Regulation on Veterinary Medicinal Products: Discussion

We will proceed with the agenda proper, which is consideration of the proposed changes to the supply of veterinary medicines. We are joined remotely by two sets of witnesses. We will first hear from representatives from the Irish Pharmacy Union, IPU, Mr. Daragh Quinn and Mr. D.J. Barry. We will then hear from Mr. Ian Scott of Scott Consulting UK Limited, who is the consultant for the Independent Licensed Merchants Association, ILMA, and Mr. Terence O'Shea of the ILMA. Our guests are most welcome.

To maximise our use of time, I will call the witnesses to make brief opening statements and I will then open the discussion to members. When the consideration is concluded, I will call on the Department officials in attendance to join us. In this regard, I remind members that the Department has already provided the briefing materials requested. I formally acknowledge this and I will welcome those officials when they join the meeting.

Witnesses who are physically present or who give evidence from within the Parliament precincts are protected pursuant to the constitutional statute by absolute privilege, but witnesses and participants who are to give evidence from a location outside the Parliament precincts are asked to note that they may not benefit from the same level of immunity from legal proceedings as a witness giving evidence from within the Parliament precincts. No clear guidance can be given on whether, or to the extent to which, the evidence given is covered by absolute privilege of a statutory nature. Persons giving evidence from another jurisdiction should also be mindful of their domestic statutory regime. If our guests are directed by the committee to cease giving evidence in relation to a particular matter, they must respect that direction. Witnesses are also asked that only evidence connected with the subject matter of the proceedings should be given and they should respect both the directions given by the Chair and the parliamentary practice that, where possible, they should neither criticise nor make charges against a person or an official by name or in such a way as to make him, her or it identifiable or otherwise engage in a speech that might be regarded as damaging to the person or to the entity's good name. I invite Mr. Quinn to make his opening statement.

Mr. Daragh Quinn

A Cathaoirleach, a dhaoine uaisle, the IPU represents more than 2,000 pharmacies in Ireland, 300 of which are committed to the supply of animal medicines. I am a pharmacist from Crossmolina in north Mayo on the Wild Atlantic Way and home to the new movie, "Wild Mountain Thyme". I did a post-graduate diploma in agricultural and veterinary pharmacy and my thesis focused on the implications of EU Directives 81/851 EEC and 81/852 EEC on the supply of veterinary medicinal products, VMPs. That thesis was subsequently published and used as a reference document by the Veterinary Medicines Directorate in the UK in establishing its regulatory system.

Members will all be familiar with pharmacies. In my professional role of pharmacist I dispense medicines and advice. Some of these medicines are prescribed by other healthcare professionals, some are counter prescribed by me in response to the symptoms presented by the patient. I refer patients to other healthcare professionals, and in the case of animals I refer to the vet. At all times, my primary concern is for the welfare of the patient.

The supply of veterinary medicines to animal owners reflects the counter prescribing protocol of medicines to our human patients. There is a sequence of questions pharmacists ask about who is the patient, what are the symptoms, how long have the symptoms been present, what treatment has been given and so on. Prior to counter prescribing any veterinary medicine for animals, additional questions are asked including about the species, the cohort stage, previous treatments, climatic factors and local factors. These medicines are always supplied with appropriate advice for administration to the animal, safety for the user, withdrawal periods, environmental concerns and disposal of surplus product and containers. At all times we provide a written or printed document with each transaction. We maintain computerised records so we can build up a database of the various VMPs obtained by animal owners. This allows us to record the use of anthelmintics, flukicides, coccidiostats, ectoparasiticides, vaccines and so on. Benefits include reduction of inappropriate and unnecessary treatments, improved safety for the user, the animal, the consumer and the environment.

Responsible persons provide a similar service in the stores of more than 900 licensed merchants and co-ops. They are trained to a professional QQI level 6 qualification, which has been approved and accredited by the Department of Agriculture, Food and the Marine as being suitable for the supply of VMPs and associated advice to the purchaser. The 2019 cohort of graduates were presented with their QQI level 6 awards in September 2019 by none other than the current Minister, Deputy McConalogue. The awards and graduation ceremonies over recent years have included contributions from Department officials, some current and some retired, which is a glowing list including Pat Brangan, Caroline Garvan, Breda Meehan, Denis Healy and Hazel Sheridan and others who emphasised the critical role of the responsible person in the supply chain of veterinary medicines. There is a significant undertaking for the student to do this course.

The chief veterinary officer of Ireland, Dr. Martin Blake, in his letter to the European Commission, which I have attached to my submission, confirms that "there was no suggestion in the HPRA Report that the channel of sale and avenues of supply of antiparasitics were a causation factor in these exempting criteria not being met." The exemption referred to under Directive 2006/130/EC allowed for the continued availability without prescription of antiparasitic veterinary medicines. So, no professional involved in the supply of antiparasitic veterinary medicines was required up to now to issue a written prescription in this regard. Why is this? This was because we had obtained an exemption from the EU. Counter prescribing of these veterinary medicines, with corresponding documentation, has been undertaken by multiple stakeholders, vets, pharmacists and qualified responsible persons.

Antiparasitic pharmaceuticals are precious commodities and many are unique molecules that are a rare commodity. We have a responsibility to safeguard their use and sustain them for the future. Antiparasitic resistance differs from antimicrobial resistance. Antiparasitic resistance is an aspect of evolution and not a new phenomenon. Fasinex, for example, was launched in the mid-1980s. Reports pertaining to resistance of that molecule in sheep in Glencar, County Sligo, were documented in ten years later. Resistance is not a simple problem. It is multifactorial and environmental, geographical and genetic aspects all have a part to play.

The HPRA report of December 2019 recommended the upregulation of antiparasitic veterinary medicines to prescription only medicine status, correct. We can no longer avail of the exemption from the prescription only medicine status of the these medicines under the directive we had availed of. The HPRA task force recommended a multi-actor stakeholder approach to future regulation. I recommend that members would repeat this in their own minds: a multi-actor stakeholder approach to future regulation. The proposal by the Department to exclude professionals other than veterinarians from issuing prescriptions is controversial. Many animal owners are reluctant to pursue their present entitlement to obtain a prescription from their veterinary practitioners to source the relevant products elsewhere as they are afraid of jeopardising their relationship with their vets. The relationship with the vet is critical at birthing, calving, lambing and testing. These are all critical times and animal owners do not want to jeopardise that relationship.

Many vets ignore their statutory obligation under regulation 43.3 of the current European Communities (Animal Remedies) (No. 2) Regulations 2007 where the prescriber of an animal remedy shall at that time, issue a veterinary prescription to the owner or person in charge of the animal. This regulation is intended to encourage competition and prevent a monopoly. The Irish experience shows that the prescription only medicine regulations have virtually excluded veterinary pharmacists from their dispensing function of veterinary medicines. The absence of competition for the supply of antiparasitic veterinary medicines, which may evolve from the implementation of this regulation, will result in price inflation to the farmer if a monopoly is permitted to develop. This will add further cost burden to Irish farmers reducing the viability of industry and making Irish food products less competitive on the world market. If EU Regulation 2019/6 is applied as proposed, then this will have an impact on merchants, co-ops and rural pharmacies. Job losses in the thousands will ensue. Jobs are a scarce commodity in north Mayo.

This will impact on many of the committee members' constituents, merchants, pharmacies, co-ops and their staff, but more importantly on farming communities. It is yet another hammer blow to rural Ireland, to those who live outside the M50.

A request made of the Department of Agriculture, Food and the Marine through the forum of the antiparasitic resistance stakeholder group to conduct an economic impact assessment in advance of implementation of this regulation was refused. However, it was confirmed that the Department had established that a proposal to separate the prescribing and dispensing of veterinary medicines in Ireland, as occurs in many Scandinavian countries with a great degree of success, would threaten the viability of rural veterinary practices. No consideration has been given to the impact of this regulation on the viability of farming, rural co-ops, rural pharmacies or rural merchants. It will just add further cost to rural living.

Last Friday, a hill farmer visited our pharmacy in Crossmolina seeking advice on treating a sick lamb. My response to the symptoms described was to refer the farmer to his vet for treatment. The farmer’s response was that a vet consultation fee of €60, combined with the cost of treatment, would exceed the value of the lamb. His decision was to allow nature to take its course. This situation will become widespread. Many hill sheep farmers, smallholders and horse owners do not routinely engage a vet. These animals are liable to be neglected and animal welfare will suffer. Farmers and animal owners care for their animals. Refusing to avail of the derogation available to us under Article 105(4), will have a detrimental effect on farm life.

There is an irony in this. As a pharmacist, I am deemed competent to supply and advise on the use of anthelmintics and ectoparasiticides for human use without the requirement of prescription. From 2022 on, however, a veterinary prescription will be required to supply and advise on the veterinary equivalent. Veterinary nurse prescribers, pharmacist prescribers and "suitably qualified persons" have all been legislated for in the UK, which availed of the derogation in the regulation.

The all-island animal health and welfare strategy was launched in 2018. It should include animal health products. However, we are one island with two different supply systems and no border. This will inevitably result in the importation of such products, reducing accountability and transparency. Currently, certain products are obtained by farmers across the Border, for reasons of cost and availability, without a prescription. Many of these are unlicensed, unregulated and undocumented in this State. According to a recent court case, an alleged importation of a veterinary product from Northern Ireland was intercepted by a departmental inspector, who stated that preventing illegal cross-border transactions was becoming more difficult to detect due to "an absence of political will". The cross-border trade, which is currently a trickle, will develop into a torrent post January 2022, with no accountability and no transparency and thereby undermining the quality assurance associated with Irish food products.

We have a limited veterinary service in parts of western regions of Donegal, Mayo, Galway, Clare, Kerry and Cork. This is widely acknowledged. The Erris region of Mayo, which is adjacent to where I live and is the size of County Louth, has one vet based in it. Many island communities have no vets. In those areas, the merchant, co-op and pharmacist provide veterinary medicines and appropriate advice. This regulation will further challenge life on the west coast.

A solution is available to the Minister, one that would maintain competition in the supply of veterinary medicines and prevent the development of antiparasitic resistance. He should authorise pharmacists and suitably qualified responsible persons to issue prescriptions for antiparasitic veterinary medicines. They have been de facto prescribing these medicines at the regulation's time of entry into force. Precedents exist in this regard under the same Department's implementation of an EU directive on the sustainable use of pesticides. The response from the European Commission in the letter I have supplied confirms the availability of the derogation to the Minister. The Department has agreed to seek the advice of the Attorney General. Let us hope he views the matter wisely.

I thank Mr. Quinn.

Mr. Daragh Quinn

May I finish with one point?

I am sorry, but I must allow time for members to ask questions. Mr. Quinn can speak again once their questions have been asked. I call Mr. Scott to give a brief presentation.

Mr. Ian Scott

I was the lead negotiator for the UK when we defended the rights of the specially qualified professional, SQP, during the four years of discussions to get this regulation to the table. I wrote the text of Article 105(4) and, with the full support of the UK Government, succeeded in securing the UK SQP system in the final stages of the regulation discussions.

The regulation entered the Statue Book on 27 January 2019, which is called entry into force, and will become enforceable by the EU on 27 January 2022. We are in the interim period to enable member states to alter national legislation in order to ensure compliance. As such, the derogation is available to be adopted in Ireland.

Turning to the role of Department of Agriculture, Food and the Marine, the Commission's original draft stipulated that member states could preside over their own distribution systems. We were all delighted with that and Irish MEPs in particular were supportive. When the matter moved to the Department's veterinary expert panel, however, the panel supported a change to make all medicines for food-producing animals require a veterinary prescription. The panel never informed any of the stakeholders of this in what appears to have been a unilateral decision. The Department then made it clear to the UK that it wanted to go it alone. The Department assured the Irish Farmers Association and the UK that this ruling would not affect Ireland and that it wanted to keep its system "under the radar". The Department specifically insisted that the UK should not refer to the Irish system in any future discussion.

Article 105(4) sets out that all medicines for food-producing animals need a veterinary prescription. The Independent Licensed Merchants Association, ILMA, accepts that this cannot be changed. Currently, licensed merchant medicines have an optional exemption from a veterinary prescription, for example, porons, flukicides, coccidiostats, fly control, sheep dip and all wormers, including horse wormers. However, Article 105(4) was included to allow professional persons other than vets to issue veterinary prescriptions. We are now at loggerheads with the Department over this derogation. The Department seems intent on dismantling the very system that it formulated, regulates and now approves.

Let us consider Irish law briefly. In 2007, it enabled the responsible person to dispense licensed medicines without a prescription. A licensed merchant may have a retail premises licensed by the Department of Agriculture, Food and the Marine to retail veterinary medicinal products. Those premises are subject to regulation, inspection and control by the Department.

A key point in the Department's contention is that only a vet can write a prescription, but the first few words in the derogation contradict this. They read: "By way of derogation from point (33) of Article 4". Article 4 is what defines a veterinary prescription. This derogation from the definition of a veterinary prescription means that the definition no longer applies, clearing the way for a member state professional to write a prescription. It also means that vets do not have exclusive rights to prescribe.

What we must do is show this committee proof that the responsible person is a professional and qualified to prescribe. If we can achieve that, the derogation can be applied.

The responsible person must have a professional qualification - Mr. Quinn referred to the QQI level 6 retail sale and supply of animal remedies. The qualifications of everyone who has passed this exam are recognised by the Department. Therefore, the responsible person is a professional. We must also prove that the responsible person was able to prescribe animal medicines at the regulation's time of entry into force. If one makes a purchase from a licensed merchant, the merchant will talk about the age, type, breed and weight of the animal, select the suitable product, provide knowledge of local situations, discuss the medicine's administration, dose rate and withdrawal period, interpret laboratory tests where applicable, and discuss labelling and storage. That is the normal procedure followed by anyone who is issuing a prescription. Accordingly, the responsible persons are, in layman's terms, both professional - they have the QQI level 6 - and qualified to prescribe by virtue of their current advisory capacity. We have legal opinion to support these two key points. In every sense of the term "responsible person in veterinary pharmacy", a pharmacist is able to prescribe and dispense under this derogation.

There is one significant difference between vets, vet pharmacists and responsible persons, which is that the responsible person does not have a regulatory body. As a solution for the Department of Agriculture, Food and Marine, we are offering to form a regulatory body for the responsible person with a code of practice that would enshrine their prescribing process to ensure responsible use, address environmental matters and only allow the responsible person to be the prescriber and dispenser and to be present at point of sale. It would also require continuous professional development training and compulsory advice on antiparasitic resistance, and include a disciplinary process. Additionally, we want to work with the Department to form a specific prescription classification just for licensed merchant, LM, medicines that does not clash with a full veterinary prescription.

I will put it in simple terms. Irish national law enabled a responsible person to dispense LM medicines without prescription. The EU regulation now requires these medicines to have a veterinary prescription. Article 105(4) allows Ireland to enable responsible person to issue a prescription.

I ask the committee to consider one more threat before I conclude, which is the view of the competition authority. The Department of Agriculture, Food and Marine argues that there is no change to the current system except that the livestock farmer and horse owner will first need to go to the vet to get the prescription. Then they can go to their favoured merchant to purchase the medicine. This is only partially true. First, by visiting the vet's premises, the vet has an immediate unfair advantage to prescribe and dispense the medicine in a one-stop-shop scenario. This will inevitably result in sales of these products being largely undertaken by vets. Second, there are identical generic LM medicines licensed so that only a vet can dispense, the prescription must specify a branded medicine and it would not be unfair to assume vets would want to prescribe brands only available from themselves.

For example, if a cattle farmer wanted to buy ivermectin such as Ivomec from the vet, he or she would prescribe Enovex, available only from vets. The same applies with eprinomectin, sold as Eprizero and Closamectin generic brands. In this way the LM is bypassed and prevented from dispensing product because the prescription can be restricted to a vet-only generic product.

In a letter to the EU, Mr. Martin Blake, the chief veterinary officer of the Department stated that there is a clear recognition that competition issues arise, and that the current competitive environment would be significantly weakened.

The committee is now aware that the Department acted against the wishes of the Irish MEPs, the European Commission and against the Irish LM distribution system that it manages. It failed to notify stakeholders of its intentions. It failed to put matters right in the year between approving this change and entry into force. It failed to take responsibility for the actions of their predecessors and is failing to avail itself of a feasible solution. The Department is in grave danger of contravening anti-competition law, which could result in costly litigation to resolve matters.

I thank both gentlemen for their presentations. This topic is generating considerable interest and concern in the farming sector. I call Senator Paul Daly, to be followed by Deputy Carthy and Senator Lombard.

I thank the witnesses for their presentation. I have been raising this issue and beating the drum for some time. If we do not get this right, I see the potential consequences for the farming community, the merchants and the veterinary union. We could walk ourselves into a situation where we will affect animal welfare issues. I thank the Chairman and my fellow committee members for their indulgence and co-operation in allowing my suggestion to have this issue put on the agenda for discussion today. I thank the ILMA and the IPU for their comprehensive submissions. I compliment them on never trying to create an us-and-them scenario with the issue. They seem to be willing to work with departmental officials to get a resolution that will help, farmers, suppliers and the animals.

I have a question about competition for the licensed merchants. How will the licensed merchants' jobs be affected if this derogation or some similar compromise is not enforced? I seek further clarification on competition and how this might affect retail prices and eat further into what is an almost non-existent margin for beef and sheep farmers.

Licensed merchants are currently legally permitted to stock and sell veterinary product which requires a veterinary licence. How does that system work at the moment?

I thank our guests for a very informative opening statements and contributions. This is a mess that should not have arisen and needs to be addressed.

I have some questions for the ILMA. There has been discussion on the role vets will be expected to play following the implementation of this regulation if it comes into place in 2022. How actively are vets involved in addressing antiparasitic resistance? What is the EU timetable, as the ILMA understands it, for the derogation to remain available for Ireland to use?

The IPU statement refers at length to the supply of veterinary medicines to animal owners and how it reflects the counter-prescribing of medicines to human patients. I ask the witnesses to elaborate on this statement so that we can get a picture of their professional opinion on how the current supply of medicines by non-vets to animal owners amounts to counter-prescribing and exactly what counter-prescribing is. Does the IPU believe counter-prescribing is actual prescribing? Do pharmacists and those in those in the LM sector essentially prescribe veterinary medical products in this manner? That will be interesting for our later conversation with departmental officials.

I believe that the derogation is available to Ireland. It is a matter of great regret that we are at this point where the committee needs to deal with such an issue, which is threatening many important businesses to our rural communities and putting them under severe strain at a time they have enough to be concerned about.

I compliment the Chairman on bringing the topic before the committee. We all have received correspondence on this issue, which affects the agricultural community regarding the competition element. These merchants provide competition in the marketplace. They provide the forum to have farmers trade competitively whether it is through co-operatives or stand-alone entities. Moving away from that model would have a great impact on the profitability not only of beef and sheep sectors but also the dairy sector.

What products might be affected by this? The public might have a greater understanding of it. There would be the usual dosing for cattle, but vaccinations for bovine viral diarrhoea, BVD, and leptospirosis are available through some if not all merchant suppliers. Will they all be affected by the lack of competition as well? Will there be a significant knock-on effect where the only main supplier will be the vet and farmers will be tied into that vet?

I do not think there will be the competition of someone going to a different vet. I think people will use the same vet they have always used, and that will compound the effect of being unable to argue one's price. That will be a significant issue in regard to the intricacies of trying to ensure a fair price for the product.

Our guests mentioned the QQI level 6 course, which has raised the standard for pharmacists. It will be a slap in the face for generations that have gone through the course if they are told that the work they have all undertaken is not credible in any sense. Will our guests elaborate on what would be the benefit of doing that course, and what the course will stand for after this, if we do not get the derogation? This is a very significant issue for our industry.

I thank our guests for their contributions, but we need to hear from the Department to see exactly why it faces a stumbling block with regard to the derogation.

There have been a number of questions. I ask our guests to keep their replies as brief as possible because six further members want to ask questions.

Mr. Ian Scott

I will lead off with the question about how vets are addressing antiparasitic resistance. As a quick example, a sheep wormer called Zolvix was launched about nine years ago. It contained a brand new anthelmintic as its active ingredient and there had not been a brand new one in 25 years. It is currently sold only by vets - it is under vet control - but the uptake of it, which has no known resistance and a very simple user message, is less than 100 l per year. If vets are addressing antiparasitic resistance effectively, why is the only non-resistant sheep wormer on the market not being used in greater quantities? I will put that on the table for the committee to think about.

Mr. Daragh Quinn

On the role of the pharmacist in a community pharmacy, obviously, patients visit their pharmacy and come to see us regarding human health. Many farmers and agricultural patients have animals for which they seek advice. We give appropriate advice following a protocol whereby we assess the circumstances. We do not make a diagnosis; we make an assessment and recommendation at the time in response to diagnostic tests. Sometimes they are faecal egg count tests and sometimes the recommendation is a response to symptoms. We have a qualification to do that. It is not just as a pharmacist; all responsible persons are equally qualified to do it.

As members have noted, the qualification has been undertaken with significant effort. Many hours of study and exams have been undertaken at significant cost to each person, and this will now be rendered redundant. These people will have spent all that time and effort, and while they still will be entitled to dispense these products, it will be only on foot of a vet's prescription. It has been understood that there is a shortage of vets throughout the country and there is a reluctance on the part of vets to issue prescriptions, which, technically, is their statutory obligation.

Mr. Quinn spoke about the shortages of vets but I fear that their work could become clogged up with minor issues. There are shortages of vets in many parts of the country. Will he comment on which countries have a derogation in place? One of our guests stated that prescriptions can issue only after a clinical or proper assessment by a vet, which goes back to my point about clogging up vets' schedules, the shortage of vets and so on. Is there any evidence that the alleged monopoly on existing prescription-only medicines, supplied primarily through vets, has resulted in significant price differences between vets and other suppliers of these prescription-only medicines? On some farms, for example, an antibiotic may occasionally be used if an animal develops pneumonia or mastitis. I come from a farming background and the farmer's best friend was always the antibiotic at hand.

I thank our guests for their contributions. Mr. Scott spoke about the European Parliament and about how its Members were not really consulted. Decisions were taken that did not come through elected representatives. Who is really pushing this? We all have pharmacies we use, whether for agriculture or health, and pharmacists are very responsible people. They ask questions and they know the farmers or the people involved. My big worry is who will monitor the cross-Border trade. That will be our biggest form of trade in the coming years because people are willing and able. They are at it already in respect of other products and this will be only a new product to them. It will be a bit like cigarettes. We tried to price them out of this country, but thousands of them are caught every week in this country, at Dublin Airport or Dublin Port, where they are brought in. There will always be a means of getting it done illegally if people feel they can get a product more cheaply in Northern Ireland or England. This would be a very serious mistake for co-operatives, pharmacies, rural Ireland and farmers.

I come from Mayo, where vets are very scarce on the ground and difficult to get. They are very busy people and I would be surprised if they are the ones who are seeking this monopoly. I hope they are not. I want to see small traders. In this country, with Dublin thinking, and in Europe, they always want to get rid of small businesses and I do not know why. They always want to get rid of businesses. It is a bit like the lockdown. The multinationals have not been affected, and the likes of Dunnes Stores, Tesco and so on have all been let open. They have not been hurt, while the small, family businesses in this country are the ones that have been affected again.

I am totally opposed to this. Who will make the final decision here? Is legislation needed? Will this come through the Dáil? Who will make the final decision as to whether legislation is needed? I believe it should be left as it is. The few co-operatives and small pharmacies that are trying to make a living and to employ people in rural Ireland should be left alone. Deputy Carthy was a Member of the European Parliament for a good few years. The people in the EU spend their time there every day, from Sunday to Sunday, thinking about how, when they get up on Monday morning, they can hurt someone who is trying to make a living in Europe. It really upsets me at times the way they think and operate and the fact that they want all the big multinationals and operators to take over small businesses. It is wrong and it should not happen.

I thank Mr. Quinn and Mr. Scott for their contributions. I will put my questions to the officials from the Department of Agriculture, Food and the Marine in the next session.

I thank our guests for their presentations. Mr. Scott stated the derogation outlined in Article 105(4) is available to Ireland to use to solve this problem.

I just want to be clear on that. Can either of the witnesses say how active vets have been on the Health Products Regulatory Authority, HPRA, in recent years? I believe this can be resolved. I got a phone call from the Minister's constituency this morning. There is a difficulty at the moment because vets are situated 30 or 40 miles from people. A local co-op or pharmacist where a farmer can get the various doses might be fairly close by. There will be a huge risk to supplies crossing the Border in either direction, with a particular impact on the Border counties. Vets go across the Border at the moment.

Was any consideration given to a grandfather right? This has been discussed in England. UK officials told what we would call the qualified persons that undertaking a course would dot the i's and cross the t's. I understand that our Department decided there was no need to do this and qualified persons could work away.

I have seen doses for cattle available in veterinary suppliers as well as a veterinary practices. There was an €80 difference in the prices of the same medicine. Are pharmacists and merchants afraid of the farmers? I totally agree with everything Deputy Ring said about Europe. He could come into my party. That said, it is not all about Europe. Cattle can be out on the streets in France. A farmer who did that here would be locked up for the rest of his or her life. The problem is in the interpretation of directives. We love interpreting everything to the letter of the law. It is time we copped on. We must ensure that farmers and local veterinary suppliers, including co-ops, marts, etc., can stay in business to maintain competition in the market.

Mr. Ian Scott

I can provide three answers. The derogation is available to us until January 2022. There is a three-year period between entry into force and the actual date of accessibility. The derogation is available now. That has also been confirmed in a letter from the EU to Mr. Martin Blake. In our opinion this is being pushed by the Department of Agriculture, Food and the Marine. It is not a European problem. The EU has quite rightly said that these products are to be prescription-only, but the derogation was implemented for a specific reason, namely, to ensure that vets do not have exclusivity on veterinary prescriptions. The Department is pushing this. I will leave the committee members to discuss this with the Department.

Finally, the Deputy raised cross-Border problems to do with the unlicensed import of medicines. It will only take one report finding that thousands of litres of unregulated product are pouring across the Border from the UK into Ireland to absolutely wreck the reputation for quality of Ireland's meat and poultry exports. It will damage traceability and many other concerns. We cannot allow that to happen. There is too much at stake.

Mr. Daragh Quinn

I applaud the intelligence and understanding shown by all members of the committee. They have a good understanding of the issue at stake. Deputy Paul Kehoe highlighted the shortage of vets. That is a serious and well-documented issue in the west. The vets in practice will now be inundated with requests for prescriptions. They will be required to interpret fecal egg count tests and many other simple tests that are well within the capability of suitably qualified persons. These responsible persons and pharmacists are very capable of interpreting a fecal egg count test and making an appropriate recommendation, and are qualified to do so. The products concerned are primarily worm treatments, fluke treatments, sheep dips, pour-on medicines and horse wormers that are commonly available in all our co-ops, LMs and pharmacies.

There tend to be price differentials between merchants, co-ops, pharmacies and vets. There is competition within the market. There are significant differences in the prices of prescription-only medicines. Unfortunately the issuance of prescriptions is greatly restricted at the moment. Not many vets issue prescriptions for antibiotics. Up to several years ago, subject to a valid veterinary prescription, I would have occasionally supplied products such as Alamycin injection, which is a first-line antibiotic treatment. I used to retail that at approximately €5 per bottle. An equivalent product supplied by a vet will cost €15, €16 or €17. That may be reflective of my particular area, but I imagine that a wider examination would reveal a price difference of 100% or 200% to the farmer. If that principle was applied to all the anthelmintic drugs, flukicides, coccidiostats, wormers and sheep dips it would make farming very challenging. The bottom line, the margin that is left to the farming community, would be diminished further.

I applaud Deputy Ring regarding his point on small family businesses. Many small rural merchants are family-owned and family-driven. They provide employment and are largely rural-based. There are very limited employment opportunities in the west. We do not have too many Apples, Googles or Amazons. Unfortunately, we are all based here on the west coast. This regulation is going to affect rural Ireland and rural employment. This will impact on the committee members' constituents. I refer also to rural isolation. Island communities and marginal communities on peninsulas in west Kerry or west Donegal are quite remote from their vets. However, a merchant that can supply these medicines may be accessible to them. I hope that as elected representatives, members will show the courage not to be hoodwinked or taken in. They represent their electorate, the people of this country. I call on them to be brave. This directly affects 150,000 Irish farms. It affects those farmers and their families as well as the people who work on those farms such as seasonal workers and people who come in to help with silage. These are the type of people who gain employment from farms. This is a much bigger issue than the concerns of pharmacists or licensed merchants. If we were to add it all up, this probably affects the best part of 400,000 or 500,000 people. It is a very significant issue. It will require the political will of the Minister to avail of the derogation.

I thank both witnesses for their comprehensive presentations. This is of significant concern to rural Deputies like myself. I represent Laois-Offaly. This is about job retention in rural communities. I understand that there will be significant job losses if this derogation is not sought. I am also very concerned that it will lead to the creation of a cartel and a monopoly. More concerning is the fact that it represents another financial burden that farmers who are already struggling to make a living do not need. I am very concerned about the whole situation. In addition to political will, we need common sense here. It is not rocket science. The derogation needs to be sought. That will hopefully put the issue to bed and protect 3,000 jobs.

Do the witnesses believe their right to earn a living as pharmacists or responsible persons will be adversely impacted if the Department does not avail of the derogation? Is the UK operating a similar system? What type of system is it operating? Could that be used as a template for Ireland's approach? My final question relates to Scandinavia. I understand that Denmark and Sweden have separated the functions of prescribing and dispensing.

Could that be a possible solution here? I understand it is working effectively in those Scandinavian countries. If we hit an obstacle, and we should not because the derogation is there to be sought and that should be the end of it, could that also be a good solution if solutions are needed?

I am interested in what is going on here because a severe penalty will be put on farmers by this. I have a conflict of interest in this regard because I am a small farmer. We know exactly what will happen here and who will be hit hardest. As I was listening to the discussion, I remembered that my father worked in a local co-operative for 48 years. He dispensed of these products in a safe manner, but all of a sudden it is being deemed that those co-operatives or regulated sales merchants are no longer safe channels to distribute these products. This will be at a severe cost to farmers. It is an attack on rural Ireland and a direct attack on farmers. We must do everything in our power as a committee to bring the derogation that is available to fruition.

I would like to ask Mr. Scott and Mr. Quinn a few questions. Mr. Scott stated that the ILMA has a legal opinion to support the interpretation of derogation 105(4). Who has seen this opinion and has it been seen by the Attorney General?

We have already heard that policing the Border against the illegal movement of UK veterinary medicinal products into the Republic will prove impossible. How do the ILMA and the IPU view the repercussions if the Department sets up measures for prescription only by vets, when over the Border the suitably qualified person can prescribe and dispense for free?

I have a few questions for the ILMA first. There are claims that anti-parasitic medicines, such as those we are talking about, have been dispensed too frequently and unnecessarily, thereby decreasing their effectiveness. If this is true, how does the ILMA propose to address the problems without having to require a vet's prescription for these medicines? Would the responsible people be monitored under the ILMA's proposed regulatory system?

Could the pharmacy union explain to us the comments on the supply of these products without veterinary prescriptions and instead upregulating them to prescription-only medicines? In other jurisdictions, are there cases of a black market emerging from the making and sale of these medicines that are only available with a vet's prescription and are there cases of the prices increasing?

Mr. Terence O'Shea

I am speaking on behalf of the Independent Licensed Merchants Association. I am a licensed merchant in that I operate two licensed merchant premises. Both are registered with the Department of Agriculture, Food and the Marine and I am also a responsible person. I have been in the industry for 38 years. When I set out first, I never thought I would appear before an Oireachtas committee in the hope of saving my business, which I have worked hard to establish over a number of years.

I will answer Deputy Nolan's question on earning a living in my profession as a responsible person. The Deputy asked if I would be affected and the answer is that I and licensed merchants in general would be. We have no doubt that job losses and the potential for business closures will be a consequence if the Department fails to avail of the derogation as provided for in Article 105(4). There is a responsibility on elected representatives, appointed Ministers and public servants to promote enterprise and employment. Any regulation, directive or legislation that fails to promote these objectives should not be enacted. If the Department proceeds to introduce the legislation, it will result in job losses and business closures. Many merchants such as myself are dependent on anti-parasitic medicines as our primary source of income and we will be forced to close. Others who offer a wider range of essential farm products will exit the industry, resulting in large-scale job losses. Multi-site merchants will find some locations unviable and will close. The important thing in all of this is that the chief veterinary officer, Dr. Martin Blake, has made quite clear in his letter to Europe that he sees issues arising with competitiveness in the marketplace if some of the existing outlets are forced to close.

It is important to draw the attention of the committee to EU Directive No. 2019/633 on anti-competitive and unfair trading practices in the agricultural and food supply chain. This directive will prohibit unfair trading practices being imposed on one trading partner by another. This was adopted on 17 April 2019 and is legally binding on all EU states. The emphasis is that as of now and as late as yesterday, I had a licensed merchant in touch with me who said his turnover in the past six weeks was affected to the tune of €32,000 because a number of his farmer clients were unable to secure prescriptions from a veterinary practice that had moved into the area and that was involved in the sale of veterinary medicines. It was making it quite clear to the farmer that it had a product on the shelf, it was providing the prescription and that is where the farmer should have been purchasing his products. The retention of veterinary prescriptions, which a farmer client is legally entitled to for a sole economic reason, will be in breach of this new EU Directive No. 2019/633. Can we introduce legislation which will encourage this malpractice? I would describe what is happening with the retention of prescriptions as a malpractice. It exists and people who do it are already in breach of SI 786 of 2007. We are proposing to introduce new legislation which will encourage this and that in turn will clearly be contrary to the provisions of EU Directive No. 2019/633.

I ask Mr. Scott to elaborate on the regulatory body he talked about in his opening statement. How will that be operated or what legislation would govern it?

Mr. Ian Scott

There is a similar system running in the UK and that also refers to Deputy Nolan's question, where we have suitably qualified persons who are regulated and monitored by their own self-financed body. There is a register and everyone on that has to take a certain amount of training per year. They are well connected, particularly on anti-parasitic resistance, and a regulatory body would formalise what is unformalised in how to write and issue a proper prescription for the responsible person. There is also a disciplinary process, which could take somebody off the register, in which case he or she cannot prescribe. One big difference is that with this code of practice in the UK, only the responsible person can advise on, dispense and sell the licensed medicines. Such a person would come into one of Mr. O'Shea's shops, for example, and the only person who can deal with an animal medicines inquiry is the suitably qualified person. It would be the same if we had a regulatory body here for the responsible person.

On Deputy Michael Collins's question about the legal opinion, reluctantly we have been forced to get a legal opinion from both a senior counsel and a solicitor on the matter of whether we can avail ourselves of the derogation. That legal opinion was directly promised to the Minister. It went to him yesterday so it is now in his inbox. We are happy to share it with the joint committee and can send it straight on so that it can be put in front of the Attorney General because it is strongly supportive of all of the matters we have come up with today.

Mr. Daragh Quinn

I thank the committee again for this opportunity. I would like to revert back to Deputy Nolan's question on a Scandinavian model for the supply of veterinary medicines. This model exists and it is effective and successful in Scandinavia.

It reduces the potential of a commercial conflict of interest, which is caused by the present dichotomy of roles engaged by veterinarians who both prescribe and dispense veterinary medicines. In human medicines, doctors prescribe and pharmacists dispense, which means there is no commercial conflict of interest. Separating prescribing and dispensing would allow vets to concentrate on their clinical work and avoid a situation such as that suggested by Deputy Kehoe where there would be a clogging up of veterinary clinics whose essential work would be diminished and pressurised. It allows the vets in Scandinavia to enhance their professional roles.

Another advantage would be to allow a more effective stewardship of veterinary medicines where resistance concerns have been identified, including both antimicrobial and antiparasitic medicines. This model would retain the expertise and accessibility of all those in the present supply model as there would be a role for prescribing vets, dispensing pharmacists and responsible persons, with each sector's expertise utilised to its optimum. No pharmacist, licensed merchant or co-operative is looking to usurp the role of any other professional. We must be conscious of the fact that there is a role for all of us. The most important element is that we look to sustain these precious medicines in the future and act responsibly.

I thank the witnesses for their presentations and insightful answers. They have given a comprehensive view of the issue and that will help us in our discussions with the Department which are going to take place imminently. I thank our guests.

Sitting suspended at 5.01 p.m. and resumed at 5.04 p.m

I thank the officials from the Department of Agriculture, Food and the Marine for coming in today. They listened to the first part of the meeting when we had presentations from stakeholders who are seriously concerned about legislation that is coming forward. I welcome Mr. Colm Forde, principal officer, Ms Caroline Garvan, veterinary inspector, and Mr. Rob Doyle, senior superintendent veterinary inspector. If one of our guests would like to open up the meeting, I will open it up to questions thereafter.

Mr. Colm Forde

We have provided a briefing note and were advised that would serve as an opening statement.

Are our guests ready to take questions in that case?

Mr. Colm Forde

We are happy to take questions.

The evidence of witnesses physically present or who give evidence from within the parliamentary precincts is protected pursuant to both the Constitution and statute by absolute privilege. However, witnesses who are to give evidence from a location outside of the parliamentary precincts are asked to note that they may not benefit from the same level of immunity from legal proceedings as a witness giving evidence within the parliamentary precincts. I can skip that advice because all the witnesses are here.

Witnesses are also asked to note that only evidence connected with the subject matter of these proceedings is to be given and they are asked to respect directions given by the Chair and the parliamentary practice to the effect that, where possible, they should not criticise nor make charges against any person, persons or entity or an official by name or in such a way as to make him, her or it identifiable, or otherwise engage in speech that might be regarded as damaging to the good name of a person or entity.

I welcome the officials from the Department. They have heard the presentations by Mr. Quinn from the IPU and Mr. Scott from ILMA, who raised two issues that relate to the Department. In some ways, I am sorry that the officials from the Department were not here at the time because when issues are raised about another party, it is an important for them to have an opportunity to respond.

Mr. Quinn said that a request of the Department, through the forum on the antiparasitic resistance stakeholder group, to conduct an economic impact assessment in advance of the implementation of the EU Regulation 2019/6 was refused. That somewhat surprised me. I would like it if our guests could give a good reason that request was refused. An economic impact statement or assessment is critical for any policy or decision that anyone takes, particularly here in Leinster House. I am disappointed if that was the case but I would like our guests to clarify if it was and why that decision was taken. Economic impact assessments are fundamental and, if it is correct, the point raised by Mr. Quinn is valid and should be addressed.

Sometimes in contributions to the committee, the punch comes at the end. Mr. Scott's assessment in his presentation ended with him saying that the Department acted against the wishes of the Irish MEPs, the EU Commissioner's original draft and the Irish LM medicines distribution system that the Department set up and regulates. He went on to say that the Department failed to notify stakeholders of its intention and alleged that it failed to put matters right in the year between approving the change and its entering into force. Those are serious criticisms of the Department and Mr. Scott said that it is in grave danger of contravening anti-competition law, which would result in costly litigation to resolve those matters.

Those are two separate statements made by two people who presented to the committee. We need to have some clarification of both of those issues from the Department.

With the indulgence of the committee, I will let the Department officials answer before I move on to other questions because the questions the Senator has asked are very specific.

Can I just ask if, at this initial stage, the officials could clarify what the Government's position was when this regulation came before the Council? That would help to provide background.

Senator Boyhan has asked specific questions, whichever of our guests would like to respond.

Mr. Colm Forde

I am happy to take those questions. We have been talking extensively, and continue to talk, to our stakeholders about how this regulation will be implemented. Our door is always open and we have spoken to Mr. Quinn on several occasions. He is a part of the antiparasitic stakeholder group that has been established in the Department and is chaired by the Chief Veterinary Officer.

The first time I heard of a claim to the effect that we refused to undertake an economic impact assessment was in that statement today. We have committed to carrying out a regulatory impact assessment, which is effectively the same thing, on how each regulation affects different elements of society, in this case the supply chain, so I do not understand where that claim came from. I am happy to follow up with Mr. Quinn on that.

The point we would make is that the previous legislation relating to veterinary medicines has been a directive. A directive in European law allows a certain level of national discretion as to how one seeks to comply with the provisions of that directive, whereas a regulation has direct effect on a member state and there is far less discretion as to what can be done at a national level. The law is basically written down here already and we know what it is. There is far less room for us at a national level and we explained that at length to our stakeholders. The regulatory impact assessment was going to focus on the areas where Ireland has national discretion. One could argue that the value of carrying out an impact in respect of on areas where we have no discretion is potentially limited. I hope that addresses that point.

We have met extensively with representatives from the ILMA but did not previously meet with Mr. Scott or are not aware of his views so they are news to us. Mr. Scott mentioned that it submitted legal opinions to the Department yesterday, which I received before 7 a.m today. I sent these on to our legal advisers. We are working with all of our stakeholders, our internal legal advisers and the Office of the Attorney General to get legal clarity on the elements of the regulation. With regard to the views expressed today, there are differences of opinion of different legal interpretations so we must make sure what we are doing is legally robust.

Regarding the charges raised by Mr. Scott about departmental officials acting against stakeholder concerns, I think Senator Boylan mentioned commenting on third parties and not having a chance to respond. None of the officials here were involved in negotiating the regulation at EU level. We have been all involved in the medicines aspect in the past couple of years by which point the regulation had already been negotiated at EU level so I am not in a position to comment on the particular points made by Mr. Scott. My view is that this would be unusual.

Could I get an answer to the question I asked about the Irish position on the regulation at Council level?

Mr. Colm Forde

As I said, none of us here was involved in the negotiation of the regulation. Does that answer the Deputy's question?

Does Mr. Forde know what the Government's position was when this came before the Council? Did it support or oppose the regulation?

Mr. Colm Forde

From what I understand, the default position is that all veterinary medicines that are used in flu-producing animals require a veterinary prescription. That is in Irish law. No person other than a veterinary practitioner has ever been permitted by law to issue a veterinary prescription. The current legislation is consistent with that. If we look outside the regulation, what has changed is that Ireland previously availed of a derogation whereby if there was no evidence of resistance to antiparasitic medicines or no evidence of environmental damage relating to them, those products could be made available without a prescription so that is how these products were permitted to be dispensed in Ireland by responsible persons and persons other than vets. The previous witnesses referred to the expert task force of the HPRA in 2019 which scientifically concluded that there is widespread resistance to these products and widespread evidence of environmental damage. In that context, the exemptions in European law which allowed these products to be provided without prescription have now changed. That HPRA report was produced after the regulation was negotiated. Apologies if that is a long-winded answer.

What was the Government's position on the EU regulation from 2019 that was agreed in 2018. That had to go before the Council and Parliament. Did the Government support it?

Mr. Colm Forde

I guess the answer is that we were not involved so I cannot answer the question definitively. I can, however, commit to coming back to the Deputy.

If Mr. Forde could do so, it would be good because serious questions are emerging and we do not have much time in the overall scheme of things. We are talking about people planning their businesses who must deal with stocks, sometimes orders and sometimes medical information. All of that is dealt with in matters of years as opposed to months so the longer there is confusion on these matters, the more difficulties there will be. I would have thought that a basic position would have been what the Government's position on or understanding of the regulation was when it was first agreed. That would have been useful. Was it brought it before Cabinet? Was the Cabinet informed about the fact that this regulation was being agreed and that it could have a large impact on businesses, veterinary practices and pharmacists? Mr. Forde spoke about the comprehensive consultation and engagement undertaken by the Department. I am not denying that there has been some but I suggest that it has not been as robust as it should perhaps have been.

I tabled a parliamentary question in July to the then Minister, Deputy Cowen. He responded that in respect of this legislation, the Department was working on the matter and the intention was to have those in the sector designated as responsible persons. Subsequent to that, it transpired that it was either never the Department's intention to do that or we are at a point where it is impossible to do that because the regulation will not allow for a derogation. The focus that should have been there at Department level was not there and we need to get to the point where we are seeking and addressing a regulation.

I have a written response to a question by the Sinn Féin MEP, Chris MacManus, to the European Commission about the derogation. The Commission said that it is up to a particular member state to confirm whether the conditions of the derogation of Article 105(4) of EU Regulation on Veterinary Medicinal Products EU 2019/6 are met. That does not sound like a European Commission that is ready to stick the boot in. I dealt with written responses from the Commission for five years. I know there is a factor of influence in terms of its written responses on these matters. Essentially, what it is saying is that it will trust us to do the right thing. That is what is in this response but the Department is taking the easy road rather than trying to facilitate the businesses and people about whom we spoke. We can hear the passion in these people's voices because it is their livelihoods about which we are talking. They are under threat of closure or of losing their jobs.

We heard other Deputies talk about the impact of this on farmers. We have heard and we know that there are vets around the country who will be handed extra responsibility and business they have not even looked for. They are already under severe pressure. My request to Mr. Forde and the Department is to go back to the drawing board. They are coming at this from a position whereby this cannot be done. They need to flip that on its head and look at how we make can it happen. It is within the Department's gift. All it takes is a strong Government position on this because the Commission will develop a lot of regulations over the next number of years with regard to antimicrobial resistance and other issues and knows that it needs the co-operation and support of member states to be able to have a strong position on all those matters. Do not leave a bad taste in people's mouths in respect of this issue, which would be fairly benign and simple to address. My call is for us to go back to the drawing board and resolve this. It is within our gift to do that.

Mr. Colm Forde

I can only assure the Deputy that we are working as hard as we can with our stakeholders. We are extremely empathetic when it comes to their situation and very aware of their position in respect of how this affects their livelihoods. We have a comprehensive action plan with 37 actions where we are trying to address those concerns. The core objective is to protect the efficacy of these products because they underpin the sustainability of our livestock sector. If antiparasitics do not work, this is a significant problem for us. We need to retain a substantive role for all people who currently supply antiparasitics.

The Deputy mentioned a parliamentary question from July 2020.

I think the answers have been relatively consistent but I am happy to address any follow-up queries. We have said to our stakeholders all along that we do not claim to have all the answers. We are more than happy to accept every single proposal, study them all in detail, work through them with our stakeholders and see what will work. We have been very open about that from the outset. We welcome every opportunity to work with Mr. Terrence O'Shea or Mr. Quinn from Crossmolina. We want to work with these people to find solutions. We will not be found wanting in that respect. However, whatever we come up with must comply with the EU regulation. Our challenge is to act within those legal parameters.

The Department's representatives should sit down with European Commission officials and say that we intend to introduce a derogation in respect of this to facilitate the trade currently carried out by responsible persons. Those responsible persons have legislative standards to which they must adhere. It is not as if we are giving people a blank cheque. We intend to do that and we want to ensure that we are doing it in line with this regulation. I believe the Commission will work with us because it is in the EU's best interests for us to be able to operate with that flexibility.

To be brutally honest and frank, I am very much taken aback. I would worry about where we are going if departmental officials answer a question by saying they are new and were not in post at the time. Bureaucracy and paper trails cause a lot of problems, but all the paper trails are there. If I had only been in a Department for five minutes, I would have my homework done before addressing a committee. If that is the Department's attitude when its officials appear to address such a vitally important issue, it is definitely compounding the problems.

I would like to return to Senator Boyhan's question. I have been reliably informed that a request for an economic impact assessment was made by ILMA. Can the Department confirm or deny that it carried out an economic impact assessment of this regulation's effect on veterinary practices and sales of medicinal products? The witnesses may not know this. They may have to come back to me on another day. I need confirmation of when and why the Department decided not to defend the current distribution system whereby it regulates the trade through responsible persons. That system has been working. MEPs voted for the status quo. Based on the information that has been put before the committee, the Department's vets in Brussels went on a solo run and took the opposite line from that taken by the Irish MEPs. Why and when did the Department change its attitude towards the status quo, which is working?

I am frustrated when I think about why we are here this evening. It seems that a hurdle has been put before us and rather than jump it, we are going to bow down before it. We are going to create a situation where different regulatory set-ups will apply North and South of the Border after Brexit. Every Department is currently working night and day to try get regulations changed, to carry out preparatory work and to put systems in place to maintain as much regulatory alignment on the island of Ireland as is humanly possible. It seems the Department of Agriculture, Food and the Marine is lying down in front of a small hurdle and allowing totally divergent regulatory regimes to emerge on the island. It has been highlighted in the first presentation to the committee.

We have spent the past two weeks discussing a forestry crisis. Prevention is better than cure. If the derogation is not availed of when this regulation is implemented, I can guarantee here and now that whoever is on this committee a year, 18 months or two years from now will be discussing another crisis. They will be wondering how to unravel it and how they got there. We can avoid that by implementing the derogation or something similar to it. Perhaps the legal advice will state that for whatever reason we cannot avail of the derogation. The Department needs to start working to defend the Irish farmer, not working for Brussels. It is time to put on the green jersey. If there is a problem, we must get out there and solve it. There are ways around this. There will have to be. Every other Department is solving problems and changing regulations to maintain alignment. Why is the Department of Agriculture, Food and the Marine not doing the same?

Mr. Colm Forde

I am happy to answer that. I repeat that we have not refused to carry out a regulatory impact assessment. We have committed to publishing findings on the impact this regulation will have on the different stakeholders. I am happy to follow up with the stakeholders on that. I do not understand how that misunderstanding arose.

I would like to make an important point about the situation when the regulation was agreed. If the HPRA task force report had not been issued, these products would still be available without a veterinary prescription. There would have been no change in the process since officials from the Department of Agriculture, Food and the Marine negotiated this file. Nothing would have changed. Irish law has not changed in this respect. The only thing that has changed is our knowledge of the impact of antiparasitic medicines.

The committee has asked what departmental officials were doing at that time. The EU regulation is entirely consistent with our previous legislation. If there was no evidence of resistance to antiparasitic medicines, they would still be available without a veterinary prescription. My veterinary colleague, Ms Caroline Garvan, may be able to tell the committee a little bit more about the HPRA task force report and its findings. The law has not changed. Perhaps we have not made that clear enough.

Ms Caroline Garvan

That is a really important point that I would like to convey as conclusively as possible. The law did not change. The Department of Agriculture, Food and the Marine did not change the law; rather, resistance to antithemolytic and antiparasitic medicines became a huge problem. This is a huge issue for the farming sector, farmers, productivity and sustainability. The change in the route of supply is intended to protect the efficacy of these products, which will benefit the farmer. The resistance is so high out there now that products are no longer effective on farms because they have been overused and misused. As such, no treatment is available. Our focus is to make these products prescription-only medicines to encourage better and more responsible use. We established this stakeholder group to consult with everybody. That is what we have done from the start. We are acutely aware of the economic impact of this change on the rural community. We are doing everything we can to work with farmers within the constraints of the legislation, that is, a regulation that has to be applied as it is worded. Our legal advice is that we cannot avail of this derogation at the moment. We will certainly review all the legal advice that is available to us. We have agreed to consult the Attorney General on this. That is our position. We did not change the law. Rather, the animal health situation changed.

I cannot accept the claim that there is a significant increase in antiparasitic resistance from departmental official.

I will not accept it either. A few members are champing at the bit to ask questions. I would like Ms Garvan to finish and then I will have a few comments to make.

Ms Caroline Garvan

I have finished making my point.

I do not agree with what Ms Garvan has said. I take exception to it. She stated that persons who have qualifications to dispense these medicines are doing so indiscriminately.

Ms Caroline Garvan

I did not-----

Ms Garvan did say that. I was listening extremely closely. She said resistance has built up because of the excessive use of products. Qualified persons are dispensing these medicines. She said they are not doing their jobs properly.

Ms Caroline Garvan

I never said that responsible persons were the drivers of resistance.

These medicines are only sold by people who are qualified.

That is the point. I might take the next two or three members togther in the interests of time. We will have Senator Lombard and then Deputies Fitzmaurice and Ring.

The information we received in the past ten minutes has been helpful. It is about the task force. When the task force produced its report, the game changed. To be honest, we have to look at what this task force is proposing. Let us suppose I went to Riverview Veterinary Group tomorrow morning and got a dose and then I went to McLaughlin's Veterinary Clinic next door. The dose I get in Riverview is not a better product. It is the same product dispensed under the same legislation. As far as I can see, the same person administers it, namely, me. There is no logic in the argument that because a farmer gets it from a merchant rather than a veterinary supplier. The latter will ensure that the farmer administers the product differently to the animal. We are looking at this the wrong way around. If what we are hearing is true, which is that we have an issue that we need to address, then it is the same person who administers the product.

The only way this matter will be solved is if we get a dose for an animal in two years' time and we have a veterinary surgeon to give it. We will be weighing every animal. We will have a veterinary surgeon in the yard. That is the only logical way we can solve this. Does anyone in this room believe that is appropriate? Does any farmer in Ireland believe that is appropriate? Does the Department of Agriculture, Food and the Marine believe it is appropriate? We are at the thin end of the wedge. If we go down this line today and agree that this is the way forward, then we will have a situation where we will not have an industry. We will have plenty of veterinary surgeons because they will be dosing every calf in Ireland, but that is where it will stop. We will have no industry.

This is a major issue. The way we are going about dealing with it needs rethinking. We must consider the competent person who gives the medication, dose, pour-on or whatever. That individual is as competent in a veterinary practice as in a merchant's practice. To have a distinction between them is totally inappropriate.

First, to go back to the comment from Ms Garvan, farmers are not idiots. If something is not working, they are not going to keep giving it. This is because we know what will happen. An animal will die. As bad as farming is, farmers are not going to keep letting that happen throughout the country.

This is the thing about the over-subscribing of medicines. A farmer may go to the vet because he has a cow with mastitis or wants a dose for hoose or worms. The farmer can get the same thing at the vet as he can get down the road. One person gets a piece of paper stating that he needs something for a particular purpose. Is the vet going to come out every time and watch the farmer throwing it down the throat of the beast or giving an injection? The way the Department is looking at this is frightening for farmers. It is absolutely frightening to think that is the mentality because of a task force or something. I am going to ask one thing. Some common sense needs to come into this. Can Mr. Forde say whether the Department is liaising with Europe?

Mr. Colm Forde

We have written to the EU on this question to see whether Ireland-----

No. Is Mr. Forde liaising directly? Who is liasing with Europe?

Mr. Colm Forde

I was in the middle of answering the question. We have written to the EU Commission to see whether Ireland could avail of the derogation that is at the centre of today's discussion, which is article 105(4). The message we got back is that we cannot.

Did anybody pick up a telephone and talk to someone and ask why the Department could not do this or ask about other ways around it? Why have we not gone down the road that the British have gone down, even if there are extra courses? In fairness to all the people who spoke today, they are willing to do this to bring them up to the standard that ticks the box.

I am asking another question now. With the approval of the Chairman and the rest of the committee, we will bring back the officials in six weeks' time. Is the Department willing or prepared to pull back from its position and some of the stuff that has been said here? Are the officials prepared to sit down with the people involved to thrash out a solution that will be good for the Department, Europe, the dispensers and that, above all, solves the issue for the farmers? Let us be honest about what we are facing here when it comes to the small farmer. It is no more than what Deputy Ring spoke about earlier when he referred to Tesco and Lidl. We need to think of the small shop in the middle of nowhere in Ireland. We need to think of the small farmer as well because he will be unable to afford what is coming down the road if we go with what is being proposed at the moment.

I want to know whether the Department is prepared to go back to the drawing board to sit down with these people. There is this business of driving on with regulations. A regulation is a regulation - we all know that - and a directive is a directive. There is a dispute at the moment over Article 105(4). There is legal evidence on the one side and on the other. Let us see how we can marry it up.

There is one thing we need to do. If I am a veterinary surgeon, it is more a question of the medicines I am trained to use as a vet. I am trained in how to do sections and how to do different things. Why can we not get a course like the one the British have available? It brings the suitably qualified person up to the standard. It allows Joe Bloggs in the sticks, where I am from or where someone else is from, to issue it and be responsible. No one is condoning anyone who is not responsible. I will say one thing. At the end of the day it is the farmer who doses his cattle. The farmer gives the injection to his cattle. Farmers do not go around willy-nilly deciding every week to throw this or that into their livestock. Every farmer knows to change the dosing as he goes along. I have no wish to see us going down a road where there are vets coming in day in and out to farmyards. I appeal to the Department to re-examine this matter in its entirety. Everyone should pull back from where they are. Everyone should sit down with the people who are acting responsibly and who are involved to bring out a solution. This can be done in a week or two.

That was one of the issues I was going to raise. The officials need to sit down with the stakeholders immediately - not next month or next year - to see whether something can be done to work out an agreement between the stakeholders. We need to consider the interpretation of the European rule. Ireland always has to go ten steps more than everyone else. Someone who spoke earlier was quite correct. In France and other European countries the way they interpret European regulations is different from how we do it. It is a bit like the lockdown. We have to go ten steps ahead of everyone else.

I will offer one example and finish at that. Many years ago, the Department made a decision that it wanted small abattoirs closed, and it succeeded. The Department paid the local authorities to have vets. All it did was break the hearts of small employers in the country. The Department destroyed them. Every time a vet came in, it would cost them so much that they had to get out of business.

What did we see last year? I am not a farmer. We have seen what the bigger factories have done during the past 20 years. They are now controlling the price of beef and the price of food. The same thing will happen here if we do not have competition in the market. What will we do? The vets will be signing the documentation and they will be selling it in the same place. That is not on.

This is my final point. The Department is not able to control what it has to control. It is now going to create another problem. How will the Department control medicine coming in from Northern Ireland that is being sold by people who are already selling illegal goods in this country? The Department will hound the farmers and the chemists but will allow the people who are bringing this medicine in to continue. It is a like what I said earlier about cigarettes. The authorities get thousands of cigarettes coming into the country every week, but they are only the ones seized. Others are being brought in all the time. How is the Department going to control that? Is Europe putting the pressure on the Department or is the Department putting the pressure on?

I have a question. Every bullock that is killed is tested for residues, as is every litre of milk that is processed. Thankfully, the level found is very low. This shows the responsible way in which the products are being used. Several years ago factories started giving us post mortem reports on animals killed to show the effectiveness of the dosing regime at farm level. That has been a significant initiative as well. We saw from the post mortem whether we had a worm or a fluke problem. The farmer could then talk to his vet and discuss the issue. Significant structures are in place.

As others have said, they are perfectly prepared for what they do to be regulated and if there is an extra course that they need to do, they are prepared to do it.

Reference was made to competition. Competition and the cost of the products are at the centre of the issue. We will destroy competition, increase the cost to the primary producer and I am yet to see where there will be a gain for the consumer. Ultimately, we should be trying to achieve a gain for the consumer but I cannot see how this extra bureaucracy will facilitate that.

Mr. Colm Forde

On the views shared by members, we are in full agreement that there are huge challenges with this regulation. We are also absolutely committed to working with all the stakeholders and on how we address them. Deputies Fitzmaurice and Ring made comments about meeting the stakeholders as soon as possible. We are already proactively engaged in that regard and have been since last year. There have been two meetings of our antiparasitic stakeholder group and it is planned that a third will take place in a couple of weeks. I assure the committee that we are working with the stakeholders as closely as possible. I mentioned the action plan, which contains 37 actions and with different subgroups responsible for these. All the stakeholders are invited to be part of those groups. We can share the action plan with the committee if it wishes or provide greater detail later. I assure the committee that we are working with them all and that we are acutely aware of potential competition issues. How we address that is dealt with in five or six of the actions in the plan. I hope that provides some comfort.

On interpreting legislation, we must take advice from our legal services team and the Attorney General. We will work with all our stakeholders in what we can do. On what other jurisdictions do, it is notable that Ireland and the UK have until now been the only countries in Europe that provide antiparasitics without prescription. Every other country in the EU requires a veterinary prescription to access antiparasitics.

The North-South challenge is something we are acutely aware of and something of which our stakeholders have made us aware. We have a close working relationship with our colleagues in Northern Ireland. We had a video conference with our colleagues in the UK Veterinary Medicines Directorate who have responsibility for regulating activities in Northern Ireland. We agreed that we would draw up a memorandum of understanding about how we will address this issue with suitably qualified persons. If a suitably qualified person in Northern Ireland was to provide medicines to a farmer in Ireland, that individual would have committed an offence. We will have protocols whereby we can inform of such things happening. Where there is a border, any economic activity in Ireland will have different laws and regulations and how that is managed is a challenge for both jurisdictions. I assure the committee that we are working with our Northern Irish and UK counterparts on how we address that matter.

On residues, I agree with the Chairman that it is an excellent programme and that the results in recent years show how safe the Irish food market is. Whenever people from third countries visit Ireland on trade missions, they always ask for a presentation on our residue programme. It is something that we can be very positive in informing them about. I think the Chairman was talking about food safety for the consumer whereas our concern with antiparasitics is really for the farmer. The scientific evidence shows us that many of these products simply are no longer working, so it is in all our interests to use them as prudently as we can to ensure that they are there to the benefit of farmers. That is not to blame anyone in the supply chain. That was not suggested by my colleague or in any report which was put out, rather to say that we all need to work together to ensure that they are used responsibly. That is also addressed in our action points. We want to work with responsible persons, with vets and farmers, to improve everyone's knowledge about how these products should be used as effectively as possible. That is in everyone's interest.

I hope I have addressed the points but I am happy to deal with any further issues.

Many of the questions I wished to pose have already been asked. The Department of Agriculture, Food and the Marine should be protecting the farmer. The farmer will be hard hit. The sector cannot take the hit at this point because it has taken many in recent years and is facing into very worrying times with the advent of Brexit. From what was said earlier, I gather that this is not a European directive but that the Department is pushing it. Is that the case?

Mr. O'Shea from west Cork made an excellent contribution. Has the Department estimated how many jobs may be lost if this goes ahead in its current form? We have heard from others that policing the Border against illegal movement of VMPs from the UK into the Republic will prove impossible. Mr. Forde said it would be policed very well but I cannot see how the Department is going to police it. How does the Department view the repercussions if a prescription-only service from vets is set up here whereas over the Border a suitably qualified person will be able to prescribe and dispense for free?

It is outrageous and reckless of the Department to try to pursue such an agenda. The Department of Agriculture, Food and the Marine should be standing up for farmers and rural Ireland. Rural Ireland is on its knees. I do not know if any of the officials is from rural Ireland but I can assure them that businesses there are struggling to keep workers on their payrolls. Farmers cannot take any more financial burden. It is absolutely reckless. I support Deputy Fitzmaurice's view that the Department needs to go back to the drawing board and work with everyone on this in order to protect jobs, protect rural Ireland and not place another burden on farmers.

A point was made in respect of the derogation. I understand that this derogation can be sought and should have been sought in 2019. It was stated there was a legal opinion on the derogation. What was this? What stopped the derogation? Did it prevent the Department seeking the derogation in 2019?

The EU confirmed in a written reply to vets their rights to prescribe as follows. As a rule Regulation (EU) 2019/6 gives a veterinarian exclusive right to prescribe veterinary medicines. However, Regulation (EU) 2019/6 provides for a derogation to that general rule in its article 1054. This contradicts the Department's assertion that only vets can write prescriptions. How do the officials respond?

I understand that if the regulations are brought in by the Department that they will wreck rural Ireland and overburden farmers, causing job losses but that they will also be in breach of EU Directive 2019/633. What is the officials' response? It is very serious that they would be so reckless with this. I cannot understand it. Farmers have a very good relationship with their agricultural merchants which has always worked well. If it is not broken, why fix it?

To follow up on something Ms Garvan said with regard to there being some medicines to which animals have developed resistance. She is a qualified veterinarian. Can she name some examples of those medicines?

Are our permanent representatives in Brussels meeting the Commission to discuss this issue? If so, how many meetings have taken place in the recent months? What position has been reached as a result? What reasons have been given for Ireland not obtaining a derogation in respect of the regulation?

I asked the witnesses who appeared earlier about the alleged monopoly relating to existing prescription vet-only medicines and the cost of such medicines. They said that the prices have increased by quite a percentage. They gave the example of sheep dip and how much that would increase were it to require a prescription.

What investigation has the Department carried out in respect of the shortage of vets? Vets are very busy people. I come from a farming background. Vets spend a great deal of time out on the road testing cattle, seeing animals or whatever as opposed to in their practices. Now, like doctors, they will have queues of people waiting to get prescriptions.

A person might not be able to get a prescription there and then. He or she might have to wait two or three days. We are going in reverse. Perhaps, Ms Garvan will comment on those issues. I am interested if Ms Garvan has a list of the medicines she is concerned about to which resistance has built up.

Ms Caroline Garvan

Considerable research is out there in terms of examples of the medicines. Teagasc recently published a paper. There are very high levels of resistance in sheep to the white drenches. There are levels of resistance to the clear treatments, which are the ivermectins. There are also indications of resistance of up to 60% to levamisole, which is the yellow drench.

We have five classes of medicines all based on colour. Research has shown, however, that resistance has developed within seven to eight years of these products coming onto the market. The parasites want to survive so they develop this resistance to combat the medicine. There is, therefore, evidence of resistance to those three classes in particular, namely, the white, yellow and ivermectin families of treatments. The level of resistance out there is frightening. We only have to look to the research to find that. Teagasc has done extensive research nationwide on this on the dairy to beef farms and found the levels of resistance increasing. It did a study in 2015 and went back in 2019. The resistance had jumped from 60% to 100%, in particular, with the white drenches. The information is readily available.

Just to go back to the Deputy's query about the financial burden on the farmer, of course, we are extremely concerned and aware of this impending change and burden on the farmer. There is, however, also the perspective that if the right medicine is used, the animals will not suffer or get scour. They will thrive better so they will finish quicker. There is, therefore, a cost benefit to the farmer and to everybody if we use them based on best practice. This best practice will be adopted and developed through the stakeholder group. It will be adopted by vets, all the key stakeholders and farmers. Guidance will be developed for everybody to improve the use of these products in the sector and improve the picture of the resistance. That is where we are trying to get to and the end result will be less of a financial burden on the farmer.

The other thing I want to come back on is that because it becomes prescription only, the vet does not have to administer the medicine or go onto the farm every time a farmer needs it. A prescription is issued as a one-off and the farmer is then free to go wherever he or she so chooses to get that medicine. The Deputy will be aware, in most cases, it is not an immediate treatment. It is prescribed over the grazing period. A person, therefore, gets the prescription on day one and can go to his or her licensed merchant whenever he or she needs that product. The person is not duty-bound to buy it all from the vet at that time. The Department has never been of the view the vet must administer this treatment. This was never in our view because we understand the cost and practicalities of getting a vet on the farm. Prescription-only medicine does not mean the vet administers the medicine.

Deputy Leddin wishes to ask a related question.

I have not yet spoken and we have limited time. We must leave in a few minutes. This is, however, related to Deputy Kehoe's question. This is probably a question for Ms Garvan given her scientific background. She spoke about the medicines that are particularly affected here but will she elaborate, perhaps, on the reasons we have this increased resistance and this serious situation in which we find ourselves? I am especially interested if any of the witnesses can confirm or otherwise a correlation between farm practices, stocking rates, herd numbers and so on and this situation of increased resistance.

Ms Caroline Garvan

The reason we have the increased resistance is because of the way we have been using these medicines. That is the bottom line, really. There are certain practices that need to be followed to use these medicines responsibly and to get the best possible outcome. There are practices such as refugia where not all the animals in the herd are treated at the one time, so a naive population of parasite is maintained on the farm. Grazing management is key. One does not dose and move to a clean pasture. These parasites only affect the younger animals, so it is all about the grazing system. There is also the quarantine element when buying in animals. They should be quarantined so that they are not immediately exposed to the parasites within a herd on the pasture.

It is a very complicated dynamic, but the bottom line is the more we use the medicines, there will be a certain development of resistance. There is also the issue if we continue to use them incorrectly or at the wrong time. For instance, a white drench must be used for treating nematodirus in sheep. It should not, however, be used later in the season because it will not affect adult worms. All these things must be borne in mind. If best practice is not followed, resistance continues to develop over time, as we have seen with antimicrobials. The more a treatment is used, the more whatever is being treated develops mechanisms to become resistant.

Sorry, Chair. I did not get any answers to my three questions.

Mr. Forde will speak now.

Mr. Colm Forde

I was going to come in on that. The Deputy will have heard different interpretations of Article 105(4) today from other witnesses. Our interpretation, however, is that it allows member states to continue to allow people other than vets to issue prescriptions if they had such mechanisms in their national legislation prior to January of 2019, which was the entry into force of this regulation. This regulation came into force in January 2019.

As I stated earlier, Ireland has never permitted anyone other than a veterinarian to issue a veterinary prescription. The products were allowed to be dispensed without a prescription. The legal advice we have, which we said we would follow up with the Attorney General's office for absolute clarity on it, is that Ireland cannot avail of that derogation 105(4).

Views were also expressed that this regulation is being driven by and is a choice of the Department of Agriculture, Food and the Marine. We have been at pains to stress to our stakeholders that there is no national discretion on this. It is written in EU legislation and has direct effect. There is no room here for Ireland to choose whether to comply with it. People have raised questions of legal interpretation and, obviously, we will seek to get that as best we can but there is no national discretion. The way we see it, we must comply with the EU law. I hope that has answered Deputy Nolan's questions.

No, I asked another question.

I believe we will have to bring the officials back in for another session because a few statements have been made that I find contradictory. We have a two-hour timeframe which the Ceann Comhairle told us we must stick to rigidly. We will not get to finish this debate.

Can I make a 30-second point?

Deputy Browne did not speak yet, in fairness.

Okay, I did not realise that. I thought all members had spoken.

I will let Deputy Carthy speak.

I will have to close the session. We must do one or two things in private session and we will not be able to conclude this debate.

It goes back to the earlier point. Mr. Forde said the regulation does not allow for the derogation to be used. From my knowledge, the regulation was supported by the Irish Government. Mr. Forde needs to find out who in his Department advised an Irish Minister to sign off on that regulation and sack that person because he or she has created a complete mess. It is that serious.

Deputy Carthy has made his point. Senator Daly has been trying to come in for a while.

We were in the middle of answering my questions when we got sidetracked based on some of Ms Garvan's comments. It is important, and as a farmer I have to put it on the record, that Ms Garvan's in her last answer on the problem did not say any one thing that would not have been said in a conversation between me as a farmer and the responsible person in the licensed merchants who supply me. We are here today to talk about the regulation. We all know about antiparasitics. That is what Ms Garvan explained. What effect does that have on the regulation? As I said, the responsible person in my merchant would have told me everything about the issue and problem when telling me which was the best dose for me to use.

One thing needs to be clarified for the record of the committee, and we need to live in the real world. I am a farmer; there are plenty of farmers here. A person will not go to the vet and say, "Give me a prescription; I will use it somewhere else down the road." We would be living in cuckoo world if we believed that. Let us get real about it. There is an onus on a person if the vet is testing his or her cattle and is doing everything else, only for the vet to see him or her going down the road.

This does not work that way. That is not how rural Ireland works. That is why the prescription is the big problem. We need the alternative of training a person, bringing them to whatever standard is required and give them a timeframe to get to that. That could be a good solution to cover what the witnesses are on about.

We will not get this finished because I am under strict instructions to finish within two hours. We had a meeting with the Ceann Comhairle and we were given strict orders. I get growled at here from my left as well. There are huge anxieties, worries, concerns and misgivings about the route we are going. The witnesses have been asked a lot of questions. We will have to have another session on this. It is significant issue for the agriculture industry. Everyone is raising issues out of genuine concern. All of us as public representatives are getting many representations on this issue. There are major concerns about issues such as animal welfare, the availability of vets and the lack of competitiveness. We can get into residues and, as I said, the post-mortems in factories are a huge factor in showing whether dosing regimes are working on farms. We have a lot more work to do on this.

I thank the witnesses for their presentations. Strenuous questions were coming in from the floor but that came from the anxiety and concerns we have about what is being proposed.

Do we have time to go into private session? I am told I have to adjourn. There are issues to be dealt with in private session. We might organise a Zoom meeting to deal with them. Is that okay? We will not do it this evening but in the near future. We are meeting next Tuesday at 4 o'clock. We might try to do it at 3 p.m. or 3.15 p.m. and have a half an hour before the meeting. We will say 3 p.m. because we have a few items to address. Is that agreeable to everyone?

3.15 p.m. or 3.20 p.m..

No, because we cannot be in the room for more than two hours.

Can we not jump out again for five minutes?

That will not work either. We will do it on Teams for at 3 p.m. on Tuesday.

The joint committee adjourned at 6.02 p.m. until 4 p.m. on Tuesday, 17 November 2020.