Joint Committee on Agriculture, Food and the Marine debate -
Tuesday, 11 Oct 2022

General Scheme of the Veterinary Medicinal Products, Medicated Feed and Fertilisers Regulation Bill 2022: Discussion (Resumed)

Chairman

Apologies have been received from Deputy Kehoe.

I remind members, witnesses and those in the Public Gallery to turn off their mobile phones. The purpose of today's meeting is to continue the pre-legislative scrutiny of the general scheme of the veterinary medicinal products, medicated feed and fertilisers regulation Bill 2022. The committee will hear from the Minister of State at the Department of Agriculture, Food and the Marine, Deputy Heydon, and officials from his Department.

All of those present in the committee room are asked to exercise personal responsibility in protecting themselves and others from the risk of contracting Covid-19.

Witnesses giving evidence from within the parliamentary precincts are protected by absolute privilege in respect of the evidence they give to the committee. This means that witnesses have a full defence in any defamation action for anything said at a committee meeting. However, witnesses are expected not to abuse this privilege and may be directed to cease giving evidence on an issue at the Chair's direction. Witnesses should follow the direction of the Chair in this regard and are reminded of the long-standing parliamentary practice to the effect that, as is reasonable, no adverse commentary should be made against an identifiable third person or entity. Witnesses who are giving evidence from a location outside the parliamentary precincts are asked to note they may not benefit from the same level of immunity from legal proceedings as witnesses giving evidence from within the parliamentary precincts, and they may consider it appropriate to take legal advice on this matter. Privilege against defamation does not apply to the publication by witnesses, outside the proceedings held by the committee, of any matter arising from the proceedings.

Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against any person outside the Houses or an official, either by name or in such a way as to make him or her identifiable. Parliamentary privilege is considered to apply to utterances of members participating online in this committee meeting when their participation is from within the parliamentary precincts. There can be no assurances in the context of participation online from outside the parliamentary precincts. Members should be mindful of this when they are contributing.

I welcome the Minister of State, Deputy Martin Heydon, and the following officials from his Department: Dr. June Fanning, deputy chief veterinary officer; Dr. Paul Corkery, senior superintending veterinary inspector; Mr. Ted Massey, senior inspector; Ms Louise Byrne, deputy chief inspector; Mr. Conor O'Mahony, principal officer; Dr. Sheila Nolan, principal officer; and Mr. Peter Collins, assistant principal officer.

I invite the Minister of State to make his opening statement. We might take the meeting in two halves, dealing with medicinal products first and fertiliser second, if that is acceptable to him.

Minister of State at the Department of Agriculture, Food and the Marine (Deputy Martin Heydon)

Very good. I am in the hands of the Chair.

I thank the committee for the invitation and opportunity to speak this evening as it engages in pre-legislative scrutiny of the Bill. Unfortunately, the Minister, Deputy McConalogue, cannot be here present for understandable reasons but, on his behalf, I thank the members for facilitating an early discussion on this topic because it is a key priority of the Department and because there are measures in it that he is seeking to have in place for the start of next year.

I am joined by my officials, whose names have been listed by the Chair. They will be here for the course of the meeting. The officials dealing with fertiliser will join us later if we reach that element.

The Bill proposes to introduce legislation that deals with two distinct aspects of agricultural life. First, it is to provide for powers to make regulations on areas that recent EU regulations on veterinary medicines left to be determined by national law, such as the retailing of veterinary medicines, for the introduction of a national veterinary prescription system, NVPS; repeal the Animal Remedies Act 1993; and modernise the legislation that governs the general veterinary medicine area. Second, the Bill will amend the Fertilisers, Feeding Stuffs and Mineral Mixtures Act 1955 by inserting new registration requirements and related provisions to enable the collection and processing of information on the manufacture, importation, sale, supply and use of fertiliser in the State.

With specific regard to the area of veterinary medicinal products and medicated feed, I wish to make some key points. The Bill is important for farmers and the wider agriculture industry. I stress that the priority of the Department from the outset has been to strike a balance between the continued availability of these products at a reasonable price for farmers, meeting regulatory requirements and protecting the rural economy.

A growing understanding of the risks of antimicrobial resistance, AMR, is among the key drivers for recent changes in EU legislation in this area. As members will be well aware, AMR poses significant challenges to society and the Irish farming sector. Responsible use of antimicrobial products in food-producing animals is a key element in helping to combat resistance. This Bill, together with SI 36 of 2022 – the European Union (Veterinary Medicinal Products and Medicated Feed) Regulations 2022, which gives effect to EU Regulations 2019/4 and 2019/6 – is a key step in dealing with the challenge of AMR.

The committee previously reviewed the EU regulations in detail and issued a comprehensive report in 2021. In drafting this Bill, which deals with matters that were left to national discretion, the recommendations of the committee were taken into account.

In addition to the implementation of certain matters of national competence as permitted by EU Regulation 2019/4 on medicated feed and Regulation 2019/6 on veterinary medicinal products, one of the main elements in the Bill is the provision of a statutory basis for the introduction of a national veterinary prescription system, NVPS, which will facilitate the electronic generation and dispensing of prescriptions of veterinary medicines for food-producing animals. This will provide greater assurance as to the traceability and use of veterinary medicinal products and in so doing, protect animal and human health and support consumer confidence. The introduction of this electronic system will also provide greater choice for farmers when getting prescriptions dispensed. This has been a central consideration of my Department in drafting this legislation. The Bill will make it mandatory for all veterinary prescriptions to be generated electronically using the NVPS. The system, in this current phase of development, will facilitate the recording of veterinary prescriptions by a registered veterinarians across eight food-producing animal species. It also caters for the dispensing of any such prescription, where appropriate, from a registered dispensing outlet such as a licensed merchant, co-operative or pharmacist outlet.

The NVPS is a free to use, standalone system to both prescribers or dispensers. However, my Department has worked alongside existing prescribing and dispensing software providers to allow them to integrate seamlessly with the NVPS. My Department has been engaging with stakeholders in relation to the NVPS since November 2020, both bilaterally and in multi-stakeholder forums. The significant communications campaign has recently escalated, most notably at the 2022 ploughing championships. The team is planning further engagements in the coming weeks and months with both veterinary practitioners and dispensers around the country regarding training and use of the NVPS. It is planned that NVPS will be extended to companion animals in time.

Turning to the second part of the Bill-----

Chairman

I propose that we take questions on the first part of the Bill before moving on to the second part.

Deputy Martin Heydon

That is perfect.

Senator Paul Daly

I welcome the Minister of State and his officials to the meeting. As he quite rightly said in his opening statement, this is the second time the committee has addressed this issue. We have already met all of the stakeholders on a couple of occasions and compiled a report. We are now compiling a second report as part of the pre-legislative scrutiny process.

Everyone who has appeared before this committee and all members of the committee itself understand the importance of handling antimicrobial and anti-parasitic resistance. That is not an issue. The stakeholders who will be most affected by the major change in the regulations which will make anti-parasitic medicines prescription-only, told us when they appeared before us how this will affect their businesses. I refer in particular to the businesses of licensed merchants, members of the Irish Co-Operative Organisations Society, ICOS, and the pharmacies in rural Ireland. As recently as last week they were before us and it was not Mystic Meg stuff. They were able to give us numbers and percentages for the drop-off in sales when antimicrobial medicines became prescription-only. They stated that intramammary sales alone are down 90%. They have come a long way in meeting the Department since their first visit here. The major issue is with the claim that the regulation will be implemented but the implementation will avoid anti-competitiveness and will enhance and increase the availability of product. That will not happen when it becomes a veterinary, prescription-only product and that has been proven in the context of the changes to the antimicrobial and intramammary products.

The solution that was put to us, loud and clear, is the inclusion of the "responsible person" when it comes to the prescribing of anti-parastic products. The responsible person has been recognised by the Department. The Department initiated the responsible person programme and stated what training and qualifications were required back in 2012. From what we have been picking up at this committee, the issue is one of differing legal opinion. I believe the Department has legal opinion from the stakeholders and from the Attorney General. In the context of an all-Ireland animal health plan, the suitably qualified person can prescribe anti-parasitics in the North of Ireland. Northern Ireland is outside the EU now but it had accepted a derogation that the suitably qualified person could prescribe anti-parasitics. What we are hearing is that the Department cannot accept the role of the responsible person because responsible persons were not prescribing at the time the regulation was introduced. Yet, the Department recognised them and they were de facto prescribing anti-parasitics from 2012. This cannot be determined on the basis of different legal opinion at the cost of rural jobs and rural businesses. We need to step up to the mark and find a solution. I hope a solution can be found and let it be an Irish solution to an Irish problem. If we do not get this right, the ramifications for jobs and businesses, as well as for animal health and welfare and the quality of our animal-based food products, will be enormous. We will have two different systems on the island and irrespective of what arguments we make against going to the North, people will do so. Anti-parasitic products will come into the North. If farmers do not dose their cattle it will cost them money but if they have to go to the grief of getting prescriptions and so on, then they will get their hands on a bottle. That will not be recorded in the context of traceability or Bord Bia systems but will be administered in the interests of the animals.

It is vitally important that we get this right but there is nothing in the Minister of State's statement to indicate that we are going to overcome that hurdle. We cannot stand over the loss of jobs that was predicted here last week. We did not hear estimates or Mystic Meg stuff. Stakeholders had proof. They told us that their antimicrobial sales dropped by 90% and if they see a similar hit or drop in their anti-parasitic products, they will go out of business. These businesses are the lifeblood of a lot of our rural communities. They have the knowledge on the ground. They understand the type of land being farmed and the type of animals being kept. They know as much about farming practices as vets do and in some cases, they know more. If the veterinarian whose care the animal is under can prescribe off site, it is in essence still the farmer who is going to be self-diagnosing. The farmer will be explaining the symptoms to the vet and then the vet will write a prescription. In that regard, it does not make sense.

I am disappointed that the Minister of State's statement did not address these problems but maybe he can address them now. In my view the only solution, having dealt with this issue for almost two years at this committee, is recognition of the responsible person. To be quite honest, as it stands at the moment I cannot see this Bill passing and I am saying that as a member of the Government.

Deputy Martin Heydon

I thank Senator Daly for raising a number of important points. Initially he talked about antimicrobial resistance and intramammary tubes, which farmers are well aware of, having used them on a very regular basis. I take on board the concerns he has raised and am aware of the points that have been made at this committee previously. Like many colleagues, I too have met merchants and businesses that have significant concerns in this area. As I said in my opening statement, this is about us getting the balance right. We definitely do not want to see a negative economic impact but we also do not want to see a negative impact on farmers who have a role to play in the context of prevention.

In terms of antimicrobial resistance as opposed to anti-parasitics, there is a clear difference in prescriptions. An intramammary is an antibiotic, as the Senator is aware and the prescription length for that is five days whereas an anti-parasitic prescription has a life span of 12 months. In many respects, anti-parasitic applications would be planned out by a farmer in the year as a preventive measure rather than as a way of dealing with symptoms.

The Senator referred to symptoms, which are an element of it. An animal might display symptoms indicating it needs a wormer or whatever, but we know that, where cattle go into a shed, dosing for liver fluke can be preventative four or six weeks later. There is a clear differentiation and they are not the same, but I take on board the Senator's points and concerns.

The Senator spoke about legal opinions that had been submitted. The latest legal opinion we have received is under consideration. We are trying to get the balance of the details right. How that works out will be in the final legislation. I accept the Senator's right to reserve his support until after he has seen the final legislation, but there are time pressures to get it in place for farmers. We have also made commitments in that space. We must get the balance right so that this legislation is robust and does what it needs to do. It is in farmers' economic interests that we get this right. Resistance to antiparasitics and so on is not a good thing. In certain parts of the world, particularly sub-Saharan Africa, such is the level of resistance to antiparasitics that ruminants cannot graze. This is a challenge. The drenches farmers are familiar with fall into four groups – white drench, clear drench, pink drench and yellow drench – and there are many products, but if a farmer's animal develops a resistance to one of the four, then it is resistant to all of the products within that group. If human health was so dependent on so few medicinal products, we would be concerned for ourselves. The Senator acknowledged this issue.

We are trying to get the balance right. Regarding the specific point that the Senator raised, we have legal opinion which we are considering.

Deputy Michael Fitzmaurice

I thank the Minister of State for attending. I wish to clarify something. Is he saying no decision has been made yet on whether the responsible person can prescribe?

Deputy Martin Heydon

As of now, we have not-----

Deputy Michael Fitzmaurice

Is that definite? We have been hearing the contrary over the past two days.

Deputy Martin Heydon

We are considering the new legal opinion that was submitted to us recently.

Deputy Michael Fitzmaurice

No decision has been made in the past day or two.

Deputy Martin Heydon

We are always open to new legal opinion. As has been outlined, we have been through a lengthy process. So far, we have not seen legal opinion that has pointed to us being able to do that, but we are considering the new legal opinion.

Deputy Michael Fitzmaurice

My understanding is legal opinion was given to the effect that it would be possible for the responsible person to do so, given that a responsible person in Northern Ireland can.

Deputy Martin Heydon

I cannot go into detail of the legal opinion.

Deputy Michael Fitzmaurice

I do not want the Minister of State to do so. I understand that.

Deputy Martin Heydon

It has been submitted and is being considered. We are keeping an open mind and are analysing it in detail. To date, we have not seen a legal opinion that we have been comfortable with that could facilitate what the Deputy has described.

Deputy Michael Fitzmaurice

The Department has not seen-----

Deputy Martin Heydon

I do not mean that in respect of the most recent opinion. I mean over the past two years.

Deputy Michael Fitzmaurice

Has the Minister of State not seen the latest opinion?

Deputy Martin Heydon

That is not what I am saying. I am saying we are considering the latest one, which was received recently. Prior to that, we had not seen anything that-----

Deputy Michael Fitzmaurice

The CVO assured the antiparasitic stakeholders committee that he had relayed to the Minister the concerns of merchants and co-ops-----

Deputy Martin Heydon

The CEO of-----

Deputy Michael Fitzmaurice

The CVO, or the chief veterinary officer. He relayed to the Minister concerns that many of the current proposals were unworkable. Has the Minister's statement that he wants solutions to this issue that will not be detrimental to the various parties involved been acknowledged within the Department? Is there a concern in the Department stemming from the submissions we have seen and the statements by bodies that have appeared before us in recent weeks? Unfortunately, we are hearing that the number of veterinary practices being sold could be in the double digits. In fairness to the Chairman, he is trying to put an end to that with his Bill. What we are hearing is that, if practices can get a hold of everything where veterinary medicines are concerned, it will be worth a great deal of money when selling the practices.

The Department is well aware that practices are being taken over in parts of the country. At one stage, someone in Donegal had to travel 50 or 60 miles to get a vet because practices had been taken over. Is the Department not concerned that farmers will be at a disadvantage and that a monopoly will take over? No Department should cod itself.

There is embarrassment in this for farmers. That is the main problem. A vet does a herd test and comes out if there is a problem with a ewe yeaning or a cow calving. How will a farmer look that vet in the eye, ask for a prescription and then say he or she is going down the road from the vet's because it might be €5 cheaper at a pharmacy or a co-op? It is not doable. We need to get this fact into our heads. We are going to create a monopoly. I am afraid the veterinary side of the Department is taking the side of the vets. As politicians, though, it is the farmer we should be considering.

Deputy Martin Heydon

Speaking as a Minister of State in the Department, I assure the Deputy that our focus is the farmer, animal health, the ability of farmers to sell their produce, and the wider food and drink industry, which at 14% of GDP is worth a great deal to our rural economy. From the perspective of animal health, food health and our reputation, ensuring antiparasitics are still of use to us down the line is critical to our farmers. If we get this wrong, we will do them a great disservice. That is our focus.

Regarding the Deputy's point on the availability of vets, a prescription for an antiparasitic lasts 12 months. At home, we plan this out. I could tell the Deputy the times of the year when we generally apply antiparasitics. There will be times when we react to an animal's symptoms, but it is usually planned.

Deputy Michael Fitzmaurice

Agreed.

Deputy Martin Heydon

When the vet is on a farm for the herd test and is examining and handling the animals, it is easy to ask him or her for a prescription there and then in the knowledge it will last the full 12 months until the next herd test.

Deputy Michael Fitzmaurice

Does that mean that the Department has made a decision and that the vet-----

Deputy Martin Heydon

No. I am just countering the Deputy's point. I told him at the beginning we had not made a decision. We have a new legal opinion, which is being considered. I am just replying to the Deputy's specific point. He painted a picture of a farmer going to a vet looking for a prescription for use on the same day. I am making the point that a prescription will last 12 months and that, in certain instances, farmers will look for it in advance of when it is needed.

Regarding the number of vets, surveys have been done and the number of vets in the country is increasing. There are more now than there were in 2019, when there were 2,948. That number has increased to 3,302. Various vets have different roles, but the most recent survey showed that 95% of farmers had a vet within 20 km of them. That information has been reconstituted and the Department is working with the Veterinary Council to undertake a repeat of the study to get more up-to-date figures. The figures I cited are quite recent, though. This is not to say any decision has been made. I am just addressing the specific points the Deputy raised.

Deputy Michael Fitzmaurice

Teagasc has referenced a study from the UK that confirmed there was no greater danger in the responsible person prescribing something compared with a vet. There was no proof it was more dangerous.

Has the Department looked at working with the responsible persons, such as through a course or whatever? We are all in favour of ensuring we keep on top of all this - everyone is responsible in that way - but there is no evidence in the UK study to show that a responsible person is any better or worse than a vet at prescribing medicines. Has that been taken on board?

Deputy Martin Heydon

To be clear, I have not said there is any such evidence, although I accept the Deputy was not suggesting otherwise. This is about what fits within a legal framework in the context of any legal challenges that might be made down the line. I might hand over to Mr. O'Mahony for the other specific questions.

Mr. Conor O'Mahony

On the question about there being no greater danger in a responsible person prescribing than there is in an SQP or a vet, I reiterate we are faced with a situation at the moment, by virtue of the up-regulation of antiparasitics, that an RP is not currently allowed to prescribe prescription-only medicines, POMs, to which antiparasitics have been regulated. As the Minister of State stressed, we recently received a legal opinion from ICOS and the ILMA, which we will have to consider fully, and it may have consequences. Notwithstanding the study showing there may be no greater or less danger in an SQP prescribing, we are left in the reality of our legal position and of implementing the requirement that antiparasitics be up-regulated to POMs. That is our position at the moment.

Deputy Michael Fitzmaurice

Does Mr. O'Mahony have a concern, in light of what I outlined earlier, that about the loss of livelihood among other co-operatives, pharmacists or whatever, and about the situation for farmers? Given the losses already among co-operatives and pharmacists, there is a huge knock-on effect here. Do our guests realise that?

Mr. Conor O'Mahony

As the Minister of State outlined in regard to the reported drop-off in intermammary sales, there are slightly different practices and behaviours with regard to antimicrobials, which are more of a just-in-time method of purchasing by farmers on foot of a prescription with a short validity period, versus being able to pre-plan the dosing regime much further in advance than would be the case for antimicrobials.

One of the key elements of the NVPS, its design and how we are going to implement it relates to ensuring that farmers have as much choice as possible. A farmer can, for example, be associated with more than one veterinary practice and he has availability and flexibility in regard to getting a prescription. He is not tied to one vet from whom he can get a prescription. There is a choice in terms of both the prescribers he or she can go to, once there is a relationship with the prescribing vet, and the dispensing outlets where he or she may purchase his antiparasitics.

We are trying to build as much flexibility as possible into how the NVPS is designed, from both a technical and a practical point of view, in order that a farmer will have choice in regard to both prescribers and dispensers. That is one of the steps we are taking to mitigate, insofar as possible, any limitations a farmer may feel he or she has, because there is more flexibility within the system, in how he or she obtains medicinal products under the proposed NVPS.

Deputy Michael Fitzmaurice

Mr. O'Mahony seems to be talking in the past tense about the responsible person. Has the decision been made? We as a committee need to know this. I will be blunt about it: if the responsible persons are taken out of the legislation, I will not support any legislation that comes before us as a committee.

Deputy Martin Heydon

I also want to be clear: the latest legal opinion was submitted recently and we are considering it. The final decision has not been made.

Deputy Matt Carthy

I thank the Minister of State and his officials for attending. I have not been a Member of this House for very long but I imagine this is a fairly unique scenario in that a Minister of State is saying to a committee that it should proceed with pre-legislative scrutiny of a Bill whose precise outcome we do not know. As both members who spoke before me indicated, one very pertinent point has been subject to all the written observations the committee has received and all the interactions we have had with organisations. It has been the subject of a report the committee produced and the Minister of State cannot give us an answer as to what the Bill will look like. It boils down to the issue of responsible persons.

In the Minister of State's view, as somebody who is as well aware of the sector as anybody in the room, would he have considered what responsible persons in licensed merchants, for example, were doing over recent years as essentially the same as prescribing?

Deputy Martin Heydon

To return to the Deputy's initial point, we have come quite quickly to pre-legislative scrutiny because there is urgency around this legislation. If we did not properly consider the most recent legal opinion we received, with all the focus it is getting at the moment, he would have a different line of attack at me, I would respectfully suggest, because it is important we look at every opportunity there.

The Deputy’s specific question, which was not dissimilar to Deputy Fitzmaurice's point, is moot. Nobody here is casting aspersions on responsible persons. It is about how we ensure that legislation we bring through will be robust, will meet the regulations it needs to meet and will meet the interpretation that will be made of it under an EU approach. Obviously, that is part of our consideration in our approach here.

I hold responsible persons in the highest regard and nobody here is suggesting the work they have done in the past is now any less important. It is about how we can make this fit and ensure that any legislation we bring in will be robust and meet the regulations that are required.

Deputy Matt Carthy

I respectfully disagree it is a moot point. Rather, I think it is a central point in how we have come to-----

Deputy Martin Heydon

Even if that is the case, I have given the Deputy a straight answer on it.

Deputy Matt Carthy

-----where we are. One of two things has happened. I might outline a scenario for the Minister of State. A derogation was provided for in the regulations and that derogation, we are now told, is null and void because it was not implemented properly, if it is the case responsible persons were not prescribing. In my view, however, they were, and I think anybody who has knowledge of the sector would agree.

The Department's case is that due to its misreading of the regulations, the derogation does not apply. The European Commission has been asked on several occasions, including by my party colleague, Chris MacManus MEP, about whether the derogation can apply to responsible persons and the response has been that it is up to the member state to adjudicate on whether a derogation applies. It is the Minister of State's Department that has said, consistently over recent months, that the derogation does not apply to responsible persons, in a manner that I would say is against common sense and the legalities of that.

The Minister of State mentioned the urgency of the regulations. The EU regulations came into effect in January 2022 and the Department deferred part of its implementation. It seems to me that internal departmental deliberations were legally offside, as the law stands.

The urgency arises from the need of the Department to become legally on-side in respect of the regulations. That opens up the bigger issue of how the Department deals with EU regulations. Time and again, when issues are raised at this committee, we are told we cannot do this or we must do that because of EU regulations as if these EU regulations came out of thin air. The Government, in other words the Department, was represented at every step of the way in relation to these regulations. I was a member of the European Parliament when they came through and we would depend on the Department to flag up potential issues in terms of its implementation at an Irish level. Nobody saw it. The people who were supposed to see it are the people who are telling us now that it cannot be done.

I must go back to the point as to the real willingness and sense within the Department to find a solution. It strikes me, if the Minister of State is considering legal opinion that has come from third parties at this late stage in the day, that there has not been that drive within the Department to find a solution. We all want to see antimicrobial and anti-parasitical resistance tackled. We all accept that it is important but we also acknowledge that there are crucial cohorts, in terms of animal welfare and in terms of the dispensing of medicines and the ability of farmers to be able to access retail outlets to purchase that and other material that are under threat if this proposed legislation, as we were led to believe would transpire, goes ahead.

Deputy Martin Heydon

I thank Deputy Carthy for raising those points. A central tenet that the Deputy leaves out of the points he is putting forward is the change in approach from an EU level to antiparasitics - the up-regulation. In European law, the default position is that veterinary medicinal products, VMPs, for food producing animals require veterinary prescription before they can be supplied. However, Ireland has historically availed of the derogation criteria, Article 34 of Regulation 2019/6 in EU law, which allowed for VMPs to be supplied without a prescription as there is no evidence of resistance to these products or environmental damage associated with their use.

Our knowledge of these products have changed following the 2019 report from the Health Products Regulatory Authority, HPRA. The HPRA is the national competent authority, as the Deputy will aware, which determines the route of sale of veterinary medicinal products. The report concluded that VMPs that are intended for use in food-producing species do not comply with the criteria for derogation from veterinary prescription specified in law and evidence now exists that, with regards to environmental demand and growing anti-parasitic resistance, these products need to be supplied under prescription. The criteria for the derogation by which antiparasitics did not require veterinary prescription no longer exist and, therefore, the requirement for a veterinary prescription for these products exists regardless of the introduction of Regulation 2019/6.

I got a bit technical there but it is to make the general point in response to the Deputy that the regulations have changed. Mr. O'Mahony may want to come in on that specific point.

Deputy Matt Carthy

Before the officials come in on this, this is a political charge but it is against the Department in terms of the structure because the criteria changed because we allowed it to change. Therein lies the problem. Nobody seemed to see it or, if they did, they kept it to themselves. I would like to know which it is. I do not know if I will ever be able to find the answer to that. The officials of the Department and the officials from the permanent representation may have realised that the criteria that allowed the derogation to be in place would be undone as a result of the new regulations. Did they inform the Minister of the day? They certainly did not bring it to the attention of members of the European Parliament that I am aware of. Did they believe, to give them the benefit of the doubt, that the new criteria would still allow for responsible persons to be able to dispense these products on the basis that they had already been doing so, as was the case in and the interpretation of our nearest neighbours when they were applying the law?

Let me ask two questions relating to that. Essentially, if one were to take what the regulation aims to do or what the stated objective is, to reduce the use of these products in order to ensure that we do not have unnecessary resistance building up, it has been implemented for a number of products. The Minister of State might give me clarification as to precisely their number. We have heard evidence from the co-operatives, the licensed merchants and the pharmacy unions, all of which state that their sales of those products have reduced by 60% to 90%, depending on the organisation. Is the Minister of State aware of what overall sales now look like compared to beforehand?

Deputy Martin Heydon

Is the Deputy talking about antibiotics now?

Deputy Matt Carthy

Yes. I refer to the regulations that are currently being applied.

Deputy Martin Heydon

I will bring in Mr. O'Mahony and maybe Dr. Corkery as well on some of the Deputy's points.

Back to my earlier point, the Deputy is not comparing like with like. In terms of antibiotics, there is a five-day length of lifespan for a prescription. Antiparasitics will have a 12-month lifespan. They are very different. The officials here can come in with the specific details in terms of numbers but the Deputy is not comparing like with like there. They are not the same in terms of the prescription process.

Deputy Matt Carthy

Okay, forget the comparison between the two. In respect of the products to which the regulations apply and that previously did not, within three of the four sectors that dispensed them we are told that sales have reduced by between 60% and 90%. Do we have information as to whether the overall sales have reduced to anything close to that?

Deputy Martin Heydon

Mr. O'Mahony will reply.

Mr. Conor O'Mahony

I thank the Minister of State. In relation to statistics or market data on the overall sales of antimicrobials, we do not maintain data on that. There is no legal basis for the recording of any gross data on antimicrobials. To give the Deputy a straight answer, we do not have that data. That data is not available. It is also confidential commercial data, which is one of the difficulties in trying to ascertain accurate figures in relation to the sales of antimicrobial products.

It is also important to note the change in relation to intermammories only came in on 28 January 2022 and there has not been a full 12-month period of that yet. We are always aware of the industry, and are aware of what Independent Licensed Merchants Association, ILMA, Irish Co-operative Organisation Society, ICOS, and Irish Pharmacy Union, IPU, stated in the past two weeks. We do not dispute those figures or anything like that because they are the figures that they state. The capacity to explore further market data is not available and it does not exist.

Deputy Matt Carthy

There are two linear arguments there. One is that the information for a full year is not available because the full year has not passed. The second point is that even if it did, we would not have it. Which is it?

Mr. Conor O'Mahony

Dr. Corkery will come in here on this one.

Dr. Paul Corkery

To let Deputy Carthy know, the driver behind the new regulations is to set a legal footing to acquire the precise data on antimicrobial sales. There are implementing Acts and delegated legislation, that currently we have officials on working groups in Brussels on, precisely on this. We will in the future have it.

I go back to the Deputy's point about reduction in the sales of antimicrobials generally. Every year, the HPRA, together with ourselves, compiles a voluntary survey and feeds it back into the European surveillance on antimicrobial use in veterinary medicine or European Surveillance of Veterinary Antimicrobial Consumption, ESVAC. We found that last year there was a reduction in the overall amount of antimicrobials sold. We have done a lot of communication within the Department and we have communicated the fact that prevention is better than cure.

Vaccines and other measures, such as biosecurity on farms, should be used instead of antimicrobials. It seems that our message is getting through. In our voluntary survey last year, there was a reduction of more than 15% in overall antimicrobial sales. We expect that antimicrobial use will reduce. In response to the question about intramammaries, the prescribing practices of vets and the fact that they can only issue a prescription for animals that they have seen and clinically examined means that the amount that they can prescribe is the amount that is necessary for the treatment of the animal. Previously, a vet would have been able, under the law, to prescribe more than was necessary just in case. The discretion regarding use of antimicrobials just in case has been reduced and it is based on risk. The vet must do a risk assessment about how much antimicrobial medication will be required. That can be followed up on by us and the Veterinary Council of Ireland under its ethical code. We expected that once we hit 29 January, we would see a fall-off, and we have on an overall level, which the Deputy was asking about. We are glad to see that. We will have precise details. We will capture it through the NVPS. I can hand the Deputy over to my colleague.

Deputy Matt Carthy

I will come to that in a moment. Dr. Corkery talked about the assessment of risk of AMR in respect of prescribing. Let us forget about the legalities for a moment but address the practice. Does he believe that responsible persons, as have been identified in the licensed merchants sector, for example, have the capacity to assess-----

Deputy Martin Heydon

Before Dr. Corkery speaks again, it is easy to sit here and ask about leaving aside the legalities. We cannot do that as a Department. We have to make sure, with anything we bring in, that the legalities are right. I will hand back to Dr. Corkery. I just wanted to make that point.

Deputy Matt Carthy

I am saying this as somebody who has supported the committee's position throughout, which is that RPs should be able to fall into the parameters of what we consider to be the derogation. If someone in the Department said that it does not believe the capacity is there, I would be interested.

Deputy Martin Heydon

I will hand back to Dr. Corkery. I know the Chair wants to come through me on this, which is fine. I want to make the point that we do not have the luxury of saying we can leave aside the legalities.

Dr. Paul Corkery

I will reply to the question about antimicrobials and whether I believe that an RP can meet the criteria. Deputy Carthy was in Brussels when the regulation was made. It specifically states that only a veterinarian can prescribe antimicrobial veterinary medicinal products and it has to be on foot of a diagnosis.

Deputy Matt Carthy

The Minister of State opened the issue of legalities again. Does he accept that we currently fall outside EU law?

Deputy Martin Heydon

This should have been implemented before now but we have to get the process right. That is why-----

Deputy Matt Carthy

We still have not got there, by the Minister of State's own admission. The Department's view is that this legislation will be completed by 1 December. Is that still the case?

Deputy Martin Heydon

We are in the hands of Members of the Oireachtas.

Deputy Matt Carthy

The NVPS was referred to. Going back to discussions with stakeholders, it appears that plans for that system are in complete disarray. Is that a fair statement?

Deputy Martin Heydon

I ask Mr. Collins to answer that. I do not concur with Deputy Carthy's terminology.

Mr. Peter Collins

The word "disarray" probably comes from a number of inaccuracies that have been mentioned here over the past two weeks by members and witnesses. There was mention of no veterinary participation in the system, no comparable products, that it will not reduce the administrative burden, that it increases border trade and that it reduces accountability. The NVPS will address all those matters. We have had vets working in the system for 12 months, since last December. A total of 20 vets have been using the system as a pilot cohort since 28 January. We have had engagement with and feedback from veterinary practitioners about how the system will work. Since then, we have made significant improvements to the system to make it more user-friendly. That is based on the feedback from those vets.

The issue of comparable products arose. We have had discussions with ICOS and ILMA about producing a comparable list so the vet can prescribe an antiparasitic product and then the licensed merchant or whoever is dispensing the product can choose from a comparable list. That list is being produced. It will be built into the system and is ready to go.

There were comments about this not reducing the administrative burden. Anybody who does not have a system will be able to use the NVPS. It has all that information. We spoke to farmers at the National Ploughing Championships. Every farmer that came to the counter welcomed the NVPS because they will have a digital prescription. They have problems with vets handing them prescriptions. All those records will be in one place at the same time.

Those are only a flavour of issues that will be addressed. I have another ten that I could go through in response to Deputy Carthy saying this is in complete disarray; it is not. We have done user acceptance testing on the system and it is ready to go. We have changed it. We are working with software companies on the integration issue. That is the last matter to address. Everything else is ready.

Deputy Matt Carthy

I will ask a question then conclude, because I know others want to come in. When will the NVPS be fully operational?

Mr. Peter Collins

The NVPS is operational at the moment. People take part voluntarily. We are waiting for legislation so that we can force everybody to use the system and report information through it.

Deputy Matt Carthy

Does Mr. Collins believe the system will be workable on 1 December on that basis?

Mr. Peter Collins

The system is workable at the moment. People are using it and still recording the information on it. We have completely changed how it works, so it will be much easier and more user-friendly on 1 December.

Deputy Matt Carthy

That is the exact opposite of what this committee heard last week from witnesses whom we consider to be important stakeholders in rolling this out.

Senator Tim Lombard

I thank the Minister of State and welcome the officials. I will follow Deputy Carthy's train of thought regarding the NVPS. Will Mr. Collins comment on how that ties into the other users of data that farmers use, such as apps and so on? Will they be interlinked? They are not at the moment. When farmers get a prescription from a vet, is that linked into their farming data? Will there be such a process?

Mr. Peter Collins

We have been developing the legislation for the past year. We have looked at who we can share the data with. We have talked with all the stakeholders and their representative groups, including farming organisations, about how we want to share the information that is on the system, if they want that information to be shared. We will have the information. We are conscious that it is not the Department's information. It is the information of the farmers, vets and dispensers. We are in discussions with those groups about how they want those data to be separated. The system is capable of sharing with all the apps the Senator mentioned. It will do so once we get the go-ahead from those representative bodies. If they want that to happen, we can make it happen.

Senator Tim Lombard

Who are the representative bodies?

Mr. Peter Collins

Mainly farming organisations.

Senator Tim Lombard

If farmers get a prescription from a vet, they can then upload it to whatever app they used to register their animals. Their profile contains everything on the same app.

Mr. Peter Collins

If the farmer so wishes.

Senator Tim Lombard

Will Mr. Collins clarify whether he means the farmer or farming organisations?

Mr. Peter Collins

The farming organisations that represent the farmers. We are looking at whether it will be shared with Bord Bia too. Farmers currently have no access to the system. We are looking at how to get the farmers direct access to the system. They can download prescriptions directly from the system if they want.

Senator Tim Lombard

Regarding the timeline, this can go live when the legislation is passed. Will it be linked to agri.ie?

Mr. Peter Collins

If the legislation passes on 1 December, this will not be ready, because we have not received the go-ahead from the farming organisations to indicate they want us to share that. They have their reasons. If the Senator wants to ask the farming organisations about those reasons, they will let him know why they want to make a considered decision before sharing the information.

Senator Tim Lombard

I thank Mr. Collins. The Minister of State is a former Chair of this committee. He has a great understanding of what is happening at the farm gate.

Deputy Martin Heydon

I was not Chair.

Senator Tim Lombard

Well, my information is incorrect. Can I ask about the idea of the 12-month prescription? Something similar is said online about the dairy health certificate, which happens on dairy farms on a particular basis. Do we need to be thinking about a more practical approach than that regarding what Mr. Corkery has just said about the vet's interaction with the animal itself? Are we looking at this on a 12-month prescription basis or are we looking at individual farm visits in order to deal with whatever the issue may be? I am looking for clarity on where the process is. Is it something similar to the dairy certificate application or will an individual call be required for the issue or plan?

Deputy Martin Heydon

I will bring in Mr. Corkery on that specific issue.

Dr. Paul Corkery

The Veterinary Council of Ireland has issued guidance to vets specifically on anti-parasitic medicines and on what they need to do. As long as they have a customer-patient practice relationship, or in other words, as long as the vet has been on that farm once and knows about the farm, they do not have to visit in order to prescribe anti-parasitic medicines. I would make the point from a veterinary perspective that in most cases in Ireland, because farmers are so well up to speed with antiparasitics and because they use them so frequently, we are not looking at clinical cases. No diagnosis is necessary. In other words, the use of antiparasitics is almost as necessary as feed is to pastoral systems. One doses and there are some ancillary tests now that are being used more frequently, such as fecal egg count tests. Those can be provided through dung samples and so on. They will help to identify resistance but there is not the necessity for the vet to visit the farm every time an anti-parasitic is required. Remember that the antiparasitics are not just those used for worms but for lice. For example, Senator Lombard happened to mention the health certificate that is used on the dairy farms. At the time the vet is doing the process, if the client asked the vet and if the vet is willing, that would be the time at which one could plan out, as some of my colleagues have said, the herd health plan for the year.

I remind the Senator that the Department is running a targeted advisory service on animal health scheme, which is an EU co-funded scheme. That scheme has only been opened up since March and there are 14,000 farmers already who have looked for this co-funded visit from a vet to be able to provide this health plan for the year. It will cover issues such as lice, mange, scab in sheep and roundworms. Where there is evidence that the products have not been working, the vet will discuss with the farmer the possibility of taking dung samples and the vet can analyse the dung samples. If this system continues as it is, the likelihood will be that there will be savings here for farmers and they will not end up using products that are not working. They will use products that will work effectively. In the long term, this will be an important solution to keep anti-parasitic medicines working in this country.

Senator Tim Lombard

On the majority of farms in Ireland, whether those are dairy or beef, there is a regular vet calling at certain times of the year, depending on how it works out. However, on the sheep farmer element, that is probably the one stage where we do not have that regular vet call on a herd test etc. Does Mr. Corkery think that that will be an extra cost? Is the veterinary power there? I will give an example of Glengarriff which is a wonderful part of the world, on Beara Peninsula, which is approximately the same size as Louth, or slightly smaller. One vet covers that entire peninsula. Geographically, with that kind of scenario for a farming base that is down there, is it going to put an extra burden on an already - and no offence now - ageing population of vets that we have there at the moment?

Dr. Paul Corkery

The first thing I would like to say, although this topic is not under discussion here tonight, is that I am an introducing the animal health Bill, which Senator Lombard might have heard about. It is again a new regulation and it is slightly behind the veterinary medicines in some ways in terms of implementation. I will let Senator Lombard know that I am aware that requires an annual visit a minimum to every farming enterprise. While sheep farmers in the past may not have seen vets on farms, in the future it is likely that they will do. To be fair, any sheep farmer who I know of does use vets for lambing and so on and there are visits. It is rare enough and I do appreciate the geography that Senator Lombard is speaking about. I also believe the fact that the vet does not have to go there to prescribe antiparasitics and can prescribe from the clinic will assist.

Senator Tim Lombard

Yet, they will still have to have the knowledge of the farm and will have to have at least one farm visit.

Dr. Paul Corkery

Absolutely, and it is a matter for that vet to convince the Veterinary Council of Ireland if necessary. There is no requirement, but if necessary, if a query was made to the Veterinary Council as to whether they have this client patient practice relationship, the vet would have to be able to say that that existed.

Senator Tim Lombard

Dr. Corkery mentioned some of the evidence that was given at the previous hearings. I realise that this is the third hearing. We previously received evidence from, I think it was Terence O'Shea from Glengarriff, who claimed that he had been in business for 40 years and that he would be out of business within six months. Does Mr. Corkery think that there will be a negative impact on these traders if this Bill comes in as it stands at the moment?

Deputy Martin Heydon

That is subjective. I have to re-iterate to Senator Lombard that the priority here has been to meet our regulatory requirements while also giving farmers the greatest choice possible and trying to minimise that impact on businesses that are in that space. It is a matter of trying to strike the right balance between all those different bits. Change is challenging for lots of different sectors in lots of different ways, but if we do not get this right, we will have a big problem down the line in terms of resistance to medicines that are important for our farming enterprises and our food production system.

Deputy Barry Cowen

I thank our guests. There is acceptance by the committee, by the industry and by all stakeholders in it that we can proceed with the dispensing duties of antimicrobials by vets exclusively. The issue here is antiparasitics. The background to this is our commitment to an all-Ireland economy, our commitment to the Good Friday Agreement, striving to ensure that the protocol is in place and that it is enforced. This is so that local products, in the North for example, can be labelled Irish and can by association be labelled European and, by association again, they can be in a position to be marketed to those markets and those third markets that the EU has agreed on behalf of its citizens and its member countries. They also have the other option, too, if they so wish, and that is the beauty of the protocol. That is recognising the huge improvements there have been in recent years in relation to that economy and our products and the efforts that are made to ensure that there is uniformity in relation to animal healthcare and so forth.

This is a proposal in relation to the national veterinary prescription system. I was listening to Mr. Collins. Is it correct that the Department is proceeding on 3 December with its implementation? Is it correct that that system will not cater for the responsible person within these outlets as it presently stands?

Mr. Peter Collins

The system is based on-----

Deputy Barry Cowen

I just asked a question about whether the responsible person will not play a role in the dispensing of that system as it is presently constituted.

Mr. Peter Collins

The way that it is working, the person who can-----

Deputy Barry Cowen

In relation to parasitics.

Mr. Peter Collins

Any dispensing outlet that is registered with the system can dispense a medicine.

Deputy Barry Cowen

Can they dispense a medicine, including parasitics?

Mr. Peter Collins

Antiparasitics.

Deputy Barry Cowen

Where is the problem, then?

Mr. Peter Collins

They can dispense the medicine. They cannot prescribe the medicine.

Deputy Barry Cowen

They cannot prescribe it.

Mr. Peter Collins

The medicine has to be prescribed by-----

Deputy Barry Cowen

They will have no role in prescribing it. It will go back to the vets who will not only have exclusivity in relation to the antimicrobials, which nobody disputes, but they will be exclusive in relation to parasitics. Is that correct? The Department is proceeding with the system on 1 December.

Mr. Peter Collins

At the moment, the system is on a voluntary basis. We cannot, because it is not in the legislation, I cannot-----

Deputy Barry Cowen

Okay, that is what I was getting at.

(Interruptions).

Mr. Peter Collins

That is where we are going.

Deputy Barry Cowen

Is it the case that the Department needs legislation in the meantime and that it would hope to have it rather than depending on a voluntary system that it wants to implement? It would rather have legislation to enforce it. Is that correct?

Mr. Peter Collins

Of course the Department would.

Deputy Barry Cowen

That is fine. Obviously Dr. Corkery has expertise in this area. One of the points he made to support that exclusion was to say that a vet - only a vet it would appear - can assess the herd needs into the future or assess resistance on the part of the animals based on the assessment of the dung, for example. Could the responsible persons not also offer such a service if they are included in the legislation to participate in the NVPS? There should not be any contention, assertion or inference that that is not possible because they are not veterinary surgeons.

As was said earlier, we need to know how long it will take for the Department to assess the opinion which seems to be the only avenue to afford the opportunity for the responsible persons to participate in the NVPS. As it stands, they will not be participating. When is that opinion expected to be assessed and responded to? At that point it might be appropriate for the Minister of State and his officials to come before this committee again because he will be in a position to prescribe the legislation and the committee can pass its judgment on it thereafter.

Deputy Martin Heydon

I thank the Deputy for those points. We only last week received the latest legal opinion which was mentioned. It is very new and we want to give it the due consideration it deserves because this topic is so important. We will have a decision on that as soon as we can. Should pre-legislative scrutiny be passed allowing the legislative process to start and if the Department were to find that legal opinion stood up to scrutiny and the legislative process had begun, it could be dealt with by way of amendment. Either way, this committee will be dealing with that legislation whenever it comes before the House.

Deputy Barry Cowen

The wish is to have adequate pre-legislative scrutiny before it is brought to the floor of the Houses, but it does not have to happen. Is that correct? I do not think the committee would proceed to accept or reject any legislation without having been advised as to the Department's response to the legal opinion before it.

Deputy Martin Heydon

We are in the hands of the committee.

Deputy Barry Cowen

The Minister of State mentioned that a parasitic prescription has a 12-month lifespan. Who determines that? I was not aware that was the case. Is that specifically stated on a prescription?

Dr. Paul Corkery

The EU regulation is silent on the duration of prescriptions for all products other than antimicrobials. It is precise on antimicrobials that it is a five-day window. For all other categories of products, such as sedatives, it is within the discretion of the member state.

Deputy Barry Cowen

Have we decided that is 12 months?

Dr. Paul Corkery

Yes, in consultation with the stakeholders; not on our own. We did not just pluck it out of the air.

Deputy Barry Cowen

I understand. I did not realise if it was on a prescription that it legally only had a lifetime of 12 months, or an extended lifetime.

Dr. Paul Corkery

It was in consultation with the Veterinary Council of Ireland, which regulates the veterinarians, and with the other stakeholders as well. We have had past experience. Antimicrobials previously could have two months or six months depending on the scenario. We had this discretion. What has been taken away from us is the discretion on antimicrobials, which is precisely five days.

Deputy Barry Cowen

Does the Minister accept that responsible persons could be able to provide the sort of assessment veterinary surgeons provide at present?

Dr. Paul Corkery

The Department has always expounded the merits and professionalism of the responsible persons. The only issue here is a legal impediment.

Deputy Barry Cowen

The legal difference of opinion can be strengthened by improving the authority, professionalism, capabilities and competencies of those responsible persons. The committee will not be found wanting in helping to ensure that is the case. Staying still and doing nothing only helps the initial opinion the Attorney General had.

Deputy Martin Heydon

I thank the Deputy for his points. The point about the 12-month duration of the prescription is new here as well. I was not aware that had not been discussed previously. It is back to the main point. The priority is to ensure whatever regulation passed here meets the regulatory requirements it needs to meet. We need to do that in a way that gives farmers the greatest choice and tries to protect our industries throughout rural areas. We need to secure our food production systems, on which our rural economy is so dependent, into the future. We need to ensure our livestock-based system, which is so important, has a strong and healthy future in the long term.

Deputy Barry Cowen

Will the Minister of State clarify that he will be back and will not proceed until the opinion is made known? It is not possible to be half-pregnant here. We go forward with all the legislation or none of it.

Deputy Martin Heydon

We have received the opinion very recently. We are in the hands of the committee as to whether we finish tonight and the committee gives the go-ahead, pending the analysis of that decision. Obviously, there is time pressure here, not just for this part of the Bill, but also for the second part of the Bill, which we will discuss in time. Some farmers are dependent on eco schemes and other measures they wish to do. We know the time pressure that exists. I would not seek to supersede or second-guess in any way the committee's competence.

Deputy Michael McNamara

As I understand it, the issue with the European legislation is whether a derogation on the prescription of antiparasitics can be entered now when one was not entered at the time. Is that correct? That is the crux of the legal conundrum we face.

Deputy Martin Heydon

Yes. We cannot avail of the derogation because of the status of the HPRA judgment.

Dr. June Fanning

The crux is we cannot avail of the derogation because of the up-regulation of antiparasitics from "prescription-only medicine licensed merchant" to "prescription-only medicine". Based on the previous EU legislation and 2019/6, to avail of the derogation, they must fit all the points under Article 34.3. The one there is the issue with is that even misuse is supposed not to have any problem from a resistance point of view. However, unfortunately, resistance to antiparasitics is already out there and has also been documented in Ireland. The problem is that the up-regulation of antiparasitics to prescription-only means they require a veterinary prescription for their use.

Deputy Michael McNamara

That was the 2019 legislation.

Dr. June Fanning

The HPRA is the competent authority that decides the designation of medicines and veterinary medicines, and it would have-----

Deputy Michael McNamara

In Ireland.

Dr. June Fanning

Yes.

Deputy Michael McNamara

As a matter of EU law, what was to stop Ireland having entered a derogation at the time? The HPRA's subsequent finding was-----

Dr. June Fanning

The point in the EU legislation - it was also in the previous EU legislation - is that there is no risk to public or animal health as regards the development of resistance to substances, even where the veterinary medicinal product containing those substances is used incorrectly. The antiparasitics were up-regulated by the HPRA because there is now known resistance to antiparasitics.

As the Minister of State said, it is important we that can use these products and keep them available for farmers so we can look after animal health and our export markets as well as all the livelihoods that are dependent on the agrifood sector.

Deputy Michael McNamara

Essentially, a derogation could not have been entered into until the HPRA made its determination that there was a risk of antiparasitic resistance developing in animals.

Dr. June Fanning

Yes.

Mr. Peter Collins

We are confusing the derogation of who can prescribe. Under Article 105(4), the derogation applies only to vets or persons who were professionally prescribing medicines prior to 2019. At that stage, RPs were not prescribing those medicines because they were not prescription-only medicines, POMS, as Dr. Fanning said. When the regulation came into force in 2019, everything was still okay. It was subsequent to that, when the HPRA decided those medicines became POMs, that the RPs were outside the derogation loop.

Deputy Michael McNamara

How did the United Kingdom enter a derogation at that time?

Mr. Peter Collins

This happened because the qualification of a suitably qualified person, SQP, in the UK had for a number of years prior to 2019 included prescribing antiparasitics. The equivalent of the RP in the North and the UK has been prescribing antiparasitic medicines.

Deputy Michael McNamara

The United Kingdom is a country with greater resources than Ireland and its much larger mission in Brussels was reflective of those resources, until the time it decided it had such great resources that it would leave the European Union, which was its sovereign decision. Would it be fair to say, in general terms, that if the UK entered a derogation on any legislation, be it on justice or home affairs, it would flag a certain amount of interest and the Irish delegation would at least look at what was happening to understand why it was doing it this way and whether it would be beneficial to us? In a variety of areas, regulation in Ireland is quite similar to that of the United Kingdom. If that was flagged, was a decision made in the Department at that time? It seems to me that a decision would have been made that we were either going the way of the United Kingdom at that time or we would bring in prescriptions for antiparasitics. As Deputy Cowen said, we are talking about antiparasitics, not antimicrobials.

Deputy Martin Heydon

I will ask Dr. Corkery to comment on that.

Dr. Paul Corkery

I will first address the question about why the UK brought in the SQP prior to the regulation. The reason was that the UK identified resistance in the parasites far earlier than we did. We did not have evidence of antiparasitic resistance for at least ten years after the UK had determined it had a problem with antiparasitic resistance; hence it did what the HPRA did in Ireland, and up-regulated. In that up-regulation, it was decided that SQPs would be allowed to issue prescriptions. Prior to the introduction of the new regulations and prior to the HPRA's report to up-regulate these medicines, any new antiparasitic medicine that was approved within the community had to have a veterinary prescription. In Ireland, a number of antiparasitic medicines have existed for a number of years that have required a prescription, for which a veterinary prescription has been issued, and we have allowed the responsible persons to dispense those.

Deputy Michael McNamara

Have those prescriptions covered a duration of 12 months?

Dr. Paul Corkery

Yes, because previous legislation allowed for that.

Deputy Michael McNamara

In the cases of all the prescriptions required for the antiparasitics, for which many were not required, the prescription was of 12 months' duration.

Dr. Paul Corkery

Yes. These were new products that thankfully came on to the market. They were not used that frequently because we did not have much evidence of resistance. There would not have been many farmers going to their vet saying they did not believe the antiparasitic medicine was working. However, it did happen. Teagasc has stated it is using antiparasitic medicine on farms. There are new research papers on these new medicines and, for a number of years, they could only be issued on foot of a veterinary prescription.

Deputy Michael McNamara

The question is whether the veterinary prescriptions, which were issued for that number of years, were of 12 months' duration.

Dr. Paul Corkery

According to the way the legislation is written, it can be up to 12 months.

Deputy Michael McNamara

Is that Irish legislation as opposed to EU legislation?

Dr. Paul Corkery

Yes.

Deputy Michael McNamara

Is it then at the discretion of the veterinarian writing the prescription?

Dr. Paul Corkery

That is right. That is what has happened to date.

Deputy Michael McNamara

As to whether we continue with a prescription of up to 12 months, which has the benefit of a certain degree of practicality, how does that compare to the practices in other European states in respect of antiparasitic prescriptions? We are told the plan is for antiparasitic prescriptions to be of 12 months' duration. How does that compare to the practice in other EU states?

Dr. Paul Corkery

In relation to other EU states, that is within their discretion.

Deputy Michael McNamara

Legally, that is true, but what is the practice? Usually, if laws are revised, they come to reflect practices. Will we move to a situation in which we have antiparasitic prescriptions of 12 months' duration now, but when legislation is revised, as is always the case, we will be looking at durations of a month or five days?

Dr. Paul Corkery

Primarily, it is the vet who determines how long the prescription will be. Member states put in place a system where it cannot be longer than a particular period. The practice in most countries depends on the pastoral arrangements. In a country like Ireland, it is usually determined by how long the products will be requited within the grazing seasons. The answer is that it is up to the vet, but it is up to the member state to determine for how long that will be.

Deputy Martin Heydon

Ireland's PastureBase system would not be comparable with all other EU countries that would have different systems.

Deputy Michael McNamara

I suppose France is our nearest EU neighbour now. What do they do in Normandy and Brittany, which are similar to us?

Dr. Paul Corkery

The one thing that is clear from France is that they only allow veterinarians to issue prescriptions for these products. I am not sure whether they have a limit on the duration, but the decision is left to the vet. I spent some time in France as the agricultural attaché for the Department; therefore, I am somewhat aware of what they do there. They have quite a restrictive system regarding the duration of prescriptions. The duration would be shorter term, of one month or two months. We would be more flexible in Ireland, but then again, one must remember that most cattle are partially housed in France, which I was surprised to see, and they go out for periods. France does not have the same issues we have because of the wet climate in Ireland.

Deputy Michael McNamara

As we have an open border with Northern Ireland, it is perfectly lawful for any general merchant in Northern Ireland to sell antiparasitics, which can be delivered to any farm here. Has it been considered that we might actually drive it underground and instead of having a greater control of and accountability around antiparasitics, we might end up with less? That is my last question. There are others I could ask but I appreciate we are running out of time.

Deputy Martin Heydon

Different laws and regulations apply in Northern Ireland and Ireland across all economic activity, and authorities on both sides of the Border work in a co-operative manner to ensure national laws are respected. In Ireland, it is only legal to buy and use veterinary medicines obtained from suppliers who are licensed in accordance with national legislation.

Deputy Michael McNamara

It is therefore illegal at the moment, if you have a prescription in Monaghan, to go across the Border and apply it in Fermanagh.

Deputy Martin Heydon

Does Dr. Fanning want to come in on that?

Dr. June Fanning

No. You have to comply with national legislation, so if you are talking about antiparasitics then-----

Deputy Michael McNamara

Whether it is antimicrobials or antiparasitics, if you have a prescription from a vet in the South, can you go across the Border and buy it lawfully and bring it back?

Dr. June Fanning

Yes, if it is licensed here, which obviously-----

Deputy Michael McNamara

But they will all be licensed here one way or the other.

Dr. June Fanning

The answer is "Yes", if you have a prescription and "No" if they are not licensed here.

Dr. Paul Corkery

Some are licensed here.

Dr. June Fanning

Some are licensed, so if it is licensed here and you have a prescription you can fill it in the North.

Deputy Michael McNamara

Then they are not committing any offence by selling it to a farmer in Cork, Kerry, Clare or wherever without a prescription.

Dr. June Fanning

Yes. Within the Single Market, so long as the product is licensed here and they have a prescription there is no problem.

Deputy Michael McNamara

Has the Department-----

Deputy Michael Fitzmaurice

I am sorry for interrupting but can they prescribe it down there if they are recognised?

Dr. June Fanning

No.

Deputy Michael Fitzmaurice

Even though it is the same Single Market the officials are talking about.

Dr. June Fanning

No. You have to comply with national legislation, so the farmer in Cork or Kerry or-----

Deputy Michael Fitzmaurice

I thought they were in the EU as well, or recognised in the EU.

Dr. June Fanning

There are obviously differences between jurisdictions in relation to-----

Deputy Michael Fitzmaurice

You can buy it down there if you have a prescription but you cannot get it.

Deputy Martin Heydon

I might bring in Dr. Corkery on that particular point.

Dr. Paul Corkery

In order to prescribe the veterinary medicinal product you have to be on the veterinary register of Ireland. You cannot be in Spain, for example, prescribing to animals in Ireland. That is clear and it is clear within the European community.

Deputy Michael McNamara

I thank the Chairman.

Deputy Michael Ring

I will be brief. I am uncomfortable. I do not like monopolies. I watched the whole proceedings and I know the officials are uncomfortable. They are doing a job for the Department and the Minister of State and they are here with him this evening. I do not like monopolies and I never have. Any time you have a monopoly you have a problem. I listened to officials from the Department of Health and other Departments in years gone by saying nobody but a doctor or nurse could give an injection in this country. When Covid came they brought in laypeople. They brought in anybody who could give an injection and they were allowed give injections. Anybody who could do anything in the area of health could do it.

I have been uncomfortable since this debate started a few months ago. I am asking the officials to go back again. I am asking the Minister of State to revisit this whole monopoly. I do not like monopolies. As the previous speakers have said, agriculture is supposed to be being dealt with on an all-Ireland level. People are people and if people along the Border are able to go into Northern Ireland they will be able to get whatever they want to get. They will be able to get prescribed whatever they want to get prescribed. If a chemist, a wholesaler or whoever wants to sell them the goods, they will be sold. Until we can have this on an all-Ireland basis, we should not be bringing forward this legislation. I do not like the way the legislation is being introduced. The Department was having many discussions with different veterinary organisations and then all of a sudden it went flat. Now the Department has made a decision it is going to push this through. I am saying it is not going to and I am asking the officials to reconsider. There is going to be chaos in December if they push this through. I am just very uncomfortable.

I have been in business all my life. The departmental officials spoke about the leniency of the Department and how good it is. I have never found the Department of Agriculture, Food and the Marine too lenient. I have dealt with a lot of farmers for 30 years and the Department is the most unreasonable outfit there ever was when it comes to the rural environment protection scheme and every other type of scheme. Then there is what the Department does to farmers over the mistakes they make and the kind of penalties it puts on them. I am uncomfortable. I support the Minister of State and want to get this legislation through. I do not like it and have not from the beginning. I do not like monopolies and hate to see people being put out of business. I am from rural Ireland and this is going to have a major effect there. It is going to have a major effect on jobs, on chemists and on animal welfare. The officials will talk about animal welfare and everything else but we are all about health and animal welfare. This is not well thought out. The Department should go back and try to get a derogation. This legislation should get put off, certainly for this year. It is something the Minister of State and the Department should look at again.

Deputy Martin Heydon

I thank the Deputy for those points. His views are passionately held. He was saying he was following the committee earlier. He would have seen in my earlier presentation that as recently as last week we received a new legal opinion from stakeholders. We are giving that due consideration to see if there is any way around this. Ultimately, we want to strike the right balance and ensure that while giving farmers the greatest possible choice we also meet the regulatory requirements we are duty bound to meet. It is about trying to get that balance right and seeing how best we can do that. I touched earlier on the points around the 12-month nature of a prescription. In many instances there is a clear gap between when a prescription is written and when the product needs to be bought. It may not always be the same day. We want the maximum regulatory flexibility we can get. That is why are giving due diligence to the latest legal opinion we have received to see if we can have as practical and flexible an approach as possible.

Deputy Carol Nolan

My first question is on the prescriptions. What percentage of them are currently being processed on the NVPS? Would the Minister of State and the officials accept that vet-only prescribing will not meet regulations, because there will be no competition? Anyone with a grain of common sense can see that. There will not be competition and it will lead to less availability. Objective 5 of Regulation (EU) 2019/6 states:

This Regulation aims to reduce the administrative burden, enhance the internal market and increase the availability of veterinary medicinal products, while guaranteeing the highest level of public and animal health and environmental protection.

Do the Minister of State and the officials accept the responsible person and the veterinary pharmacist have critical roles to play if this objective is to be achieved? Their roles are not apparent from the draft regulations. Do the Minister of State and the officials acknowledge that as a result of the moves made by the Department in 2012 to endorse a personal qualification for the responsible persons that committed them to include several prescribing responsibilities, responsible persons were prescribing these medicines when the EU regulation came into force in 2019?

I would like answers to those questions. I am calling for a fair resolution here. There is going to be a lot of wrong done and much of it to rural businesses. I am concerned about that. This must be got right. There must be proper collaboration with the stakeholders who have provided the Department with a legal opinion.

Deputy Martin Heydon

I thank the Deputy for raising those points. She outlined them well. I am going to go to the officials, especially Dr. Corkery and Mr. Collins, to answer some of her specific questions on the percentage of prescriptions and the vets element.

Let me bring it back to the start. The process here and the reason we are doing this is to ensure we have the best possible health standards for our animals. As I have said previously, we are trying to strike the right balance between giving the greatest choice possible to farmers, meeting our regulatory requirements and ensuring the sustainability of our pasture-based livestock system, which is crucially important to rural Ireland and our rural economy. Many of the members present come from constituencies where it is so important. A threat is posed to the health of our animals by resistance to certain medicines upon which we are so dependent. That is the motivation behind these practices. Now it is about getting the elements for our own national competence into national legislation to try to apply them as best suits our country while complying with the regulatory requirement, as we need to do. It is a balance and a challenge. I do not profess that it is perfect or that the final solution will be perfect.

Any stakeholders in this who come with legal opinion believe there are ways around the legal challenges we all know exist and which members of the committee are aware of and have dealt with extensively in the previous report. We are actively analysing them to see if there is some way to try to apply those that would best suit our system. It is about getting that balance right, which is ultimately what we want to do, while also recognising that the motivation here is the longer term threat to the health of our livestock in a pasture-based system, which is so important to our rural economy. I will bring in Mr. Collins first on the percentage of prescriptions query and then I will bring in Mr. Corkery on the vets point.

Mr. Peter Collins

I will first address the Deputy's query on the percentage of vets who are using written prescriptions. As I mentioned earlier to Deputy Carthy, there are 20 vets using the system on a pilot basis for us, and 100% of the scripts they are writing are going onto the national veterinary prescription system, NVPS. Those written scripts are dispensed prescriptions. There are no undispensed prescriptions on that system at all. They are using it in a capacity for us to get practical feedback on the practical application of the system. They give us information on what is good about it, what is working and what does not work. They are talking to farmers about it, asking how it works, and the farmers are getting the SMS texts or the prescriptions on those.

Deputy Carol Nolan

With regard to the number of prescriptions, not the number of vets, do we know what is the number or percentage of prescriptions?

Mr. Peter Collins

I would not have the percentage figure.

Deputy Carol Nolan

Could I get that information in a reply to a parliamentary question to me?

Mr. Peter Collins

Absolutely. That is no problem.

Deputy Carol Nolan

I thank Mr Collins. I would need that.

Mr. Peter Collins

Yes, if the Deputy could submit it, we could do that.

Dr. Paul Corkery

I will deal with objective No. 5. Objective No. 5 is about the availability of product. Previously, each member state would have had its own authorising agency, such as the Health Products Regulatory Authority, and its own number of products that each market would have. This new regulation has brought in access to products in other markets in certain circumstances. The first thing it has done is to make sure the prescription issued by a vet is valid throughout the community. This is one way in which the availability has been increased. That prescription can be used throughout the community but one must use the products that are, in the main, authorised in the member states. There are circumstances where those products are not available and there are some that are specifically for exotic animals and equines.

Ireland is such a small market within the veterinary medicinal products sphere that we need products from other member states. Prior to this regulation it was much more difficult to access them. The provision in Article 110 of the veterinary medicinal products regulation relates to what we know as the "cascade". For example, one can go to Lithuania for a product if the product is not available here or if that product is not available with those ingredients. This is where the market has been greatly improved in the context of objective No. 5. It is very important we are able to utilise this system of accessing medicines in other EU member states, and for the European Medicines Agency, EMA, to facilitate that. The EMA has designed a new database, the union product database, UPD. The agency has made that database available to all of the member states. We now have a big repository of all the drugs available throughout the community that we can access if we are in short supply or if we do not have them in this market. It would not be fair to say this regulation is not being implemented here. My division in the Department, along with Mr. O'Mahony's section, are communicating the benefits around the accessibility and availability of products, of which there are very many for vets and for animals. At the end of the day this is to ensure there is enhanced animal welfare so that, for example, the gerbil or other pet animals that might need a particular treatment will have access to product and so we have access to certain products for horses, along with vaccines. It is all to ensure there is more preventative medicine and less use of antimicrobials, which is another of the objectives. This is where the availability comes in. We are utilising all of those flexibilities this new regulation extends to us.

Deputy Martin Heydon

I want to clarify the point about a reply to a possible parliamentary question.

Mr. Conor O'Mahony

With regard to the request for information requested via a parliamentary question, if I understand Deputy Nolan correctly, will the question be about the percentage of total prescriptions issued that were recorded on the NVPS?

Deputy Carol Nolan

Yes.

Mr. Conor O'Mahony

We would not have that information because we do not collect data on the total numbers of prescriptions issued by vets. As Mr. Collins has said, the 20 vets currently using the NVPS on a pilot system are recording their scripts, but we would not know the total gross number of scripts issued. Therefore, we would not have the data to answer that parliamentary question.

Deputy Carol Nolan

Would the vets not be supplying that information so the Department could get a picture to see it rolled out on a voluntary basis? Would it not have made sense to see how many prescriptions had gone through? What is the reason for not having this information?

Mr. Conor O'Mahony

We do not have a legal basis to make it mandatory to record prescriptions, which is one of the purposes of this Bill. I just wanted to clarify this point.

Deputy Martin Browne

I welcome the Minister of State and the officials. I have two questions that may have been answered already. The first question is on the refill on the Internet. I see that the Irish Creamery Milk Suppliers' Association has said that farmers should be able to purchase veterinary medicines from legitimate sources online, be that in Ireland or the EU. Will the Minister of State explain if this means medicines that are approved in Ireland and are not subject to prescription will be precluded from being purchased online from outside of Ireland by a farmer?

Deputy Martin Heydon

Is the Deputy asking about medicines that do not need a prescription?

Deputy Martin Browne

Yes.

Deputy Martin Heydon

Yes, they can be acquired across the Single Market if they are medicines that do not require a prescription. Medicines that do not require a prescription can be acquired across the Single Market.

Deputy Martin Browne

In an interview in July the chief veterinary officer said significant changes were coming but that he was not necessarily sure whether they would be as big as they might appear to be. Since then, some members of the major milk producing co-operatives have experienced the budget 9% reduction in the intra-mammary tubes status. This raises questions about the Department's preparedness and competence to address adequately what is being addressed through this legislation. We are still in the dark about the Attorney General's advice, which is another factor that brings the whole thing into question as far as I am concerned. The Minister of State is saying this pre-legislative scrutiny is being rushed because of a sense of urgency. What if the Minister of State were looking at this from any other position than from where he is. If he was looking at it on his own, would he find it acceptable? Did the Department give any consideration to ensuring the reps could have similar abilities such as the suitably qualified persons? Does the Department believe this ship has sailed at this stage?

Deputy Martin Heydon

I thank Deputy Browne for raising those points. I will deal first with the intra-mammary tubes. Similar points were raised here earlier. As I pointed out, they are antibiotics and they are subject to a prescription that has a five-day life span. That is as long as a prescription for an antibiotic would last. What is proposed here for a new prescription for antiparasitics is a 12-month life span. We are trying to strike the right balance between safeguarding and offering farmers the greatest choice while also meeting our legal regulatory requirements and trying to ensure we are very mindful of the impact on merchants here. The 12-month licence makes it very clear there could be a significant gap between the day a prescription is acquired and the day the product is purchased. Obviously, given that intra-mammary tubes are antibiotics, that gap is only five days. It stands to reason that if one gets a prescription that will last for five days, we would probably expect this product to be purchased that same day or very close to it. They are not necessarily comparing like with like.

To answer the Deputy's other question, if I were sitting in any other chair here, I would see the balance that there is. I would see the great regard in which we all hold the responsible persons and for the role they have played in the past, but I would also see the challenges of the up-regulation that antiparasitics have brought in. I would see the challenge of trying to maintain the maximum flexibility and choice for farmers while also making sure we meet our regulatory requirements.

I would also see, taking a fair-minded approach, the great medium and longer term threat if we do not take a serious approach to how antiparasitics are used in livestock. Earlier, I highlighted that there are only four key groups of drenches, as farmers would know them, and lots of products come from them. Only four key groups of drenches have active ingredients and if our livestock become resistant to any one of those four groups the number of options available will be reduced. Preventing such a situation is the motivation for this legislation. This is about giving assurances to the very farmers that the members and myself represent. We must ensure that their livestock and pasture-based system, which is so crucial to farmers and the rural communities in which farmers live, is protected long into the future. Our approach is about trying to strike the right balance.

Deputy Martin Browne

If there is a sense of urgency, why are we still in the dark about the advice given by the Attorney General?

Deputy Martin Heydon

As I outlined earlier, we are not sitting in the dark about the Attorney General's advice. As recently as last week we received a new legal opinion from stakeholders. As I pointed out earlier, if I came in here tonight and said, "We had a quick look at it, we are not accepting it and we are not giving it the due consideration that it is worth", then we would be having a different discussion and, rightly, members would have a right go at me for that. I reassure the committee that we received the advice recently and we are giving the advice its due consideration. We are going through the advice with a fine-tooth comb to see if it can work and are assessing whether we believe it would stand up to the regulatory scrutiny experienced by all legislation. That is why we do not have absolute clarity on that legal point tonight.

Deputy Martin Browne

Can the Minister of State indicate when we, as a committee, will get that advice after the Department has conducted its analysis? How long does he expect that it will take the Department to assess the advice?

Deputy Martin Heydon

As soon as we can but we want to ensure we give the advice due consideration. We are all aware of the time pressure concerning this legislation, and not just for this element but for the fertiliser element, which we will discuss later. That directly impacts on farmers in respect of the range of options they will have, for the eco schemes that they can join and all the rest.

The legislation is very much in the hands of the committee in terms of the pre-legislative scrutiny and in the hands of Members of the Oireachtas as to how legislation passes through the two Houses and goes through those phases. The Department must ensure, when we come back with our adjudication on the latest legal opinion, that we can say hand on heart that we have gone over the legal opinion with a fine-tooth comb and analysed it inside out and ensured that we have looked at it in every way and if there is a way it can be accepted and integrated then great but, if not, we want to be able to say that we have gone through it in that way. We received the legal opinion last week and I assure the Deputy that we are working hard and fast to ensure that we go through it. We are doing that work with an element of wanting to make sure that we do it speedily we are not going to rush our work to the extent that we do not give this the due consideration that it deserves.

Chairman

Senator Daly and Deputies Carthy and Fitzmaurice wish to ask supplementary questions.

Senator Paul Daly

From what I heard this evening, if one is on the outside looking in and not as well versed as we are on this subject after our series of meetings over two years then it would seem that a 12-month prescription is a lifeline for merchants, pharmacists and co-operatives. In reality, and for clarity, all that we can put into legislation or regulation is that a prescription can be "up to 12 months" because it is the veterinarian himself who will decide. Am I right to say it is the vet who decides the duration of a prescription?

Let us say a vet tests my cattle in March and I ask him on the day to give me a prescription for antiparasitic treatment that will last until this time next year. Let us say he turns around to me and says that it would not be ethically professional for him to prescribe something that a farmer might use next harvest. Considering that I do not know whether there will be a drought or a wet summer or what the climatic conditions will be like between now and then and vets says to me that it would not be ethically professional for a vet to do so and will not give an annual prescription, is he or she in the right to do so and the Minister of State, his officials or me would have a foot to stand on to tell him that he had to give me an annual prescription?

What has been said here is that we are putting up a camouflage of an annual prescription as a lifeline for the merchants, pharmacists and the co-operatives but we are handing even more power to the vet who will decide whether he will and he or she will be covered by professional ethics by saying he or she will not. Power is, therefore, being handed over.

When we started this conversation I was the first to speak and I mentioned anti-competitiveness and availability. Handing vets more power will not solve the anti-competitive issue. Deputy Fitzmaurice mentioned you would feel ashamed to look a vet in the eye and say you will go somewhere else to buy them. You are now looking the vet in the eye yet he refuses to give the prescription and he will be within his right to refuse. I want this matter clarified before we finish.

I wish to mention an issue that has not been mentioned The French prescribing system and its issues have been mentioned. In our previous deliberations - and I do not have my notes with me so I cannot give an exact quote - it emerged that Scandinavian countries have discovered that decoupling led to the best results in their antiparasitic plan. Why has Ireland not examined decoupled prescribing and dispensing? We should let vets be vets and suppliers be suppliers. The Government has not even addressed the idea of separating prescribing and dispensing.

I have a fond memories of a previous meeting where we discovered that Scandinavian countries have statistical proof that shows they have the best results in handling antiparasitic resistance and in those countries vets are vets and suppliers are suppliers. We have not even discussed the option. If the merchants, co-operatives and the pharmacists stand to lose if we get this right, why do we not go down that road and maybe the vets will lose a small bit? In Ireland we have a one-way street in this area.

Deputy Martin Heydon

I thank the Senator for his questions and Dr. Corkery will answer the questions about an annual prescription and decoupling.

Dr. Paul Corkery

First, I will answer the question about the duration of a prescription. As I said earlier, the EU made it an absolute requirement that an antimicrobial prescription-----

Senator Paul Daly

I talked about antiparasitic treatments and everyone accepts the requirement regarding an antimicrobial prescription.

Dr. Paul Corkery

That is how things are done. It is done in law. If in the Bill we put in a provision that a prescription for antiparasitic medicine will have a duration of 12 months then that is what it will have. I recall saying earlier that the current situation is that a vet can decide that a prescription will be for as long as the vet determines. In this legislation that we are scrutinising it is possible to insert a provision stating, "A prescription for anti-parasitic medicines shall be valid for one year", and if we get the go-ahead to ensure the NVPS is the only way in which a vet can issue a prescription, then the NVPS will default to 12 months.

Senator Paul Daly

Is the Veterinary Council of Ireland on board with that?

Dr. Paul Corkery

Yes.

Senator Paul Daly

Is the VCI on board with vets being legally obliged to give me a prescription for a product that I may use 364 days later irrespective of what conditions have changed on my farm or with the climate?

Dr. Paul Corkery

In the same way as the VCI had to adopt the law of the Union in terms of the five-day window for an antimicrobial, yes.

Senator Paul Daly

Is it professionally wise that a vet can give me, a farmer, a prescription for a medicine that I can use in 365 days and an RP cannot tell me what I can use tomorrow?

Dr. Paul Corkery

This goes back to the difference between antimicrobials and antiparasitics. As I said earlier, these are almost in the nature of feed. In Ireland, one does not see symptoms. There is generally no necessity for a diagnosis. They are required, they are different and they are part of a herd health plan, which is why the TASAH scheme, which I mentioned earlier, is so important.

Senator Paul Daly

I know, as a farmer, without being a vet or an RP, that depending on whether it is a wet or dry summer, I will not know until the end of that summer season when I go to dose my cattle before putting them inside in the fall because a drought will have one consequence on my land and a very wet summer will have another consequence. I could end up therefore, throwing a prescription I get in March prior to the summer on the fire.

Deputy Matt Carthy

On that point, the difficulty is not the duration but the quantity. As has been said, a vet is obliged to provide a prescription that will last 12 months but he or she can only prescribe a quantity suitable for just one month. Is that a fair comment?

Dr. Paul Corkery

No. We have provided in the national veterinary prescription system that it can be part dispensed.

Deputy Matt Carthy

That will be at the discretion of the vet.

Dr. Paul Corkery

The way this will work is that the vet will ask how many weanlings a farmer has and the answer may be, for example, 100. The prescription will be written for product for all weanlings in the herd. It is the actual product volume that is the requirement.

Deputy Michael Fitzmaurice

I want to come in on this because a few things need to be clarified. Over the past six or seven months vets have called meetings in hotels throughout the country. We see vets giving us biscuits and sandwiches and all different stuff while they tell us what is coming down the line. It was made very clear to farmers in many places throughout the country that vets would be calling out to the farms to decide what prescription would be needed. Has the Department made any allowance for this in the legislation? The answer is that it has not. Has it made any allowance for the farmers who will have to pay more money than previously? The signal being given out by the Department seems to be of a jolly thing of vets doing herd tests and when the farmers and vets are sitting in the jeep afterwards, when the farmers are giving the vets a few hundred euros for the herd test, they will say they want products for fluke or other issues for the year, the vet will write out the prescription and everyone will be happy. This is not how it will end up. Farmers are at the end of the barrel of a gun on this one. The vets will have the opportunity to screw farmers and that is the fact whether or not the Department wants to admit it. This is how the legislation is being written. Farmers throughout the country will be at the end of this stick with vets. It has already happened. I have seen the build up to this where vets are bringing people to hotels. I have never seen it previously and it has been happening over the past six months. They are getting farmers ready to bring them in.

Chairman

I want to make a point and I have not spoken all evening. The Department is speaking about 12-month prescriptions that will be of benefit to reduce resistance in animals. In actual fact a 12-month prescription, if given by a vet, would be counter-productive to what the Department is trying to achieve. If vets give the full possible coverage that farmers need for the year they would be providing drugs the farmers might not need depending on various circumstances. To say that vets will give 12-month prescriptions that will help to reduce resistance in animals is a fallacy and it is wrong. If we get a dry year farmers will not need a fluke dose. If we get a wet year they will need it. When we get damp weather we have more fluke than in a dry year. To think vets will say on 1 March or 1 April that they can predict what farmers will need for 12 months is wrong and misleading.

Senator Paul Daly

They will not do it.

Chairman

They will not do it and it is wrong. To say that on one day of the year farmers will know what they will need for the year is wrong. If, for example, there was an offer for something that farmers might need it would be counter-productive to what we are trying to achieve. Let us cut out the nonsense and be square. A 12-month prescription will not happen in reality. If it does happen in reality it will cost the farmers money.

Senator Paul Daly

I have one more point to make on this.

Chairman

Senator Daly has been very quiet all evening.

Senator Paul Daly

Is it true that if farmers go to the merchant with a vet's prescription the responsible person dealing with them must give the exact product on the prescription and cannot give a generic equivalent?

Dr. Paul Corkery

One of the ten recommendations the committee put to us was to examine the substitution of generic products. We discussed this with the HPRA and came up with what HPRA has advised us to call a comparable product list. This comparable product list will be available. The dispenser, be it the co-op or the licensed merchant, will be able to examine the prescription and will have been given, in our national veterinary prescription system, every product that can be substituted for it. This will include the product it will have on its shelf. We have worked with the Irish Co-operative Organisation Society and the Independent Licensed Merchants Association to ensure this is workable. Recently they proposed additional changes and we have accommodated them.

Senator Paul Daly

The Department has accommodated them by tying them to a list. This is where I was coming from in my first point. The responsible person will not have that much wriggle room if I have a prescription since March and I have had a bad summer. The provider will have to give what the Department and the HPRA have decided is an identical product.

Dr. Paul Corkery

It is a sensible list. For example, if we were speaking about car parts and a clutch it would have all of the clutches available that would suit the car model. It depends on the species. The product has to be authorised for the species. It is a comprehensive list that will allow for the type of generic substitution that the Senator recommended we introduce.

Senator Tim Lombard

We are two hours into the debate and we have another hour to speak about fertiliser. The Department has explained where the process started and ended. The Chair has made a valuable point on whether it will work at the end of the day. There are all types of land and we have seen all sorts of weather this year. We have had unbelievable weather that I have never seen before. If this fails, which it could, what is plan B? Will we go down the line of having prescription only and dispensing only? Have we thought about what plan B will be? Plan A has been put in front of us and it is questionable, to say the very least. Obviously there is a plan B somewhere in case we do not meet the targets. Will we go down the dramatic road of removing dispensing completely from vets? Will we have it for another entity to deal with? I am very concerned that plan A, according to the Chair's analysis, might fail and plan B has not even been thought up.

Dr. Paul Corkery

We are4 always open to changing course if it is necessitated. The question in some regards relates to the question asked by Senator Daly about decoupling. That matter, as Deputy Carthy knows, was discussed at length in the European Parliament. It looked at whether there is evidence to suggest that with regard to antimicrobials, decoupling would improve the situation and reduce the amount of antimicrobials dispensed. It did in Sweden but other member states, which I would prefer not to mention, that have coupled are the heaviest users of antimicrobials. There was another matter. It was considered that if we decoupled in countries that had not decoupled prior to the treaty that introduced the Single Market it could amount to a state aid if one sector were prioritised over another.

On the previous occasion I came before the committee I mentioned a situation where a vet is asked to attend to an animal on an island. The vet can determine what is wrong, make a diagnosis, decide what the treatment is and issue a prescription. Is this any good to the islander if the vet walks away and says the animal cannot be treated because dispensing and prescribing have been decoupled? These are the reasons behind it. It is not only in Ireland but in the European Union. The feeling at the European Parliament was this cannot happen. There are parliamentary debates to support this.

The Chair asked about prescriptions being issued at the start of the year. For example, when the herd health plan is being made for dairy farmers they may be issued a prescription for fly tags or pyrethroids to prevent flies during the summer. We may then not have a very dry warm summer, such as what we had this year, when there are an awful lot of flies. The product would not have to be dispensed.

It is the same with regard to what the Senator said about the flukicide. If a person does not believe he or she has a problem, just because it is on the prescription-----

Chairman

In fairness, Mr. Corkery is telling us that the Department is bringing in legislation to try to reduce the use of different remedies and that once a year a veterinarian is going to give the Department a foolscap page of what he or she might want. Let us be honest and fair; Mr. Corkery might think that is a constructive way of going about reducing the use of antibiotics. We take milk samples approximately six times per year. We take faeces samples to dictate our dosing regime. Mr. Corkery is telling me that I can have a foolscap page of anything I might want and that is the reason the Department is bringing in this proposed legislation. As has been said, we are creating a monopoly on who will control it. Mr. Corkery is saying a veterinarian will give a prescription. That will not last. Once this proposed legislation comes into force, that 12-month prescription will not last a year.

Senator Paul Daly

Veterinarians will not deal with anyone, and they would be in the right not to. It would not be professionally ethical for them to do it.

Chairman

No, they will not do it. We have seen that if one doses for fluke and it is not there, it creates resistance. There is no point in saying it does not. Unless samples are being taken, however, we will not know whether the level of fluke is there. Mr. Corkery is telling us that the Department is going to hand a farmer access to all this instead of going down the route of him or her going to a responsible person with a milk sample and getting the product he or she needs, which can be proven from the milk sample. This will not achieve what we want it to achieve and it will create a monopoly as well. Ultimately, it will add significant extra cost for farmers.

Deputy Martin Heydon

I will come back to a previous point. Obviously, the Chairman's points about the responsible person are valid. They were echoed by other members of committee. We are looking at the latest legal opinion to see if we can make that work. Outside of that, pre-legislative scrutiny is all about having these types of detailed debates around impediments where the Department officials, as very experienced people in the area of agriculture, food and the marine, would have an insight. It is open to the committee to make recommendations about that length of time. If it is the committee's recommendation that it would be a different length of time, that is a possibility. We take on board the points that have been made, however.

Chairman

We have been very consistent this evening. We all want to see this proposed legislation achieve its objectives-----

Deputy Martin Heydon

I understand that.

Chairman

-----and we want to do it in a cost-effective manner. It is in all our interests to reduce the use and make sure we do not get resistance. In practice, however, a 12-month prescription cannot work.

Deputy Matt Carthy

Before Senator Paul Daly came in, I wanted to talk about the potential of putting in place a legislative framework that would have what he described well as decoupling. For ordinary people, what we are talking about in that instance is exactly what happens for human medicine whereby a GP prescribes and a person purchases in a chemist. That system is in place for very good reason, which is to ensure that the person who is prescribing is not incentivised to over-prescribe where there would be a profit motive behind that.

I was peripherally involved with some of the discussions at an EU level. My recall of that is different from Mr. Corkery's, which I will not dispute. My recollection is not that the European institution said this cannot happen, but that it will not happen at an EU-wide level. My understanding was that the discretion was left very much at a member state level. However, I do recall that in stark contrast to my experience regarding whether a derogation is in place, the Irish Government was very active on that particular point in opposition to any suggestion that there would be an EU-wide decoupling of the prescribing and selling of animal medications. I had sympathy with the arguments that said it could make veterinarians unviable in some peripheral rural areas, and that there may be instances where emergency prescribing and dispensing would be required within a short timeframe. However, the first argument is lost with the enthusiasm with which we are moving forward on a piece of proposed legislation that could potentially make many other very important businesses for rural communities unviable, particularly our licensed merchants and our co-operative sector.

The Minister of State prefaced quite a number of his remarks on the basis that he is still considering the legal opinion and new legal advice he has received. When we go into the depth of the responses we have been receiving, however, I do not get a sense of an open mind. I get a sense that the Minister of State is plámásing us by saying that the Department received further legal advice and that he and his officials are looking into it. However, every single substantive response we have received to any of the questions that have been put very clearly point to the view that minds have been made up in the Department, and we are proceeding along this basis.

I will make this final point. Mr. Corkery mentioned state aid, which, unfortunately, is one of these things at EU level where what suits the goose does not always suit the gander. Once the EU puts in place a measure, it cannot breach state aid rules. My view of this proposed legislation is that it is in breach, at the very minimum, of the principles of the Competition Act. There are, if you like, four sectors through which this type of medication is dispensed and prescribed, depending on what term we are going to use. In the aftermath of this proposed legislation, there will basically be one.

The advice we have received and the testimonies we have received through written submissions do not just come from those sectors that gave evidence but from what I can see, also from virtually every farm organisation. The people at the front line who represent farmers are telling us that if this happens on the basis the Department has indicated, it will make providing medication to animals more expensive for their members. This is at a time when margins are already tight.

I have two questions in that regard. Will the Minister of State examine the full outworkings of decoupling and look at decoupling as an option? As I said, it is not something for which I would have advocated but we are coming into extreme circumstances, and it is only through this that we will be able to save many local businesses that will otherwise be under threat.

Can the Minister of State give us a timeframe for the examination of that new legal advice, as he has indicated? I do not believe we can close the pre-legislative scrutiny process relating to this proposed legislation until we have received an assessment of the Department's adjudication on that.

Deputy Martin Heydon

I thank Deputy Carthy for those supplementary questions. Dr. Corkery outlined earlier the challenges around decoupling, not just in terms of state aid. State aid rules were investigated by my Department, however, and it was found that to restrict the supply of veterinary medicines from one grouping for economic reasons would be considered state aid. A sound evidential basis in veterinary medicine is required to justify any partial or full prohibition on veterinarians doing that.

I will bring the Deputy back to my earlier point about having maximum flexibility for farmers in as much as possible in terms of their livelihoods and the role they play. This situation has already been outlined. A farmer in that space may need a prescription and need the product that same day on a farm that may be in a very isolated area, such as on an island or some equally isolated location. We are tying the hands of that farmer to have the ability to access it if we decouple. That is the very clear position on that issue.

In terms of the Deputy's second point, the timeframe is very clear. It is as soon as possible. I would love to see this being a solution, The Deputy talked about the tone and the references beyond that legal opinion. Let us be clear; the committee has gone through this for two years. We have all looked at this issue. We have all heard from the various stakeholder groups and had them appear before the committee. We have not up until now been able to find a legal regulatory mechanism that will allow us to be able to deal with the issue of the responsible person in Ireland in the proposed legislation.

If the legal opinion had not come in last week, we would still be in that position. I would love this new legal opinion to work. We owe it to everybody involved to analyse it , ensure that we go through it with a fine-tooth comb, turn it inside out and see if we can make it work. That would be to the benefit of the merchants, rural Ireland and everybody involved.

I understand the misgivings and concerns that colleagues have raised, but whatever legislation we bring through, we are duty-bound, on this side of the table, to make sure that it fits the regulatory and legal requirements that we have to meet. We will make that decision as soon as possible. I would love for it to work. Before that came in, we had not found a legal opinion that would work and that we believed would stand up to that scrutiny. That is being straight and honest about it.

Deputy Michael Fitzmaurice

Who looks at the legal opinion? Is it the veterinary section or is there a senior counsel involved?

Deputy Martin Heydon

Obviously, the Department of Agriculture, Food and the Marine has its own legal team to look at legal opinions. The Attorney General also has a key role to play in legal advice for the Government .

Deputy Michael Fitzmaurice

So the Attorney General is going to look at the opinion? Is the veterinary section not going to be looking at it?

Deputy Martin Heydon

In order to provide absolute clarification, the legal services team in the Department of Agriculture, Food and the Marine is looking at the opinion

Deputy Michael Fitzmaurice

Is it the Attorney General or legal services?

Deputy Martin Heydon

The legal services team is looking at it now.

Deputy Michael Fitzmaurice

Why would the Minister of State decide not to take it to the Attorney General to get an opinion on it and instead get legal services in the Department of Agriculture, Food and the Marine to look at it?

Deputy Martin Heydon

Before going to the Attorney General, the legal services section of the Department would look at it.

Deputy Michael Fitzmaurice

I understand that, but would the Minister of State not make sure?

Deputy Martin Heydon

I have not said that it will not come to that. I have not given a clear timeframe on it. I am saying that as soon as possible,-----

Deputy Michael Fitzmaurice

Will the Minister of State give an undertaking to the committee that he will do that?

Deputy Martin Heydon

Our legal services team is looking at it. I am giving a commitment that the opinion will be gone through with a fine-tooth comb by my Department in order to see if there is any way we can make it work. It would solve a lot of problems on all sides. We know that expedience is needed in passing this proposed legislation. Does the Deputy think that if we could find a solution that we were happy would stand up to legal scrutiny, we would not go for it with both hands? Of course we would. I would like that. The Deputy should rest assured that the mechanisms are being looked at through the legal services section there. The option is open for it to be looked at further.

Deputy Michael Fitzmaurice

I do not know the answer to this question, so the Minister of State might educate me. Is the legal services team in the Department made up of solicitors or barristers?

Deputy Martin Heydon

Barristers and solicitors within our Department.

Deputy Michael Fitzmaurice

Dr. Corkery made a point earlier that the HPRA was on about antiparasitic resistance. When did it become a problem as far as the Minister of State is aware?

Deputy Martin Heydon

I understand that the HPRA report was published in December 2019. That was-----

Deputy Michael Fitzmaurice

In 2014, Dr. O'Shaughnessy wrote a report about the serious problem with antiparasitic resistance. It was roughly around the same time that the Brits wanted us to chip in with them, according to my understanding, in going the way that they were going to make sure that basically the competent person could give out the medicines. There was a Department document written at that stage that highlighted the serious problem in it. How come nothing was done then?

Deputy Martin Heydon

I will refer to Mr. Corkery on that one.

Dr. Paul Corkery

From memory, in the context of that report, the number of herds and flocks were quite small. When they were taken overall, they were not statistically significant, and still allowed us-----

Deputy Michael Fitzmaurice

Just to be clear, the report referred to a high level of antiparasitic resistance.

Dr. Paul Corkery

Yes A high level in the flocks and herds that were examined. That is accurate. They were not statistically significant at a national level, but there was enough to prompt the HPRA to look again at the criteria to ensure that we met the derogation criteria that allowed us-----

Deputy Michael Fitzmaurice

It took them five years to do that, did it?

Dr. Paul Corkery

Gathering information on a national level takes time. The way in which we gather this information is through the Department's network of regional veterinary laboratories. What it requires is substantial submissions of carcases and dung samples. It did take time. Not only in Ireland but also in other countries, it takes time, with a lot of these salient types of diseases, to be able to say that there is an emerging problem.. They are not like the viral diseases that we know of that emerge in an explosive fashion.

Chairman

We have spent two and a half hours on the first half of this legislation. I think it is clear that there is unease here as to how this is going to work in practice. The Minister of State was very attentive in listening to the members. I trust he will go back and examine the legal opinion that the Department has, and take on board the views that members have expressed. Next, we will look at the second part of the proposed legislation, which I hope will not take another two and a half hours. We will suspend proceedings while the new witnesses are coming in.

Sitting suspended at 9.26 p.m. and resumed at 9.31 p.m.

Chairman

I will read the note on privilege again. Witnesses giving evidence within parliamentary precincts are protected by absolute privilege in respect of the evidence given to the committee. This means witnesses have a full defence against any defamation action from anything said at the committee meeting. However, witnesses are expected to not abuse this privilege and may be directed to cease giving evidence on an issue at the Chair's direction. Witnesses should follow the direction of the Chair in this regard and are reminded of the long-standing parliamentary practice to the effect that, as is reasonable, no adverse commentary should be made against an identifiable third person or entity. Witnesses who give evidence from a location outside the parliamentary precinct are asked to note they may not benefit from the same level of immunity from legal proceedings as a witness giving evidence from within the parliamentary precincts and may consider it appropriate to take legal advice on this matter. Privilege against defamation does not apply to publications by witnesses outside the proceedings held by the committee and to any matters arising from the proceedings.

We will take the second half of Minister of State at the Department of Agriculture, Food and the Marine, Deputy Heydon's statement on fertiliser as read, as all Members here have read it.

Deputy Michael Fitzmaurice

I thank the Minister of State, Deputy Heydon, for coming in. I have a few short questions. I have worked on cross-country pipelines. One does a way leaves, roadway or whatever one wants for different types of work and construction. If one is doing a way leave one could be going through 20 to 100 different farms. It could be 100 m wide or 50 m wide, depending on the job one is doing. The ground has to be what we call "reinstated" as one would be going through the farmer's land. Who accounts for that fertiliser? Is it put on to the nitrates of the farmer on each individual system or how does it work?

Deputy Martin Heydon

Sorry I want to-----

Deputy Michael Fitzmaurice

Say we went through-----

Deputy Martin Heydon

On the analogy of going across farms, is Deputy Fitzmaurice talking about contractors?

Deputy Michael Fitzmaurice

Yes. For instance, if one went from Clane to Leixlip cross-country-----

Deputy Martin Heydon

There are not many green fields at that end of Kildare.

Deputy Michael Fitzmaurice

It still needs water or whatever.

Deputy Martin Heydon

Yes, it does.

Deputy Michael Fitzmaurice

One needs to put a pipe underneath, so one is taking out a 50 m way leave.

Deputy Martin Heydon

Yes.

Deputy Michael Fitzmaurice

One is disturbing the ground and one has to put it back. The contractor has the job of reinstating it. It has to be put back the way it was.

Deputy Martin Heydon

Yes.

Deputy Michael Fitzmaurice

One has to fence it and do everything. What I am asking the Minister of State is who is accountable for that fertiliser? Is it the contractor or is it farmers on the individual land? The contractor-----

Deputy Martin Heydon

To take Deputy Fitzmaurice's analogy, he said a contractor has a load of fertiliser and spreads it from Clane to Leixlip.

Deputy Michael Fitzmaurice

Yes. The contractor has to put that ground back to what it was and give it back to the farmer.

Deputy Martin Heydon

That is a very specific point on which I might defer to my officials. Would the contractor be applying fertiliser in that specific space?

Deputy Michael Fitzmaurice

No farmer likes to have grass just thrown in with other-----

Deputy Martin Heydon

Sorry. That is right because the way leave would be going through farmland. I was thinking it was on the side of a road. I might bring in Ms Byrne-----

Deputy Michael Fitzmaurice

What about cross-country pipelines?

Ms Louise Byrne

I thank Deputy Fitzmaurice for his question. To be clear, agriculture contractors are professional fertiliser end users as defined in the legislation. In those circumstances if they are spreading fertiliser on behalf of a farmer, the farmer will potentially buy that. There are a number of scenarios-----

Deputy Michael Fitzmaurice

No, Ms Byrne is not getting what I am saying. I am not taking about agriculture contractors; I am talking about a civil contractor. Some four or five big civil contractors do that construction. I will use the example of putting a big water pipeline from some part of Kildare to, say, Intel. It is a Government job that the civil contractor will price for the likes of Irish Water or otherwise. One has to go through people's land. There is a way leave. These are civil contractors and not agriculture contractors. Who is responsible for that?

Ms Louise Byrne

Those civil contractors will be professional fertiliser end users under the legislation as defined. If they are buying the fertiliser to apply that fertiliser, they will also have to register as a fertiliser economic operator under the legislation.

Deputy Michael Fitzmaurice

The civil contractor.

Ms Louise Byrne

Yes, if they are buying and selling that fertiliser.

Deputy Michael Fitzmaurice

They are not selling it. They are using it to reinstate land. That is what I am trying to-----

Ms Louise Byrne

Are they not selling the fertiliser?

Deputy Michael Fitzmaurice

No. The contractor gets a contract to dig a hole and then it has to put the ground back as normal. That is what I am trying to establish.

Ms Louise Byrne

On whose land it is?

Deputy Michael Fitzmaurice

It is on farmers' land. However, it is a way leave.

Deputy Martin Heydon

I would say on a number of farmers' lands.

Deputy Michael Fitzmaurice

Maybe Ms Byrne can come back to me. I do not want to keep-----

Deputy Martin Heydon

I might bring in Mr. Massey on that as well.

Mr. Ted Massey

To fully understand Deputy Fitzmaurice's question, in this case is a contractor supplying the fertiliser?

Deputy Michael Fitzmaurice

Yes.

Mr. Ted Massey

Is the farmer supplying it to a number of different farmers in a continuous process?

Deputy Michael Fitzmaurice

The contractor is supplying it to farmers because there is a 50 m way leave. Irish Water will have done a deal with the farmers to put a pipe from Ballymore Eustace to Leixlip, for instance. It goes cross-country, but all that ground has to be reinstated because of the way leave. Whose responsibility is it? Is it the farmer on whose land the fertiliser is put on? The civil contractor has to reinstate all the ground, put in the pipe and do everything as a contact with Irish Water or otherwise. That is all. If it is an issue the witnesses have not come across, they can reply to me later. I have no problem waiting.

Mr. Ted Massey

As my colleague said, if the contractor is involved in the application of fertiliser, it has to register as a professional fertiliser end user. If it is involved in supplying the fertiliser to the farmer, it also registers as a fertiliser economic operator-----

Deputy Michael Fitzmaurice

These are civil contractors; they are not supplying farmers.

Mr. Ted Massey

Whoever is supplying it registers. In this case I assume it is applying it on a number of farms so it attributes the fertiliser that goes to each farm on the database. If there are ten farmers involved, the smaller farmers obviously have less land, so there is less fertiliser attributed to them, while the larger farmers have more attributed to them pro rata with where the fertiliser was actually used.

Deputy Michael Fitzmaurice

Yes but a big problem will ensue there, and I mean no disrespect. Farmer Joe has a way leave gone through Irish Water for six to eight months and the reinstatement will be done in September. If I am working on my fertiliser spreadsheet, what I am allowed to use or what my targets are, and the contractor puts out a lot more, which it will because it has to try to grow grass and not go back on it, there is a danger it will not know the amount or the volume. It is going to be complicated.

Deputy Martin Heydon

That is a very specific point. The unfortunate farmer having that way leave go through their land, it would happen at a once-off point. So-----

Deputy Michael Fitzmaurice

Yes it happens-----

Deputy Martin Heydon

The point is that it would be applied on a per farm basis. I know what Deputy Fitzmaurice is saying from a civil contractor's perspective but from the farmer's perspective, it not something that will happen very regularly. It will happen once. It will be applied to the farm and there will obviously have to be communication between the civil contractor and the farmer as to how much fertiliser can be spread on the land so they are within their means on that. As I have said, in terms of the overall point about this Bill, my focus is on how this will impact farmers on an annual and an ongoing basis.

Deputy Michael Fitzmaurice

Okay.

Deputy Martin Heydon

The point raised by Deputy Fitzmaurice is valid but it would be a one-off occasion if it happened.

Deputy Michael Fitzmaurice

In my part of the country, there are smaller farms. There would be a small merchant perhaps selling 200 tonnes to 1,000 tonnes to farmers in an area. I am talking about a local shop in which you can buy a pair of boots, the dinner or get steaks. I am talking about a small operation in a rural area. What is the cost involved in an IT system for the likes of them, or is there any?

Deputy Martin Heydon

I will ask Ms Byrne to respond. It depends on the business processes.

Ms Louise Byrne

I thank Deputy Fitzmaurice. This matter was raised at our stakeholder consultative committee meetings and we have asked stakeholders to provide an estimate on the likely IT costs.

Ms Louise Byrne

This matter was raised at our stakeholder consultative committee meetings and we have asked our stakeholders to provide an estimate of the likely IT costs, whenever that information is available. They could not provide that until they were in a position where they had what is known as the application programme interface, which is the tool that will allow merchants to connect their IT systems to our national fertiliser database. Separately, we have been engaging with officials in other Departments and agencies about what supports may be available. We have asked for detailed submissions on what those likely costs will be. There is a cost, and we acknowledge that, but the cost depends very much on the systems.

Deputy Michael Fitzmaurice

The Minister of State will know this himself, coming from a rural county. I am afraid the smaller operator will just get out of selling fertiliser and we are going to leave it to the big operators, again, if there is a big cost to those small shops that sell small amounts of fertiliser.

Deputy Martin Heydon

I take on board the Deputy's point. The last thing we want is any reduction in competition in this area that would be to the detriment of the farmer or that would discommode people. Ultimately, these measures can assist farmers in some ways. There have been a number of interventions to make it easier for those small companies whose core business is perhaps not selling fertiliser, as the Deputy outlined. They might do different things and sell a small amount of fertiliser. They have options open to them. They can use the application programming interface, API, system or they can log on through agfood.ie to register that way. The system is pretty straightforward.

Deputy Michael Fitzmaurice

I have concerns on Northern Ireland but I will let the others look after that.

Deputy Matt Carthy

I absolutely support the principle of this part of the legislation. It could be a very valuable tool in terms of putting measures in place at a later stage that would incentivise individual farms to reduce emissions. The difficulty I have with it is a fairly obvious one. What procedures are envisaged for a farmer from, for example, my county, who happens to go to a merchant? It may be across the Border, but it may be their closest merchant. What provision is in place in that instance? How will that operate?

Deputy Martin Heydon

We have highly integrated supply chains on the island of Ireland, as the Deputy will be aware. Farmers and other professional fertiliser end users can continue to purchase fertiliser from Northern Ireland and vice versa. We are keen to ensure that trade continues. We do not want to discommode that trade as normal between two jurisdictions. However, this proposed legislation does place a legal obligation on anyone importing fertiliser into the State to register as a fertiliser economic operator and to submit data on imports to a national fertiliser database. We have developed a system to make the registration process as simple as possible for farmers. I acknowledge there are concerns in the industry and the concerns it has in relation to the issue. There have been discussions on this matter in the consultative committee meetings. We cannot legislate for other jurisdictions, but my Department has been in close contact with colleagues in the area. In terms of farm controls, which are risk-based and include specific checks on the import of fertilisers, these checks will be a key focus of on-farm controls in the roll-out of the national fertiliser database.

Deputy Matt Carthy

That does not reassure at all, I have to say. As it stands in the legislation, if I as a farmer go to any merchant in this State, purchase fertiliser and give my herd number, the onus will be on the merchant to upload all of that and it will be assigned. It is a very simple process. Am I supposed to say to somebody who might be in the parish of Cullaville - the parish crosses the counties of Monaghan and Armagh - that if they happen to be driving home and they have an empty trailer and decide to pull in to load up with a dozen bags of fertiliser for whatever reason, they need to register as a fertiliser economic operator? In all honesty, what does the Minister of State think the chances of that happening are?

Deputy Martin Heydon

That process has been made very simple for farmers. I would not-----

Deputy Matt Carthy

It is simpler not to do it if we are talking about simplicity and the reality of these things.

Deputy Martin Heydon

I do not underestimate the vast majority of farmers' ability to be aware of guidelines, rules and laws, to stay within them and to do so in a way that has been made very simple. Farmers do that all the time-----

Deputy Matt Carthy

So they go across, they buy, they come back, they go online and then register themselves. Do they do that before they buy it or after?

Deputy Martin Heydon

I will bring Ms Byrne in on this in terms of the actual process.

Ms Louise Byrne

The answer is "Yes". Farmers who are end users will register with us as a professional fertiliser end user. We also recognise that some farmers will import fertiliser directly or they may sell or transfer fertiliser from farm to farm. In those circumstances, we have made the system as simple possible so that when they are on the agfood.ie log-in page, which farmers are very familiar with, under the national fertiliser database tab there will be a very simple pop-up box to ask if you are importing or selling fertiliser and if you want to register as a fertiliser economic operator. It will simply be a tick box. The process is straightforward. They will still have to submit the details concerning the products they have imported. All of those products have been uploaded onto the fertiliser database, including products that are distributed and sold in the North of Ireland, to make that process as simple as possible for farmers.

Deputy Matt Carthy

Does the Minster of State not see the potential for the overall figures to become distorted as a result of somebody forgetting to register as a fertiliser economic operator or forgetting to upload the entirety of what they purchased?

Deputy Martin Heydon

The Deputy is painting a picture of a very onerous task that we are saying very clearly is not. To say very clearly back to the Deputy, the farmer only needs to register once. I know many farmers who go on the agfood.ie system to mark a range of different things, whether it is to click in for schemes or going online to register the movement of cattle. People have cattle going in and out of their holdings all the time. Farmers have shown themselves to be very capable of doing that. This is a once-off process that is a tick-the-box on that system.

Deputy Matt Carthy

Today, I realised a direct debit came out because I forgot to tick the box to cancel it, even though I reminded myself about 100 times. Sometimes people do forget. Let me ask the other way around-----

Deputy Martin Heydon

It is a process that only happens once or twice a year.

Deputy Matt Carthy

I will ask the question the other way around. A farmer from County Fermanagh travels to his local merchant who happens to be in County Monaghan. What happens in that instance when he purchases? What does the merchant in that instance do to record the fact that farmer has bought a quantity of fertiliser?

Deputy Martin Heydon

Ms Byrne can answer that. I just want to make sure there are no mistakes in terms of what goes on the record.

Ms Louise Byrne

In those circumstances the farmer is not obliged to register as a professional fertiliser end user. He will go to the merchant and buy the fertiliser, and the merchant in those circumstances is registered as a fertiliser economic operator and is obliged to submit returns to the Minister through the national fertiliser database. We will have information on those sales that are, in essence, outside of the jurisdiction.

Deputy Matt Carthy

So he will say, for example, he has sold 200 bags of fertiliser to somebody outside of the jurisdiction.

Ms Louise Byrne

Yes.

Deputy Martin Heydon

The whole process here is so that we can adequately show the information. We do not want to stop merchants in the Deputy's constituency in counties Monaghan or Cavan from selling produce if they have a customer who comes from Northern Ireland. As calculations are done about the impact of fertiliser spread, we need to be able to show and it is important we clearly say that something went outside the jurisdiction.

Deputy Matt Carthy

As I said, I support the objectives of this legislation. How will the Department know somebody who told a merchant they were from outside the State was actually from outside of the State?

Deputy Martin Heydon

The farmer from Fermanagh was not in the Republic. The farmer in the Republic has to register.

Ms Louise Byrne

Our expectation of how this will work in practice is that farmers will be registered as professional fertiliser end-users at the start and the identification number will be their herd number. Obviously a farmer from the North does not have to provide a herd number. To be honest, there is no definitive way we will know that, but we will have the overall data about fertiliser flows. We will seek to verify that data having regard to our risk-based controls under the nitrates action programme that my colleague Mr. Massey can speak about; under integrated controls division, ICD, cross-compliance checks; and also under the eco-schemes. The matter must be considered in the round and when we look at all of the data together we will be in a better position to assess whether there is full compliance with the database.

It is in everyone's interests to have full compliance. As part of our extension of the nitrates derogation we gave a commitment to the European Commission that we would have a national fertiliser database. From our point of view, it has many other significant benefits as this national fertiliser database will seek to achieve many of the objectives we pursue relating to our environmental and climate ambitions. We want a fully functioning system that is reliable and accurate. We accept any new system needs a period of bedding-in and we need to build compliance. We will actively engage with farmers. We have made the system as simple as possible to try to encourage regulatory compliance. We are learning as we go and are taking on board stakeholder views at our stakeholder committee.

Deputy Matt Carthy

I concur with Ms Byrne about the importance of doing this and of getting it right. It is a good phrase "to have a system that is fully functional, reliable and accurate". I contend it is not possible to do that on a partitionist basis.

Finally, I ask the Minister of State, Deputy Heydon, what interaction he has had at ministerial or official level with his sister department in the North. Why have we not sought to roll this out on a co-ordinated all-Ireland basis which would resolve all of the issues I have raised?

Deputy Martin Heydon

Detailed discussions and ongoing engagement have taken place between officials in the Department of Agriculture, Food and the Marine and the Department of Agriculture, Environment and Rural Affairs in Northern Ireland. I cannot speak on behalf of the Minister, Deputy McConalogue, who has responsibility for this area but I am sure he has discussed it with his counterparts as well. Ultimately, Deputy Carthy would like to see this done on an all-island basis. That would be the cleanest way to answer his points and it may happen in time, but for now we will work with the situation we have, in close co-operation and with the safeguards that have been outlined by Ms Byrne. Obviously, it is a different jurisdiction and we cannot force them to participate, but detailed discussions have taken place and I believe they will be open to it in time.

Deputy Matt Carthy

I agree with the Minister of State that the vast majority of people will adhere to this system and work to ensure it is fit for purpose because it is in the interests of Irish agriculture to have a system that stands up to scrutiny. The problem is some people will always try to circumvent some rules and the anomalies I have drawn attention to will allow that to happen, I would argue, fairly easily. Yet the alternative does not bear thinking about - that we would put a hard border in place for this, which is something that would be used by political opponents. We should only implement this aspect of the legislation when we have an all-Ireland framework in which it can operate. I believe, unless the Minister tells me otherwise, this is one of those areas where there would not be political opposition from within the assembly or Executive if we ever get it back up and running and that the soundings from the Department of Agriculture, Environment and Rural Affairs would be positive. We are talking about an all-Ireland agricultural sector that is equally important in County Fermanagh as in County Monaghan.

Deputy Martin Heydon

My understanding from the engagement we have had with officials in the Department of Agriculture, Environment and Rural Affairs is that they share our view on the importance and benefits of it. We have not received any negative indications such that the Deputy said he would be concerned about. They see merit in it. Obviously we cannot preempt what future administrations up there might do. Hopefully Stormont will resume sitting as soon as possible and have an active assembly that we can engage with more on a political level as well. They definitely see that.

I make the point again that there are significant penalties that will focus the minds of the very few farmers the Deputy talks about who might consider trying to breach this. I expect compliance to be positive but for those who do not comply, there are significant consequences.

Senator Tim Lombard

I will be brief as time is against us. Could the Minister of State give the committee the timelines for when this legislation on the nitrates action plan and other key elements will be enacted?

Deputy Martin Heydon

Ultimately we are in the hands of the committee which is carrying out pre-legislative scrutiny. We are in the hands of the Oireachtas. As Minister of State I would not in any way preempt how long it might take for the Houses to pass this legislation. However, we are all acutely aware, notwithstanding the concerns and challenges raised in the committee, of the impediment and the importance for farmers of passing this. A number of eco-schemes are due to commence on 1 January 2023 which might not be able to commence if we do not have this legislation in place and those schemes give farmers a number of options around liming, fertiliser, fertiliser application and different elements. Ideally we would like to see as much consensus as we can, resolve as many of the issues as we can and get the best possible solution to those that cannot be resolved, but ultimately we would like to get this legislation in place before the end of the year because that is critical. We heard earlier about the timelines for the NVPS but that is not within our gift and I will not second guess the role of Members of the Houses.

Senator Tim Lombard

Regarding the nitrate derogation, which is an important part of the picture, where does this fit in?

Deputy Martin Heydon

This was a clear commitment we gave as part of the derogation to the nitrates directive as it was for the other countries which are in receipt of the derogation.

Senator Tim Lombard

Can the Minister of State elaborate on the registers involved, including phosphorous, P, nitrogen, N, potassium, K, and sulphur, S? Are they all part of it? Will all compounds be registered or which ones will be registered?

Deputy Martin Heydon

For now it will be N, P, and K.

Senator Tim Lombard

Sulphur is not part of it.

Deputy Martin Heydon

That is correct.

Senator Tim Lombard

Is it planned to extend it to the other trace elements?

Deputy Martin Heydon

Yes, that may happen down the line.

Senator Tim Lombard

Smaller operators such as GAA clubs, soccer clubs or people growing potatoes in their back gardens do not have a herd number or the potential to get one. Where do they tie into this scenario?

Deputy Martin Heydon

Many are registered. Golf courses and the like are professional. Ultimately the definition relates to commercial activity. If someone is growing a few spuds in the back garden, that is not a commercial activity.

Senator Tim Lombard

I will give the Minister of State a scenario he is probably aware of regarding sand-based pitches. There is one in my parish. We need to apply nitrogen to that every six weeks to make sure the grass grows. Otherwise the grass will not germinate on a continuous basis. Sand-based pitches in the complex use a significant amount of fertiliser. How does the derogation apply to that?

Deputy Martin Heydon

Greenkeepers, golf courses, sports turf and similar operators are covered by this. They have to register as users. It depends whether the club purchases the fertiliser separately or if it is sold by the operator. An operator might offer an overall package where the club pays X amount of money for the process and part of the cost is for the fertilser.

It is the same as a farmer dealing with a contractor in that the vast majority of farmers will sell fertiliser on their own account, the contractor will collect it in the co-op, and it will be paid and charged to the farmer. In some limited instances, the contractor buys it or the local merchant has the contractor as part of it, and it is all one bill. The contractor is the end user in that case. It would depend on those circumstances for the GAA club and whether its members are buying the fertiliser themselves or whether they are the end user.

Senator Tim Lombard

To tease out my point, I will take a GAA club in my parish as an example that might use 3 tonnes a year. They will have to register now as an end user going forward.

Deputy Martin Heydon

That is my understanding, if they are purchasing the fertiliser themselves.

Senator Tim Lombard

Which they do.

Deputy Martin Heydon

I will clarify that for the Senator and come back to him on it.

Senator Tim Lombard

First, timelines are tight if we are talking about next April.

Deputy Martin Heydon

I will say again, there is a clear differentiation here in general terms between commercial activity and non-commercial activity. Therefore, somebody who goes into a chain of DIY stores and buys a small amount of fertiliser for their lawn will not have to register for this.

Senator Tim Lombard

Okay.

Deputy Martin Heydon

Somebody who is growing a few carrots or spuds out the back and is putting a very small bag of fertiliser on them, is not commercial activity. A golf course is seen as commercial activity; green keepers are included. I will come back to the Senator and to the committee to clarify the exact point in terms of a GAA club.

Senator Tim Lombard

I would not consider GAA, soccer and rugby clubs commercial activities. They are a club run by a parish and a parish entity. That clarification would be helpful because whether they fit into this criteria is one of the issues that came up in the past few weeks, in particular with the new technologies agreed over the last decade about going over to sand-based pitches, rightly or wrongly.

Deputy Martin Heydon

The Senator has raised a very valid point. As somebody who started out as a Deputy before pre-legislative scrutiny, the merit of this process I see is that we can tease through these issues and give absolute clarification before we get the legislative process underway properly. I will come back to the committee and clarify the specific point in relation to GAA clubs and soccer clubs, if the Senator is happy with that for now. This will clarify the differentiation between the likes of golf clubs, which are definitely commercial, and the others that are not. We will provide the clarity as to exactly where that defining line is.

Senator Tim Lombard

I thank the Minister of State.

Senator Paul Daly

I will be brief as most of the questions I intended asking have already been asked, that last question being one of them. I see the relevance and the importance of the Bill and I welcome it. We want to see it in action but there is a slight flaw in the sense that the register is going to record what a person purchases, not what is spread. I can see the Northern Ireland Border issue being a problem. It has been a problem throughout all our lives as where there is a border, there will always be something coming over or back across it that should not be and will never be recorded anywhere. If we get down to the environmental issues, there is also the amount of fertiliser that is spread on a particular square meterage of land. If you stockpile your fertiliser, if as a dairy farmer you have had a good year and you buy in a lot of fertiliser at the end of that year, nobody is ever going to know where or when it was spread or at what rate it was put on the land. Again, if the Minister of State is doing his environmental calculations and I have 100 acres and I buy the standard equivalent amount of fertiliser as somebody with 100 acres would buy, how does he know I am not putting all of that fertiliser on 50 acres and none on the other 50? From an environmental point of view, it is a problem that we will be recording what we purchase and not what we spread and where we spread it.

Deputy Martin Heydon

I accept the Senator's concerns and the points he has articulated very clearly. At the beginning of this process, there is a one-off opportunity or requirement of farmers to declare opening stock on their farm holding. The opening stock of those dairy farmers who had a high income and may have purchased some fertiliser at the back end of the year will be recorded in the beginning of the next year and the process will be there for farmers to register that. At the end of every year, there will be a closing stock record, we will also have the full detail of the sales and what was purchased from the merchants, and that will give the overall figure of what has been spread throughout the year. We will have the opening stock, the closing stock and what has been purchased throughout that 12 month period as well.

Senator Paul Daly

Does the Minister of State think that will work, again going back to the question on the Border?

Deputy Martin Heydon

We are putting safeguards in place. In every process there are always ways in which people might try and get around it and that is the reason we will have an inspection regime and controls and measures in place to act as a deterrent. What is also really important about this process is that it is easy to use. We do not need to add layers of complexity and red tape for farmers. We have to recognise also that this tool will be a big addition to farmers. I say this as a farmer myself.

(Interruptions).

Deputy Martin Heydon

I take on board the Chair's guffaw.

Chairman

We are told every time it will get simpler. I have yet to see it happening anyway.

Deputy Martin Heydon

The general principle of the system is that the reporting burdens are being reduced here and this system is about making life easier for farmers. It is to all of our benefit that we do this and have a better handle on how much fertiliser is spread here. We will definitely have a much clearer picture on that with this process in place than we have to date.

Also, the Senator talked about how much fertiliser is spread. When we get this legislation in place before the end of the year, this mechanism will allow an eco-scheme that rewards farmers for precision spreading and make sure we are doing that better. Looking at it in the round, everything we are doing cumulatively is about assisting farmers and it is to all farmers' benefit not only to have a better handle on this but that we see an improvement in water quality across our country and improved nitrate reviews down the line. It is in all our benefit that we get this back the right way and I am confident the system will work well.

Senator Paul Daly

I hope it does but I have reservations. I would prefer if there was some way of monitoring what is actually spread rather than what is purchased. With the border issue, there will be opportunities for a very intensive farmer, who will have a neighbour or family member who might not be near as intense, and they will put fertiliser on their register. That potential is there. I am not saying they will and I am not denigrating people or practices, but as long as you are only recording the purchase and not what is actually being spread on a particular holding, there are a few windows of opportunity there for it to be abused.

Deputy Martin Heydon

With the Chair's indulgence, I will bring in Mr. Massey on that point.

Mr. Ted Massey

The Senator's points are very valid. There will always be people who will try to exploit certain circumstances but as the Minister of State has said, that is why we have a system of on-the-spot inspections and on-farm controls. Our inspectors go out on the ground to verify things are correct. If the legislation progresses and we get the database in place, those controls will feed into that and verify the quality of the data we have in the database itself. We are looking at risk-based controls at merchant level and at farm level to ensure we have a robust database that will deliver what it is intended to do.

Chairman

I apologise for my utterances but we are being told for a long time that things are going to be simplified and red tape is going to go out of compliance issues but in actual fact, each year brings more. I agree that this fertiliser register is necessary but it will create more bureaucracy and paperwork and that is unfortunately a consequence of it.

Deputy Martin Heydon

Can I make one wrap-up point on that and take on board that sentiment felt strongly by farmers. I argue that on the fertiliser side of things, this will reduce the reporting burden on farmers, but also-----

Chairman

I am sorry but we did not have to report about fertiliser up to now at all.

Deputy Martin Heydon

Not only in relation to that point but on the earlier point we discussed in the first two and half hours of this meeting, there is the bigger picture here. It is not just about what is the most convenient for farmers today or tomorrow. It is about protecting this industry and future-proofing it.

Chairman

No, I have no argument on that. I accept the reason it is being done but it is not reducing bureaucracy.

Deputy Martin Heydon

Farmers keep records under the nitrates directive. They are used to that reporting requirement.

Senator Tim Lombard

Those in the nitrates derogation have to produce documentation every year to show what was spread, what was in the closing entry each year and for the following year. On that point, can the Minister of State explain where this legislation is going to fall in terms of the need for that to happen and the work that is required? It will be a major change for farmers and particularly for the cohort who are tied up in actual derogation itself. Will the Minister of State clarify that point if possible?

Deputy Martin Heydon

Mr. Massey will answer that very valid point about derogation farmers.

Mr. Ted Massey

As the Senator is probably well aware, derogation farmers are subject to increased requirements. Every year they are obliged to submit details on their fertiliser purchases and use, closing stocks and the like. At the moment that imposes a significant burden on those farmers because they have to gather paperwork, go to their adviser and upload the information onto a system. This new provision will streamline all of that and all of the data will be on the system. The farmer will be able to look at the system and see what information is stored. There will be a record of all purchases and the nutrient concentration in those purchases. If we can get to a point where we have a reliable database, then we can say to farmers that there is now no need for them to engage in an administrative burden and paper-based record-keeping system.

Senator Tim Lombard

The technology used on farms has changed how we operate over the past five years. For example, an app allows farmers to register a calf on the system within an hour of its birth. This new system will be on the Department's software. In time, will there be a link to the information apps in order that we can have updated information every month where this information is going to sit?

Ms Louise Byrne

With this technology we must walk before we run.

Senator Tim Lombard

So that is nose up.

Ms Louise Byrne

Stakeholders have called for this data to be available in real time, thus making it accessible by farmers. We are saying this is a new system and we must bed it in. The data will come into the national fertiliser database and, primarily, the information will be fed in by the fertiliser economic operators. Let us walk before we run and over time the data will be given back to farmers. At the moment the information is in the form of reports on the system. As time progresses and once we have the system bedded in, we can then look at other opportunities for sharing that information. A farmer will always get access to his own data and a merchant will always get access to the data on fertiliser that he or she sold. Over time, that is where we want to get to so that the new system will be useful for farmers to use to inform their management decisions on their farms.

Chairman

I thank the Minister of State and his officials for participating in this meeting, which has been a long session. The next public meeting of this committee will take place on Wednesday, 12 October at 5.30 p.m., when the committee will continue its examination of the peat supply in the horticulture sector. As there is no further business, the meeting now stands adjourned.

The joint committee adjourned at 10.13 p.m. until 5.30 p.m. on Wednesday, 12 October 2022.