Charlie McConalogue (Donegal, Fianna Fail) | Oireachtas source

I thank Deputies Michael McNamara and Carol Nolan for tabling the Topical Issue. Certainly, this has exercised minds in the farming community across the country over the last number of months. I have been looking at it and trying to address it. It is good to have the opportunity today to update the House on the current position. I acknowledge and thank the Joint Committee on Agriculture, Food, and the Marine for its recommendations and observations on the EU Regulation 2019/6 on veterinary medicines which has, undoubtedly, a direct effect on all EU member states. The Deputy pointed out the responsible persons approach in the UK and the derogation it received. This is not available to us now. The UK, of course, is leaving. Obviously, Northern Ireland is in a different position, in terms of the cross-Border and one-island approach to animal health. All other EU member states issue medicines on prescription basis at the moment. The UK would have been the only one, as well as Ireland, that would have had the responsible persons. The difference was that our responsible persons were not issuing prescriptions but in the UK, they were. Indeed, they play and will continue to play an important role in our national set-up.

The EU Regulation 2019/6 legislates for the authorisation, use, and monitoring of veterinary medicine products in the EU. The legislation came into effect on 28 January 2019. It will apply to all EU member states from 28 January of this coming year. The regulation followed the adoption of a proposal in 2014 to develop fit-for-purpose veterinary legislation, which would no longer be based on the equivalent human medicines authorisation system. I confirm that all existing retailers of veterinary medicine, including licensed merchants and veterinary pharmacists, will continue to be legally permitted to sell antiparasitic medicines. I fully support the report by the Joint Committee on Agriculture, Food, and the Marine and the observation it made that licensed merchants and veterinary pharmacists provide an excellent service to farmers in rural Ireland. I fully concur with that. However, from 28 January 2022, antiparasitic medicines will become prescription-only medicines, in line with EU law. From then, antiparasitic medicines can only be supplied on foot of a veterinary prescription, issued by a registered professional practitioner.

My Department received comprehensive advice from the Office of the Attorney General on 12 April 2021. It confirmed that the derogation provided for in article 1054 of EU Regulation 2019/6 is not available in Ireland. The conclusion of the advices was shared with the stakeholders to provide final clarity in advance of the antiparasitic resistance stakeholder group meeting on 15 April 2021. In line with standard Government policy, it is not possible to share the detail of the Attorney General's advices. Legal advices confirm that regulation 2019/6 solely permits the prescribing of veterinary medicines to be a function undertaken by registered veterinary practitioners. Licensed merchants and veterinary farmers will continue to play a valuable role in dispensing veterinary medicines.

Separately, my Department has also availed as legal advices to assess Ireland's options for separating the prescribing and dispensing of veterinary medicines, known as decoupling. 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-----

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