the Rungis market in Paris one morning at 4.30 a.m. I saw lamb and beef from the finest place in the country — Kilbeggan — where we know how to produce beef and lamb. The French had little blue and white flags on their meat so their consumers would know what lamb and beef was French. We are such good Europeans we are almost terrified of identifying exactly what is good in this country. We should brand our products to show off our good, green image.

The Minister referred to intramammaries. That was an aspect of the bad old days when we were qualifying in agriculture and when perhaps excess was used. However, there are now somatic cell counts and other processes in creameries and elsewhere throughout the country. If somebody slips up, he or she loses a whole container of milk, not just on one day but for the following two days also. One would want to be the greatest fool to let a 400 gallon tank of milk go down the drain three days in a row. Farmers are as good as guardians of their products as any qualified person — I speak as a qualified agriculturist. They are as good as anybody else. If they were not, they would be lost and their demise would be accelerated if they did not deal with this issue in a safe way.

The Minister reassured me with some of the points she made. In the early 1970s I qualified at UCD. Some of those I qualified with now practise medicine and dispensation. They have 30 years' experience and are as good as anyone else in this regard. They should be trusted. I know my local vet, who has enough to do.

It is time the points system for entry to veterinary studies was done away with. It is nonsense that one would need 600 points to become a vet. Some people in rural Ireland would make excellent vets and whether they get an A in honours mathematics has nothing to do with it. One would be better to have a good scientific background. It is time we examined the curriculum to ensure an adequate supply of vets throughout the country. The system for access to a veterinary degree is too restrictive and excludes those who have spent their lives on farms and know animals, which is what it is all about.

Farmers are the greatest custodians of our produce. They would be fools if they did anything to harm their own products or created a difficulty for the country. That risk is in the past. However, I am concerned that we might place farmers in an unworkable situation. I wrote to the Minister with examples of this. The situation was so tight I was afraid the Minister would return to the bad old days of an unregulated black market.

Mary Coughlan (Donegal South West, Fianna Fail)
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No.

Willie Penrose (Westmeath, Labour)
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That is always the danger. The Minister might say I am mad.

Mary Coughlan (Donegal South West, Fianna Fail)
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Coming from a Border area, I understand the problem.

Willie Penrose (Westmeath, Labour)
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The Minister should mind what a fool says. Fair access to animal remedies is important, as is the reduction of bureaucratic interference and financial burdens.

My brother raises suckler cows and no one takes greater care of animals. He is out until 1 a.m. and up at 6 a.m. One would not look after a family as well. Yet, the bureaucrats and technocrats in Europe think the like of him are not fit to look after animals. It is time to cry "stop".

Some might say I am eurosceptic — I am when I hear of some of the suggestions from the great brain boxes of Europe who try to put impediments in the way of growth. There is jealousy involved. We are a country rich in natural product — grass, animals and otherwise — and they want to put impediments in our way. If a prescription is issued for a specific branded product rather than an active ingredient, farmers might not have the opportunity to purchase from an outlet. They need to have outlets of their choice.

The Minister should not sign off on any regulations before coming back to fools like ourselves. We might know better than the technocrats. I have had enough of this racket. In 2001 I received an assurance in the House and when I receive such an assurance, I take it as the equivalent of an affidavit from the Minister. I am very annoyed. I told farmers the position as I understood it but the commitments were not lived up to. I might be fooled once but not twice.

What is the position if a vet is not available to issue a prescription for a medicine? I saw a report on television on the situation in Bangor Erris. What happens when a cow has mastitis, grass tetany or other diseases? Is the farmer supposed to wait until the cow puts her four legs up in the air? Let us get real. What is the advice on these diseases? These are practical issues. Some might think that, as a member of the Labour Party, I know nothing about farming; I know a lot more than many. That is why the people of Westmeath have faithfully returned me and will again.

Seymour Crawford (Cavan-Monaghan, Fine Gael)
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The Deputy should watch Senator O'Rourke.

Willie Penrose (Westmeath, Labour)
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Mary is a grand person.

I will speak up on behalf of those people. There will be many loopholes in these regulations. At the first opportunity, somebody will say this is the regulation, this is how it is implemented and to hell with all those excuses from the like of Penrose, who knows nothing about it. We know something about it. When this regulation is brought in — it is only a draft regulation at present — I will do what is necessary to ensure the interpretation given to it reflects the realities on the ground, not what somebody feels is right. There is too much paternalism in this country and in Europe. It is time to give farmers an opportunity. There is already this racket whereby people cannot produce free range eggs which are the finest eggs in the country. Will we say to farmers they cannot produce a drop of milk because they do not have a prescription for this particular intramammary? It is time we cried stop to the madness and bureaucracy coming from Europe.