Charlie McConalogue (Donegal, Fianna Fail) | Oireachtas source

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.