JOINT COMMITTEE ON EUROPEAN AFFAIRS debate -
Wednesday, 1 Mar 2006

Veterinary Medicinal Products: Presentation.

Chairman

Apologies have been received from Ms Avril Doyle, MEP.

Item No. 1 on our agenda is a discussion with officials from the Department of Agriculture and Food on the draft Commission decision on animal medicines. We are joined by Mr. Richard Healy, Mr. Pat Brangan and Mr. Philip Kirwan from the Department of Agriculture and Food. We touched on certain issues in the past and agreed to follow up on what the Commission was proposing on animal medicines. This committee was concerned at the derogation sought by the Department of Agriculture and Food and it now seems this concern was justified.

Directive 2004/28/EC states that a veterinary prescription shall be required for dispensing to the public certain veterinary products. At the time the measure was adopted it was agreed the expert committee, following the presentation of a proposal by the Commission, would determine which products would be covered by this requirement. In October 2005 this committee considered the matter of veterinary medical products for food producing animals and wished the Department success despite concerns being raised at the approach adopted by the Department. It was suggested that, if a wide derogation was not granted by the expert committee, a failure to widen the range of qualified persons permitted to prescribe veterinary medicines, in a way similar to the approach adopted in Britain and Northern Ireland, would result in higher costs to the end user and perhaps result in the emergence of a cross-Border black market.

The Department had contended that changes to the national approach to prescriptions were not required until 1 January 2007 as Article 67 of the adopted measure provided for the Commission to advance a proposal through the expert committee to effectively provide a derogation. A derogation would arise from the Commission proposing, and the expert committee agreeing, to exclude a range of products from the requirements for a prescription. On 9 February the Commission circulated a draft of the derogation it was proposing on the matter. I thank the Department for forwarding its note on this matter. The Department indicates that the proposed criteria would place severe restrictions on the range of medicines which could remain off-prescription. I understand particular concerns relate to the suggestion that exempted products may contain only the active substances listed in Annex 2 of Council Regulation EEC 2377/90, which are substances that require a withdrawal period, and that medical products administered by injection would be excluded from the derogation.

The Commission has not formally presented a proposal to the expert committee on the derogation from requiring a veterinary prescription to dispense veterinary products to the public. Perhaps the most productive approach for our committee to pursue is to determine the possible implications of adopting the current consultation paper as the basis for a derogation for existing veterinary products. More importantly, we should explore what submission, if any, our committee might make to the commission to advance an alternative proposal. We have not done so previously.

Previously, we examined agriculture in a number of different general areas. In this matter, we are pursuing the implementation of a particular EU directive. Members will agree we had difficulties with the way in which the nitrates directive has been implemented, particularly regarding impact assessments. Last October, Department officials made it clear to us this was preferable as they did not believe following the British model was the optimum way to pursue it. Unfortunately, it seems as though the Commission is adopting a stricter approach than we were led to believe. The reason for today's hearing is to ask the Department of Agriculture and Food what is the situation and what can we expect from the consultation with the Commission.

The departmental officials will make a presentation, after which it will be opened up to members.

Mr. Richard Healy

I thank the Chairman. When we appeared before this committee last October we explained the background to the new legislation on veterinary medicines being prepared at that time, with a view to transposing EU Directive 2004/28 and to amend and update certain aspects of existing national legislation.

The Minister signed the new regulations into law on 17 November after a comprehensive consultation procedure with all stakeholders, including in particular, the statutory animal remedies consultative committee. The committee will recall that one of the new requirements of the EU directive is that veterinary medicines for food producing animals should be supplied only on the basis of a veterinary prescription, unless exempted from this requirement under criteria to be drawn up at EU level before 1 January 2007. Combined with this requirement was another provision which permitted member states to retain existing national prescription and distribution arrangements pending a decision at EU level on the exemption criteria.

As we informed the committee last October, the Department decided to avail of this provision which, in effect, means all existing off-prescription medicines will remain off-prescription until next January. In view of this, farmers are continuing to get such medicines as wormers and certain vaccines without prescription. We informed this committee last October that the Department does not agree with the requirement that all medicines for food producing animals should be available only on prescription. We also mentioned that, in our view, all existing off-prescription medicines, with the exception of antibiotic intramammaries, should remain off-prescription and we explained that we had made a submission to the European Commission setting out criteria which would achieve this objective.

As we notified to the committee last week, the European Commission began a public consultation phase on the exemption criteria on 9 February by publishing draft criteria on the website of DG Enterprise. The consultation period lasts until 17 March. I want to emphasise that these criteria are not yet formal Commission proposals. In effect, the Commission is inviting national authorities and other interested stakeholders in the industry, including farm organisations, to submit their views on the draft proposals. We are encouraging these stakeholders to engage with the Commission under the public consultation process.

Given that what is involved is a European Commission procedure, it is difficult to predict a precise timeframe for decisions on the criteria. However, there are a number of stages to be gone through following the end of the public consultation phase before the proposals are eventually adopted. Initial discussions with member states are scheduled for the end of March, after which the Commission will finalise a formal proposal. That will be followed by a discussion and a vote in the regulatory committee. Having regard to all of these stages, our best estimate is that it will be at least mid-year before the process is completed.

Our preliminary analysis of the draft criteria is that they would place severe restrictions on the range of medicines which could remain off-prescription. The consultation document does not provide for an explicit list of medicines to be exempted. Rather, it sets down a set of criteria which will be implemented by regulatory authorities in member states when deciding on the appropriate routes of supply for individual medicines and, in particular, whether medicines can be supplied only on the basis of a veterinary prescription.

The main principles underlying the criteria are that any medicine with a withdrawal period should be prescription only and that only those medicines which do not present a risk to human or animal health, even if administered without a veterinary prescription, can be supplied without a prescription. The document appears to consider only those medicines which are administered by the oral or topical route as meeting this requirement.

It seems the criteria would leave little room for manoeuvre for regulatory bodies to exempt individual veterinary medicinal products from the mandatory prescription requirement. In view of this, medicines such as wormers would, under the criteria, require a prescription. In addition, it is also envisaged under the draft criteria that all injectable products would be restricted to prescription only and this would include the majority of vaccines.

Our major difficulty with the Commission's approach is that it is too general and does not take proper account of a scientific risk to benefit balance of specific categories of individual veterinary medicinal products. We believe that, as was the case under the previous EU legislation, it should be left to the expert judgment of scientific bodies such as the Irish Medicines Board to determine on a scientific basis what restrictions should be placed on the availability of individual products. Our approach to the forthcoming negotiations at EU level on the draft criteria will, therefore, focus on trying to have them adapted to better reflect a science-based risk approach.

The exemption criteria are closely linked with the issue of what category of persons will be permitted to write prescriptions. As the committee will recall, the regulations which the Minister signed last October confined the writing of prescriptions to veterinary practitioners. However, the Minister made it clear that she would review this issue in light of the outcome of the exemption criteria. That remains the position.

If the exemption criteria are not substantially amended to meet our requirements, we will, in consultation with stakeholders, review the existing prescription arrangements with a view to considering whether persons other than vets should be permitted to prescribe certain of those medicines which would have to be recategorised as prescription only as a result of the adoption of the exemption criteria.

I mentioned that the Department had made a preliminary submission to the Commission on the issue of the exemption criteria last March. We will be making a further submission before the 17 March deadline with a view to having more flexible criteria introduced. We accept that this will be a difficult process but are committed to seeking an outcome which will retain the off-prescription status for most of the medicines which currently enjoy that status.

Chairman

The presentation states:

If the exemption criteria are not substantially amended to meet our requirements, we will, in consultation with stakeholders, review the existing prescription arrangements with a view to considering whether persons other than vets should be permitted to prescribe certain of those medicines which would have to be recategorised as prescription only as a result of the adoption of the exemption criteria.

If my memory serves me correctly, a number of members of this committee advocated that the Department do exactly that at the very beginning and that the British model was the one we should have pursued. We did not do that and now we find ourselves in the current situation. Can Mr. Healy address that?

Mr. Healy

Our view is quite simple. We were faced with two choices last October. We could have followed the British approach, which would have involved recategorising a range of off-prescription medicines as prescription only and then going on to permit what the British called "suitably qualified" persons to prescribe those products. The alternative was to do what we did, which was to await the outcome of the exemption criteria negotiations before we took a decision on the approach to adopt. We did not adopt the British approach because we felt that would undermine our negotiating position with the European Commission with regard to the exemption criteria. It would have effectively shown the Commission that we were not serious in pursuing our full demands on the criteria. One of the concerns we have is that the British have undermined our position by taking the approach they did last autumn. They have demonstrated to the Commission that they are not seriously pursuing the exemption criteria and that has made the task all the more difficult for us.

Chairman

If it is a question of the British changing their position, that does not seem likely.

Mr. Healy

No. The other reason we did not adopt that approach was that we would have had to recategorise certain medicines as prescription only. We did not see the logic of doing that, given that we did not think those medicines should be prescription only. By not adopting the British approach, we have delayed, by at least 14 months, the recategorisation of those medicines as prescription only. If we had followed the British approach, farmers would have had to get prescriptions for some products they are currently buying over the counter. Perhaps we will have to adopt a prescription approach from 1 January 2007 but at least we have delayed, by 14 months, the recategorisation of those medicines. That has saved the Department and farmers a lot of hassle.

Chairman

That is fair enough.

Senator Quinn

I thank Mr. Healy for his explanation because I am puzzled by this. When I was on the expert committee that eventually led to the establishment of Bord Bia, which was a very good committee that produced an excellent report, I was in the minority. I was the only one who did not believe that Bord Bia should report to the Department of Agriculture and Food. This was based on my belief that the Department is always overly influenced by the farmer lobby. The Department is, once again, proposing what suits farmers rather than what is best for all our citizens. In this case I think I am correct in saying that it is only Great Britain and Ireland that have not yet accepted this and are the only two member states who have found a way not to bring this directive into being.

I do not understand why the veterinary surgeons have not had a hearing. My bias is based on the fact that the Department of Agriculture and Food always bends over backwards to do whatever is in the farmers' interests, even if that is only in the short-term interests of agriculture rather than the long-term interests of the citizens as a whole. My concern is that this is happening once again. Am I going over the top in suggesting that the various veterinary associations are unhappy with what is happening here and do not appear to have been given a hearing?

Mr. Healy

The point raised by Senator Quinn clearly demonstrates the dilemma that faces a regulatory body such as the Department of Agriculture and Food. We must ensure that decisions we take adequately protect human and animal health, while not being overly burdensome on the farming community.

Veterinary medicines are not a homogenous group of substances. They range from very high-risk substances to those which scarcely deserve to be called medicines. What is at issue here is whether a prescription should be required for all veterinary medicines. As I understand it, we do not require a prescription for all human medicines.

The current position is that a significant number of veterinary medicines require a prescription, while a substantial number do not. The decision as to whether a medicine requires a prescription is based on analysis by the Irish Medicines Board, taking account of the nature of the medicine itself. The effect of the European Commission proposal would be to put all veterinary medicines into the prescription only category.

The Irish Medicines Board has an ongoing review system in place for veterinary medicines. It has decided that a large range of medicines should not be prescription only, based on its risk assessment. This is not based on the Department's risk-assessment but on that of the Irish Medicines Board. What we are being asked to do by the European Union is to recategorise 95% of those medicines as prescription only, when the expert veterinary medical opinion in the Irish Medicines Board is that there is no need to do that.

We are not kowtowing to any particular stakeholder. We have had consultations with the farming, pharmaceutical and veterinary organisations and will have to take a decision based primarily on the implications for animal and human health. Where there are no animal or human health risks, we will take a decision in favour of the farming lobby. Where there are serious animal or public health risks, we will take a decision in favour of the consumer.

Senator Quinn

Am I correct in saying that Britain and Ireland are the only two countries which went in that direction and that the others have accepted the proposal?

Mr. Healy

In the 2004 negotiations on the original directive, it was clear that except for Ireland, the UK, the Netherlands and Portugal, member states were happy to accept the Commission's proposal. I do not know the views of the new member states but suspect that given the background, quite a few will adopt the same position. I want to make it clear that our view is based on the risk assessment of individual products and our difficulty with the Commission proposal is that it represents a blanket approach which would automatically convert to prescription only the vast majority of veterinary medicines, even those which we do not believe present risks to human or animal health.

Chairman

Essentially, what Mr. Healy is saying is that regulatory bodies, whichever they may be, are not being given wiggle room with regard to the criteria.

Mr. Healy

Yes. We would prefer to retain the existing system, which effectively means that bodies with expertise, such as the IMB, can decide whether individual products should be prescription only. We do not want those bodies to be circumscribed in arriving at such decisions.

Deputy Harkin

I thank the Department officials for their explanation of the matter. On the question of whether the Department will always suit the farming lobby, Mr. Healy clearly stated that risk assessment was central to this matter. Senator Quinn will be aware that Irish farmers are already well regulated but have to compete with produce from countries outside the EU which do not have the same kind of regulatory regime.

It seems the Commission is seeking to ensure that all medicines become prescription only. That does not make sense, given that I could walk into a chemist shop on Grafton Street and, without a prescription, buy a range of medicines for myself or others. By taking this approach to veterinary medicines, the Commission is defying logic. We should instead consider the matter in terms of scientific knowledge and risk assessment.

Mr. Healy claimed that we previously had two choices, the British model or the suitably qualified adviser system. Do we still have those choices? He did not consider the British model as the optimum one because it would require certain veterinary products to be reclassified prescription only. However, we have moved on since then. When making its decisions, did it not occur to the Department that the Commission would be more, rather than less, restrictive and, in that context, the British model should have been given closer consideration?

Mr. Healy

The Commission's ultimate proposals were irrelevant to the decision we took last October. We chose to wait for the Commission to make its decision because the outcome of that would have effectively determined whether we needed to follow the British model, at least in part. If we had been completely successful in securing the type of criteria which would not re-categorise any existing off prescriptioin medicines, amendment to legislation would not have been required and the writing of prescriptions would continue to be restricted to veterinarians.

At this stage, it is almost certain that we will not achieve such an outcome and it is likely that a significant percentage of existing off-prescription medicines will have to become prescription only. We will then be faced with the question of whether to follow the British model by allowing non-veterinarians to prescribe. If the existing criteria are adopted, we will have no option but to permit non-veterinarians to prescribe some veterinary medicines based on the criteria and the qualifications we set down.

Senator Dardis

I thank Mr. Healy and his colleagues for returning here to speak on this matter. I am hesitant to enter this debate because, when I spoke on the nitrates debate, I was apparently categorised as anti-farmer.

Chairman

Everyone knows that.

Senator Dardis

It suggests that one should not ask searching questions here. I am anxious to learn how anybody who spent an entire working life in agriculture can be described as anti-farmer.

I do not agree with Senator Quinn's proposition that this directive is not in the long-term interest of citizens, although parts of it may not be. The provisions on antibiotics are the most important elements because problems did arise in terms of residue and overuse and, from a meat marketing point of view, it is important that controls are in put place. I agree with the proposals Mr. Healy made last October with regard to how we should proceed and I continue to believe that the Department has taken the correct approach.

It is fascinating that, as Deputy Harkin noted, a range of human medicines may be purchased over the counter in a chemist shop, yet the equivalent in buying animal remedies will not be permitted. It is a matter of how far down the chain one goes and it seems that the directive goes beyond what would be scientifically prudent.

Questions arise of relevance to this committee, one of which is whether we can express an opinion on subsidiarity in this instance. I am of the view that the committee should make a submission on the matter, although I realise we do not have a lot of time to do so. According to Mr. Healy, the draft criteria provide "that any medicine with a withdrawal period should be prescription only and that only those medicines which do not present a risk to human or animal health, even if administered without a veterinary prescription, can be supplied without a prescription". Who determines the risk to human or animal health? He noted the agencies here which are competent to do so, such as the Irish Medicines Board but, at the European level, who makes decisions on what is acceptable?

With regard to qualified persons, co-op staff build up a lot of experience by standing behind the counter for a very long time, even if they do not have formal qualifications. The advice they can offer their customers is as good as or, in some cases, better than that of veterinary practitioners. How can that type of activity be protected under the directive?

Have we reached the point where an amateur bee keeper in County Kerry will be told that a veterinary prescription will be needed before his or her product can be consumed or sold? In terms of the value of his activity this is a disproportionate imposition on him or her.

Mr. Healy

I thank the Senator. The authorities in the individual member states will interpret the criteria on a product by product basis. The difficulty is that at least two of them are specific and tie the hands of the regulatory authorities to an undesirable extent. The two criteria with which we have difficulty are 2(a) and 2(g), which give regulatory authorities little scope for interpretation. The other criteria listed are open to interpretation.

Senator Dardis

Could Mr. Healy explain what he means?

Mr. Healy

Under 2(a), the Commission proposes to restrict the exemption to products or formulations that require no particular knowledge or skill in using these products. It then states "this applies in particular to formulations administered by oral or topical route". The end of that sentence restricts that criterion to medicines administered orally or topically. No. 2(g) restricts exempted medicines to those which have no withdrawal period. Those two criteria eliminate a large number of medicines from the possible exemption list and severely limit the scope of regulatory bodies in interpreting the criteria.

There is a degree of subsidiarity in the definition of a prescriber. It is left to member states to decide who is allowed to prescribe and what qualifications are appropriate. We would examine the possibility of permitting qualified people employed by co-ops to prescribe certain products although we will not allow them to prescribe antibiotics. They are already selling these products and from selling to prescribing is a small step.

Chairman

This has been explained a couple of times. If these criteria are not dealt with or loosened will we extend the range of people allowed to sell these to include licensed merchants and pharmacists?

Mr. Healy

Although no firm decisions have been taken, it is likely that we are going in that direction.

Proinsias De Rossa, MEP

I will not risk being accused of being anti-farmer. I would like to be accused of being pro-public health. One must ask why bother with a European directive? There are numerous reasons, one of which is the need to ensure that when we export or import food we have confidence that we can eat it without risk to our health. To have that confidence in food which is transported across the EU requires Europe-wide criteria. Rather than apply detailed requirements to each member state, criteria are being developed which member states can interpret. The question is who interprets.

Chairman

The Department is saying our regulatory bodies will not have that latitude to determine the criteria.

Proinsias De Rossa, MEP

The Department's view, which Mr. Healy has stated two or three times, is that the criteria are too narrow and do not allow enough latitude for interpretation. This is the argument for maintaining the existing regime in spite of the European directive because we are happy with the current situation. Based on what is claimed to be science we have failed to implement the nitrates directive for 13 years. Unfortunately the "science" is dictated by interest groups. Objective science has been ditched in the implementation of the nitrates directive.

Chairman

This committee takes a different view.

Proinsias De Rossa, MEP

I am entitled to express my view. Will Teagasc have a role in deciding what medicines can be used in food-producing animals? If so, I will be uneasy. Who decides whether medicines administered to food-producing animals should be available over the counter or by prescription? Is it intended that the mechanism in place be changed? Mr. Healy mentioned that a vote will take place in the regulatory committee. How does that vote take place? Does it require a simple majority, unanimity or a qualified majority vote, QMV? Will that be the final decision? Who are the members of that committee? The point has been made that since humans can get certain medicines over the counter from a chemist, these regulations on food-producing animals are burdensome. We do not eat each other, but are expected to eat the animals into which these products are being pumped.

Chairman

I am not sure the Commission had that in mind.

Mr. Healy

I thank Mr. De Rossa. There is a difference of opinion among the member states, particularly between the continental states and Ireland and the UK. For historical reasons most veterinary medicines have been prescription-only on the continent. One could ask why. The opinion in Ireland and the UK is that there is no scientific reason for it. As Deputy Harkin explained, a range of human medicines can be bought over the counter, and there is no reason why all animal medicines should be prescription only.

Proinsias De Rossa, MEP

There are criteria for exemptions.

Mr. Healy

The concept of exemption criteria was introduced only after a difficult struggle on the part of a minority of member states, particularly Ireland and the United Kingdom. The majority did not wish to allow any exemptions, which defies logic, particularly when the situation pertaining to human medicine is taken into account.

Proinsias De Rossa, MEP

Mr. Healy is not comparing like with like. Human and animal medicines do not have the same function with regard to the end product.

Mr. Healy

They should both be based on scientific analysis. Both are risk-based.

Senator Dardis

Both face strict regulatory controls during their development. They do not come to market unless they are cleared by a regulatory body.

Proinsias De Rossa, MEP

We could have another debate on that. Why should we be expected to eat a product off the shelf of a supermarket into which medicines over which we have no control have been pumped ?

Chairman

The Department is saying Mr. De Rossa is creating a problem that may not exist. He is conjuring a danger which is not actual. The Department is saying that the regulatory bodies charged with this task should be allowed to carry it out. Our domestic regulators should be allowed to make their own analysis based on scientific evidence. It is a salient point which we can support.

Proinsias De Rossa, MEP

Many studies show that chicken, for example, is pumped full of unnecessary medicines to produce plump-looking cutlets on the supermarket shelf. They are also pumped full of non-medicinal additives such as water. Why can we not have controls so that we know precisely what we are eating?

Deputy Harkin

We do have controls.

Proinsias De Rossa, MEP

We do not. The Department's argument is that farmers should be able to buy these medicines over the counter and use them on animals willy nilly.

Deputy Harkin

It is not.

Chairman

That is not the basis of an argument for what Mr. De Rossa is proposing because it is a different matter.

Mr. Healy

Mr. De Rossa is labouring under the false assumption that just because a product is prescribed by a vet it is safer than another product. The vet has no control over the administration of the vast majority of veterinary medicines. The vet prescribes the product and the farmer administers it. It is the responsibility of the farmer to ensure that any withdrawal period is properly complied with. Writing a prescription provides no additional guarantee that a farmer will comply with the withdrawal period. That is why we do not regard it as necessary.

Proinsias De Rossa, MEP

Would it not restrict the availability of a particular medicine? I can buy 100 packets over the counter but with a prescription for a maximum of one per day over two weeks the application of the drug would be limited.

Mr. Healy

It affords some limitation and that is why certain products are controlled in that way. There is a range of products which we do not think requires such a level of control. A residue testing programme is in place on products before they are prepared for the consumer and in general our testing programme has revealed a high level of compliance by farmers with the withdrawal periods. There is no difficulty with residues of medicines in food that needs to be addressed in that way and the situation has, in fact, improved significantly over the years. We should leave such things to the experts such as the Irish Medicines Board in order that they can decide on the appropriate route of supply and whether a prescription is required for a product, based on its assessment of the characteristics and nature of that product.

Senator Dardis

We cannot test Mr. De Rossa's carcase for residues.

Proinsias De Rossa, MEP

Unless I was suspected of being on illegal substances.

Senator Dardis

Some legal substances leave residues.

Deputy Kirk

I welcome the officials from the Department of Agriculture and Food. I will start with Mr. Healy's last point. The Department envisages that a farmer in, for example, County Louth or County Waterford, who has a particular problem in his dairy herd, goes to his local vet in Dundalk or Dungarvan to collect a prescription and returns to administer it. If he does not administer the full prescription of antibiotics but keeps what is left in a safe shelf in his dairy and uses it to treat an animal with similar symptoms the following week it creates a problem for many parties, namely the veterinary surgeons who issue the prescriptions, the pharmacists and, in many cases, the veterinary surgeons who operate the farm supplies outlet and give the prescription to the farmer to use as he sees fit. The key factor is the sense of responsibility of the individual farmer.

I have witnessed dramatic changes in the past ten to 15 years. There is now in the industry a core of young, well-educated, well-informed and well-prepared people, which, given the economics of the industry, are necessary qualities for survival. The big problem is in the area of food imports. In a globalised market the degree of control exercised over imports does not match that over home produce.

Farmers constantly complain about the level of regulation. I do not necessarily agree with them because regulation is necessary and I am sure inspectors do not make non-routine visits to farmers without good reason. Some food products entering Ireland and elsewhere in the EU are from questionable places, which I will not mention for obvious reasons. Mr. De Rossa mentioned poultry products, about the integrity of which there have been certain allegations. Mr. De Rossa's point is quite valid. I ask Mr. De Rossa what is being done at community EU level to ensure sufficient control? What is being done to assure the consumer about the integrity of a product?

Let us say, for example, that Mr. de Rossa sets up a dairy farm in north County Dublin and supplies liquid milk to Glanbia, which is the principal local processor in Leinster. I assure him that if he indiscriminately used an intramammary antibiotic which got into the milk and was then transported to Drogheda or Athy, within a matter of hours officials from Glanbia would descend on his farm. They would do so to investigate why an antibiotic residue is in the milk coming from the farm. This is because the person collecting the milk will have taken a sample, which will have been sent to the laboratory at the collection point. It can then be processed to clearly identify the integrity of the collected product, or lack thereof. With regard to the integrity of food produce, that is the real safety net.

What is being discussed here today is relevant, in that it will give consumers a confidence in the integrity of the food products from Ireland. Ultimately, the real test will be if there is an antibiotic residue in the liquid milk collected on farms, or in animals taken to be slaughtered in the processing factory in Ballyjamesduff, or any other facility. That is the safeguard for the consumers. The big difficulty with this provision, although I accept it must be introduced on the basis that it reassures consumers about a product's integrity, is that more production costs are being piled on the individual farmer, even with the economics of farming as they are. The pebble is grinding on the individual farmer's heel in this way.

The economics of farming now, without the single farm payment, do not stack up. It may seem sensational to state this in this joint committee, but barring a dramatic change, there will be food shortages in Europe within five years if the current regime continues. It is not possible, given most of the current price levels which are available for individual products, to continue producing indefinitely. A staying power within the industry has been developed because these people have nowhere else to turn. Some young people are fascinated with farming and food production and are prepared to stay with it. There is an issue of a scaling up within the industry, which will I hope consolidate prospects for viability in the long term. That is the underlying issue we must regard in speaking about this matter. As these remarks are more general, I will ask specific questions.

Will the prescriptions envisaged be taken on a case by case basis, or will veterinary surgeons be able to speak to a farmer in Claremorris or Castlecomer about a range of veterinary products in anticipation of the calving season, for example? Will prescriptions be issued on that basis? If a farmer has a specific problem on his farm in the early morning and contacts the veterinary office, will a vet call out or write a prescription?

On the issue of suitably qualified people, if ten young farmers under 30 years of age are anxious to have total qualification in the running of their enterprise, will they be in a position to apply to the Department of Agriculture and Food, indicating that they require a course to allow them to become suitably qualified to deal with antibiotics, intramammaries or other veterinary products which they anticipate using?

Proinsias De Rossa, MEP

To remind Mr. Healy, I asked specific questions.

Mr. Healy

One of the questions asked was whether Teagasc will have any role in this area. It will not. Teagasc does not have expertise in this area, and the relevant body is the Irish Medicines Board. We are working closely with that body on this issue. With regard to the regulatory committee, the vote will be taken by a qualified majority. In the event that the Commission's proposal does not garner a qualified majority, it can go to the Council. If the Council fails to take a decision, the Commission can adopt the proposal, unless the Council rejects it by a qualified majority.

Proinsias De Rossa, MEP

Does it require unanimity to reject?

Mr. Healy

No, a qualified majority will suffice.

Proinsias De Rossa

I thought it needed a qualified majority to be accepted but unanimity to be rejected.

Mr. Healy

A qualified majority can reject it. The regulatory committee procedure is quite complicated. I doubt it will be necessary for the proposal to go to the Council. I suspect the Commission will do its sums and ensure the proposal it submits to the committee will secure the necessary qualified majority.

Proinsias De Rossa, MEP

Does the same weighting apply in the committee as in the Council?

Mr. Healy

Yes. With regard to Deputy Kirk's questions on whether there are too many controls or regulations, I should point out that farmers have benefited significantly from the introduction of regulations, particularly in the context of BSE. One of the major benefits of regulations is that they reassure consumers. Farmers have benefited enormously with regard to the beef issue, for example. The introduction of a range of controls in the 1990s and the early years of this decade has significantly reassured consumers about the quality and safety of beef. That has resulted in a significant increase in the consumption of beef. It has also succeeded in reopening third country markets that were previously closed.

Farmers have benefited in tandem with consumers from regulations, as prices are much higher than they were four or five years ago. Farmers are often the ultimate beneficiaries of regulatory controls. While the system is not perfect, imports from third countries are subject to controls and arrangements which are equivalent to those applied to European farmers. Farmers may be unwilling to accept this, but that is the position. The European Union Food and Veterinary Office regularly reviews the issue of these third countries, with a view to ensuring that the product supplied is in accordance with systems equivalent to those applying to European farmers.

With regard to whether prescriptions can be issued on a case by case basis, we have removed the requirement from previous regulations that a veterinarian must visit a farm and examine an animal clinically prior to writing a prescription. A veterinarian will now use his or her professional judgment to decide whether a farm visit is required to make a diagnosis and write a prescription. The vet will decide this on a case by case basis, taking into account knowledge of the farm, farmer and herd. The veterinarian must visit the farm at least once a year. It will be possible for a farmer to get a supply of intramammary medicine, for example, which would be sufficient for the season. He or she would not need to return to the vet every time a tube is needed. On the basis of the vet's knowledge of the farmer and the herd, it will be possible to prescribe an appropriate quantity of medicine for the farmer.

Deputy Kirk asked a question regarding suitably qualified persons and whether farmers would be permitted to qualify. At present there are qualified persons who can dispense and sell veterinary medicines in co-operatives and licensed merchants. The intention would be that it is those people who would be upskilled to a level which will qualify them to prescribe whatever medicines we decide need not be prescribed by a veterinarian. At this stage we do not envisage that farmers will be deemed suitably qualified persons.

Deputy Connolly

What is the wisdom of having a different system from the British system of administering medication? If cheaper medicine is available across the Border, there is a strong likelihood that it will make its way south of the Border. There is the tradition that if it is available that could happen.

Chairman

There are some precedents for that happening.

Deputy Connolly

There are full vans going down the road and empty vans returning and making it more cost effective on the unapproved routes. In regard to EU directives, we apply them more strictly than our European colleagues. Deputy Harkin has talked about walking into a chemist in Grafton Street. I have no doubt that if I walk into a chemist anywhere on the Continent I can get antibiotics for myself without any form of prescription. I get a sense that this may happen with this issue also. We can get all kinds of medication for humans on the Internet and people see it as a way of self-medicating. I imagine farmers will possibly continue to medicate cattle because they would have a good knowledge of what to do but there would be a tendency to start sourcing this on the Internet. We are aware of the type of medication that can be obtained through the Internet but when laboratory tests are carried out, it is not the type of medication it was supposed to be.

Mr. Healy

On the question of whether it is appropriate or sensible to have different arrangements in Ireland and the United Kingdom, the first point is that we try to have as many common policies as possible with Northern Ireland to ensure problems do not arise in cross-Border trade, but ultimately, we have to take decisions based on our own assessment of what is right for this country. In so far as possible we align our arrangements with Northern Ireland and then the United Kingdom.

As far as the United Kingdom is concerned, many people were arguing in the autumn that we should adopt the British system lock, stock and barrel but those who did so, perhaps did not look at the fine print. In many respects the British system is more restrictive than our system. For example, intramammaries have been available in the United Kingdom only on prescription and can only be purchased either from a vet or a pharmacist. In Ireland they are currently available from licensed merchants as well as pharmacists. When the regulations were amended last year, to take effect from 1 January 2007, we provided that intramammaries would be available only on veterinary prescription but we are still permitting that prescription to be dispensed by a pharmacist or a licensed merchant.

In many respects our system is more flexible than that in the United Kingdom or Northern Ireland. By and large, prices are lower in Ireland than in the United Kingdom which means that if there is any cross-Border trade it will be in the other direction, not in our direction, so we need not be overly concerned.

Internet sales are illegal. In regard to prescription only medicines, there is a legal requirement in our regulations that if one has a prescription only medicine in one's possession one must have a prescription to go with it. If one buys on the Internet one does not have a prescription to accompany that product and one is acting illegally.

Deputy Connolly

It is a new development and people are treating their own health by sourcing medication in that way. It is likely that if there is a saving to be made there it will be made.

Mr. Healy

We are conscious of that and it is an issue to which our special investigation unit is constantly alerted. We will keep it under careful watch.

Chairman

Are there any further questions?

Senator Dardis

I have no further questions. My questions were answered on the road.

Chairman

I thank the delegation for coming before the committee. The question for the committee — Senator Dardis probably repeated it — is whether we should make a submission as the Joint Committee on European Affairs. Our approach, having listened to the views of the Department, is that there is a concern with regard to the criteria being too narrow and in view of this I propose that be the basis of our submission. Whether there is some dissension I do not know. I suggest we prepare a paper and put it to members before the deadline and if members agree on it we can submit it. This would be done with the help of the delegation. If the delegation considers this would be helpful we will do it.

Mr. Healy

It cannot do any harm. We would welcome any support we can get. As I said, we are encouraging all stakeholders to make submissions to the Commission. We will assist the joint committee in preparing its submission.

Chairman

I thank the delegation for attending.

Proinsias De Rossa, MEP

I do not object to making a submission or arguing that the criteria are too narrow but I do not want them to be useless or irrelevant.

Chairman

As soon as a draft is prepared I will make it available to Mr. De Rossa and if he has a problem with it and wants to amend it he can register that problem.

Proinsias De Rossa, MEP

Thank you.

Deputy Harkin

If it really is consultation and if the outcome of the consultation helps to inform the opinion then it has to be worthwhile, otherwise it is a useless exercise and we are wasting our time when decisions have already been taken. We have to work on the basis that this is genuine consultation which will help to determine the outcome.

Senator Dardis

The only question at issue is what is agreed.

The joint committee went into private session at 3.20 p.m. and adjourned at 3.55 p.m. until 2 p.m. on Wednesday, 8 March 2006.