Dáil debates
Thursday, 15 July 2021
Saincheisteanna Tráthúla - Topical Issue Debate
Veterinary Medicines
2:45 pm
Michael McNamara (Clare, Independent)
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This Topical Issue was originally put down by Deputy Nolan. I thank the Ceann Comhairle for allowing me to pursue this in her stead given she could not be here due to unforeseen circumstances. I thank the Minister for coming here in person. None of us are too reluctant to criticise the fact that a senior Minister does not come in to answer Topical Issues so when the Minister is here, I would like to thank him for the fact he is here.
Over a year ago, the Oireachtas Joint Committee on Agriculture, Food and the Marine looked at this issue and the changes that may or may not be required by EU law with regard to the prescription of veterinary medicines, in particular antiparasitics. Up to now, Ireland has enjoyed a derogation, as did the UK, with regard to the prescription or sale of antiparasitics as opposed to antimicrobial medicines through merchants. A number of them are in operation across the country, including Clare, and play a vital role in the supply of animal medicines. There has been a particular need for antimicrobial medicines this year. I am not a veterinarian but I say as a farmer that there has been a problem with fluke and worms this year and this is something many farmers would acknowledge.
The majority of farmers will have gotten medicines from a merchant until now. That avenue has been closed off, perhaps because of the European Union law. My understanding, based on the evidence given before the Joint Committee on Agriculture, Food, and the Marine, was that the European Union introduced a regulation on that matter, whereas the United Kingdom entered a derogation to that in 2014. For whatever reason, we did not enter a derogation. There are some who would suggest that was because veterinarians had a greater sway in the Department of Agriculture, Food and the Marine than, perhaps, merchants did. For whatever reason, we did not enter a derogation at that time. We could have done. It was the practice. A member state was allowed to enter a derogation, but we did not. Of course, it does not matter anymore in the United Kingdom, and I will come back to that in a minute. Up to 2018, we could have entered a derogation, but we did not. Now it seems that at the time the matter was before the Joint Committee on Agriculture, Food, and the Marine, the advice from the Attorney General was awaited. However, it seems that some clarification has been obtained that it is no longer possible to enter a derogation nor is it possible to retrospectively regularise the situation in Ireland for the purposes of entering that derogation. If possible, the Minister might provide some clarity on that. The fear is that we will see a potential monopoly of supply in veterinarians, in circumstances where there is an increasing number of veterinary practices being bought up by commercial entities, rather than operating separately. Two or three weeks ago, Deputy Jackie Cahill introduced a Private Members' Bill in the House on that matter.
This is a very real fear. The purpose of this is to ensure the separation of prescription and dispensing. By seeking to pursue that, we might achieve the exact opposite: a monopoly, where large conglomerates that own veterinary practices have a monopoly on both dispensing and prescription of animal medicines.
2:55 pm
Charlie McConalogue (Donegal, Fianna Fail)
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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-----
Seán Ó Fearghaíl (Kildare South, Ceann Comhairle)
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Thank you, Minister.
Charlie McConalogue (Donegal, Fianna Fail)
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Such decoupling is not solely for the purposes of economically assisting one sector of an industry over another.
Seán Ó Fearghaíl (Kildare South, Ceann Comhairle)
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I thank the Minister.
Michael McNamara (Clare, Independent)
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If we could take a step back, the purpose of all of this is to reduce the overuse of antibiotics, antimicrobials and antiparasitics so that we do not have a build-up of resistance and that we do not have antibiotic resistance or antiparasitic resistance. As a farmer and, maybe more importantly, as a consumer, I greatly welcome that. However, how do we achieve that end? The Minister's second point about the decoupling of prescriptions and dispensing was that it cannot be for the economic benefit of one group over another. I agree with that, but the purpose of all of this is not economics. It is about animal health and, by extension, human health, and making sure that we do not have antibiotic resistance either in animals or in humans as both would be equally worrying.
Rather than looking at the economics of the situation, we need to look at - I do not have this information but I am sure that the Department of Agriculture, Food and the Marine does - the extent of the use of antibiotics and antiparasitics in Ireland, as well as how that fits in with international, particularly European, trends. The use of medicines is far more prescribed in Europe and there is a greater consciousness of not overusing animal medicines than there might be, perhaps, in other parts of the world, such as South America or Australia. Hence, we hope to continue to be able to provide a higher-quality product.
On that basis, I ask that the Minister's Department continues to look at this decoupling of prescriptions from dispensing so that we do not have these large conglomerates that employ veterinarians, rather than the old way, where every village and large town had a family-run veterinary practice. This is also so that we do not end up with a corporate model that controls the prescription and the dispensing of medicines, which would be very negative for health, as opposed to the economy of our country.
Seán Ó Fearghaíl (Kildare South, Ceann Comhairle)
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I thank the Deputy and ask the Minister to conclude.
Charlie McConalogue (Donegal, Fianna Fail)
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I thank Deputy McNamara. I will complete the points I was making. The Department's view was that there was an absence of a sound veterinary medicine evidential basis for a partial or full decoupling. As a result, decoupling does not currently appear to be a viable option. The Department shared the outcome of these advices with the members of the antiparasitic resistance stakeholders group. In response to concerns raised about prescribing particular branded veterinary medicines, I intend to permit substitute medicines to be dispensed, that contain the same active substances as the main prescribed medicine. This will sustain competition for all suppliers of veterinary medicines, to the benefit of Irish farmers and their livestock. Antimicrobial resistance and antiparasitic resistance both pose significant challenges to Irish farmers and, indeed, to human health, as a follow-on. It is an important issue and it is crucial that we addresses it in a serious manner that is required. Obviously, there is an EU regulation with which we have to be legally compliant.
Our legal advice is clear that it requires prescription-based issuing. The key thing that I am trying to achieve is that it does not impact on the capacity for competition in the market and that we find a mechanism where we can have it on a prescription basis but that competition remains, with continuing availability of sources of the prescription for farmers. It is a significant issue for licensed merchants, for whom it is a key part of their business. We are cognisant of that concern. I am continuing to work through this and looking at the situation to try to find a way that ensures that we are compliant, that we address the issues of antimicrobial and antiparasitic resistance, that we ensure that there is competition in the market and that we do not add costs to farmers. I thank Deputy McNamara for raising it.