Matt Carthy (Cavan-Monaghan, Sinn Fein) | Oireachtas source

EU Regulation No. 2019/6 on veterinary medicinal products had been due to come into effect in January 2022. I first raised concerns about the transposition of that regulation with a predecessor of the Minister in July 2020 after some concerns had been raised with me and other Deputies by stakeholders.

At that time, a response to a parliamentary question from the then Minister stated that:

The specific rules will be determined by National law and it is the intention of my Department to provide for Responsible Persons who operate within the Licensed Merchant sector to continue to have a role in the dispensing of veterinary medicinal products as provided for in the current legislation.

Of course, as time passed, the responses of successive Ministers changed and became less committal, which raised fears in those in the co-operative and licensed merchant sector, in particular, as well as those pharmacists who provide valuable and necessary access to veterinary medicinal products in many rural communities.

The purpose of this regulation is largely to combat antimicrobial resistance and ensure the correct and proper controls and dispensing of veterinary medicinal products more generally. I want to put on the record that we absolutely support the intention of limiting antimicrobial resistance, which is one of the greatest threats to human health internationally. Ireland, of course, must play its part in addressing it.

The fact is, though, that the European Union recognised that the existing prescribing and dispensing regime on this island was already sufficiently robust in that a derogation was placed into the regulation specifically to allow for the continuation of those existing prescribing regimes in Ireland, both North and South, and Britain.

Prior to the withdrawal agreement, Britain availed of that derogation. I am told that the British Government reached out to its Irish counterparts to facilitate a joint approach towards the derogation and was told that Ireland was not interested in its approach.

I later learned from officials within the European Commission that they were confused as to why Ireland had not availed of the derogation. This was effectively indicated by responses my colleague, Sinn Féin MEP Chris MacManus, received when he put questions to the Commission.

It has seemed for quite some time that the Department has stood against the recommendations of the Joint Committee on Agriculture, Food and the Marine with regard to this Bill, as well as various approaches and legal opinions that have been suggested and brought forward by stakeholders.

Now, it seems on the face of it that the Minister and Department have accepted to some degree that the role of responsible persons does need to be protected. This is clearly in line with the recommendations of the Oireachtas committee because responsible persons are well-educated and well-qualified in the field in which they ply their trade. They have obtained level 6 qualifications, which will essentially be deemed worthless if we proceed as was initially intended.

We have seen this in the absolute collapse in sales of anti-inflammatory products at some co-operatives after similar regulations impacted those products, with sales dropping by over 80% in some cases. As I understand it, it appears there is an acceptance now of what would be described as common sense and that there has been a conversion, but it is not reflected in this legislation.

We are close to resolving this issue in a way everyone can get on board with. Nobody is talking about liberalising the prescription or dispensation of antibiotics. In terms of antiparasitics and vaccines, a mechanism is required whereby the client patient practice relationship can be amended regarding farmed ruminants and equine in cases only where those animals are covered by herd health plans operated by licensed merchants, co-operatives or pharmacies.

I have been advised that the preferred route is to achieve this through a change to the Veterinary Council of Ireland’s code of ethical prescribing and if that can be achieved, then job done. If it does not appear to be feasible, however, then it is still my view that it is up to us collectively as legislators to resolve this situation in primary law.

Given that there has been a weak approach to this regulation to date, I do not believe it is either fair or practical for us to leave this solely in the hands of the Minister and his officials simply to pass this legislation with a promise or a hint that responsible persons will be taken care of down the line. We have seen where that has gotten us in the past.

My request and appeal to the Minister is that he clearly engages with the Veterinary Council of Ireland to secure the necessary amendments at that level in advance of Committee Stage. Otherwise, I believe we will need to bring forward amendments to the legislation at Committee Stage so that nobody is left beyond any doubt that the matter has been resolved.

I have a continued concern with regard to pharmacists, whose code of conduct prohibits them from having a beneficial relationship with what is prescribed. It would be appreciated if the Minister could speak to this and inform us of how he plans to approach that matter ahead of Committee Stage.

With regard to this aspect of the Bill, there have been concerns among the farming community, in particular, that this legislation could damage competition, reduce farmers' ability to shop around for veterinary medicinal products and drive up costs. We now have this national veterinary prescription system, NVPS, proposal. It does appear, however, that the system itself appears to have been beset with delays. Internal Department communications I received under a freedom of information request saw officials express concern as to whether the NVPS will actually deliver significant access to generic products.

With this in mind, it would be useful ahead of Committee Stage if the Department could provide the Joint Committee on Agriculture, Food and the Marine with a briefing paper as to how the engagements with the Health Products Regulatory Authority on this matter are being dealt with, as well as the scope of the generics list that will be available.

In terms of the national fertiliser database, of course, this can play an important role in monitoring fertiliser use across the State and assist to deliver improved water quality and reduce greenhouse gases and ammonia emissions, which is something on which we collectively agree and which are aspirations we share.

There is one obvious problem with the so-called national fertiliser database in that it is not actually national. In the absence of an all-Ireland approach, there are clear concerns as to how measures will be effective, particularly in Border communities, with which the Minister will be well aware in his own constituency, where it is very possible that a farmer's nearest merchant is actually just across the road but happens to be in a different county and different jurisdiction.

Sinn Féin wants to work with the Minister on Committee Stage to ensure that stakeholder concerns regarding the level of data gathered and that the overhead this might place on farmers has been fully addressed, alongside the concerns raised with regard to that limitation in terms of the scope of cross-Border trade. It is not true to say that the situation will be the same for farmers operating on a cross-Border basis who are purchasing fertiliser in County Tyrone if they live in County Monaghan or even vice versa. The fact is that they will have to register as both fertiliser end users and fertiliser economic operators simply for doing the same thing as somebody in a different part of the country, namely, going to the local merchant to purchase fertiliser. That creates concerns.

With regard to the NVPS and the national fertiliser database, concerns have been expressed by farmers as to how their data may be used for purposes outside of what we understand the primary purposes of the legislation to be. I am sure the Minister will welcome farmers being security conscious in the context of their data. With a view to addressing these concerns, has a data protection impact assessment has been carried out? If not, will the Minister ensure that it is carried out for the NVPS and the national fertiliser database? I hope he is sincere in saying that he is willing to engage with stakeholders and the Oireachtas Joint Committee on Agriculture, Food and the Marine as we move to Committee Stage. The stated intentions of the Bill are laudable but we cannot allow a situation where it puts additional financial pressures on farmers or puts local key business in rural communities out of existence.

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