JOINT COMMITTEE ON AGRICULTURE AND FOOD debate -
Wednesday, 20 Jul 2005

EU Veterinary Directive: Presentations.

Chairman

We are joined by representatives of the Irish Pharmaceutical Union, the Animal Plant Health Association and the IFA to discuss implementation of a EU veterinary directive — 2004/28/EC. Is it agreed that each group will make a presentation which will be followed by a question and answer session? Agreed.

On behalf of the committee, I welcome Mr. Seamus Feely, secretary general of the IPU; Mr. Padraig Staunton, MPSI, vice-chairman of its veterinary pharmacy committee, and Mr. Rory Culliton, manager of that committee; Mr. Seamus Maguire, vice-chairman, and Mr. Brendan Barnes from the Animal Plant Health Association; and Mr. Michael Flynn, chairman of the animal health committee of the IFA, Mr. Seán O'Leary, from its management and national animal health committees, and Mr. Fintan Conway, the association's secretary.

I draw attention to the fact that while members of the committee have absolute privilege, this does not apply to witnesses appearing before the committee. Members are also reminded of long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the House or an official by name or in such a way as to make him or her identifiable.

Mr. Seamus Feely

I thank the Chairman. I propose to summarise the submission supplied to the committee.

The future success of agriculture depends on consumer confidence. An important element of that confidence is the knowledge that animal medicines are used in an ethical manner and not subject to misuse or abuse. On the other hand, we must ensure farmers have ready access to medicines if and when needed.

In terms of the impact of the implementation of the new directive, the union wishes to put five main points before the committee. Pharmacists play an important role in the safe distribution of animal health remedies. This role should be continued and there is considerable potential to develop that role further. Pharmacists have the knowledge and skills to provide advice, second only to that provided by veterinarians, to farmers. The prescription only medicine exempt, POME, category has worked well and retains many of the safeguards associated with the prescription only medicine, POM, category. It is also cost effective and convenient from the perspective of farmers.

In the implementation of the EU directive the union strongly advocates that pharmacists should be accorded prescribing rights for products currently covered under POME, plus a range of other products. The directive offers the potential to ensure a strong competitive supply chain. The Minister must address this issue in the regulations that she will introduce later this year rather than relying on the exemption provisions, which offer no solution. Failure to implement the directive in a manner that secures the continuance of the existing supply chain will undermine competition, increase costs on farmers and deprive them of a choice and access to frequently used veterinary medicines.

In paragraphs 2 and 3 of our submission, we state that pharmacists are available at 1,300 outlets, which remain open for long hours, throughout the country. While pharmacists command just 12% of the veterinary market, from farmers' and pharmacists' perspectives, continuing pharmacy involvement in this market is important.

As part of the 1996 regulations, instead of one pharmacy category of prescription only medicines, the Irish Medicines Board was given the authority to categorise products as veterinary surgeon only, VSO, POM, POME and pharmacy sale. This is now a well established practice and the Irish Medicines Board has invested considerable resources in its implementation. These categorisations have largely worked well and should be continued, albeit in a different manner, to ensure competition in this sector in the future.

As regards pharmacists prescribing, farmers, particularly those who are involved in dairy, sheep and pig farming and who have day to day experience of seeing common conditions, are well-trained at their business. In that context, POME is important because it keeps down costs and allows easy access and multiple channels of distribution.

The new directive must be given effect in national law from 31 October. Article 67 of the amended directive restricts the supply of veterinary medicinal products for use in food producing animals to veterinary prescription only. However, the definition of a veterinary prescription, namely, "any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law ", does not restrict the entitlement to issue veterinary prescriptions to registered veterinary practitioners but provides for veterinary prescriptions to be issued by a professional person qualified to do so in accordance with applicable national law.

Furthermore, paragraph 2 of the recital to Directive 2001/82/EC, as amended, states "the primary purpose of any rules for the production and distribution of veterinary medicinal products must be safeguarding of public health". Significantly, paragraph 3 of the recital qualifies this as follows: "However, this objective must be achieved by means which will not hinder the development of industry and trade in medicinal products within the Community". The Department must, therefore, ensure that in transposing the directive into Irish law it does not impact negatively on the veterinary medicines market. This view is shared by the Competition Authority. In this context, there is no reason pharmacists and other appropriately qualified persons should not be given prescribing rights in order that they can prescribe products covered as of now under the prescription only exempt category. These should be supplemented by a range of other products such as flea treatments for dogs, trace elements, calcium and magnesium and vaccines not yet categorised.

Prescribing by pharmacists and other appropriately qualified persons can be regulated in such a way that it does not undermine the overall responsibility of veterinarians for animal health and husbandry through the development of appropriate protocols. In chapter six we highlight the fact that if the Minister does not take a liberal approach in implementing this directive, it will undermine competition, increase costs, and reduce choice and access. It will also create a black market in medicines as the UK Government will introduce a more liberal regime.

More than 300 pharmacists in rural Ireland partly depend on the supply of these products to farmers for their living. That is an important factor in this context. We see two options for transposition of the directive. It can be adopted with regard to prescription only medicines and the Minister can avail of the exemptions under Article 67 of the directive. Alternatively the potential of the directive to maintain a viable market in Ireland can be utilised.

Given that the restriction on supply of veterinary medicinal products for food producing animals to veterinary prescription only is a general principle of the directive, while the issue of prescriptions is not restricted to veterinary practitioners, it is unlikely that anything other than a limited number of products will be approved for exemption from prescription control. Whereas products such as teat dips and emollient ointments might be exempted, it is highly unlikely that the broad range of veterinary medicinal products for use in food producing animals and which are not currently prescription only in Ireland, such as vaccines and anthelmintics, would be granted an exemption.

Rather than seeking to utilise the exemption provisions in the amending directive extensively, the Minister should enact regulations to implement the directive in full and provide for persons other than veterinary practitioners to issue veterinary prescriptions. With reference to existing controls, the Minister could enact a tiered prescription regulatory framework for veterinary medicinal products. These tiers would be products limited to prescription by veterinary practitioners for administration by veterinary practitioners or under their supervision, products limited to prescription by registered veterinary practitioners for supply by them or from a pharmacy on foot of a prescription issued by a veterinary practitioner, products limited to prescription and supply personally by veterinary practitioners and pharmacists, and products which can be prescribed by a veterinary practitioner, a pharmacist and other suitably qualified persons for supply by veterinary practitioners, pharmacies and other licensed outlets. If the Minister were to follow this model, Ireland may only need to apply for approval for a limited number of exemptions under Article 67 for products uncontrolled at present but which fall within the general definition of a veterinary medicinal product under the directives.

The clear benefit of combining a tiered prescription regime with applying for approval for exemption from prescription control for a limited number of products is that Ireland would use the provisions of the directives to their fullest and, in so far as is possible within the terms of the directives, maximise national input into determining how veterinary medicinal products for use in food producing animals are controlled in this country. With a tiered prescription model as previously outlined, varying controls for the supply of these products could be decided nationally with respect to welfare and market concerns.

The Minister must transpose the provisions of the directive by 30 October this year. The critical issue to be addressed in the transposing regulations will be the regulatory framework to give effect to the directive's general principle that veterinary medicinal products for use in food producing animals must be supplied on veterinary prescription only. Having regard to the existing regulations for the supply of such products and the overall intent of the directives not to place undue obstacles or restrictions on the supply of veterinary medicinal products, the Minister should give full effect to the directive's provisions by introducing a tiered system for the prescribing of veterinary medicinal products that gives prescribing rights to professional persons other than veterinary practitioners, who are qualified to do so, coupled with seeking exemptions from prescription control for a limited number of products under Article 67 of the directive. Pharmacists, with their professional standing, knowledge of veterinary medicinal products and experience in supplying and advising on the safe, effective and rational use of such products are appropriately entitled within the terms of the directive to be granted prescribing rights for a selected range of products in any transposing regulations introduced.

The approach the union has adopted is not contrary to the overall intent of the directive or the policy that the Department is endeavouring to implement. I appeal to the committee to support our view that the new regulations should allow suitably qualified persons to write prescriptions. That is the only way to ensure farmers continue to have a choice with regard to where and from whom they buy veterinary medicines. It is also the only way to prevent a monopoly supplier of veterinary medicines and a black market emerging, which is in no one's interests.

The IPU thanks the committee for this opportunity to put forward its views and would be happy to respond to any issues or questions that members may wish to raise.

Chairman

I thank Mr. Feely. The committee will suspend for two minutes while the next delegation prepares its presentation.

Sitting suspended at 3.16 p.m and resumed at 3.19 p.m.

Chairman

I welcome Mr. Seamus Maguire, vice chairman of the Animal Plant Health Association, who will make a presentation.

Mr. Seamus Maguire

I thank the Chairman for giving us this opportunity to make a presentation to the committee. Much of what I will say has been covered by the presentation by the Irish Pharmaceutical Union. I will emphasise a number of points.

This legislation must be in place by January 2007. It means an appropriately qualified person will be placed between the distributor and the farmer.

The definition of a veterinary prescription is any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national laws. This is important because it gives national governments freedom to decide who the qualified persons will be in this regard. It will be the responsibility of the governments to decide and there is no specific EU directive governing that decision.

The proposal of the Animal and Plant Health Association is that there would be three categories of product, namely, POM type A, B and C products. A POM A product would be a veterinary surgeon only product. It is a product that would be strictly controlled by the veterinary surgeon in that he or she would have to personally administer it to the animal. POM A products include a limited number of rare but dangerous items. POM B products include items such as injectable antibiotics that would be on sale in recognised outlets such as pharmacies or veterinary surgeries. The third group of products, POM C, is the most important as it accounts for approximately half of the market. They are currently known as licensed merchant, or LM, products. POM 3 products include routine items such as anthelmintics, vaccines and health management products which farmers have been using for many years, in some cases since the 1950s.

The Animal and Plant Health Association proposes that a number of people should be eligible to supply or prescribe the products to which I refer. Obviously, veterinary practitioners are included here, as well as, for example, life science graduates, pharmacists, agricultural science graduates and dairy science graduates, provided they have completed a course at University College Dublin. The agricultural faculty in UCD has already agreed to run this course and to provide the necessary training. Members may be aware that the faculties of agriculture and veterinary medicine at UCD will be combined shortly.

We make our proposals for a number of different reasons, one of which is the fact that there will be a common distribution system across the island of Ireland. The United Kingdom is introducing a classification system which is quite similar to the A, B, C system I have just outlined. However, the POM C products will be much more freely available in Britain than is the case here. In that context, where products are confined within the Irish marketplace, our association believes that cross-Border trade will take place, with restricted products entering the Republic from Northern Ireland. Effectively, a black market will develop.

Approximately half of the veterinary medicine products, accounting for approximately €40 million to €50 million of the market per annum, currently fall into the LM category. With the development of black market trade, VAT revenue will be lost on those products. Furthermore, many of the current distributors, particularly the co-operatives that operate on small margins, depend to a large degree on the distribution of animal health products. Our association is concerned about the potential for job losses in the co-operative sector if LM products are imported from Northern Ireland. We also do not want to see a monopoly being created, where veterinary surgeons will have total control of the animal health product business.

The system in place works extremely well and our association does not have any major issues with it. Of all of the LM products in the C category, in 2004 not one turned up in residue tests on food-producing animals. This proves that the system works well. An effective distribution network, involving co-operatives and pharmacies, is also in place. It is questionable whether veterinary surgeons, given the type of regime that could be proposed, would be capable of catering for the needs of farmers. There are simply not enough veterinary surgeons or outlets to meet the demand and animal welfare problems could potentially arise.

Under our proposals, we would have a system of full accountability and traceability to ensure that our food products, and particularly our exports, would be fully certifiable. On the other hand, if a black market is allowed to develop, we will not be able to certify our food products with any degree of confidence.

The Department of Agriculture and Food has proposed that a number of products be included on the exempted list but our association believes this list will not work. Ireland may propose an exempted list which will include products that will not come under the POM regime. However, all member states of the European Union must agree to the contents of the list and many states are of the opinion that only a small number of products will make it on to the final list. Our association agrees with this view, as does the European Agency for the Evaluation of Medicinal Products, EMEA, because there is a need for unanimous agreement among member states. Once a particular product has an MRL or maximum residue level, it will give rise to disagreements among the member states. For example, vaccine products do not have MRL issues but, in certain countries, some are on free sale while others are available only from veterinary surgeons or pharmacies. It will, therefore, be difficult to arrive at a cohesive list. Our association believes that it will not happen and if the Department of Agriculture and Food pursues this matter, the supply of certain medicines will become very restricted.

Chairman

I thank Mr. Maguire. I now invite Mr. Michael Flynn, chairman of the animal health committee of the Irish Farmers Association, to make his presentation.

Mr. Michael Flynn

I thank the Chairman for giving me the opportunity to address the committee. Irish farming and the food industry are facing substantial changes as a result of the recent decisions taken at EU level, by world leaders at the G8 summit and at the WTO talks. The abolition of export refunds has given increased market access to countries outside the European Union. This is leading to the globalisation of the food industry and it will have implications for all concerned. Ireland is a high-cost economy and increasing regulation is leading to a significant cost burden on farmers, who struggle to remain efficient and maintain competitiveness. To maintain competitiveness, farmers look to implement preventative health strategies, which can improve animal performance and productivity while ensuring the viability of the farm.

The EU directive requires that all veterinary medicines for food producing animals be issued on a prescription only basis. It is vital that when the Department introduces the regulations, a sensible regime that increases competitiveness and promotes the adoption of preventative health strategies should be put in place. Unfortunately, to date the Department has not proposed to do this. It has proposed to confine the writing of prescriptions to vets, an act which would seriously erode competitiveness. This will lead to a monopoly, which would not be in keeping with the spirit of the directive. The Commission refused to write regulations that would confine prescription writing to vets only, despite intense lobbying by the veterinary profession.

The relevant regulation concerning veterinary prescriptions states: "Any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law". This contrasts with what is occurring in the United Kingdom, where the Department for Environment, Food and Rural Affairs is proposing that suitably qualified persons such as pharmacists and licensed merchants, in addition to vets, be allowed to write prescriptions for husbandry management drugs.

The proposed regime applying to veterinary medicine is much more rigorous than that applying to human medicine. Furthermore, to suggest that pharmacists and other suitably qualified personnel are incapable of writing a prescription or even distributing veterinary medicines on foot of a prescription detailing the active ingredients of the products prescribed is nonsense. The proposed Irish legislation, stipulating that vets must write a script naming branded products to be used, particularly in the case of intramammaries, is blatantly anti-competitive. It will completely destroy any semblance of competition in the market and give dominance to a number of major brand names associated with particular companies. It will force the removal of generic products from the market and institutionalise malpractice. It will incentivise manufacturers with large budgets to target the promotion of products to the veterinary professional, which could potentially lead to inappropriate prescription of certain drugs.

The onset of generic drugs on the market is crucial in controlling price and creating real competition. The generic market, by its nature, relies on high volumes sold at lower profits, whereas branded products return higher margins. The restriction of supply routes or product availability access in any market allows for a distortion of trade, ultimately leading to higher prices being paid by the end user.

This draft legislation will greatly restrict outlets for veterinary medicine and have serious implications for the competitiveness of agriculture and animal production. A recent survey by the IFA demonstrated that over-regulation of the market and restricting supply routes has had a major impact on prices. In the United Kingdom, for example, prior to restrictions, antibiotics such as Pen-Strep sold through vets and pharmacies could be bought for €2.50 to €4 per 100ml bottle. The same medicine costs €12 to €14 today when bought through a vet, or €6 to €8 through a pharmacy. A starker contrast is evident in comparing prices between Ireland and the United States. A P13 IBR vaccine bought in Ireland costs €4.40 per animal, compared with 91 cent in the United States. This clearly shows that if restrictions are put in place, prices will escalate.

The approach the Department is taking on the regulation of veterinary medicines is in contradiction of best international practice. Many of our major competitors are promoting the adoption of preventative health strategies. The Irish Medicines Board recognises this and has indicated that the route of supply, particularly for the "kill vaccines" such as blackleg vaccines and other routine management drugs, should be maintained through the licensed merchant system. If the supply of "kill vaccines", anthelmintics or wormers, electrolytes and other routine management drugs are restricted by confining prescription writing to vets, consequences will become apparent. These include escalation in the cost of medicine and the assured emergence of a black market as Ireland has a border.

A black market has emerged in Denmark and a similar emergence could have major implications for the Irish food exporting business. One can only imagine the effect if the media picked up such a story. The increased use of antibiotics and frontline medicine will lead to an increase in resistance to antibiotics. MRSA is an example of this. Any resistance to antibiotics in food animals has implications for human health, but will also lead to a decline in animal welfare as people will try to use as little medicine as possible, perhaps only using medicine in an emergency.

Unless major changes are made to the proposed regulations, serious implications will become apparent for the future of the industry. There will also be negative repercussions for animal health. As part of the solution, the IFA proposes that suitably qualified people, such as pharmacists and appropriately trained life science graduates, in addition to vets, be allowed to write prescriptions for certain categories of veterinary medicine. The definition of what constitutes a veterinary medicine must be amended to reflect what is happening internationally.

I thank the committee for allowing me to make this presentation. If the members have any questions, I would be glad to answer them.

Chairman

I thank the IFA delegation. Questions may now be taken from members of the committee.

Deputy Naughten

I welcome the three delegations before the committee. As they respond, each organisation might comment on the fact that the proposals put forward by each of them are quite similar. Very little difference is apparent between them.

This is a major issue which has significant implications for the cost of medicines within the agricultural sector and for a potential black market for veterinary medicines. It is critically important that the issue be dealt with in a sensible and straightforward manner which achieves targets but ensures traditional supply routes will be maintained and developed. My colleague, Avril Doyle, MEP, had a very strong opinion on this issue when it came before the European Parliament before the directive was written into law at European level. We must be extremely careful in how these proposals are structured.

A number of questions arise on this issue. If the route suggested by the Department of Agriculture and Food is to be taken, what are the implications for the overall market price of veterinary medicines? The IFA gave two very specific examples of large mark-ups when supply routes have been restricted. Has any study been carried out of these implications? The Competition Authority has taken a keen interest in this as it believes this issue will have major implications for the cost of veterinary medicines.

All the members here dealt with the Veterinary Practice Bill 2004 a number of weeks ago, teasing out implications from it. Every presentation on it discussed the manner in which veterinary practice is changing, with the majority of vets going into the profession being women and going into small animal practice, which is lucrative. This means the majority of vets will be located in larger towns. In many rural parts of Ireland, including my constituency, it will be difficult in future to get a vet. If there is no local distribution network, many parts of the country will not be able to avail of veterinary medicines.

With regard to the directive, it is specifically stated that it cannot hinder the development of industry or the legitimate trade in medicinal products. This must be the basic kernel of any solution forthcoming on the issue. It was indicated that vets should be allowed to issue a prescription and that exemptions should then be allowed. It now appears that this would be wholly inappropriate and will not succeed in achieving goals as the 25 member states need to agree on it. This is a virtually worthless goal to pursue. Will the witnesses comment on this?

The Animal and Plant Health Association made the point on pharmacists. In the United Kingdom it is proposed to have a more liberal regime than is being proposed here. Perhaps the witnesses could elaborate on the UK proposals and why we should not take a similar route.

Perhaps the other groups could comment on my point about the IFA submission. If the proposals are put forward in such a manner that not only will vets write prescriptions but also the brand names of prescribed products, this is anti-competitive, and it is against this Government's ethos. For example, the Department of Health and Children is specifically trying to discourage GPs from naming branded products and is opting for generic brands because of the massive cost implications involved for the health service. It would be blatantly anti-competitive, have major implications as regards cost and cannot be tolerated under any circumstances.

Deputy Ó Fearghaíl

I thank the three groups for their submissions. It is very useful for the committee to meet them again and to be updated on their concerns about this directive. Deputy Naughten has made many of the relevant points and I do not want to rehash those. However, perhaps the Animal Plant Health Association will tell the committee more about the practical implications of the idea that scripts could be written by somebody with appropriate life science qualifications. Is it envisaged that somebody will be available to farmers in the local co-op shop on an ongoing basis to write scripts, or is that practicable, at all, on a day-to-day basis?

It is vital that the committee, having heard these submissions, interacts with the relevant officials in the Department of Agriculture and Food who are dealing with this directive. Allowing for holiday difficulties etc., we should meet the relevant officials in the Department again to discuss these issues to find out their thinking and decide on how a level of practicality may be brought to bear. We must have regard to animal health, the safety of the food chain and the whole issue of competitiveness and cost efficiency.

Deputy Hoctor

I, too, welcome each of the three groups and thank them for their submissions. They have been very clear and share a common denominator in terms of their concerns.

My first question is for the IPU. It appears the IPU did not succeed in gaining the support of its counterparts in Europe as regards the discussions and presentations prior to December 2003 as indicated by what it has put before the committee today, so what happened? I would like to hear its comments on that. Where do we stand as regards its counterparts in Europe?

My second question is addressed to the IPU, the IFA and the Animal Plant Health Association. Compilation of an inventory of exempted medicines was mentioned. Has this been started and would it not be wise to do this in conjunction with the partners who are before the committee today so that some common denominator may again be presented? No doubt the committee will urge the Minister to take her time in this matter and to give full consideration to the outcome and the impact for all the partners. I am particularly concerned for the farming community, which is ultimately the group that delivers in terms of the product for the consumer. Nonetheless, I am aware of the concerns of all the partners represented here. How far have we gone as regards compiling that inventory of exempted medicines that we believe will be acceptable to the partner groups here? This should be a clear list to be presented, as our case to the Department, which would revert to the committee for consideration as part of its scrutiny role of proposed European legislation.

Mr. Padraig Staunton

I hope I can remember all the questions. On the exemption list, we fear this will not work. The 25 countries must agree to each list and if a product is exempted in one country, then it is automatically exempted in every other. It will be impossible to obtain unanimity on such a list. By definition the list would be very short, not reflecting the needs of Irish farmers and Irish animal husbandry. Based on our communications with European colleagues we understand that no agreement will be reached. If it does not happen before the end of 2006, my understanding is that it will be impossible. National law will apply and no exemptions at all will be forthcoming. If by the end of 2006 we do not reach agreement on the exemption list, then it will just peter out. Does Mr. Culliton agree?

Mr. Rory Culliton

Yes, the criteria for the exemptions will not be established until September 2006. Then, as the decisions are made at European level, each of the products that fails to be exempted, automatically reverts to what in our case is prescription only medicine status. We will gradually find that products will slot back in as prescription only medicines until the relevant authorities decide to alter the regulations or revisit them, which is something that is being planned. Why not make the decision now, employ the resources being committed and decide what Ireland wants to have as a route of distribution rather than making a decision by default based on what the other 24 countries will decide for Ireland? The latter option would always be tempered by what they have decided. We saw how long it took this pharmacy regulation to reach final decision stage at European level. It means the entire processing procedure would have to be revisited.

On the subject of our European colleagues and the point Deputy Hoctor raised, we have been discussing it. We have surveyed our colleagues through the European pharmaceutical group. In most countries where pharmacists have been involved, practice has been undermined by national regulation, which has increasingly worked towards veterinary monopolies. In spite of regulations, in most countries where vets were invited to write prescriptions, none was received in pharmacies. That has been a problem they are trying to address at European level.

To come back to an earlier question by Deputy Naughten, as regards the impact it might have on price, the first question to be answered is: where will the farmers get them? There are no vets available in west Mayo, in regions of the Ring of Kerry or in west Donegal. Will vets take up practices on foot of a promise? In areas where there are single veterinary practices, are they to have days off? Pharmacists may give them cover for days off under the emergency prescription regulation in order that the vet can have a half-day on a Saturday. Pharmacies are open on Saturday and there is always a pharmacist present. Any members of the committee who are rural Deputies or Senators will be aware that the pharmacies tend to open for an hour or two on Sunday. That is a phenomenal service because pharmacists are scarce. While people may have a certain feeling about income levels, the reality is that it is a service provision on a Sunday because they cannot get locums and we frequently find that we cannot get pharmacists to meetings because, being unable to get locums, they cannot get a day off no matter how important a meeting is. Locums are a difficulty, yet those pharmacists will work on Sundays as a service to their customers. Access is there. Vets are out doing testing and factory licensing. Vets are not available even where veterinary services are provided, although if a pharmacy is open, a pharmacist will be there. That will be a major element in terms of cost. If there is no vet, what will happen?

Mr. Staunton

The IPU and pharmacists in general are on record as saying that open generic prescription for humans and animals is the most desirable way to go and that pharmacists or the payment authority might decide which product is to be supplied. I will defer to Mr. Feely on the life science graduate question.

Deputy Hoctor asked how far we have gone in preparing a list. We have done no work on that because we feel it is a dead end.

Mr. Feely

To answer a point raised by Deputy Naughten, we understand that in the United Kingdom there is a plan to introduce four categories in terms of supply. One category would be prescribed by a vet, following a diagnosis, with the products to be dispensed by a vet or a pharmacist. Another category can be prescribed by an exceptionally qualified professional and can be dispensed by a vet, pharmacist or a suitably qualified person. There will also be a category which does not require a prescription but may only be supplied by a vet, a pharmacist or a suitably qualified person, which clearly would include people who work in licensed merchant stores. Finally, there will be an authorised veterinary category, essentially a general sales list of medicines.

In the draft proposals, anyone who can write prescriptions will be called a "registered qualified person". One of the interesting features of the current proposal is that as we understand it, a written prescription will not be required except where the person writing the prescription is not supplying the product. We would always perceive a prescription to be something written in manuscript form, but under the UK proposals, as they stand, it will be more a concept than a written document and the prescription will be written only in instances where people come to a pharmacist or a vet who does not have the product. In such cases the pharmacist or vet will write a prescription for the person to take to someone else for supply. This is the broad picture of where the United Kingdom is proposing to go.

Mr. Flynn

The directive is very clear in that a prescription can be written by a professional person qualified to do so. The spirit of the directive in that regard is to avoid creating a monopoly, as would happen in this country if we go down the road being proposed. If we do that, we will have a huge black market, as I mentioned, because of the Border. Farmers are now being asked to be competitive and to be as efficient as possible. How can they be if they are facing a monopoly? That will arise if the proposed legislation goes through.

In every other sector of industry and society, monopolies which have been in place for 100 years are being torn down and pulled apart. We have seen that when they are pulled apart, the cost of the service to the consumer reduces. We must be very aware of costs in farming today because we are being asked to produce beef, milk and other products at world prices as agreed at the WTO conference. We must therefore be competitive and have low costs such as those of all our competitors, like South America, where costs are very low.

I gave an example of the cost of a P13 vaccine in the United States. In this country it costs about 20 times as much. Allowing other people to write prescriptions along with the vets will keep the market open and competitive and give us the reduced costs we need.

The issue of residues was not raised. All the testing carried out by the Department of Agriculture and Food in recent years has shown practically nil residues because the cost of veterinary medicine is currently high and people will not use it unless they must. All farmers using any product on a food-producing animal are very aware of the withdrawal periods and the human health concerns involved. The results of the residue testing over the past few years show how well farmers have lived up to their responsibilities in that regard. That is how we want to continue in the future.

Mr. Maguire

Deputy Naughten asked why we are going for a regime slightly different from that in the UK in terms of people who may prescribe. It was the opinion of all stakeholders that we perhaps needed to have a higher standard than our UK counterparts. The reason is simple. Nine out of ten animals are exported from this country and therefore need certification. By allowing people such as vets and others who are closely involved with the industry, such as life science graduates who have taken this module in UCD, we would set that standard for ourselves in Ireland. It would give us reasonably broad distribution. It would not create a monopoly but would keep the standard high enough in order that at the end of the day we could certify the nine out of ten cattle being exported. That is why we have taken a step further than we needed and further than our UK colleagues.

The question was asked where these graduates will come from. Many of them already work for the co-op movements. As far as I know, all the Teagasc advisers who advise farmers are life science graduates. They would be able to prescribe products for routine use.

Deputy Naughten

That would be great if we could keep the Teagasc offices open.

Mr. Maguire

That is another issue.

Mr. Seán O’Leary

I am in broad agreement with many of the statements made by Deputy Naughten. The cost implications were covered by Mr. Flynn, but there is a dichotomy in terms of what the world incorporated wants from farmers, so to speak. It wants cheap food and the removal of all import and export tariffs and of any form of protectionism. It wants food at the lowest price and the highest standards. One cannot have everything. That sort of contradiction must be addressed. Farmers cannot be everything.

We have had one of the most regulated systems within the European Union. Farmers have bought into quality product. As Mr. Flynn said, in terms of residues and detection, the penalties are highly restrictive and farmers no longer fall into that trap. The results bear this out. On the other hand, farmers are expected to accept lower prices for their products. If one considers the examples noted, the proposals as put forward by the Department will lead to an increase in costs. That has been borne out by all speakers here today.

As a dairy farmer, I would like to see the existing lines of supply kept open. Even the licensed merchants and the co-ops which are not represented here today are trained in the handling of products and keep detailed stock control of products coming in and out which can be checked. One must ask if the person who supplies the product increases or decreases the risk of residues to humans. The risk surely lies in the use of the product and in its handling by farmers.

Common or garden type products such as intramammaries and vaccines are normal day-to-day products used by dairy farmers. It is important, therefore, that their cost is kept down. A tightening of the regulation would not be in farmers' interests or serve the consumer any better than the current arrangement. If a prescription is to be written only by a vet, a farmer will be faced with getting the product as supplied by the vet at whatever price he or she deems necessary. As we know, one pays a little more than if buying it from a co-operative or pharmacist. One can argue that a farmer should simply take the prescription and go elsewhere for the product. However, I doubt whether a vet will write a prescription for nothing. As has been demonstrated in other European states, the vet will become a one-stop shop. We are told every day that we live in a market economy and that it is the golden cow. There will be one supply line only, the vet. We will pay dearly for this.

Mr. Brendan Barnes

As a result of the mid-term review, there is a growing number of part-time farmers with off-farm incomes in the agriculture sector. It must be remembered that times of availability will restrict the number of outlets such farmers can approach in the evenings or at weekends. This will have serious consequences.

In UCD veterinary and agricultural science studies have been combined. The courses have been adapting in recent years. For example, many agricultural science graduates take the parasitology module. One now sees more up-skilling. It is not just a question of doing a degree anymore. Everyone involved must continue up-skilling in various areas. Modules for up-skilling are available to those who qualified in a particular area in the past. Courses and modules will be available to people in, say, Teagasc or those involved in the co-operative structure. There is the possibility that we will have experts to some degree in specific areas. It has already happened in the tillage sector. One will end up having the same knowledge base applied to the animal health area.

Deputy Crawford

I welcome the three groups. The one useful matter that has emerged is their togetherness in principle on most of the issues involved.

As a dairy farmer, I know this has been an issue for a long time. However, I pay tribute to the vets for the services they provide. We can worry about them getting hold of this in toto. However, we can at least still get a vet out at night or the weekend when we cannot get a doctor. We must pay tribute to them for what they have done.

This is a frightening issue. The farming community is now asked to do everything to the letter of the law. However, the proof of the pudding is in the eating. The fact that residues are not a problem shows that farmers have been responsible. There is a simple reason for this. If a test is done on a milk tank in my yard, before it is emptied, a further test will be conducted. If any residue is found in the tank, it can be easily traced. The farmer who supplied the product with illegal residues will pay the price. Farmers know this and the proof lies in the fact that residues have not been found in either milk or cattle for some time.

A follow-up meeting is vital. However, I do not agree with the mechanism to do this. Officials from the Department of Agriculture and Food will do whatever they are told and are there to give the Minister advice. However, it is the Minister who will sign this regulation into force and unlike a Bill, it cannot be debated on the floor of the House. I, therefore, propose that the committee invite the Minister to discuss this issue in light of the information we received today and our own individual knowledge. It must be discussed as a matter of urgency. If the regulation is signed into force in October or November, there will be no point in us discussing it afterwards. When I was junior spokesperson on agriculture, with my colleague, Mr. Alan Dukes, I agreed with the then Minister for Agriculture and Food, Deputy Walsh, to urgent measures to deal with the foot and mouth disease outbreak. The measures were to be reviewed by the Dáil within 12 months. Either my memory is gone or the 12 months are not up because this certainly has not happened. The Minister comes from a Border constituency where the issue of black market supplies is prevalent. If the regulation is not implemented in an organised fashion or a meaningful way, black market supplies will become a problem.

Ireland exports nine out of ten animals. However, we are importing a significant quantity for food manufacturing. If we are to be serious about our anxiety for the consumer, all products must be treated equally. It is wrong that farmers are put through the mill with unworkable red tape. As an ordinary farmer, I often go to my veterinary office at 10 a.m. However, the vet may be away at a neighbour's farm due to calving or herd-testing. Who will deal with me in the office? There will be one wee girl behind the counter who will provide me with the product I need. One is better doing this through a pharmacy or co-operative where one can talk with an individual with a much higher level of expertise. We need to be careful we do not tie ourselves in a knot. This is a problem in parts of counties Donegal and Mayo. Thankfully, in counties Cavan and Monaghan it has not yet emerged. We must realise the number of farmers who meet the vet in his or her office is low. It will be a complete waste of time to tie up this issue with ordinary run-of-the-mill veterinary products, although I accept we must certify the nine out of ten cattle we export but if we are to be serious about our anxiety for the consumer, we must have a level playing field.

When the Chairman was in the United States he saw what is happening there. We know what is happening in Brazil and other places. Some of the countries from which we are buying the beef that replaces our product on the supermarket shelves do not have a system of traceability, let alone a record of hormone treatment or anything else. We must act sensibly to ensure that the primary producers here are not put out of business so that more product of dubious origin replaces theirs.

Senator Callanan

I welcome the three organisations to the meeting and thank them for their presentations. The first two stakeholder groups have their own interests which we accept as legitimate. The IFA representatives represent the user and producer.

I second the proposal by my colleague, Deputy Ó Fearghaíl. With due respect to Deputy Crawford, I agree with his point but that should be said at the later meeting. We should first meet Department officials to tease out the position of the Department, then invite the Minister to the committee.

Farmers produce food to a high standard. They have an expertise that may not be clearly understood and taken into consideration. It may be without parallel in Europe. Deputy Crawford was right to say the level of food imports begs the question whether they are subject to the same standard of examination and scrutiny that we apply to food in Ireland, which must be produced to the highest standards. Do consumers want food produced to the highest standard? If they did we would not import beef from Brazil, chicken from Asia and so on. Someone must buy this food but no guarantee or assurance about it can be offered to the consumer.

I seldom agree with Deputy Crawford but on this occasion he is right about several issues. Veterinary surgeons operate to a high standard. It would be most unfair to suggest otherwise. The relationship between the veterinary surgeon and the farmer is such that, by and large, the produce required is the product sold. We farmers are wise enough, and the farming representatives would agree, that it does not take us long to find out that one veterinary surgeon is different from another. We would apply a practical solution when that arises.

Deputy Crawford was also right about the tank of milk and the residue. If it is found to be wrong then it is done with. The three groups came here with a specific interest. What percentage of residues was found in any food product, especially since the introduction of the ante and post mortem inspections of beef and meat product? Saying there is "little" does not mean much. If we are serious we need to know exactly how much.

Chairman

Some members have spoken about the veterinary surgeons but no one criticised them. I would not like an impression to be conveyed that any visitors to this committee criticised the veterinary surgeons or anybody else. We all have the highest respect for the veterinary surgeons, as we do for the groups of people here today who also do good work. We want to see fair play on a level pitch, particularly for the farmers who will suffer if we cannot reach agreement on this directive.

Mr. Maguire

Deputy Crawford said we seem to speak with a single voice. That is true. The Irish Pharmaceutical Union, the Irish Farmers Association and the Animal and Plant Health Association have agreed that the prescription only medicine proposal is the best way forward for the industry. Other groups not represented here, namely, the Irish Co-operative Organisation Society and the Irish Creamery Milk Suppliers Association are in favour of our proposal. The Food Safety Authority of Ireland has given it broad agreement and the Consumers Association of Ireland has agreed to it. The Irish Medicines Board is neutral which is exactly as we would have expected. We also have agreement from the Agricultural Merchants Association. In broad terms, all the stakeholders are singing from the same hymn sheet.

I do not have the exact figures on residues for Senator Callanan. To the best of my knowledge in 2004 we had residues in poultry and fish. Both products were available only on prescription. The level of residue in products through the licensed medicine route, the prescription only medicine type C, about which we spoke, was nil. I am almost sure of these figures which are available from the Food Safety Authority of Ireland and have only recently been published.

Senator Callanan

Was the fish farmed or wild?

Mr. Maguire

It was farmed.

Mr. Staunton

The transposition of this directive into Irish law, if done as proposed, would be a very serious step for rural pharmacy and a point of no return for pharmacies dealing in veterinary medicine. I am not trying to be melodramatic but the pharmacy percentage of the market has declined in recent years. Several factors are to blame. One is that the volume of product used in many cases does not make it easy for pharmacies to handle for example, fork-lifts full of teat dip. As Mr. Feely pointed out, the pharmacy percentage has slipped to 12%. I am not being theatrical when I say if this regulation is transposed it will wipe us out of the market altogether. Once out of the market it is very difficult to re-establish oneself.

I endorse the Chairman's comments in that we are not here to criticise veterinarians, for whom we have the highest respect. They provide an excellent service both inside and outside hours. We are simply saying that there is room for our expertise and for that of licensed merchants in satisfying the need of farmers to procure medicines of the highest quality and use them in accordance with the best advice.

Mr. O’Leary

I agree with Senator Callanan. Looking at the current regulations, what happens on farms and how the system operates, everyone will agree that the two are not the same thing. When formulating the legislation, that practicality should be foremost in our minds. We must have a system that works for both veterinarians and farmers. That should be paramount.

Mr. Flynn

The fact that no residues were found in beef, lamb or dairy products in 2004 shows that farmers are being responsible. The current regime is working. When people buy products, they observe the withdrawal limits. That proves beyond any doubt that we are producing food to the highest standard in the world. It is sad that we are being asked to compete with meat that has no traceability whatsoever. It should always be emphasised to the consumer that what we in Ireland produce meets the highest standards.

I mentioned vaccines in my presentation. They are used as routine management tools to prevent disease. It is always better to prevent a disease on a farm than have to treat it with antibiotics. As well as protecting animal and human health, we are also trying to cut down on the use of antibiotics. Since so many diseases are appearing that are resistant to them, whatever products are in use we want to work. We must keep in mind that preventive medicine is always better.

Chairman

The system that has been in place for years has worked extremely well. I was involved in dairying myself a few years back. One was able to go into the chemist, and commercial travellers came around. I do not know what company they represented. Brian Stafford is still at that work. I never saw any danger or harm in going to one's local co-operative, the chemist or the veterinary surgeon. Ultimately, it was the farmer's responsibility, since he was the man who had the biggest loss if he did the job wrongly. The farmers were extremely sensible people, and that is still true. As Deputy Crawford said, if one has to pay for a whole tanker of milk, one will not take that chance. If one's bullock is about to be thrown into a skip to go to the factory, there is a great deal of money involved and one will simply not risk it.

Someone spoke of there being no veterinarians in counties Mayo, Donegal and so on. One of our local veterinarians was telling me that they wanted him to go from Kells to rural Dublin, since they could not get a veterinarian there. They are all in the small animal business. The situation is that serious and does not affect the west or County Donegal only. It is happening very close to us and will get worse as the years go by, since there will be ever fewer people interested in doing that tough work. It is as simple as that.

Are there any other questions?

Deputy Hoctor

I seek clarification from the IPU. The submission states that we have 1,300 outlets. Would it be true to say not all pharmacies provide veterinary medicine? I came across one in my constituency that must have been one of the leading farmers' pharmacists, but it no longer dispenses veterinary medicine. I would be interested to know the percentage of the 1,300 outlets dispensing veterinary medicine.

Mr. Staunton

Between 300 and 400 are actively involved in veterinary medicine. I do not want to whinge or cry about this, but it is not profitable, since we are supplying goods to someone else's business and that person seeks high value all the time. Farmers are mobile and want to get medicine at the lowest possible cost. We have to compete extremely hard. Some pharmacies are not well placed geographically to accommodate farmers pulling up with trailers and so on. They do not have room for large volumes or the bulky items that sometimes comprise veterinary medicines. One will find that perhaps one pharmacy in a town will have a special interest in veterinary medicine and will stay at that while others drop away. Probably one third or perhaps 25% of pharmacies will have a significant interest. Even urban pharmacies now have an interest in pet medicines and so on. They are involved in that market, but in large animal practice there are approximately 300.

Mr. Culliton

It has become an extremely competitive business. If one has a pharmacist in Athboy, County Meath who does high volume trade, he will be able to offer products at a competitive price. The farmers will travel from 20 miles around and bypass other pharmacies that might be trying to get into that business but cannot get that kind of price reduction. They will ignore them. One will get only one or two chances, and if one is not competitive, the farmers will go to the next person down the road. That is also a feature of the trade.

Chairman

We have two proposals. I seek unanimity on this.

Deputy Ó Fearghaíl

Senator Callanan's proposal is useful.

Chairman

Yes.

Deputy Ó Fearghaíl

He proposed that we very quickly bring in the officials and thereafter meet the Minister on the matter.

Deputy Crawford

As long as we can get agreement and ensure that the Minister does not sign the regulations before we get the opportunity. That is my main anxiety. As my colleagues have said, we have only one bite at this cherry and I have seen too many regulations signed. I am happy as long as the Minister is put on warning that we want a meeting with her.

Chairman

We shall write to the Minister and inform her of the result of today's meeting. We can ask the officials and her to attend. The regulations should not be introduced until we have had time to discuss them with her.

Deputy Naughten

Yes, that is critically important.

Chairman

Is that agreed? Agreed. On behalf of the committee, I thank the representatives of the Irish Pharmaceutical Union, the Animal Plant Health Association, and the Irish Farmers' Association for attending and for the way in which they responded to members' questions. As we have another group to meet and some private business to attend to, we will suspend the meeting for a couple of minutes.

Mr. Flynn

I thank the Chairman for having us here today. I hope that the committee takes our proposals on board.

Chairman

I thank Mr. Flynn and the others once more.

Sitting suspended at 4.28 p.m. and resumed at 4.32 p.m.