Mr. Ian Scott:

I was the lead negotiator for the UK when we defended the rights of the specially qualified professional, SQP, during the four years of discussions to get this regulation to the table. I wrote the text of Article 105(4) and, with the full support of the UK Government, succeeded in securing the UK SQP system in the final stages of the regulation discussions.

The regulation entered the Statue Book on 27 January 2019, which is called entry into force, and will become enforceable by the EU on 27 January 2022. We are in the interim period to enable member states to alter national legislation in order to ensure compliance. As such, the derogation is available to be adopted in Ireland.

Turning to the role of Department of Agriculture, Food and the Marine, the Commission's original draft stipulated that member states could preside over their own distribution systems. We were all delighted with that and Irish MEPs in particular were supportive. When the matter moved to the Department's veterinary expert panel, however, the panel supported a change to make all medicines for food-producing animals require a veterinary prescription. The panel never informed any of the stakeholders of this in what appears to have been a unilateral decision. The Department then made it clear to the UK that it wanted to go it alone. The Department assured the Irish Farmers Association and the UK that this ruling would not affect Ireland and that it wanted to keep its system "under the radar". The Department specifically insisted that the UK should not refer to the Irish system in any future discussion.

Article 105(4) sets out that all medicines for food-producing animals need a veterinary prescription. The Independent Licensed Merchants Association, ILMA, accepts that this cannot be changed. Currently, licensed merchant medicines have an optional exemption from a veterinary prescription, for example, porons, flukicides, coccidiostats, fly control, sheep dip and all wormers, including horse wormers. However, Article 105(4) was included to allow professional persons other than vets to issue veterinary prescriptions. We are now at loggerheads with the Department over this derogation. The Department seems intent on dismantling the very system that it formulated, regulates and now approves.

Let us consider Irish law briefly. In 2007, it enabled the responsible person to dispense licensed medicines without a prescription. A licensed merchant may have a retail premises licensed by the Department of Agriculture, Food and the Marine to retail veterinary medicinal products. Those premises are subject to regulation, inspection and control by the Department.

A key point in the Department's contention is that only a vet can write a prescription, but the first few words in the derogation contradict this. They read: "By way of derogation from point (33) of Article 4". Article 4 is what defines a veterinary prescription. This derogation from the definition of a veterinary prescription means that the definition no longer applies, clearing the way for a member state professional to write a prescription. It also means that vets do not have exclusive rights to prescribe.

What we must do is show this committee proof that the responsible person is a professional and qualified to prescribe. If we can achieve that, the derogation can be applied.

The responsible person must have a professional qualification - Mr. Quinn referred to the QQI level 6 retail sale and supply of animal remedies. The qualifications of everyone who has passed this exam are recognised by the Department. Therefore, the responsible person is a professional. We must also prove that the responsible person was able to prescribe animal medicines at the regulation's time of entry into force. If one makes a purchase from a licensed merchant, the merchant will talk about the age, type, breed and weight of the animal, select the suitable product, provide knowledge of local situations, discuss the medicine's administration, dose rate and withdrawal period, interpret laboratory tests where applicable, and discuss labelling and storage. That is the normal procedure followed by anyone who is issuing a prescription. Accordingly, the responsible persons are, in layman's terms, both professional - they have the QQI level 6 - and qualified to prescribe by virtue of their current advisory capacity. We have legal opinion to support these two key points. In every sense of the term "responsible person in veterinary pharmacy", a pharmacist is able to prescribe and dispense under this derogation.

There is one significant difference between vets, vet pharmacists and responsible persons, which is that the responsible person does not have a regulatory body. As a solution for the Department of Agriculture, Food and Marine, we are offering to form a regulatory body for the responsible person with a code of practice that would enshrine their prescribing process to ensure responsible use, address environmental matters and only allow the responsible person to be the prescriber and dispenser and to be present at point of sale. It would also require continuous professional development training and compulsory advice on antiparasitic resistance, and include a disciplinary process. Additionally, we want to work with the Department to form a specific prescription classification just for licensed merchant, LM, medicines that does not clash with a full veterinary prescription.

I will put it in simple terms. Irish national law enabled a responsible person to dispense LM medicines without prescription. The EU regulation now requires these medicines to have a veterinary prescription. Article 105(4) allows Ireland to enable responsible person to issue a prescription.

I ask the committee to consider one more threat before I conclude, which is the view of the competition authority. The Department of Agriculture, Food and Marine argues that there is no change to the current system except that the livestock farmer and horse owner will first need to go to the vet to get the prescription. Then they can go to their favoured merchant to purchase the medicine. This is only partially true. First, by visiting the vet's premises, the vet has an immediate unfair advantage to prescribe and dispense the medicine in a one-stop-shop scenario. This will inevitably result in sales of these products being largely undertaken by vets. Second, there are identical generic LM medicines licensed so that only a vet can dispense, the prescription must specify a branded medicine and it would not be unfair to assume vets would want to prescribe brands only available from themselves.

For example, if a cattle farmer wanted to buy ivermectin such as Ivomec from the vet, he or she would prescribe Enovex, available only from vets. The same applies with eprinomectin, sold as Eprizero and Closamectin generic brands. In this way the LM is bypassed and prevented from dispensing product because the prescription can be restricted to a vet-only generic product.

In a letter to the EU, Mr. Martin Blake, the chief veterinary officer of the Department stated that there is a clear recognition that competition issues arise, and that the current competitive environment would be significantly weakened.

The committee is now aware that the Department acted against the wishes of the Irish MEPs, the European Commission and against the Irish LM distribution system that it manages. It failed to notify stakeholders of its intentions. It failed to put matters right in the year between approving this change and entry into force. It failed to take responsibility for the actions of their predecessors and is failing to avail itself of a feasible solution. The Department is in grave danger of contravening anti-competition law, which could result in costly litigation to resolve matters.