Regulation of Veterinary Medicines: Discussion (Resumed)

For the first session on the regulation of veterinary medicines, I welcome the following representatives of the Health Products Regulatory Authority, HPRA: Dr. J. Gabriel Beechinor, director of veterinary sciences, and Dr. David Murphy, manager, committee for medicinal products for veterinary use, CVMP. Both are joining remotely and are welcome. We have received their opening statement and briefing material, 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 whether or the extent to which participation is covered by the absolute privilege of a statutory nature.

I now invite questions from members. I call Senator Victor Boyhan.

I thank the Chairman. I must apologise as I have to go to another meeting shortly and I will not be able to stay for the entire meeting. In reflecting on the statements from the witnesses and where all of this debate is going, I have given this issue some consideration. When I stand back from this, it strikes me that at the core of this debate, which we must never lose sight of, is human health, the human food chain, animal health and animal welfare. That has to be paramount above anything else, and the link between those is critical. On the one hand, we are familiar with routine warmers and doses, and the fact people can go into distributors and buy those. It is similar to the analogy of going in to get a cough bottle in the supermarket. That is the reality. I can go and get a cough bottle, although I will not consume it, which is the only difference. It is very important we do not lose sight of the importance of the human food chain, responsible animal husbandry and animal welfare. That is the point I wanted to make.

While I will not be present for all of the meeting, and I again apologise for that, I have a question I want to ask of the witnesses on the FETAC level 6 training, of which many of us are aware. What is their understanding of the FETAC level 6 professional qualification, which is applicable to responsible persons, RPs.? I think it is at a very high level and of a very high standard. I know people who have done this training and who can administer these antiparasitic drugs, and so on. That is the issue. I am conscious that we cannot be seen to be held up in terms of vested interests, be they veterinarians, distributors or otherwise. It is important we give a range of options. I do not believe veterinary prescriptions are needed for the administration of certain drugs but there are clearly serious implications for other types of ministrations or medications. I would be interested to hear the witnesses' view on that.

I thank those who have engaged in what really is a very difficult debate, to which there are different aspects. As I said, it is important that human health and animal health and welfare are primary in any decision we take in regard to these matters.

Those were mainly observations and I am not sure the Senator had a question for the witnesses.

My question is whether the witnesses are familiar with the FETAC system.

Dr. J.G. Beechinor

First, the HPRA is pleased to come before the committee today to assist it in its deliberations. I should point out that, as Senator Boyhan mentioned, our job as regulator is to ensure the safety and efficacy of the products and to ensure they comply with the legislation. That is really the nub here. When we look at the development of products, we could talk about antiparasitic drugs. Perhaps the Senator remembers tiabendazole. It came out in 1961 and resistance emerged in 1964. Levamisole came out in 1970 and resistance emerged in 1979, ivermectin came out in 1981 and resistance emerged in 1988, and moxidectin came out in 1991 and resistance emerged in 1995. Basically, we are dealing with precious commodities. We do not have a pipeline of new drugs to effectively deal with resistance. Therefore, I agree with the Senator that we must place animal health centre-stage in this debate.

The Senator asked about the professional qualifications at FETAC level 6. That is not an area for the HPRA and we do not regulate licensed merchants. However, we would acknowledge that licensed merchants have made, continue to make and, we expect, will continue to make a valuable contribution to the supply of anthelmintics into the future.

I welcome the witnesses. I have one question which is a kind of "Do you believe?" or "Do you not believe?" question regarding what is happening. Do they believe that relegating the role of the RP, the farm vet and the veterinary nurse to the role of stockist, and excluding them from the European Platform for the Responsible Using of Medicines in Animals, EPRUMA, advice is demoralising and alienates those with substantial experience and the professional stakeholder groups? Do they or do they not believe that?

Dr. J.G. Beechinor

I thank the Deputy. I am aware of the interest of licensed merchants in this area and, as I said, of their contribution over many years. For us, this is not around that. The Department regulates how the system operates on the ground. The issue for us is that the products have to comply. We regulate the products and the products have to comply with the requirements. That is the EU regulation and, because it is the EU regulation, we, as regulator, would be negligent if we did not do that. We have had evidence of resistance building for a number of years.

If I appeared before the committee this evening, members may well ask: "What in God's name, were you doing? Were you asleep at the wheel? How much evidence do you need, for God's sake?" The criteria are as plain as night and day. Basically, our job as a regulator is to ensure that the products are regulated in accordance with the legislation, because otherwise, the future of our food products would be in jeopardy.

Is Dr. Beechinor saying that he believes in it?

Dr. J.G. Beechinor

I am saying that it is not our role. We do not have a role in regulating the licensed merchants. We believe that all actors currently employed in the system ought to have a future in the system, but we do not regulate them and we are aware that the Department has created a multi-stakeholder group. It has done that in the last year. We expect that initiatives, and so on, will be rolled out to ensure that the licensed merchants have a future. However, it is not our role to do this.

I welcome the witnesses to the committee.

I get it. I am with the witnesses and I see where the HPRA is coming from in that its role in the whole system is really the product demarcation or whatever, in conjunction with the EMA. The Department has to look at the issue at hand, which, from an anti-parasitic point of view, has boiled down to the question of whether medicines are prescription or non-prescription. If medicines require a vet prescription, then where do the licensed merchants, etc., fit into the equation? There has been an outcry from the farm organisations, the merchants and others in respect of where we are going with this. The witnesses' deliberations this evening will help to inform those who will make the decision or formulate the policy, whereas it may not be their definitive role.

With that in mind, I ask Dr. Beechinor to elaborate a little bit more on the findings on the task force report. I will cite some sections of the report and he can confirm whether what I say is true and elaborate on my points. Would it be true to say that in the HPRA's assessment, 28 farms were assessed out of a total of 140,000 farms in Ireland, where some limited anti-parasitic resistance was found? I ask Dr. Beechinor to elaborate on that.

It is also stated in the report that while there is anti-parasitic resistance on a European-wide basis, the only place that the actions taken have resulted in a reduction of resistance is in Scandinavia, where the action taken was a decoupling of prescribing and providing. Perhaps Dr. Beechinor could comment on that. In the other parts of Europe, where the policy adopted was veterinary prescription, the anti-parasitic resistance has actually remained on an upward curve. I would like a comment on that also.

In conclusion, based on the task force report, it was recommended that the Department of Agriculture, Food and the Marine consider elaborating the system for veterinary prescription of anti-parasitic medicines where support for evidence-based prescribing is available. It was asserted that professionals who are able to offer an evidence-based assessment should be prescribers. Would that not include suitably qualified persons in a licensed merchant situation?

I am aware that I am concentrating specifically on the anti-parasitic resistance element. I acknowledge what Senator Boyhan has said. I am aware of the one-health approach, but I am also aware of the fact that an anti-parasitic resistance is not going to affect human beings. I do not want to sound flippant. However, it is vitally important for good husbandry and animal care of the farmer and those who are responsible for animals. I would appreciate it if Dr. Beechinor would elaborate more on the points I have raised, which are nearly all taken from the task force report.

Dr. J.G. Beechinor

The HPRA monitors medicines. We do that for human and veterinary medicines. As the Senator is aware, in the context of Covid, we are monitoring adverse reactions to medicines, and so on. We have been doing such work on the veterinary side for years.

There are spontaneous reports of a lack of effectiveness. The odd report does not mean that much until it is scientifically investigated. Our role as regulator is to ensure that we do not just have a little cluster of reports here and there on an annual basis, but that we are able to stand back and see the bigger picture. The bigger picture for us is filled not just with what happens on the ground in Ireland, but throughout the EU and indeed the wider world.

To answer the Senator's question, there is research. The research is not done by the HPRA. It is done by organisations such as Teagasc or published in peer-reviewed journals, demonstrating that the research is scientifically valid. Teagasc started producing reports from around 2006. It first produced reports on sheep, including many thousands of them. Therefore, I am not talking about a few sheep; it is thousands of sheep. Data on cattle followed. The first report containing data on cattle was produced by a Department of Agriculture inspector in 2014. It was a confirmed case in which he effectively managed it, treated the animals, took faecal egg counts and so on, confirmed it and wrote it up. In 2018, Teagasc came in on the back of that and did a study on 16 farms throughout Ireland. It found that there is resistance in every farm. Not only did it find that there is resistance in every farm, but multiple resistance.

That is the evidence from Ireland. I acknowledge that some farmers may not even know that they have a problem. Indeed, some farmers may not have a problem. However, the majority of farmers do. Resistance is ubiquitous; it is everywhere. It is a natural process. We have seen, in the context of Covid in places such as India, how resistant strains emerge. It is genetic. As soon as parasites multiply, they exchange genetics and throw up resistant genes. That is what then leads to resistance on the farm. As products are used, resistance emerges.

The Senator mentioned Scandinavia. Notwithstanding that products are prescription-only medicines, they still get resistance. The Senator is absolutely right that making products prescription-only medicines is not the silver bullet that is going to cure things. What it is, is a step in the right direction. It is our job to ensure that the products comply with the legislation. If we do not do that, the European Commission, which is aware of this report, will find out. The European Commission audits our national residue plan every four, five or six years. It is a risk-based approach. If it comes knocking on our door to ask how we are implementing the requirements for the authorisation of medicines and the residue controls and so on, it will know that the products do not comply. The regulation is crystal-clear - if resistance occurs, the products cannot be regulated other than by prescription.

The Senator also asked about the specially qualified person, SQP. The SQP term is a UK one. As I understand it, in the UK the SQPs have been given rights to prescribe. However, we do not have that system in Ireland. That system is unique to the UK, as far as I know. Everywhere else in Europe, and indeed in the UK, these products are prescription-only medicines. Basically, we must bring Ireland into compliance because we are not, currently.

I apologise in advance, but I have a meeting clash. I thank the representatives of the HPRA for being here this evening.

Could our guests outline the interactions that have taken place between their organisation and the Department of Agriculture, Food and the Marine in respect of the implementation of the directive? Does the Health Products Regulatory Authority, HPRA, have a position on whether the current duties performed by those in the licensed merchants sector amount to prescribing? That would be important for the committee to know.

Could the HPRA give its position on how e-prescriptions work in practice whereby farmers and those in the licensed merchant sector only get prescriptions five days after a vet would have offered them on the farm? Is it the case that by allowing that wait period of, potentially, up to five days before they can access medicines from a licensed merchant, then animal welfare could be at risk, that is, if farmers do not immediately source the product from a vet. Is it equally the case that e-prescriptions are essentially worthless if animals have been dosed five days prior?

Dr. J.G. Beechinor

I refer to the discussions with the Department on the implementation of the regulation. The regulation, as Deputy Carthy knows, is directly applicable but within that is the current SI 786 of 2007 which is the national legislation involved in transposing the current Directive 2001/82/EC dealing with veterinary medicines. I apologise; I know this is highly technical. The statutory instrument has to be revised in national legislation.

In doing that, the new regulation provides choices for member states as to how they want to enact certain features. For example, we can decide if we want to have an electronic package leaflet with the product, a paper copy or both. That is a matter for the Department to decide because that is its territory.

The Health Products Regulatory Authority, HPRA, regulates the products. The Department of Agriculture, Food and the Marine regulates downstream in terms of the licensed merchants, wholesalers, retailers, vets and so on. The Veterinary Council of Ireland also has a role and will be coming in later this evening-----

I apologise for interrupting. Can I get a clarification in relation to this directive? Has Dr. Beechinor engaged directly, as in sat around a table or in written form, with the Department?

Dr. J.G. Beechinor

Yes, we have. We have ongoing meetings with the Department, probably every three months, to discuss this and other subjects. I wanted to say that-----

Every three months. That is spot on.

Dr. J.G. Beechinor

However, we do not have any role in e-prescribing. That is for the Department. We have no role in there. Questions which refer to the validity of prescriptions and so on are probably more appropriate for the Veterinary Council of Ireland and the Department. They are not for us. Our job is around the safety and efficacy of the products and ensuring they comply with the legislation. It is no more and no less.

My colleague, Dr. Murphy, is available to the committee as well. He is chairman of the committee for veterinary medicinal products at the European Medicines Agency. I think he may want say a few words.

Dr. David Murphy

I thank the Chair for the invitation to participate in this meeting. I will answer Deputy Carthy's question around whether the activity the licensed merchants are engaged in amounts to prescribing. As Dr. Beechinor indicated, based on the finding of the HPRA report, the conditions for continuing to authorise these products outside of prescription control is not an option open to us. Given the conclusions of the HPRA report, it follows that these substances or products should come under prescription control.

The regulation sees that prescription control comes under the remit of a veterinarian or the veterinary profession. That, again, is in the regulation. In terms of what licensed merchants have been doing to date, they have been dispensing anti-parasitic substances, but up to this point the majority of those substances have not subject to prescription. In that sense, I would suggest that they are not prescribing.

Under Irish legislation, prescribing is a function for veterinary practitioners, as I understand it.

I welcome Dr. Murphy and Dr. Beechinor to this evening's meeting. May I ask about the packaging pertaining to the products? I have noticed in recent weeks that there has been a major change in packaging among some suppliers. I think they have moved ahead of the regulations and have begun doing packaging. Has the packaging been agreed by the witnesses? Is it a project they have been aware about, that the packaging has moved forward before the legislation?

Regarding food safety and the anti-parasitic drugs being used and the two-tier system we have on the island due to Northern Ireland regulations and southern Ireland regulations, I ask the witnesses to comment on the fact we have major quantities of food or product moving from the North to South which have different regimes regarding anti-parasitic drugs. How will that affect our food product going forward?

Large quantities of milk come South and large numbers of live animals go North. I am not too concerned about the large numbers of live animals going North but rather about the large quantities of milk coming South. They are under a different regime regarding how they deal with the parasitic issue even though we are on the same island. How will that impact on food safety issues? Will there be issues regarding licensing and the all-island approach to food? Will the witnesses comment on those issues?

What do the witnesses believe should happen regarding those regulations? Are they applicable in terms of working in an all-island scenario regarding the food products?

Dr. J.G. Beechinor

Since the report was prepared in December 2019, the HPRA has engaged with a wide spectrum of stakeholders, including farmers, licensed merchants, the Department of Agriculture, Food and the Marine, companies and so on. We have engaged with them to ensure that the products comply by January 2022, which is when the new regulation becomes applicable.

In terms of labelling of packages, a company may produce a product for Ireland once or twice a year, so it needs to get it right. It needs to sequence the change with other changes. For example, we update the warnings on products. We may decide it needs a new environmental warning, so in order to avoid companies having to destroy labelling and waste money, we try to sequence our time of changes to try to make it easier on the companies. That is why we wanted to announce it well in advance.

There is a certain wash through time from products in the current cycle, that is, in the distribution chain. Depending on the product, that might take six months or longer to wash through. We are trying to work with companies through that process.

I accept Senator Lombard has probably, at this point in time, seen products on the market change because this change process has started and products have issued with the approval of the HPRA. Companies cannot make this change without submitting a variation application the HPRA. We have incentivised that, so they do not pay any money for it. It is not of their making, so they should not be out of pocket for it. We have incentivised that. That change process is happening and that is to ensure everybody is aware of the next steps and to minimise the costs on the industry.

In terms of Northern Ireland and the different regimes, it is a valid question but it is really for the Department of Agriculture, Food and the Marine.

It is my understanding that this may still be a live issue with the Department through the Northern Ireland protocol. It is not my area. I believe that it is the expertise of the Department, which would be best placed to comment on it. From our discussions with the Department it has said that a suitably qualified person, SQP, in Northern Ireland can only prescribe in respect of herds in Northern Ireland. They cannot do otherwise. I do not know whether, in the fullness of time, this regime will continue. Prompted by a European Commission audit they may say there is laxity in the system, for example. None of us around this table wanted to see what we saw on a recent "Prime Time" programme. Again, I would expect the European Commission to be alive to that. It is not our area, however, and I do not believe we should comment.

I welcome the witnesses to the committee. What is the Health Products Regulatory Authority's, HPRA, overall view on the use of the licensed merchants? Could the HPRA foresee a way, whether it is through upskilling or attaining additional qualifications, that they could continue to keep hold of their corner of the market. The HPRA opening statement says "Anthelmintic resistance in parasites ... has been demonstrated in European countries which have similar farming and animal husbandry conditions to those in Ireland". Yet, a briefing document that we got from the Department says that it is not aware of any member state that permits anthelmintic veterinary medicines to be supplied for food producing animals in the absence of veterinary prescriptions issued by a veterinary practitioner. Does this indicate that the responsible persons in the licensed merchants are not the root of the problem here? Dr. Beechinor referred to the "Prime Time" programme. Given the recent report that we saw on "Prime Time", which showed the ease with which people can improperly acquire the antimicrobial products North and South, does Dr. Beechinor believe that these new regulations may increase the level of demand for these products on the black market or through unscrupulous practices?

Dr. Beechinor or Dr. Murphy?

Dr. J.G. Beechinor

I will take that question. I qualified as a vet in 1982. The reason I bring it up is that the principles we learned at the time were quite different from what is in place now. Basically, back then our goal was a parasite-free animal or a parasite-free herd. The idea was to blanket treat the cohort of animals with an effective product and nuke the parasites. Unfortunately, the parasites have become resistant. Nuking the parasites only give the fellas that are resistant an open field, so that is no longer the rule book. The difficulty is that science evolves and we are now looking at a goal for sustainable parasite control based on diluting the effects of resistant parasites with bio-security, quarantine, new treatment protocols for purchased animals and building resilience into the animals, possibly through genetic programmes and building resilience into the animals by gradually exposing them to parasite challenge so it is not an overwhelming challenge. This is what the science says. As a veterinarian there are probably others who are more expert than I to speak about how to treat. Those people, and maybe the Veterinary Council of Ireland or Teagasc, might want to add comment to that. My point is that the science is changing. I would agree with the Deputy that licensed merchants are not the root of the problem. The root of the problem is parasite resistance. We must preserve the efficacy of these products into the future. As I said earlier, my colleague Dr. Murphy, who is involved in the EU committee, can speak from experience but we are not seeing new products coming around the corner every five or ten years. The lack of new compounds is a problem, and not just with anti-parasitic products but also with antibiotics. Perhaps Dr. Murphy will join in on that please.

Dr. David Murphy

On Dr. Beechinor's point, the anti-parasitic compounds are a precious commodity. The last new broad spectrum anti-parasitic wormer product for cattle and sheep was authorised ten years ago. That product contains the active substance derquantel. In 2009 we had a product called Zolvix, containing monepantel. They are the two substances that were most recently authorised. There has been nothing new in the broad spectrum anti-parasitic anthelmintic field since then. I emphasise that these compounds are a precious commodity. If one considers the major worm species of cattle and sheep, essentially there are just five classes or wormers available to treat these. These five can be used in sheep but only three of the classes can be used in cattle. Within those classes of substances there are multiple different substances. If there is resistance to one substance within a class then typically there will be resistance to all substances in that class. We are talking about a very small pool of products, so we do need to take steps to preserve them. It is clear that anti-parasitic resistance is an issue. That is not just a conclusion of the HPRA report. Within Ireland bodies such as Animal Health Ireland and Teagasc would also agree on this, as do the European Medicines Agency and other animal health bodies outside of Ireland. Everybody agrees that anthelmintic resistance and anti-parasitic resistance generally is a serious issue and that it needs to be tackled. The issue is not so much about providing access to these products. In fact, as Dr. Beechinor has said, one of the principal goals or objectives in order to maintain the efficacy of these products into the future is to restrict access, in some respects, and to preserve them and only use them when they are required. This is why the legislation is framed the way it is. Basically, it requires that these substances are subject to prescription control. It is important to make the point that this is a step in the right direction, as Dr. Beechinor has said. It is a step, along with other steps, that needs to be taken to preserve the long-term efficacy of these products. This is in everybody's interests and especially in the interests of the animals that we treat, from the point of view of animal health and animal welfare. It is also in the interests of the farming community more generally in promoting animal productivity and farm sustainability. It is an important issue but, as Dr. Beechinor has said, the move to prescription control is not in itself a silver bullet. There are other measures that need to be taken.

On the question of the licensed merchants and where they fit into the equation, that is largely an issue for the Department to consider and I understand that it is engaged with licence purchasers and other stakeholders at this moment in time to ensure that in any new system there will be competition in the dispensing regime.

I thank Dr. Beechinor and Dr. Murphy for providing a very interesting insight into the work of the HPRA. Some of my questions have been covered already. The Department told us that it had engaged extensively with stakeholders over the past two years, with in excess of 12 meetings on the regulations with various regulatory bodies, including the HPRA and the Veterinary Council of Ireland, VCI. I assume that covers the meetings referred to earlier in response to Deputy Carthy. The Department specifically referenced bilateral meetings with its Northern Ireland and UK counterparts. Have the witnesses had any discussions with their UK counterparts? I appreciate that the witnesses are keen to delineate their role in this and to stress that their concern is solely to look after the product and not the sale or distribution of same but have they had any discussions with their UK counterparts? Have they conducted any risk assessment of the likely outcome of the changes to how products are sold here? The anti-parasitic resistance challenge has been a real eye-opener. It is great to get an insight into that and to get that knowledge today. It is fair to say that it demonstrates a real tug of war between nature and science. I ask for the witnesses' personal view on what is at issue here. Has there been a lack of investment by companies? Do companies not see an opportunity for business here? Why are new products not coming on stream as we would wish? Dr. Beechinor mentioned a number of household names in his opening statement, well-known brands that suddenly lost their efficacy in a matter of five to nine years. I am interested to hear if there is a lack of research and development, a lack of investment or if it purely comes down to capacity issues.

Dr. J.G. Beechinor

The Department of Agriculture, Food and the Marine invited the HPRA to join a meeting along with the UK's Veterinary Medicines Directorate and we have set up a regular schedule of such meetings into the future. That deals with what could be described as common issues. The HPRA plays a supportive role in those meetings to assist the Department in terms of issues that may affect the availability or monitoring of veterinary medicines. We have had excellent relations with the UK over the years, particularly in the period when it was a member of the EU. We used to meet our UK counterparts very regularly at different fora. They were part of the European Medicines Agency committees, so we met them on a monthly basis there. We also had regular meetings outside of that, at the heads of medicines agencies committee, which meets on average four times a year. Obviously since Brexit the UK has dropped out of that network but to answer the Deputy's question, we have side-bar meetings in place with the UK, separately. The HPRA and the regulatory authorities in the UK have put in place systems to make sure that we can deal with common areas. About 50% of the veterinary medicines on the market today have a common label with the UK. The Irish market is smaller than the UK market, relatively speaking, but what we would like to do is to keep those products with a common label because that will help with availability, to the benefit of everyone in Ireland. The short answer to the question is yes, we have regular meetings.

I will ask my colleague, Dr. Murphy, to speak about the issue of investment. There are incentives in the new legislation which might be of interest to the committee.

Dr. David Murphy

I do not have a definitive answer to the Deputy's question to be perfectly honest but I would say that coming up with a new molecule that will have an anti-parasitic effect is a challenge in itself. Coming up with a new molecule that has an anti-parasitic effect and is safe for administration in animals adds a further challenge. One must also consider consumer and environmental safety issues. I am pretty sure that companies are screening molecules all of the time in terms of their potential for development but the number of molecules that make it through are very few and far between. We have evidence of that, given that the newest molecule to the market in Ireland was introduced approximately ten years ago. As was pointed out at the start of this meeting, what is paramount in terms of the use of veterinary medicinal products is that while efficacious, they are also safe. Again, that is safe for the target animal, the person using the products, the consumer who is consuming food produce and the environment. In Europe in particular, as well as in other parts of the world, the requirement threshold for new substances is very substantial so the investment required to meet that threshold will be very significant. I repeat the point that coming up with a molecule that is both effective and safe is a challenge and is one of the issues limiting the pipeline.

I thank Dr. Beechinor and Dr. Murphy for joining us today and enlightening us on the issue of parasitic resistance. What Dr. Beechinor laid out in his opening remarks is quite alarming. It is good that we are receiving this information from the HPRA now because it will help us in our deliberations. I invite the witnesses to give their opinion on the effect of stocking rates and agricultural intensification on parasitic resistance. Is it a factor? Is it something that we should be addressing or that the HPRA, in its dealings with the Department, has raised as a relevant issue?

Dr. J.G. Beechinor

Basically, resistance can occur because of different factors. These include parasitic factors and management factors like too-frequent dosing or under-dosing, cloud factors, sub-therapeutic drug levels after initial dosing and so on. Our understanding of some of these issues has increased over the years. We believe that this is the time to deal with it and we welcome the fact that the Department has set up this coalition of interested parties because ultimately we all have to work together. We are all pretty much on the same side here in understanding that we must respond to the scientific evidence that has emerged. None of us has a monopoly on wisdom. Farming is changing, climate change is happening and so the way in which the parasite expresses itself is changing. Is it the parasite? Is it the change in management?

Is it the fact herd sizes have increased? All of these put pressure on the resources we have. In some cases maybe we do not need a chemotherapy agent at all. Maybe the investment in the next generation of chemotherapy agents will be in the vaccines area. We currently have a vaccine for hoose and, to respond to an earlier question on incentivisation, there is research ongoing and the new regulation puts in data protection provisions to incentivise the development of new molecules. There is not one single factor in this but rather a multitude of factors. This is the best chance we have to get it right.

My first question relates to a multi-stakeholder approach. I notice the Health Products Regulatory Authority, HPRA, report makes it clear that tackling antiparasitic resistance needs a multi-stakeholder approach. Currently, 75% of antiparasitic medicines are dispensed with advice from the responsible persons and vet pharmacists but the Department of Agriculture, Food and the Marine refuses to include these professionals in providing advice and prescribing. Does the HPRA support this strategy? If responsible persons have not caused the resistance, why not include them in prescribing?

There are 1,600 responsible persons and 300 vet pharmacists, all of whom are keen to address antiparasitic resistance recommendations in the report. This presents an irresistible opportunity to unite all prescribers with common training and uniform knowledge transfer to farmers. However, what incentive is there to commit to the training expense and time if they cannot prescribe or advise on antiparasitic resistance?

All antiparasitic medicine prescribers will have to apply best practice, which includes a regulatory body, a code of practice, qualification in chosen species, training in antiparasitic resistance, sole prescribing supervision over the counter, an annually updated register and a prescribing protocol involving compulsory antiparasitic resistance questioning and disciplinary powers. Does the HPRA support these requirements?

Dr. J.G. Beechinor

I thank the Deputy for the question. Page 38 of the report deals with this topic. Basically, neither licensed merchants nor prescription control on its own can prevent resistance. These are a step in the direction of ensuring the products we use comply with legislation. If we do not do this properly, there is a cost to everybody. Most farmers recognise this and realise it does them no favours to use products they do not need to. By turning this around, we can preserve the efficacy of the products and it will end up putting money in farmers' pockets because they will not have to spend money unnecessarily. In some cases we do not even need to rely on medicines and we can work through quarantine and other tools.

The literature indicates that anybody intending to deliver an antiparasitic should look at which species of parasite are the most important to consider for the age and type of animal, what stages of the parasite are likely to be present, which drugs provide the proper spectrum of activity, what host dynamic properties exist and how they will play out, which animals require treatment, and whether drugs that are intended for use are still effective against the parasite species. What will be needed in future is evidence-based prescribing, with knowledge of the farm, the system and the parasites.

As I mentioned earlier, we should also include factors such as whether we are having a dry summer or weather conditions that have changed such that another parasite could be responsible for the scour, slow growth or whatever. It is about using a range of diagnostics, supported by farmer and farm knowledge.

With regard to access to medicine, we have no issue with licensed merchants and we do not regulate them. We agree that knowledge of this matter is still in its infancy. There are many people, including me as a veterinarian, who know the science has moved on. Upgrading our skills is as much a challenge for veterinarians as it is for licensed merchants. Perhaps the witnesses from the Veterinary Council of Ireland will be able to assist the committee on the questions around best practice because it is an area downstream of the HPRA.

I thank the witness. That concludes this session of the meeting. On behalf of the committee I thank Dr. Beechinor and Dr. Murphy for their very informative contribution. They were very helpful in answering our questions.

Dr. J.G. Beechinor

We thank the committee for the opportunity to come before it.

We appreciate the input.

Sitting suspended at 7.26 p.m and resumed at 7.28 p.m.

From the Veterinary Council of Ireland we have Ms Niamh Muldoon, registrar and chief executive officer; Mr. Joe Moffitt, president; and Dr. Ailis Ní Riain, deputy president. They are joining remotely from a witness room in Kildare House. They are very welcome to the meeting. We have received the opening statement from the witnesses, which has already been circulated to members. We have limited time due to Covid-19 safety restrictions so the committee has agreed that the opening statement can be taken as read and we will use the full session for questions and answers, as we did in the first half of the meeting. 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 on 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 whether or the extent to which participation is covered by the absolute privilege of a statutory nature.

I welcome the witnesses from the Veterinary Council of Ireland and I have a number of questions or statements on which they could elaborate. They arise from the submission to the committee.

I will follow up a very interesting deliberation we had in the past hour with the HPRA.

Something came through very loud and clear on the issue of antiparasitic resistance. I am conscious that the VCI submission is very much based on the antibiotics side. On the antiparasitic side, based on what I have been listening to for the last hour, I wonder whether the product is the problem here, irrespective of whether it is prescribed and administered by a vet, or prescribed and sold by a responsible person or suitably qualified person and administered by the farmer himself? We are engaged in a box-ticking exercise with regard to the EU regulation. We are not going to solve the problem, if there is a problem with antiparasitic resistance, with the products we have available. As I said, it will make absolutely no difference who is or is not prescribing it or administering it if there is not a broader range of product. Based on their submission to us and what we have heard in the last hour, will the VCI representatives comment on that? What do they say about the HPRA task force report, which found, on a Europe-wide basis, that the only area and the only action which had a positive effect in reducing antiparasitic resistance was in Scandinavia, where the action taken was the decoupling of prescribing and dispensing? In other words, the vets prescribed and another agency dispensed. I would like a comment on that because in the other areas that introduced the policy of vet prescription that is proposed here, it did not have the desired effect. In fact, an increase in antiparasitic resistance was recorded.

I was on the previous agriculture committee when the council came before us. We had a lot of debate and deliberation on the veterinary practice ownership issue. The council stood firm on allowing multinationals to buy up and amalgamate small practices. We are where we are on that but with that in mind, if this regulation goes through as currently proposed and we do not take the derogation, are there enough vets in the country to prescribe what is required? Do we have enough vets, veterinary practices and services in rural areas to be able to meet the needs of the farming community, assuming we do not take the derogation?

I wish to give the witnesses, as professionals and as vets, a brief example. It says in the regulation that a veterinary prescription is valid for five days only and also that a veterinary prescription is "limited to the amount required for the treatment concerned". I am using the example of a farmer who thinks he has an issue and calls out the vet. Dung sampling and observation is done. It is a rather large herd and parasites are identified in it, but not in the entire herd. In the VCI representatives' opinion, what does the vet do then, under the new system? Does he give the farmer a prescription to dose all the cattle or does he start doing a full test, so that what he prescribes is limited to the amount required for the treatments concerned? I would like council representatives' professional opinions on that.

I thank the Senator. I ask the VCI representatives to introduce themselves when they speak for the first time. Which of them would like to take the Senator's questions?

Ms Niamh Muldoon

I will do so. My name is Niamh Muldoon and I am registrar of the Veterinary Council of Ireland. I am joined this evening by Mr. Joe Moffitt, who is the president of the council, and Dr. Ailis Ní Riain, who is the deputy president. I thank the committee for the invitation to appear before it today. We hope to be of assistance to it in its deliberations on the matters at hand.

Senator Paul Daly asked whether antiparasitic resistance will remain regardless of who prescribes the product. Ultimately, the HPRA task force report of December 2019 dealt with much of that issue. The VCI is the independent statutory body charged with regulating the veterinary professions. Therefore, we are not best placed to comment on issues related to the products. Our role in assisting and offering definitions to some of these veterinary medicine regulations is to ensure that when a prescription is given by a veterinary practitioner, it is given based on a strong threshold of knowledge and given for the appropriate use of any individual product.

The council adopts no policy on the decoupling of veterinary medicines. Ultimately, it is a policy matter for the Department of Agriculture, Food and the Marine. We are the regulatory body so market forces are not a matter on which we can comment. Our role concerns the public interest, the best interests of animal health and welfare and public health.

The Senator raised ownership and referenced our previous appearances before the committee. He queried whether there are enough vets in the country to offer the services required in relation to both antimicrobial products and antiparasitic products. We have 3,015 registrants on our register of veterinary practitioners. We believe there are enough vets in the country to service all the nation's requirements. Vets are woven into the fabric of every community across the country. We do not foresee any of these regulations being a difficulty or posing any threat to services or the treatment and care available for animals.

The Senator's final point related to the five-day validity period for a prescription referenced in the veterinary medicine regulations. That five-day validity period relates only to prescriptions of antimicrobial products and as such would not be relevant for antiparasitic products. I think the concern related to dosing with antiparasitics. That five-day limit, as specified under the veterinary medicine regulations which we know will be imposed on all European countries, relates only to antimicrobial products such as antibiotics and not to antiparasitics.

I thank the witnesses for coming in. Animal welfare will suffer following this. The Department knows that costs to farmers will also increase. Vets already charge for prescriptions if they do not supply the veterinary medicines. My worry is that in some instances in rural Ireland, animals that are of low value will not be given the treatment. It is obvious, unfortunately, what is going to happen here. Essential antiparasitic treatments will be avoided and parasitic diseases will be left to run their course, causing untold levels of animal suffering. That is the view of many people out there, sadly. It is going to happen and I would like the council representatives' views on those matters.

Ms Niamh Muldoon

I might open the response and then invite my colleagues to offer their comments. The intention of this regulation is to improve both animal health and welfare and human health and offer some protections in that regard. It offers an opportunity for Ireland and other European countries to advance the standards in practice in relation to medicines. It also affords an opportunity for a Europe-wide standard to be adopted. Ultimately, that is going to benefit animal health and welfare, and indeed public health.

On the concerns about low-value animals, farmers across the country are the first guardians of the welfare of animals. I believe we are very fortunate in this country in terms of the level of experience and expertise we have among our farmers and indeed our veterinary practitioners. I do not believe these regulations should pose a difficulty in animal welfare terms or otherwise. Mr. Moffitt, who, in addition to being the president of the council is also a veterinary practitioner, may have some comments to add.

Mr. Joe Moffitt

I will take Senator Paul Daly's questions in order. On the suggestion that the product is the problem and that it really does not matter who prescribes or dispenses it because it is essentially a box-ticking exercise, the whole area of antiparasitic resistance is a dynamic between the animal, the parasite and the environment. We are in a situation where our products are losing their usefulness and efficacy.

What the veterinary medicine regulations envisage is proper management of the products where they are applied, using the least amount of product to get the best and most targeted amount of response such that the usefulness of these products can be prolonged. As regards the decoupling, we are the regulatory authority and we regulate the veterinary profession so that prescribing is done with due diligence and whatever dispensing is also done with due diligence.

With regard to multinationals buying small practices, every year there is an increasing number of veterinary surgeons on the register and a significant proportion of those coming onto our register are interested in pursuing a career in farm animal and rural practice. We do not at present envisage any deficiency.

With regard to Senator Daly's point on prescriptions being valid for five days and the animal welfare concerns of Deputy Collins, these regulations foresee a common-sense attitude and a reasonable response, and a relationship between farmers and vets such that products are prescribed or dispensed on the basis of clinical examination or proper assessment, which we have helped the Department of Agriculture, Food and the Marine to define, such that animals are properly cared for by their owners supported by the veterinarians. We hope to ensure this continues. These regulations may give a somewhat more structured approach in this regard. Animals will continue to be cared for properly, possibly with better disease control and outcomes for the animals and less expense for their owners in the longer term.

Dr. Ailis Ní Riain

The committee has heard relatively comprehensive answers from my colleagues. The only addition I will make is it is a matter of focus for the Veterinary Council that all of our registrants practise and prescribe ethically. On the rare occasions this does not occur, there are other remedies or sanctions available to us.

I cannot understand how it will be less expensive. It is dead right to say animal welfare is of huge importance to farmers but, sadly, they will be massively out of pocket. They cannot afford the new rules and regulations that are coming in and, unfortunately, something has to give. Either the farmers will pack up or the animals will be left to suffer. I am not making up the story. I know what will happen because farmers are struggling desperately as it is at present. They do not see any light at the end of the tunnel. I cannot see how it will be less expensive. I can see how it will be extremely costly to get prescriptions from vets. Perhaps the witnesses can explain to me how it will be less expensive.

Ms Niamh Muldoon

We understand these regulations will bring about some required changes. These changes are recommended and required by Europe on the basis of improving animal health and welfare and public health. It is very plausible there will be an increased or additional cost at the outset. I am aware some speakers who appeared before the committee referenced the potential opportunities and savings in the long run through minimising the use of medicines, potentially better outcomes for animals, minimising disease and offering a greater return in terms of the productivity of the animal. We cannot shy away from the fact there is the potential for some additional costs to be associated with these regulations. The role of the Veterinary Council is veterinary regulation and it is probably a matter more appropriate for the Department of Agriculture, Food and the Marine, which may deem fit to invest in public health in matters such as this. This is a matter on which the Veterinary Council cannot comment.

I welcome the witnesses to the committee and thank them for coming before us. Given we are seeing new regulations coming in that will have an impact on licensed merchant businesses with qualified persons throughout rural Ireland, are the witnesses saying it is their belief licensed merchants and their qualified persons have been issuing too much of these medicines? We have also heard the concerns of some farmers that vets will possibly corner the market on issuing prescriptions for the products in question. Now we hear about a new web-based national veterinary prescribing system. If this is the future, why were promises made some time ago that a framework would be implemented that would give farmers greater choice in sourcing their veterinary medicinal products from a vet or a licensed merchant? It never actually happened. Why has the Veterinary Council of Ireland not acted to ensure farmers and licensed merchants have prompt access to prescriptions as opposed to relying on e-prescriptions, which we all know can take up to five days to arrive? Granted vets have no Internet out in the fields but a delay of five days does not seem a reasonable turnaround time. It is not in the interests of farmers, animal welfare and the sector generally and indicates an issue with competitiveness more than anything else.

Ms Niamh Muldoon

I will open the response and then ask the president of the Veterinary Council to assist with further comments. Regarding reference to the impact on rural businesses, the Veterinary Council, in considering some of the definitions of the terms contained in the veterinary medicines regulations, has engaged very broadly with many stakeholders to the antiparasitic stakeholder group. We have met licensed merchants and their representatives. We have met the co-operatives, farming bodies, veterinary representatives, Teagasc, Animal Health Ireland and agricultural consultants. We are very much aware there are differing approaches to these regulations from various stakeholders. We accept there may be some impact on business, but ultimately these regulations require veterinary prescriptions for certain products.

The route of supply of all of these medicines will remain unchanged. While, for example, antiparasitic medicines will now require a veterinary prescription, the same option in terms of choice of supplier will remain to any individual farmer or animal owner. The Department of Agriculture, Food and the Marine is looking at the introduction of an electronic prescribing system in an effort to ease access to the range of suppliers for these medicines so that if and when farmers or individual animal owners obtain a prescription, they have freedom of choice regarding where they will source or obtain the medicine product.

The Deputy queried whether the Veterinary Council can comment on whether qualified persons have been supplying excessive quantities of medicines. We can make no comment in this regard. The Health Products Regulatory Authority produced a task force report in December 2019 which recommended that some of these products have veterinary prescription requirements. As the regulator and independent statutory body regulating vets, veterinary nurses and veterinary premises, we cannot make a comment on matters in the past. Our role, in the public interest, is to offer some of these definitions in supporting the introduction and implementation of these regulations.

Ms Muldoon said people can source the products in the same places but we all know that, even if the merchant has to wait five days to get it, the farmer cannot afford to wait five days. This cuts down the farmer's options, and he must then go to a vet.

He may have been using the merchant all his life, but now, with the new system and a five-day delay, it does not give him an option because he needs the medicine for his animals as soon as possible and not wait five days for it to come through on the e-prescriptions system.

Ms Niamh Muldoon

As I understand it, it is intended that the electronic prescription system would enable access to any prescription immediately, so there should be no delay. Does the Deputy's reference to five days relate to the validity period of a prescription for an antimicrobial product? For example, if a vet issues a prescription for an antimicrobial or antibiotic product, that prescription will only be valid for five days so can only be filled for a period of five days. As I understand it, however, the intention in the development of this electronic prescribing system is that the prescription would be available immediately, so there should be no such delay. Ultimately, however, that electronic prescribing system sits under the Department of Agriculture, Food and the Marine, so it would be better informed in that regard.

I welcome the guests and thank them for attending the meeting. I will be very brief. Regarding the practice of practitioners giving out prescriptions where complaints are made, does the Veterinary Council of Ireland investigate those complaints? If it does, have any of these people been prosecuted or lost their veterinary licences over recent years?

Is it really necessary to have just veterinary people making these prescriptions? As the witnesses know and as Ms Muldoon herself said, to be fair to her, there will be a cost factor for farmers and it will be very hard on them. As other speakers have said, they are already in difficulty with regard to profit, and this will put a further regulation on them. I believe farmers are over-regulated. No matter what is prescribed, doctors and veterinary surgeons and people such as the witnesses will always say there is an overprescribing of these products.

Like other people, what I am worried about is competition. I know that is not the Veterinary Council of Ireland's problem. Its problem is to make sure these people are prescribing what they are prescribing as they should be prescribing it. People have said this one is prescribing too much and that one is prescribing too much. I have not seen many prosecutions over the years. The witnesses might fill me in on that, please.

Ms Niamh Muldoon

Certainly. The Veterinary Council has a number of regulatory tools open to it in respect of disciplinary action. We issue a code of professional conduct to all our registrants. It is binding on every registrant, so every individual, veterinary nurse or vet, is bound by the terms of that code of conduct. Equally, we have a role in education, supervising different programmes of continuing veterinary education and making sure all vets and vet nurses on our register maintain their competence throughout the journey of their careers. There are also the disciplinary aspects.

Deputy Ring referred specifically to complaints. Yes, the Veterinary Council will deal with somewhere between 30 and 40, and sometimes up to 50, complaints a year about various matters. There are very extreme sanctions available to the council if and when there is a finding of professional misconduct of any individual whereby he or she has been found to fall below the expected standards. As for specific examples, I can tell the Deputy that last year, in 2020, four vets were suspended from practice, that is, not allowed to practise for a period ranging from two months to six months. We had three vets suspended for six months and one vet suspended from practice, suspended from our register, for a period of two months. That is the most extreme of sanctions if you consider that, in effect, an individual's livelihood is being taken away. The High Court supervises and endorses the sanctions imposed by the Veterinary Council. Suffice it to say, the council will always act in the public interest in making sure the highest standards are imposed on and expected of all our registrants. It is, in part, one of the elements of ensuring we have such high standards of practice throughout the country.

I will go back to a point Senator Daly made. In practice, out there on farms, especially, say, from the last week of January to now, there is lambing going on, an awful lot of calving going on and cows with mastitis. On a dairy farm, at seven or eight o'clock in the evening, the farmer will be milking his cows under an awful lot of pressure for labour. How will the service be provided such that when an animal wants an antibiotic, it will get it within a very short time? I would like the witnesses to elaborate a little more on that. No matter how well managed a farm is, there will, unfortunately, be problems at various stages. A cow can get mastitis for any variety of reasons. It is perfectly understandable and obvious that in the case of a difficult calving, the vet has to be called, but then there are treatments that are fairly routine for farmers but which have to be done in the interest of the animal's health. If not done quickly, the animal's health will deteriorate very quickly. I see the vets around my part of the country for those three or four months of the spring. They are under maximum pressure. The only ones who look as tired as the farmer after the spring are the vets.

How will it work in practice that the call will be able to be taken and the proper treatment will be available quickly for the animal, first, from an animal welfare point of view and, second, from an economic point of view and to avoid unnecessary losses? Will the witnesses again go through how they think this will work in practice? I think it will bring significant extra cost to the administration of drugs but I would like to see how it could work physically.

Ms Niamh Muldoon

I will open the response and then ask the Veterinary Council president to assist with some additional comments. We at the Veterinary Council regulate for a 24-hours-a-day, seven-days-a-week service, so it is a particularly onerous expectation on all our vets, but the truth is that that requirement is there. The Chairman referred to the need to call vets out at different hours of the day and to different times of the year being particularly busy periods.

As for some of the terms contained in the veterinary medicine regulations, there are some terms the Veterinary Council intends to include in our code of professional conduct. Some of those terms refer to either a clinical examination, which may be required in some circumstances, or, in the alternative, a proper assessment of the health status of an animal. Ultimately, the guidance and the code the Veterinary Council issues will require a threshold of knowledge to be held by any veterinary practitioner before he or she discharges the privilege of prescribing. Once that threshold of knowledge is met, that threshold being a true and accurate knowledge of the farm, the animal, the herd, the husbandry, the conditions and the history, there is a very strong knowledge base on which to rely before issuing any diagnosis or prescription. A vet is not required to go out on every single occasion to the animal or to the yard. What the Veterinary Council, in terms of the definitions, is saying is that once a threshold of knowledge has been reached, there is a safe basis on which to provide a diagnosis and-or prescription.

The veterinary medicine regulations refer to risk in the recitals. We talk about the avoidance or minimising of the use of antimicrobial medicines in particular but also all medicines. The rule of the Veterinary Council is to offer some guidance in our code to ensure sufficient knowledge of the circumstance and input to seek to offer strong disease control. I will hand over to my colleague, Mr. Moffitt, who may be able to make some further comments.

May I put a supplementary question to Ms Muldoon following what she said there? From what I hear her saying, the farmer would have to be able to converse with his vet to get the product he needs. Let us take a Sunday evening or Sunday night, at eight or nine o'clock. In the vast majority of practice, vets operate on a rota and only one will be on call. A lot of the time he will be out physically doing a call. In practice, I hear what Ms Muldoon is saying clearly to me, that it is from his knowledge he will have to prescribe. From what she is saying, however, the farmer will have to have a direct conversation with the vet to get the drug prescribed.

Coming from a farm, I see that will be very difficult and problematic during a busy spring period. I can imagine a lot of tempers getting very frayed while farmers try to make sure they are able to get what they need as quickly as possible.

Mr. Joe Moffitt

I do not see that will be a problem. It is something that goes on now anyway where the farmers and the vets have an ongoing relationship, and when difficulties crop up, they are able to manage to sort them out between them.

On the licensed merchants and the pharmacists, we hope their expertise would be retained at the dispensing end. No real change to the supply routes is envisaged in the regulations and we would expect the knowledge which they have built up and the relationship they have built with farmers over the years will be retained and would feed into the whole knowledge base.

Deputy Ring said regulations bring cost. That is a reasonable assumption in this situation where there is an increased expectation on prescribing that there be increased cost at the beginning. We feel there is a large public interest section in this on antimicrobial resistance. The antiparasitic resistance goes to the heart of the sustainability of agriculture in the country. Most players in this situation would hope there would be some mitigation towards the costs at the beginning but that the requirement for them would reduce as time goes on and further savings were achieved through less use of drugs, better disease control and less ultimate expense on the farmers.

If there are any other unanswered questions, I ask members please to come back to us because we are trying our best to answer them all as we go along.

This issue has had an awful lot of debate at this committee. There is serious unease about how it will work in practice on farms. As Deputy Ring said, there is a financial worry but we also have a welfare worry about how more regulation will benefit. We are very concerned about it.

I want to follow on from the point the Chair made. It is well known that I am a suckler farmer and the Chair is a dairy farmer. The Chair highlighted the business of a dairy farm in the months of February, March and even into April. That is the very time the suckler farmer will be considering putting out his or her cattle and will want them treated for parasites before putting them out. It will double up the workload at that particular time. Based on what was said here, when vets are under pressure, we have been led to believe here that a consultation over the phone will suffice for the provision of a prescription. I fail to see why a consultation with the responsible person is not identical. If it is basically the farmer making the observation, giving his or her observed diagnosis over the phone to a veterinary surgeon, then I do not see the difference in the farmer doing the same to a person behind the counter at the merchants, who is a responsible person and is recognised as a responsible person by the Department of Agriculture, Food and the Marine and is suitably qualified as per the definition and restrictions of the Department. What Mr. Moffitt has just said is basically that when under pressure, when time constraints are of the essence, his people will give a prescription for product over the phone to a farmer based on the farmer's own observation and diagnosis. Will the witnesses please tell me then what is the difference in a responsible, suitably qualified person doing the same when it is in essence the farmer who will be making the diagnosis?

Ms Niamh Muldoon

First, you must separate the two proposed regimes. We know the veterinary medicine regulations offer much stricter controls in relation to antimicrobial products. The validity of the prescription will be for five days only, individual animal data are required, and there is a greater threshold for prescription of those antimicrobial products. Separately, we have the antiparasitic medicines. The HPRA task force report recommended that those products would require a veterinary prescription. That is a very significant change in the practice and approach we had previously seen coming into force next January. How do we approach that? It might be that there is potential for a herd health parasite control programme to be put in place. Maybe a vet would offer some analysis on the husbandry, conditions, grazing, pasture management and all the factors that would feed in to a control programme relating to parasite contro,l after which a prescription could be offered for treatments as appropriate in the circumstances in the opinion of the veterinary practitioner, the only person who can offer a diagnosis and the only person who can offer a veterinary prescription.

It is not that we are saying a phone call to the vet is going to fix every ailment. Equally, it is not that the Veterinary Council will make any comment on the role of the licensed merchants or suitably qualified or authorised persons. Our role, as regulator, is to regulate the practice of veterinary medicine. It is in that context we will ultimately issue the code of professional conduct. What is being proposed is a very different practice from that which the country has enjoyed to date. We know the recommendations are coming in the best interests of maintaining efficacy of products, as the committee heard earlier from the HPRA, and the basis for its recommendation that the antiparasitic medicines would require a veterinary prescription. Equally, the veterinary medicine regulations require a much more stringent approach Europe-wide in the use of antimicrobial products, all of which is done in the best interests of animal health and welfare and, indeed, public health.

Thank you. Since there are no other questions, on behalf of the committee, I thank Ms Muldoon, Mr. Moffitt and Dr. Ní Riain of the Veterinary Council of Ireland for sharing their expertise.

The joint committee adjourned at 8.08 p.m. until 3.30 p.m. on Tuesday, 4 May 2021.