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Joint Committee on Agriculture and the Marine debate -
Tuesday, 23 Mar 2021

Regulation of Veterinary Medicines: Discussion

I welcome the following subject matter experts to the meeting: from UCD School of Veterinary Medicine, Professor Simon More and Ms Catherine McAloon; and from Animal Health Ireland, Ms Finola McCoy. We have received their opening statement, which has already been circulated to members. As we are limited in our time due to Covid-19 safety restrictions, the committee has agreed that the opening statements will be taken as read so that we can use the full session for questions and answers. All opening statements are published on the Oireachtas website and publicly available.

Witnesses are protected by absolute privilege in respect of their evidence to the committee. However, if they are directed by the committee to cease giving evidence in relation to a particular matter and they continue to so do, they are entitled thereafter only to a qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and they are asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against any person, persons or entity by name or in such a way as to make him, her or it identifiable. Participants who are in locations outside the parliamentary precincts are asked to note that the constitutional protections afforded to those participating from within the parliamentary precincts do not extend to them. No clear guidance can be given on the extent to which participation is covered by the absolute privilege of a statutory nature.

I now invite questions from members.

I welcome Professor More, Ms McAloon and Ms Finola McCoy and I thank them for their very comprehensive submission. The only problem I had was that, as a layman, I struggled with many of the medical and technical terms. I had to read much of the detail a second time. The submission was based mainly on the antibiotic stewardship of the dairy industry. It related more to antimicrobial resistance than antibiotics. I ask for the Professor More's opinion on antiparasitic resistance since the directive we are considering proposes that antiparasitic veterinary medicines become prescription only. Where do we stand with antiparasitic resistance? What benefit would there be to us making antiparasitic veterinary medicines prescription only?

Professor Simon More

I thank the Senator for his questions. We come here specifically to provide scientific perspectives on intramammary antimicrobial use. I do not want to stray that area because it is not one in which we are subject experts. The whole purpose here is to provide scientific advice in those areas in respect of which we have expertise.

I thank our guests for their very comprehensive statement. They compare Ireland with Denmark and the Netherlands in some detail. I take it that is because those two countries would be considered to be operating best practice. At several points in the submission, they mention that Ireland is many years behind both countries. The table provided is very useful. Some of the stewardship measures in the Netherlands have been introduced fairly recently. Will Ireland remain years behind no matter what or is it possible for it to advance some of the measures that have been outlined as important in the fight against antimicrobial resistance in a speedy timeframe if the measures were agreed at a political level? In other words, is the infrastructure in place to allow us to do this sooner?

Much of our debate on this EU regulation has focused on the potential impact it will have on licensed merchants and others who currently distribute some products. The witnesses' analysis suggests that Denmark is the flagbearer for best practice. I understand that the distribution of veterinary medicines in Denmark and Sweden is very similar to the primary care system that operates here in Ireland for human medicine. In other words, there is a separation of prescribing and dispensing of veterinary medicines. Should we examine that model for Ireland to ensure there is a multi-stakeholder approach as has been advocated by the Health Products Regulatory Authority, HPRA, and the Chief Veterinary Officer, CVO, and also remove any potential financial incentive for somebody to overprescribe? I am not suggesting that is a widespread practice, but it is always possible somebody will do that.

Professor Simon More

I thank the Deputy. I will seek to answer these questions and then I might ask my colleagues to follow up. In response to the first question, certainly Denmark and the Netherlands are leading. We did not choose them solely for that reason. It was also because, as I stated in the footnote on page 3, the dairy sectors are quite similar in having a very strong export perspective and also a focus on the highest-quality product, for example, with infant formula.

The Deputy asked if we would always be behind those countries. I certainly hope not. I think they provide factors critical to success and they are fundamentally focused on an integrated, proactive, forward-thinking approach. Even the Dutch, who came later, have rolled it out over a ten-year period. We do not have that much time.

Regarding the critical factors for success, some of them, for example the banning of preventive use, will happen anyway because of the new regulation. The national database will also happen; Ireland is required to enact that. We have an opportunity to introduce benchmarking nationally by sector, by farm, by prescriber. We need clarity on the level of veterinary oversight. I believe they provide international best practice about what that means, including a one-to-one relationship between vet and farmer, mandatory veterinary visits which could be timed with other veterinary visits of course, an annual evaluation of plans, treatment guidelines, national targets and restriction on these highest priority critically important antimicrobials. I absolutely believe that we can catch up, but we need to move to this proactive approach.

In the paper, I highlight some decisions that have been made in the past and are still active, which we believe really constrain progress. They essentially do not really address some of the hard questions we need to address.

Deputy Carthy spoke about decoupling. Veterinarians have differing objectives that relate to both the welfare of the animal and also the business reality. That is accepted. Different countries have taken different approaches, such as, for example, Sweden and Italy. My understanding is that vets in Italy cannot sell veterinary medicinal products. In Denmark, the approach is different in that the percentage of profit that can be made from those products is capped at 5% to 10%. The Dutch, who did a detailed review back in 2011, took a completely different approach. They decided that the best way forward was to have prescriber benchmarking and one-to-one relationships. Essentially, this means that detailed information is necessary in the level of veterinary oversight. These are all different approaches to the same issue.

I thank the witnesses for the fine statement they forwarded to members before the meeting. I have one brief question. Faecal egg counts are used to determine the impact for farmers of the development of resistance of parasite burdens. Is this best practice? Is it the gold standard or are there other ways to use these tests in isolation?

Professor Simon More

That is a question on antiparasitics. I do not want to cover it because it is not our area of expertise. We could say the same thing about the tests that are used as part of a farm investigation or about data that is collected with respect to mastitis control, which is where we are coming from today. Our firm view is that a level of veterinary oversight on intramammary antibiotics is critical and, therefore, test results are important with respect to those. As we highlight and argue in our paper, it is important to have detailed veterinary oversight of the mastitis situation. I hope the Deputy can understand that we are not here with expertise on antiparasitics but we are here to discuss another area that is critical to veterinary medicines, namely, the prescribing of intramammary antibiotics. In Ireland, that is different from other member states and will need to be considered carefully in light of the new veterinary medicines regulation.

Deputy McNamara indicated that he would like to come in.

I meant to indicate that I wish to speak later in the meeting. I have a question on the legislation and the legislative regime.

I thank the witnesses for participating. Could they elaborate on the prescriber benchmarking and what they mean by that? Would they have a concern if there is a different regime being used north of the Border, which for many farmers is only walking distance across an invisible line? Are they concerned that we should be in line with each other, North and South, to achieve the best outcomes for our farmers and the industry? I note the mention of Denmark and Netherlands in the submission. The witnesses talked about veterinary practitioners and one has to look at the smaller farmer as against the bigger farmer. The witnesses are not bothered about cost but do they think there is a danger that it will cost smaller farmers an awful lot more because the bigger guys will be getting more stuff? If this goes down the road that it seems to be going down, would the witnesses recommend that it would be better to have a separation, as Deputy Carthy pointed out earlier, such as in the example of a doctor and a chemist? One could get the prescription in one place and get the medicine in the other. It is hard for a farmer to walk into a veterinary practitioner's office and ask for a prescription and then walk down the road and get it at the local co-operative, for example. What are the witnesses thoughts on that for the benefit of the whole industry?

Professor Simon More

I might pass the second, third and fourth questions to my colleague, Ms McAloon, but I would like to tackle the first question on prescriber benchmarking. What has happened in Denmark and, in particular, in the Netherlands is that they set up systems to capture prescribing data. That is first used to understand how much antibiotic is used and then to benchmark. This means that they are seeking to understand the situation at national level, then at the sectoral level, then at the level of the prescriber and finally at the level of the farm. I will focus on the prescriber. They capture prescribing data electronically and then for each prescriber in the country, after taking account of the type of farms they prescribe to and of the species involved, such as, for example, pigs versus cattle, they are then able to determine who prescribed the heaviest 10% of product. These are the people who they then spend some time essentially talking through the prescribing practices with in order to try to see why it is that they are such heavy prescribers.

These prescribing targets, which are farm and prescriber targets, have proved to be one of the critical factors for the Dutch, for example. They set a target of reducing the amount of antimicrobial medicinal products used in food production by 20% in 2009. By 2011, they had dropped it down to 50% of 2009 targets and by the time they got a little bit further, they said they could reduce the total amount of antimicrobial medicinal products used in the country by 70%. They have continued to drive down antibiotic use without any effect on the safety of animals. That is important because if we think of the farm to fork strategy of the European Commission, it is seeking a 50% reduction in antimicrobial usage in farm animal production by 2030. The Dutch, Danes, French, Germans and a number of other countries are dramatically reducing antimicrobial usage. That has not happened here yet. This is a critical factor for success in us being able to do this.

Before I pass to Ms McAloon to answer the other three questions, I will highlight why this is so important. It is important because there are antibiotics being used in the dairy production sector in Ireland at the moment that are among the few alternative products left on the market for the treatment of severe sepsis and respiratory tract infection in people. This issue of seeking to drive down antimicrobial usage in the food sector is important, both in legislation and from a moral point of view.

My colleague, Ms McAloon, will answer Deputy Fitzmaurice's other questions.

Ms Catherine McAloon

I will add a few points to Professor More's response to Deputy Carthy's original question. On whether we can do it quickly, much can be achieved if we have an agreed motivation and a collaborative approach within the sector across all levels of industry. On the regulation and change that will be required to the status quo in prescribing antimicrobials related to mastitis, there are certainly things we need to do, some more urgently than others. There is currently a gulf between the legislation and the mindset among both vets and farmers and an understandable fear as we move away from blanket dry cow therapy. Ultimately, there is a need to address communications and frame this legislation as positively as we can because the narrative around opportunities to improve our prudence in antimicrobial usage and in addressing quality to reduce the need for antimicrobials in the first place, provides us with a real opportunity to keep pace with our competitors.

During discussions in CellCheck we have looked at whether those things are achievable, such as a communications strategy that could be co-ordinated nationally in upskilling vets and farmers. The targeted advisory service on animal health, TASAH, dry cow consults that CellCheck has implemented have been very successful as reported by vets and farmers alike, so the framework for some of this is already in place. We are told that on increasing the need for milk recording, infrastructure could be put in place quite quickly. There is certainly a positive opportunity there if the collaborative effort is agreed and the motivations are brought in line.

I thank Deputy Fitzmaurice for his questions. I will elaborates on the issue of bringing us into line with Northern Ireland. There are a couple of points on this. Our industry is quite different in that it is manufacturing-based with milk supply contracts, milk going into infant formula and niche markets that are quite different from sales north of the border. With that in mind, and trying to protect and promote the market we have in infant formula, there is a real need to move with best practice in antimicrobial usage and prescribing. Ultimately, mastitis is quite farm-specific and the epidemiology of problems relating to mastitis is quite unique and specific to farms, which means we need bespoke solutions for them. It is certainly possible to apply best practice and that is what we should strive to do in prudent antimicrobial use within the dairy sector here. We need to push on and achieve that.

On the question relating to cost, it is a very valid concern among farmers. The overall point of this regulation is to reduce antimicrobial usage but also to move towards more prudent use. Regardless of who sells the antimicrobial, the national goal is to reduce usage overall through a co-ordinated effort to improve milk quality and reduce the need for antimicrobials. Mastitis is a very costly disease. Teagasc has reported a difference of €20,000 in farm profit between a bulk tank cell count of 100,000 compared to a bulk tank cell count of 400,000. There are significant costs associated with individual mastitis cases and overall, if done properly and safely, reducing mastitis on farm and the need for antimicrobials, will be a cost benefit in the long run.

Ms McCoy may be able to add some further points on this, but the idea of where we can purchase drugs is not necessarily something we can comment on in terms of scientific best practice. The Danes and the Dutch, who are both very successful in their quest to reduce antimicrobial usage in their dairy sectors, are operating different models. From the scientific point of view, our focus will certainly be on bringing prescribing in line with best practice.

I have one short additional question. Can the same results be achieved if a person was suitably qualified and trained? When Ms McAloon mentioned two different countries, is she saying that so long as the person has the proper training, and the farmers work with them, it is achievable?

Ms Catherine McAloon

I am saying that our current prescribing practices are out of line with international norms and international best practice. Our focus, particularly within the document supplied, is really on the overhaul of prescribing practices as opposed to sales. Prudent prescribing and the need to change and address our current status quo in prescribing for intramammary antibiotics will be necessary to bring us into line with best practice.

I welcome our three speakers. This is very informative. Their presentation took much of the technical jargon out of the process and that is greatly appreciated. I will probably echo what many other speakers said in that I have concerns that the proposals, as set out, for the veterinary medicines regulations will increase costs for farmers. Ultimately, farmers and everybody on this committee are absolutely determined to ensure best practices. We are very proud of our food production in this country and, indeed, farmers are very proud of it. We are also very proud of our commitment and track record in animal health and welfare. Unfortunately, if there is a cost factor and costs are driven up, the animal will suffer ultimately, which would be a retrograde step.

We have not touched on the risk of displacement in our rural communities. There are many businesses for which the core part is the sale of antibiotics. Several of my colleagues have alluded to models in operation on the Continent that could perhaps be replicated here. I appreciate it is not part of the witnesses' remit to speak to those issues. However, it is important that Veterinary Ireland is aware of my preference, and the preference articulated by many of the farmers in my constituency, which is for a model similar to that available in some EU countries. If we have to fully comply with the regulations as set out, there has to be a model in place, similar to some EU countries, where there is the opportunity to get a prescription but also to buy at an alternative outlet.

Professor Simon More

I reiterate the critical point made by Ms McAloon that our focus is very much on seeking to ensure prescribing meets international best practice. We appreciate that sales are a different issue, but it is prescribing we wish to focus on. I will pass to my colleague, Ms McCoy, who may have additional comments to make.

Ms Finola McCoy

I will come back to the concern over cost increases. I would argue quite the contrary. Our goal, and the aim in all that we do, is to support farmers to get the best outcomes. The changes or opportunities we face include required change under legislation in how antibiotics are prescribed. That will be required . As an industry, what we can do collectively is support farmers through that transition because supports and help will be necessary. There is also an opportunity as part of that, as outlined by Ms McAloon and Professor More, to improve milk quality overall. That brings with it a financial gain.

We are talking about reducing the need for and, therefore, the use of antibiotics. That comes with financial benefits. We are also talking about improving efficiencies and overall mastitis control on farm. That comes with financial opportunities and benefits. Blanket dry cow therapy is the practice of giving all cows an antibiotic tube at the end of their lactation or at drying off.

For some of those cows it is a necessary treatment, but for the other cows, this is done just in case, and that just-in-case use of the antibiotic is no longer acceptable under new regulations. From talking to farmers who have successfully moved away from what we refer to as blanket dry cow therapy, they are all extremely happy they have done so for various reasons, including cost savings, but also, and I do not think we should underestimate this, the ease of management and reduced stress levels of managing such a herd the following spring. Whey they implement that change successfully with the correct supports from their service providers, it is a success and yields benefits in terms of costs. I do not think we should assume this will cost more. It has the potential to save farmers money.

I am pulling my hair out listening to this debate. Do the witnesses not think there has been a complete lack of joined-up thinking when it has come to dealing with this issue? We are talking about cell count in a farm setting. One of the two things that have been mentioned is milk recording. What have we done with milk recording in recent years? We have put a VAT rate increase on it. We have a very low percentage of farmers who take up milk recording, something like 40%, and although we are trying to increase that figure, we have decided to put a tax on the practice. Where is the joined-up thinking in that scenario? Milk recording is valuable to all farms, not alone for calculating cell count but for production and calculating the amount of solids all the way through the process.

On the available equipment, we talk about dry cow and mastitis but nobody talks about things like cluster flush. If a person puts a cluster flush product into a milking parlour, it reduces the cell count at a dramatic rate because there is peracetic acid going through the unit every time before it goes to a cow. As a dairy farmer who went through a problem this spring in my milking parlour, and trust me, I had black hair a few months ago, it is the most stressful period of a person's life trying to control it, and I had a wonderful vet who went through the entire milking process with me one evening because I thought I was going mad. The lack of joined-up thinking in the entire Department in terms of what is required to reduce cell count is the most frustrating thing on the farmyard. We should reduce the VAT rate on milk recording. We should be talking about the peracetic acid and dipping cows so one cow does not transmit an infection to other cows. That is where the big business is for me regarding trying to control the cell count issue.

When it comes to the actual therapy required, the witnesses are right. It is important we have the ability to dry cow tubes and-or a cow depending on what cow has what issue. The only way to do that in many ways is to have milk recording, and we have gone the wrong way around that. In fact, we have gone the other way. If a person goes to a farm discussion group tomorrow morning, others at it will say their milk recording bill is going up and will ask if it is viable. Have we any concept of what is happening on the farm itself? Where is the joined-up thinking? Because of that, we are losing the argument at the farm gate. All the information packages in the world will not deliver it until we start talking about the infrastructure that is required. I personally believe things like dipping clusters from one unit to the other is the key. That is the ultimate. It has not been mentioned here yet today. If that is done, it actually reduces the cell count in the tank by up to 300,000 straight away, and I have experience of this. It can go from 500,000, when there is a serious problem, down to 120,000-130,000 in a matter of days because the infection is actually limited.

That is the kind of conversation we need to have. An awful lot of issues need to be thrashed out here. We are only seeing a part of the debate here today. I want to see a real campaign on milk recording, and the only way to do that is to do something about the price and to have a campaign on it. The infrastructure, what is required on a farmyard regarding the milking parlour system, is probably the most important thing of all. I thank the Chairman and apologise for my tone.

I welcome our guests. They all have made a good argument and I compliment them on that. Senator Lombard has covered this issue very well. He has the practical experience of farming - I do not - and he has raised some of the issues that I had intended to raise.

I have two quick questions. They may not be fair questions but I will put them to our guests anyway. I feel and farmers feel they are over-regulated in this country. Are we over-regulated? Why do we always start with where it is going to affect the farmer? Why did the organisations not start by taking on the vets who prescribe the medication for animals? Why does it always have to be the farmer who has to pay the price? Why do we always start at the bottom in this country and not at the top in bringing in regulations? It reminds me that when it comes to Covid-19, every other illness does not matter now. There is only one illness in this country that matters now and that is Covid. People who are dying with cancer, who have mental health issues and every other kind of an issue do not seem to matter now.

Will there not now be a major monopoly with vets prescribing and selling at the same time? We are all human beings, and if there is a profit to be made, naturally enough, they will try to make that profit. I am from rural Ireland and we are finding it hard enough to survive. Farmers and chemists are finding it hard enough to survive, yet we are regulating both out of business now. It seems to be the professional classes looking after the professional classes.

Deputy Nolan is the last speaker and I suggest she asks her questions before we return to the witnesses.

I want to take up one of the points Deputy Fitzmaurice raised when he asked about the alignment in terms of this regulation and why it cannot be aligned with the North. I would expect to have more details on that. Were surveys carried out to see if this is possible? Have the witnesses borne in mind that it may lead to medicines being sought illegally, which will lead to animal welfare issues? Have the witnesses borne in mind that England has a good system? I cannot see how we could be very different from England. I find it hard to believe and I would like to see some reports or research on that which would show that clearly.

In terms of the points that have not been taken on board here by the representatives present, and I thank them for their presentations, any changes under this are going to lead to serious inconvenience for farmers. If something is not broken, why fix it? What is in place is working very well and farmers know their agri-merchants well. While I support the need to reduce the use of antibiotics, I just find it hard to fathom that the representatives have not thought about the job losses. We are already facing huge job losses with the pandemic and Brexit. There is employment in rural communities where there would not be anything else other than the local agri-merchant, and 3,000 jobs are at stake here. It is a system that is working well, and the witnesses say it is not going to work if we align with the North and their system.

I saw one farming organisation out today which has tens of thousands of members who are all farmers, to the best of my knowledge, and they seem to be very happy with it and are recommending we do this and align with the North, which is common sense. I do not buy the answer that was given that it cannot be done. I would like to see more research and details as to why it cannot be done or why we cannot do the same as they are doing in England. I find that incredible.

We need to take on board that it is going to be a serious inconvenience for farmers. I cannot see it being any way cheaper, and it is going to cause animal welfare issues because it will create a black market of people getting medicines across the Border. That is what is going to happen. I hope the witnesses will be constructive and fair minded about this because it is no good when we have issues. I certainly do not want to be a Deputy bringing up that we now have major issues because of regulations that were brought in.

I also hope there will be more engagement with all stakeholders. The cases being put forward are genuine and fair and are coming from farmers themselves and farm organisations which have done their homework and are listening to their members.

Senator Lombard and the two Deputies made some strong points. I ask the witnesses for their final comments.

Professor Simon More

I agree with Senator Lombard about the need for joined-up thinking, a single voice and common objective. That is the most important lesson we learned from the countries that have been able to move, namely, there is agreement and a common objective. My colleague Ms McCoy will speak more on this. We seek a host of things that are necessary to come from many directions towards a common objective. We highlight in the paper some of the past decisions which have made it more difficult for us. One third of dairy farms - about 5,000 - will really struggle with the shift to selected dry cow therapy because they do not have mastitis under the level of control needed. We could greatly benefit from Bord Bia providing an impetus to support the move towards lower cell counts. Similarly, the date adjustment and the interpretation currently used, which I outlined in the paper, mean that it is possible for farmers to continue to supply even if they have a serious problem. They are things that need to be addressed. I agree with the Senator on all the points he raised.

On cluster flushing, the fundamental requirement is a very detailed investigation of the problem, as the Senator spoke of, to ensure that any recommended actions will actually address the drivers of the problem. Also there must be very detailed discussion, as there was in the Senator's case, between the farmer and the investigating veterinarian to agree a plan that is workable and is associated subsequently with review. We would support milk recording. We have a fundamental issue now, as the Senator highlighted, as we shift towards selective dry cow therapy. We need individual cow information. We need to know which cow needs to be treated based on evidence of infection. The simplest and most effective way to do that is through milk recording.

Deputy Ring spoke about over-regulation. Again, it very much highlights the need for a multi-pronged approach, which is what Senator Lombard spoke of. It most certainly does not focus solely on what farmers need to do. There is a whole host of different actions that are important. Many relate to farmers but many do not.

I will pick up on three of the points raised by Deputy Nolan and my colleagues will respond to others. On alignment with the North, obviously it is important to work very closely with our Northern neighbours. We are governed by EU regulation which is what is driving what is happening at the moment. On 28 January 2022, we will need to be aligned with the new veterinary medicines regulation. On serious inconvenience to farmers, the key driver is antimicrobial resistance which is one of the key global issues we will increasingly face in coming years. What we see with Covid now is what we may potentially see with antimicrobial resistance unless we are able to take the actions that are necessary now. Otherwise, we will end up in an era where we no longer have any effective antimicrobials. Deputy Nolan spoke of things we should do. We are very much seeking to provide the committee with as best an understanding as we have of science-based information. Our whole purpose is to hopefully inform the committee about the science. We appreciate that science is only one of the components in the decision-making process, we fully understand that, but we hope that we are able to provide science-based information to help support it in as clear a way as possible.

Ms Catherine McAloon

To respond to Senator Lombard, there can be unanimous agreement on the need for milk recording. That has been shown in other countries which have moved towards selected dry cow therapy where it is a mainstay. Unfortunately, I cannot comment on who will pay for it but it is something that must be done. We are operating at about 50% of the national herd represented by milk recording and the larger farms are over-represented in that. In a recent Teagasc survey among farmers to understand the barriers to milk recording, cost and time were mentioned least. Infrastructure, supports and not understanding its benefits were the reasons they did not engage in it. In addition to having a meaningful campaign around the issue and joined-up thinking, we need to be unanimous on the message of milk recording, delivered by whatever means are necessary.

On the cluster flush, as someone who does a lot of mastitis investigations, and I regularly recommend it, I am pleased to hear about the engagement in understanding the epidemiology of the farm problem and the meaning for change that was turned out as a result. It is a fundamental principle that must be adhered to in delivering this regulation. It is about tackling those problems in a bespoke manner that focuses on the individual farm so that change can be achieved.

A meaningful campaign and joined-up thinking are essential, along with a collaborative approach in the industry so that we get the communication right. There is a fear among farmers about the move away from blanket dry cow therapy. For years, we advised that was the correct thing to do and now, since we understand antimicrobial resistance, we are moving away from that. It requires a monumental sea change in opinion to do this. Even for things such as milk recording, our survey data shows that the understanding of the link between milk recording and antimicrobial resistance is not there at farm level, that milk recording is a necessity in figuring out what cows to treat and which cows are safe to use an alternative such as a teat sealant. A campaign on this and getting the communication right is a necessity. The motivation should not be solely regulation, it is an approach and requirement that is necessary to address the global public health threat of antimicrobial resistance which in no other time has been so well understood by the public and consumer, given the pandemic.

On Deputy Ring's points on regulation, there is scientific evidence that supports the need to move away from blanket dry cow therapy and overhaul our approach to antibiotic use in agriculture. There are also societal pressures. This discussion is coming from the legislative pressure that is there and has put a timeline on it. Yes, the regulation will be difficult and a challenge but ultimately it is a huge opportunity to improve milk quality and up our game in that and to improve our use of antimicrobial stewardship as an industry. That is something which we can promote internationally as part of our brand. There is a significant responsibility on vets as well as farmers to deliver this properly. There will have to be upskilling among vets and industry-wide so that everyone is brought into line and up to scratch to deliver this safely. Benchmarking antimicrobial usage at farmer user and prescriber level usage has been key to the success of the delivery of this internationally.

The idea on benchmarking and whether it will leave us open to an independent audit will be key to ensuring there will not be over-prescribing regarding the issues raised.

I thank Deputy Nolan for her comments. I have a couple of points to make. In terms of the North and the UK system, there are some significant differences. Recent figures indicate about 70% of UK herds engage in milk recording. Their pathogen and profile of mastitis is largely not contagious mastitis, which is what we deal with in Ireland, and which makes dry cow decisions quite different. In addition, there are certain milk supply contracts in the UK in which milk recording and engaging in selective dry cow therapy is something which must be done to sell the milk out the farm gate. It is a condition of supply. Ultimately, the issue of prescribing by a vet is largely similar. In terms of those few changes, we need to be aware we are not necessarily always comparing like with like.

On the final comment made by Deputy Nolan, and I again thank her for her contribution, the key for us is changing the approach to prescribing and prudent usage of antimicrobials which if done properly can only be a positive for the sector. I thank members for their questions and affording me the opportunity to speak.

We are way over time, so I have to conclude this session. We have another session and we have kept the witnesses waiting. On behalf of the committee, I thank Professor More, Dr. McAloon and Ms McCoy for briefing it on the issues around the regulation of veterinary medicines. I thank them for an informative discussion. I propose we suspend the meeting to allow the other witnesses to come online. Is that agreed? Agreed.

Sitting suspended at 7.31 p.m. and resumed at 7.33 p.m.

We are joined by the following representatives of Veterinary Ireland: Mr. Conor Geraghty, president; Mr. Tadhg Gavin, food-animal chair; and Mr. Finbarr Murphy, chief executive. I am sorry for keeping the witnesses waiting. All the witnesses are appearing from a witness room on the parliamentary precincts. They are very welcome to the meeting. We received their opening statement which has been circulated to members. As we are limited in our time due to Covid-19 restrictions, the committee has agreed that the opening statement will be taken as read so that we can use the full session for questions and answers. All opening statements are published on the Oireachtas website and are publicly available.

Witnesses are protected by absolute privilege in respect of the evidence they give to the committee. However, if they are directed by the committee to cease giving evidence in relation to a particular matter and they continue to so do, they are entitled thereafter only to a qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and they are asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against any person, persons or entity by name or in such a way as to make him, her or it identifiable.

Participants in the meeting in a location outside the parliamentary precincts are asked to note that the constitutional protections afforded to those participating from within the parliamentary precincts do not extend to them. No clear guidance can be given on the extent to which participation is covered by the absolute privilege of a statutory nature.

I now invite questions from members. I thank the witnesses for their statement which is clear and concise. There is one point I would like to highlight before I hand over to other members of the committee. It reads:

Critically important antibiotics need to be controlled and preserved [I think we would all agree with that], this is best achieved by [the] reclassification as Veterinary Practitioner Only medicines. Therefore, these drugs could only be administered directly by a veterinary surgeon, where the need arises. This would drastically reduce usage and misuse of surplus antibiotics on animals not intended to be treated.

That is a very strong statement. In practice on farms, farmers have an awful lot of work to do in husbandry of the animals. The buck starts and stops with the farmer as regard the health of the animals. In practical terms, one might have an animal, for example, a Friesian bull calf, a lamb or a ewe, the value of which is X but significantly below a call-out fee. I am not questioning the call-out fee of the vet because any professional person needs to be paid. In order to ensure proper animal welfare standards and to ensure an animal gets treated when it needs to, surely that point in practice is not practical in animal terms. I am strongly of the view that a farmer will only use an antibiotic when it is absolutely necessary. Obviously, I would say that it has to be done under veterinary supervision but to state that financially we can bring a vet out to every animal that is sick on the farm cannot work in practice. I am seriously concerned that if this is enforced rigidly, one would have animal welfare issues on farms and none of us want to encounter that. How do the witnesses think this would work in practice? I accept fully that vets give a great service to farmers in rural Ireland but in economic and animal welfare terms, how could that work in practice?

Mr. Conor Geraghty

I will take that question. Critically important antibiotics are a subset of antibiotics. They are not all antibiotics. Through the Irish National Action Plan, INAP, which is the stakeholder group that looks at antimicrobial resistance, we have agreed across industry these highest-priority critically-important antibiotics are used only in second-line treatments and in some cases only after a culture and sensitivity test is carried out. It is our view this is not practical, in that if one has treated an animal and left some of the antibiotics there is a temptation for those antibiotics to be used as first-line treatments. Ultimately, they would have been prescribed for another animal and it leads to a situation which, essentially, cannot be policed. If we really want to reduce the use of these highest-priority critically-important antibiotics - these are three separate categories of antibiotics which are vital for human health so much so that they are the last line of defence in hospitals for treating human patients - they should be taken out of general circulation and only used for severely sick animals where there is no other option. It might be a misunderstanding. We were not suggesting all antibiotics be administered only by a vet who attends the animal in person.

I accept that is good clarification. It did not read it or interpret it in that way but I accept Mr. Geraghty's clarification.

I thank the witnesses for coming in. Hopefully, we will get more information from them than we did from the last witnesses. This is a very hot topic within the agricultural community. One hears words like "monopoly", "more money for the vets", "costs" and "prescription charges" used. I hear them on a regular basis from farmers.

I have three or four quick questions. What is the real on-the-ground impact for farmers of the development of resistance antiparasitic drugs such as fluke or worm doses and what has caused this?

I asked the last witnesses the following question but they said it was not within their remit to answer it. Faecal egg counts are used to determine parasite burdens. Is this the gold standard or are there other issues with using these tests in isolation?

Following on from my earlier comments about veterinary input into the cost on farms, how does Veterinary Ireland propose having an increase in input from a private veterinary practitioner, PVP, on farm management is a worthwhile cost to farmers? In terms of the Department of Agriculture, Food and the Marine, are the witnesses frustrated it has not decided the direction it will take on this issue?

Farmers want this sorted out but they want something they can operate with as well.

Mr. Tadhg Gavin

I will try to answer the questions in order. One of the main reasons for the change in antiparasitics is development of resistance has been established. What does resistance to anthelmintic mean for a dairy, beef or sheep farmer? It means the drugs we traditionally use get benefit from the use of grassland pasture management to grow our cattle no longer work against parasites. It is a natural occurrence in these drugs but it is driven by overuse. These drugs are used more frequently than they need to be and at the incorrect time and dosage.

The knock on effect is these parasites which cause welfare and performance losses in cattle and sheep are not killed off as effectively as before. Calf rearing units see significant resistance to some of the main drugs categories for stomach worms. This has a huge impact on performance and animal welfare.

Some farms are now limited in what drugs will work which drives cost because the choice of drugs available is limited and they are often restricted to the few newer drugs. The level of production they can achieve is reduced and feed and conversion efficiency is reduced and the animals do not thrive. Animals not being able to thrive is a major cost to farms. We address this by using the right dose at the right time and when necessary.

Fecal egg counts have been bandied about. It is a useful test practitioners use on a regular basis to establish a parasite burden on a farm or in an animal but it is not without limitations. It does not detect prepatent infection which is infection before the eggs are laid. Nematodirus in sheep is a major issue. Hoose lungworm infection in cattle will not be detected until it is too late in terms of a fecal egg count. We embrace these tests. They are a string in our bow in the treatment and management of parasites on a farm but they are not the gold standard. It would be foolish and dangerous to rely on the interpretation of fecal egg counts when prescribing anthelmintics.

Veterinary practitioners need their farm clients to be profitable. How does veterinary intervention bring value to a farm? The recently implemented CellCheck programme is a good example. The main point of carrying out dry cow consults is to reduce the amount of antibiotics used and to move away from blanket dry cow therapy. There is an initial key saving for the farmer in that he is not purchasing unnecessary antibiotics. These consults are to reduce antibiotics but also to consider the reasons for using them.

Antibiotics are used to treat a disease. We consider why the antibiotics are being used rather than considering the supply routes and who prescribes them. Vets see why the diseases are on farms when they visit and what can be done to negate the risk, therefore reducing the need for antibiotics. CellCheck is a good example of how vets going on to farms can reduce cost and improve productivity.

Knowledge transfer is another programme which was run in recent years. A recent paper which considered its results showed how sheep mortality decreased following this programme. Farm outputs were improved and overall costs were reduced.

I ask that the witnesses introduce themselves, so the secretariat has their names for the record.

I thank our guests and reiterate the Chair's thanks for the work vets do across the country alongside our farming community. As Deputy Kehoe said, I am sure the witnesses are aware that some interpret the witnesses' position on the EU regulation on veterinary medical products as a money grabbing exercise to concentrate wealth in the hands of vets at the expense of the licensed merchants and other responsible persons.

I previously raised a point that there was a clear distinction in human medicine between the person prescribing the medicine and the person buying it. The medicine is prescribed by a GP and purchased in a pharmacy. The separation of prescribing and dispensing of veterinary medicines has been advocated by the Health Products Regulatory Authority and the Chief Veterinary Officer, CVO. Does Veterinary Ireland deem it a suitable way to proceed to ensure its members are not overburdened, the licensed merchants remain viable, as an important asset to many rural communities, and in terms of the health benefits I previously mentioned?

Veterinary Ireland made a bold statement in its statement that Ireland was fortunate in that every farm had access to a vet 24 hours per day, 365 days per year. It is not universally true. The witnesses will be aware of issues that arose when Donegal Animal Hospital moved into lay ownership. Veterinary Ireland called for the Department to investigate the operation of the practice. Is it fair to say that a farm does not always have access to a vet at all times?

Veterinary Ireland's statement said that antiparasitic resistance represented a clear and present danger, with which I agree. The danger it presents to the Irish agrifood industry was mentioned. Veterinary Ireland will be aware that the industry operates on an all-Ireland basis but there is a divergence North and South. Following the implementation of the regulation, that divergence will be at 90 degrees and present a sustained threat and challenge. Do the witnesses have a proposal on how we address that while recognising that it does not appear likely the British will move towards the EU system in the short term?

Zolvix is a new product available on prescription from licensed merchants. It is a vital tool in reducing sheep worm resistance. Take up by many vets in prescribing of the product seems to have been poor. Could our guests give us an explanation as to why?

Mr. Finbarr Murphy

I will deal with the first two questions from Deputy Carthy. I will deal with the issue of the decoupling of prescribing and dispensing in the context of the human health service. We do not believe the decoupling of prescribing and dispensing veterinary medicines would benefit the agricultural industry or lead to a reduction in antimicrobial usage. The implementation of such a proposal would have a number of negative impacts.

It would decrease competition in the sale of veterinary medicines. It would unfairly exclude veterinary practitioners from the veterinary medicine market, within which there is strong competition. It would reduce the element of choice and convenience for the consumer. It would be detrimental to animal health and welfare. Currently, there is no economic basis for clinical work in large animal practice. We do not want to see the cost of clinical veterinary services giving rise to animal welfare issues. It would threaten the viability of rural veterinary practices. The sale of drugs is one service area which gives rise to an income stream to support veterinary practices. Private veterinary practitioners operate without any State subsidy. There is no subsidy available for the employment of vets, for computerisation, for practice staff such as veterinary or administrative support staff, or for professional indemnity or practice premises.

One can contrast this with the supports available to maintain GP services in rural areas. The State subsidises the provision of this service to the tune of approximately €120,000 per GP per annum. In-direct subsidies through the payment of a rural practice allowance are valued at €20,000. The allowances for the employment of practice secretaries, nurses and practice managers amount to €93,000. In addition to this, there is a 95% reimbursement of medical indemnity costs. Ultimately, decoupling will leave some of the most isolated farms in rural Ireland without veterinary services. Any policy decision to take away the dispensing of veterinary medicine from veterinary practitioners would lead to a loss of veterinary and veterinary support staff from veterinary practices, which are of significant value to rural areas and local economies. Our policy choices need to support the veterinary infrastructure footprint nationwide and not reduce it.

Between vets and support staff, there are about 6,000 people employed in veterinary practices. Furthermore, experience has shown in EU member states where veterinarians are not allowed to dispense veterinary medicines, this did not lead to reduced use or reduced sales. Neither did it lead to a lower frequency of antimicrobial resistance. The Berenschot report ordered by the Dutch ministry examined in detail the effects of decoupling prescriptions and sale of veterinary medicinal products by veterinarians. It concluded restricting the sale of antimicrobials by veterinarians would not be effective. On the contrary, it recommended strengthening the position of the veterinarian as gatekeeper for antimicrobial use in animals.

It is the view of both Veterinary Ireland and the Federation of Veterinarians of Europe that separating the veterinary prescribing of antimicrobials from the right to dispense antimicrobials is not the solution to combating antimicrobial resistance. The human health model of when the doctor prescribes and the pharmacist dispenses medicines was mentioned earlier. We need to be aware the human health model is a very costly model versus what exists under the animal health model. The State spends more than €3 billion a year in the cost of drugs for General Medical Services, GMS, patients and reimbursements under the drug payment and long-term illness schemes. It buys coverage for 53% of the population. GPs are directly reimbursed in excess of €600 million a year in fees and allowances in respect of medical card patients, including €160 million in allowances for the employment of support staff. Pharmacists receive €400 million per annum in fees. That amounts to in excess of €1 billion in State support for GPs and pharmacists. Therefore, it is important stakeholders recognise the veterinary service is provided in a very lean and efficient manner. Changing the model would ultimately make the provision of veterinary services more expensive while reducing the service for farmers and the public.

Deputy Carthy commented on our claim that vets are available in every parish in the country, 24 hours a day, 365 days a year. I concede there may be local areas where issues arise occasionally. The issue he referred to in County Donegal arose in the context of a lay corporate purchasing and closing down of a practice, and the vets did not really have a say in it. By and large, we are fortunate to have extensive coverage of veterinary practitioners in every parish in the country. We have approximately 1,000 vets employed in food animal practice.

There are many other question for the witnesses to answer so we will move on.

I want to talk about the antiparasitic dosing stuff, to put it simply, and the farmer who gets it in a place other than a veterinary practice. I note Veterinary Ireland, VI, has stated that obtaining a prescription and the red tape is basically nothing, and that it will cost us nothing. Are the witnesses saying VI will give out prescriptions for free?

The witnesses talk about the vets around the country. We are lucky with the number of vets in our area and they are good, which is something I have always said. They have spoken about the viability of vets and it is very important to keep them in one's area - I would be the first person to say that - but is it at a cost of losing someone in the co-operative or someone who is administering it? Would it not be a better ploy if the vets came out in support of the fact that we need a licensed person who has gone through courses in order that they can give out the dosing stuff? I am not talking about injections for mastitis or whatever; I am talking about antiparasitic medicines.

The farmers in Northern Ireland are trusted to give antiparasitic medicine to their cattle. There is the equivalent of a responsible person or a chemist. Going by what VI has said, is the thinking that the farmer here is not as sharp as the farmer in Northern Ireland? Is it not better that we, Veterinary Ireland and qualified persons, work on this together? There is plenty of work for them all. To be frank, I do not want to see anyone losing out on this. To be blunt, if vets have a hold on prescriptions, they will have a hold on the whole thing and it will be anticompetitive. As politicians, we will then have to go down a road to fight for a situation like the doctors have by putting a separate gap between it. I will say one thing about the doctors. There might be one farmer going to the doctor but there might be 50 cattle, so there is a better chance the vet would get more out of that person than the doctor regardless of the figures the witnesses referred to.

Mr. Conor Geraghty

I do not know where to start.

Mr. Geraghty will have to start somewhere.

Mr. Conor Geraghty

It is essential to know the prescription is not a service. The prescription is the result of a service. It is an outcome. The outcome to the service might be no prescription, if no dosing stuff is required. The system at the moment is that anthelmintics, dosing stuff, and other products for lice and mange etc. are non-prescription medicines. A farmer can decide what to use, when to use, and how often to use it. These products had been prescription-only under regulations dating back to 2005. We have seen since 2007, a derogation in Ireland because there was no resistance in 2005 and that was allowed ride until the HPRA, rather than Veterinary Ireland, decided it was no longer possible to enact that derogation. There have been many published studies by the Department and Teagasc on the rise of anthelmintic resistance in Ireland, which we are seeing on the ground as Mr. Gavin mentioned earlier.

The idea of bringing them in as prescription-only products is not to allow vets to sell them. It is to ensure that before a farmer makes a parasite control plan or decision on his or her farm, he or she will converse with his or her vet and look at the best approach to control parasites. This may not only be through the use of chemicals. It may be through pasture management, delaying treatment or targeted treatment, or treating a subset of the population to minimise the effect of this resistance, which is growing.

This can be done in many guises. The idea is to get away from a farmer deciding on a Saturday morning to dose cattle that day but rather to take a more planned approach that can be discussed with the vet in advance. Out of this service we envisage a prescription would be furnished. I am not saying the service would be free but I do not believe the prescription is a red tape service that will just attract a fee without any of the other aspects also.

As a result of this, we will have less product used and better bang for our buck. We have countless examples of money being wasted on these products at wrong times or for the wrong disease. We will also get better thriving. Overall, if we embrace this properly, vets can help farmers make better decisions. As it is today, these products will be available for sale in all of the outlets where they are available at present. It will be a conversation for each farmer and his or her vet. I do not believe vets will have a hold over farmers. History has shown the opposite is more often the case.

I welcome the witnesses. I do not know whether I agree with anything that has been said so far. Last Saturday morning, I had the opportunity to be in one of the wholesalers that under the current regulations can sell these products. I was shown products which have come online in recent weeks, which now state on the packaging they will be prescription only medicines. Even though the legislation has not changed, the packaging for these products has already changed. Companies have assumed the legislation is coming on board and are packaging the products for it. We need to talk about this. They have moved ahead of us and have said what is happening here is null and void and the change will happen anyway, and the companies are packaging appropriately. Have the witnesses come across this? I came across it last Saturday morning.

The debate we are having on resistance is very important. We have to clarify what is happening in the dairy industry itself. The vaccination programmes in the dairy industry for infectious bovine rhinotracheitis, bovine viral diarrhoea and leptospirosis have greatly reduced the use of antibiotics throughout the industry because of their effectiveness. We need to acknowledge the major work we have done in this regard when we are having this debate.

One of the issues I have heard is that we need to look at dates when dosing will take place and the weights and amount per animal. Will we have a vet in the yard telling us an animal is 600 kg? Is this a practical solution to what we are proposing? I realise a plan could be put in place whereby we could have a pasture management plan of rotating animals in front of bigger stock. When it comes to the practical implications of what is being proposed with regard to the weight of animals and the amount per dose, are we saying a vet could have a better handle than a farmer on judging the weight of an animal? Will we be weighing every animal in the crush for the dose? This issue needs to be thought out with regard to how we will deliver it on the ground.

What happens if this fails? What happens in five years' time if the microresistance project we are embarking on totally fails? What is plan B? What will the Veterinary Council of Ireland propose? Will the Department have to take it on board? Will we go back to the Teagasc advisers with a Teagasc programme put in place? If this is to be the golden bullet for our problem, that is fair enough, but do we have a plan B? Have we spoken about it? Have we asked what happens if this fails? Where will we go with the programme then?

Mr. Conor Geraghty

The first issue raised is the packaging. The decision to make the products prescription-only medicines from the end of January 2022 was taken in 2019 through the enactment of the regulation from Europe. The HPRA then decided that derogation could not be applied for. The products referred to by the Senator will be prescription only from 2022. The issues being discussed here are regarding route of supply and whether there will be decoupling. As part of the regulation from Europe they will be prescription-only medicines.

The Senator asked whether we will have vets on farms weighing animals. That is not the way a prescription works. If we prescribe something, we are prescribing a product that is required. If a product is required for a subset of animals on a farm, it will be prescribed and the dose rate will be so many millilitres or so many grams per kilo live weight. I do not think it has ever been envisaged that a doctor would go in and administer a medicine himself or herself, and the same will apply to this. I am not aware of any suggestion that vets will be on farms weighing and dosing cattle.

I call Senator Daly.

I asked what happens if this fails. What is plan B?

Mr. Conor Geraghty

I apologise; I missed that bit. We have farms at present where plan A has failed. I certainly have them in my practice, as does Mr. Gavin and as do vets throughout the country. It is more common in cattle-rearing farms, as Mr. Gavin has said, and on sheep farms. Plan B has already been implemented. It means we cannot rely on chemical control of parasites on these farms and we have to implement grazing management plans, whereby the top end of the sward is grazed with smaller animals and the pastures are grazed out with older immune animals. It means farmers have to fence off some areas, for example for fluke, where sheep or cattle cannot be put. It means instead of closing 60% of a farm for silage, the farmer takes paddocks so the same paddocks are not grazed ten or 11 times a year, because the parasite build-up is too high. There are all sorts of ways of tackling it if it happens.

There is no doubt we have resistance. Resistance is not just there because a product was used with or without a prescription. Resistance is there because the product is used. When a product is used on a population of parasites, it will kill 90%, 95% or 99% of those parasites but the percentage that is left will multiply and eventually will become the dominant group. If the same product is always used, they will become resistant and that is how it works. It is about strategies.

This is part of a strategy that is already there. Having veterinary advice will remove the temptation to use the more convenient product, which has meant some farmers using the same product on cattle for years and years because it is pour on and handy, or perhaps they have used products where they are not necessary, for example, on sheep farms where all the ewes are dosed every time the lambs are dosed, which is not necessary, or lambs being dosed early in springtime before there is any need to do so, which is not necessary. All of these represent a build-up of resistance. There is also a potential cost saving to farmers because they do not need to use these products. I hope this answers the Senator's question. It is not all or nothing. We are living with this on a small percentage of farms at present and we are hoping that by instituting change, which we did not ask for but it is our duty to uphold, we can slow this down and perhaps even reverse it on the majority of farms in the country.

I welcome the witnesses and thank them for their presence. I am fortunate enough to benefit from the great service the vets provide daily and hourly in my area. Unfortunately, in my role here today the praise has to end there and I must be slightly critical.

I would have to be slightly critical based on the Veterinary Ireland submission, which I would like to quote. This is our third meeting on this issue and we have focused mainly on antiparasitic resistance and the need, under the EU regulations, for these to become prescription-only medicines. The submission, at No. 4, page 5, states:

Anti-parasitic medicinal products are a precious resource that must be used only when necessary to preserve their efficacy and ensuring that pasture based livestock production can continue. They cannot be used to attract customers to co-op and merchant stores to sell non-medicinal commodities such as fencing materials and silage plastic. This is not prudent practice and has ultimately led us to the position we find ourselves at present.

That is a very strong statement and one that needs clarification here today. Without going back to quote other sections of the submission, while I have been reading this for political purposes as a politician, I am a farmer, ultimately. It is like learning a second language in that people will always think in their first one. Therefore, I was reading this as a farmer and I noticed some other passages within the presentation. The last page of the submission states, "The removal of any income stream from farm animal veterinary practice will render a proportion of the practices unviable and reduce service and competition in the area." As a farmer, I feel that is very accusing of farmers, responsible persons, licensed merchants and pharmacists in what is said, namely, we are where we are because of their recklessness. I find that a very disparaging and condescending statement.

I have three questions based on what I have read out. Will the witnesses clarify why they went down that road and why they seem to have turned this into an "us and them" issue? It is seen as more of a market share issue than what is our priority here, which is, first, the animal, and second and third, in no particular order, the consumer and the farmer. Veterinary Ireland has very much turned this into an issue of market share and an "us and them" issue, even in regard to its customers, the farmers. Will the witnesses comment?

With regard to the issue of making antiparasitics prescription-only medicines, will the witnesses comment on the fact antimicrobial medicines have been prescription only for more than 30 years, yet antimicrobial resistance has grown immensely within both animals and humans? In the opinion of the witnesses, why will changing the regulation to do the same thing with antiparasitic medicines have any positive effect?

Who wants to deal with this?

Mr. Conor Geraghty

I will deal with it. I would not agree with Senator Daly's interpretation that our present submission has been about market share or has not been about resistance. Certainly, we would never get into an "us and them" situation. As a veterinary representative organisation, we sit on all the stakeholder groups in the country, from the Animal Health Ireland ones to the antiparasitic resistance stakeholder group, and we have never been found wanting in putting our shoulder to the wheel to push for change and consensus within those groups. Anyone who sits on those groups will concur with that.

Second, with regard to the difference between prescription-only medicines and a licensed merchant product, a product is labelled LM, for licensed merchant, or POM, for prescription-only medicine. One cannot advertise, discount, offer on sale or use as a promotional product any product that is POM. If anyone picks up the pages of the Irish Farmers’ Journal, the Farming Independent or whatever other newspaper they read as a farmer, they will not see advertisements for POM products on the page because that is illegal. These are to be used prudently and not to be advertised to encourage people to use them. That is one of the key differences between antiparasitic products that are POM or non-POM.

Third, with regard to antimicrobials, the Senator is correct that antimicrobial resistance is a growing problem. This was highlighted by the man who invented antimicrobials, Mr. Fleming, in that, when he got the Nobel prize for the discovery of penicillin, he said that as soon as it is used, resistance will develop. The more any of these products are used, the more resistance will develop.

The other problem with resistance in antimicrobials is that this resistance is not alone in an individual animal or human, it is also in the environment, and bacteria with the resistance gene can infect other bacteria. Where, for example, waste is coming into the environment from hospitals, that can make its way into agriculture and, vice versa, where resistance is developing in agriculture, it will find its way to humans.

Prescription-only medicines are not going to limit resistance. We have to change the way we use these products. For the past 20 years, we have seen this both in human and veterinary medicine. There have been huge advertising campaigns over the past two decades with regard to human medicines to tell people that if they have flu, they do not need an antibiotic, and these campaigns have been quite public.

Over the same period, as Senator Lombard pointed out, the amount of vaccine or preventative medicine being used by farmers in this country, which was driven by the veterinary profession given these herd health plans were driven by vets, has increased by over 200%. If we look back at our usage of antimicrobials from 2010 to now, it was quite steady as an industry all during that period until the last report, which showed it has reduced. During that time, we have had a massive increase in our national herd, for example, and we have gone through dairy expansion. Despite an ever-increasing pressure on the system, therefore, we have managed to, at worst, keep it steady and, recently, make gains and reduce it. I know some looking at the previous figures would like to see a bigger reduction but the fact we have increased vaccination rates, engaged with farmers on herd health and maintained the steady or declining use of antimicrobials is testament to the efforts of veterinary practitioners and farmers in the country working together, which is what we do, to help reduce animal disease.

To reiterate the point on anthelmintic resistance, it is not about an "us and them". To address something that was missed on Deputy Carthy's question about Zolvix, the reason Zolvix was not used is because it was treated by the veterinary profession as a precious resource only to be used as a last resort, where it was needed for that tiny percentage of farms that could not use anything else. Given the fact we were not using enough, the company did not find it viable to keep selling it and we perhaps have supply issues as a result. It is typical of how serious the veterinary profession was about this last anthelmintic dose that it was only to be used where there was nothing else to use. That is why it was not used in huge quantities. It was preserved so we would not have resistance to that as well.

Is there any appetite among the experts to return to the previous regime, with proper training? I appreciate there is a legal difficulty regarding the possibility of retrospective legislation, or statutory instruments that are retrospective, and whether that would comply with the EU regulation is not entirely clear. Is it absolutely necessary that vets prescribe, not from a legal perspective but rather from the point of view of driving down the overuse of medicines and thereby creating resistance?

Mr. Conor Geraghty

I thank the Deputy. I am not sure I entirely understand the question. Our information, which is probably the same as the Deputy’s information as we are only a stakeholder rather than being in the inner circle, is that all anthelmintics will be prescription-only medicine from the end of January 2022.

We are aware from being on the antiparasitic stakeholder group that advice was sought from the European Commission on this status. Further advice is sought from the Attorney General and we have not got it yet.

To be clear, I am not asking Mr. Geraghty to comment on the reality of it. My question is whether, from a practical perspective, he thinks it is necessary from the perspective of achieving the objective of reducing overuse of medicines and ensuring there is not antimicrobial or antibiotic resistance. Vets drove this, although I am not suggesting any mala fides. It was the thinking at the time. One might suggest there was an equal tendency among doctors for a number of years to give everyone who came to see them an antibiotic and they would leave happily and pay whatever doctors wanted to be paid. Everybody realises on the veterinary and the human medicine sides that antibiotic use has to be reduced. Is there no scope for training the existing suppliers from the practical point of view of reducing overmedication?

Mr. Conor Geraghty

To clarify, is the Deputy talking about antiparasitics or antibiotics?

Mr. Conor Geraghty

For antiparasitics, the existing responsible persons who are there to dispense those medicines, also employed by veterinary practices, are trained on a short course on how to dispense and advise on dosing etc. We have no issue with that and that avenue of sale will remain post 2022. Prescribing of veterinary medicines is entirely different. As it is an act of veterinary medicine, one has to be a vet to do so.

What is the situation regarding dry cow antibiotics, Opticlox or stuff like that, which is used if a bullock has a pink eye, a sore eye or gets a prod in the eye when out wintering or in a feeding ring? What about medicines like that?

Mr. Conor Geraghty

They are all prescription only at the moment and have been for many a year. When one gets them from a vet, one will get a prescription to accompany them. In certain cases, especially with dry cow tubes, many vets supply prescriptions and those prescriptions are filled at third-party locations. There is a bit of scaremongering here because this is the case already and nothing will change with those products. There will be a more onerous watchful eye on prescribing practices, as previous speakers have said, and there will be more audits on farms and vets to make sure they follow best practice. Many of the products the Deputy has mentioned are already prescription only and availability will remain as is.

I am quite unclear. What exactly will change as a result of the implementation of the new European Union legislation?

Mr. Conor Geraghty

There are two aspects. The first is to do with antimicrobials, or antibiotics as we would know them, and the second concerns antiparasitics, which is an Irish issue because we have obtained a derogation for these being prescription only up to now.

I will start with antibiotics. I might be very simplistic on this because it is a huge legislative measure. The main change is that we can no longer rely on antibiotics as a preventative. We can only used them on sick animals. The previous speakers were talking solely about mastitis and blanket dry cow therapy but that applies to all sorts of things. It applies to blanket treating animals bought in in case they get pneumonia, for example. It applies to using CTC powder for calves that might get cough and to blanket treatment for watery mouth in lambs at birth. All these practices will no longer be allowed. That is one simple thing.

The second major one is the possible restrictions on critically important antibiotics. We may not have access to all of them in the agrifood sector. There will certainly be restrictions on them and maybe a requirement on vets to have evidence that they are the only prudent thing to prescribe in certain cases. In other words, one would not be allowed to use them without a culture and sensitivity test first to say these are the only ones that can be used.

On antiparasitics, the big change for Ireland is that, rather than being licensed merchant, LM, products available in co-operatives, licensed merchants, pharmacists and vets, they will still be available in all those outlets but will only be able to be dispensed on foot of a veterinary prescription. There is a pile of other things in there that will be different but those are the main points.

I thank Mr. Geraghty.

Mr. Geraghty talks about scaremongering. The reality is - and I have a copy of a document to this effect - there were certain places around this country advertising that, where one needed a prescription, the prescription was free if one bought the goods there. If that starts around Ireland, then God help the small farmer. I know where Mr. Geraghty is from and his practice is not far from me. He knows the size of farms, especially in the west and north-west of Ireland. If that starts, the big guy with 300 or 400 cows will always be the winner because he will have buying power. That is the big fear among farmers and it is not scaremongering. It is reality. I have a copy of it showing what has gone on, not in my part of the country but in another part. I would be very careful about the word "scaremongering".

I thank the speakers for coming in. I take up the point Senator Paul Daly made on the Veterinary Ireland claim in its submission that the use of medicines to attract other sales of non-medicinal products has led to the establishment of antiparasitic resistance. The language there is quite accusatory and divisive and I am concerned. It is not true because earlier in the submission, it is stated that the development of resistance is an evolving process which increases every time these types of medicines are use. I would like to get the witnesses' response on this. I feel it is unnecessarily divisive and the tone is wrong.

There is acceptance among stakeholders that these veterinary medicines will need to become prescription medicines and that addressing resistance is an absolute priority but the HPRA and the chief veterinary officer insist on a multi-stakeholder approach. Will Veterinary Ireland engage to create a specifically focused prescription that all parties can issue, which would be a way of ensuring a multi-stakeholder approach? I hope that happens and we do not have a situation where a monopoly is set up and other businesses cut. If we have cuts in rural Ireland in terms of businesses, there will be job losses in areas that cannot afford to lose any more jobs.

Mr. Tadhg Gavin

I will take Deputy Nolan's questions. On use, she answered the question herself. She is correct that every time these products are used, the parasites that are exposed to the products develop resistance. It is the overuse that drives that resistance. As Mr. Geraghty alluded to, these products can be advertised and that is used to promote sale. When the products become prescription only, they cannot be advertised so there will not be a marketing edge to the sale of these products.

On the prescription, that is an act of veterinary medicine and it is not just based on one simple facet but on a three-pronged approach of test data, clinical examination and on-farm risk assessment.

Those three parameters are used to decide whether a prescription is necessary. That is the key. The greatest achievement in this will be if a farmer decides that he or she needs to dose, has a conversation and, ultimately, no prescription is issued. The result will be that a product that needs to be spared is not used on that occasion, and that will be the best outcome.

I might pass to Mr. Geraghty to respond to Deputy Fitzmaurice.

Mr. Conor Geraghty

As for whether Veterinary Ireland will engage with regard to resistance, we are engaging. We are a member of the antiparasitic resistance stakeholder group and have committed to that. We have also been very engaged with iNAP, which has been operating for longer. We have taken part in, and led, some of the changes and some of the farmer guidelines that have emerged from that. There is no question that Veterinary Ireland will engage.

To respond to Deputy Fitzmaurice, there will always be individuals who try to gain a commercial edge in any sector. It is not limited to the veterinary sector but there is a good deal of competition within the sector at the moment. Some of the products we deal with have the tightest margins of any prescription-only medicine products. I am sure some of the committee members from the south will concur with that. Products such as Bovivac S and Rotavec Corona are very tightly priced and are prescription only.

Farmers can choose their vet and can change their choice every day if they wish, especially in the area of the country where the Deputy and I come from, where there is ample choice. Farmers will work with vets who help them manage their livestock and provide them with a service, and this will be just another part of that service. In fairness, our discussion about market shares shows that the majority of farmers are already using their vets to engage, to be advised and to make the correct choices on farms. They also buy some of that product at other locations such as co-operatives or licensed merchants.

All in all, in the common model that exists on the ground, there is no divisiveness between farmers and vets. Farmers and vets, especially at this time of the year, depend on each other and are in regular contact. There is a difference between this part of the island and the other side of the Border. We as an agrifood industry in the Republic depend on exporting 90% of our food to third markets, whether Russia, China, South Korea or the US, to survive. Farmers in the North have the English population to feed, so they are not as heavily dependent on exports. When food is being exported, reputation is key. We have a more stringent regulatory system here. It is common knowledge, and has been highlighted recently by the Irish Farmers' Journal, that there is a more lax system in the North. The Irish name, when we engage in trade missions and or when food audits come here from third countries, is worth an awful lot because we are probably a bit more heavily regulated than some countries that do not depend on exports. That is the space we are in because we need to export food and to ensure that we are best in class.

I thank the witnesses from Veterinary Ireland, Mr. Geraghty, president, Mr. Gavin, chairman of the food animal group, and Mr. Murphy, chief executive. I thank them for engaging with us on this very important topic. As was said earlier, this was our third meeting on the subject. Ultimately, we want to protect the reputation of Irish food and food producers but we also want something practical that will work on the ground. The engagement was very constructive.

We will adjourn until 9 a.m. on 29 March 2021, when we will have a private meeting on MS Teams.

The joint committee adjourned at 8.35 p.m. sine die.
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