Joe O'Reilly (Fine Gael)
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I welcome the Minister for Agriculture, Food and the Marine, Deputy McConalogue, to the House.

Victor Boyhan (Independent)
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I welcome the Minister to the House. I know he is a very busy Minister and there is pressure on his time so I appreciate him coming here to deal with this matter.

The matter relates to EU Regulation 2019/6 in regard to veterinary medical products, which is to come into effect in January 2022. The antiparasitic resistance stakeholder group has sought a regulatory impact assessment in advance of the implementation of EU Regulation 2019/6 on veterinary medical products. There was a very detailed discussion on the matter at the Oireachtas Joint Committee on Agriculture, Food and the Marine, of which I am a member, but a lot more discussion is required. The meeting was lengthy but there were many items we did not manage to complete. This is an ongoing issue, which I am sure has exercised the Minister's officials, who were at that meeting.

This EU regulation will restrict the sale of antiparasitic drugs for livestock to farmers by making it illegal for anyone other than a vet to prescribe to them. These drugs are routine medicines given to animals to kill parasites such as gut worm, liver fluke and many others. Currently, these medicines are available from licensed merchants across this country, pharmacies and vets. As such, there is a wide chain of distribution of these medicines. A restriction has been proposed to deal with what is known as "antiparasitic resistance". I understand and acknowledge the concerns of vets and officials of the Department of Agriculture, Food and the Marine in regard to this matter, which are valid concerns. However, in removing the pharmacies and licensed merchants from the chain, we run the risk of creating a monopoly around these products. Rural pharmacies and licensed merchants will be impacted, farmers will have to pay prescription charges, possibly adding to the cost in regard to these matters, and we run the risk of increased prices and the creation of a monopoly in regard to veterinary and agricultural medicines.

There is much talk of a shared island. I am in favour of a shared island. Northern Ireland has a derogation from this regulation. If we do not do that, we enter into uncertainty with separate jurisdictions and separate approaches to dealing with this, with all of the negative issues arising in that regard. This is a concern. It is important that we have consistency of approach in how we deal with this across the island of Ireland. We cannot, will not and should not compromise on human or animal health and safety and an important knock-on effect on the food chain. I understand the chain of events and I understand the concern of the Minister's officials, but I also understand the concerns in regard to the need for a unified approach across the island of Ireland.

I urge the Minister to seek definitive legal advice from the Attorney General on this matter. It is important that an economic assessment of the impact of this regulation is undertaken. The antiparasitic resistance stakeholder group is seeking an economic assessment of the impacts of the regulation. These are critical issues in regard to agriculture, animal welfare, animal health, the food chain and responsible persons, all of which are within the Minister's brief. We may need to improve issues around responsible persons in terms of the impact of this regulation, ultimately, this regulation will impact on rural communities in terms of cost.Has the Minister received legal advice on this? If not, is it his attention to seek such advice from the Attorney General? Is it his intention to seek a derogation from this regulation?

Joe O'Reilly (Fine Gael)
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The Minister is welcome. I hope the temper and mood of his response will not be coloured by the events of recent days, specifically of Sunday last.

Charlie McConalogue (Donegal, Fianna Fail)
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My congratulations to the Leas-Chathaoirleach's county. Despite the tremendous disappointment we felt in Donegal, there was also great joy to see Cavan progress-----

Joe O'Reilly (Fine Gael)
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I must say that Donegal is my favourite holiday place.

Charlie McConalogue (Donegal, Fianna Fail)
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We can certainly agree on that. I thank the Leas-Chathoirleach and wish Cavan the best of luck in the semi-final.

I thank Senator Boyhan for raising this matter which he has also raised with me privately and at the recent meeting of the Oireachtas Joint Committee on Agriculture and the Marine. EU Regulation 2019/6 on veterinary medicinal products comes into effect in January 2022, and as part of the transposition project, my Department has committed to undertaking a regulatory impact assessment, RIA. This process essentially addresses the same issues that an economic impact assessment would address. The RIA will focus on areas where Ireland has national discretion with regard to transposing the regulation and specifically where intended policy decisions may impact stakeholders.

The antiparasitic resistance stakeholder group was established by my Department primarily to address the concerns stakeholders have with the changing route of sale of antiparasitics and its impacts. At this juncture, the RIA, which evaluates all the impacts, costs and benefits of the proposed policies, cannot be finalised until the relevant policy options have been agreed. These include the length of validity of a prescription for antiparasitics, the definition of a proper assessment and the development of a secure electronic prescribing system. It is my intention that policies will be developed in a pragmatic manner that will deliver a substantive role for all stakeholders who currently operate in the supply chain for veterinary medicines while protecting the efficacy of the products to the ultimate benefit of Irish farmers. Irish farmers would be the big losers if we allow resistance to antiparasitics to deteriorate further.

On the question of seeking a derogation to Regulation 2019/6, when it was signed into law in January 2019, the regulation provided for the exact same regulatory regime as currently exists in Ireland, that is, antiparasitics can be supplied without prescription. The regulation did not change that. However, in line with its statutory remit, the Health Products Regulatory Authority, HPRA, established an expert task force in February 2019 which reported in December 2019. The task force identified risks in terms of the environmental safety of antiparasitics and conclusive evidence of widespread anthelmintic resistance. These findings meant Ireland could no longer avail of Article 34(3) of Regulation 2019/6 which exempts certain products from requiring a prescription. It is this report that has had the effect of requiring Ireland to make antiparasitics subject to a prescription and not the new regulation. Ireland has no national discretion on this issue.

A derogation under Article 105(4) was never a legal avenue open to Ireland as it refers to allowing someone other than a vet to prescribe certain medicines, but only if our national law allowed this prior to January 2019. Ireland clearly does not fall into this category as no one other than a vet has ever been legally allowed to prescribe, and the legal advice received to date by my Department reaffirms this view. As recently as last week, a response to a written EU parliamentary question made it clear that the derogation can only apply if national law allowed someone other than a vet to prescribe. My Department is engaging further on the matter with the Attorney General's Office for a definitive legal view as I am aware that other stakeholders have presented an alternative legal interpretation. While we continue to explore all avenues, at this point, the Department's view remains clear that Article 105(4) is not an option open to Ireland.

My Department remains committed to working with all stakeholders over the coming year in delivering a regulatory framework that provides a role for all actors currently in the supply chain while ensuring farmers have access to important antiparasitics that help them manage their farms and animal health.

Victor Boyhan (Independent)
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I thank the Minister for his response. I share all of his concerns as set out in his response. What gives me hope is the fact that he has not ruled out ongoing engagement with all of the stakeholders, which is critical.As I have said, the Minister will be aware of the issue of responsible persons and of the distribution networks of antiparasitics in rural communities. He will be conscious that any increased costs arising from veterinary prescription charges would be of concern. He will be, and should be, concerned about the potential for a monopoly to develop and about the inconsistency arising from having different regimes North and South. It is one island with regard to agriculture, or at least it should be. That is our objective and aim. I thank the Minister for his response. It is important that we have ongoing discussion in that regard. I will bring his response back to Oireachtas Joint Committee on Agriculture and the Marine. I thank him again for his time.

Charlie McConalogue (Donegal, Fianna Fail)
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I thank Senator Boyhan. I am very much aware of the issues and of the concerns among wholesalers and merchants with regard to the potential impact this regulation may have on their businesses. I am also aware of concerns among the farming community as to whether any change could lead to an increase in costs or additional challenges for farmers. I see the role of the stakeholders' group as important. While we have to comply with our obligations under EU regulations, I want to ensure that we meet those obligations in a practical manner which takes into account the situation facing farmers to ensure that costs do not increase. It is also important to recognise the role played by licensed merchants in this process and the significant business they have in this regard. We are obliged to work to ensure that resistance to antiparasitics does not build up. We must do everything required of us in that regard but I will work with the stakeholders' group over the coming period to develop a way to implement the derogation which takes into account all of those various factors.