EU Regulation on Veterinary Medicinal Products (Resumed): Department of Agriculture, Food and the Marine

The purpose of this meeting is to discuss EU Regulation 2019/6 on veterinary medicinal products, which will apply in all EU members states' jurisdictions from 28 January 2022. The joint committee published a report on the regulation of veterinary medicines earlier this year. It put forward ten recommendations, observations and conclusions and highlighted issues regarding responsible persons, possible anti-competitive practices and costs to farmers. Today, officials from the Department of Agriculture, Food and the Marine will be updating us on veterinary medicine regulations. We are joined by Mr. Rob Doyle, deputy chief veterinary officer, Dr. Paul Corkery, senior superintendent veterinary inspector, and Mr. Peter Collins, assistant principal officer. They are all welcome. The officials will have ten minutes to make an opening statement before we move to questions and answers.

Before we begin, I have an important notice on parliamentary privilege. Witnesses are protected by absolute privilege in respect of the evidence they are to give to the committee. However, if they are directed by the committee to cease giving evidence on a particular matter and they continue to do so, they are entitled thereafter only to qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter in these proceedings is to be given. They are asked to respect the parliamentary practice to the effect that where possible they should not criticise nor make charges against any person, persons or entity by name or in such a way as to make him, her or it identifiable.

I call on Dr. Corkery to make his opening statement.

Dr. Paul Corkery

I thank the Chairman, Deputies and Senators for inviting the Department today. I am joined today by our director, Mr. Doyle, and Mr. Collins, assistant principal officer, both of whom are engaged in the policy and proposed implementation of the veterinary medicinal products regulation 2019/6. We welcome the opportunity to appear before the Joint Committee on Agriculture, Food and the Marine to provide updates and contribute to its discussions on the new regulation, which will come into force in January 2022.

The Department is conscious that the legislation is complex, and that regulation of veterinary medicinal products is itself complex. It is important to recall that the main objectives of these new regulations are to free up availability of veterinary medicinal products across the EU, while also introducing some additional controls to address the clear evidence of the sustained escalating resistance to certain veterinary medicinal products. Highlighting the additional controls which Ireland is implementing to address this global concern only helps to provide greater international market confidence in Ireland’s ability to produce the safest, highest-quality exports from its agriculture sector. As members will know, Ireland exported some €14.2 billion worth of agrifood in 2020 - with dairy produce at €5.1 billion and beef at €2.3 billion. The Irish agrifood sector makes a significant contribution to employment, accounting for 7.1% of total employment, especially in rural and coastal areas. This equates to 163,600 jobs. Meeting the higher level of controls in the EU veterinary medicines regulations will be pivotal to Ireland's ability in maintain these agribusiness employment and food export figures.

In ensuring that all concerns associated with the various elements and processes required or introduced under the new regulations have the opportunity to be considered, the Department has undertaken extensive stakeholder engagements since 2019. These are ongoing. We have met regularly with the multiple representative bodies in the sector, representing farmers, licensed merchants, pharmacists, veterinarians, co-ops, dairies, wholesalers, feed mills, educational groups and software companies. We have listened to their concerns, researched suggestions they have made as to possible options and included their suggestions in our planning for the implementation of these new regulations wherever possible. However, some suggestions were not legally feasible. We have also established regular contact and information-sharing links between Department officials on both sides of the Border. The Department is working on enabling the continuation of all retail outlets, and associated jobs, available to farmers, thus supporting competition in the marketplace and jobs in rural areas. We are ensuring farmers have control over where they purchase antiparasitics, as they did heretofore, notwithstanding that some of them will be prescription only. We have worked with stakeholders on a range of activities to reduce and reverse, wherever possible, the increased resistance patterns in both antibiotics and antiparasitics for the benefit of farmers and society. We are working with the Health Product Regulatory Authority, HPRA, to maximise the availability of veterinary medicinal products on the Irish market. We are working with the Veterinary Council of Ireland, VCI, to ensure alignment between our respective regulatory functions in the context of these new regulations.

Department officials have been before this committee on this matter on two previous occasions. In that context, I do not wish to repeat much of what members have already considered. However, the Department welcomes the committee’s recent comprehensive report on the matter and we appreciate the opportunity today to discuss the recommendations, observations and findings of the report, along with the chance to provide updates outlining the progress made in the intervening period on related matters pertaining to veterinary medicine regulation in Ireland. The committee’s report highlighted the importance of the role licensed merchants and veterinary pharmacists play in rural Ireland in particular and recommended this continue. The Department wholeheartedly supports this view and wishes to assure members that all existing retailers of veterinary medicines, including licensed merchants and veterinary pharmacists, will continue to be legally permitted to sell anti-parasitic medicines, as well as a whole range of other veterinary medicinal products they currently sell, as they have done heretofore. It is the Department’s view that responsible persons employed in licensed merchants, veterinary pharmacists and veterinary practitioners will all continue to play an important advisory role in supplying veterinary medicines to farmers thereby safeguarding animal health and welfare, public health, and supporting jobs in the agriculture sector.

When Department officials last appeared before the committee in February, legal advices were awaited from the Office of the Attorney General on the issue of the availability of the derogation in article 105(4) of the EU regulation. Those comprehensive advices were subsequently received within the Department on 12 April and the outcome was subsequently shared with this committee and the anti-parasitic resistance stakeholder group. This confirmed that the derogation provided for in Article 105(4) is not available to Ireland. This means that only registered veterinary practitioners may issue a veterinary prescription in Ireland. Veterinary practitioners have a key role to play in seeking to mitigate the problem of resistance to both antibiotics and antiparasitics. In that context, the VCI is the independent statutory body that regulates the practice of veterinary medicine and veterinary nursing in Ireland. The VCI is reviewing its professional codes of conduct. These are the rules that veterinary practitioners and nurses must comply with in order to practice veterinary medicine and veterinary nursing in the State.

The objective of the code is to ensure a consistent ethical and professional provision of veterinary service in the public interest.

This updated Veterinary Council of Ireland code, which takes into account various elements and objectives of these new regulations, is currently open for public consultation. In the draft code, it is set out that in order for a veterinary practitioner to prescribe veterinary medicines, including antiparasitics, they must have established a relationship with a client or farmer. This is defined as an agreement between an animal owner or a keeper of animals and the veterinary practitioner or practitioners within a veterinary practice to provide veterinary services that demonstrate real and ongoing clinical veterinary practitioner or animal contact at the owner’s farm premises. This is designed to ensure that the best prescription choices are made in respect of the animals to be treated for the benefit of the animal, its owner and indeed wider society, mitigating the risk of the continued development of resistance to antibiotics and antiparasitics. The draft code recognises that farmers may choose to have, and often do have, such working relationships with more than one veterinary practitioner.

As highlighted by the committee, greater access and choice of veterinary medicinal products for farmers, along with maintaining fair competition of products, is hugely important to ensuring retention of competitive veterinary medicine supply channels such as licensed merchants and pharmacies. The Department’s objective is to place the farmer at the centre of decision-making as to where he or she purchases antiparasitic medicines and any other relevant veterinary medicinal products through the introduction of a national veterinary prescription system, NVPS, which is currently being developed. Without going into the technical details, essentially veterinary practitioners will electronically issue a prescription for animals under their care to a centralised Department system. Prescription details will then be made available to farmers by email or text. The farmer can then produce the prescription ID details contained in the email or text to the dispenser of their choice, be that a licensed merchant, a pharmacist or co-op, or indeed from the prescribing vet if they so choose. This will allow greater access and management of prescriptions as required. The introduction of the system provides the farmer with greater control over where they choose to purchase their medicines from.

All dispensers registered for the NVPS will have equal access to dispensing antiparasitics. As per recommendations of this committee, the system is currently being developed to allow for alternative or generic products, based on the active substances detailed on the prescription, to be dispensed as an alternative to a named product, as necessary. This is a welcome suggestion by the committee and one we are happy to be able to deliver on for the benefit of Irish farmers and retail suppliers alike. This will likely reduce costs to farmers and provide more choice and opportunities to retailers in the area.

While acknowledging the increased global risk of resistance to antimicrobial and antiparasitic veterinary medicinal products, the Department is acutely aware of the economic burden of parasites on Irish agriculture in general. A recent scientific paper suggested that this burden could be in the region of up to €237 million per annum. In order to support the farmers and agribusinesses potentially impacted by these factors, the Department has in the past and continues now to provide and develop support schemes such as the sheep welfare scheme and the beef environmental efficiency programme, BEEP, which include faecal egg counting for some of those parasites. The Department is currently working to develop a further antiparasitic measure to be introduced under the targeted advisory service on animal health scheme to assist farmers.

In growing the awareness of the issues surrounding resistances, the work of Ireland’s national action plan, INAP, on antimicrobial resistance stakeholder group and the antiparasitic resistance stakeholder group are both informed by extensive work plans. Each plan consists of a range of measures which aim to educate all actors in the production chain on addressing both antimicrobial resistance and antiparasitic resistance. Appropriate strategies will be implemented to deal with each kind of resistance. The INAP group only recently met while the antiparasitic resistance group will meet again in the near future. Between meetings, work continues in following through on the extensive action lists.

In addressing the recommendation in the committee report on the issue that is known as decoupling, which is breaking the link between the prescriber and dispenser, the Department sought legal advice on the issue. The advice received was that for such decoupling to be permissible, a sound evidential basis in veterinary medicine is required to justify any partial or full prohibition on veterinarians selling the veterinary medicines that they prescribe. Such decoupling could not be solely for the purpose of economically assisting one sector of an industry over another. This would be seen as providing state aid to one sector over another and is not allowed. The Department’s view is that there is an absence of such sound veterinary medicine evidential basis and, therefore, decoupling is not an option legally available to us. This aspect was also considered by the European Parliament during negotiations on the regulations in 2014 and it concluded, similar to the Department, that there is no substantive evidence which shows a correlation between decoupling and improved animal or human health, or a reduction in resistance development. The Department shared the outcome of these advices with members of the antiparasitic resistance stakeholder group in advance of its meeting on 15 April.

The Department noted that the committee also raised concerns about access to veterinary practitioners. We also note more recent commentary on this matter. While this concern is not directly linked to the introduction of the new veterinary medicinal product regulations, EU Regulation 2019/6, the matter was addressed as an action arising under the national farmed animal health strategy. The Department carried out research and analysis into the distribution and accessibility to farmers of large-animal veterinary services in rural Ireland. The outcome of this analysis was relatively positive, in that it identified that large animal veterinary services are available within 20 km to more than 95% of Irish livestock farms. While the provision of veterinary services to members of the public in Ireland is a private sector activity, nonetheless the Department will, from a public policy perspective, continue to monitor this position closely, recognising that it is critical that Irish farmers are adequately supported with the provision of veterinary services in the best interests of animal health and welfare.

I thank the Chair and the committee for the invitation to speak today and we are happy to address any questions the committee may have on the topic.

I thank the representatives of the Department for their attendance. I will make four or five statements, coupled with questions. Perhaps I will go through them all at once because some of the answers may be interlinked and if we go over and back, we may get bogged down in one issue and I will not cover the others.

This regulation was introduced in Europe on 27 January 2019. It is now 6 October 2021 and the regulation is due to be enacted on 22 January. How did we get here with very little progress made? Two and a half years, or more, have passed. We are now at the eleventh hour and we are still talking about it, with no concrete, definitive solution on the table. How did that happen? How did we get here?

I would like our guests to elaborate and answer a few questions on a couple of points arising from their submission.

They continually refer to extensive stakeholder engagement. Can they confirm that the last stakeholder meeting was in April, which is five months ago? What progress in finding a solution to this problem has been made since April without any further negotiations with the stakeholders? I find it hard to believe that they would believe there has been extensive stakeholder engagement when we are reaching the eleventh hour when it comes to decision-making and there has not been a meeting in six months.

What is the Department proposing in its national veterinary prescription system? Is it a one-off prescription for the year? When is it done? Will there be a charge to the farmer? What costs are associated? At this juncture, on 6 October, do the officials believe that even if all stakeholders, farmers, merchants, pharmacists, vets and departmental officials are happy with that system that it could be operational by 22 January? I have monitored progression on this issue very closely since the outset and have had contact with stakeholders from all sides. The word on the street is that the vets are not buying into this. Without the vets buying into it, it will not happen.

What solution can we come up with? The vets are saying they do not have the technology. Can the technology be developed and in place in every veterinary practice by 22 January? I do not think so. They do not have the staff to provide the service especially during calving times and during peak seasons. Even if every other stakeholder were happy, the vets are saying they could not implement this by 22 January. In that scenario, what happens on 22 January?

I ask the officials to comment on their legal opinion on decoupling especially from a European perspective. Decoupling exists in Sweden and Denmark and it has been proven in all analysis that they have achieved the best rate of reducing antimicrobial and antiparasitic resistance. I am not promoting decoupling or suggesting it may be the best solution, but it certainly should not be taken off the table when it has been proven to be the model that is working best in other European countries where it has been enacted.

While we can argue and say it is illegal, we know if this is not solved properly, we will have an influx of product from the North of Ireland under the shelf, down the back roads illegally. It is going to happen; the dogs on the streets will know about it. On numerous occasions the Department's submission stressed that we need to be seen to be portraying the best-quality traceability and best production processes for the beef and other food we are exporting. Once Bord Bia's customers throughout the world realise that there is not an all-island health policy in Ireland and that product can be brought, albeit illegally, from one jurisdiction to another, more than likely administered and for obvious reasons because of where it came from not recorded in any traceability procedures, that will ring alarm bells with our customers all over the world. That will do our product much more harm than the good we are trying to achieve here. I ask the officials to comment on that.

Dr. Paul Corkery

For ease, I will answer the Senator's questions in reverse order. Regarding the North and the South, it is clear in the regulation that a veterinary prescription can be filled within the community. The way that we understand that is that an individual must be there in person with a veterinary prescription from their own member state. Vets here in the South may work in the North as well but in order to work legally in the South they must be on the VCI register of vets.

What Dr. Corkery is talking about is going the legal route. If a farmer is going to the North, they are not going the legal route; let us call a spade a spade. No vet will be involved. A farmer will walk into a licensed merchant in the North, buy a gallon of dosing liquid, put it in the boot of the car and come home. It will be administered and not recorded. That is what I am talking about. I am not talking going to the North and doing it legally.

Dr. Paul Corkery

I am saying it is not legal for an SQP in the North to provide a prescription to a person in the South. People can go up there and get product, but it will be illegal to use the product down here.

I prefaced what I said by saying that I knew it was illegal. However, we need to try to put up the barriers at the earliest juncture possible to avoid illegal trading. The point I am making is what we are doing here is promoting illegal trading.

Dr. Paul Corkery

As I said, we are working with the authorities in the North to ensure that does not happen. We have our own traceability system, our usage requirements and recording requirements. We also have our Bord Bia quality assurance inspections to make sure. In addition, we have residue checks. There are very serious consequences for a farmer found to have any of those residues. We regularly check those randomly on farm, at slaughter plants and where we have any suspicion of illegal activity.

Would Dr. Corkery not agree none of that would be necessary if we had a common all-island animal health policy, which we are striving for? If this were part of that, it would not be necessary to do any of that.

Dr. Paul Corkery

I spoke to my colleagues about it earlier. We are moving in the community towards having a harmonised model in these regulations. It is not a cliff edge. By 2027 all the products that exist in all the member states must be on a centralised system, called the Union product database. The European Union is moving towards having harmonised medicine availability throughout the whole community. In time, not only will we have it North and South, but we will have it throughout the entire community. We will have a harmonised set of veterinary medicinal products throughout the community.

Dr. Corkery is right in the question Senator Paul Daly asked him. We are talking about Northern Ireland, which is now outside a harmonised EU structure. The Senator asked how we will deal with that.

Mr. Rob Doyle

I might take that question. I thank Senator Paul Daly for the question. We understand that in many areas there is a difference between the North and the South. It is a risk anywhere a border exists. In addition to what my colleague, Dr. Corkery, described, we also have the official control system where we have on-farm inspections. Farmers are inspected and we also have the residue sampling. The penalties for being found with a medicine that is not legal are draconian. There are really serious penalties, including exclusion of animals and product from the food chain.

I am not talking about illegal medicines. I am talking about the very same product that I can buy locally but just buying it in the North. The product is not illegal but where I buy it is illegal. I am talking about using the very same product, but it is a question of where I source it.

Mr. Rob Doyle

I understand the question, but if someone buys a legal product up North and uses it down here, it is still an illegal use. If a farmer has a residue for Trodax or whatever, they will be required to have a prescription for the supply of that veterinary medicine. If they are unable to supply a prescription for it, that is an illegal use of that veterinary medicine.

I beg to differ on that.

Dr. Paul Corkery

I will move on to the second last question the Senator had about decoupling. He mentioned Sweden and Denmark. One of the differences in Sweden and Denmark is that a farmer must nominate a single veterinary practitioner and must have a contract in place with them. Therefore, there is no room for competition in that regard. In some of the other countries - it is probably better not to mention them - the usage levels are far higher than they are in countries without decoupling. That is what the European Medicines Agency provided to the European Parliament. Every member state is obliged to provide data on the usage of antimicrobials within that country. Countries are ranked based on the usage, on a fairly complex system, based on the amount of biomass of animals they have.

Ireland ranks favourably in that rank order but some of the countries that have decoupled do not and that is the analysis the Parliament took into account. It said that it cannot show a benefit here collectively when we look at some of the bigger countries that have decoupled. There is no antimicrobial resistance benefit for humans or animals.

Is it not true to say that Sweden and Denmark have the best results?

Dr. Paul Corkery

They have. They have a different system from here and they have decoupling. As I said, however, decoupling is not the only factor. The real reason we cannot use it here is that the legal opinion is that it would amount to state aid. One cannot do it unless one has a justification on veterinary grounds and because of those figures I spoke about, that justification just is not there.

Are new state aid rules not common across the entire Union? How can they do it in other countries?

Dr. Paul Corkery

They did it before this regulation came into effect. I will go back to the first question of the Senator's that I can recall. If I am not mistaken, he asked why it has taken us so long to get to where we are. The Senator might look at the European Parliament debates, which happened back in 2014. This is substantial legislation that is going through, which is bringing in big change, especially with regard to the harmonisation of products. It will make it much better for smaller markets such as Ireland to have availability. We sometimes struggle to get certain products in our small market. Some of the players are not interested in the market because it is so small. That is why we have a system of animal remedies licences through which we can allow products in form other member states. With this new legislation, that will not be required as much because we will have more access to products. The process is still under way, however.

The regulation was signed on 31 December 2018 and then it had to wait a month so we were into 2019. It is, therefore, in force but it will come into effect next January. If one looks on the European Commission's website, more than 20 delegated and implementing Acts are to be put in place to give effect to this regulation and we are only halfway there. Recently, there has been a delay with one of them and we were very satisfied that it actually went through one of the delegated Acts. It went through a scrutiny procedure in the European Parliament. It was in relation to the antimicrobials that are going to be designated for human use only. They are going to be taken out of the animal health sphere. Thankfully, it is going to be a scientific-based process. The European Centre for Disease Prevention and Control, ECDC, the European Food Safety Authority, EFSA, and the European Medicines Agency, EMA, will provide scientific justification for taking out an antimicrobial like that. That is one example of an Act that has yet to go through. An implementing Act on a model prescription also has to come through. It likely will not be there before 28 January next year. Within the regulation itself then, not everything comes into effect on 28 January next year. There are certain parts of it that are phased, for example-----

With respect, I am concentrating on the dispensing of antiparasitic medicine. Where are we on that between now and January?

Dr. Paul Corkery

We are going to maintain all the existing retailers. We are, therefore, going to use the national veterinary prescription system, NVPS, which my colleague, Mr. Collins, will talk about in a second. We are going to maintain that. We are going to have that up and running in January to facilitate the sale of antiparasitic medicines.

That is irrespective of the point I made that veterinarians will not have the technology and software.

Dr. Paul Corkery

We will be providing the access portal. Perhaps at this juncture I will hand the Senator over to-----

Dr. Corkery might comment on my question about the stakeholder engagement.

Dr. Paul Corkery

Yes. The Senator is right. The last time we met with the antiparasitic stakeholder group was in April. At that stage, we gave it time to consider the legal findings of the summary we shared with it from the Attorney General’s Office. Within the Department, we are advancing all fronts insofar as we can. There has been much activity in the Ireland’s national action plan, INAP, on antimicrobial resistance stakeholder group and only recently, the Minister launched the implementation committee, which many of the stakeholders on the antiparasitic group also attend.

I know but I am quoting the Department's report which states that it has had extensive stakeholder engagement. The decision is down to the eleventh hour and there has not been stakeholder engagement since April. With the greatest of respect to Dr. Corkery, that says a lot.

Dr. Paul Corkery

With respect, we have 22 various stakeholder groups in relation to this legislation on veterinary medicines, which we are bringing on and advancing. One of the key reasons we did not have a meeting with the antiparasitic stakeholder group is that a delegated Act on good distribution practice is about to go through. It has only just gone through and we are waiting for the scrutiny period to expire. Until now, medicines were regulated in terms of good distribution practice up to the wholesaler level. It is now extending right through to the farm, therefore, there are changes that are relevant. We did not really have anything new since April to bring to the group, if that answers the Senator's question. I will hand over to my colleague on the NVPS.

Mr. Peter Collins

I thank Senator Daly. It is good to know first of all that people are actually taking notice of the NVPS. I welcome that. Second, I will just say that the development of the NVPS is part of the Article 57 requirement whereby member states must submit data on sales usage and actual usage of antimicrobials in the member states.

Part of the solution that has also been developed is to introduce competition for all prescriptions across the market in Ireland. It is hoped that all stakeholders will remain within the sector and be able to buy their medicines wherever they wish to get them. That provides greater choice for farmers in the area of where they can get those medicines from. That is in development. That is what we are hoping to achieve in developing the system.

As the Senator said, some veterinarians have been saying they will not go live and are not buying into it. We have had multiple stakeholder engagements. I know Dr. Corkery mentioned stakeholder engagements but, again, this is across the sector. We have spoken to licensed merchants, co-operatives and multiple feed mills in the last week or two. We have had focus groups with all the veterinarians. A number of veterinarians are developing their own systems as well and we are trying to integrate the system with those at the same time. Veterinary Ireland has been in as part of the procedure of looking at the system we have developed to date.

At the moment, it is a free-to-use software solution. It will be an app or a tablet. We are currently not installing any software into practices. They will be able to download and use the app themselves. We know that 82% of veterinarians out there are not currently using prescription software to generate prescriptions in the market, although 18% of them are. We are looking at providing the system and hope to have it go live in late January-early February. People will be able to log on to the system. Many veterinarians were working with software companies in the background. These are veterinary software companies. We are also talking to the dispensing software companies about their point of sale software. It is, therefore, all quite complex in trying to get the integration. If veterinarians are using the software providers they have at the moment, they will not know that they are interacting with the NVPS system. The integration will be going on in the background. Similarly, when the point of sale software is loading and when they log on at their front end, it will bring back the information into their front-end system. They will not, therefore, know they are logging onto the NVPS system at the time they are actually using it. We are, therefore, well advanced in the development of the system.

I know the Senator said they have not been buying in but they have all been engaging with us in the development and testing of the system. We are hoping to carry out testing of certain elements of the system in terms of the prescription and dispensing modules and search elements in the next four weeks. We hope certainly to go live at the end of January. At the moment, we are considering the transition phase. We are at that cliff edge where if we just shut off all paper scripts, which are currently in use, it might not be the best practice. We are, therefore, looking at introducing a temporary transition phase where people will be able to transition to the electronic system and similarly use the paper system at the same time.

I asked if it was up and running and if everybody was happy with it. Is it prescription per incident or an annual prescription? Does a person have to contact his or her veterinarian every time he or she needs a prescription?

Mr. Peter Collins

Is that for antiparasitics or for all veterinary medicines? Every single veterinary prescription written will be expected to be sent to the NVPS system.

But a farmer will have to contact a vet. If a farmer wants to dose his or her cattle today, he or she needs to contact a vet to get a prescription. If a farmer has a sheep with maggots tomorrow and needs antiparasitic boron, he or she needs to contact the vet again. Does a farmer have to get a separate prescription for every transaction?

Dr. Paul Corkery

It does require an element of forward planning. However, the VCI has said that the prescription can last up to 12 months. There are many different antiparasitics, including repellants for blowfly such as Clik. A farmer will have a record of what he or she purchased and will know what he or she will likely need for the next year. It is a production process that is well embedded in the system. The farmer knows the time of the year when he or she needs fly tags or Clik, but he or she can ask his or her vet for a prescription for all those products in one go when he or she chooses. The vet may be on the farm for a different reason and the farmer may ask about treating a sick animal - maybe not an emergency call at night. The Senator understands what I mean. It can happen prior to-----

I understand what Dr. Corkery means but I cannot see how it works. Can any of the witnesses tell me how many prescriptions merchants or pharmacists receive for a product that is a prescription-only medicine?

Dr. Paul Corkery

We know they receive several thousand for lactating dry cow therapy-----

That is just one product. What about other antimicrobial products?

Dr. Paul Corkery

I met recently with the Irish Co-operative Organisation Society regarding prescription vaccines. Most of the products licensed merchants sell outside the vaccines that do not require prescription require a prescription. They are allowed to sell antifungal agents, which are on veterinary prescription. They definitely receive prescriptions.

It is minimal.

I thank the officials for coming before us. They spoke about co-operatives, merchants and vets. Have they met the responsible persons?

Dr. Paul Corkery

The responsible persons work for the licensed merchants-----

I know that. Have the witnesses met them?

Dr. Paul Corkery

As a group, we have not met the responsible persons. In some cases, we may have. Some of the licensed merchant representatives who represent the various companies are actually responsible persons themselves. It would have been open-----

Have the witnesses met the responsible persons around the country and have they looked at the impact on their careers and livelihoods, as distinct from their employers, be they co-operatives, vets or merchants?

Dr. Paul Corkery

We have. One of the things that people-----

So the witnesses have met them to go through that.

Dr. Paul Corkery

We have met with their organisation. It is open to the organisation to put forward-----

If they are working for me, it is my business I am looking at, not them. I am talking specifically about them. Have the witnesses met the body of people referred to as responsible persons? Basically, they are the people who are have authority to give the products out. What is the impact of this on them as a group?

Dr. Paul Corkery

No, we have not.

Does Dr. Corkery not think that this is not great for consultation?

Dr. Paul Corkery

We will consider meeting with them-----

Yes, but the door is closed at this stage. Let us be honest. We heard back from the veterinary side of it three or four months ago that the game is up and that the Department was driving on with it. There is no point in doing it to say "Well, we met this one and the other one". There is no point doing it at the last minute. This should have been done months ago. As I listened to Senator Paul Daly, it was astonishing to hear that last May was the last time other groups were met.

With less than four months to go and in the unlikely event of the e-prescribing system being ready, my understanding is that vets are allowed to upload up to five days after dispensing? Is this correct?

Mr. Peter Collins

The regulation-----

The e-prescribing system is probably not ready. From everything I have read, it is my understanding that vets will be allowed to upload up to five days after dispensing.

Dr. Paul Corkery

The regulation states that antimicrobial medicines must be dispensed within a five-day period. It is very prescriptive regarding the time from when the vet writes the prescription, to when the product is dispensed. That is for antimicrobials only. It is not for antiparasitics.

Regarding uploading, this is why I handed over to my colleague. There is no decision in respect of that. We do have-----

It is our understanding that they are being allowed to upload up to five days after dispensing. Is this correct?

Mr. Peter Collins

After dispensing, they are allowed to upload so that is recording the information on the system. If that has happened, then the medicine has actually been administered or presented to the animal's owner. We will be providing timeframes to allow people to upload the recording of that prescription information to the system. The idea behind the system is that it will allow non-dispensed medicines to be available immediately to people from whatever outlet they see fit to use but if it is dispensed already, it is not the case that it is needs to be immediately uploaded onto the system.

Does this not present a scenario that prevents anyone other than a vet from dispensing medicine? Is it not correct that it eliminates anyone other than a vet?

Dr. Paul Corkery

What that means is that someone is obliged to record the dispensing. As a result, it also applies to licensed merchants. It applies to anybody who needs to record on the system that he or she has dispensed a product. This means it applies to all retailers equally. They must all put the products up. We are not saying that they must put the information up immediately after they sell a product. We are giving them a period during which they can put it up, which I think is standard practice across many systems. Let us say they dispensed a product just before closing time on a Friday evening. We do not expect that information to be on our database at that moment. As I understand it, we are giving them five days.

Mr. Peter Collins

The distinction is that non-dispensed medicines need to be up on the system immediately to allow people to be able to dispense them, but if they are dispensed, there is no immediate need for them to be up on the system. The dispenser is not going to be able to dispense because it has already gone but if the vet has not dispensed that medicine - he or she has written the prescription and is the only person who could write it - he or she needs to upload it to the system immediately.

Would it be fair to say that the document received by some of the bodies that gave the Department a legal opinion was a two-liner and that the Attorney General did not agree with it? Why was the full document not given to those people when they were good enough to give the Department a legal opinion?

Dr. Paul Corkery

That was the instruction that came from the Office of the Attorney General.

In fairness to anybody trying to put forward their case to it, they were good enough to give the Department a legal opinion. Should the Department not be good enough to give them the opposite legal opinion in detail to allow them to study it? Why was this not done?

Dr. Paul Corkery

As I understand it, this is standard practice with legal opinion. It is for the person who seeks it.

It is very easy to write a two-liner and say that Michael Fitzmaurice does not agree with something.

Dr. Paul Corkery

I can assure the Deputy that it is not a two-liner.

I have been informed that it is a two-liner. Considering how close the Border is, are our guests concerned that, with the different set-up in different areas, a problem will arise whereby certain farmers will get stuff across the Border whether we like it or not?

Dr. Paul Corkery

As we said already, we are sure that it is completely illegal to use a product here that has not been prescribed here. Products can legally be sourced in the North, if one has a valid prescription from the south. That must be done in person.

That is okay. Let us consider a farmer with a herd of five, ten or 15 suckler cows in the west or in any other part of Ireland. A farmer with 50 or 60 sheep will be affected more. Say a vet comes to do a herd test for me once a year and I tell the vet that I give them a fluke dose either before or after they go out in June or July and another two weeks after they have come back in. On the day of my herd test, can I get all of the dosing for fluke and worms? Can I get all of that, or a prescription for all of that, when I explain to the vet my pattern each year? Can I get a prescription that day or will I have to go to a vet on different occasions and get a piece of paper? I am not talking about pneumonia drugs or anything like that. I am talking about fluke and worm doses and Clik Pour On, to which our guests referred earlier. I am talking about the run-of-the-mill stuff I need during the year. Can a vet give me those prescriptions on the day of a herd test? Why was it not brought in that the vet had to give it compulsorily?

There is an awful problem arising here that our guests do not see. A farmer could be going to the co-op or the local merchant to get their dosing material. There is an embarrassment involved here that if someone does not get it from the vet, they will be looking over your shoulders. Whether we like that or not, that is the way it is. Farmers are now being driven into a corner because they have to get these products from a vet and, in many cases, at much dearer prices. Is a farmer entitled to get all the full pattern of what they need for the year on the day of their herd test, if they want it?

Dr. Paul Corkery

I will go back to the 18 suckler animals or 30 sheep that come back in. The one thing I am most afraid of is that the farmer will get relatives, family members and hire-in labour to help bring in the herd and dose it to no avail. My fear is that there is resistance there. The farmer gives the product and it is as useful as holy water because it is not effective.

The Deputy asked a specific question. On the day of a herd test, will he be able to get a prescription for what would be considered herd management for the year?

Dr. Paul Corkery

I will answer. One is entitled to ask a vet and the vet is entitled, in law, to give all of those products if the vet sees fit to do so. That is important. It is a decision for the vet. The regulation is clear that these products are gated through vets. In other words, there is no access to antimicrobial products for animals anywhere in this land unless a vet prescribes them. The answer is that the Deputy can ask for the prescriptions he requires and it is likely he will get them. However, it is a matter for the vet to decide.

The vet is legally entitled to do it.

Dr. Paul Corkery

That is right.

He is entitled to give the prescription, not the product.

The prescription, yes.

Dr. Paul Corkery

That is right. As we have said, and I want to try to simplify it-----

What is the vet legally entitled to do?

In that case, the problem solved. That is it. It is a case of how much one pays the vet. That is what it comes down to.

I will be quite honest, I have concerns about what the Department is doing. We are leaving a body of people who are extremely experienced with the system that is in place. The Department missed a beat in 2014 and 2015 when, as I understand it, the Brits wanted Ireland to work with them. We thought it was better to drive on. The regulation now seems to be the problem.

I ask the witnesses to give us the full printout of the legal advice document. It should be standard under freedom of information. The taxpayers are paying. Our guests should look long and hard at a providing course that will allow a qualified person, for example, a person in the merchants who is qualified to give it out, to achieve a certain standard. To be clear, I am talking about doses for fluke, worms and the like; I am not talking about highly sophisticated stuff.

The decision was made a few months ago. It is abysmal to hear that the Department did not meet those qualified persons and has not met the other groups since April of last year when we are within two months of the regulation coming around the corner. The decisions were made. The deal is done with the vets. It was a bad way to behave when we talk about consultation. That is about sitting down with all the relevant parties on a constant basis to solve something. Our guests should go back and see about a course that will allow people to become qualified to a European standard and will get those people to fill the gap. Farmers, licensed merchants, vets and the representatives of the Department are all looking to ensure we give the right doses, have everything right for cattle, have them ready for export and everything. We are all in agreement. However, given the way it is being done, there is a fear out there among the farming community that it will drive some farmers out of business. Dr. Corkery mentioned earlier that 95% of farmers have fair access to vets. What about the other 5%? Do we not bother or worry about them? Are we going down the road of driving smaller farmers out the gap? If such farmers had an unfortunate situation whereby they had to call vets on different occasions in order to get stuff, it would put them out of business. I think our guests need to go back and do some thinking.

Mr. Peter Collins

With regard to the non-engagement since April 2015, we have not met with the group since that date. There have, however, been multiple meetings with all of the stakeholders in that period. We have not sat down with the group directly, although we have been working to get that group reconvened. We have, however, sat down with most of those stakeholders on an individual basis on more than one occasion since the meeting at that time. It is incorrect of the Deputy to say we have not met those stakeholders.

With respect, the representatives from the Department have admitted that they have not met the people who will be affected the most.

Mr. Peter Collins

That is not true.

It is their livelihoods that are at stake.

Mr. Peter Collins

We have met with all those stakeholders, including all the licensed merchants. The Deputy said we have not met individually with the responsible persons themselves and that is probably correct. We did receive a number of communications from them in our open public consultation on the regulations last year. We have met Acorn Independent Merchants and the Independent Licensed Merchants Association, ILMA. We have met with two other licensed merchant groups which pertain to represent most of the responsible persons in the licensed merchants association. We have, in some way, met those people and representative bodies. It is not correct to say we have not met them. We have listened to them.

I welcome our guests. It is good to have guests in the same room as us. This is the first occasion that has happened for a long time. Tá fáilte romhat go léir. I thank Dr. Corkery for his opening statement.

In it he welcomed the committee's report on this issue. Which of the recommendations has the Department accepted and plans to implement?

Dr. Paul Corkery

We accept all of them.

Dr. Paul Corkery

Yes. If the Deputy were asking me about one of the recommendations we benefitted most from it would be the committee's recommendation on generic medicines. Since the recommendation we have looked at what has been happening on the human side with generics for some time now. We went back to the Commission and asked if it would be within our prerogative-----

Dr. Corkery is referring to recommendation No. 6.

Dr. Paul Corkery

Yes. We asked if it be within our prerogative to allow it and we intend to.

Recommendation No. 1 was: "... that the Department of Agriculture, Food and the Marine ensures the continuation of the existing network, which includes Licensed Merchants and Veterinary Pharmacists ...".

Dr. Paul Corkery

Yes. We are going to continue to ensure all those retailers have the same-----

It continues: "... as a recognised route of supply ...".

There is not much about a recognised route.

Okay. Recommendation No. 3 was that the Department's legal advice "should be shared with all stakeholders impacted."

Dr. Paul Corkery

Yes. I have addressed that one already. However, we have summarised it and we have presented it insofar as we can.

Okay. In his opening statement, Dr. Corkery states: "... the main objectives of these new Regulations [include freeing] ... up availability of veterinary medicines across the EU ...". What is meant by that?

Dr. Paul Corkery

Until recently, each member state would have its own list of products authorised by its own equivalent competent authority, as the HPRA does here. Thus what is happening over time is the EMA itself, just as it was the body that approved the Covid vaccines, will be doing the approvals for most veterinary medicines going forward. Any new medicine has to be approved through the European centralised process. All those new medicines must be prescription only. Throughout the whole community now, those prescriptions are by vets.

How will that free up availability?

Dr. Paul Corkery

For example, we issue special animal remedy licences and if we run out of a product here, say a vaccine, and a similar product is authorised in any other member state, we can issue a licence to import that product. What happens now is if it is on the centralised database system we do not have to issue a special licence, it is automatically authorised here.

That is as a result of the veterinary medicines regulation. That regulation was agreed at a European level in 2019, is that right?

Dr. Paul Corkery

It was at the end of December. It was signed by the Council on 31 December.

At the Council level, was it a qualified majority vote?

Dr. Paul Corkery

I cannot tell the Deputy. I do not know. I assume so.

Ireland supported the regulations.

Dr. Paul Corkery

Yes, as I understand it.

Did Dr. Corkery know at that stage these issues would be created with licensed merchants and responsible persons?

Dr. Paul Corkery

The Deputy is asking if the Department knew.

Dr. Paul Corkery

No, it did not because of what was in existence at that stage in relation to non-prescription products, specifically those derogated products. Article 34 of the regulation helps here. It basically says every veterinary medicinal product needs a prescription. Then it says there are criteria under which you can derogate a product to not require a prescription. It was similar in the previous directive of 2001, regarding the criteria.

Our understanding was antiparasitic products would stay non-prescription. That is part of the HPRA's remit. It performs what is know as pharmacovigilance. It gives feedback on the effectiveness and adverse reactions to products. For example, if a vet went out to a farm and injected cattle and there was an adverse reaction, perhaps a skin condition, he or she would report it back to the HPRA. The authority accumulates all the information and it was finding there was pharmacovigilance that said certain antiparasitic products were not working. This had nothing to do with the new veterinary regulations. Even if we did not have the new veterinary regulations, the HPRA report under the previous directive would have meant we had enough regulation of these products. It happened previously back in 2003 to 2007 in relation to lactating and dry cow intramammary tubes. It was an up-regulation. Scientific evidence comes into play. The HPRA has to do this. It must check to see if these products are still meeting the conditions of the derogation from prescription, and it did that. Even if we did not have these new veterinary regulations, we would still have the issue of antiparasitics. Nobody back in 2018 could have foreseen this was going to happen because the evidence did not emerge back them. The evidence emerged in sheep and if you-----

I have to say this is the longest answer to a "Yes" or "No" question I have ever come across. It is very interesting.

Dr. Paul Corkery

I am sorry. I was being helpful.

Dr. Corkery was.

The follow-on question was whether or not the Government sought to amend the regulations, which clearly it did not because it did not foresee this would be an issue. We have been dealing with this issue pertaining to the concerns around the derogation. In the Department's briefing circulated to us, I think, at the end of April, it mentioned the chief veterinary officer wrote to the European Commission in June 2020 inquiring as to the ability of Ireland to avail of the derogation. Dr. Corkery is now saying the derogation was not there in any case.

Dr. Paul Corkery

The derogation was not there once the new regulation was agreed. The new regulation under article 105 states prescriptions shall be issued by veterinary practitioners only.

Is Dr. Corkery saying the chief veterinary officer wrote to the European Commission to ask whether Ireland would be able to avail of a derogation that did not exist?

Dr. Paul Corkery

In June 2020?

Dr. Paul Corkery

Yes.

Dr. Paul Corkery

It was for clarification. That is my understanding.

Okay. The following September the Commission responded to a written question from Mr. Chris MacManus, MEP, which stated: "It is up to the particular Member State to confirm whether the conditions of the derogation of Article 105(4) of Regulation (EU) 2019/6 are met." Our chief veterinary officer is writing to the Commission to see whether we can avail of a derogation that did not exist and the Commissioner is responding to MEPs telling them it is essentially up to member states to decide themselves whether they met the conditions of a derogation that does not exist.

Dr. Paul Corkery

The Deputy will recall I said at the start this was very complex. There are many conditions in article 105.

Okay. The chief veterinary officer wrote to the Commission and the reply received confirmed that in order to avail of the derogation a professional would have to be prescribing under national law on the date. On 14 July, my colleague, Deputy Cowen, who I welcome to the meeting, then the Minister for Agriculture and the Marine, responded to a parliamentary question I submitted saying:

... it is the intention of my Department to provide for Responsible Persons who operate within the Licensed Merchant sector to continue to have a role in the dispensing of veterinary medicinal products as provided for in the current legislation (heretofore).

Dr. Paul Corkery

They continue to dispense. There is no issue with the dispensing of these products. They continue to dispense them once they have a prescription. To be fair to the responsible persons, they do a specific course that is Quality and Qualifications Ireland, QQI, level 6. They spent 35 hours in full contact for a week and they do 60 hours of their own study outside that. They are needed and necessary within the system. They do a great job and will continue to do their job.

I remind Dr. Corkery of the question I put. I asked for "the reason [The Minister's] Department did not seek to introduce legislation to place those in industry currently responsible for the dispensing of medication from operating as a responsible person under the EU Veterinary Medicinal Products Regulation 2019/6." That was my question. I have outlined the response. Does Dr. Corkery see how an inference could be taken that would suggest that licensed merchants will in fact be able to continue, as was previously the case?

It had not been agreed yet what was going to be done. It was an opinion.

Dr. Paul Corkery

It does not appear that complex to me because I am working with it every day. I can see the distinction between the two functions. The responsible persons never, ever prescribed. They never produced a prescription.

On 3 November 2020, I asked what was essentially the same question of the Minister, Deputy McConalogue. His was a much more detailed answer. It read: "Ireland has no national discretion to now provide for a regime which would permit Responsible Persons in Licensed Merchants or pharmacists to dispense antiparasitic veterinary medicines without a veterinary prescription issued by a veterinarian." Does Dr. Corkery see a difference between the two responses?

Dr. Paul Corkery

Yes. The "without" clause means that they cannot dispense without a prescription.

Is Dr. Corkery trying to say that these two responses are the same?

I think they are.

Dr. Paul Corkery

They are to me.

Okay. Is Dr. Corkery saying that the basis for all of this was the chief veterinary officer's engagement with the Commission?

Dr. Paul Corkery

The basis for all of this is the report of the HPRA into the effectiveness of antiparasitic veterinary medicinal products. Some of them are not effective. It is no one's fault - it is evolution, it is nature. Every beast, every living cell, tries to continue living, tries to outdo the medicines meant to kill it. It is evading the medicines.

Nobody is arguing against that. The question is not whether this medication should be freely available without checks and balances. The question is whether responsible persons, as previously designated, will be in a position to dispense these products.

Dr. Paul Corkery

They were never designated that way, Deputy. That is why I am-----

They can provide the medication today.

Dr. Paul Corkery

They can dispense medication if a farmer asks them.

Next January, they will not be able to.

Dr. Paul Corkery

They can if the farmer has his or her prescription. The Veterinary Council of Ireland has stated that those prescriptions can be up to 12 months in duration as opposed to prescriptions for antiparasitics, which have durations of five days. If the Deputy does not mind me saying so, most of these responsible persons, RPs, are in veterinary practices.

Absolutely, but many are in licensed merchants,-----

Dr. Paul Corkery

And co-ops.

-----as we have discussed. Dr. Corkery has spoken about the Department's engagement with many stakeholders. Was one set of stakeholders the veterinary-----

Dr. Paul Corkery

Veterinary Ireland.

Can I take it that it was in support of the Department's interpretation of this regulation?

Dr. Paul Corkery

It is complex. A great deal of onus is being placed on vets in this regulation to prescribe more prudently, especially in terms of antimicrobials. They will not be able to pick the highest priority antimicrobials without a justification. There is much in this regulation that does not suit vets because it is regulating antimicrobials in particular. A vet must now legally provide a justification for the use of certain high-priority and critical antimicrobials. There are two lists. I do not want to make this answer longer than the last one, but there is the WHO list of antimicrobials and a categorisation of them. The European Medicines Agency, through its antimicrobial advice ad hoc expert group, AMEG, has set another list of "avoid" medicines, "caution" medicines and so on.

I accept all of that.

Dr. Paul Corkery

There is a pecking order.

Would the same criteria not apply to a responsible person?

Dr. Paul Corkery

The difference is, as has been said throughout the parliamentary debates, that the professionals have fitness-to-practice procedures. A vet goes to college for five years. If a vet does something wrong or inappropriate with these medicines, a fitness-to-practice committee can be established and the vet can be struck off-----

I do not want-----

Dr. Paul Corkery

-----for a period. What could we do with the responsible person? It is a different set of circumstances. That is what the regulation recognises, namely, where there is a fitness-to-practice process, professionals are the correct people to guard us and society from the overuse of antimicrobials.

Is Dr. Corkery concerned at all for those farmers who might not be able to access vets?

Dr. Paul Corkery

I was speaking to my colleagues beforehand and compared two places where I had worked as a veterinary practitioner, one of which was in Bandon, where there was all the choice one would like in terms of veterinary practices-----

Dr. Paul Corkery

-----and licensed merchants, LMs. The other was Bere Island. I was asking my colleagues to imagine what would have happened had I gone out to Bere Island to treat herd after herd - there are a good few herds on the island, which is a nice, fertile bit of ground - and told farmers that I could not supply them with the antimicrobials there and then and that they would have to travel to the pharmacy because we had decoupled. That would not have made much sense. We are concerned about the 5%. We are going to monitor the situation. We would-----

There are 482 herds in Mayo and 75 in Kerry that are more than 40 km away from a vet, but crucially for the next issue I wish to discuss, 20% of herds in Donegal and 30% in Louth are more than 30 km away from a practice. Something that the latter two counties have in common is that they could be closer to a dispensing merchant across the Border than to one on this side. Dr. Corkery mentioned that the Department had been working with authorities in the North to try to resolve this issue. What types of interaction have been taking place and what sorts of solution have been proposed or are forthcoming?

Dr. Paul Corkery

We meet the Veterinary Medicines Directorate, VMD, which is based in London and covers the North. We also meet officials from the North's Department of Agriculture, Environment and Rural Affairs, DAERA. We understand from them that changes are taking place in how they regulate medicines in the North. That is as much as I can say about that. Those bodies understand and have offered to make their suitably qualified persons, SQPs, aware of the fact that, for products that are prescription medicines down South, their SQPs cannot sell to farmers who present in the North without a prescription and that it is illegal for those farmers to use such products down here. As is the case in all EU member states where someone is allowed to move across the border, if a farmer in Donegal has a prescription, he or she can move across the Border if something there is closer. There is an exact provision for that.

"Prime Time" showed a documentary on this and the Irish Farmers' Journal ran a feature on it. According to those, people without a valid address in the North were able to acquire prescription medicines. Is Dr. Corkery satisfied that his Department has the resources and is in a position to address this issue? One of his senior inspectors told a court that it did not have the resources to deal with these matters sufficiently.

Dr. Paul Corkery

May I tease out the Deputy's question? Is he referring to dealing with what happened in the North where sales occurred? We have no jurisdiction there.

To deal with the general issue of people who should not have access to prescription medicines being able to get them in the North, South, east, west or wherever. In this instance, I am particularly interested in the cross-Border aspect.

Dr. Paul Corkery

In the South in our jurisdiction-----

No, I mean farmers in this jurisdiction sourcing prescription medicines illegally.

Dr. Paul Corkery

We have controls in place to deal with illegal medicines. We have compliance checks. We have checks across the entire system at retail level and farm level. Where we identify that, we deal with it.

How many infractions or instances of that happening have been identified this year?

Dr. Paul Corkery

I do not have those figures to hand.

Is it many? Is it dozens?

Dr. Paul Corkery

I cannot answer.

Perhaps we could get that answer.

The Chairman will be glad to hear that I am coming to the end. A number of committee members have mentioned the annual prescription. Does Dr. Corkery recommend it as a standard practice?

Dr. Paul Corkery

Is the Deputy referring to a 12-month prescription?

Dr. Paul Corkery

It is in the draft Council guidelines.

I know it is permitted, but if Dr. Corkery was speaking at a conference of vets, would he recommend it as a mechanism to be employed?

Dr. Paul Corkery

Every vet will have a framework for working out how he or she will go about providing these prescriptions. Vets will look to what products were used last year and probably, on occasion, to faecal egg counting, often supported and subsidised by the State.

They are going to look to the Department's veterinary advisers for that advice. What would Dr. Corkery's advice be?

Dr. Paul Corkery

The honest answer is that it is a matter for the VCI, and the council allows for it in its draft code. If those codes are agreed to, of course, I will support the VCI in saying that they are permitted for 12 months.

My final question goes back to the availability of veterinary practices. I presume that means Dr. Corkery is very excited about the Chairman's legislation on corporate ownership.

We will stick to veterinary medicines.

It is connected, a Chathaoirligh.

Dr. Paul Corkery

Of course, we are interested in it.

Okay, Deputy Carthy. I call Senator Lombard.

Thank you for letting me in, Chairman. I am due to speak on an issue in the Seanad momentarily. Can I get clarification from Dr. Corkey in respect of the responsible persons? He mentioned that the witnesses have not met them in the past few months. He might give us the date of when he is proposing to meet them.

Dr. Paul Corkery

It might have been Mr. Collins. We met the representative bodies of the responsible persons. It is a little like asking if one met all the people in the Department. One usually meets the representative body. The representative body is the Independent Licensed Merchants Association, ILMA. We met ICOS, which has many responsible persons among its members, and Veterinary Ireland, which employs-----

Does Dr. Corkery intend to meet the responsible persons?

Dr. Paul Corkery

I meet lots of them. As I said earlier, some of them are on our antimicrobial stakeholder group and some of them are the owners of the businesses., the small businesses. I have definitely met many of them in the recent past. We know that many of them attend the meetings because they have done the course. It is not a course that one must update every year. It is a course one did once upon a time for many of the guys. They have reached the requirement and they know what they are doing. They are very knowledgeable and they give a great deal of good advice to farmers. They will continue to do so.

Dr. Corkery mentioned Bandon, which I know exceptionally well. It is an unusual one to mention because probably two of the biggest veterinary practices in Ireland are based there. I believe the issue lies further west. There are more than 3 million sheep in Ireland. Is Dr. Corkery worried about the costs that will be put on flock owners in particular when it comes to that side of the industry? The majority of these would have rare use for a vet. Obviously, herd testing would be separate because it is not applicable. Has a cost-benefit analysis or been carried out of what this could cost the sheep industry in respect of the use of vets when it comes to prescriptions? Has it been costed? I assume Dr. Corkery is not looking at blanket prescriptions, whereby prescriptions would just be given without looking at the animals. Can he explain how he thinks this is going to work and what he thinks the cost would be for the relevant sheep farmer who, on average, would probably never need a vet?

Dr. Paul Corkery

First, a vet can write a prescription in these instances. As long as he or she has an established relationship with the farmer, he or she can write the prescription for the antiparasitics without seeing any of the animals in this particular case. I said in the report that somebody could have more than one vet, and the Senator knows that. One can pick and choose and have as many vets as one wishes.

To return to the point about the cost, sometimes penny wise and pound foolish applies to veterinary medicines and antiparasitic products. The report that came out recently said that antiparasitic resistance is costing us €237 million. It could be costing us that, and that is the assessment in this paper. That is because the product is not working properly. I have first-hand experience. I did my PhD on sheep, incidentally, even though I grew up in cattle country. Dairy is all around me, although I keep a few sheep for my sins. When the product does not work and one is looking at a dirty backside for a long time, it is difficult to deal with. I believe that money spent on ensuring we have the right product and the optimal use of a product is better, as well as shared knowledge. That is where I believe there will be a great economic benefit in what is happening. One can look at Africa. There are parts of it where one cannot actually raise cattle because the parasites have taken over. The people have given up raising cattle. Fortunately, this country is not there yet, but with these extended mild autumns there is a massive burden of parasites on pasture and we must ensure that we have a kill. We also have to make sure that we have new product.

What we are trying to do - it is nobody's fault, as I said earlier, as it is evolution of these parasites - is to try to use these products better so we can extend their shelf life until we have new research and new products. Mankind will have new products.

I have a final question.

I have a supplementary question and then I will let the Senator back in. Surely the post mortem facilities in factories are a far better mechanism for ensuring that the dosing regime on farms is working, rather than another big layer of bureaucracy.

Dr. Paul Corkery

That is another aspect of it or another aid. It is in one of our actions in the antiparasitic stakeholder group.

Dr. Corkery said a minute ago that he wants to see if these medicines are working. Surely the post mortem is the ultimate test.

Dr. Paul Corkery

I am sorry. I do not-----

One gets the liver and the lungs and one will know-----

Dr. Paul Corkery

I do not agree with you, Chairman. The damage is well done at that stage. It is when they are on the farm, and most farmers know that.

I am a farmer. When the liver and the lungs are perfect, one will know that one's testing regime is working and is effective. A great deal more use should be made of post mortems. You are introducing regulations to make sure the dosing is working, and we can use post mortems to show that it is working at farm level.

Dr. Paul Corkery

Can I show you how that would happen, whereby one would have a clear result anyway but one might have encountered antiparasitic resistance? When they were younger the farmer may have treated them and they did not respond. Then the farmer may have had to treat them again with a product that worked. It is one aspect of it. I agree with you, Chairman, that we need to use the post mortem data more. We are pushing towards that, and it is one of our actions in the antiparasitic stakeholder group.

I apologise for interrupting you, Senator Lombard.

I must leave as I have to go to the Seanad. Thank you, Chairman, for letting me in.

Okay. I call Deputy Flaherty.

I thank the witnesses. I will try to be brief. They have been over an awful lot and I do not want to repeat it. I have a few brief questions and whoever is most relevant can respond to them. Have any veterinary practices declined outright and said they are not taking part?

Dr. Paul Corkery

No.

How much is this system going to cost?

Dr. Paul Corkery

The system is being developed by the Department.

How much will it cost?

Dr. Paul Corkery

I will refer that to my colleague.

Mr. Peter Collins

The system is a free-to-use system-----

How much is it costing the State to provide this system?

Mr. Peter Collins

There has not been a full cost-benefit analysis carried out on it yet as to how much it costs, but under-----

I mean the cost so far. Obviously, the Department has entered into contracts with suppliers. What is the ballpark figure for what it is going cost?

Mr. Peter Collins

I do not have those figures at present. However, the costs part of it and whether it is needed are two different things. Article 57 requires that member states have the system, so there is a need for it.

I know that, but I am just curious about the cost. As a follow-up, could the witnesses provide us with a breakdown of the cost to date?

Mr. Peter Collins

We can, indeed.

Also, can they provide the management cost and details of contracts the Department has entered into in terms of managing the system annually in the future?

Related to that, is an annual charge for the management of the system being passed on to vets? Given the significant investment by the State in this new system, and the fact that vets are effectively getting an edge in the market and we are edging a number of suppliers out of the sector, surely there has to be a scenario where there is a charging mechanism for vets.

Mr. Peter Collins

I am not sure where we are edging vets out of the market with this, but I do not see that happening.

No, not edging out vets. I meant edging out suppliers, farm stores and so forth, which will not longer be able to do what they are doing now as a result of the new situation with responsible persons. Can Mr. Collins come back to me on whether there is a plan for vets on an annual basis? It seems reasonable, particularly if we are giving access to what will, in effect, be a guaranteed market. Surely there has to be some onus and responsibility on them financially to fund the system which enables that.

Mr. Peter Collins

I can come back to the Deputy immediately on that. There is no charge for anybody to use the system. It is part of the regulatory requirement by the EU for all member states to supply information on antimicrobial usage and sales. The EMA has provided advice to the European Commission that it will accept prescription information as usage data, even though not all prescriptions may be filled. The EMA is accepting usage data under Article 57, however. The Department previously made attempts to try to collect information regarding usage. It has been a huge resource burden and effort to try to get that information in the porcine sector in the past few years. Trying to get that information has been quite complex. The introduction of the new NVPS is seen as an immediate way to collect that information, with a minimal cost compared with what we would need to do if we tried to collect it from all the different sectors on the various species. We would need to collect that information from, whereas people entering the information directly on a prescription system gives it to us at the push of a button.

Mr. Collins is right. I accept his bona fides in the context of what he is doing. There has to be a mechanism to charge vets for providing this system, however. That is my point. Mr. Collins might come back to me on the cost data and the likely cost of contracts into which the Department is entering in order to maintain this going forward.

I will pick up on a point that was made in response to a question from Deputy Fitzmaurice. Dr. Corkery stated that there is an option for a farmer to request what I would call a bulk cert whereby he or she could get an annualised prescription. Has the farmer any recourse if a vet says he or she will not do that and that the farmer can get products each time they are needed and that he or she will be charged each time?" I appreciate that this is probably an issue for the VCI but is it something the Department has considered? Is there going to be provision to safeguard farmers in the type of situation I have outlined?

Dr. Paul Corkery

The fact is that a farmer is free to have as many vets as he or she wants or to go to another vet. That is what we have look at. We have listened to farmers and vets and we do not foresee that problem. When one speaks to farmers about their vets, generally, because they have chosen those vets, they are pretty happy with them. I hope that somewhat answers the Deputy's question. I do not envisage the type of problems-----

It does to some extent. We have to look at this from the point of view of where the pitfalls are. I see a pitfall for a farmer who wants to try to streamline his or her costs, particularly the small farmer who is operating on very tight margins. That farmer wants to minimise the number of times he or she has to request a prescription and, ultimately, incur a cost. I take Dr. Corkery's point that he has discussed the matter with farmers and that there is an option for them to change that. I do not believe that is satisfactory. There should be a safeguard whereby a farmer should have protection in order that he or she can seek an annualised prescription or a monthly or quarterly prescription, if he or she so wishes. I would appreciate it if Dr. Corkery could come back to me on that point and see if he can explore building in that safeguard in his ongoing discussions with the vets.

In the unlikely event of, say, somebody taking a legal challenge against this and where that person would automatically seek full disclosure, he or she would be entitled to the Attorney General's opinion. Given the scale of the change involved with this new system, on behalf of the committee, I ask Dr. Corkery to go back to the Attorney General and ask him to give permission to provide the relevant advice to the people who have sought it. That is not an unreasonable request. That is my fourth follow-up for Dr. Corkery. Could he do that for us and revert to the committee with the Attorney General's position?

Mr. Collins might send the answers to Deputy Flaherty's questions back through the committee secretariat and we can distribute them to members. I call Deputy Michael Collins.

I will be brief. I will share my time with Deputy Nolan so I will try to make my questions as brief as possible. Is the Department of Agriculture, Food and the Marine aware of the proposal that has been presented by farmers' associations, co-operatives, pharmacists and many vets and merchants to form a regulatory body for responsible persons? Why has the Department not consulted with the latter? Their jobs are under threat. A code of practice and prescribing protocol could be carefully built. This move would ensure that an assessment of herd health would be met and advice would be given on all aspects of how to address resistance before a medicine is dispensed. This would enable the responsible person to issue an advisory prescription that in no way undermines or challenges the full veterinary prescription. This is another viable option that the Department has dismissed. Why?

Mr. Rob Doyle

With the permission of the Chairman, I might take that question. The legal position is very clear that these medicines are now prescription-only medicines. They can only be dispensed on foot of a prescription and the legal advice is that the only person who can write a prescription is a veterinary surgeon. That option is, therefore, not legally available.

Has the Department looked at this legally or has it just accepted it as being something that is not possible? As already stated, people's jobs and livelihoods are at risk. Everybody's main priority should be the people who have done their jobs so well down through the years. It is not just that they turned up on the doorstep all of a sudden and were the cause of a problem. What we have here is going to cause extra costs to the farmer and a serious headache for many people. I ask that the Department perhaps go back and look at this again, and maybe talk to the legal experts about what happens on farms in reality in order to get the picture on the ground as far as farmers are concerned.

I will get to the non-members when I have finished with the members of the committee. We have extra time today so everyone will get an ample opportunity to question the witnesses. Deputy Ring is the next member to speak.

I will be very brief. The more I have listened during this meeting and at those we have had in recent weeks, the more I am uncertain about what is actually going to happen. I really believe that the Department, and I want this to be put on the record, is making a big mistake. There will be difficulties down the line.

I noted down a few of the answers some of the officials gave when they were questioned, particularly with regard to the Border. I am not satisfied that this issue can be dealt with properly. We are going to have a big problem whereby people will be cross the Border to get their medicine and the State will incur a loss as a result. We had this before with cigarettes and with many other products in this State, even with drink, up to a point, until drink became cheaper in the South than in the North. That is what is going to happen in this instance.

I want to ask the officials a question. The Department has long insisted that the way to dispense this medication is through a prescribing web, which it is actually developing. I am told that the design of the web is way behind already. The Department is talking about 28 January as the date on which it will launch this website and have it up and running.

Has the Department a contingency plan if this is not going to happen? I do not have an awful lot of confidence in some of the Departments when people cannot leave this country and thousands of people cannot get a passport. Now we have another Department taking on more responsibility and I am afraid that it will not be able to deliver. Can Mr. Collins update me on the website? Is the Department behind already? Will the Department be ready for 28 January and is there a contingency plan in place?

Mr. Peter Collins

The Deputy is right that we have taken on a huge and onerous task. We have looked at different options but the main objective is to keep a competitive market and provide farmers with a greater choice as to where they get medicines. Obviously we want to collect the information in one go so that we can report to the EU on that basis. There are a number of reasons for introducing the system. Building it and getting contractors on board has been a challenge. The contractors have been in since March and we have been doing a lot of the business requirements and the collection of information since then as well as prior to that. There has been a lot of development and movement on the system in the last four or five months. A considerable amount of work has been done on the back end systems to put this all together.

We have had a number of stakeholder engagements. I am not sure from where the Deputy heard that the Department is way behind. We have heard a couple of those rumours and we are not sure from where people got that information. We have spoken to vets, licensed merchants, feed mills, dispensers, pharmacy companies and pharmacy software companies. All of those people are involved in the whole spectrum of prescribing and dispensing everywhere. We have put all of those together.

We have done an awful lot of designing and development at this stage. We have done some focus groups. We hope to have a few more focus groups in the next couple of weeks. Starting in November, we hope to have what we call user acceptance testing. At that time we will do some internal tests across the Department and then we will extend the testing to the dispensers and vets to see how they can see the system.

At the moment we are still on track and on time in terms of what we are trying to deliver. There are elements to system in terms of what we can deliver and what people call the minimal viable product. It will not have bells and whistles hanging off it and it will not be the most fantastic system one will see in the world. It will be functional and will do exactly what we hope it will do which is to allow people to write prescriptions and for people to dispense medicines from those prescriptions.

The system will probably not go live on 28 January because it is a Friday. I imagine that we will go live on the following Monday, 31 January. We are considering introducing a soft approach to go live, which is a transition phase that will be allow the continuation of paper prescriptions for people who may not be technically astute or where we have not got around to fully training people in the timeframe that remains. We will not directly cut people from using paper prescriptions, which have been used for the last 30, 40 and 50 years. We will slowly introduce the system. The system will be introduced and available for everybody to use, who wants to use it, on 31 January.

Has the Department a contingency plan if anything goes wrong?

Mr. Peter Collins

The contingency plan is that we will retain the paper system until we get the new system up and running.

I thank the Chairman for the opportunity to join with members in discussing and trying to conclude this issue. Unfortunately, this matter has gone on for too long without finding a solution with which we are all satisfied.

The Attorney General has ruled that there is no derogation from the EU regulation so there is no point revisiting the issue again. I take the word, as we always do, of the Attorney General. I thought that he had set a new precedent when, during the summer, he publicly issued details of his decision on attendance at an event in the Merrion Hotel but obviously not.

Decoupling is out owing to certain geographical areas of the country that are sparse when it comes to veterinary practices and suppliers. Let us put that aside too.

The roll out of the system comes down to how the Department implements it. The members represent people and are representative of the Dáil that put the Minister in charge who, in turn, instructs the officials in the Department to do their job. That is the way it is and as it should be. There is a feeling here that an annual test offers an opportunity to audit the supplies required during a given year for the herd. We should not be led and dictated to by the Veterinary Council of Ireland. Where does it state in legislation that it has the authority to decide how an EU regulation is implemented? There is no other authority in the State nor should there be that has that authority. It should not be the case in this instance. It is all down to how the vets interpret this and apply it to the system that the Department is putting in place. The vets can do it with an annual test and they should be instructed to do so by means of an annual prediction. Anything supplementary to that, they can do individually thereafter. Obviously this all comes down to what is in it for vets. The Department should talk to the vets and reach an agreement.

This committee represents the country as a whole and there is cross-party agreement. It would appear that there is unanimity among the members here and, therefore, by association, there is unanimity among the Deputies in the Dáil. The Dáil is asking that the Minister, in conjunction with the Department, instructs the Veterinary Council of Ireland, if that is the authority it must deal with, that its members should cater for those who wish their test to be an adjudication on the amount of supply, especially of antiparasitic medicines, that is made thereafter. It is as simple as that as far as I can figure out. I do not know why we are going around the houses about the issue.

As Deputy Ring rightly said, a system is being put in place, and I imagine that is being done at much expense. Let us put the system in place and cater for one or the other but primarily cater for a system whereby the annual test is the annual audit of what supplies are required for the year thereafter. I do not think that is too complicated.

I accept and acknowledge that it is very unfortunate that there was no potential for a derogation. The Attorney General has ruled accordingly and it has implications for some responsible persons who work within practices or suppliers.

With all due respect to Deputy Carthy, of course he would seek to play a bit of politics with this matter and try to dissect my answers back in July of last year during the short term I answered questions and then when the current Minister, Deputy McConalogue, did so last November. Deputy Carthy implied or inferred that it was the Government's fault that we did not retain the ability of responsible persons to dispense without a prescription. We accept, appreciate and understand all that but it is high time that this matter was put to bed. It is high time the Veterinary Council of Ireland was instructed. The Department vis-à-vis the Minister vis-à-vis the Members of Dáil Éireann are best judged to represent and adjudicate on behalf of their constituents and the farming fraternity throughout the country, who believe that this is the only way that this matter can be resolved.

Dr. Paul Corkery

We will give that due consideration. The one thing that we do not want is to be is in conflict with the Veterinary Council of Ireland. It would appear that with the prospect of a prescription valid for antiparasitics for up to 12 months-----

With all due respect, it is the members who have been elected and given the authority to interpret legislation, and instruct the Department to act in the best interest of the industry, not it. If it wants to get on this side of the table then it knows what to do.

A key recommendation in the report compiled by the Independent Licensed Merchants Association stated that if it is not possible to avail of a derogation then the Department needs to explore further a possible adoption of a mechanism to allow responsible persons in licensed merchants, but also pharmacists, to have a role alongside veterinary practitioners in terms of the antiparasitic veterinary medicines. The Department said that it cannot use the derogation so what actions has it taken to find another mechanism?

The committee produced a strong cross-party report that contained very clear and strong recommendations. We spoke to the licensed merchants and farmers, which resulted in all of our recommendations.

Ignoring those recommendations would be detrimental. How on earth is this system going to work when we do not have enough vets to fulfil current demand in terms of the work that is required in this State? I ask the witnesses to respond on that issue.

In terms of the thousands of jobs involved, we are in a very vulnerable, volatile situation in terms of Brexit and the affect of the Covid-19 pandemic on businesses, particularly those in rural areas. Has an impact analysis been done? Is anyone fighting in the corner of the businesses in question or is it the intention to create another cartel and put the control of this in the hands of a few, as is already happening in the beef sector? To be honest, we are fed up with this. We have had enough of it; we want change. The people and businesses in this country want change. They want fairness. It is frustrating and beyond belief that the Department did not fight that corner or carry out an impact analysis. It appears to be happy to do what the EU tells it and more, without question and or putting the case of businesses or rural Ireland to the fore. As I said, we run the risk of putting control in the hands of a few through the formation of what could be a cartel. I have nothing against vets. they do great work and are under immense pressure, but they are not enough of them. Common sense needs to prevail here. A fair resolution must be found. It is not good enough to ignore the enormous work of this committee in terms of its report. On a cross-party basis, we were all on the same page. It appears, however, that the Department is going to turn a blind to all of our work. That is beyond belief. I would like a comprehensive response on the issues I have raised.

Mr. Rob Doyle

I will try to answer the Deputy's questions. Overall, there are enough vets in the country. The VCI has never had as many vets on the register. It is recognised that there are some rural areas where there are some challenges. The VCI and the Department are monitoring that.

EU regulations are binding on Ireland. It is the law. We must comply with this regulation.

It is about the Department's interpretation of the regulation. This country seems to go further than it needs to in terms of regulations. We tend to punish our people all of the time. It is up to the Department to interpret the regulation fairly for everybody. Would Mr. Doyle accept that it is down to the Department's interpretation of the regulation?

Mr. Rob Doyle

On this particular issue, the Attorney General has made the interpretation. It is the interpretation of the Attorney General that, legally, the only people who can prescribe are vets. We have endeavoured to create a system that provides for additional competition. The Department is conscious of the cost to farmers, and there are measures under the rural development plan to support antiparasitic measures, that is, there is funding for faecal egg sampling in the sheep welfare scheme and in the beef scheme. There is a pilot scheme looking at antiparasitic challenges in sheep, which is supported under the rural development plan at no cost to the farmers involved. We are also looking at a broader scheme to support farmers in regard to antiparasitic issues on their farms. I could not accept that we have ignored the recommendations of the committee. In response to other Deputies, we pointed out where we have made specific changes as requested by members of the committee.

There is very little change. It is not substantial. Returning to my question, given that the derogation cannot be sought, what other mechanisms will the Department consider to try to give the responsible persons some sort of role? Is that on the cards within the Department or is it a done deal that the responsible persons will be shut out such that we will see job losses unnecessarily? Is that the case or will another way be found to enable them to work alongside the veterinary practitioners?

Mr. Rob Doyle

Their role has not changed. Dispensing can still be done from licensed merchants as heretofore for the same range of products. This will still require the responsible persons in those businesses to oversee that dispensing.

With respect, Mr. Doyle, the role has changed. Currently, such persons can advise a herd owner as to what medicines to use. Under the regulation, they will be dispensing rather than advising. The role will change under this regulation.

Mr. Rob Doyle

In terms of prescribing, the legislation is clear. The legal basis is that only a vet can prescribe. I cannot see a role that will allow responsible persons to prescribe because that is not permitted within the legislative framework we have.

I seek some clarification on a number of points. Mr. Doyle said that it will be possible to get a 12-month prescription.

Mr. Rob Doyle

For antiparasitics.

Yes. The farmer is not restricted to the vet who carries out the herd test. He or she can use any vet who has knowledge of his or her herd.

Mr. Rob Doyle

Yes.

As with dry cow antibiotics, you can use a vet that has knowledge of your herd but it does not have to be the vet that carries out the herd test. That is fine. From an animal welfare perspective, will it be possible for herd owners to have some antibiotics on hand at particular times of the year? For example, in the spring it will not be practical for a vet to be in every yard at the same time. Is provision made for a herd owner to have a product in reserve for a prescribed time of the year?

Dr. Paul Corkery

I will take that question. The regulation is about risk and providing for a risk of disease. Where a farmer's vet perceives that there is a risk and a requirement for an antimicrobial for a particular disease or condition, that can be done. There is provision for that but we would not like it to be said that there is a stock available on farm. There is a rider on that. The condition is that the vet identified a risk and prescribed for it. The regulation does not allow for prophylactic use of antimicrobials, that is, just-in-case use. There is no provision to give an animal that is clinically healthy an antibiotic. However, where there are conditions that are occurring on a farm which the farmer can identify and in respect of which he or she can administer a medication to prevent the condition - I am speaking of ecoli mastitis, which is a severe, acute, painful condition for an animal and in respect of which there is only a short window in terms of treatment and it is not possible to get a vet on-site on time - the vet, where satisfied that there is a risk of that condition occurring based on history and knowledge of the herd, can provide treatment for therapy but it is limited in the amount. It cannot be a huge stock; it has to be representative of the risk.

This is fine. When it comes to mastitis, the quicker you can get a treatment into an animal, the chance of recovery is far better. From an animal welfare point of view, time is of the essence. If you are milking cows and you see a cow with mastitis, time is of the essence. The quicker you can get a tube into the cow the better the chance of recovery. Where you are rearing calves you will have a situation where there is pneumonia or scour and you will need to get treatment in quickly. I am glad that has been recognised. That is important.

The next speaker is Senator Paul Daly. He will be followed by Deputy Carthy.

Further to the deliberations, I am seeking clarification on a number of issues that were raised. Deputy Fitzmaurice referred to the proposal of it being allowable for the vet to upload the information up to five days after the dispensing. I am speaking here as a farmer as much as a public representative. Is it the case that if I have an issue at home and I ring my vet, and both of us are busy, he is not going to say, knowing that he has five days: "Call to the office, I will ring the girl or fellow in the office, you collect the bottle and do your job and I will put it up on the system in the next five days." How is the licensed merchant going to compete with that? That is the first issue I have with what was stated earlier.

The second issue is a serious one. As a public representative and an administrator, I cannot stand over what the was stated earlier, namely, that it would be at the discretion of or up to the vet to decide whether to give an annual prescription or whether the vet could tell the farmer that due to way he operates, the latter will have to get a prescription every time. It was suggested that a farmer could go to another vet down the road. If he lived where I live, he would be going a long way down the road to get a second vet. I am lucky to have one nearby. This is not going to work. I say that as a farmer. I try to be a politician here but, ultimately, I am representing farmers. This is not going to work; it cannot work. I cannot stand over this. The Department is leaving it wide open to the vet to make the decision.

There might be one vet who will come out, carry out the herd test and he will probably even do a health management plan with the farmer, which is what we should be doing here. There should be a health management plan on the day of the herd test. I appreciate that there would have to be some alternative for sheep. The farmer and the vet could put a little time aside on the day of the herd test and do a health management plan for the year. The farmer has the prescription and then can go wherever he or she wishes. It is not a case of making a telephone call to a vet who is somewhere calving a cow and who says: "Go in and collect the bottle and I will do up the prescription afterwards". The relevant witness stated that there will be fair play for all the suppliers, including the licensed merchants. How will that work in the circumstances to which I refer? They are gone. It is not only the responsible person, but his boss and his business. They are closing their doors. In the part of the country I come from, it is a small outfit in a one-horse town. The bigger operations might survive, but small outfits need the parasitic medicines they are selling at present to keep their businesses open. When they go, it is not just that one goes to the big town to get one's medicines or one gets them directly from the vet. There is nowhere to get one's paling stakes, wire or batteries for the electric fence. The Department is going to wipe that out.

This will not work, and I cannot stand over it. The witnesses' answers have been very vague. As I said, it is letting the vet make the decision. If this happens, the annual prescription has to be written into it - end of story. The vet does not make up his mind on the run. The five-day aspect will be a major issue. I appreciate what was said about somebody coming in a 4.55 p.m. on a Friday or Saturday evening and the information is not put up immediately. That is okay if the prescription is handed over and it is available in the merchant's premises. If that is the situation with the vet - I realise I am repeating myself but this is important enough to repeat it for a third time - and he is out doing a section and can say on the mobile telephone, "Call into my office, collect the bottle and I will do the paperwork afterwards", how can the witnesses say that the system will be competitive for the merchants or the co-operatives? They will be gone. The witnesses are writing off rural Ireland here.

Third, if this was going to work, and it will not, what awareness campaign has been done with farmers? How many farmers know what is facing them if they decide to dose a few cattle next February before putting them out to some early grass? They will be in the licensed merchants or in the pharmacies where they will not be able to be served because they will be told they need a prescription. They do not know that. No awareness campaign has been carried out. There is no preparation. The system is not ready to run. It was stated that the web prescribing system would create competition, but now it is being stated that paper prescriptions will also be acceptable. If one goes to the vet to get the paper prescription and one is in his office and the stuff is right there on the shelf, one will buy it there even though it might be a fiver dearer. It saves one driving another two miles down the road with the prescription. This is not working.

The witnesses need to contact Brussels in the morning and say that we need a two-year extension to get this right. We are not prepared. That is in the interests of the stakeholders, in the interests of dealing with antimicrobial and antiparasitic resistance correctly, properly and efficiently, in the interests of animal welfare and in the interests of not closing down rural Ireland. I formally propose that the committee write to the Minister and make a request or demand, at this late stage and given that we are so far away from a workable solution, that there be a two-year extension in order to ensure we get this right, once and for all.

Dr. Paul Corkery

With regard to the five-day window for uploading dispensing details, we are not saying the prescription can wait for five days. The prescription has to be put up immediately by the vet and be available to those who are dispensing, including the vet. It is the dispensing detail, so there is another detail beyond the prescription that our system-----

While Dr. Corkery is answering, I ask him to clarify the position relating to the scenario I outlined. The vet is busy and is out doing something. How does he write the prescription? Can he ring and get somebody in his office to do the prescription on his computer, somebody who is the equivalent of the responsible person in the merchants?

Dr. Paul Corkery

No. The prescription is an app on the telephone. It is the same as the app for registering calves. It is simple to use. The vet will be using it very frequently and it will not take very long. As Veterinary Ireland tells us, the prescription is an outcome of the work the vet has done and the knowledge the vet has of the herd. It would be remiss of me to say that we could instruct a vet or a doctor, for example, on what to do. The vet has that discretion in his or her professional training to be able to see what is the right choice based on that farm. It is not one-size-fits-all. It is customised to the particular farm.

I take the 12 months issue on board. We recognise that there is an opportunity for it to be done for cattle at the tuberculosis test, but it is more difficult for sheep. I take the Senator's point.

Dr. Corkery takes my point on board, but is he going to implement it?

Dr. Corkery can understand the issue with the vet having the discretion. Some will do it and some will not. That cannot and will not work.

The app will generate a prescription in its own right, will it not? Then one can print one's prescription from the app and go off with that.

Mr. Peter Collins

No.

Does one have to go to the practice to get it?

Mr. Peter Collins

The idea behind it is-----

It is all centralised.

Mr. Peter Collins

It is centralised.

Why can I not access it with my own printer?

Mr. Peter Collins

At present, farmers will not be accessing the system directly. When a script is generated by the vet, one will get an automatic text or an email.

The person does not collect it. That is not fair, and that is the problem.

Mr. Peter Collins

The person will get a text or an email which will state exactly what medicines are on the prescription, which are on the system. One can then bring that to any place one wishes.

Bring the message.

Mr. Peter Collins

The person can bring that message, email to wherever he or she wishes to go to get the prescription filled. The person walks in and hands in his or her ID number and the dispenser will be able to dispense the medicine. We are allowing what we call a main ID for this prescription, or it could be four lines of the prescription. If the person wants separate things dispensed in separate outlets or the person may want the antiparasitics dispensed only in the licensed merchants, he or she will be able to bring that prescription in with just that line ID to the licensed merchant, give the merchant the number and the merchant will be able to dispense it from there.

One still needs to go to the vet. It is as simple as that.

I will follow up on a few of my previous questions, one of which related to the North-South issue. Can I take it as read that the witnesses accept that any divergence, North or South, from the all-Ireland animal health policy is a bad thing and that it is better when we are co-ordinated?

Dr. Paul Corkery

Yes, it is. We support that. We have a lot of interaction with our colleagues in the North in order to harmonise things as much as we can.

Do the witnesses see a route by which we can harmonise the positions in this instance? The difficulty is that it is not devolved. As a result, we are dependent on Westminster, which is not in harmonising form at present.

The Deputy should put his own input into it up there.

Unfortunately, that is the problem. It is not in Stormont, and the Minister is not in too much of a harmonising form either. Do the witnesses see a route by which we can address it? I am from County Monaghan, and this is an issue. We can talk about all the protections that are in place or whatever is the case. It will not be Monaghan farmers, by the way, and I wish to clarify that. However, there is going to be an issue. It is one of the first things that jumps out at anybody who has looked at this. Even vets will say that when one speaks to them privately.

Does Mr. Doyle see a route by which we can put in place a mechanism to ensure we have an all-Ireland position?

Mr. Rob Doyle

Yes, I do. There are a number of ways of doing it but many elements are based on risk. One of the tools we will have is the veterinary prescribing system. Perhaps part of our risk assessment is farmers who do not have prescriptions for medicines, for which they should have. That would allow us to identify that issue as a potential risk for inspection. There are various ways of handling risk.

Apparently the smart way to obtain home heating oil in many places is to get a half a tank of oil filled by a local supplier and to get the other half of it filled from across the Border, where the price is substantially cheaper. There will be a bigger price difference between the two jurisdictions when our colleagues put the carbon tax up again next week.

Now, now. The Deputy is straying from the topic.

That is what happens when we diverge. It creates anomalies. There will always be somebody who will try to beat the system. I am not convinced any additional measures are being put in place here to address that.

If a farmer has a cross-compliance inspection and has drugs for which he cannot account with respect to their source and a prescription, he would be subject to a severe penalty.

Mr. Rob Doyle

Absolutely.

The Department is not proposing any change. That is provided for already.

Mr. Rob Doyle

No. That system will remain. The Bord Bia obligations will remain but our inspections will also remain in place.

If a farmer gets a 12-month prescription and has to buy products at different times during the year, how will that work given he will have only one prescription?

Mr. Peter Collins

That will depend on exactly what is written on the prescription. If a certain number of products are on it, the farmer can have the prescription part-dispensed through the year.

Who will keep a record of that?

Mr. Peter Collins

It will be on the system. If a farmer presents his identification, ID, to get a prescription dispensed and asks for 50 rather than 100 antibiotic tubes, when he calls to the dispenser the next time, there will only be 50 tubes available to that dispenser to dispense to the farmer. The dispenser will keep a running track of that record for the farmer.

What about antiparasitics?

Mr. Peter Collins

The prescription, even if it is an annual one, will have to be specific as to the amount and almost timed.

I image there is a guesstimate of the year's supply.

If one were to require more of a product than the amount prescribed for some reason, one would have to get a separate prescription.

A farmer will only dose calves five or six times a year. The prescription will cater for that.

Mr. Rob Doyle

The Chairman, as a farmer, will know it is a partnership in a way between the vet and the farmer. They work together to protect the health of the animals. That is what we also expect will happen in this case. I fully agree with the proposal regarding a health plan. We are aware of the benefits of that and are examining ways whereby we could possibly support measures towards that.

This was going to stop with the Department anyway. I apologise for cutting across Deputy Carthy's time.

No problem. It is a good discussion because we are getting down to the practicalities and there are many practical problems.

To return to the Attorney General’s advice and Department's reading of it, Mr. Doyle indicated the Attorney General's advice was emphatic. What was the question put to him? Mr. Doyle indicated the Attorney General suggested the advice should not be published. Can the remit the Department gave the Attorney General be published?

Mr. Peter Collins

The question was around who has been able to prescribe veterinary medicines in the State and who can only prescribe veterinary medicines.

Mr. Peter Collins

I think that was the question.

Anybody could answer that question.

Mr. Peter Collins

The Deputy could answer it, but the question was with respect to people stating that responsible persons were prescribing, but the question was that they are not prescribing. Only veterinary practitioners were prescribing medicines. Responsible people were dispensing medicines.

There was no reference to seeking a derogation.

Mr. Peter Collins

There was reference to it. I do not have it to hand but I can get it for the Deputy.

If Mr. Collins could provide the question, it would be useful.

Mr. Peter Collins

I can get the question for the Deputy.

There were a number of references to the value of licensed merchants in the Department's opening statement. Does the Department have specific proposals in that regard? This is probably a broader question for the Department in terms of how we can support their viability.

Dr. Paul Corkery

There are 750 products. In light of the new classification that appears in the regulation under article 34, we are examining the retail element. It will certainly be supplying everything it had been supplying in the past in terms of dispensing and making sales. Because of the cutback on antimicrobials, the prediction is the vaccine market will become the big market. That is a very important area where good distribution practice is essential. Sometimes it involves cold chain vaccines. The advice to the farmer about maintaining cold chain conditions right up to crush side when they administer the vaccine between 2oC and 8oC is essential to having an effective vaccination campaign. For dairy herds, there is a major uptake in vaccines across different diseases such as salmonella and leptospirosis. A large array is being used and more will be used more because antimicrobials will not be available. The responsible persons will have a very important role in the sale and advice as to how to handle those products.

I note Dr. Corkery's responses to the questions about e-prescriptions and all that comes from that and his earlier response regarding decoupling. Many people who are not farmers would find one element of this difficult to envisage. If a vet advises a farmer he needs a product and the vet happens to have it in his van and can give it to the farmer, it will be very hard for the farmer to say "No" to that and to ask the vet to upload his prescription, send him a text message and say he will go to the licensed merchant for it. The defence of the coupled system is the example of the very peripheral area where there is only one vet. An island was referenced in an earlier response. We are dealing with thousands of items of regulation and legislation that have been enacted despite the impact they have on those same communities. Do the officials accept we must do something? If we were to compare the situation to a man who attends his doctor who offers to prescribe his patient with a product and hand it to him, it would be very difficult for the patient to say "No" to that offer and say he would go to the Main Street to get the product in the chemist shop.

Dr. Paul Corkery

I have had conversations with responsible persons, RPs, and licensed merchants, LMs, about this. We recognise that is a genuine concern. Farmers have a relationship with their vet. I am talking specifically about antiparasitics. They are used throughout the year at different times. To use the example Deputy Cowen mentioned, a prescription is given when the herd test is done, say in January. There will be several line items such as fly treatments, worm doses, and so on listed. It will be acceptable for the farmer to say he does not want to buy those products in one fell swoop and that he will buy them periodically during the year when it suits his finances, given that this is a low margin businesses. Sometimes, he would buy from the co-operative because that is his line of credit. We do not envisage prescribing for antiparasitics will be as difficult as people first thought. The farmer can say he needs a prescription and will need it during the year, he understands the vet can give it to him for 12 months and he will ask for it for three, four or five items. It is likely the vet will accede to the request.

I wish to return to an earlier point regarding our approach to EU legislation. When I was a member of the European Parliament I worked on quite a number of files dealing with antimicrobial resistance. It is one of the big global challenges we face. If we screw it up, it could have a devastating impact on human health, not to mention animal health.

I am sure it is the Government's starting position and the starting position of any rational person would be to support measures that are aimed at tackling antimicrobial resistance. There was a deficiency in identifying a potential problem within this regulation and it was not noticed that it could have an effect on our member state. That is the issue we have been discussing for the past couple of hours and I know about it because as MEPs we would have been dependent on the briefing we would receive from the permanent representation, that is, the Irish Government's position, to highlight potential issues for Ireland and they were never highlighted in this regard. The witnesses have acknowledged that the Department did not see it. Does the Department intend to put in place a basis whereby the extensive consultation the witnesses have mentioned happens while the files are in process as opposed to happening after the regulation has been signed off and into the future?

Dr. Paul Corkery

Does the Deputy mean in the future?

Dr. Paul Corkery

A lot of the 1,750 products are not prescription-only. It has happened in the past that intramammary tubes were unregulated and the same has happened with antiparasitics so it could happen with any of the products that are available.

The question is not necessarily product specific. It is about antimicrobial resistance legislation. I know it will keep coming at European level because the Commission is under pressure from some member states and from some elements within the European Parliament to continue to review and strengthen any provisions that are in place. I am saying that the starting point should be that we would support measures that tackle antimicrobial resistance but that we also need to be cognisant of the potential impacts it would have. The best way to do that is to ensure we have ongoing engagement with all the stakeholders that can be identified prior to Ireland adopting a position at a European level.

Dr. Paul Corkery

We do that. The most recent example of that is in the delegated act on reserving certain antimicrobials for human use. Based on the feedback from our stakeholders, we believed they would be better served with as many products to treat animals as possible. We also believed that only products, especially antimicrobials that were required for human use and for which we had alternatives for animal health, would be designated as for human use only. There is a product we are concerned about and we have had feedback from our equine stakeholders on it. It is an antibiotic called rifampin that is used to treat rhodococcus equi pneumonia and that is the only antimicrobial that works for that condition. We are hopeful that with the delegated act we will have that taken into account along with other animal welfare issues and that we will still be able to use that product. I take the Deputy's point.

I have to go Chair.

Assuming and expecting that the Department is directed to ensure that system caters for a 12-month prescription and thereafter, will the Department put a review system in place to identify any issues that arise, to acknowledge the difficulties there may be or that are envisaged by the licensed merchants, for example, or to ascertain if it has had the impact envisaged by some in order for us to respond to that vis-à-vis compensation or whatever? Can the witnesses give some indication that this is not just a fait accompli and done and dusted for a day and ever more? Is there a review system in place?

Dr. Paul Corkery

We will take the feedback from the stakeholders. The Health Products Regulatory Authority will also be central; that is where this started. It will deal with the feedback from the stakeholders on products that are ineffective and we will have a measure of the outcomes from that. We will continue to work with the antiparasitic stakeholder group and we will examine the national veterinary prescribing system as well. We will have that data to help us analyse the products.

Senator Paul Daly wants to know about his proposal of looking for an extension. What is Dr. Corkery's view of that?

Dr. Paul Corkery

I will take that proposal back but I do not think it is possible. This is a regulation that was signed off on by the European Council on 31 December 2018.

The witnesses have heard plain and clearly the recommendation of this committee on the system the Department is putting in place and on how it should work. As I said, it is seldom one gets all-party agreement on a recommendation such as this and on the implications it would have. I would hope the Minister will be as firm as we are in telling the Department to do that.

When Dr. Corkery says he will take the proposal back, will he take it to Brussels or will he just take it back across the road?

The Department can take it as an instruction to the Government and the Minister.

Dr. Paul Corkery

We attended the EU's Standing Committee on Veterinary Medicinal Products so we will see what other member states are doing. We will look for what the Senator is suggesting but-----

It was operating.

Senator Paul Daly has made a proposal that we write to the Minister and look for an immediate response from him and Deputy Carthy seconded the proposal before he left. As there were no objections I take it that is agreed? Agreed.

On behalf of the committee I thank the officials from the Department of Agriculture, Food and the Marine for briefing us. This regulation will have a significant impact on the agriculture sector and I have asked the Department to take on board the concerns and suggestions raised today.

The joint committee adjourned at 7.56 p.m. until 5.30 p.m. on Wednesday, 13 October 2021.