Mr. Daragh Quinn:

A Cathaoirleach, a dhaoine uaisle, the IPU represents more than 2,000 pharmacies in Ireland, 300 of which are committed to the supply of animal medicines. I am a pharmacist from Crossmolina in north Mayo on the Wild Atlantic Way and home to the new movie, "Wild Mountain Thyme". I did a post-graduate diploma in agricultural and veterinary pharmacy and my thesis focused on the implications of EU Directives 81/851 EEC and 81/852 EEC on the supply of veterinary medicinal products, VMPs. That thesis was subsequently published and used as a reference document by the Veterinary Medicines Directorate in the UK in establishing its regulatory system.

Members will all be familiar with pharmacies. In my professional role of pharmacist I dispense medicines and advice. Some of these medicines are prescribed by other healthcare professionals, some are counter prescribed by me in response to the symptoms presented by the patient. I refer patients to other healthcare professionals, and in the case of animals I refer to the vet. At all times, my primary concern is for the welfare of the patient.

The supply of veterinary medicines to animal owners reflects the counter prescribing protocol of medicines to our human patients. There is a sequence of questions pharmacists ask about who is the patient, what are the symptoms, how long have the symptoms been present, what treatment has been given and so on. Prior to counter prescribing any veterinary medicine for animals, additional questions are asked including about the species, the cohort stage, previous treatments, climatic factors and local factors. These medicines are always supplied with appropriate advice for administration to the animal, safety for the user, withdrawal periods, environmental concerns and disposal of surplus product and containers. At all times we provide a written or printed document with each transaction. We maintain computerised records so we can build up a database of the various VMPs obtained by animal owners. This allows us to record the use of anthelmintics, flukicides, coccidiostats, ectoparasiticides, vaccines and so on. Benefits include reduction of inappropriate and unnecessary treatments, improved safety for the user, the animal, the consumer and the environment.

Responsible persons provide a similar service in the stores of more than 900 licensed merchants and co-ops. They are trained to a professional QQI level 6 qualification, which has been approved and accredited by the Department of Agriculture, Food and the Marine as being suitable for the supply of VMPs and associated advice to the purchaser. The 2019 cohort of graduates were presented with their QQI level 6 awards in September 2019 by none other than the current Minister, Deputy McConalogue. The awards and graduation ceremonies over recent years have included contributions from Department officials, some current and some retired, which is a glowing list including Pat Brangan, Caroline Garvan, Breda Meehan, Denis Healy and Hazel Sheridan and others who emphasised the critical role of the responsible person in the supply chain of veterinary medicines. There is a significant undertaking for the student to do this course.

The chief veterinary officer of Ireland, Dr. Martin Blake, in his letter to the European Commission, which I have attached to my submission, confirms that "there was no suggestion in the HPRA Report that the channel of sale and avenues of supply of antiparasitics were a causation factor in these exempting criteria not being met." The exemption referred to under Directive 2006/130/EC allowed for the continued availability without prescription of antiparasitic veterinary medicines. So, no professional involved in the supply of antiparasitic veterinary medicines was required up to now to issue a written prescription in this regard. Why is this? This was because we had obtained an exemption from the EU. Counter prescribing of these veterinary medicines, with corresponding documentation, has been undertaken by multiple stakeholders, vets, pharmacists and qualified responsible persons.

Antiparasitic pharmaceuticals are precious commodities and many are unique molecules that are a rare commodity. We have a responsibility to safeguard their use and sustain them for the future. Antiparasitic resistance differs from antimicrobial resistance. Antiparasitic resistance is an aspect of evolution and not a new phenomenon. Fasinex, for example, was launched in the mid-1980s. Reports pertaining to resistance of that molecule in sheep in Glencar, County Sligo, were documented in ten years later. Resistance is not a simple problem. It is multifactorial and environmental, geographical and genetic aspects all have a part to play.

The HPRA report of December 2019 recommended the upregulation of antiparasitic veterinary medicines to prescription only medicine status, correct. We can no longer avail of the exemption from the prescription only medicine status of the these medicines under the directive we had availed of. The HPRA task force recommended a multi-actor stakeholder approach to future regulation. I recommend that members would repeat this in their own minds: a multi-actor stakeholder approach to future regulation. The proposal by the Department to exclude professionals other than veterinarians from issuing prescriptions is controversial. Many animal owners are reluctant to pursue their present entitlement to obtain a prescription from their veterinary practitioners to source the relevant products elsewhere as they are afraid of jeopardising their relationship with their vets. The relationship with the vet is critical at birthing, calving, lambing and testing. These are all critical times and animal owners do not want to jeopardise that relationship.

Many vets ignore their statutory obligation under regulation 43.3 of the current European Communities (Animal Remedies) (No. 2) Regulations 2007 where the prescriber of an animal remedy shall at that time, issue a veterinary prescription to the owner or person in charge of the animal. This regulation is intended to encourage competition and prevent a monopoly. The Irish experience shows that the prescription only medicine regulations have virtually excluded veterinary pharmacists from their dispensing function of veterinary medicines. The absence of competition for the supply of antiparasitic veterinary medicines, which may evolve from the implementation of this regulation, will result in price inflation to the farmer if a monopoly is permitted to develop. This will add further cost burden to Irish farmers reducing the viability of industry and making Irish food products less competitive on the world market. If EU Regulation 2019/6 is applied as proposed, then this will have an impact on merchants, co-ops and rural pharmacies. Job losses in the thousands will ensue. Jobs are a scarce commodity in north Mayo.

This will impact on many of the committee members' constituents, merchants, pharmacies, co-ops and their staff, but more importantly on farming communities. It is yet another hammer blow to rural Ireland, to those who live outside the M50.

A request made of the Department of Agriculture, Food and the Marine through the forum of the antiparasitic resistance stakeholder group to conduct an economic impact assessment in advance of implementation of this regulation was refused. However, it was confirmed that the Department had established that a proposal to separate the prescribing and dispensing of veterinary medicines in Ireland, as occurs in many Scandinavian countries with a great degree of success, would threaten the viability of rural veterinary practices. No consideration has been given to the impact of this regulation on the viability of farming, rural co-ops, rural pharmacies or rural merchants. It will just add further cost to rural living.

Last Friday, a hill farmer visited our pharmacy in Crossmolina seeking advice on treating a sick lamb. My response to the symptoms described was to refer the farmer to his vet for treatment. The farmer’s response was that a vet consultation fee of €60, combined with the cost of treatment, would exceed the value of the lamb. His decision was to allow nature to take its course. This situation will become widespread. Many hill sheep farmers, smallholders and horse owners do not routinely engage a vet. These animals are liable to be neglected and animal welfare will suffer. Farmers and animal owners care for their animals. Refusing to avail of the derogation available to us under Article 105(4), will have a detrimental effect on farm life.

There is an irony in this. As a pharmacist, I am deemed competent to supply and advise on the use of anthelmintics and ectoparasiticides for human use without the requirement of prescription. From 2022 on, however, a veterinary prescription will be required to supply and advise on the veterinary equivalent. Veterinary nurse prescribers, pharmacist prescribers and "suitably qualified persons" have all been legislated for in the UK, which availed of the derogation in the regulation.

The all-island animal health and welfare strategy was launched in 2018. It should include animal health products. However, we are one island with two different supply systems and no border. This will inevitably result in the importation of such products, reducing accountability and transparency. Currently, certain products are obtained by farmers across the Border, for reasons of cost and availability, without a prescription. Many of these are unlicensed, unregulated and undocumented in this State. According to a recent court case, an alleged importation of a veterinary product from Northern Ireland was intercepted by a departmental inspector, who stated that preventing illegal cross-border transactions was becoming more difficult to detect due to "an absence of political will". The cross-border trade, which is currently a trickle, will develop into a torrent post January 2022, with no accountability and no transparency and thereby undermining the quality assurance associated with Irish food products.

We have a limited veterinary service in parts of western regions of Donegal, Mayo, Galway, Clare, Kerry and Cork. This is widely acknowledged. The Erris region of Mayo, which is adjacent to where I live and is the size of County Louth, has one vet based in it. Many island communities have no vets. In those areas, the merchant, co-op and pharmacist provide veterinary medicines and appropriate advice. This regulation will further challenge life on the west coast.

A solution is available to the Minister, one that would maintain competition in the supply of veterinary medicines and prevent the development of antiparasitic resistance. He should authorise pharmacists and suitably qualified responsible persons to issue prescriptions for antiparasitic veterinary medicines. They have been de facto prescribing these medicines at the regulation's time of entry into force. Precedents exist in this regard under the same Department's implementation of an EU directive on the sustainable use of pesticides. The response from the European Commission in the letter I have supplied confirms the availability of the derogation to the Minister. The Department has agreed to seek the advice of the Attorney General. Let us hope he views the matter wisely.