Seanad Éireann debate -
Tuesday, 20 Jun 2023

Vol. 295 No. 2

Veterinary Medicinal Products, Medicated Feed and Fertilisers Regulation Bill 2023: Second Stage

Question proposed: "That the Bill be now read a Second Time."

Minister for Agriculture, Food and the Marine (Deputy Charlie McConalogue)

I am pleased to bring the Bill to the Seanad. I welcome the support it received when it concluded its passage through the Dáil on 31 May.

The Bill legislates for two areas. The first part seeks to modernise the area of veterinary medicines and medicated feed. Last year, we saw the implementation of two new EU regulations in this area. The Bill reinforces those regulations in Irish legislation in a once-in-a-generation change. It shows our commitment to the key objectives of the regulations, namely, addressing antimicrobial resistance, AMR, and protecting the supply of veterinary medicines and medicated feeds while supporting Irish farmers and businesses through this unique period.

The second part of the Bill provides, through the amendment of the Fertilisers, Feeding Stuffs and Mineral Mixtures Act 1955, for the creation of a national fertiliser database which will collect data on import, sale, supply and use of fertilisers and allow for analysis of these data to assist in the administration of other Department schemes.

I thank the Senators who have engaged with my Department during the past three years on the issues at the core of this Bill. I also thank the members of the Joint Committee on Agriculture, Food and the Marine for their valuable work through meetings with my Department and their work on the pre-legislative scrutiny report, as well as on the amendments incorporated on Committee Stage which have helped to strengthen the Bill before the House.

Ireland's agrifood sector plays a vital role in our rural communities and our rural economy. It is our largest indigenous sector and accounts for almost 7% of gross national income and more than 9% of exports in value terms. The sector employs more than 170,000 people and total exports of agrifood products last year were estimated by my Department at €18.7 billion. This Bill and the matters provided for within it will play a key role in the success of our agrifood sector going forward.

In January 2022 I enacted SI 36 of 2022: European Union Veterinary Medicinal Products and Medicated Feed Regulations to give effect to EU Regulation 2019/4 on medicated feed and EU Regulation 2019/6 on veterinary medicinal products. This Bill provides for powers to make regulations on areas that these recent EU regulations left to be determined by national law such as the retailing of veterinary medicines. The Bill will repeal the Animal Remedies Act 1993 and will provide for the introduction of a national veterinary prescription system, NVPS. This system, being developed by my Department, will position Ireland as a leader within the EU in terms of regulatory oversight on the use of veterinary medicinal products in food-producing animals, which ultimately helps us to protect human and animal health and our shared environment. It provides us with the best opportunity to access new trade markets and increases the viability of our food-producing sector, thus protecting and supporting jobs in our economy and in rural Ireland in particular.

Tackling antimicrobial resistance, AMR, is accepted as being critically important to achieving the best public, animal and environmental health outcomes as well as to achieving economic, environmental and socially sustainable development and ensuring food security. The European regulation is now a cornerstone to support the achievement of the objectives set in the European One Health Action Plan and in the farm to fork strategy against AMR. The regulation recognises the important role of the animal health sector in addressing the One Health challenge of AMR, which has been referred to as the silent pandemic. This Bill strengthens Ireland's position in the global fight against AMR and supports a sustainable agrifood sector.

Actions taken to improve animal health and prevent disease are key to reducing the use of antibiotics and effectively tackling AMR. These actions align well with Ireland's national farmed animal health strategy, with one of the key enabling principles being that prevention is better than cure. This Bill provides a wide range of measures to fight AMR and promote a more prudent and responsible use of antimicrobials in animals. These measures serve to protect public health as well as animal health by working to keep antibiotics with us as effective disease treatments into the future. Veterinary practitioners as the prescribers, and indeed gatekeepers, of antibiotics have a key role to play to promote the responsible use of antibiotics in the animal health sector. The farming sector has a responsibility to work collaboratively with veterinary practitioners and other farm advisory professionals to ensure the best possible health outcomes for their animals and to use antibiotics only when absolutely necessary. The growing understanding of the risks of AMR is among the key drivers of recent EU veterinary medicinal regulation change. AMR is a global health threat posing significant challenges to human and animal health and to the farming sector.

The Bill also provides for the introduction of the new national veterinary prescription system, NVPS, and the collection and effective use of the data collected therein. This has the potential to provide local, national and international benefits across the sector to multiple stakeholders. The system itself is a free-to-use digital online platform that is accessible from any desktop or mobile device which allows veterinary practitioners record and issue veterinary prescriptions to their clients for veterinary medicinal products including medicated feed. The introduction of the NVPS will do a number of things.

It will meet the Government's commitment under its digital strategy to introduce greater digital services to its citizens. It will assist with Ireland's national "one health, one welfare", AMR and antiparasitic resistance programmes by identifying where and when particular medicines are being used and why, to what levels and in which animal species. This information was never previously available to the policymakers addressing these international disease issues. It will also assist with the development and provision of farmer education policies on the effective and good use of veterinary medicinal products, VMPs. With this education, it is expected that vets and farmers alike will prescribe and use less medication over time, ultimately resulting in huge financial savings to farming communities. It will also provide greater choice and control to individual farmers on where they purchase their medications. It will help develop the sustainability of the food-producing farming community. The data will assist policymakers in identifying alternative medicinal options and practices from a farming perspective through detailing good farming and prescribing practices. The NVPS will simplify and reduce administrative burdens by digitalising cumbersome and labour-intensive manual prescription and dispensing processes, while providing assurances to international trading partners that Ireland is at the forefront of safe food production with the highest level of regulation on the supply and use of medications in its food-producing animal population. It will aid Ireland with its EU regulatory veterinary medicinal products usage data submission commitments under EU regulations. Finally, it will help with efficiently directing limited Department and other national resources when scheduling inspections or introducing national programmes.

I am committed to ensuring a competitive marketplace for the supply of all veterinary medicines and a continuation of the current routes of supply into the future. The importance of competition in the marketplace and protecting the choice of the farmer in where he or she purchases antiparasitic veterinary medicines is central to the work of my Department. The Bill, when enacted, will also enable the collection and processing of information on the import, manufacture, sale, supply and use of fertiliser in the State. It will enable data related to fertilisers and lime to be collected from the point of import into the State, or manufacture for sale, to an end user. The Climate Action Plan 2023, Food Vision 2030 and the EU farm to fork strategy have all set ambitious targets to reduce fertiliser use, including reducing emissions associated with chemical fertiliser use by more than 50% by the end of this decade. There is also a need to improve water quality, especially in specific catchment areas.

The Bill is divided into three Parts. I will not have time to go through them in detail. Senators will have to read my script. The Bill has received a lot of scrutiny and involvement from the Oireachtas committee and stakeholders. It has received significant time and commitment on Committee and Report Stages in the Dáil as well. I look forward to Senators' contributions on Second Stage and to further engagement as we proceed to Committee and Report Stages and bring the Bill through to enactment. I thank the Cathaoirleach for scheduling the Bill today and Senators for their time.

Acting Chairperson (Senator Erin McGreehan)

I thank the Minister and call Senator Paul Daly, who has eight minutes.

Senator Paul Daly

I welcome the Minister and thank him for all the work he has put into the Bill up to this Stage. Without going over what he said, we are here today in the context of EU Regulations 2019/6 and 2019/4 in respect of the manufacture of medicated feed. The regulations were agreed in 2018 and came into effect in January 2022. The regulations set out rules for the manufacture, import, export, sale, supply, distribution, advertisement, control and use of veterinary medicinal products and medicated feed, aiming to modernise legislation, stimulate innovation and increase the availability of VMPs and strengthen the EU's campaign against AMR. These regulations have direct effect, leaving some details for member states to provide for in national law.

Part of the Bill relates to fertiliser regulation and the establishment of a fertiliser database.

I thank the Minister and his officials and all the stakeholders involved for their work on the legislation to date. It has been a long-drawn-out process in many regards. These regulations were introduced in 2018 and the national debate has been happening since. As the Minister mentioned, the Bill received a lot of scrutiny in the Oireachtas committee. We had hearings prior to the pre-legislative scrutiny, PLS, and then the PLS. The Minister has brought in some amendments and made changes along the way, and that is to be appreciated. It is important legislation for animal health and welfare and it is vital that farmers are equipped to deal with the challenge of both AMR and antiparasitic resistance. The majority of the Minister's contribution placed an emphasis on AMR, as has been the case through all our debates. Everybody who has been involved - all stakeholders and everybody we met at the agriculture committee - has had no issue with the regulation when it comes to antimicrobial resistance. That relates to the prescription and sale of antibiotics. I do not think anybody along the way mooted any change on where we were on that. From an animal and, indeed, human health point of view, it is vital that we get the prescription and distribution of antibiotics right to limit AMR going forward. The biggest part of our debate, which I will come to later, was about the making of all antiparasitic products prescription medicines only.

It is important that the Bill and future regulations made under it reflect the aims of the overarching European legislation in ensuring that the regulatory framework for veterinary medicines should be adapted to scientific progress, current market conditions and economic reality, while continuing to ensure a high level of protection of animal health, animal welfare, environment and safeguarding of public health. I again thank the Minister and his officials, and all stakeholders who engaged with the Oireachtas joint committee both through our hearings and the PLS. I also very much welcome the amendments the Minister has tabled to the Bill on the back of those during the Bill's passage through the Dáil. I would like him to ensure that the necessary statutory instruments to be made under the Bill are implemented in a practical, fair and even manner to ensure that everyone across the supply chain of veterinary medicines can continue to work together in improving animal health and welfare and supporting rural businesses throughout Ireland.

The introduction of the NVPS and the national fertiliser database during our deliberations received a lot of discussion with regard to the whole area of data storage and data sharing. I know the Minister has been in contact with the regulator and is happy that all the information that will be gathered on both the fertiliser database and the NVPS will be handled in the correct manner. This, however, was an issue the farmers in particular were very concerned about as to who would have their information and with whom that information may be shared. I for one appreciate the value of all that information, as the Minister said, and it will be vital information for the Department to have at its disposal, particularly from the fertiliser end of things, when it comes to getting things right in controlling our water quality, the application of our environmental schemes and our nitrates regulations. I welcome the fact that the Minister is happy and I take it at face value that he is after his consultation with the regulator because it was an issue for the farming community as to who would have access to their information, where that information would go and by whom it would be used.

There were ongoing issues from both perspectives from the aspect of the technology that was going to be used for both the NVPS and the recording of the fertilisers and how usable it would be for the people who would need to be inputting the information to that and, therefore, I hope the Department can keep an eye on the evolution of both systems.

As I said earlier, the biggest point of discussion during our deliberations was probably on making antiparasitic treatments become prescription-only medicines and how they would then be dispensed. At the moment, before the changes, a person can go to a merchant, pharmacist or co-operative and, in collaboration with a responsible person, get those treatments. The Minister stated that one of the themes of the regulation was to stimulate innovation in and increase the availability of veterinary medicinal products. There was a fear from the word go that, depending on how this was regulated, we could end up with a monopoly on the market and seriously affect the supply chain and the competitiveness from the perspective of farmers when they go to acquire medicines.

The committee looked at the different potential solutions that are in use throughout Europe. One of these involves a complete decoupling whereby only vets could prescribe while somebody else dispensed, in a way similar to the doctor-pharmacist relationship here. However, we found that would limit the role of vets and their ability to enhance their practices. While it has proven to be one of the most effective ways of controlling antimicrobial and antiparasitic resistance on a European level where it has been introduced, we did not see it as the solution.

I welcome the amendment and look forward to the statutory instrument. Other members of the committee are in the House and they may have other opinions. Following all our deliberations, however, I believe that the Bill now satisfies all the stakeholders. I thank the stakeholders who engaged with the committee on an ongoing basis during the entire process. It is important to say at this juncture that, while there were people who had opinions based on the competitiveness and the sale of the products, everybody who was involved was genuinely interested in and concerned with addressing the antimicrobial and antiparasitic resistance aspects of the regulations.

Senator Victor Boyhan

I welcome the Minister. This is a very important Bill, which, while technical in nature, boils down to two things, as the Minister rightly said. It is down to the veterinary medicines and medicated animal feedstuffs, which are clearly very important, and it is down to fertilisers. What are we down to? We are down to animal health, public health, the health of our soils and the environmental initiatives.

There has been cross-governmental collaboration on this legislation. I welcome that. There was a requirement in the context of what happened in Europe, and we have to follow on in that regard. I genuinely welcome that. I do not wish to go into too much detail about the practices involved, other than to say that farmers know the benefits of good environmental practices and animal health and welfare. Their livelihoods, as we all know, are intrinsically linked to the health of the soil and the animals and sustainable farming, and, ultimately, the sustainability of their communities and incomes. That sounds like a bit of a mouthful but it is important that we keep stressing the importance of the health of our animals and our soil and how environmental initiatives are compatible with sustainable and profitable agriculture. That is a difficult message to get over to everyone. We are all on a journey, and we are at different stages of that journey. However, it is becoming more acceptable, reasonable and politically favourable to advocate strongly for the importance of the health of our soil and animals.

I have long argued that there is a need to look at appointing veterinary technicians. We need to look at this matter. It is slightly related to this legislation. I do not believe that highly paid veterinary surgeons are needed to go out to administer everything when it comes to veterinary products. They have the final say and recommendation, but the reality is that many among a generation of people in farming will know what it was to give a bullock a bottle or a dose, as the expression was, and hope for something good to happen.

I am not talking about putting the welfare of animals at risk. I am calling on the Minister to look at how we can improve the issue of farm veterinary technicians, particularly for large practices. All over the country, I meet with farmers who say they cannot get vets, even in large practices. Vets are telling me that themselves. I met many of them in the west a few weeks ago, where we discussed the difficulty of getting people into big veterinary practices.

Much of the legislation hinges on the development of a database. The national fertiliser database will help us to meet the commitments Ireland has agreed to in the negotiations with the European Commission. I accept that. All EU member states that are availing of the nitrates derogation have set out, or are in the process of setting out, their national fertiliser database. There are issues around the IT systems relating to that and to the capability of that. Who is the data holder? I spoke to a number of people from the co-ops. Remember, some of the co-ops are involved in the nomination of candidates to the Seanad. They are keenly watching this Bill. There is an issue about who the database holder is. This is nothing that cannot be overcome. However, when this legislation is eventually enacted, we will need a simpleton’s guide or a question-and-answer sheet that sets out all those issues. Who are the end users?

Horticulture is also involved in this. Golf clubs are consumers of large amounts of fertiliser. There may be many situations of leaching into our waterways. There is the horticultural aspect, the landscape aspect and the market garden aspect. There is a whole range of things. I am in favour of a national fertiliser database. Hopefully, it will provide reliable data on fertiliser and where it is going accumulatively. It is important the end user, such as the farmer, the grower, the amenity horticulturist, or whoever it is, clearly knows where it is going and the amounts they are using.

I mention the labelling of veterinary medical products and the veterinarian or the person who receives a veterinary medical product. This refers to the labelling affixed to the packaging or the prescription. It includes supply information, prescription identification information, details of the prescribed veterinarian, the date of retail, the dosage and the duration of the treatment. All of this will be set out in the legislation, as will the period of time, the licensing issues, etc. Again, this is about animal welfare and animal health. It makes sense that we address that.

I refer to the issues around the national database. We spoke about how various bodies will have access to this database, such as the Food Safety Authority of Ireland in performing its regulatory functions. The Health Products Regulatory Authority, the Veterinary Council of Ireland, the Pharmaceutical Society of Ireland, Bord Bia, the European Commission and the European Court of Auditors will also have access to it. A huge number of people will also have access to this information. I do not have a problem with that because if one is above board, is doing what is legal and is in compliance with the rules and the regulations, it makes sense. It also makes sense in terms of the funding and the various eco-schemes, such as for fertiliser.

If people are to be incentivised, it is important that we will have traceability. Traceability is key in agriculture, as it is in food. The Minister might confirm that organics will have to register. It is right that they do. Some people suggested that the organic sector will not have to register, but organics have to register under the proposed legislation. Why would they not have to? The excessive use of lime has an impact on land. It has an impact on our ecosystems and our biodiversity too. I do not think it is a bad thing.

The non-farmer professional fertiliser end users are to be assigned a unique identity tag. There is a lot of work involved. Where I envisage potential problems here are around the IT sector and the administration of the system. The Minister might advise how that is progressing because this was to be done earlier in the year. Things have run on a bit, but how are we engaging with that? What is the feedback now from the co-ops and the agri-merchants? They were initially quite hostile to all of this. They have come a long way. As a previous Senator said, we have ironed out some issues and there has been better understanding and better dialogue around the issues concerned. The data are important. That is the real thing.

Going back to what I said, this is about food, healthy soils, regulation and compliance with EU regulations and the requirements we have been asked to step up to. It has been a long time coming, but it is right. I will finish where I started by saying that farmers do not need to be lectured about good environmental practices and animal welfare. Their livelihoods are intrinsically linked to the health of our good soils, to animals and to sustainability.

It is important that we work with them and acknowledge the enormous progress that has been made by this sector with respect to the environment. I support this legislation. I am keen to hear a little more about the administration of the IT systems and how they are progressing. As I stated earlier, there is a real case now to look at a proper certified qualification for a veterinary technician. There will be a learning curve with all this legislation. Through the agri-climate rural environment scheme, ACRES, the green cert or any eco-agri scheme, we have to build a model for the people involved in these sectors to be able to understand the science and the importance of compliance. I wish the Minister well with it.

Senator Seán Kyne

The Minister is welcome. I acknowledge the work that has been done by the Joint Committee on Agriculture, Food and the Marine. My colleague, Senator Lombard, cannot be here and has asked me to cover this Bill. I was first contacted about it almost two years ago by individuals at home who had concerns that - I will not say the Minister - the Department was trying to monopolise the market for vets and that it would put jobs at risk. I am not sure whether that was ever the intention or the case, but certainly, concern was expressed to me about the perception that might have been in the industry. The changes arising from discussions on Committee Stage and whatever involvement the Minister has had have ensured a much more favourable and appropriate Bill as regards balancing the needs of farmers, retailers and, most importantly, ensuring human health and animal health in the prescribing of antiparasitic and antibiotic medicines. Antimicrobial resistance is hugely important in animal and human health and it is an issue that should be regulated to ensure we limit its level. The Bill can assist in ensuring there is a better understanding by Irish farmers and better engagement to ensure AMR is reduced.

The use of prescribed persons was regulated before this and they can continue to assist because individuals working in the industry are highly qualified. There was concern that removing them from being able to be involved in this would in some way question their competence and what they have done in the past and that would be regrettable. I therefore welcome the changes that have been made. We all know the importance of medicines. As someone who has been involved in farming all my life, I think medicines should be used sparingly but when necessary. No farmer wants to see an animal suffering.

The use of vets is important. However, as others have said, access is difficult in some parts of the country in certain large practices, though neither my late uncle nor I have ever had an issue in accessing vets and high-quality care. However, it is important that we ensure we also have an adequate number of vets. I welcome recent discussions about a new veterinary college to ensure the supply of vets to carry out the important work they do. The vast majority of farmers comply with and abide by rules and regulations. There are always individuals who will try not to. That is not to be commended but it happens in a small number of cases. That is why regulations in all aspects of life are required.

The second issue is the fertiliser register.

Again, as a former REPS planner, I know of the importance of accurate receipts and everything else that goes with sale and distribution of fertilisers. I believe we have seen a natural decrease over recent years in agricultural sales and purchases because of regulations but also because of the cost of them. There is a reduced need for fertiliser with the better education and training of people, the better use of clover and rotation grazing, and everything else that goes with that. Many young farmers are now more educated, with the Teagasc green certs and so forth. Practices are improving, which is certainly to be welcomed.

There is still a large amount of fertiliser being purchased and there are parts of our country which, unfortunately, have seen water quality continue to be impacted because of agricultural and, indeed, other practices. It is certainly not just agriculture and there is certainly a great deal less of this now. I certainly know that in the 1980s many more fish kills would have been commented on on the RTÉ news, whether they were caused by silage effluent or the likes of that. That has been tidied up in the main. Some accidents may happen, unfortunately, and they are completely regrettable, but a very significant investment has been made by the Government and farmers to ensure these issues are not as prevalent as they were in respect of the levels of slurry storage and silage effluent. Certainly, fertiliser has had and can still have an impact in respect of diffuse pollution. Proper and adequate records are important in respect of all the various biodiversity and all the other agricultural schemes. They are also important in respect of data collection where we can adequately state what the position is lest there be any doubting Thomases with regard to the use of fertilisers, the role farmers play, and the contribution they make towards reducing the use of nitrogen and nitrogenous fertilisers and, consequently, the impact on climate, together with the legislative requirements on agriculture in the role it needs to play with regard to climate change, which I welcome.

The third issue I want to raise is the renewed focus by the European Commission on reinvigorating the whole issue of Mercorsur. We obviously know the importance of trade deals and the need for the European Union to lessen the reliance on China and, perhaps, other countries. While we in this Chamber are debating the issues of animal welfare and quality, and rightly so, and we know of the importance and quality of Irish meat, it would be retrograde in the balancing of that were we to see deals being agreed for beef imports coming in from Brazil and elsewhere where the environmental record of afforestation or deforestation is so evident and so disagreeable to the majority of people in the European Union. This is something I see the European Union commenting on again in recent days and something that is likely to continue to be of concern, notwithstanding the importance of trade deals with areas outside of the European Union.

I compliment the Minister on his engagement with this legislation and wish the Bill's passage through the House the very best.

Acting Chairperson (Senator Shane Cassells)

I thank Senator Kyne. I note the guests of Senator Micheál Carrigy from the active retirement group in Newtownforbes in County Longford, who are in the Distinguished Visitors Gallery. They are very welcome and I hope they enjoy their day in Leinster House and in Seanad Éireann.

I also acknowledge the presence of Deputy Paul McAuliffe in the Visitors Gallery along with his guests, Professor Catherine Shannon and her niece. Professor Shannon is from Massachusetts and is a long-time friend of Ireland and of the late John Hume during his work of campaigning for peace in Ireland. I acknowledge her presence here today.

Senator Lynn Boylan

My colleagues in the Dáil have spoken at length about some of the issues of concern they have with this legislation. It is interesting because I worked on the One Health strategy when I was an MEP and one of the things it highlights is the length of time it takes for EU legislation to make its way to national level. There is also the conversation we are having here about the importance of when the EU decides on a direction of travel, where it is important that member states are able to design how that regulation will be then implemented at the member state level.

When I was working on the One Health strategy, the other thing was how serious antimicrobial resistance is and how little attention it gets in mainstream media. No matter how much you tried to convince newspapers to cover it at the time, they had no interest whatsoever. It is not just an agricultural issue; this is an issue that affects public health. It also affects our business in terms of our being a food producing nation. We absolutely need this legislation and we need to do so much more collectively at the EU level to fight against antimicrobial resistance. It is well documented that we are running out of new antibiotics for human use and increasingly bacterial infections are becoming resistant to the antibiotics we have. We have to admit, however, that we are very fortunate in Ireland as to the standard of food production we have. Also, at a wider EU level, we have far superior animal husbandry and veterinary practices than those of many other countries across the world. Irish and EU citizens are beneficiaries of that and of the farm to fork strategy, something that is the envy of citizens of America and of Canada.

I worked closely on the One Health strategy and when we talked to our counterparts in America, they would say that idea of animal husbandry and getting it right all along the food chain, the traceability, and the administration of medicines to livestock are so important. They would point to the fact that farmers were able to administer drugs to entire herds in their country. They would point to the fact that the use of chlorination was a way of overcoming the farm to fork strategy. It did not matter how the poultry was reared. Once it was dipped in chlorine at the end process, it was fit for human consumption. Something we raised again in our opposition to TTIP, CETA and Mercosur was just how important it is that in regard to the standards we have fought so hard for, and farmers have had to make sacrifices to come up to that standard, we do not undermine them by doing trade with countries that have far inferior food and animal husbandry standards. I worked closely with the Canadian NGO Food & Water Watch on that very issue.

As some said, the other element of this legislation is the national fertiliser database. It is essential that we monitor the application of fertilisers. It was only late last week that the EPA produced a report that showed there has been no improvement in water quality. It has very clearly stated that it is agricultural practices that is causing the deterioration and the lack of progress on our water quality. It pointed to Uisce Éireann as well but was very clear that we need to change our agricultural practices if we want to bring our water quality up. This means reducing fertiliser use is very much part of that process of improving the water quality but it is also vital in tackling both our climate and ammonia emissions.

One thing that was flagged by my colleagues in the Dáil was that it is unfortunate that the database will not be an all-Ireland database. Our rivers and our groundwater do not recognise borders. Likewise, we know that every single day people, including farmers, go between the two jurisdictions to buy products and to avail of services.

The other area of concern, which has been touched on by many Members in the Houses, is around the use of data in this database and the concerns farmers, and others such as the horticultural sector, have about the purpose of the data and what they will be used for and who will hold them. It is good to hear the Minister say that he has had reassurances from the Data Regulator but questions still remain on that.

I look forward to engaging with the Minister on Committee and Report Stages. We will probably bring amendments forward to address some of the concerns which were flagged with him in the Dáil.

Senator Eugene Murphy

I certainly agree with my colleagues that there is positivity about this. As was said by several speakers, the reality is we have to move in this direction. We have to deal with the legislation coming from Europe but, as Senator Boylan and others mentioned, the reputation we have for our food is really important.

We must enhance that reputation even more and keep it there. Given that we export €15.5 billion worth of agricultural products every year, with the possibility that we can grow more, it is extremely important that we deal with that matter.

On the national veterinary prescription system, most farmers, once things are explained to them, want a good, tight system that ensures there is no abuse of the system. Naturally, we must treat our animals and look after them. However, we must also ensure that there is no abuse of the system. In certain instances in the past, there were abuses. Let us all be clear about that.

It is also important to state that it was tricky to get the balance right in the context of the legislation, especially with Brexit and the Northern Ireland situation. Senator Paul Daly and I have spoken about this matter in the past. We had to ensure that the market could not be flooded with materials from Northern Ireland, particularly as the latter and Britain are no longer part of the EU.

I commend the agriculture committee. Senator Paul Daly is a member of the committee, which is chaired by Deputy Cahill. The committee has a good, sensible approach to all these matters. I have indicated previously that the progress we are making in this and many other areas is because of the way the Minister has spoken to the farming community and explained matters to its members. That is crucial to success in all these areas. When I talk to farmers individually, they all more or less agree with this type of situation being developed. They know the importance of our food business and want to keep it secure. Where farmers co-operate with this there will be more advance payments as well. It is the right move and the right way to go. I compliment all involved and hope this will lead to an even better system for agricultural goods as we go forward.

Senator Aisling Dolan

I welcome the Minister. I thank him for bringing forward this Bill. It is great to see how his Department is embracing the digital side of things. It would be great to see that across a number of other Departments.

Antimicrobial resistance is a crucial issue. We see the regulations pharmacists and chemists have to look at in order to try to manage antimicrobial resistance, especially in hospitals and other health settings. This is looking at our food chain. If he has time, the Minister might comment on how he sees the NVPS working in the first year and how he would evaluate it after a year or so. It is great that it is free and that it will be available over the phone as well as with a laptop and so on. How do we ensure all vets are going to be able to use this system? In doing this we are trying to ensure that best practice is rolled out across the country. When it comes to best practice, there is probably a role for Teagasc in rolling this out and working with farmers. Has the Minister any ideas on how that might work when the Bill is enacted?

We are talking about improving animal health, preventing disease and so on. This will be important for farmers and for us in the long term because we hope it will open up more international markets for us. The health side of what we are doing here will combine with our reputation for grass-fed beef. What about the costs of this? Have we carried out any research into potential costs for farmers on the prescription side as a result of this? How can we support them in terms of access to all types of antibiotics? There is probably access to a lot of generics and so on, but is the Department examining ways to ensure that the costs relating to farmers are monitored and managed?

The other aspect is the fertiliser database, which the Minister mentioned. This is important. We hope to see more competition in the context of costs.

They will not be as bad as they were previously. There will be a roll-out to farmers of the fertiliser database. Will those be integrated or two separate systems?

Minister for Agriculture, Food and the Marine (Deputy Charlie McConalogue)

I thank all Senators for their wide-ranging and well-thought-out contributions, which I will certainly take on board. I wish to recap on some of the key objectives. One of the main objectives of the Bill is to ensure that the recently introduced EU legislation, which I gave effect to earlier this year with the enactment of SI 36/2022, European Union (Veterinary Medicinal Products and Medicated Feed) Regulations 2022, could be implemented in international law. The Bill before the House is, therefore, an important part of that objective. I am also conscious of the views expressed by Senators today and the views of stakeholders throughout the extensive engagement process and the consultation I have had with them on this legislation as to the importance of ensuring that end users of veterinary medicinal products continue to have choice as to where they purchase certain products. We have had considerable engagement on that over some time to reach what I believe I can be a balanced outcome.

I am focused on ensuring that a competitive marketplace for the sale and supply of veterinary medicinal products continues into the future. All existing stakeholders in this area, be they veterinarians, co-ops, licensed merchants or pharmacists, will continue to have a role on this aspect ensuring competition and choice for the farmer. I am keenly aware of the impact that additional costs can have on farmers especially in the times we are currently in. I am confident of achieving the objectives of this Bill, and the overarching EU regulations will in fact reduce costs on farm through reduced but more effective use of veterinary medicinal products.

I have given great consideration to the upgrading by the Health Products Regulatory Authority of antiparasitic veterinary medicines to prescription-only medicines. It has given rise to much debate during our stakeholder engagements, with the Oireachtas committee and in the Dáil. I am fully committed to the stated aims of protecting against both antiparasitic and antimicrobial resistance to protect human health, importantly, while ensuring our farmers have products that work on their animals that in turn lead to healthier animals and long-term benefits for the farmer, for agribusiness in Ireland and indeed for the environment. I am committed to appropriate and proper prescribing of veterinary medicines. I also want to ensure the maximum availability of outlets for farmers to ensure competition through the existing veterinary medicine retail network in the face of the change in route of supply of antiparasitic veterinary medicinal products. I am committed to keeping all the current supply lines open.

I have also included a provision in section 6 to allow me to bring in secondary legislation that will set out the requirements for a proper assessment for the prescribing of certain medicines by a veterinary practitioner as provided for in the EU regulations. I intend to bring in a regulation to set out those requirements necessary to undertake a proper assessment in order to permit a veterinary practitioner to prescribe antiparasitic veterinary medicinal products. I take this opportunity to reiterate a critical point, namely, that veterinary practitioners will have a reserved right to prescribe such veterinary medicines.

This is a complex matter and I must guard against potential unintended consequences. The focus of my officials will now turn to developing these requirements in consultation with relevant stakeholders. I recognise the need to ring-fence the amendment to non-therapeutic treatment of animals as I am cognisant of the duties and professional responsibilities of veterinary practitioners and the value they bring to their clients. I assure them it is not the intention now or in the future to interfere with the need for veterinary intervention in therapeutic matters.

On the introduction of the national veterinary prescription system, it is my belief that in years to come we will look back at this moment as a turning point in Ireland's battle against antimicrobial and antiparasitic resistance. The level of potential insights available to all parties through the collection of veterinary prescription and dispensing data and the use of veterinary medicines will be invaluable for future policy direction.

The system will provide for the digitalisation of an historical set of practices and will provide greater options to the farming community on where and when they obtain their medications for animal welfare.

It is also hugely important to remember the greater regulatory oversight, via the national veterinary prescription system on the use of veterinary medication, has on the capacity to uniquely separate Ireland's agrifood producers to other EU nations when seeking access to international markets, and this will be vitally important in the continued growth of our nationwide sector.

With regard to matters raised during the Second Stage debate in respect of fertilisers, I will comment on a number of significant issues that have been raised in the Seanad and the Dáil. In the Dáil, a particular issue around North-South trade was mentioned by some Deputies. I know that some Senators have taken on board that I reiterated in the Dáil there are no provisions in the Bill that will disrupt cross-Border trade. The trade in fertilisers will continue. Farmers are free to purchase fertiliser from outside the State, as they have been up to now. The only additional requirement will be that such transactions are imports and farmers buying from Northern Ireland, as an example, will have to register as a fertiliser economic operator. The Department will include on-site inspections as part of its compliance verification programme, including risk-based on-farm inspections and inspections at an importer and merchant level, to confirm that accuracy of information being loaded onto the database.

Concerns have also been raised about data protection. I assure the House that my Department has taken the steps necessary to ensure the data collected under this Bill will comply with all aspects of data protection regulations, rules and requirements. The robust data-sharing provisions in the legislation will allow the specific sharing of data with other bodies to achieve environmental and sustainability targets to be fully in line with the general data protection regulation and other data legislation.

I thank the Members of the Seanad for their engagement. I look forward to Committee Stage and the remaining Stages.

Question put and agreed to.

Acting Chairperson (Senator Shane Cassells)

When is it proposed to take Committee Stage?

Senator Paul Daly

Next Tuesday.

Acting Chairperson (Senator Shane Cassells)

Is that agreed? Agreed.

Committee Stage ordered for Tuesday, 27 June 2023.

Cuireadh an Seanad ar fionraí ar 4.12 p.m. agus cuireadh tús leis arís ar 5.02 p.m.

Sitting suspended at 4.12 p.m. and resumed at 5.02 p.m.