JOINT COMMITTEE ON AGRICULTURE AND FOOD díospóireacht -
Wednesday, 27 Nov 2002

Vol. 1 No. 1

Animal Remedies Regulations: Presentations.

Chairman

I welcome to the meeting Mr. Declan O'Brien and Mr. Tom Reilly, director and vice-chairman, respectively, Animal and Plant Health Association; Mr. T. J. Flanagan, ICOS; Mr. Seán O'Leary and Mr. Declan O'Neill, IFA Animal Health Committee, together with the other representatives from the organisations concerned.

Before I ask Mr. O'Brien to make his presentation I wish to draw attention to the fact that while members of the joint committee enjoy absolute privilege, the same privilege does not extend to witnesses appearing before the committee. Members are also reminded of the long-standing parliamentary practice that they should not comment on, criticise or make charges against any person outside the House or any official by name or in such a way as to make him or her identifiable.

I now invite Mr. O'Brien to make his presentation which should not exceed ten minutes. I will call speakers in the order in which they made their representations to the committee.

Mr. Declan O’Brien

It is a pleasure to be here today.

The purpose of this meeting is to examine the distribution of veterinary medicines. In representing the manufacturers of these products we have a very deep interest in the process. In advance of placing our products on the market we must get a licence from the Irish Medicines Board. Typically, a company will spend ten years and perhaps €200 million developing a product before it is placed on the market. One of the most important elements we must prove is safety - for the farmer, animal, environment and the consumer. Having spent €200 million developing a product, members will appreciate that we have a deep interest in making sure our products are used correctly. We want them distributed through appropriate distribution routes.

In terms of various issues, we have concerns about what is happening. Before mentioning them we should examine the monitoring work carried out by the Department of Agriculture and Food. In 2001 it took appropriately 67,000 samples of animal based produce which it tested for residues of a wide range of medicines and other substances. The results were extremely good. Only 0.58% of samples contained any residues.

Specifically, I would like to talk about three issues, intramammaries vaccines and work at EU level. On intramammaries, the Minister for Agriculture and Food asked the Irish Medicines Board some time ago to review distribution routes. The board identified three issues: residues, resistance of bacteria in animals and the possibility of transfer of resistance to humans. As regards residues, the monitoring work carried out by the Department clearly shows that we do not have problems in relation to excessive residues of antibiotics in milk. The co-operatives which purchase milk have found similar results. There are practically no residues.

As regards the development of resistant bacteria in animals, the report from the Irish Medicines Board does not provide any information. It would have been useful if it had looked at resistance in this jurisdiction versus other similar countries where there are different distribution routes. However, it failed to do this. We know from our information that there are no differences. The distribution routes in this country for intramammaries work extremely well. We know this from comparing the situation with the United Kingdom where there is a prescription regime. The levels of resistance are low but similar in both countries.

As regards resistance transfer to humans, there is no information to suggest that there are any problems arising from the use of antibiotics to treat mastitis. We do not have bacteria from milk infecting the human population which is related to the use of antibiotics. We do not have resistance transferring to other bacteria related to the use of antibiotics for treating mastitis. Objectively, the system works well. An analysis of the Irish Medicines Board's report shows no justification for changing distribution routes. That is our strong message to the committee.

The other mantra we frequently hear is that all antibiotics should be available on prescription, a concept with which we strongly disagree. We have a system which demonstrates safety. One could argue that if we had a prescription regime, there might be an increase in the usage rates of intramammaries which the committee may be surprised to hear. If we look at other systems across the European Union, we know from our statistics that the usage rate of products in Ireland is about middle of the league. Our distribution routes are not causing excessive use. One could argue that if we followed the Scandinavian model referred to in the Irish Medicines Board's report, we would use a lot more antibiotics. That would be negative.

We believe the current distribution routes work. The usage data demonstrates this fact. However, we are open to improvements. We advocate that we should gather statistics at a per farm level, work out the average usage rate of products, identify the top 10% of users and attempt to provide on-farm information to reduce the rate of use. By doing that, we argue we would have a system of continuous improvement. We ask the committee to support our view that the distribution regime should not be changed.

As regards vaccines, these products have traditionally been on free sale. They are administered to animals to provide immunity against disease for the animal, the animal's offspring or both. Farmers are well aware of the utility of the products. We, as an industry, strongly advocate the use of vaccines. We prefer to treat animals to prevent disease rather than using medicines to treat sick animals. Using vaccines is the better option. Farmers are well aware of how to use vaccines. As regards monitoring results, we do not have residues because the products in question have a zero withdrawal period and are naturally occurring constituents in the body of the animal in many cases. We do not have problems with residues.

I come from a farming background. I grew up vaccinating sheep and other animals. I know how to use the products in question and that farmers are intelligent and literate beings, just like any other sector of the community. They are well able to read the instructions on use, just as people dwelling in the city are able to read instructions on the use of products to treat fleas or internal parasites in their cats and dogs. It is not difficult to do this.

We are concerned about the Irish Medicines Board's policy that all the products in question should be available only from the vet or the vet and the pharmacist. As many members represent rural constituencies, they are aware of the existence of licensed co-operatives and private merchants who traditionally distribute these products, of which perhaps they sell in excess of 60%. The Irish Medicines Board's policy will put them out of business. We do not see any reason to do this. This morning we had a meeting of our manufacturers at which I was appalled to learn that licences which were being issued for products which had always been supplied through the co-operatives and merchants were now being confined to vet and pharmacy use only. The Department has the final say on how these products are distributed. It stated at a previous committee meeting that it would take an independent view. However, from our knowledge of what is happening, it is taking a more conservative view than the policy advocated by the Irish Medicines Board. If that policy continues in the next couple of weeks, licensed merchants will be out of this business rapidly. There is no justification for such a scenario. I ask the committee for its support to send a strong message to the Department not to isolate and take the licensed merchant out of the market.

My final point relates to the EU review of legislation on the package of directives and other legal instruments dealing with veterinary medicines. As regards distribution, there is a proposal that all medicines destined for use in food producing animals, including the vaccines to which I referred, should only be available under a prescription regime. We, as an industry, are opposed to this concept. It is utterly illogical to require a farmer to obtain a prescription to use a vaccine in his or her sheep. I keep using that example because it is a good one. The concept becomes farcical if one considers the need to call out a veterinary surgeon to examine a new born animal in advance of putting iodine on the animal's navel. It beggars belief. While the latter concept is a caricature of what might happen, it illustrates the ridiculous nature of the concept. We were delighted when the European Parliament rejected the proposal in October. However, we face a big uphill battle in the Council.

Many member states have their products available only under prescription regimes. In many states only the veterinary surgeons supplied medicines, something I do not have a problem with. However, in other member states, such as our own, different routes of distribution have developed. We do not believe there is any logic, sense or reason to confine these products to prescription regimes. We ask for the committee's support to convey these views to the Minister and his staff. As they are involved in negotiating this issue on behalf of Ireland, they should send a strong message that we should retain the right to decide how medicines are distributed by each member state. Subsidiarity should prevail. We should decide how medicines are distributed in our market. If we decide on a licensed merchant system, so be it. If Germany wishes to have everything on a prescription regime, so be it. We should decide at national level.

I thank the committee for the opportunity to address it. I look forward to the presentations from the other parties present and our discussions afterwards.

Mr. T. J. Flanagan

I also have a document which I will circulate later. It is in two parts, the first of which outlines what I will say, while the second gives background information on the mastitis control programme we operate in the dairy co-operatives.

The distribution of antibiotic intramammary products is carried out by, among others, a network of licensed milk processing co-operatives which operate a mastitis control programme with their suppliers. ICOS, in representing the milk processors, is firmly of the view that suggested amendments to this system will not do anything to safeguard human health, but will at the same time result in significant increases in the cost of these medicines, with a detrimental effect on animal welfare.

The milk processors have the ultimate vested interest in ensuring that the food they provide is of the utmost quality and are convinced that the system currently in operation gives consumers a huge degree of protection from the antibiotic residue. Under regulation 25 of Statutory Instrument No. 507 of 1998, all milk processors must operate a system for the detection of substances, veterinary drugs and contaminants specified.

The current system involves the testing of every load of milk delivered to the co-operative, with samples retained from every farm on every collection day. Suppliers whose milk is found to contain antibiotics or other residues are subject to severe penalties and should a tanker be deemed not fit for processing due to the presence of such residues, the offending supplier will be levied with the cost of rejection and disposal of that tanker.

Under the Department's 2001 national residue monitoring plan, the results of which were published recently, from 1,027 samples of milk tested for illegal residues, no samples tested positive. This result is consistent with those obtained from the co-operatives' own testing regimes. The co-operative, as part of the mastitis control programme, the details of which are outlined in the accompanying document, constantly monitors the milk quality criteria of relevance to mammary health and communicates this information to milk suppliers through a comprehensive farm advisory network. It is appropriate that the body which maintains these records also distributes and records the sale of the therapeutic products for the treatment and control of both conditions.

Under a conventional prescription only medicine regime, prescriptions must be processed by a veterinary store or a pharmacy. I see two major weaknesses with this system. First, a regime where the vet prescribing the medicine also sells the product is inherently flawed as there is a commercial incentive to prescribe more of the therapy than is absolutely necessary. Second, the processing of prescriptions through pharmacies will add nothing to the protection of human health as a modern pharmacy has become an urban focused retail outlet, to a large extent focusing on the sale of cosmetics and giftware and which will have no connection to the herd in question or the milk it supplies. Furthermore, staff in pharmacies lack sufficient expertise or training in the administration or safe usage of these products.

Given that the Irish Medicines Board accepted that in practice it is not realistic to expect that a farmer can call a vet to each individual routine case of mastitis and that consideration should be given to whether a clinical examination would be necessary immediately before the vet prescribes intramammary bacterials, it is doubtful as to what benefit can be derived from operating a prescription only regime, where the main benefit of such a regime - namely, clinical examination - is not applied.

Co-operatives and food producers are sensitive to consumer concerns and are conscious that if a perception that human health is being compromised exists, it must be addressed. Given that co-operatives are confident that the system currently in operation goes farthest towards safeguarding human health, while ensuring that animal welfare is not compromised through excessive costs of medication, the solution must lie in a more successful communication of the merits of the system to those who seek to undermine it without sufficient evidence.

Chairman

Two representatives from the IFA animal health committee are present, Mr. Séan O'Leary and Mr. Declan O'Neill. I call Mr. O'Leary.

Mr. Séan O’Leary

I thank the Chairman and the committee for affording us the opportunity to present our case. It will be recalled that we visited the Oireachtas last year and lobbied many different parties on this issue. On that occasion we found almost 100% support for our position and we hope it continues to prevail at this level. Many of the points I intend to cover have already been addressed in the presentations by previous speakers, so I hope Members will bear with me.

The Department's proposal to further restrict the supply routes for veterinary medicines, animal vaccines and intramammary tubes by reclassifying them as prescription only medicines will do nothing to safeguard human health, but will add further layers of bureaucracy, eliminate competition, inflate on-farm veterinary costs significantly and have a negative impact on animal welfare.

The Irish Medicines Board recognised that using intramammary tubes is a practical means of treating mild infections of mastitis. Having reviewed the available data, or the lack of it in the case of the Irish situation, we find that there is no justification for making intramammary tubes prescription only medicine. To do so under the current prescription regime would be impractical and logistically unworkable.

Data pertaining to the Irish situation was not available but a review of medical research journals from around the world shows that only a portion of anti-microbial resistance in human pathogens can be blamed on the use of drugs in animals destined for the food chain. This resistance is caused mainly by the practice of using antibiotics in the water or feed as growth enhancers. This practice has been discontinued in the European Union. Research evidence shows that the widespread inappropriate use of anti-microbials for humans is responsible, in the main, for rising levels of resistance.

In a recent informal survey undertaken among private vets by members of the IFA's animal health committee, it was ascertained that their industry is facing a major infrastructure problem. Many vets involved in large practices are leaving general practice and are not being replaced, with the result that, in the short-term, many areas of the country will end up without an acceptable level of cover. The reclassification of intramammary tubes as POMs will further exacerbate this problem. Insisting that vets diagnose and administer the initial treatment will be unworkable as there are not sufficient numbers of vets practising in the country.

There will be animal welfare implications if the interval between detection and initiating treatment is unduly prolonged. If this situation becomes a reality, animal welfare will deteriorate, culling rates will rise and become excessive and dairying will become even more unprofitable. Under the proposed regime it may be impractical for many dairy farmers to remain in business.

The proposed reclassification of intramammary products as POMs will have serious cost implications for dairy and suckler farmers. If we look at the United Kingdom figures of 50 cases per 100 cows and assume a similar figure for this country - there is no data available at present for Ireland - the average veterinary bill for a 100 cow dairy herd would increase by €2,500 to €3,100 per annum. Initial results of a price survey for intramammary tubes carried out by the IFA shows price differences varying by 40% to 80%. Invariably, products sold through pharmacies and shops owned by vets charged higher prices. If the supply routes for intramammary products are further restricted and competition removed from the market place, farmers will be forced to pay substantially higher prices.

It is acknowledged that Ireland adheres to the strictest definition of prescription only medicine. A vet must examine animals and a clinical diagnosis must be made before any medicine may be prescribed. This is in sharp contrast to other European Union states where a more liberal approach is taken. The Department must insist that harmonisation of the definition of POM across the 15 member states takes place. If this is not done as a priority, serious trade distortion will occur and this will be to the detriment of the entire Irish dairy industry.

The Irish agri-industry operates to high standards, and if there are deficiencies in the control measures, these can be remedied. There are major financial disincentives in place to discourage farmers from supplying milk containing anti-biotic residues. Official results show that farmers observe the necessary withdrawal periods as contamination is an ever decreasing problem. Reclassifying intramammaries as POMs ignores the fact that dairymen are professionally qualified stockmen capable of making their own informed decisions. I will welcome the opportunity to answer questions later.

Mr. Declan O’Neill

As a farmer, my opposition to this proposal is based on practicality, the lack of competition and the inherent lack of respect for farmers and dairy farmers as professionals. A few years ago I recall making what I thought was an outrageous joke to the effect that soon a situation would arise where it would be necessary for farmers to have a vet in the milking parlour. As matters stand at present with regard to POMs, it is necessary for a vet to be present because mastitis must be treated immediately. The Department has hinted it may be prepared to consider other ways of defining a prescription, but we have not heard any practical suggestions.

The other area is competition, which is crucial. Until now, prescription only medicine has meant veterinary only to the farmer. This has happened slowly over the past ten to 12 years, almost annually, where a produce has come under POM. In effect, that means it becomes veterinary only. As Mr. Flanagan said earlier, one has a situation where a vet, to use an analogy with human medicine, is both doctor and chemist. Anyone in the profession will say vets' prescriptions are as rare as hens' teeth. Once in that position they have enormous control, where something is prescription only. We want to see controls - a controlled market where there is competition and vibrancy and where there are a number of suppliers who are responsible, trained people - the co-ops, the pharmacists and the vets. The vets are part of that.

Also, there must be respect for the farmer as a professional. The view is almost inherent in these proposals that if a vet puts a signature on something it automatically becomes safer. Most farmers are now trained professionals and, as has been said, antibiotics do not get into milk any more. Farmers are totally responsible about that. We know one does not give one tube of anything. One must complete the course, although I do not know the effects of having a vet's prescription for that. For example, I use a particular product which works but if there is a problem with that I go to my vet. If there is something new and different I go to my vet and talk about it; that is already happening. In practice this will close down the supply and increase costs. Members from rural communities will note that milk prices have gone down 10p this year and all animal product prices have fallen. We do not need unnecessary extra costs.

Deputy Timmins

I thank the speakers for attending. I do not know what stage the Veterinary Medicine Bill is at; it has not yet been published.

It is interesting to hear the different submissions from the animal health committee of the IFA and ICOS. A strong message seems to be coming across - the points made are that this measure will not assist farmers, it will impact on animal welfare, there will be increased input costs and there are practical ramifications for chemists. The animal health speakers pointed out that the pharmacy is not geared towards animal products. In many rural areas there are no pharmacies in any case so one may end up with a second veterinary pharmacy. We are only members of this committee for a few weeks but this is something we will examine.

At present, where does one get intramammary products? Does one get them from the local co-op or the vet and keep a supply oneself? For example, how often would someone with 50 cows use those? I want to get an idea of the additional cost before calling in a vet, as there is a shortage of vets in Ireland, particularly in rural areas where they are needed most.

Where is the motivation for this coming from? We are all trying to satisfy the consumer, and rightly so, but a balance has to be struck to prevent this going overboard. The more regulations we have, the more difficulties we seem to run into. Part of that is due to the concentration of economic power and bigger operations, but where is the motivation for this coming from? We will have to invite representatives of the Irish Medicines Board to come to the committee - it is a pity we did not have them here today, although it might have become too confrontational - and one feels the vets themselves are pushing for this. Where is the real motivation coming from?

Deputy Upton

I thank the delegations for their clear and comprehensive presentations. It has been a useful learning exercise for me and gives me a different perspective to hear these points of view.

Regarding the licensed suppliers, what training, if any, do they receive? Who delivers that training and is it validated? That may be a key to the qualifications of those people to deliver the product. I take some issue with the matter of resistance and the transfer of resistance but to be fair, a significant flaw in the document from the Irish Medicines Board is that it has not provided us with any information on that. I would have liked that to be dealt with in more detail but that is not the delegations' problem. It is something I would like to take up with the Irish Medicines Board but I would like that information to be provided.

Regarding harmonisation across the EU, can the delegations indicate what is happening in the UK and particularly the North? At some stage we will have an all-island animal health protocol and it is very important to sing from the same hymn sheet as the North.

Regarding harmonisation across Europe, Mr. O'Leary commented that we do not have that harmonisation and we should have some more clarity on that. We are all into European trade and we have to have consistent procedures across Europe.

What are the actual quantities of intramammary antibiotics regularly used either at single farm level or nationally? We should have some idea of the volume and how frequently they may be used in a given farm.

Deputy Ó Fearghaíl

I concur with the remarks of other Deputies and I thank the delegations for their comprehensive and clear presentations. I fully accept the cases they have made. Urgent attention is needed when a cow is observed in the early stages of mastitis and it would be unworkable to have to send for the vet, wait for him to come, hope he comes that day and then go forward. The proposal to go down the prescription only medicines route does not make sense for an operational, day to day basis.

Our primary consideration has to be public health. Mr. O'Brien put statistics before us in relation to the Department's own investigations and its 67,000 samples, stating that 0.58% of samples were found to contain residues. Can we have more information on that, as the level of residue in those cases would be very important? We accept the majority of farmers know how to use these medications and are doing so responsibly, but how does one deal with the isolated incidents in which proper usage is not occurring? I agree with Deputy Timmins that we should consider meeting the Irish Medicines Board but I accept the logic and common sense of the presentations that have been made.

Deputy Hayes

I also welcome the delegation. This is an important debate which will have many angles to it. One issue that has been ignored is the fact that we are dealing with a new generation of farmers. We are dealing with specialists and people who are highly educated in their field. I would go so far as to say that many farmers could give lessons to veterinary surgeons. These people do not abuse animals, but I accept that such abuse did occur in the past. We are now dealing with specialists, people who know the business. These individuals could not survive in today's climate but for the fact that they are specialists in their field. They are also experts at record-keeping, which is now an important part of their way of life.

The effect prescription only medicine will have on the farming community will be huge. I would like the representatives present to tell me what will be the costs of this to producers. We need this information because, if the figures got into the public arena they would be prohibitive to many people. I have no doubt there is a determination and strongly held views, not just in the Department but on the part of the Irish Medicines Board, that we must go down this road. We need to know what the costs involved will be because if one must have a veterinary surgeon in the milking parlour almost every day it will make farming almost impossible. The point must be made that we are dealing with specialists, people who know their business very well and, therefore, we should move carefully down the route suggested.

I am pleased that such a good debate will take place. Most Members who represent rural constituencies are aware that there is grave concern among farmers in this regard. I welcome the delegation and look forward to an interesting debate.

Deputy Ferris

I thank the delegation for their presentation and I support them. As someone who comes from a farming background, I am well acquainted with the policy of treating animals, etc. In regard to treating mild infection and mastitis, it now seems that initial light doses must be administered by veterinary surgeons and prescribed medicines must be given accordingly. I cannot understand this logic in regard to something that worked successfully and helped in a very active way to reduce the problem of mild infection and mastitis.

On harmonisation, I cannot understand why we are trying to push something on our community which is not reflected throughout Europe. Irish farmers are being penalised. I am concerned also about the argument being put forward in regard to the cost factor. The marginal level for viability will become increasingly smaller and will be an extra burden on the farming community. It will have the added effect of driving more people off the land. The imposition of a proposal such as this could result in forcing practices underground, which could lead to the operation of an illegal industry. This is something which needs to be factored into the argument. Imposing an additional financial burden on people will result in their waiting to see if an animal will weather the problem, which will inevitably result in animal losses. I would appreciate the delegation's views on the fact that a cowboy element could be introduced into the equation as well as the possibility of increased animal losses.

Deputy Wilkinson

I thank the delegation for the presentation, the logic of which is very evident. As someone who, in another walk of life, had to milk cows, I wonder what road we are going down. If this proposal is introduced, when a veterinary surgeon visits a farm, must he be present at every milking until the infection is cleared up? When it is cleared up, will he have to attend the following week and go through the same process? There seems to be very little logic in this proposal. While everyone accepts that the penalties introduced for unhygenic practices in milk production were needed, the proposal would represent bureaucracy gone mad. The cost factor would be simply enormous. I cannot see how the proposals can be enforced without great cost. The Department and all those concerned would want to look seriously at this measure before enforcing it.

Deputy Blaney

I agree with other speakers in relation to their presentations. The cost of tubes would be impossible to predict because the requirements would vary from year to year. I do not doubt that the cost to farmers would run into millions of euro. It is another nail in the coffin of smaller farmers throughout rural Ireland.

Veterinary surgeons are scarce enough in rural Ireland. Instead of questioning the role of farmers in treating animals, perhaps people might spend their time looking at some of the new veterinary surgeons coming out of college, particularly veterinary surgeons coming in to the country. These people come here for the first couple of years to practice. I think they just come here to learn from their mistakes and then go away. This causes far more damage than anything else.

As someone who comes from a farming background, I think these are terrible proposals.

Senator Callanan

Like other speakers I welcome the presentations made this afternoon by those people representing the various organisations. It is probably correct to say that food production must be of a high quality and standard. What people provide consumers with is of crucial importance to our markets and our ability to sell our produce. I am not aware of any evidence which suggests that the changes as outlined would lead to better practices. Perhaps there is information from discussions with the Department as to why it suggests these amendments. As outlined in the various presentations to the committee and from information available to us outside, there is no evidence that the use or misuse of drugs is affecting what is provided to the consumer. Producing food to the highest standard is what food production is about and it is being done.

I will ask a direct question of the representatives present. Is a pressure group operating somewhere to have POMs reclassified? If there is a clear answer to that, I would like to hear it. We may all have suspicions——

Deputy Hayes

The Senator has an inside track.

Senator Callanan

——but it is reasonable to ask that question because there is no evidence that changes are required or that POMs would improve the present structure or the distribution method. My questions are simple enough, although others may not think so, and I would like to hear answers.

Mr. O'Brien, in his presentation, stated that the Irish Medicines Board referred to the Scandinavian model for treating mastitis, that this model involves the use of intramammaries coupled with antibiotics which can be injected and that the ability of many of those antibiotics used in Scandinavia to cross into the mammary gland is extremely limited. He also said less than one part in 10,000 may cross into the other. That may suggest that this is happening here, if Ireland's situation is similar to the Scandinavian one. However, the Department has found no breakdown in its independent monitoring. It is also not found in the sampling of dairies around the country. I would like clarification on that although I do not want to labour the point. I support with conviction what has been said here.

Chairman

Will the Senator say that to the Minister?

Deputy Carty

I welcome those who made presentations and especially my neighbour, Mr. Tom Reilly. I support what has been said here today. It is important that we invite members of the Irish Medicines Board at some future date to have a presentation from it and define the angle from which it is coming. It is not practical to get a vet every time a cow gets sick or there is a mastitis outbreak. It is a dangerous road to go down. However, I support and welcome the delegation and support what other speakers have said.

Senator Coonan

I welcome the presentations. I am on a learning curve and I have listened with interest to what was said. The organisations present have nothing to worry about because all sides of the House believe this Bill is useless and will not get the support of Members. We may be wasting our time discussing it but it is important to note the points made today. This is of tremendous concern to the farming community which is already penalised, over-regulated and suffering from severe bureaucracy.

The penalties in place are enough to deter farmers; they will respond if they are losing money. As has been pointed out, farmers are now very professional, careful in their farming habits and particularly careful about their animals for which they have high regard. Farmers want to maximise production. I am glad that we have been made aware of the problems by the groups who made presentations. That will be taken on board.

Mr. O’Brien

I will deal with the issues relevant to me and other speakers will deal with issues on which they have specific information. On the juicy issue of the motivation behind this, the veterinary profession has published a position paper calling for a prescription regime for intramammaries. That is one pressure group clearly looking for this.

The Irish Medicines Board committee that drew up the report was very biased. The committee was made up mainly of members from one profession and very few from other professions. There were a great number of veterinary surgeons on it. As a scientist, if I was on that committee I would disassociate myself from the report because of its lack of information and facts, and its conclusions which were suppositions based on preconceived ideas rather than facts. There is a motivation for regulators to live in a zero risk world. They want to regulate things to the highest level and, if they have done that, they feel they cannot be criticised as they have taken the most conservative approach possible.

The training of licensed merchants is controlled by 1996 legislation issued by the then Department of Agriculture, Food and Rural Development. Licensed merchants must undergo a training programme which is approved by the Department. My association has an associate company which provides such training but there are probably three other companies providing training around the country. The Department set the validation standard and must approve training programmes before it will recognise the training. My association delivers training in conjunction with personnel from Teagasc.

On harmonisation, in the UK and Northern Ireland products are available on a prescription regime. This means the veterinary surgeon has a relationship with the farmer and is present on the farm at least twice per year. In reality, the farmer will obtain a quantity of intramammaries and use them as he or she deems fit. We are not in harmony with the UK and if we wish to have an all-Ireland policy, Northern Ireland should change the way it does things and adopt our way.

There is absolute disharmony with regard to the prescription concept across the EU. I totally agree with the very tough system we have. The veterinary surgeon must examine the animal and must have a knowledge of the farm and animals over time. There must be a relationship between farmer and vet. By contrast, in the Netherlands the vet is the only person who can supply and, therefore, does not need to know the farmer and may never see the animal. Between those extremes lie the various regimes across the EU. It is utter disharmony and I see it as a difficult system to harmonise.

On the figures for the volume of antibiotics in terms of the number of lactating intramammary tubes used per cow, my association carried out a survey across Europe via our trade association colleagues in different countries. The figure in Ireland is 1.6 tubes per cow per year while the figure in France is 2.5, and 1.4 in the Netherlands. Those figures multiplied by the number of cows will give the number of tubes. For dry cow intramammaries, my association is pleased that it is at the upper end of usage. Most people in the dairy industry advocate that every dairy cow should be treated with dry cow therapy. In that way, infection is killed during the dry cow period and the need to use products during the lactating period is minimised when there is most concern about residues. Approximately 75% of cows receive dry cow therapy, but it should be 100%. In other European countries it varies and I read figures of 67%, 69%, 71% and, in Germany, a very low 49%. The figure of 0.58% represents 388 violations out of 67,000 residues. Some 340 of those relate to antibiotics used in the pig industry and the committee should note with great interest that all of those products are prescription only medicines. As one of my colleagues said, the idea of putting something under prescription does not equate with safety. Those concepts are at best vaguely related. The issue of safety comes down to the farmer observing the withdrawal period, nothing more, nothing less. It is the farmer who must deliver safety.

The market is valued at €6 million and we estimate that products which go through the veterinary route sell at a differential of at least 30%, which is to add on €2 million straight away. However, if you take out the main competition factor between the veterinary surgeon and the co-ops, you eliminate one stream of competition completely. If we look at the UK, the products trade at a price approximately double that at which they trade here and we could be looking at an extra cost to dairy farmers of up to €6 million per annum. History tells us that if you introduce draconian measures to make something impossible to acquire, you stimulate an underground, illegal market. Nobody wishes to see that in this case and we should not risk the possibility unless there are compelling reasons. Animal losses are also an issue, but in the dairy context farmers will treat their animals because you cannot take a chance with mastitis which you must treat as rapidly as possible. Every dairy farmer is aware of that. The vet, who will happily do other things, does not have to attend until the infection is cleared up because if he or she did the cost of the regime would skyrocket to unbelievable levels.

The Scandinavian model in terms of residues was mentioned and the figure of 1 part in 10,000 was quoted as that which gets into the intramammary gland. This model was held up by the Irish Medicines Board as a very good one and it was used to justify the introduction of a prescription regime here. I am horrified by what happens in Scandinavia. Not alone does it deliver very little antibiotic to the intramammary gland via the injectible route, much worse, it delivers a full therapeutic dose to every bacteria in every other part of that animal. If one wanted to precipitate resistance problems, that is the way to do it. That is justification for saying that prescription regimes are not the gold standard in terms of how we should do business. There are other ways and the way we do it here is very good.

A couple of members of the committee mentioned the concept of a Bill. The problem is that there is no Bill, the policy was changed by the Department. There is a statutory instrument in place since 1996 and changes can be made through it. Can the committee prevent such an initiative? The vaccination process is happening as we speak and companies are receiving licences which take the licensed merchant out of the business. It is a policy shift on the part of the Department and I beg the committee to reverse it. We have pleaded with the Department and the Irish Medicines Board but they do not listen. They have not justified this in front of the previous Oireachtas committee with responsibility for this area. Colleagues asked them to identify the reasons for the change and no response was forthcoming which is why I reiterate my plea.

I will hand over to my colleagues to discuss some of the other points.

Senator Callanan

Before he finishes, may I ask Mr. O'Brien if the Veterinary Council has pronounced on this issue, or was it the veterinary association?

Mr. O’Brien

The Veterinary Council has not pronounced on it. Veterinary Ireland, the trade association representing veterinary surgeons, has.

Senator Callanan

The term "under one's care" is difficult to define and we are aware of practices from the past which may still continue whereby treatments are described over the phone.

Mr. O’Brien

In terms of the intensive industries of pig, poultry and fish, there is a legal requirement for the veterinary surgeon to visit farms once every 60 days. He or she can prescribe in between for materials. In terms of dairy and sheep farming, the concept of being "under care" is not clearly defined, but there are many different things the Department looks for. For example, the vet must carry out TB testing and where a trading relationship exists, it must be seen. There may be evidence of a relationship, but whether it exists all the time or not, I am not sure.

Mr. Flanagan

Mr. O'Brien has covered the vast bulk of the points. I wish to make points in relation to pressures and motivation, the origins of which are quite obvious to us. Two commercial groups stand to gain significantly if these changes are put in place and we feel that is very unfair. It will affect animal welfare and will add nothing to human health.

Mr. O'Brien alluded to the large number of tests that were made and I refer the committee to the Department's national residue monitoring plan. It found zero levels of residues in the 1,027 milk samples taken. This morning I spoke to our biggest co-op which has 6,000 suppliers and, in the last year, tested four positive samples. The milk from those samples entered pig slurry at the suppliers' expense. Regarding Senator Callanan's questions about the concept of animals being "under one's care", the Department accepts the need for a new definition of the term "prescription" given that the Irish Medicines Board accepts it is not practical to have a vet clinically examine every animal prior to prescription of an intramammary product. In the context of that, we need to examine where the value is added in going from prescription only, given that a vet will not even see the animal. They have to be describing a new type prescription because the current definition is no longer valid. What, then, is the point?

Mr. O’Leary

Many of the questions have been answered by Mr. O'Brien and Mr. Flanagan. I put forward a figure of 50 cases per 100 cows in the UK and I cannot argue with that as it is an accurate enough rate of occurrence. The extra cost of the product if it became prescription only has been covered by Mr. O'Brien. The average veterinary call-out fee is in or around €40, and if one multiplies that by the number of extra cases, that produces an additional cost. The motivation factor has been dealt with by the two previous speakers and I concur with what they have said. The Irish Medicines Board should be contacted again about this because, as a number of committee members have said, it has not come up with evidence and has put nothing on the table to justify the change to the system. Until it does so, I cannot see a need for change.

Other countries and occurrence numbers have been dealt with, as has training for suppliers. The residue figures have also been dealt with. We did not address the point of how every farmer keeps records. When the farmer identifies a case of clinical mastitis he milks out the cow and treats it with an antibiotic. He records the use of the antibiotic in the animal remedies register every farmer is legally obliged to have and fill out and he completes the course, generally, after three infusions and three milkings in a row. As Mr. O'Brien has said, if the problem persists, the farmer seeks advice from his veterinary surgeon who recommends a different antibiotic and the procedure recommences. That is how things operate with cases of clinical mastitis and, as Mr. O'Brien has said, in cases of dry cow treatment. Spring-calving herds are drying-off at this stage of the year and the procedure basically involves cleaning the teat ends and applying the dry cow treatment. The withdrawal period has to be acknowledged and, typically, this tends to be around 42 days for dry cow treatment.

With regard to Deputy Ferris's questions on the black market, I hope we will not return to the situation which obtained in the past with some of the products. It will not happen to the same extent because everything in regard to animal remedies has to be recorded. If a supplier fails a milk test, the Department can check back on the animal and if it is found that a product was used without being recorded and acknowledging the withdrawal period, then the penalty is very severe. Having said that, where there is money to be made there are always a few people that will take a chance.

At present, there are little or no animal losses resulting from cases of clinical mastitis. There may be some in the odd case of e.coli-type mastitis which occurs once or twice a year. As has been said, by and large, dairy farmers are professionals. Early intervention is vital in those cases, which emphasises the point that treatment needs to be available on site and available for use by farmers. It should not be necessary for every infusion to be supervised, but it must be in accordance with the law as it stands. With the assistance of the committee we hope to get around that one.

Mr. O’Neill

I said previously that practicality, competition and the professionalism of the farmer were the main points. I believed the Department would deal with the practicalities, to some extent, in bringing forward the proposals. I fear that it will look as if all the problems have been solved, if previous experience is anything to go by. Competition will not be dealt with because, in the past where prescription-only usage has come into force, it has meant that almost all of the business went to the vets. We want to see the business of the professionals in the intramammaries market continue; those within the co-ops and the pharmacies who have been trained and who the vets currently supply, as well as the vets.

The question of the motivation has been dealt with already. The committee members represent their constituents and most of them are also farmers. However, we are all food consumers and food safety impinges on us all. I seriously question the perception that because a vet puts his name to something, it is therefore much safer. I welcome the remarks of Deputy Hayes about how professional farmers are, in general. They are the custodians of the animals that become part of the food supply. It is their professionalism that is on the line. Their level of expertise should be recognised. They already identify illnesses in animals and even when a vet is called they administer the drugs. In one sense it does not matter if there is a prescription, as the guidelines in regard to the administration of the drugs have to be adhered to. Farmers are responsible for withholding the animal from the food chain until it is clear of an antibiotic. That is part of their professional routine.

Those who are concerned about the food safety implications should look and see whether this regulation will improve things or if it is merely a PR exercise to give a certain section more of the business at the expense of another. What benefit will accrue from this? No practical benefit will accrue. There may be something to be gained by those who believe a vet's signature will bring about a PR benefit. Somebody asked what the cost of this will be. It will result in the restriction of competition. There is an assumption that vets are in competition with one another, but they are not. Very often they operate in different districts anyway. We have seen an escalation in the price of anything that has come under the "prescription only" category. There should be an investigation into the mark-up on such drugs, as the cost to farmers is escalating to such an extent.

Mr. O'Leary referred to the area of animal welfare. In the organic industry it was found necessary to change the approach to antibiotics due to animal welfare concerns. If one is too restrictive in regard to antibiotics then animals die. They were culling too many and that was not right.

Mr. O’Leary

I wish to introduce the chairman of the IFA animal health committee, Mr. John Stack. He had to attend another meeting today and has just joined us now.

Chairman

He is more than welcome.

Deputy Timmins

I accept the point made about competition. When a vet is called out to treat an animal can he write a multiple prescription? There was a reference to a limit of 1.6 tubes but it has been said that it might take three or four to cure one animal. Hypothetically speaking, a farmer could be looking at about €2,000 per year in veterinary fees.

Has the committee met the Minister and, if so, what is his view in this regard? Mr. O'Leary stated that the previous committee supported their efforts. Was the signing of regulations in the past put off because of interventions made to the committee? I was not aware until now that it can be brought in by statutory instrument and the signing of regulations. Perhaps we could write to the Minister and ask him to postpone it until we hear the views of the medicines board and other bodies.

Deputy Upton

I reiterate the point made by Deputy Timmins in regard to the Irish Medicines Board. The point made by Mr. Flanagan was very important. My priority is consumer protection and human health. It makes no sense to me that, if we are to proceed in the way proposed, a veterinarian will simply sign a prescription. That will not change anything because he will not have seen the animal. I am not suggesting for a minute that he should see the animal every time because that is totally impractical. It will not be of any help to human health or to the food chain. That is why the Irish Medicines Board has to tell us what it is all about because it says that, in practice, it is not realistic for the farmer to call the veterinarian and that clinical examination should be considered before the veterinarian prescribes anything and that it is doubtful as to what benefit can be derived from operating a prescription only regime. I can only see people signing off on a piece of paper without any benefit in terms of animal or human health.

Deputy Blaney

Are the 1.6 tubes per cow for dairy cows only? What about other suckler cows?

Chairman

Is it agreed that we should bring in the Irish Medicines Board and the veterinary people as early as possible?

Senator Callanan

I think we should.

Chairman

We will have the Minister here in a couple of weeks and we can discuss it with him then and ask him to delay making an order until we meet the other people. Is that agreed?

Deputy Ferris

Regarding the supplier, a comment was made that the medical suppliers of the product would determine the price. Obviously, if veterinarians are working with certain suppliers, there will be no control over the market at all and the people who will ultimately lose out are the users.

Mr. O’Leary

Mr. O'Neill and I were discussing Deputy Ferris's last point before coming in. He outlined that there are probably 20 intramammary products for clinical mastitis. Of course relationships build up between veterinary practitioners and different suppliers. Each has one supplier that he uses by and large. Obviously, some products will come under pressure and the veterinarian will prescribe the product with which he has a certain affinity. It can lead to questions as to how those relationships build up.

The lobbying we did here last year involved the same debate. It has been running for the best part of 18 months. It is not a new debate but a reopened one. We have not met the Minister as a group. I met him last Saturday and he was pretty non-committal. He said he would have to act on the report of the Irish Medicines Board. I do not think he is entirely sure what he will do with it. He indicated that he was looking at something in relation to mastitis control programmes and the in-built relationship. That is as much as I could gather.

Mr. O’Brien

With regard to the 1.6 tubes per cow, if one takes it that there are 2.2 million dairy cows, that gives a figure on the total number of tubes. If one takes it that there is an average of three tubes used per case of mastitis, one ends up with a figure of 1.17 million occasions when a veterinary surgeon would have to examine an animal and provide treatment. The fee per call-out is €40, which amounts to a colossal €47 million. In reality, nobody expects that scenario to unfold, no matter what systems we adopt.

If we were to opt for some prescription regime, it is recognised that, to be practical, one cannot have the veterinarian examining each animal. We will end up in circumstances such as those in other counties where the veterinarian provides a quantity - a box or whatever - of these tubes to be used by the farmer over a period of time. The veterinarian will not actually be involved in supervising the use of those products. Once again, this highlights the facade of control that a prescription concept may suggest. It delivers very little real control.

We have not met the Minister but we have a path beaten to the door of his Department. We have discussed this issue on many occasions. We feel we cannot make any more progress with the officials in the Department because they say the Minister has decided to accept the concepts put forward by the IMB report. We argue it is a flawed report but they say it is no longer within their power to discuss it because the Minister wants to go a certain direction. That is why we are here and we want the committee's support to try to intervene.

The use of intramammaries in the suckler herd seems to be at a fairly low level, based on speaking with the company. We have worked our numbers where the vast majority of the product is used, namely on dairy cows rather than on suckler cows.

Mr. Flanagan

Following up on the point on contacts we have all had with the Minister and his officials, the Minister and his officials have reassured us that they do see the merit in maintaining the system that operates at the moment. However, they are afraid of their lives of the public perception of the Department ignoring the IMB report and of the bad guys in the industry riding roughshod over food safety and human health concerns once again. The greatest problem we have is one of perception and we need to educate ourselves and the public to some extent about the reality.

I am interested to hear the comments of Mr. O'Leary that the Minister thought a solution would need to be built upon the mastitis control programme. This programme is operated solely by the co-operatives, not by the veterinary practitioners or pharmacies. If the Minister sees that the solution lies there, there is no need to change anything because that programme exists as we speak.

Mr. Stack

I apologise for being late. I was at a meeting but I imagine my two colleagues performed very well in my absence. I met the committee members' predecessors 12 months ago regarding this ongoing issue. I attended two IMB meetings in the past couple of years. They did not enhance my knowledge because the reasons for going down this route were not put forward sufficiently clearly to those who attended. The board took it upon itself to go down a certain route and reiterated this 18 months later. I appreciate the committee's bringing the board in here.

One question that has to be asked clearly is, "What are the benefits to human health?" Deputy Upton has referred to this. There is no benefit whatsoever. Controls are in place and if a farmer makes an accidental mistake, as has been said already today, there are plenty of penalties in place. I am not telling the committee what to do but somebody has to take control of the issue. The Minister seems to be going along the line of what the IMB has said and I hope that this committee will put the hand-brake on him.

Chairman

I thank the three bodies for coming here today and making a very strong case to the committee. I compliment all the speakers. We will be meeting the Minister on this day in a fortnight and we will bring this issue to his attention forcefully and ask him to stand back until we meet the IMB and the veterinary people. As a former farmer, I understand the delegations' concerns. If one loses a tanker of milk or has an animal that must be disposed of, one will not do it a second time because it hurts the pocket. Farmers have been careful and responsible over the years. They are now very well educated in the intricacies of their work and must be complimented on the magnificent job they do. They have the full support of this committee.

The joint committee went into private session at 5.31 p.m. and adjourned at 5.35 p.m. until Wednesday, 11 December 2002.